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Full text of "Report of program activities : National Institutes of Health. Clinical Center"

NIH Clinical Center 

SUMMARY ANNUAL REPORT OF PROGRAM 
ACTIVITIES 

July 1, 1976 through September 30, 1977 



/ 




July 1, 1976 through September 30, 1977 



PUBLIC HEALTH SERVICE, NATIONAL INSTITUTES OF HEALTH 

SUMMARY ANNUAL REPORT OF PROGRAM ACTIVITIES 
CLINICAL CENTER 

OFFICE OF THE DIRECTOR 



CONTENTS 

General OD-1 

Mission of the Clinical Center OD-1 

Leadership Changes OD-1 

ACRF ....'.'.'.'.'.'.'. OD-1 

New Services OD-2 

Medical Board 0D-3 

Safety 0D _ 3 

Training 0D _4 

Associate Program OD-5 

Medical Information System OD-5 

Research Accomplishments OD-6 

EE0 OD-7 

Office of Clinical and Management Systems OD-8 

Office of Planning and Policy Development OD-10 

Office of Clinical Reports and Inquiries OD-11 

Honors and Awards OD-21 

Professional Activities OD-21 

Bibliography OD-22 



OD-i 



tic 

3/ 
'977 



July 1, 1976 through September 30, 1977 

PUBLIC HEALTH SERVICE, NATIONAL INSTITUTES OF HEALTH 

SUMMARY ANNUAL REPORT OF PROGRAM ACTIVITIES 
CLINICAL CENTER 

OFFICE OF THE DIRECTOR 

General 

The Clinical Center provided facilities, patient care, and support services 
for NIH physicians who conducted clinical research for 8 of the 11 Insti- 
tutes and the National Institute of Mental Health during FY 1976. With the 
exception of direct physician care, hospital services were provided by 
Clinical Center staff. Department members conducted research in their own 
specialties to develop and improve current technology to meet the needs of 
the clinical programs. Opportunities for advanced training were provided to 
young physicians, medical students, nursing students, and members of the para- 
medical professions. Exchanges of information between investigators at NIH 
and biomedical personnel elsewhere were encouraged. 

Mission of the Clinical Center 

(1) To ensure the highest possible level of medical care to each patient; 

(2) To provide optimal resources and facilities for clinical research; (3) 

To perform research on methods and systems involved in patient care and study; 
(4) To disseminate information to professionals and to the public relevant to 
clinical investigation; (5) To develop and maintain training programs in the 
techniques and ethics of biomedical research and clinical research; (6) To 
interact with scientists and physicians, nationally and internationally, on 
mutual problems of clinical research, such as policy, education, ethics, and 
priorities. 

Leadership Changes 

The leadership of the Clinical Center changed in July 1977. Dr. Mortimer B. 
Lipsett, returned to the NIH as Director of the Clinical Center and Dr. Griff 
T. Ross became Deputy Director. Mr. Howard E. Kettl, formerly Deputy Asso- 
ciate Director on Operations of the NIH, assumed the position of Chief Exec- 
utive Officer. 

ACRF 

Excavation for the Ambulatory Care Research Facility (ACRF) commenced in May 
1977. Preparatory to construction, entrances were relocated, parking areas 
were changed, and pedestrian and vehicular traffic patterns were altered. 
Stage I of the construction, involving all substructures, is on schedule and 
should be completed during the middle of the next fiscal year. 

In conjuction with ACRF construction, a planning effort was begun to assure 
the programmatic and spatial integration of the old and new facilities. Under 

0D-1 



the direction of the Clinical Center Director, a committee representing the 
NIH community, is addressing a number of important issues, including the \ 
disruptions and inconveniences caused by ACRF/CC construction, post ACRF/CC 
space assignments and associated logistics, and Clinical Center modernization. 

During the fiscal year the planning of a number of Clinical Center projects 
was completed. Construction of a nine-bed medical intensive care unit will 
be completed by May of 1978. Dr. Byron McLees , formerly of the Pulmonary 
Branch, NHLBI, has been appointed Head of the Department of Critical Care 
Medicine and is recruiting staff for this unit. 4 

In a related decision, design of an expanded hospital-wide pediatric unit was 
completed. The NICHD unit will serve all clinical programs and will open in 
1978 fiscal year. 

New clinic facilities were designed in order to accommodate expanding out- 
patient programs and to offset the loss of space caused by ACRF construction. 
The project includes the remodeling of NIMH facilities, the addition of 
satellite services in x-ray, clinical pathology, and nutrition, and a general 
expansion of examination and treatment rooms. 

Several construction projects began this year. These included the renovation 
of the main kitchen, the construction of a recovery room within the tenth- 
floor operating room, the conversion of the ninth-floor solarium into a 50- 
person conference room, and the activation of a trash chute system. Renova- 
tion of the Clinical Center's fabric care department was completed, making it 
one of the most advanced, environmentally sound facilities of its kind. A 

New Services 

An endoscopy service was established for use by all Institutes. The new unit 

which is m full operation, was created through the combined efforts of the 

NHLBI NIAMDD, and the Clinical Center and is directed by Dr. Ronald Crystal 
(.NHLBI) and Dr. Denis McCarthy (NIAMDD) . 

The Outpatient Department initiated a centralized appointment system to 
increase efficiency. Physician time in the clinics has been reduced while the 
number of clinic visits has increased. 

Dr. John Fletcher has joined the Clinical Center staff on a part-time basis 
as a Special Assistant to the Director for Bioethics. Dr. Fletcher will be 
working with physicians on ethical issues in their research pursuits as well 
as conducting his own research on "natural third parties in the consent 
process." He also will be developing orientation programs for review A 
committee members. ■ 

Dr James Balow has joined the Clinical Center staff as Nephrology Consultant 
and has assumed responsibility of consultation in renal disease and renal 
dialysis. Need for this service has been increasing and Clinical Center 
capabilities for providing comprehensive medical care have been strengthened 
greatly. 6 



4 



OD-2 



Medical Board 

The dramatic changes occuring in the Clinical Center's physical appearance 
this past year were accompanied by equally important changes in hospital 
policy. The bylaws, regulations, and responsibilities of the CC medical 
board, the hospital's policy making body, were revised and updated to make 
daily operations more efficient and bring the Clinical Center into compliance 
with the regulations of the Joint Commission on Accreditation of Hospitals. 
Changes included (1) developing procedures to delineate clinical privileges 
among clinical care physicians. A clinical investigator must now be granted 
permission by the appropriate clinical director to perform specialized pro- 
cedures enumerated on a prepared list. This delineation of privileges is 
intended to strengthen lines of accountability and responsibility (2) estab- 
lishing a Quality Assurance Committee for maintaining quality patient care. 
The Committee has strengthened the internal mechanisms for problem identifica- 
tion and resolution by combining the functions of several earlier committees 
and establishing four new areas of responsibility (clinical associate repre- 
sentative, a medical audit committee, and a therapeutic subcommittee). Sig- 
nificant accomplishments of the Quality Assurance Committee include codifica- 
tion and revision of all medical records, the establishment of a death review 
mechanism; restructuring of the research review process to simplify the review 
and approval of new clinical research protocols (3) developing a protocol 
impact statement that provides early warning to departments affected by pro- 
posed studies. Such an early warning device can help the departments avoid 
shortages and overloads. 

Safety 

The issue of patient and staff safety took on new importance with the initia- 
tion of ACRF construction and CC renovation. The Emergency Evacuation Plan 
was revised to take into account the new exit problems. The Clinical Center 
Multidisciplinary Safety Committee, which develops safety policy for the CC 
and which is responsible for maintaining a safe hospital environment, under- 
took a number of safety projects. 

The Committee developed a patient area environmental safety program involving 
periodic surveys of all patient units to assure compliance with program safety 
requirements. The Environmental Safety Branch of DRS will conduct the surveys. 
It also developed a set of safety procedures for the operation, maintenance, 
and inspection of non-clinical electrical equipment. A list of emergency 
procedures was drawn up for use in times of essential equipment failure or 
power outages. Smoking regulations were put into effect throughout the hospi- 
tal and a manual on smoking regulations has been distributed to nurses. 

The safety commission also sponsored basic electrical safety seminars for 
nurses, strengthened the maintenance and inspection program for patient 
electrical equipment (particularly monitoring equipment) , helped establish a 
cardiopulmonary resuscitation course for CC employees, and developed and 
implemented a CC corridor clean-up program to maintain NIH safety codes. 



OD-3 



Training 

ethLYof bio^H lent i reS ° UrC \ S ^ the CC f ° r teachin § ^medicine and the 
only to the S :: rSSearch : ^ commitment to teaching is, indeed, secol 

c£ Su^a^S "rr^cHo oe t?e r r id d ** ^T ^^ P *^ 
y us ouc research to bet L er understand and treat disease. 

bWd\:fl fe p r rofe a ss y io e n? Cati0nal ^° rt » iti " t0 ""erent segments of the 

SStSe^S^ n f ? r . MediC ^ Students is a collaborative effort by eight ' 

PH« ^ in-d h^urs^ in SSST.^ 6 "? 1 ^ TeChn0l ° 8y Md the " to 
Medicine, EndocrLologyStabolism ll Sub ^ ecia l tles : Computers in Clinical 
Infectious Diseases, Nuclear MedSn Pvfb^ Genet ; CS ' Hematology-Oncology 
Oncology. These coar p ^lf I ' P ^ scho P ha ™acology, and Surgical 
sicianScientists as well T / T^ *" * Cl ° Se relation with phy- 
appropriat! r Search studiL ^f*.^™* ", individual patients in' 1 
workup, discussion and IL' , Patients are assigned to students for 
special rounds clinicfl,, ^^l StUdentS thuS take an ac tive part in 

*- have retu^^f il^lS^ St.^^eSS^ ^ 

the 6 wI^tdiLf LsoISilf of? ti0n ^ the SCienC6S (n ° W a — di -d by 
cians and scientists Se seri« of ° n : CampUS advanced courses to physx- 
3,0 m Associates, senl^ E^SeE^ SS^S^^r^ ^ 

S'J^^^^^^^^"^ - d -cture series have 
to its graduate and undergraduate educ, Jn Publishes as a concomitant 

Staff Conferences. These Conf er^nr P^ams , the Combined Clinical 
research findings of NIH scientists %****' ^J? 1 ™*. interdisciplinary 
are published eight times a year in Vh ! pr ° Ceedln § s of these Conferences 
approximately 12 000 renrintf^ the Annals of Intgrnal^fedicine, and 
throughout the natLn and the ^^^^^^^^^^T^ dentists 

X^^SXf^S^^:^ " el§ht CC NUrS ^ inferences 
copies of these proceeding are dStr?h ^ ^^ Ten to twelve thousand 
hospitals, and other ^^"£^^1^^: ° f "»"**■ ^^ 

K"^ ^ *■ apartment of | 

Blood Bank. Programs in thfse Department attrae ^ 1 - lcal . Pat holo g y , and 
throughout the country and abroad! tS attrac t physicians and nurses 



0D-4 



Associate Program 

The Office of the Associate Program carried out its usual activities as a 
focal point for recruitment of Clinical and Research Associates for the vari- 
ous Institutes and Divisions of the NIH. The basic problem in the past few 
years has been that there are many fewer applicants since the ending of 
obligated military service for young physicians. The decision of the American 
Board of Internal Medicine to phase out the so-called "short tract" option, 
whereby participation in a sub-specialty training program could also be 
credited as a third year of residency in general internal medicine, probably 
also accounts for some of the loss of interest in Associateships. Finally, 
there may currently be less interest among young physicians in careers in 
research or sub-specialization, and more in primary care. How these problems 
can be best be addressed in the long run is still not clear. 

The interview period and matching program were advanced in time from June to 
late April, in order to allow potential Associates to make their commitments 
about 15 months in advance, at a time they are likely to be considering 
other options, rather than two years in advance. The option of commitments 
27 months in advance remains open. Thus, vacancies not filled in a given 
matching year are more likely to be filled in the next one. 

For the second year, the catalog which describes the Associate Program was 
sent by direct mail to 4th year students and to physicians in the first 
two years of post-graduate training throughout the country. Advertisements 
were also placed in major medical journals. 

1180 applications were distributed on request; 242 applications were made; 
162 candidates were interviewed; 90 were selected for appointment. These 
figures are similar to those of the previous year. It appears that the 
information about the Associateships is reaching its target, but that the 
interest it generates is barely sufficient to meet recruitment requirements. 
In the coming year, changing the format of the catalog and the nature of 
the publicity effort will be considered by the NIH Education Committee and 
the Associate Program. 

Medical Information System 

The Technicon Medical Information System (MIS) is a total hospital computer 
system through which all patient care related activities in the Clinical Center 



OD-5 



are 



initiated. The primary functions of the MIS are to accept physicians"' 

» ?n , rT UniCate the C ° ntentS ° f those orders to nursing personnel and al 
ancillary departments, and generate computer printed portions of the medical 

mtltr? *l ^^ rep ° rtS ' ^dications given and nursing notes. Users of 
MIS include physicians, nurses, and ancillary medical personnel. 

Sixteen of twenty-six nursing units, the operating rooms, all ancillary de- 
partments except laboratories, are using MIS for fll patient-care activities 
It is anticipated that the remaining units will be fully operational next 
year and that there will be a direct computer-to-computer link between SlS ar 
the Honeywell system in the laboratory. \ 



Research Accomplishments 



J 



Over the past year Clinical Center investigators produced a number of notabli 

A hitherto unknown form of hepatitis distinct from a type A (infectiousl and 
Ce'nce iZTl h t P T i \ haS bee " ">«™™»- Investigators from he c nice! 

eTat tas ^tS"^ "sponsrhi: for "oTof ^t-transfosi' 
screened for rllZ "\P atlents receiving noncommercial blood from donors 

:r\ r d\ e L e tio f rof h :his eP r:sidu S a? hStiti:?" 8 - *"*«» '«*" "* *° «*4 



SrSns 8 of r Sri^ ^^"^ that * ^ority of black Africans and 
investigators fstablished^n J" reS±Stant to P - viva* , malaria, Blood Bank and 
cells rnnff! c J fc antl § ens Present on the surface of red blood 

an" enTahse TlTUTt Us^t ^TZ.ll ^ T^ >"" 1 "' ^ 

orlhemicai m^ans IflV ? "° ^ "' ^ ^ 'SS^ITr^ 

decreasing maTSa 8 ^ lnVaSl ° n ° f S ° me malarlal P^asitea, thereby 

s:L c L\ c s:rdi:i-;L 8a irLL n p:L 1 i:rr:iSi::- c i- e --f™ ta °f---- 

sectional views of the upper abdomen Th G = scanner for obtaining cross- 

nooroscopic ima g e, is prLLf vaSi^n S^CS^^E^T" 

S,^niran P 8 1o\^dLlraX°ha r rh:e„ 1 "de:e?op P ed C b 1 U cc invest "t^ ^ 

tion with NHLBI and DCRT scientiJ, tk j investigators m coopera- 

visualization of the working hear yiSdsT"?-" ' - Wh±Ch ° fferS ^~^^% 
ventricular Wn n ZT S , rt ' y ields quantitative measures of left * 

ventricular function. This technique appears to be superior m th t ■ 

electrocardiogram for dPt P rt-i no uL /■ superior to the exercise 

disease. detecting heart disease, particularly coronary artery 

ud F xug or tne limb. Implementation of these 



OD-6 



n 



procedures has produced significant reductions in time between surgery and 
fitting of the final prosthesis. 

Studies by Clinical Pathology investigators on the purification and biologic 
characterization of coagulation proteins have revealed marked differences in 
the factor VHI/von Willebrand factor protein in the hemophilia A and von 
Willebrand's disease (two diseases associated with a similar coagulation 
defect and bleeding) . The carbohydrate portion of the protein has been found 
to play a pivotal role in the interaction with platelets during normal blood 
clotting and may play an important role in the development of atherosclerosis. 

Investigators in this department also have established that young platelets 
are heavier than older ones and have developed a method to isolate younger 
platelets from whole blood for the first time. The method of separation 
devised by these scientists can be used to distinguish between diseases 
(thrombocytopenia) resulting from either platelet destruction or failure of 
platelet production. 

The Diagnostic Radiology Department has been intensively evaluating the CAT 
body scanner. They have shown that it is the best tool for diagnosing early 
metastatic cancer of the lung. They are comparing its diagnostic accuracy 
with other techniques in difficult diseases of the liver and pancreas. 

EEO 

The Clinical Center published its first Affirmative Action Plan for Equal 
Opportunity. In observance of National Secretaries Week, a two day seminar 
entitled "Self Assessment and Career Development for Secretaries" was con- 
ducted by an independent consultant, Ms. Barbara Thompson, an expert in the 
area of Career Development and Vocational guidance. 

Clinical Center employees elected the following representatives and alternates 
to the EEO Advisory Committee: Mr. Joseph Hambrick and Ms, Rosalie Smith as 
representatives from Nursing and Ms. Elsilee DesBordes and Ms. Barbara Scott 
as alternates; Ms. Yasmin McMahon and Ms. Ella Thompson, Medical Record Depart- 
ment; Ms. Monica Stankus and Ms. Peggy Spina, Clinical Pathology and Blood 
Bank Departments; Mr. Bernard Scott and Ms. Dorothy Wiggins, Environmental 
Sanitation Control Department; and Ms. Annebelle Vick and Ms. Martha Thomas, 
Nutrition Department. 

Ms. Jean Harris, Nursing and Ms. Peggy Spina, Clinical Pathology, were 
selected as Clinical Center delegates to the NIH Women's Advisory Committee. 

Mr. Harry Hill, Clinical Pathology, was elected chairperson of the Clinical 
Center EEO Advisory Committee and appointed to a 3 year term as an EEO 
Counselor. 

EEO Special Achievement awards were presented to Ms. Betty B. Colbert, Blood 
Bank; Mr. Harry H. Hill, Clinical Pathology; Ms. Mary E. Swader, Environmental 
Sanitation Control; and Chaplain Robert I. White, Spiritual Ministry, 



OD-7 



N- 



Office of Clinical and Management Systems 



The Office of Clinical and Management Systems assists the staff of the 
Clinical Center by providing services of systems analysis, computer systems 
evaluation, and management engineering. It coordinates the planning, develop 
ment, implementation, and operation of all computer and automated systems 
within the Clinical Center; provides a working liaison between the Clinical 
Center, the Division of Computer Research and Technology, and the various 
Institutes to assure optimal and integrated clinical management and informa- 
tion systems; assists Clinical Center management to apply the techniques of n 
operational planning, facility development, resource allocation, and program ) 
evaluation and review; and, initiates and conducts research and education 
programs in clinical and management systems. 

i 
A large portion of the Office's activities during this period involved the 
continuing implementation of the computerized Medical Information System (MIS 
Fifteen more nursing units were added to the system bringing the implementa- 
tion up to the 70% mark of inpatient services. Over 100 protocol and pre- 
structured order sets were gathered, processed, and implemented in the system; 1 
Over 1,000 change requests and problem reports were resolved by this office ir ; 
conjunction with the MIS installation. Physician training in the use of MIS 
included the critical July 1 turnover period. Physicians now directly enter 
70% of the orders processed via MIS. The successful conversion of the DCRT- 
based Admissions/Transfer/Discharge and Biographic File system was accomplish- 
ed. Over 120,000 patient records were transferred successfully from one sys- 
tem to the other so that MIS is now the chief repository of on-line patient 
information. A problem tracking scheme was established to assure Clinical g 
Center department heads that all difficulties encountered in the use of the I 
MIS were identified and that solutions were defined and pursued in a timely 
fashion. 

Clinical Information Utility: The Clinical Information Utility which stores 
medical information at DCRT and retrieves it on request for medical research- 
ers in the various Institutes, was enhanced by MIS-acquired information. A 
medications file was established enabling physicians to request results of 
laboratory tests, biographic data, discharge diagnosis, and medication 
information. 

Laboratory Computer System: The Chief, OCAMS, also serves as the Chief, 
Laboratory Computer Service, Clinical Pathology Department, permitting this 
office to support the Laboratory Computer Service, especially in matters per- 
taining to the Honeywell Laboratory Information System. During this reporting : 
period, the Honeywell System was successfully put through acceptance testing. 
Various enhancements to the system's software and operating modes were 
designed and put into operation by OCAMS staff. The Microbiology portion off 
the system was successfully implemented during this period as well. 

Workload Reporting System for Clinical Center Departments (RMS - Resource 
Monitoring System) was totally implemented throughout the Clinical Center and 
began serving as the Clinical Center's input to the NIH-wide manpower manage- 
ment program. It also serves as a base for the Clinical Center's reporting 
through the zero-based budgeting activities. The RMS represents three, years 

fll 

0D^8 



i 



of development, study, and modification to the system to make it suitable for 
internal Clinical Center use as well as for other organizational demands which 
the Clinical Center must satisfy. 

The office participated in a Medical Records System Working Group, with the 
use of an outside consultant, to define the present and future scope and role 
of the Clinical Center Medical Record System. This office served as a re- 
source and a source of guidance to the Group and the consultant. 

A candidate for the Masters Degree in Health Care Administration from the 
George Washington University completed a paper on staff input in the develop- 
ment of the Medical Information System. The office continued to project com- 
puter needs for the next five years as the Clinical Center's input to the 
NIH-wide Automatic Data Processing (ADP) plan. Through this year's and pre- 
vious years' projections, the Clinical Center has been able to make rational 
decisions for computerization and proceed in an orderly fashion to automate 
various functions. The office served as a resource to the Clinical Center 
Bed Utilization Committee and provided the design of a mechanism to allow 
physicians to maintain current knowledge of the availability of beds for their 
patients throughout the hospital. The office continued to be a focal point 
of data security and Privacy Act implementation with regard to automated sys- 
tems. A group of Privacy Act inspectors were given a tour through the various 
Clinical Center facilities. Their report was reviewed and appropriate secur- 
ity measures are being implemented through this office. The office continued 
to be the focal point for patient care statistics based on patient admissions 
and discharges. Statistical reports on a routine basis and on demand were 
produced. The office supervised the orderly conversion of source data prep- 
aration from the DCRT-based admission system to the MIS. 

Outside Activities: The office continues to be a resource for the hospital 
community in fields of medical information systems, laboratory computer sys- 
tems, and management information systems. Papers were presented to the 
American Institute of Industrial Engineers Health Services Division Conference, 
the 7th International Technicon Congress, the HEW Senior Staff Development 
Seminar on the use of management information systems, a Laboratory Systems 
Seminar at the National Naval Medical Center, and at a Computers and Patient 
Care Seminar for the Maryland Hospital Education Institute. The office is 
also represented on the Medical Information Systems Users Group, representing 
Technicon clients around the country, directed toward improvements in the 
performance of the Technicon MIS. 

Staffing: The office added a Systems Analyst to the staff, thus providing 
needed depth in the day-to-day management of the MIS and a vitally needed 
source of ideas for additional functions for the system. 

During the next year the Office expects to complete the inpatient aspects of 
the Medical Information System and the Outpatient Clinics as well. A major 
goal is the complete interface of the Honeywell System with MIS so that orders 
can be automatically exchanged between the two systems. This involves an 
extensive programming effort and coordination by the vendors and will be a 
pronounced improvement in the MIS service. 



OD-9 



In addition to the Lab-to-MIS interface, the major objective for the labora- 
tory system will be the successful completion of interface of the SMAC 20- i 
channel analyzer so that automation of these results will be total. 

The addition of Radiology, Nuclear Medicine, and data from other Departments 
to the Clinical Information Utility service will be a major objective in the 
next year. Such information will enable us to approach the notion of a full 
service utility for medical information retrieval. 

As a result of changes in several departments, the RMS has restudied these 
Departments and re-established workload reporting standards. The objectives 
for the coming year will include re-evaluations in Clinical Pathology, Diag- 
nostic Radiology, Pharmacy, and Nuclear Medicine. 

The Office will establish centralized MIS training for members of all hospital 
departments as well as physicians. Centralized training will assure coordina- 
tion and continuity of current information transmission for all users. The 
Office expects to extend its management engineering techniques to Clinical 
Center Departments through enhancement of the MIS capability and improvement 
in non-computer related functions. A position for Management Analyst, GS-12 
was created, and after filling this position the Office expects to play a 
greater role in productivity studies and further applications of the Resource 
Monitoring System. 

The Office recognizes that with the installation of the MIS, its staff is in 
a unique position to provide information to other government and community 
agencies which deal with such matters. Such an obligation is discharged by j 
speaking to various groups, bringing representatives to the Clinical Center f 
for on-site observations of the systems, and publication. With implementation' 
of peak workload to be completed during this year, time availability for such 
support activities for others will be increased. 

Office of Planning and Policy Development 

Research review has continued to be the major emphasis of the office. During 
Fiscal Year 1977 the review process was restructured in response to a mandate 
from the Medical Board. The resulting mechanism provides a single uniform 
review of both patient and normal volunteer research protocols. Pursuant to 
this action the Clinical Research Committee and the Volunteer Research Review 
Panel were abolished and replaced by clinical research subpanels within each 
Institute. Memberships for each subpanel were developed in accordance with 
HEW guidelines as prescribed in 45 CFR 46. 






The Medical Board Services Section provides staff assistance to the subpanels^. 
upon request and continues to serve as the central clearinghouse for intra- %) 
mural clinical research protocols. The Section's computer file has been 
brought up-to-date with revisions made daily in order to maximize it as an 
investigator resource. In addition to serving as the tool for identifying 
projects due -for the required periodic review, the computer file is being used 
to prevent hospital admission abuse. On a quarterly basis each clinical 
branch, clinical director, nursing unit and the Admissions Office receive a 
listing of the clinical research protocols that are in an active status This 

f 

OD-10 



list is supplemented each month with pen and ink changes for each clinical 
area. 

As the issue of credentials has come to the medical/legal forefront the 
Office has been instrumental in coordinating the delineation of privileges 
for physicians and dentists and for establishing a category of staff affili- 
ates. Plans have been made for performing a complete audit of the credentials 
to insure that JCAH requirements have been met and to assist the Office of 
the Director in obtaining accreditation renewal for the hospital. 

The Medical Administrative Series of the Clinical Center's Policy and Commun- 
ication Bulletin has continued to expand and be recognized as the sole auth- 
oratative source of policy decisions regarding clinical care. Issuances this 
fiscal year have ranged from a revision in the informed consent policy to meal 
tickets for patients' relatives boarding on nursing units. 

To assist physicians and their secretaries, the MBSS published several sup- 
plementary aides. Revised staff directories were printed listing in-house 
staff and consultants. In addition, procedures were described for obtaining 
consultative services. A guide to the MBSS was issued for the first time and 
has proved to be an invaluable aid to secretaries of physicians participating 
in patient care. The guide covers nearly all the MBSS functions and instructs 
secretaries on procedures needed for their interactions with that office. 

Two new functions were being assumed at the end of Fiscal Year 1977. With the 
change in review process and centralization of the approving authority for 
protocols with the Director, CC, the contact point for filing "Notices of 
Claimed Investigational Exemption for a New Drug" (INDs) was relocated to the 
MBSS from the Office of the Deputy Director, CC. This move was intended to 
streamline the protocol approval process and eliminate a duplication of 
protocol files. 

A formal committee management function was established in the Clinical Center 
with the maintenance of files and processing of reports to emanate from the 
Office of Planning and Policy Development. 

Participation in the planning function occurred on two levels. First, there 
was development of Institute program assumptions to aid Clinical Center de- 
partments in preparing their budgets. On the broader scene the Office col- 
laborated with the Office of the Director in preparing the Clinical Center's 
first submission to the NIH Forward Plan. 

Office of Clinical Reports and Inquiries 

Clinical Center information, publications, press, and public affairs activi- 
ties are centered in the Office of Clinical Reports and Inquiries. The office 
is responsible for advising the Director and Executive Staff on ways to en- 
hance the Clinical Center's public and professional image as a preeminant 
clinical research facility, and on the effective interpretation and reporting 
of research findings produced within the Center. These findings are of inter- 
est and concern to many audiences, including Congress, the Department, and 
other Government agencies, scientists, physicians, voluntary health agencies, 
and the general public. 

0D- 11 



ti 



The Office initiates many programs and responds to Congressional and Depart-; 
mental, NIH, and internal and public requests. It keeps all Clinical Center i 
personnel informed of hospital activities, provides all hospital departments 
with communications assistance, and supports the functions of the CC's hosp- 
ital service departments to ensure the delivery of the highest quality of 
patient care. 

Mrs. Shelbia Lengel was appointed chief of the OCRI in August and served until 
May 1977, when she became Information Officer for the NIDR. CC Administrative 
Officer Steve Galen took over as Acting Chief until July when Lanny Newman w 
selected to head the Office. 

Press Activities 



i 



International, national and local news media showed an increased interest in 
Clinical Center programs. There were a number of magazine and newspaper 
articles on the D'Alessio twins who underwent open-heart surgery in the NHLBI, 
Press interest in the Sutherland family, being followed by NIH physicians for 
unusual familial incidence of cancer, remained high. Communications support 
was provided to crews broadcasting a segment of the NBC's Today Show from the 
Clinical Center. The OCRI also provided support for the development of two 
upcoming network television programs: The NBC program, Weekend, is preparing 
a 20-minute segment on the Clinical Center Normal Volunteer program; NBC also 
is planning a 3 1/2 hour prime time program on health care in America. 

Communications support was provided for visits to the Clinical Center by First 
Lady Rosalynn Carter and HEW Secretary Calif ano. . 

Medical and Paramedical Communications 

The proceedings of ten NIH Combined Clinical Staff conferences were edited by 
this Office and prepared for publication in the Annals of Internal Medicine . 
OCRI sent out nearly 12,000 reprints in response to requests by practicing 
physicians. These conferences and the proceedings are a primary means of 
sharing the results of NIH investigations with physicians everywhere. 

The Office edited an estimated 150 professional papers prepared by Clinical 
Center staff for publication in medical and scientific journals, and provided 
editorial services during manuscript preparation. 

Two editions of the booklet Current Clinical Studies and Patient Referral 
Procedures were prepared and mailed to practicing physicians and dentists to 
notify them of NIH intramural clinical programs to which they may nominate 
patients. An additional 36 supplementary announcements of new protocols also / 
were sent out . 



'.II 



Four Nursing Clinical Conferences were presented this year by the Nursing 
Department. In addition to assisting in the preparation of programs, invita- 
tions and publicity, the OCRI prepared and printed conference proceedings to 
share nursing techniques developed at the Clinical Center with nurses through- 
out the country. Approximately 12,000 reprints have been sent out. 



i 



OD-12 



A new monthly publication, Director's Update , was begun in March to communi- 
cate clinical information to over 700 physicians in the Clinical Center. The 
OCRI helped plan the new publication and will coordinate its preparation and 
distribution. 

Patient Communication 

A comprehensive new information program for patients regarding hospital facil- 
ities and services was begun. The first edition of the Clinical Center 
Patient's Handbook was published, offering general information about hospital 
activities and policies. There is room in the handbook for inserts covering 
individualized information for patients about the specific nursing unit and 
medical program they will encounter. 

A Patient's Bill of Rights was developed in cooperation with the Director's 
office and the Medical Board. This publication, along with a new document 
explaining the Privacy Act, will be included in the kit. 

A leaflet was prepared and other information made available to patients about 
the patient representative program. 

This past year the hospital's preadmissions functions were turned over to the 
OCRI. Approximately 650 patient referrals to the Clinical Center from private 
physicians were processed through this office. The unit also responded to 
approximately 90 Congressional and 150 general inquiries by letter and 
telephone. 

Recruitment 



A major campaign to support the Patient Emergency Fund was undertaken this 
past year to bolster dwindling reserves. The fund is essential to the present 
patient care program since many patients would leave the hospital if the emer- 
gency financial assistance offered through the fund were not available. Dur- 
ing the past year a brochure about the fund was developed and an extensive 
promotional campaign was undertaken. Over S800 was raised at the annual 
benefit Softball game. 

Recruitment of blood donors also has become critical and a major program was 
begun to communicate blood needs. The OCRI conducted several media and 
poster/table-tent campaigns and has recently completed a new full color blood 
donor recruitment brochure. 

As a result of this effort, blood collections rose 9 percent and the list of 
platelet donors in the Blood Bank files rose 17 percent. 

Revised editions of the Associate Training Programs catalogue and the Clinical 
Electives for Medical Students brochure were issued and distributed. Last 
year a member of the OCRI staff attended the annual National Medical Associa- 
tion meeting in Los Angeles with the Associate program exhibit. Literature on 
the program was distributed. 



OD-13 



I 



The OCRI helped revise the publication Clinical Electives for Nursing Student 
This brochure, which goes to senior nursing students in baccalaureate pro- 
grams, is a valuable recruiting tool. 

In addition, this Office revised the Handbook for Staff Physicians . OCRI also 
helped develop a guidebook of services provided by the Whole Body Counter 
Section of the Nuclear Medicine Department. A guidebook on the use of the 
MIS which goes to physicians, dentists and nurses who attend MIS orientation 
training was prepared. 



Employee Communications 



'I 



An extensive program of employee communications was inaugurated this past year 
to help promote a sense of unity essential to the smooth operation of the 
hospital. Closeup , the employee newsletter appeared monthly and included 
feature articles on such topics as the meaning of black history to Clinical 
Center employees and the function and activities of CC administrative officers 

The OCRI prepared a number of handbooks and brochures for various hospital 
departments to acquaint personnel with special procedures relating to those 
departments. Publications were prepared for the Departments of Nutrition, 
Environmental Services Control, and Respiratory Therapy. 

Public Education 

The first of 12 weekly lectures in a series entitled Medicine for the Layman 
will be presented at the Masur auditorium on September 20. The series was 
conceived as a way of educating the public about health and disease in an 
interesting fashion. It is based on the premise that an informed public is 
the best guarantee for continued support of the biomedical research. 

Special Events 

The Special Events staff planned, coordinated and directed specific programs 
for 57,821 visitors to the NIH in FY 1977. Included were 505 visitors from 
41 foreign countries and 1,574 domestic visitors. The Section consulted, 
planned and provided staff assistance for 298 scientific and administrative 
meetings attended by 55,742 visitors in the Masur Auditorium. Activities of 
the Special Events Section over the past year included scheduling 461 appoint- 
ments with NIH researchers, arranging 275 film showings for 1,282 visitors, 
conducting 238 tours for 1,192 visitors, collecting, assembling, and distrib- 
uting 11,374 publications, and answering 1,484 public inquiries by letter and 
telephone. In addition, the Section maintained the NIH Speakers Bureau, fill- 
ing 47 requests for speakers, and administered an interpreter roster, calling 
upon individuals to assist in interpreting for 43 foreign visitors and 
foreign-born patients. It also maintained an invitation list for all NIH 
lectures, dedications and ceremonies. As Executive Secretary for the NIH 
Lecture Committee, the Section Head was responsible for administrative arrange 
ments for 4 NIH Lectures, the G. Burroughs Mider Lecture and the R. E. 
Dyer Lecture. 



t 



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0D-16 



VISITORS DURING FISCAL YEAR 1977 - By Ziacir.line 



A. Domesti : - Total 1.57 1 * 

Laboratory Science 10 

Medical 97 

Paramedical 309 

Administrators 68 

Hospital Administrators . . 25 

Teachers 3h 

Graduate School 137 

College 511 

High School Ill 



Laymen 1'0 

Medical Educators 2 

Employees 

Science Writers 

Clergy 39 

Press 1 

Architects 

Statesmen 2 

Technology 

Patient 1 



Foreign - Total 505 

Laboratory Science 92 

Medical .198 

Paramedical 7^ 

Administrators 

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Teachers 1 

Graduate School 3 

College 35 



Laymen 

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Foreign Visitors by Country of Origin - Fiscal Year 197' 



Aftica 32 

Australia 7 

Austria 1 

Brazil 3 

Canada 5 

Chile 1 

Colombia 1 

Denmark 3 

Dominican Republic 1 

Egypt 18 

England *+6 

Estonia 1 

France °1 

Germany 11 

Greece 1 

Hungary 1 

India 9 

Iran 2 

Israel 1 

Italy 21 

Japan 90 

Korea 1 

Kuwait 2 

Latin America 1 

Madagascar 1 

Manila 1 

Mexico 6 

Netherlands 12 

Pakistan ] 

Philippines k 

Poland 10 

Rumania 7 

Sri Lanka 1 

South Africa 1 

South America 15 

Sweden 15 

Switzerland 17 

Turkey 6 

USSR 36 

West Germany 3 

Yugoslavia 1 



0D- 19 



»-t 



NIH LECTURE SERIES 
Fiscal 1977 

The Special Events Section is responsible for administrative arrangements 
for the NIH Lecture Series. 



i 



R.E. Dyer Lecture: 



NIH Lecture: 



September 29, 1976 Attendance: 350 
Hugh 0. McDevitt, M.D. 
Professor of Medicine 
Chief, Division of Immunology 
Stanford University School of Medicine 
Stanford, California 

Title: "Selective Expression of I Region Genes 
in Lymphocyte Subpopulations" 

November 17, 1976 Attendance: 400 
Paul Berg, Ph.D. 

Willson Professor of Biochemistry and former 
Chairman of the Department of Biochemistry at 
Stanford University School of Medicine 
Title: "Dissections and Reconstruction of the 
SV40 Genome" 



NIH Lecture: 



December 8, 1976 Attendance: 

Gerald M. Edelman, M.D. , Ph.D. 

Professor of Biochemistry 

Rockefeller University 

New York, New York 

Title: "Cell Surface Modulation" 



550 



NIH Lecture: 



March 2, 1977 
Mary Leakey, D.Sc. 
Olduvai Gorge 
Nairobi, Kenya 
Title: "Early Man" 



Attendance: 830 



G. Burroughs Mider Lecture: 



NIH Lecture: 



May 18, 1977 Attendance: 525 

Maxine F. Singer, Ph.D. 

Head, Section on Nucleic Acid Enzymology 

Division of Cancer Biology and Diagnosis 

National Cancer Institute, NIH 

Title: "Monkey Business: Sequences in the 

Monkey Genome and Their Interaction with 

Simian Virus 40 DNA" 

September 19, 1977 Attendance: 530 

Max F. Perutz, Ph.D. 

Medical Research Council 

Laboratory of Molecular Biology 

University Postgraduate Medical School 

Cambridge, England 

Title: "Fundamental Research in Molecular 

Biology: Its Relevance to Medicine" 

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t 



i 



Honors and Awards 

Dr. Griff Ross received the Fred Conrad Koch Award of the Endocrine Society 
for achievement in endocrinology and the Ashbel Smith Distinguished Alumnus 
Award, University of Texas Medical Branch, Galveston, Texas. 

Dr. Mortimer Lipsett was presented the Distinguished Leadership Award by the 
Endocrine Society for his contributions to endocrinology. 

Professional Activities 

Dr. Lipsett was appointed as member of the Committee on Scholarly Communica- 
tion with the People's Republic of China's Steriod Chemistry and Biochemistry 
Delegation to visit the Peoples Republic of China, sponsored by the National 
Academy of Sciences. He served on the Subspeciality Committee on Endocrinology 
and Metabolism of the American Board of Internal Medicine; the Council for 
Research and Clinical Investigation Awards Committee of the American Cancer 
Society; and the Endocrinology and Metabolism Advisory Committee, Food and 
Drug Administration. Dr. Lipsett was also appointed Associate Editor of 
Cancer Research Editorial Board, elected to office of Secretary General, 
International Society of Endocrinology and served as Executive Secretary of 
The Endocrine Society. 

In addition, the Director presented a paper on "Impaired Organ System Effects 
of Cancer on Nutrition: Endocrine, Musculo-skeletal, and Central Nervous 
Systems." Workshop Conference on Nutrition & Cancer Therapy, American Cancer 
Society. 

As member of the faculty for The Institute for Continuing Education, he 
participated in symposium on "Recent Advances in Endocrinology and Metabolism, 
St. Thomas, V.I. 

He delivered lectures on "Endocrine Treatment of Cancer," at Science Writers 
Seminar on Endocrinology, sponsored by NIAMDD and The Endocrine Society, 
Bethesda, Md. ; "Estrogens and Cancer" and "Hirsutism — Modern Language and 
Treatment" at Atlanta Graduate Medical Assembly program, "Two Days of Internal 
Medicine — Endocrinology for the Internist," Atlanta, Ga.; "Functioning 
Ovarian Tumors," at University of Tennessee Second Annual Gynecologic Endo- 
crinology Symposium, Memphis, Tenn. ; "Estrogens and Cancer," at Akron City 
Hospital Eleventh Annual Cancer Symposium, Akron, Ohio; "Male Hypogonadism," 
"Estrogens and Cancer," at Florida Endocrine Society Annual Meeting; and 
"Hirsutism" at University of Miami School of Medicine Reproductive Endocrin- 
ology Lecture Series. 



Dr. Ross was elected president of the Endocrine Society, Honorary Fellow, 
American Gynecological Society and served on the Albert Lasker Medical 
Research Awards Jury. He was invited to present the First Carl Gemzell 
Lecture on "The Ovulatory Process in Women" at the Symposium on "New Leads 
on Contraception" on the Five Hundredth Anniversary of the University of 
Uppsala, Sweden. He also spoke at the French Endocrine Society Meeting, 
Toulouse, Franch. 

OD-21 



Bibliography 

Canfield, R. E. and Ross, G. T. : A new reference preparation of human 
chorionic gonadotropin and its subunits. Bull Who 54:463, 1976 

Chen, H-C. , Hodgen, G. D. , Matsuura, S. , Lin, L. J., Gross, E. , Reichert, 
L. E. , Jr., Birken, S. , Canfield, R. E. and Ross, G. T. : Evidence for a 
gonadotropin from nonpregnant subjects that has physical, immunological, and 
biological similarities to human chorionic gonadotropin. Proc Natl Acad Sci ~ 
USA 73:2885-2889, 1976. " " I 

Goldenberg, R. L. , Powell, R. D. , Rosen, S. W. , Marshall, J. R. and Ross, 
G. T. : Ovarian morphology in women with anosmia and hypogonadotropic 
hypogonadism. Am J Obstet Gynecol 126:91-94, 1976. 

Hodgen, G. D. , Wilks, J. W. , Vaitukaitis, J. L. , Chen, H-C, Papkoff, H. and 
Ross, G. T. : A new radioimmunoassay for follicle-stimulating hormone in 
macaques: Ovulatory menstrual cycles. Endocrinology 99:137-145, 1976. 

Hoffman, P. G. and Ross, G. T. : Amenorrhea and weight loss in young woman- 
anorexia nervosa. JAMA 235:308, 1976. 

Louvet, J-P., Harman, S. M. , Nisula, B. C. , Ross, G. T. , Birken, S. and 
Canfield, R. : Follicle stimulating activity of human chorionic gonado- 
tropin: Effect of dissociation and recombination of subunits. Endocrinology 
99:1126-1128, 1976. 

Lipsett, M. B. : Adrenal carcinoma. In Charyulu, K.K.N, and Sudarsanam, A. 
(Eds.): Hormones and Cancer. New York, Stratton International Medical Book 
Corp., 1976, pp. 197-203. 

Lipsett, M. B. : Effects of cancers of the endocrine and central nervous 
systems on nutritional status. Cancer Res . 37:2373-2376, 1977. 

Lipsett, M. B.: Estrogen use and cancer risk. JAMA 237 : 1112 -1115 , 1977. 

Lipsett, M. B. : Regulation of Androgen Secretion. In Martini, L. and 
Motta, M. (Eds.): Androgens and Antiandrogens . Raven Press, New York, 1977, 
pp. 11-17. 

Lipsett, M. B.: Regulation of testicular functions. Andrologia 8:43-60, 1976. 

Lipsett, M. B., Ross, G. T. : The Ovary. In Ingbar, S. H. (Ed.): The Year 
in Endocrinology , 1975-1976, New York, Plenum Press, 1976, pp. 89-108. 

Ross, G. T. : Congenital anomalies among children born of mothers receiving 
chemotherapy for gestational trophoblastic neoplasms. Cancer 37: 
1043-1047, 1976. 

Ross, G. T. : Hormones and preantral follicle growth in women. Mayo Clin Proc 
51:617-620, 1976. 



0D-22 






Ross, G. T. : On intraovarian control of oogenesis in the human. In 
Crosignani, P. . and Mishell, D. R. (Eds.): Ovulation in the Human . London, 
Academic Press, 1976, pp. 127-140. 

Ross, G. T. : Preovulatory determinants of human corpus luteum function. 
Eur J Obstet Gynecol Repro Biol 6:147-155, 1976. 

Schreiber, J. R. , Rebar, R. W. , Chen, H-C. , Hodgen, G. D. and Ross, G. T. : 
Limitation of the specific serum radioimmunoassay for human chorionic 
gonadotropin in the management of trophoblastic neoplasms. Am J Obstet 
Gynecol 125:705-707, 1976. 

Schreiber, J. R. , Reid, R. and Ross, G. T. : A receptor-like testosterone- 
binding protein in ovaries from estrogen-stimulated hypophysectomized 
immature female rats. Endocrinology 98:1206-1213, 1976. 

Schreiber, J. R. and Ross, G. T. : Further characterization of a rat ovarian 
testosterone receptor with evidence for nuclear translocation. Endocrinology 
99:590-596, 1976. 

Vaitukaitis, J. L. , Ross, G. T. , Braunstein, G. D. and Rayf ord , P. L. : 
Gonadotropins and their subunits : Basic and clinical studies. Recent 
Prog Horm Res 32:289-331, 1976. 

Vaitukaitis, J. L. and Ross, G. T. : Clinical studies of gonadotropins in 
the female. Pharmac Ther C 1:317-329, 1976. 

Vigersky, R. A., Loriaux, D. L. , Andersen, A. E. , Lipsett, M. B. : Anorexia 
Nervosa: Behavioural and hypothalamic aspects. Clin Endocrinol Metabol 
5:517-535, 1976. 

Vigersky, R. A., Loriaux, D. L. , Howards, S. S., Hodgen, G. B., Lipsett, M. B. , 
Chrambach, A.: Androgen binding proteins of testis, epididymis, and plasma in 
man and monkey. J Clin Invest 58:1061-1068, 1976. 

Wilks , J. W. , Hodgen, G. D. and Ross, G. T. : Luteal phase defects in the 
rhesus monkey: The significance of serum FSH:LH ratios. J Clin Endocrinol 
Me tab 43:1261-1267, 1976. 



0D-23 



July 1, 1977, through September 30, 1977 

PUBLIC HEALTH SERVICE: NATIONAL INSTITUTES OF HEALTH 

SUMMARY OF ANNUAL REPORT OF PROGRAM ACTIVITIES 
CLrNICAL CENTER 

BLOOD BANK DEPARTMENT: 



CONTENTS 

I Missions and Goals 

II Department Activities 

A. Service Responsibilities 

B. Department Organization 

C. Donor Program 

D. Laboratory Service 

E. Professional Activities 

F. Honors and Awards 

III Major Progress 

A. Progress in Research 
1 . Hepatitis 

2 Immunohematology 

3. Other Research Activities 

B. Progress in Training and Development 

IV Future Objectives 

V Blood Bank Department Organizational Chart 

VI Publications 

VII Protocols on Ongoing Research Projects 

1. 51 Cr RBC Survival as a Measure of Transfusion 
Compatibility. 

2. Use of Hepatitis B Immune Globulin Following 
Accidental Exposure to HBsAg positive serum. 

3. Role of Hemagglutinating and IgE penicillin antibody in 
donor blood. i 



BB- 1 
BB- 2 
BB- 2 
BB- 3 
BB- 3 
BB- 3 
BB- 4 
BB- 5 
BB- 6 
BB- 6 
BB- 6 
BB- 3 
BB- 9 
BB-10 
BB-11 
BB-13 
BB-15 
BB-17 
BB-17 

BB-20 

BB-23 



4. Prospective Study of Post -transfusion Hepatitis in BB-26 
Open Heart Surgery. 

5. Investigation of the Efficacy of Frozen Washed Blood for BB-29| 
the Prevention of Post -transfusion Hepatitis. 

6. Infectivity of HBsAg-positive saliva and semen. BB-32 

7. Hepatitis Transmission in a Renal Dialysis Unit. BB-35 j 

8. Assessment of the Infectivity of HBsAg -Containing Blood; BB-38'| 
In Vitro Assays of DNA Polymerase and e- Antigen. 

9. Chronic Sequelae of Non-A, Non-B Hepatitis. BB-42 ' 

10. The Duffy Blood Group Determinant and Susceptibility to BB-45 j 
Malaria. 

11. Chido (Ch ) Antibody Production Induced by Cancer BB-48 
Immunotherapy. 

12. Mechanism of Vertical Transmission of Hepatitis B Virus. BB-51 

13. Transmission of Non-A, Non-B Hepatitis in Chimpanzees. BB-54:i 



14. Longitudinal Study of £ Antigen in Health Workers and BB-57 

Patients who are Chronic Carriers of HBsAg. 



I 



15. Evaluation of Anti-Core Antibody and Serum Transami- BB-60' 
nase as Indicators of the Infectivity of HBsAg -Negative 
Donors. 

16. Identification of the Non-A, Non-B Hepatitis Agent and BB-63 
the Development of Serologic Markers. 

17. Hepatitis B Vaccine Trial Among Renal Dialysis 
Patients. 

18. Evaluation of the hepatitis risk of hospitalized patients 
undergoing invasive procedures, but not receiving blood 
transfusion. 

19. Alterations in Whole Blood Oxygen Affinity Following 
Transfusion. 

20. Delineation of Antibody in Sera of Leukemia Family 
Members. 

21. Hypothesis of X-linkage in Bipolar and Uni -polar BB-78 
Affective Disease. 



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■66 


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-69 






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-72 


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1 

•75 



1.1 



* 



I. BLOOD BANK MISSIONS AND GOALS 

The NIH Clinical Center Blood Bank has three basic missions to fulfill: ser- 
vice to Clinical Center patients, teaching the disciplines of blood banking and 
immuno hematology, and conducting developmental research. 

The primary mission of the Blood Bank Department is service to Clinical 
Center patients. The largest portion of this service consists of providing 
safe, effective blood and components in support of patient care research at 
the NIH. Approximately half of the blood transfused at NIH is obtained from 
NIH volunteer blood donors phlebotomized in this department; the remainder 
is drawn from the Washington Regional Blood Program of the American Red 
Cross and crossmatched in the Blood Bank Department. 

This department strives to make maximal use of blood and its components 
with minimal wastage or loss. Thus, donors registered in our computer files 
are recruited when needed for specific patient requirements. In addition, the 
maximum number of components from each unit is prepared whenever possi- 
ble (e.g., red cells for those with anemia, platelets for those with thrombo- 
cytopenia, etc. ) 

The service mission of the Blood Bank includes provision of consultation and 
blood products to all the NIH Institutes and to the community when necessary. 
We have cooperative agreements with the American Red Cross, the Ameri- 
can Association of Blood Banks, and other groups involved in providing blood. 
We maintain a sophisticated referral laboratory for the Washington metropo- 
litan area as well as for more distant parts of the United States; we attempt 
to provide answers and, frequently, compatible blood. We work closely with 
the Red Cross in the collection of blood, with joint blood drives, and in the 
husbanding of blood resources in the community. The Blood Bank provides 
pheresis of patients and normal donors to supply numerous blood samples 
and components to clinical and laboratory scientists at NIH; this latter ser- 
vice is limited only by the demands of patient related activities. Through our 
"blood assurance" program we guarantee the blood needs of NIH employees 
and their families. 

The second mission of the Blood Bank is teaching. We provide a varied edu- 
cational experience to physicians enrolled in our 1-2 year blood bank training 
program, one of the few American Medical Association approved programs 
in the country. In addition, physicians from the Clinical Center Clinical 
Pathology Department, the Georgetown University Pathology Department and 
Hematology Divisions at local medical schools participate in training exper- 
iences of varying length; medical students may also spend elective time in 
our department. Blood Bank technologists obtain a year of graduate training 
in our AABB approved Specialist in Blood Banking program which qualifies 
them for subspecialty certification. We are active in in-service education 
for our staff and for other Cinical Center staff members. Members of this 
Department also teach and provide consultation for local hospitals, univer- 
sities, military facilities and many organizations and facilities all over the 
country. 



B3-1 



Research is the third mission of the Blood Bank. This research is directed j 
toward better and safer blood products as well as the elucidation of difficult I 
patient-care or laboratory problems. Many of the research activities here 
have resulted in reduction of the risk of posttransfusion hepatitis. Our hepa- 
titis research, as well as research contributions in red cell immunology, 
have resulted in practical advances recognized nationally and internationally. 

The goals of this Department are to improve our efforts in the three areas 
of service, teaching, and research. We shall continue to provide the most g 
up-to-date, effective hemotherapy, to provide optimal patient care support, \ 
to create a stimulating learning environment, and to foster exciting investi- 
gative effort. We can thus accomplish our missions, continue to attract com- 
petent, knowledgeable staff, and maintain our position of respect in the blood 
banking world. We plan to continuously expand the NIH employee participa- 
tion in our donor program in order to replace donors who are lost and to pro- 
vide a larger donor base for the varied transfusion requests for CC patients, 
community needs, and for our participation in the AABB Rare Donor File. 

II. DEPARTMENT ACTIVITIES 

SERVICE RESPONSIBILITIES 

The Blood Bank Department's primary function remains the provision of safe 
and effective blood and blood products. Seventy five hundred units of whole 
blood and red cells were transfused during the past year. Approximately 
52% of this blood was drawn in the Blood Bank . This represents a 9% in- 
crease in both transfusion and collection. Blood Bank physicians continued 
their clinical consulting role and evaluated close to one hundred suspected 
transfusion reactions, 60% of which were in fact transfusion related (Table 
1); however, there were no fatalities attributed to transfusion. In addition, 
Blood Bank physicians assisted patient care physicians in managing numer- 
ous immunohematologic problems including the first case of known recurr- 
ence of an anti-Pi -^platelet antibody in a patient with posttransfusion 
purpura. 

The Blood Bank continued to prepare fresh frozen plasma, cryoprecipitated 
antihemophilic factor, and frozen red cells. Factor VIII commercial con- 
centrate, a dried, standardized, licensed product, again was available by 
contract. Use of these components has not differed substantially from 1976 
to 1977. 

Therapeutic procedures have increased in the past year: more than 60 
phlebotomies have been performed on patients with polycythemia and hemo- 
chromatosis. The arrival of the Blood Bank's first cell separator (Haemo- m 
monetics Model 30), while purchased primarily for component preparation, 
has added flexibility for therapeutic procedures. Requests have been re- 
ceived for machine -assisted exchange transfusion, plasma exchange, and 
cell removal for therapeutic purposes. 






The plateletpheresis Center continued to function satisfactorily at close to 
maximum efficiency. It routinely prepared approximately 12 00 units of 
platelets per month (17% increase) and continued to enlarge its list of HLA s 



BB-2 



typed, potential donors. The Blood Bank is the primary backup for Clinical 
Center platelet needs, although Red Cross single donor platelets are now 
available through contract with this Blood Bank should patient requirements 
temporarily exceed our combined platelet producing capacity. 

The Blood Bank, in general, met increasing requests for blood products from 
the NIH research community. We performed an average of 50 plasmaphere- 
sis procedures per month for research purposes. Approximately 300 blood 
samples a month were drawn in the Blood Bank for NTH laboratory studies. 
This service has been limited at times by space and personnel restrictions. 
Supplying research samples must not interfere with our provision of thera- 
peutic blood products for patients which takes precedence. 

DEPARTMENT ORGANIZATION 

The Blood Bank Organizational Chart is appended. Dr. Harvey G. Klein was 
appointed Assistant Chief and Chief of the Blood Services Section. Ms. Mary 
Ann Tourault has assumed the supervisory role in the Donor Recruiting Unit 
in addition to her responsibilities as laboratory supervisor. Dr. Richard J. 
Davey of the Immunology Section assumed responsibility for the Blood Bank 
training and education programs. 

DONOR PROGRAM 

The Blood Bank continued its policy of supplying all volunteer blood and be- 
gan to label the blood with the "volunteer 1 designation. Active recruitment 
of volunteers continued and the roll of active donors increased to 2 300 thus 
permitting the Blood Bank to supply more than 50% of all blood transfused in 
the Clinical Center, despite an increased volume of transfusions; the remain- 
der was supplied by the Washington Regional Red Cross. 

The mobile operation at the Westwood Building, begun in 1976 and sponsored 
jointly with the Red Cross, was carried out three times in 1977. Each effort 
resulted in more than 50 units of blood and an average addition of 30 new do- 
nors to the Blood Bank computer files. With the success of this operation, 
we further increased donor collections by reaching out to other, less acces- 
sible, NIH buildings. 

The Blood Assurance Program continued to provide blood for all NIH em- 
ployees and their families regardless of whether they donated blood. During 
the past year, some 900 units were supplied for NIH employees. This re- 
mains one of the most liberal assurance plans in the country. 

LABORATORY SERVICE 

The Blood Bank offers laboratory service and clinical consultation around- 
the-clock, seven days a week. During the past year the laboratory staff 
determined the blood group and type of 3000 new patients and performed 
4500 direct Coombs' tests, 6200 patient screening tests for irregular anti- 
bodies, and 22000 crossmatches. There was no instance of a transfusion 
reaction related to clerical or technical error during this period. 



33-3 



Because of the unusual disease spectrum in our patient population and the ( 
number of multitransfused individuals at the Clinical Center, as well those 
on investigational protocols, many difficult and unusual transfusion problems 
were again encountered. These problems, which often involve unusual anti- 
bodies, rare red cell antigens and poorly characterized white cell antibodies, 
required sophisticated laboratory procedures as well as extensive investi- 
gation beyond the usual work of a service laboratory. Anti-Chido antibodies 
have been found in melanoma patients who are sensitized with melanoma 
cells. The loss of blood group antigens in patients with Hodgkins disease hasi 
been encountered and several individuals with five or more unusual red cell " 
antibodies have been investigated and managed. 

The laboratory has expanded its already extensive inventory of frozen red 
cells and antisera. These reagents, together with the computerized donor 
file, have permitted the service laboratory to solve unusual transfusion pro- 
blems and locate compatible blood. In those instances when in vitro compa- 
tibility is questioned, a modified 51Cr red cell survival study has proved 
valuable as a rapid, reliable, in vivo determination of compatibility. 

PROFESSIONAL ACTIVITIES 

Members of the Blood Bank Department's professional staff made numerous 
contributions to the scientific and general public on a local, national and in- 
ternational level during the past year. The following are examples of such 
staff participation. 

Ms. Mary H. McGinniss continued active participation on the Committee on i 
Scientific Programs of the American Association of Blood Banks and was an" 
invited speaker at the Florida Association of Blood Banks in Tampa and the 
California Blood Bank System meeting in San Francisco. She continued to 
be a member of the Governor of Maryland's Commission on Hereditary Di- 
seases and was featured with Drs. Holland and Alter in the Montgomery 
County Sentinel's article, Blood Banking Detective . 

Ms. Mary Ann Tourault was again invited to participate in the American 
Association of Blood Banks Invitational Conference. She continued to parti- 
cipate in the Rare Serum and Cell Exchange Program. She was elected to 
the Board of Directors of the Metropolitan Washington Blood Bank Associa- 
tion and reappointed to the American Association of Blood Bank's Technicj 
Manual Committe. Ms. Tourault was also reappointed to the faculty of Mont 
gomery Community College where she lectured and supervised student tech- 
nician training. 



*s • 



Dr. Harvey Klein was a hematology attending physician at the Johns Hopkins^ 
Hospital each week throughout the year and attending physician of the NHLBI 
Molecular Hematology Branch Inpatient Service. He continued to serve as a 
consultant to the Blood Division of NHLBI. He was certified in Hematology 
by the American Board of Internal Medicine and in Blood Banking by the 
American Board of Pathology. 



•i 



BB-4 



Dr. Richard Davey continued to serve as clinical assistant professor of med- 
icine at Georgetown University where he performed attending and teaching 
duties. He was certified in Hematology by the American Board of Internal 
Medicine and in Blood Banking by the American Board of Pathology. 

Dr. Harvey Alter continued as clinical associate professor of medicine at 
Georgetown University and helped teach the hematology course to second year 
medical students there. He was guest speaker at the National Academy of 
Science, visiting Professor at the American College of Physicians, and ad- 
visor to the National Library of Medicine. He served on the American Red 
Cross Advisory Committee, the NIH Infectious Disease Committee, the 
NHLBI Chimpanzee Utilization Committee and the NIH Hepatitis Liaison Com- 
mittee, becoming Chairman of the scientific working group of that committee. 
He has been appointed to the committee on Scientific Programs of the Amer- 
ican Association of Blood Banks. 

Dr. Paul Holland was reappointed clinical associate professor of medicine 
at George Washington University and clinical associate professor of pathology 
at Georgetown University. He spoke at conferences at each medical school 
and supervised the training of their residents and fellows who rotated through 
the Blood Bank Department. Dr. Holland continued to be an active consultant 
to NHLBI for studies on transfusion transmitted viruses, plastic toxicity in 
transfusion, and non-A, non-B hepatitis. He was active as a member of the 
NIH Viral Hepatitis Studies Coordinating Committee and a member of the 
Technical Alanual Committee of the American Association of Blood Banks. He 
was guest speaker at the Hematology Institute in Warsaw and the Medical 
Academy in Kracow, Poland and at the Institute of Medicine and Mathematics 
at Ohio University. 

HONORS AND AWARDS 

Dr. Harvey Alter received the Distinguished Service Medal for his outstanding 
research contributions in hepatitis. 

Ms. Mary McGinniss received the NIH Director's Award for her outstanding 
achievement in the field of immunohematology. Ms. McGinniss also received 
the Ivor Dunsford Memorial Award given by the American Association of 
Blood Banks for research and development of technics in immunohematology. 

Ms. Wanda Chappell received the NIH Merit Award for her outstanding work 
in blood banking. 

Ms. Betty Colbert received the Equal Employment Opportunity Award. 

Ms. Mary Ann Tourault, Ms. Helen Burgess and Ms. Lucille Kilmain re- 
ceived individual Superior Performance Awards. The technical staff of the 
laboratory unit received a Group, Superior Work Performance Award. 

The Blood Bank Nursing Unit, Ms. Wanda Chappell, Ms. Marie Moroney, 
Ms. Frances Shoup, Ms. Marilyn Vander Ven, Ms. Virginia Weber, and Ms. 
Elsie Yanchulis received a Superior Performance Group Award. 

BB-5 



Ms. Shirley Gregg, Ms. Deloris Koziol, Ms. Barbara Orr, Ms. Elaine 
Collins and Ms. Virginis Weber received Quality Increase Awards. 

Ms. Elaine Collins received a cash award for an employee suggestion. 

III. MAJOR PROGRESS 

PROGRESS IN RESEARCH 

Developmental research is, with service and training, one of the three ma- 
jor areas of responsibility and progress in the NIH Blood Bank. The re- 
search efforts of the Blood Bank can be conveniently divided into research 
in hepatitis, research in immunohematology, and research in other related 
fields. 

HEPATITIS 

This year has seen the expansion and near completion of several hepatitis 
investigations, under the overall direction of Dr. Harvey Alter. This in- 
cludes expansion of an existing study of post -transfusion hepatitis (PTH) and 
the initiation of a large collaborative effort relating to hepatitis B in dialysis 
units in preparation for clinical trial of a hepatitis B vaccine. A summary 
of projects nearing completion is as follows: 

(1) In a study of the use of Hepatitis B Immune Globulin (HBIG) following ac- 
cidental needlestick, there is thus far significantly greater protection when 
HBIG is given in divided doses one month apart as compared to the same dose 
given initially as a single bolus. This study was instrumental in the recent J 
FDA recommendation for HBIG to be administered in two 5 ml. doses one 
month apart. 

(2) In a study of the efficacy of frozen-deglycerolized red cells in the pre- 
vention of PTH, it was shown that such mechanical intervention was not suc- 
cessful in totally removing the hepatitis B virus (HBV). Units of human 
blood were "spiked" with a known infectious dose of HBV and subsequently 
frozen and then deglycerolized by the two major methods currently in use 
for the preparation of frozen red cells for human use. A total of four such 
units were prepared and transfused to chimpanzees. Each of the four chim- 
panzees developed hepatitis B; in two the disease was mild and delayed but 
in two it was typical of acute hepatitis following the transfusion of HBsAg 
positive blood which was not frozen. This is the first study to definitively 
test the efficacy of frozen blood in relation to hepatitis prevention and may 
have major impact on the usage of this product. 



(3) A cooperative study was undertaken to ascertain the importance of the 
"e" antigen (HBeAg) in predicting hepatitis B infectivity. Using donor-reci- 
pient pairs in a VA study of accidental needlestick exposure to HBsAg, it was 
clearly shown that HBsAg -positive blood which is also "e" antigen-positive 
is markedly more infectious than HBsAg -positive blood which is "e ' antigen- 
negative. In collaboration with the VA and NIAID, we are currently expanding 
the number of donor -recipient pairs to further evaluate the importance of 



9 



5B-6" 



"e" antigen and to correlate it with DNA polymerase. We are also looking at 
the impact of HBeAg on the interpretation of clinical trials for HBIG. Thus 
far the close association of "e" antigen with infectivity has been maintained. 
Among those who received HBeAg -positive needlesticks (i.e. infectious ma- 
terial), HBIG has been shown to be clearly superior to ISG as a prophylactic 
measure in the prevention of Hepatitis B. 

(4) Since not all HBsAg positive material is equally infectious and since 
some might not be infectious at all, the infectivity of HBsAg-positive saliva 
and semen was assessed in chimpanzees. Two chimps were given either 
HBsAg-positive saliva or semen intravenously and both showed evidence 

of type B infection. This demonstrated that these secretions contained not 
only HBsAg, but also infectious viral particles. The experiments did not 
prove that saliva and semen are infectious by their natural routes of trans- 
mission; but, combined with previously published epidemiologic studies, 
this conclusion seems highly likely. Hepatitis B thus may be spread by oral 
and venereal contact as well as by blood. 

(5) A 4 year study of hepatitis prevalence in a large dialysis unit was com- 
pleted but the data are not yet collated. 

(6) The Blood Bank was unsuccessful in its attempts to establish a reliable 
test for cell mediated immunity to hepatitis B and has abandoned this pro- 
ject. Although there have been sporadic reports of success in this area, 
these have been difficult to confirm and most laboratories are also having 
difficulty with this assay. 

(7) Our study of the causes and prevention of PTH continues, and we have 
now enrolled over 450 open heart surgery patients in our most recent phase. 
These studies indicate that approximately 8°/c of multiply-transfused open- 
heart surgery patients developed PTH and that 80% of this is due to the "non- 
A, non-B hepatitis virus(es) with the remainder due to hepatitis B despite 
the exclusion of HBsAg-positive donors by RIA. In addition to these inci- 
dence figures, this large study has had several interesting ramifications, in- 
cluding: (a) the evaluation of a very promising radioimmunoassay for antibody 
to the hepatitis B core antigen; (b) the evaluation of a test for detecting he- 
patitis B carriers who may carry this virus in a complexed and previously 
undetectable form; (c) the evaluation of the chronic sequelae of non-A, non-B 
hepatitis. A major effort has been made to follow and recall patients whose 
SGPT remains elevated greater than 6 months following transfusion. Pre- 
liminary evidence indicates that at least 25% of acute non-A, non-B hepatitis 
progresses to chronic transaminitis, chronic persistent hepatitis, chronic 
active hepatitis, or cirrhosis. Non-A, non-B appears to have more serious 
chronic sequelae than type B hepatitis; and, since many cases are anicteric 
in their acute form, non-A, non-B hepatitis may be the precipitating event 

in many cases which later present as unexplained chronic active hepatitis 
or cryptogenic cirrhosis, (d) The evaluation of implicated donors-a major 
effort has been made to recall donors involved in one or more cases of non- 
A, non-B PTH to see if they themselves have a chronic asymptomatic hepa- 
titis that might be detected by persistent liver enzyme elevations. Such re- 
call has implicated two potential donors and has led us to re -evaluate, in a 



3B-7 



prospective fashion, the value of screening donors for SGPT. (e) The accu- 
mulation of pedigreed donor and recipient sera which may harbor the non- 
A, non-B virus: Acute phase sera from two hepatitis patients, chronic 
phase plasma from two patients and plasma from an implicated donor have 
been inoculated into five chimpanzees to see if a transmissible agent can be 
detected, (f) In collaboration with Dr. Purcell of NIAID, we are continuing 
to search for a serologic marker for the non-A, non-B agent(s). There have 
been some encouraging results thus far, but it is too early for speculation 
regarding such a marker. 

(8) Work has continued in evaluating the significance of HBsAg subtypes. 
We have been evaluating individuals with the unusual finding of heterotypic 
subtype antibody which coexists with antigen of an alternate subtype. Dr. 
Holland has been instrumental in organizing a pedigreed panel of subtype re- 
agents which will be distributed internationally by NIAID. 

Lastly, CCBB has entered into a large, multihospital, collaborative study 
under the direction of Dr. Wolf Szmuness of the New York Blood Center, 
which, over the next 1-1/2 to 2 years, will establish baseline hospital inci- 
dence figures of hepatitis B in renal dialysis units (we are conducting sur- 
veillance in 5 units of the Metropolitan Washington Renal Dialysis Center). 
At the end of this time these units will serve as the primary study areas for 
clinical trials of hepatitis B vaccines currently in preparation. 

IMMUNOHEMATOLOGY 

The immunohematology laboratory, under the direction of research biolo- 
gist Mary H. McGinniss, has continued to serve as a major reference center f 
for problems in transfusion related immunohematology. Approximately 80 
cases were referred to this laboratory from both local and distant hospital 
laboratories, with the vast majority of these referred problems being satis- 
factorily resolved. 

Two especially interesting cases at the Clinical Center involved the loss of 
normal red blood cell antigens (one not previously reported) in patients with 
hematologic malignancies. In one patient, the loss of group A antigen pre- 
dated the ultimate diagnosis of acute myelogenous leukemia and thus may be 
a marker for this disease in some patients. The second patient's red cells 
also showed acquisition of a cell antigen with terminal sepsis; this was 
thought to be due to coating of red cells by bacterial polysaccharides with 
specificity similar to the red cell antigen. Three papers on these findings 
are in preparation. In addition, based on studies of a patient at Georgetown 
University, a case of the saline agglutinating phenomenon was identified and 
will be published. 



A strong research interest in the realtionship of drug therapy to transfusion 
related problems has continued during the past year. Data continue to ac- 
cumulate on the possible untoward effects of the passive transfer of penicil- 
lin-antibodies through transfusion to patients who are receiving penicillin. 
While this may be a rare consequence of transfusion, the documentation of 
this possible reaction is important since the clinical symptoms could erron- 



B3-8 



t 



eously be attributed to other factors, such as a reaction to white cells or plas- 
ma proteins. When this study is completed, statistical data will be available 
which will allow correlation of these rare patient reactions with the presence 
or absence of hemagglutinating penicillin antibody or IgE penicillin antibody 
in donor plasma. In addition to the penicillin project, antibodies to neomycin, 
nafcillin, and chloramphenicol have been studied and related laboratory test 
systems delineated. The chloramphenicol work will result in a publication. 

Ms. McGinniss, along with Louis H. Miller, M. D. , LPD, NIAID, continued 
to study the relationship between the infectivity of various malaria species 
and the presence or absence of certain blood group antigens. Present work 
consists of: 

(1) biochemically isolating the Duffy factor (implicated in P. vivax ) from the 
red cell surface 

(2) studying the evolution of the Duffy antigens from old world and new world 
monkeys 

(3) further defining the possible role of the En a ~ blood group factor impli- 
cated in the invasion of red blood cells by P_. falciparum . 

Other, shorter investigative studies by the immunohematology laboratory 
were done at the request of blood bank and clinical pathology physicians, plus 
on occasion for NIAID physicians. 

OTHER RESEARCH ACTIVITIES 

In collaboration with the NHLBI, Dr. Harvey Klein is investigating alterations 
in whole blood oxygen affinity following blood transfusion. Patients with vary- 
ing types of anemia are being studied to determine whether changes in oxygen 
affinity occur in transfused red cells which may influence or alter the course 
or presentation of the underlying disease. 

Dr. Richard Davey is studying the characteristics of poorly defined red cell 
alio- and autoantibodies through the use of the rapid -sequence, 51 chromium 
red cell survival technique. Of particular interest in these studies has been 
the characterization of the in vivo behavior of the anti-H antibody found in the 
plasma of individuals with the rare "Bombay" red cell phenotype. Work is in 
progress on elucidating the mechanism of red cell destruction in patients 
without demonstrable alloantibodies. Dr. Davey is also delineating the health 
maintenance benefits associated with blood donor screening. 

A major project of the entire senior staff, now in the developmental stages, 
is the preparation of a concise manual of blood banking and immunohema- 
tology for use by medical students and housestaff. It is anticipated that the 
major writing and editing efforts related to this manual will take place over 
the next year, with publication scheduled for late 1973. 



33-: 



PROGRESS IN TRAINING AND DEVELOPMENT 

I 
The training of health professionals in the fields of blood banking and immu- 
nohematology and the continuing education and development of the permanent 
staff are major goals of the Blood Bank Department. 

The central element of the training program for physicians is the Blood Bank 
rotation for NIH Clinical Pathology residents. This 3 month program has re- 
cently been reorganized into well-defined teaching modules, each module ad- 
dressing an important aspect of blood banking. Individual modules are under |j, 
the direction of one of the Blood Bank's senior staff. Key elements of this 
program include teaching by objectives and the extensive use of case study 
material. Hematology fellows and pathology residents from Georgetown Uni- ; 
versity hospital again participated in this training program during the past 
year. 

In addition to this basic rotation, the Blood Bank offers more extensive 
training experiences for pathology residents during the second year of their 
residency. Drs. Ritchard Cable and Jerry Kolins have recently completed 
more extensive, second year training experiences in the Blood Bank. They 
actively participated in the service, teaching and research activities of the 
Department. Dr. Cable has subsequently accepted the Directorship of the 
Syracuse Regional Blood Program and Dr. Kolins has accepted a position 
as blood bank director in a community hospital. 

In July 1977 the Blood Bank accepted its first physician in the recently AMA 
accredited fellowship program in Blood Banking. This fellowship is designed 
to prepare the trained pathologist or hematologist for a career in blood bank -M 
ng or related disciplines. 

A further major educational committment of the Blood Bank is directed 
toward the technical staff and trainees. There are three students currently 
enrolled in the AABB accredited program for Specialists in Blood Banking 
(SBB). These students are progressing through a structured experience in 
both theoretical and practical aspects of blood banking. Many recent grad- 
uates of this program are now chief technologists at major local and regional 
hospitals. The SBB program is currently being revised in accordance with 
suggestions made by the AABB. 



Major changes include: 

1. Formalization of admission criteria 



2. Development of a standard curriculum which insures coverage of major 
subject areas 

3. Development of specific content objectives to be used as learning guides 
and as standards for evaluation 

The new SBB curriculum will be instituted with the class of students enter- 
ing in the summer of 1977. 






BB-10 



# 



In addition to the SBB program, the Blood Bank has other teaching programs 
on a technical level. Medical laboratory students from the Allied Health 
School of Montgomery College rotate through the Blood Bank, learning basic 
laboratory techniques of immunohematology. Visiting technologists from var- 
ious parts of the U. S. have spent time in the Blood Bank during the past year, 
reviewing and updating their skills in laboratory immunohematology. 

The Blood Bank continues to conduct regularly scheduled meetings and con- 
ferences for the continuing education of the entire staff. These conferences 
include a journal club, clinical -laboratory correlation conference, residents' 
rounds, and weekly staff meetings with invited guest lecturers. Members of 
the Blood Bank professional staff have attended and participated in numerous 
professional meetings and conferences during the past year. The senior staff 
is now responsible for the FAES evening course, Immunohematology and 
Blood Banking (Immunology 508). Taught for years by Dr. Holland and Ms. 
McGinniss, it had to be expanded to include both spring and fall sessions dur- 
ing the past year to meet increasing enrollment requests. 

It is anticipated that this strong commitment to education and training will re- 
sult in continued progress in this area during the forthcoming year. 

IV. FUTURE OBJECTIVES 

Within the limitations of space and money, the future of the Blood Bank is 
optimistic and exciting. There are major opportunities for expanded re- 
search, teaching, and service functions. 

There are several functions at NIH which would be best integrated into a co- 
hesive unit which most logically would have the Blood Bank as the focal point. 
These would include the procurement and storage of HLA matched platelets 
and white cells and the establishment of an HLA typing laboratory. In most 
institutions where granulocytes and platelets are provided, this function is 
logically integrated with the provision of red cells, frozen cells, and other 
specialized blood products. The Blood Bank looks forward to its expansion 
into these service functions and forsees excellent opportunities for collab- 
orative research with NCI and other institutes. Similarly, the ability to per- 
form HLA typing and possibly other tissue typing would provide the Blood 
Bank with an expanded role not only in transfusion service, but possibly also 
in transplantation programs. It is our feeling that, with the necessary space 
and a somewhat expanded staff, the Blood Bank could provide these services 
at considerable savings to the government as compared with the current con- 
tract mechanism. Future transfusion practice will probably also call for an 
expanded use of frozen blood and we are already moving rapidly into this area. 
Although our chimpanzee studies mitigate against the safety of frozen blood 
from hepatitis, this product has many other advantages which justify its use. 

With the acquisition of a Haemonetics Model 30 plasmapheresis apparatus, 
and possible future acquisition of more complex apparatus, the Blood Bank 
may become increasingly involved in therapeutic plasmapheresis and plasma 
exchange. This would be for such conditions as macroglobulinemia, hyperli- 
pidemia, immune complex disease and exchangeable toxins. 



BB-H 






I 



We will do further studies on the importance of the HBeAg, on the mechan- | 
isms of non -percutaneous hepatitis transmission, on the management of the i 
chronic HBsAg carrier and particularly on the risk of HBsAg positive health 
workers. In addition we will continue our surveillance of hepatitis in dialy- 
sis units (as a prelude to our participation in hepatitis B vaccine trials) in 
the future. 

In the area of immunohematology, we will continue to seek relationships be- 
tween blood groups and disease. This will include investigations of an anti 
precursor antibody found primarily in leukemic families, evaluation of red 
cell antigens as malaria parasite receptor sites, and searches for loss of rb' 
antigens in malignant states and the acquisition of antigens in sepsis. Studies j 
on malaria in collaboration with Dr. Louis Miller will be directed primarily I 
toward establishing a receptor site for Falciparum malaria similar to the 
Duffy site in Vivax malaria. Possibly such sites can be altered to prevent 
cell penetration of this parasite. 

Lastly, the Blood Bank looks to an intensified teaching program. The resi- 
dent rotation for physicians from our Clinical Pathology Department and from 
local hospitals and our technologist program for Specialist in Blood Banking 
are undergoing further re -evaluation and revision. These programs will be 
even more comprehensive and organized in the future. In addition, several 
of our medical staff will participate in the teaching program of the Uniformed . 
Services Medical University School as well as continue to participate and 
expand their teaching committments at other nearby medical schools. 






1 



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BB-13 



TABLE I 



TRANSFUSION REACTION DATA 



CLINICAL CENTER - JAN -DEC, 1976 



Units Transfused 



Whole blood and Packed RBC ' s 



Washed RBC s 



Frozen RBC s 



# 

6704 
371 
436 



TOTAL 



7511 



Reported Reactions (confirmed) 
Febrile, non-hemolytic 
Urticarial 
Other * 
Hemolytic 
TOTAL 



# 


% 


Risk 


46 


78 


0.61% 


11 


19 


0.15 


2 


3 


0.03 





- 


- 



59 



100 



0.79% 



* 1 case non- immunologic hemolysis, 1 case chills only 



BB-lU 



V. PUBLICATIONS 

Alter, H. J. : International Forum: The frequency of post-transfusion hepa- 
titis after the introduction of radioimmunoassay tests for hepatitis B surface 
antigen. Vox Sang . , in press. 

Alter, H.J.: Hepatitis B and the Health Worker: Prospective Studies In 
Perspective. Ann. Int. Med . 85: 671-672, 1976. 

Alter, H. J. , Purcell, R. H. , Gerin, J. L., London, W.T., Kaplan, P.M., 
McAuliffe, V. J. , Wagner, J. A. and Holland, P. V. : Transmission of hepa- 
titis B to chimpanzees by hepatitis B surface antigen positive saliva and 
semen. Infection and Immunity . 16: 928-933, 1977. 

Alter, H. J. , Seeff, L.B., Kaplan, P.M., McAuliffe, V. J. , Wright, E.C., 
Gerin, J.L., Purcell, R. H. , Holland, P.V. and Zimmerman, H. J. : Type 
B Hepatitis: The infectivity of blood positive for e antigen and DNA polymer- 
ase after accidental needlestick exposure. New. Engl. J. Med . 295: 909- 
913, 1976. 

Davey, R. J. , Esposito, D.J., Jacobson, R.J. , and Corn, M: Partial Ex- 
change Transfusion as Treatment for Hemoglobin SC Disease in Pregnancy. 
Archives of Internal Medicine , in press. 

Davey, R. J. , Shashaty, G.G. and Rath, C.E.: Acute coagulopathy following 
infusion of prothrombin complex concentrate. Amer. J. Med . 60: 719-722, 
1976. 

Dienstag, J.L., Feinstone, S. M. , Purcell, R.H., Wong, D.C., Alter, H. 
J. and Holland, P. V. : Non-A, Non-B Post -Transfusion Hepatitis. Lancet 
1: 560-562, 1977. 

Gerety, R. J. , Poplack, D.G., Hoofnagle, J. H. , Blaese, R. M. , Holland, 
P.V. and Barker, L.F. : Hepatitis B virus infection in the Wiskott-Aldrich 
Syndrome. J. Ped . 88: 561-564, 1976. 

Gloskowska-Moraczewska, Z., Holland, P.V., Madalinski, K. and 
Kalinowska, B. : Podtypy antygenu powierzghniowego wirusa hepatitis B 
wystepujace w poise e. Acta Haemat. Pol . VII: 189-193, 1976. 

Holland, P.V.,: The use of hepatitis B immune globulin (HBIG) in the 
prevention of hepatitis. Acta Haemat. Pol . VIII: 97-102, 1977. 

Holland, P.V. and Alter, H.J. : Current Concepts of viral hepatitis. 
In Drew, W.L. (Ed.): Viral Infections : A Clinical Approach . Philadel- 
phia, F.A. Davis Co. , Chapter 7, 1977, pp. 189-211. 

Klein, H.G., Aledort, L. M. , Bouma, B.N., Hoyer, L.W., Zimmerman, 
T.S. and De Mets, D. L. : A cooperative study to evaluate methods for 
detecting the carrier state of classic hemophilia. N. Eng. J. Med . 2 96: 
959-962, 1977. 



BB-15 



Koziol, D. E. , Alter, H. J. , Kirchner, J. P. and Holland, P. V. : The de- 
velopment of HBsAg -positive hepatitis despite the prior existence of antibody 
to HBsAg. J. Immunol . 117: 2260-2262, 1976. 

Madalinski, K. , Holland, P. V. , Moraczewska, Z., Kalinowska, B. and 
Alter, H. J. : Subtypes of HBsAg in Eastern and South-Eastern Europe. 
Vox Sang. 32:224-229, 1977. 



Mason, S. J. , Miller, L. H. , Shiroishi, T. , Dvorak, J. A. and McGinniss, 
M. H. : The duffy blood group system and susceptibility to Plasmodium 
knowlesi malaria. Lancet, in press. " 



■ 



Miller, L. H. , Mason, S. J. , Clyde, D.F. and McGinniss, M.H. : The re sis 
tance factor to Plasmodium Vivax in blacks. N. Engl. J. Med. 295:302-303. 
1976. 

Miller, L. H. , Haynes, J. D. , McAuliffe, F. M. , Shiroishi, T., Durocher, 
J. R. and McGinniss, M. H. : Evidence for Differences in Erythrocyte Sur- 
face Receptors for the Malaria Parasites, Plasmodium falciparum and Plas - 
modium knowlesi . J. Exp. Med . 146: 277-281, 1977. 

Moraczewska, Z., Madalinski, K. and Holland, P.V.: Simultaneous Pre- 
sence in Serum of HBsAg and Anti-HBs of Different Specificities. Inter - 
virology, in press. * " 



Purcell, R.H., Alter, H.J. and Dienstag, J. J. : Non-A, Non-B hepatitis. 
Yale J. Biol. & Med. 49: 243-250, 1976. 



Rothman, I.K. , Alter, H.J. and Strewler, G. J. : Delayed Overt hemolytic 
transfusion reaction due to anti-U antibody. Transfusion 16: 357-360, 1976. 



« 



Vyas, G.N., Roberts, I., Peterson, D. L. , and Holland, P. V. : Non- 
specific test reactions for antibodies to hepatitis B surface antigen in chronic 
HBsAg carriers. J. Lab. Clin. Med. 89: 428-432, 1977. 






♦ 



1 

BB-lo 



M I THSSN !.*.% ^i;."'C£ INF ;■.';;' ON EXCHANGE U.S. DEPARTMENT Or 
PROJECT NUMBER ' v Oe NOT use U:>s ;:»'.ce) HEALTH. ECUCATIC.'J, AND WELFARE 

pCblic health service 

INTRAauriAL°RESEARCH PROJECT Z 01 -CC -02001 -02 -BB 



PERIOD COVERED 

July 1. 1976 - Sept ember 30* 1977 

TITLE Of PROJECT [flO characters or less) 



51 Cr RBC Survival as a Pleasure of Transfusion Compatibility 



NAMES, LABORATORY USD INSTITUTE AFFILIATIONS, AND TITLES OF PRINCIPAL INVESTIGATORS AND ^LL "HER 

PROFESSIONAL PERSONNEL ENGAGED ON THE PR0JEC1 

Principal Investigator: Richard Davey, M. D. , Senior Investigator, Blood 

Bank Department, CC 

Other: Paul V. Holland, M. D. , Chief, Blood Bank Department, CC 

Harvey J. Alter, M. D. , Chief, Immunology Section, Blood Bank, CC 
Mary Ann Tourault, Supervisory Technologist, Blood Bank, CC 



COOPERATING UNITS (if anj) 



jLAB/BRANCH 

Blood Bank Department 



SECTION 

I 

Immunology j 

I INSTITUTE AND LOCATION 

Clinical Center, Building lOA/Room 1E33, NIH, Bethesda, Maryland 20014 ! 



TOTAL MANYcARS: 



PROFESSIONAL: 



OTHER: 



CHECK APPROPRIATE EOX(ES) 
{Ha) HUMAN SUBJECTS 

Q(al) MINORS □ (a?) INTERVIEWS 



□ (b) HUMAN TISSUES 



(c) NEITHER 



SUMMARY OF WORK (20C words or less - underline keywords) 

The inability to find compatible blood for transfusion is not an uncommon oc- 
currence. A procedure has been developed whereby a small amount of 51 Cr 
labeled donor red cells which are incompatible by in -vitro techniques are 
transfused into the potential recipient and the in- vivo survival of the trans- 
fused cells determined. Survival characteristics of these cells allow decisions 
to be made with greater certainty regarding the safety of standard transfusions. 

In the patients studied thus far, two cases of the rare " saline auto- agglutinating 
phenomenon " have been shown to have no significance clinically when appropri- 
ate precautions are taken. In addition the suspected incompatibility of group 
O red cells with a rare "Bombay O" recipient has been documented. In other 
instances "incompatible" blood for important surgery has been able to be re- 
leased, whereas previously it would have been difficult to predict the relative 
i hazard of transfusing such blood. 

It is anticipated that further patients will continue to be included in this study 
when in-vivo crossmatch incompatibility is encountered. 



PHS-6040 



3B-1" 



ZOl-CC -02001 -02-BB 
Blood Bank Department 
Clinical Center 
Bethesda, Maryland 

PHS-NIH 
Individual Project Report 
July 1, 1976 - September 30, 1977 

Project Title: A Rapid Technique for Determining In -Vivo Red Cell Survival! 
in Patients Demonstrating In -Vitro Incompatibility with all 
Donor Red Cells 

Previous Serial Number: NIH-76-CC-36 

Principal Investigator: Richard J. Davey, M. D. 

Other: Paul V. Holland, M.D. 
Harvey J. Alter, M. D. 
Mary Ann Tourault, MT(ASCP)SBB 

Cooperating Units: None 

Man Years: Total: 1 

Professional: 1 

Project Description j,' 

Objectives : 

A. To evaluate in detail a procedure for the rapid determination of the sur- 
vival in -vivo of Chromium (51 Cr) labeled red blood cells (RBC's) and 
to determine this procedure's clinical significance in predicting trans- 
fusion safety in patients for whom compatible blood cannot be found by 
in-vitro techniques. 

B. To utilize this rapid 51 Cr survival procedure to clarify the clinical 
significance of certain specific rare red cell antibodies (e.g. anti-H 
in Bombay O, anti-Chido). 

Methods Employed : 

A small sample (1.0-2.0 ml) of test red cell suspension is labeled with 
20 u Ci of 51 Cr, washed, and infused into the patient. Serial blood samples J 
are subsequently drawn and the survival characteristics of the infused cells 
determined by measuring the radioactivity of each sample. 



f 



BB-18 



Major Findings : 

Since approval of this study the following observations have been made. 

A. Two unusual cases of "saline agglutinating phenomenon" have been 
documented and described. Patients with this phenomenon have a 
serum factor which agglutinates all red cells which have been washed 
in saline, thus complicating laboratory crossmatching efforts and 
rendering the infusion of saline containing fluids potentially hazard- 
ous. Survival studies using cells washed in various media permitted 
a decision to be made which resulted in a safe open-heart surgical 
procedure being done on one patient. 

B. People with the rare inherited blood group called "Bombay O" have in 
their serum an antibody which reacts in -vitro against all normal ABO 
blood groups. The clinical significance of this antibody was investigated 
through 51 Cr survival studies in a person with the "Bombay O" blood 
group. It was determined that the antibody was strongly active in-vivo 
and that "Bombay O" people can safely receive blood only from other 
"Bombay O" donors. 

C. Patients who required transfusion with panagglutinating antibodies 
and with antibodies against high incidence or poorly described RBC 
antigens were studied. The clinical significance of each patient's 
antibodies was determined by a 51 Cr survival study, with decisions 
made as to the relative safety of transfusion. 

Significance to Biomedical Research and the Program of the Clinical Center 

The primary goal of the Clinical Center Blood Bank is to provide safe blood 
products to Clinical Center patients. This 51 Cr red cell survival procedure 
provides a valuable tool in defining the relative safety of transfusion in 
patients for whom compatible blood cannot be found by in-vitro techniques. 
If this procedure proves to have significant clinical value, it is hoped that it 
will become a widely used blood bank investigative technique. 

Proposed Course : 

Continued use of 51 Cr survival technique in appropriate patients. 

Presentations : 

"The Saline Agglutinating Phenomenon" - Presentation at the Annual Meeting 
of the American Association of Blood Banks, San Francisco, California, 
November 1976. 

Publications in Preparation : 

The Saline Agglutinating Phenomenon 
Signifance of Anti-H in the Bombay (Q ) Patient 



EB-19 



SMI i HSUN l.'.U iUUNCE i.VTC-V'A.-lOM EXCHANGE 
PROJECT NUMBER [uu NOT use i.!:-s sf-ice) 



U.S. DEPARTMENT OF 
HEALTH, EDUCATION, AND WELFARE 
PUBLIC HEALTH SERVICE 
NOTICE OF 
INTftASURAL RESEARCH PROJECT 



PROJECT NUM5E." 



Z01-CC-02002-02-BB 



PERIOD COVERED 

July 1, 1976 - September 30. 1977 4 

TITLE CF PROJECT (60 characters or less) ~~ "~ 

Use of Hepatitis B Immune Globulin Following Accidental Exposure 



NAMES, LABORATORY AND INSTITUTE AFFILIATIONS, AND TITLES OF PRINCIPAL INVESTIGATORS ANO ALL 0TH c R 
PROFESSIONAL PERSONNEL ENGAGED ON THE PROJECT 

Principal Investigator: Harvey G. Klein, M.D., Chief, Blood Services 

Section, Blood Bank Department, CC | 

Other: Harvey J. Alter, M. D. , Chief, Immunology Section, Blood Bank CC 
Paul V. Holland, M. D. , Chief, Blood Bank, CC 
David DeMets, Ph.D. Biometrics Researcher, National Heart and 
Lung Institutes 



COOPERATING UNITS (if any) 

NHLBI 



LAB/BRANCH " " " 

Blood Bank Ppp artm ent 



SECTION 



I mmunology Section 



INSTITUTE ANO LOCATIC: 

2 1 I "'*' , 



CHECK APPROPRIATE B0x(E3) 
#fa) HUMAN SUBJECTS Q ( b ) HUMAN TISSUES Q (c) NE|Th£R 

D (aQ MINORS fl (a2) INTERVIEWS 



SUMMARY CF WORK (200 words or less - underline keywords; 



JZJZr. Y ?l?°u\ e ?' r u andomized d °uble blinded trials have demonstrated 
the efficacy of high titer hepatitis B immune globulin (HBIG) in affording tem- 
K P n a n S A 1Ve ^^ to individuals accidentally exposed to low doses of 
SX^S Jt m / terial - In b ° th Studi6S ' a 5 ml Section of HBIG was given 
rSSS ° n \ W ff ° f ex P° sure ^ a second injection one month later. This 
dosage schedule was chosen arbitrarily. 



I 



A single dose schedule of HBIG has proved efficacious in prophylaxis of spouses 
an^de^for 3 *' h How — ' these two dosage sched'ule?, ^Slefn^ction 
studvolfns tn 3 pnr-mf9nn aV H ne r r 1 been com P a ^ed in a controlled study. This 
study plans to enroll 300 individuals accidentaly exposed to hepatitis B oositive 

ZublT^in6:/f V t 0Pmen ^ 0f h6patitiS - Candida tel will be ranfomfzedTn a ' 
double blinded fashion and treated with the same dose of HBIG in either a sirMe' 

L^sS^^T^ md nine tysLx individuals Lvefeen enrol? 

sixt^nth^d^t M?££t£ ^^ *******' f6Uowln * ^° S ^ ^ ! 



BB-20 

FHS-6040 ' 

(Rev. 10-76) 



Z01-CC-02002-02-BB 
Blood Bank Department 
Clinical Center 
Bethesda, Maryland 

PHS-NIH 

Individual Project Report 

July 1, 1976 - September 30, 1977 

Project Title: Comparison of single dose and divided dose administration 
schedules of Hepatitis B immune globulin: Efficacy in 
preventing hepatitis B following accidental exposure (needle 
stick). 

Previous Serial Number: 76-CC-2 

Principal Investigator: Harvey G. Klein, M.D. 

Other: Harvey J. Alter, M. D 
Paul V. Holland, M. D. 
David De Met s, Ph.D. 

Cooperating Units: NHLBI 

Man Years: Total: 2 

Professional: 1 
Other: 1 



Project Description 



Objectives : 



To determine whether a single injection of hepatitis B immune globulin (HBIG) 
is as effective as a divided dose injection schedule in preventing hepatitis B 
caused by accidental exposure. 

Methods Employed : 

Exposed individuals are referred by telephone to the Clinical Center Blood 
Bank. The purpose of the study is explained and a telephone questionnaire 
is used to determine eligibility for study. 

Individuals who qualify are required to send blood specimens to the Blood 
Bank to assure exposure to an infectious source and susceptibility of the 
individual. Simultaneously, the individual is supplied with an informed 
consent form which further explains the purpose of the study. 

Individuals who enter the study are randomized in a double blinded fashion 
to the single injection or divided dose schedule. Each receives the same 
total dose of HBIG. Serial blood samples are mailed and a follow-up 
clinical symptom questionnaire must be completed at month six and month 
12. 

BB-21 



Major Findings : 

This study was initiated eighteen months ago. Two hundred and ninety-six 
individuals have been entered. Initial results show statistical superiority 
for a two dose injection regimen. We are in the final stages of the follow- 
up period. 

Significance to Biomedical Research and Programs of the Clinical Center 

The Clinical Center Blood Bank has had a longstanding interest in the pro- 
blem of hepatitis caused by blood and blood products. This study should 
(1) add further information about the natural history of hepatitis following 
HBIG administration (2) answer the question of whether a single injection 
is as effective as a divided dose schedule, a question of great practical 
importance and (3) provide valuable serum samples for studying other 
markers of hepatitis and hepatitis infectivity. 

Proposed Course : The study should be completed within one year. 

Publications: None 



BB-22 



SMITHSONIAN SCIENCE INFORMATION EXCHANGE 
PROJECT NUMBER (Do NOT use this space) 



PERIOD COVERED 

July 1, 1976 - September 30, 1977 



TITLE OF PROJECT (80 characters or less] 

"Role of Hemagglutinating and IgE penicillin antibody in donor blood' 



NAMES, LABORATORY AND INSTITUTE AFFILIATIONS, AND TITLES OF PRINCIPAL INVESTIGATORS AND ALL OTHER 
PROFESSIONAL PERSONNEL ENGAGED ON THE PROJECT 

Principal Investigator: Mary H. McGinniss AB(ASCP)SBB 

Biologist Clinical Center Blood Bank 

Other: Harvey J. Alter, M.D., Chief, Immunology Section 
Clinical Center Blood Bank 
Richard J. Davey, M.D., Senior Investigator 
Clinical Center Blood Bank 



U.S. DEPARTMENT OF | PROJECT NUMBER 

HEALTH, EDUCATION, AND WELFARE 
PUBLIC HEALTH SERVICE 
NOTICE OF 
INTRAMURAL RESEARCH PflOJECT 



Z01-CC-02003-03 BB 



COOPERATING UNITS (if any) 



LAB/BRANCH 

Blood Bank Department 



SECTION 

Immunology 



INSTITUTE AND LOCATION , „„,... , 

Clinical Center, Bldg. 10A, Room 1E33, NIH, Bethesda, Md. 20014 



TOTAL MANYEARS: 

0.5 



PROFESSIONAL: 

0.5 



OTHER: 



CHECK APPROPRIATE BOX(ES) 
[W^a) HUMAN SUBJECTS □ (b) HUMAN TISSUES fj (c) NEITHER 

Q(al) MINORS S*Ta2) INTERVIEWS 



SUMMARY OF WORK (200 words or less - underline keywords) 

Several years ago it was reported by us that some patients on penicillin ther- 
apy, when transfused with donor blood containing hemagglutinating penicillin 
antibody, suffered an untoward reaction similar to anaphylaxis or serum sick- 
ness. We are attempting to establish a prospective, control study to deter- 
mine if passively transferred antipenicillin antibody can induce allergic mani- 
festations in patients who are receiving penicillin or penicillin derivatives as 
part of their therapy. Donors will be screened for a history of penicillin hy- 
persensitivity and their blood will be tested for anti-pencillin antibodies by 
hemagglutination and radioimmunoassay techniques. Recipients of blood from 
donors with a history of penicillin hypersensitivity will be followed for un- 
toward reactions following penicillin therapy and will also be tested for IgG 
and IgE anti -penicillin antibodies. Appropriate controls will be similarly fol- 
lowed. 



BB-23 



PHS-6040 
(Rev. 10-76) 






Serial No. Z01-CC-02003-03 BB 
Blood Bank Department 
Clinical Center 
Bethesda, Maryland 

PHS-NIH 
Individual Project Report 
July 1, 1976 - September 30, 1977 

Project Title: Passive Transfer of Penicillin Hypersensitivity in 
Transfused Blood 

Previous Serial Number: Z01-CC -02003-02 BB 

Principal Investigator: Mary H. McGinniss, AB(ASCP)SBB 

Other Investigators: Harvey J. Alter, M.D. 

Richard J. Davey, M.D. 

Cooperating Units: Inside NIH 

None 

Outside NIH 
None 

Man Years: Total: 0.5 

Professional: 0.5 
Other: 

Project Description 

Objectives : 

A. To study the incidence and type of untoward reaction patients on penicil- 
lin therapy may experience when transfused with blood from a donor 
having a history of penicillin allergy and/ or hem agglutinating or IgE 
penicillin antibody. 

B. To gather data on the number of NIH donors having these types of anti- 
bodies and to do a statistical analysis on the data. 

Methods Employed : 

1. All donors will be questioned regarding a history of penicillin allergy. 
Those with such history will be divided into those with anaphylactic re- ( 
actions and those with just rash. The next consecutive donor after the 
donor giving a positive history of penicillin allergy will serve as a con- 
trol, 

2. An aliquot of serum will be obtained from both allergic and control pa- 
tients and the aliquot tested for IgM, IgG (hemagglutination) and IgE 
(RAST) anti -penicillin antibody. 



BB-2U 






3. Recipients of blood from allergic and control patients will be followed for 
untoward reactions occurring within 48 hours of transfusion. Such reac- 
tions will be correlated with whether or not the recipient is being treated 
with penicillin or a penicillin derivative. 

4. Pre and post transfusion samples will be obtained from those recipients 
who received blood from a donor with detectable anti penicillin antibody 
to determine if passive transfer can be documented. 

Major Findings : 

In 1971, at the American Association of Blood Banks meeting, we reported 
findings in three patients on penicillin suffering untoward reactions which 
retrospectively could only be attributed to the passive infusion of penicillin 
antibody in donor blood. This was the impetus for the present study. 

In the original study, of 2 9 patients who received a unit(s) of blood known to 
contain hemagglutinating penicillin antibody, three (107c) had untoward reac- 
tions of the serum sickness variety which could not be attributed to any other 
factor. 

Subsequently 9 new cases of possible urticarial or serum sickness type of 
reactions following blood transfusion to patients receiving penicillin have 
been observed. A causal relation between donor anti -penicillin antibody 
and recipient reaction has, however, been difficult to document because the 
radioimmunoassay for IgE anti -penicillin antibodies is not working optim- 
ally. 

Significance to Biomedical Research and the Program of the Institute : 

A. Identification of another possible cause of untoward reaction of blood 
transfusion. 

B. If it can be shown that some penicillin reactions in patients are due to 
passive transfer of anti -penicillin antibody, then such patients will not 
need to be restricted from future penicillin therapy. 

C. Similary if it can be shown that such a mechanism for penicillin reactions 
exists, then patients being treated with penicillin will have to receive 
blood from donors without a history of penicillin allergy and/or without 
demonstratable anti -penicillin antibodies. 

Proposed Course : 

Setting up a working radioimmunoassay test for detecting IgE penicillin anti- 
body, continued testing of new NUi donors for hemagglutinating penicillin 
antibody and monitoring of patient's response to such transfusions. 

Publications: None 



BB-25 



smi thsun : ..'. UiiCNce r;.-:-. wo'i exchange 

PROJECT NUMBER (oo nOT use ':••* spice J 



U.S. DEPARTMENT OF j PROJECT NUM6ER 
HEALTH, EDUCATION, AND o'ELFARE j 
PUBLIC HEALTH SERVICE 

,ntra«ural°resLSh project ZOl -CC -02005 -08 BB 



PERIOD COVERED 

July 1, 1976 - September 30, 1977 



TITLE OF PROJECT (SO characters or less) 

Prospective Study of Post -transfusion Hepatitis in Open Heart Surgery 
Patients ■ 



NAMES, LABORATORY AND INSTITUTE AFF ILI ATI CIS, AND TITLES OF PRINCIPAL INVESTIGATORS AND ALL OTHER 
PROFESSIONAL PERSONNEL ENGAGED ON THE PROJECT 

Principal Investigator: Harvey J. Alter*, M.D., Chief, Immunology Section, 

Clinical Center Blood Bank 

Other: Paul V. Holland, M. D. , Chief, Clinical Center Blood Bank 

Robert H. Pur cell, M. D. , Head, Hepatitis Virus Section, LID, NIAJJj 
Andrew G. Morrow, M. D. , Chief, Clinic of Surgery, NHLI 



COOFERATING UNITS (if any) 

NIAID, NHLI 



LAB/BRANCH 

Blood Bank Department 



SECTION 

Immunology Section 



INSTITUTE AND LOCATION 

Clinical Center, Bldg. lOA/Room 1E33, NIH, Bethesda, Maryland 20014 



TOTAL MANYEARS: PROFESSIONAL: 

12 4 



OTHER: 



CHECK APPROPRIATE EOX(ES) 

[V(a) HUMAN SUBJECTS Q (b) HUMAN TISSUES □ (c) NEITHER 



□ (al) MINORS Tj<T.2) INTERVIEWS 



SUMMARY OF WORK (200 words cr less - underline keywords) 

To prospectively follow all adult patients undergoing open heart surgery for 
the development of post -transfusion hepatitis and by appropriate serologic 
tests to determine the causative agents. Primarily interested in investigating 
the incidence of " non-A, non-B " hepatitis and to see if there are any epidemi- 
ologic or serologic clues to its prevention. This study will also compare the 
clinical course of the various forms of PTH and determine the frequency 
with which chronic hepatitis developes. 



i 



BB-26 



PHS-604C 
(Rev. l0-7b^ 



Serial No. Z01 -CC-02005-08 BB 
Blood Bank Department 
Clinical Center 
Bethesda, Maryland 

PHS-NIH 
Individual Project Report 
July 1, 1976 - September 30, 1977 

Project Title: Prospective Study of Posttransfusion Hepatitis (PTH) in Open 
Heart Surgery Patients. 

Previous Serial Number: Z01-CC -02005-07 BB 

Principal Investigator: Harvey J. Alter, M.D. 

Other Investigators: Robert Pure ell, M.D. 

Paul V. Holland, M.D. 
Andrew G. Morrow, M.D. 

Cooperating Units: Inside NIH 

NIAID, NHLI 

Outside NIH 
None 

Man Years: Total: 12 

Professional: 4 
Other: 8 

Project Description 
Objectives : 

1. To prospectively follow all adult patients undergoing open heart surgery 
at NIH for evidences of PTH. 

2. To determine the relative occurrences of type B, type A and type non-A, 
non-B hepatitis. 

3. To determine the effectiveness of various tests for HBsAg for screening 
blood donors. 

4. To compare the clinical course of the various forms of PTH and to deter- 
mine the frequency with which chronic hepatitis develops. 

5. To develop improved screening methods for type B and type non-B hepa- 
titis. 

Methods : 

1. All adult patients undergoing open heart surgery are followed for six to 
nine months with serial tests for SGPT, HBsAg and anti-HBs. 



BB-27 



2. Cases of hepatitis are additionally tested for serologic response to CMV, 
EBV and the hepatitis A virus; if type B disease, they are tested for anti 
core antibody, e antigen, DNA polymerase and are subtyped. 



I 



3. Donors are tested by the most sensitive methods for HBsAg currently 
available. In addition donors will be tested for SGPT to see if this relates 
to recipient hepatitis. 

Major findings : Studies to date have demonstrated: 

1. The increased risk of blood containing HBsAg. I 

2. A 90% reduction in hepatitis by exclusion of commercial and HBsAg posi- 
tive donors. 

3. The superiority of RIA over CEP as a donor screening method. 

4. The fact that approximately 90% of PTH is now due to a previously unrec- 
ognized virus (or viruses) currently termed "non-A, non-B. " 

5. That the type A hepatitis virus is almost never implicated in PTH: neither 
have the CMV or EBV been implicated in our cases. 

6. That non-A, non-B hepatitis is generally less acutely severe than type-B 
but that it tends to frequently become chronic. 

Significance to Biomedical Research and the Program of the Clinical Center 

These studies have been instrumental in establishing many key points con- I 
cerning the frequency, etiology and prevention of PTH at the Clinical Center 
and across the United States. 

Proposed Course : See objectives and methods. 

Publications : 

Holland, P.V., Alter, H. J. , Purcell, R.H., Walsh, J.H., Morrow, A.G., 
and Schmidt, P. J. : The infectivity of blood containing the Australia antigen. 
In Prier, J.E. and Friedman, H. (Eds.): Australia Antigen . Baltimore, 
University Park Press, 1973, pp. 205-211. 

Alter, H.J., Holland, P.V., Purcell, R.H., Lander, J. J. , Feinstone, S. M. 
Morrow, A.G., and Schmidt, P.J. : Posttransfusion hepatitis after exclusion 
of the commercial and hepatitis B antigen positive donor. Ann. Int. Med. 77: 
691-699, 1972. 



Feinstone, S. M. , Kapikian, A.Z., Purcell, R.H., Alter, H. J. , and Holland, 
P. V. : Transfusion-associated hepatitis not due to viral hepatitis type A or 
B. N. Eng. J. Med . 292: 767-770, 1975. 

Alter, H. J. , Holland, P. V. , and Purcell, R. H. : The emerging pattern of 
post -transfusion hepatitis. Am. J. Med. Sci. 270: 329-334, 1975. 



BB-28 



SMITHSONIAN SCIENCE INFORMATION EXCHANGE 
PROJECT NUMBER (Do NOT use this space) 



PERIOD COVERED 

July 1, 1976 



U.S. DEPARTMENT OF 
HEALTH, EDUCATION, AND WELFARE 
PUBLIC HEALTH SERVICE 
NOTICE Of 
INTRAMURAL RESEARCH PROJECT 



PROJECT NUMBER 



ZOl-CC -02006-03 BB 



September 30, 1977 



TITLE OF PROJECT (80 characters or less) 

Investigation of the Efficacy of Frozen Washed Blood for the Prevention 
Df Post -transfusion Hepatitis 



NAMES, LABORATORY AND INSTITUTE AFFILIATIONS, AND TITLES OF PRINCIPAL INVESTIGATORS AND ALL OTHER 
PROFESSIONAL PERSONNEL ENGAGED ON THE PROJECT 

Principal Investigator: Harvey J. Alter, M.D., Chief, Immunology Section, 

CCBBD 



Other: 



COOPERATING UNITS (if any) 

American Red Cross and Bureau of Biologies, FDA 



LAB/BRANCH 

Blood Bank Department 



Paul V. Holland, M. D. 
Lewellys Barker, M.D 



Chief, Blood Bank Department, CC 
Chief, DBBP, Bureau of Biologies, FDA 



Edward Tabor, M.D., 
Robert Gerety, M.D., 
Jay Hoofnagle, M. D. , 
Richard Kahn, Ph. D. , 
Harold Merryman, M. 



Clinical Associate, Bureau of Biologies, FDA 
Head, Hepatitis Section, Bureau of Biologies, 
Hepatology Fellow, V A Hospital, Wash., D.C. 
Scientist, American Red Cross 
D. , Research Scientist, American Red Cross 



FDA 



SECTION 



Immunology Section 



INSTITUTE AND LOCATION 

Clinical Center. Building 10A/ Room 1E3 3, NIH, Bethesda, Maryland 20014 



TOTAL MANYEARS: 

2 



PROFESSIONAL: 



1 



OTHER: 



CHECK APPROPRIATE BOX(ES) 
G (a) HUMAN SUBJECTS 

□ (a1 ) MINORS □ (a2) INTERVIEWS 



□ (b) HUMAN TISSUES 



¥{c) NEITHER 



SUMMARY OF WORK (200 words or less - underline keywords) 

Human blood will be inoculated with a well characterized inoculum known to 
uniformly cause hepatitis in chimpanzees. The infected blood will then be 
frozen and washed by two different methods and then transfused to four to 
six chimpanzees. If the chimps do not develope hepatitis suggesting freez- 
ing is effective, they will serve as their own controls and the second time 
receive the same inoculum which has been washed but not frozen. If they 
still do not get hepatitis, they will then receive the same inoculum in direct 
transfusion without prior washing or freezing. 



3B-29 



PHS-6040 
(Rev. 10-76) 



Serial No. Z01-CC-02006-03 BB 
Blood Bank Department 
Clinical Center 
Bethesda, Maryland 

PHS-NIH 

Individual Project Report 

July 1, 1976 - September 30, 1977 

Project Title: Study in Chimpanzees of the Efficacy of Frozen Blood for the I 
Prevention of Post -transfusion Hepatitis 

Previous Serial Number: Z01-CC-02006-02-BB 

Principal Investigator: Harvey J. Alter, M.D. 

Other: L. Barker, M.D. , P.V. Holland, M. D. , E. Tabor, M. D. , 
R. Gerety, M. D. , H. Merryman, M. D. , R. Kahn, Ph. D. 
and J. Hoofnagle, M. D. 

Cooperating Units: Inside NIH 

None 

Outside NIH 

ARC and BOB, FDA 



Man Years: Total: 2 

Professional: 1 
Other: 1 

Project Description 

Objectives : 

1. To see if blood with a known infectious dose of hepatitis B virus can be 
rendered non-infectious by freeze -washing or washing alone. 

Methods : 

1. Blood will be "spiked" with a dose of HBV -proven to be uniformly infect- 
ive in chimps. 

2. Two units of inoculated blood will undergo the typical freeze wash cycle 
employed at NIH (IBM method) and two will undergo the standard freeze- 
wash cycle at ARC (Haemonetics method). These will then be transfused 
to four susceptible chimpanzees. 

3. If the chimpanzees do not develop hepatitis or serologic evidence of type 
B infection, they will then serve as their own controls and receive a 
second transfusion of "spiked" blood this time being washed but not frozen. 



* 



3B-30 



$ 



4. If the chimpanzees do not develop hepatitis after step (3), they will 
receive the same inoculum this time without any prior treatment. 

Major Findings : 

All four inoculated chimps developed evidence of type B infection despite 
prior treatment of the blood by freezing and deglycerolization (F and D). In 
two of the chimps it appeared that this process attenuated the disease and 
prolonged the incubation period, but in the other two full blown hepatitis B 
developed. We would conclude that in the chimpanzee model freezing and 
deglycerolization as typically performed on human blood units was not ade- 
quate to prevent type B hepatitis infection. 

Significance to Biomedical Research and the Program of the Clinical Center 

This study refutes previous claims in uncontrolled human studies that freez- 
ing and deglycerolization of blood renders blood hepatitis free. It does not 
negate the use of frozen blood because this product has many other potential 
advantages, but it does potentially negate the one use of frozen blood which 
would justify its routine application in all transfusion settings. The study 
does not answer the question of the efficacy of freezing and deglycerolization 
for the prevention of type non-A, non-B hepatitis and, at present, human 
trials will be necessary for this. 

Proposed Course : 

Because each of the chimps became infected in the first phase of the study, 
there is no need for them to serve as their own controls to receive washed 
but unfrozen blood or to receive blood which has not been treated. The 
study will thus be prepared for publication and terminated. 



BB-31 



SMITHSONIAN SCIENCE INFORMATION EXCHANGE 
PROJECT NUMBER (Do NOT use this space) 



U.S. DEPARTMENT OF 
HEALTH, EDUCATION, AND WELFARE 
PUBLIC HEALTH SERVICE 
NOTICE OF 
INTRAMURAL RESEARCH PROJECT 



PROJECT NUMBER 

Z01-CC-02007-02 BB 



PERIOD COVERED 

July 1. 1976 - September 30. 1977 



TITLE OF PROJECT (30 characters or less) 



Tnfectivit.y of HRsAg-positive saliva and semen 



NAMES, LABORATORY AND INSTITUTE AFFILIATIONS, AND TITLES OF PRINCIPAL INVESTIGATORS AND ALL OTHER 
PROFESSIONAL PERSONNEL ENGAGED ON THE PROJECT 

I 

Principal Investigator: Harvey J. Alter, M.D., Chief, Immunology Section, 

CCBBD 

Other: Robert Pur cell, M.D., Chief, Hepatitis Viruses Section, NIAID 
John Gerin, M. D. , Chief, Molecular Anatomy Program, Union 
Carbide 
Paul V. Holland, M. D. , Chief, Blood Bank Department, CC 



COOPERATING UNITS (if any) 



NIAID and AEC 



CHECK APPROPRIATE BOX(ES) 
g'fa) HUMAN SUBJECTS 

D (al) MINORS □ (a2) INTERVIEWS 



LAB/BRANCH 

Blood Bank Department 



SECTION 

Immunology Section 



4 



INSTITUTE AND LOCATION 

Clinical Center, Building 10A, Room 1E33, NIH, Bethesda, Maryland 20014 

TOTAL MANYEARS: I PROFESSIONAL: lOTHER: 

1.5 0.5 1 



□ (b) HUMAN TISSUES 



□ (c) NEITHER 



SUMMARY OF WORK (200 words or less - underline keywords) 

HBsAg-positive saliva and semen from persons with an epidemiologic history 
suggesting non- par enteral transmission of hepatitis B will be inoculated into 
chimpanzees . The chimps will be followed for clinical, enzymatic, and sero- 
logic evidence of type B hepatitis and the inoculum will be characterized for 
the predominant type of particle and for DNA polymerase and e antigen . 



* 



BB-32 



PHS-6040 
(Rev. IO-76) 



Serial No. Z01 -CC -02007-02 BB 
Blood Bank Department 
Clinical Center 
Bethesda, Maryland 

PHS-NIH 
Individual Project Report 
July 1, 1976 - September 30, 1977 

Project Title: Infectivity of HBsAg-positive saliva and semen 

Previous Number: Z01-CC-02007-01-BB 

Principal Investigator: Harvey J. Alter, M.D. 

Other: Robert Purcell, M.D. 
John Gerin, M.D. 
Paul V. Holland, M.D. 

Cooperating Units: Inside NIH 

NIAID 

Outside NIH 

AEC 

Man Years: Total: 1.5 

Professional: 0.5 
Other: 1 

Project Description 

Objectives : 

To determine if HBsAg -positive saliva and semen are infectious. 

Methods : 

1. HBsAg-positive saliva and semen specimens obtained from individuals 
with a history suggesting non-parenteral spread of type B hepatitis will 
be inoculated into chimpanzees. The chimps will then be followed with 
serial tests to establish the development of hepatitis and serologic re- 
sponses to the type B hepatitis virus. If hepatitis developes, liver biop- 
sies will be obtained. 

2. The inocula will be characterized regarding the presence of Dane par- 
ticles, DNA polymerase, and e_ antigen as well as the subtype of HBsAg. 

Major Findings : 

One chimp inoculated intravenously with HBsAg-positive saliva has develop- 
ed type B hepatitis. This has proven that HBsAg-positive saliva is infect- 
ious. A second chimp inoculated intravenously with HBsAg-positive semen 
has developed probable hepatitis (died before completion of study). 



BB- 



33 



Significance to Biomedical Research and the Program of the Clinical 
Center 

There is increasing indirect evidence that hepatitis B can be transmitted 
by routes other than blood. In addition, HBsAg has been detected in both 
saliva and semen. This suggests that these secretions might be the vehicle 
for non -par enteral transmission. However, there is also considerable evi- 
dence that most hepatitis B antigen is non- infectious. No one has ever dem- 
onstrated that HBsAg when found in saliva and semen is associated with in- 
fectious particles. Our experiment has now documented that saliva, and 
probably semen, with HBsAg in it is indeed infectious and can result in hep- 
atitis B after inoculation. 

Proposed Course : Study complete 

Publications : 

Alter, H.J. , Purcell, R. H. , Gerin, J. L. , London, W.T., Kaplan, P.M., 
McAuliffe, V. J. , Wagner, J. A., and Holland, P.V.: Transmission of 
Hepatitis B to chimpanzees by hepatitis B surface antigen positive saliva 
and semen. Infection and Immunity 16: 928-933 (June 1977). 



BB-3U 






SMITHSONIAN SCIENCE INFORMATION EXCHANGE 
PROJECT NUMBER (Oo NOT use this space) 



U.S. DEPARTMENT OF 
HEALTH, EDUCATION, AND WELFARE 
PUBLIC HEALTH SERVICE 
NOTICE OF 
INTRAMURAL RESEARCH PROJECT 



PROJECT NUMBER 

Z01-CC-02008-05-BB 



PERIOD COVERED 

July 1, 1976 



September 30, 1977 



TITLE OF PROJECT (80 characters or less) 



Hepatitis Transmission in a Renal Dialysis Unit 



NAMES, LABORATORY AND INSTITUTE AFFILIATIONS, AND TITLES OF PRINCIPAL INVESTIGATORS AND ALL OTHER 
PROFESSIONAL PERSONNEL ENGAGED ON THE PROJECT 



Principal Investigator: 



Harvey J. Alter, M.D., Chief, Immunology Section, 
Blood Bank Department, CC 



Dther: Paul V. Holland, M. D. , Chief, Blood Bank Department, CC 
Jacqueline C. Melpolder, Research Technologist, CCBBD 
L. Segal, M.D., Staff Physician, MWRDC 
J. Frank, Chief Nurse, MWRDC 
W. Cirksena, M. D. , Staff Physician, MWRDC 
J. Knepschield, M.D., Staff Physician, MWRDC 



COOPERATING UNITS (if any) 

Metropolitan Washington Renal Dialysis Center 



LAB/BRANCH 

Blood Bank Department 



SECTION 

Immunology Section 



INSTITUTE AND LOCATION 

Clinical Center, Building lOA/Room 1E33, NIH, Bethesda, Maryland 20014 



TOTAL MANYEARS: 
4 



PROFESSIONAL: 



OTHER: 



CHECK APPROPRIATE BOX(ES) 
S*fa) HUMAN SUBJECTS 

D (al) MINORS B^a 2 ) INTERVIEWS 



□ (b) HUMAN TISSUES 



□ (c) NEITHER 



SUMMARY OF WORK (200 words or less - underline keywords) 

This study consists of the long-term, prospective follow-up of patients 
undergoing renal dialysis in a large metropolitan center. Patients will be 
monitored for the development of hepatitis B antigen and antibody and for 
the development of other forms of hepatitis . Epidemiologic patterns of 
spread will be analyzed and the frequency and severity of hepatitis 
among patients and staff will be compared. 



BB-35 



PHS-6040 
(Rev. 10-76) 



Serial No. Z01 -CC-02008-05-BB 
Blood Bank Department 
Clinical Center 
Bethesda, Maryland 

PHS-NIH 
Individual Project Report 
July 1, 1976 - September 30, 1977 

Project Title: Hepatitis Transmission in a Renal Dialysis Unit 

Previous Project Number: Z01-CC-02008-04-BB 

Principal Investigator: Harvey J. Alter, M.D. 

Other: L. Segal, M.D., J. Melpolder, B. S. , W. Cirksena, M.D. 

J. Knepschield, M.D., J. Frank, R.N., andP.V. Holland, M.D. 

Cooperating Units: Inside NIH 

None 

Outside NIH 

Metropolitan Washington Renal Dialysis Unit 

Man Years: Total: 4 

Professional: 2 
Other: 2 

Project Description 

Objectives : 

1. To determine the overall incidence of hepatitis in a large renal dialysis 
unit, and to determine the proportion which is B and non-B. 

2. To determine the duration of HBsAg-positivity among patients and the 
number who develope serologic evidence of type B infection without 
enzymatic evidence of hepatitis. 

3. To test the hypothesis that renal dialysis patients, as opposed to staff, 
are unable to clear HBsAg and tend to become chronic carriers. 

4. To determine the relative infectivity of dialysis patients with HBsAg by 
measuring e_ antigen in their sera. 

5. To try to elucidate the mode of hepatitis B virus transmission within 
dialysis units. 



BB-36 



Methods Employed : 

1. Renal dialysis patients and staff at the MWRDC will be tested monthly 
for SGPT, HBsAg and anti-HBs. 

2. HBsAg positive individuals will be subtyped and tested for e antigen. 

3. From these data, the incidence of hepatitis, serologic resnonse to HBsAg, 
duration of HBsAg, subtype of HBsAg, duration of transaminase elevation 
and relative infectivity can be assessed in patients and staff. 

4. To establish epidemiologic patterns from logbooks and environmental 
sampling for HBsAg. 

Major Findings : 

To date, the frequency of hepatitis B virus (HBV) transmission is extremely 
high. At least 25% of patients show evidence of HBV infection. A previously 
unreported finding is that most dialysis patients handle HBV infection very 
well and manifest only transient antigenemia. Those who have transient 
antigenemia tend to have HBsAg detectable only by RIA, whereas chronic 
carriers have higher titers of HBsAg. As in other dialysis units, the ayw sub- 
type predominates. Hepatitis B infection is less frequent, but more severe, 
among staff members. Data from this study through 12/31/76 is currently 
being analyzed for publication. 

Significance to Biomedical Research and the Program of the Clinical Center 

This dialysis unit has been closely followed almost since its inception, and 
the incidence figures and patterns of spread provide useful data on hepatitis 
transmission in this setting. The finding that most dialysis patients actually 
handle HBV infection quite well has not been previously reported. This di- 
alysis unit will provide baseline data for clinical trials of a hepatitis B vac- 
cine and will likely be one of the units involved in these trials. 

Proposed Course: See objectives. 



BB-3T 



SMITHSONIAN SCIENCE INFORMATION EXCHANGE 
PROJECT NUMBER (Do NOT use this space) 



U.S. DEPARTMENT OF 
HEALTH, EDUCATION, AND WELFARE 
PUBLIC HEALTH SERVICE 
NOTICE Of 
INTRAMURAL RESEARCH PROJECT 



PERIOD COVERED 

July 1, 1976 - September 30, 1977 



PROJECT NUMBER 

Z01-CC-02009-03-BB 



TITLE OF PROJECT (80 characters or less) 



Assessment of the Infectivity of HBsAg-Containing Blood Using In- Vitro 
Assays of DNA Polymerase and e-Antigen 



Don!c^i B ° RAT0RY AHD 'NSTITUTE AFFILIATIONS, AND TITLES OF PRINCIPAL INVESTIGATORS AND ALL OTHER 

PROFESSIONAL PERSONNEL ENGAGED ON THE PROJECT o.^H.una all UTHtR 

Principal Investigator: Harvey J. Alter, M.D., Chief, Immunology Section! 

Blood Bank Department, CC 

° ther: Hospft r al, S Wash M 'D C ^^ HepatLtiS Studies ' Veterans Administrate 
Paul Kaplan, Ph. D. , Research Scientist, Molecular Anatomy Branch, 

Vincent McAuliffe, M.D., Clinical Associate, LID, NIAID 
John Gerin Ph. D. Head, Molecular Anatomy Program, Union Carbii 
Elizabeth Wright, Ph.D., Statistician, VA Hospital, Wash D C 
Robert Pure ell, M.D., Head, Hepatitis Virus Section, LID, NIAID 
Paul V. Holland, M. D. , Chief, Blood Bank Department, CC 



COOPERATING UNITS (if any) ~ 

VA Hospital, Washington, D.C. 

NIAID, Molecular Anatomy Program, AEC 



LAB/ BRANCH " 

Blood Bank Department 



SECTION 



Immunology Section 



INSTITUTE AND LOCATION 



af?%^^^^ NIH, Bethesda. Marv^nH snout 



OTHER: 



CHECK APPROPRIATE BOX(ES) 
S/f.) HUMAN SUBJECTS D (b) HUMAN T I SSUES D (c) NEITHER 

D (al) MINORS Q ( a 2) INTERVIEWS 



SUMMARY 0F W0RK (200 words or less - underline keywords) 



Donor-recipient pairs involved in the VA cooperative study to evaluate 
nepatitis g immune globulin following accidental needlestick will be tested 
to determine the association between DNA polymerase and e antigen in 
the donor and hepatitis in the recipie nt. Preliminary e viden5eT5Hca?e S 
these will be good indicators of infectivity. maicaxes 

£. a i diti ° n ' health worke rs with acute and chronic hepatitis will be tested 
tor these same parameters to assess their relative infectivity. 



BB-38 



PHS-6040 
(Rev. 10-76) 



Serial No. Z01-CC-02009-03 BB 
Blood Bank Department 
Clinical Center 
Bethesda, Maryland 

PHS-NIH 

Individual Project Report 

July 1, 1976 - September 30, 1977 

Project Title: Assessment of the Infectivity of HBsAg -Containing Blood 
Using In - Vitro Assays for DNA Polymerase and e Antigen 

Previous Serial Number: Z01-CC -02009-02 BB 

Principal Investigator: Harvey J. Alter, M.D. 

Other: L. Seeff, M.D., P. Kaplan, Ph.D., V. McAuliffe, M.D. 
J. Gerin, Ph.D., E. Wright, Ph.D., R. PurceU, M.D. 
and P. Holland, M.D. 

Cooperating Units: Inside NIH 

NIAID 

Outside NIH 

Washington V. A. Hospital and AEC 

Man Years: Total: 3 

Professional: 2 
Other: 1 



Project Description 



Objectives: 



1. To test donor and recipient pairs enrolled in a VA cooperative study of 
hepatitis following accidental needle stick to determine if: 

(a) the measurement of DNA-polymerase and e_ antigen in the donor will 
predict the hepatitis outcome in the recipient and, 

(b) to see if the infectivity of the inoculum correlates better with recip- 
ient hepatitis than does the treatment received (i. e. type of gamma 
globulin). 

2. To test HBsAg-positive health workers to see if DNA polymerase and 
e -antigen correlate with the duration of antigenemia and the degree of 
SGPT elevation. 



B3-39 



Methods Employed : 

1. In the VA study, donors will be tested under code to determine the pre- 
sence of hepatitis B specific DNA polymerase and e antigen. When the 
determinations are complete, the code will be broken and an estimate 
made of the correlation between these in vitro parameters in the donor 
and hepatitis in the recipient. DNA polymerase will be measured by 
incorporation of 3H thymidine into DNA and e antigen by gel diffusion. 
Nee die stick recipients have been prospectively and carefully monitored 
for hepatitis. 

2. In the health worker study, serial samples will be obtained from those 
with acute disease, those with chronic hepatitis, and the asymptomatic 
carrier state. 

Major Findings : 

A very strong association was found between the presence of DNA polymer- 
ase and the presence of e antigen in HBsAg-positive sera. More significant- 
ly, each was strongly associated with the infectivity of the blood in which 
they were detected; DNA and e antigen positive blood resulted in hepatitis in 
the vast majority of recipients accidently inoculated with such blood whereas 
DNA and e negative blood did not result in infection (p<. 001). (See publica- 
tions). 

Significance to Biomedical Research and the Program of the Clinical Center 

The ability to determine the relative infectivity of an HBsAg carrier by an i 
in - vitro method is extremely important in situations of potential non-parent- " 
eral transmission or in situations where the inoculum is small, such as ac- 
cidental needlestick. It may have major implications for antigen -positive 
health workers. 

These studies also suggest that the recently completed clinical trials of HBIG 
must be reevaluated to determine the infectivity of the inoculum because this 
may be more important than the treatment received. 

Proposed Course : 

This study is now being expanded so as to examine all patients and recipients 
in the VA trial of HBIG for the prevention of hepatitis following accidental 
needlestick. The impact of e antigen testing on interpretation of this clinical 
trial is also being evaluated? Preliminary evidence indicates that if one looks 
only at recipients of infectious blood (i. e. e or DNA positive) then the effect g. 
of HBIG as compared with ISG is even more striking than previously reported! 



BB-I4Q 



Publications : 

Alter H J Seeff, L. B. , Kaplan, P.M., McAuliffe, V. J. , Wright, E.C., 
TPrin I*L Pure ell, R. H. , Holland, P.V. and Zimmerman, H. J. : Type 
B Hepatitisi The infeetivity of blood positive for e antigen and DNA polymer- 
ase after accidental needlestick exposure. New Engl. J. Med . 29o: 909-913, 
1976. 



BB-ia 



SMITHSONIAN SCIENCE INFORMATION EXCHANGE 
PROJECT NUMBER (Do NOT use this space) 



July 1. 1976 - September 30. 1977 



PERIOD COVERED 



U.S. DEPARTMENT OF 
HEALTH, EDUCATION, AND WELFARE 
PUBLIC HEALTH SERVICE 
NOTICE OF 
INTRAMURAL RESEARCH PROJECT 



PROJECT NUMBER 

Z01-CC-02010-03 BB 






TITLE OF PROJECT (80 characters or less 



Chronic Sequelae of Non-A, Non-B Hepatitis 



NAMES, LABORATORY AND INSTITUTE AFFILIATIONS, AND TITLES OF PRINCIPAL INVESTIGATORS AND ALL OTHER 

PROFESSIONAL PERSONNEL ENGAGED ON THE PROJECT vtoimAlUKb AND ALL OTHER 

Principal Investigator: Harvey J. Alter, M.D., Chief, Immunology Section J 

Blood Bank Department, CC 

Other: Paul V. Holland, M. D. , Chief, Blood Bank Department, CC 

Robert Pure ell, M.D., Head Hepatitis Virus Section, LID, NIAID 
Paul Berk, ■M.D. , Chief, Section on Diseases of the Liver. DDB 
NIAMDD 



COOPERATING UNITS (if any) 

NIAID, NIAMDD 



LAB/ BRANCH 

Blood Bank Department 



SECTION 



Immunology Section 



_ 

-4 



NST1TUTE AND LOCATION " " ■ . 

Clinical Center, Building 10A /Room 1E33, NIH, Bethesda, Maryland 20014 

TOTAI M4MVCABC. I — . J 



TOTAL MANYEARS: 



PROFESSIONAL: lOTHER: 







CHECK APPROPRIATE BOX(ES) 
BT(a) HUMAN SUBJECTS D (b) HUMAN TISSUES Q(c) NEITHER 

D (al) MINORS gf(a2) INTERVIEWS 



SUMMARY Oh WORK (200 words or less - underline keywords) " 

Patients identified as having non-A, non-B hepatitis will be followed as long 
as possible. Liver biopsy will be obtained when the SGPT is elevated for 
more than 6 months and then as indicated thereafter. Biopsy material will 
be saved for fluorescent studies when reagents for non-A, non-B hepatitis 
become available. ""'" r 

All patients developing non-A, non-B hepatitis following open heart surgery 
will be followed with serial studies of SGPT to determin e the incidence 
of chronic liver disease and to compare this incidence with those having type 
B hepatitis. s J ^ 



I BB-U2 

PHS-6040 " " 

(Rev. 10-76) 



Serial No. Z01 -CC-02010-03 BB 
Blood Bank Department 
Clinical Center 

Bethesda, Maryland 

PHS-NIH 
Individual Project Report 
July 1, 1976 - September 30, 1977 

Project Title: Chronic Sequelae of Non-A, Non-B Hepatitis 

Previous Serial Number: 76-CC-2 

Principal Investigator: Harvey J. Alter, M.D. 

Other: R. Pure ell, M. D. 
P. Berk, M.D. 
P. Holland, M.D. 

Cooperating Units: Inside NIH 

NIAID, NIAMDD 

Outside NIH 
None 

Many Years: Total: 2 

Professional: 2 

Project Description 

Objectives : 

1. To establish long-term follow-up of patients identified as having non-A, 
non-B hepatitis in post -transfusion hepatitis (PTH) studies conducted at 
NIH since 1963. 

2. To determine by SGPT the frequency of chronic hepatitis. 

3. To determine by liver biopsy the histologic pattern of non-A, non-B hepa- 
titis and to save biopsy specimens for future immunofluore scent studies 
when reagents become available for non-A, non-B hepatitis. 

Methods Employed : See objectives 

Major Findings : 

Chronic hepatitis frequently follows acute non-A, non-B hepatitis and in the 
patients thus far biopsied the histologic picture is similar to chronic type B 
hepatitis, showing features of either chronic persistent or chronic active 
hepatitis. 



BB-1+3 



Significance to Biomedical Research and the Program of the Clinical Center I 

Non-A, non-B hepatitis now accounts for 80% of PTH and is thus a major 
transfusion hazard. While it tends to be less acutely severe than type B 
hepatitis, preliminary evidence suggests that it progresses to chronic hepa- 
titis with considerable frequency. Very little is known about this disease 
and it is imperative that clinical and serologic studies be undertaken. It is 
possible that a high percentage of chronic active hepatitis and cryptogenic 
cirrhosis represent the chronic sequelae of a previously unrecognied case j 
of anicteric non-A, non-B hepatitis. 

Proposed Course : See objectives. 

Publications: None 



BB-U4 






SMITHSONIAN SCIENCE INFORMATION EXCHANGE 
PROJECT NUMBER (Do NOT use this space) 



U.S. DEPARTMENT OF 
HEALTH, EDUCATION, AND WELFARE 
PUBLIC HEALTH SERVICE 
NOTICE OF 
INTRAMURAL RESEARCH PROJECT 



PROJECT NUMBER 

Z01-CC-02011-03-BB 



PERIOD COVERED 



■ Tulv 1. 1976 _ September 30 _ 1977 



TITLE OF PROJECT (BU characters or less) 

The Duffy Blood Group Determinant and Susceptibility to Malaria 



NAMES, LABORATORY AND INSTITUTE AFFILIATIONS, AND TITLES OF PRINCIPAL INVESTIGATORS AND ALL OTHER 
PROFESSIONAL PERSONNEL ENGAGED ON THE PROJECT 

D rincipal Investigator: Louis H. Miller, M.D., Head Malaria Section, LPD, 

NIAID 

pther: Mary McGinniss, AB(ASCP)SBB, Research Biologist, Clinical 
Center Blood Bank 
Paul V. Holland, M.D., Chief, Clinical Center Blood Bank 



COOPERATING UNITS (if any] 



;aboratory Parasitic Diseases, NIAID 



LAB/BRANCH 

Blood Bank Department 



SECTION 

immunology Section 



INSTITUTE AND LOCATION 

Clinical Center, Bldg. 10A, Room IE 33, NIH, Bethesda, Maryland 20014 



TOTAL MANYEARS: 

2 



PROFESSIONAL: 



OTHER: 



CHECK APPROPRIATE BOX(ES) 

j^fa) HUMAN SUBJECTS □ (b) HUMAN TISSUES 

D(al) MINORS [V(a2) INTERVIEWS 



□ (c) NEITHER 



SUMMARY OF WORK (200 words or less - underline keywords) 

Working with an in vitro model for invasion of red cells by malaria mero - 
zoite , this study has demonstrated that human red cells lacking the Duffy a 
and b antigens are resistant to invasion. This corresponds well with epidem- 



iologic studies which show that approximately 70% of West African and Amer- 
ican blacks are resistant to Vivax malaria. A similar proportion of these 
blacks are Duffy a and b negative whereas the Duffy negative genotype is ex- 
tremely rare in other racial groups. The close association between the 
Duffy negative genotype and resistance to Vivax malaria has also been con- 
firmed by retrospective analysis of 11 volunteers experimentally inoculated 
with P. Vivax. A larger study in humans is planned; this will involve cor- 
relation of Duffy phenotypes of U. S. servicemen who acquired malaria in 
South -East Asia and comparison with the frequencies of Duffy phenotypes in 
a. control population. 



3B-U5 



PHS-6040 
(Rev. 10-76) 



Serial No. Z01-CC-02011 -03-BB 
Blood Bank Department 
Clinical Center 
Bethesda, Maryland 

PHS-NIH 
Individual Project Report 
July 1, 1976 - September 30, 1977 

Project Title: The Duffy Blood Group Determinant and Susceptibility to 
Malaria J 

Previous Serial Number: Z01-CC-02011 -02-BB 

Principal Investigator: Louis H. Miller, M.D. 

Other: Mary H. McGinniss, AB(ASCP)SBB 
Paul V. Holland, M.D. 

Cooperating Units: Lab. Parasitic Disease, NIAID 

Man Years: Total: 1 

Professional: 1 

Project Description 
Objectives : 

1 ' JL US 1 a £f d ° el i CUlture techn ^e to determine if invasion of erythro- 
cytes by Plasmodium falciparum is dependent upon antigenic deteVm^n 
ants™ the erythrocyte membrane similar to th5t?3o?VW 

2 ' -ent^e^al **■»*» the sequence of 

" S^SSS^^ *> ~ malaria, 

4 - iieT/o^s e :^zz en ^^r c receptors - e - sponsibie ** ™- 

Methods Employed : 

U of KKrV™™ meroz ° ites are added to RBC in culture and the degree 

or de stroy thlt site withTpeSlc l&S&'k ^^eltSS. * ^ 

j 

BB-U6 



3. Blood Samples for Duffy phenotype are being collected in U.S. service- 
men who had malaria in South-East Asia. 

Major Findings : 

Thus far one cell among many tested was not invaded normally by P. falci- 
parum parasites. This is a very rare cell known as En(a-). This cell lacks 
sialic acid and therefore M and N antigens. This cell is also Wr(b-) which 
is a universal antigen. One person who is En(a+) is Wr(b-). We have made 
plans to secure these rare cells and other cells having low levels of sialic 
acid to see if low invasion by P. falciparum parasites is due to lack of sialic 
acid, or the lack of the En a or Wr b antigens. 

Significance to Biomedical Research and the Program of the Clinical 

Center 

1. Elucidation of the mechanisms of red cell invasion by P. falciparum. 

2. Increased knowledge of erythrocyte polymorphisms. 

3. x^ccumulation of data which could culminate in a vaccine or other 
means of malaria prevention. 

Publications 

1. Miller, L. H. , Mason, S. J. , Clyde, D.F., and McGinniss, M.H. : The 
resistance factor to Plasmodium vivax in blacks. N. Eng. J. Med. 
295: 302-304, 1976. 

2. Miller, L.H. , Haynes, J. D. , McAuliffe, F. M. , Shiroishi, T., 
Durocher, J. R. , and McGinniss, M.H. : Evidence for differences in 
erythrocyte surface receptors for the malarial parasites, Plasmodium 
falciparum and Plasmodium knowlesi. J. Exp. Med. 146: 277-231, 1977. 



33-i;7 



SMITHSONIAN! SCIENCE INFORMATION EXCHANGE 
PROJECT NUMBER (Do NOT use this space 



U.S. DEPARTMENT OF 
HEALTH, EDUCATION, AND WELFARE 
PUBLIC HEALTH SERVICE 
NOTICE OF 
INTRAMURAL RESEARCH PROJECT 



PERIOD COVERED 

April 1, 1977 - September 30, 1977 



PROJECT NUMBER 

Z01-CC-02012-01 BB 



TITLE OF PROJECT (80 characters or less) 

Chido (Ch a ) Antibody Production Induced by Cancer Immunotherapy 



NAMES, LABORATORY AND INSTITUTE AFFILIATIONS, AND TITLES OF PRINCIPAL INVESTIGATORS AND ALL OTHER 
PROFESSIONAL PERSONNEL ENGAGED ON THE PROJECT 

PI: Mary L. Gustafson, MS, MT(ASCP)SBB, Senior Technologist, 

Clinical Center Blood Bank { 

Other: Rite hard G. Cable, M. D. , Assistant Chief, Blood Services Section 
Clinical Center Blood Bank 

William D. Terry, M.D., Associate Director, Immunology Branch 
DCBD, NCI * y aL^i^n, 

Richard J. Hodes, M.D. , Head, Immunology Section, Immunology 
Branch, DCBD, NCI SJ 

Susan Gross, R.N. , Immunotherapy Research Nurse, Immunology 
Branch, DCBD, NCI SJ 




^.AB/BRANCH 

Blood Bank Department 



INST I TUTE AND LOCATION " " 

Clinical Center, Bethesda, Maryland 20014 



SECTION " 

Blood Services Section 



TOTAL MANYEARS: 

0.5 



PROFESSIONAL: 

0.5 



CHECK APPROPRIATE BOX(ES) 
D U) HUMAN SUBJECTS 

□ ( a1 ) MINORS H (a2) INTERVIEWS 



OTHER: 





3^ 



) HUMAN TISSUES 



□ (c) NEITHER 



SUMMARY OF WORK (200 words or less - underline keywords) " 

On routine testing, it was discovered that two patients with malignant mela- 
noma had developed the red blood cell antibody , anti-Chido ( Cte), foUlowing the 
initiation of cancer immunotherapy in the treatment of their disease. We are 
currently testing the un-antigen status of the remaining persons in this protoco 
to see if the number varies from the statistical norms of 98% Cha positive. WA 
are attempting to test the Ch a antigen status of three cell lines of neuraminadfi 
treated and untreated cul tured melanoma cells used for injection in this protoco'i 
to determine if these cells can be responsible for inducing antibody production. 



PHS-6040 
(Rev. 10-76] 



3B-2+8 



Serial No. Z01-CC-02012-01 BB 

Blood Bank Department 
Clinical Center 
Bethesda, Maryland 

PHS-NIH 

Individual Project Report 

July 1, 1976 - September 30, 1977 

Project Title: "Chido(Ch a ) Antibody Production Induced by Cancer 
Immunotherapy' ' 

Previous Serial Number: None 

Principal Investigator: Mary L. Gustafson, MS, MT(ASCP)SBB 

Other Investigators: Ritchard G. Cable, M.D. 

William D. Terry, M.D. 
Richard J. Hodes, M.D. 
Susan Gross, R.N. 

Cooperating Units: Inside NTH 

NCI 

Outside NIH 
None 

Man Years: 

Total: 0.5 
Professional: 0.5 
Other: 

Project Description 

Objectives : 

To determine the Ch a antigen status of the cell lines used in the treatment 
of persons with malignant melanoma to determine whether these cells are 
responsible for inducing antibody production. 

Methods Employed: 

- 

Ch a antigen status of individuals is determined by a serum agglutination inhi- 
bition procedure. Absorption-elution techniques will be employed in the ex- 
perimental testing for the Ch 3- antigen on the neuraminadase treated and un- 
treated melanoma cells from culture. 

Maior Findings: 

i ■' ■ — i 

To date, one other person in this protocol appears to be Chr negative. 

BB-I19 



Significance to Biomedical Research and the Program of the Institute : 

This may demonstrate the first evidence of red blood cell antibody produc> 
tion following treatment of cancer immunotherapy. 

Proposed Course : 

See objectives and methods. 

Publications: None / 



BB-50 



sm I THSON ;.-.•< t^lCNOC INF c ';. i dm EXCHANGE 
PROJECT NUMBER luo NOT use lis* s sf»ice) 



U.S. DEPARTMEfll CF 
HEALTH, EDUCATION, ANO WELFARE 
PUBLIC HEALTH SERVICE 
KlOT ICE Of 
INTRADURAL RESEARCH PROJECT 



PROJECT NUMBER 

Z01-CC-02013-01 BB 



PER I CO COVERED 

July 1, 1976 - September 30, 1977 



TITLE CF PROJECT (SO characters or less) 

Mechanism of Vertical Transmission of Hepatitis B Virus 



NAMES, LABORATORY AND INSTITUTE AFFILIATIONS, AND TITLES OF PRINCIPAL INVESTIGATORS AND ALL OTHER 
PROFESSIONAL PERSONNEL ENGAGED ON THE PROJECT 

Principal Investigator: George Grady, M.D. 
Others: Harvey J. Alter, M.D. CCBBD 



COOPERATING UNITS (if any) 

Mass. Department of Public Health 



LAB/BRANCH 

Blood Bank Department 



SECTION 

Immunology Section 



INSTITUTE AND LOCATION 

Clinical Center, Bldg. lOA/Room 1E33, Nffl, Bethesda, Maryland 20014 



TOTAL MANYEARS 



PROFESSIONAL: 

0. 5 



OTHER: 



0.5 



CHECK APPROPRIATE BOx(ES) 
"J (a) HUMAN SUBJECTS 

(at) MINORS □ (a2) INTERVIEWS 



□ (b) HUMAN TISSUES 



h£ 



NEITHER 



SUMMARY CF WORK (200 words or less - underline keywords) 

Maternal -fetal transmission is felt to be responsible for a large number of 
chronic carriers of HBsAg. The mechanism by which the virus is trans- 
mitted from mother to infant is however unclear with the three main pos- 
sibilities being: (1) transplacental transmission prior to birth (2) swallowing 
of maternal blood at the time of delivery (3) post partum transmission via 
breast feeding or maternal handling. 

We will attempt to sort these possibilities by delivering the infants of HBsAg- 
positive chimpanzees by Caesarian section and by having the infant reared 
separate from the HBsAg-positive mother. 



3B-51 



FH3-6040 
!o... <n ~c\ 



Serial No. Z01-CC-02013-01 BB 
Blood Bank Department 
Clinical Center 
Bethesda, Maryland 

NIH-PHS 
Individual Project Report 
July 1, 1976 - September 30, 1977 

Project Title: Mechanism of Vertical Transmission of Hepatitis B Virus 

Previous Serial Number: None 

Principal Investigator: George Grady, M. D. 

Other: Harvey J. Alter, M. D. , CCBBD 

Cooperating Units: Massachusetts Dept. of Public Health 

Man Years: Total: 1 

Prof e s sional : 0.5 
Other: 0. 5 

Project Description 

1. To see is maternal -fetal hepatitis transmission occurs despite the ab- 
sence of any post-partum contact between mother and infant. 

2. To see if the possibility of blood ingestion by the fetus can be avoided 
by bloodless Caesarian section and to see what impact this has on 
maternal -fetal transmission. 

3. To see if prepartum transmission can be documented by the presence 
of HBsAg in cord blood or by the presence of hepatitis related antigens 
in fetal liver tissue obtained at the time of delivery. 

Methods : 

1. Chronic HBsAg carrier chimpanzees will be housed and bred in the lab- 
oratory for Experimental Medicine and Surgery (LEMSIP). The carriers \ 
employed will be e_ antigen positive to document their potential infectivity. i 

2. Chimps will be delivered by as atraumatic and bloodless Caesarian 
section as possible. fj 

3. At birth, samples will be obtained for HBsAg and e_ antigen testing from 
maternal blood, cord blood, fetal venous blood and amniotic fluid. A 
liver biopsy will also be obtained from the fetus and stained by fluo- 
rescent techniques for the presence of HBcAg and HBsAg. 

4. The fetus will have no contact with the HBsAg-positive mother after 
delivery and will be followed for the development of type B hepatitis. ^ 

BB-52 



Major Findings : 

The first infant so studied developed type B hepatitis 7 weeks after delivery. 
This rules out post-partum contact as the cause of hepatitis transmission, 
but does not distinguish the other possibilities because the Caesarian section 
was not entirely bloodless. Against transplacental transmission, was the 
finding of HBsAg -negative cord blood and fetal venous blood. However, liver 
biopsy was not performed at the time of birth. 

Significance of Findings : 

It has been estimated that maternal-fetal transmission of hepatitis B may be 
the major cause for the development of the HBsAg carrier state. Through- 
out the world this isproioably a far more significant route of transmission than 
blood transfusion. Any studies which elucidate the mechanism of such trans- 
mission may help in its prevention. It has already been proposed that mothers 
who are HBsAg -positive be delivered by Caesarian section. These studies may 
shed light on the rationale for such an approach. 

Proposed Course : 

The carrier mother whose fetus has already been followed will be inpregnated 
as soon as possible and the second fetus delivered by a more meticulous C- 
section and also biopsied at the time of delivery. In addition, the offspring 
of other carrier chimps will be similarly followed (there are currently 3 such 
carriers at LEMSIP). 



BB-53 



jmithson:.-.n i.^i;'-'ce";;rrcr..' i A;io f i exchange 

PROJECT MJM3ER [uo KOT uje ii;»s sf-ice) 



HEALTH, EDUCATION, AND WELFARE 
PUBLIC HEALTH SERVICE 

..TRAMURAL^Ii/cH FSOJECT ZOl -CC -0201 4 -01 CC 



PERIOD COVERED 

July 1, 1976 - September 30, 1977 



TITLE OF PROJECT (SO characters or less) 

Transmission of Non-A, Non-B Hepatitis to Chimpanzees 



NAMES, LABORATORY AND INSTITUTE AFFILIATIONS, AND TITLES OF PRINCIPAL INVESTIGATORS AND ALL OTHER 
PROFESSIONAL PERSONNEL ENGAGED ON THE PROJECT 

Principal Investigator: Harvey J. Alter, M.D. 

Other: Robert Pure ell, NIAID 
Paul V. Holland, CCBB 



I 



COOPERATING UNITS (if anyj 

NIAID 



LAB/ BRANCH 

Blood Bank 



Department 



SEC! ION 

Immunology Section 



INSTITUTE AND LOCATION 

Clinical Center. Bldg. lOA/Room 1E33. NIH. Bethesda. Maryland 20014 



TOTAL MANYEARS: 



PROFESSIONAL: 



OTHER: 



1 



CHECK APPROPRIATE BOX(ES) 
G (a) HUMAN SUBJECTS 

□ (al) MINORS □ (a2) INTERVIEWS 



□ (b) HUMAN TISSUES 



&(< 



c) NEITHER 



SUMMARY OF WORK (200 words or less - underline keywords) 

80-90% post -trans fusion hepatitis now appears related to a third human 
hepatitis "virus" tentatively termed " non-A, non-B . " There are several 
pieces of evidence to suggest this is a virus but to date this agent has 
not been observed, has not had an identifiable antigenic marker , has not 
been grown in culture and has not been transmitted to animals . This study 
will attempt to identify bloods with -a high probability of containing this 
virus and will then attempt chimpanzee inoculation. 



BB-5U 



PHS-6040 
(Rev. 10-76} 



Serial No. Z01-CC-02014-01 BB 
Blood Bank Department 
Clinical Center 
Bethesda, Maryland 

PHS-NIH 

Individual Project Report 

July 1, 1976 - September 30, 1977 

Project Title: Transmission of Non-A, Non-B Hepatitis to Chimpanzees 

Previous Serial Number: None 

Principal Investigator: Harvey J. Alter, M.D. 

Other: Robert Pure ell, NIAID 
Paul V. Holland, CCBB 

Cooperating Units: NIAID 

Man Years: Total: 2 

Professional: 1 
Other: 1 

Project Description 

1. To prove that non-A, non-B hepatitis is due to a transmissable agent. 

2. To transmit this agent from human blood to chimpanzees and if success- 
ful from chimpanzee to chimpanzee. 

3. To obtain plasmapheresis units from infected chimpanzees to aid in char^ 
acterization of the virus and development of serologic tests. 

Methods : 

1. Potentially infectious sera will be obtained from patients with acute and 
chronic non-A, non-B hepatitis and from donors implicated in such 
transmission. 

2. Depending on the volume of sample available either 1 ml or 75 ml will 
be inoculated into chimpanzees and the animals followed for six months 
for evidence of enzyme (SGOT/SGPT) elevations. 

3. Animals with elevated SGOT/SGPT will be plasmapheresed and have 
liver biopsies. Biopsy material will be observed for evidence of hepa- 
titis, but will also be frozen for subsequent immunofluorescent tests 
should they become available. 

4. Acute phase plasma from reactive chimps will be administered to addit- 
ional animals in an attempt to demonstrate serial passage. 

BB-55 



Major Findings : 

Pedigreed samples have been obtained over the past year and five chimpan- 
zees have been inoculated. No hepatitis has occurred in the first four weeks 
post inoculation. 



Proposed Course : 






Since we are dealing in the blind as regards this proposed agent(s), addition' 
al inocula will be accumulated and as many chimps as can be obtained, inoc- 
ulated. The problem of transmission is complicated in that there is no way 
to currently assess the susceptibility of a given chimpanzee so that a single 
inoculum may be infectious in one chimp and not in another. 



Publications: None 



« 



BB-56 



* 



SMITHSUN'.».N i,UlCICE I KF CWA ." ' ON EXCHANGE' U.S. DEPARTMENT OF PROJECT NUMBER 
FROJtCT NUMBER {ou /.OT use il:>s sp-ice) HEALTH, EDUCATION, AND WELFARE 

PUBLIC HEALTH SERVICE 



NOTICE OF 
INTRAMURAL RESEARCH PROJECT 



Z01-CC-02015-01 BB 



PERIOD COVERED 

July 1, 1976 - September 30, 1977 



TITLE OF PROJECT (80 characters or less) 

Longitudinal Study of e_ Antigen in Health Workers and Patients Who- Are 
Chronic Ca rri ers of HBs Ag 



NAMES, LABORATORY AND INSTITUTE AFFILIATIONS, AND TITLES OF PRINCIPAL INVESTIGATORS AND ALL OTHER 
PROFESSIONAL PERSONNEL ENGAGED ON THE PROJECT 



Principal Investigator: Harvey J. Alter, M.D. 

Other: Robert Pur cell, M.D. 
Joel Spero, M.D. 
Herbert Polesky, M. D. 



(COOPERATING UNITS (it any) 

Lab Infectious Disease, NIAID, University of Pittsburg Blood Bank, 
Minneapolis War Memorial Blood Bank 



LAB/BRANCH 

Blood Bank Department 


SECTION 

Immunology Section 


INSTITUTE AND LOCATION 

Clinical Center, Bldg. lOA/Room 1E33, N! 


[H, Bethesda, Maryland 20014 


10TAL MANYEARS: 

1.5 


PROFESSIONAL: 

0.5 


OTHER: 

1 



CHECi; APPROPRIATE BOX(ES) 

iffa) HUMAN SUBJECTS □ (b) HUMAN TISSUES □ (c) NEITHER 

□ (al) MINORS Q (a2) INTERVIEWS 



SUMMARY OF WORK (200 words or less - underline keywords) 

e_ antigen has been shown to be an excellent marker to define those HBsAg - 
positive individuals most likely to transmit hepatitis B . Implicit in this state- 
ment is the fact that e_ antigen-positive health workers and patients will carry 
an additional stigma and may be placed under more stringent restrictions 
than HBsAg -positive individuals who are e_ antigen negative. Before any such 
decisions can be rendered, it must be ascertained if the presence or absence 
of e antigen is an invariant feature of any given HBsAg -positive individual or 
if il varies over the course of time. 



3B-5T 



PhS-b040 
(Rev. 10-.V 



Serial No. Z01-CC-02015-01 BB 
Blood Bank Department 
Clinical Center 
Bethesda, Maryland 

PHS-NIH 
Individual Project Report 
July 1, 1976 - September 30, 1977 

Project Title: Longitudinal Study of e_ Antigen in Health Workers and Patient: 
Who Are Chronic Carriers of HBsAg 

Previous Serial Number: None 

Principal Investigator: Harvey J. Alter, M.D. 

Other: Robert Pure ell, M.D. 
Joel Spero, M. D. 
Herbert Pole sky, M.D. 

Cooperating Units: Lab Infectious Disease, NIAID, University of Pittsburg 

Blood Bank, Minneapolis War Memorial Blood Bank 

Man Years: Total: 1. 5 

■ Professional: 0. 5 
Other: 1 

Project Description 

Objectives: 






1. To measure e_ antigen in serial samples from the same HBSAg-positive 
individuals including a minimum of 3 samples over at least one year per- 
iod. Samples will be obtained from health workers, dialysis patients, 
hemophiliacs and asymptomatic blood donors. 

2. To ascertain if e_ antigen is persistent or variable over this time span 
and thus whether its predictive value can be reliably interpreted. 

Methods : 

1. e_ antigen will be measured by rheophoresis or counterelectrophoresis 
until a more sensitive test is developed. 

Major Findings : None to date I 

Proposed Course: See objectives 



BB-58 



t 






Significance : 

If judgements regarding the management of HBsAg-positive carriers are to 
be made on the basis of the presence or absence of e antigen, it is essential 
to know if such presence or absence is an invarianOeature of a given individ- 
ual or subject to change over time. If the latter pertains, then a differential 
handling of HBsAg carriers based on the presence or absence of e antigen 
is probably not warranted. 



3B-59 



SMITHSONIAN SCIENCE INFORMATION EXCHANGE 
PROJECT NUMBER (Do NOT use this space) 



U.S. DEPARTMENT OF 
HEALTH. EDUCATION, AND WELFARE 
PUBLIC HEALTH SERVICE 
NOTICE Of 
INTRAMURAL RESEARCH PROJECT 



PROJECT NUMBER 



1 



Z01-CC-02016-01 BB 



PERIOD COVERED 



July 1. 1976 - September 30. 1977 



TITLE OF PROJECT (80 characters or less 

Evaluation of Anti-Core Antibody and Serum Transaminase as Indicators 
of the Infectivity of HBsAg -Negative Donors 



NAMES, LABORATORY AND INSTITUTE AFFILIATIONS, AND TITLES OF PRINCIPAL INVESTIGATORS AND ALL OTHER 
PROFESSIONAL PERSONNEL ENGAGED ON THE PROJECT 

Principal Investigator: Harvey J. Alter, M.D. 

Other: Paul V. Holland, M.D. , Chief, Blood Bank Department, CC 
Deloris Koziol, Medical Research Technologist, CCBBD 



COOPERATING UNITS (if any) 

None 



LAB/BRANCH 

Blood Bank Department 



SECTION 

Immunology Section 



INSTITUTE AND LOCATION 

Clinical Center, Bldg. 



lOA/Room 1E33, NIH, Bethesda, Maryland 20014 



TOTAL MANYEARS: 
1. 



PROFESSIONAL: 



0.5 



OTHER: 



1 



CHECK APPROPRIATE BOX(ES) 
Sj(a) HUMAN SUBJECTS 

D (al) MINORS □ (a2) INTERVIEWS 



□ (b) HUMAN TISSUES 



□ (c) NEITHER 



SUMMARY OF WORK (200 words or less - underline keywords) "' " 

Despite sensitive radioimmunoassay tests for HBsAg applied to all donor 
blood, some type B~hepatitis continues to occur following transfusion. It 
has previously been suggested that HBsAg negative individuals who have 
anti-core antibody may transmit the hepatitis B virus. The availability of 
a new sensitive radioimmunoassay for anti-core antibody allows this pos- 
tulate to be tested in our prospectively followed, open heart surgery patients 
Similarly, we can ascertain if chronic carriers of non-A, non-B hepatitis 
have elevated serum transaminase ; and, if so, whether this could be employed 
to screen donors and reduce the frequency of post -transfusion hepatitis due 
to this agent. 



< 



» 



3B-60 



PHS-6040 
(Rev. IO-76] 



Serial No. Z01-CC-02016-01 BB 
Blood Bank Department 
Clinical Center 
Bethesda, Maryland 

PHS-NIH 

Individual Project Report 

July 1, 1976 - September 30, 1977 

Project Title: Evaluation of Anti-Core Antibody and Serum Transaminase as 
Indicators of the Infectivity of HBsAg -Negative Donors 

Previous Serial Number: None 

Principal Investigator: Harvey J. Alter, M.D. 

Other: Paul V. Holland, M. D. 

Deloris Koziol, Medical Research Technologist 

Cooperating Units: None 

Man Years: Total: 1.5 

Professional: 0.5 
Other: 1 



Project Description 



Objectives : 



To determine if HBsAg-negative donors who have anti-core antibody are 
more likely to transmit type B hepatitis then those who lack anti-core 
antibody. 

To determine if donors with elevated SGPT are more likely to transmit 
non-A, non-B hepatitis than donors with normal SGPT and to ascertain 
if this would be a practical way to screen for chronic carriers of this 
presumed virus. 



Methods: 



We have now prospectively followed over 400 patients to determine if 
they developed post -transfusion hepatitis and, if so, by what etiologic 
agent. All donors to type B and non-A, non-B hepatitis cases will be 
tested for anti-core antibody as will the donors to at least 30 patients 
who did not develope hepatitis (approximately 500 donors in all). Data 
will be analyzed to see if there is any positive correlation between the 
presence of anti-core antibody in the donor and hepatitis in the recipient. 

All donors to open heart surgery patients will be tested for SGPT. These 
tests will be performed in a sample obtained at the time of donation, but 



BB-61 



will not be tested until approximately 3 days after transfusion. The re- 
sults of transaminase tests will not be known at the time of transfusion, 
but recipients will be followed prospectively for the development of 
hepatitis. Data will be analyzed to see if there is a positive correlation 
between the presence of elevated donor transaminase and the development 
of recipient hepatitis. 

3. When an elevated transaminase is found (initially tested under contract 
by Bionetics Lab), the same sample will be retested by the Clinical Chem- 
istry lab at NIH. If the elevated value is confirmed, the donor will be re- ( 
called and at least 2 units of plasma obtained by plasmapheresis for sub- 
sequent study should hepatitis develop in the recipient. 

Major Findings ; None to date 

Significance to Biomedical Researchandthe Program of the Clinical Center 

Any test system which could reliably detect carriers of hepatitis B who are 
below the detectability range of RIA tests for HBsAg or which could detect 
chronic carriers of non-A, non-B virus would have major impact on the in- 
cidence of post -transfusion hepatitis. 



I 



BB-62 



SMITHSONIAN SCIENCE INFORMATION EXCHANGE 
PROJECT NUMBER (Do NOT use this space) 



U.S. DEPARTMENT OF 
HEALTH, EDUCATION, AND WELFARE 
PUBLIC HEALTH SERVICE 
NOTICE OF 
INTRAMURAL RESEARCH PROJECT 



PROJECT NUMBER 

Z01-CC-02017-01 BB 



PERIOD COVERED 

July 1, 1976 to September 30, 1977 



TITLE OF PROJECT (30 characters or less) 

Identification of the Non-A, Non-B Hepatitis Agent and the Development 
of Serologic Markers 



NAMES, LABORATORY AND INSTITUTE AFFILIATIONS, AND TITLES OF PRINCIPAL INVESTIGATORS AND ALL OTHER 
PROFESSIONAL PERSONNEL ENGAGED ON THE PROJECT 

Principal Investigator: Harvey J. Alter, M.D., CCBBD 

Others: Robert Purcell, NIAID 

Stephen Feinstone, NIAID 

John Gerin, Molecular Anatomy Program 



COOPERATING UNITS (if any) 

Laboratory Infectious Disease, NIAID 
Molecular Anatomy Program, AEC 



LAB/BRANCH 

Blood Bank Department 



SECTION 

Immunology Section 



INSTITUTE AND LOCATION 

Clinical Center, Building lOA/Room 1E33, NIH, Bethesda, Maryland 20014 



TOTAL MANYEARS: 



PROFESSIONAL: 



OTHER: 



CHECK APPROPRIATE BOX(ES) 
B^a) HUMAN SUBJECTS 

□ (al) MINORS □ (a2) INTERVIEWS 



□ (b) HUMAN TISSUES 



□ (c) NEITHER 



SUMMARY OF WORK (200 words or less - underline keywords) 

Plasma units derived from: either donors implicated in non-A, non-B 
hepatitis or patients with acute or c hronic non-A, non-B hepatitis will be 
ultracentrifuged. The pellet derived by ultracentrifugation will be reacted 
against a radiolabeled IgG fraction obtained from patients convalescent 
from non-A, non-B hepatitis in a solid phase radioimmunoassay system. 



BB-63 



=HS-6040 
(Rev. 10-76) 



Serial No. Z01-CC-02017-01-BB;! 
Blood Bank Department 
Clinical Center 
Bethesda, Maryland 

PHS-NIH 
Individual Project Report 
July 1, 1976 - September 30, 1977 

Project Title: Identification of the Non-A, Non-B Hepatitis Agent and the 
Development of Serologic Markers 

Previous Serial Number: None 

Principal Investigator: Harvey J. Alter, M.D. 

Other: Robert Pure ell, NIAID 

Stephen Feinstone, NIAID 

John Gerin, Molecular Anatomy Program 

Cooperating Units: NIAID, Molecular Anatomy Program, AEC 

Man Years: Total: 2 

Professional: 1 
Other: 1 

Project Description 
Objectives : 

1. To obtain a large quantity of non-A, non-B viral antigen. 

2. To establish a sensitive detection system for this presumed viral agent. 

Methods : 

1. Semi-purify non-A, non-B viral antigen by ultracentrifugation of plasma 
units, clinically presumed to carry this agent. 

2. Prepare radiolabeled IgG from plasma of persons who have recovered 
from non-A, non-B hepatitis in the hopes that they contain specific 
antibody. 

3. React the antigen and antibody in a solid phase radioimmunoassay systenu 

4. If an assay can be developed, the antigen pellet will be further purified by 
Cesium chloride and sucrose gradients. 

Major Findings : None to date 

Proposed Course : See objectives and methods 

BB-6U 



Significance to Biomedical Research and the Program of the Clinical 
Center 

The development of a detection system for non-A, non-B viral agent(s) 
would be highly significant in that none are currently available and in that 
this agent(s) currently is responsible for over 80°/c of post -transfusion hepa- 
titis and probably responsible for a great deal of chronic active hepatitis. 



BB-65 



SMITHSONIAN SCIENCE INFORMATION EXCHANGE 
PROJECT NUMBER (Do NOT use this space) 



PERIOD COVERED 

July 1, 1976 - September 30, 1977 



TITLE OF PROJECT (80 characters or less) 

Hepatitis B Vaccine Trial Among Renal Dialysis Patients 



U.S. DEPARTMENT OF 
HEALTH, EDUCATION, AND WELFARE 
PUBLIC HEALTH SERVICE 
NOTICE OF 
INTRAMURAL RESEARCH PROJECT 



PROJECT NUMBER 

Z01-CC-02018-01 BB 



NAMES, LABORATORY AND INSTITUTE AFFILIATIONS, AND TITLES OF PRINCIPAL INVESTIGATORS AND ALL OTHER 
PROFESSIONAL PERSONNEL ENGAGED ON THE PROJECT 

Principal Investigator: Wolf Szmuness, M. D. , Chief, Epidemiology, 

New York Blood Center 

Other: Cladd Stevens, M. D. , NYBC 
Edward Harley, NYBC 
Harvey J. Alter, M. D. , CCBB 



COOPERATING UNITS (if any) 

New York Blood Center 



LAB/BRANCH 

Blood Bank Department 



SECTION 

Immunology Section 



INSTITUTE AND LOCATION 



Clinical Center, Building lOA/Room 1E33, NIH, Bethesda, Maryland 20014 



TOTAL MANYEARS: 



PROFESSIONAL: 



OTHER: 



CHECK APPROPRIATE BOX(ES) 
fi'fa) HUMAN SUBJECTS 

D (al) MINORS $y<?2) INTERVIEWS 



□ (b) HUMAN TISSUES 



□ (c) NEITHER 



SUMMARY OF WORK (200 words or less - underline keywords) ~~ ~ 

A two part study is being undertaken to evaluate a hepatitis B vaccine being 
produced by NIAID. In the first phase baseline seroepidemiologic data 
will be obtained in 1 dialysis units in NYC and the Metropolitan Washington 
Renal Dialysis Unit. When the hepatitis B vaccine is available (approximately 
Fail of 1977) a prospective, controlled, randomized double blind trial of its f 
efficacy will be undertaken in these same dialysis units. 



4 



BB-66 



PHS-6040 
(Rev. 10-76) 



Serial No. Z01 -CC-02018-01 BB 
Blood Bank Department 
Clinical Center 
Bethesda, Maryland 

PHS-NIH 

Individual Project Report 

July 1, 1976 - September 30, 1977 

Project Title: Hepatitis B Vaccine Trial Among Renal Dialysis Patients 

Previous Serial Number: None 

Principal Investigator: Wolf Szmuness, M. D. 

Other: Cladd Stevens, M. D. , NYBC ■ 
Edward Harley, NYBC 
Harvey J. Alter, M. D. , CCBB 

Cooperating Units: New York Blood Center 

Man Years: Total: 6 

Professional: 2 
Other: 4 



Project Description 



Objectives: 



1. To obtain baseline incidence figures on hepatitis B and non-A, non-B 
among a large number of renal dialysis patients and staff. 

2. To try to assess patterns of hepatitis spread in these units based on sero- 
logic and epidemiologic parameters. 

3. To evaluate the effectiveness of a hepatitis B vaccine in reducing the fre- 
quency of type B hepatitis among patients and staff. 

Methods : 

1 . Patients and staff in multiple dialysis units will be monitored monthly for 
elevation of SGPT and appearance of HBsAg and anti-HBs. More frequent 
sampling and additional tests such as those for subtyping, e antigen and 
anti-core antibody will be employed when a positive result is obtained. 

2. When the hepatitis B vaccine is ready for clinical trials, patients and 
staff of these dialysis units will be randomly assigned to receive hepatitis 
B vaccine or placebo and the effectiveness of each assessed over a one 
year period in each individual. The hepatitis B vaccine will be prepared 
from a purified preparation of 20 nm HBsAg-containing particles which 



BB-67 



have been formalin treated and which have already been shown to be non- 
infectious, but immunogenic in chimpanzees. Patients and staff will be 
monitored as above. 

3. Other potential methods of decreasing the risk of hepatitis will also be 
employed including the administration of HBIG to those accidentally in- 
oculated with HBsAg-positive material and the isolation of positive pa- 
tients as recommended by the CDC. 

4. All serologic and epidemologic data will be computerized. 
Major Findings : 

Study is just in preliminary phase and sufficient data hav e not been accumu- 
lated for analysis. 

Significance to Biomedical Research and the Program of the Clinical 

Center """ "" " — 

Dialysis patients and staff remain a very high risk population for hepatitis _ 
and represent one of the few US populations in which a hepatitis vaccine can 
be clinically evaluated. If the vaccine proves effective, it will have vast imp- 
lications, not only for dialysis patients and staff, but also for patients and 
staff in institutions, for medical personnel in general, for inner city and sex- 
ually promiscuous populations and for many foreign populations where hepa- 
titis B frequencies are extremely high. 

Proposed Course : See methods and objectives. i 

Publications: None 



« 



BB-68 



ISM I THSac :,-.'. WlCNCE I NFCf. :•!.',.' ON EXCHANGE! U.3. DEPARTMlflT CF I PROJECT NUMBE3 



_Jnly 1. 197 B - Sep tember 30. 1977 

'TITLE OF PROJECT (80 characters or less) 

Evaluation of the hepatitis risk of hospitalized patients undergoing 
invasive procedures, but not receiving blood transfusion 



PROJECT NUMBER loo )<0T u;e t»is s^ice; 



HEALTH. EDUCATiC'l, AND «ELFARE 
PUBLIC HEALTH SERVICE 
NOTICE OF 
INTRAMURAL RESEARCH PROJECT 



Z01-CC-02019-01 BB 



PERIOD COVERED 



NAVES, LABORATORY AND INSTITUTE AFF IL I ATI CNS, AND TITLES OF PRINCIPAL INVESTIGATORS AND ALL OTHER 
PROFESSIONAL PERSONNEL ENGAGED ON THE FROjECT 

Principle Investigator: Harvey J. Alter, M.D. 

Chief, Immunology Section, CCBB 

Other: Paul V. Holland, M. D. 

Chief, Blood Bank Department, CC 

Robert H. Pur cell, M. D. 

Head, Hepatitis Virus Section, LID, NIAID 



COOPERATING UNITS (it any) 

NIAID, NHLBI 



lab/branch 

i Blood Bank Clinical Center 



SECTION 

Immunology Section 



INSTITUTE AND LOCATION 

Clinical Center, Building lOA/Room 1E33, NIH, Bethesda, Maryland 2001 -i 



TOTAL MANY EARS: PROFESSIONAL: OTHER: 

3.5 0.5 



CHECK APPROPRIATE 30x(ES) 

tHa) HUMAN SUBJECTS ( b ) HUMAN TISSUES n ( c ) NEITnER 

□ (al) MINORS fcj»*fa2) INTERVIEWS 



SUMMARY CF WORK (200 words or less - underline keywords) 

This is a new study which will serve to supplement and control project Z01- 
CC-02005-07-BB. Cardiac patients will be enrolled if they undergo closed 
mitral comniissujot'orny or cardiac catheterization but do not receive 
blood. They will then be followed prospectively for 6 months and hepatitis 
rates compared with patients undergoing open heart surgery. This should 
provide data on the relative risk of hepatitis between transfusion exposure 
and exposure to a hospital environment and the types of hepatitis associated 
with each. 



BB-69 



PHS-6G40 
(Rev. 10-75} 



Serial No. Z01 -CC -02019-01 BB 
Blood Bank Department 
Clinical Center 
Bethesda, Maryland 

PHS-NIH 
Individual Project Report 
July 1, 1976 - September 30, 1977 

Project Title: Evaluation of the hepatitis risk of hospitalized patients undei 
going invasive procedures, but not receiving blood transfusic 

Previous Serial Number: None 

Principal Investigator: Harvey J. Alter, M. D. 

Other: Paul V. Holland, M. D. 

Robert H. Pure ell, M. D. 

Cooperating Units: NIAID, NHLBI 

Man Years: Total: 3. 5 

Professional: 0.5 
Other: 3 

. 
Project Description 

1. To determine if there is a viral hepatitis risk which accompanies hospitali 
ization and invasive procedures such as closed mitral commissurotomy^ 
and cardiac catheterization. 

2. To compare this hepatitis risk with patients with similar cardiac lesions 
who require transfusion as part of corrective surgical procedures for their 
cardiac lesion. 

3. To determine the type of viral hepatitis in each group (i. e. B versus 
non-A, non-B) and thus to establish the absolute incidence of non-A, 
non-B hepatitis related to blood transfusion. 

Methods: 



1. All patients undergoing closed mitral commissurotomy or cardiac cathe- 
terization (with or without coronary angiogram) will be followed for six 
months with serial tests for SGPT, HBsAg and anti-HBs. 

2. Cases who develope hepatitis wiH be additionally tested for serologic re- 
sponses to CMV, EBV and the hepatitis A virus; if type B disease, they 
will be additionally tested for anti-core antibody, e antigen and will be 
subtyped. ~ 

Major Findings : Study just beginning. 



♦ 



BB-70 



Significance to Biomedical Research and the Program of the Clinical Center 

This study will serve as a control for project no. Z01-CC-02005-07-BB 
and will define the baseline hepatitis incidence which accompanies hospital- 
ization and invasive procedures not accompanied by blood transfusion. 

Proposed Course : See objectives and methods 

Publications: None 



BB-71 



t,ci inaum.-..-. s«iK.^t i i;,rw...(n. | iuN tXCKANufc U.i. JtPAKT.VEN T CF PROJECT NUMBER 



PROJECT NUMBER loo KOI use iii-s sRce) 



HEALTH. EDUCATION, AMD WELFARE 
PUBLIC HEALTH SERVICE 

U0UC£ ^ Z01-CC-02020-01 BB 

INTRAMURAL RESEARCH PflCJECT 



PERIOD COVERED 

July 1, 1976 - September 30, 1977 

TITLE OF PROJECT (80 characters or 1 e s sj 



Alterations in Whole Blood Oxygen Affinity Following Transfusion 



S^rf^rplr^'c, U j? T,TUT£ FILIATIONS, AND TITLES OF PRINCIPAL INVESTIGATORS AND ALL OTHER 
PROFESolC.,«L PERcu.'.f.EL ENGAGED ON THE PROJECT 

Principal Investigator: Harvey G. Klein,* M.D., Chief, Blood Services 

Section, Blood Bank Department, CC 

Other: Robert M. Winslow M. D. , Senior Investigator, National Heart 
Lung and Blood Institute 



COOPERATING UNITS (if any) 

i 
| 

NHLBI 



lab/branch 



Blood Bank Department 



SECTION 



j Blood Services Section 



INSTITUTE AND LOCATION 



iClinical Ce nter, Bldg 10A/Room 1E33. NIH, Beth esda. Maryland 20014 

pOTAL MANYEARS. j PROFESsIoSSG JOTHER: ~ 

2 1 1 



CHECK APPROPRIATE BOx(ES) 
S^) HUMAN SUBJECTS Q ( b) HUMAN TISSUES Q {c} NE|TH£R 

□ (al) MINORS G (a2) INTERVIEWS 

SUMMARY OF WORK (200 words or less - underline keywords) 



seas! st e ates^ y Jt?rTp e H d h that " wh<>le " b ^d oxygen affinity varies in different dil 
fj JLn f characterized by anemia . 'Ihe tact that whnlR hlnnH oxygen afffinit 
is reduced m persons with sickle-TeTT anemia has been known for Sy yetrs 
recent report indicates that non-transfused children with ho^ozy^u^ttSL-" 
semia may have a paradoxical increase in anemia. There is very iTle ouanSl 
usLn^Sot^ C ° nCer T? se ^ Ganges in whole blood O, afSnty %*%% 

POSsTbl ^that nost'^n.? at6S W ? Ch "^^ ^^sion of rid cells! It is quite 
possiDie mat post -transfusion changes in Oo affinity actually result in 9 mor P 

fs^omnf^ftSrSnorf 3 ^ 6 ^ ^4°^ ^luTi tL^e^ceTmilieu 
a,^K * } f P concerning thalassemia major suggests, whole blood 

rtatefSf fhaTas S e r m a S fU . Si °S ma ^ differ significantly in such liferent disease 
P asia ffiS' sickle celL anemia, aplastic anemia and myeloid meta - 



auirp tran«fii=inn m \ ■ * i , 2 """•*"■"./ VVJJ - L uc "icasurea m patients who-Aj 

f^TthSrweek w„R r *h transfusi ° n (2) d ^y *>r 5 days (3) weekly there! 
sured as wrfT A Whol + e + b J ood ox yg en affinity of the transfused blood will be mea 
fnf^ J u ^^^^tative estimate of the percent of transfused ceUs remain- 
ing in each sample will be derived by differential agglutination (Ashby technique! 



PHS-6040 T3T3 _-= 

(Rev. 10-76! BB ~ 72 



Serial No. Z01 -CC -02020-01 BB 
Blood Bank Department 
Clinical Center 
Bethesda, Maryland 

PHS-NIH 
Individual Project Report 
July 1, 1976 - September 30, 1977 

Project Title: Alterations, in Whole Blood Oxygen Affinity Following 
Transfusion 

Previous Serial Number: None 

Principal Investigator: Harvey G. Klein, M.D. 

Other: Robert M. Winslow, M.D. 

Cooperating Units: NHLBI 

Man Years: Total: 2 

Professional: 1 
Other: 1 



Project Description 



Objectives: 



1. Determine what alterations occur in whole blood oxygen affinity and 2,3 
DPG following transfusion. 

2. Determine whether any changes in oxygen affinity occur in the transfused 
red cells which might suggest an influence of the "disease milieu. " 

3. Determine whether such changes vary according to the blood product 
transfused (fresh blood, bank blood, frozen blood). 

4. Follow these alterations as the transfused red cells are eliminated from 
the recipient's circulation. 

Methods Employed : 

This study will be carried out over a one year period. Patients who require 
transfusion on the Molecular Hematology Service will be studied. The studies 
will initially be confined to patients with thalassemia, sickle cell anemia and 
aplastic anemia. Initially patients of blood group A, B, or AB will receive 
group O ("universal donor' ) packed red cells. A 5 cc pretransfusion speci- 
men as well as a 5 cc aliquot from the transfused cells will be obtained for 
measurements of whole blood oxygen affinity and 2, 3 DPG levels. Whole blood 
2 affinity will be measured by the technique of Rossi-Bernardi. A one hour 
post -transfusion specimen, daily specimen for 5 days and weekly specimens 
for three weeks will be drawn. Percent of transfused cells remaining will be 

BB-T3 



measured by differential agglutination (Ashby technique) and correlated with 
changes in O, affinity. Additionally the recipient's cells will be lysed in vitrd 
by use of an anti-A or anti-B hemolysin. This will permit separation oTCanl 
fused from recipient cells in the post -transfusion specimen. Oxygen affinity 
can then be determined directly on the remaining transfused cells and on the 
whole blood. These determinations permit calculation of O affinity of the 
lysed recipient cells. In this way it should be possible to determine whether 
specific changes occur in the transfused cell population posttransfusion and 
what component is the major influence in changes in whole blood O affinity. 

A second series of studies using ABO identical transfusions of red cells and I 
whole blood can be carried out if donor and recipient are not identical for a 
minor blood group This is necessary to permit separation of donor from 
recipient cells following transfusion. For these studies, differences in the 

fpT^i? $Z d Cel l M antigen WU1 be Used to distinguish donor from recip- 
ient cells. This antigen was chosen because of its low antigenicity, rarity 
of clinical importance of anti-M isoantibodies, and presence of an anti-M 
reagent potent enough to effect the required separation. 

Major Findings : 

This project has been underway for less than one year. Three oatients have 
been scheduled to date. It is too early to draw firm conclusions^ 

Significance to Biochem ical Research and the Program of the Clinical Center 

J n h i S +h P 5° jeCt ? as P ractical importance in the management of blood resources 

u ^.transfusion approach for chronic anemia. Results of these studies 
should indicate the physiologic changes that result in different anemia states 1 
when various red cell preparations are transfused. anemia states 

Proposed Course : 

This study should have its initial phase completed within one year. 
Publications: None 



BB-7k 



i 



SMITHSONIAN SCIENCE INFORMATION EXCHAN 
PROJECT NUMBER (Do NOT use this space) 



PERIOD COVERED 

July 1, 1976 - September 30, 1977 



U.S. DEPARTMENT OF 
HEALTH, EDUCATION, ANO WELFARE 
PUBLIC HEALTH SERVICE 
NOTICE OF 
INTRAMURAL RESEARCH PROJECT 



PROJECT NUMBER 



Z01-CC-02021-02 BB 



TITLE OF PROJECT (80 characters or less) 

"Delineation of Antibody in Sera of Leukemia Family Members" 



NAMES, LABORATORY AND INSTITUTE AFFILIATIONS, AND TITLES OF PRINCIPAL INVESTIGATORS AND ALL OTHER 
PROFESSIONAL PERSONNEL ENGAGED ON THE PROJECT 

Principal Investigator: Mary H. McGinniss AB(ASCP)SBB Research Biologist 

Clinical Center Blood Bank 

Other: Harvey J. Alter, M. D. , Chief, Immunology Section Clinical Center 
Blood Bank 



COOPERATING UNITS (if any) 

None 



lab/branch 

Blood Bank Department 



SECTION 

Immunology Section 



INSTITUTE AND LOCATION 

Clinical Center, Building lOA/Room 1E33, NIH, Bethesda, Maryland 20014 



TOTAL MANYEARS: 

1/3 of 1-1/2 



PROFESSIONAL: 

same 



OTHER: 



CHECK APPROPRIATE BOX(ES) 

□ (a) HUMAN SUBJECTS 

□ (al) MINORS □ (a2) INTERVIEWS 



□ (b) HUMAN TISSUES 



#£) 



NEITHER 



SUMMARY OF WORK (200 words or less - underline keywords) 

Several years ago an antibody was found in the sera of family members of 
some leukemia patients. This antibody reacts only with red cells of a very 
rare phenotype. 163 leukemia patients and family members and 165 normal 
donors sera have been tested. This antibody is found significantly more 
frequently in the sera of patients with leukemia and their family members 
as compared with controls (p< .01). 

This antibody may define an allele of a specific blood group system thought 
to be amorphic. In this respect, it will expand the genetic concept of this 
system. 



BB-T5 



PHS-6040 
(Rev. 10-76) 



Serial No. Z01-CC -02021 -02 BB 
Blood Bank Department 
Clinical Center 
Bethesda, Maryland 

PHS-NIH 
Individual Project Report 
July 1, 1976 - September 30, 1977 

Project Title: Delineation' of Antibody in Sera of Leukemia Family 
Members 

Previous Serial Number: None 

Principal Investigator: Mary H. McGinniss, AB(ASCP)SBB 

Other: Harvey J. Alter, M. D. 

Cooperating Units: Inside NIH 

None 

Outside NIH 
None 

Man Years: Total: .5 

Professional: . 5 
Other: 



Project Description 



Objectives : 



A. To establish in a larger number of patients if the association of this "anti- 
precursor" antibody with leukemia and leukemic families is maintained and 
if so if this antibody has any predictive role in the development or course 
of leukemia. 

B. To better understand this "new" red cell antigen-antibody system, to 
determine its genetics and to determine any relationship to other defined 
red cell antigens. 



Methods Employed : 

Standard antibody screening techniques of sera from leukemia patients and 
their family members and a comparable number of sera from other sources 
vs routine cells and cells from donors of the rare phenotype which define 
this "new" antibody. 

Major findings : 

A. To date the sera of 163 leukemia patients and their family members 

and 165 normal donor sera have been tested. A chi square of difference 

BB-76 



i 



in antibody frequency among these two populations was found to be sig- 
nificant at the l°/c level. 

B. The antibody defines an allele thought to be amorphic in a major blood 
group system. 

Significance to Biomedical Research and the Program of the Clinical Center : 

If this antibody response proves to be induced by an environmental factor 
found mainly in leukemia family groups, it has potential for aiding our under- 
standing of the etiology of leukemia and possibly of predicting those who are 
"leukemia prone. " It may also define a basic red cell antigenic determinant 
which will aid our understanding of the complex structure on the cell mem- 
brane. 

Proposed Course : 

A. Continuation of screening program as outlayed above and extension to 
other target groups i.e. doctors caring for leukemia patients and other 
patient populations. 

B. Long term follow of persons with this antibody to see if they have a less- 
er or greater risk of developing leukemia than family members without 
such antibody. 

C. Potential use of this antibody to perform immune electron microscopy of 
red cells and serum from patients with leukemia to see if a virus particle 
is detected. 

Publications: None 



BB-77 



SMITHSONIAN SCIENCE INFORMATION EXCHANGE 
PROJECT NUMBER (Do NOT use this space) 



U.S. DEPARTMENT OF 
HEALTH, EDUCATION, AND WELFARE 
PUBLIC HEALTH SERVICE 
NOTICE OF 
INTRAMURAL RESEARCH PROJECT 



PROJECT NUMBER 

Z01MH0083-03 AP 



PERIOD COVERED 

July 1, 1976 - September 30, 1977 



TITLE OF PROJECT (80 characters or less) 

Hypothesis of X-linkage in Bi-polar and Uni -polar Affective Disease 



NAMES, LABORATORY AND INSTITUTE AFFILIATIONS, AND TITLES OF PRINCIPAL INVESTIGATORS AND ALL OTHER 
PROFESSIONAL PERSONNEL ENGAGED ON THE PROJECT 

Principal Investigator: Elliot Gershon, M. D. NIMH AP branch 
Other: Mary H. McGinniss, CCBB Research Biologist 



CTO&af &m& B7dod Bank 



LAB/BRANCH 

NIMH AP branch 



SECTION 

Affective Disorders 



INSTITUTE AND LOCATION 

NIMH Clinical Center Building 10, Room 3N218 



TOTAL MANYEARS: 



PROFESSIONAL: 



OTHER: 



CHECK APPROPRIATE BOX(ES) 
6^Ta) HUMAN SUBJECTS 

D (al) MINORS □ (a2) INTERVIEWS 



□ (b) HUMAN TISSUES 



□ (c) NEITHER 



SUMMARY OF WORK (200 words or less - underline keywords) 

It has been reported that one form of affective disease (manic-depressive 
disease) may be carried on the X chromosome . Phenotypes , including Xg 
typing, have been done on 190 bipolar and 43 unipolar patients and their 
family members. Statistical data are incomplete on this project. 



« 



i 



BB-78 



PHS-6040 
(Rev. IO-76) 



Serial No. Z01MH0083-03 AP 
Blood Bank Department 
Clinical Center 
Bethesda, Maryland 

PHS-NIH 

Individual Project Report 

July 1, 1976 - September 30, 1977 

Project Title: Hypothesis of X-linkage in Bi-polar and Uni-polar Affective 
Disease 

Previous Serial Number: Unknown 

Principal Investigator: Elliot Gershon, M.D. 

Other: Mary H. McGinniss, AB(ASCP)SBB 

Project Description 
Objectives : 

1. To confirm or reject previously published claim that a gene involved 
in one form of manic depressive disease may be carried on the X sex 
chromosome. 

2. By statistical analysis to see if any correlation exists between manic 
depressive disease and any of the commonly known red cell antigens. 

Methods Employed : 

1. Mental health evaluations and complete red cell phenotyping including Xg 
typing. 

Major Findings : None to date 

Significance and Proposed Course : See Objectives 

Publications: None 



3B-79 



July 1, 1976, through September 30, 1977 

PUBLIC HFALTH SERVICE, NATIONAL INSTITUTES OF HEALTH 

SUMMARY ANNUAL REPORT OF PROGRAM ACTIVITIES 
CLINICAL CENTER 

CLINICAL PATHOLOGY DEPARTMENT 

CONTENTS 

I. Departmental Missions and Goals CP-1 

II. Department Activities 

A. Service Productivity CP-1 

B. Personnel CP-2 

III. Major Progress 

A. Service 

Office of the Chief CP-2 

Clinical Chemistry CP-3 

Hematology Service CP-3 

Laboratory Computer Service CP-4 

Microbiology Service CP-4 

B. Research and Development 

Office of the Chief CP-5 

Clinical Chemistry Service CP-6 

Hematology Service CP-8 

Laboratory Computer Service CP-9 

Microbiology Service CP-10 

C. Training 

Office of the Chief CP-12 

Clinical Chemistry Service CP-12 

Hematology Service CP-12 

Microbiology Service CP-13 

IV. Future Objectives 

Office of the Chief CP-13 

Clinical Chemistry Service CP-13 

Hematology Service CP-14 

Microbiology Service CP-14 

V. Presentations CP-1 5 

VI. Formal Training Courses Completed by Staff CP-15 

VII. Publications CP-16 

VIII. Intramural Project Reports CP-23 



CP-i 



.Inly 1, 1976, through September 30, 1977 

PUBLIC HEALTH SERVICE, NATIONAL INSTITUTES OF HEALTH 
CLINICAL CENTER 

CLINICAL PATHOLOGY DEPARTMENT 

I . DEPARTMEN T MI SSIONS AND GOALS 

The Clinical Pathology Department of the Clinical Center has the following 
four major missions and goals: 

1. To provide the optimum laboratory medicine support to patient- 
care physicians and their patients within the Clinical Center. 

2. To act as a consultant to patient-care physicians regarding 
the interpretation of laboratory data and patient care 
problems in hematology. 

3. To educace and train clinical pathology residents, clinical 
associates and visitors in the discipline of laboratory 
medicine. 

To conduct a program of research and development in the area 
of laboratory medicine. 

II. DEPARTMENT ACTIVITIES 

A. Service Productivity. 

Using the newly established Resource Monitoring System 
for counting, the Clinical Pathology Department performed 
1,-185,098 tests during FY-j.977 and had an average monthly work- 
load ratio index of 88. The workload from the Outpatient 
Clinic continued to increase and now accounts for 31% of the 
total workload. 

The Hematology Service has continued in a major role as the 
Hematology consultants to the physicians and patients in the 
Clinical Center. This year the number of clinical consultations 
and interpretation of laboratory data has increased approxima- 
tely 30% over the previous year. Many of these consultations 
resulted in improved patient care, better coordination of 
laboratory tests, as well as proper interpretation of the 
results in complex clinical settings. The Hematology Service 
this year lias read over 3000 bone marrows of patients in the 
Clinical Center, including bone marrow biopsies, clot sections, 
iron stains and bone marrow aspirate smears. 



CP-1 



II. DEPARTMENT ACTIVITIES 
B. Personnel. 

Two visiting scientists concluded their tenure: one returned to 
France, the other to Belgium. 

Two scientists completed their fellowship training and joined the 
Chemistry Service as staff chemists. 

Dr. Mark Zweig was appointed Assistant Chief of the Chemistry 
Service, replacing Dr. Maurice Green. 

The Chief of the Chemistry Service resigned to accept an appoint- 
ment as Head of the Clinical Chemistry Section of the Mayo Clinic and 
the Chief, Clinical Pathology succeeded him, while ontinuing his 
responsibilities as Chief of the Department. 

Dr. Laurence Corash ,was appointed Assistant Chief of the Hematology 
Service, replacing Dr. Henry Tan who resigned. 

A programmer has been recruited and trained to maintain and modify 
the Honeywell System. This has markedly increased the Service's abili- 
ty to implement changes requested by the laboratories. 



III. MAJOR PROGRESS 

A. Service. 

A Phlebotomy_ and Urine Collection Team under the Office of the 
Chief was begun in September 1976. Most of the members of the Team 
have been recruited to date and manuals on phlebotomy and urine col- 
lection have been written. The Team now performs all phlebotomy 
services for the Outpatient Department, all routine early morning phle- 
botomy for patients on the 5th, 10th, 11th, 12th and 13th floors of 
the Clinical Center and obtains all blood cultures during the day. 
Plans have been made to construct a new outpatient laboratory hematolo- 
gy area in the outpatient section which, in concert with the 
Phletobomy area, will allow patients to be seen and have blood drawn 
more quickly and efficiently than previously. 

A complete and extensive revision of, "Clinical Pathology and 
Blood Bank Guide" was coordinated by the Office of the Chief to enable 
patient-care physicians to utilize laboratory services more easily and 
efficiently. It contains a master table of all tests available at 
NIH and via contract. 

Inspection of the entire laboratory was conducted to meet the re- 
quirements for accreditation by the College of American Pathologists. 
The deficiencies were noted in a memorandum to the service involved and 
a written response was required. In addition, those deficiencies that 
involve fire and safety were sent to Mr. Vinson R. Oviatt, Chief, 
Environmental Safety. 



CP-2 



III. MAJOR PROGRESS 

A. Service. 

The Clinical Chemistry Service continued to review and update 
routine methods. New procedures and reference methods have been deve- 
loped for possible inclusion on the SMAC analyzer. 

Improved computer operation for the Clinical Chemistry Service has 
enabled a more rapid reporting of data: an electrowriter is used to 
report data to three nursing units; efficient collection and deliverance 
of specimens to the laboratory by the blood drawing team has reduced 
delays in reporting of results. A gradual introduction of two-batch 
running of certain tests within a day has also reduced delay in re- 
turning results to physicians. 

The analytical procedure for T was re-evaluated, and TSH measure- 
ments were introduced into routine service. A simpler and more specii 
nephelometric method in urinary protein was introduced. More tests were 
made available by the Pediatric Microchemical Laboratory to ensure- com- 
parability with the results obtained by the Main Laboratory. 

The Hematology Service this year has established better quality 
control techniques of their analytical systems. Because of the 
importance of platelet counts for the Clinical Center patients receiving 
the Variety of drugs which reduce bone marrow function, a new system for 
quality control and maintenance of the automated platelet counters was 
adopted to ensure that there are at least three quality control checks 
on platelet counts. 

New hematologic tests were added for Clinical Center patients. 
After thorough testing, a radioimmunoassay for ferritin was instituted 
as a standard procedure in the laboratory. This assay may be useful in 
differentiating the anemia of chronic inflammation from that of iron 
deficiency anemia, and also may be of value in the diagnosis of relapse 
of acute leukemia, Hodgkin's disease, and various lymphomas. 

A Honeywell ACS 1000 microscope was acquired from the National 
Cancer Institute. This microscope, a semiautomated differential 
counter, is used in our initial attempt at automated differential 
counts . 

A high incidence of thrombocytopenia in Clinical Center patient^ 
receiving a new drug, Valproate, was identified. Studies are underway 
to identify the mechanism of the thrombocytopenia. 

The coagulation laboratory of the Hematology Service is the only 
laboratory in this area that can offer carrier detection assays of 
Hemophilia A, a test which measures Factor VIII procoagulant activity, 
and Factor VIII antigen. Up to 95% of obligate carriers of Hemophilia 
A can be detected by correlation of the ratio of antigen to procoag'i- 
ant activity. 



CP-3 



To improve tests to identify patients with thrombotic tendencies, 
the coagulation laboratory now performs the crossed antigen-antibody 
Immunoelectrophoresis on antithrombin III, a protein that may be of 
importance in modulating the delicate balance between bleeding and 
thrombosis. Qualitative abnormalities of this protein can now be 
indicated by these immunologic studies or by the functional studies 
of the biologic activity. 

To more accurately quantitate thrombocytolytic states, the 
Hematology Service now offers an assay of the serotonin content of 
peripheral blood platelets for the estimation of mean platelet age. 
This test appears to be sensitive and specific for the indication of 
a reduced mean platelet age which suggests that thrombocytopenia may 
be due to destruction of platelets. 

Techniques using small amounts of blood to determine the electro- 
nic size distribution of human platelets have been undertaken and are 
a rapid and sensitive technique to discern increased mean platelet 
volume. Increased platelet volume suggests increased platelet destruc- 
tion resulting in an altered (younger) mean platelet population. 

The assay of B 9 binding proteins, transcobalamine I, II, III, by 
a newly described technique requiring microliter quantities of serum 
was introduced which is useful in delineating different types of 
acute and chronic leukemias that develop following chemotherapy and 
may be abnormal in a variety of myeloproliferative disorders. 

Plans have been developed to remodel the routine Hematology 
laboratory to make more efficient use of space and provide a better 
work flow. 

Transmission of laboratory results to physicians has been 
improved by the Laboratory Computer Service by printing interim 
reports in the early afternoon each weekday and Sundays. The 
Microbiology Service now enters and reports their laboratory 
results through the Honeywell system. A statistical analysis of 
laboratory values obtained on normal volunteers since 1970 has 
been carried out to provide NIH clinical investigators data on the 
long-term stability of analytical methods used by the Clinical 
Chemistry Service. 

Renovation of the Microbiology laboratory was begun in December 
1976, and is now largely completed: the admissions and processing area 
has been enlarged from its previously extremely cramped quarters; 
a new biologic hazard hood permits the safe handling of both mycobac- 
teriologic and mycologic specimens in this area; another laminar flow 
hood has also been installed within the TB-mycology area itself; all the 
diagnostic sections of the laboratory have been separated from adminis- 
trative and research areas. These rearrangements have facilitated both 
communications and specimen transport among the various sections of the 
laboratory. 



CP-4 



A newly appointed Chief Medical Technologist will be responsible 
for coordinating the diagnostic functions of the various subunits of 
the Microbiology Service, evaluating the Service's diagnostic 
methodologies and consulting with patient-care physicians regarding 
culturing techniques and the interpretation and limitation of test 
procedures . 

All Microbiology laboratory data are now being reported out 
through the new Honeywell computer system. Using cathode-ray 
terminals and specially developed templates, microbiologic data 
on patients is incorporated in the patient cumulative summary 
reports and stored in retrievable form, thus greatly facilita- 
ting future investigational access. 

The laboratory procedure manuals underwent extensive critical 
revision. Procedures which had been found to be unproductive 
have been modified or eliminated, and new procedures have been 
introduced. Other procedures have been changed to maximize the 
clinical usefulness of the data. Specific changes include the 
following: 

1. A new set of guidelines were developed for handling 
specimens for anaerobic culture, both to maximize the yield of 
anaerobic organisms from bone fide anaerobic infections and to 
minimize the anaerobic processing of specimens not optimally 
collected for the isolation of anaerobic organisms. 

2. Fungal slants on a routine basis for blood cultures was 
discontinued, as a) the medium currently used for bacterial 
culture of blood will grow most potentially pathogenic yeasts, 
and b) fungi which grow in tissues in the mycelial phase can 
almost never be cultured from blood regardless of the medium 
used . 

3. Reporting throat cultures was changed so that only 
organisms known to be pathogens would be reported. 

4. A new standard for performing the anaerobic dextrose 
test to distinguish between Micrococci and Staphylococci was 
introduced . 

B. Research and Development. 

The Office of the Chief prepared a 14 page Pathology Question- 
naire which evaluated the relationships between space, personnel 
and test volume. This Quesionnaire was sent to approximately 100 
academic pathology departments throughout the country. A 50% 
response rate was obtained and the data is now being analyzed. 

Pyrogenicity , mitogenicity, complement activation, and limulus 
amebocyte lysate gelation were correlated with 17 different endotoxins 



CP-5 



and related compounds. A correlation existed among pyrogenicity , 
mitogenicity and limulus activation, but complement activation did not 
correlate with any of these three properties. 

The effect of magnesium deficiency on the structure of erythro- 
cyte membranes was concluded. After two weeks on a magnesium-deficient 
diet, plaques appeared on the erythrocyte membrane and became larger 
with time. This membrane abnormality could not be reversed by 
in vitro incubation with normal concentrations of magnesium. 

The utility of the -limulus test for the detection of bacterial 
endotoxin in joint fluid was studied. The results with 71 joint 
fluid specimens from 47 patients indicate that the limulus test 
is nonspecific and has little clinical value. Synthetic adjuvants 
were evaluated for pyrogenicity and limulus reactivity. These studies 
have defined a compound (MDP) that is markedly pyrogenic but negative 
in the limulus test. 

The effect of induced fever on the production of serum amyloid A 
was studied. The results show that one episode of induced fever with 
etiocholanolone results in a marked elevation of serum amyloid A 
for a 6 to 7 day period. 

Various analytical instruments including several channels of the 
Technicon SMAC were evaluated by the Clinical Chemistry Service . 
Particularly, sodium, potassium, chloride, and bicarbonate were examined 
with a view to incorporating these onto the SMAC and performing all the 
routine assays on that instrument or plasma. Several different models 
of blood gas analyzers were evaluated, and the Beckman chloride/C0 o 
analyzer was examined for suitability for performing STAT assays in the 
main laboratory. A separate STAT laboratory within the main Clinical 
Chemistry laboratory was set up to enable more rapid turnaround of 
emergency requests. This involved a major redistribution of instruments 
within the laboratory, as /well as the introduction of some specifically 
to process this ever-growing workload. 

The Clinical Chemistry Service used the miniature centrifugal 
gas. analyzer for the nephelometric assays of specific proteins. 
The system has now been completely checked out for IgG measurements 
and both IgA and IgM are being studied at the present time. The 
concept of the analyzer would enable many different specific proteins 
to be measured at the same time. 

A technique has been developed to measure hemoglobin at the 
2.0 mg/dl level to determine the influence of different blood drawing 
procedures, and different collection tubes on hemolysis. This study 
is being conducted in conjunction with the Clinical Pathology Depart- 
ment Phlebotomy Team and the Oak Ridge National Laboratories. At 
Oak Ridge, the influence of evacuated blood tubes on aerosol formation 
(concerned with possible dissemination of hepatitis virus) is being 
evaluated in conjunction with the study of problems of hemolysis. 



CP-6 



1. A technique for the measurement of concentration of free 
anti-epileptic drugs in serum was developed. Comparison of both free 
and total concentration of drugs with the therapeutic response in 

Lleptic patients has been initiated. 

2. A study of the suitability of a recommended national proto- 
col for the evaluation of analytical instruments using the Perkin- 
Elmer KA 150 enzyme analyzer as a model has been completed. 

3. High pressure liquid chromatography to determine creatinine 
free from interference from other Jaffe reacting compounds was used. 

The calorimetric estimation of lactate dehydrogenase isoenzyme 
activities in serum, and a study of the simultaneous calorimetra 
measurement of free and total cholesterol in serum was completed. 
Farther work was done on the calorimetric determination of chymo- 
trypsin and trypsin in body fluids. New amylase and lipase procedures 
were evaluated. They resulted in the introduction of ttie amylase 
procedure into routine use. Renal function in patients with must !l 
wasting diseases was studied and compared with creatinine clearance 
(using different procedures to measure creatinine) with radio- 
isotopically labelled iothalamate to determine glomerular filtration 
rate. 

The extraction test for occult blood measurement is now routinely 
used to confirm equivocal or positive screening tests. The non- 
carcinogenic tetramethylbenzidine may be substituted for benzidine in 
screening tests. 

In conjunction with workers under an NHLBI contract, the association 
between platelet function and atherogenesis was studied. It was 
determined that platelet sensitivity to i n vitro stimuli is increased 
by a prior saturated fat diet, and that platelet survival is shortened 
in these animals. Fibrinogen consumption is increased in these 
animals. Animals with most marked atherosclerosis have lowered Levels 
oi serum thyroxine and triiodothyronine. In another study it was 
determined that platelet function can be prolonged by adjusting the 
osmolality of the anticoagulant. Viability can be assessed by 
measurement of lactate dehydrogenase, lactic acid or phosphorus. 
Superoxide dismutase and/or catalase are not prophylactic in 
platelet preservation in v itro . The titration calorimeter has 
enabled a study of the binding of bilirubin to albumin and, because 
of its increased sensitivity, a study of the basal heat output from 
washed erythrocytes. 

Procedures for the radioimmunoassay of the individual isoenzymes 
of creatine kinase were developed. The methods are being applied to 
a study of reference values for children and other population groups, 
patients with psychosis, myocardial infarction and muscular disorders, 
patients affected with Duchenne muscular dystrophy and relatives if 
patients with this disease. Further refinement of methods are 



CP-7 



continuing. These include development of a procedure for the MB 
hybrid and improvement of the existing methods to reduce the assay 
time to one day. 

In the area of research, the Hematology Service has continued 
in two major fronts, (1) blood coagulation and (2) morphology. 
In blood coagulation, the main interests have been in the studies 
of Factor VIII, von Willebrand factor, fibrinogen and platelets. 
Studies have progressed on the characterization of the Factor VIII 
and von Willebrand factor abnormalities in von Willebrand' s 
disease and studies of this Factor VHI/von Willebrand factor protein 
in the role of this protein in the revascularization of the ischemic 
brain tissue. In addition, work is continuing in the investigation 
of ristocetin-induced platelet agglutination and the role of the 
ristocetin and the von Willebrand factor. 



Work has continued in the area of congenital dysf ibrinogenemia 
with two additional families being identified this year. In 
addition, work on the acquired dysf ibrinogen found in patients with 
hepatoma have revealed that the abnormal fibrinogen synthesized 
by these patients appears to be related to abnormally high sialic 
acid content. This high sialic acid content interferes with the 
ability of the fibrinogen to properly polymerize and increases the 
thrombin time Partial removal of the sialic in the patient's 
fibrinogen results in the normalization of coagulation studies. 

Progress in platelet research has included the measurement of 
endogenous platelet serotonin by a sensitive double isotope 
radioassay in total whole blood populations and in their density- 
dependent subpopulations. Results reveal a strong positive cor- • 
relation between platelet density and serotonin content, making 
it a useful age-dependent platelet marker. 

Patients with Chediak-Higashi syndrome have been studied in 
relation to the properties of their platelets. Platelet survival 
is shortened, platelet serotonin content is abnormal; however, alpha 
granule release in response to thrombin is normal. The major Chediak- 
Higashi platelet defect is a reduced number of dense body storage 
sites. 

Platelets have been isolated by the Stractan system and subjected 
to f rceze-fraction and freeze-etch microscopy to explore membrane 
morphology. 

Accurate sizing of whole blood platelet populations is being 
carried out in a prospective study for the evaluation of thrombo- 
cytopenia. The data is being correlated with Cr platelet 
survival and clinical presentation. Preliminary results reveal that 
this technique is able to determine hyperdestructive platelet dis- 
orders. 



CP-8 



Platelet survival, platelet aggregation and bleeding time 
in nine normal volunteers receiving propanalol therapy was performed. 
Preliminary results indicate that platelet survival is normal, 
and that platelets do not become hyperactive during the drug with- 
drawal period. 

Participation in the French, American, British Group (FAB) 
for the classification of acute leukemias has continued. A 
workshop and a combined clinical staff conference on the 
classification of acute leukemia has been sponsored. 

An intense morphologic study of 41 cases of Waldenstrom's 
macroglobulinemia has been completed. Three morphologic subtypes 
of this disease were identified. 

Studies on the effect of various stains on the morphologic 
characteristics of blast cells have been undertaken this year and 
demonstrate that the type of stain used can markedly alter the 
characteristics of blast cells. 

The use of cytochemistry in the Hematology Service has increased 
for the diagnosis of various types of malignant tumors and has added 
to the specificity and accuracy of hematologic diagnosis of 
Clinical Center patients. 

Analysis of variance techniques have been used by the Laboratory 
Computer Service to evaluate the performance of the SMAC multichannel 
analyzer used by the Chemistry Service. The effectiveness of 
alternate quality control strategies has been studied by computerized 
analysis of control specimen results. 

A quality control nomogram for arterial pH and pCO determina- 
tions has derived from a computer analysis of 1976 blood gas results. 

In preparation for running more assays on the SMAC, several 
evaluation are in progress in collaboration with the Chemistry 
Service: comparison of serum and plasma results for tests currently 
run on the SMAC, comparison of SMAC plasma electrolyte results to 
those obtained with the currently used AutoAnalyzer system, and 
evaluation of the accuracy of the SMAC urine acid, LDH, and Urea 
Nitrogen results. 

Studies continue to evaluate a technique to determine glomerular 
filtration rate by nonlinear regression analysis of plasma dis- 
appearance curves of labeled compounds. 

Enhancements to the Honeywell hardware and software proposed 
by the vendor have been evaluated. The items to be ordered will 
permit connecting the SMAC analyzer directly to the Honeywell 
system, increzse the speed and responsiveness of the system, and 
provide more flexibility in its operation. 



CP-9 



During the past year, two alternate laboratory computer systems 
proposed by Technicon were evaluated for use at NIH. Both were 
found unsuitable. 

Specifications for a link to connect the Honeywell system to 
the Technicon Medical Information system in the Clinical Center 
have been worked out, and a contract will be signed to begin work. 
When completed, the interconnection will permit direct computer-to- 
computer transmission of test requests and test results, which will 
then be available to patient care personnel through MIS terminals 
and printouts. 

A system for identifying clinical laboratory specimens with 
machine readable bar code labels was evaluated. Preliminary 
steps have begun to implement the system in the Chemistry and 
Hematology laboratories. 

In the Microbiology Service work is continuing on the speciation 
of clinically significant isolates of non-Pneumococcal alpha- 
hemolytic Streptococci. At present, the procedures involved remain 
too complex and time-consuming for incorporation into the routine 
diagnostic areas of the laboratory. 

The Mini Tek system, the API-20 Anaerobic Strip, and the API 
Lactobacillus 50 Strip have been evaluated to determine if the use 
of these materials might facilitate the speciation of the alpha- 
hemolytic Streptococci. 

Bacteriophage typing for epidemiological purposes of clinically 
significant isolates of Staphylococcus aureus from Clinical Center 
patients and patients in other area hospitals continued. Because 
of a significant incidence of Clinical Center patient infections 
with Staphylococcus aureus lysed by bacteriophage 94, a survey of 
.Staphs aureus nasal carriage in selected Clinical Center staff 
members was undertaken; several carriers were identified and 
subsequently treated. Overseeing has continued of the bacteriophage 
typing of selected isolates of Staphylococcus epidermidis and the 
serotyping of selected isolates of Pseudomonas aeruginosa . 

The collection of lyophilized organisms has been reorganized. 
The organisms have been catalogued numerically and alphabetically. 
The collection is used for teaching and research purposes, and to 
provide organisms to outside investigators that may be unobtainable 
elsewhere. 

The detection of bacteremia using an electrical impedance 
detection system was studied. The prototype instrument has been 
improved and connected to a laboratory computer, which can be queried 
regarding the status of particular cultures. This system, coupled 
with initial lysis and filtration of blood prior to its presentation 

than convon"r r, i all °r/ 0re "^ and s ™ s± ^e detection of bacteremia 
tnan conventional methods. 



CP-10 



The accumulation and analysis of Staphylococcus aureus bacterio- 
phage typing data are continuing. This file of epidemiologic data 
extends back for approximately 20 years, and reveals the changing 
incidence pattern of different Staph , aureus bacteriophage types iso- 
lated from Clinical Center patients. 

A survey of Staphylococcus aureus carriage was conducted in the 
Pediatric Oncology Branch clinic population. Comparisons will be 
made of the incidence of Staph , infections in carriers and non-carriers. 
Should the infection rate prove higher in the carriers, attempts may 
be made to lower the carriage rates . 

The Differential III laser light scattering instrument was 
evaluated for its potential usefulness for the rapid determination of 
antibiotic synergistic effects. 

The organization of the microbiology data base which has been 
accumulated by the laboratory computer system is in progress. Central 
DCRT facilities are being used to organize and retrieve the data in 
such a way as to expedite data searches and minimize their cost. 

Studies of a resistant Corynebacterium species which has 
been isolated with increasing frequency for immunosuppressed 
Clinical Center patients were continued. Additional isolates are 
being collected and studied, and a selective medium was devised 
for this organism in an attempt to define its normal habitat. 

The Dynatech MIC-2000 96 channel dispenser was evaluated to 
determine the accuracy and reproducibility of the amount of fluid 
it dispensed. In addition, a battery of antimicrobial agents was 
dispensed by the instrument and stored at -20°C and -70°C , 1 these 
antimicrobials were subsequently examined at intervals to determine 
their potency. Accuracy of repetitively dispensed volume was 
found to be satisfactory, and the antimicrobial agents tested were 
found to retain their potency for at least 2 weeks at -20°C and 
for 4 months at -70°C. 

Blastocystis hominis , a protozoan parasite of the human 
gastrointestinal tract, was studied with particular emphasis on 
ultrastructure, physiologic characteristics, life cycle, and toxin 
characterization. 

5-f luorocytosine sensitivity tests were performed on 34 yeasts 

isolated from Clinical Center patients. The Service also served 

as a reference center for checking the sensitivities of yeasts sent 

from outside hospitals, as this sensitivity test is not yet routinely 

available. In addition, 6 molds were tested for sensitivity to 

miconazole, 5-f luorocytosine, and amphotericin B. Plate sensitivity 

tests were performed on 5 Nocardia isolates. The data obtained from 
these specialized sensitivity testing procedures both provided 

useful information in the management of individual patients and 



CP-11 



added to the relatively small fund of knowledge available re- 
garding the antimicrobial sensitivity of some of these organisms. 

III. MAJOR PROGRESS 

C. Training. 

The residency training program in the Clinical Pathology 
Department admitted four first year residents: they joined four, 
second-year residents in the program. Each rotation of the 
first year residency training program was evaluated by the 
residents using an evaluation sheet developed by the Office of 
of the Chief. All comments and evaluations were transmitted 
to the Chiefs of the Services . Changes in residency program and 
rotation were made where indicated by the residents' appraisal. 

The senior staff and residents continued to have weekly 
clinical pathology rounds at which interesting patients, laboratory 
problems and original research were presented and discussed. 

The Resident-Consultant rotation for second year residents was 
expanded to include a one-week course in management, a series 
of three lectures given by the Chief of the Clinical Pathology 
Department, and an opportunity for the resident to attend 
several policy making and management meetings with the Chief of the 
Clinical Pathology Department. In addition, the Resident-Consultant 
continued to interact with all patient-care physicians concerning 
any problem with the laboratory. A bi-weekly conference, organized 
and conducted by the residents, discussed some 64 topics in 
clinical pathology in a systematic manner. 

Two Research Fellows completed their post-doctoral fellow- 
ship training programs. 

The Clinical Chemistry Service continued to provide weekly 
lectures on applications of clinical chemistry. The residency 
training program was expanded to include much more training of a 
practical hands-on nature, as well as providing both a practical 
understanding of instrumentation and the comparative merits and 
applicability of different analyzers. By routinely reviewing 
all abnormal data, the resident physicians are able to suggest 
the further workup of patients. 

The Hematology Service coordinated the Hematology-Oncology 
Clinical Electives, and the Hematology Service continued its 
major role in the teaching of this elective and received con- 
sistently high ratings by the medical students. Fourteen medical 
students took rotations on the Hematology Service from September 
1976 through May 1977. The senior staff gave each student a 
great deal of time in the instruction of bone marrow and peri- 
pheral blood interpretation. The Hematology Service and the 



CP-12 



Molecular Hematology Branch (NHLBI) continued to cooperate in 
sponsoring combined monthly hematology rounds, and the staff 
conducted weekly bone marrow morphology conferences for the Solid 
Tumor Branch of the National Cancer Institute. At least twice 
weekly, the Senior Staff and Residents of the Hematology Service, 
and interested physicians from other Clinical Center Institutes 
participated in Hematology rounds, where patient-care and labo- 
ratory problems are presented and discussed. 

The Hematology Service had three guest workers during the 
year. One, the Chief Medical Resident of Georgetown University 
Hospital, spent six months in the Hematology Service. A Clinical 
Associate from the Radiation-Oncology, NCI, DCT, spent six months 
in the Hematology Service and a Senior Staff member of the Laboratory 
of Pathology, NCI, spent two months in the Hematology Service. 

Seven individuals from universities, hospitals and other 
U. S. Government agencies received training in the Microbiology 
Service. 

Weekly conferences were held for all Microbiology Service 
technologists to discuss interesting cases, Service policies and 
new techniques and methods. Guest lecturers included Dr. Rudolph 
Hugh, Professor of Microbiology at George Washington University 
who delivered several lectures on the identification of non- 
fermentative Gram-negative rods. 

Seniors from the University of Maryland, majoring in 
microbiology, received supervision on specific research project 
which gave them direct experience with original research. 

IV. FUTURE OBJECTIVES 

The Phlebotomy Team will expand to 20 permanent full time 
employees. During the coming year, all phlebotomy for patient- 
care analyses, blood cultures, and sterile urine collection 
will be performed by the Team between the hours of 6:30 a.m. and 
1.1:00 p.m.. so that the Clinical Pathology Department can 
implement quality control for specimen collection within the 
Clinical Center, which will enhance the accuracy of laboratory 
results . 

The Clinical Chemistry Service will pursue further means to 
increase efficiency in the laboratory while attempting to introduce new 
tests into routine service. Many of the potential tests involved are 
radioimmunoassay procedures and, where feasible, automated or partially 
automated assay systems will be evaluated. 

The Clinical Chemistry Service will add additional tests to the 
SMAC analyzer and work with its manufacturer to improve the specificity 
of the procedures we have rejected because of their inherent nonspeci- 
ficity. Additional tests on this system will free manpower to perform 

CP-13 



other tests. Interfacing of the SMAC with the computer is now feasible 
and when done, will reduce technologist time and facilitate early 
reporting of data. This will be further improved with installation of 
the automatic specimen identification system that is currently under 
evaluation by the Laboratory Computer Service. 

The Hematology Service will introduce new techniques, update and 
increase the number of older, established laboratory procedures that 
will be of paramount importance to patients in the Clinical Center. In 
particular, attempts will be made this year to evaluate automated 
differential counters. The Service will continue its research in the 
area of clinical hematology to improve and introduce new laboratory 
tests to be better able to predict bleeding, thrombosis, increased 
platelet destruction, and qualitative and quantitative abnormalities of 
coagulation factor proteins. Training and clinical consultations will 
continue to be an important aspect of the Hematology Service goals. 

It is hoped that as the Hematology Service expands its armamen- 
tarium of tests, more space will become available for the introduction 
and evaluation of these new tests, and equipment to facilitate handling 
the increasing workload in the Hematology Service. 

During the coming year the Laboratory Computer Service plans to 
complete the linkage between the Honeywell laboratory computer and the 
Clinical Center Medical Information System (MIS) . This goal has the 
highest priority and will permit laboratory tests to be requested 
directly through the MIS terminals and to be reported through the MIS 
terminals and printers on the wards. Installation of the enhanced 
Honeywell system will reduce the delays experienced in using the 
system and reduce the amount of data which must be entered manually. 
The computerized system for monitoring blood cultures will be expanded 
as use for routine patient specimens increases. Computer techniques 
will be applied to the automation of antimicrobial susceptibility 
testing. Research will continue in the computerized interpretation of 
clinical laboratory measurements. 

We hope that significant restructuring of technologist functions 
in the Microbiology Service ,- particularly as regards supervisory level 
medical technologists, will result in more effective and harmonious 
laboratory operation. 

The procedures of sensitivity testing will most probably be 
altered during the coming year, as it is anticipated the Dynatech 
MIC-2000 96 channel dispenser will be incorporated into routine labo- 
ratory use to facilitate the determination and reporting of antibiotic 
sensitivity patterns. 

Those sections of the laboratory manual which had not been com- 
pletely revised during this fiscal year will undergo a critical re- 
vision in the next several months to eliminate any procedures now 
considered outmoded or ineffective and to incorporate such new 
techniques as are useful in diagnostic microbiology. 

CP-14 



Among new procedures that will be evaluated during the coming 
fiscal year are: a selective medium for the isolation of Group A 
beta-hemolytic Streptococci, the use of killed, antibody-coated 
Staphylococci to identify certain Lancefield group of beta-hemolytic 
Streptococci. 

Many of the research and development projects in which members 
of the laboratory have participated during this fiscal year will be 
continued (see the "Proposed Course" sections of the PHS forms 
#6040 describing the particular projects). 

V. PRESENTATIONS 

Eighteen members of the Clinical Pathology Department made 79 
formal presentations at universities and various national, and 
international meetings. 

VI. FORMAL TRAINING COURSES COMPLETED BY STAFF 

Fourteen Commissioned Officers participated in 21 formal 
training courses. 

Thirty-seven Civil Service employees participated in 40 formal 
training courses. 



CP-15 



VII. PUBLICATIONS 

Bennett, J. M. , Catovsky, D. , Daniel, M. T., Flandrin, G. , Gal ton, D. A. G. 
Gralnick, H. R. and Sultan, C. : Proposals for the classification of the 
acute leukaemias. Brit. J. of Hematology 33:451-458, 1976. 

Borer, W. Z. : The chemical analysis of body fluids in chemical diagnosis 
of disease. Brown, S. S., Mitchell, F. L. and Young, D. S., eds . Elsevier, 
Amsterdam (in press). 

Brown, S. S. , Mitchell, F. L. and Young, D.. S. eds. Chemical Diagnosis 
of disease. Elsevier, Amsterdam (in press) . 

Coller, B. S. and Gralnick, H. R. : Studies on the mechanism of ristocetin- 
induced platelet agglutination: Effects of structural modification of 
ristocetin and vancomycin. J. of Clin. Invest, (in press) . 

Corash, L. , Shafer, B. , Weiberg, D. and Steinfeld, M.D. : Platelet 
sizing of whole blood total platelet populations. Philadelphia Workshop 
on Platelets, Book, Government Printing Office . October 1976 (in press). 

Corash, L. , Tan, H. and Gralnick, H. R. : Heterogeneity of human whole 
blood platelet subpopulations. I. Relationship between buoyant density, 
cell volume, and ultrastructure. Blood 49: 71-87, 1977. 

Elin, R. J. : Role of magnesium in membranes; erythrocyte and platelet 

function and stability. In Cantin, M. (Ed.): Proceedings of the Second 

International Symposium on Magnesium . Spectrum Publications, New York 
(in press) . 

Elin, R. J. , Sandberg, A. L. and Rosenstreich, D. L. : Comparison of 
the pyrogenicity, limulus activity, mitogenicity and complement 
reactivity of several bacterial endotoxins and related compounds. , 
J. Immunology 117: 1238-1242, October 1976. 

Elin, R.J. and Tan, H. K. : Erythrocyte membrane plaques from rats with 
magnesium deficiency. Blood 49: 657, 1977. 

Elin, R. J. and Tan, H. K. : Formation of plaques on erythrocyte membranes 
from rats with magnesium deficiency. In Cantin, M. (Ed.): Proceedings 
o f the S econd In ternational Symposium on Magnesium . Spectrum Publications, 
New York. (in press). 

Elin, R. J. and Wolff, S. M. : Bacterial endotoxins. In Laskin, A. I. and 
Lechevalier, H. A. (Eds.); CRC Handbook of Microbiology . Cleveland, 
Ohio, CRC Press. (in press). 

Elin, R. J., Wolff, S. M. and Finch, C. A.: Effect of induced fever on 
serum iron and ferritin concentrations in man. Blood 49: 147-153, 1977. 



CP-16 



Fisher, R. I., Jaffe, E. S., Braylan, P. C. , Andersen, J. C. and 

Tan, H. K. : Immunoblastic lymphadenopathy : evolution into a malignant 

lymphoma with plasmacytoid features. Am. J. of Med. 61: 553-559, 1976. 

Forman, D. T. and Young, D. S. : Drug interference in laboratory testing. 
Ann. Clin. Lab. Sci. 6:, 263-271, 1976. 

Forman, D. T. and Young, D. S. : Drug interference in laboratory testing. 
In Clinical Chemistry . Forman, D. T. and Mattoon, R. W. Eds. American 
Chemical Society, Washington, D. C. pp. 271-284, 1976. 

Gelfand, J. A., Elin, R. J., Berry, F. W. and Frank, M. D. : Endotoxemia 
associated with the Jarisch-Herxheimer reaction. N. Eng. J. Med. 
295: 211-213, 1976. 

Gill, F. A., Robinson, R. , MacLowry. J. D. and Levine, A. S. : The 
relationship of fever, granulocytopenia, and antimicrobial therapy 
to bacteremia in cancer patients. Cancer 39: 1704-1709, 1977. 

Gralnick, H. R. : Congenital dysf ibrinogenemia. In Hematology , 2nd 
Edition. Edited by W. J. Williams, E. Beutler, A. J. Erslev and R. 
Wayne Rundles. (in press), 1977. 

Gralnick, H. R. , Coller, B. S., Shulman, N. R. , Andersen, J. C. and 
Hillgartner, M. : Factor VIII. Ann. Int. Med. 86: 598-616, 1977. 

Gralnick, H. R. , Sultan, Y. and Coller, B. S.: von Willebrand's disease 
combined qualitative and quantitative abnormalities. N. Engl. J. Med. 
296: 1024-1030, 1976. 

Greco, F. A., Kolins, J., Rajjoub, R. K. , Brereton, H. D. : Hodgkin's 
disease and granulomatous antiitis of the central nervous system. 
Cancer 38: 2027-2032, 1976. 

Green, J. and MacMillan, D. : Quality control for blood gas instrumentation: 
an evaluation of the Technicon blood gas analyzer. In Advances in 
Automated Analysis . (in press). 

Hande, K. R. , Witebsky, F. G., Brown, M.D., Schulman, C. B., Anderson, 
S. E. , Jr., Levine, A. S., MacLowry, J. D. and Chabner, B. A.: Sepsis 
with a new species of Corynebacterium . Ann . Int . Med . 85: 423-426, 1976. 

Hicks, J. M. and Young, D. S.: Obligations of the pediatric clinical 
chemistry laboratory. In The Neonate: Clinical Biochemistry, Physiology 
and Pathology. Young, D. S. and Hicks, J. M. (Eds.). Wiley, New York, 
PP. 325-336, 1976. 

Hoover, H. C. , Jr., Ketcham, A. S., Millar, R. C, Gralnick, H. R. : 
Osteosarcoma: improved survival with anticoagulation and amputation. 
Cancer . (in press) . 



CP-17 



125 
Horvath, A. and Gralnick, H. R. : The I fibrinogen euglobulin lysis 

test. Am. J. of Clin. Path. (in press). 

Ingle, J. N. , Tormey, D. G. and Tan, H. K. : The bone marrow examination 
in breast cancer: diagnostic considerations and clinical usefulness. 
Cancer . 1977, (in press). 

Jaffe, R. M. : Platelet interaction with connective tissue. In Platelets 
in Pathology and Biology . Gordon, J. (Ed.) Academic Press, 1976, 
pp. 241-279. 

Jaffe, R. M. : A test for occult blood. U. S. Patent Serial No. 498-109 
(Final number pending). 

Jaffe, R. M. : The laboratory evaluation of well people. Proceedings 

of the Seventh Annual Meeting of the American Association of Comprehensive 

Health Planners . Washington, D. C. (in press). 

Jaffe, R. M. and Zierdt, W. : A new occult blood test not subject to 
false negative results from reducing substances. J. Lab. Clin. Med. 
(In press) . 

Kagan, R. L. , Schuette, W. H. , Zierdt, C. H. and MacLowry, J. D.: Rapid 
automated diagnosis of bacteremia by impedance detection. J. Clin. 
Microbiol. 5: 51-57, 1977. 

Landefeld, T. , Boguslawski, S., Corash, L. and Boime, I.: The cell-free 
synthesis of the alpha subunit of human chorionic gonadropin. Endocrinology 
98: 1220, 1976. 

Mabry, J., Gralnick, H. and Carbone, P.: Fourteen year remission of 
acute leukemia in a patient exposed to thorostrast. Cance r (in press). 

MacLowry, J. D. , Robertson, E. A. and Elin, R. J.: The place of the 
computer in diagnostic medical bacteriology. In Progress in Clinical 
Pathology Vol. 7, 1976-1977. Gruen and Stratton, New York and Longon. 

Markovic, N. , Markovic, 0. and Young, D. S.: Enzyme kinetics in single 
cells: concept and model. Clin. Chem. (in press). 

McClean, S. , Kabat, A., Sampugna, J., Purdy, W. C. and McCormick, G. : 
Analysis of the effect of malaria on lipid composition of rhesus plasma. 
Anal. Chim. Acta 86: 255-261 (1976). 

McClean, S. W. , Young, D. S. and Yonekawa, W. : Anticonvulsants in serum, 
determined with a fully mechanized enzyme analyzer-. Clin. Chem. 23, 
116-118, 1977. 

Mulvihill, J. J. Gralnick, H. F., Whang-Peng, J. and Leventhal, B. G. : 
Multiple childhood osteosarcomas in an American Indian family with 
erythroid macrocytosis and skeletal anomalies. Cancer , 1977 (in press). 



CP-18 



Nishi, H. H. and Young, D. S. : Concepts and design of a mechanized 

microchemistry system for discrete analyses. In Microtechniques for 

the Clinical Laboratory . Werner, M. (Ed.) Wiley, New York, pp. 361-380, 1976, 

Nishi, H. H. and Young, D. S. : Rapid analysis of specific proteins by 
a discrete kinetic approach. In Automated Immunoanalysis , edited by 
R. F. Ritchie (in press). 

Norton, J. A., Shulman, N. R. , Corash, L. , Smith, R. L. , Au , F. and 
Rosenberg, S. A. : Severe thrombocytopenia following intralesional 
BCG therapy. Cancer , 1977 (in press). 

Panek, E. , Cook, G. A. and Cornell, N. W. : Effects of 5- (tetradecyloxy)- 
2- furoic acid on lipid synthesis and on the metabolism of rat hepatocytes. 
Biochim. Biophys. Acta (in press) . 

Panek, E. , Young, D. S. and Bente, J.: Analytical interference in drugs 
in clinical chemistry. Amer. J. Med. Technol. (in press). 

Phillips, B. P. and Zierdt, C. H. : Blastocystis hominis : an ameba with 
pathogenic potential. Experimentation Animale 7: 155-156, 1976. 

Phillips, B. P. and Zierdt, C. H. : Blastocystic hominis : pathogenic 
potential in human patients and in gnotobiotes. Exper. Par as it. 39: 
358-364, 1976. 

Piomelli, S. , Corash, L. : Hemolytic anemia secondary to enzymatic 
defects of the erythrocyte. In Harris, H. and Hirschorn, K. (Eds.). 
Advances in Human Genetics , Vol. 6, pp. 165-240, 1976. 

Rehak, N. N. , Janes, G. and Young, D. S.: Calorimetric enzymic measure- 
ment of uric acid in serum. Clin. Chem. 23, 195-199, 1977. 

Rehak, N. N. and Young, D. S. : Determination of free and total 
cholesterol in serum by kinetic microcalorimetry. Clin. Chem. (in press). 

Rehak, N. N. and Young, D. S. : Determination of lactate dehydrogenase 
isoenzyme activity by kinetic microcalorimetry. Clin. Chem. (in press). 

Reynolds, H. Y. , DiSant-Agenese, P. A., and Zierdt, C. H. : Mucoid 
Pseudomonias aeruginosa - A sign of cystic fibrosis in young adults 
with chronic pulmonary disease? JAMA 236: 2190, 1976. 

Robertson, E. A., Macks, G. C. and MacLowry, J. D. : Analysis of the 
cost and accuracy of alternative strategies for Enterobaceriac eae 
identification. J. Clin. Microbiol. 3L 421-424, 1976. 

Robertson, E. A., and Young, D. S. : Evaluation of SMAC performance by 
analysis of variance of quality control data. In Advances in Automated 
Analysis . (in press). 



CP-19 



Rodbard, D. and McClean, S. W. : Automated computer analysis for enzyme 
multiplied immunological techniques. Clin. Chem. 23, 112-115, 1977. 



Rosenthal, S. , Canellos, G. P., DeVita, Jr., V. T. and Gralnick, H. 
Characteristics of blast crisis in chronic granulocytic leukemia. 
Blood 49: 705-714, 1977. 



R. 



Rosenthal, S. , Canellos, G. and Gralnick, H.F.: Erythroblastic trans- 
formation of chronic granulocytic leukemia. Am. J. of Med, (in press). 

Rosenthal, S. , Canellos, G. P., Whang-Peng, J. and Gralnick, H. R. : 
Blast crisis of chronic granulocytic leukemia: morphologic variants 
and therapeutic implications. Am. J. of Med, (in press). 



Savage, D. D. , Kagan, R. L. , Young, N. 
Cardiobacterium hominis endocarditis : 
characterization of the organism. J. 



A. and Horvath, A. E. : 
description of two patients and 
Clin. Microbiol. 5: 75-80, 1977. 



Siest, G. and Young, D. S. (Eds.) Drugs interferences and drug measure- 
ment in clinical chemistry. Karger, Basel, 1976. 



Spellman, Jr., G. G. , Macoviak, J. A. and Gralnick, H. R. : Comparison 
of polymerization of ancrod and thrombin monomers. Blood , (in press). 

Spiegel, A. M. , DiChiro, G. , Gordon, P., Kolins, J., Omaya, A. K. , 
and Pomeroy, T. C. : Diagnosis of radiosensitive hypothalamic tumors 
without craniotomy: endocrine and neuroradiologic studies of intra- 
cranial atypical teratomas. Ann. Int. Med. 85: 290-293, 1976. 



Spielberg, S. A., Garrick, M. 
Rogers, L. and Schulman, J.: 
thione synthetase deficiency. 
Sciences , 1977 (in press). 



D., Corash, L. M. , Butler, J., Tietze, F. , 

Biochemical heterogeneity in human gluta- 

Proceedings of the National Academy of . 



Sweet, J. B. , Gill, V. J., Chusid, M. J. and Elin, R. J.: Bacteremia, 
NBT, and limulus assays following dental extraction: effect of topical 
antiseptics. J. Amer. Dental Assoc, (in press). 



Tan, H. K. and Lamberg, J. D. : 
of morphological criteria. Am. 



Diagnosis of acute leukemia: 
J. Clin. Path, (in press) . 



variability 



Tuazon, C. U. , Perez, A. A., Elin, R. J. and Sheagren, J. N. : Detection 
of endotoxin in cerebrospinal and joint fluids by limulus assay. 
Arch. Int. Med. 137: 55-56, 1977. 



Van Steirteghem, A. C. 
physiological fluids. 



Dekker, New York (in press) 



and Young, D. S. : Amino acid determination in 
In Amin o Acid Determination . Blackburn, S. (Ed.) 



CP-2Q 



Whang-Peng, J., Gralnick, H. R. , Knutsen, T. , Brereton, H. , Chamg, P., 
Schecter, G. P. and Lessin, L. : Small F chromosome in myelo- and 
lymphoprolif erative diseases. Leukemia Research 1: 19-30, 1977. 

Young, D. S. : Automation. In Fu ndamentals of Clinical Chemist ry. 

Tietz, N. W. (Ed.), 2nd Edition". Saunders, Philadelphia, pp. 187-211, 1976. 

Spina, P. : This lah's concern: the quality of working life. Medical 
Laboratory O bserver: 9, 37-40, 1977. 

Young, D. S. : Biological variability. In Chemical Diagnosis of Disease. 
Brown, S. S. , Mitchell, F. L. and Young, D. S. (Eds.) Elsevier, Amsterdam 
(in press) . 

Young, D. S. : Classification of enzvmes and current status of enzyme 
nomenclature and units. Ann. Ciin. Lab. Sci. 7, 93-98, 1977. 

Young, D. S. : Clinical Chemistry. In Mc Graw Hill Yearbook of Science 
and Technology . Lapedes, D. N. (Ed.), 1977. (in press). 

Young, D. S. : Factors affecting laboratory data. Medical Letter , (in press) 

Young, D. S. : Interpretation of ciinical chemical data with the aid of 
automated data processing. Clin. Chem. 22, 1555-1561, 1976. 

Young, D. S. : Interpretation of clinical laboratory data. In Accuracy 
in Trace Analysis: Sampling, Sample Handling, Analysis. Volume I. 
LaFleur, P. D. (Ed.) NBS Special Publication , 422, 109-122. U.S. 
Department of Commerce, 1976. 

Young, D. S. : Metrication and medicine. In Proceedings of a National 
Conference on Metrication. Todd, P. M. (Ed.) (ir. press). 

Young, D. S. : Recent applications of the centrifugal fast analyzer. 
In Organizati on des Laboratoires- Biolog ie Prospective . Siest, G. (Ed.) 
L 1 expansion Scientifique Francaise, Paris, pp. 187-190, 1976. 

Young, D. S. : Reporting of laboratory data in SI units. J. Forensic 
Sc i. (in press). 

Young, D. S. and Hicks, J. M. (Eds.) Th e Neonate: Clinical Biochemistry, 
Phys iology and Pathology . Wiley, New York, 1976. 

Young, D. S. , Hicks, J. M. and Pestaner, L. C. : Directory of rare 
analyses. Cli n. Chem. 23: 323-383, 1977. 

Young, D. S. and Panek, E. : Effects of drugs on the analytical procedures 
of a multitest analyzer in drug interferences and drug measurement in 
clinical chemistry. Siest, G. and Young, D. S. (Eds.) Karger, Basel, 
pp. 10-20, 1976. 



CP-21 



Young, D. S. and Schwartz, J. K. : Cancer. In Chemical Diagnosis of 
Disease . Brown, S. S., Mitchell, F. L. and Young, D. S. (Eds.) 

Zierdt, C. H. , Kagan, R. L. and MacLowry, J. D.: Development of a 
lysis-filtration blood culture technique. J. Clin. Microbiol. 5, 
46-50, 1977. 

Zierdt, W. S. : A simple device for concentration of parasite eggs, 
larvae, and protozoa. Am. J. Clin. Path, (in press) . 

Zweig, M. : Influence of methotrexate on three methods for the deter- 
mination of cerebrospinal fluid protein. Clip. Chem. (in press). 



CP-22 



'SMITHSONIAN SCIENCE INFORMATION EXCHANGE 
PROJECT NUMBER (Do WOT use this space) 



U.S. DEPARTMENT OF 
HEALTH, EDUCATION, ANO WELFARE 
PUBLIC HEALTH SERVICE 
NOTICE OF 
INTRAMURAL RESEARCH PROJECT 



PROJECT NUMBER 
ZOl CC 00001-03 CP 



PER 1 00 COVERED 

July 1, 1976 to September 30, 1977 



TITLE OF PROJECT (80 characters or less) 



Analytical Methodology: Development and Interpretative Application 



NAMES, LABORATORY ANO INSTITUTE AFFILIATIONS, AND TITLES OF PRINCIPAL INVESTIGATORS AND ALL OTHER 
PROFESSIONAL PERSONNEL ENGAGED ON THE PROJECT 

D.S. Young, CC/CPD Chief, Clinical Chemistry Service 

M. Green, CC/CPD Staff Chemist 

R.M. Jaffe, CC/CPD Staff Physician 

M.H. Zweig CC/CPD Acting assistant chief. Clinical Chemistry Service 

E.A. Roberston CC/CPD Assistant chief. Laboratory Computer Service 



COOPERATING UNITS (if any) 



lab/branch 

Clinical Pathology Department 



SECTION 

Clinical Chemistry Service 



INSTITUTE ANO LOCATION 

Clinical Center, N .T .H., Reth esda , Md . 



TOTAL MANYEARS: 
6 



PROFESSIONAL: 
2 



OTHER! 



CHECK APPROPRIATE 80X(ES) 

□ (a) HUMAN SUBJECTS 

□ (al) MINORS □ (a2) INTERVIEWS 



[] (b) HJMAN TISSUES 



□ (c) NEITHER 



SUMMARY OF WORK (200 words or less - underline keywords) 

Analytical methods in use in clinical laboratories have been evaluated. 
New method s and instrumentation have been studied and effects of drugs on 
test values determined. Continued work with automatic interpretation of 
effects of drugs has shown that it is possible to assist physicians in 
understanding influence of drug therapy in changing laboratory test values. 



CP-23 



Project No. Z01 CC 00001-03 CP 

1. Clinical Pathology Department 

2 . Clinical Chemistry Service 

3. Bethesda, Maryland 

PHS-NIH 

Individual Project Report 

July 1, 1976 through September 30, 1977 

Project Title: Analytical Methodology: Development and Interpretative 
Application 

Previous Serial Number: Z01-CC-00001-02-CP 

Principal Investigator: Donald S. Young 

Other Investigators: Maurice Green 

Mark H. Zweig 



Russell M. Jaffe 
E. Arthur Robertson 



Man Years : 

Total 6 
Professional 2 
Other 4 



Project Description 



Objectives 



1. To upgrade the quality of clinical laboratory data within NIH and 
elsewhere. 

2. To facilitate the correct interpretation of laboratory data. 
Methods employed : 

1. Reference methods have been developed against which other methods can 
be compared. These methods are well characterized with respect to 
accuracy, precision, sensitivity and specificity. 

2. Data bases have been developed in a computer file to list effects of 
drugs on laboratory tests, conversion factors from traditional to 

SI units, and centers where unusual clinical laboratory tests are 
perfDrmed throughout the country. 

Major fin dings: 

Deficiencies in analytical methods have been identified and alternative 
methods studied in depth. By appropriate selection of method it is possible 
to avoid erroneous answers due to nonspecif icity of the procedures. Drugs 
have been added to serum to their therapeutic concentration and effects 
observed on many different procedures on several different analyzers. 



CP-24 



Project No. Z01 CC U0001-01 CP 
Significance : 

This work has upgraded the quality of some tests in this laboratory and 
has the potential for doing the same thing in other laboratories when the 
same methods are used. By alerting physicians to drugs as a possible cause 
of abnormal data it has been possible to explain the cause of the unusual 
values and to prevent extensive and unnecessary workups of patients. 

Proposed course : 

Continued development and evaluation of methods will be undertaken. 

Honors and awa rds : 

Dr. Young received the 1977 Bernard F. Gerulat award for the New Jersey 
section, American Association for Clinical Chemistry, the 1977 AACC award 
for outstanding contributions to clinical chemistry and one of the 1977 
NTH Director's awards. 

Publications : 

Forman, D.T. and Young, D.S. Drug interference in laboratory testing. 
An. Clin, Lab. Sci. 6, 263-271, 1976. 

Forman, D.T. and Young, D.S. Drug interference in laboratory testing 
in Clinical Chemistry, Forman, D. R. and Mattoon, R. W. eds. American 
Chemical Society, Washington, D. C. pp 271-284, 1976. 

Jaffe, R. M. A test for occult blood. US patent serial no. 498-109. 

McClean, S. W. , Young, D. S. and Yonekawa, W. Anticonvulsants in 
serum, determined with a fully mechanized enzyme analyzer. Clin. Chem. 
23, 116-118, 1977. 

Rodbard, D. and McClean, S. W. Automated computer analysis for 
enzyme-multiplied immunological techniques. Clin. Chem. 23, 112-115, 1977. 

Young, D.S. and Panek, E. Effects of drugs on the analytical pro- 
cedure of a multitest analyzer in Drug interferences and drug measurement in 
Clinical Chemistry. Siest, G. , and Young, D. S. eds. Karger, Basel, 
pp 10-20, 197 6. 



CP-25 



SMITHSONIAN SCIENCE INFORMATION EXCHANGE 
PROJECT NUMBER (Do NOT use this space] 



U.S. DEPARTMENT OF 
HEALTH, EDUCATION, AND WELFARE 
PUBLIC HEALTH SERVICE 
NOTICE OF 
INTRAMURAL RESEARCH PROJECT 



PROJECT NUMBER 

ZOl- CC 00002-01 CP 



PERIOD COVERED 



July 1, 1976 to September 30, 1977 



TITLE OF PROJECT (80 characters or less) 

Clinical Laboratory Applications of Microcalorimetry 



NAMES, LABORATORY AND INSTITUTE AFFILIATIONS, AND TITLES OF PRINCIPAL INVESTIGATORS AND ALL OTHER 
PROFESSIONAL PERSONNEL ENGAGED ON THE PROJECT 

Nadja N. Rehak, Visiting Scientist, CC, CPD 

Russell M. Jaffe, Staff Physician, CC, CPD 

Donald S. Young, Chief, Clinical Chemistry Service 



COOPERATING UNITS (if any) 



LAB/BRANCH 

Clinical Pathology Department 



SECTION 

Clinical Chemistry Service 



INSTITUTE AND LOCATION 

Clinical Center, NIH, Bethesda, Md. 



TOTAL MANYEARS: 

3. 







PROFESSIONAL: 

1.0 



OTHER: 



2.0 



SUMMARY OF WORK (200 words or less - underline keywords) 

Two different calorimeters have been used to study various biological 
phenomena in body fluids. Measurements have been made of bilirubin binding 
to albumin and the heat output from washed erythrocytes has also been studied 
Measurements of chymotrypsin , trypsin and pepsin activity in gastrointestinal 
secretions have been made. Differentiation of lactate dehydrogenase isoenzymes 
by calorimetry has been accomplished. Studies are continuing on the measure- 
ment of free and total cholesterol using specific enzymes. 



CP-26 



PHS-604G 

02-75) 



Project No. Z01-CC 00002-01 CP 

1. Clinical Pathology Department 

2. Clinical Chemistry Section 

3. Bethesda, Maryland 

PHS-NIH 
Individual Project Report 
July 1, 1976 through Sept. 30, 1977 

Project Title: Clinical laboratory applications of microcalorimetry 

Previous Serial Number: none 

Principal Investigators: Dr. N.N. Rehak 

Dr. R.M. Jaffe 

Other Investigators: Dr. D.S. Young 

Cooperating Units: none 

Man Years: 



Total: 


3.0 


Professional: 


1.0 


Other: 


2.0 



Objectives : 

To determine the feasibility of calorimetry as a practical technique in 
clinical laboratory practice. To use calorimetry for assessing cellular 
metabolism. 

Methods Employed : 

Calorimetric assays were compared against conventional methods. When 
differences in test values were observed these were actively followed up. 

Major findings : 

The calorimeter can be used to measure certain enzymes rapidly with 
obviation some of the problems that affect spectrophotometric measurements. 
Determination of lactate dehydrogenase subunits can be accomplished more 
rapidly and efficiently by calorimetry than by electrophoresis. Likewise, 
the determination of free and ester cholesterol is more simple using calori- 
metry than conventional techniques. 

Significance: 

It is possible to make certain determinations more accurately and with 
greater specificity with the calorimeter than with other methods. This has 
potential implications for the improvement of health care. 



CP-27 



Project No. Z01-CC-00002-01 CP 
Proposed course : 

The titration calorimeter computer programs will be further refined to 
improve throughput of analyzers and provide greater flexibility. Modifica- 
tions to improve sensitivity are also to be undertaken, and redesign of the 
stirrer should eliminate problems of hemolysis that affect measurements on 
intact cells. 

Further applications of the calorimeter to make additional measurements 
of substances that require complex separations at the present time are 
planned. These include vanillylmandelic acid and 5-hydroxyindoleacetic 
acid in urine. The purity of enzymes used as reagents for clinical labora- 
tory tests will also be studied. 

Honors and awards: none 

Publications: 



Rehak, N.N., Janes, G. and Young, D.S. Calorimetric enzymatic measure- 
ment of uric acid in serum. Clin. Chem. 23, 195-199 (1977). 



CP-28 



SMITHSONIAN SCIENCE INFORMATION EXCHANGE 
PROJECT NUMBER (Do NOT use this space) 



U.S. DEPARTMENT OF 
HEALTH, EDUCATION, AND WELFARE 
PUBLIC HEALTH SERVICE 
NOTICE OF 
INTRAMURAL RESEARCH PROJECT 



PROJECT NUMBER 



ZOl CC 00003-01 CP 



PERIOD COVERED 
J uly 1 , 19/ 



Tiily 1, 197ft - SppfPTnhP.r 30 1977 
TITLE OF PROJECT (80 characters or less) 



Staphylococcus aureus Carriage and its Relationshio to Infection in a 
Pediatric Population with Malignant Disease 



NAMES, LABORATORY AND INSTITUTE AFFILIATIONS, AND TITLES OF PRINCIPAL INVESTIGATORS. AND ALL OTHER 
PROFESSIONAL PERSONNEL ENGAGED ON THE PROJECT 

Dr. Stephan K. Ladisch, Clinical Associate, Pediatric Oncology Branch 
Division of Cancer Treatment, NCI 

Dr. Charles H. Zierdt, Microbiologist, Microbiology Service, CPD, CC 

Dr. Frank G. Witebsky, Asst. Chief, Microbiology Service, CPD, CC 

Dr. Philip A. Pizzo, Senior Investigator, Pediatric Oncology Branch, 
Division of Cancer Treatment, NCI 



COOPERATING UNITS (if any) 

Pediatric Oncology Branch, Division of Cancer Treatment, NCI 



LAB/BRANCH 



Clinical Pathology Department 



SEC 



Mi rrnhinlnpy Sprvjrp 



INSTITUTE AND LOCATION 

Clinical Center, National Institutes of Health, Bethesda, Maryland 



20014 



TOTAL MANYEARS: 

0.5 



PROFESSIONAL: 

0.1 



OTHER: 



0.4 



CHECK APPROPRIATE BOX(ES) 
U (a) HUMAN SUBJECTS 

D (al) MINORS □ (a2) INTERVIEWS 



□ (b) HUMAN TISSUES 



£(0 



NEITHER 



SUMMARY OF WORK (200 words or less - underline keywords) 

Carriers of Staphylococcus aureus in the Pediatric oncology Branch 
clinic population are being identified using cultures of anterior nares 
swabs. All Staphylococcus aureus isolates are phage typed . Comparisons 
will be made of the incidence of Staphylococcal infections in carriers 
and non-carriers . Should the infection rate prove higher in carriers, 
attempts may be made to lower the carriage rate. 



CP-29 



PHS-6040 
(Rev. IO-76) 



Project No. Z01 CC 00003-01 CP 

1. Clinical Pathology Department 

2. Microbiology Service 

3. Bethesda, Maryland 



PHS-NIH 

Individual Project Report 

July 1, 1976 through September 30, 1977 



Project Description 

Objectives : 

The objectives of this study are to determine the anterior nares 
carriage rate of Staphylococcus aureus in the Pediatric Oncology Branch 
clinic population. If more infections caused by Staphylococcus aureus 
are found in carriers as compared with non-carriers, an attempt may be 
made to decrease the carriage rate, and thereby, hopefully, also the 
infection rate. 

Methods Employed : 

Routine culturing procedures are employed for the identification of 
Staphylococcus aureus . All isolates, both from the nose and from any 
sites of infection, are further characterized by bacteriophage typing 
to assess the likelihood that in a given patient isolates of Staph, aureus 
from the nose and from a site of infection are both the same. 

Major Findings : 

Many persistent carriers of Staphylococcus aureus have been identified. 
However, more data is required before any general conclusions can be drawn. 

Significance to Biomedical Research aud rhw Program of the Institute : 

Staphylococcus aureus infections are a cause of significant morbidity 
in immunosuppressed patients. If a predisposing factor (such as Staph, 
aureus nasal carriage) can be defined and eliminated, significant patient 
benefit will accrue. 

Proposed Course : 

More data will be collected in order to have sufficient members of 
cases to allow for meaningful conclusions to be made. 

Honors and Awards : 

None 
Publications : 

None 



CP-30 



SMITHSONIAN SCIENCE INFORMATION EXCHANGE 
PROJECT NUMBER (Do NOT use this space) 



U.S. DEPARTMENT OF 
HEALTH, EDUCATION, AND WELFARE 
PUBLIC HEALTH SERVICE 
NOTICE OF 
INTRAMURAL RESEARCH PROJECT 



PROJECT NUMBER 

Z01-CC-00004-02-CP 



f 



PERIOD COVERED 



July 1, 1976 to Sept. 30, 1977 



TITLE OF PROJECT (80 characters or less) 
Radioimmunoassay of Creatine Kinase: A model for RIA of human serum isoenzymes. 



NAMES, LABORATORY AND INSTITUTE AFFILIATIONS, AND TITLES OF PRINCIPAL INVESTIGATORS AND ALL OTHER 
PROFESSIONAL PERSONNEL ENGAGED ON THE PROJECT 

Dr. Andre C. Van Steirteghem, Visiting Scientist, CP,CC 

Dr. Mark H. Zweig, Staff Physician, CP,CC 



COOPERATING UNITS (if any) 

Dr. Alan N. Schechter, Section of Maromolecular Biology, Laboratory of 
Chemical Biology, NIAMDD 



LAB/BRANCH 
Clinical Pathology Department 



SECTION 
Clinical Chemistry Section 



INSTITUTE AND LOCATION 
CC, NIH, Bethesda, Maryland 



20014 



TOTAL MANYEARS: 

2.5 



PROFESSIONAL: 

1.5 



OTHER: 



1.0 



NUMMARY OF WORK (200 words or less - underline keywords) 

Since the catalytic activity of the most commonly measured human serum 
enzymes is not necessarily relevant to their clinical usefulness in diagnosis 
and is only a convenient tool for assay, determination of the total mass of 
each enzyme or isoenzyme released into the circulation by normal cellular activ- 
ity or damage is more relevant and desirable. Radioimmunoassay (RIA) offers th< 
high degree of specificity and sensitivity required to measure enzyme mass and 
to simultaneously distinguish isoenzyme species having the same catalytic activ- 
ity but having different clinical significances. Creatine kinase (CK) was 
chosen as a model for this approach because of its clinical importance and rela- 
tively ^simple isoenzyme structure and distribution. To develop RIA's for CK, 
isoenzyme purifications were necessary to provide material for immunization of 
animals as a source of antibodies for preparing an I-*-" radiolabeled tracer and 
for standards. The RIA's developed for these two isoenzymes are applied to the 
diagnosis and study of diseases of the heart skeletal muscle, brain, thyroid and 
other organs and to the detection of heterozygous carriers of muscular dystrophy 






CP-31 



PHS-6040 
(12-75) 



Project No. Z01-CC-00004-02-CP 

1. Clinical Pathology Dept. 

2. Clinical Chemistry Section 

3. Bethesda, Maryland 

PHS-NIH 

Individual Project Report 

July 1, 1976 through Sept. 30, 1977 

Project Title: Radioimmunoassay of Creatine Kinase: A model for RIA of 
human serum isoenzymes 

Previous Serial Number: Z01-CC-00004-01-CP 

Principal Investigators: Dr. Andre Van Steirteghem 

Dr. Mark H. Zweig 

Other Investigators: None 

Cooperating Units: Dr. Alan N. Schechter, LCB, NIAMDD 

Man Years: 



Total: 


2.5 


Professional: / 


1.5 


Other: 


1.0 



Project Description 



Objectives: 



1. To develop and optimize radioimmunoassays for the muscle (CK-MM) and 
brain (CK-BB) isoenzymes of human creatine kinase (CK) in serum and 
other fluids. 

2. To apply the RIA's developed to the diagnosis and study of disease of 
tissues and organs containing CK". 

3. To apply these assays to the detection of heterozygous carriers of 
muscular dystrophy. 

Methods Employed 

1. Previously immunized sheep, rabbits and burros were boosted by injection 
of the original iramunogens. Blood was collected two weeks later, for the 
preparation of antisera. 

2. Radioiodination of purified CK was performed by Hazelton Laboratories 
(Vienna, Virginia). The chloramine-T method was used for CK-MM and the 
conjugation method of Bolton and Hunter for CK-BB. 

3. The standard components of an RIA system, radiotracer, specific antibody, 
and precipitating antibody were assembled into a specific and sensitive 



CP-32 



Project No. Z01-CC-00004-02-CP 
assay for each of the two CK isoenzymes. 
Major Findings: 

1. The RIAs were optimized and found to be practical, reproducible and 
accurate. Sensitivity and specificity were particularly high. The 
specificity of both assays for their respective isoenzymes was greater 
than the specificity reported by other workers. 

2. For the muscle isoenzyme* reference ranges for healthy adults were deter- 
mined by assaying the sera of laboratory workers and blood bank donors. 
A close correlation was found between the enzymatic activity measured by 
conventional assays and the mass concentration as determined by RIA in 
these sera. In patient sera a similar relationship between enzymatic 
activity was found, but the correlation was not as close. 

3. Whereas the amounts of brain isoenzyme in sera have usually been low or 
undetectable by assays of enzymatic activity, virtually all sera from 
healthy subjects and from patients had measureable amounts when deter- 
mined by RIA. A reference range for healthy persons was determined. 

Proposed Course: ' 

1. The RIAs for the brain and muscle isoenzymes of CK will be applied to the 
measurement of isoenzyme concentration in the serum, cerebrospinal fluid 
and muscle biopsy extracts of patients. Some of these applications are 
under way. Patients of interest include those with psychosis, neuro- 
muscular disorders (especially muscular dystrophy and polymyositis) , 
myocardial disease, prostatic carcinoma, and patients undergoing cardiac 
and neurosurgical procedures. 

2. A RIA for the cardiac isoenzyme, CK-MB, will be developed to obtain a 
highly sensitive and specific measurement of the concentration in serum. 

3. To obtain definitive data on the tissue distribution of CK isoenzymes, 
human tissue extracts will be assayed using RIA procedures. 

4. Fractionation of CK into mitochondrial and non-mitochondrial forms will 
be attempted with the intent to determine molecular differences and to 
study the clinical significance of the appearance of each type in human 
serum. 

Honors and Awards : none 

Publications ' 

1. Van Steirteghem, A.C., Zweig, M.H. and Schechter, A.N. Radioimmunoassay 
of the brain isoenzyme of human creatine kinase. Clin. Chem. 23, 1125, 
1977. (abstract; paper presented July, 1977 at American Association for 
Clinical Chemists meeting in Chicago) . 



CP-33 



Project No. Z01-CC-00004-02-CP 

2. Zweig, M.H., Van Steirteghem, A.C. and Schechter, A.N. Radioimmunoassay 
of the muscle isoenzyme of human creatine kinase. Clin. Chem. 23, 1143, 
1977. (abstract, paper presented July, 1977 at American Association for 
Clinical Chemists meeting in Chicago). 



CP-34 



SMITHSONIAN SCI 
PROJECT NUMBER 






CE INFORMATION EXCHANGE 
NOT use this space) 



U.S. DEPARTMENT OF 
HEALTH, EDUCATION, AND WELFARE 
PUBLIC HEALTH SERVICE 
NOTICE OF 
INTRAMURAL RESEARCH PROJECT 



PROJECT NUMBER 



Z01-00005-03-CP 



PERIOD COVERED 

July 1, 1976 to September 30, 1977 



TITLE OF PROJECT (80 characters or less) 
Development of a microchemical analytical system for pediatric analyses. 



NAMES, LABORATORY AND INSTITUTE AFFILIATIONS, AND TITLES OF PRINCIPAL INVESTIGATORS AND ALL OTHER 
PROFESSIONAL PERSONNEL ENGAGED ON THE PROJECT 

H.H. Nishi, CC, CPD - Research Biochemist, Principal Investigator 
D.S. Young, CC,CPD - Chief, Clinical Chemistry Service 



COOPERATING UNITS (if any) 
BEIB,NTH 



LAB/BRANCH 



Clinical Pathology Department 



SECTION 



Clinical Chemistry Service 



INSTITUTE AND LOCATION 

Clinical Center, NIH, Bethesda, Md. 



TOTAL MANYEARS: 

3.5 



PROFESSIONAL: 
1.2 



OTHER: 



2.3 



SUMMARY OF WORK (200 words or less - underline keywords) 

Because of the increasing usage of the miniature centrifugal fast analyzer 
as an analytical tool for routine clinical chemistry laboratories, it was 
incorporated into our microchemical analytical system. The purpose of this 
combination was to study the flexibility and effectiveness of the microanalyti- 
cal system when used with a miniature centrifugal fast analyzer. The newly 
created system was evaluated for specific proteins analyses using the kinetic 
rate measurement of human serum IgG as a model. A new assay method for the 
determination of immunoglobulin G was developed for the system. Technical 
aspects of this study has been completed save for the rechecking of certain 
critical points, the write-up of the study has been started and will be ready 
for publication soon. 



CP-35 



PHS-6040 



Serial No. Z01-00005-03-CP 

1. Clinical Center, Clinical Pathology 
Department 

2. Clinical Chemistry Service 

3. Bethesda, Maryland 



PHS-NIH 

Individual Project Report 

July 1, 1976 through Sept. 30, 1977 

Previous Serial Number: Z01-00005-02-CP 

Principal Investigator: Harold Nishi 

Other Investigator: Dr. Donald Young 

Mrs. Jane Kestner 

Cooperating Units: Inside NIH 

Mr. Charles McCarthy, BEIB 
Mr. Charles Wicks, BEIB 
Mr. Leonard Aberbach, BEIB 

Man Years: ' 

Total: 3.5 

Professional: 1.2 

Other: 2.3 






Project Description 



Objectives: 



1. To test the flexibility of the microanalytical system using the miniature 
centrifugal fast analyzer as the optical detection device. 

2. To develop a new rapid microchemical procedure for the determination of 
specific proteins of neonate and infant care work. 

Methods Employed: 

The combined microanalytical and the miniature centrifugal analyzer sys- 
tems were used to develop a kinetic rate measurement of antigen-antibody 
precipitin digitally controlled rotor loader and the miniature centrifugal 
fast analyzer used in the nepitelometric mode. The new (combined) system 
provided the advantage of computer assistance in assembling antilog data and 
computations of it parallel analyses. The hard data for each of the 17 
samples were provided by the teletype machine. 

Major Findings: 

The microanalytical system used with the miniature centrifugal analyzer 
was found effectual in the assay of immunogobulin G in small quantities of 
human serum. Complete analysis of 17 serum samples required only 10 seconds 
with a coefficient of variation of ±1.0% during within rotor analysis. The 



CP-36 



Project No. Z01-00005-03-CP 

serum immunoglobulin results agreed well with those obtained by the reference 
method of end-point procedure. The coefficient of correlation of the new 
kinetic rate procedure to the reference method was 0.97. 

Significance: 

Based on the aggregate of our experience, we believe that this equipment 
truly provides a single, simple, reliable system for emergency, routine, and 
pediatric analyses. The discussed tests represent only those that were 
selected for the purpose of critical evaluation on the newly developed micro- 
analytical system. We have performed other test procedures on this apparatus. 

Proposed course: 

The microanalytical analyzer will be installed in our micro-chemistry 
laboratory for use in neonate and infant care work. We will continue to 
develop new microchemical procedures for clinical laboratory use. 

Honors and awards: 



Inventor - employee award (H.H. Nishi) 

Received two awards for two U.S. Patents (H.H. Nishi) 

Publications: ' 



Nishi, H.H. and Young, D.S. Rapid analysis of immunoglobulin G, A, and M by 
the kinetic rate procedure, Richie, (ed.). Automated Immunoassay (in press). 



CP-37 



Project No. Z01-00005-03-CP 
PUBLICATIONS 1977 

1. The Preparation and Characterization of a Thymic Independent Antigen: 
-Dinitrophenyl-1-Lysine-Ficoll. McMaster, P.R.B., Owens, J., and W.E. 
Vannier. Immunochemistry 1977. 1_4: 189-196. 

2. Hapten Specific Delayed Hypersensitivity to -2 ,4-Dinitrophenyl-l-Lysine- 
Ficoll in Guinea Pigs Immunized with 2,4 Dinitrophenyl-Keyhole Limpet 
Hemocyanin. McMaster, P.R.B., Owens, J., Weichbrod, R. , and R. Asofsky. 
J. Exp. Med. 1977. 145: 1101-1114. 

3. Hapten Specific Leukocyte Migration Inhibition. Inhibition of Cells 
from Animals Immunized with DNP-KLH by -DNP-1-Lysine-Ficoll. McMaster 
P.R.B., Owens, J. and R. Asofsky. J. Immunol. 1977. 118: 1335-1337. 



CP-38 



I TrtSONl AN SCIENCE INFORMATION EXCHANGE 
PROJECT NUMBER (Do NOT use this space) 



U.S. DEPARTMENT OF 
HEALTH, EDUCATION, AND WELFARE 
PUBLIC HEALTH SERVICE 
NOTICE Of 
INTRAMURAL RESEARCH PROJECT 



PROJECT NUMBER 



ZOl CC 00006-02 CP 



PERIOD COVERED 

July 1. 1976 - September 30, 1977 



TITLE OF PROJECT (80 characters or less) 

Use of Laser Light Scattering for Rapid Determination of Potential 
Antibiotic Synergy 



NAMES, LABORATORY AND INSTITUTE AFFILIATIONS, AND TITLES OF PRINCIPAL INVESTIGATORS AND ALL OTHER 
PROFESSIONAL PERSONNEL ENGAGED ON THE PROJECT 

Dr. James D. MacLowry, Chief, Microbiology Service 

Dr. E. Arthur Robertson, Asst. Chief, Laboratory Computer Service 



COOPERATING UNITS (if any) 

None 



LAB/u.. ...tfH 



Clinical Pathology Department 



SECTION 



Microbiology Service, Laboratory Computer Service 



\ i 



INSTITUTE AND LOCATION 

Clinical Center, National Institutes of Health, Bethesda, Maryland 20014 



TOTAL MANYEARS: 

0.9 



PROFESSIONAL: 
.1 



OTHER: 



.8 



CHECK APPROPRIATE BOX(ES) 
D (a) HUMAN SUBJECTS 

D (al) MINORS □ (a2) INTERVIEWS 



□ (b) HUMAN TISSUES 



(c) NEITHER 



SUMMARY OF WORK (200 words or less - underline keywords) 

The Differential III laser light scattering instrument is being evaluated 
for its potential usefulness for rapidly determining antibiotic synergy. 



CP-39 



PHS-6040 
(Rev. IO-76) 



Project No. Z01 CC 00006-02 CP 
Project Description 



Objectives 






Evaluation of a prototype light scattering instrument, the Differential II 
for its potential use in clinical microbiology. 

Methods Employed : 

Antibiotic combinations are being evaluated with a novel laser light 
scattering instrument to detect changes in bacterial growth. 

Major Findings : 

The laser light scattering technique is very sensitive to the presence of 
and shape of particles. It has been necessary to capture the output of 
the instrument for computer analysis to detect significant changes. 

Significance to Biomedical Research and the Program of the Institute : 

If this instrument and method can be made to work in a consistent fashion, 
it is possible that there will be a number of applications in clinical 
microbiology which would be useful. Specifically the ability to rapidly 
assay serum bactericidal activity and antibiotic bacteriocidal activity 
would be very useful if they can be done in a reasonable time frame with 
minimal cost. 

Proposed Course : 

Evaluation will continue until instrument has been adequately evaluated. 

Honors and Awards : 

None 

Publications : 

None 



CP-40 



MITHSONIAN SCIENCE INFORMATION EXCHANGE 
PROJECT NUMBER (Do NOT use this space) 



U.S. DEPARTMENT OF 
HEALTH, EDUCATION, AND WELFARE 
PUBLIC HEALTH SERVICE 
NOTICE OF 
INTRAMURAL RESEARCH PROJECT 



PROJECT NUMBER 



zoi cc 00007-01 CP 



PERIOD COVERED . 

July 1, 1976 - September 30, 1977 



TITLE OF PROJECT (80 characters or less) 

Organization and |use of Laboratory Data Base in Clinical Microbiology 



NAMES, LABORATORY AND INSTITUTE AFFILIATIONS, AND TITLES OF PRINCIPAL INVESTIGATORS AND ALL OTHER 
PROFESS. ONAL PERSONNEL ENGAGED ON THE PROJECT 

Dr. James D. MacLowry, Chief, Microbiology Service 

Dr. Frank G. Witebsky, Asst. Chief, Microbiology Service 

Dr. Thomas Lewis, Chief, Laboratory Computer Service 



COOPERATING UNITS (if any) 

Mr. William Vincent, DCRT 



LAB/BRANCH 

Clinical Pathology Department 



SECTION 

Microbiology Service and Laboratory Computer Service 



institute and location Clinical Center, National Institutes of Health, 
Bethesda, Maryland 2001U 



TOTAL MANYEARS: 



1.1 



PROFESSIONAL: 



OTHER: 



1.0 



CHECK APPROPRIATE BOX(ES) 
D (a) HUMAN SUBJECTS 

□ (al) MINORS □ (a2) INTERVIEWS 



□ (b) HUMAN TISSUES 



3 (c) NEITHER 



SUMMARY OF WORK (200 words or less - underline keywords) 

The data base accumulated by the laboratory computer system was 
organized. This is accomplished by using the central DCRT facilities 
and organizing retrieval to expedite data searches and minimize their 
cost. 



CP-41 



PhS-6040 
(Rev. IO-76) 



Project No. Z01 CC 00007-01 CP 
Project Description 

Objectives : 

To efficiently utilize the patient data which is being accumulated. 

Methods Employed : 

Using the DCRT IBM 370 System and data derived in this laboratory, cumulative 
information for specific time intervals with large numbers of patients can 
be analyzed. 

Major Findings : 

Can efficiently collate large amounts of data. 

Significance to Biomedical Research and the Program of the Institutes : 

These programs have already been made available to interested investigators 
to study their patients. Also, makes it possible to analyze patient data 
rapidly and cheaply. 

Proposed Course : A 

These programs will be refined as more data is accumulated to enable more 
sophisticated retrieval. 

Honors and Awards: 

i 

None 

publications : 

None 






CP-42 



.'.MITHSGNIAS SCIENCE INFORMATION EXCIMSSI 
PROJECT NUMBER (Oo HOT use this »p»ce) 



..'.;.. UtHAKTHtNl Or | PROJECT NUMBER 

HEALTH. EDUCATION, AND WELFARE 
PUBLIC HEALTH SERVICE 
NOTICE OF 

INTRAMURAL RESEARCH PROJECT 



ZOl CC 00008-01 CP 



FlHIGO COVERED 

July 1, 1976 - Sep tember 30, 1977 

TITLE OF PROJECT (BO ch»r»ctera or less) 

Evaluation of Some Aspects of Dynatech MIC-2000 
96 Channel Dispenser 



i _ , ; . ; 

fHA«ES f LABORATORY AND INSTITUTE AFFILIATIONS, AND TITLES OF PRINCIPAL INVESTIGATORS AND ALL OTHER 
■ PROFESSIONAL PERSONNEL ENGAGEO ON THE PROJECT 

j Dr. Philip R. B. McMaster, Resident Physician, Clinical Pathology Dept, CC 

Dr. Frank G. Witebsky, Asst Chief, Microbiology Service, CPD, CC 

! Dr. James D. MacLowry, Chief, Microbiology Service, CPD, CC 

Dr. E. Arthur Robertson, Asst Chief, Laboratory Computer Service, CPD, CC 



|C00PERATIN5 UNIT - , (if iny) 
None 



.Au/uSA'.CH 

Clinical Pathology De partmen t 



Microbiology Service and Laboratory Computer Service - 
-.- a-.: LCCATiC.fi Clinical Center, National Institutes of Health, 



Bethesda, Maryland 2 0014 

I'AWASS: I PROFESSIONAL! 

0.5 0.4 



0.1 



' •" - 1 a t £ lx;e:) 

a .,•«'. S'JuoICTS ^ (b) H'^MAN TISSUES ^ (c) NEITHER 

(aly triN-.fi;, ~ (a2) INTERVIEWS 

,.»J<A.'-. • Or n'^r.'. UOO words or less - urderli r e keywords) 

The Dynatech MIC-2000 96 channel dispenser (manufactured by 
Cooke Laboratory Products, 900 Slaters Lane, Alexandria, Va. 22314), 
an instrument comprising part of the Dynatech MIC-2000 System for 
antimicrobial susceptibiJ i ty testing of bacteria, was evaluated to 
determine the accuracy and reproducibility of the amount of fluid 
it dispensed. Also, a battery of antimicrobial agents was dispensed 
and stored at -20° C and -70° C; these antimicrobials were subsequently 
examined at intervals to determine their potency. 



L 



CP-43 



Project No. Z01 CC 00008-01 CP 
Project Description 

Objectives : 

The Dynatech MIC 2000 96 channel dispenser was evaluated to determine 
accuracy and reproducibility of the volumes it dispensed into each of the 
96 wells of a microtiter plate. In addition, a battery of antimicrobial 
agents was dispensed, frozen, and stored at -20°C and -70°C; these 
antimicrobials were subsequently examined at intervals to determine their 
potency. 

Methods Employed : 

Disposable capillary pipettes were used to measure the volumes dispensed; 
it was determined that the volumes could be assessed accurately by 
measuring the length of the column volume of fluid in the pipette. Anti- 
microbial potency was determined by removing a certain amount of anti- 
microbial solution from the wells of the microteter plates, placing the 
solution on a filter paper disc and measuring the zone of inhibition of 
growth of Staphylococcus aureus . 

/ 
Major Findings : 

Accuracy of repetitively dispensed volume was found to be satisfactory. 
The antimicrobial agents tested were found to retain their potency for at 
least 2 weeks at -20°C and 4 months at -70°C. 

Significance to Biomedical Research and the Program of the Institute :, 

As the instrument was found to be satisfactory with respect to the para- 
meters evaluated, it is planned to incorporate it in the near future in 
the Microbiology Service sensitivity section, for use in routine sensiti- 
vity testing. Determination and reporting of the antimicrobic sensitivity 
pattern of bacterial isolates from patients at the Clinical Center should 
thereby be facilitated, as certain features of the machine allow com- 
bining into one array the different arrays of antimicrobials currently 
employed. 

Proposed course : 

The project has been completed. A manuscript reporting the findings in 
detail is in preparation. 



CP-44 



SMITHSONIAN SCIENCE INFORMATION EXCHANGE 
PROJECT NUMBER (Do NOT use this space) 



U.S. DEPARTMENT OF 
HEALTH. EDUCATION, AND WELFARE 
PUBLIC HEALTH SERVICE 
NOTICE OF 
INTRAMURAL RESEARCH PROJECT 



PROJECT NUMBER 



ZOl CC 00009-03 CP 



PERIOD COVERED 



July 1 . 19,76 - Septemb e r 3 0, 1 977 

TITLE OF PROJECT (80 characters or less) 



Blastocystis hominis, Structure, Pathegenesis, and Classification 



NAMES, LABORATORY AND INSTITUTE AFFILIATIONS, AND TITLES OF PRINCIPAL INVESTIGATORS AND ALL OTHER 
PROFESSIONAL PERSONNEL ENGAGED ON THE PROJECT 

Dr. Charles H. Zierdt, Microbiologist, Microbiology Service, CPD, CC 



COOPERATING UNITS (if any) 

None 



LAB/BRANCH 

Clinical Pathology Department 



SECTION 

Microbiology Service 



INSTITUTE AND LOCATION 

Clinical Center, National Institutes of Health, Bethesda, Maryland 20014 



TOTAL MANYEARS: 

0.1 



PROFESSIONAL: 

0.05 



OTHER: 



0.05 



CHECK APPROPRIATE BOX(ES) 

□ (a) HUMAN SUBJECTS 

□ (al) MINORS □ (a2) INTERVIEWS 



□ (b) HUMAN TISSUES 



£ 



(c) NEITHER 



SUMMARY OF WORK (200 words or less - underline keywords) 

Blastocystis hominis , a protozoan parasite of the human gas tro intes tinal 

tract and an organism implicated in the causation of human diarrhea , is 
being studied in terms of its morphology, physiology, and pathogenetic 
features such as toxin production . 



CP-45 



PHS-6040 
(Rev. 10-76) 



Project No. Z01 CC 00009-03 CP 

I 
Project Description 



Objectives 



Continuing study of Blastocystis hominis , newly designated protozoan 
parasite of man. 

Me thod s Emp loy ed : 

Study of diarrhea caused by B^_ hominis , and the ultrastructure, physiology 
and life cycle of this organism. 

Proposed Source : 

Study will be continued of a toxin active in the guinea pig and rabbit 
ileum, as well as of an infectious diarrhea model, using the guinea pig. 

Honors and Awards : 

None 

Publications : 

None 



CP-46 



SMITHSONIAN SCIENCE INFORMATION EXCHANGE 
PROJECT NUMBER (Do NOT use this space) 



U.S. DEPARTMENT OF 
HEALTH, EDUCATION, AND WELFARE 
PUBLIC HEALTH SERVICE 
NOTICE OF 
INTRAMURAL RESEARCH PROJECT 



PROJECT NUMBER 



ZOl CC 00010-02 CP 



PERIOD COVERED 



July 1. 1976 thr o ugh S eptember 30 , 1977 

TITLE OF PROJECT (o° characters or less) 



Effect of Magnesium Deficiency on Erythrocyte Structure and Function 



NAMES, LABORATORY AND INSTITUTE AFFILIATIONS, AND TITLES OF PRINCIPAL INVESTIGATORS AND ALL OTHER 
PROFESSIONAL PERSONNEL ENGAGED ON THE PROJECT 

PI: Dr. Ronald J. Elin Chief, Clin. Path. Dept. CP CC 

OTHER: Dr. Henry K. Tan Asst. Chief, Hemat. Serv. CP CC 

Dr. Laurence Corash Staff Physician, Hemat. Serv. 



COOPERATING UNITS (if any) 



None 



LAB/ BRANCH 



SECTION 



Hematology Service 



INSTITUTE AND LOCATION 



CP, CC, NIH, Bethesda, Maryland 20014 



TOTAL MANYEARS: 

1.0 



PROFESSIONAL: 

0.25 



OTHER: 

0.75 



CHECK APPROPRIATE BOX(ES) 
□ (a) HUMAN SUBJECTS 

D (al) MINORS Q (a2) INTERVIEWS 



□ (b) HUMAN TISSUES 



(c) NEITHER 



SUMMARY OF WORK (200 words or less - underline 'keywords) 

Magnesium deficiency in experimental animals produces an anemia and a 
shortened erythrocyte survival . Erythrocytes from rats deficient in 
magnesium were examined using freeze-fracture electron microscopy. 
The results show an erythrocyte membrane abnormality in the form of a 
plaque which develops after the animals have been on a magnesium- 
deficient diet for two weeks. These plaques enlarge in size with 
progressive magnesium deficiency. The plaques are unaltered by 
in vitro incubation of the red cells with normal concentrations of 
magnesium. 



CP-47 



PHS-6040 
(Rev. 10-76) 



Project No. Z01 CC 00010-02 CP 

1. Clinical Pathology Dept. 

2. Hematology Service 

3. Bethesda, Maryland 

PHS-NIH 

Individual Project Report 

July 1, 1976 through September 30, 1977 

Project Title: Effect of Magnesium Deficiency on Erythrocyte Structure 
and Function 

Previous Serial Number: None 

Principal Investigator: Dr. Ronald J. Elin 

Other Investigators: Dr. Henry K. Tan 

Dr. Laurence Corash 

Man Years: 

Total: 1.0 
Professional: 0.25 
Other: 0.75 / 



Project Description 



Objectives : 



Define and characterize membrane abnormalities associated with deficiency of 
magensium. Determine the effect of magnesium deficiency on erythro- 
poiesis. 

Methods Employed : 

The erythrocyte specimen was prepared by freeze-fracture and etching. The 
etched surface was coated with carbon and platinum. The specimen was then 
studied using an electron microscope. Erythrocytes from magnesium-deficient 
rats were separated on the basis of age using a stractan gradient. The 
magnesium concentration and pyrophosphatase activity were determined for 
each population of erythrocytes using standard techniques. 

Major Findings : 

The erythrocytes from magnesium-deficient rats develop a membrane alteration. 
The membrane abnormality which is in the form of a plaque was observed on 
the erythrocytes of animals who had been on a magensium-def icient diet for 
a period of two weeks. These membrane plaques increased in size to a maximum 
diameter of between 50 to 100 nm and frequency with progressive magnesium 
deficiency. These plaques were present on erythrocyte ghosts prepared by 
osmotic lysis. The membrane plaques were unaltered by incubating the cells 
in normal concentrations of magnesium. Erythropoiesis in magnesium-deficient 
rats appears to be normal since reticulocytes and very young erythrocytes 

CP-48 



Z01 CC OOOlO-01-CP 

containing normal concentration of magnesium and erythrocyte pyrophos- 
phatase. 



Significance to Biomedical Research and the Program of the Department : 

This is the first membrane abnormality of erythrocytes in experimental 
animals that is related to an abnormality in mineral metabolism. Magnesium 
has been clearly established as an essential element for biochemical 
processes involving energy production. In this study, magnesium has 
been shown to be important for normal membrane structures. This is part 
of a series of studies by the department to define factors which influence 
erythrocyte survival and function. The structural and biochemical 
abnormalities of erythrocytes in magnesium deficiency occur after the 
cell has entered the vascular space. Thus, the bone marrow is able to 
produce a normal cell but an environment deficient in magnesium produces 
erythrocyte abnormalities. 

i 
Proposed Course : 

This project will now be extended to study factors of erythropoiesis that 
enable the synthesis of a relatively normal cell in magnesium deficiency. 

Honors and Awards : 

None 

Publications : 

Elin, R. J. and Tan, H. K. : Formation of plaques on erythrocyte membranes 
from rats with magnesium deficiency. Blood. 1+9: 657 > 1977- 



CP-1+9 



SMITHSONIAN SCIENCE INFORMATION EXCHANGE 
PROJECT NUMBER (Do NOT use this space) 



U.S. DEPARTMENT OF 
HEALTH, EDUCATION, AND WELFARE 
PUBLIC HEALTH SERVICE 
NOTICE Of 
INTRAMURAL RESEARCH PROJECT 



PROJECT NUMBER 



ZOl CC 00011-04 CP 



PERIOD COVERED 



July 1, 1976 through September 30, 1977 



TITLE OF PROJECT (80 characters or less) 
Platelet Aging 



NAMES, LABORATORY AND INSTITUTE AFFILIATIONS, AND TITLES OF PRINCIPAL INVESTIGATORS AND ALL OTHER 
PROFESSIONAL PERSONNEL ENGAGED ON THE PROJECT 



PI: Dr. L. M. Corash 
Other: Dr. Henry K. Tan 
Dr. Mark Perlow 



Staff Physician 
Asst. Chief 
Staff Fellow 



Hematology Service CP,C( 
Hematology Service 



CP,Cd 



N, LP 






COOPERATING UNITS (if any) 



LAB/BRANCH 



SECTION 



Clinical Pathology Department 



Hematology Service 



INSTITUTE AND LOCATION 



TOTAL MANYEARS: 



CP, CC, NIH, Bethesda, Maryland 20014 



1.0 



PROFESSIONAL: 



0.5 



CHECK APPROPRIATE BOX(ES) 
@ (a) HUMAN SUBJECTS 

D (al) MINORS p (a2) INTERVIEWS 



OTHER: 



0.5 



□ (b) HUMAN TISSUES 



□ (c) NEITHER 



SUMMARY OF WORK (200 words or less - underl ine' keywords) 

Blood platelets have a finite life span in the peripheral circulation and under 
normal steady state conditions are removed by a discrete aging process. Earlier 
studies had suggested that there were structural, metabolic, and functional 
differences between young and old platelets. Existing methods to isolate 
platelets for study were inadequate. An efficient method to quantitatively 
isolate pure blood platelets has been developed in this laboratory. Experi- 
ments have shown that there is a strong relationship between platelet density 
and platelet structure, metabolism and function . Use of a non-human primate 
model has shown that these density dependent characteristics do correlate with 
platelet age. Thus, it is now possible to isolate age dependent platelet co- 
horts and to measure age dependent parameters of pure whole blood platelets. 
These techniques provide a means to analyze mechanisms of platelet aging to 
estimate platelet turnover rates , and to isolate platelets of improved quality 
for potential use in therapeutic transfusion. 



CP-50 



PHS-6040 
(Rev. IO-76) 



Project No. Z01 CC 00011-04 CP 
PHS-NIH 
Individual Project Report 
July 1, 1976 through September 30, 1977 



Project Title: Platelet Aging 

Previous Serial Number: 

Principal Investigator: Dr. Laurence M. Corash 

Other Investigators: Dr. Henry K. Tan 

Dr. Mark Per low 

Man Years: 



Total: 


1.0 


Professional: 


0.5 


Other: 


0.5 



Project Description 



Objectives : 



1. Isolation of pure whole blood platelets which are structurally and 
functionally intact. 

2. Correlation of platelet density with structure, metabolism and function. 

3. Development of a sub-human primate model to prove that platelet density 
is an age dependent parameter. 

4. Evaluation of platlet size, serotonin content and glycolytic rate as a 
means to estimate platelet turnover rate in patients with various platelet 
disorders. 

Methods Employed : 

Platelets were isolated from whole blood and separated into density de- 
pendent cohorts by use of isosmolar arabino-galactan discontinuous grad- 
ients and ultra-centrifugation. Cell volume distribution was measured 
with an electronic particle counter equipped with a logarithmic amplifier 
and a small computer. Platelet ultrastructure was viewed with trans- 
mission electron-microscopy. Platelet function was evaluated by aggre- 
gation to standard platelet stimulating agents. A sensitive double iso- 
topic radioactive assay was adopted to measure endogenous serotonin con- 
tent. The rhesus monkey model was developed to isolate density depend- 
ent platelet cohorts which were labelled and radiochromium and reinfused 
into donor animals to measure cohort life span. 



CP-51 



Project No. Z01 CC 00011-04 CP 
Major Findings : 

1. Pure whole blood platelets in high yield can be isolated by this technique. 

2. Traditional isolation methods are biased in favor of smaller, lighter 
platelets. 

3. Platelets can be effectively isolated from plasma proteins and then be 
reconstituted to a functional state with autologous plasma. 

4. There is a significant correlation between platelet density and cell 
volume, structure and organelle content. 

5. A well defined range of platelet size distribution exists and was defined 
for a large population of normal subjects. 

6. Simultaneous platelet size determination and standard radiochromium 
platelet survivals were performed in patients. There is a strong correlation 
between decreased platelet life span and increased platelet volume. 

7. The rhesus monkey model has shown that heavy platelets have a longer 
survival than do light platelets. Introduction of a heavy platelet cohort 
label into the bottom of a 'gradient results in progressive migration of the 
label up through the gradient, thus clearly demonstrating that heavy platelets 
become light platelets. 

8. Heavy platelets contain four times the serotonin content of light 
platelets, thus serving as a useful age dependent marker. 

Significance 

Earlier techniques have not been able to efficiently isolate whole blood plate- 
lets. This method removes all plasma proteins from platelets which was 
not possible by earlier methods. For the first time age dependent platelet 
cohorts from a total whole blood platelet population can be isolated. Sub- 
sequent study of these cell cohorts will permit evaluation of aging effect on 
platelets in disease. This method will also provide diagnostic information to 
discriminate diseases with increased platelet destruction from diseases with 
failure of platelet production. It will also facilitate studies to determine 
if platelet disorders are due to a qualitative protein defect or a quantitative 
protein defect. This study provides a new method to explore platelet aging. 

Proposed Cours e: 

The project is now being extended to apply the method to patients with platelet 
disorders. The animal model will be manipulated to perform in vivo ex- 
periments which cannot be performed in patients. 

Honors and Awards 

None 



CP-52 



Project No. Z01 CC 00011-04 CP 
Publications : 

1. Corash, L. , Gralnick, H. R. : High Yield Quantitative Isolation of 
Human' Platelets from Whole Blood. BLOOD 44: 919, 1974. 

2. Corash, L. , Tan, H. , Gralnick, H. : Heterogeneity of Human Whole Blood 
Platelet Subpopulations. I. Relationship Between Buoyant Density, Cell 
Volume, and Ultrastructure. BLOOD 49: 71-87, 1977. 

3. Corash, L. , Shafer, B., Weinberg, D. , Steinfeld, M. B. : Platelet Sizing 
of Whole Blood Total Platelet Populations. Workshop on Platelets. 
Philadelphia, Pa., October, 1976, in press. 

4. Andersen, J., Gralnick, H. , Corash, L. : Partial Characterization of 
Platelet Associated Factor VIII. Circulation 54_: 11-115, 1976. 

5. Corash, L. , Costa, J., Tan, H. , Shafer, B., Fauci, A. S., Wolff, S. M. : 
5-Hydroxytryptamine Metabolism, Alpha Granule Release, and Life Span 
of Chediak-Higashi Syndrome Platelets. Clin. Res., 1977, in press. 

6. Norton, J. A., Shulman, N. R. , Corash, L., Smith, R. L. , Au, F. , 
Rosenberg, S. A.: Severe Thrombocytopenia Following Intralesional 
BCG Therapy. Cancer, 1977, in press. 



CP-53 



'SMITHSONIAN SCIENCE INFORMATION EXCHANGE 
PROJECT NUMBER (Do NOT use this space) 



U.S. DEPARTMENT OF 
HEALTH, EDUCATION, AND WELFARE 
PUBLIC HEALTH SERVICE 
NOTICE OF 
INTRAMURAL RESEARCH PROJECT 



PROJECT NUMBER 



ZOl CC 00012-09 CP 



PERIOD COVERED 

July 1, 1976 through September 30, 1977 



TITLE OF PROJECT (80 characters or less) 

Investigation of Hemorrhagic and Thrombotic Disorders in Man 



NAMES, LABORATORY AND INSTITUTE AFFILIATIONS, AND TITLES OF PRINCIPAL INVESTIGATORS AND ALL OTHER 
PROFESSIONAL PERSONNEL ENGAGED ON THE PROJECT 



PI.: Dr. Harvey R. Gralnick 



Chief, Hematology Service 



CP CC 



COOPERATING UNITS (if any) 



LAB/BRANCH 

Clinical Pathology Dept., Clinical Center 



SECTION 

Hematology Service 



INSTITUTE AND LOCATION 

CP, CC, NIH, Bethesda, Maryland 20014 



TOTAL MANYEARS: 



9.0 



PROFESSIONAL: 



4.5 



OTHER: 



4.5 



CHECK APPROPRIATE BOX(ES) 
§ (a) HUMAN SUBJECTS 

S (al) MINORS Q (a2) INTERVIEWS 



£] (b) HUMAN TISSUES 



□ (c) NEITHER 



SUMMARY OF WORK (200 words or less - underline keywords) 

Investigation of congenital and acquired hemorrhagic and thrombotic 
disorders in man to elucidate the clinical entities and to investigate the 
jmolecular basis for the defects. This has involved purification of coagula- 
tion proteins , immunologic investigation of coagulation proteins and 
inhibitors, and defining the role of these proteins in normal hemostasis 
and abnormal hemostasis. 



CP-54 



PHS-6040 
(Rev. IO-76) ' 



Project No. Z01 CC 00012-09 CP 

1. Clinical Pathology Dept, 

2 . Hematology Service 

3. Bethesda, Maryland 

PHS-NIH 

Individual Project Report 

July 1, 1976 through September 30, 1977 

Project Title: Investigation of Hemorrhagic and Thrombotic Disorders in Man 

Previous Serial Number: 

Principal Investigator: Dr. Harvey R. Gralnick 

Man Years: 

Total: 9.0 

Professional: 4.5 

Other: 4.5 



Project Description 



Objectives : 



Define and characterize normal and abnormal coagulation proteins, inhibitors, 
and cof actors associated with clinical disorders of hemostasis. 

Methods Employed : 

Purification and isolation of various coagulation proteins, determination of 
functional defects, and molecular characterization of the defect. In addi- 
tion multiple immunologic techniques are utilized for elucidation of abnormal 
proteins. 

Major Findings : 

Three families with congenital dysf ibrinogenemia have been fully described 
and elucidated. These families have defects in the conversion of fibrinogen 
to fibrin which interferes with normal hemostasis in two of the three 
families. The abnormalities vary in each family and in some families have 
been related to the release of f ibrinopeptides and in others to polymeriza- 
tion of fibrin monomers. Studies of the pathological aspects of fibrinogen 
have indicated the importance of fibrinogen in maintenance of normal 
hemostasis. In particular, defects were observed in immunologic techniques, 
clotting techniques, and in the ability of fibrinogen to cross-link. In one 
family the abnormal fibrinogen also had a markedly shortened intravascular 
survival. 



CP-55 



Project No. Z01 CC 00012-09 CP 



Significance to Biomedical Research and the Program of the Department : 

These studies elucidate some of the molecular defects associated with abnor- 
mal hemostasis and thrombosis and have allowed a greater understanding of the 
pathophysiology of blood coagulation. Not only have individual patients 
benefited from the elucidation of these defects in proper therapy but our 
greater understanding of blood coagulation in general has developed. This is 
part of a series of studies by this service to define the factors associated 
with hemorrhage and thrombosis in man. 

Proposed Course ; 

This project will be extended to study other coagulation states and throm- 
botic states. 

Honors and Awards : 

None 

Publications ; 

1. Gralnick, H. , Abrell, E. , and Bagley, J.: Heparin Treatment for 
Hemorrhagic Diathesis of Acute Promyelocytic Leukemia. Am. J. Med. 
52: 167, 1972. 

2. Gralnick, H., Givelber, H., Shainoff, J., and Finlayson, J.: Fibrinogen 
Bethesda: A Congenital Dysf ibrinogenemia with Impaired Fibrinopeptide 
Release. J. Clin. Invest. 50: 1819, 1971. 

3. Gralnick, H. and Abrell, E. : Studies of the Procoagulant and Fibrino- 
lytic Activity of Promyelocytes .in Acute Promyelocytic Leukemia. 

Br. J. Haematol. 24: 89, 1973. 

4. Gralnick, H. and Finlayson, J.: Congenital Dysf ibrinogenemias. Ann. 
Int. Med. 7_7_: 471, 1972. 

5. Gralnick, H., Marchesi, S. and Givelber, H. : Intravascular Coagulation 
in Acute Leukemia. Blood 40: 709, 1972. 

6. Gralnick,. H., Givelber, H., and Finlayson, J.: A New Congenital 
Abnormality of Fibrinogen: Fibrinogen Bethesda II. Thromb . Diath. 
Haemorrh. 29: 562, 1973. 

7. Gralnick, H. and Tan, H. : Acute Promyelocytic Leukemia: A Model for 
Understanding the Role of the Malignant Cell in Hemostasis. Hum. 
Pathol. 5: 661, 1974. 



CP-56 



Project No. Z01 CC 00012-09 CP 



8. Fratantoni, J., Pollet, R. , and Gralnick, H.: Heparin-induced 
Thrombocytopenia: Confirmation of Diagnosis with In Vitro Methods. 
Blood 45:. 395, 1975. 

9. Gralnick, H. and Sultan, C. : Acute Promyelocytic Leukemia: Haemorrhagic 
Manifestation and Morphologic Criteria. Br. J. Haematol. 2_9: 273, 1975. 

10. Greipp, P. and Gralnick, H.: Platelet to Leukocyte Adherence Phenomena 
Associated with Thrombocytopenia. Blood 4_7_: 513, 1976. 

11. Hoover, Jr., H. C, Ketcham, A. S., Millar, R. C, and Gralnick, H. R. : 
Osteosarcoma: Improved Survival with Anticoagulation and Amputation. 
Cancer, In press. 

125 

12. Horvath, A. and Gralnick, H. R. : The ' I Fibrinogen Euglobulin Lysis 

Test. Am. J. Clin. Path., In press. 

13. Spellman, Jr., G. G. , Macoviak, J. A., and Gralnick, H. R. : Comparison 
of Polymerization of Ancrod and Thrombin Monomers. Blood, In press. 

14. Gralnick, H. R. : Intravascular Coagulation I and II. Postgraduate 
Medicine, In press. 



CP-57 



SMITHSONIAN SCIENCE INFORMATION EXCHANGE 
PROJECT NUMBER (Do NOT use this space) 



U.S. DEPARTMENT OF 
HEALTH, EDUCATION, AND WELFARE 
PUBLIC HEALTH SERVICE 
NOTICE OF 
INTRADURAL RESEARCH PROJECT 



PROJECT NUMBER 



ZOl CC 00013-10 CP 



PERIOD COVERED 

July 1. 1976 through September 30, 1977 



TITLE OF PROJECT (80 characters or less) 

Chemical and Structural Studies on the Human Factor Vlll/von Willebrand 
Factor Protein 



NAMES, LABORATORY ANO INSTITUTE AFFILIATIONS, AND TITLES OF PRINCIPAL INVESTIGATORS AND ALL OTHER 
PROFESSIONAL PERSONNEL ENGAGED ON THE PROJECT 



PI: 



Dr. Harvey R. Gralnick 



Chief, Hematology Service 



CP CC 



COOPERATING UNITS (if any) 

Dr. Barry S. Coller, Div. of Hematology^ School of Medicine, State Univ. of N.Y. 

Stony Brook, N.Y. 

Dr. Yvette Sultan, Dept. of Hematology, Hopital Saint-Louis, Paris France 



LAB/BRANCH 

Clinical Pathology Dept . , Clinical Center 



SECTION 

Hematology Service 



INSTITUTE AND LOCATION 

CP, CC, NIH, Bethesda, Maryland 20014 



TOTAL MANYEARS: 



10.0 



PROFESSIONAL: 



5.0 



CHECK APPROPRIATE BOX(ES) 
(a) HUMAN SUBJECTS 

g (al) MINORS Q (a2) INTERVIEWS 



OTHER: 



5.0 



S (°) HUMAN TISSUES 



□ (c) NEITHER 



SUMMARY OF WORK (200 words or less - underline keywords) 

The long-range purpse of this project is to initially study the immunologic 
aspects of the factor Vlll/von Willebrand factor protein and then to study 
the biochemistry and structure of this protein in man. The topics of present 
interest are: (1) the defect of the factor VTIl/von Willebrand factor protein 
in hemophilia A , (2) the defect of the factor Vlll/von Willebrand factor 
protein in von Willebrand 's disease , (3) the importance of carbohydrate con- 
tent in biological functions , (4) the relationship of carbohydrate content 
to atherosclerosis, (5) the mechanism of thrombin activation , and (6) biochem- 
ical characterization of the biologically active sites of the factor Vlll/von 
Willebrand factor protein. 



CP-58 



PHS-6040 



Project No. Z01 CC 00013-10 CP 

1. Clinical Pathology Dept. 

2 . Hematology Service 

3. Bethesda, Maryland 



PHS-NIH 

Individual Project Report 

July 1, 1976 through September 30, 1977 

Project Title: Chemical and Structural Studies on the Human Factor Vlll/von 
Willebrand Factor Protein 

Previous Serial Number: 

Principal Investigator: Dr. Harvey R. Gralnick 

Other Investigators: Dr. Barry S. Coller 

Dr. Yvette Sultan 



Man Years: 



Total: 10.0 
Professional: 5.0 
Other: 5.0 



Project Description 



Objectives : 



Define and characterize the normal factor Vlll/von Willebrand factor protein,' 
to elucidate the defects of the protein in hemophilia and von Willebrand 's 
disease and then to ascertain its role in atherosclerosis. 

Methods Employed : 

This has been accomplished by limited alpha chymotrypsin digestion of cryo- 
precipitate or other concentrates of factor VIII followed by gel chromato- 
graphy on Sepharose 4B. 

Major Findings : 

Individuals with hemophilia A have a protein identical to normal in all 
respects except that it lacks clot-promoting activity while in von 
Willebrand 's disease it has been found that the protein is quite hetero- 
geneous. In some patients there is a complete absence of the protein with 
all its associated biological functions (quantitative defect) while in other 
patients there is a qualitative defect where the protein is present in normal 
amounts; however, it is deficient in biological activity. A major finding 
has been that the carbohydrate moiety of the factor Vlll/von Willebrand 



CP-59 



Project No. Z01 CC 00013-10 CP 

factor protein is most important in its interaction with the platelets and 
vessel wall and may play an important role in the maintenance of normal 
hemostasis and propagation of atherosclerosis. 

Significance to Biomedical Research and the Program of the Department : 

These studies further our long-term project of investigating hemorrhagic and 
thrombotic clinical disorders. The finding of the importance of carbohydrate 
in the interaction of platelets with vessel wall or with each other may not 
only be of major significance in the understanding of von Willebrand's 
disease but may be equally important in understanding the propagation of 
atherosclerosis . 

Proposed Course : 

This project will be continued in its present phase with greater emphasis 
placed on the contribution of carbohydrates to platelet/platelet and 
platelet/vessel wall interaction. In addition, studies are underway to 
localize the sites on the factor Vlll/von Willebrand factor protein which 
are involved in these interactions. Modification of these sites will be 
attempted in an effort to reproduce in vitro a von Willebrand's disease-like 
state. 

Honors and Awards: 



1976 Fight for Sight Award for "von Willebrand Factor and Effect on 

Platelet Aggregation of Plasma from Diabetics with Retinopathy." Association 

for Research in Vision and Ophthalmology, Inc. 

Publications : 

1. Gralnick, H., Abrell, E. , and Bagley, J.: Immunologic Studies of Factor 
VIII (Antihemophiliac Globulin) in Hemophilia A. Nature 230 : 9, 1971. 

2. Marchesi, S., Shulman, N. , and Gralnick, H.: Studies on the Purification 
and Characterization of Human Factor VIII. J. Clin. Invest. 51: 2151, 
1972. 

3. Gralnick, H. , Coller, B., and Marchesi, S.: Immunological Studies of 
Factor VIII in Haemophilia and von Willebrand's Disease. Nature New 
Biology 244: 281, 1973. 

4. Gralnick, H., Coller, B., and Marchesi, S.: Studies of the Human Factor 
Vlll/von Willebrand Factor Protein. I. Comparison of the Protein Found 
in Normal, von Willebrand's Disease and Hemophilia A. Thromb. Res. 

6: 93, 1975. 



CP-60 



Project No. Z01 CC 00013-10 CP 

! 

5. Gralnick, H., Marchesi, S., and Coller, B.: Theoretical Approach to 
Molecular Biology of Factor VIII: Heterogeneity of the Molecule. 
Ann. NY Acad. Sci. 240: 378, 1975. 

6. Coller, B., Hirschman, R. , and Gralnick, H.: Studies of the 
Factor Vlll/von Willebrand Factor Antigen on the Platelet Surface. 
Thromb. Res. 6: 469, 1975. 

7. Gralnick, H. and Coller, B.: Studies on the Factor Vlll/von Willebrand 
Factor Protein. II. Identification and Characterization of the von 
Willebrand Protein. Blood 46: 417, 1975. 

8. Gralnick, H. , Coller, B., and Sultan, Y.: Studies of the Human Factor 
Vlll/von Willebrand Factor Protein. III. Qualitative Defect in von 
Willebrand's Disease. J. Clin. Invest. 5_6: 814, 1975. 

9. Gralnick, H., Coller, B. , and Sultan, Y.: Carbohydrate Deficiency of 
the Factor Vlll/von Willebrand Factor Protein in von Willebrand's 
Disease Variants. Science 192 : 56, 1976. 

10. Gralnick, H. and Colier, B.: Molecular Defects in Hemophilia A and 
von Willebrand's Disease. Lancet, April 26, 1976. 

11. Coller, B., Franza, Jr., B., and Gralnick, H.: The pH Dependence of 
Quantitative Ristocetin Aggregation: Theoretical and Practical 
Implications. A New Device for Maintenance of Platelet-Rich Plasma pH. 
Blood 47: 841, 1976. 

12. Gralnick, H. R., Sultan, Y., and Coller, B. S.: von Willebrand's 
Disease Combined Qualitative and Quantitative Abnormalities. N. Engl. 
J. Med. 296: 1024, 1977. 

13. Gralnick, H. R. , Coller, B. S . ,' Shulman, N. R., Andersen, J. C, and 
Hilgartner, M. : Factor VIII. Ann. Int. Med. 86: 598, 1977. 

14. Coller, B. S. and Gralnick, H. R. : Studies on the Mechanism of 
Ristocetin-Induced Platelet Agglutination: Effects of Structural 
Modification of Ristocetin and Vancomycin. J. Clin. Invest., In press. 



CP-61 



SMITHSONIAN SCIENCE INFORMATION EXCHANGE 
PROJECT NUMBER (Do NOT use this space] 



U.S. DEPARTMENT OF 
HEALTH. EDUCATION, AND WELFARE 
PUBLIC HEALTH SERVICE 
NOT I GE OF 
INTRAMURAL RESEARCH PROJECT 



PROJECT NUMBER 



ZOl CC 00014-01 CP 



PERIOD COVERED 



July 1, 1976 through September 30, 1977 



TITLE OF PROJECT (80 characters or less) 

Platelet Serotonin Metabolism 



NAMES, LABORATORY AND INSTITUTE AFFILIATIONS, AND TITLES OF PRINCIPAL INVESTIGATORS AND ALL OTHER 
PROFESSIONAL PERSONNEL ENGAGED ON THE PROJECT 



PI: L. M. Corash, M.D„ 
Other: J. Costa, M.D. 



Staff Physician Hematology Ser. CP, CC 
Staff Physician LCS, NIMH 



COOPERATING UNITS (if any) 



LAB/BRANCH 



Clinical Pathology Dept. 



SECTION 



Hematology Service 



INSTITUTE AND LOCATION 



TOTAL MANYEARS: 



CP t CC f NTH, Bet 



iesda, Maryland 20014 



O.S 



PROFESSIONAL: 



0.1 



OTHER: 



0.2 



CHECK APPROPRIATE BOX(ES) 
S (a) HUMAN SUBJECTS 

□ (al) MINORS □ (a2) INTERVIEWS 



D (b) HUMAN TISSUES 



□ (c) NEITHER 



SUMMARY OF WORK (200 words or less - underl i ne 'keywords) 

Serotonin is a vaso-active amine which is highly concentrated in the blood 
platelet. Release of serotonin in response to platelet activating stimuli may 
play a role in many pathologic states. The absence of platelet serotonin is 
associated with severe platelet dysfunction and a hemorrhagic diathesis. We 
have modified a sensitive assay to accurately measure platelet endogenous 
serotonin content in normal subjects and patients. Young, heavy platelets 
contain four times the serotonin of old, light platelets . Thus, platelet 
serotonin content may be a useful means to measure platelet turnover rates . 
Isolation of age dependent platelet cohorts permits the study of serotonin 
uptake, content and release in a variety of pathologic states. 



CP-62 



PHS-6040 
(Rev. 10-76)' 



Project No. Z01 CC 00014-01 CP 
PHS-NIH 
Individual Project Report 
July 1, 1976 through September 30, 1977 



Project Title: Platelet Serotonin Metabolism 

Previous Serial Number: 

Principal Investigator: Dr. Laurence M. Corash 

Other Investigators: Dr. J. Costa 

Man Years 



Total: 

Professional: 

Other: 


0. 
0. 
0. 


,3 

,1 
,2 


Project 


De 


scription 





Objectives : 

1. Measurement of platelet endogenous serotonin content. 

2. Quantification of serotonin storage sites and transport rates in age 
dependent platelet cohorts. 

Methods Employed : 

Platelets were isolated by use of arabino-galactan gradients. Serotonin 
transport was measured by rapid uptake of radioactive serotonin and formal- 
dehyde fixation. Serotonin content was measured by a specific double iso- 
tope dilution assay. 

Major Findings : 

1. Serotonin storage sites, platelet dense bodies, are distributed in an age 
dependent fashion among platelets. 

2. The rate of transport is equal in young and old platelets. 

3. Young platelets contain four times the serotonin content of old platelets. 
This is due to a decreased number of storage cites. 

Significance : 

Platelet serotonin is important for normal platelet function and may play a 
role in pathologic states that involve the platelet release reaction. The 
methodologies developed in this study serve to better understand these 
disorders . 

Awards and Honors : None 

Publications : 

Corash, L. , Costa, J., Tan, H., Shafer, B., Fauci, A. S., Wolff, S. M. : 
5-Hydroxytryptamine Metabolism, Alpha Granule Release, and Life Span of 
Chediak-Higashi Syndrome Platelets. Clin. Res. 25: 337A, 1977. 



CP-63 



SMITHSONIAN SCIENCE INFORMATION EXCHANGE 
PROJECT NUMBER (Do NOT use this space) 



U.S. DEPARTMENT OF 
HEALTH, EDUCATION, AND WELFARE 
PUBLIC HEALTH SERVICE 
NOTICE OF 
INTRAMURAL RESEARCH PROJECT 



PROJECT NUMBER 



ZOl CC 00015-01 CP 



PERIOD COVERED 



July 1, 1976 through September 30, 1977 



TITLE OF PROJECT (80 characters or less) 

Platelet Survival and Function in Patients with Hypercholesterolemia 



NAMES, LABORATORY AND INSTITUTE AFFILIATIONS, AND TITLES OF PRINCIPAL INVESTIGATORS AND ALL OTHER 
PROFESSIONAL PERSONNEL ENGAGED ON THE PROJECT 



PI: L. M. Corash 
Other: J. C. Andersen 
E. Schaefer 



Staff Physician 
Staff Fellow 
Staff Physician 



Hematology Service CP, CC 
Hematology Service CP, CC 

IR S NHLBI 



COOPERATING UNITS (if any) 



LAB/BRANCH 



Clinical Pathology Department 



SECTION 



Hematology Service 



INSTITUTE AND LOCATION 

CP, CC, NIH, Bethesda, Maryland 20014 



TOTAL MANYEARS: 



1.0 



PROFESSIONAL: 



0.5 



OTHER: 



0.5 



CHECK APPROPRIATE BOX(ES) 
□ (a) HUMAN SUBJECTS 

D (al) MINORS Q (a2) INTERVIEWS 



□ (b) HUMAN TISSUES 



□ (c) NEITHER 



SUMMARY OF WORK (200 words or less - underline keywords) 

Abnormal platelet survival and function have been postulated to play a role in 
the accelerated atherosclerosis seen in familial hypercholesterolemia. In 
order to test this hypothesis, platelet survival measured by radiochromium 
and platelet aggregation were determined in a series of patients with marked 
hypercholesterolemia. Decreased platelet survival has been found, thus 
implicating the platelet as a possible contributor to the atherosclerosis 
associated with this disorder. 



CP-64 



PH8-6040 
(Rev. 10-76^ 



i Project No. Z01 CC 00015-01 CP 

PHS-NIH 
Individual Project Report 
July 1, 1976 through September 30, 1977 

Project Title: Platelet Survival and Function in Patients with 
Hypercholesterolemia 

Previous Serial Number: 

Principal Investigator: Dr. Laurence M. Corash 

Other Investigators: Dr. J. C. Andersen 

Dr. E. Schaefer 

Man Years 

Total: 1.0 

Professional: 0.5 

Other: 0.5 

Project Description 

Objectives : 

1. To measure platelet survival in patients with familial hypercholesterol- 
emia. 

2. To measure platelet aggregation to adenosine 5 'diphosphate, epinephrine, 
and collagen in these patients. 

Methods Employed : 

Platelet survival was performed with a standard radiochromium technique. 
Platelet aggregation was measured by a modification of the Born and Cross 
method with careful control of pH and platelet concentration. 

Major Findings : 

Platelet survival was significantly short in five out of seven subjects 
and appeared to be less in older subjects with more severe artherosclerosis. 
Platelets from these patients were more sensitive to epinephrine than those 
of normal controls. 

Significance : 

These findings indicate that decreased platelet survival is important in the 
pathogenesis of atherosclerosis and that anti-platelet agents may be useful 
in these patients. 

Honors and Awards : None 

Publications : 

Corash, L., Schaefer, E. , Poindexter, E., Andersen, J.: Platelet Function 
and Survival in Familial Hypercholesterolemia. Circulation 54: 11-117, 1976. 



CP-65 



SMITHSONIAN SCIENCE INFORMATION EXCHANGE 
PROJECT NUMBER (Do NOT use this space) 



U.S. DEPARTMENT OF 
HEALTH. EDUCATION, AND WELFARE 
PUBLIC HEALTH SERVICE 
NOTICE OF 
INTRAMURAL RESEARCH PROJECT 



PROJECT NUMBER 



ZOl CC 00016-01 CP 



PERIOD COVERED 



July 1, 1976 through September 30, 1977 



TITLE OF PROJECT (80 characters or less) 

Qualitative Improvement of Blood Transfusion Using Young Cell Cohorts 



NAMES, LABORATORY AND INSTITUTE AFFILIATIONS, AND TITLES OF PRINCIPAL INVESTIGATORS AND ALL OTHER 
PROFESSIONAL PERSONNEL ENGAGED ON THE PROJECT 



PI: 



L. M. Corash 



Staff Physician 



Hematology Service, CP, CC 



COOPERATING UNITS (if any 

S. Piomelli, Dept, 



of Pediatrics, New York University School of Medicine 
New York, New York 10016 



LAB/BRANCH 



Clinical Pathology Department 



SECTION 



Hematology 



NSTITUTE AND LOCATION 

CP. CC. NIH, Bethesda, Maryland 20014 



TOTAL MANYEARS: 



0.8 



PROFESSIONAL: 



CHECK APPROPRIATE BOX(ES) 
C (a) HUMAN SUBJECTS 

D (al) MINORS □ (a2) INTERVIEWS 



0.5 



OTHER: 



0.3 



□ (b) HUMAN TISSUES 



□ (c) NEITHER 



SUMMARY OF WORK (200 words or less - underline keywords) 

The purpose of this study is to demonstrate that Stractan separated young red 
blood cells can be transfused into autologous non-human primate donors and 
that these cells have an improved survival compared to whole blood. Prelimin- 
ary studies have shown that young red cells from rabbits can be isolated and 
transfused by this method. These cells demonstrate a markedly improved survi- 
val compared to unfractionated whole blood. The eventual goal of this project 
will be to explore the use of this system for human transfusion, thus reducing 
the transfused iron load in patients with chronic anemias. 



CP-66 



PHS-6040 
(Rev. 1 0- 76 "I 



Project No. Z01 CC 00016-01 CP 



PHS-NIH 

Individual Project Report 

July 1, 1976 through September 30, 1977 



Project Title: Qualitative Improvement of Blood Transfusion Using Young 
Cell Cohorts 

Previous Serial Number: 

Principal Investigator: Dr. Laurence M. Coarash 

Other Investigators: None 

Man Years 



Total: 

Professional: 

Other: 




0, 
0, 
0, 


.8 

5 

.3 






Proj 


ect 


Descrip 


tion 



Objectives : 

1. Development of a rhesus monkey model to examine the survival of Stractan 
separated age dependent red cell cohorts. 

2. To determine if naturally occurring arabino-galactan antibodies exist 

in humans and rhesus monkeys and to determine if they develop in animals after 
exposure to arabino-galactan treated cells. 

Methods : 

Age dependent red cell cohorts were obtained with arabino-galactan density 
gradients. Red cell life span is measured with radiochromium or radioactive 
cyanate. 

Major Findings : 

Young red cells from rabbits have an improved survival compared to old red 
cells when transfused in autologous donors. 

Significance : 

This technology may provide a means for qualitatively improved red cell 
transfusion, thus limiting iron overload in patients with chronic transfusion 
requirements. 

Awards and Honors : NIH Grant HL 19946-1. "Reduction of Iron Overload 

in Thalassemia" 



CP-67 



Project No. Z01 CC 00016-01 CP 
Publications : 

1. Corash, L. , Piomelli, S., Seaman, C, Comisa, C. : High Resolution 
Separation of Blood Cell Types by Density Gradient Centrifugation. 
Blood 42: 1006, 1973. 

2. Corash, L. , Piomelli, S., Chen, H. , Seaman, C, Gross, E. : Separation 
of Erythrocytes According to Age on a Simplified Density Gradient. J. 
Lab. Clin. Med. 84: 147-151, 1974. 

3. Corash, L. , Seaman, C, Comisa, C, Reibman, J. R. , Piomelli, S.,: 
Separation of RBC's with Improved Survival from Normal Blood. 
Ped. Res. 8: 399, 1974. 

4. Corash, L., Seaman, C, Reibman, J., Tytun, A., Piomelli, S.: 
Qualitatively Improved Blood Cell Transfusion: A New Approach to 
Therapy of Chronic Anemias. 16th Meeting, Int. Soc. Hem., Kyoto, 
Japan, 1976. 



CP-68 



SMITHSONIAN SCIENCE INFORMATION EXCHANGE 
PROJECT NUMBER (Do NOT use this space) 



U.S. DEPARTMENT OF 
HEALTH, EDUCATION, AND WELFARE 
PUBLIC HEALTH SERVICE 
NOTICE OF 
INTRAMURAL RESEARCH PROJECT 



PROJECT NUMBER 



ZOl CC 00017-01 CP 



PERIOD COVERED 



July 1, 1976 through September 30, 1977 



TITLE OF PROJECT (80 characters or less) 

Distribution of Erythrocyte Plaque Lesion Relative to Erythrocyte Age in 
Mg# Deficient Rats 



NAMES, LABORATORY AND INSTITUTE AFFILIATIONS, AND TITLES OF PRINCIPAL INVESTIGATORS AND ALL OTHER 
PROFESSIONAL PERSONNEL ENGAGED ON THE PROJECT 

PI: Ronald J. Elin, M.D., Ph.D., Chief, Clin. Path. Dept., CP, CC 
Other: Henry K. Tan, M.D. Assistant Chief, Hematology, CP, CC 



COOPERATING UNITS (if any) 

None 



lab/branch 



Clinical Pathology Dept., Clinical Center 



SECTION 



INSTITUTE AND LOCATION 

Clinical Center, Clin. Path. Dept., NIH, Bethesda, Maryland 20014 



TOTAL MANYEARS: 



1.0 



PROFESSIONAL: 



1.0 



OTHER: 



1.0 



CHECK APPROPRIATE BOX(ES) 
J (a) HUMAN SUBJECTS 

□ (al) MINORS □ (a2) INTERVIEWS 



□ (b) HUMAN TISSUES 



(c) NEITHER 



SUMMARY OF WORK (200 words or less - underline keywords) 

Study initiated to further investigate the nature of the erythrocyte membrane 
plaque lesions in Mg// deficient rats . Initial separation of erythrocytes by 
Stractan gradient shows differential appearance of plaque lesions in older 
more senescent erythrocytes while the youngest subpopulation of erythrocytes 
fails to demonstrate significant lesions. 



CP-69 



PHS-6040 
(Rev. 10-76) 



Project No. Z01 CC 00017-01 CP 

1. Clinical Pathology Dept. 

2. Hematology Service 

3. Bethesda, Maryland 

PHS-NIH 
Individual Project Report 
July 1, 1976 through September 30, 1977 

Project Title: Distribution of Erythrocyte Plaque Lesion Relative to 
Erythrocyte Age in Mg# Deficient Rats. 

Principal Investigator: Dr. Ronald J. Elin 

Other Investigators: Dr. Henry K. Tan 

Man Years: m ^ , , ~ 

Total: 1.0 

Professional: 1.0 

Other: 1.0 

Project Description 

Objectives : 

Determine time of appearance of erythrocyte membrane lesions in magnesium 
deficient rats. 

Methods Employed : 

Erythrocyte separation by the Stractan method of Piomelli and Corash groups 
red cells by buoyant density. This correlates with red cell age. Sub- 
populations of erythrocytes obtained by this method are examined by freeze 
etch electron microscopy and the results compared for the different age groups. 

Major Findings : 

Membrane lesions appear in young erythrocytes, become larger and more 
numerous with senescence. 

Significance : 

This is the first membranous lesion associated with a metal ion deficiency 
in mammals . Previously a report by Branton described cell membrane changes 
in magnesium deficient bacteria. 

Course : 

Continue further elucidation of defect of magnesium deficiency and its 
relationship to membrane structure and function. 



CP-70 



SMITHSONIAN SCIENCE INFORMATION EXCHANGE 
PROJECT NUMBER (Do NOT use this space) 



U.S. DEPARTMENT OF 
HEALTH, EOUCATION, AND WELFARE 
PUBLIC HEALTH SERVICE 
NOTICE OF 
INTRAMURAL RESEARCH PROJECT 



PROJECT NUMBER 
ZOl CC 00018-01 CP 



PERIOD COVERED 



July 1. 1976 through September 30, 1977 



TITLE OF PROJECT (80 characters or less) 

Erythrocyte Changes Associated with Magnesium Deficiency in Man 



NAMES, LABORATORY AND INSTITUTE AFFILIATIONS, AND TITLES OF PRINCIPAL INVESTIGATORS ANO ALL OTHER 
PROFESSIONAL PERSONNEL ENGAGED ON THE PROJECT 



PI; 



Ronald J. Elin, M.D., Ph.D., Chief, Clin. Path. Dept., 



CP, CC 



Other: Henry K. Tan, M.D. 



Assistant Chief, Hematology, CP, CC 



COOPERATING UNITS (if any) 

Frederic C. Bartter, M.D., Hypertension & Endocrine Branch 



HLBI 



LAB/ BRANCH 

Clinical Pathology Dept., Clinical Center 



SECTION 



INSTITUTE AND LOCATION 

Clinical Center, Clin. Path. Dept., NIH, Bethesda, Maryland 20014 



TOTAL MANYEARS: 



1.0 



PROFESSIONAL: 



1.0 



OTHER: 



1.0 



CHECK APPROPRIATE BOX(ES) 
% (a) HUMAN SUBJECTS 

□ (al) MINORS □ (a2) INTERVIEWS 



□ (b) HUMAN TISSUES 



□ (c) NEITHER 



SUMMARY OF WORK (200 words or less - underline keywords) 

Study initiated to determine if erythrocyte lesions are present in those rare 
cases of magnesium deficiency in man with concomitant low red cell magnesium. 
Normal controls, cases of Bartters syndrome with isolated magnesium deficiency 
and cases of idiopathic magnesium deficiency. All cases are examined before 
and after Stractan separation. Initial results indicate that magnesium 
deficiency in man produces both a membranous and an intracorpuscular defect . 



CP-71 



PHS-6040 
(Rev. 10-76) 



Project No. Z01 CC 00018-01 CP 

1. Clinical Pathology Dept. 

2. Hematology Service 

3. Bethesda, Maryland 



PHS-NIH 
Individual Project Report 
July 1, 1976 through September 30, 1977 

Project Title: Erythrocyte Changes Associated with Magnesium Deficiency in 
Man 

Previous Serial Number: 

Principal Investigator: Dr. Ronald J. Elin 

Other Investigators: Dr. Henry K. Tan 

Man Years: 

Total: 1.0 

Professional: 1.0 

Other: '1.0 

Project Description 
Objectives : 

To determine if erythrocyte membrane lesions occur in those patients with 
prolonged magnesium deficiency and anemia. Certain patients with Bartter's 
syndrome fall in this category. 

Methods Employed : 

Determination of serum and erythrocyte levels of magnesium. Freeze fracture 
electron microscopy. 

Major Findings : 

Erythrocytes from patients with low erythrocyte magnesium and anemia show an 
intracorpuscular as well as membranous lesion. The intracorpuscular lesion 
consists of multiple sac-like structures within the matrix of the red cell. 
The membranous lesions consist of elevated and depressed granularity irreular 
outline. They are not generally reminiscent of analogous lesions in the rat 
RBC. 

Significance : 

To establish first metal ion deficient anemia in man, a rare cause of 
deficiency anemia. 



CP-72 



.MITH30NIAN SCIENCE INFORMATION EXCHANGE 
PROJECT NUMBER (Oo NOT use this spice) 



U.S. UtPAHTMtNT Or 
HEALTH, EDUCATION, AND WELFARE 
PUBLIC HEALTH SERVICE 
NOTICE OF 
INTRAMURAL RESEARCH PROJECT 



PROJECT NUMBER 



ZOl CC 00019-01 CP 



PERIOD COVERED 



July 1, 1976 - September 30, 1977 



TITLE OF PROJECT (80 chsrsctera or less) 

Resistant Corynebacterium Species - Further Characterization and 
Identification of Normal Habitat 



NAMES, LABORATORY ANO INSTITUTE AFFILIATIONS, AND TITLES OF PRINCIPAL INVESTIGATORS AND ALL OTHER 
PROFESSIONAL PERSONNEL ENGAGED ON THE PROJECT 

Dr. Vee J. Gill, Supervisory Microbiologist, Microbiology Service, CPD, CC 

Dr. Frank G. Witebsky, Asst. Chief, Microbiology Service, CPD, CC 

Dr. Philip A Pizzo, Senior Investigator, Pediatric Oncology Branch, 
Division of Cancer Treatment 



[COOPERATING UNITS (if tny) 

Pediatric Oncology Branch, NCI 



| LAB/BRANCH 

Clinical Pathology Department 



actio;. 

Microbiology Service 



ir.ST.T.T and LOCATION clinical Center, National Institutes of Health, 
Bethesda. Maryland 20014 



TCTA.u WAt.YEARC 

1.0 



PROFESSIONAL! 
0.3 



OTHERi 



0.7 



C -CCr. APFHC "MATE EOX(ES) 



: (a; 



iUMAN SU3JECTS 



G (b) HUMAN TISSUES 



U(c) NEiTHER 



;: (ai) minors ~\ ( a 2) interviews 



NUMMARY OF WORK (cDO words or lees - underline keywords) 

A resistant Corynebacterium species has been isolated with 
increasing frequency from severely immunosuppressed patients at 
the Clinical Center. Additional isolates of this organisms are 
being collected, biochemically characterized, and studied for 
pattern of antimicrobial susceptibility- A selective 

medium has been developed to isolate the organisms easily from 
mixed flora; this will be used to try to identify the organism's 
normal habitat. 



CP-73 



Project No. Z01 CC 00019-01 CP 
Project Description 
Objectives : 

Further characterize, with respect to biochemical characteristics and anti- 
biotic sensitivity pattern, a resistant Corynebacterium species. 

Determine the normal habitat of this organism. 

Methods Employed : 

Organisms isolated from a variety of clinical specimens and found to be this 
antibiotic - resistant Co ryneb ac te rium species are evaluated for their 
biochemical characteristics and specific antimicrobial - sensitivity 
pattern by in vitro testing procedures. An antibiotic - containing medium 
has been devised for the isolation of this organism from sites with a mi ed 
microbial flora; survey cultures are obtained from patients in whom this 
organism has been found, to attempt to define its normal habitat. 

Major Findings : This organism has been isolated with increasing fre- 
quency from immunosuppressed patients at the Clinical Center. There has 
been some variation found in antibiotic sensitivity of the isolates, but all 
have been sensitive to low concentrations of vancomycin. There has been some 
variability in sensitivity to erythromycin and tetracycline. The organism 
has been isolated from a variety of sites; preliminary studies suggest that 
the organism's normal habitat is skin sites such as axilla and groin. 

Significance to Biomedical Research and the Program of the Institute : 

This organism can be a significant pathogen, particularly in compromised 
hosts. (See publication below.) Further characterization of the species 
and its ecology is important for understanding the pathogenesis of, and 
selecting appropriate treatment for, disease caused by this organism. 

Proposed Course : 

The project will be continued to further define the characteristics of the 
organism and its normal habitat. 

Publications : 

Hande, K.R., Witebsky, F.G., Brown, M.D. , Schulman, c.B., Anderson, Jr.,M.D., 
Levine, A.S., MacLowry, M.D. and Chabner, B.A. Sepsis with a New Species of 
Corynebacterium . Ann. of Int. Med., 85:423-426, 1976. 



CP-74 



ITHSONIAN SCIENCE INFORMATION EXCHANGE 
OJECT NUMBER (Do HOT use this space) 



U.S. DEPARTMENT OF 
HEALTH, EDUCATION, AND WELFARE 
PUBLIC HEALTH SERVICE 
NOTICE OF 
INTRAMURAL RESEARCH PROJECT 



PROJECT NUMBER 
ZOl CC 00020-01 CP 



JRIOO COVERED ^_, 

July 1, 1976 to September 30, 1977 



ITLE OF PROJECT (80 characters or less) 

Analysis of the Plasma Membrane of Normal Human Platelets 



Ws, LABORATORY AND INSTITUTE AFFILIATIONS, AND TITLES OF PRINCIPAL INVESTIGATORS AND ALL OTHER 
I0FESSI0NAL PERSONNEL ENGAGED ON THE FROJECT 

: PI: Henry K. Tan, M.D. Assistant Chief, Hematology CP, CC 

Laurence Corash, M.D. Staff Physician, Hematology CP, CC 



OPERATING UNITS (if any) 

None 



NCH Clinical Pathology Dept., Clinical Center 



ICTION 



Hpmat-ology Service 



STITUTE AND LOCATION 

linical Center, Clin. Path. Dept., NIH, Bethesda, Maryland 20014 



1TAL MANYEARSi 

1.0 



PROFESSIONAL! -, Q 



OTHERi i.o 



CECK APPROPRIATE BOX(ES) 

[;(•) HUMAN SUBJECTS Q (b) HUMAN TISSUES Q (c) NEITHER 

[ (si) MINORS p (a2) INTERVIEWS 

«MARY OF WORK (200 words or lass - underline keywords) 

taalysis and demonstration of true external surface of platelets obtained 
:om normal volunteers. Correlation of changes induced by glycerol , 
j.utaraldehvde . BSG , normal saline and distilled water on the etched platelet 
rface as observed by freeze fracture microscopy . 



CP-75 



■I.MITHSONIAN SCIENCE INFORMATION EXCHANGE 
PROJECT NUMBER (Oo NOT us« this space) 



U.K. litH/iIUHfcNT [» 
HEALTH, EDUCATION, AND WELFARE 
PUBLIC HEALTH SERVICE 
NOTICE OF 
1HTRANU8AI RESEARCH PROJECT 



PROJECT NUMBER 
ZOl CC 00021-01 CP 



PER 1 00 COVERED 



July 1, 197 6 - September 30, 1977 
TITLE OF PROJECfTeO chiractera or less) 



Mycologic Sensitivity Testing 



•NAMES, LABORATORY AND INSTITUTE AFFILIATIONS, ANO TITLES OF PRINCIPAL INVESTIGATORS AND ALL OTHER 
PROFESSIONAL PERSONNEL ENGAGED ON THE PROJECT 

Ms. Anne E. Jennings, Medical Technologist, Microbiology Service, CPD, CC 
i 

Dr. John E. Bennett , "finical Mycology Section, Laboratory of Clinical 
Investigation, NIAID 



(COOPERATING UMU (if «ny) 



Clinical Mycology Section, LCI, NIAID 



.«&/ 



iifiA'.C-' 

Clinical Pathology Department 



Microbiology Service 



'iT. T ' A'.j LOCATION 



Clinical Center, National Institutes of Health, 



•tLinC 



— • BcthQgda, Maryl and-- -20014 

ROFESSIONALi 



JL2.. 



0.1 



OTHERi 



:- i-r-.ii" iA-: c:x(e:) 

- '*'. G'J5 U -CTS 
si; ICiNCRS Z (eZ) INTERVIEWS 



Z (b) H'JMAN TISSUES 



fir(c) NEITHER 



: ;;« 



t-'-l Of »'Cfi< (ktO words or less - underline keywords) 

Antimicrobial sensitivity testing of yeasts is being done with 
5-Fluorocytosine ; antimicrobial sensitivity testing of molds is being 
done with Miconazole , 5-Fluorocy tosine , and Amphotericin B ; antimicrobial 
sensitivity testing of Nocardia is being done with Sulfadiazine, 
Trimethoprim, Minocycline, Ampicillin, Rifampin, Erythromycin. 



CP-76 



1-^040 



Project No. Z01 CC 00021-01 CP 

Project Description 

Objectives : 

Determination of antimicrobial sensitivity of species of pathogenic yeasts 
to 5-Fluorocytosine, and of species of pathogenic molds to Miconazole, 
5-Fluorocytosine, and Amphotericin B. 

Methods Employed : 

In vitro determination of antimicrobial sensitivity testing was performed 
using test tube serial dilution technique involving use of roller drum 
for the yeasts and molds. The susceptibility of the various Nocardia 
sp. was determined by the use of the agar dilution technique. 

Major Findings : 

Most of the molds and yeasts examined proved to be susceptible to the 
antimicrobials tested. The sensitivity of the Nocardia isolates varies sig- 
nificantly among the different antimicrobials tested. 

Honors and Awards : 

None 

Publications : 

None 



CP-77 



„MITH50NIAN SCIENCE INFORMATION EXCHANGE 
PROJECT NUMBER (Do HOT use this space) 



U.S. ULPAKTMLNT Ur 
HEALTH, EDUCATION, AND WELFARE 
PUBLIC HEALTH SERVICE 
NOTICE OF 
INTRADURAL RESEARCH PROJECT 



PROJECT NUMBER 
ZOl CC 00022-03 CP 



PERIOD COVERED 



I 



July 1, 1976 - September 30, 1977 



t TITLE OF PROJECT (80 characters or less) 



Detection of Bacteremia using an Electrical Impedance Detection System 



NAMES, LABORATORY AND INSTITUTE Af FILIATIONS, AND TITLES OF PRINCIPAL INVESTIGATORS AND ALL OTHER 
PROFESSIONAL PERSONNEL ENGAGED ON THE PROJECT 

Dr. Charles H. Zierdt, Microbiologist 

Dr. James D. MacLowry, Chief, Microbiology Service 

Dr. Robert Kagan, Resident, Nuclear Medicine 

Mr. William Schuette, Engineer, Biomed. Engrg & Instr. Br. 

Dr. E. Arthur Robertson, Asst. Chief, Laboratory Computer Service 

Mr. Robert Harshman, Computer Programmer, Laboratory Computer Service 



COOPERATING UMTS (if any) 

Biomedical Engineering and Instrumentation Branch, DRS, NIH 



I LAB/ BRANCH 



lCTJCI 



Clinica l Pafhnlngy Ppparfmpnr 



Microbiology Service Nuclear Med., Lab Computer Svc, Biomed Engrg & Instr Br 



INSTITUTE AND LOCATION 



Clinical Center, National Institutes of Health, 
-B ethc c da. Maryland 2001 4 



!Sda , Mary. 
PROFESSIONAL! 



;T0TAl. MANYEARS: 

! l.o 

» 

C.-iECK APPROPRIATE EOX(ES) 
! 
2 (a) hJMAN SUBJECTS 



0.5 



OTHERi 



0.5 



3(b) HUMAN TISSUES 



D (c) NEITHER 



U- 



(al) MINORS Q (a2) INTERVIEWS 



C'JMMARY OF WORK (200 words or less - underline keywords) 



A prototype instrument has been constructed and improved which 
allows the monitoring of blood cultures with an electrical impedance 
detector . This has been connected to a laboratory computer, which 
can then be queried about the status of cultures. 



CP-78 



Pi- 3-6040 

(Rev. 10.76) 



Project No. Z01 CC 00022-03 CP 

Project Description 

Objective : 

An attempt is being made to more rapidly detect positive clinical blood 
cultures in an automated fashion. 

Methods Employed : 

A prototype impedance detector has been developed and connected to a de- 
dicated computer in the laboratory. This represents a novel approach to 
detection of bacterial cultures by using a very minimum amount of human 
intervention. The blood has been lysed and filtered before presentation 
to the detector to increase bacterial yield. 

Major Findings : 

Blood cultures are detected mere rapidly and fewer colony forming units can 
be detected than by conventional methods. 

Significance to Biomedical Research and the Program of the Institute : 

This methodology may enable a routine diagnostic laboratory to detect 
bacteremia more rapidly than with conventional means. 

Proposed Course : 

We will continue to evaluate patient specimens in parallel with our tra- 
ditional method to confirm the initial observations with this method. 

Honors and Awards : 

None 

Publications : : 

1. Zierdt, C.H., Kagan, R. L. and MacLowry, J.D.: Development of Lysis- 
Filtration Blood Culture Technique. J. Clin. Microbiol. 5:46-50, 1977. 

2. Kagan, R. L. , Schuette, W. H. , Zierdt, C. H. and MacLowry, J.D.: 
Rapid Automated Diagnosis of Bacteremia by Impedance Detection. J. 
Clin. Microbiol. 5:51-57, 1977/ 



CP-79 



SMITHSONIAN SCIENCE INFORMATION EXCHANGE 
IPROJECT NUMBER (Oo NOT u»« thl» »piee) 



U.S. UtWWTMiNT (* 
HEALTH, EDUCATION, AMD WELFARE 
PUBLIC HEALTH SERVICE 
NOTICE OF 
INTRAMURAL RESEARCH PROJECT 



PROJECT NUilP.FP 

ZOl CC 00023-01 CP 



PER 1 00 COVERED 

_ July 1, 1 976 - September 30, 1977 

i TITLE (if PSOJEGTlBO eh»r»cttr» or lest) 

Cell wall deficient Streptococci Causing Disease in Man 



: NAMES, LABORATORY AND INSTITUTE AFFILIATIONS, AND TITLES OF PRINCIPAL INVESTIGATORS AND ALL OTHER 
! PROFESSIONAL PERSONNEL ENGAGED ON THE PROJECT 



Dr. Charles H. Zierdt, Microbiologist, Microbiology Service, CPD, CC 



; COOPERATING bf.li: (if any) 

None 



_Ab/LSA\C-i 

Clinical Pathology Department 



Microbiology Service 
• i".0 lOOA* i 



. '"AVEA-.O: 



.05 



Clinical Center, National Institutes of Health, 

**^ fe?te la nd 20 1 4 joth e'r; 

.05 



::ts 



Z (b) HUMAN TISSUES 



X (c) NEITHER 



la 1 ) ViNun 

...'/.VA'. : Of • 



_' t2 ) INTERVIEWS 

(cOO nsnli or less 



u-derlme keywords) 

A collection of cell wall deficient , Gram variable , pleomorphic 
organisms has been collected from cases of endocarditis, urethritis, 
fever of undetermined origin, brain abscess, and other deep abscesses. 
Two strains of this collection have recently reverted to definitive 
parent forms, both of which are Strepcococcus sanguis . This data is 
being prepared for publication. The strains have been well documented 
through ultrastructure , guanine-cytosine base ratios , acrylamide gel 
protein patterns , fatty acid profiles via gas liquid chromatography , 
morphological and biochemical characteristics. 



CP-80 



Project No. Z01 CC 00023-01 CP 

Project Description 

Objectives : 

In-depth study of this group of pathogenic bacteria. 

Methods Employed : 

Electron microscopy, guanine-cytosine base ratios, acrylamide gel patterns, 
and gas-liquid chromatography have been used for the characterization of 
these organisms. 

Significance to Biomedical Research and the Program of the Institute : 

These organisms have been implicated in a number of infectious disease 
processes in man. 

Proposed Course : 

On completion of the studies of the organisms collected thus far, the data 
collected will be prepared lor publication. 

Honors and Awards : 

None 

Publications : 

None 



CP-81 



PROJECT. NUMBER (Oo NO" use this space) 



.mithsonian science information exchange 



U.K. UtPSHTHfcNT Ur 
iEALTH, EDUCATION, AND WELFARE 
PUBLIC HEALTH SERVICE 
NOTICE OF 
SPiTRAHURAL RESEARCH PROJECT 



PROJECT NUtfBES 

ZOl CC 00024-20 CP 



PERIOD COVERED 

Jj!lly_l^_1976 - Sept e mber 30, 1977 

TITLE OF PROJECT (80 characters or less) 

Analysis of 20 years of Staphylococcus aureus Bacteria Phage Typing 

iNAHES, LABORATORY" AND INSTITUTE AFfTlTaTk^sTaND TITLES OF PRINCIPAL INVESTIGATORS AMD ALL OTHER 
PROFESSIONAL PERSONNEL ENGAGED ON THE PROJECT 

Dr. Charles H. Zierdt, Microbiologist 
i 

Dr James D. MacLowry, Chief, Microbiology Servcie 

i 

Dr. E. Arthur Robertson, Asst. Chief, Laboratory Computer Service 

Mr. Reginald Williams, Research Medical Technologist, Microbiology Service 



COOPERATING UNITS (if any) 



None 



| lab/branch 

■ Clinical P athology Department 
j SECT I 01; 



Microbiology Service, Laboratory Computer Service 



AND LOCATION clinical Center, National Institutes of Health, 
Bethesda, Maryland 2001 



'07 AL MA.'iYEARC 

1.0 



PROFESSION ALT 
0.5 



OTHERi 



0.5 



■CCH APPROPRIATE EOX(ES) 
(a) HUMAN SUBJECTS 

(al) MINORS J (a2) INTERVIEWS 



3 (b) HUMAN TISSUES 



□((c) NEITHER 



;UMMARY Of WORK (200 words or less - underline keywords) 

Analysis of the phage typing data to date reveals: 1. That the 
"major" epidemic strains of S^. aureus increased in the early 1960 's 
to high levels and declined in the mid-1960' s, not to reappear. 
2. The world-wide epidemic strain 80/81 appeared in the Clinical Center 
in March of 1959, immediately spreading through the hospital and via 
employees, to their families. It disappeared from the Clinical Center 
in 1965, and has not reappeared. 3. At present there are in the 
Clinical Center no "epidemic types." 4. Phage typing patterns are 
less clearcut, particularly in the mixing of reactions of phage and 
from lytic groups I, II, III, and Miscellaneous. 



CP-82 



FH>6040 
(Rsy.' 10.lt) 



Project No. Z01 CC 00024-20 CP 

Project Description 

Objectives : 

Statistical analysis of 22,000 bacteriophage typed Staphylococcus aureus 
strains, from Clinical Center patients, 1957 to 1977. 

Methods Employed : 

Reconstruct the epidemiology of Staphylococcus aureus infections in the 
Clinical Center over the past 20 years using the central DCRT computer 
facilities. 

Honors and Awards : 

None 

Publications : 

None 



CP-83 



July 1, 1976, Through September 30, 1977 
PUBLIC HEALTH SERVICE, NATIONAL INSTITUTES OF HEALTH 

SUMMARY ANNUAL REPORT OF PROGRAM ACTIVITIES 
CLINICAL CENTER 

DIAGNOSTIC RADIOLOGY DEPARTMENT 

CONTENTS 

Department Missions and Goals DR-1 

Departmental Activities DR-1 

Major Projects and Research DR-4 

Problems DR-5 

Publications DR-6 

Tables : 

1. Number of X-Ray Examinations FY 1977 DR-9 

2. Comparison of Activity DR-9 

3. Summary of Departmental Activities DR-1 

Project Reports : 

1. Effect of Total Exclusion of Arterial Inflow to the Liver . . DR-ll 

2. Epidural Venography for the Detection of Epidural Masses . . . DR-1 3 

3. Development of a New Plastic Material for Transcatheter 
Embolization DR-1 5 

4. Development and Evaluation of a Ultrasonic Real Time Scanning 
Device DR-1 7 

5. Development and Clinical Evaluation of Ultrasonic Signal . . . DR-1 9 

6. Demonstration of the Effect of Chemotherapy on Carcinogen 

Induced Hepatomas on Rhesus Monkeys DR-21 

7. IV Hepatosplenography DR-23 

8. Evaluation of CT Body Scanning in Oncologic Patients DR-25 



DR i 



July l, 1976, through September 30, 1977 

PUBLIC HEALTH SERVICE, NATIONAL INSTITUTES OF HEALTH 

SUMMARY ANNUAL REPORT OF PROGRAM ACTIVITIES 
CLINICAL CENTER 

DIAGNOSTIC RADIOLOGY DEPARTMENT 

DEPARTMENTAL MISSIONS AND GOALS 

While our primary mission remains to provide the best possible radiographic 
service to the patients of The Clinical Center, research and educational activ- 
ities are of ever more importance. During the past several years, there has bee 
a multifold increase in our participation in inter-departmental clinical radio- 
graphic conferences, an activity which has proven intellectually stimulating and 
at the same time has significantly improved the quality of patient care. Even 
more striking has been the increase in research productivity of the Diagnostic 
Radiology Department which has more than doubled the number of publications sine 
those listed in last year's annual report. 

Increasing departmental emphasis is being placed on the use of interventional 
radiographic techniques with the development, perfection, and use of such 
techniques having become a major departmental goal. Studies of embolization in 
the definitive treatment of inoperable arteriovenous malformations, and as a 
palliative method of handling unresponsive neoplasms are receiving ever more 
departmental research attention. As evidence of this investigative orientation 
the use of the radiographic animal research facility for the development of new 
radiographic diagnotic and therapeutic approaches is at close to its maximal. 

DEPARTMENTAL ACTIVITIES 

The service demands for conventional radiographic examinations, relatively 
stable for several years, increased moderately during the past year (5%) from 
45,168 conventional x-ray examinations on 34,074 patients, perhaps reflecting 
increased bed occupancy between July 1, 1976 and June 30, 1977, to 47,284 con- 
ventional x-ray examinations on 36,953 patients. (Both observed data and that 
projected until September 30, 1977 is detailed in the accompanying tables.) 

The CT scanning units have proven an extraordinarily valuable adjunct to our 
diagnostic armamentarium with a total of 2200 patients receiving 2750 head scans 
and 619 patients receiving 704 body scans. (Scans are reported as the total 
number of examinations with and without contrast medium administration so that 
patients receiving both studies are considered as having had two scans.) The 
patient load for the CT head scanner is supplied by the Clinical Center and by 
the metropolitan area D0D hospitals. From the latter institutions we accept 
selected neurosurgical patients whose pathology complements our own head scan- 
ning experience. This mutually beneficial arrangement will be continued until 
such time as the WRAMC and NNMC purchase their own scanners. All the patients 
scanned on the CT body unit are from NIH - D0D patients are accepted for scan- 
ning only if their disease or expected pathology is of particular research 
interest to our staff. The computerized tomographic scanners require the full 



DR-1 



A 



time of two radiologists and four technicians 



Unexpectedly costly is the maintainance of the CT equipment with routine 
contracts costing us about $30,368. per year. All emergency service after 
regular working hours is provided only at additional and unconscionably e>i 
bitant cost. 

Ultrasound examinations peaked last year at 1284 which we thought was our 
saturation point; but between July 1, 1976 and June 30, 1977, a total of 1 
such examinations were performed, of that total 280 scans were done with U 
new real-time scanner cooperatively developed by this department. Besides! 
creasing the number of scans performed by 21% since last year, the ultrasc: 
graphic section has remained very active in the development and evaluationf 
new scanning equipment and techniques (see list of publications and section 
Project Reports). Two full-time radiologists and two full-time technician^ 
required to provide the Clinical Center with these services. 

It should be noted here that CT head scanning, CT body scanning, 
and ultrasound scanning represent new diagnostic activities, the 
responsibilities for which we have assumed with virtually no in- 
crease in professional or technical staff. 

The impact of CT and ultrasound on the nature of and number of special stu 
done in the department is very difficult to analyze. CT has had a profoun 
effect upon the numbers of conventional neurodiagnostic (pneumoencephalogr 
and cerebral angiogram) studies, and has replaced traditional studies in m 
cases. At the same time the numbers of patients admitted to NINCDS who re 
such studies has diminished. Thus, both of these factors are responsible I 
the striking decrease in the number of conventional neuroradioqraphic exam! 
tions. r 

HEAD CEREBRAL 
DATES CT ANGIOS PNEUMOS 

7-1-74 - 6-30-75 - 135 52 
7-1-75 - 6-30-76 1877 94 13 
7-1-76 - 6-30-77 2750 67 9 

In spite of the decline in neuroradiology procedures, the total number of 
special studies done in the department has increased slightly from 645 in 
to 713 in 1977. However, numbers alone are grossly misleading. A dramatii 
increase in the number of very time-consuming, multi-vessel angiograms, ver 
samplings, and embolizations has increased the number of manhours devoted 
the performance of special studies by about 50%. The difference between a 
usual cerebral or renal angiogram and a parathyroid localization study is 
parable to the difference between an appendectomy and a coronary arterial t 
pass- the more complex procedures requiring significantly more time as wel 
the involvement of a larger staff. 

Operating at close to its full capacity, the radiographic research facility^ 
produced 745 investigative studies. As radiology has evolved in the past u] 
years towards becoming a more active and interventional medical specialty M 
opportunities for promising radiologic research have burgeoned Many of trU 
areas of promising investigation require lengthy preliminary laboratory ancj 

DR-2 



animal work - the majority of the research listed in the Project Reports has 
demanded such studies. Some of the anatomic and physiologic observations made 
in this research facility promise development of valuable new diagnostic and 
therapeutic tools (see Project Reports on epidural venography, intravenous 
hepatography, and plastics for embolization). Two full-time technicians man 
the research facility and work in conjunction with a rotating group of radi- 
ologists. As a result of this ever increasing workload the space allotted to 
us for non-human research projects has become totally inadequate. 

Teaching and educational contributions by the department continue to grow. We 
now preside over a total of twelve regularly scheduled clinically oriented 
radiologic conferences per week. A number of staff members have been invited 
lecturers at local and state medical society meetings; and the staff continues 
to give teaching sessions at DC General, National Naval Medical Center, GW 
University, and the Armed Forces Institute of Pathology. 

No new major capital equipment was installed during the past year, though the 
CT body unit was updated (only six months after purchase) thereby permitting 
more rapid acquisition of scanning data and slightly increasing the number of 
patients which can be scanned in a working day. An automated chest unit and 
diagnostic table were purchased for use in the outpatient department; but their 
installation is delayed because OPD renovations failed to remain on schedule. 
When operational, this unit will permit immediate viewing of the films in the 
outpatient department by physicians seeing the patients and will have the 
ancillary beneficial spinoff of decreasing hospital elevator traffic to the 
6th floor of The Clinical Center by about 35%. From our capital expenditures 
budget of this year, we have committed funds for the purchase of a new ultra- 
sonic scanning unit to replace the hopelessly outdated unit now in use. In- 
stallation is expected within the next several months. 

It is our intention to postpone the purchase of major radiographic equipment 
until the new Department of Radiology is open. By careful planning and judiciou 
use of our severly limited space the department is probably adequately equipped 
to handle our anticipated needs until the universal replacement of major capital 
equipment which will take place when we move into the ACRF. There is, however, 
an imponderable which must be mentioned - rapid advances in the special imaging 
techniques of CT may make it possible that between now and 1980-81 our body 
scanner will have to be replaced. 



DR-3 



MAJOR PROJECTS AND RESEARCH 

Listed below are the major projects now requiring the investigative eff 
of the department. The appended descriptions of the projects are adequ 
and require no summation. (See Project Reports pg. DR-ll-DR-27) 

1. Effect of Total Exclusion of Arterial Inflow to the Liver 

2. Epidural Venography for the Detection of Epidural Masses 

3. Development of a New Plastic Material for Transcatheter 
Embolization 

4. Development and Evaluation of a Ultrasonic Real Time Scanning 

Device 

5. Development and Clinical Evaluation of Ultrasonic Signal 

6. Demonstration of the Effect of Chemotherapy on Carcinogen Induce 

Hepatomas on Rhesus Monkeys 

7. IV Hepatosplenography 

8. Evaluation of CT Body Scanning in Oncologic Patients 



DR-4 



PROBLEMS 

The major problem areas in the DRD are chronic and ongoing - they have been 
discussed in the past but corrective action has been minimal or lacking. 

1. Adequate space for patient waiting, radiologist's reading areas, and 
locker room for technical staff has been sacrificed to permit the 
necessary addition of CT and ultrasound facilities. Our halls are 
congested with patients, some acutely ill, waiting for examination. 
Some physicians are forced to work in converted janitorial closets 
and technician locker space has been moved into already overused 
corridors. 



2. Govermental physician salaries remain absolutely non competetive with 
those offered in university setting (note the crescendo in NIH physicia. 
attrition rate). By reason of the absence of income incentive ewery 
effort must be made to maintain a stimulating clinical and research 
environment with adequate funding of research activities. 

3. Last year the inadequate research facilities avilable to the staff 
were decried. The available research area has been further signifi- 
cantly erroded by the loss of animal holding space - animal subjects 
must now be housed in the research area - an unconscionable situation 
in an institution devoted and dedicated to fostering superior research. 



DR-5 



PUBLICATIONS 



Crystal, R.G., Filmer, J.D. , Roberts, W.C., Moss, M.L , Line B R and 
8 R r° fi d Q:7«V-io7^ di ° Path1C Pulm ° nary Fibr0Sis - Ann - of Intern Med 



85: 769-788, 1976 



Danforth, D.N., Jr., Triche, T. , Doppman, J.L., Beazley RM Perrinn 
P V and Recant L. : Elevated Plasma Proglucagon-like Component wit a' 
Glucagon-Secreting Tumor: Effect of Streptozotocin. NEJM 295: 242-245, 

DiChiro, G Doppman, J.L. and Wener, L.: Computed Tomography of 
Spinal Cord Arteriovenous Malformaions. Radiol. 23: 351-354,1977 

Doppman, J.L: Parathyroid Localization: Arteriography and Venous 
Sapling. Rad iologic Clinics of North America XIV: 163-188, 1976 

Doppman, J.L.: Embolization of Arteriovenous Malformations- Soinal 
An£iomas_, New York, Springer-Verlag, 1977, pp - In Press? h2ml 

Doppman, J L. and Geelhoed, G.E.: Atypical Radiographic Features in 
Pneumocystis cannii Pneumonia. J. Natl Cancer . j jjn^^. Iq 1 ^ 

Doppman, J.L. and Girton, M. : The Absence of Vasopastic Response of the 
Anterior Spinal Artery to Subarachnoid Blood. J. Neurosurg^ 64-67' 

Doppman J.L and Girton, M: An Angiographic Study of the Effect of 
Laminectomy in the Presence of Acture Anterior Epidural Masses J 
Neurosurg 45: 195-202, 1976 p iwbbes. j 

Doppman, J.L. , Brennan, M.F., Koehler J and Mary <: 1 rr c 
^Parathyroid Localization.' J^ul^t^^, i CT ^ ,nB 

Doppman JL., Marx, S.J., Brennan, M.F., Beazley, R H Geelhned r 

gag ^J^^paSiL x-s asar 

Mrteries. J. Com put. Assisted Tomoqr^ 1: 330-332 1977 

Francis, R.S Vermess,M. and Waldmann, R.A. : Ataxia-Telanoiectasia 
j_ Can Assoc of Rad iologist 27; 92-95, 1976 leiangiectasia. 



DR-6 



Geelhoed, G.W. and Doppman, J.L.: Embolization of Ectopic Parathyroid 
Adenomas. A Percutaneous Treatment of Hyperparathyroidism. The 
American Surgeon . In Press 

Johnson, R.E., Zimbler, H., Berard, C.W., Herdt, J and Brereton, H.D.: Radio- 
therapy results for Nodular Sclerosing Hodgkin's Disease after Clinical Stag- 
ing. Cancer 39: 1439-1444, 1977 

Kollarits, C.R., Di Chiro, G., Christiansen, J., Herdt, J.R., Whitmore, 
P., Vermess, H. and Michels, R.G.: Detection of Orbital and Intraocular 
Foreign Bodies by Computerized Tomography. Ophthalmic Surg. 8: 45-53, 
1977 

Kollarits, C.R., Moss, M.L., Cogan, D.G., Doppman, J.L., Di Chiro, G. 
Curler, G.B., Marx, S.J. and Spiegel, A.M.: Scleral Calcifications in 
Hyperparathyroidism. Demonstration by Computed Tomography. J. Comput 
Assisted Tomogr. In Press 

Maguire, R. and Doppman, J.L.: Angiographic Abnormalities in Partial 
Budd-Chiari Syndrome. Radiol . 122: 629-635, 1977 

Mills, S.R., Doppman, J.L. and Nienhuis, A.W.: Computerized Tomography 
in the Diagnosis of Disorders of Excessive Iron Storage of the Liver. 
J. Comput. Assisted Tomogr. 1: 101-104, 1977 

Niefeld, J. P., Michaelis, L.L. and Doppman, J.L.: Suspected Pulmonary 
Metastases: Correlation of Chest X-Ray, Whole Lung Tomograms, and 
Operative Findings. Cancer 39: 383-387, Feb. 1977 

Ramu-Peylan, N. , Poplack, D.G., Blei, L. , Herdt, J.R., Vermess, M. and 
Di Chiro, G. : Computer Assisted Tomography in Methotrexate Encepha- 
lopathy. J. Comput. Assisted Tomogr. 1: 216-221, 1977 

Redlin, L. , Francis, R.S. and Orland, M.M. : Renal Abnormalities in 
Agnogenic Myeloid Metaplasia. Radiol 121: 605-608,1976 

Schaner, E.G., Balow, J.E. and Doppman, J.L.; Computed Tomography in the 
Diagnosis of Subcapsular and Perirenal Hematoma. Am. J. Roentgenol . 
129: 83-88, 1977 

Schaner, E.G., Head, G.L., Doppman, J.L. and Young, R.C. : Computed 
Tomography in the Diagnosis, Staging and Management of Abdominal Lymphoma. 
J. Comput. Assisted Tomogr. 1: 176-180, 1977 

Schaner, E.G., Head, G.L., Kalman, M.A., Dunnick, N.R. and Doppman, 
J.L.: Whole Body Computed Tomography in the Diagnosos of Abdominal and 
Thoracic Malignancy: Review of 600 Cases. Cancer Treatment Reports In 
Press 

Schuette, W.H., Norris, G.F. and Doppman, J.L.: Real Time Two Dimen- 
sional Mechanical Ultrasonic Sector Scanner with Electronic Control of 
Sector Width. Proceedings SPIE 96: 345-348, 1976 



DR-7 



A 



Shawker, T.H.: Changes in Normal Anatomical Structures Due to the 
Growth and Spread of Abdominal Malignancies. Proceedings of the Second 
International Technology Transfer Workshop on Diagnostic Ultrasound 
Imaging, April 1977, Cairo, Egypt. In Press 

Shawker, T.H., Schuette, W.H. and Whitehouse, W.C.: Real Time Sector 
Scanning of Common Abdominal Disease. Proceedings of the Second Inter- 
national Technology Transfer Workshop on Diagnostic Ultrasound Imaging, 
April 1977, Cairo, Egypt. In Press 

Shawker, T.H., Schuette, W.H., Whitehouse, W.C. and Rifka, S.M.: An 
Ultrasonic Real Time Sector Scanner for the Assessment of Early Fetal 
Development (Work in Progress). Proceedings of the Second International 
Technology Transfer Workshop on Diagnostic Ultrasound Imaging, April, 
1977, Cairo, Egypt. In Press 

i 

Shawker, T.H. and Steinfeld, A.D. : Ultrasonic Evaluation of the Pulsatil 
Abdominal Mass. JAMA In Press 

Vermess , M. , Adamson, R.A. , Doppman, J.L. and Girton, M.: Computed 
Tomographic Demonstration of Hepatic Tumor with the Aid of Intravenous 
Iodinated Fat Emulsion: An Experimental Study. Radiol . In press 

Wood, J.H., Parver, M. , Doppman, J.L. and Ommaya , A.K.: Experimental 
Intraoperative Localization of Retained Intracerebral Bone Fragments 
Using Transdural Ultrasound. J Neurosurg 46: 65-71, 1977 

Wood, J.H., Doppman, J.L., Lightfoote, W.E., Girton, M. and Ommaya, 
A.J.: Role of Vascular Proliferation on Angiographic Appearance and 
Encapulation of Experimental Traumatic and Metastatic Brain Abscesses. 
J. Neurosurg . In Press 



DR- 



Observed 7/1/76 



Inpatients 

Outpatients 

EHS 

TOTAL 



NUMBER OF X-RAY EXAMINATIONS 


6/30/77 




Patients 


X-Ray Exams 


21,047 

13.230 

2676 


26,375 

18,143 

2766 



Exams per Pt. 



36,953 



47,284 



1.25 
1.37 
1.03 

1.29 



Observed and Projected 7/1/76 - 9/30/77 



Inpatients 

Outpatients 

EHS 

TOTAL 



26,817 


33,862 


17,624 


24,862 


3493 


3641 



47,952 



61 ,778 



1.26 
1.37 
1.04 

1.28 



COMPARISON OF ACTIVITY 



Observed 7/1/76 - 6/30/77 



Total Number of Patients examined 
Total Number of X-Ray Examinations 
Total Number of X-Rays per Pt. 
Special Procedures (excludes 

Ultrasound and NHI Cath Studies 



1976 



645 



1977 



713 



Change 



34,079 


36,953 


+2874 


45,168 


47,284 


+(5%) 


1.32 


1.28 


-.04 



+68 



Observed and Projected 7/1/76 - 9/30/77 

Total Number of Patients Examined 34,079 

Total Number of X-Ray Examinations 45,168 

Total Number of X-Rays per Pt. 1.32 
Special Procedures (Excludes 

Ultrasound and NHI Cath Studies 645 



47,952 

61 ,778 

1.28 

806 



+13,873 
+16,610 
-.04 

+161 



DR-9 



SUMMARY OF DEPARTMENTAL ACTIVITIES 





FY 76 


7/1/76-6/30/77 


% Change 


7/1/76-9/3 


# MDs 


12 


13 


+8 


13 


# Technicians 


26 


27 


+3.7 


27 


# Other Staff 


20 


23 


+15 


23 


# X-Ray Exams 


45,168 


47,284 


+5 


61 ,778 


# Special Exams 


645 


713 


+10 


891* 


# CT Head 


1,877 


2,750 


+45% 


3,437* 


# CT Body 


59 


704 


+838 


880* 


# Publications 


19 


40 


+110 


54 


# Ultrasound Exams 


1,284 


1,560 


+21 


1 ,950* 


# Animal Research Exams 


381 


735 


+93 


919* 



Personnnel Costs $802,882 $862,489 +7 

Budget Total $1,256,350 $1,481,904 +1£ 



1/l/76 at :nd f j/ 9 30 r / e 77 25% ^^ *'" th ° SS ° bSe ™ ed ™ Period between 



DR-10 



Smithsonian - cie:-ce information exchange! u.s. department of | project number 

>ROJL"CT NU.VSER (Do NOT use this sr^cej HEALTH. EDUCATION, J::D WELFARE 

PUBLIC HEALTH GEP.VICE 
NOTICE OF 
INTRAMURAL RESEARCH PROJECT 



ZOl CC 04008-01 -DR 



PERIOD COVER EO 



July 1, 1976 - September 30, 1977 



TITLE OF PROJECT (SO characters or less) 

EFFECT OF TOTAL EXCLUSION OF ARTERIAL INFLOW TO THE LIVER 



NAMES, LABORATORY AND INSTITUTE AFFILIATIONS, AND TITLES OF PRINCIPAL INVESTIGATORS AND ALL OTHER 
PROFESSIONAL FERSOfJNEL ENGAGED ON THE PROJECT 



PI 



Dr. J. L. Doppman 



OTHER Mary Girton 
Richard Diggs 



Chief 

RT 
Technician 



DRD CC 

DRD CC 
DRD CC 



COOPERATING UNITS (if any) 



LAB/BRANCH 

Diagnostic Radiology Department 



SECTION 



INSTITUTE AND LOCATION 

CC, NIH, Bethesda, Maryland 20014 



TOTAL MANYEARS: 
1 



PROFESSIONAL: 



1 



OTHER: 



CHECK APPROPRIATE S0X(,E5J 

□ (a) HUMAN SUBJECTS. 

□ (al) MINORS □ (a2) INTERVIEWS 



□ (b) HUMAN TISSUES 



£j (c) NEITHER 



SUMMARY OF WORK (200 words or less - underline keywords) 

Objectives: 

A. to compare hepatic artery embolization accomplished by 
Gelfoam, autologus clot, or other commonly used clinical 
techniques with complete obturation of the hepatic arterial 
bed using an injectible plastic . 

Methods Employed 

The proper hepatic artery is selectively catheterized in monkeys and 
either the right branch or all intrahepatic branches are emboli zed with 
1 to 2 cc of silicone rubber . Serial blood chemical determinations are 
performed as well as serial x-rays to document the acute insult to the 
liver. As hepatic function tests return to normal, arteriography is 
repeated to evaluate the development of hepatic arterial collaterals. 
The monkeys are sacrificed and their livers studied microscopically. 

DR-11 



PH 3-6040 
(Rev. 10-76) 



A second group of monkeys undergo embolization of a single hepatic 
artery branch , usually the right and will be compared with a group of 
monkeys whose hepatic arteries are proximal ly obstructed by Gel foam, the 
commonly used clinical technique. 

Major Findings 

Gel foam obstruction of the hepatic arteries caused minimal hepatic 
dysfunction and all livers at autopsy were normal. The explanation is a 
rapid development of hepatic arterial collaterals within several hours 
of proximal hepatic artery obstruction. This prevents significant 
disturbances in hepatic function and accounts for the normal livers at 
autopsy. 

In livers whose arterial beds were totally perfused with silicone, acute 
hepatic swelling occurred and persisted for the first two weeks, coin- 
ciding with a marked elevation of liver enzymes and alkaline phosphatase. 
These changes gradually subsided over six weeks and in some animals 
never reached normal levels. Autopsy revealed multiple infarcts throughou 
the livers with large bile cysts which in at least two instances became 
grossly infected. 

Significance of Research 

Treatment of liver metastases by hepatic artery ligation has produced 
dramatic but often short lived palliation. We are particularly in- 
terested in infarcting functional hepatic metastases of islet cell or 
carcinoid tumors as many of these patients are incapacitated not by 
tumor bulk but by tumor end products. This laboratory study was under 
taken to demonstrate that permanent hepatic dearterial ization , as 
produced by injectible plastics, is not tolerated by the liver . 



DR-12 



SMITHSONIAN SCIE'.CE INFORMATION EXCHANGE 

PROJECT NUMBER (Do NOT use this s;ace) 



U.S. : NT OF 
HEALTH, EOUCATION, ANC WELFARE 
PUBLIC HEALTH SERVICE 
NOTICE OF 
INTRAMURAL RESEARCH PROJECT 



PROJECT NUMBER 



Z01 CC 04009-01 -DR 



PERIOD COVERED 



July 1, 1976 - September 30, 1977 



TITLE OF PROJECT (30 characters or less) 

EPIDURAL VENOGRAPHY FOR THE DETECTION OF EPIDURAL MASSES 



NAMES, LABORATORY AND INSTITUTE ,FF ILI ATI ONS, AND TITLES CF PRINCIPAL INVESTIGATORS AND ALL OTHER 
PROFESSIONAL PERSONNEL ENGAGED ("I THE PROJECT 



PI Dr. N. Reed Dunnick 

OTHER Dr. J. L. Doppman 
Mary Girton 
Richard Diggs 



Staff Radiologist 

Chief 

RT 
Technician 



DRD CC 

DRD CC 

DRD CC 

DRD CC 



COOPERATING UNITS (if any) 



LAB/BRANCH 

Diagnostic Radiology Department 



SECT I ON 



INSTITUTE AND LOCATION 

CC, NIH, Bethesda, Maryland 20014 



TOTAL MANYEARSs 

.16 



■ROFESSIONAL: 



OTHER: 



CHECK APPROPRIATE BOX(ES) 

□ (a) HUMAN SUBJECTS 

□ (al) MINORS U 2 ) INTERVIEWS 



□ (b) HUMAN TISSUES 



2 (c) NEITHER 



SUMMARY OF WORK L2C0 «ords or le-.s - underline keywords) 

Objectives ; 

A. To evaluate the sensitivity of epidural venography vs . myelograp hy 
in the detection of small epidural masses . 

B. To clinically test epidural venography in patients with 
epidural metastase s to determine its sensitivity and whether 
this single examination will permit definition of (1) multiple 
epidural masses as well as (2) the cranial extent of completely 
obstructing masses. 



DR-13 



PHS-6040 
(Rev. IO-76) 



Methods Employed 

The classic method for evaluating spinal cord compression in patients 
with known primary malignancies is myelography. By the time symptoms 
develop, a complete subarachnoid block is generally demonstrated and one 
must frequently resort to cisternal myelography to define the cranial 
margin of the intraspinal mass for radiation therapy port placement In : 
addition, metastases to the epidural space are often multiple and 
myelography will only demonstrate the most caudal mass producing complete 1 
obstruction. Performing lumbar puncture to inject contrast media is not 
totally safe in patients with incomplete spinal blocks due to epidural 
tumor. Cord herniation has been initiated requiring emergency laminectom 
to prevent irreversible cord damage. 

For these reasons, the technique of epidural venography is being eval- 
uated as an alternate diagnostic approach. 

Methods Employed 

Epidural masses are simulated in monkeys by percutaneously introducing 
through intervetebral foramina small Fr. Fogarty balloon catheters The 
balloon is inflated with silicone which polymerizes to produce a permanent 
epidural mass. Epidural venography and myelography with a water soluble 
contrast have been performed in these animals. These preliminary 
studies indicate that myelography is a more sensitive test detecting 
very small epidural masses which fail to produce any abnormality in the 
epidura, venogram. However, most symptomatic epidural masses produce 
complete subarachnoid block and when the myelogram demonstrates comolete 
block in these animals, the epidural venogram was also grossly positive 
In addition, by performing retrograde azygography , it was usually 
possible to define the upper as well as the lower margins of the epidural 
mass, important information not obtainable from the myelogram which 
demonstrates only the caudal margin of a complete obstruction. 

Significance of Research: 

Metastases to the epidural space are frequently encountered in the tumor 
population at NIH. Combined lumbar and cisternal myelography are often 
necessary to define the extent of the epidural mass for radiation 
treatment or for laminectomy. We plan to perform epidural venography in 
addition to myelography in patients with epidural metastases prior to 
radiation therapy y 

Proposed Course 

A cooperative study with radiation therapy is being developed. 



DR-14 



MITHoO.'il AM SCIENCE INFORMATION EXCHANG 
ROJECT NUMBER (Do NOT use this ^pace) 



U.3. DEPARTMENT OF . PROJECT NUMBER 

HEALTH, ED'JCATIC;., AND WELFARE i 

PUBLIC HEALTH SERVICE ' 
NOTICE Or 

INTRAMURAL RESEARCH PROJECT < Z01 CC 0401 0-01 -DR 



PERIOD COVERED 



July 1, 1976 - September 30, 1977 



TITLE OF PROJECT (80 characters or less) 

DEVELOPMENT OF A NEW PLASTIC MATERIAL FOR TRANSCATHETER EMBOLIZATION 



NAMES, LABORATORY AND INSTITUTE AFFILIATIONS, AND TITLES OF PRINCIPAL I WEST I GATORS AND ALL OTHER 
PROFESSIONAL PERSONNEL ENGAGED ON THE PROJECT 



PI Dr. J. L. Doppman 

OTHER Dr. Robert Bowman 
Mary Girton 
Wi 11 iam Aven 



Chief 

Chief 

RT 

Technician 



DRD CC 

IRTD NHLBI 
DRD CC 
IRTD NHLBI 



COOPERATING UNITS (if any) 

Outside NIH: Dr. Louis L. Wood, Research Associate, W.R.Grace & Co. 

Columbia, MD 



LAB/BRANCH 

Diagnostic Radiology Department 



SECTION 



INSTITUTE AND LOCATION 

CC, NIH, Bethesda, Maryland 20014 



TOTAL MANYEARS: 
1 



PROFESSIONAL: 



OTHER: 



CHECK APPROPRIATE BOx(ES) 
J (a) HUMAN SUBJECTS 

□ (al) MINORS H (a2) INTERVIEWS 



□ (b) HUMAN TISSUES 



$ (c) NEITHER 



SUMMARY OF WORK (200 woras or less - underline keywords) 

Objectives: 

A. To evaluate hydrophylic polyurethane prepolymers as possible 
agents to be used for embolizing tumors through percutaneous 
catheters. 

B. To determine tissue toxicity of such plastics if they prove 
technically suitable as transcather embolizing agents. 



Methods Employed: 

A varity of techniques for reducing the viscosity and decreasing the 
expansion of hydrophylic polyurethane prepolymers were investigated. 
Dimethyl sulfoxide was originally used as a diluent but caused hem- 
orrhagic pneumonias when excreted through the lungs in animals. In 



PnS-6040 
(Rev. IO-76) 



addition, the expansion of these polymers due to the generation of CO 
at tne time of polymerization made it difficult to prevent proximal 2 
propagation of the embolus and spill over into major vessels These 
initial technical evaluations were accomplished in a series of dogs 
cats and monkeys. At our request, Dr. Louis Wood at W. R Grace & Co 
developed a new polyurethane prepolymer that generated less CO during 
polymerization and had reduced viscosity. Transcather embolization of B 
number of spleens, livers and kidneys in a series of cats and monkeys 
proved the material to be an effective embo1_jzin Q_ggpnt Y 

Acute toxicity studies' in a series of six lambs were performed Right 
kidneys were embolized with Hypo! and serial chemical determinations 
over three months were obtained. The embolized kidneys were examined 
histological y atthe time of autopsy. No significant abnormal 
of renal or hepatic function were apparent from the serial chem caf 
determinations. At autopsy, the embolized kidneys were grossly in- 
farcted but in many instances disolution of arterial walls and transmit 

SIlS'SxlJlS? P ° lymer had ° CCUrred SU99eSt1ng slgnlflcLrSeffl 

Major Findings 

Sizalinn P °!h^ eth r f ° amS are SUitable agents for transcather 
embolization. They polymerize on contact with serum and although snm P 

expansion occurs due to C0 2 production, it is not excessive and can 

toxi- it * i? n aooears T~ "A' "^ the mt ^ al h " no "me te 
toxiciuy, it appears to have considerable long-term tissue toxicity 

Since these are hydro phy He polymers, they may be invaded by tsue' 

oScts and F r? e e r t^lT the /f ease ° f potential lylar^inoenlc end 
products. Further evaluation and long term tissue toxicity is underway. 

Significance of Res earch 
_ _ 

Tumor embolization for palliation and reduction of bulk are becomina 
more frequently requested techniques. Gelfoam and si W are the 

A be° tefp «Il2 SiaW ""! UnSatisfact -y *>r * -mber oTre ons . 
Imhl / ? material for transcatheter embolization would have a 

ZZl ?e f s?o P „ P s: Cat,0 " S " the f,e,ds ° f °"^y - congen'u^g". 

Publications: 

Doppman J.L., Aven, W., Bowman, R.L., Wood, L L and Girtnn M • 






DR-16 




U.S. DEPARTMENT OF 
HEALTH, EDUCATION, AND WELFARE 
PUBLIC HEALTH SERVICE 
NOTICE OF 
INTRAHURAL RESEARCH FROJECT 



PROJECT NUMBER 



ZOl CC 04007-01 -DR 



PERIOD COVERED 



July 1, 1976 - September 30, 1977 



TITLE OF FROJECT (80 characters or less) 

DEVELOPMENT AND EVALUATION OF A ULTRASONIC REAL TIME SCANNING DEVICE 



NAMES, LABORATORY AND INSTITUTE AFFILIATIONS, AND TITLES OF PRINCIPAL INVESTIGATORS AND ALL OTHER 
PROFESSIONAL PERSONNEL ENGAGED )N THE PROJECT 



PI Dr. Thomas H, Shawker Staff Radiologist 

William H. Schuette Electrical Engineer 



OTHER Willard C. Whitehouse Chief 
Joanne Evans RT 



DRD CC 
BEI R 



PSD CC 
DRD CC 



COOPERATING UNITS (if any) 



LAB/ BRANCH 

Diagnostic Radiology Depa rtment 



SECTION 



INSTITUTE AND LOCATION 

CC, NIH, Bethesda, Maryland 20014 

TOTAL MANYEARS: 
1 



I PROFESSIONAL: 

3 



OTHER: 



CHECK APPROPRIATE BCX(ES) 
Q (a) HUMAN SUBJECTS 

□ (al) MINORS □ (a2) INTERVIEWS 



□ (b) HUMAN TISSUES 



(c) NEITHER 



SUMMARY OF WORK (2C0 words or less - underline keywords) 

Objectives: 

To develop a versatile real time scanner using the sector scanning 

in abdominal s canning in chi ldren and adul ts . A 



principle for use i 
sector scanner to p 
abdomen has been de 
tation Branch by Wi 
Early experience ha 
vascular anatomy . 
tumors as well as a 
bel ieve that this s 
for real time abdom 

Publ ications: 



roduce real time ultrasonic imaging of the chest and 
veloped in the Biomedical Engineering and Instrumen- 
lliam H. Schuette and is being clinically evaluated, 
s been largely directed towards defining normal 
We are beginning to accumulate a series of abdominal 
group of patients with very early pregnancies and 
canner represents the most versatile machine available 
inal scanning. 



Schuette. W.H., Norris, G.F. and Doppman, J.L.: Real Time Two Dimen- 

— m=n 



PHS-6040 

/ o i n -> r \ 



sional Mechanical Ultrasonic Sector Scanner with Electronic Control of 
Sector Width. Proceedings SPIE 96: 345-348, 1976 

Shawker, T.H., Schuette, W.H. and Whitehouse, W.C.: Real Time Sector 
Scanning of Common Abdominal Disease. Proceeding of the Second Internati 
Technology Transfer Workshop on Diagnostic Ultrasound Imaging, April 
1977, Cairo, Egypt. In Press 

Shawker, T.H., Schuette, W.H., Whitehouse, W.C. and Rifka, S.M.: An 
Ultrasonic Real Time Sector Scanner for the Assessment of Early Fetal 
Devlopment (Work in Progrss). Proceedings of the Second International 
Technology Transfer Workshop on Diagnostic Ultrasound Imaging, April, 
1977, Cairo, Egypt. In Press. 



DR-18 



J SMITHSONIAN SCIENCE INFORMATION i"XCHANGE| U.S. DEPARTMENT OF 

PROJECT NUMBER '.Do NOT use this i.pace) HEALTH, EDUCATION, AND WELFARE 

PUBLIC HEALTH SERVICE 
NOTICE OF 
INTRAMURAL RESEARCH PROJECT 



PERIOD COVERED 



PROJECT NUMBER 



ZOl CC 04004-02-DR 



July 1, 1976 - September 30, 1977 



TITLE OF PROJECT (30 characters or less) 

DEVELOPMENT AND CLINICAL EVALUATION OF ULTRASONIC SIGNAL 



NAMES, LABORATORY AND INSTITUTE AFFILIATIONS, AND TITLES OF PRINCIPAL INVESTIGATORS AND ALL OTHER 
PROFESSIONAL PERSONNEL ENGAGED r N THE PROJECT 

PI Dr. Thomas H. Shawker Staff Radiologist DRD CC 
OTHER Dr. John L. Doppman Chief DRD CC 



COOPERATING UNITS (if any) 

Outside NIH: Dr. M. Linzer, National Bureau of Standards 

Gaithersburg , MD 



Lab/branch 

Diagnostic Radiology Department 



SECTION 



INSTITUTE AND LOCATION 

CC,NIH, Bethesda, Maryland 20014 

TOTAL MANYEARS: "PROFESSIONAL: 

1 3 



OTHER: 



_l 



CHECK APPROPRIATE EOX(ES) 

□ (a) HUMAN SUBJECTS 

□ (al) MINORS fj (a2) INTERVIEWS 



□ (b) HUMAN TISSUES 



3 (c) NEITHER 



SUMMARY OF WORK (200 words or le.s - underline keywords) 

Objectives : 

To develop and clinically evaluate an ultrasonic tissue characterization 
unit. 

Methods Employed: 

We have completed the construction of an ultrasonic tissue analyser 
which provides far more qualitative and quantitative data on ultrasonic 
parameters than are currently available with any other imaging device. 
This analyser measures such variable factors as sound velocity, maximum 
and minimum reflections and the complex impedance of tissue interfaces. 
We are currently in the process of interfacing this unit with a new 
clinical scanner and will soon begin to acquire clinical scans for 
evaluation. 

DR-19 



PHS-6040 



Major Findings: 

Ultrasonic scanners currently available use a scan converter to produce 
the gray scale images of internal organs but without any evidence of 
quantitative analysis of the refected sound waves. Since tissues of 
different structures have varying ultrasonic signatures , we hope that 
this new analyser will enable us to begin to identify quantified tissue 
components on the basis of their characteristic ultrasonic reflections . 
The previous year was a year of technical and equipment development. 
The upcoming year will be the year of clinical evaluation . 



DR-20 



iMI'THSONIAN SCIENCE INFORMATION EXCHANGE 

'ROJECT NUMBER (Do NOT 'Jse this space) 



U.S. DEPARTMENT OF 
HEALTH, EDUCATION, \UD WELFARE 
PUBLIC HEALTH SERVICE 
NOTICE CF 
INTRAMURAL RESEARCH PROJECT 



PROJECT NU 



Z01 CC 04012-01 -DR 



PERIOD COVERED 



July 1, 1976 - September 30, 1977 



TITLE OF PROJECT (80 characters or less) 

DEMONSTRATION OF THE EFFECT OF CHEMOTHERAPY ON CARCINOGEN INDUCED 
HEPATOMAS ON RHESUS MONKEYS 



NAMES, LABORATORY AMD INSTITUTE AFFILIATIONS, AND TITLES OF PRINCIPAL INVESTIGATORS AND ALL OTHER 
PROFESSIONAL PERSONNEL ENGAGED ON THE PROJECT 



PI Dr. M. Vermess 

Dr. R. H. Adamson 

OTHER Richard Cysyk, PhD 
Mary Girton 



Associate Chief 
Chief 



RT 



DRD 
LCHPH 

LCHPH 
DRD 



CC 

NCI 

NCI 
NCI 



COOPERATING UNITS (if any) 



LAB/BRANCH 

Diagnostic Radiology Department 



SECTION 



INSTITUTE AND LOCATION 

CC, NIH, Bethesda, Maryland 20014 



TOTAL MANYEARS: 



PROFESSIONAL: 



OTHER: 



CHECK APPROPRIATE BOX(ES) 
□ (a) HUMAN SUBJECTS 



□ (b) HUMAN TISSUES 



£1(0 



NEITHER 



D (al 



INORS 



(a2) INTER/IEWS 



SUMMARY OF WORK (200 words or less - underline keywords) 

Objectives : 

To demonstrate the effects of different cytostatic drugs on carcinogen 
induced hepatomas in Rhesus monkeys by different imaging techniques. 
Experimental testing of a new contrast material in malignant tumors of 
the liver is one of the primary objectives of this study. 

Methods Employed : 

Two imaging methods are employed in this investigation: 

A. Injection of an experimental contrast material containing emulsified 
oily contrast mat erial (Ethiodol). Following the injection, 
computerized tomographic scans of the Rhesus liver are obtained 
with our EMI 5005 total body scanner. 

DR-21 



PHS-6040 



B. Selective hepatic angiography with conventional water soluble 
contrast media. Selective catheterization of the hepatic 
artery was performed by a cut-down of the external femoral artery. 
Flowing the injection of the contrast material directly into the 
hepatic artery, serial films of the liver are obtained. 

Findings : 

In the three Rhesus hepatomas examined to date, the chemotherapeutic 
agents arrested tumor growth but did not appreciatively decrease size of 
the existing tumors. 

Significance of Research : 

The significance of this project is two-fold; it permits the in vivo and 
repeated evaluation of the effectiveness of chemotherapeutic agents 
an carcinogen induced hepatoma and gives an opportunity to evaluate 
a new, experimental contrast media in actual tumor situations. 



DR-22 



^HnriSOKIAN SCIENCE INFORMATION '.XCHANGE 

PROJECT NUMBER l v 0o NOT use this s?ace) 



U.S. DEPARTMENT OF 

HEALTH, EDUCATION, AND WELFARE 
PUBLIC HEALTH SERVICE 
NOTICE OF 
INTRAMURAL RESEARCH PROJECT 



PROJECT NUMBER 



ZOl CC 04011 -01 -DR 



PERIOD COVERED 



July 1, 1976 - September 30, 1977 



TITLE OF PROJECT (80 characters or less) 

IV HEPATOSPLENOGRAPHY 



NAMES, LABORATORY AND INSTITUTE AFFILIATIONS, AND TITLES OF PRINCIPAL INVESTIGATORS AND ALL OTHER 
PROFESSIONAL PERSONNEL ENGAGED PN THE PROJECT 



PI Dr. Michael Vermess 

OTHER Dr. R. N. Adamson 
Dr. J. L. Doppman 
Dr. Dulal Chatter ji 
George Grimes 
Mary Girton 



Associate Chief 

Chief 
Chief 



RT 



DRD 



CC 



LCHPH 


NCI 


DRD 


CC 


PHAR 


CC 


PHAR 


CC 


DRD 


CC 



COOPERATING UNITS (if any) 



LAB/BRANCH 

Diagnostic Radiology Department 



SECTION 



INSTITUTE AND LOCATION 

CC.NIH, Bethesda, Maryland 



CHECK APPROPRIATE BOX(ES) 
3 (a) HUMAN SUBJECTS 

□ (al) MINORS H ( a 2) INTERVIEWS 



TOTAL MANYEARS: 
1 



Tr'ROFESSIONAL: 



OTHER: 



□ (b) HUMAN TISSUES 



J (c) NEITHER 



SUMMARY OF WORK (200 «oras or lers - underline keywords) 

Objectives: 

A. The develop a contrast material which if intravenously injected 
would selectively opacify the liver and spleen for diagnostic 
imaging by computerized tomographic scanners . The contrast material 
has to be of sufficiently low toxicity to permit clinical use with 
the doses required. 

Methods : 

Based on previous experiments performed in France, numerous emulsions of 
different particle sizes have been prepared and are being tested following 
intravenous injection of rabbits and monkeys. The emulsion consists of 
emulsified iodinated poppy seed oil (Ethiodol) which is a commercially 
available contrast material used primarily for lymphangiography. 
DR-23 

PHS-£040 
(Rev. 10-76) 



Findings : 

Of the eight different emulsions tested, emulsion No. 8 with the particle 
size primarily between 1-2 microns appears to opacify optimally the 
liver and spleen f ol 1 owing low dose intravenous injection (0.2 ml/kg ) . 
Normal intrahepatic structures such as the inferior vena cava as well as 
some of the biliary channels becomes clearly visible thirty minutes 
following the intravenous injection of the above dose. The same emulsion 
was used at a dose rate of 2 ml/kg (intravenous dose) for conventional 
radiographs of the liver and spleen. No toxic effect was recognized on 
the animals even after the higher dose rate. 

Future objectives : 

After determination of the most adequate emulsion (probably No. 8) 
extensive toxicity work will have to be done in order to approve this 
contrast material for human use. Primary objective is to test this 
contrast material on patients with proven cancer to demonstrate liver 
metastases of smaller size than previously detectable. 



Publications 



Vermess, M., Adamson, R.A., Doppman, J.L. and Girton, M. : Computed 
Tomographic Demonstration of Hepatic Tumor with the Aid of Intravenous 
Iodinated Fat Emulsion: An Experimental Study. Radiol In Press 



DR-2 4 



[SMITHSONIAN SCIENCE INFORMATION EX U.S. DEPARTMENT Of 



PROJECT NUMBER t,Do NOT Uie this space) 



PROJECT NUMBER 



HEALTH, EDUCATION. AND WELFARE i 
PUBLIC HEALTH SERVICE 
NOTICE OF 
INTRAliURAL RESEARCH PROJECT ^01 CC 04006-01 -DR 



PERIOD COVERED 



July 1, 1976 - September 30, 1977 



TITLE OF PROJECT (SO characters or less) 

EVALUATION OF CT BODY SCANNING IN ONCOLOGIC PATIENTS 



NAMES, LABORATORY AND INSTITUTE AFFILIATIONS, AND TITLES OF PRINCIPAL I'.VESTIGATORS AND ALL OTHER 
PROFESSIONAL PERSONNEL ENCAGED ON THE PROJECT 



PI Dr. J. L. Doppman 
Dr. E.G. Schaner 



OTHER Dr. N.R. Dunnick 
Dr. G.L. Head 



Chief 

Staff Radiologist 



Staff Radiologist 
Staff Radiologist 



DRD CC 
DRD CC 



DRD CC 
DRD CC 



COOPERATING UNITS (if any) 



LAB/BRANCH 

Diagnostic Radiology Department 



SECTION 



INSTITUTE AND LOCATION 

CC,NIH, Bethesda, Maryland 20014 



TOTAL MANYEARS: 



1 



PROFESSIONAL: 



OTHER: 



CHECK APPROPRIATE BOX(ES) 
DC] (a) HUMAN SUBJECTS 



□ (b) HUMAN TISSUES 



G (c) NEITHER 



□ (a1 ) MINORS 



(a2) INTERVIEWS 



SUMMARY OF WORK (200 words or less - underline keywords) 

Objectives: 

To compare CT scanning in the detection and follow-up of tumors with 
other imaging modalities, especially conventional radiography, ultrasound 
and isotopic scanning . 

Methods Employed: 

Ultrasonic scanning is being performed in patients with a variety of 
tumors with particular emphasis on lymphoma, pancreatic carcinoma , 
adrenal carcinoma and pelvic masses . In addition, we are scanning 
extremities and the retroperitoneum in patients with soft tissue and 
osseous sarcomas. Computerized scans are performed in addition to the 
usual staging workup and we are attempting to compare CT scanning with 
these more conventional modalities. 



DR-2 5 



PHS-6040 
(Rev. 10-76) 



Major Findings: 

CT scanning appears to be the most sensitive technique for detecting 
pancreatic masses, surpassing ultrasound in obese patients. CT does not 
do as well as ultrasound when the patient is cachectic and normal 
retroperitoneal fatty tissue planes have been lost. Normal adrenal 
glands can be visualized in most patients and CT scanning is an accurate 
way of defining both adrenal tumors and bilateral adrenal hyperplasia. 
These studies are being compared with ultrasound and the results 
of arteriography and venous sampling . CT is also providing previously 
unavailable anatomic information about the extent of soft tissue sarcomas 1 
both in the retroperitoneum and in the extremities. Envoi vement of 
muscle groups can usually be predicted as well as the relation to 
important neurovascular structures. 

Significance of Research 

Both the detection of tumors and the determination of their extent are 
important responsibilities of imaging systems in the workup of cancer 
patients. CT body scanning provides, in an non-invasive manner, anatom- 
ical information about tumors that previously was unavailable or could 
be obtained by more invasive studies. 

Publications: 



Doppman, J.L., Brennan, M.F., Koehler, J.O. and Marx, S.S.: CT Scanning 
for Parathyroid Localization . J Comput Assisted Tomogr 1: 30-36, 1977 

Schaner, E.G., Balow, J.E. and Doppman, J.L.: Computed Tomography in 
the Diagnosis of Subcapsular and Perirenal Hematoma. Am J Roentgenol 
129: 83-88, 1977 

Schaner, E.G., Head, G.L., Doppman, J.L. and Young, R.C.: Computed 
Tomography in the Diagnosis, Staging and Management of Abdominal Lymphoma. 
J Comput Assisted Tomogr 1: 176-180, 1977 

Schaner, E.G., Head, G.L., Kalman, M.A. , Dunnick, N.R. and Doppman, 
J.L.: Whole Body Computer Tomography in the Diagnosis of Abdominal and 
Thoracic Malignancy - Review of 600 Cases. Cancer Treatment Reports In 
Press 



DR-26 



July 1, 1976 through September 30, 1977 

PUBLIC HEALTH SERVICE, NATIONAL INSTITUTES OF HEALTH 

SUMMARY ANNUAL REPORT OF PROGRAM ACTIVITIES 
CLINICAL CENTER 

ENVIRONMENTAL SANITATION CONTROL DEPARTMENT 

CONTENTS 

Missions and Goals ES-1 

Department Activities ES-1 

Table 

1. Formal Training - Classroom ES-3 

2. Positions Filled By Recruitment ES-5 

3. Number of Separations, Resignations, etc ES-6 

A. Reasons for Personnel Leaving ES-7 

Major Progress in Research, Services, Training and Development ES-8 

Future Objectives Directed Toward Meeting Goals ES-9 



ES-1 



July 1, 1976 through September 30, 1977 

PUBLIC HEALTH SERVICE, NATIONAL INSTITUTES OF HEALTH 

SUMMARY ANNUAL REPORT OF PROGRAM ACTIVITIES 
CLINICAL CENTER 

ENVIRONMENTAL SANITATION CONTROL DEPARTMENT 

MISSIONS AND GOALS 

The primary objectives of the Environmental Sanitation Control Department 
during the year were to: 

1. Provide the safest possible sanitary environment consistent with the 
activities of the various institutes and services in the Clinical Center. 

2. Provide a dependable, efficient, vertical transportation service responsive 
to the requirements of patients, emergencies, staff, and visitors. 

3. Study the Department's manpower requirements and formalize its work and 
personnel procedures. 

4. Orient, train, and supervise its personnel so that they are proficient in 
carrying out the program objectives. 

5. Test various products and equipment in order to utilize the most modern 
housekeeping practices. 

6. Cope with day-to-day environmental problems within the Clinical Center and 
to study the total environment as it relates to an institutional setting. 

7. Develop an objective evaluation of the housekeeping program. 

DEPARTMENT ACTIVITIES 

Employee turnover continues to be low. Fifty-one new employees entered on 
duty and 43 left. Table 4 shows that 14 resigned, 7 transferred, 5 retired, 
15 were terminated, and 2 deceased. 

Individual employees and groups received 31 letters of appreciation or 
commendation from building tenants for services rendered. 

The Department coordinated the selection, procurement, and installation of 
approximately 2,000 yards of carpeting during the year. In Januarv the 
Department began enforcing new, more stringent safety standards in accordance 
with DHEW Safety Standards for Floor Coverings. The major provisions of the 
new standards include a new flooring radiant panel test standard, use of the 
"Pill Test" for surface flammability instead of the "Tunnel Test", smoke 
density and static control requirements, and standards for easy access for the 



ES-1 



handicapped. We have been able to find 13 carpet qualities within GSA 
Contract Schedules that meet DHEW standards. 

The Department was included in the Resource Monitoring System (RMS). The RMS 
Index measures the amount of time assigned to housekeeping by the Clinical 
Center compared to a standard hospital of similar size and patient- census. 

The cleaning schedules in the Patient Area Section were reviewed, and updated 
since many work plans had not been reviewed since 1967. The review panels 

met regularly with the affected employees, housekeeping leaders, supervisors, 
the Department secretary, and the Chief, ESCD. 

Since the implementation of the Clinical Center's Smoking Policy, cigarette 
wall urns were removed from walls and public corridors. Those wall urns 
located at the elevator banks remained in order to give people a place to 
discard cigarettes. "No Smoking" signs were posted at entrances and in 
locations in public corridors. "Smoking Permitted" signs were posted in 
waiting rooms . 

New personal clothing lockers were installed in the men's lockerroom B1B19A 
and a new ceiling, wall, and floor materials were installed in the lounge 
section. Changes in the women's lockerroom B1D25 are being planned. 

Service elevators 9 and 15, and passenger elevators 17 and 18, were master 
keyed. Key control is with the Office of the Chief, ESCD. 

The Department provided assistance to NIAID in a project to collect approx- 
imately 15,000 1000 ml empty IV bottles for shipment to Bangladesh. 

All ESCD employees received copies of the newly revised "Handbook for 
Employees, Clinical Center's Environmental Sanitation Control Department." 



ES-2 



TABLE 1 
ENVIRONMENTAL SANITATION CONTROL DEPARTMENT 

April 1, 1976 through June 30, 19 77 
Formal Training - Classroom ' 

GOVERNMENT STAFF-HOURS 

Leadership Training I m 344 

Leadership Training II 432 

Alternative Management Approaches to the 70 's 72 

Management of Conflict and Agreement 48 

Supervisory and Managerial Effectiveness 16 
Civil Service Commission 

Personnel Management for EEO Specialists 24 

Leadership and Women 24 
Department of Agriculture 

Women as Supervisors 48 

Effective Listening 21 

Impact on Management's Right to Manage 24 

Labor Management Relations 8 

EEO Orientation 6 

Pre-Retirement Planning 112 
National Bureau of Standards 

Color in the Health Care Facility 8 

Design Constraints for the Physically Handicapped 8 

Color in Mental Health Facilities 8 

Adult Education 1,053 

Effective Writing 30 

Medical Terminology 40 

ABC Stenoscript 70 

Refresher Typing 32 

Better English Us Cage 40 

TOTAL 2,478 

NON-GOVERNMENT 

4th National Hospital Nursing Supervisors Management 

Conference 16 

Managing Housekeeping Services 32 

Custodial Management Workshop 21 
National Executive Housekeepers Courses 

Work Controls 20 

Psychology 20 

Oral Communications 20 

TOTAL 129 



ES-3 



Table 1 continued 



Principles of Management 

*Modern Management and Supervision 

*Accouting I 

*Personnel Management 

*Management-Employee-Employee-Motivation 

*Management- Employee-Employee-Management 

♦Techniques of Reading and Writing 

*Social Psychology 

introduction to Sociology 

♦Successful Supervision 



36 
15 
36 
36 
60 
60 
36 
36 
36 
30 



WITHIN DEPARTMENT 



Procedures and Orientation 
Health Employee Learning Program 
All Employee Training 



TOTAL 



2,370 
844 
482 



3,696 



GRAND TOTAL 



6,303 



♦Attended course on employee non-duty time 



ES-4 



TABLE 2 
POSITIONS FILLED BY RECRUITMENT 
ENVIRONMENTAL SANITATION CONTROL DEPARTMENT 

April 1, 1976 through June 30, 1977 



MONTH 


GENERAL 
SCHEDULE 


OTHER 
WAGE BOARD 


WG-03 

1 


WG-02 

i 


WG-01 


i 

i TOTAL 
1 




April 






1 


i 1 

5 


■ 


j 

j 




May 












i 




June 








2 


1 




July 








! 4 


-*- 


r 




August 








3 




1 3 




September 








1 1 > 


October 










! " 


November 








- 




-*■- — - - 




December 






2 


U 


l 


- 




January 








3 


i 






February 








3 








March 








1 




- 




April 








a 


- 


; 




May 








* 




- 




June 




III 

j i 


SUB- TOTAL 




2 
1 


1 

1 


6 


51* 





*Total includes 15 700-hour appointments and 6 NTE 1-vear appointments 



TABLE 3 

NUMBER OF SEPARATIONS, RESIGNATIONS, ETC., BY MONTH & GRADE 

ENVIRONMENTAL SANITATION CONTROL DEPARTMENT 

Aoril 1, 19 76 through June 30, 19 77 



MONTH 


WAGE 
SUPERVISOR 


WAGE 
LEADER 


i 

WG-03 


WG-02 


WG-01 


TOTAL 




i 








April 


! l 
i 


2 




3 


May 


I l 


2 




3 


June 






1 




1 


July 






2 




2 


Aug us t 




2 


2 


1 


5 


September 




1 


1 


2 


1 


5 


) etcher 






1 




1 


N'ovsnber 




1 


2 




3 


December 




1 


9 


1 


1 


5 


January 






2 




2 


February- 






1 


1 


2 


March 






2 




2 


April 




2 


2 


4 


May 


. - >. 




2 




2 


June 


l j 


2 




3 


SUB-TOTAL 


i 


2 


3 


26 


6 


43* 



*Total includes 8 700-hour appointments and 5 1-year appointments, 



ZS-* 



TABLE 4 
REASONS FOR PERSONNEL LEAVING 
ENVIRONMENTAL SANITATION CONTROL DEPARTMENT 

April 1, 1976 through June 30, 1977 



RESIGNATIONS 


TRANSFERS 


RETIREMENTS 


TERMINATIONS 


DECEASED 












Resigned when 
faced with possible 
disciplinary action 

5 


Improved 

career 

opportunities 

4 


Retirement 
disability 

2 


Separation 
during 

probationary 
period 

2 


2 


To accept non- 
government 
position 

4 


Transport- 
ation 

1 


Retirement 
optional 

3 


Termination 
of temporary 
appointment 

4 




Moving away 

1 


Higher 
salary 

2 




Expiration 
of temporary 
appointment 
8 




Health 

2 






Abandonment 

of position 

1 




Transportation 

1 










Personal 

1 


- 








SUB-TOTALS 14 


7 


5 


15 


2 



TOTAL - 43 



ES-7 









MAJOR PROGRESS IN RESEARCH, SERVICES f TRAINING AND DEVELOPMENT 

Building renovations continued to present the Department with its greatest 
challenge. In addition to uncounted minor projects, during the vear there 
were several major projects affecting all areas of the building. While 
renovations are in progress the natural reaction is to throw in the dust 
towel and give .up on housekeeping until- conditions settle and housekeeni 
can be handled in a normal routine fashion. 



! 



i 



However, renovation creates conditions which call for an actual intensi-'icatii 
of housekeeping activities. There is a very real problem of maintenar.ee 
becoming considerably more difficult, both from a psychological and a era:' 
performance standpoint, while at the same time it becomes more important. 

Adjacent areas must be protected from contamination by the soils and waste 
material produced in renovation. Floors can become badlv damaged bv scratch 
or abrading, by tracking in of particles of concrete, metal chins, splinters, 
mud, etc. Air-borne waste particles and dust can damage office equipment and | 
mechanical systems. Comfort becomes an important factor. People react to 
unpleasant conditions caused by excessive dust and soil. Infection control 
becomes more difficult. 

During renovation the basic housekeeping principle is isolation: Keening the 
remodeling work and its by-products completely isolated from the portior 
building not involved. Some of the more effective steps in this direction art* 
containment barriers around the work area, mats and runners in connecting arej| 
to entrap as much soil and dirt as possible and restriction of sightseers 
walking through the area and tracking soil back into other areas. 

Throughout the year the Department enjoyed substantial success in its naicr 
initiatives to improve the housekeeping service offered to Clinical Center 
tenants. Two significant achievements resulted: A Special ^roiects Tear -as 
formed and a program for cleaning "Red Seal" rooms was established. 

Need for a Special Projects Team was perceived as a means for ESCD becoming 
a positive on-going force in the Clinical Center's clean-up effort. A team 
consisting of 5 to 6 wage grade employees and a leader was formed under direct, 
operational control of Chief, ESCD. The team's functions were (1) provide 
special cleaning in public corridors and lobbies consisting of wall and ceil 
working and floor stripping and refinishing in concert with the Clinical 
Center's floor-by-floor Operation Clean-up effort; (2) maintain new Clinical 
Center entrances; (3) provide response for clean-up after building emereencie? 

(4) prepare meeting set-ups in Masur Auditorium and Medical Board Room: -r.d 

(5) provide cleaning service for "Red Seal" rooms. 

The Department began offering limited cleaning service in 81 "'ed Seal" -re- 
located throughout the building. These rooms are in building areas normal!' 
serviced only by the Night Service Section and, because of occupant security 
requirements, are not available for cleaning unless the occupants are present), 
Assistant Chief, ESCD, and two housekeeping aids developed and coordinated 

ES-8 



cleaning schedules" for these rooms with cooperation from the various room 
occupants. By the end of the year there were 104 rooms on this "Red Seal" 
service. 

The emergency assistance program for the Department operated satisfactorily 
during the year. Elevator Operators and others were briefed several times on 
emergency procedures. The Special Projects Team received special training 
and equipment for emergency assistance. Water pick-up equipment was renovated 
and replaced during the year and operated in a very satisfactory manner. The 
following emergencies were encountered during the year: 



Floods 

Fires 

Acid Spills 

Others 



43 calls far 100 staff-hours 

37 calls for 18-1/2 staff-hours 

3 calls for 1-1/2 staff-hours 

43 calls for 17 staff-hours 



ESCD completed change-over to use of cardboard boxes for medical pathological 
waste handled by our personnel. This was the first operational phase of the 
program of conversion to paper packaging of waste, activation of trash chutes, 
and elimination of GI cans for waste handling in the Clinical Center. In 
preparation for trash chute activation several trials have been made using the 
paper bag system for handling waste. 

Three floor maintenance machines were evaluated. A two-speed machine was the 
most promising. The type machine demonstrated was very effective and capable 
of significantly improving productivity and quality. The specific machine 
was too noisy for use in this house. Other two-speed machines are being 
evaluated. An ultra-hi-speed floor polisher and a push sweeper were also 
shown. Neither meet our current requirements. 

Carpet extractor eauipment was evaluated. After a literature review two 
machines were selected for evaluation . The "Brillo" extractor had several 
deficiencies and was found not suitable. The "Steam-X" was the best 
extractor we have seen. One "Steam-X" was acquired on a lease basis for long- 
term evaluation. 

An in-use bacteriological evaluation was made on "TBO," a quaternary ammonium 
germicidal detergent. This product was found to be about equal to our 
presently approved germicidal detergents, "1-Stroke" and "LpH." 

"Brawn," a heavy-duty cleaner, and "Spritz," a spray-and-wipe cleaner, were 
found to be satisfactory, but not significantly better than our present 
products. 

FUTURE OBJECTIVES DIRECTED TOWARD MEETING GOALS 

1. Implement new solid waste handling system based on reactivation of existing 
Clinical Center trash chutes. 

2. Complete refresher training and certification in basic work procedures for 
all Department supervisors, leaders and employees. 

ES-9 



3. Support and encourage upward mobility for employees so that they may work 
at their fullest potential. 

4. Continue to study the feasibility of phasing out manual passenger elevator 
service and converting to automatic passenger elevators. 

5. Continue program of replacement of Clinical Center personal lockers. 

6. Publish new cleaning procedures in "Clinical Center Cleaning Procedure 
Manual," and revise 25% of Programmed Work Plans. , 

7. Continue to test new products and equipment. 

8. Coordinate selection of textiles and fabrics for draperies, furniture, anc 
wall and floor coverings within the Clinical Center. 



ES-10 



July 1, 1976, through June 30, 1977 



PUBLIC HEALTH SERVICE, NATIONAL INSTITUTES OF HEALTH 

SUMMARY ANNUAL REPORT OF PROGRAM ACTIVITIES 
CLINICAL CENTER 

FABRIC CARE DEPARTMENT 



TABLE OF CONTENTS 

PAGE 

I. MISSION AND GOALS FC-1 

II . ACTIVITIES FC-2 

III. FUTURE OBJECTIVES FC-U 



FC-i 



July 1, 1976, through June 30, 1977 

PUBLIC HEALTH SERVICE, NATIONAL INSTITUTES OF HEALTH 

SUMMARY ANNUAL REPORT OF PROGRAM ACTIVITIES 
CLINICAL CENTER 

FABRIC CARE DEPARTMENT 

I. MISSION AND GOALS 

The primary objectives of the Fabric Care Department during Fiscal Year 
1977 were to: 

ft 

1. Provide quality fabric care services at the most reasonable cost 
consistent with the needs of patient care and research in the 
Clinical Center and other N.I.H. installations on the Bethesda 
Campus, the Poolsville Animal Farm, the Landau, Westwood, Auburn 
Buildings, the Baltimore Cancer Research Center, and St. Elizabeth's 
Hospital. 

2. Coordinate and adjust work schedules to allow contractors to perform 
major renovation activities and install equipment while still 
maintaining quality fabric care services to the N.I.H. community. 

3. Study the department's manpower utilization requirements for possible 
reduction of permanent full-time staff. 

k. Complete bed pillow replacement program for patient care. 

5. Select and provide training for an Assistant Chief of the department. 

6. Assist Material Management staff incorporate the department's new 
linen store inventory into the N.I.H. Uniform Cost Accounting System. 

■ 7- Reduce the number of budgeted overtime hours by 25$. 

8. Select and purchase a new flatwork ironer. 

9- Remove the belt conveyor and modify the existing monorail to improve 
transportation and storage of soiled linens. 



FC-1 



II. ACTIVITIES 

A. Production 

Laundry Operations: 



F.Y. '77 F.Y. '76 Percentag 



1,800,000 1,787,9^0 
15,200 14,900 



170,900 



153,737 



10.5/S 
1.0)2% 



9.% 



56,163 


49,300 


8.1$ 


6,020 


4 ,803 


h.9% 


39,100 


U6,609 


-6.2% 


776 


81+9 


-11.6% 


632 


615 


.037 



Pounds Washed and Finished 
Pounds Dyed 

Dry Cleaning Operations: 

Pounds Dry Cleaned and 
Finished 

New Linen Stores: 

Items Issues 

Items Repaired 

Items Altered 

New Items Fabricated 

Number of Items Stocked 

1. The department was able to meet the increasing demands for 
service with no major problems or additional staff during the 
major renovation and equipment installation project. 

2. Reduced permanent, full-time staff by two positions. We have 
reduced the authorized permanent, full-time staff of the 
department from 49 to 37 since 1974. 

3. Reduced the number of budgeted overtime hours by 33 1/3$. 
(F.Y.-76 - 1,500 hours - - F.Y. '77 - 1,000 hours). 

B. Renovation 

1. The renovations are completed except for a few minor repairs 
and adjustments. This project to improve the work environment 
for employees was started August 1976 and should be completed 
as of September 1, 1977. The following improvements are now 
completed: 

a. A new mezzanine was constructed along the east wall to 
provide 5,000 additional square feet of floor space and 
now accommodates new toilet and locker room facilities and 
a new spacious conference/break room. 

b. The old locker room area has been renovated into larger 
newly designed offices. 

c. The gates at the tunnel entrance were replaced with automat:: 
roll-up doors to keep out incinerator debris, smoke, cold 
winter drafts, and odors. 



FC-2 



d. A new central air conditioning system provides a cool, 
comfortable work environment in all work areas. 

e. The illumination has been increased with the installation of 
new flourescent lights into a new suspended accoustical 
ceiling. 

f . A new lint exhaust system has been installed to alleviate 
housekeeping problems resulting from dust and lint fallout. 

g. The old office has been renovated into a new sewing and 
issue room. 

h. A new P. A. system complete with an F.M. radio pipes music 
continuously throughout the plant. 

i. The interior of the facility and equipment has been painted 
in a lively color scheme to enhance the appearence of the 
work areas. 

j . New furniture has been purchased for offices and conference/ 
break room. 

k. A new flatwork ironer was selected and ordered. 

1. The belt conveyor removed and existing monorail was 

modified to improve transportation and storage of soiled 
linens. 

m. A modern fire protection system has been installed and 
tested. 

n. The newly designed, all glass entrance enhances the decor 
of the modern N.I.H. Fabric Care Facility. 

C. Personnel 

1. Selected an Assistant Chief of the Department. 

2. Four employees attended Basic Adult Education classes 
( 720 man hours ) . 

3. Four employees attended selected training classes 
(185 man hours) . 

k. The department sponsored nine (9) job related training 
sessions (310 man hours). 

5. Employees in the Fabric Care Department were awarded 
Superior Performance Awards ( 36 employees ) . 

6. One employee attended the Alcohol Rehabilitation Counselling 
sessions. 

FC-3 



7. Three employees transferred to other positions within N.I!!, 
D. Completed Programs 

a 

1. Bed pillow replacement program completed. All bed pillows! 
now in use and in inventory meet the Commerce Department's 
Flammability Standard FF-U-72. 

2. The department's new linen store inventory was successful] 
incorporated into the N.I.H. Uniform Cost Accounting Syste. 

III. FUTURE OBJECTIVES 

1. Provide technical and administrative training for new assistar, 

2. Review manpower requirements in an effort to reduce authorize 
permanent full-time staff by two positions. 

3. Continue to improve quality of service to the N.I.H. communil 
at a reasonable cost. 

k. Establish a two to three year plan for replacing several key 
employees nearing retirement. 

5- Reduce budgeted overtime useage by 12$. 

6. Draft Employee Handbook for Fabric Care employees. 

7. Complete and publish Fabric Care Procedural Manual to be used 
by the N.I.H. community. 



FC-1* 



July 1, 1977, through September 30, 1977 

PUBLIC HEALTH SERVICE, NATIONAL INSTITUTES OF HEALTH 

SUMMARY ANNUAL REPORT OF PROGRAM ACTIVITIES 
CLINICAL CENTER 

MEDICAL RECORD DEPARTMENT 

CONTENTS 

Department Missions and Goals MR-1 

Activities MR-1 

Progress MR-1 

Future Objectives MR-4 



MR-i 



July 1, 1976 through September 30, 1977 

PUBLIC HEALTH SERVICE, NATIONAL INSTITUTES OF HEALTH 

SUMMARY ANNUAL REPORT OF PROGRAM ACTIVITIES 
CLINICAL CENTER 

MEDICAL RECORD DEPARTMENT 

DEPARTMENT MISSIONS AND GOALS 

The Medical Record Department maintains a medical record for every registered 
Clinical Center patient. The prime objective is to insure that each medical 
record is complete, accurate, safeguarded, and available to authorized per- 
sonnel. To this end, systems are maintained which provide: (l) immediate 
access to and release of medical records and information to authorized users; 
(2) a computerized listing of each patient by diagnosis and operation: (3) an 
analysis by Institute of discharged inpatients; (h) a systematic arrangement 
of reports within the medical record; (5) transcribed medical reports and 
communication with referring physicians. 

ACTIVITIES AND PROGRESS 

Education and Training 

Orientation was held for employees from a number of Clinical Center Departments 
and Institutes. Lecture tours were given to Public Health Service student 
medical administrators and other visitors. 

Personnel attended workshops on a variety of work-related subjects such as 
record management, microfilming, confidentiality aspects of medical records, 
Privacy Act, medical audit as well as campus sponsored office procedural courses 
for clerical personnel. 

Continuing education and cross-training of employees within the department 
was effected. 

Activities and Progress 

Minimum medical record requirements and general policies relating to major 
medical record systems were codified in July 1976 and published as a Medical 
Record handbook. The handbook was extensively revised and expanded for release 
in July 1977 for use by physicians and health professionals participating in 
patient care. 

The arrangement of medical record contents has been revised to assist users in 
referencing and identifying reports as well as to reduce misfiling. 

A significant policy change became effective in April 1977; that is, all medical 
records including incomplete records and reports are retained in the Medical 
Record Department for review and completion. Medical records are released for 
inpatient readmissions and outpatient visits only. This change required major 



MR-' 



revisions in procedures as well as acceptance and adjustment on the part of 
personnel and physicians. On a trial basis, an exception has been made to 
release completed records for a 2^-hour period. This temporary change was 
necessary due to the need for physicians to prepare either oral or written i 
munication to the patient's referring physician. The effectiveness of this 
exception to the policy will be evaluated and results analysed prior to amei 
ing the basic policy. 

Six medical audits were completed during the period from January to July 19/ 
The Medical Record Department played a key role in abstracting and tabulatir 
the required data, and participating in the ongoing analysis of the results 
the audits. 



Several changes were made to improve the total turn-around time for the trar;; 
cription of medical dictation and mailing of medical reports to the referririj 
physician. Examples are: additional courier service for transmitting dictsi 
tion and medical reports inhouse, to and from offsite services; revision of 
systems to simplify identification of physician's dictation and improve cler 
processing; provision of continuing education to offsite transcription servi 
the printing on MIS of discharge letters addressed to the referring physicic 
Of significance, there was a reduction in total turn-around time from 10 to 
days, and at present to 3 days for kl% of the workload. 

A concentrated program was conducted jointly with the Medical Record Committ; 
to improve the identification of medical reports which are received for incl 
si on in the medical record. Meetings were held with Clinical Directors and 
Clinical Center Department Heads in order to arrive at mutual resolutions, 
a result, basic requirements, means for the disposition of unidentified mate! 
and a change in the patient addressograph system were established. 

The implementation of the microfilm program has been delayed because of mult; 
factoral causes. The Request for Proposal is in its final draft stage, the: 
request for approval of the program and purchase of required equipment have 
been submitted; a policy for the disposal of the original medical record anc 
archival security microfilm remains to be negotiated with the Management Pol: 
Branch. 

The Chief, Medical Record Department is a member of a work group studying th 
total system relating to medical records at the Clinical Center. The study 
includes an analysis of the present system and identifying a system which wil 
accommodate the needs for the Ambulatory Care Research Facility. Proposed M 
approaches or recommended revisions will be formalized for discussion and aei 
tance before implementation. 



MR-2 



WORK PRODUCTION STATISTICS 

July I, 1976 to June 30, 1977 - Actual 
July 1, 1977 to September 30, 1977 - Projected 



Column A 



-Column B 



7-1-76/6-30-77 7-1-77/9-30-77 
(Actual) (Projected) 



Column C 
TOTAL 



I . Medicolegal Section 

Total number of requests 
Average requests per day 

I I . Record Processing Section 
Incomplete records as of 

5-31-77 
Incomplete records as of 

9-30-77 



7098 
32 



731 



1739 
27 



622 



8837 
30 



677 



I I 



Fi les Section - Record Circulation 

Complete Records 24333 

Clinics & Admissions 58687 

Incomplete Records 13305 



5776 

14290 

5492 



30109 
72977 
18797 



Transcribing Section 
Belts received 
Belts transcribed 



14987 
15009 



3993 
4105 



18980 
19114 



Figures for belts transcribed are greater than belts received due to belts 
remaining at beginning of the month. 



Projected figures 7-1-77/9-30-77 are based on actual figures 7~1 "76/9-30-76 , 



MR-3 



FUTURE OBJECTIVES 



Develop and implement an automated system for collecting and reporting deli 
quent medical records in order to 1) provide timely and accurate informatio 
to physicians to help reduce the period that a medical record remains incom 
plete and to insure compliance with minimum record requirements; and 
2) eliminate outdated reports and information that result from the manual s 
of collecting and reporting deficiencies. 

Implement by January 1978, the four year program for microfilming about 62, 
medical records; finalize the microfilm system for use at the Clinical Cent 

Implement new approaches identified by the special work group for the Clini ] 
Center medical record system. 

Continue the investigation of system changes for dictation of medical repor . 

Continue the investigation of developing an automated system for medical rein 
circulation and location. 

Redesign the physical layout of the department in order to accommodate spac 
for microfilm equipment and staff, physician's reference room, and medicolel 
personnel . 









HR-h 



ANNUAL REPORT - MEDICAL RECORD DEPARTMENT 

PROBLEMS 

Approximately 650 unscheduled outpatient visits a month cause problems in 
Medical Record Services. Although cooperation from physicians has been im- 
proving, there are still temporarily lost records and records with major in- 
compl et ions . 

Another major problem is an inability to recruit medical record administrators. 
The apparent reason is that Civil Service standards set this series at a rela- 
tively low grade level, resulting in lack of incentive for prospective appli- 
cants. 



MR-5 



July 1, 1976 through September 30, 1977 
PUBLIC HEALTH SERVICE, NATIONAL INSTITUTES OF HEALTH 
SUMMARY ANNUAL REPORT OF PROGRAM ACTIVITIES 
CLINICAL CENTER 
DEPARTMENT OF NUCLEAR MEDICINE 

1 

CONTENTS 

Department Missions and Goals NM-1 

Department Activities NM-2 

Major Progress in Research, Services, Training 

and Development NM-4 

Future Objectives Toward Meeting Goals NM-6 

Research Projects NM-16 

Functional Mapping of Kidney Dynamics NM-16 

ECG-Gated Scintigraphic Angiocardiography NM-19 

The Metabolism of 65 Zn and 69m Zn in Patients with 

and without Taste Abnormalities NM-24 

Studies of Copper Metabolism in Man Using 67 Cu and 

64 Cu NM-27 

Ventilation-Perfusion Relationships in Idiopathic 

Pulmonary Fibrosis NM-3 1 

TABLES 

I. Comparison of Whole Body Measurements for Fiscal 

Years 1976 and 1977 NM-8 

II. Ten Year Record of Whole Body Measurements NM-9 

III. Other Analyses Related to Whole Body Metabolism 
Studies NM-10 

IV. Radiopharmaceutical Section Statistical Data NM-11 

V. Isotopes and Products Received, Registered, and 
Formulated - FY 77 NM-12 

VI. Diagnostic Nuclear Medicine Section Patient Visits 

by Fiscal Year NM-14 

GRAPHS 

Growth of Clinical Center Nuclear Medicine Service 

to NIH Patients NM-15 



NM-i 



July 1, 1976 through September 30, 1977 

PUBLIC HEALTH SERVICE, NATIONAL INSTITUTES OF HEALTH 
SUMMARY ANNUAL REPORT OF PROGRAM ACTIVITIES 
CLINICAL CENTER 
DEPARTMENT OF NUCLEAR MEDICINE 

DEPARTMENT MISSIONS AND GOALS 

Applied Physics Section 

The Applied Physics Section performs two basic functions: 1) to 
supply technical and professional assistance to the Department of 
Nuclear Medicine and other investigators in the resolution of selected 
diagnostic and experimental problems requiring Nuclear Medicine 
technology and 2) to independently develop novel diagnostic 
procedures, from concept through hardware, aimed at resolving selected 
problems of medical diagnosis. 

Diagnostic Imaging Section 

This section serves the clinical research goals of the NIH through the 
in vivo diagnostic use of radioactive pharmaceuticals in the 
evaluation of diseases that are under study in both the inpatient and 
outpatient population. Pictures (images) are created, through the use 
of complex detectors of radioactivity, that demonstrate the site and 
progression or regression of disease. The information obtained is 
used by the physicians in their choice of therapy and to assess the 
results of therapy. Improvement of existing techniques and 
development of new techniques of patient study are major goals, and 
these tests must have minimal morbidity for the patient. The primary 
goals are to improve accuracy and to provide more data with which to 
evaluate the patient. 

Radiopharmaceutical Section 

The major responsibilities of the Radiopharmaceutical Section are its 
service functions, quality control efforts, and involvement in the 
dose dispensing system employed in the Diagnostic Imaging Section. 
Services consist of the procurement, receipt, registration, 
formulation, and development of all radiopharmaceuticals intended for 
use in Clinical Center patients. Quality control efforts consist of 
assaying, radiochemical and radionuclide purity checks, pH 
determination, particle sizing, and a host of other considerations 
necessary to establish the pharmaceutical quality of the products. 



NM-i 



■ 



Whole Body Counter Section 

The Whole Body Counter Section provides the NIH community with a 
unique facility for direct quantitative measurements of uptake and 
retention of biologically active materials and trace elements labeled 
with gamma-ray emitting radionuclides, and evaluation of the amount 
and identity of unknown radionuclides in the human body. It also 
serves as a source of information and support for investigators 
desiring to design special counting systems for the measurement of 
biological samples containing radionuclides. 

DEPARTMENT ACTIVITIES 

Applied Physics Section 

In accord with its mission, the APS intensified its collaborative 
efforts with NHLBI/CB, DCRT/LAS, and DCRT/CSL during FY 77 in the 
pursuit of non-invasive methods for detecting and diagnosing cardiac 
disease. 

Equipment 

Imaging equipment, work space, and expendables were provided by NM/CC 
and DCRT. Radiopharmaceuticals were provided by the Radiopharmacy 
Section/NM. 

Diagnostic Imaging Section 

The components necessary to achieve the above mission require 
continued upgrading. The field of Nuclear Medicine is fast changing 
and requires a constant refreshment of departmental physician and 
technician knowledge. Electronic equipment is costly and is under 
continual development by private industry. Medical diagnostic 
capability can be improved and maintained only if a program of 
continued, well chosen acquisition of newly created electronic devices 
is followed. Equipment was improved through the acquisition of an up- 
to-date whole body imaging device provided in the FY 77 budget. A 
program of improving other imaging devices (gamma cameras) is underway 
and should be aided by the FY 78 budget. 



NM-2 



DIAGNOSTIC IMAGING SECTION — PERSONNEL 

Physicians/Technicians Secretaries/Receptionists 

FY 77 7 / 7 6 

Patient visits increased 26% in FY 77 compared with a 13% increase in 
FY 76 due in part to additional nuclear medicine studies, but it was 
mainly attributable to computerized transmission tomography (CT) 
studies. CT studies became routinely available in this section of the 
Department when NINCDS provided a new CT instrument September 1976. 
Please see updated graph titled "Growth of Clinical Center Nuclear 
Medicine Service" on page 15. 



Whole Body Counter Section 

Three major equipment changes were made in FY 77. These were the 
completion of our low energy photon human counter system, installation 
of an automatic data collection system to go with the Packard 
Instrument Company model 5220 "Autogamma" well counter, and the 
acquisition of a triple "diskette" data storage system for the Wang 
2200 data processing system. The low energy photon counting system 
will allow measurement of previously undetectable gamma-ray and X-ray 
emitting radionuclides such as 1-125 and will improve the ability of 
the Section to measure bremsstrahlung X-rays from P-32 and other high 
energy beta particles emitters. 

The automatic data acquisition system includes an RS-232 interface 
which is connected between the "Autogamma" well counter and a Texas 
Instruments Company "silent 700" portable data terminal. The "silent 
700" is in turn connected to a Memodyne model 181 cassette tape 
system. The cassette tape system records the data in a form 
compatable with the Wang 2200 system that will allow direct data 
transfer between the systems. 

Finally, a triple "diskette" data storage device was purchased and 
installed for our Wang 2200 data processing system. This unit will 
rapidly store and retrieve up to 786,432 bytes of information on three 
low cost, interchangeable diskette platters. The diskette system 
represents a substantial increase in the data handling capability of 
the Section and should allow the eventual incorporation of all Section 
records into disk storage with a resulting large reduction in space 
allocated to file storage and increased efficiency in file acquisition 
and updating. In addition, the expanded storage capacity will provide 
input file areas for large volumes of raw data for computation and 
storage. 



NM-3 



MAJOR PROGRESS IN RESEARCH, SERVICES, TRAINING AND DEVELOPMENT 
Applied Physics Section 

Four major objectives were realized in the Applied Physics Section 
during FY 77: 1) implementation of a minicomputer based real-time 
cardiac imaging system tailored to clinical requirements, (APS-DCRT) ; 
2) Recognition and validation of the ability of this system to 
visualize and quantitate cardiac function during bicycle exercise as 
well as at rest, (NHLBI-APS) ; 3) assembly and preliminary patient 
evaluation of a (prototype) portable hand-held scintillation probe for 
continuous bedside measurement of cardiac function (APS-NHLBI) ; and 
(4) design assembly and human engineering evaluation of a 
microprocesser version of the probe system for use in the intensive 
care unit (DCRT/CSL-APS) . 

Diagnostic Imaging Section 

A computerized tomography apparatus which was installed in April 1976 
in the Department of Nuclear Medicine by NINCDS is now utilized to 
study patients and support NIH clinical research projects. In 
addition, clinical studies are made on patients from the Washington V.A., 
Walter Reed, National Naval Medical Center, and Andrews Air Force 
Base hospitals. This CT device, shared cooperatively with the 
Department of Radiology/CC/NIH, provides diagnostic support to NIH 
patients as well as patients of the above noted U. S. Government 
hospitals. 

Gated Cardiac Blood Pool Studies: This project has accelerated in the 
past year. The Cardiology Branch/NHLBI refers approximately 25 
patients per week and has purchased a computer and placed it in this 
department. Clinical Center support for this project is to be matched 
through the acquisition of a state-of-the-art gamma camera. This 
latter device is critically needed to further this project and will 
probably be acquired in FY 78. 

The Pulmonary Research Protocol continues in cooperation with DCRT and 
the Pulmonary Branch/NHLBI. Approximately 15 patients per week are 
studied. 

The Thrombus Detection Study is underway with the Surgery Branch/NCI 
and is being evaluated for its utility in the detection of post 
operative thrombus formation. The objective is to avoid or lower the 
incidence of pulmonary embolus . 



NM-4 



Computerized renography with functional mapping continues with DCRT. 

Ultrasound with computer support is also under development with DCRT. 
The system is being applied to comparative radionuclide studies. 

New Services offered by this section of the Department of Nuclear 
Medicine: CT brain studies; gated cardiac blood pool studies; 
thrombus detection; computerized renography. 

A new radiopharmacy area to prepare and administer 
radiopharmaceuticals to patients is under construction in the 
Diagnostic Imaging Section. The old radiopharmacy space will be 
renovated and given to the Applied Physics Section. 

Radiopharmaceutical Section 

In its second full year of operation, the Radiopharmacy' s role in the 
Diagnostic Imaging Section's dose dispensing system continued to be an 
effective means to control and dispense radiopharmaceuticals, and it 
ensures good radiation safety practices. 

Thanks to the combined efforts of the Radiation Safety Branch and 
Radiopharmacy, a method for unit dose packaging of Xenon-Xe-127 was 
developed by modifying the existing dispensing system; the new 
dispensing system lowered radiation levels during its operation. 

During the initial stages of the Functional Mapping of the Kidney 
Dynamics Research Project, Radiopharmacy labelled Sodium-Iodohippurate 
1-123 for the investigator until commercially prepared material became 
available . 

A total of 23 different radionuclides were received which constituted 
66 different product formulations (Table V) . Products not previously 
received and/or formulated were Technetium-99m Red Blood Cells, 
Indium-Ill Diethylenetriaminepentaacetic Acid, Sodium Iodide 1-123, 
Sodium Iodohippurate 1-123, and Ytterbium-169 
Diethylenetriaminepentaacetic Acid . 

Consultations were given to various paramedical personnel and 
regulatory agencies. The Radiopharmacy Section also provided two 
preceptorships to the Duquesne University Controlled Internship 
Program in Pharmacy. 



NM-5 



<* 



Whole Body Counter Section 

During FY 77 the number of research and diagnostic studies made by the 
Whole Body Counter Section decreased slightly due in part to the 
completion of a major study of zinc metabolism initiated in FY 75 by 
NHLBI. 

The Section completed patient measurements for three major human 
studies: iron metabolism in patients suffering chronic iron overload, 
studies of the metabolism of zinc in. patients with defects of taste 
and smell, and studies of copper metabolism in humans using Cu-64 and 
Cu-67. 

The zinc studies represent the largest and most detailed 
investigations of zinc metabolism ever done with radionuclides: they 
are the first human studies to involve oral and intravenous 
administration of zinc radionuclides to the same subjects to 
investigate the effects of route of entry on metabolism. Publication 
of these results is expected in FY 78. 

Appended tables provide a complete breakdown of the number and types 
of studies performed by the Section in FY 77. The Whole Body Counter 
Section was involved in studies leading to three publications and two 
presentations at national scientific meetings during FY 77. 

FUTURE OBJECTIVES TOWARD MEETING GOALS 

Applied Physics Section 

We will continue clinical studies with the real-time cardiac 
imaging system, and the refinement of the real-time system through 
continued software development and hardware acquisition. 

We will evaluate the portable microprocessor-probe system in the 
intensive care unit. 

This section will undertake planning and design for a microprocessor 
version of the real-time imaging system in association with DCRT. 

Requirements for fabrication of a lightweight, low volume, portable 
imaging device tailored specifically to cardiac studies will be 
investigated . 



NM-6 



Investigation of the limitations associated with these methods will 
continue. 

Diagnostic Imaging Section 

Acquisition of the latest gamma camera systems is of great importance , 
since the existing systems have become limitations to the support of 
service and clinical research of this section of the Department of 
Nuclear Medicine. 

Improved service through better and more rapid performance of existing 
studies is intended along with the development of newer studies to 
meet clinical research needs. 

Radiopharmaceutical Section 

The future objectives of the Section are to continue to collaborate 
with the service and research efforts of the Diagnostic Imaging 
Section and other Clinical Center investigators with involvement in 
the formulation, development, and quality control of all 
radiopharmaceutical products intended for patient administration. 

The Radiopharmaceutical Section anticipates the use of a new 
radiopharmaceutical dispensing area within the Diagnostic Imaging 
Section in FY 78 which should lend itself to a more efficient 
operation of the unit dose program. 

Whole Body Counter Section 

The Whole Body Counter Section has emphasized medical research 
measurements for the past six years and will continue to do so during 
FY 78. Efforts to inform the NIH community of the availability of our 
services will include the distribution of a pamphlet and presentation 
of information about whole body counting and other available services 
through the Office of Radiation Safety: "Radiation Safety Branch 
Courses for Employees Using Radionuclides." 



NM-7 



4i 

TABLE X 



Comparison of Whole Body Measurements 
for Fiscal Years 1976 and 1977 



Isotope 1976 1977 * 



Research Studies 



Personnel Monitoring Studies 



Zn-65 - 


689 


191 


Cu-67 


564 


157 


Cr-51 


50 


14 


K-40 


137 


26 


1-131 " 


444 


960 


1-125,129 


32 





Fe-59 





22 


Cu-64 


395 


115 


idies 


2311 


1485 


1-125,131 


999 


1164 


Whole Body 


690 


832 



1689 1996 



* Fiscal Year 1977 values estimated from 7/76 through 5/77 
plus scheduled increases, expressed as yearly rates. 



Percentage of Whole Body Counts by Institutes 

FY 1976 FY 1977* 



DRS 


48.0 


56.4 


cc 





0.4 


NCI 


1.1 





NHLI 


19.3 


15.6 


NINDS 


0.05 


0.0 


NIAMDD 


28.5 


26.8 


NIA 


3.1 


0.8 




100.0 


100.0 



* Fiscal year 1977 values estimated from 7/76 through 5/77 
plus scheduled increases expressed as percentage of yearly 
rates. 



NM-8 



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NM-9 



TABLE III 



Other Analyses Related to Whole Body Metabolism Studies 

FY 1976 FY 1977* 



Excreta Studies 






Cu-67 


217 


90 


Cu-64 


97 


36 


Zn-65 


8 







322 


126 


Blood Studies 






Samples Taken 


518 


247 


Red Cell Washings 


614 


241 




1132 


488 


Blood Counts 






Cu-67 


604 


278 


Cu-64 


451 


192 


Zn-65 


878 


328 




1933 


798 


Tissue Sample Counting 




Sr-85,Cel44 an 


i 




Yb-169 


2263 


5386 


Br-82 


177 







2440 


5420 



* Fiscal Year 1976 values estimated from 7/76 through 5/77 
plus scheduled increases expressed as yearly rates. 



NM-10 



TABLE IV 

Radiopharmaceutical Section Statistical Data 

FY 76 *FY 77 **% Change 

Service Requests 2,224 3,090 + 11% 

Work Units 24,173 36,664 + 21% 

■ 

Unit Dose Requests 5,000 8,714 + 39% 

RPS Assays 3,857 5,441 + 13% 

Radionuclidic Purity Checks 633 651 - 18% 

RPS Expenditures $111,832.93 $160,196.13 + 15% 



* - 15-month period 

** - pro-rated over 12-month period 

Note: The decrease in number of radionuclidic purity checks performed is 
attributable to the discontinuance of use of Mercury-Hg-197 
Chlormerodrin. 



NM-11 



TABLE V 



Isotopes and Products Received, Registered, and Formulated - FY 77 

1. H-3 - Bilirubin 

Thymidine (Methyl H-3) 

2. C-14 - Dopamine 

Imipramine 

3. P-32 - Chromic Phosphate Suspension 

Sodium Phosphate 

4. Ca-47 - Calcium Chloride 

5. Cr-51 - Erythrocytes 

Erythrocytes (Heat-Treated) 
Human Serum Albumin 
Platelets 
Sodium Chromate 

6. Co-57 - Cyanocobalamin Capsules 

7. Co-58 - Cyanocobalamin Capsules 

8. Fe-59 - Ferrous Citrate 

9. Cu-64 - Copper Chloride 

Copper Chloride Plasma 

10. Cu-67 - Copper Chloride 

11. Ga-67 - Gallium Citrate 

12. Se-75 - Selenomethionine 

13. Mo-99 - Mo-99/Tc-99m Generator 

14. Tc-99m - Diethylenetriaminepentaacetic Acid 

Dipho sphonat e 

Human Serum Albumin (E.M.) 

Macroaggregated Human Serum Albumin 

Pyrophosphate 

Red Blood Cells 

Sodium Pertechnetate 

Stannous Human Serum Albumin 

Sulfur Colloid 



NM-12 



Table V, Page 2 



15. In-111 - Diethylenetriaminepentaacetic Acid 

Indium Chloride 

16. 1-123 - Sodium Iodide Oral Solution 

Sodium-o-Iodohippurate 

17. 1-125 - c-1 Esterase Inhibitor 

Chylomicrons 

Fibrinogen 

High Density Lipoprotein 

High Density Lipoprotein A-l 

High Density Lipoprotein A-2 

Human Growth Hormone 

Human Serum Albumin 

Low Density Lipoprotein 

Microaggregated Human Serum Albumin 

Procine Insulin 

Sodium Iodide Calibration Solution 

Sodium Iothalamate 

Very Low Density Liporotein 

18. Xe-127 - Xenon Gas 

19. 1-131 - Alpha, 1-Antitrypsin 

High Density Lipoprotein 
High Density Lipoprotein A-l 
High Density Lipoprotein A-2 
Low Density Lipoprotein 
Porcine Pro-Insulin 
Sodium Iodide Capsules 
Sodium Iodide Oral Solution 
Sodium Iodide Uptake Solution 
Sodium-o-Iodohippurate 
Sodium Rose Bengal 
Very Low Density Lipoprotein 

20. Xe-133 - Xenon Gas 

Xenon in Saline 

21. Yb-169 - Diethylenetriaminepentaacetic Acid 

22. Hg-197 - Chlormerodrin 

23. Tl-201 - Thallium Chloride 



NM-13 



TABU VI 

Diagnostic Nuclear Medicine Section 
Patient Visits by Fiscal Year 

Date 1967 1968 1969 

Total 

Yearly % Change 

Yearly % Change from 1967 



Date 

Total 

Yearly % Change 

Yearly % Change from 1967 



Date 1973 1974 1975 



2568 


3093 
20% 
20% 


1637 
47%* 
36%* 


1970 


1971 


1972 


2181 
33%* 
15%* 


2308 

0% 
7%* 


2950 

28% 
15% 



4688 


7039 


7098 


59% 


50% 


0% 


82% 


174% 


176% 



Total 

Yearly % Change 

Yearly % Change from 1967 



Date 1976 1977 



Total 








8054 


10056 


Yearly % 


Change 






13% 


25% 


Yearly % 


Change 


from 


1967 


214% 


292% 



* Decrease 

** Covers period Oct. 1, 1976 - Sept. 30, 1977 (TQ 76 not included for 

validity of comparison) 

Figures for July, Aug. & Sept. are estimates 



*** 



NM-14 



PATIENT VISITS i(1,000's) 




NM-15 



wt» bAWiimtuL 



PROJECT NUMBER* (bo"KOT use this space) 



t | iitwn ( Wl 



HEALTH, EDUCATION, AND WELFARE 
PUBLIC HEALTH SERVICE 
NOTICE Cf 
INTRAHURAL RESEARCH PROJECT 



rnuucui uuniDcn 



Z01 CL 00002-02 NM 



PERIOD COVERED 

July 1, 1976 to June 30, 1977 



4 



TITLE OF PROJECT (SO characters or less) 
Functional Mapping of Kidney Dynamics Research Project 



NAMES, LABORATORY AND INSTITUTE AFFILIATIONS, AND TITLES OF PRINCIPAL INVESTIGATORS AND ALL OTHER 
PROFESSIONAL PERSONNEL ENGAGEO ON THE PROJECT 



PI: P. R. Bradley-Moore 

OTHER: J. J. Bailey 

R. J. Farkas 

M. A. Douglas 

B. R. Line 

S. L. Bacharach 

A. E. Jones 

G. S. Johnston 



Senior Staff Fellow 
Head, Medical Application 

.Section 
Chief, Radiopharmacy 

Section 
Programmer 
Research Analyst 
Physicist 
Assistant Chief 
Chief 



NM CC 
LAS DCRT 

NM CC 

i 

LAS DCRT 
LAS DCRT 
NM CC 
NM CC 
NM CC 



COOPERATING UNITS (if any) 
LAS DCRT 



lab/branch 



Department of Nuclear Medicine 



SECTION 



Diagnostic Imaging Section 



INSTITUTE ANO LOCATION 

CC, NIH, Bethesda, Maryland 20014 



TOTAL MANYEARS: 

0.75 



PROFESSIONAL: 

0.60 



CHECK APPROPRIATE BOX(ES) 
Eh?{a) HUMAN SUBJECTS 

D (al) MINORS D (a2) INTERVIEWS 



OTHER: 



0.15 



□ (b) HUMAN TISSUES- 



□ (c) NEITHER 



SUMMARY OF WORK (200 words or less - underline keywords) 

This work studies diagnostic imaging of, and report generation 
kidney abnormalities seen by nuclear medicine methods. 



\to describe, 



It includes the application to dogs and patients of new and es 
radiopharmaceuticals and computer programs based on mathematic 
of the kidney, with intercomparison and validation of differing 
by double-blind reporting of operated animal kidneys . 



tablished 

al models 

methods 



NM-16 



PHS-6040 
(Rev. 10-76) 



Z01 CL 00002-02 NM 

Project Description 

Objectives : 

To improve nuclear medicine diagnosis of kidney abnormality 

A. By using new radiopharmaceuticals to improve the available quality 
and quantity of information. 

B. By adapting a computer program established here to the new tracer 
agents and by the development of new computer programs to improve the 
diagnostic yield by non-invasive, non-toxic methods, that permit 
visualization during renal dysfunction too severe for adequate 
intravenous pyelography. 

Methods Employed : 

A. DTPA for patients. Developed at Brookhaven National Laboratories, 
Diethylene Triamine Pentacetic Acid (DTPA) labelled with Tc-99m is now 
commercially available and approved and is now being routinely used 
for patient care. 

B. OIH-I-123 for Dogs. Ortho-Iodo-Hippuric Acid (OIH) labelled with 
Iodine-123 in the NIH radiopharmacy (and more recently obtained from 
Davis, California) has been used with DTPA and OIH-I-131 in a 
double-blind animal study to compare the three. 

C. Data Taking. Data is being taken in a flexible format on Magnetic 
Tape. 

D. Data Analysis. The tapes are analyzed using the established 
computer program (1) and a data base is being built up at the same 
time as new programs are being developed for trial. 

Findings : 

Improvement in available information is evidenced by the observed 
counts from one kidney of approximately 1,000,000 (DTPA); 800,000 
(OIH-I-123); 3,000 (OIH-I-131). 

Significance of the Research Program : 

A. Much improved statistical validity of observation with expected 
higher resolution from the high count rate will permit seeing smaller 
lesions better than before. 



NM-17 



Z01 CL 00002-02 NM 

B. Use of two radiopharmaceuticals with differing paths of excretion 
(DTPA-Glomerular Filtration) , COIH-Tubular Secretion) promises 
elucidation of differeing patho-physiological mechanisms in renal 
dysfunction. 

Proposed Course : 

Completion of data taking and data analysis. 

Honors and Awards : 

None. 

Publications : 

Agress, H., Levenson, S.M., Gelfand, M.J., Johnston, G.S., Bailey, 
J.J.: Functional mapping and related computer-generated images in 
radionuclide renography. Applied Radiology 1: 202-208, 
November-December, 1976. 

Bradley-Moore, P.R., Line, B.R., Klickna, J., Johnston, G.S.: 
Proceedings of the Seventh Symposium on Sharing of Computer Programs 
and Technology in Nuclear Medicine, Atlanta, Georgia, January 1977. 



NM-18 



U.S. DEPARTMENT OF 
HEALTH, EDUCATION, AND WELFARE 
PUBLIC HEALTH SERVICE 
NOTICE OF 
INTRAMURAL RESEARCH PROJECT 



PROJECT NUMBER 

ZOl CL 00007-02 NM 



PERIOD COVERED 
July 1, 1976 to June 30, 1977 



TITLE OF PROJECT (80 characters or less) 
ECG-Gated Scintigraphic Angiocardiography 



NAMES, LABORATORY AND INSTITUTE AFFILIATIONS, AND TITLES OF PRINCIPAL INVESTIGATORS AND ALL OTHER 
PROFESSIONAL PERSONNEL ENGAGED ON THE PROJECT 



PI: 



OTHER: 



J. S. Borer 

S. L. Bacharach 

M. V. Green 



K. M. Kent 

J. J. Bailey 

M. A. Douglas 

H. G. Ostrow 



Senior Investigator 
Physicist 

Chief, Applied Physics 
Section 

Senior Investigator 
Head, MAS 
Programmer 
Engineer 



CB NHLBI 
NM CC 
NM CC 



CB NHLBI 
LAS DCRT 
LAS DCRT 
CSL DCRT 



COOPERATING UNITS (if any) 
CB NHLBI 
LAS DCRT 
CSL DCRT 



LAB/BRANCH 
Department of Nuclear Medicine, 



CC 



SECTION 
Applied Physics Section 



INSTITUTE AND LOCATION 
Clinical Center. NIH. Bethesda. Maryland 20014 



TOTAL MANYEARS: 

5.0 



PROFESSIONAL: 



2.5 



OTHEfl: 



2.5 



CHECK APPROPRIATE BOX(ES) 
2 (a) HUMAN SUBJECTS 

□ (al) MINORS Q (a2) INTERVIEWS 



(b) HUMAN TISSUES 



□ (c) NEITHER 



SUMMARY OF WORK (200 words or less - underline keywords) 

High temporal resolution ECG-gated scintigraphic angiocardiography is a 
computer-based, radiotracer imaging procedure that allows non-invasive 
visualization of the chambers of the working heart, at rest, during bicycle 
exercise, during therapeutic intervention, etc. The procedure yields 
quantitative measures of left ventricular function such as ejection fraction, 
peak, ejection rate, etc. Work is continuing to assess the accuracy of these 
data in man and to establish findings for the method in selected disease 
categories. Variations of this technique are being explored that will 
result in an inexpensive, portable device capable of continuous real-time 
measurement of left ventricular function at the bedside. 



NM-iq 



PHS-6040 
(Rev. 10-76) 



Z01 CL 00007-02 NM 
Project Description 
Objectives : 

A. To verify the ability of high temporal resolution ECG-gated 
scintigraphy of the heart to noninvasively visualize and measure 
cardiac function in man. 

B. To explore variations in the concept of ECG-gated scintigraphy 
that will result in a bedside device capable of continuous, 

non- invasive monitoring of left ventricular function. 

Methods Employed : 

Comparative studies are continuing in which selected patients are 
studied with the various forms of ECG gated scintigraphy under 
investigation in the APS, and by conventional radiographic and echo 
procedures used to evaluate left ventricular function. During FY 77 
these studies evolved into a large scale clinical evaluation of the 
technique in patients with coronary artery disease, valvular disease 
and other cardiac abnormalities. During this period more than 350 
patients were studied in the Diagnostic Imaging Section by APS 
technical personnel. The increase in patient studies was the result 
of three factors: 1) the APS/DCRT development of a clinically 
useful, real-time cardiac imaging system; 2) recognition and 
validation of this system's ability to visualize and quantitate 
cardiac function during bicycle exercise (NHLBI/APS) and 3) 
establishment of normal values for the procedure (during rest and 
exercise) in 32 normal volunteers (NHLBI/APS) . 

Progress was also made toward a portable cardiac function monitor 
through assembly and testing of a prototype minicomputer-based gated 
scintillation probe system. Comparative camera-probe studies were 
performed in 50 patients to establish the operational characteristics 
of this device. Based on these findings, a microprocessor version of 
the probe system was constructed by DCRT/CSL and is now undergoing 
evalution in the DNM prior to its use in the intensive care unit in 
various NHLBI protocols. 

Findings : 

A. Real-time cardiac imaging during rest and bicycle exercise. 

A comparison of rest-exercise results in normal subjects with those 
obtained in patients with coronary artery disease, but with normal 
left ventricular (LV) function at rest, demonstrated that the 
scintigraphic technique possesses a high sensitivity in detecting 
functionally significant coronary disease. In normal subjects LV 



NM- 20 



Z01 CL 00007-02 NM 



ejection fraction invariably increased with exercise and no wall 
motion abnormalities developed. In contrast, it was observed that in 
each patient, ejection fraction fell during exercise and at least one 
wall motion defect developed. These findings suggest that 
rest-exercise imaging can be successfully employed to detect the 
presence, effect, and probable location of functionally- significant 
coronary lesions. 

In the study of symptomatic patients with aortic regurgitation it was 
found that LV ejection fell during exercise. In asymptomatic patients 
with aortic regurgitation a duality in exercise response was observed: 
some increased their ejection fractions (as do normals) while others 
diminished their ejection fractions. These findings suggest that 
scintigraphic rest-exercise testing might be used to time surgical 
intervention in these patients before a depression in myocardial 
function has occurred, thus improving long term post operative 
survival . 

A comparison of pre- and post-operative exercise studies in patients 
undergoing coronary artery bypass grafting indicated that surgical 
therapy improved LV function during exercise in the majority of these 
patients. Pre-operative exercise studies with and without 
nitroglycerin produced similar results. 

B. Portable probe system. 

Fifty patients were studied both with the prototype probe system and 
with the scintillation camera. A comparison of probe-camera results 
indicated that timing and magnitude variations in LV volume measured 
by the probe were virtually identical to those determined from the 
camera studies. Difficulties were encountered, however, in 
determining an appropriate LV background correction for the probe. 
Fortunately, background determination is not critical when the probe 
is employed as a monitor, since changes in LV function are the 
quantity at issue. These findings imply that the probe can be used 
successfully to monitor LV function at the bedside. 

Significance of the Research Program : 

ECG-gated angiocardiography is potentially of value in the detection 
and management of cardiac disease. The method requires only an 
intravenous injection of radiotracer and is otherwise utterly non- 
invasive. It is rapid, safe and can be repeated under varying 
circumstances such as exercise, medication, etc., for periods of 
up to six hours without further tracer administration. This 
characteristic also makes the technique suitable for continuous LV 
function monitoring in the acutely ill patient. Efforts presently 
underway will result in a portable system capable of continuous LV 
function monitoring at the bedside. 

NM-21 



f 



Z01 CL 00007-02 NM 
Proposed Course : 

Continuation of validation and development work. 
Honors and Awards : 
None. 
Publications: 



Bacharach, S. L., Green, M. V., Borer, J. S., Douglas, M. A., Ostrow, 
H. G., Johnston, G. S.: A real-time system for multi- image gated 
cardiac studies. J. Nucl. Med. 18: 79-84, January 1977. 

Bacharach, S. L., Green, M. V., Borer, J. S., Line, B. R., 
Bradley-Moore, P. R., Ostrow, H. G., Johnston, G. S.: Real-time 
collection, analysis and display of nuclear medicine data. 
Proceedings of the Seventh Symposium on the Sharing of Computer 
Programs and Technology in Nuclear Medicine, Atlanta, Georgia, January 
1977. 

Bacharach, S. L., Green, M. V., Borer, J. S., Douglas, M. A., Ostrow, 
H. G., Johnston, G. S.: Real-time scintigraphic cineangiography. 
Proceedings. Computers in Cardiology. IEEE Catalog No. 76CH1160 - 1C, 
IEEE Computer Society, Long Beach, California, October 1976. 

* Borer, J.S., Bacharach, S.L., Green, M.V., Kent, K.M., Epstein, 
S.E.: Rapid evaluation of left ventricular function during exercise 
in patients with coronary artery disease. Abstract. C;Lrc . 54 (II-6) : 
4, October 1976. 

Borer, J.S., Bacharach, S.L., Green, M.V., Kent, K.M., Epstein, S.E., 
Johnston, G.S.: Real-time radionuclide cineangiography in the 
noninvasive evaluation of global and regional left ventricular 
function at rest and during exercise in patients with coronary artery 
disease. N. Engl. J. Med. 2 96: 839-844, April 14, 1977. 



* Borer, J.S., Bacharach, S.L., Green, M.V., Kent, K.M., Epstein, 
S.E.: Effect of nitroglycerin on global and regional left ventricular 
function during exercise. Abstract. Clin. Res. : 1977. (In press). 

* Borer, J.S., Bacharach, S.L., Green, M.V., Kent, K.M.: Exercise 
response of the normal and abnormal left ventricle in man. Abstract. 
Amer. J. Cardiol. : 1977. (In press). 



NM-22 



Z01 CL 00007-02 NM 



* Green, M.V.: Studies of the heart with ECG-gated scintigraphy. 
Invited paper. Abstract. Transactions of the Amer. Nucl. Soc, 
American Nuclear Society, New York, June 1977. (In press). 

* Kent, K.M., Borer, J.S., Green, M.V., Bacharach, S.L., Mcintosh, 
C.L., Conkle, D.M., Epstein, S.E.: Effects of coronary artery bypass 
operation on global and regional left ventricular function during 
exercise. Abstract. Clin. Res. : 1977. (In press). 

* Mack, B.A., Farkas, S., Quigley, C., Bacharach, S.L., Green, M.V., 
Johnston, G.S.: Technical requirements in ECG-gated heart studies 
performed at rest and during exercise. Abstract. J. Nucl. Med. Tech: 
June 1977. (In press). 

* Indicates material presented orally at corresponding meeting. 



NM-23 



SMITHSONIAN SCIENCE INFORMATION EXCHANGE 
PROJECT NUMBER (Do NOT use this space) 



U.S. DEPARTMENT OF 
HEALTH, EDUCATION, AND WELFARE 
PUBLIC HEALTH SERVICE 
NOTICE OF 
INTRAMURAL RESEARCH PROJECT 



PROJECT NUMBER 



701 CL ooor>Q-m 



PERIOD COVERED 



July 1. 1976 through September 30. 1977 



TITLE OF PROJECT (80 characters or less) 

The Metabolism of Zn and Zn in Patients with and without Taste 

Abnormalities • 



NAMES, LABORATORY AND INSTITUTE AFFILIATIONS, AND TITLES OF PRINCIPAL INVESTIGATORS AND ALL OTHER 
PROFESSIONAL PERSONNEL ENGAGED ON THE PROJECT 



Principal Investigator: 
Other Investigators: 



Gerald S. Johnston M.D. 
Roger L. Aamodt Ph.D. 
Fredrick Bartter M.D. 
Robert I. Henkin M.D. 



CC:NM 
CC:NM:WBC 
NHLBI:IR 

Georgetown Univers] 
Medical Center 



COOPERATING UNITS (if any) 

Georgetown University Medical Center, Washington, D.C. 
NHLBI 



LAB/BRANCH 

Department of Nuclear Medicine 


SECTION 

Whole Body Counter Section 


INSTITUTE AND LOCATION 

Clinical Center, NIH. Bethesda. Maryland 20014 


TOTAL MANYEARS: 
1 


PROFESSIONAL: 

.25 


OTHER: 


.75 



CHECK APPROPRIATE BOX(ES) 
[2(a) HUMAN SUBJECTS 

D (al) MINORS □ (a2) INTERVIEWS 



□ (b) HUMAN TISSUES 



□ (c) NEITHER 



SUMMARY OF WORK (200 words or less - underline keywords) 

Patients with ideopathic hypogeusia show a loss of taste acuity following 
infection or surgery. Both of these processes are associated with increased 
excretion of zinc in the urine and decreased serum zinc concentration. This 
study is designed to investigate zinc metabolism in these patients and to 
compare them to patients with hypogeusia following head trauma, patients 
without hypogeusia, but with other unrelated diseases and .patients .with 
terminal diseases. Measurements after administration of Zn of m Zn will 
include whole body counting , partial body gamma-ray measurements, and 
measurements of gamma-ray activity in blood, urine and stool. 



NM-24 



PHS-6040 
(Rev. 10-76) 



Z01 CL 00009-03 NM 



Project Description 
Objectives ; 

A. To study the metabolism of zinc in patients with taste and smell 
dysfunction in order to identify those who exhibit abnormal absorption, 
distribution, retention or kinetics. 

B. To determine the effects of zinc ion therapy on the metabolic 
parameters discussed above. 

Methods Employed ; 

Following oral administration of 10 uCi of Zn-65, the NIH Whole Body 
Counter and probe systems will be used to measure Zn-65 in the total 
body and selected tissues for a period of 300 days. Patients will be 
given a placebo during this period. For a subsequent 300 day period 
patients will receive 100 mg/day of Zn++ orally and measurements will 
be continued for another 300 days. Blood and excreta samples will 
also be collected and Zn-65 activity determined by gamma-ray 
spectroscopy. During both phases of the study, measurements of taste 
and smell acuity (threshold and forced scaling for each sensory 
modality) will be made. 

Findings ; 

A. The absorption patterns of 63 unselected, untreated patients have 
been characterized and found to have a much wider than expected range 
(20-90%) . Little data had been previously available for zinc 
absorption by humans. 

B. Retention of Zn-65 was generally found to agree with previously 
reported values following intravenous administration with the 
exception of one patient with congenital hypogeusia who exhibited a 
markedly shortened half-time (143 days).. 

C. Administration of ZnS04 (100 mg/day) to patients who had 
previously been given Zn-65 resulted, in most cases, in a marked 
change in their retention of the radionuclide. This finding "is 
important both in terms of the physiology of zinc in man, but also 
for its implications to the treatment of humans with high body burdens 
of zinc radionuclides. 



NM-25 



1 



Z01 CL 00009-03 NM 



Significance of the Research Program ; 

Studies of zinc metabolism in patients with taste and smell 
dysfunction are a small part of an interdisciplinary program which 
attempt clinical, metabolic, and pathophysical abnormalities in these 
patients. Beyond this, zinc is an essential trace metal, the 
importance of which is just being recognized. These studies will 
contribute to knowledge about zinc metabolism and may provide insights 
into ways of increasing absorption in people with absorption 
difficulties and removing radioactive Zn-65 following accidental 
uptake in order to reduce the radiation dose. 

Proposed Course : 

Patient studies with Zn-65 have now been completed. The continuation 
of these studies will involve data analysis and preparation of data 
for publication. Dr. Mones Berman (C, LTB) is assisting with analysis 
of data from Zn-69m studies, and is expected to also contribute to 
data analysis of Zn-65 studies. 

Honors and Awards : 

None. 

Publications : 

None. 



NM-26 



SMITHSONIAN SCIENCE INFORMATION EXCHANGE 
PROJECT NUMBER (Do NOT use this space) 



U.S. DEPARTMENT OF 
HEALTH, EDUCATION, AND WELFARE 
PUBLIC HEALTH SERVICE 
NOTICE OF 
INTRAMURAL RESEARCH PROJECT 



PROJECT NUMBER 



ZOl CL 00011-03 NM 



PER I 00 COVERED 

July 1, 1976 through September 30, 1977 



TITLE OF PROJECT (80 characters or less) 

A 7 A/ 

Studies of Copper Metabolism in Man using Cu and Cu. 



NAMES, LABORATORY AND INSTITUTE AFFILIATIONS, AND TITLES OF PRINCIPAL INVESTIGATORS AND ALL OTHER 

PROFESSJONAL PERSONN EL ENGAGED ON THE PROJECT-, . .. T „ _, „ T ., mT , _., 

Principal Investigator: E. Anthony Jones M.D. NIAMDDrDI 

P. D. Berk,. M.D. NIAMDDrDI 

John Vierling M.D. NIAMDDrDI 

Roger L. Aamodt Ph.D. CCrNM 



Other Investigators r 



COOPERATING UNITS (if any) 
NIAMDD 



lab/branch 

Department of Nuclear Medicine 



SECTION 

Whole Body Counter Section 



INSTITUTE AND LOCATION 

Clinical Center, NIH, Bethesda, Maryland 20014 



TOTAL MANYEARS: 
1 



PROFESSIONAL: 
0.2 



OTHER: 



0.8 



CHECK APPROPRIATE BOX(ES) 
Q[(a) HUMAN SUBJECTS 

Q(al) MINORS □ (a2) INTERVIEWS 



Q (b) HUMAN TISSUES 



□ (c) NEITHER 



SUMMARY OF WORK (200 words or less - underline keywords) 

Copper, although present in the body in small amounts, is essential for life. 
In certain diseases, copper metabolism is abnormal, however, the mechanisms of 
copper homeostasis are poorly understood. An important potential cause of 
abnormal copper metabolism is defective absorption. It is possible that 
increased copper absorption may contribute to the increased hepatic copper 
which occurs in Wilson's disease and chronic cholestasis. Alternatively, 
copper absorption may be impaired in diseases of the small intestine, such as 
adult celiac disease. Studies of copper absorption and metabolism are being.-., 
conducted using the NIH whole body counter systems using, simultaneous, oral 

administration of Cu and intravenous administration of Cu. In-vivo gamma- 
ray measurements of the liver and thigh areas, total body retention , and 
activity in blood and excreta will provide information about absorption and 
retention of copper in normal, subjects and in patients with disorders of 
copper metabolism. It is hoped that such studies will provide insights into_ 
the normal metabolism of copper on the mechanisms of abnormal copper metabolism 

which result in disease. 



PHS-6040 
(Rev. IO-76) 



NM-27 



Z01 CL 00011-03 NM 



Projects Description 
Objectives : 

A. To evaluate quantitatively the metabolism of copper in health and 
specific diseases associated with abnormalities of copper metabolism. 

B. The ultimate goals include a comprehensive understanding of normal 
copper metabolism, and an evaluation of the significance of specific 
abnormalities of copper metabolism in patients with hepatolenticular 
degeneration and their relatives and patients with primary biliary 
cirrhosis and other disease states. 

Methods Employed : 

A. Studies using Cu-67 alone. After the intravenous injection of 
Cu-67 serial measurements are made of whole body radioactivity (using 
a scintillation probe), and radioactivity in whole blood, red cells, 
plasma, ceruloplasmin, urine and feces. With the exception of hepatic 
radioactivity, these measurements are made for a period of 13 days. 
Plasma ceruloplasmin-bound Cu-67 determination involves the removal of 
non-ceruloplasmin-bound Cu-67 from plasma samples by passage of these 
samples down small columns of activated charcoal. Plasma 
non-ceruloplasmin-bound Cu-67 are determined by subtracting 
radioactivity in ceruloplasmin from that in whole plasma. The curves 
of total body, hepatic, whole blood, red cell, plasma ceruloplasmin 
radioactivity are defined and the total excretion of radioactivity in 
urine and feces .calculated. 

B. Studies using Cu-67 and Cu-64. Studies are also being conducted 
in which Cu-67 is being administered by intravenous injection and 
Cu-64 is being administered simultaneously by mouth. The subsequent 
protocol is the same as for studies using Cu-67 alone except that both 
Cu-67 and Cu-64 radioactivity are measured in all experimental 
specimens. In measuring Cu-67 and Cu-64 simultaneously an appropriate 
correction is made for the radioactivity due to Cu-64 which cannot be 
excluded when measuring Cu-67. The plasma disappearance curve of 
non-ceruloplasmin-bound Cu-67 is used to correct the plasma 
non-ceruloplasmin-bound Cu-64 curve for losses employing deconvolution 
and integration procedures on a digital computer. This enables the 
total Cu-64 which passes from the gut lumen to the plasma to be 
calculated. This quantity less the amount of the administered Cu-64 
which does not appear in feces gives an estimate of the biliary 
secretion of Cu-64 and hence of the enterohepatic circulation of this 
metal. 



NM- 28 



Z01 CL 00011-03 NM 



Findings ; 

A. The ranges of whole body Cu-67 retention for normals and 
homozygotes and heterozygotes for hepatolenticular degeneration have 
been defined. 

B. There was appreciable incorporation of Cu-67 into ce'ruloplasmin in 
normals and a similar degree of incorporation in heterozygotes for 
hepatolenticular degeneration. In contrast, incorporation of Cu-67 
into ceruloplasmin in homozygotes for hepatolenticular degneration was 
minimal . 

C. After administering Cu-67 intravenously and Cu-64 orally to normal 
volunteers, plasma curves of non-ceruloplasmin-bound Cu-67 and Cu-64 
have been defined and the feasibility of studying the enterohepatic 
circulation of copper using these two isotopes has been established. 

Significance of the Research Program : 

In certain disease states marked variation in the content of copper in 
plasma and various organs is known to occur. However, the mechanisms 
by which copper homeostasis is maintained in health and disturbed in 
disease are poorly understood. Increasing attention has been focused 
on copper metabolism in hepatolenticular degradation since the 
refutation of the concept that low ceruloplasmin concentration is 
primary biliary cirrhosis and raises the possibility that abnormal 
copper metabolism may contribute to the pathogenesis of this disease, 
the etiology of which is at present unknown. 

A potentially important cause of deranged copper metabolism is a 
defect in the intestinal absorption of the metal. For example, it 
is possible that increased copper absorption may contribute to the 
increased hepatic copper which occurs in hepatolenticular degeneration 
and chronic cholestasis. Alternatively, copper absorption may be 
impaired in diseases of the small intestine mucosa. Lack of reliable 
methods, variability in hepatic copper uptake, and the presence of an 
enterohepatic circulation for copper have hitherto prevented 
acquisition of reliable data on absorption. Using the double 
radionuclide technique outlined, it is possible to quantitate the 
intestinal absorption and biliary secretion of copper in human 
subjects and hence to determine whether there is a derangement of 
intestinal absorption or biliary secretion of copper in specific 
diseases states. 

Proposed Course : 

Patient studies with Cu-64 and Cu-67 ar now essentially complete. 
Continuation of these studies will involve preparation and analysis of 
data and kinetics analysis. 

NM-29 



Z01 CL 00011-03 NM 



Honors and Awards ; 
None. 

Publications ; 
None. 



NM-30 



IPROJECT NUMBER [Oo'kOT' us"e"thfs space")" 



HEALTH, EDUCATION, AMD WELFARE 
PUBLIC HEALTH SERVICE 
NOTICE OF 
INTRAMURAL RESEARCH PROJECT 



PERIOD COVERED - 

July 1, 1976 to June 30, 1977 

TITLE OF PROJECT (80 characters or less) 



> HWI.VI I'-JHIULII 



Z01 CL 00019-02 NM 



Ventilation-Perfusion Relationships in Idiopathic Pulmonary Fibrosis 



NAMES, LABORATORY AND INSTITUTE AFFILIATIONS, AND TITLES OF PRINCIPAL INVESTIGATORS ANO ALL OTHER 
PROFESSIONAL PERSONNEL ENGAGED ON THE PROJECT 



PI: B. R. Line 

OTHER: A. E. Jones 

J. J. Bailey 

R. C Crystal 

J. D. Fulmer 



Research Analyst LAS DCRT 

Assistant Chief, Dept. Nuc. Med. NM CC 

Head, Medical Application Section LAS DCRT 

Head, Pulmonary Branch, NHLBI PB NHLBI 

Chief, Clinical Service, Pulmonary PB NHLBI 
Branch, NHLBI 



COOPERATING UNITS (if any) 
PB NHLBI J 

LAS DCRT 



LAB/8RANCH 

Department of Nuclear Medicine 



SECTION 

Diagnostic Imaging Section 



WTifaFma.. 



Maryland 20014 



TOTAL MANYEARS: 



PROFESSIONAL: 



0T ¥?5 



D (*>) HUMAN TISSUES 



D (=) NEITHER 



CHECK APPROPRIATE BOX(ES) 
^L(a) HUMAN SUBJECTS 

D (al) MINORS D (a2) INTERVIEWS 

SUMMARY OF WORK (200 words or less - underline keywords) " 

Computer based scintigraphic data has been collected and characterized in 

more than 450 patients with a wide spectrum of functional pulmonary 

disorders . Algorithms to investigate this data base are under active evaluation 

Progress has been made toward the goal of rapid and reliable estimation 

of pulmonary ventilation-perfusion -characteristics . Effort is being directed 

toward modeling the interaction of several tracer characterized compartments 

(ventilation, perfusion, inflammation, tissue density). 



NM-31 



PHS-6040 
(Rev. 10-76) 



Z01 CL 00019-02 NM 
Project Description 



Objectives: 



A. To develop and implement computer based scintigraphic data 
manipulation techniques to investigate time dependent regional 
respiratory parameters (regional alveolar gas exchange, 
ventilation-perfusion maps, washin and washout gas flow 
characteristics) . 

B. To apply regional descriptors to the analysis of patient clinical 
status. Modeling techniques are to be employed to describe the 
functional state of the patient and detect changes in the components 
of respiratory function (ventilation, perfusion, V/0, disease 
activity, degree of fibrosis). 

C. To evalute and develop methods of determining regional ventilation 
to perfusion ratio values. To derive from these regional estimtes of 
PC02, P02, CaC02, Ca02 to evaluate regional gas exchange 
characteristics . 

Methods Employed ; 

Scintigraphic studies are performed using the 99m-Tc MAA radionuclide 
to determine perfusion distribution. Xe-127 gas is administered for 
the characterization of ventilation. Ga-67 citrate and Co-57 (flood 
source) are used for disease activity and lung tissue density 
measurements. All data is collected on a minicomputer and volume 
information is fed into the data stream to determine respiratory cycle 
phase characteristics. 

Findings : 

Gallium 67 citrate correlates with the degree of pulmonary fibrosis 
and the number of PMN cells determined by analysis of bronchoalveolar 
lavage. Appears promising as a noninvasive technique to determine 
cellular infiltration and disease activity (inflammation) . 

Significance of the Research Program : 

There are no other methods for assessing regional pulmonary function. 
Quantitation of gas exchange and evaluation of the competence of 
alveolar gas and blood distribution in various pathophysiologic states 
is now possible regionally. This scintigraphic technique is 
essentially non-invasive, repeatable and can be performed in all but 
the most critically ill patients. The technique can be extended to 
study the effects of exercise and therapy on pulmonary gas exchange. 



NM-32 



Z01 CL 00019-02 NM 



Proposed Course : 

Further efforts in data reduction, model definition and analysis. 
Work to date has been primarily in methods development . Future work 
will be centered on the analysis of the interrelationships of the data 
compartments sampled. 

Honors and Awards : 

None. 

Publications : 

Crystal, R.G., Fulmer, J.D., Roberts, W.C., Moss, M.L., Line, B.R., 
Reynolds, H.Y.: Idiopathic pulmonary fibrosis: clinical, histologic, 
radiographic, physiologic, scintigraphic, cytologic, and biochemical 
aspects. Ann. Int. Med. 85: 769-788, 1976. 

Dunham, R.G., Line, B.R., Johnston, G.S.: A comprehensive software 
system for producing functional maps. Proceedings of the Seventh 
Symposium on the Sharing of Computer Programs and Technology in 
Nuclear Medicine, Atlanta, Georgia, January 1977. 

Kushner, T.R., Line, B.R., Bacharach, S.L., Johnston, G.S.: A 
spirometric method for gating Xenon ventilation studies. Proceedings 
of the Seventh Symposium of Sharing of Computer Programs and 
Technology in Nuclear Medicine, Atlanta, Georgia, January 1977. 

Line, B.R., Dayhoff, R.E., Bailey, J.J.: An algorithm for the 
production of regional gas partial pressures and blood contents from 
scintigraphic and physiologic data using an alveolar gas exchange 
model. Proceedings of the Seventh Symposium on the Sharing of 
Computer Programs and Technology in Nuclear Medicine, Atlanta, 
Georgia, January 1977. 

Line, B.R., Fulmer, J.D., McLees, B.D., Jones, A.E., Crystal, R.G.: 
The application of scintigraphic image data to a model of alveolar 
function for the quantitation of regional 02-CO2 gas exchange in human 
disease. Abstract. Am. Rev. Resp. Pis. . 115: 348, April 1977. 

Line, B.R.: A command processing system for the analysis of 
scintigraphic data. Proceedings of the Fifth International Conference 
on Information Processing in Medical Imaging, June 1977. 

Line, B.R., Fulmer, J.D., Jones, A.E., Reynolds, H.Y., Roberts, W.C., 
Crystal, R.G.: 67-Gallium scanning in idiopathic pulmonary fibrosis: 
correlation with histopathology and bronchoalveolar lavage. Abstract. 
Am. Rev. Resp. Pis. 113: 244, April 1976. 



NM-33 



Z01 CL 00019-02 NM 



Line, B.R., Fulmer J.D., McLees, B.D., Crystal, R.G., Jones, A.E., 
Bailey, J.J. : Regional 02-CO2 partial pressures and pulmonary venous 
contents from ventilation-perfusion scans. Abstract. J. Nuc. Med, 
18: June 1977. 



NM-34 



' 



July 1, 1976 through September 30, 1977 

PUBLIC HEALTH SERVICE, NATIONAL INSTITUTES OF HEALTH 

SUMMARY ANNUAL REPORT OF PROGRAM ACTIVITIES 
CLINICAL CENTER 

NURSING DEPARTMENT 

CONTENTS 

Department Missions and Goals . . . 1 

Major Department Activities 1 

Major Progress in Service, Training and Development and Research 3 

Future Obj ectives Directed Toward Meeting Goals 7 

Publications 8 

Tables ■ 

1 . Recruitment Facts 9 

2. Staffing Data - Nursing Department 10 

3 . Nursing Department Staif in School 11 



Nr-i 



PUBLIC HEALTH SERVICE, NATIONAL INSTITUTES OF HEALTH 

SUMMARY ANNUAL REPORT OF PROGRAM ACTIVITIES 
CLINICAL CENTER 

NURSING DEPARTMENT 

I. Department Missions and Goals 

The Nursing Department at the Clinical Center- exists to provide nursing 
services to patients and support to their families in a biomedical 
research environment. In addition to clearly identifiable and time- 
honored nursing practices, the Nursing Department assumes the respons- 
ibility for many expanding nursing activities recognized as physician 
services through the Joint Physician-Nurse Committee of the NIH Medical 
Board, i.e., the, professional nurse's interdependent role is one of 
coordination and collaboration in patient care. 

In order to achieve the departmental missions, the following goals have 
been identified and are being pursued: 

1. To maintain an environment that supports high morale and a committed, 
caring performance by all members of the Nursing Department. 

2. To improve nursing services to patients and to eliminate those non- 
nursing activities that are inconsistent with the highest quality 
of nursing care. 

3. To provide, develop, and support the necessary nursing leadership 
to facilitate care. 

4. To evaluate and enhance the effectiveness of the nursing program 
and individual nursing practice. 

5. To identify and investigate areas of nursing research to improve 
nursing practice. 

6. To foster a climate where creative approaches and the spirit of 
inquiry prevail. 

7. To offer opportunities for students and other guests to share ideas 
and grow in the unique environment of the Clinical Center. 

8. To influence health care and nursing practices beyond the confines 
of the Clinical Center through active participation in professional 
and community affairs. 

II. Major Department Activities 

A. To achieve its goals and missions, the Nursing Department has : 



Nr- 1 



1. Implemented the unit manager concept in the Outpatient Department. 

2. Recommended the establishment of a Phlebotomy and Urine Collec- 
tion Team under the direction of the Clinical Pathology Department. 

3. Supported the unit dose system. 

4. Been actively involved in the computerized Medical Information 
System (MIS) . 

5. Made full use of an Administrative Assistant in the Office of 
the Chief Nurse. 

6. Provided the first collaborative program between the Child Health 
and Human Development Nursing Service and the Neo-natal Nursing 
Service of the Navy Medical Center. 

7. Developed a Patient Classification System to plan nursing care 
and use available staff more effectively. 

8. Reorganized the Nursing Department's committee structure into 
four broad standing committees: Administrative Policy Committee, 
Nursing Practice Committee, Education Committee, and Nursing 
Research Review and Development Committee. 

9. Established the Administrative Council as a cohesive corporate 
body, with comparable leadership groups in each of the nursing 
services. 

10. Recognized that a larger nursing "float" pool of generalists 
would not facilitate improved nursing care to patients in the 
environment of the Clinical Center. 

11. Selected nine clinical nurse experts and one clinical nurse 
educator to identify staff learning needs and advise and/or 
offer educational programs. 

12. Continued to experiment with various models of leadership for 
nursing services. 

To improve nursing services and professional leadership Nursing 
Department staff members participated in: 

1. The Ad Hoc Committee on Rating Criteria to develop a conceptual 
model for recognition of the full professional nursing role. 

2. The Nurse Career Development Committee, PHS . 

3. The Quality Care Assurance Committee and the Joint Physician- 
Nurse Committee of the NIH Medical Board. 



Nr-2 



4. The Clinical Center Committee for the Ambulatory Care Research 
Facility and the Critical Care Medicine Unit. 

5. The Easton Update, 1977. 

6. The Civil Service Commission's Factor Evaluation System received 
substantial professional review and recommendations from the 
Administrative Council of the Nursing Department. 

C. As a part of its continuing commitment to influence health care and 
nursing practices beyond the Clinical Cen,ter, dynamic involvement of 
Nursing Department staff members was achieved through a broad range 
of professional contacts. 

1. Annually, a nursing service chief is appointed to the nursing 
program planning committee of the Annual Meeting of the Associa- 
tion of Military Surgeons of the United States (AMSUS) . This 
year, two representatives were appointed because for the first 
time in AMSUS history, a nurse, Dr. Faye Abdellah, Chief Nurse 
Officer, Public Health Service, will serve as General Program 
Chairman. 

2. The Chief of the Nursing Department has been appointed to the 
following national committees: 

a. American Hospital Association Committee on Physicians. 

b. National Health Council Board of Directors. 

c. American Nurses' Association Study Committee on Credential- 
ing in Nursing. 

3. The Chief of the Nursing Department serves as Consultant to the 
Surgeon General, U.S. Army for Nursing Service Administration. 

4. Staff members serve as program consultants to the V.A. Nursing 
Service, V.A. Hospital, Washington, and participated in the First 
Research Conference on Nursing Information Systems sponsored by 
the College of Nursing, University of Illinois. 

5. Staff members delivered papers at the 83rd Annual Meeting of the 
Association of Military Surgeons of the United States (AMSUS), 
and the Second National Cancer Conference of the American Cancer 
Society. 

6. Many nurses are active on committees of their nursing associa- 
tions and other professional organizations. 

III. Major Progress in Service, Training and Development and Resea rch 

A. Nursing Service 



Nr-3 



1. Major Progress has been achieved in several ways to improve 
nursing care in the Clinical Center. 

2. Primary nursing continues to be implemented and refined as the 
modality for delivering nursing care at the Clinical Center. 

3. Three clinical conferences were presented. Monographs are : - ilr.g 
•developed for each of them: 

a. Cancer Nursing Service - "Laminar Air Flow - Nursing Care ■ 
the Pediatric Oncology Patient." This was later repeated foi 
the nursing community with guests attending beyond our three 
state area. 

b. Mental Health Nursing Service - "The Consultative Process in 
Mental Health Nursing." 

c. Child Health and Human Development Nursing Service - 
"Cystinosis: Family Centered Nursing Care." 

4. The Nursing Department co-sponsored with the Association of Pedi- 
atric Oncology Nurses a program for professional nurses, "Accept- 
ing the Challenge of Pediatric Oncology," November 1976. 

5. The centralized Nursing Audit Committee has stimulated the devel- 
opment of 31 outcome criteria sets in patient care areas. Retro- 
spective audit data retrieval was completed on the 11 most 
frequently admitted patient populations. Data retrieval on t'r 
remaining 20 criteria sets continues. The Audit Committee, to 
share the insights gained from the audit, sponsored a seminar 
open to our staff and community on, "Nursing Audit: Yesterday, 
Today and Tomorrow." It was attended by 245 staff and visitors 
in May 1977. 

6. The Outpatient Nursing Service developed a 28 page "Nurse Guide 
to Cancer Chemotherapy" for use in patient teaching. 

7. The Allergy and Infectious Diseases Nursing Service's Committee 
on Discharge Planning which includes a pharmacist, prepared a 
patient teaching booklet for use on discharge, entitled 
"Personal Health Record." 

B. Training and Development 

1. A department-wide self -paced nephrology nursing course was 
developed and implemented. Thirty-five professional nurses 
completed level 1 which was planned to enhance general competencies 
in providing nursing care to patients with renal problems; addi- 
tional staff will be offered this opportunity. Participants and 
extramural consultants have been laudatory. Articles are in 
preparation for publication. 



Nr-4 



2. Formal agreements for educational opportunities were effected 
with the Schools of Nursing at the University of Maryland and 
the Catholic University of America for master and doctoral level 
nursing programs. A contract was signed with Marymount College 
to provide clinical practice experience for students in the 
baccalaureate program. 

3. Forty-two clinical elective students, 18 Co-Step students, and 
38 Cancer work-study students, all senior students in baccalaur- 
eate programs, were offered clinical practice opportunities. 

4. Twenty-six Stride (Marymount College) nursing students are 
counted against the Nursing Department ceiling while enrolled 
in their program of study and are unavailable for nursing 
service. Ten are first year students, twelve are second year 
students, while five are in the upper level baccalaureate pro- 
gram. Seventeen of these students are from the Clinical Center; 
nine are from other institutes. Since its inception, 35 NIH 
employees have been graduated from the two year associate degree 
program; 31 remain in the Nursing Department. 

5. The "brown bag" luncheon feature of the monthly inservice calen- 
dar has been extended to "breakfast" and "supper club" conferences 
to assure broader participation of personnel on all tours of duty. 
In addition, summer re-runs of significant conferences of the 
past year have been offered. 

6. Manv initiatives are extant in the Nursing Department to improve 
orientation and staff development programs. Among them are: 

a. The complete revision of the general orientation program for 
professional nurses. The Nursing Department can now bring 
in new employees twice a month rather than once a month as 
previously and, in addition to its other subjects, now 
includes "Legal Aspects of Nursing." 

b. Two nine hour courses were developed and presented by Nursing 
Department staff members: "The Primary Nurse Role and the 
Nursing Process" and "Nursing Management for Patient Care." 
The latter course was primarily for RN's on the Cancer Nursing 
Service. In addition, a two part course was developed by a 
clinical nurse expert on "The Nursing Care of the Patient on 

a Respirator." This course was developed for the nursing 
staff of the Allergy and Infectious Diseases Nursing Service. 

7. A Foreign Nurse Exchange Program sponsored jointly by the Clinical 
Center, Nursing Department and the National Cancer Institute was 
initiated. Mr. Peter Barkes from the Royal Marsden Hospital, 
London, became the first exchange nurse to gain new knowledge 

and skills in cancer nursing practices in a research setting. 



Nr-5 






8. A Nursing Department has been created within The Foundation for 
Advanced Education in the Sciences, Inc. (FAES) , the Graduate 
School at NIH. Eleven courses will be offered. 

9. The Chief, Nursing Department, offered three leadership seminars 
of four two -hour sessions for the Administrative Council and the 
Evening and Night Supervisors to enhance' leadership skills and 
problem solving in nursing service administration. 

C. Research 

1. The third research symposium was held in March 1977, "Nursing 
Research: Issues and Answers" with six nurse scientists partici- 
pating in the formal program and remaining to assist staff 
members in research pursuits. 

2. Two staff members completed research projects this year and one 
nursing service completed an evaluative study: 

a. Miss Dorothy Belling, Clinical Nurse Expert, Heart and Lung 
Nursing Service, "Arterial Blood Gas Alterations Using 
Various Suctioning Techniques." 

b. Mrs. Ruth Carlsen, Clinical Nurse Educator, Mental Health 
Nursing Service, "Nursing Needs Fulfillment." 

c. Allergy and Infectious Diseases Nursing Service, "Evaluation 
of the Tempa-dot Thermometer." 

3. Research projects in progress: 

a. Miss Susan Simmons, Clinical Nurse Expert, Mental Health 
Nursing Service and candidate for the master's degree at 
Catholic University, "The Relationship of Rotating Tours to 
Nurses' Cognitive Capacity." 

b. Mrs. Freddie Grice and Oatpatient Nursing Service, "Does 
Body Position During the Administration of Chemotherapy Make 
a Difference in the Amount of Duration of Nausea and Vomitii 

c. Cancer Nursing Service, "An Investigation of Prophylactic 
Oral Hygiene to Reduce Bacterial and Fungal Mouth Flora in f 
an Effort to Diminish Oral Mucositis Subsequent to Chemo- 
therapy. " 

D. Significant Awards and Honors 

1. Mrs. Josef ina Sistoza, Evening-Night Supervisor, was one of 17 
PHS Nurses who served in Lebanon in December 1976. She was the 
recipient of a Special Achievement Award for outstanding services 
rendered. 



I 



Nr-6 



2. Mrs. Mary Louise Taylor, Clinical Nurse Educator, Heart and 
Lung Nursing Service, was the recipient of the recently 
established NIH Merit Award, the second highest honor award 
presented by NIH for Civil Service employees. She was cited 
"for developing and implementing the Nursing Department's 
instructional program for nephrology nursing." 

3. Miss Beth Price, Clinical Nurse Expert, Neurology Nursing 
Service, received generalist certification in medical-surgical 
nursing practice from the American Nurses' Association. 

A. Mr. Thomas Ralston, Heart and Lung Machine Technician, Surgical 
Nursing Service, has been certified by the American Board of 
Cardiovascular Perfusion. 

5. Mrs. Barbara Inman, who recently received an associate degree 
in applied sciences through the Stride Nursing Program at 
Marymount College, was named to "Who's Who Among Students in 
American Junior Colleges." 

6. Miss Ferguson will receive the honorary degree of Doctor of 
Science in August 1977 at the Marymount College Commencement 
exercises of the first B.S.N, students. This is in recognition 
of her belief in and support of the program as well as serving 
as a role model. 

IV. Future Objectives Directed Toward Meeting Goals 

The Nursing Department will continue to strive for excellence in 
nursing care and support to biomedical research as we assume the full 
professional role through practice, education and research. We 
recognize that a dynamic leadership and peer consultation facilitate 
goal achievement . 

No major new programs are envisioned for the coming year, rather a 
strengthening of those in place with continual evaluation and refine- 
ment, an integral part of each endeavor. Special attention will 
continue to be focused on organization for care, the continued learning 
of staff and the improvement of communications. 



Nr- 7 



Publications 

Braz, J., Loving, M. , Aitken, J. and Synder, A.: Wegener's Granulomatosis: 
A Nursing Clinical Conference. U.S. DHEW, PHS, NIH, CC. DHEW Publ. No. 
(NIH) 77-1106. Wash., D.C. , U.S. Govt. Print. Off., 1977, 25 pp. 

Thrasher, R.D.,' Mahon, M. , Croyle, G. and Keating, A.: Insights into 
Opthalmic Nusing Through Caring for a' Patient Undergoing a Vitrectomy: A 
Nursing Clinical Conference . U.S. DHEW, PHS, NIH, CC. DHEW Publ. No. (NIH)' 
77-1105. Wash., D.C, U.S. Govt. Print. Off., 197.7, 15 pp. 

Chabner, B. A. ,. Johnson, R.E., Young, R.C., Canellos, G.P. , Hubbard, S.P., 
Johnson, S.K., DeVita, V.T.: Sequential nonsurgical and surgical stagi 
non-Hodgkins lymphoma, Annals of Internal Medicine , 85:149-154, 1976. 

Grant, J. P., Pittman, M.A. , Maher, M.N. , and Jones, R.S.: Parenteral 
nutrition in the management of enterocutaneous fistulas. NCMJ. 38:327-330 
1977. 

Ryan, L.J., Gearhart, M.K. , and Simmons, S.: From personal responsibility 
to professional accountability in psychiatric nursing. JPN and Mertal H^alt l 
Services. 15:19-24, 1977. "I 

Schein, P.S., DeVita, V.T. , Hubbard, S., Chabner, B.A., Canellos, G.P., 
Berard, C. , Young, R.C.: Bleomycin, adriamycin, cyclophosphamide. 
vincristine and prednisone (BCOP) combination chemotherapy in the treatment 
of advanced diffuse histiocytic lymphoma. Annals of Internal Medicine 
85:417-422, 1976. " 

Smith, E.C., Liviskie, S.L., Nelson, K.A. , and McNemar, A.: Reestablish: \ 
a child's body image. American Journal of Nursing . 77:445-447, 19 77. 



Nr-8 



RECRUITMENT FACTS 
JULY 1, 1976 - JUNE 30.' 1977 



MONTH 



NUMBER OF RN'S ENTERED 



INTERVIEWED 



ON DUTY 



* WJMBER OF SUPPORTIVE ENTERED SEN TOR STUPE V 

NURSING PERSONNEL ON DUTY ENTERED 0:. D„ 

INTERVIEWED" 



JULY '76 


41 


AUGUST 


28 


SEPTEMBER 


36 


OCTOBER 


36 


NOVEMBER 


47 


DECEMBER 


32 


JANUARY '77 


49 


FEBRUARY 


49 


MARCH 


42 


APRIL 


50 


HAY 


61 


JUNE 


51 



TOTALS 



BIT 



15 
16 

7 
10 

7 

2 
10 
12 

6 

12 

**14 

22 

ITT 



16 
12 
11 
19 
13 
18 
12 
14 
7 
8 
13 
23 

"TOT 



4 
5 
1 
1 
4 
6 
1 
3 
2 
2 
1 
3 



3 Co-Steps 

12 Summer N.A. 's 



8 Clinical Elective: 



8 Clinical Elective: 



8 Clinical Elective: 
5 Co-Steps 



8 Co-Steps 

9 Sunr.er N.A. 's 

7 Clinical Elective: 
18 Cancer Work Stua> 



♦Supportive Nursing Personnel includes licensed practical nurses, nursing assistants, 
heart-lung machinr technicians and cleric -typists 

** Includes ten graduates of the Stride Nursing Program 



Nr-9 



STAFFING DATA - NURSING DEPARTMENT 



Total number of positions 

Total nj-ber of positions filled 

Total number of vacancies 



July 1. 1976 
611* 
597* 
14 



June 30, 1977 
627 
618 
9 



Admiristr;ti ve 

Total" nuT.be r of positions 

Total number of positions filled 

Total number of vacancies 



22 

22 





22 

20 
2 



*26 students in Stride Nursing 
Program at Karymount not included 

Clinical Instructors 



Total number of positions 

Total number of positions filled 

Total number of vacancies 



7 
5 
2 



8 
6 
2 



Nurse Clinicians 

Total nu-be r of positions 

Total number of positions filled 

Total number of vacancies 



25 

23 
2 



32 

28 

4 



Staff Nurse 

Total number of positions 

Total number of positions filled 

Total number of vacancies 



324 

340 
+16 



343 

352 

♦9 



Practic al 
Total 



Nurse 



number of positions 
Total number of positions filled 
Total number of vacancies 



44 

35 

9 



29 
29 





Te chnical Positions 
"Total number of positions 
Total number of positions filled 
Total number of vacancies 

Nursing Assistants 

Total number of positions 

Total number of positions filled 

Total number of vacancie's 



8 
6 
2 



81 
8 



12 
11 

1 



84 

4 



C lerical 

Total number cf positions 

Total number of positions filled 

Total number of vacancies 



51 

46 

5 



51 

48 

3 



Nr-10 



Position 

m 

LPN 
RA 

Dale Clerk 

Secretary 

Heart I Lung Technician 

Total 



Hurslng Department Staff In School 

Full Tlae 
2 • 



Part Tine 


Stride Program 
Full Time 


Mob 


Upward 
ility Program 


68 


5 ** 




1 




5 *** 




1 




17 *** 




7 


13 


3 *** 




4 




1 **• 




— 




— > 




— 




31 




13 



* 2 Wis fully funded by Nursing Department 
** B.S. Extended Program 
*** A. A. Program 



Nr-11 



July 1, 1976, through September 30, 1977 

PUBLIC HEALTH SERVICE, NATIONAL INSTITUTES OF HEALTH 

SUMMARY ANNUAL REPORT OF PROGRAM ACTIVITIES 
CLINICAL CENTER 

NUTRITION DEPARTMENT 

CONTENTS 

Department Missions and Goals Nt-1 

Department Activities Nt-2 

Major Progress in Research, Services, Training, and Development .... Nt-3 

Future Objectives Directed Toward Meeting Goals Nt-5 

Problems Nt-6 



July 1, 1976, through June 30, 1977 



PUBLIC HEALTH SERVICE, NATIONAL INSTITUTES OF HEALTH 

SUMMARY ANNUAL REPORT OF PROGRAM ACTIVITIES 
CLINICAL CENTER 

NUTRITION DEPARTMENT 



I. DEPARTMENT MISSIONS AND GOALS 

The Nutrition Department of the Clinical Center assumes the responsi- 
bility for the total food service of the patients. The goal of the Nutrition 
Department is to achieve patient satisfaction while at the same time providing 
controls and services to meet a wide variety of needs of the research proto- 
cols with a nutrition component. To fully implement patient care, diet 
counseling services are provided for outpatient studies and for patients upon 
discharge from the hospital. 

For a number of years these missions have been accomplished with the 
use of facilities and staff through decentralized tray service. In 1972-73 
an administrative decision was made to change to centralized tray service, 
and up until May 1977, all efforts were focused on planning, remodeling, and 
implementing centralized tray service. To achieve this, the following changes 
were implemented this year: 

1. The menus were revised to add items and reduce write-ins. (This 
required the revision of worksheets for ordering from the main 
kitchen, revision of recipe files, and revision of work routines 
to assume additional work load.) 

2. Patient nourishment procedures were revised to standardize and 
reduce the individual preparation from each floor kitchen. 

3. A number of individually-packaged food items were purchased 

Nt-1 



and introduced. 

4. A new organizational structure for the total Department was 
designed, and work routines for 101 nonprofessional staff were 
written. An additional assistant kitchen manager was recruited 
to implement the new program. 
In December 1976 the remodeling construction in the main kitchen j 
began and during the fiscal year one-third of these remodeling plans were 
completed. This required complete relocation of staff and cooking and baki 
equipment and limited refrigeration and freezer space. 

In May 1977 the decision was made to eliminate our plans for central 
ized tray service and to continue with decentralized tray service. This re 
quired a restructuring of food service worker positions in the Patient Dietc- 
1c Service by utilizing 35 hour positions on the late shift. This was inif- 
ted September 11 , 1977. 

The Department's goals include active participation in the Clinical 
Center Safety Program, the Clinical Center Equal Employment Opportunity Pro- 
gram, and the NIH Labor Management Relations Program. 
II. DEPARTMENT ACTIVITIES 

During the period July 1, 1976, through September 30, 1977, the Nutri- 
tion Department served 436,837 meals. Twenty-seven percent of these meals 
were a part of a research protocol having a nutrition component. These prot, 
cols involve the control of nutrients, calories, fluids, and/or metabolic 
studies. To provide these services, 13 individual service units and a main 
kitchen and storeroom were staffed for 15 months, and the 8th floor metabolic 
kitchen was operated for 13 months. These kitchens were staffed with: 

101 food service workers 
13 cooks and bakers 

Nt-2 



I 






7 metabolic cooks 
42 nonprofessional supervisors (dietetic assistants and kitchen managers) 

9 clerical staff 
22 registered dietitians 

194 Total 

During the 15 months of this fiscal year, 35 food service workers were 
on temporary appointments not to exceed one year. As of September 11, 1977, 
these positions were converted to part-time career conditional appointements 
(35 hour) . 

Two major decisions affecting personnel were made during this year. On 
August 1, 1976, the Civil Service Commission ruled in favor of the dietetic 
assistants' appeal and granted them grade classifications of GS-05 and GS-06. 
In October 1976, in a case brought to arbitration by AFGE, Lodge 2419, the 
decision was made that under the present negotiated agreement, a union officer 
would be permitted time to investigate a grievance before it was documented 
in written form. 

The total expenditures for the Department for the 15 month period were: 

Personnel - $3,457,650 

Food - 767,595 

Equipment and Supplies - 151,770 

III. MAJOR PROGRESS IN RESEARCH, SERVICES, TRAINING, AND DEVELOPMENT 

During this period on a daily basis, 16-25 patients were on Category IV 

diets, 73-91 patients were classified as Category III, and 88-111 patients 

were classified as Category II. 

* Category IV Requires extensive professional time and care in planning 
diets which are an integral part of the research sutdy. 

Category III Requires professional staff to plan the diet order for the 
individual patient and to provide the physician with infor- 
mation to interpret his project. 

Category II Requires professional staff to write the diet, or food 

service supervisor to adapt the food service to the patient. 



Nt-3 



2. 
3. 



In addition, the Nutrition Department provided these additional se 
essential to the control of a number of protocols: 

1. An average of 53 patients were on fluid intakes each day. 

appropnate nutrient being controlled by dietary Intake J 

The Laminar Flow Unit has serviced an average of 3-4 patients duri, 

this period. Because of the extended length of stay, in Ju , y 1976 , the 

cooked food diet was expanded to include additional specialty items. This 

change in procedure brought about an increase in petty cash purchasing, wh 

involved additional services from Financial Management staff and NIH Hesse 

Plans for a dietitian's office to provide diet counseling were mad, 

with the ACRF architects. Plans were also made with the ACRF architects | 

provide office space and teaching lab space for two dietitians and clerical 



staff. 



To assist NICHHD with implementing their premature baby program, we 
Provided their food service from the metabolic kitchen unit and located and 
Purchased a number of special products such as a special demoralized infa 
formula for treatment of ideopathic hypercalcemia. 

The period October ,976 through February ,977 was devoted to evaluat 
usage and adequacy of matrices originally designed with the Technicon repre 

sentative. A number of changes were reaupstpd t+ ,-«. *• • 

y were requested. It is anticipated that the< 

changes „i„ be made by October 1, ,g 77 . Prior t0 Deceraber ^ ^ ^ 
-ns were trained to use the Technicon equipment. Five meetings were held 
wnh the Technicon staff to evaluate and identify requests for change in the 

2TJ1 in Ju,y 1977, a member of the profe "'-°-' *™ j«'«- «- 

weeKiy advisory group. 



Nt-4 



! 



Considerable emphasis has been placed on training for all groups in 
the Department. Two meetings per month were held for the professional staff 
with speakers invited for one of these meetings. In addition, plans were 
made to provide training experiences for appropriate staff members as a means 
of improving our service and to become aware of recent advances in the area of 
nutrition. 

This year we have sponsored staff in the following training programs: 

6 staff in Adult Education 

3 staff in Upward Mobility College 

1 assistant kitchen manager completed a two-year program and 
received an Associate of Arts Degree in Food Management 

1 secretary completed a stenoscript class. 

11 staff participated in the Clinical Center Leadership Training 
Program (including Motivational Dynamics) 

7 Information Sessions were held for the entire Nutrition Department 
staff which included a recent health film and a report from the 
Nutrition Department Representative to the Clinical Center EEO 
Advisory Committee. 

The Department provided consultation to 90 dietitians and college 
students throughout this year. Each has spent an average of three hours in 
the Department. 

The dietitians and kitchen manager staff participated in six national 
meetings during this period. 

A senior member of the staff has served as a member of the Advisory 
Committee to the Clinical Center's Patient Representative. 
IV. FUTURE OBJECTIVES DIRECTED TOWARD MEETING GOALS 

During this next year we expect to accomplish the following: 

1. Finish the remodeling of the main kitchen and reestablish a 

quality controlled decentralized food service for the patients of 

Nt-5 



the Clinical Center. 

2. Implement a program to develop diet instruction materials and 
procedures to be used in the Diet Instruction Service in the new 

ACRF Building. 

j 

3. Reveiw the Nutrition Department matrices and make changes to mee 
the needs of the new Institute that will be planned by Technicon! 
during this next year. 

4. Renegotiate the current agreement with AFGE Lodge 2419. 

5. Reestablish an extensive inservice training program for nonprofe: 
sional staff. 

V. PROBLEMS 

Many problems have been experienced this year with personnel. We J 
to have 1-2 employees on jury duty throughout the year and 1-2 employees on 
leave due to long-term illnesses. The use of temporary appointments of food 
service workers has contributed to a high turnover rate. I 

Remodeling has required a number of adjustments for the Main Kitchen 
staff. With careful planning this has been achieved with minimum inconvenie:e 
to the patients. 

The demand for outpatient diet instruction as a part of the new 'j 
protocols has presented a need for a full-time dietitian to be assigned to 
these programs and office space assigned. 

Many of the companies that service the Nutrition Department have j 
initiated new service procedures as a result of the energy crisis, which has 
presented problems to us. For example, Ross Laboratories will accept an 
order only once a week, which prevents our being able to be responsive to the 
need for a new product not routinely stocked. 



Nt-6 



To assure the accuracy of studies we have to assume the responsibility 
of monitoring labels and products. In August 1976 upon analysis of the Salt 
Free Bread, we found the levels of sodium too high. Upon investigation we 
found a subcontractor was involved and that he had not adhered to the 
established formula. 

The United Parcel Service strike influenced the increase in food costs. 
It forced us to use air freight on a number of occasions resulting in added 
expense and the need to increase our inventory on some food items. 



Nt-7 



July 1, 1976, through June 30, 1977 

PUBLIC HEALTH SERVICE, NATIONAL INSTITUTES OF HEALTH 

SUMMARY ANNUAL REPORT OF PROGRAM ACTIVITIES 
CLINICAL CENTER 

OFFICE OF OCCUPATIONAL MEDICINE 

CONTENTS 

I Department Missions and Goals 00M-1 

II Department Activities 00M-2 

III Major Progress in Research, Services, Training, and Development . .OOM-J 

IV Future Obj ectives Directed Toward Meeting Goals 00M-4 

V Selected Workload Statistics 00M-6 



July 1, 1976, through June 30, 1977 
PUBLIC HEALTH SERVICE, NATIONAL INSTITUTES OF HEALTH 

SUMMARY ANNUAL REPORT OF PROGRAM ACTIVITIES 
CLINICAL CENTER 

OFFICE OF OCCUPATIONAL MEDICINE 

Department Missions and Goals 

The Office of Occupational Medicine, through programs executed by the Occupa- 
tional Medical Service, has several primary goals to provide a medical program 
to assure that employees are able to perform their duties without hazard to 
themselves or others: optimum job assignments in relation to medical fitness; 
emergency and preventive medical services to assist employees to meet their 
work related health needs; medical monitoring for adverse effects related to 
environmental health hazards including biohazards, toxic chemical hazards, and 
radiation hazards; and clinical consultation for occupational disease and ex- 
posure to toxic agents both for employees and Clinical Center patients at the 
request of Institute clinicians. 

The Chief, Office of Occupational Medicine, in his additional role as NIH 
Occupational Health Officer, serves as the Project Officer for the Occupational 
Medical Service contract. He serves as the NIH Director's delegated official 
to monitor relationships between the contractor and NIH management and staff. 
He promulgates guidelines and practices to insure NIH compliance with the 
regulations of the Office of Workers' Compensation Programs, Occupational 
Safety and Health Act, and directives of the Civil Service Commission. Through 
personal observation, regular conferences, review of required reports submitted 
by the contractor, and various program effectiveness surveys, compliance with 
contract specifications is also insured. 

The Occupational Medical Service is also responsible for maintaining essential 
services and facilities to provide emergency treatment for on-the-job illness 
or injury of employees, providing health education and preventive medical pro- 
grams to make employees aware of the importance of maintaining good health, 
advising management and employees in resolving work related health problems, 
assisting management in evaluating handicapped individuals in terms of specific 
job assignments, developing and executing a comprehensive mental health program 
including alcoholism and drug abuse, and planning and carrying out medical 
surveillance and monitoring programs designed to minimize environmental health 
hazards. Close working relationships are maintained with the Division of 
Personnel Management, the Environmental Health and Safety Program, DRS , and NIH 
Institute Clinical Directors. 

On July 1, 1977, the Employee Health Service title was changed to Occupational 
Medical Service. This change more accurately reflects the basic mission of the 
program as a provider of both therapeutic and preventive occupationally related 
medical services. The Occupational Medical Service includes all elements of 
the Federal Employee Occupational Health Program as specified by Executive and 
HEW Directives. 



00M-1 



Department Activities 

In the third year of the Occupational Medical Service contract, the departing 
continued and strengthened those programs initiated during the first two ve 
of operation. Dr. Barbara Wasserman, Assistant Medical D recto slarf 

Srience 111 iTllf ^^ "J J" ^ ^ >"" ° f ^SinS Medici, 
experience. Dr. Wasserman assumed her duties with the OMS staff in May 197 

following a year as Director of Clinical Services at University Health c 
University of Maryland. She has strenghtened the OMS clinical car program 
n 1S gently Pining preventive health programs in the area of hyperte, 
sion, rubella screening, and medi-- 
combinant DNA research activities 



=.-,-„„ u 1 1 . — .-—.— -« fj.u 5 j.auia _lu me area or hvDerte 
sion rubella screening, and medical monitoring of personnel engaged 2 re- 
combinant DNA rpspar^ -„*-,-„-,•*--,■ & F ouimcx engaged m re- 



OccioS? 8 *, M^™" 7 ? 77 ' the Medical D± r«tor, "1th the Chief, Office of 
NlS wTS MedlClne ' ^ meetings with Clinical Center Administration a 
reLcation oTSroM/H ^hitectural Engineering consultants to plan for 

sijg? s-sir to^t^^rirtnsSfr 1 ^: -r™r 
sets: cr^r^^^rsr^ur-^^^^ 

?n„:ti„ a nal SUbmltted J° *? """ ^-^ ^.Uo/ano a lo^o/prope 

functional space within the new area. proper 

Nil ^oaTl^nce^Each rerllcte/th^ FT""? ° f *«• significant 1 

leased 2/7 77 and (3) No 2^339 l^P^ f " ° H " ^J^Abuse, re-~ 
5/25/77. 339-1 Fitness for Duty E xaminations , releasee 

« £'££2 (^f' Neg0ti ff C — ts Action, ODA, an updaJ 

accordance „£**£ InSucSons S^! i^ ^^T^ ^^ ° ff±Cer * 
of the OMS contract Tn Zt tor soliciting proposals for renegotiation 

ation was S gir ^L^TSt^^ ^ST^LVS^^ 

Sal h regret T^^^fT * ^^^^^T^ 

comprehensivefcon iitentir ou tstandT e * ^^ "" Staff the benef±tS ° f 
program. Under the chairmLshinot d ^' ° CCU P ati °n^ and preventive medical 
nical Factors Fv.ll? r P S 0ccu P a tional Health Officer, a Tech- 
fltlA So Evaluation Committee, composed of outstanding specialists in th 

ng r e Hi a^stalT"' ^S^ 7 ^^ ^"^ W^S?, f °A 
trcor' JJn ? 7 I in tne RFP ' and included that the present con- 
NationalHeaSh Service, %h OSt aCCeptable ' The Committee f elt'conf ident tha^ 
re.mrl Services, the present contractor, has the capability and 

SL U nari ns \S c :r o rHStr dinS 0c "» al "**1 ^gram fol ss 



OOM-2 



Major Progress in Research, Services, Training, and Development 

The average monthly frequency of employee visits to the OMS is essentially the 
same when compared to the previous year's report. A significant gain was made 
in the area of alcoholism and drug abuse now titled Public Health Employee 
Assistance Program. Six percent of the workload fell into this category. There 
was a three fold increase in alcohol and drug abuse related treatment visits. 
This reflected a major training effort as well as increased activity on the 
part of the psychiatirc staff and counselor. The other categories remained 
essentially the same with a slight decrease in personal visits and an increase 
in visits related to specific preventive medical programs, (see attached table) 

During this reporting period, all workload data for the OMS was entered into 
the OMS Workload System. This computer system is a basic package utilizing 
an IBM 2741 Remote Terminal, DCRT Honeywell Computer, and the Wilbur System. 
To save running costs, edit programs were run during evening hours for a 20% 
reduction. This system provides the following: workload on a monthly basis 
and annual reporting required by the Civil Service Commission, epidemiological 
data including rates by location, occupational category, and Institute; periodic 
scheduling 1-365 days; and monitoring of Office of Workman's Compensation 
Programs actions. During the year additional programs were written and 
specific queries made to the data bank. OMS was the only user authorized to 
meet Privacy Act requirements that were reviewed by DCRT and the Clinical Center 
Privacy Act Coordinator. 

During this reporting period, the Occupational Medical Service became one of 
the first Clinical Center Departments to use the Medical Information System 
(MIS) . OMS cadre worked with the MIS contractor to develop an operations 
manual and trained physicians, nurses, and health technicians in the use of 
the System. During the entire reporting period, OMS has used the MIS for 
requests to Radiology, Blood Bank, and Central Sterile Supply. The System 
has proved efficient, and its utilization has been professionally stimulating 
to the OMS staff. However, MIS as used by OMS is not designed for records 
retention, so employee entries as patients are deleted after five days from 
the last change of record or report. 

OMS participated in the realignment and redesignation of responsibilities among 
Clinical Cneter committees. Changes came about as a result of concern for the 
safety and health of patients and employees. OMS continued to provide pre- 
ventive medical services for Clinical Center employees. In July 1976, Clinical 
Center Safety Planning Committee, which had previously been concerned mainly 
with disaster planning and fire safety, changed its name to the Multi-discipli- 
nary Safety Committee and assumed an expanded role in safety and health for 
Clinical Center employees. The Medical Director, OMS, participated actively 
in this Committee in evaluating programs for the continued health of all 
Clinical Center employees. In February 1977, the Clinical Center Infections 
Committee was restructured and OMS was asked to participate as an Ad Hoc 
member, working closely with the hospital epidemiologist to provide input and 
participation in Committee deliberations. 

The Medical Director, Psychiatric Consultant, and Mental Health Counselor 
participated in the education of NIH administrative and supervisory staff to 



00M-3 






implement the NIH Alcoholism and Drug Abuse Program. OMS expanded this prog] 
to meet the guidelines of the Public Health Employee Assistance Program deal: 
not only with alcoholism and drug abuse, but the entire spectrum of mental h< 
problems. Training courses and orientation seminars were held for all BID 
Personnel Officers, DPM Branch Chiefs, EEO Coordinators and Union Represent, 
tives. Following this orientation, ten groups of first-line supervisors re- 
ceived training. These training programs consisted of two hours of formal 
didactic orientation, followed by discussion. The success of this orientatic 
and utilization of the program was reflected in increasing numbers of referrs! 
and visits to the mental health counselor and psychiatric consultant. 

In August and September 1976, Occupational Medical Service nurses participate' 
in a testing program for Swine Flu vaccination conducted by the National Inst- 
tute of Allergy and Infectious Disease. This program tested vaccines on 
different age groups of employees, monitoring the effectiveness of vaccine ar 
the dosage to be used in the program. In October 1976, OMS conducted health 
education programs through the NIH news media, which outlined availablitiy of 
vaccine for the NIH population. During the early part of the program, bivale: 
vaccine was obtained from the Montgomery County Health Department to immunize 
laboratory workers who conducted research using the A Victoria Strain in ex- 
perimental subjects. (The month of November saw the culmination of several 
weeks of planning) OMS used a team approach to schedule immunizations in the 1 
health units as a convenience to the NIH population. An OMS physician super- 
vised the immunization team and reviewed requirements for bivalent vaccine. 
The program was accepted well by NIH employees and a total of 5,669 received 
the influenza vaccine. The percentage of acceptance in the NIH population fa 
exceeded that in the surrounding communities. It was felt that this reflecte 
the scientific interest of the NIH population and the convenience of the pro- 
gram. No central nervous system problems were diagnosed in vaccinated NIH 
employees. 

Future Objectives Directed Toward Meeting Goals 



' 



Occupational Medical Service intends to continue to support surveillance 
examinations of employees exposed to hazardous work environments both in the 
patient care area and research. OMS will also continue working closely with 
the NIH Biohazards Committee and the Environmental Health and Safety Program, 
DRS, for early identification of hazards. The OMS medical staff will remain 
cognizant of infectious agents, oncogneic viral agents, and chemical carcino- 
gens in research. In particular, since OMS anticipates the rapid development 
of protocols for medical surveillance in recombinant DNA research, the staff 
will develop surveillance standards which will be as specific to the exposure 
as scientifically possible. Coordination with NIH scientists in intramural 
and extramural programs will be maintained to assure knowledge of the latest 
research and clinical developments in the area of carcinogensis and infection 
diseases. The emphasis will be on aspects of prevention with consideration 
of environmental controls as well as biologic monitoring. 

Occupational Medical Service will expand its role in the treatment and counsel 
mg of employees with non-occupational illness. Specifically, problems re- 
lated to monitoring illness and liaison with personal physicians and communis 
medical care services will be explored to establish a program of hypertensive' 

1 

00M-4 



screenin3 and hypertensive control in the work setting. The control of hyper- 
tension in the work setting is of current interest to the National Heart, Lung 
and Blood Institute, as well as the American Academy of Occupational Medicine 
and the American Occupational Medical Association. Many on-going programs have 
been formulated in private industry and interest is developing in the Federal 
sector. The OMS program will be coordinated closely with NHL BI and their 
Interagency Technical Committee on Hypertension. Guidelines for the care of 
hypertensives among Federal employees will be reviewed and applied in the 
development of this important preventive medical program. 

Occupational Medical Service will expand the current Alcoholism and Drug Abuse 
Program to meet objectives of the recently established Public Health Employee 
Assistance Program. Two trained mental health counselors with experience in 
alcoholism and drug abuse have been assigned to the Program, as well as other 
areas of mental health, and this will allow expansion in the areas of education, 
treatment programs, and hours of medical support. One important future aim is 
to reach a higher percentage of upper grade employees. Occupational Medical 
Service recognizes this will require coordination particularly with Employee 
Relations and Recognitions Branch, DPM, and other units of PMB. 



00M-5 



SELECTED WORKLOAD STATISTICS JULY 1976 - JULY 1977 



Average 



Occupational Injury 
Occupational Disease 
Preventive Medical Visits 
Personal Visits 
PHEAP 

(Public Health Employee 
Assistance Program) 



Total 


Monthly 


Percent of 


Visits 


Frequency 


Workload 


3,137 


262 


9 


966 


81 


3 


19,939 


1,662 


56 


9,347 


778 


26 


2,278* 


189 


6 



Total Visits 35,667 



2,972 



100% 



^Includes 1,630 visits for alcohol and drug abuse 



OOM-6 



July 1, 1976, through September 30, 1977 



PUBLIC HEALTH SERVICE, NATIONAL INSTITUTES OF HLALTH 

SUMMARY ANNUAL REPORT OF PROGRAM ACTIVITIES 
CLINICAL CENTER 

OUTPATIENT DEPARTMENT 



CONTENTS 

Program Objectives OP-1 

Departmental Activities OP-1 

Progress Achieved OP-2 

Other Activities OP-3 

Plans OP-4 



OP-i 



July 1, 1976, through September 30, 1977 

PUBLIC HEALTH SERVICE, NATIONAL INSTITUTES OF HEALTH 

SUMMARY ANNUAL REPORT OF PROGRAM ACTIVITIES 
CLINICAL CENTER 

OUTPATIENT DEPARTMENT 

PROGRAM OBJECTIVES 

The overall objective of the Outpatient Department is to give administrative 
support and to assist the professional members of the Clinical Center 
staff to provide excellence in patient care. 

The following are the individual objectives for each section, which 
individually and collectively meet the overall objectives of the Department. 

Admissions - The objective of this section is to admit both the inpatient 
and the outpatient in the most expeditious manner possible, ensuring that 
all information received and transcribed is accurate. 

The Clinics - This section provides a setting in which physicians are able 
to conduct examinations and/or treatments of ambulatory patients on a timely 
basis, with assistance from other members of the Clinical Center staff. 

The Travel Office - This section provides and arranges transportation for 
patients of the Clinical Center, taking into consideration the patients 
personal needs, comfort, and care, when and if medical problems are present. 

Special Ambulatory Care Program - The objective of this program is to 
offer participating Institutes and physicians a method of treating 
ambulatory patients, not living within a comuting distance, on an Outpatient 
basis. 

Local Transportation - The objective of this section is to provide 
transportation for patients, when the patient is essential to a study, and 
cannot provide his own. 

Messenger and Escort Service - This section's objective is to transport 
patients and specimens expeditiously, always mindful of the necessary 
safety measures to be taken during the transportation. 

DEPARTMENTAL ACTIVITIES 

These activities are designed to meet the overall objectives of the Department 
as well as those of the individual Sections to provide the support necessary 
for the highest quality patient care. 



0P-1 






1. To maintain the maximum productivity of the employees within the 
Department. 

2. To fully implement the centralized appointment system for all the 
Institutes and to make refinements to meet the needs of each clinic. 

3. To refine the supply system. 

4. To increase the number of patients preadmitted to the Clinical Center 
so that the patients spend less time in the Admissions Office. 

5. To reorganize the Admission Office by extending the coverage to 
twenty four (24) hours a day, seven (7) days a week. 

6. To establish a training program in public relations, telephone procedure 
interviewing techniques, etc. for all clerical employees within the 
Department. 

7. To assist the architect in the redesign of the Outpatient Department 
to increase treatment space and relocate some of the ancillary services to 
the main clinic area. 

8. To expand the hours of coverage of the Messenger and Escort Service. 

9. To purchase a computerized reservation system for the Patient Travel 
Office. 

10. To inform the Institute physicians of the rules and regulations of 

the Special Ambulatory Care Program, the Travel Section, and the Admissions 
Section. 

11. To effectively reduce the money spent on travel, and the Special 
Ambulatory Care Program, without curtailing patient care. 

PROGRESS ACHIEVED 

1. Some of the training programs to improve the output of work of the 
various employees of the Department are: Inservice training sessions 
(especially for the Outpatient Unit Clerks), participative management, 

and individual counselling sessions. This process is an indefinite one, as 
it is difficult to place limitations on it, if it is to be successful. 

2. The centralized appointment system has been implemented for all the 
clinics currently using the main clinic. Currently we are refining 
individual clinics from block appointments to individual times for the 
patients. 

3. A full-time supply technician has been hired, who will be helped by 
several students in the Stay-in-School Program. At present the examination 
room maintenance part of the system has begun. This was the last 
administrative function that nursing service was performing. 

OP-2 



4. The number of preadmissions made by the Admissions Office is approximately 
85 percent. This is an increase of 39 percent from last year. This means 

a patient may not have to spend more than five minutes in the Admissions 
Office before either going to the Clinics or to an inpatient nursing unit. 

5. The reorganization of the Admission Office began in May, 1977. As 
a result of the reorganization, Admissions staff have a variety of 
functions; admissions, information duties, handling various clerical tasks 
which were performed by the Administrative Officer of the Day heretofore. 
Also, a policy and procedure manual has been developed and is being used 
by the clerks. 

6. This course will begin in September, 1977. Since most of our work 
is the initial contact point between the public and NIH, we thought the 
course would be quite beneficial. 

7. Since the Ambulatory Care Research Facility will not be completed until 
1981, the present space allocated to the clinics is not large enough for 
the expected influx of patients through the next several years. Because 
of this, an architect was hired to design an expansion of the Outpatient 
Department. Included within this design is the concept of centralization 
of as many of the ancillary services as possible, or to provide satellite 
coverage within the clinic proper. 

8. The Messenger and Escort Service provided its service on an 8:00 a.m. 
to 4:30 p.m. tour of duty Monday through Friday. The service is now 
available seven days a week from 8:00 a.m. - 11:00 p.m. 

9. A contract was let with United Airlines to lease their Apollo System, 
a computerized reservation system. This system will effectively reduce 
the hiring of additional staff and the amount of time needed to process 

the paperwork in the office. The Apollo System will be installed September 

9. 1977. 

10. The physicians of the various Institutes who are authorized to use 
the Special Ambulatory Care Program were oriented by the supervisors of the 
SACP, Travel, and Admissions Sections. This is an ongoing program for 

all new Clinical Center associates. 

11. One of the measures taken to reduce the monies spent was to decrease 
the number of guardians (escorts) of patients transported to the Clinical 
Center and placed in the SAC Program. In addition, another was to more 
strictly enforce Travel and SACP regulations. 

OTHER ACTIVITIES 

1. The Department has been involved with the architects in the design 
and development of the Ambulatory Care Research Facility. 

2. The Department has been involved with the personnel from Technicon 
concerning the Hospital Information System and its interface with the 
Admissions Section, the Clinics, and other Clinical Center Departments. 

0P-3 



PLANS 

1. To continue to refine the centralized appointment system used by the 
various clinics. 

2. To reorganize the clinic schedule so that the patient flow is more 
evenly distributed. 

3. To further refine the supply system in the Outpatient Department. 



OP-4 



July 1, 1976 through September 30, 1977 

PUBLIC HEALTH SERVICE, NATIONAL INSTITUTES OF HEALTH 
SUMMARY ANNUAL REPORT OF PROGRAM ACTIVITIES 
CLINICAL CENTER 

PATIENT SERVICES DEPARTMENT 

General PS- 1 

Anesthesia Support Section PS- 1 

Normal Volunteer Program PS- 1 

Chart A - Estimate of the Number of Volunteers 
By Institute for Period July 1, 1976 - 

September 30, 1977 PS-12 

Patient Activity Section PS- 3 

Patient ' s Library . , PS- 6 

Physiological Monitoring Section PS- 6 

Chart B - Physiological Monitoring Section PS-13 

Respiratory Therapy Section PS- 6 

Television Engineering Section PS- 7 

Anesthesiology Service PS- 9 



PS-i 



July 1, 1976 through September 30, 1977 






PUBLIC HEALTH SERVICE, NATIONAL INSTITUTES OF HEALTH 
SUMMARY ANNUAL REPORT OF PROGRAM ACTIVITIES 
CLINICAL CENTER 

PATIENT SERVICES DEPARTMENT 
GENERAL 



In June 1976 physiological monitoring responsibilities transferred from the 
Nursing Department to an independent Section within the Patient Services 
Department. The Department is now composed of the Anesthesia Support 
Section, the Normal Volunteer Program, the Patient Activity Section, the 
Physiological Monitoring Section, the Respiratory Therapy Section, and 
the Television Engineering Section. 

Within the Patient Services Department's responsibilities is management of 
the anesthesia contract with Georgetown University. Dr. George W. Shaffer, 
Chief, Patient Services Department, is project officer for this contract 
and Mr. Thomas Johnson, Administrative Officer, is the alternate project 
officer. 

The administrative aspects of the clinical service provided by a nephrologist 
consultant, Dr. James Balow, NIAID, are also the responsibility of the 
Patient Services Department. The technician assigned to work with Dr. Balow 
is an employee of the Department. 



Anesthesia Support Section 

The four nurse anesthesists who were members of the Patient Services 
Department have transferred from NIH or resigned from Civil Service. 
Their responsibilities have been assumed by members of the Georgetown 
University contract staff as required in the contract. 

The slots vacated by the nurse anesthesists have been transferred to the 
Patient Activity Section and the Respiratory Therapy Section. 

Mr. Charles Brooks has been appointed as supervisor for the anesthesia 
technicians who are members of the Patient Services Department. 



Normal Volunteer Program 

Normal Volunteers are healthy individuals who have been admitted to the 
Clinical Center in order to serve as a volunteer subject for approved 



PS-1 



research projects. The Normal Volunteer Program is responsible for 
recruiting volunteers through contracts with sponsoring agencies This 
Section audits utilization practices of volunteers after their a sig^ent 
and xs responsible for the career experience aspects of the program 

During the past year, there has been an overall increase in the number 
of normal volunteers in all categories - inpatient, outpatient and off J 

"diclSr^t £*" " "*"*"" ^ * ^ ^^ ^ 

The volunteers are from nine to seventy-six years of age with 26 30 vears 

rep-rfsent tTToT'of Til T* 8 " ^ ° f th * ^^ ^volunteers - who 
represent bl.bU/o of all volunteers - is 22.53 years. 

This year there have been more male than female volunteers. The reason 
?A reversal . fr °* last year is that medical research investigators 
have been requesting more males and more males have been applying to 
become volunteers. <»FFJ-ying to 

Volunteers often spend their free time working In career development 

£253 Sneer" aelr. ° f£iCe8 ' " d ° th « "• 11 * bl » "^STS the 
Ssnr^pecTin-e ^rticuSrc^ee". 81 ™ V ° 1U " teerS * Sli ° PSB ° f ""« '1 

All volunteers, with rare exception, take career assignments Durins thl 

College Sterling College and the Gila River Indian Community.' Se loss 
LVcXa-wi^^^ 

Uni^itT^ver^rV 1111 h administrati - P-sonnel of Dartmouth 

±n till Z\^7r tl' Jr Hampshire are in Progress and should be completed 

Tn!i ! the first students from there in September 1977 Also 

of Pho^if^ilo 1 !' Ph ° eni ? S r 1Ce Unit ' ^^ Health IdvSry Boa d,' I, 
with eSsting ones are e aSo \ **""* ° perational - These new resources alor 
needs L , adequate enough to allow us to meet our volunteer 

other-colL^ who's IT^l^L^V^^ ^ ™ **" 



I 



PS-2 



The Division of Management Survey and Review completed their survey of the 
Normal Volunteer Program. The findings were not significant although they 
helped us revise a particular form for the Outpatient Department - Off-site 
Section of this program. 

TV Channel 4 (NBC) is tentatively planning to do a late Saturday night 
presentation of the Normal Volunteer Program. 

Patient Activity Section 

The Patient Activity Section offers Clinical Center patients a diversified, 
patient-centered program of therapeutic recreation activities (social, 
music, arts and crafts, adapted sports, and dramatics), active and passive, 
on and off the reservation. The activities are offered to all patients in 
the Clinical Center, at outdoor areas on the Reservation, and in selected 
local sites. All programs were organized, executed, and evaluated under 
the guidance of a professional staff of Therapeutic Recreation Specialists 
and Assistants. Patient interest in the program continued to grow, and 
their realization of the value of recreation as a vital part of their 
rehabilitation and "daily living" pattern helped them to better tolerate 
their research protocols and to make better use of their leisure. Approximate! 
76% of the patient population this year became involved in our program. 

With the addition of two full-time positions, the Patient Activity Section 
is able to provide full-time coverage of three Mental Health Units and 
in pediatric oncology. Full-time coverage is also provided on the 
Neurology Units and the West Wing Outpatient Clinic. Part-time coverage 
is provided on other Mental Health Units and in the Cancer Units. 

A special program has been initiated on a part-time basis at the United 
Inn for the SACP patients and their families. Featured activities 
utilized motel facilities or featured trips into the community. 

In addition to topical social and recreational programs, the Section 
has a special program entitled "A Happening." The focus of this program is 
geared to special interest groups. Activities include lectures, concerts, 
tours, and "special" trips. Attendance was small again this year, but 
the activity seems worthwhile enough to continue. 

The children's program staff was instrumental in the design of a playroom 

and therapeutic recreation program on the new Pediatric Unit. The 

Patient Activity Section is working closely with the nursing staff on 

this unit in striving for the optimal approach to various child patients. 

The therapeutic recreation staff provides unit programs when appropriate 

and provides individual (one-to-one) contact with the children when necessary 

either because type of treatment or other special circumstances. 

In addition to repeating the Jacques Cousteau film series, "Undersea 
World," a Classic Film Festival was initiated this year. This film series 
featured three - four week "theme" programs which included: 1) Classic 
Horror Film Festival; 2) Alfred Hitchcock Classic Films; and 3) Classic 
Comedy Series. 

PS-3 



Community support via free tickets to theatres and concerts, gifts, and 
their response to recreational needs, especially at holiday' time was 
overwhelming. 

The Patient Activity Section has an active student f ieldwork/internship 
program. This year seven recreation majors came to the Clinical Center 
for their f ieldwork/internship studies. Five of the students were from 
the University of Maryland, two from Florida State University, Tallahasse 
Florida and one was a graduate student from Springfield College, SpringfJ 
Massachusetts. These students were given a complete exposure to the tota 
therapeutxc recreation program, as well as other related Clinical Center I 
disciplines including: OT, PT, Social Work, Spiritual Ministry, etc The- 
stay_ lasted from three to six months, depending upon the particular school 
curriculum requirement. 

One of the University of Maryland fieldwork students, as part of her 
assignment within the Section, implemented a Patient Activity Section Intl 
Survey. The results were as follows: 

1) 56% (or 206) of the patient census (370) were surveyed. 

2) 96% were aware of the recreation program. 

3) 73% actually participate in the program. 

4) Arts & Crafts is the most popular (26%) activity. 

5) 38.5% became aware of activities via the Patient Activity Section Week- 
Bulletin. 

ll ll'll are T r f ° f th£ Pat±ent Librar y> an d 47.1% visit the Patient Lili 
/; 54.y/o use the bookcart visits as their library contact. 

Statistics : There were 5,407 adult patient activities, with an average o 
14 activities per day. The average daily patient participation was 188 a, 
the average participation per programmed activity was 14. There were 
7,754 children's activities, with an average of 20 activities per day. Tl 
average daily patient participation was 76, and the average participation 
per programmed activity was 4. The increase in the average number of 
activities and the average daily participation has risen considerably ovei 
the past year because of the increase in "bedside" programming. 

Patti Lutz, Therapeutic Recreation Specialist, was listed under "acknowlece- 

?h n J* a A ST r Written b ^ Dr - Erlc Caine on Huntington's Dementia for 
the Wexler Adult Intelligence Scale, which she administered on her own tir 
to patients on a mental health unit. 

Members of the Patient Activity Section are involved in non-Clinical Cent, 
professional activities such as: 

The Executive Board of the Therapeutic Branch of the Maryland Recreation \ 
Parks Association; meetings preparing for the White House Conference on 
the Handicapped held in May 1977. 

Sair^ f '^ atlent Activ±t y Section is Evolved in the following activitie: 
Chairman Therapeutic Branch, Maryland Recreation and Parks Association, 
! ei \ 8 Committee and Education Session; Chairman, National Recreation 
and Parks Association Mid-Atlantic Forum on Innovative Programming; 

I 



PS- 4 

I 

l 



Member, Program Committee and Educational Session; Chairman, Maryland 
State Conference on Recreation; Steering Committee, Mid-Eastern Symposium 
on Therapeutic Recreation. 

Patient's Library 

The Patient's Library added 502 new books to the collection this year to 
bring the total to 6,954. The 9,651 patients who visited the library 
increased the circulation to 16,146, an increase of more than 3,000 over 
last year. Magazine circulation also increased from 799 to 805 per month. 

The Bedtime Story Hour continues on Wednesday evenings with the assistance 
of a Red Cross Volunteer and Normal Volunteers. Six Red Cross Volunteers 
also assisted the library staff in various library services including taking 
bookcarts to nursing units. 

Mrs. Swim, Library Supervisor, was an integral part of the Mental Health 
inter-disciplinary team in a study of hyperactive children. Mrs. Swim 
worked with 30 different child patients, two per week, for approximately 
2-3 hours per week. She was required to evaluate their reading ability, 
chart the general reactions of the patient during library activity periods, 
and to relay specific patient behavior in relation to the type or quality of 
drug intake. 

Physiological Monitoring Section 

The Physiological Monitoring Section transferred to the Patient Services 
Department from the Central Nursing Service in June 1976. The Section 
is responsible for supplying and applying physiological and metabolic 
monitoring equipment for Clinical Center patients. Services are provided 
from 7 a.m. to 12:30 a.m. Monday through Friday and on an on-call basis at 
all other times. 

This Section has provided care for an increasing number of patients. With 
the upcoming addition of a medical intensive care unit and the expansion of 
the surgical intensive care unit, a critical need for more skilled technicians 
is anticipated. Immediate recruitment of at least two individuals with a 
sound background in patient care and monitoring instrumentation should provide 
the high quality of patient care necessary. 

The statistics in Chart B indicate a marked increase in the services provided 
by this Section. 



Respiratory Therapy Section 

The Respiratory Therapy Section provides respiratory care treatments for 
Clinical Center patients. 

During the past year, this Section has extended its coverage to provide an 

PS-5 



in-house technician at all times except between the hours of 12 midnight 
through 8 a.m. Saturdays, Sundays, and holidays. A technician is availat 
at these other hours on a rotating on-call basis. 

The Section now performs blood-gases for the Anesthesiology Service. The 
established hours for this service, from 8 a.m. to 4:30 p.m., fluctuate t 
conform to research studies. 

All members of this Section are receiving training from the Rehabilitatic 
Department in techniques of performing chest physical therapy. Training 
should be completed by July 18 at which time the Respiratory Therapy Seed 
will assume complete responsibility for this service. 

A contract agreement has been signed between Columbia Union College and ti 
Respiratory Therapy Section. The purpose of the affiliation, which began 
in May, is to provide clinical experience for students enrolled in degree; 
programs in respiratory therapy at the college. The training offered the 
students is in areas specifically requested by the college. There is a 
specific curriculum for each of the college levels. 

As a result of the newly assumed duties of this Section, i.e., additional 
coverage, the academic affiliation, and chest physical therapy, the staff 
has been increased by one full-time, permanent position and four part-tim. 
permanent positions. 

Television Engineering Section 

The Television Engineering Section has worked with the NIH Library to 
establish a location for viewing videotapes, to place selected Television 
Engineering videotapes in circulation for viewing by Clinical Center stafi 
and to plan for a cooperative effort with NLM to access their videotape 
library to make it directly available to Clinical Center staff. 

The Section collaborated with Diagnostic Radiology and the Biomedical and 
Instrumentation Branch, DRS to develop the circuitry which would provide te 
necessary synchrony for every television frame to record one complete ultis 
scan. Playback from videotape and transfer to the videodisc permits discit 
portions to be selected for stop or slow motion analysis. 

As a representative of an ad hoc committee on the Patient TV System, this 
Section will be responsible for providing technical expertise and input fc 
the planning of the closed circuit channels. 

An additional X-ray room in Diagnostic Radiology has been equipped with 
the Image Intensifier Video System and intercom system which connect with 
the Television Engineering Control Room for instant recording and direct 
communication with Television Engineering personnel. This is the fourth 
room m Diagnostic Radiology to be equipped with these capabilities. 

Engineering support has been given the Diagnostic Radiology Department 

xn the evaluation of the television images produced by the EMI head and bo 

scanners. 

PS-6 



Existing television cables were relocated to connect the Diagnostic Methodology 
Section, NIDR, to Television Engineering. This collaboration was mutually 
advantageous in that the full capabilities of Television Engineering were 
immediately available to Diagnostic Methodology and Television Engineering 
had access to the unique digital transforms available through computer 
processing in Diagnostic Methodology. 

Television and audio cables between Television Engineering and the Nuclear 
Medicine Department were reactivated to provide the capability of videotaping 
and video analysis. Computer generated ventricular scans are converted to 
the television format for storage, labeling, and replay to the heart cath 
conferences. These data are also available for direct replay into the 
surgical area if a visual refresh is necessary during open heart surgery. 

The analytical facilities of this Section have been used in the analysis 
of the opacified ventricle in 35 dog studies conducted by NHLBI. 

In collaboration with the Clinical Hemotalogy Branch, NHLBI, drawings and 
tracings representing clumped erythroid colony boundaries are analyzed in 
Television Engineering by the recently acquired commercial video analyzer. 
Preliminary investigations are being made to the direct determination of 
area from the microscopic image by placing a television camera on the 
microscope. This would eliminate the need for tracing and would permit 
area data to be acquired directly from the video image. 

The use of a low light level television camera to locate and define the 
intercellular spaces of flat epithelia has been undertaken in cooperation 
with the Kidney and Electrolyte Branch, NHLBI. The use of television in 
conjunction with a photomultiplier tube has facilitated the repositioning 
and verification of exact area of interest surrounding the intercellular 
space. Photographs can be taken from the television image or videotapes 
can be made for repeated analysis of this image to determine differential 
reaction within the field. 

During the past year, the Television Engineering Section continued its 
participation in the following collaborations: 

- With the Cardiology Branch, NHLBI, producing ventricular determinations 
and net forward ejection fractions for information on the condition of heart 
patients. 

- With the Surgery Branch, NHLBI, providing visual coverage of the surgical 
field with surgeon's audio and neurosurgical operating procedures while 
simultaneously analyzing heart catheterization material. 

- With Clinical Neurosciences Branch, NINCDS, study of cortical metabolism 
in cats monitoring levels of NADH oxidation using a television fluorometer 
system to detect reflected and fluorescent light emitted from the exposed 
cortex. 

- With Collaborative and Field Research, NINCDS, obtain information on 
epileptic patients through telemetered recordings. 



PS-7 



-With Laboratory Parasitic Diseases, NIAID, generated a more efficient 1 
video system used to determine the mean projected area profile distribS 
m vertebrate cells. "J-J-J-e axscrxbu, 



Anesthesiology Service 

Anesthesia services are provided via a contract with Georgetown Univers; 
The contract whxch was awarded last year has been renewed for the perio 
July 1, 1977 through June 30, 1978. P^rxoc 

The Anesthesiology Service provides anesthesia and related support servi 
to all patients of the Clinical Center requiring such support These 
services xnclude: administration of anesthesia to patients undergoing 
surgxcal and diagnostic procedures where anesthesia coverage is needed 
provxsxon of consultative services in anesthesia related problems the 'u 
of pain relxevxng techniques to selected patients with chronic pain synd 

SiSTSSc^ TeZlL? t d . guidance to the Re ™- Th -- —2 

The Anesthesiology Service personnel on duty included staff anesthesiolo 1 
nurse anesthetists, anesthesia residents, and medical secretaries claJ ■ 
as follows, based on the yearly average: ' CJ - ass * 



Staff Anesthesiologists io 

Nurse Anesthetists [[[ 3 

Secretaries 2 



I 



Anesthesxologxcal Services provided from April 1, 1976 through March 30 1 
Anesthesia and/or supportive treatment was given in 1495 instants inci J 
1,295 surgxcal operations and 200 diagnostic procedures. 

SSSHT SSrViCeS ^^^^ ■ — blocks, and resuscitations) 

* 

undert^r 111 ^ 3 ^^ 13 ' 1 " d±Splay the nature of the anesthesia procedures 
ZerlttTs ^ the COmpleXit ^ and P-tracted duration If ma^ of 

classified Ifrl r r8lC f Pr ° cedures were Performed. These procedures 
classxtxed as to type of surgery were as follows: 

Thoracic , 1 -, 

ht , . 411 

Neurologxcal 58 

General o-,o 

Urological -^ 

Perineal g3 

Face, head and neck 126 

Eye, ear, nose and throat 52 

Dental , 

Orthopedic 37 

Miscellaneous 2.97 



PS- 8 



. 






The table below classifies patients as to sponsoring Institutes: 

Institute Procedures Percent 

NCI 794 53 

NHLBI 387 26 

NINCDS 104 7 

NEI 38 3 

NICHD 21 1 

NIAMDD 94 6 

NIAID 44 3 

NIMH 13 .9 

The surgical staffs of the Institutes listed below were responsible for 

the number of procedures done under anesthesia as indicated: 

Institute Procedures Percent 



NCI 921 62 

NHLBI 383 26 

NINCDS 110 8 

NEI 44 2 

NIDR 4 .3 

NIAMDD 17 1 

Special 16 1 



Changes and Improvements 

An extensive in-depth investigation of the effects of hyperthermia on cancer 
treatment in selected patients was undertaken in collaboration with physicians 
from NCI with the serendipitous objective of quantitating physiologic changes 
in patients requiring anesthesia for these hyperthermia treatments. 

Recruitment of anesthesiology staff has markedly increased to provide more 
efficient and intensive anesthesia and respiratory support to the Clinical 
Center patients and investigative functions. An improvement in anesthesia 
and respiratory care will follow with the availability of new recovery room 
facilities which are about to be instituted. With the establishment of 
a new recovery room facility and appropriate staffing, the immediate 
postoperative difficulties encountered by surgical patients may be 
expeditiously solved. 



Future Objectives 

Basic work is underway to reach the goal of even more complete respiratory 
therapy coverage when the new Ambulatory Care Facility and its expanded 
recovery, intensive care, and respiratory areas are available. The 
Anesthesiology Department has been closely associated with the plans for 
this facility which will provide expanded opportunities for improvements 
in anesthesia and respiratory care. 

PS-9 



Opportunities to combine the Department's clinical functions with appropi 

investigative activities related to anesthesia and physiology, such as 

the hyperthermia program, will be eagerly accepted by the enlarged, capat 1 
and versatile staff presently at hand. 



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PS-12 



July 1, 1976, through September 30, 1977 






PUBLIC HEALTH SERVICE, NATIONAL INSTITUTES OF HEALTH 

SUMMARY ANNUAL REPORT OF PROGRAM ACTIVITIES 
CLINICAL CENTER 

PHARMACY DEPARTMENT 



CONTENTS 

Pharmacy Service Ph-1 

Central Sterile Supply Service Ph-4 

Pharmaceutical Development Service Ph-5 

Problems Ph-6 

Publications Ph-7 

Table I - Pharmacy Department Statistical Date Ph-8 

Intramural Project Reports Ph-10 



Ph-i 



July 1, 1976, through September 30, 1977 



PUBLIC HEALTH SERVICE, NATIONAL INSTITUTES OF HEALTH 

SUMMARY ANNUAL REPORT OF PROGRAM ACTIVITIES 
CLINICAL CENTER 

PHARMACY DEPARTMENT 



PHARMACY SERVICE 

I. Mission and Goals 

Pharmacy Service is responsible for the interpretation and transcription 
of medication orders, and for the monitoring and dispensing of all medica- 
tions ordered for patients in the Clinical Center. Specifically, this is 
accomplished by dispensing unit dose medication to individual patients with 
each dose individually packaged and labeled; filling drug orders for patients 
going on pass, being discharged, or outpatients; extemporaneously preparing 
all intravenous additive solutions ordered for inpatients and outpatients; 
filling drug requisitions for nursing units and clinics not on unit dose 
system; bulk compounding and packaging products not available commercially; 
maintaining all investigational drug dispensing records; providing drug 
information and clinical services for physicians and nurses. 

II. Service Activities (based on 12 months - 7-1-76 to 6-30-77) 

a. Unit doses of medications dispensed to inpatients increased by 52% and 
total number of unit doses packaged increased by 41%. 

b. Total number of intravenous admixtures prepared increased by 22%. 

c. Total number of outpatient prescriptions filled increased by 6.5%. 

d. Requests filled by the Officer-of-the-Day increased by 29%. 

e. Pharmacy service hours were extended in the Unit Dose and Intravenous 
Additive Units. The Unit Dose Dispensing Unit extended hours from 8:30 a.m. 
to 5 p.m., 5 days/week, to 7 a.m. to 11:30 p.m., 7 days/week. The Intra- 
venous Additive Unit extended hours from 7 a.m. to 5 p.m., 5 days/week, to 

7 a.m. to 9 p.m., Monday through Friday, and Saturdays, Sundays, and 
holidays, 7 a.m. to 6 p.m. 

f. Additional space of 150 sq. ft. was provided for the Pharmacy Service 
for the expansion of the unit dose program. 

g. The Unit Dose Dispensing Unit, Intravenous Additive Unit, and Inpatient 
Dispensing Unit was physically rearranged and new modular shelving units 
were purchased for each Unit. This was done to provide a more efficient 
work flow and traffic pattern with the limited floor space in the pharmacy. 

III. Major Progress 

The unit dose drug distribution system was expanded to include 7 additional 
nursing units (NHLBI Nursing Service and NIAMDD Nursing Service). This 



Ph-1 



I 



"1 

resulted in an increase in coverage from 175 beds in FY 1976 to 335 beds i; 
FY 1977. Pharmacy Service continued its policy of assigning specific 
pharmacists clinical responsibilities for these 7 additional units in addi 
tion to the drug distribution functions. Pertinent information concerning 
each new unit (protocols, staffing patterns, and drug information) was com 
piled by these pharmacists. By familiarizing themselves with the drug 
therapy and protocols used on their assigned units they were better preparl 
to interpret and review all new drug orders for appropriateness, dosage, ail 
possible interactions. The pharmacists made daily visits to their assignee 
nursing units to communicate directly with physicians and nurses; they 
became the prime providers of drug information on their assigned units. 
Although requested to do so by physicians and nurses, lack of time and in- 
adequate staffing prevented the pharmacist from providing more formalized 
clinical services such as conducting drug histories on new patients and 
providing drug counseling to patients being discharged. 

The Chief, Pharmacy Service, served on an Executive Committee designed to 
facilitate MIS computer implementation throughout the hospital. Through fi 
close interaction with the system, alterations and modifications were made 
in various pharmacy matrices and ordering paths to best accommodate new 
nursing units entering the MIS system. 

Staff pharmacists also provided invaluable assistance in the MIS computer 
implementation on their assigned units by acting as a liaison between 
nursing unit and the Pharmacy Service. In some cases they provided direct 
instruction to physicians on the medication ordering portion of the MIS 
system and, in all cases, the pharmacist interpreted, reviewed, and verifie 
all medication orders input by physicians and "agents for" the physician. 
They suggested improvements and refinements in the MIS system that were 
relative to their functions as pharmacists. 

A large increase (22%) in the number of intravenous admixtures prepared by 
the Intravenous Additive Unit necessitated the distribution of the workload 
in the evenings and a change in the expiration times, and delivery of the 
intravenous admixtures to the unit. In addition, the Intravenous Additive 
Unit pharmacist went daily to 4 NCI nursing units to monitor the intravenou 
admixture usage. This procedure has enabled the pharmacists to better 
predict the need for continuation and preparation of the intravenous bottle 
and has helped decrease waste and intravenous admixture returns. 

The Intravenous Additive Unit provided the data for every patient on total 
parenteral nutrition. The data was then entered into a computer and 
analyzed by the NCI Surgery Branch. 

All nursing units, as well as ancillary patient care areas, were routinely | 
inspected to insure proper drug control and storage. 

The Pharmacy Service assisted the Infections Control Committee in their 
review of antibiotic usage in the Clinical Center by surveying intravenous 
gentamicin usage throughout the hospital. This was done by a staff pharma- 
cist monitoring, on a daily basis, all gentamicin admixtures prepared by 
the Intravenous Additive Unit. 



Ph-2 



■ 



The Pharmacy Department's one-year residency program in hospital pharmacy 
was approved for accreditation by the American Society of Hospital Pharma- 
cists. The program has been operational for 3 years. 

This residency training program included practical experience in hospital 
pharmacy dispensing, and clinical experience and training through rotation 
to different nursing units conducted by a clinical pharmacist, and 
familiarization with Clinical Center ancillary departments such as Diagnostic 
Radiology, Blood Bank, etc. Completion of residency required an administra- 
tive project to develop a surveillance program for microbial contamination 
of intravenous admixtures prepared by the Pharmacy Department. A procedure 
was developed and data collected to determine the feasibility and cost 
effectiveness of continuing this surveillance project on a routine basis. 

A Pharmacy and Therapeutics Committee was established to serve as an advisory 
group to the medical staff and to serve as an organizational line of communi- 
cation between the medical staff and the Pharmacy Department on all matters 
related to the use of drugs. Recommendations of this Committee are pre- 
sented to the Quality Assurance Committee and then to the Medical Board for 
adoption. 

Members of the Pharmacy Department continued to meet on several occasions 
with architects and consultants regarding space allocations, renovations, 
and planned Pharmacy Department activities in the Ambulatory Care Research 
Fac i 1 i ty . 

A revised edition of the Pharmacy Department Catalog was published and dis- 
tributed to physicians, dentists, nursing units, and other appropriate 
individuals. 

The Pharmacy Department instituted a practice of receiving and reviewing all 
research protocols involving the use of drugs, both commercial and investi- 
gational. A copy of the protocols, along with a computerized listing of 
them from each institute, are on file in the pharmacy. 

The Chief, Pharmacy Service, served as a member of the newly formed Cardio- 
pulmonary Resuscitation Committee (a subcommittee of the Quality Assurance 
Committee). This committee is methodically reviewing all procedures and 
techniques involving CPR in the Clinical Center. The CPR manual was updated 
and all appropriate drug changes were made by the Pharmacy Department. 

IV. Future Objectives 

a. Expansion of unit dose drug distribution system to include all Clinical 
Center nursing units. This involves expanding the program to cover the 
remaining 10 nursing units (8 NCI and 1 NICHD and 1 NEI) not presently on 
the system. 

b. Development of a computerized intravenous admixture system by pharmacy 
and MIS personnel to accommodate all phases of centralized intravenous 
admixture preparation. 

c. Expansion of the professional role of the pharmacist to include more 
clinical functions such as conducting drug histories on newly admitted 



Ph-3 



patientsandproviding discharge medication interviews. 

d. Feasibility of a satellite intravenous admixture unit in the outpatien 

clinic will be explored. Currently, intravenous solutions that need to be ( 

administered within one-half hour after mixing are being prepared in the 

clinic. 

CENTRAL STERILE SUPPLY SERVICE 

I. Missions and Goals 

Central Sterile Supply Service provides clean and sterile supplies used in j 
patient care which includes processing, assembling, sterilizing, and issuin 
of a variety of packs, trays, sets, instruments, and utensils. Also, 
numerous preprocessed disposable items, both clean and sterile, are procure 
stored, and issued to patient care areas. The distribution of the supplies' 
is accomplished by a 24-hour mobile exchange cart delivery system. 

n - Service Activities (based on 12 months, 7-1-76 thru 6-30-77) 

a Requisitions filled increased 17% with 35,236 requisitions estimated fo ; i 
7-1-76 thru 6-30-77. 

b. Items issued totaled 4,429,553 with 5,536,941 estimated for July 1 197< 
thru September 30, 1977. 

c. Number of trays and sets prepared increased 9% with 17,777 estimated fo 
July 1, 1976, thru September 30, 1977. 

d. Turnover rate of personnel was 25%. 

e. Acquisition of gravity steam sterilizer for decontamination process. 

f. Five full-time permanent employees attended some type of schooling or 
Upward Mobility program, which represented an average of 20 man-hours per 
week. K 

III. Major Progress 

a. A heat sensitive chemical indicator strip was incorporated into each 
item steam sterilized to insure presence of sterilization parameters. 

b. The soiled processing area was physically separated from clean productic 
areas through the use of wall partitions. 

c. A Product Review and Standardization Committee, composed of Central 
Sterile Supply Service, Nursing, and the Procurement Branch, was initiated 
to evaluate new commercial products. 

d. Monthly medical aid inservice education program was initiated. 

IV. Future Objectives 

a. Revision of stock control methods to facilitate inventory and procuremen 
activities. 

b. Acquisition of additional sterilizing equipment for decontamination 
process. 

c. Replacement of linen wrappers with 2-way crepe paper wrappers for 
sterile surgical packs. 



Ph-4 



PHARMACEUTICAL DEVELOPMENT SERVICE 

I. Missions and Goals 

The Pharmaceutical Development Service (PDS) is responsible for the regis- 
tration and control of all investigational drugs used for patients in the 
Clinical Center. This group also develops, formulates, and assays many of 
the investigational drugs used by physicians in their clinical research 
studies and prepares a summary of this data for the FDA. 

The goals of this group are to provide elegant pharmaceutical products and 
to assist physicians in their clinical research by supplying services such 
as drug identity and analyses of in vitro and in vivo samples, setting up 
single and double-blind studies, maintaining disposition records, and pro- 
viding drug information. 

II. Service Activities (based on 12 months, 7-1-76 thru 6-30-77) 

The workload of the Service increased substantially over the last year as 
follows: 65.5% increase in the number of units formulated, developed, and 
issued; a 58.7% increase in the number of new investigational drugs pro- 
cessed; 13.7% increase in all requests processed; and a 12.1% increase in 
investigational drugs registered. 

III. Major Progress 

The facilities and capabilities of the PDS have been improved through the 
addition of a few new instruments and the renovation of other equipment. 
New instruments purchased included a gas-liquid chromatograph equipped with 
both flame ionization and electron-capture detectors to replace obsolete 
GLC; a multiple spindle dissolution apparatus which is required for dis- 
solution testing by the USP; a stainless steel freeze-drier; and a glass 
still in the analytical area to obtain water of a high purity for chemical 
analysis. 

The quality of sterile products prepared was improved by mechanically modify- 
ing and adding inline water filters to an existing vial washer. 

An intravenous emulsion with a globule size of 2 microns capable of making 
the liver and spleen opaque which can then be used for computerized scans of 
the liver has been developed and prepared for the Diagnostic Radiology 
Department. This unique preparation is a major breakthrough. 

The procedure for the Cholestyramine Type II Coronary Intervention Study was 
changed to decrease order processing time and storage space. 

IV. Future Objectives 

a. Conduct in vivo testing of clinical dosage forms developed by PDS. 

b. Conduct dissolution testing on all oral dosage forms prepared by PDS. 

c. Develop a stability testing program for all drugs sealed in unit dose 
packages. 



Ph-5 



4* 

Problems 

Pharmacy Service 

in thp e n P fn51S? y r ne 5 dS t0 r! :° mplete thS Unit d0Se drug dis tribution system 
in the Clinical Center. There are currently 335 beds (16 nursing units) o 
the system and 186 beds (11 nursing units) still to be completed The svs, 
cannot be completed unless the Pharmacy receives 5 additional positions ab, 
our current on board full-time posisions of 79 Motions aD. e 

b. There currently is inadequate space to function effectively at our 
present level of service. We have requested 1000 sq. ft of additional 

aSdUion l h 500 , r n Ce l Ved - 3 °; h Sq - ft °/ SpaCe and a 'LlLni to re e° anl 
aaaitional 500 sq. ft. in the near future. 

nf m oH,- in ? deqUat ^ deliver ^ s y stem (Pneumatic tube system) for dispatching 
of medications, due to expansion of the unit dose system will require 

current if ^fecT^* ^ <** * $ "*" ** in the 6Venin 9 S ' ^ 
d There is a need to coordinate with the outpatient clinics the schedulin 
of patient visits in order to alleviate the overburdening of the outoatie t 
Pharmacy at specific times each week. For example: on Thursday a^rnoo 
between 1 and_4 p.m. the outpatient dispensing unit is deluged wi?h as many 
as 300 prescriptions to fill in that period of time. y . 

Central Sterile Supply Service 



a. Inadequate storage space. Pharmacy has requested: 1 ,000 sq ft of 
space to remove supplies from the corridors; 1,500 sq. ft of space in the 
Central Sterile Supply Service for operational activities and 2 000 q ft 
of space for the storage of backup supplies q " 

of d ^ lr0nmental conditions are such that they lend to rapid accumulation 



* 



thP illfi I and J^dequate sterilizing and cleaning equipment will requit 
the immediate purchased new equipment costing approximately $100,000 
d. There is a great time lag between the initiation of work requests and 
completion of projects by the Engineering Branch. requests and 

?sf I5? r !nH S / 9reat time !!? between submitting Request for Personnal Actic 
(SF-52) and receiving certificates of eligibles for job interview. 

Pharmaceutical Development Servirp 

?; tla ^ der t0 r XP ! nd 0Ur Pharmacokinetics studies on the various drugs use 
in the Clinical Center, two additional full-time employees are needed 
soacl has hL 3 Sever V^ of space in PDS. An additional 600 sq ft f 
ve P s a ti g a a t?on1i n dr^s eSted ^ ^^ ^^ and the ^e o> ?n- 
renova^on'o? lU!^ ™ the com ^ tio " of work requests. For example, 
ZllTsZt beef Parted?™ " M reqU6Sted and aPPr ° Ved tW ° years ^ and t0 



Ph-6 



PUBLICATIONS 

Chatterji, D. and Gallelli, J.F.: Assay of methotrexate in presence of 
its decomposition products by high pressure liquid chromatography. 
Accepted for publication, J. Pharm. Sci . 

Chatterji, D. , Frazier, A., and Gallelli, J.F.: Thermal and photolytic 
decomposition of methotrexate in aqueous solutions. Accepted for publica- 
tion, J. Pharm. Sci. 

Chatterji, D., Frazier, A., and Gallelli, J.F.: Identification and 
quantitation of impurities in methotrexate. Accepted for publication, 
J. Pharm. Sci. 

Daniels, C.E. and Tangrea, J. A.: Use of patient-oriented drug data sheets 
in counseling patients before discharge. Hosp. Pharm. 12: 230-242, 1977. 

Gladding, G.D. and Ballew, T.D.: Proper stock rotation is colored with a 
positive marking. Hosp. , J.A.H.A. 51 : 154-155, 1977. 



Ph-7 



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Ph-9 



SMITHSONIAN SCIENCE INFORMATION EXCHANGE 
PROJECT NUMBER (Do NOT use this space) 



PERIOD COVERED 



U.S. DEPARTMENT OF 
HEALTH, EDUCATION, AND WELFARE 
PUBLIC HEALTH SERVICE 
NOTICE OF 
NTRAMURAL RESEARCH PROJECT 



PROJECT NUMBER 



ZOl-CC-00001-01 PHA 



1y 1 , 1976 , to .Sept e mber 30, 1977 



TITLE OF PROJECT [SOT Characters' or less)" 

Assay of Methotrexate in Presence of Decomposition Products by HPLC, 



NAMES, LABORATORY AND INSTITUTE AFFILIATIONS, AND TITLES OF PRINCIPAL INVESTIGATORS AND ALL OTHER 
PROFESSIONAL PERSONNEL ENGAGED ON THE PROJECT 



D. C. Chatter ji 
J. F. Gallelli 



Staff Fellow 

Chief, Pharmacy Department 



Pharmacy, CC 
Pharmacy, CC 



COOPERATING UNITS (if any) 



LAB/BRANCH 



SECTION 



Pharmaceutical Development Service 



d 



INSTITUTE AND LOCATION 

CC, NIH, Bethesda 



TOTAL MANYEARS: 

0.6 



CHECK APPROPRIATE BOX(ES) 
□ (a) HUMAN SUBJECTS 

D (all) MINORS p (a2) INTERVIEWS 



PROFESSIONAL: 

0.6 



OTHER: 



□ (b) HUMAN TISSUES 



□ (c) NEITHER 



SUMMARY 0F WORK (200 words or less - underline keywords) " '" 

nhn^t/ff^ 5 USin ? a Str ° ng anion exchan 9e resin column and a perchlorate 
a J h uffer as eluent were developed. The method was demonstrated to be 
; U r „ ' Presence of large amounts of thermal and photolytic decomposi- 

foSs P was pJ?; h lIJhp2 P S llCablll - y ° f - t u iS meth0d in aSSayin 9 commercial dosar 
forms was established by comparing with other methods published in the 
literature. 



Ph-10 



PHS-6040 
(Rev. IO-76) 



• 



SMITHSONIAN SCIENCE INFORMATION EXCHANGE 
PROJECT NUMBER (Do HOT use this space) 



U.S. DEPARTMENT OF 
HEALTH, EDUCATION, ANO WELFARE 
PUBLIC HEALTH SERVICE 
NOTICE OF 
INTRAMURAL RESEARCH PROJECT 



PROJECT NUMEEn 



Z01-CC-00002-01 PHAR 



PERIOD COVERED 



July 1, 1976, to September 30, 1977 



TITLE OF PROJECT (30 characters or less) 

Thermal and Photolytic Degradation of Methotrexate in Aqueous Solutions 



NAMES, LABORATORY AND INSTITUTE AFFILIATIONS, AND TITLES OF PRINCIPAL INVESTIGATORS AND ALL OTHER 
PROFESSIONAL PERSONNEL ENGAGED ON THE PROJECT 

D. C. Chatter ji Staff Fellow Pharmacy, CC 

A. G. Frazier Physical Science Technician Pharmacy, CC 

J. F. Gal lei li Chief, Pharmacy Department Pharmacy, CC 



COOPERATING UNITS (if any) 



LAB/ BRANCH 



Pharmaceutical Development Service 



SECTION 



NSTITUTt AND LOCATION 

CC, NIH, Bethesda 



TOTAL MANYEARS: 
1 



PROFESSIONAL: 



0.6 



|0THEfi: 



0.4 



CHECK APPROPRIATE BOX(ES) 

□ (a) HUMAN SUBJECTS 

□ (al) MINORS □ (a2) INTERVIEWS 



□ (b) HUMAN TISSUES 



G (c) NEITHER 



SUMMARY OF WORK (200 »ords or less - underline keywords) 

The chemical kinetics and product analysis of thermal and photolytic degrada- 
tion of methotrexate (MTX) in aqueous solution was studied. Major degradation 
products were identified using simple column chromatography and HPLC. These 
studies led to a mechanism of decomposition of MTX in aqueous solutions. 
The stability of various commercial dosage forms and one I.V. infusion solu- 
tion of MTX was studied and found to be acceptable within the recommended 
storage periods. The impurities commonly present in commercial MTX were 
found not to be due to degradation products, but were from the synthesis of 
MTX itself. 



Ph-11 



PHS-6040 
(Rev. 10-76) 



- 



SMITHSONIAN SCIENCE INFORMATION EXCHANGE 
PROJECT NUMBER (Do NOT use this space) 



U.S. DEPARTMENT OF 
HEALTH, EDUCATION, AND WELFARE 
PUBLIC HEALTH SERVICE 
NOTICE OF 
INTRADURAL RESEARCH PROJECT 



PROJECT NUMBER 



Z01-CC-00003-01 PHAR 



PERIOD COVERED 

— — .liily 1, 197FJ , to Septem ber 30 , 1977 

TITLE OF PROJECT (80 characters or less) 

Identification and Quantitation of Impurities in Methotrexate. 



NAMES, LABORATORY AND INSTITUTE AFFILIATIONS, AND TITLES OF PRINCIPAL INVESTIGATORS AND ALL OTHER 
PROFESSIONAL PERSONNEL ENGAGED ON THE PROJECT 

D. C. Chatterji Staff Fellow Pharmacy, CC 

A. G. Frazier Physical Science Technician Pharmacy, CC 
J. F. Gal lei 1 i Chief, Pharmacy Department Pharmacy, CC 






COOPERATING UNITS (if any) 



LAB/BRANCH 



SECTION 



Pharmaceutic al Development Service 



INSTITUTE AND LOCATION 

CC, NIH, Bethesda 



TOTAL MANYEARS: 

0.8 



CHECK APPROPRIATE BOX(ES) 
□ (a) HUMAN SUBJECTS 

D (al) MINORS □ ( a 2) INTERVIEWS 



PROFESSIONAL: 
0.4 



OTHER: 



0.4 



□ (b) HUMAN TISSUES 



□ (c) NEITHER 



SUMMARY OF WORK (200 words or less - underline keywords) ' ~ 

Methotrexate USP, commercial methotrexate, and MTX for investigational use 
were chromatographed by gradient elution on DEAE cellulose column. In com- 
mercial and USP methotrexate, six different peaks (excluding MTX peak) were 
obtained. Identity of 2 peaks were presented for the first time, using NMR 
and MS techniques. Percentage purity of MTX samples were found to be of the 
order of 86% calculated on anhydrous basis. Investigational use MTX showed a 
completely different spectrum of impurities, although percentage purity of 
the sample was the same as USP methotrexate, i.e , 86% 



Ph-12 



PHS-6040 
(Rev. 10-76) 



July 1, 19 76, through September 30, 1977 

PUBLIC HEALTH SERVICE, NATIONAL INSTITUTES OF HEALTH 

SUMMARY ANNUAL REPORT OF PROGRAM ACTIVITIES 
CLINICAL CENTER 



REHABILITATION DEPARTMENT 



CONTENTS 



I. Departmental Missions and Goals Rh-1 

II. Department Activities Rh-1 

III. Major Progress Rh-2 

IV. Future Objectives Rh-4 

Addendum I. Services Provided by the Rehabilitation Department. . . Rh-5 

Addendum II. Rehabilitation Department Staffing Pattern Rh-8 

Tables: 

1. Physical Therapy Service: Statistical Report FY 77 Rh-9 

2. Physical Therapy Service; Comparative Statistics FY 73-77 . . . Rh-10 

3. Physical Therapy Service: Number of New Patient Admissions by 
Institute: Comparative Statistics FY 77 Rh-11 

4. Occupational Therapy Service: Summary Report by Institutes of 
Number of Patients Treated, Number of Treatment Hours, FY 77. . Rh-12 

5. Occupational Therapy Service: Comparative Statistics, FY 77; 

Patient Treatments and Treatment Hours Rh-13 

6. Rehabilitation Department, Office of Chief: Number of Patient 
Evaluations by Physiatrists, FY 73-77 Rh-14 

7. Speech Therapy Service: FY 77 Rh-15 

Intramural Research Projects: 

1. Podiatric Evaluation and Treatment of Patients with R.A Rh-16 

2. Study of Factors Accelerating Rehabilitation in Above-Knee 

Amputees Rh-17 

3. Correlation of Activity of Psoriatic Arthropathy with Psoriasis 

in Patients Receiving PUVA Rh-18 

4. Biofeedback in the Management of Raynaud's Phenomen Rh-19 

5. Chest Wall Syndrome Masquerading as Coronary Artery Disease . . Rh-20 



Rh-i 



July 1, 19 76, through September 30, 1977 

PUBLIC HEALTH SERVICE, NATIONAL INSTITUTES OF HEALTH 

SUMMARY ANNUAL REPORT OF PROGRAM ACTIVITIES 
CLINICAL CENTER 

REHABILITATION DEPARTMENT 

I. Departmental Mission and Goals 

The primary mission of the Rehabilitation Department is to provide 
physiatric evaluation and treatment, physical therapy, occupational therapy, 
and speech therapy for patients participating in Institute studies. 

An equally important mission of the Department is to support efforts of 
and collaborate with Institute physicians engaged in research pertaining to 
evaluation or treatment of rehabilitation problems. 

A third mission is to initiate both clinical and basic research 
independent of the Institutes in rehabilitation of mentally and physically 
handicapped individuals. 

A fourth mission is to advocate and defend the rights of handicapped 
persons, and to use educational, preventive, and legislative means to accomplish 
this goal. 

II. Department Activities 

A. Physical Therapy, Occupational Therapy, Speech Therapy, and 
physiatric services are presented in Addendum I. 

B. Staffing pattern is presented in Addendum II. 

C. Patient Care Statistics 

Patient care statistics are presented in detail in Tables 1-3 for 
Physical Therapy, 4-5 for Occupational Therapy Service, Table 6 for 
physiatrists, and Table 7 for speech therapy. 

Not included in the annual report are the Resource Monitoring System 
statistics which show that the average time spent per patient visit 
is 30 minutes and that the majority of treatments require skilled 
therapists, rather than aides. 

As of July 25, 1977, patients requiring bronchial drainage and 
preoperative and postoperative breathing exercises for lung expansion 
and pulmonary toilet were transferred to the care of the respiratory 
therapists. 



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^t 



III. Major Progress 
A. Services 



4. 



• Significant improvement and organization in services were dtov* 

auicSTT r FY 'I 77 ' S P ecifica "X> Patients arTbeing seen! 
quickly, ixmbs are being delivered on schedule, the amputee ell 

Major pr „ gr ess has been made £ the roiling frees ^""nda, 

avSuS i :„ f 3 ha "„ d c S Ctl0n "■*»««• M stanLSzationVf Sol 
evaluations, including some gait evaluation, cl standardize"™ 

-throyas 5 ^ 6 ^ 1 ^ — ««* ° f *■*«<" ^Sf " SnT" j 

Development of a program aimed at a non-pharmacolosic nor, 
invasive approach to the management of chronic pain uti^X. 
the transcutaneous nerve stimulator ^IT+l P Utlllzln " 
stimulator, and bi.f^^^^*«£J£«- 

The Occupational Therapy Mental Health program was redesi«n»rf 
graded from basic £X skll!s to J»l lndependent Motioning 
-arapv tre ^"ais ^SS^l^^r 1£"H 

S"Sf ASSIST ^USt^i'T r s i s " ntl " - ~* 

treatment goals ana outcome. " b " ter do<: <-«""ion of 



B. Research 



o^eogentTs^correveafs"" 1 ? 1 1CS ° f the " eat «« ° f *« -ItJ 

wound g heali„g r :n7a r :ir ly a de* rSd^e"^" CaS " ng °" 
and delivery of limb a* ™ ae " eas f d , tlrae between amputation 

receiving rigid Jressin, Th "^ th ° SS patientS not 

Phantom 'limb* pai and ^"fin^ ^J "^ r6SpeCt t0 
significant) to the ILllZ i prosthesis (not statistically 

surgery £ compared 25 ^ ^ ambulated within 24 hours of 

delayed -til^ture're'mo^al 56 ^^ Wh ° Se ^ Ulati ° n is 



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' 






2. Preliminary evaluation of statistics on patients with psoriatic 
arthritis receiving psoralen ultraviolet light therapy reveals 
two subtypes of patients: a) one group shows skin response and 
joint response to be highly correlated, and these patients have 
distal, asymmetrical arthritis; b) the other group shows independ- 
ence of joint and skin response, and these patients have axial 
arthritis, resembling spondylitis. 

3. The Rehabilitation Department in conjunction with the NHLBI 
Cardiology Branch has developed a musculoskeletal examination 
for patients with atypical angina that evaluates the contribution 
of cervical and thoracic spine problems and chest wall pathology 
to the angina. Preliminary evidence shows that treatment aimed 
at relieving musculoskeletal problems results in significant 
amelioration of symptoms and improvement in exercise tolerance 

in selected patients. 

4. Other studies in progress which have not yielded adequate data to 
report are: a) "Evaluation of the Response of Raynaud's 
Phenomenon to Biofeedback," b) "Podiatric Evaluation of the 
Rheumatoid Foot Comparing Accommodative with Corrective Therapy," 
c) "Evaluation of the Quality of Life Patients with Soft Tissue 
Sarcomas Receiving Amputation Versus Limb Sparing Local Tumor 
Resection. " 

5. Publications: 

a) Clinical Use of Immunosuppressive Drugs: Part II, N. Lynn 
Gerber $ A. D. Steinberg, Drugs , 11:90-112 (1976). 

b) Ribavirin: Efficacy in the Treatment of Murine Autoimmune 
Diseases, L. W. Klassen, D. R. Budman, G. W. Williams, 

A. D. Steinberg, N. L. Gerber, Science , 2/25/77, vol 195, 
pp 787-789. 

c) Therapeutic Studies in NZB/NZW Fi Mice. V. Comparison of 
Cyclophosphamide and Chlorambucil: N. L. Gerber, D. Powell, 
A.D. Steinberg, Arthritis 5 Rheumatism , July-August 77, 
vol 20, No. 6, pp 1263-68. - 

d) The Hand in Mixed Connective Tissue Disease: R. A. Lewis, 
J. P. Adams, N. L. Gerber, et al., Hand , in press. 

Training 

The Rehabilitation Department has established a core curriculum for 

the continuing education of department physical therapists. 

A similar curriculum is being established for occupational therapists, 



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more 



IV. Future Objectives 
A. Patient Care 

1. The Department is generally concerned with providing nun- 
comprehensive services, especially in the area of discharge 
planning, pediatric rehabilitation, rehabilitation of the cance 
patient, and the rehabilitation of the severely handicapped 

2 ' llt^A^? 17 ' a 1 maj0r 6ff0rt is "nderway to establish reliable 
disability' 6ValUating di ^ility and the impact of the^f™ 

3 ' varJetv t o? n H^n e / PPliCati ° n ° f the ™°Plastic material to a 
variety of disorders, assessment of efficacy and durability 

takiTof th e : S n° f the USe ° f thSSe materia " S is a future under- 
taKmg of this Department. 

4 ' b^ e m ^! d / 0r K! SWinunin g P° 01 is significant, and efforts will 
be made to obtain one. 

B. Research 

2 * t n m ° r !^ uantitativ ^ reproducible method to evaluate treatment 
developed " imPr ° Ving rehabilitat -n of patients is beL" 

2. Another area of particular commitment is to evaluate treatment 
prosthetics, and orthotics in a quantitative way as these ' 

modalities affect locomotion and'upper extremity Xnction 

way that"! 6 , ?f ed *? 6Valuatin S these interventions in a 
2d the iZJ? T° 1Ve analySlS ° f move ^nt, pathomechanics, 
and the impact of corrective devices on pathomechanics. 

C. Training 

III imCTAhT™ trainin ^/ e are implementing and evaluating 
rne impact of the core curriculum for therapists. NIH staff train 



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- 



Addendum I. Services Provided by the Rehabilitation Department 
A. Physical Therapy Service 

1. Tests and measurements 

Manual muscle evaluation 

Joint range of motion measurements 

Electrodiagnostic testing, including chronaxie measurements 

and strength-duration curves 
Progressive resistance exercise evaluation 
Girth, length, and volumetric measurements 
Quantitative muscle testing 
Extremity and spinal joint evaluation 
Posture evaluation 
Self-care evaluation 

2. Heat, including: 

Superficial -- hot packs, paraffin bath, whirlpool 
Deep -- shortwave diathermy, microwave, ultrasound 
General body heat -- Hubbard tank 

3. Therapeutic exercise: 

General exercise -- passive, active, assistive, and resistive 

Muscle reeducation and facilitation techniques 

Joint range of motion and articulation 

Ambulation training 

Pre- and postoperative orthopedic surgery program 

Training in self-care activities 

Breathing exercises 

4. Miscellaneous: 

General and local application of ultraviolet light 

Bronchial drainage 

Cervical and pelvic traction 

Application of splints and casts to maintain joints in good 

anatomical and functional position 
Instruction to patients and family in home-care program 

(application of heat, exercise, use of self-care aids) 
Fitting and dispensing canes and crutches 
Prescription and procurement of correct shoes, braces, corsets, 

splints, and prostheses 
Measurement for Jobst compression garments 
Temperature and EMG biofeedback training 
Transcutaneous nerve stimulation (for pain) 



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B. Occupational Therapy Service 

1. Physical and functional restoration: 

Basic mobility and functional training of the blind 

Design and fabricate upper extremity orthoses 

Improve functional endurance 

Improve coordination 

Infant and early childhood developmental stimulation 

[includes parent training) 
Instruction in joint protection and energy conservation 
Maintain or regain joint range of motion 
Neuromuscular facilitation and inhibition techniques 
Prevention or retardation of hand deformities in rheumatoid 
arthritis and systemic lupus erythematosus 

2. Evaluation and testing: 

Developmental testing 

Evaluation of adult hemiplegics 

Functional hand evaluation 

In-depth activities of daily living evaluation, including 

self-care, homemaking and job 
Perceptual motor testing 

Record patient's behavior patterns for use in evaluation of 
T ,2f s . reactions in specific research studies (NIMH) 
Timed functional activity testing for patients on studies 
Upper-extremity motor development testing 

3. Psychiatric adjustments: 

^and^nf^^ 165 in . relation t0 needs of research studies 

and report observations of patient's behavior 
Aid patient in making acceptable social adjustment 

"££%££ J%££ therapy progr *° as a ^ «•»< 

4. Prevocational exploration: 

Explore skills, interests, and work habits 
Increase work to tolerance 

Maintain special skills required by patient's job 
Make recommendations on patient's performance and aptitudes 
tor use m vocational planning 

C Speech Therapy Service 

1. Evaluation and assessment of: speech articulation oral- 
s'* 1 3nd ° ral - m0tor functioning, voice S vocal 
pathologies, vegetative oral functions such as swallowing 
and chewing, oral-sensation, dentition as it affects speech, 

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linguistic performance, verbal and auditory memory and 
attention, comprehension of spoken, written and manual 
communication, academic-educational and pre-academic skills, 
cognitive functioning as it relates to language, auditory 
discrimination, and general levels of language development. 
Individualized remediation strategies are implemented appropriate 
to the meet the needs of those patients with communication 
disorders . 

Office of the Chief 

1. Evaluation of Institute patients referred for physical medicine 

and rehabilitation; prescription and supervision of therapy. 

2. Participation in establishing executing research protocols in 

patient care. 

3. Attendance at Institute Rounds: NCI, NIAMDD, NINCDS. 

4. Participation in research endeavors with other Institute 

scientists not involving patients. 

5. Supervision of the NIAMDD orthopedic resident. 

6. Participation in Clinical Research Panel NIAMDD. 



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Addendum II Rehabilitation Department Staffing Pattern 

Office of the Chief 

Chief, Rehabilitation Department 1 

Assistant Chief 1* 

General Medical Officer 1 

Secretaries 3 

Clerk-typist, WAE 1_ 

7 



Physical Therapy Service 

Chief, Physical Therapy Service 1 
Assistant Chief 1 

Staff Physical Therapists 5 

Physical Therapy Assistants 2_ 

9 



Occupational Therapy Service 

Chief, Occupational Therapy Service 1 
Staff Occupational Therapists 5*' 

6 



Speech Therapy Service 

Speech Pathologist 1** : 

* Appointed 8/1/77 

** Vacancies filled after 10 and 4 months 

*** Part-time employee 



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PHYSICAL THERAPY SERVICE 

Table 1: STATISTICAL REPORT FISCAL YEAR 1977 
(July 1, 1976 to October 1, 1977) 



INSTITUTE 


Number of Different 
Patients Treated FY 77 


Number of Patient 
Visits FY 77 


IP 


OP 


IP 


0? 


NCI 


928 


477 


4840 


1149 


NEI 


18 





30 





NHLBI 


139 


65 


1161 


276 


NIAID 


185 


15 


785 


39 


NIAMDD 


269 


272 


2179 


1188 


NICHD 


47 


5 


164 


17 


NIDR 


13 


12 


20 


16 


NIMH 


138 





270 





NINCDS 


937 


163 


4294 


412 


TOTALS 


2674 


100 


13,743 


3,097 



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PHYSICAL THERAPY SERVICE 
Table 2: COMPARATIVE STATISTICS - Fiscal Years, 1973-1977 




Estimates for July-Sept. 1977 



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Rh-11 



Table 4: 



OCCUPATIONAL THERAPY SERVICE 

SUMMARY REPORT BY INSTITUTES OF NUMBER OF PATTENTS TREATED 
NUMBER OF TREATMENT HOURS" - FISCAL YEAR 19 77 





I 

'INSTITUTES 


NUMBER OF DIFFERENT 
PATIENTS TREATED 


NUMBER OF PATIENTS 
TREATMENTS 


NO. OF TREATMENT 
HOURS 






IP 


OP 


IP 


OP 


IP OP 




NCI 


169 


27 


620 


49 


406 


50 




NEI 


7 


i ! 


40 


1 


29 


1 




NHLBI 


16 


! 


71 


39 


54 


39 




NIAID 


29 


13 


80 


67 


76 


67 




NIAMDD 


117 


105 


594 


226 




516 


208 




NICHD 


71 


1 
55 | 


259 


50 


228 


51 




NIDR 


- 


7 ! 


- 


3 


_ 


3 




NIMH 


794 


9 1 


10,788 


22 


13,158 


21 




NINCDS 


471 


64 ; 


2,143 


62 


1,848 


63 


TOTALS 


1,774 


291 


14,595 [ 


519 


16,315 


503 




Estimates : 


For July- i 


Sept. 1977 











Rh-12 



OCCUPATIONAL THERAPY SERVICE 

Table 5: COMPARATIVE STATISTICS: FISCAL YEAR 1977 
PATIENT TREATMENTS AND TREATMENT HOURS* 



Fiscal 
Years 




"irier of Different 
Patients Treated 


Number of Patients 
Treatments 


No. of Treatment 
Hours 




IP 


OP 


IP 


OP 


IP 


OP 


1973 


1,583 


556 


10,129 


36 2 


14,121 


365 


19 74 


1,195 


444 


11,332 


260 


16,119 


268 


1975 


1,220 


359 


10,522 


353 


15,205 


361 


1976 


1,411 


235 


12,052 


599 


25,373" 


525 


1977 


1,774 


294 


14,595 


519 


16,315 


503 



Estimates for July-Sept. 1977 

'"The drop in treatment hours from FY 1976 to 77 reflects a decrease in 
number of staff from 3 mental health OT's to 2 mental health CT's and 
a stricter definition of what constitutes an O.T. treatment hour and 
rigidly separating it from recreational activity. 



Rh-13 



REHABILITATION DEPARTMENT - OFFICE OF THE CHIEF 



Table 6: 


NUMBER OF PATIENT EVALUATIONS 
FISCAL YEARS 1973-1977 


BY PHYSIATRISTS , 


Fiscal 

Year 


Total 


1973 


900 


1974 


839 


1975 


897 


1976 


848 


1977 (estimated 
J.A.S.) 

Including 
consultant 


1494 
+ 131 

1625 







Rh-14 



Table 7: SPEECH THERAPY SERVICE 
Fiscal Year 1977 



INSTITUTES 


TOTAL NUMBER OF PATIENTS TREATED 


TOTALS 


IP 


OP 


NIAID 
NIMH 

NINCDS 

NCI 

NICHD 

NHLBI 

NIDR 

NIAMDD 

COURTESY 


16 



171 

20 
3 

15 
2 
1 



9 


67 
6 


29 

16 


16 


25 



238 

26 
3 

44' 

18 
1 

16 


TOTAL 


228 


143 


371 



Statistics represent period 1/1-9/30/77 (speech pathologist 
entered on duty 1/1/77, 20 hours /week) 



Rh-15 



aMITHSGNlAN SCIENCE INFORMATION EXCHANGE 
PROJECT NUMBER (Do NOT use this space) 



U.S. DEPARTMENT OF 
HEALTH. EDUCATION, AND WELFARE 

p5BU SoT H ^i s£Rv,cE 

iNTRAMURAL RESEARCH PROJECT 



PERIOD COVERED 

2 years ("beginning June, 19771 

TITLE OF PROJECT (30 characters or less) 



PROJECT NUMBER 
77-CC-A-132 



Pediatric Evaluation and Treatment of Patients with R.A. 



N. L. Gerber, M.D., Chief, Rehabilitation Department CC 

Joseph Reed, RPT, Physical Therapy Service, Labi lit at ion Department, CC 



COOPERATING UNITS (if any) 



LAB/BRANCH 



SECTION ' ' 

Rehabilitation Dep artment 

INSTITUTE AND LOCATION ' 

Clinical Center, 5D-37 



TOTAL MANYEARS 

1/5 



PROFESSIONAL: 

1/10 



OTHER 



1/10 



D (b) HUMAN TISSUES 



□ (c) NEITHER 



CHECK APPROPRIATE BOx(ES) 
Lj (a) HUMAN SUBJECTS 

D (al) MINORS □ ( a 2) INTERV I EWS 

This study is designed to compare the efficarv of i *•« 

management of foot problems in patienffw,^ ^ different approaches to I 

will be assign ed either eSs SvSSiT! I rheumatoid arthritis Patients 
provide comfort in shoes or correct v T ?' Wlth the ^^^ft inserts 1 
ties in foot alignment Patient , treatm ^t to try to control abnormal!-. 

g nt. Patients will be monitored for progress of disease. 



« 



PHS-6040 
(Rev. 10-76) 



Rh-16 



SMITHSONIAN SCIENCE INFORMATION EXCHANC 
PROJECT NUMBER (Do NOT use this space) 



U.S. DEPARTMENT OF 
HEALTH, EDUCATION, AMD WELFARE 
PUBLIC HEALTH SERVICE 
NOTICE Of 
INTRAMURAL RESEARCH PflOJECT 



PROJECT NUMBER 



PERIOD COVERED 

3 years beginning January, 1976 



TITLE OF PROJECT (80 characters or less) 

Study of Factors Accelerating Rehabilitation in Above-Knee Amputees 



NAMES, LABORATORY AND INSTITUTE AFFILIATIONS, AND TITLES OF PRINCIPAL INVESTIGATORS AND ALL OTHER 
PROFESSIONAL PERSONNEL ENGAGED ON THE PROJECT 

Naomi L. Gerber, M.D., Chief, Rehabilitation Department, CC 

William Thorpe, M.D., Surgery Branch, NCI 

Physical Therapy Service, Department of Rehabilitation, CC 



COOPERATING UNITS (if any) 



LAB/BRANCH 

Surgery Branch 



SECTION 



INSTITUTE AND LOCATION 
NCI 



TOTAL MANYEARS: 
1 



PROFESSIONAL: 

1/10+ per year 



OTHER: 

1/2 per year 



CHECK APPROPRIATE BOX(ES) 
3 (a) HUMAN SUBJECTS 

□ (al) MINORS rj (a2) INTERVIEWS 



□ (b) HUMAN TISSUES 



□ (c) NEITHER 



SUMMARY OF WORK (200 words or less - underline keywords) 

A study evaluating ability of Physical Therapists to apply rigid dressing intra- 
operatively to above-knee amputees , and evaluation of the benefit to patients 
who are ambulated immediately postoperatively, when compared with those not 
ambulated until the wound is healed. Patients are evaluated with respect to 
wound healing, quality of ambulation, and attitude toward rehabilitation. 



PHS-6040 
(Rev. 10-76) 



Rh-17 



SMITHSONIAN SCIENCE INFORMATION EXCHANGE 
PROJECT NUMBER (Do NOT use this space) 



U.S. DEPARTMENT OF 
HEALTH. EDUCATION, AND WELFARE 
PUBLIC HEALTH SERVICE 
NOTICE OF 
INTRAMURAL RESEARCH PROJECT 



PERIOD COVERED 

2 years (beginning November 1976) 



PROJECT NUMBER 

76-CC-98 



TITLE OF PROJECT (30 characters or less) 



Correlation of Activity of Psoriatic Arthropathy with Psoriasis in Patients 1 



Receiving PUVA 



NAMES, LABORATORY AND INSTITUTE AFFILIATIONS, AND TITLES OF PRINCIPAL INVESTIGATORS AND ALL OTHER 
PROFESSIONAL PERSONNEL ENGAGED ON THE PROJECT o.^/uu^ aw ALL UTHER 

N. L. Gerber, M.D., Chief, Rehabilitation Department, CC 

Werner Barth, M.D., Washington Hospital Center (off site) 

John Decker, M.D., ARB, NIAMDD 

A. Eric Jones, M.D., Nuclear Medicine, CC 

T. Nigra, M.D., Washington Hospital Center 



COOPERATING UNITS (if any) 



Washington Hospital Center, Rheumatology § Dermatology Section 
Nuclear Medicine 



lab/branch 



Arthritis § Rheumatism 



SECTION 



INSTITUTE AND LOCATION 

NIAMDD 



TOTAL MANYEARS: 

2/3 



CHECK APPROPRIATE BOX(ES) 
03 (a) HUMAN SUBJECTS 

D (al) MINORS □ ( a 2) INTERVIEWS 



PROFESSIONAL: 

1/3 per year 



OTHER: 



□ (b) HUMAN TISSUES 



□ (c) NEITHER 



SUMMARY Oh WORK (200 words or less - underline keywords) _ ~ 

Study is designed to evaluate the efficacy of psoralen treatment on the 
arthropathy associated with psoriasis. 






ioint ,1 , f , th8re ^ tW ° typSS ° f P atie *ts, those with periphery 
to PUVA n T me ^ th6 t r , 3 ° int reSp ° nSe P arall *ls the response of the skin 
to PUVA. Those with axial skeletal involvement do not have a correlation of I 
skin response to treatment with joint response. 



PHS-6040 
(Rev. IO-76) 



Rh-18 



- 



SMITHSONIAN SCIENCE INFORMATION EXCHANGE 
PROJECT NUMBER ^Oo NOT use this space) 


U.S. DEPARTMENT OF 


PROJECT NUMBER 


HEALTH, EDUCATION, AND ..ELF ARE 
PUELIC HEALTH SERVICE 










NOTICE OF 


77-CC-22 




INTRADURAL RESEARCH PROJECT 





I PER I CO COVERED 

5 years (February, 1977) 



TITLE OF rRG^cCT ^50 cnaracters or less) 

Biofeedback in the Management of Raynaud's Phenomenon 



NAMES, LABORATORY AND INSTITUTE AFFILIATIONS, AND TITLES OF PRINCIPAL INVESTIGATORS AND ALL OTHER 

PROFESSIONAL PERSONNEL ENGAGED ON THE PROJECT 

N. L. Gerber, Chief, Rehabilitation Department, CC 

Bernard Frankel, M.D., NINCDS, SN 

Dali Patel, M.D., N'HLBI-IR 

John Decker, M.D., ARB , NIAMDD 

Mrs. Cynthia Smith, OTR, Chief, Occupational Therapy Service, CC 



COOPERATING UNITS (if any] 



LAB/BRANCH 



SECTION 



INSTITUTE AND LOCATION 

NINCDS, NIAMDD, NHLBI 



TOTAL MANYEARS 



1/10 



PROFESSIONAL: 

1/20 per year 



OTHER: 

1/20 per year 



CHECK APPROPRIATE BOx(ES) 
£ (a) HUMAN SUBJECTS 

□ (al) MINORS 7J (a2) INTERVIEWS 



□ (b) HUMAN TISSUES 



[] (c) NEITHER 



SUMMARY OF «/GRK (200 -ords or less - underline keywords) 

Patients with Raynaud's phenomenon are taught temperature biofeedback and 
and muscle relaxation using EMG feedback in an attempt to relieve symptoms of 
Raynaud's phenomenon and control the temperature of the distal digits. 

Only 3 patients have received treatment to date. All were able to learn the 
technique; none had lasting benefit from treatment 



:-c040 



nu i n 



SMITHSONIAN SCIENCE INFORMATION EXCHANGE 
PROJECT NUMBER (Do NOT use this space) 



U.S. DEPARTMENT OF 
HEALTH, EDUCATION, AND WELFARE 
PUBLIC HEALTH SERVICE 
NOTICE OF 
INTRAMURAL RESEARCH PROJECT 



PROJECT NUMBER 



77-H-CC-114 



PERIOD COVERED 



2 years (.Tune, 1977) 



TITLc OF PROJECT (30 characters or less) 

Chest Wall Syndrome Masquerading as Coronary Artery Disease 



NAMES, LABORATORY AND INSTITUTE AFFILIATIONS, AND TITLES OF PRINCIPAL INVESTIGATORS AND ALL OTHER 
PROFESSIONAL PERSONNEL ENGAGED ON THE PROJECT 

Stephen Epstein, M.D., Chief, Cardiology Branch, NHLBI 

Naomi Gerber, M.D., Chief, Rehabilitation Department, CC 

Lamont Smith, RPT, Rehabilitation Department, CC 

Michael Green, MS, Chief, Applied Physics Section, Nuclear Medicine, CC 

Stephen Bacharach, Ph.D., Physicist, Applied Physics Section, Nuclear Mediciv 

Jeffrey Borer, M.D., Senior Investigator, NHLBI, CB 



COOPERATING UNITS (if any) 

Rehabilitation Department, CC 



LAB/BRANCH 

Cardiology 



SECTION 



INSTITUTE AND LOCATION 
NHLBI 



TOTAL MANYEARc 

2/5 



PROFESSIONAL: 

1/5 to date 



OTHER: 

1/5 to date 



CHECK APPROPRIATE BOX(ES) 
g (a) HUMAN SUBJECTS 

□ (al) MINORS 3 (a2) INTERVIEWS 



□ (b) HUMAN TISSUES 



□ (c) NEITHER 



SUMMARY OF WORK (200 words or less - underline keywords) 

Patients with chest pain and normal coronary arteries as demonstrated by 
radionuclide scan are evaluated for non-cardiac, musculoskeletal component to 
explain chest pain. '"' 

Several diagnostic manuevers are performed, and if diagnosis is musculoskeleta 
problem, patients receive treatment for this. 

Follow-up stress test for exercise tolerance will be done to assess efficacy 
of treatment. 



PHS-6040 



Rh-20 



July 1, 1976, through September 30, 1977 

PUBLIC HEALTH SERVICE, NATIONAL INSTTTOTES OF HEALTH 

SUMMARY OF ANNUAL REPORT OF PROGRAM ACTIVITIES 
CLINICAL CENTER 

SOCIAL WORK DEPARTMENT 

CONTENTS 

I . Mission and Goals. ,. SW-1 

II . Activities : SW-2 

Group Work SW-2 

Contract/Consultant - Staff Train ing. .SW-3 

Education '. SW-3 

Allergy and Infectious Diseases Social 

Work Section. SW-3 

Arthritis, Metabolism and Digestive Di s ea s e s 

Social Work Section SW-4 

Cancer Social Work Section SW-5 

Child Health and Human Development Social Work 

Section SW-6 

Heart, Lung and Blood Social^ Work Section SW-6 

Neurological and Communicative Diseases and Stroke/ 

Eye Social Work Sections SW-7 

III. Special Projects SW-7 

1. NTH Patient Emergency Fund SW-7 

2. Wig Contract SW-9 

3. Payment for Burial SW-9 

IV. Major Progress in Services Training and 

Development SW-9 

1. Department Reorganization SW-9 

2. Computerized Medical Information System SW-9 

3. Participation in Orientation, Training and 
Development SW-10 

4. Ccmmittee Representation SW-10 

5. Training SW-10 

6. On-Call System SW-10 

7. Licensing SW-10 

V. Future Objectives SW-11 



sw-i 



VI. STAFF PROFESSIONAL ACTIVITIES OUTSIDE THE CLINICAL CENTER, SW-11 
TABLES 

1. Inpatient Coverage by Percentage SW-13 

July 1975 through May 1976 

July 1976 through May 1977 

2. Number of Clients Provided with Social Vfork Services SW-14 

July 1976 through May 1977 

3 . Group Activity Report SW-15 

July 1976 through May 1977 

4 . NTH Patient Emergency Fund Expenditures SW-16 

July 1976 through June 1977 



SW-ii 



July 1, 1976, through September 30, 1977 

PUBLIC HEALTH SERVICE, NATIONAL INSTITUTES OF HEALTH 

SUMMARY ANNUAL REPORT OF PROGRAM ACTIVITIES 
CLINICAL CENTER 

SOCIAL WORK DEPARTMENT 

I. MISSION AND GOALS 

The Social Work Department's primary mission and goal is to support the 
clinical research mission of Clinical Center and to enhance the excellence 
of medical care. In collaboration with other professionals and disciplines, 
the depa rtme nt explores in depth the multi-faceted repercussions of chronic 
illness. In order to pursue these objectives, the staff identifies 
significant problems of chronic illness and works with patients and their 
families on an individual basis and through the group modality to help them 
deal more effectively with the emotional, environmental, and cultural 
conditions that can enhance or impede the course of treatment. With the 
support and help provided by the depa rtm ent's staff, patients are assisted 
to build networks of mutual support with their families, members of the 
hospital community, and, when they leave the hospital, to bridge the gap 
between the hospital and their home communities.. 

An important part of the department's missions and goals is its commitment 
to share with other social work professionals and with students the insights 
into medical social work it gains in the unique biomedical research setting 
of the Clinical Center. Thus, as part of its professional responsibilities, 
and as a corollary of its primary goals, the Social Work Depa rtm ent's staff 
participates in a variety of ongoing professional training, and the 
department carries on an active teaching pr ogr a m of graduate students in 
cooperation with universities. 

Number of Patients Provided with Service in Various Categories 

Each month the department reported on the number of patients and their 
family members served in four principal categories: (1) Preadmission -. 
services to persons before their acceptance as an outpatient or inpatient 
for admission to a Clinical Center project; (2) Inpatient - services to 
persons occupying a bed in the Clinical Center; (3) Clinic - services to 
persons under outpatient trea t ment who had never been inpatients; and 
(4) Follow-up - services to those outpatients who had been former inpatients. 



SW-1 



SUMMARY OF NUMBER OF PATIENTS SERVED 



CATEGORY 


: FY 1976 
: Patients Served 
July 1975 - May 1976 


: FY 1977 

: Patients Served 

: July 1975 - May 1976 




Number 


:% of Total 


: Number 


% Of Total 


Preadmission 


144 


2.0 


: 109 




• - 1.4 


Inpatient : 


5,240 


: 71.5 


5,513 




: 70.7 


Clinic : 


487 


: 6.6 : 


587 




7.5 


Follow-up : 


1,458 


19.9 


1,593 




20.4 


TOTAL 


7,329 


7,802 



For monthly services provided, percent of inpatients covered, and indirect 
services to clients, see Tables 1, 2, and 3. 

II. ACTIVITIES 

Group Work 

Group work modality continued to expand with the addition of four new groups. 
In all, 11 groups have been developed by the Social Work staff: (1) The 
Parkinson's Group (NTNCDS) ; this inpatient group was formed during FY 1976; 
since January 1977 the Group was extended to include outpatients and their 
families. (2) The Group Rap Sessions (NIAMDD) were established in FY 74 and 
continued to be an effective therapeutic medium which helped patients with 
systemic lupus erythematosus cope with the psychological manifestations of 
this illness. The group generally consisted of eight patients. (3) The 
Steroid Group was established in FY 75 and was comprised of six patients 
with various illnesses whose, common bond was steroid treatment. (4) The 
Sjogren's Group and (5) The Rheumatoid Arthritis Group (NIAMDD) were 
established in FY 77 for patients and their relatives. Combined, they 
represented 14 patients. (6) Special Ambulatory Care Patients' Group was 
started in FY 75 and continued to benefit patients housed in the United Inn 
Motel. These patients, housed off -campus, are cancer patients who suffer 
particular anxiety, isolation, and stress. (7) The Parents' Group of the 
Pediatric Oncology Service with a core group of five, continued for its 
fifteenth year, but was expanded because of the shift in patient population 
to include sizeable numbers of young adult patients with their special 
problems. (8) The 12-West Medicine Branch with 5 or 6 patients began FY 77 
for patients with cancer. (9) NCI Surgery Branch Outpatient Group with 
approximately seven patients weekly began in FY 77 for new cancer surgery 
, patients seen in the Screening Clinic. (10) The Radiation and Medicine 
■ Group for relatives of cancer patients began in FY 77 with 5 to 8 patients. 
(11) The Pediatric Oncology Group continued to meet with parents, patients, 
social worker and a physician. 



SW-2 



Oomtract/Consultant - Staff Training 

In FY 75, the department continued its consultant program to provide 
training and consultation in group work. Two-hour sessions were provided 
bi-monthly from September 1976 through June 1977 to 19 staff members and 
eight University of Maryland students and the department chief. With the 
staff's developing expertise in using the group modality, the participating 
staff wished to consolidate its experience with "groups" through writing 
and publications. As a result two additional hours a month for individual 
consultation were provided, and participating staff members led patient or 
family groups, or planned to initiate additional, new groups. 

Education 

For the second year the department continued its contacts with various 
colleges and universities; the department continued its collaboration with 
the graduate program of the School of Social Work and Community Planning, 
University of Maryland, Baltimore, and supervised eight students during 
FY 1977. 

This training commitment involved the teaching of casework and group work 
process, introducing the students into this complex setting, work with the 
University field advisor in bi-monthly conferences, and attendance at 
meetings of an inter-agency consortium. Nine staff members were involved, 
and as a result of the educational goals of the department a new "Student 
Handbook" was prepared by a committee. The department also participated 
in the Summer Student Program with a total of 11 students, three of whom had 
graduate degrees from the University of Maryland and the University of 
Alabama. Supervision was provided by various staff members in the 
department. 

Section Reports 

Allergy and Infectious Diseases Social Work* Section 

The department was fortunate to secure an experienced psychiatric social 
worker who can serve the considerable number of patients with deep seated 
psychological problems and, by virtue of her training as a nurse, also can 
understand the complicated medical aspects of diseases under study. Since 
her arrival, both the number of patients served and the quality of the 
service have substantially increased. The additional social work time was 
used for in-depth exploration of problems that helped more guarded patients 
to share their concerns and provided meaningful and consistent emotional 
support during their hospitalization. More time was available for follow 
through once the patients had left the Clinical Center. 

A protocol on insulin resistant diabetes increased the need for social work 
services. The protocol called for relatively short admissions (7-14 days) 
which required the social workers to move in rapidly to make a diagnostic 
assessment and treatment plan; furthermore, the complications that accompany 
diabetes required considerable support. Patients on this protocol came from 



SW-3 



the mid-western part of the United States and from all socio-economic 
levels, ages, races, and religions. A few had serious psychological problems, 
apparently unrelated to their diabetes and allergy, but nonetheless interfered 
with their optimal social functioning. 

Regular and intensive casework was necessary for another group of young adult 
patients whose illnesses were severe or life- threatening. This group of 
patients, despite their different diagnoses, shared a number of problems: 
illness had disrupted or radically altered vocational and career plans; 
illness had upset the normal timetable of their efforts to become self- 
sustaining adults, or had brought about a regression to earlier adolescent 
stages which was a source of great concern to both patients and their 
families; their illnesses necessitated unusually long periods of hospitaliza- 
tion and outpatient treatment. Regular and intensive casework was necessary 
for these young people and their families; the social worker helped them 
identify basic family patterns of interaction and understand how illness had 
cut across them. They were helped in working toward solutions to their 
difficulties that were at once realistic and emotionally satisfactory. 

The presence of a social worker was of particular importance during the 
termination phase of the Institute Director's protocols which had both 
practical and emotional repercussions for patients. The social worker 
reviewed the meaning of this event with all terminated patients, both in 
terms of losing important relationships with caretakers and in terms of 
problems in securing alternative medical care. This institutional attention 
helped to reduce patients' lingering sense of abandonment or rejection. 

Arthritis, Metabolism and Digestive Diseases Social Work Section 

Patients being followed by the Pediatric Metabolism Service were teenagers 
and young adults. For this group of patients career choice and marital 
relationships constituted the main focus of social work intervention. 

The main objective of social work staff on the Liver Service was to help 
defuse the anger against employers of patients who had sustained liver damage 
as a result of industrial exposure to polyvinyl chloride. 

The Social Work Department staff with the Arthritis and Rheumatism Service 
continued the programs with systemic lupus erythematosus, Sjogren's syndrome, 
mixed connective tissue disease, collcgen disorders, and rheumatoid arthritis. 
The social worker, as a member of the clinical team, focused on helping the 
individual patients utilize emotional, physical, and intellectual resources 
in coping with intrinsic problems endemic in chronic illness. 

To better understand and aid in the unit management of steriod- induced 
central nervous system lupus episodes of psychosis among the systemic lupus 
erythematosus patients, several interviews were videotaped with patients 
following their recovery in later months as they reflected on what was 
helpful or not for them during this psychotic period. The tapes were 
important learning aids. 



SW-4 



The Hematology Branch planned a comprehensive hemophilia diagnostic treatment 
pro g r am in which social work services would again be incorporated into the 
therapy program as it was several years ago. The group sessions, as well as 
individual casework services vaere designed to meet the special needs of this 
patient group and their families. 

Cancer Social Work Section 

During this reporting period the National Cancer Institute had a high inpatient 
census as well as a rapidly expanding outpatient clinic, both with a high 
incidence of seriously ill and dying patients. This Institute is complex 
with new configurations and realignments that involve frequent changes in 
personnel, protocols, patient populations, and disease entities. These 
conditions required a committed social work staff having utmost flexibility, 
expertise, and ability to set priorities to meet the multiple challenges. 

Comprehensive social work coverage was provided to the 12-bed Unit of the 
Metabolism Branch. Six patient and family groups were developed for in- 
and outpatients to meet the needs of the larger number of high-risk patient 
and family constellations. Of approximately 300 patients who participated 
in the Radiation Oncology protocols, all new radiation outpatients were seen 
by a social worker within one week of their initial work-up at the Clinical 
Center. About 100 of these patients were provided long-term casework 
services, and an additional 100 were screened arid provided brief services as 
indicated at same point during their treatment program. 

From the beginning of FY 77, one worker has seen on an individual or family 
basis all the patients and families who came to the Surgery Branch clinic 
for the first time. The purpose of this intervention was to provide an 
orientation to the Clinical Center and to assess these patients' psycho- 
social functioning. 

As part of the department's ongoing educational commitment, four summer 
students (graduate) here for a three-month period, were assigned to work in 
the outpatient clinic to gain more adequate data to more effectively evaluate 
the needs of patients and families, effective treatment modalities, and the 
most significant and appropriate points of intervention. 

The stress occasioned by the large number of seriously ill and dying patients 
and the grief experienced by patients, family members, and staff required 
frequent psychological consultation to assure the highest quality of 
comprehensive psychosocial and medical care. 

Social Work Department staff participated in the regularly scheduled inter- 
disciplinary meetings on the Pediatric Oncology Unit with a psychiatric 
' consultant. Parallel meetings were held with the nursing staff and social 
worker on the Surgery Branch. These meetings provided a forum in which to 
discuss difficult patient problems and staff feelings in this stressful 
milieu and to arrive at improved ways of coping by staff, patients, and 
families. 



SW-5 



The Cancer Social Work Section met on a bi-monthly basis to make a broad 
review of the problems of patients and their families and to develop new ways 
to meet these problems more effectively. These reviews facilitated meeting 
such problems as: the transfer of all Ewing's Sarcoma patients from the 
Radiation Branch to the Pediatric Oncology Service. In this instance, 
families needed help to cope with the change in physicians and the disruption 
felt by patients transferred to another service. The social work staff 
worked with families' and patients' anxieties when medical services changed 
with the change in protocols. Such a change, although necessary, places a 
strain on patients and their families in addition to that caused by their 
illness. 

Protocols change and new ones are added. An example of the latter is the 
testicular cancer project begun in FY 77 which will enlist a total of 300 
patients in the next three years. The Social Work Department staff, using 
the group and individual intervention modalities, will have to deal with the 
chemotherapy regimen and its inevitable devastating side effects, the 
psychological impact of the diagnosis for these young men, the resultant 
sterility, and the identity crisis resulting from their impaired sexual 
functioning. Ongoing emotional support as well as knowledgeable sexual 
counseling is essential for this group of patients. 

Child Health and Human Development Social Work Section 

This Institute involved three Branches: the Reproduction, Endocrinology and 
Pediatric Branch. The major objective for the first two Branches was to 
continue social work services and coverage which was accomplished through 
multidisciplinary conferences and constant cooperation with the nursing staff. 
Psychiatric consultations enabled the staff to discuss frankly their negative 
feelings about demanding and/or terminally ill patients and in the long-run 
improved overall patient care. 

The Pediatric Branch recruits patients from other Institutes, and these 
pediatric patients require specialized care. The social work staff member 
provided service to all these patients and families regardless of diagnosis. 

Heart, Lung and Blood Social Work Section 

The retirement of the program supervisor and maternity leave of another 
staff member resulted in an increased burden for the three staff members in 
this Social Work Section. An effective change was made in social work 
coverage on Cardiac Surgery and the Diagnostic Cardiology Branch - two 
workers were assigned to each Service. Patients were divided between the 
two workers, and an individual patient was followed by one worker throughout 
his hospitalization. Thus, if a patient became a surgical candidate later, 
a relationship had already been established. This plan was facilitated by 
the fact that both workers had participated in twice weekly rounds with the 
clinical team of all patients. The social worker was the person who provided 
continuity of service, assisted in the transition from a medical to a surgical 
unit, and helped prepare the patient insofar as possible for the surgical 
experience. 



SW-6 



In the Molecular Hematology Branch the social worker's main focus was the 
patients' and relatives' reactions to the severe emotional and physical 
effects of chronic illness. Patients' and families' depression, anxiety, 
family and marital conflicts, role reversals, and need for supportive 
community resources were of central concern. 

Other illnesses, such as suspected factitious hypokalemia required a 
systematic psychological-psychiatric evaluation program to provide a clearer 
picture of the illness in emotional and physical terms. Social workers could 
then help patients deal with their self -induced illness. 

Neurological and Communicative Diseases and Stroke/Eye Social Work Sections 

Because of many changes in personnel in the Neurology Social Work Section, 
stop-gap measures were necessary to provide coverage on this Service. 
Primary goals of this Section ware: (1) to help patients and families deal 
more effectively with the social, environmental, and personal problems 
occasioned by their illness; (2) to enhance the patient's ability to improve 
his "quality of life"; and (3) to establish closer working relationships 
among social workers, nurses, rehabilitation personnel, and physicians. 

On Medical Neurology, social workers had more visibility and participated in 
weekly Medical Neurology and Multiple Sclerosis Branches rounds and attended 
a special weekly meeting with the Medical Neurology associates, nurses, and 
physical therapists. There were, in addition, weekly grand rounds alternating 
between the two Units. Teaching rounds ware also initiated to provide an 
opportunity for social workers to make contributions of their expertise to 
patient care. 

The preparation and filming of the Surgical Neurology's Parkinson group as 
an educational instrument was a rewarding experience for patients and spouses, 
and most importantly, the group felt exhilarated about making a significant 
contribution . 

Social work responsibilities to the National Eye Institute was on a referral 
basis. Social workers emphasized coordination of activities with all 
professional disciplines. The major social work goal was the identification 
of community and national resources for the visually handicapped so that 
patients and families would be knowledgeable about the services available to 
them designed to facilitate their adjustment to visual loss. 

III. SPECIAL PROJECTS 

NTH Patient Emergency Fund 

This fund, administered by the department Chief, continued to serve a crucial 
need in providing services and emergency funds for Clinical Center patients 
and families which could not be paid out of Government appropriations. This 
*fund is financed by donations from former patients, family members, friends 
4 of patients, and NTH employees. 



SW-7 



One special source of income was the annual gift from NIH employees at 
Christmas time under the "Davis Plan" whereby employees donated to the NIH 
Patient Emergency Fund in lieu of sending Christmas cards to fellow employees. 
The Christmas "Davis Plan" drive totaled $6,091.24 for FY 1977. 

During the period from July 1976 through June 1977, the five principle areas 
of expenditures from the Patient Emergency Fund and the amounts spent were: 

Special programs (nursing unit parties, supplies, etc.) $ 4,317.50 

Patient transportation 1,073.25 

Allowance to relatives to assist with living costs 37,052.68 
while visiting Clinical Center patients 

Patient miscellaneous expenditures (clothing, 1,707.63 

special devices) 

Basic necessities (small weekly spending allowance 1,327.50 
for patients without funds) 

TOTAL ANDUNT SPENT (July 1976 through June 1977) $45,478.56 

The balance in the fund as of July 1, 1977, improved markedly over July 1, 
1976; however, compared with the July 1, 1975 balance, much ground remained 
to be regained. 

BALANCE AS OF JULY 1 1977 1976 1975 



$10,000 $ 6,300 $18,400 

Patients and family members assisted: 

AS OF JULY 1 1977 1976 1975 

Total 

NCI 

Other Institutes 

Contributions to the fund (deposits) in 1977 increased significantly over 
1976. 

1977 1976 1975 



306 


278 


425 


154 


169 


189 


152 


109 


236 



$49,000 $35,700 $38,100 
Withdrawal from the fund in 1977 declined slightly from 1976. 

1977 1976 1975 

$45,500 $47,900 $52,600 



SW-8 



average expenditure (withdrawal) per beneficiary (patient or family 
member).. 

1977 1976 1975 



$150 $172 $124 

The weekly cost for room and board averaged about $80.00 to $84.00. The food 
allowance of $4.00 a day was raised to $5.50 in May 1977, and was based on 
Clinical Center cafeteria prices. This was in contrast to those patients on 
the Special Ambulatory Care Program who received a $9.00 a day food allowance 
in the same period. 

See Table 4. 

Wig Contract 

The contract for Clinical Center patients' wigs continued to be administered 
through the Social Work Department and approximately 400 wigs, adult and 
child, costing $30,500, were processed in a 12-month period. Staff members 
were involved in making the arrangements with the patient and provider, and 
helped handle their feelings of loss and change in their self-image. 

Payment for Burial 

In May 1977 the Social Work Department was given the responsibility to decide 
whether a full or partial contract was required for patient's burial expenses. 

IV. MAJOR PROGRESS IN SERVICES, TRAINING AND DEVELOPMENT 

Department Reorganization 

The department was reorganized to provide for greater efficiency with positions 
for a deputy chief and two program supervisors who would share administrative 
and supervisory responsibility for the various Institutes. The department 
however still faces growing work loads with the ever increasing numbers of 
outpatients and increasing newly instituted protocols of the Cancer Institute 
in addition to their ongoing protocols. 

Computerized Medical Information System 

MIS became operative on several nursing units, and the depa rt ment was able 
to begin to evaluate our social work software program and to incorporate 
needed revisions. Several reports were reviewed to ascertain the quality 
and utilization of the system. On the whole, reports contained rich 
information and were redeemed from a "canned" quality by the judicious use 
of typed comments. Workers used the system without undue difficulty and learned 
to report economically and fluently. Once Technicon delivers to us the 
ability to report in a five day period after a patient has been discharged, 
we expect the system to work smoothly and well for us. A VMT and printer 
were installed for the Social Work Department, 



SW-9 



Participation in Orientation, Training, and Educational Programs 

Four major new patient/family groups were added making a total of eleven 
groups in an expansion of this important social work modality. 

Social Work Department staff provided training to Clinical Center Departments 
and hospital personnel, e.g., the clinical associates, nurses and student 
nurses, Hematology Section, technologists, Spiritual Ministry, Pharmacy, and 
Patient Activity Section, as to the psychosocial aspects of various illnesses, 
work with the dying patient, the needs of infants and parents, and the 
effects of genetic handicaps upon patients and families. 

Committee Representation , 

__ 

There was wider representation on Clinical Center committees which broadened 
staff's perspective and provided an opportunity to make a contribution 
within the hospital system. The Social Work Department broadened its 
contribution within the hospital through wider representation on Clinical 
Center committees 

Training 

Eleven staff members participated in professional training courses. Two 
secretaries attended the Upward Mobility College. Four staff members 
attended national social work meetings. 

Major professional activities of staff members as listed in the Appendix 
reflected a wide-range of professional expertise among the department's 
staff members, and recognition by their professional groups at both the local 
and national level. These activities were essential to keep abreast of 
changes in the health field and social work practice, and to communicate to 
others the special social work role in the research setting of the Clinical 
Center. 

On-Call System 

To increase the efficiency of coverage by the Social Work Department, as of 
May 1977, the department staff formalized its "on-call" system for evenings 
and weekends. Workers were provided beepers, and all inquiries, requests, 
and subsequent action by the Social Work Department were documented to 
evaluate the kinds of services rendered. 

Licensing 

This year the State of Maryland required licensing of social workers "to 
protect the public by setting standards of qualifications, education, training 
and experience for those who seek to engage in the practice of social work and 
by providing high standards of professional performances for those engaged in 
the profession of social work". Although not required of social workers 
employed by the Federal government, all staff members with the exception of 
two who were licensed in New York, either were licensed or their applications 
Were pending. 

SW-10 



V. FUTURE OBJECTIVES 

1. The outpatient department has never been adequately covered, but with the 
increased numbers of outpatients, increased professional staff will be 
required to meet the full-range of responsibilities satisfactorily. 
During FY 1977, approximately one- third of staff time was devoted to 
services to outpatients which did not begin to meet the documented need 
on the Cancer Institute. 

2. Improved "accountability" through the Medical Information System, 
updating the statistical reporting system and developing quality and 
quantity assurance, including professional review procedures. 

2>. Continued exploration of strategies for increasing funds for the NIH 
Patient Emergency Fund. 

4. Development of a retrieval mechanism to assemble aggregate data from 
Medical Information System with which to evaluate program planning for 
improved patient care. 

5. In addition to its monitoring of sample reports, the MIS cadre began to 
draft a paper on our department's Medical Information System Program 
which will be of use to the department and the profession as a whole. 

6. Increased integration and improvement of the student training program. 

7. Publish material about Clinical Center patient and family groups for the 
25th anniversary of Clinical Center and the Social Work Department. 

8. Long-range goals include social work research relative to the psycho- 
social dimension of chronic illness. 

9. On NICHD Pediatric Branch, interdisciplinary weekly meetings continued 
to be helpful for optimal planning on behalf of patients. The staff 
were in the process of addressing the issue of preadmission contact 
between the unit and new patients and their families who might not know 
what to expect of an NIH pediatric admission. As a result of these 
meetings, a booklet is being designed to answer some of the structural 
and process questions. Also, plans for the future include a regularly 
scheduled parent group meeting to include all parents whose children are 
on the Pediatric unit regardless of diagnosis. In addition, specially 
structured intervention is planned for special diagnostic groups and 
their families. 

VI. STAFF PROFESSIONAL ACTIVITIES OUTSIDE THE CLINICAL CENTER 

Mrs. T.ihby E. Ely 

Panelist, Georgetown University School of Nursing and Continued Education, 
workshop entitled "Health Care of Persons with Lupus Erythematosus", November 
11, 1976. 



SW-11 



Mrs. Kathryn K. Himmelsbach 

Member, NCI Clinical Research Committee Subpanel. 

Member, Program Evaluation Committee, American Cancer Society, D.C. Chapter. 

Member, Social Workers' Sub-Committee, American Cancer Society, D.C. Chapter. 

Member, Board of Directors, American Red Cross, Montgomery County Chapter. 

Member, Executive Committee, American Red Cross, Montgomery County Chapter. 

Vice-Chairman, Service to Military Families Committee, American Red Cross, 
Montgomery County Chapter. 

Member, Ladies' Board, Georgetown University Hospital. 

Member, Washington Hospice Society, Inc. 

Panelist, Community Cdncer Education Day, Howard University, subject - 
"Social Work with the Breast Cancer Patient and Family". 

Panelist, St. Mary's College Seminarians, Baltimore, Maryland, subject - 
"Work with Death and Dying" . 

Panelist, American Cancer Society Second Annual Conference in Human Values 
and Cancer Patient, Chicago, Illinois, September 8, 1977. 

Panelist, Oral Cancer Society, Georgetown University Dental School, sponsored 
by the American Career Society of D. C. , subject - "Medical and Psychosocial 
Aspects of Head, Neck and Mouth Cancer". 

Mrs. Ruth W. Kaneshiro 

Member, National Association of Social Work Abstract Committee. Abstracts 
written for the quarterly journal, Abstracts for Social Work from The Journal 
of Nervous and Mental Diseases . 

Miss Marjorie E. McKinney 

Member, Executive Board of Leukemia Society of America. 

Miss Barbara A. Murphy 

Member, Subcommittee for Social Workers of the Career Development Committee 
for Health Service Officers. 



SW-12 



TABLE I 
SOCIAL WORK 
INPATIENT COVERAGE BY PERCENTAGE 
JULY 1975 throucfo MAY 1976 



INSTITUTE 


INPATIENT CENSUS 


INPATIENTS SERVED 


PERCENT COVERAGE 


NCI 


2,541 


1,715 • 


67.5 


NHLBI 
NICHD 


2,290 


1,885 


82.0 


NIAID 


703 


317 


45.0 


NIAMDD 


757 


622 


82.2 


NINCDS 
NEI 


1,053 


701 


66.6 


TOTAL 


7,344 


5,240 


71.4 



JULY 1976 through MAY 1977 



INSTITUTE 


INPATIENT CENSUS 


INPATIENTS SERVED 


PERCENT COVERAGE 


NCI 


2,987 


1,846 


61.8 


NHLBI 
NICHD 


2,248 


1,743 


77.5 


NIAID 


904 


498 


55.1 


NIAMDD 


927 


710 


76.6 


NINCDS 
NEI 


1,237 


716 


57.9 


TOTAL 


8,303 


5,513 


66.4 



SW-13 



TABLE 2 
NUMBER OF CLIENTS PROVIDED WITH 
SOCIAL WORK SERVICES 
JULY 1976 through MAY 1977 





(1) 


(2) 


(3) 


(4) 


TOTAL 
CC 

PATIENTS 


TOTAL 


sw 

SEC. 


CC 

^ATTKNT 


FAMILY 
MRMRRR 


CC 

PATTRNT 


FAMILY 

MRMRTTR 


CC 

PATTEN" 


FAMILY 

P MEM 


CC 

PATTFNT 


FAMILY 
MEM. 


FAMILY 
I MEMBER 


1976 


6 




544 




25 




118 




-693 




JUL 




2 




284 




10 




44 




340 


AUG 


12 




526 




30 




182 




750 






4 




311 




10 




55 




380 




12 




516 




87 




147 




762 




SEPT 




2 




335 




37 




60 




434 


OCT 


19 




495 




28 




198 




740 






11 




352 




20 




58 




441 


NOV 


6 




469 




21 




147 




643 








1 




315 




21 




45 




382 


DEC 


10 




417 




20 




156 




603 






3 




292 




12 




51 




358 


1977 


5 




485 




28 




169 




687 




JAN 








273 




22 




68 




363 


FEB 


9 




501 




94 




115 




719 






4 




311 




17 




67 




399 


MAR 


16 




533 




92 




119 




760 






5 




325 




32 




44 




406 


APR 


1 




• 494 




95 




108 




698 






1 




318 




31 




37 




387 


MAY 


13 




533 


391 


67 




134 
1593 


50 


747 








1 






32 
244 


474 




109 




5513 




587 


579 


7802 








34 




3507 


4364 



(1) PREADMISSION 

(2) INPATIENT 

(3) CLINIC 

(4) FOLLOW-UP 



Service between acceptance for project and admission. 
Person occupying a CC bed at any time during the month. 
Service where patient has never been an inpatient. 
Service to former inpatient. 



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&4 



July 1, 1976 through September 30, 1977 



PUBLIC HEALTH SERVICE, NATIONAL INSTITUTES OF HEALTH 

SUMMARY ANNUAL REPORT OF PROGRAM ACTIVITIES 
CLINICAL CENTER 

DEPARTMENT OF SPIRITUAL MINISTRY 



CONTENTS 

Overview SM-1 

Staff SM-1 

Chapel Service SM-2 

Pastoral Ministry to Patients and Their Families SM-3 

Work with Staff SM-5 

Research Committees SM-5 

EEO SM-5 

Education and Training SM-6 

Consultation SM-6 

Lectures SM-6 

Professional Meetings and Training SM-6 



SM-i 



July 1, 1976 through September 30, 1977 

PUBLIC HEALTH SERVICE, NATIONAL INSTITUTES OF HEALTH 

SUMMARY ANNUAL REPORT OF PROGRAM ACTIVITIES 
CLINICAL CENTER 

DEPARTMENT OF SPIRITUAL MINISTRY 

OVERVIEW 

The basic task of the Department was to provide spiritual ministry to 
patients and their families who welcomed the ministrations of a clergy- 
man and to hold religious services in the hospital. It also included 
acting as liaison with religious groups not represented by the staff 
chaplains. Fundamental to this task was the bedside ministry to patients 
and family members and the religious services held in the fourteenth 
floor Chapel. Other tasks of the Department included consulting with 
fellow staff members of the Clinical Center, attending multidisciplinary 
conferences, membership on research committees, working with the Clinical 
Center EEO Advisory Committee, participating in educational and orientation 
seminars, lecturing, and consulting with other clergy and community groups. 

As patients and their families experienced the crises of coming to the 
hospital, being seriously ill, anticipating surgery or other therapies, 
leaving the hospital, and, for some, facing death, the department endeavored 
to "rejoice with those who rejoice and weep with those who weep" as a 
religious friend, guide, and counselor. 

Statistics indicated the following average religious preferences of newly 
admitted patients: Jewish - 7%; Catholic - 26%; Protestant and others - 
67%. 

STAFF 

Chaplain LeRoy Kerney served as Chief of the Department and as a Protestant 
Chaplain. Chaplain Robert White and Chaplain William Payne were the other 
Protestant Chaplains. 

Father Eugene Linehan, S.J. served in the hospital on a five day basis 
with Father Michael Griffin and Father Vincent O'Brien serving on days 
not covered by Father Linehan. Assistance during the day was increased 
in the new contract to allow for several part-time priests to bring an 
additional twenty hours of coverage to patients and their families. 



SM-1 



Mrs Emma Ditman who is certified as a Pastoral Associate provided volunt^ 
service A small group of seminarians from the School of TheoWv Catholi 
Unxversxty, came for supervised training during the school year! 

^usMl'igyf^N 15 "?' : h ° haS SerV6d ° n a half ~ time basis, retired 
August 31, 1976. Negotxations were successful in arranging a half-tim* 

position at the Clinical Center and a half-time position at St Elizabeth's 

Hospital. Rabbi Joseph Levine was appointed to these position; August 1977. 

CHAPEL SERVICE 

Regular chapel services were held during the vear fnr th a m o-;„ f .- 

Mrs. Frances Viernstein was our Sunday Chap^/organist ^ ^ ^^ 

These services were: 
Protestant 



Catholic 



Jewish 



Sunday, 10:00 a.m. Holy Communion Service, 
the first Sunday of each month. 

Sunday and weekdays, 11:15 a.m. Daily distribution 
of Communion to bedridden patients. 



1 



Friday, 4:30 p.m. 
In addition to the regular services, these special services were held; 

Protestant : World Wide Communion - 1st Sunday in October 
Thanksgiving Day Service 
Christmas Carol Service 
Christmas Day - bedside visitation 
Good Friday Service - (participation by Protestant 
and Catholic clergy and patients) 



Catholic 



Jewish: 



Holy Days of Obligation Mass 
Special Blessing of Throats 
Distribution of Ashes - Ash Wednesday 

Rosh Hashana Sukkoth 
Yom Kippur Chanukah 
Memorial Services 



Purim Shavuoth 
Passover 






( 



CHAPEL SERVICE 

Noted Js'thelac^^hat ^ 63 V"? r6S ° UrCe f ° r b ° th P atients **d ***f, 
attendance at 11 'is f ^ ?' Patlent Clin±C de velops, so does the 
attendance at 11.15 service. It supplies for these patients spiritual 



SM-2 



i 



nourishment and the sense of Community sorely needed for so many filled 
with the anxiety of treatment. Today's Liturgy is much richer in terms 
of Feast Days and the varied Bible Readings so that it contributes 
mightily to our Catholic Pastoral Care. 

Patients, family and staff have remarked that some of their most meaningful 
worship experiences have occurred during their stay here. In the Clinical 
Center there is among patients a deeper awareness of a sense of community 
and caring, and a freedom to express their deepest concerns with the 
assurance that here they are understood and accepted. Although those who 
attend may be almost complete strangers prior to worship, they discover 
the reality of what it means to be part of the body of Christ and the truth 
of Paul's comment: "If one member suffers, all suffer together; if one 
member is honored, all rejoice together". (I Cor 12:26) Chaplains find 
that through our worship together we are continually refreshed and renewed, 
strengthened and supported, as those who worship together share their 
concerns, their courage, and their faith. 

PASTORAL MINISTRY TO PATIENTS AND THEIR FAMILIES 

The department attempted, when possible, to have a staff member visit all 
patients prior to major surgery, patients who were on the seriously ill 
list, and families of patients who died. All Catholic patients were 
contacted through the sacramental ministry of the Catholic chaplain. The 
Jewish chaplain was able to see all the patients of the Jewish faith. Most 
of the Protestant patients were visited. Priority was given to the terminally 
ill, the seriously ill, and those scheduled for surgery. All referrals by 
staff, relatives and pastors, as well as direct patient requests were seen. 
Clergymen from the community were called upon to minister to special 
patients, e.g., patients requesting special rites from clergymen of their 
own denominations. These included several Greek Orthodox priests who 
were routinely called to minister to the Greek-speaking patients. 

Pastoral problems which the chaplains encountered included: loneliness, 
grief, fear, guilt, anxiety, loss of spiritual meaning, boredom, identity 
crisis, and changes in body- image and body-function. Pastoral methods 
included pastoral conversations, pastoral counseling, sacraments, blessings, 
prayer, scripture, and worship. On occasion, the chaplains helped patients 
and their families resolve dilemmas of conscience, conflicts of values, 
and difficulties in accepting radical therapies. 

All members of the staff endeavored to be sensitive to the patient's own 
understanding of religion for himself, and, in turn, become a resource 
person' for the patient to discover or rediscover his own spiritual strength. 

The complex work of a chaplain calls for familiarity with the medical 
situation, medical knowledge, sensitivity to emotional issues, and work with 
staff and family, and is illustrated by the following stories: 

A patient facing an open heart operation had left her husband and twelve- 
year-old daughter and was in the process of seeking a divorce. The day of 
the operation the husband appeared unexpectedly and waited in the solarium 

SM-3 



opposite the patient's sister and brother-in-law. They were unwilling to 
speak to each other. The tension and anger was sensed by others in the 
solarium. 

The twelve-year-old daughter was at her father's house waiting to hear the 
outcome of her mother's operation. 






In talking with the husband and then with the sister the Chaplain sensed a 
problem if the patient did not survive. The sister had not been permitted 
to speak to the child (her niece) in the past six months of the estrangement 
If her mother died, the child would need the support of her mother's family 
as well as her father's. On the other hand, if the patient survived, the 
post-operative period would be more difficult if the present tension and 
bitterness were not relieved. 

Through several discussions with both parties the Chaplain was able to assist 
them in laying aside their differences temporarily for the sake of the 
child's welfare and they began to plan together with the Chaplain's assistanc 
how they might both talk with the child on the telephone once the word came 
from the doctor. 

Through the long day, they gradually and painfully made a kind of peace. 
Good news came and they all talked to the child. During the days of 
recuperation the child visited regularly and all the family maintained the 
truce. 

The sister was gratified that she could now have a normal relationship with 
her niece and the patient and her husband began to verbalize some of their 
problems and an awareness that they should not let their child become 
"a football" in their marital dispute. 

The Chaplain felt that the patient's recovery was uneventful partly because 
the tension within the family had been greatly reduced. The husband continue 
to contact him after the patient's discharge for guidance in the marital 
dispute. 

A social worker requested a Chaplain visit a young boy with a terminal illness 
who wanted to talk to a Chaplain. He wanted to read the Bible and pray 
but didn't know how to do either. He was visited regularly and talked 
about his concerns, about his loneliness, about death and how he had 
difficulty going to sleep because he was afraid he wouldn't wake up. The 
Chaplain shared with him in many ways. He taught him the 23rd Psalm and 
discussed its meaning, talked about prayer and how one could talk to God just 
like we talk to each other, and then, after praying together they played 
checkers and just talked. He also took some pictures of the patient for 
the patient so that he would have some to send home to his family. The 
meaning of the relationship was typified in the patient's remark to one of 
the staff, "That chaplain guy, he really likes me." 



A Chaplain became involved with an amputee, who had one thoracotomy and was 
undergoing a difficult series of chemotherapy treatments. During one treat- 
ment procedure the staff informed the patient that the scan had shown a 



SM-4 



|! 



tumor on his other lung which interrupted the chemotherapy. He was faced 
with the decision about further surgery. He became very emotional (a reaction 
which his mother had never seen before) and even said some angry things 
about God and the patient wondered where he was in all of this. The mother 
spoke with the chaplain, but the patient avoided him for several days saying 
he didn't want to talk about it. In one of the conversations with the 
mother, the chaplain told her that he certainly could understand her son's 
anger: reading Scripture made it clear that many of God's people became 
angry with God and even cursed the day they were born. The Chaplain pointed 
out that it was really only people who had faith who could get angry with 
God. She told the chaplain later that when she shared this conversation 
with her son, he smiled for the first time in a long while. It was a 
revelation to the young man and opened up the possibility for him to deal 
with his feelings and concerns more openly and honestly. 



Pastoral Ministry statistics for two typical months 'follow: 

Protestant Catholic 



Admissions October 1976 
February 1977 



Discharges October 1976 
February 1977 



Pre-Ops 



Seriously 
111 

Deaths 



October 
February 

October 
February 

October 
February 



Jewish 



340 


(67%) 


132 


(26%) 


37 


(7%) 


319 


(68%) 


120 


(26%) 


28 


(6%) 


381 


(70%) 


122 


(23%) 


39 


(7%) 


322 


(70%) 


116 


(25%) 


22 


(5%) 


67 




20 




11 




67 




34 




5 




7 














2 




2 









13 




6 









4 




6 










WORK WITH STAFF 

Group seminars with staff members dealt with family, emotional, and treat- 
ment problems. Staff attended a number of weekly multidisciplinary meetings, 

Frequent, informal consultation with nurses, doctors, and social workers 
concerning a particular patient's progress and condition was helpful in 
carrying out an effective plan of pastoral care and visitation. 

RESEARCH COMMITTEES 

Chaplain Kerney was a member of the National Institute of Mental Health 
research review committee. 

EEO 

Chaplain White received an EEO Award for his service as a member and 
chairperson of the EEO Advisory Committee. 



SM-5 



EDUCATION AND TRAINING 

Chaplain Kerney participated on a panel on "Terminal Illness" with student 



nurses , 



Chaplain Kerney met with a group of seminarians from Wesley Theological 
Seminary, a group of college students from Baltimore and two visiting 
Catholic Sisters from a college in Virginia. 

Chaplain White participated in the monthly orientation of new nursing 
staff conducted by the Nursing Education and Training Department. 

Chaplain White participated on a panel on "Death and Dying" in a Clinical 
Nurse Seminar. 

CONSULTATION 

Chaplain Kerney served on a committee to evaluate clinical pastoral educatio 
students at Walter Reed Army Hospital. 

Chaplain Kerney served on a nominating committee for the selection of a 
chaplain at Suburban Hospital, Bethesda, Maryland. 

Chaplain Kerney served on a task force of the College of Chaplains, a divisii 
of the American Protestant Hospital Association to evaluate and recommend 
changes in the organization. 



LECTURES 



I 



Chaplain White lectured and led a discussion on "Living With the Dying" 
at Grace Presbyterian Church in Springfield, Virginia. 

Father Linehan spoke to the ecumenical ministerial organization of Rockville 
on the ministry of the Department of Spiritual Ministry. 

Father Linehan lectured to the local Jesuits on "Death and Dying." 

Chaplain Kerney lectured and participated on a panel on "Ministry to the 
Heart Patient" at the Veterans Hospital in Baltimore, Maryland. 

PROFESSIONAL MEETINGS AND TRAINING 

Chaplain White was an elected commissioner to the annual meeting of the 
Synod of the Piedmont United Presbyterian Church. 

Chaplain White attended a symposium on the Nature of a Humane Society at 
the University of Pennsylvania. 

Chaplain White participated in the Supervisory Training Program course 
on "Motivational Dynamics." 



SM-6 






i 



\ _ 



Chaplain White attended an International Task Force Seminar-Retreat on 
the North American/Third World Church, Washington, D. C. 

Father Linehan attended the Third Annual Institute on Theological Concerns 
of the Health Apostolate, New York, New York. 

Chaplain Kerney attended the annual meeting of the College of Chaplains, 
a division of the American Protestant Hospital Association, Cincinnati, 
Ohio. 

Chaplain Payne attended a one day lecture/demonstration by Virginia Satir 
at the University of Maryland. 



SM-7 



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