Full text of "Documentation planning for the U.S. health care system"

DOCUMENTATION

PLANNING FOR THE

U.S. HEALTH CARE SYSTEM

DOCUMENTATION

PLANNING FOR THE

U.S. HEALTH CARE SYSTEM

Edited by

JOAN D. KRIZACK

THE JOHNS HOPKINS UNIVERSITY PRESS

Baltimore and London

For Rebekah (who's always first in my book), \)^0

Nanny, Dapes, Carol, Barbara, Marc, and Rocky. I ^ O A

Printed in the United States of America on acid-free paper

The Johns Hopkins University Press
2715 North Charles Street
Baltimore, Maryland 21218-4319
The Johns Hopkins Press Ltd., London

Library of Congress Cataloging-in-Publication Data

Documentation planning for the U.S. health care system / edited by Joan D. Krizack.
p. cm.
Includes bibliographical references and index.
ISBN 0-8018-4805-9 (acid-free paper)

1. Archives, Medical — United States. 2. Medical records — Management — United
States. I. Krizack, Joan D.
R1I9.8.D63 1994

651.5'04261'0973— dc20 94-9566

CIP

A catalog record for this book is available from the British Library.

JOHNS HOPKINS

The Johns Hopkins University Press

2715 N.Charles street
Baltimore MD 21218-4363

Anieriai's Oldest University Press / Founded 1878

TRANSFER OF COPYRIGHT

For a good and valuable consideration, the receipt of which is acknowledged, The Johns Hopkins
University Press, 2715 North Charles Street, Baltimore, Maryland 21218, sells, assigns and
transfers to Joan D. Krizack of Northwestern University, Boston, Massachusetts, the
copyright to the book entitled Documentation Planning for the US Health Care System,
authored by Joan D. Krizack, with all literary property right, title and interest to and in the .
aforementioned book. The United States Copyright Registration is dated 20 May 1994, and the
registration number is TX 3-826-644.

IN WITNESS WHEREOF, I have executed this instrument in Baltimore, Maryland on
March 8, 2000

THE JOHNS HOPKINS UNIVERSITY PRESS

fs D. Jordan [ ,
Director, The JohnsHopkins Univershy Press

ACCEPTED

n D. Krizack \

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CONTENTS

List of Contributors vii
Acknowledgments ix
Introduction, Joan D. Krizack xi

CHAPTER 1

Overview of the U.S. Health Care System, Joan D. Krizack 1

CHAPTER 2

Facilities That Deliver Health Care, Joan D. Krizack 13

CHAPTER 3

Health Agencies and Foundations, Peter B. Hirtle 43

CHAPTER 4

Biomedical Research Facilities, Paul G. Anderson 73

VI CONTENTS

CHAPTER 5

Educational Institutions and Programs for Health Occupations,
Nancy McCall and Lisa A. Mix 1 07

CHAPTER 6

Professional and Voluntary Associations, James G. Carson 149

CHAPTER 7

Health Industries, James J.Kopp 181

CHAPTER 8

Documentation Planning and Case Study, Joan D. Krizack 207

APPENDIX A

Selected Landmarks in the History of Health Care
in the United States 237

APPENDIX B

Health-Related Discipline History Centers 241
Index 253

LIST OF CONTRIBUTORS

Paul G. Anderson, Ph.D., Associate Director for Archives and the History
of Medicine, Washington University School of Medicine, St. Louis,
Missouri

James G. Carson, Ph.D., Independent Archival Consultant, Chicago, Illi-
nois, and former Curator of the American Medical Association Historical
Health Fraud Alternative Medicine Collection

Peter B. Hirtle, M.A., M.L.S., Archives Specialist, Technology Research
Staff, National Archives and Records Administration, Washington, D.C.

James J. Kopp, Ph.D., Vice President, Library Systems, P.S.S., Ltd., Reston,
Virginia

Joan D. Krizack, M.A.T., M.S., Hospital Archivist, Children's Hospital,
Boston, Massachusetts

Nancy McCall, M.L.A., Archivist, the Alan Mason Chesney Medical
Archives, the Johns Hopkins Medical Institutions, Baltimore, Maryland

Lisa A. Mix, M.L.A., Processing Coordinator, The Alan Mason Chesney
Medical Archives, the Johns Hopkins Medical Institutions, Baltimore,
Maryland

VII

ACKNOWLEDGMENTS

My first debts of gratitude are to the National Historical Publications and
Records Commission, which funded this project, and to the Andrew J.
Mellon Foundation, the Research Division of the National Endowment for
the Humanities, and the University of Michigan for funding earlier re-
search on hospitals. A special thanks is due to Andre Mayer for his
insightful criticism and unflagging support throughout. I also wish to
thank fellow archivists who offered advice and encouragement: Frank
Boles, Megan Sniffin-Marinoff, David W. Nathan, Jeffrey L. Storchio,
Joan Warnow-Blewett, and Nancy W. Zinn. Thanks to Helen W. Samuels
and the Mellon group: Bruce H. Breummer, Bridget Carr, Terry Cook,
James M. O'Toole, and D. Gregory Sanford, for stimulating discussions of
functional analysis which resulted in refinements of this work. Co-con-
spirators Paul G. Anderson, James G. Carson, Peter B. Hirtle, James J.
Kopp, Nancy McCall, and Lisa A. Mix deserve thanks and congratulations
for enduring my seemingly endless requests for revisions. Several Johns
Hopkins University faculty and staff members offered valuable criticism:
Karen Butter, Elizabeth Fee, Alan Lyles, Harry Marks, and Robert Miller.
I also wish to thank Wallace Daly for unlocking the mysteries of RUN and
Peter Carini for providing eleventh-hour reference service. Finally, I am
indebted to Anne Malone and Peggy Slasman for allowing me to refine the
documentation planning process at Children's Hospital and to the rest of
the staff of the Development and Public Affairs Office for their computer
expertise, friendship, and support.

INTRODUCTION

JOAN D. KRIZACK

During the 1970s, the archival profession began to question the methods
it used to select records for preservation. In a series of seminal articles, F.
Gerald Ham challenged archivists to rethink their traditional approach to
appraisal and devise a methodology suited to selecting modern records
produced by modern institutions.^ Several archivists accepted Ham's chal-
lenge and wrote books grounded in the assumption that appraisal is based
on disciplinary or institutional functions and activities.^ For reasons that
are not apparent, this approach to appraisal first took hold in the fields of
science and technology, but by the mid- 1 980s archivists began to translate
the new methodology to other fields.^

All of this work was based on the belief that archivists need to
understand the context in which records are created (i.e., the functions
and activities that generate records) before they can make appropriate
appraisal decisions. The principle that appraisal must be grounded in an
understanding of context had been advocated at least since the mid-
1950s,4 but it had not previously been incorporated into selection meth-
odologies.

The focus of appraisal research shifted from disciplines to institutions
after Helen Willa Samuels introduced the "documentation strategy" con-
cept in 1985.' As defined by Patricia Aronsson, Larry Hackman, and
Samuels, a documentation strategy is an interinstitutional approach to
documenting an "ongoing issue, activity, or geographic area."^ Samuels's
article and the documentation strategy concept reinforced the notion that
analysis and planning are necessary first steps in the appraisal or selection
process. Samuels also assumed the absolute necessity of an active ap-

XII INTRODUCTION

proach to selecting documentation, something that Howard Zinn, Hans
Booms, F. Gerald Ham, and others had begun advocating in the 1970s7

The archival community had mixed reactions to the concept of docu-
mentation strategy, which was often interpreted in ways other than had
been intended; nonetheless, several archivists boldly attempted to apply
the concept. The proposed documentation strategy for the high-technol-
ogy companies located around Route 128 in Massachusetts by Alexander
and Samuels never advanced beyond the hypothetical level,^ and Cox's
actual but unfinished attempt to carry out a documentation strategy for
western New York raised substantive issues about the concept's practical-
ity and viability.^ Two retrospective applications of the documentation
strategy concept — one to analyze the range of topics of collections already
held by manuscript repositories and the other applied to a historical topic,
nineteenth-century quartz mining in Northern California — were more
successful. ^°

In conducting research on the U.S. health care system and thinking
about how to apply the documentation strategy concept to health care in
Massachusetts, I came to the conclusion that the theory underlying docu-
mentation strategy could best be applied at the institutional level. ^ ' In fact,
if the documentation strategy concept is to be employed, it will most
successfully be employed among a group of institutions that have already
embraced the concept internally.

To accentuate the distinction from the documentation strategists' call
for interinstitutional planning and cooperation, the internal process advo-
cated in this book is referred to as documentation planning. The term
documentation plan, first used by German archivist Hans Booms to describe
the proactive approach to selecting an appropriate documentary record
for society, ^^ was redefined almost twenty years later to apply to specific
types of institution, namely, hospitals and colleges and universities.'^ In
Canada the term macro-appraisal theory has recently arisen to refer to the
underlying assumption of documentation planning: selecting documenta-
tion from the top down (i.e., beginning with an analysis of the institution's
functions and the records' context) rather than from the bottom up (i.e.,
beginning with an examination of various record series). ''^

This book includes in the documentation planning process an addi-
tional tier of analysis, system analysis, which is an analysis of the larger
system of which the institutions to be documented are a part (in this case,
the U.S. health care system). The book provides background information
on the U.S. health care system and the functions of the various types of
institution and organization within it, thus establishing the context neces-
sary to undertake the planning stage of the documentation planning

INTRODUCTION XIII

process. Adding this analysis to a general knowledge of historical research
trends, historiographic techniques, traditional appraisal criteria, ^^ and a
specific understanding of their institution's history, mission, culture, and
resources will enable archivists to prepare effective documentation plans,
thus ensuring the deliberate selection of appropriate archival materials. In
addition, the overviews and typologies presented in this work will be
useful to students, historians, and other researchers who need to under-
stand and assess the "big picture" before they can focus on more special-
ized aspects of the U.S. health care system.

This work also describes the second element of documentation plan-
ning, the planning process, and provides as an example a portion of the
documentation plan devised for Children's Hospital, Boston. The Chil-
dren's Hospital documentation plan illustrates the concept of documenta-
tion planning and is, therefore, meant to be descriptive rather than
prescriptive. Applying the documentation planning process and devising
an actual documentation plan have not previously been attempted; there-
fore, the Children's Hospital documentation plan provides a necessary test
case and model for other institutions, both within and outside of the
health care field.

As T. R. Schellenberg noted, "analysis is the essence of archival
appraisal. "^^ Deciding what material to collect, the archivist's most intel-
lectually stimulating task, has become progressively more challenging
since the middle of the twentieth century because the nature of institu-
tions and organizations has changed. In modern society, institutions arc
often components of multinational conglomerates or divisions of holding
companies; even freestanding institutions are not truly self-contained but
are linked to other institutions and organizations, both public and private,
through cooperative agreements, funding arrangements, and governmen-
tal regulations. Such interconnections complicate the archivist's task by
increasing the duplication of information and physically dispersing re-
cords. At the same time, more sophisticated reprographic and communi-
cations technologies have increased the quantity of records (electronic
and hard copy) produced and the amount of information stored. To cope
with these changes, the archival profession needs to adopt a proactive
approach to documenting institutions and to pay increasing attention to
the several levels of analysis underlying the archival selection process:
institutional analysis, interinstitutional analysis, and system analysis. ^^

Whether or not one agrees with the need for, or efficacy of, large-scale
cooperative documentation strategy initiatives, it should be clear that
decisions on selecting the records of a single institution for preservation,
whether by an archivist employed by that institution or by one working at

XIV INTRODUCTION

a historical society or other collecting repository that has acquired a body
of institutional records, should also be informed by an understanding of
the place of that institution in the larger universe. Indeed, it could be
argued that large-scale documentation strategies are possible only if the
participating institutional archives have first come to terms with their
internal issues.

Archivists can meet the challenge of documenting contemporary
institutions by carefully planning what aspects of their institution they are
going to document — in other words, by formulating specific plans that
outline the deliberate selection of appropriate records. Documentation
plans also identify functions and activities that are poorly documented, in
which cases it might be desirable for the archivist to create records (e.g.,
oral histories) to fill in the gaps. A documentation plan is formulated in
two stages, analysis and selection. The first stage consists of three tiers of
analysis: (1) an institutional analysis, (2) a comparison of the institution
with others of the same type, and (3) an analysis of the relationship of the
institution to the larger system of which it is a part — in this case, the U.S.
health care system. ^^ The selection stage consists of making decisions
about what to document at three levels: (1) the function, (2) the activity
or project, and (3) the record series. An added benefit of documentation
planning is that it increases archivists' understanding of their institutions
and how they operate, which will be helpful when performing other
archival activities such as processing and reference. Furthermore, the
documentation planning process increases the visibility of the archives
program.

Documentation planning takes a holistic or contextual approach to
record selection and appraisal by adding the third and most general level
of analysis to the process, thereby providing archivists with a bird's-eye
view of their own institution's situation in relation to the larger systems of
which they are part. When archivists are faced with the challenge of
making their way through the labyrinth of appraisal, a bird's-eye view is
preferable to a ground-level view. Selecting and appraising records, like
mastering a labyrinth, can be accomplished more efficiently and effec-
tively if archivists have an overview, if they carefully plan a course of
action instead of making each decision as the need arises. Without this
"map" or understanding of the institution in its larger context, archivists
are forced to rely on luck, instinct, or precedent when making selection
decisions.

Chapter 1 of this work describes the U.S. health care system in terms
of its functions and the institutions and organizations that carry out those
functions. Chapters 2 through 7 describe the types of institution and

INTRODUCTION XV

organization composing the health care system in terms of their functions
and discusses some of the activities through which those functions are
fulfilled. Because archivists are most often responsible for documenting
institutions or organizations and because the U.S. health care system's
structure is formed to a great extent by institutions and organizations,^^
this approach is appropriate. Furthermore, functional analysis enables
archivists to work across departmental lines, which may shift, and to
devise documentation plans based on what the institution does instead of
how it is organized at the moment. ^'^ This type of analysis provides
archivists with the topical, societal, and institutional contexts they need to
design effective documentation plans. The analyses presented in Chapters
1 through 7 categorize and classify aspects of health care institutions,
enabling archivists to select consciously which aspects to document more
fully than others. Assuming that the available resources are not sufficient
to document in great detail every aspect of every institution, archivists can
use the analysis as a tool to assist them in making difficult decisions about
which aspects to document and to what extent — in other words, to assist
them in devising documentation plans.

The approach to selecting documentation presented here is suggestive
rather than prescriptive. Archivists are encouraged to adapt as necessary
the documentation process and plan presented in Chapter 8 to suit their
specific institution. The goal is to provide the context and guidance
necessary to support the development of plans for all types of institution
and organization in the U.S. health care system, not to dictate what
records should be preserved.

It is important for archivists to realize that the health care environ-
ment is rapidly changing. Regulations, technologies, diseases, and meth-
ods of treatment and financing are constantly evolving. Although it is not
likely that the nation's health care system will be nationalized in the near
future, the Clinton administration is expected to implement significant
reforms. Most of these reforms will directly affect how health care deliv-
ery is financed. They may affect the configuration of health care institu-
tions, but the functions of the U.S. health care system will remain the
same.^^

During a period of great change for the health care system, much of
which is motivated by a desire to contain costs, the documentation
planning process remains viable and indeed takes on special importance
for health care institutions. Because the functions of the health care
system will not change, they provide a base from which to gauge institu-
tional and organizational change and on which to make archival selection
decisions. As the health care system becomes more highly integrated.

XVI INTRODUCTION

moreover, the emphasis of the documentation planning process on inter-
institutional and system analyses also becomes more significant. With the
increasing incidence of consolidations, alliances, and mergers among
health care institutions and departments within these institutions, docu-
mentation planning can provide a foundation for preserving the records of
emerging or reconfigured institutions and those that no longer exist.

In this new world, the traditional justifications for archival programs
continue to apply. Archival programs can conserve resources by eliminat-
ing the costly storing of unnecessary records, and they can improve
efficiency by providing access to important information that is needed for
current institutional operations. Thus, even though the institutions and
organizations described in this book will change in nature and type, the
book presents a glimpse of the U.S. health care system at a particular point
in time, and the concept of documentation planning and the documenta-
tion planning process remain effective tools for selecting appropriate
records to document health care institutions and organizations.

NOTES

1. F. Gerald Ham, "The Archival Edge," American Archivist 38 (January 1975):
5-13; "Archival Strategies for the Post-Custodial Era," American Archivist 44
(Summer 1981): 207-16; and "Archival Choices: Managing the Historical
Record in an Age of Abundance," American Archivist 47 (Winter 1984): 1 1-22.

2. The first of these was Joan Warnow et al., A Study of Preservation of Documents at
Department of Energy Laboratories (New York: American Institute of Physics,
1982). There followed Joan K[rizack] Haas, Helen Willa Samuels, and
Barbara Tripple Simmons, Appraising the Records of Modern Science and
Technology: A Guide (Cambridge: MIT 1985; distributed by the Society of
American Archivists); Bruce H. Bruemmer and Sheldon Hochheiser, The
High-Technology Company: A Historical Research and Archival Guide
(Minneapolis: Charles Babbage Institute, University of Minnesota, 1989); and
American Institute of Physics Study of Multi-Institutional Collaborations in High-
Energy Physics (New York: American Institute of Physics, 1991 ).

3. See, for example, Patricia Aronsson, "Appraisal of Twentieth-Century
Congressional Collections," in Nancy E. Peace, ed.. Archival Choices: Managing
the Historical Record in an Age of Abundance (Lexington, Mass.: Lexington
Books, 1984), 81-104; and Joan D. Krizack, "Hospital Documentation
Planning; The Concept and the Context," American Archivist 56 (Winter
1993): 16-34. (The latter article was submiued for publication in its final form
in December 1989.) Aronsson's work was recently expanded in The
Documentation of Congress: Report of the Congressional Archivists Roundtabk Task
Force on Congressional Documentation ( 1 992).

INTRODUCTION XVII

4. See Theodore R. Schellenberg's 1956 article, "The Appraisal of Modern Public
Records/' reprinted in Maygene F. Daniels and Timothy Walch, eds., A
Modern Archives Reader: Basic Readings on Archival Theory and Practice
(Washington, D.C.: National Archives and Records Service, 1984).

5. Helen Willa Samuels, "Who Controls the Past?" American Archivist 49 (Spring
1986): 109-24.

6. Ibid., 115.

7. Howard Zinn, "Secretary, Archives and the Public Interest," Midwestern
Archivist 2 (1977): 14-26; Hans Booms, "Society and the Formation of a
Documentary Heritage; Issues in the Appraisal of Archival Sources,"
Archivaria 24 (Summer 1984): 69-107 (original German version published in
1972); Ham, "The Archival Edge"; and Patrick M. Quinn, "The Archivist as
Activist," Georgia Archive 5 (Winter 1977): 25-35.

8. Philip N. Alexander and Helen W. Samuels, "The Roots of 128: A
Hypothetical Documentation Strategy," American Archivist 50 (Fall 1987):
518-31.

9. Richard J. Cox, "A Documentation Strategy Case Study: Western New York,"
American Archivist 52 (Spring 1989): 192-200.

10. Judith E. Endleman, "Looking Backward to Plan for the Future: Collection
Analysis for Manuscript Repositories," American Archivist 50 (Summer 1987):
340-53; and Maureen A. Jung, "Documenting Nineteenth-Century Quartz
Mining in Northern California," American Archivist 53 (Summer 1990): 406-18.

1 1. Krizack, "Hospital Documentation Planning."

12. Booms, "Society and Documentary Heritage," 105.

13. Krizack, "Hospital Documentation Planning," and Helen Willa Samuels
Varsity Letters: Documenting Modern Colleges and Universities (Metuchen, N.J.:
Society of American Archivists and Scarecrow Press, 1992).

14. For example, Richard Brown, "Records Acquisition Strategy and Its
Theoretical Foundation: The Case for a Concept of Archival Hermeneutics,"
Archivaria 33 (Winter 1991-1992); 34-56; and Terry Cook, "Mind over
Matter: Toward a New Theory of Archival Appraisal," in Barbara L. Craig, ed..
The Archival Imagination: Essays in Honour of Hugh A. Taylor (Ottawa:
Association of Canadian Archivists, 1992), 38-70.

15. For traditional appraisal criteria, see Schellenberg, "Modern Records," and F.
Gerald Ham, Archives and Manuscripts: Appraisal and Accessioning (Chicago:
Society of American Archivists, 1992). Also, Frank Boles and Julia Marks
Young identified and categorized appraisal criteria in Archival Appraisal (New
York: Neal-Schuman, 1991).

16. Schellenberg, "Modern Public Records," 68.

17. It should be noted that Schellenberg was writing about governmental archives
and referring to the need for analysis at the agency and record series levels.

18. This is not a new idea; it is an extension of the strategy for appraising
governmental records advocated by Theodore R. Schellenberg in Modern
Archives: Principles and Techniques (Chicago: University of Chicago Press,
1956), 52.

XVIII INTRODUCTION

19. Milton I. Roemer, Ambulatory Health Services in America: Past, Present, and Future
(Rockville, Md.: Aspen Publishers, 1981), 30.

20. For a more detailed explanation of functional analysis and its value, see Helen
Willa Samuels, "Rationale for the Functional Approach," in Varsity Letters:
Documenting Modern Colleges and Universities (Metuchen, N.J.: Scarecrow Press,
1992), 1-18.

21. For more specific information on impending health care reforms, see Chap-
ter 2.

DOCUMENTATION

PLANNING FOR THE

U.S. HEALTH CARE SYSTEM

CHAPTER 1

Overview of the U.S.
Health Care System

JOAN D. KRIZACK

The U.S. health care system is complex and constantly changing. Since
World War II, it has grown to become one of the two largest American
industries. In 1992 the nation spent $838.5 billion, or 14 percent of the
gross national product, on health care — a higher proportion than that
spent by any other country. Compared to other nations' systems, health
care in the United States is decentralized and competitive, characterized
by a mix of public and private health care institutions and organizations.^
In fact, the United States is one of only two developed countries (the other
is the Republic of South Africa) that does not have a health care system
run by its government.

If a health care system is defined as "a group of curative and preventa-
tive service components — organized, coordinated, and controlled to
achieve certain goals,"^ then the U.S. health care system may be more
accurately described as a nonsystem, largely because of the predominance
of free enterprise and the absence of nationalized health care.' It is,
nevertheless, stable and resilient, both because it is decentralized and
diverse and because the medical profession itself exercises tremendous
power through organizations such as the American Medical Association.
The government's role is also powerful and is primarily exercised through
governmental regulation, especially regarding third-party payment mech-
anisms and health care standards.

Broadly viewed, the health care system has six major functions:

• patient care (diagnosis and treatment)

• health promotion (activities aimed at encouraging good health, such
as fitness programs and informational campaigns)

OVERVIEW OF THE U.S. HEALTH CARE SYSTEM

• biomedical research

• education (of health care professionals)

• regulation and formulation of policy (regulation establishes standards
for institutions and practitioners; formulation of policy involves
coordinating health care services within a specified region or
jurisdiction on a suprainstitutional level)

• provision of goods and services (such as pharmaceuticals,
wheelchairs, diagnostic and therapeutic equipment, and malpractice
and health insurance)

These functions are carried out by diverse institutions and organiza-
tions that interact and overlap with one another, each institution encom-
passing one or more functions in its mission (sometimes along with other
functions that are not related to health care). The institutions may be
classified as:

• health care delivery facilities (e.g., hospitals, nursing homes,
hospices),

• health agencies and foundations (e.g., U.S. Department of Health and
Human Services, Robert Wood Johnson Foundation),

• biomedical research facilities (e.g., Boston Biomedical Research
Institute; Acupuncture histitute, Monterey, California),

• educational institutions for the health professions (e.g., Massachusetts
College of Pharmacy and Allied Health Sciences, Forsyth Dental
Center School for Dental Hygienists, Bowman Gray School of
Medicine),

• professional and voluntary associations (e.g., American Nurses
Association, American College of Healthcare Executives, American
Cancer Society), and

• health industries (e.g., Merck, Codman and Shurtleff, Johnson &
Johnson, Blue Cross/Blue Shield).'^

These institutions are funded by governments, voluntary contributions,
investors, philanthropic foundations (notably the W. K. Kellogg, Robert
Wood Johnson, and Rockefeller foundations), or by a combination of
these methods. 5

The matrix depicted in Table 1-1 is a visual representation of the
conjunction of the health care system's functions and organizations.
Although the matrix is artificial and contrived, it provides archivists with
an overview of an extremely complex system in terms that are meaningful
to their work.

Brief descriptions of the six categories of health care institutions and
organizations follow. In-depth studies of each category are provided in
Chapters 2 through 7.

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OVERVIEW OF THE U.S. HEALTH CARE SYSTEM

HEALTH CARE DELIVERY FACILITIES

Health care delivery facilities are numerous and varied, but the most
important are hospitals, which account for 44 percent of all health care
dollars spent. ^ Although their major function is to provide patient care,
some facilities, including hospitals, are also involved in three of the other
five functions of the health care system: health promotion, biomedical
research, and education.

Two general categories of health care facility exist: ambulatory care
facilities (which offer a range of services from routine treatment and coun-
seling to relatively complex services for conditions that do not warrant
hospitalization) and in-patient facilities. Some facilities, notably hospitals,
provide both ambulatory and in-patient services, and some hospitals run
satellite outpatient clinics. Physicians' offices, clinics, health maintenance
organizations (which, like Kaiser Permanente, may also own hospitals),^
hospital emergency rooms and outpatient departments, and freestanding,
for-profit "emergicenters" or "surgicenters" are settings for ambulatory
care.

Physicians' offices may house a single physician or a group of physi-
cians in private practice; the trend today is toward group practice.^ Physi-
cians may also see private patients in an office located in or near a hospital.
Public health clinics are open to all in need of health services but predomi-
nantly serve individuals with lower incomes or without health insur-
ance.^ Clinics are numerous and diverse, consisting of government spon-
sored clinics (public health agency clinics, neighborhood health centers),
special voluntary clinics (family planning or cancer detection clinics),
for-profit outpatient clinics (Healthstop, located in the Boston area and
elsewhere), and clinics within institutions such as elementary and second-
ary schools, colleges and universities, prisons, industries, and businesses.
Limited outpatient health services may also be provided in the patient's
home by private nurses and other health care professionals, for-profit
health care businesses, voluntary agencies (the Visiting Nurses Associa-
tion), hospitals, and hospices.

In-patient care is provided in nursing homes, hospices, freestanding
birthing centers, substance abuse facilities, and hospitals. With the excep-
tion of nursing homes, these facilities may also provide outpatient care.

HEALTH AGENCIES AND FOUNDATIONS

Health agencies, one of the most complex and diverse components of the
U.S. health care system, may be public or voluntary agencies. Public health
care agencies exist at all levels of government — federal, state, and local. At

HEALTH AGENCIES AND FOUNDATIONS

the federal level, the government is involved in all six of the functions
defined above. The federal government plays a direct role in the delivery of
health care (for example, through Veterans Administration hospitals), but it
also has an indirect role, providing funding and delegating authority to
public and private institutions or organizations to carry out primary health
care activities. •^ Recently, the federal government has become less involved
in providing patient care and more involved in funding it.'^ Although the
federal government is involved in biomedical research, educating health
care professionals, and promoting health, its primary roles are in funding
health care services and in regulation and policy formulation, especially
through the Food and Drug Administration. The Department of Health and
Human Services is responsible for most federal activity related to health
care. It is subdivided into four major units: the Health Care Financing
Administration, which oversees the Medicare and Medicaid programs, set-
ting standards for care; the Social Security Administration; the Administra-
tion for Children and Families; and the Public Health Service, which engages
in a broad range of general and specialized health care activities.

The Public Health Service, in turn, comprises eight agencies: the
Substance Abuse and Mental Health Services Administration; the Centers
for Disease Control; the Food and Drug Administration; the Health Re-
sources and Services Administration, which is the primary focus for the
federal government's patient care programs and administers the Gillis W.
Long Hansen's Disease Center in Louisiana; the Agency for Toxic Sub-
stances and Disease Registry; the National Institutes of Health, which
includes fourteen research institutes, one hospital, and several centers and
divisions; the Indian Health Service, which provides health care services
to native Americans and Alaskan natives; and the Agency for Health Care
Policy and Research. ^^

This sketch outlines only part of the federal government's role in the
health care system. Other governmental agencies outside the Department
of Health and Human Services have health care responsibilities as part of
their missions. All branches of the U.S. military, for example, run hospitals
for their employees, the Department of Transportation operates Coast
Guard hospitals (which are staffed by Public Health Service staff), and the
Department of Veterans Affairs is responsible for approximately 170
hospitals, the country's largest network of public hospitals. ^^ The Defense
Department also administers the Uniformed Services University of the
Health Sciences and conducts extensive programs of biomedical research.

Although the federal government plays a significant role in the health
care system, the ultimate responsibility for the health and welfare of the
general public and the legal authority in health care matters rest with the
states, i"* To this end, each state has an agency responsible for health care, but

OVERVIEW OF THE U.S. HEALTH CARE SYSTEM

it is important to understand that there is significant variation in their roles.
The missions of state health care agencies include five of the six functions of
the health care system. These agencies are involved in formulating state-
wide policy, administering programs that receive federal funds, such as
Medicaid. They are also involved in regulation through licensing health
professionals and facilities, establishing rate-setting commissions for hospi-
tals, and providing safety codes for housing, institutions, and industry. The
states educate and train health professionals through formal programs in
state colleges and universities. They also engage in biomedical research,
which outside of the college and universities setting is usually epidemiologi-
cal in nature. States promote health and work to prevent illness by monitor-
ing, for example, the quality of food and water supplies and by communica-
ble disease control. States also provide patient care through institutions for
people with mental or emotional difficulties, people with developmental
disabilities, and chronically ill people, among others. In some states it is
difficult to distinguish state from local patient care.

The primary functions of local health agencies are the coordination
and regulation of health care services at the local level and the delivery of
health care; however, the range of activities within these functions varies
greatly from state to state. Local health departments record and analyze
health data, work to prevent illness by educating the public in health
matters, provide environmental health services, and administer health
services through the operation of health care facilities. Usually these
services are limited to activities such as immunization, well-baby exami-
nations, and screening for chronic diseases, but sometimes they cover the
full range of health care services. Local health departments may also
provide school health services. ^^

Foundations, which may be defined as organizations that exist to
distribute private funds to nonprofit institutions and organizations, also
play a key role in the health care system.'^ Local foundations may support
neighborhood hospitals, while national foundations support biomedical
research (e.g., the W. K. Kellogg Foundation), medical education (the
Rockefeller Foundation), and policy formulation (the Commonwealth
Fund). They exert significant influence on health care policy through
policy studies and through their funding decisions.

BIOMEDICAL RESEARCH FACILITIES

Biomedical research takes place in laboratories, departments, and institu-
tions involved in pursuing knowledge related to health care. Research
facilities may be freestanding (e.g., the Worcester Foundation for Experi-

EDUCATIONAL INSTITUTIONS FOR THE HEALTH PROFESSIONS

mental Biology) or part of another institution such as a hospital (the Eaton
Peabody Laboratory of Auditory Physiology at the Massachusetts Eye and
Ear Infirmary), academic health center, industry, and the federal govern-
ment. Biomedical research laboratories in hospitals may be sponsored by
outside organizations such as medical schools, private foundations, or
voluntary health agencies. Biomedical research takes place both in institu-
tions whose sole function is investigative work and, more often, in
institutions in which research is only one of several functions (for exam-
ple, teaching hospitals).

EDUCATIONAL INSTITUTIONS FOR THE HEALTH PROFESSIONS

There are thirty-five major categories of health care profession in the U.S.
health care system. ^^ Membership in each of these professions requires
specific training, ranging from in-house training for nurses' aides and
orderlies to postdoctoral training for medical specialists and subspecial-
ists. Institutions involved in educating health professionals may have
this as their primary function (e.g., the Massachusetts College of Phar-
macy and Allied Health Sciences, and the Forsyth Dental Center School
for Dental Hygienists) or it may be one of a number of functions, as is
the case for teaching hospitals. Educational programs for many health
care professionals, including physicians, nurses, medical records per-
sonnel, dental hygienists, and laboratory technicians, are offered by tech-
nical high schools, colleges or universities, and for-profit educational
organizations.

Education for certain health professionals occurs wholly or in part in
hospitals. In the past, most nurses were trained in hospital-based pro-
grams, but recently many of these programs have been phased out. Now
nurses also receive degrees from academic institutions. Although univer-
sities are the major site for physician education, hospitals are the setting
for physicians' extensive clinical training. Teaching hospitals^^ are most
often owned by universities, medical schools, or an umbrella organiza-
tion. In some cases the teaching hospital and medical school have a formal
affiliation that does not include ownership. Recently, some academic
institutions have formed holding companies that control their hospitals.

Hospitals also provide continuing education for health professionals.
In the case of nurses and physicians, for example, continuing education
programs are regularly offered to enable these professionals to maintain
licensure or be relicensed. Continuing education programs may also be
sponsored by professional associations, universities, or corporations out-
side the hospital setting.

OVERVIEW OF THE U.S. HEALTH CARE SYSTEM

PROFESSIONAL AND VOLUNTARY ASSOCIATIONS

All health care professions have professional associations. Their major
function is education, and they may also engage in accreditation or
certification activities. Many of these societies are also involved in formu-
lating policy and regulating health care services, mainly through legisla-
tive lobbying efforts. Some associations are national in scope; regional or
local associations may be independent or branches of national groups.
Professional associations are funded for the most part by membership
dues. Some of the larger national associations maintain administrative
headquarters, which are often centrally located in the Midwest. (The
American Medical Association and the American College of Healthcare
Executives, among others, are headquartered in Chicago.) The purpose of
these associations is to advance the specific profession in the health care
field; to elevate professional standards through accreditation or certifica-

FIGURE 1-1 Hillary Rodham Clinton, chair of the president's Task Force on
National Health Reform, addressing the American Medical Association's House of
Delegates, 1993. Source. American Medical Association

THE CHANGING NATURE OF THE U.S. HEALTH CARE SYSTEM

tion activities; to provide pertinent information, usually through meet-
ings, newsletters, and journals; and to protect the profession's interests by
legislative lobbying. ^^

Voluntary associations also play an important role in the U.S. health
care system. These associations support biomedical research and some-
times provide health care services to individuals; in most instances, how-
ever, their most important function is to educate the public. ^° Their
funding comes from private and corporate contributions, subscription
fees, and fund-raising events. These associations may be concerned with a
specific disease or organ (for example, the American Cancer Society and
the American Heart Association), the health of special groups (Planned
Parenthood Federation of America, the National Easter Seal Society for
Crippled Adults and Children), certain types of health service (the Visiting
Nurses Association, which provides home health care), or health policy
(the National Health Council and the National Safety Council). ^^ Some
voluntary associations are not primarily related to health but are involved
in the health care system. Fraternal organizations, for example, may fund
medical research (the Lions Club funds eye research) or run nonprofit
hospitals (the Shriners sponsor children's specialty hospitals).

HEALTH INDUSTRIES

Companies providing goods and services related to health care delivery
support the basic patient care function of the U.S. health care system. In
addition, some companies, particularly pharmaceutical companies, are
involved in biomedical research. Health industries include pharmaceutical
companies; hospital supply companies, which produce disposable prod-
ucts such as syringes, surgical drapes, and sterile gloves; companies that
manufacture appliances, including wheelchairs and prosthetic devices;
pharmacies; and companies that manufacture diagnostic instruments (for
example, x-ray machines and other imaging systems) or therapeutic
equipment (such as incubators and lasers). Some companies provide
services, for example, clinical laboratory tests, laundry service, manage-
ment expertise, and health insurance.

THE CHANGING NATURE OF THE U.S. HEALTH CARE SYSTEM

As noted in the Introduction, some reforms in the U.S. health care system
are expected during the Clinton administration. Although the reforms will
not result in a national health program and the system will remain

1 OVERVIEW OF THE U.S. HEALTH CARE SYSTEM

distinctly American, significant changes will be legislated. These changes
which are focused on insurance reform will affect payment mechanisms,
and they may affect the nature of health care institutions and organiza-
tions composing the U.S. health care system, but they will not affect the
functions of the broader system.

Reform of the nation's health care system is being undertaken in a
effort to control costs and extend basic health care coverage to the 37
million Americans who are without health insurance. Hospitals, health
maintenance organizations, and other health care delivery facilities will
continue to be subject to financial pressures aimed at controlling costs. To
remain competitive in the marketplace, they are merging, combining
services, or forming alliances. The merger of Columbia Healthcare Cor-
poration and Galen Health Care Inc. in late 1993, for example, and the
subsequent merger with HCA-Hospital Corporation of America created
the largest chain of for-profit hospitals in the country. The new entity,
Columbia Healthcare Corporation, owns one-hundred ninety hospitals in
twenty-six states and two foreign countries. ^^ Not-for-profit hospitals are
also redefining themselves. In the Boston area, for example, Boston
University Medical Center, the New England Deaconess Hospital, and
Massachusetts General Hospital, among others, are shaping alliances with
hospitals in southeastern Massachusetts to increase their patient bases;
community hospitals north of the city have merged to create a more
efficient, competitive system; and five Harvard Medical School-affiliated
teaching hospitals have formed the Harvard Medical Planning Group,
under the leadership of the medical school's dean, to discuss a cooperative
strategy for eliminating duplicated medical services.-^'

Other health care institutions will be affected by health care reform.
Because the government will play an even stronger regulatory role,
governmental agencies will evolve, though national and state responsibil-
ities remain to be sorted out. At this point, too, it is not clear how research
facilities and educational institutions will be affected. Academic health
centers — where health care delivery, research, and education are joined —
cannot provide health care services as inexpensively as other health care
delivery facilities, and they are concerned about maintaining a competi-
tive edge while engaging in education and research. 2"* It is almost certain
that in the new atmosphere that stresses efficiency and cost control,
emphasis will be placed on educating primary care physicians and re-
searching topics related to primary care. The health industries will un-
doubtedly be affected by price constraints if not controls, and alliances are
already forming between health industries and hospitals. For example,
Baxter International Inc., the world's largest hospital supply company,
and American Healthcare Systems, one of the largest hospital groups in

NOTES 1 1

the United States, have reached an agreement covering medical and
surgical supplies that American will purchase from Baxter.^^ The health
insurance industry may be transformed into a few giant companies that
negotiate services for large groups of clients or into companies that
manage networks of health care providers. Professional and voluntary
associations are the organizations least likely to be directly affected by
health care reform, but the altered system will mean significant changes
for at least some of them.

NOTES

1 . J. Rogers Hollingsworth, A Political Economy of Medicine: Great Britain and the
United States (Baltimore: Johns Hopkins University Press, 1986), 3, 163.

2. James M. Rosser and Howard E. Mossberg, An Analysis of Health Care Delivery
(New York: John Wiley & Sons, 1977), 1.

3. Milton I. Roemer, An Introduction to the U.S. Health Care System (New York:
Springer Publishing Company, 1986), 2.

4. Adapted from Rosser and Mossberg, Health Care Delivery, 24-63, and Roemer,
U.S. Health Care System, 5-12.

5. This book deals with the U.S. health care system in institutional terms.
Therefore, folk medicine provided by friends or relatives in the home and
health promotion activities, such as exercise classes that are conduaed
outside the institutional structures outlined here, are not covered by this
work. Veterinary education and research, however, are included because
they are integrated within the U.S. health care institutions as defined above.

6. "Is the Business of Medicine Business?" New York Times Book Review, 5 April
1992, 11.

7. A health maintenance organization (HMO) is a comprehensive system of
therapeutic and preventative health services that are provided to an enrolled
population for a fixed per-person sum.

8. Russel C. Coile, Jr., The New Medicine: Reshaping Medical Practice and Health Care
Management (Rockville, Md.: Aspen Publishers, 1990), 240.

9. Stephen J. W^illiams and Paul R. Torrens, Introduction to Health Services (New
York: John Wiley & Sons, 1984), 164.

10. Roemer, U.S. Health Care System, 6.

1 1. Anthony R. Kovner, and contributors. Health Care Delivery in the United States,
4th ed. (New York: Springer Publishing Company, 1990), 306.

12. United States Government Manual, 1989-90 (Washington, D.C.: U.S.
Government Printing Office, 1990).

1 3. Williams and Torrens, Introduction to Health Services, 172.

14. Joellen Watson Hawkins and Loretta Pierfedeici Higgins, Nursing and the
American Health Care Delivery System (New York: Tiresias Press, 1982), 34.

15. Rosser and Mossberg, Health Care Delivery, 2S, and Kovner, Health Care
Delivery, 123.

1 2 OVERVIEW OF THE U.S. HEALTH CARE SYSTEM

16. The Foundation Directory (New York: Foundation Center, 1989), Introduaion.

17. Hawkins and Higgins, Nursing, 111.

18. See page 33 for the definition of a teaching hospital.

19. Rosser and Mossberg, Health Care Delivery, 33-34.

20. Hawkins and Higgins, Nursing, 45.

21. Adapted from Roemer, U.S. Health Care System, 9, and Rosser and Mossberg,
Health Care Delivery, 29, 32-33.

22. "The Hospital World's Hard-Driving Money Man," New York Times, 5 October,
1993, Dl.

23. The five are Beth Israel, Brigham and Women's, Children's, Massachusetts
General, and New England Deaconess hospitals.

24. For more information on academic health centers, see Chapter 5.

25. "A $4 Billion Supply Deal for Hospitals" New York Times, 26 Oct 1993.

ANNOTATED SELECTED BIBLIOGRAPHY

For an excellent history of medicine in the United States,see Paul Starr, The Social
Transformation of American Medicine: The Rise of a Sovereign Profession and the
Making of a Vast Industry (New York: Basic Books, 1982). This volume, which
won the 1984 Pulitzer Prize for general nonfiction, traces the origins of
medical practice through the growth of corporate medicine, from 1760 to
1980.

A highly recommended source that describes the basic elements of the U.S. health
care system and their interaction is Anthony R. Kovner, and contributors
Health Care Delivery in the United States, 4th ed. (New York: Springer Publishing
Company, 1990).

Other good sources that describe the U.S. health care system include Steven Jonas,
An Introduction to the U.S. Health Care System (New York: Springer Publishing
Company, 1992) and David Barton Smith and Arnold D. Kaluzny, The White
Labyrinth: A Guide to the Health Care System (Ann Arbor, Mich.: Health Admin-
istration Press, 1986). "Historical Evolution and Overview of Health Services
in the United States," chapter 1 in Stephen J. Williams and Paul R. Torrens,
Introduction to Health Services (New York: Wiley, 1984), describes the types of
health care program within the system as a whole.

Although somewhat dated, a valuable source comparing the U.S. health care

system with the systems of other countries is Marshall W. Raffel, ed.. Compar-
ative Health Systems: Discriptive Analysis of Fourteen National Health Systems
(University Park: Pennsylvania State University Press, 1984). Another source
that compares health care systems is J. Rogers Hollingsworth, A Political
Economy of Medicine: Great Britain and the United States (Baltimore: Johns
Hopkins University Press, 1986). Chapter 2, "The Medical Delivery System of
the U. S., 1890-1970," provides a good historical overview with comparisons
made to England and Wales.

CHAPTER 2

Facilities That Deliver Health Care

JOAN D. KRIZACK

The delivery of health care, which may be defined as the provision of
diagnostic and therapeutic services to individuals and the promotion of
good health, is the primary function of the U.S. health care system. Like
the system itself, it involves a complex mix of institutions, organizations,
and individuals and a variety of public and private sponsors.

Institutions that deliver health care may be classified according to
whether they offer in-patient care, ambulatory (outpatient) care, or both.
(See Tables 2-1 and 2-2 for a typology of health care delivery settings.)
In-patient care is care given to a patient confined to an institution over-
night or longer. Most in-patient care is provided in a hospital; however,
free-standing birthing centers, hospices, nursing homes, prison and school
infirmaries, and substance abuse facilities may also offer in-patient care.
Ambulatory care is generally understood to refer to health care provided
to individuals not confined to a hospital.^ Because governmental regula-
tions limit reimbursement for Medicare and Medicaid patients and be-
cause other third-party payers are implementing cost-containing rules,
ambulatory care services are expanding to include procedures that for-
merly were performed only on an in-patient basis. Some institutions,
including most hospitals, provide ambulatory services in addition to in-
patient care. (See Table 2-2 for a typology of ambulatory care clinics.)

Hospitals, which have been described as "the center of both medical
practice and the experience of illness,"^ are the institutional focus of the
U.S. health care system. For this reason, and because the functions and
activities of a hospital parallel those that occur in other in-patient and

1 4 FACILITIES THAT DELIVER HEALTH CARE

TABLE 2-1 Typology of health care delivery settings

In-Patient Care Settings

Birthing centers

Hospices

Hospitals

Nursing homes

Secondary school, college, and university infirmaries

Substance abuse programs

Ambulatory Care Settings
Private physician offices

Solo practice

Group practice

General/family practice group
Single specialty
Multispecialty
Institutional settings

Business/industry

Health maintenance organizations

Holistic health centers

Hospitals

Prisons

Private homes

Schools
Freestanding clinics (see Table 2-2)

ambulatory settings, this chapter will concentrate on hospitals. A brief
discussion of other in-patient and ambulatory care settings, focusing on
their distinctive characteristics, follows the discussion of hospitals.

HOSPITALS

Of all the institutions that engage in the delivery of health care, hospitals
are the most central to the U.S. health care system. With the increasing
use of expensive medical technology in both diagnosis and treatment, the
hospital has become the central health care institution in the United
States. In 1990 the number of hospitals in the United States was 6,649' (as
compared to 3,535 institutions of higher education),'^ and $256 billion
was spent on hospital services (almost 39 percent of the $666.2 billion
spent on health care).'

HOSPITALS ' ' 15

TABLE 2-2 Typology of ambulatory clinics

According to Clientele Served

Clinics for Alaskan natives

Clinics for native Americans

Clinics for military personnel and their dependents

Clinics for poor people

Geriatric clinics

Migrant worker healtfi clinics

Maternal and infant clinics

Neighborhood/community clinics ("free" clinics)

Rural clinics

Teen clinics

Women's clinics

According to Condition(s) Diagnosed/Treated

AIDS and HIV clinics

Ambulatory surgery centers

Arthritis clinics

Birthing centers

Cancer detection centers

Dental clinics

Diabetes climes

Diagnostic imaging centers

Dialysis centers

Emergency (urgent) care clinics (emergicenters)

Family planning clinics

Heart disease clinics

Immunization clinics

Mental health clinics

Obstetrics and gynecology clinics

Pain relief clinics

Primary care clinics

Rehabilitation centers (cardiac, physical)

Sexually transmitted or venereal disease clinics

Sports injury clinics

Substance abuse clinics

Surgicenters

Tuberculosis screening clinics

Vision disorder clinics

FACILITIES THAT DELIVER HEALTH CARE

FIGURE 2-1 The Hunnewell Building of Children's Hospital, Boston, circa 1919.
Milk from the cows in the foreground was pasteurized in the hospital's Milk
Laboratory and given to patients to prevent them from contracting bovine tuber-
culosis. Source: Children's Hospital Archives

Hospitals were not always the focus of medical practice, education,
and research that they are today. In the eighteenth and nineteenth
centuries, poor people who were sick went to hospitals, while the iniddle
and upper classes received medical care at home. With the introduction of
antisepsis, however, hospitals became safer, and since the early twentieth
century they have become indispensable to providing medical care, edu-
cating health care professionals, and conducting bioinedical research.^'

Hospitals perform four of the six functions of the U.S. health care
system defined in Chapter 1. In addition to the patient care, education,
and biomedical research functions, inany hospitals have health promotion
programs, although it should be noted that historically, the U.S. health
care system has emphasized treatment over prevention. Regulation is not
a function of hospitals, which are themselves regulated by federal, state,
and local governmental agencies. Neither are they involved in health care
policy formulation. Hospitals do, however, influence health care policy

HOSPITALS 1 7

and regulation mainly through the lobbying activities of state hospital
associations and the American Hospital Association.

TYPES OF HOSPITAL

A hospital may be broadly defined as a health care treatment facility with
six or more in-patient beds7 Hospitals in the Unites States compose a
heterogeneous, decentralized, and fragmented grouping of institutions
about which it is extremely difficult to generalize. Nevertheless, it is
important to attempt to categorize them and describe their similarities and
differences, thus providing a broad context within which archivists can
construct documentation plans. As with most efforts at classification,
some hospitals cannot neatly be placed into one category (mobile hospi-
tals), and some fit equally well into more than one category (women's and
children's hospitals).

For the purpose of this study, hospitals are categorized in terms of five
characteristics: (1) ownership or control, (2) degree of independence, (3)
the type of patient treated or services provided, (4) whether or not the
hospital is involved in educating or training health care professionals, and
(5) whether or not the hospital is involved in biomedical research. (See
Tables 2-3 and 2-4.) The first three characteristics are the most important
from an archival standpoint because they have the greatest impact on the
types of record created and where the records are located. If a hospital
engages in educational activities and/or biomedical research, the types of
record created will obviously reflect these activities; conversely, if a
hospital does not engage in education and research, no records reflecting
these activities will exist. Because the patterns of hospital ownership and
control are relatively diverse and complex (see Table 2-4), as are the
various configurations in which a hospital is part of a larger organization,
they are described in detail below.

Ownership or Control: Government The federal government, most
state governments, and many local governments own and operate hospi-
tals. In 1991 the federal government ran 5 percent of the nation's hospi-
tals; state and local governments operated 26 percent.

In the federal government the organization most directly concerned with
health care is the Department of Health and Human Services (DHHS).
The division of the DHHS most directly concerned with the delivery of
health care is the Public Health Service, which in turn comprises
eight agencies. Within the Public Health Service, for example, the Sub-
stance Abuse and Mental Health Services Administration jointly adminis-
ters, with the District of Columbia, St. Elizabeths Hospital, in Washington,

1 8 FACILITIES THAT DELIVER HEALTH CARE

TABLE 2-3 Typology of hospitals

Ownership/Control (see Table 2^)

Degree of Independence
Freestanding
Larger organization

Health care company

Health maintenance organization

Holding company

Multihospital system or chain

Part of a university, industry, business

Patients Treated or Services Provided
Type of patient treated

Black hospitals

Geriatric tiospitals and nursing homes

Hospitals for employees of specific businesses/industries

Hospitals serving native Americans/Alaskan natives

Military hospitals

Pediatric hospitals

Prison hospitals

School/university infirmaries

Veterans hospitals

Women's hospitals (women's and children's hospitals are sometimes
combined)
Type of service provided

Alcohol/drug abuse hospitals

Burn hospitals

Cancer hospitals

Chronic disease hospitals/hospices

Communicable diseases hospitals

Convalescent hospitals

Diabetes hospitals

Epilepsy hospitals

Eye, ear, nose, and throat hospitals

Eye hospitals

General medical and surgical hospitals

Homeopathic hospitals

Hospitals for mentally retarded people

Immunology and respiratory (including tuberculosis) hospitals

Leprosaria

Maternity hospitals

Orthopedic hospitals

Osteopathic hospitals

Physical rehabilitation hospitals

Psychiatric hospitals

Hospital Engages in Education
Hospital Engages in Research

HOSPITALS "' " 19

TABLE 2-4 Hospital ownership or control

Governmental Ownership
Federal
Department of Defense

Air Force

Army

Navy
Department of Health and Human Services, Public Health Service

Health Resources and Services Administration

Indian Health Service

National Institutes of Health, Clinical Center
Department of Justice, Bureau of Prisons
Department of Transportation, U.S. Coast Guard
Department of Veterans Affairs
State

State health agencies (long-term facilities for chronically ill, people with

developmental disabilities, and people with mental or emotional

difficulties)
State prison/reformatory hospitals
State university medical school hospitals
Local

City/county joint hospitals
City hospitals
County hospitals
District hospitals

Private Ownership
Voluntary (nonprofit)

Business/industry

Church or religious order

Community group

Fraternal organization

Health care cooperative/coUeaive

Health maintenance organization

Private university
Proprietary (for profit)

Corporation

Individual owner

Partnership

20 FACILITIES THAT DELIVER HEALTH CARE

D.C., which is a psychiatric hospital for residents of the District of Columbia
and the Virgin Islands; the Health Resources and Services Administration
provides health care services to Hansen's disease (leprosy) patients and
others at the Gillis W. Long Hansen's Disease Center, in Carville, Louisiana;
the Indian Health Service runs 50 hospitals and more than 300 clinics for
native Americans and Alaskan natives^; and the National Institutes of
Health's Warren Grant Magnuson Clinical Center consists of a 540-bed
hospital and laboratory complex.^

Other departments of the federal government are also involved in the
delivery of health care. The Department of Defense, for example, controls
army, navy, and air force hospitals, both in this country and abroad,
providing health care services to military personnel and their dependents.
Through the Department of Veterans Affairs, the federal government also
operates approximately 170 veterans hospitals, the majority of which are
general hospitals but some of which are psychiatric hospitals. The Depart-
ment of Justice, Bureau of Prisons, Health Services Division, provides
health care services for prisoners in federal institutions and runs the
Medical Center for Federal Prisoners, a large referral hospital. The Depart-
ment of Transportation runs U.S. Coast Guard hospitals in Kodiak, Alaska,
and New London, Connecticut.

State governments operate long-term facilities providing care for people
with mental or emotional difficulties and people with developmental
disabilities; in 1 99 1 250 state mental hospitals were in operation, though
the patient population was reduced only a fraction of what it had been a
generation earlier. State prison, state reformatory, and state university
medical school hospitals (for example, the University Hospital at the
University of Michigan Medical School) arc controlled to some extent by
state governments. Historically, states also ran hospitals for tuberculosis
patients (Glenridge Hospital, Glenville, New York, for example, which
closed in 1978).

Local governments, embodied in districts, counties, and cities, may also
run hospitals. In 1991 local governments controlled 1,393 hospitals
(1,352 general, 15 psychiatric, and 26 other), or 21 percent of all U.S.
hospitals. District hospitals, found in a few states, including California, are
governed by boards of directors who are elected by district residents;
county hospitals are generally run by county boards of supervisors (for
example. Cook County Hospital, Chicago); and city hospitals are owned
by municipal governments and managed by appointed boards of citizens
(Boston City Hospital). Sometimes city and county governments jointly
control a hospital.

Most public hospitals were founded to provide health care to indigent
people who were not served by voluntary hospitals. Today, public hospi-

HOSPITALS '' 21

tals include teaching hospitals, a small number of large general hospitals
treating primarily indigent people, some hospitals in urban areas in which
the patient profile is similar to that in voluntary hospitals, and many small,
rural hospitals.'^

Ownership or Control: Private The sizable number of voluntary
hospitals was born of the country's ethnic and religious diversity. ^^ Histor-
ically, voluntary or nonprofit hospitals were established by community
leaders or by religious or ethnic groups to serve the "deserving poor"
and individuals who became ill while away from home. Voluntary hos-
pitals provided free care and were paternalistic toward their patients.
As a rule, however, they did not treat indigent, contagious, morally
lacking, mentally ill, or chronically ill patients; this task was left to public
hospitals. '2

Voluntary hospitals, which accounted for 51 percent of U.S. hospitals
in 1991, are owned and/or operated by seven types of organization: (1)
churches or religious groups (including Baptist, Lutheran, and Roman
Catholic churches, the Salvation Army, the Sisters of Mercy, and the
Alexian Brothers); (2) private universities (e.g., Boston University's Uni-
versity Hospital); (3) fraternal organizations (the Shriners); (4) industry
(railroad and lumber companies); (5) community groups composed of
citizens who organize to provide health care for their community and
make annual contributions (Beth Israel Hospital, Boston)^'; (6) health
maintenance organizations (Kaiser Foundation Health Plan, Inc.); and (7)
cooperatives, which are owned by those who use their services (Group
Health Cooperative of Puget Sound). '"^

Proprietary or for-profit hospitals are usually set up as partnerships or
corporations. They emerged where community groups could not raise the
funds necessary to establish voluntary hospitals. In the late nineteenth
century and well into the twentieth century physicians often owned
hospitals because it was convenient to have a hospital close to their offices.
Furthermore, by starting their own hospital, physicians who did not have
admitting privileges in existing hospitals could treat patients needing
hospitalization instead of referring them to a colleague. Such physician-
owned hospitals, once common, are now rare.

During the Depression, many proprietary hospitals were closed or
merged with voluntary or public hospitals. After the passage of Medicare
and Medicaid legislation in 1965, however, the number of proprietary
hospitals rose again, because they were now reimbursed for interest on
their debt, plant depreciation, and capital equipment. ^^ After for-profit
hospitals were reimbursed by the government for Medicare and Medicaid
patients, they became more like voluntary hospitals. At the same time.

22 FACILITIES THAT DELIVER HEALTH CARE

voluntary hospitals became more like for-profit hospitals because the
government reimbursed them for some of their charity work.

Before 1965, the American public held a strong prejudice against the
for-profit hospital sector because the practice of medicine was viewed as
charity or a service to humanity. This prejudice lessened to some extent
once voluntary and proprietary hospitals became more like each other. ^^
Proprietary hospitals, however, continue to lag behind the hospital indus-
try as a whole in conducting research and providing outpatient services,
emergency services, health promotion services, and education for medical
professionals.^''

For the past several years, the number of proprietary hospitals has
remained stable. ^^ In 1991, 17.5 percent of hospitals were proprietary,
representing a decrease of 0.4 percent since 1950; however, the number
of beds and admissions in proprietary hospitals both increased signifi-
cantly during this period.

Degree of Independence Whether a hospital is freestanding or part of
a larger organization is important to understanding where documentation
is located. Obviously, if the hospital is freestanding there are fewer
possibilities than if it is part of a larger organization. There are several
configurations for a hospital within a larger organization. A hospital may
be one of the institutions composing a holding company. The Massachusetts
Eye and Ear Infirmary, for example, is part of the Foundation of the
Massachusetts Eye and Ear Infirmary, which is an umbrella organization
made up of the nonprofit infirmary and the Circle Company, a for-profit
real estate company that owns a hotel and a parking garage with several
storefronts. A few health maintenance organizations (HMOs) own one or
more hospitals. An example is Kaiser Permanente, which owns more than
twenty-five.^^ Hospitals are also owned by health care corporations, such as
National Medical Enterprises, Inc., which in 1992 owned thirty-six gen-
eral hospitals, thirty-two rehabilitation hospitals, seventy-five psychiatric
hospitals and substance abuse facilities, eighty-five nursing homes, and
thirty-five diagnostic centers in the United States, in addition to hospitals
in Australia, Great Britain, Spain, and Singapore. •^^

Multihospital systems are three or more voluntary hospitals (e.g., Ad-
ventist Health System) or governmental hospitals (e.g.. Veterans Admin-
istration hospitals) that collaborate through ownership, management, or
lease arrangements to enhance patient care. Their for-profit counterparts
are hospital chains such as Columbia Healthcare Corporation, which was
founded in 1985 by Richard L. Scott and merged in 1993 with Galem
Health Care and HCA-Hospital Corporation of America, creating a net-
work of one hundred ninety hospitals in twenty-six states and two foreign

HOSPITALS 23

countries. 2^ In 1986 one third of all U.S. hospitals were divisions of
multihospital systems. ^^

Finally, hospitals may be part of a university (there are 45 public
university hospitals in the United States), industry, or business. The Univer-
sity Hospital in Boston, for example, is owned by Boston University; and
at the turn of the century many of the larger railroad, mining, and
lumbering companies built, owned, and operated hospitals for their em-
ployees.^' With the dramatic rise in the cost of operating health care
facilities and the increased availability of group health insurance, com-
pany-owned hospitals are no longer common; however, in an attempt to
hold down rising health care costs, several large corporations are estab-
lishing in-house clinics and pharmacies for their employees.^"*

REGIONAL PATTERNS

Certain patterns of hospital ownership and control are more prevalent in
some areas of the country than in others. Proprietary hospitals were
begun in areas where the population was too poor or too scattered to
support a voluntary hospital. The majority of proprietary hospitals, there-
fore, are located in the South, West, and Southwest^^; California, Texas,
Florida, and Tennessee claim the most.^^ Voluntary hospitals are still most
prevalent in the northeastern, mid-Atlantic, and midwestern states,
where the wide variety of religions and ethnic groups were able to amass
the necessary capital to fund hospitals in the late nineteenth and early
twentieth centuries. ^^

ORGANIZATION AND FUNCTIONS OF HOSPITALS

Hospitals differ from each other and from other institutions, not only by
their ownership and control but also according to the functions that they
perform. Four of the functions — patient care, health promotion, biomedi-
cal research, and education — replicate the broad functions of the U.S.
health care system, as shown in Table 1-1. The fifth function, administra-
tion, is not unique to hospitals but is a requisite function of all institutions.
It is important to understand all of these functions and their recordkeep-
ing implications in terms of the distinctions between hospitals and busi-
nesses.

American hospitals are similar to businesses and have become more
so since the passage of Medicare and Medicaid legislation in 1965, which
created a large base of paying population for which hospitals competed.
Since the mid-1960s, nonprofit hospitals have been forced to adopt some
of the management activities, such as marketing, employed by for-profit

24 FACILITIES THAT DELIVER HEALTH CARE

hospitals. ^^ It is not uncommon for nonprofit tiospitals today to have
marketing managers or marketing departments. Nonprofit hospitals were
again forced to adopt some of their for-profit counterparts' strategies in
1983 when the federal government changed its method of Medicare
reimbursement from "reasonable cost" to a fixed rate based on the
patient's diagnosis. ^^ Thus, all hospitals were forced to become more
efficient or lose money when treating Medicare patients.

Several important differences also set hospitals apart from businesses.
The major difference, and probably the one that has the most effect on
records creation, is the nature of the hospital's organizational structure.
Hospital organization is not strictly hierarchical but comprises two main
components: an administrative component and a clinical or medical
component. Each component is organized differently, and no theoretical
model integrates them.^°

The administrative component, which is responsible for hospital man-
agement, is usually organized in a strict hierarchical fashion. The organi-
zation of the medical component, which is responsible for patient care,
education, and biomedical research, is flatter, and its members typically
work in teams across departmental lines. To complicate matters further,
the two components overlap, and many hospital employees report to two
supervisors, an administrator and a physician. The chief technician of a
pathology laboratory, for example, generally reports to the physician in
charge of the medical operations of the laboratory and to the administra-
tor responsible for the laboratory's financial operations. Many hospitals
have a joint committee in place to bridge the gap between the medical and
administrative components. This administrative/medical dichotomy,
which is referred to in the professional literature as a "dual authority
structure," has also affected the credentials of hospital chief executive
officers, which seem to alternate between management and medical
degrees. The current trend in nonprofit hospitals is toward physician chief
executive officers.''

Another significant difference between hospitals and businesses is
that while businesses employ all the individuals on their staffs, physicians
who work in hospitals may not be employed by the hospital. In the past,
very few physicians were paid by hospitals; instead, hospitals extended
privileges to physicians to admit their patients. The patient paid two fees,
one to the physician and the other to the hospital for use of the facilities,
nursing care, diagnostic tests, medical supplies, and medication. In con-
trast, certain types of physician, such as radiologists and anesthesiologists,
have traditionally been employed by hospitals and receive a salary. Differ-
ent arrangements between physicians and hospitals are now common
practice, and hospitals routinely employ physicians individually or as

HOSPITALS 25

groups. Newer alliances between hospitals and groups of physicians,
called physician hospital organizations, are the result of pressures to
contain costs. Their main purpose is to contract with managed care
organizations (HMOs and preferred provider organizations) and self-
insured employers, and to manage health care delivery. To further com-
plicate the issue, physicians in teaching hospitals may also have an
appointment at an affiliated medical school. Whatever the arrangement
between physicians and hospitals, a two-pronged organizational scheme
is the prevailing pattern.

There are several significant differences between hospital patients and
consumers of business products and services. Patients are not always able
to comparison shop; they generally are not concerned with the cost of
health care, especially if they have health insurance; and they have little
control over what they are buying because the physician decides which
drug or procedure is best for them (although sometimes patients will be
offered a choice among a small number of treatment options).

Other differences between hospitals and businesses include the fact
that hospitals do not manufacture a uniform product or provide a uniform
service; rather, hospitals provide health care services that are tailored to
each patient. In addition, physicians significantly influence both the sup-
ply and the demand for a service or product, whereas in business supply
and demand are determined independently. Finally, in business techno-
logical advances are usually cost-efficient; in hospitals they are usually
not, since technological advances increase cost because specially trained
personnel are needed to operate new and often expensive diagnostic and
therapeutic equipment. '^ There may, however, be several departments or
services within a hospital that are run as businesses. Hospital pharmacies,
gift shops (often run by the auxiliary), and optical shops are examples. In
addition, a hospital's parent company may own for-profit businesses, such
as nursing homes, alcohol and drug treatment centers, freestanding emer-
gency centers, ambulance services, HMOs, doctors' office buildings, pro-
gressive care retirement communities, hotels, and parking facilities.

Hospital Organization The clinical activities of hospitals are usually
organized into medical departments or services, but there is no standard
organizational model. One of three criteria is generally used in defining
departments: (I) the organ or organ system that is treated, (2) the skill
involved, and (3) the age or sex of the patients. The number of medical
departments in a hospital varies according to the hospital's size and degree
of specialization, but most general hospitals include the following depart-
ments: anesthesiology, emergency medicine, internal medicine, obstet-
rics/gynecology, pathology, pediatrics, psychiatry/neurology, radiology/

26 FACILITIES THAT DELIVER HEALTH CARE

diagnostic imaging, and surgery. More specialized medical departments
include ophthalmology, preventive medicine, and urology. ^^

The nonclinical activities of hospitals fall into six categories: govern-
ance, external relations, fiscal affairs, operations management, facilities
management, and human resources. Hospitals are often organized so that
vice presidents are responsible for these activities.

The following sections, organized by hospital function, discuss the
activities and mechanisms peculiar to hospitals, which archivists need to
understand to make sense of the resulting records.

Administration All institutions engage in administrative activities that
are necessary to conduct business. Hospitals are no exception; they engage
in activities related, for example, to institutional governance, fiscal man-
agement, personnel management, and research management, much as
other businesses do. Two hospital activities, however, accreditation and
regulation, warrant further discussion because they are complex and
distinctive.

Since 1952, hospital accreditation has been carried out by the Joint
Commission on Accreditation of Healthcare Organizations (JCAHO).
Representatives of five organizations make up the commission: the Amer-
ican College of Physicians, the American College of Surgeons, the
American Dental Association, the American Hospital Association, and the
American Medical Association. In accrediting hospitals, the JCAHO is
concerned with three areas: (1) quality of patient care, (2) hospital
organization and administration, and (3) hospital facilities. The accredita-
tion process consists of an extensive survey that is filled out by hospital
administrators and a site visit by a JCAHO accreditation team consisting of
a physician, one or two nurses, and sometimes a hospital administrator.
Hospitals may be accredited for three years with or without contingencies,
and hospitals that are regarded as "marginal" are publicly identified as
such. Beginning in mid- 1993, the JCAHO instituted unannounced sur-
veys of randomly selected accredited organizations to better gauge and
ensure compliance with commission standards. The surveys are con-
ducted at the midaccreditation point of a 5 percent sample of all organiza-
tions that participate in the three-year accreditation process. One sur-
veyor will conduct a one-day survey limited to the five performance areas
in which hospitals generally have the most problems: safety management,
life safety, medical staff appointment and privileging, infection control,
and governance. In 1995, the JCAHO will implement new standards that
are organized functionally instead of departmentally. Although the
JCAHO is a private organization and JCAHO accreditation is not man-
dated by law, Medicare and Medicaid legislation requires hospitals to meet

HOSPITALS 27

Standards equal to JC AHO standards to receive payment; thus, virtually all
hospitals seek JCAHO accreditation.

Hospitals are the most extensively regulated institution in the United
States.^'* Since the passage of Medicare and Medicaid legislation, hospital
regulation has increased dramatically. Before that time, regulations were
aimed mostly at the condition of the facility. Today, they have been
expanded to cover the quality and cost of care. Regulation of hospitals has
been described as lacking in "consistency, parsimony and clarity. "'' This
is because hospitals are regulated by a wide range of private organizations
(e.g.. Blue Cross and the JCAHO) and public agencies representing all
three levels of government, without any attempt at coordination. Often,
the regulations of different bodies conflict with one another.

Hospital regulation falls into four categories: ( 1 ) facilities regulation,
(2) planning regulation, (3) quality and appropriateness of care, and (4)
payment. ^^ All states require hospitals to be licensed, although the scope
of mandatory facilities regulation varies from state to state, and in some
states JCAHO accreditation guarantees state licensure. State licensing
regulations usually concern hospital organization (requiring an organized
governing body, organized medical staff, and administrator), the provi-
sion of certain specified services, and standards for facilities, equipment,
and personnel. State governments also have certain building code re-
quirements that apply to all facilities. These include regulations regarding
elevator and boiler performance, waste disposal, fire safety, and electrical
and plumbing facilities. In addition, hospitals are subject to state and
federal legislation that affects, for example, the dispensing of narcotics and
alcohol, the disposal of hazardous waste, radiation safety, water and air
quality, labor practices (including job safety), and educational require-
ments for teaching programs.

Planning is defined by the American Hospital Association as "an
orderly process for determining the health care needs of a specific popula-
tion and developing an appropriate health care capability to meet those
needs. "^^ The federal government was involved in hospital planning
regulation from 1946, when the Hill-Burton Hospital Survey and Con-
struction Act was passed, until 1986. This legislation provided for hospital
construction or renovation mostly in rural areas where there was a
shortage of beds. Currently, some states control capital expenditures for
construction, expansion, and modernization of health care facilities as
well as the purchase of costly technology, such as radiologic imaging
devices. The purpose of this legislation is to avoid unnecessary duplication
of services and to control costs. This certificate-of-need review process
involves considerable documentation and lengthy reviews at the local,
regional, and state levels.

FACILITIES THAT DELIVER HEALTH CARE

The quality and appropriateness of care, the third type of hospital regula-
tion, has been in effect since the passage of the 1965 Medicare legislation,
which requires that the appropriateness and necessity of care provided to
Medicare patients be evaluated by an examination of patient records.
Because of this regulation, hospitals established quality assurance and
utilization review committees to monitor and analyze patient admissions,
length of stay, and allocation of resources. In 1972 the federal government
legislated the creation of professional standards review organizations
(PSROs) comprised of local physicians who were paid by the DHHS to
monitor physician behavior and evaluate the quality and necessity of
services covered by Medicare and Medicaid. Since 1984, the review
contracts have been awarded to peer review organizations (PROs), which
are nonprofit, community based, physician-directed agencies and have
more authority than the PSROs. One PRO per state reviews admissions
and re-admissions, validates diagnoses, and reviews exceptional cases and
quality of care. Each PRO has a contract with the Health Care Financing

FIGURE 2-2 Children's Hospital, Boston, 1990. A corner of the Hunnewell
Building is visible on the left. The thirleen-floor John F. Enders Pediatric Research
Building is located to the far right. Source: Children's Hospital Archives

HOSPITALS 29

Administration that specifies how it will carry out these activities. If
medical audits reveal unacceptable practice, the government does not
reimburse the offending hospital for Medicare patients. In many cases
hospitals participate in the review process through in-house professional
services review departments, which are monitored by the PRO.

The quality of care in hospitals is also regulated by several obligatory
committees that seek to ensure a high standard of patient care. These
committees are generally overseen by a hospital's Professional Services
Review Committee or another group with responsibilities for quality
assurance. They include the Credentials Committee (which ensures that
physicians have the necessary and appropriate credentials), the Infection
Control Committee, the Medical Records Committee (which reviews the
"content, appropriateness and timeliness"^^ of official patient records),
the Pharmacy and Therapeutics Committee (which reviews drug utiliza-
tion and patient responses), the Radiation Committee, the Safety Com-
mittee, and the Tissue Committee (which examines tissue removed from
patients to determine whether surgery was indeed necessary).

Whereas the other types of regulation indirectly aim at controlling costs,
the final type of hospital regulation, regulation of payment, directly influences
the cost of hospital services. At both state and local levels, retrospective
reimbursement has been replaced by prospective payment. At the state
level, payment regulation is sometimes controlled by a rate-setting commis-
sion that prospectively approves rates for hospital services. The federal
government controls rates for in-patient hospital care to Medicare and
Medicaid patients through diagnosis-related groups (DRGs). Historically,
only fees for hospital services were regulated; physicians were reimbursed
according to a system of "customary, prevailing, and reasonable" charges.
This changed with the adoption by federal regulators, some private insurers,
and other third-party payers of the recently formulated resource-based
relative value scale (RBRVS) for physician fees. Developed at the Harvard
School of Public Health, the RBRVS standardizes physician fees according to
three factors: (1) the duration and intensity of the work, (2) the cost of
providing the service, and (3) the cost of physician training. ^^

Just as hospitals are accredited by the JCAHO and licensed by the states,
health care practitioners are also licensed.*^ Licensure usually involves
fulfilling certain educational requirements and passing an examination.
Which of the numerous health care professions require licensure, however,
varies among the states. In most states the hospital is responsible for
ensuring that medical and technical personnel meet governmental stan-
dards; therefore, hospitals often employ registrars whose function is to
document the credentials of physicians and other health care practitioners.
(See Chapter 5 for more information on licensing health care professionals.)

30 FACILITIES THAT DELIVER HEALTH CARE

Patient Care Patient care, which encompasses diagnosis and treat-
ment, is the primary function of hospitals and what distinguishes them
from other institutions within and outside of the health care system.
Patient care is often divided into three levels — primary care, secondary
care, and tertiary care — based on the severity of the condition to be
treated. Primary care denotes care that is simple to give, or the evaluation
of a condition and referral to a specialist. Although primary care does not
require hospitalization, individuals may receive primary care in a hospital
setting. Treating individuals with infections, or victims of minor accidents,
and providing annual physical examinations are examples of primary
care. Secondary care is more specialized care for conditions that require
day surgery or hospitalization. Treating victims of burns or serious acci-
dents and extracting tonsils are examples of secondary care. Tertiary care
is the most specialized level of care and generally involves the most
advanced medical knowledge and technology available. Because of this,
most teaching hospitals that are part of academic health centers specialize
in tertiary care. Tertiary care includes treatment for cancer and for con-
genital and metabolic disorders.^' Some hospitals engage in all three levels
of care, although many smaller hospitals refer tertiary care cases to larger
hospitals.

Diagnoses may be made by health care professionals without the aid
of technology (as when they prescribe treatment on the basis of their
observations or information provided by patients) or with the aid of
technology. There are three main catories of diagnostic technology: sam-
ple analysis, intrinsic energy analysis, and external energy probes. Sample
analysis consists of analyzing the chemical and cellular components of
body fluids and tissues. Examples of sample analysis include blood tests,
tumor biopsies, and spectroscopy. Intrinsic energy analysis measures
internal energy conditions, such as temperature, sound, and pulse. Elec-
troencephalographs, for example, are devices that record the electrical
activity of the brain. The third category of diagnostic technology, external
energy probes, is used to determine the size, shape, and location of
internal organs. External energy probes work by directing beams of
energy into the patient and analyzing the energy that comes out. Exam-
ples of external energy probes are ultrasound and x-ray imagers. "^^

Hospital laboratories are an important element in patient diagnosis.
Two types of laboratory — clinical pathology and research — may exist in a
hospital, but only clinical pathology laboratories are involved with diag-
nosis. Through sample analysis, they provide information that assists
health care personnel in diagnosing disease.

Patient treatment may be classified as internal therapy (medication).

HOSPITALS 3 1

external therapy (casts, bandages, advice on life-style changes), mental
therapy, or surgery. Patient treatment may further be distinguished ac-
cording to whether the patient remains in the hospital overnight (in-
patient) or is treated and released (outpatient). Hospital outpatient de-
partments first appeared in the 1920s, and since then they have increased
in number, scope, and complexity."^' Outpatient services consist of emer-
gency care and general diagnosis and treatment for nonemergency condi-
tions to individuals referred by themselves or a physician. It is noteworthy
that in the last several years the length of hospital stays has decreased, and
some procedures, such as cataract surgery, that were previously per-
formed on an in-patient basis are now performed as ambulatory surgery,
eliminating the need for an overnight hospital stay. This change is due to
improved techniques and to revised Medicare and Medicaid reimburse-
ment regulations aimed at cost containment.

Advances in communications technology have significantly altered
the delivery of patient care. Computer networks link physicians to one
another and physicians' homes and offices to hospital laboratories and
finance departments. Physicians can readily update medical records using
voice recognition technology, and diagnostic imaging departments are
able to store images on optical disks instead of film. Furthermore, patients
can carry with them their medical record on a card about the size of a
credit card. For an overview of how computerization has affected health
care, see Nina W. Matheson, "Computerization and a New Era for Ar-
chives" in Nancy McCall and Lisa A. Mix, eds.. Designing Archival Programs
in the Health Fields (Baltimore: Johns Hopkins University Press, 1994).

Health Promotion Health promotion, also called consumer health edu-
cation, is the process of communication and education that "helps each
individual to learn how to achieve and maintain a reasonable level of health
appropriate to his particular needs and interests, and to be motivated to
follow health . . . practices which contribute to his state of health and
well-being."'*^ Historically, hospitals in the United States have not partici-
pated very actively in health promotion. This trend seems to be reversing
due to the need to contain costs: by 1987, health promotion programs were
offered in more than one third of U.S. hospitals."*' Community hospitals are
especially conscientious about health promotion programs, and it is not
unusual for them to offer (free or at a moderate cost) literature concerning
health issues and health education classes in how to stop smoking, reduce
stress, or maintain a healthier diet. Health promotion programs may also
include health support groups, health screening, physical fitness classes,
family life education, and rehabilitation.

32 FACILITIES THAT DELIVER HEALTH CARE

Biomedical Research Biomedical research is similar to scientific/tech-
nological research, with the exception that biomedical research may be
more clinical; therefore, the records of research done in hospitals are often
similar to those produced by research in a university .^^ Hospitals may
embark on research projects jointly with universities or corporations, thus
affecting the location and ownership of project records. Biomedical re-
search in the hospital setting may be scientific/technological in nature or a
combination of scientific/technological and medical. Recently, the trend
in hospitals has been to increase research and development activities to
produce new products with commercial potential. Often these activities
are conducted in cooperation with pharmaceutical companies. This type
of diversification is aimed at enabling hospitals to remain viable in a
competitive environment.'^^

Biomedical research in whatever setting is regulated just as scientific/
technological research is regulated. Hospitals, like other institutions per-
forming research involving animals or humans, must have animal care
committees and human subject committees. These are federally mandated
committees that closely monitor federally funded research involving ani-
mals or humans. If abuses occur, committee members are obliged to
report them to the National Institutes of Health. (For more information on
biomedical research and biomedical research facilities, see Chapter 4.)

Education In a hospital setting, education and training may occur at
many levels. Hospital personnel are given on-the-job training in infection
control and safety procedures; laboratory and radiology technicians are
trained; nursing students are provided with undergraduate education or
specialty training; graduate students earn master's degrees in nursing,
dietetics, or physical therapy; other graduate students work on research
projects in hospital departments or laboratories as part of doctoral degree
work; medical students go through rotations, which lead to M.D. degrees;
physicians are given postgraduate education as residents or fellows; and
allied health care professionals in all disciplines attend hospital-sponsored
in-service programs or continuing education courses to retain their certifi-
cation or licensure or to update their knowledge and skills. To this end it is
not uncommon for hospitals to have an education department, or for
medical departments to hire managers to deal primarily with education.
Hospitals may also provide the clinical facilities necessary for programs
that they do not sponsor. In addition, hospitals often provide trustee
education and management development courses. (See Chapter 5 for
information on educational institutions and programs for health care-
related occupations.)

Certain hospitals are identified as teaching hospitals. According to the

NURSING HOMES 33

American Hospital Association, a teaching hospital is "a hospital that
allocates a substantial part of its resources to conduct, in its own name or
in formal association with a college, courses of instruction in the health
disciplines that lead to the granting of recognized certificates, diplomas, or
degrees, or that are required for professional certification or licensure. "^^
Although this definition does not mention research, the reality is that the
majority of teaching hospitals also engage in biomedical research, and
hospitals that engage in research are also usually defined as teaching
hospitals.

Historically, the majority of teaching hospitals in the United States
were public hospitals; today, however, the majority of teaching hopitals
are voluntary. ^^ For-profit hospitals generally avoid engaging in teaching
and biomedical research because they are not profitable activities; how-
ever, a few investor-owned companies began purchasing or leasing teach-
ing hospitals in the early 1980s, for a variety of complex reasons. ^° In
1991, 19 percent (1,238) of all hospitals were teaching hospitals. Of these,
30 percent were government owned (18 percent state and local, 12
percent federal) and 70 percent were privately owned (67 percent not-
for-profit, 3 percent for-profit). Although the term "teaching hospital"
traditionally referred to affiliation with a medical school, today it also
denotes affiliation with other educational institutions. The Veterans Ad-
ministration Hospital in Ann Arbor, Michigan, for example, is affiliated
with the University of Michigan Medical School and thirty-four other
educational institutions.

NURSING HOMES

Nursing homes and hospitals are similar in many respects. For example,
they both provide in-patient medical care, are heavily regulated, are
licensed by the JCAHO, and provide training for health care professionals.
Yet they have one basic difference: nursing homes are primarily places
where people live and secondarily where they receive medical care. For
this reason health care professionals play a less significant role in control-
ling and operating nursing homes. ^^

Until relatively recently, hospitals provided long-term health care for
elderly and convalescent people. Although hospitals still provide long-
term care, nursing homes provide most of it. In fact, the nursing home
industry is the third largest element of the health care system. ^^ In 1991
there were 15,913 certified nursing homes in the United States,^^ and
$59.9 billion (about 7.5 percent of the total spent on health care) was
spent on nursing home care.^'^

34 FACILITIES THAT DELIVER HEALTH CARE

Most likely the first nursing home began in the early 1930s in Chicago
or Detroit. 55 The Social Security Act of 1935 increased the number of
people who were able to purchase nursing home care and caused proprie-
tary nursing homes to dominate the market. Until World War II, nursing
homes generally were small, run by the owner, and staffed by the
immediate family. With increasing governmental regulation of the indus-
try, especially Social Security Act amendments in 1950, 1972, and 1974,
these "mom and pop" nursing homes were forced out of business because
they could not afford to comply. Nevertheless, proprietary nursing homes
are still the norm. Since the late 1960s, publicly held corporations have
owned and operated nursing homes, and in 1991 for-profit organizations
owned 67.3 percent of the nursing homes in the United States, while 25.9
percent were owned by nonprofit organizations and 6.8 percent by gov-
ernment. ^^

Until 1989 nursing homes were licensed to provide two types of care:
skilled care and intermediate care. Skilled care provided services that "(1)
require the skills of technical or professional personnel . . . [andl (2) are
provided either directly by or under the supervision ... of such person-
nel. "^'^ Intermediate care consisted of "health-related care and services to
individuals who do not require the degree of care and treatment which a
hospital or skilled nursing facility is designed to provide, but who . . . require
care and services (above the level of room and board) which can be made
available to them only through institutional facilities. "^s Nursing homes
were designated either as skilled nursing facilities, which the federal govern-
ment reimbursed under Medicare and Medicaid, or as intermediate care
facilities, which were reimbursed under Medicaid only; or they provided
both levels of care. Since 1990, all nursing homes are referred to as nursing
facilities and are required to provide the same level of care.

Nursing homes engage in four of the five functions in which hospitals
engage: administration, patient care, health promotion, and education
and training. The most important function, patient care, includes nursing
and medical care (e.g., injections, catheterizations, and physical therapy),
personal care (assistance in eating, dressing, and bathing), and residential
services (food preparation, cleaning, and organizing social activities).

For skilled nursing facilities to participate in Medicare and Medicaid,
they must provide or provide for the following services: nursing, dietetic,
specialized rehabilitative, pharmaceutical, laboratory, radiologic, dental,
and social. They are also required to keep medical records, have infection
control and utilization review committees, provide activities for nursing
home residents, meet local health and safety standards, have a transfer
agreement with a hospital, and meet disaster preparedness require-
ments. ^^

HOSPICES 35

HOSPICES

Hospice is a term used to identify both institutions and programs. The
National Hospice Organization defines a hospice as "a centrally adminis-
tered program of palliative and support services which provides physical,
psychological, social, and spiritual care for dying persons and their fami-
lies. Services are provided by a medically supervised interdisciplinary
team of professionals and volunteers. Hospice services are available in
both the home and inpatient settings. . . . Bereavement services are
available to the family. "^° This definition covers the five basic elements of
hospice care: (1) patient and family are treated as a unit, (2) care —
consisting at a minimum of medical direction, nursing services, social
services, spiritual support, volunteer services, and bereavement counsel-
ing — is managed by an interdisciplinary team, (3) patient care is palliative
rather than curative, (4) care is available in the patient's home, and (5)
bereavement care is provided for the family after the patient's death. ^^

In the past, "hospice" referred to inns run by religious orders. The first
health care-related hospice opened in London in 1967 under the direction
of Dame Cicely Saunders. The first hospice in the United States was the
Hospice of Connecticut, in New Haven, which opened in 1974, and by
1992 the number of hospice programs had grown to about 2,000.^^ The
hospice concept caught on in part because the roles of hospitals and
nursing homes changed with the increase in governmental regulation of
their utilization and because the federal government no longer viewed
them as the most appropriate (i.e., cost effective) institutions to deal with
terminally ill patients (those with less than six months to live). In 1983
federal laws that allow Medicare reimbursement for home hospice care
went into effect.

Just as there is a variety of types of hospital, so is there a range of types
of hospice. The ownership of hospices may be private and for-profit,
voluntary, or governmental. Hospices may be independent or part of
larger institutions such as hospitals, skilled nursing facilities, HMOs, home
health agencies, or psychiatric facilities. In addition, there are several
models for hospices owned by hospitals. They may be freestanding institu-
tions, a discrete unit within the hospital, or beds scattered throughout the
hospital. Community-based hospice programs usually do not provide
direct care. Instead, they coordinate care by contracting for services from
existing agencies and hospitals. In 1992 26 percent of hospices were
divisions of hospitals, 41 percent were owned by independent corpora-
tions, and 20 percent were affihated with home health agencies.^'

Hospices perform four of the five functions of a hospital: administra-
tion, patient care, education, and biomedical research activities. Hospices

36 FACILITIES THAT DELIVER HEALTH CARE

have little involvement in health promotion because of the nature of the
patient clientele, although services to families might be classified under
this heading. Educational activities in a hospice may include the training
of residents and interns if the hospice is connected to a teaching hospital-
otherwise these activities are limited to the hospice staff, who most likely
did not receive training or education specific to hospices before working in
one. Although hospices seem unlikely settings for research, some of them
engage, for example, in studies of approaches to palliative care or antitu-
mor therapies.^*

Because hospices are a relatively recent development in the health
care system, their regulation by the government did not become an issue
until the 1980s. In 1983 the JCAHO and the National Hospice Organiza-
tion developed standards for evaluating hospice programs. Also, Blue
Cross/Blue Shield, Medicare, and Medicaid reimburse providers for cer-
tain hospice services.

AMBULATORY CARE SETTINGS

Ambulatory care is generally provided in one of two settings, physician
offices or clinics. ^^ Although most ambulatory care is provided by physi-
cians in office-based practices, it is also common for individuals to go
directly to a hospital clinic for primary care, often because they do not
have health insurance. ^^ Physician offices may be organized as individual or
group practices, although the number of solo practices is declining as the
number and size of group practices increase. ^^ Solo practitioners are most
often specialists who provide secondary care only. Physicians may also
contract their services out on a part-time basis or may be part of an
independent practice plan or association, in which they contract with a
prepaid group health plan but see patients in their own offices.

The term group practice refers to a variety of legal and financial
arrangements. Legal arrangements include sole proprietorships, associa-
tions, professional corporations, and partnerships. Financial arrange-
ments most commonly include situations in which the patient pays and
the physician is remunerated on a fee-for-service basis, or the patient
prepays and the physician is either remunerated at a flat rate for each
patient or on salary. ^^ A growing trend is hospital-based group practices.
This may mean that the group of physicians comprises the hospital's
medical staff; alternatively, the group and hospital may be independent,
and, while the group treats all of its in-patients in the affiliated hospital,
the hospital also accepts patients from other physicians. The first group
medical practice was organized in 1887 in Minnesota by Dr. William W.

ARCHIVES PROGRAMS IN HEALTH CARE DELIVERY FACILITIES 37

Mayo, who formed a partnership with his two sons. Today the trend is
away from solo practice and toward group practices, which may be
devoted to the practice of general or family medicine, a single specialty
(such as ophthalmology or obstetrics and gynecology), or multiple special-

ties

Until the early part of the twentieth century, the term dink connoted
medical charity. Today a clinic is usually defined as a setting in which
diagnostic or therapeutic services are provided on an ambulatory basis
rather than to in-patients.^^ Clinics are numerous and varied. They may
be general or specialized, and freestanding or part of a larger institution.
(See Table 2-2 for a categorization of clinic types according to the clientele
served and the condition diagnosed or treated.) Non-institutionally based
clinics may be sponsored by private individuals or corporations (e.g.,
American Medical International Diagnostic Services); local, state, or na-
tional government (East Boston Neighborhood Health Center); voluntary
entities (the American Cancer Society's cancer detection clinics); or a
combination of these groups. Freestanding ambulatory care facilities pro-
viding emergency and urgent care services were first established in 1973
in Delaware and Rhode Island.

Institutionally based clinics are found in institutions whose primary
function is health care related as well as in those whose primary function
is not health care related. Institutions such as HMOs, holistic or alternative
health centers, and hospitals (emergency services, ambulatory services,
and satellite clinics) are in the first category. Business and industry
(employee health clinics and wellness programs), prisons, private homes
(home care"^^ programs sponsored by hospitals, visiting nurse associations,
public health agencies, and health care companies),''^ and schools are in
the second category.

ARCHIVES PROGRAMS IN HEALTH CARE DELIVERY FACILITIES

HOSPITALS

Although some hospitals and academic health centers have active archival
programs, the percentage is small. The Society of American Archivists'
1 99 1 directory lists only twenty hospital archivists; the New England
Archivists' 1991 handbook and directory lists an additional three hospital
archivists; the Guide to Repositories of the Science, Technology and Health Care
Round Tahle"^^ mentions another twelve archival programs collecting hos-
pital records. (The archives program at Children's Hospital, Boston, is too
new to have been listed in any of these directories.) The American
Hospital Association's Guide to Historical Collections in Hospital and Healthcare

38 FACILITIES THAT DELIVER HEALTH CARE

Administration adds about 250 institutions (including state universities) to
the number collecting hospital records, but most of these institutions do
not have programs run by professional archivists. Although these num-
bers do not include city and state archives that collect hospital records,
they still indicate that only a small percentage (somewhere in the neigh-
borhood of 5 percent) of hospitals have programs to preserve their
historical records.

A cursory search of Research Libraries Information Network on-line
data base (RLIN) provided more evidence that hospitals are underdocu-
mented. A corporate heading search of "hospitals" uncovered 2,250
entries; the same type of search for "colleges and universities" yielded
21,000 entries. Even if one takes into account the fact that academic
institutions are more likely than freestanding hospitals to have listed their
records in RLIN, there are approximately ten times as many entries for
colleges and universities than for hospitals.

HOSPICES AND NURSING HOMES

If hospitals are underdocumented, hospices and nursing homes are virtu-
ally undocumented. In searching the various guides to archival reposito-
ries, I did not find a single hospice or nursing home that had its own
archives program. A search of RLIN yielded no entries for hospices and
only 59 for nursing homes.

It is unlikely that health care facilities other than hospitals will choose
to maintain in-house archival programs. Perhaps the most reasonable way
to document nursing homes, hospices, and ambulatory clinics is to iden-
tify selected records to be placed with a city or state archives, historical
society, or other appropriate repository.

Although the data presented here are more impressionistic than
scientific, they clearly demonstrate that health care delivery facilities are
in need of systematic documentation. I am not advocating that all health
care delivery facilities maintain in-house archival programs that docu-
ment in detail their every aspect. I do believe that these institutions should
consider developing archival programs (in-house or external) to suit their
specific needs and capabilities. The purpose of this work is to facilitate
development of such programs.

NOTES

L Lois Rakus Keefe, "A Conceptual Model of Ambulatory Care Programs and
Delivery Systems in the U.S." (unpublished thesis in partial fulfillment of the

NOTES 39

requirements for fellowship in the American College of Hospital
Administrators, Chicago, December 1981), 15.

2. Morris J. Vogel, review of The Care of Strangers: The Rise of America's Hospital
System, by Charles E. Rosenberg, Bulletin of the History of Medicine 62 (Summer
1988): 284.

3. American Hospital Association, Hospital Statistics, 1992-93 Edition (Chicago:
American Hospital Association, 1992). The statistics in this publication are
based on 1991 figures. Unless otherwise noted, all subsequent statistics are
from this source.

4. The editors of The Chronicle of Higher Education, The Almanac of Higher Education
(Chicago: University of Chicago Press, 1991).

5. Katharine R. Levit et al., "National Health Expenditures 1990," Health Care
Financing Review 13, no. 1 (1991): 29-54.

6. Stephen J. Williams and Paul R. Torrens, eds.. Introduction to Health Services
(New York: John Wiley & Sons, 1984), 172.

7. American Hospital Association Guide to the Health Care Field, 1987 Edition
(Chicago: American Hospital Association, 1987), A13.

8. Anthony R. Kovner, and contributors. Health Care Delivery in the United States
4th ed. (New York: Springer Publishing Company, 1990), 305.

9. The Clinical Center provides patient care only to individuals with illnesses
that are being studied at one of the institutes; general diagnostic, treatment,
and emergency services are not offered.

10. J. Rogers Hollingsworth, A Political Economy of Medicine: Great Britain and the
United States (Baltimore: Johns Hopkins University Press, 1986), 80-81.

11. Ibid., 5.

12. Ibid., 75.

13. It is interesting to note that Jewish hospitals fall into the last category rather
than the first, for they are supported by members of the Jewish community
but are not controlled by the synagogue. Similarly, black hospitals are
community hospitals supported by the African-American community.

14. Revised and updated from Florence A. Wilson and Duncan Newhauser,
Health Services in the United States (Cambridge, Mass.: Ballinger, 1985), 9.

1 5. Hollingsworth, Political Economy of Medicine, 74.

16. J. Rogers Hollingsworth and Ellen Jane Hollingsworth, Controversy about
American Hospitals: Funding, Ownership, and Performance (Washington, D.C.:
American Enterprise Institute for Public Policy Research, 1987), 63.

1 7. Ekaterini Siafaca, Investor-Owned Hospitals and Their Role in the Changing U.S.
Health Care System (New York: F & S Press, 1981 ), 117.

18. Russell C. Coile, Jr., The New Medicine: Reshaping Medical Practice and Health
Care Management (Rockville, Md.: Aspen Publishers, 1990), 29.

19. Most health maintenance organizations do not own hospitals but have
agreements with specific hospitals where their members are treated.

20. National Medical Enterprises, Inc., Annual Report, 1992.

21. "The Hospital World's Hard-Driving Money Man," New York Times, 5 Oct.
1993, DI.

40 FACILITIES THAT DELIVER HEALTH CARE

22. Kovner, Health Care Delivery, 143.

23. Paul Starr, The Social Transformation of American Medicine: The Rise of a Sovereign
Profession and the Making of a Vast Industry (New York: Basic Books, 1982), 202.

24. "Frustrated Firms Open Their Own Clinics to Try to Control Workers' Medical
Costs," Wall Street Journal, 23 March 1993, Bl.

25. Siafaca, Investor-Owned Hospitals, 62.

26. Rollings worth and Hollingsworth, Controversy about American Hospitals. 27, 62.

27. Ibid., 26-27.

28. Donald W. Light, "Corporate Medicine for Profit," Scientific American 255
(December 1986):42.

29. Diagnosis-related groups (DRGs) are a form of prospective payment under
Medicare for in-patient hospital services. Under this system, hospitals are paid
a specified amount for services provided based on a patient's classification
into one of approximately 500 DRGs, regardless of what the care actually
costs and with some adjustments made for teaching hospitals and regional
variations in cost of living. Psychiatric, rehabilitation, children's, and long-
term hospitals are excluded from DRG regulations.

30. Luther P. Christman and Michael A. Counte, Hospital Organization and Health
Care Delivery (Boulder: Westview Press, 1981), 28.

3 1 . Coile, The Nev/ Medicine, 242.

32. Jonathon S. Rakich and Kurt Darr, eds.. Hospital Organization and Management:
Text and Readings (New York: SP Medical and Scientific Books, 1983), 597-
600.

3 3 . Kovner, Health Care Delivery, 161-62.

34. Siafaca, Investor-Owned Hospitals, 29.

35. American Hospital Association, Hospital Regulation: Report of the Special
Committee on the Regulatory Process (Chicago: American Hospital Association,
1977), 2.

36. Siafaca, Investor-Owned Hospitals, 33, and American Hospital Association,
Hospital Regulation (1977), 113.

37. American Hospital Association, Hospital Regulation (1977), 11.

38. Donald I. Snook, Jr., and Edita M. Kaye, A Guide to Health Care Joint Ventures
(Rockville, Md.: Aspen Publishers, 1987), 195.

39. William C. Hsiao et al., "Resource-Based Relative Values: An Overview,"
Journal of the American Medical Association 260 (October 1988): 2347-53.

40. The American Hospital Association defines licensure as "the process by which
an agency of government grants permission to an individual to engage in a
given occupation, upon finding that the applicant has attained the minimal
degree of competency necessary to ensure that the public health, safety, and
welfare be reasonably well protected." American Hospital Association,
Guidelines: Licensure of Health Care Personnel (Chicago: American Hospital
Association, 1977), 1.

41 . James M. Rosser and Howard E. Mossberg, An Analysis of Health Care Delivery
(New York: John Wiley &- Sons, 1977), 16.

42. Williams and Torrens, Health Services, 287.

NOTES 41

43. Milton I. Roemer, Ambulatory Health Services (Rockville, Md: Aspen
Publishers, 1981), 48.

44. Myra E. Madnick, Consumer Health Education: A Guide to Hospital-Based
Programs (Wakefield, Mass.: Nursing Resources, 1980), 1.

45. Coile, The New Medicine, 152.

46. For a discussion of scientific/teclinological research from the standpoint of its
component activities, see Joan K(rizack) Haas et al.. Appraising the Records of
Modern Science and Technology: A Guide (Cambridge: MIT, 1985).

47 . Coile, The New Medicine, 3 5 .

48. "Definition of a Teaching Hospital," American Hospital Association
Memorandum, 11-15 Nov. 1967, as quoted in William E. Hassam, Hospital
Pharmacy (Philadelphia: Lea & Febiger, 1986), 45.

49. Hollingsworth and Hollingsworth, Controversy about American Hospitals, 47.

50. Committee on Implications of For-Profit Enterprise in Health Care, Institute
of Medicine, Bradford H. Gray, ed., For-Profit Enterprise in Health Care
(Washington, D.C.: National Academy Press, 1986), 145.

51. Catherine Hawes and Charles D. Phillips, "The Changing Structure of the
Nursing Home Industry and the Impact of Ownership on Quality, Cost and
Access," in Gray, ed., For-Profit Enterprise, 492-541.

52. Ibid., 492.

53. American Health Care Association, Issue and Data Book for Long Term Care
(Washington, D.C.: American Health Care Association, 1993), 49.

54. "Aid for Chronic Illness and Other Long-Term Care," New York Times, 21 Feb.
1993, L25.

55. Wesley Wiley Rogers, General Administration in the Nursing Home (Boston: CBI,
1980), 166.

56. American Health Care Association, Issues and Data Book, 49.

57. From the Code of Federal Regulations as quoted in Bruce C. Vladek, Unloving
Care: The Nursing Home Tragedy (New York: Basic Books, 1980), 135.

58. Idem.

59. Federal Register, 39, no. 12, pt. Ill (Thursday, 17 Jan. 1974): 2238-49.

60. National Hospice Organization, Standards of a Hospice Program of Care, 6th rev.
(McLean, Va.: National Hospice Organization, 1979).

61. Paul R. Torrens, ed.. Hospice Programs and Public Policy (Chicago: American
Hospital Association, 1985), 7, 37.

62. Telephone conversation with Glenn Gillen, Communications Manager for the
National Hospice Organization, 28 June 1993.

63. Idem.

64. Jack M. Zimmerman, Hospice: Complete Care for the Terminally III (Baltimore:
Urban and Schwarzenberg, 1986), 46.

65. A case could be made that pharmacies and health food stores, where
pharmacists and employees advise customers on over-the-counter
medications, vitamin therapy, and homeopathic remedies, are also settings
for ambulatory care.

66. Williams and Torrens, Health Services, 139, 156.

42 FACILITIES THAT DELIVER HEALTH CARE

67. CoWe, The New Medicine, 240.

68. Steven Jonas, Health Care Delivery in the United States (New York: Springer
Publishing Company, 1981), 146.

69. Milton I. Roemer, An Introduction to the U.S. Health Care System (New York:
Springer Publishing Company, 1986), 21-22.

70. Roemer, Ambulatory Health Services, 29.

7 1 . Home care is defined by the Joint Commission on Accreditation of Healthcare
Organizations as providing professional nursing and at least one other
therapeutic service. See JCAHO, Accreditation Manual for Hospitals, 1988
(Chicago: JCAHO, 1987), 53.

72. The bulk of the records documenting home care resides with the provider of
care and not in patients' homes.

73. This guide was produced by the Science, Technology and Health Care Round
Table of the Society of American Archivists in 1988.

SELECTED ANNOTATED BIBLIOGRAPHY

Three outstanding books on the history of hospitals in the United States are

Charles E. Rosenberg, The Care of Strangers: The Rise of America 's Hospital System
(New York: Basic Books, 1987), which discusses hospitals in their social
context from 1800 to 1920; Rosemary Stevens, In Sickness and Wealth: Ameri-
can Hospitals in the Twentieth Century (New York: Basic Books, 1989), an
excellent book that picks up where Rosenberg left off; and Morris J. Vogel,
The Invention of the Modern Hospital: Boston, 1870-1930 (Chicago: University of
Chicago Press, 1980), an important study that outlines the development of
the modern hospital by focusing on the multitude of Boston hospitals.

Histories of specific types of hospitals include: Harry F. Dowling, City Hospitals: The
Undercare of the Underpriviledged (Cambridge: Harvard University Press, 1982),
a history of hospitals owned by cities, counties, regional authorities, or less
frequently states, from the founding of the almshouse hospital in Philadel-
phia in 1731 to the mid-1970s; Vanessa Northington Gamble, The Black
Community Hospital: A Historical Perspective (New York: Garland, 1987); Janet
Golden, ed.. Infant Asylums and Children's Hospitals: Medical Dilemmas and
Developments, 1850-1920 (New York: Garland, 1987); Diana Elizabeth Long
and Janet Golden, eds.. The American General Hospital: Communities and Social
Contexts (Ithaca: Cornell University Press, 1989); and Kenneth M. Ludmerer,
"The Rise of the Teaching Hospital in America," Journal of the History of
Medicine and Allied Sciences 38, no. 4 (1983): 389-414.

Many histories of specific hospitals exist, some scholarly and some not. The

American Hospital Association's Resource Center publishes a list of hospital
histories in its collection. The list is available free of charge by writing to the
American Hospital Association, Center for Hospital and Healthcare Adminis-
tration History, 840 North Lake Shore Drive, Chicago, IL, 6061 1.

CHAPTER 3

Health Agencies and Foundations

PETER B. HIRTLE

Of the various types of nonprofit corporate bodies composing the U.S.
health care system, two have historically performed the same broad range
of functions: governmental health care agencies and private foundations.
Both have played and, in the case of government agencies, continue to
play significant roles in patient care, health care promotion, biomedical
research, the education of health care professionals, and policy formula-
tion. (Governmental agencies are also involved with the regulation of the
health care system.) In addition to engaging in these functions directly,
health care agencies and foundations also provide financial support for
other corporate institutions (such as hospitals, universities, and research
institutions) and individuals who carry out these functions. In their roles
as a funding source for patient care or, in the case of health care agencies,
as a provider of patient care, agencies and foundations are an important
component of the U.S. health care system. ^ Their contributions to that
system are considered in this chapter in two major sections: federal, state,
and local agencies with their broader responsibilities are addressed first,
followed by an analysis of foundations.^

GOVERNMENTAL AGENCIES

The United States, unlike most other industrial nations, lacks a centralized
national health system. The absence of such a system in the United States,
however, does not mean that health care is unimportant to the govern-
ment. Federal agencies are active in every function of the U.S. health care
system (see Table 3-1). Furthermore, the level of government involve-

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FUNCTIONAL ANALYSIS 45

ment with health care is significant. American governments (federal,
state, and local) are the single largest source of funds spent each year on
health care: in 1990 $282.6 billion, or 42.4 percent of the total expendi-
ture on health in the United States, came from public funds. ^ Federal and
local governments were the most important source of funding for health
services and supplies expenditures, which include outlays for goods and
services relating directly to patient care and public health plus expenses
for administering the programs, providing 33.1 percent of such funding.*
In addition to funding certain activities of other entities, governmen-
tal agencies in the United States employ over 1.6 million people in direct
patient care.' They also regulate private providers and health-related
industries, and recently they have taken an increased role in establishing
standards for care and judging compliance with them, and in planning for
the general delivery of health services. Some governmental agencies are
active in health promotion, while others support biomedical research and
education. Despite the lack of a centralized national health care system,
governmental health care agencies play an important role in defining the
nature and activities of the health care system in the United States.

FUNCTIONAL ANALYSIS

Governmental agencies address almost all the functions of the U.S.
health care system. The only exception is that they do not generally
provide goods and services (other than insurance services). In the rare
instances in which governmental agencies do provide products to the
health care system, it is usually because the commercial market for the
products is so small that the private sector cannot effectively address the
need. Of the remaining functions of the health care system in which
governmental health care agencies are actively involved, the importance
of their role varies. Health care agencies play a dominant role in regulation
and policy formulation, in health promotion, and biomedical research.
Their activities in support of patient care and the education of health care
professionals, while significant, complement similar activities in the pri-
vate sector.

Almost as important as the direct involvement of governmental agen-
cies with the functions of the U.S. health care system is their role in
financing activity carried out by other groups. The amount of money
spent by the federal government on direct patient care in federal facilities,
for example, is dwarfed by the amount paid by the government through
the Medicare program to other health care providers. Similarly, much
more is spent on funding research outside of the federal government

HEALTH AGENCIES AND FOUNDATIONS

(extramural programs) than on the federal government's internal (intra-
mural) research programs. Although funding by governmental agencies
of health care activities does not constitute a separate function in the
analysis followed in this book, funding does have serious implications for
the kinds of record generated by those agencies, and will be considered in
this chapter where appropriate.

The involvement of governmental agencies with health care takes
place on three levels: federal, state, and local. The functions of health care
agencies at each level are not distinct; governmental health care agencies
at each of the three levels may provide patient care, fund or conduct
biomedical research, promote health, formulate policy, regulate health
care, or educate health care professionals. As a consequence, governmen-
tal agencies occasionally duplicate each other's efforts, while other activi-
ties may fall between the cracks and be left unaddressed. Furthermore,
identical functions are often performed by different agencies in different
states or even within a state. ^

FIGURE 3-1 A Public Health Service physician inspecting Chinese immigrants in
1924. Medical inspection of aliens was one of the important early activities of this
federal health agency. Source: National Library of Medicine, Bethesda, Md.

FUNCTIONS OF FEDERAL HEALTH CARE AGENCIES 47

To understand how a system so irrational in structure and inefficient
in its use of resources developed, we must understand the factors that
brought it into existence. The nature of governmental involvement with
health care is shaped by a combination of legal and historical factors.
Because the U.S. Constitution does not clearly mandate responsibility for
health care, all health care activities performed by the federal government
must be performed under the general stipulation that instructs the federal
government to provide for the general welfare and to regulate interstate
commerce. The Constitution establishes for the nation a tripartite federal
government, with responsibility for health care divided among the execu-
tive, legislative, and judicial branches. Although the laws and appropria-
tions passed by the U.S. Congress, and the judiciary's interpretation of
those laws, are important to the health care system, the agencies that are
usually charged with implementing the laws are located in the executive
branch.

Since powers not vested in the federal government are specifically
reserved to the states, state governments have played an important role in
the U.S. health care system. Many states have further delegated responsi-
bilities to local governments, establishing the third layer of government
involvement with health care. Historically, state and local governments
have limited their health responsibilities to protecting citizens against the
dangers of community life through public sanitation and communicable
disease control. Individuals, unless they are indigent, are responsible for
their own health. In the absence of total governmental responsibility for
health care, and in the spirit of America's belief in voluntary and private
activities in support of the government, many activities that in other
countries might be assumed by the government have in the United States
been undertaken by voluntary organizations or private foundations.

The U.S. health care system, therefore, has developed in a decentral-
ized, haphazard fashion. But while federal, state, and local governments
may not have assumed absolute responsibility for different functions
within the system, the general focus of health care agencies at the federal,
state, and local levels does differ.

FUNCTIONS OF FEDERAL HEALTH CARE AGENCIES

Several key activities dominate federal involvement in the U.S. health
care system. The federal government provides patient care for selected
populations, formulates much of the U.S. health care policy through
regulation or reimbursement criteria, engages in biomedical research and
health promotion, and is a major educator. Underlying each of these

48 HEALTH AGENCIES AND FOUNDATIONS

functions is the federal government's role as the source of much of the
U.S. health care system's basic financial support.

PATIENT CARE

Providing patient care is one of the oldest of the federal government's
health care functions and at the same time one of the least established;
there is still little consensus on the extent to which the federal govern-
ment should care for patients. The first federal action on health care
outside of the army and navy was the establishment in 1798 of the Marine
Hospital Service, now known as the Public Health Service. For most of its
first century of existence, the mandate of the new organization was
constrained, limited only to providing medical services to merchant sea-
man and funded through a mandatory employment tax on their wages. ^
Providing health care to individuals was generally considered to be a state
or local responsibility; seamen were deemed a federal responsibility be-
cause they were transients who could make no fair claim to the generosity
of the local community.

During the past century the federal government gradually accepted
the responsibility to provide patient care to other specific groups, such as
native Americans, veterans, and federal prisoners, even as the Public
Health Service's original function of caring for seamen was abolished. The
general delivery of patient care to the population as a whole, however,
remains outside the scope of the federal government's sphere of activity.

The Department of Health and Human Services (DHHS) is the federal
agency most actively involved in the health care system in general and
patient care in particular. As befits a department in a government that
historically has not had a clear mandate to deliver health care to its people,
the agency is relatively new. It is rooted in the Federal Security Agency,
which was created in 1939 to bring together into one agency all of the
federal programs in the fields of health, education, and social security. The
Federal Security Agency was raised to cabinet-level rank and renamed the
Department of Health, Education, and Welfare in 1953; with the creation
of a separate Department of Education in 1979, the DHHS was estab-
lished.^

The DHHS is divided into four major operating divisions: the Social
Security Administration, the Health Care Financing Administration, the
Administration for Children and Families, and the Public Health Service.
As the principlal sources for funding, the Social Security Administration
and the Health Care Financing Administration have an indirect impact on
the U.S. health care system. The Public Health Service and its component
agencies have the greatest direct impact on health care.

FUNCTIONS OF FEDERAL HEALTH CARE AGENCIES 49

The Health Resources and Services Administration (HRSA), one of the
component agencies of the Public Health Service, is the primary focus for
patient care programs within the federal government. In addition to
providing support for efforts to improve the education of health profes-
sionals, HRSA provides services to specific groups through demonstration
grants and direct patient care programs. Among the activities supported
by HRSA are the Community Health Centers program, the Bureau of
Prisons medical programs, and the Gillis W. Long Hansen's Disease Center
in Carville, Louisiana. The Indian Health Service, formerly a part of HRSA,
is now an independent agency within the Public Health Service. Its
function is to provide patient care to native American and Alaskan natives
through a network of hospitals, health centers, and clinics. The Substance
Abuse and Mental Health Services Administration, another agency within
the Public Health Service, supports demonstration programs in the treat-
ment of substance abusors and people with mental or emotional difficul-
ties.

Patient care is provided by agencies outside the DHHS as well. The
Department of Defense is an important provider of patient care, operating
an extensive system of medical facilities that provide treatment to active
duty and retired military officers. In addition, the military funds the
Civilian Health and Medical Program of the Uniformed Services, the
system that supports patient care for entitled beneficiaries in nonmilitary
hospitals. The Veterans Administration, an independent cabinet-level
agency, operates the largest centrally run hospital system in the United
States. It is intended to meet the medical needs of veterans who have
service-related disabilities, are aged 65 and over, or are medically indi-
gent.

Despite a historical reluctance on the part of federal governmental
agencies to be involved in direct patient care and the limits on eligibility
for treatment in federal facilities, delivery of medical services to individu-
als has become an important federal activity.

HEALTH PROMOTION

In contrast to patient care, the general promotion of public health has long
been viewed as a federal function. Beginning with quarantine restrictions
in the nineteenth century, the federal government has developed a
number of ways to foster the general public health while leaving most
patient care activities to the states or to individuals themselves. Health
promotion activities occur in many federal agencies and take a variety of
forms.

The Centers for Disease Control and Prevention (CDC), headquar-

50 HEALTH AGENCIES AND FOUNDATIONS

tered in Atlanta, Georgia, is the national agency primarily responsible for
disease prevention, with a focus on infectious disease. The CDC directs
quarantine programs, investigates outbreaks of previously unrecorded
diseases, develops health education programs, sets standards for clinical
laboratories, provides grants to states for local preventive campaigns, and
conducts active research programs at home and abroad. CDC scientists, for
example, were the first to identify Legionnaires' disease. The CDC led the
campaign to eliminate smallpox from the world, and the first published
notice of infection with the human immunodeficiency virus (HIV), the
retrovirus associated with autoimmune deficiency syndrome, appeared in
a CDC epidemiological report.

Outside of the DHHS, the U.S. Department of Agriculture (USDA) is
involved with human as well as animal and plant health. Nutrition in
particular has been a concern of the USDA, which administers the Women
and Infant Care and Food Stamp programs. Both programs were estab-
lished to combat the harmful effects of malnutrition. In addition, in the
interest of public health, the USDA inspects meat and dairy products and
promotes proper nutrition. The Department of Labor administers the
Occupational Safety and Health Administration (OSHA), which seeks to
develop and enforce workplace safety and health standards.

BIOMEDICAL RESEARCH

Perhaps in no area has federal involvement with health care been as
productive as in the area of biomedical research. Federal scientists identi-
fied the causes and treatment of diseases such as pellagra, hookworm,
tularemia, and Legionnaires' disease; dentists working in the Public
Health Service were among the first to note the beneficial effects of
fluoride on teeth and to push for the general fluoridation of water; and
federal scientists led in developing an understanding of and treatment for
HIV infection. Furthermore, as was noted earlier, the federal government
is a major source of the funding for research carried on by others in
universities, hospitals, and research institutes.

The most important agency in the federal government devoted to
biomedical research is the National Institutes of Health (NIH). The primary
function of the NIH is basic biomedical research, which is conducted in
seventeen research institutes, one hospital, and numerous supporting
centers and divisions.^ Through its extensive extramural grant program,
the NIH supports most fundamental clinical research in this country and,
through its visiting scientist programs, serves as an important center for
diffusing biomedical knowledge worldwide. The intramural and extramu-

FUNCTIONS OF FEDERAL HEALTH CARE AGENCIES 51

ral research programs of the NIH together account for almost two thirds of
all federal investment in biomedical research.

Biomedical research is also carried on in a number of different agen-
cies both within and outside of the DHHS. Within the DHHS, the CDC
maintains a large intramural research structure dedicated to investigating
the source of disease outbreaks, and the newest Public Health Service
agency, the Agency for Health Care Policy and Research, funds projects to
ensure the most cost-effective use of health resources. Outside the DHHS,
the Department of Defense maintains several important research insti-
tutes focusing on medical fields of particular concern to the military, such
as tropical and arctic medicine. The Environmental Protection Agency
(EPA) conducts research on the harmful effects of air, water, and ground
pollution and seeks to implement the results of its studies through legisla-
tion and regulation. The Department of Energy has established laborato-
ries investigating the effect of radiation on humans and, in support of its
research efforts, is playing a key role in the current project to map the
human genome. GENBANK, for example, one of the first molecular
sequence data banks, began at a national laboratory run by the Depart-
ment of Energy in New Mexico. ^°

POLICY FORMULATION AND REGULATION

Almost every federal agency concerned with health care is also involved
in regulation and policy formulation. In some agencies, regulation is the
primary function. Most notable in this regard is the Food and Drug
Administration (FDA), one of the agencies that compose the Public Health
Service. The FDA is charged with protecting the public from the dangers of
poorly manufactured or ineffective pharmaceuticals, medical devices,
radiological equipment, foods, and food additives. The FDA evaluates new
products before they are marketed to ensure their safety and efficacy;
periodic inspection after marketing helps ensure the continued safety of
the products. To support its work, the FDA maintains an extensive set of
laboratories and a criminal investigations unit, but it also relies heavily on
the self-reporting of the companies involved.

The FDA's stringent regulatory requirements are frequently a source
of controversy, as is the alleged failure of the agency to enforce them. A
decision about the safety of silicon breast implants, a food additive such as
saccharin, or grapes from Chile can keep the agency in the news for
weeks. Because both personal and financial risks are involved with every
decision, the volume of records generated by these FDA decisions is
substantial. A single new drug application submitted by a pharmaceutical

52 HEALTH AGENCIES AND FOUNDATIONS

company seeking FDA approval may contain from 10,000 to over one
million pages. '^ Because of the size of the applications, the FDA has been
one of the federal agencies pioneering the use of digital optical storage
media for the management of records.

A second, less overt form of regulation and policy formulation has
emerged as a product of the federal government's role as the primary
source of reimbursement for patient care expenditures, especially through
the Medicare and Medicaid programs. Medicare is a nationwide health
insurance program designed to help pay for hospital costs, nursing home
care, physician services, and prescription drugs for the elderly, individuals
receiving social security disability payments, and people with end-stage
renal disease. Medicaid is a federally aided, state-operated program that
provides medical benefits for certain low-income people of all ages in need
of medical care. Both programs were enacted in 1965, by Titles 18 and 19
of the Social Security Act. These two programs now account for most
federal health care expenditures — $175.9 billion in 1990.^^

Both Medicare and Medicaid are modeled on private insurance pro-
grams; benefits and services are bought from private vendors, with the
government itself providing few benefits. Medicare and Medicaid are
primarily transfer programs. The regulations they issue are necessary for
them to carry out their primary mission — supervising the administration
of private or state-run health programs that are funded in part with
federal dollars. As a purchaser of patient care, the government sets
standards that providers must meet before public funds will be paid to
them.^' Hence the state-run programs must set payment guidelines and
standards of performance for hospitals and other patient care providers,
establishing to a large degree the nature and extent of medical care given
in this country — in other words, formulating health care policy. For
example, beginning in 1972 the federal government authorized and
financed 182 professional standards review organizations (PSROs). Be-
fore federal funds could be received for hospital services, the PSROs had to
review hospital records to see if hospitals were providing more care than
was necessary. The PSROs were later revised into a smaller number of
professional review organizations (PROs) and given the task of reviewing
hospital services with the emphasis on minimizing inaccurate diagnostic
data and unnecessary admissions. ^"^ "The requirements for review of
hospital stays by PSROs and PROs," as one analyst has recently noted,
"have subjected physicians to far more scrutiny of their practice than was
previously the case. These requirements . . . have obliged physicians and
hospital personnel to be more diligent and detailed in making entries in
medical records and to document the reasons for medical decisions more
extensively than before." '^ The result in hospitals and physicians' offices

FUNCTIONS OF FEDERAL HEALTH CARE AGENCIES 53

has been a massive increase in the volume of official patient records. ^^
Much of the structure of the modern hospital, the activities which it
performs, and the documentation generated in the performance of these
activities have been shaped by the payment policies issued by the Health
Care Financing Administration (the agency that administers most federal
programs for the reimbursement of patient care). Usually, if Medicare or
Medicaid refuses to pay for a certain procedure, an extended hospital stay,
or an experimental drug, these options are not offered to the patient. As
containment of spiraling health care costs becomes an ever-greater prior-
ity, it is likely that the Health Care Financing Administration will play a
greater role in indirectly regulating the U.S. health care system.

EDUCATION

Although most education of health care personnel in the United States
takes place in nonfederal institutions, federal agencies do play a small but
important role. The government maintains its own medical school, the
Uniformed Services University of the Health Sciences. At the NIH, CDC,
EPA, and other research institutions, the government manages a series of
pre- and postdoctoral and other postprofessional research and training
programs. These institutions also develop many specialized educational
tools as part of the continuing education of health service professionals.
The federal government has also funded students during times of per-
ceived shortages of health professionals. During World War II the Cadet
Nurse Corps was established within the Public Health Service to pay for
the education of nurses in approved schools of nursing; over 169,000
students were admitted to the program during its five-year existence. ''' In
the 1960s and 1970s fear of an anticipated shortage of physicians led to a
direct capitation program whereby medical schools were given subsidies
in proportion to the number of students enrolled in their programs. ^^
Although governmental support of general medical education in universi-
ties has decreased greatly, the government remains an important source
of financial support for medical education at institutions outside of the
federal structure.

PROVISION OF GOODS AND SERVICES

Given the size of federal expenditures for health care, it is not surprising
that the federal government is directly or indirectly the single largest
purchaser of health care goods and services. The federal government is not
itself, however, a major provider of goods and services. One exception is a
program to provide rare or experimental drugs. In 1981, for example.

54 HEALTH AGENCIES AND FOUNDATIONS

pentamidine was distributed only by the federal government. An upsurge
in requests for it was one of the first signs alerting the government to the
presence of a deadly new disease, later identified as HIV infection. ^^

THE RECORDS OF FEDERAL AGENCIES IN THE NATIONAL ARCHIVES
AND RECORDS ADMINISTRATION

Federal agencies produce a large volume of records as they devise and
implement their programs. The policy for creating, maintaining, and
disposing of federal executive branch agency records is controlled by the
Federal Records Act. The act recognized that most federal records — 95
percent or more, according to the National Archives and Records Admin-
istration — are of little potential historical value. A small percentage, how-
ever, are likely to be of enduring importance because of their primary or
secondary value, in particular their ability to adequately and properly
document "the organization, functions, policies, decisions, procedures,
and essential transactions of the agency. "^'^

Records judged to be of enduring value are deposited in the National
Archives, either in Washington, D.C., or at one of the eleven field
branches. The records of health care agencies are well represented among
the holdings of the archives. Separate record groups (the fundamental
unit of archival organization) have been established for the DHHS (RG
468), for its predecessor agency, the Department of Health, Education,
and Welfare (RG 235), and for many of its subsidiary agencies such as the
Health Resources and Services Administration (RG 512), the CDC (RG
442), the Public Health Service (RG 90), the NIH (RG 443), the FDA (RG
88), the Agency for Health Care Policy and Research (RG 510), and St.
Elizabeths Hospital (RG 418). The Office of the Army's Surgeon General
(RG 112) and the Navy's Bureau of Medicine and Surgery (RG 52) also
have their own record groups, as does the Veterans Administration (RG
15). The National Archives and Records Administration remains the single
best source for historical information about the U.S. health care system.

STATE HEALTH AGENCIES

State health agencies are involved in almost all of the U.S. health care
system's functions; as is the case with the federal agencies, only the
provision of goods and services is an insignificant state function. Although
the activities of the state health agencies may be in the same functional
areas as the federal government, their emphasis is different. Historically,
the responsibility for the general health, safety, and welfare of the popula-

PATIENT CARE 55

tion rested with the states, not with the federal government. Whereas the
federal government does not provide patient care to the general popula-
tion, state health agencies have themselves either developed programs in
this area or delegated responsibility for such programs to local govern-
ments. In addition, state health agencies have placed a greater emphasis
on health promotion activities. Much medical education is based in state
universities, and the states have played an ever-increasing role in regula-
tion. Biomedical research, a major function of the federal government, is
of secondary importance at the state level except for research at state-
sponsored universities.

Although these broad generalizations about the functions performed
by state health agencies hold true for almost all states, how these functions
are carried out, the specific agency that is assigned the function, and the
relative importance of the functions vary from state to state. Each state has
developed a unique health care system structure reflecting its particular
history, economic conditions, and health problems. Thus, fifty-five organ-
izational schemes for state health functions have evolved (one for each
state, the District of Columbia, and the territories of American Samoa,
Guam, Puerto Rico, and the Virgin Islands). ^^

Despite such diversity, some generalizations about the common func-
tions of state health care agencies can be made. The Association of State
and Territorial Health Officers (ASTHO) defines a generic "State Health
Agency" as "the Agency vested with primary responsibility for public
health within their jurisdictions." This generally means that the state
health agency is responsible for "setting statewide public health priorities,
carrying out national and state mandates, responding to public health
hazards, and assuring access to health services for under-served state
residents. "-^^ In Maryland, for example, the state agency is the Depart-
ment of Health and Mental Hygiene. ASTHO surveys have further defined
six core programmatic activities found in almost every state health
agency: personal health, environmental health, health resources, labora-
tory services, general administration and services, and funding for local
health department activities outside the programmatic areas listed. Ser-
vices in these programmatic areas may be delivered through the state
agency itself, local health departments, or a combination of the two.

PATIENT CARE

Almost all state health agencies provide patient care, which constitutes
the bulk of their expenditures. Of the $9.5 billion spent by state health
agencies in fiscal year 1989 for direct health care expenditures and
in grants to local officials, three fourths went for personal health activi-

56 HEALTH AGENCIES AND FOUNDATIONS

ties.^^ Most States support two types of programs: ambulatory care for
public health concerns and institutional care for certain long-term condi-
tions.

Ambulatory services are often conducted in conjunction with local
health departments, and the programs frequently target individuals with
low incomes. Maternal and child health care, including prenatal and
postnatal care, family planning, and immunization, are common activi-
ties. Dental health programs, especially preventive measures such as
fluoridation of water supplies, and communicable disease control pro-
grams, including immunization and the control of sexually transmitted
and other infectious diseases, are also features of most state health agen-
cies.

Institutional services are directed at long-term, chronic conditions,
the treatment of which is beyond the financial capabilities of private
insurance or individuals. Tuberculosis hospitals, now rare, were a preva-
lent example of state-sponsored institutional support of individuals with
chronic disease.^'* Sixteen state health agencies operate public hospitals,
long-term care facilities, or other types of in-patient care facilities. ^^ Other
states sponsor care for the handicapped, including programs for handi-
capped children, people with speech, physical, or occupational disabilities,
and individuals who can be treated at home.

As with the federal government, the reimbursement for patient care
delivered by private hospitals and physicians is also an important activity
of state health agencies, accounting for the lion's share of the state health
budget. Foremost among the reimbursement programs is Medicaid. Al-
though the federal government defines the range of coverage available
under Medicaid and provides significant funding, Medicaid is adminis-
tered at the state level. States may decide whether or not to participate in
Medicaid (all currently do) and choose which specific programs they will
offer beyond the basic health insurance for individuals receiving public
assistance. ^^ States vary widely in what they will cover under Medicaid,
and any coverage beyond the scope of the federal program becomes the
responsibility of the state. In sum, states have tremendous discretion in
designing their Medicaid programs.

HEALTH PROMOTION

State involvement in pubic health began with attempts to control commu-
nicable diseases and to ensure a safe food and water supply through
sanitation. Such activities remain at the heart of most state health agen-
cies' activities. Among the activities performed by the states in this area

PATIENT CARE 57

are the following: consumer protection and sanitation, especially in regard
to food, milk, sanitation, and zoonotic disease control (rabies, Lyme
disease, etc.); water quality control, including the provision or testing of
water, sewage disposal, and pollution controls; solid and toxic waste
control and disposal; radiation control; air quality control; and occupa-
tional safety and health. For example, the Department of Health in
Missouri's Public Health Laboratory performs a number of tests on public
and private water supplies: the Chemistry Unit determines the presence of
minerals, nitrates, pesticides, and other chemicals in the water, and the
Environmental Bacteriological Unit tests for the presence of coliform
bacteria.

POLICY FORMULATION AND REGULATION

One of the first activities undertaken by states to understand the nature of
disease in their communities and to promote better health was collecting
and disseminating health and vital statistics. In recent years the role of
state health agencies in analyzing and controlling state health resources
has increased dramatically. The National Health Planning and Resources
Development Act of 1974 requires that each state designate one agency as
the state health planning and development agency; in most cases this is
the state health agency. In addition many states have a state health
coordinating council.

State health agencies may assist with the construction of new health
facilities, coordinate the development of emergency services, and provide
clinical laboratory services. In particular, they may require that a "certifi-
cate of need" be acquired before any new hospital construction takes
place or expensive new equipment is purchased. The certificate attests to
the fact that more hospital capacity or technology (a magnetic resonance
imaging machine, for example) is needed. State health agencies may also
regulate pharmacies, clinical laboratories, blood banks, and ambulance
service. In addition, states license and regulate health professionals and
support personnel, directly influencing the type and level of service
available in each state. All states, for example, set certain minimum
standards of training, and many require participation in a continuing
education program as a prerequisite for continued licensure. Finally, most
states regulate the private health insurance industry, and some regulate
health maintenance organizations. Some mandate that certain minimum
benefits be included in each insurance plan, and many have insurance
commissioners who oversee the activity of insurance companies in the
state.

58 HEALTH AGENCIES AND FOUNDATIONS

EDUCATION

Many states have established or fund schools for the training physicians,
nurses, dentists, and veterinarians as part of the state higher education
system, and all states have courses at some level in the educational system
(including community colleges) for training health personnel. Over half of
the medical schools in the United States, for example, are part of a state
university system; in addition, many private schools,or students attending
them, receive some state support. In some states, students receive finan-
cial aid for their professional education in exchange for a commitment to
practice for a specified period in underserved communities.

BIOMEDICAL RESEARCH

In 1989 state and local governments spent over $1.3 billion on health
research and development.^^ Most of the money came from the states,
and much of it was directed to state universities. All state medical schools
have active programs for biomedical research, although the nature, direc-
tion, and search for funding of individual projects is normally left to the
discretion of the individual investigator. The association of biomedical
research with commercial and technological advancement has led many
states to develop biotechnology and other centers for applied biomedicine.
Although to date state support has primarily been of research infrastruc-
ture, in the future states may play a more direct role in supporting
biomedical research. ^^

THE RECORDS OF STATE AGENCIES IN STATE ARCHIVES

State archival agencies predate the formation of the National Archives.
The Alabama Department of Archives and History, the first agency in any
state specifically designated to serve as the official custodian of the state's
records, was established in 1 90 1; the National Archives did not come into
existence until the National Archives Act of 1934. Subsequent develop-
ment of state archives was slow; it was not until the mid-1970s that every
state in the union had established a formal archival program. ^^

Despite the comparatively long existence of some state archives, the
management of state governmental records is often deficient. As the
Report of the Committee on the Records of Government noted:

[M]any state archivists have only a general estimate of the number of
state government records outside of the archival system. In some states,
less than a third of the agencies have been touched by current records
management procedures. Other state archivists acknowledge that weak

LOCAL HEALTH AGENCIES 59

agency liaison is the rule rather than the exception in their programs. In
many instances, state agencies simply keep their own records. In
Pennsylvania, for example, the records center reported that of the four
thousand series of records scheduled for transmittal, only twelve
hundred were actually in the records center. Discussing this issue with
the Committee, one state archivist stated unequivocally that most state
records either are not preserved or are preserved by accident. ^°

If the records of a state government agency run the risk of being lost,
as recent surveys have suggested, records from heahh care agencies are
particularly at risk. As noted earlier, much of the work of health care
agencies in the states involves the direct provision of health care service.
Records from these agencies frequently include information of a private
nature concerning patients at mental hospitals, state-run clinics, and other
state-sponsored agencies. Access to the records must be carefully con-
trolled and limited, further limiting their potential use in an archival
repository. In Michigan, for example, the Department of Mental Health
was unwilling, for legal and ethical reasons, to transfer the patient records
of the Ionia State Hospital for the Criminally Insane to the state archives
when the hospital closed. After diligent negotiation with the department
on the mechanisms by which access would be provided to the material,
the state archives was able to reach an agreement with the department.
Since then the records of nine other state mental hospitals have also been
accessioned. The efforts of the Michigan state archives in this instance,
however, appear to be unique; one must conclude that in many other
states similar records would either remain with the parent agency or be
destroyed.^' Recent work on access to medical records indicates that the
problems associated with the confidential nature of state medical records
can be overcome, suggesting that this may in the future be less of an
impediment to the preservation of state records. ^^ It should be noted that
there is no need to save all the patient records of every mental hospital in
the United States. What the Michigan example illustrates, however, is
some of the impediments to efficient retention of state health agency
records.

LOCAL HEALTH AGENCIES

Defining exactly what a local health department is and how many there
are in the United States is no easy task. C. A. Miller, using the definition of
a local health department as "an administrative and service unit of local or
state government, concerned with health, employing at least one full-time
person and carrying some responsibility for the health of a jurisdiction

60 HEALTH AGENCIES AND FOUNDATIONS

smaller than a state," concluded in 1977 that there were between 1,073
and 2,073 local health agencies in the country. ^^ ASTHO, using a similar
definition, concluded in 1981 that there were 3,264 local health depart-
ments in forty-four states and territories, and no substate units in twelve
other states and territories. More recently, the Public Health Foundation
has concluded that there are nearly 3,000 official local health departments
providing direct community health services.'"^

Because of the disparity in definitions and numbers, it is difficult to
describe accurately the universe of local health departments. Neverthe-
less, certain generalizations can be made. Local health activities center on
health promotion, broadly defined. Haven Emerson in 1945 identified the
six basic activities of local public health work, and all fall within our
definition of health promotion: vital statistics collection, communicable
disease control, environmental sanitation, support of public health labora-
tories, maternal and child health promotion, and health education. ^^ In
practice, the local health agency is often responsible for childhood immu-
nizations, restaurant inspections, urban rat control, and rabies control. In
addition, local health departments are usually responsible for providing
patient care to the poor, either in community health centers, clinics, or
general hospitals. For example, the clinics of the Madison, Wisconsin,
Department of Public Health offer to residents of the city services such as
health advice, immunizations, dental care, and testing for sexually trans-
mitted diseases. Of particular importance are the services they provide to
immigrants and participants in the Women, Infants, and Children Pro-
gram. Community-sponsored hospitals can range in size from a few beds
to hundreds of beds. The 926-bed Cook County (Illinois) Hospital is an
example of a large community hospital. The activities of local health
agencies may be carried out independently or performed in partnership
with or as a subagency of the state health department.

Local health agencies are minimally involved with functions of the U.S.
health care system other than health promotion and patient care. At one
time municipal laboratories were important sources of biomedical research.
The most notable example is the former city laboratory that has become the
New York Public Health Research Institute in New York City. Under the
directorship of Hermann Biggs and W. H. Park, the laboratory was an
important center for bacteriological investigation. Today the many universi-
ties in New York City have assumed the local biomedical research function.
The patient care function involves some local health agencies in medical
education, as many general hospitals are affiliated teaching hospitals of
medical schools. And local governments are able to regulate certain medical
services through zoning laws, business regulations, and the establishment of

LOCAL HEALTH AGENCIES 6 1

local health and safety codes. Health promotion and patient care remain,
however, the major functions common to most local health agencies.

RECORDS OF LOCAL HEALTH AGENCIES

Although no formal assessment of the extent of documentation available
in municipal and local archives has ever been conducted, it is likely that
even fewer records relating to local health agencies have been preserved
at the local level than at the state level. In his manual for local records
officers, H. G. Jones noted that "a great majority of the political subdivi-
sions in the United States — counties, towns, cities, special-purpose dis-
tricts, etc. — remain without a[n archival] program of their own and
receive little effective assistance from professionals at a higher level of
government. "^^ The situation for health records within the few jurisdic-
tions that do maintain archives may even be worse, given the traditional
lack of interest in health records. Jones provided a brief subject analysis of
local records "most commonly of interest to researchers."'^ Health rec-
ords are not found among them.

Local authorities have traditionally drawn on three possible avenues
for preserving their records: establishing a local archives, transferring
material to other repositories, such as historical societies, and transferring
material to state agencies. In his book on local records, Bruce Dearstyne
recommends that each jurisdiction establish its own municipal or local
archives.'^ A government-maintained local archives is the most likely to
have complete holdings of local records, and preserving records in their
context is an important component of local practice. Both Baltimore and
Philadelphia, for example, have established archives rich in local health
records, reflecting the importance of American medical practice in both
cities. The records for Baltimore's Health Department date from 1798, just
five years after governmental involvement with health in the city began.
Initial governmental interest was in quarantine and infectious disease
control, but over time municipal involvement with health expanded.
During the twentieth century, the agency became responsible for inspect-
ing food, monitoring occupational safety, enforcing housing hygiene and
regulating environmental quality. Starting in the 1960s, the department
began supervising programs relating to child health, clinics, mental
health, and addictions. Philadelphia's archives contains minutes and other
records of its Board of Health and the Department of Public Health. The
records of many of the clinics and hospitals managed by the city, including
the Philadelphia General Hospital and the Philadelphia Nursing Home, are
also retained.'^

62 HEALTH AGENCIES AND FOUNDATIONS

Yet, while the existence of a locality-sponsored archives may, as
Dearstyne recommends, be the best way to protect the completeness and
context of the records, the experience in Baltimore and Philadelphia
suggests that even the presence of a municipal archives may not be
sufficient to preserve records. As of 1984, the bulk of Baltimore's records
predate World War I. Twentieth-century records, the guide notes, are
"varied and small in volume." In Philadelphia the situation is similar.
Although records for the early period of the city's history are relatively
complete, record schedules for modern records may be outdated, placing
the bulk of modern city records at risk. Fortunately, Philadelphia will
shortly begin a grant-funded reevaluation of city record schedules, and
new schedules that better reflect the nature and importance of modern
records will be established. "^^

Baltimore City has also transferred medical records to other institu-
tions or agencies. The records of the city's infectious disease hospital,
Sydenham Hospital, for example, are housed at the National Library of
Medicine. Because the collection was too large to preserve in its entirety,
a sample of every tenth patient register volume was made. This example
illustrates the danger of transferring records to other agencies or reposito-
ries: there is no assurance that the collection will be retained as a whole.
Transferring records to either a state or private repository may be accept-
able if the alternative is destruction, but if possible, it should be avoided.

The examples of Baltimore and Philadelphia indicate the weaknesses
of even the best local records programs. Local records are invaluable as
sources for documenting public health efforts, and selected records are
worthy of preservation. Jones and Dearstyne have attempted to draw the
attention of local government officials to the importance of these records,
and it is hoped that local records will in the future receive more of the
attention they deserve.

FOUNDATIONS

A foundation is defined by the Foundation Center as a "nongovernmen-
tal, nonprofit organization with its own funds (usually from a single
source, either an individual, family, or corporation) and a program man-
aged by its own trustees and directors, which was established to maintain
or aid educational, social, charitable or other activities serving the com-
mon welfare, primarily by making grants to other nonprofit organiza-
tions.'"^^ The first charitable foundation in the United States was estab-
lished in 1867, when George Pcabody established the Peabody Fund. The
period since World War II has seen an explosive growth in their numbers.

FOUNDATIONS

FIGURE 3-2 Headquarters of the Howard Hughes Medical Institute, the
world's largest private charitable organization, in Chevy Chase, Maryland, 1993.
Source: Howard Hughes Medical Institute; William K. Geiger, photographer

Today there are over 31,000 private foundations, ranging in size from
large national foundations such as the Ford, Rockefeller, and Carnegie
foundations to small local foundations. In interest and scope of activity
they are similar to governmental agencies because foundations, too, act
on national, state, and local levels. The Foundation Center distinguishes
four common types of foundation:

• Independent foundations, usually established by an individual or
family and operating with a broad charter;

• Community foundations, publicly supported organizations that
derive their funds from many donors and that usually limit their
giving program to their immediate area;

• Corporate foundations, established by corporations to distribute tax-
free up to 10 percent of their profits; and

• Operating foundations, designed primarily to operate a specific
research, social welfare, or other program.

Foundations with a special interest in health and medicine compose a
large percentage; of the 31,000 foundations in the United States, more
than 2,500 have a history of awarding grants relating to health matters. In
1991 almost 16 percent of all foundation grants were for health care

64 HEALTH AGENCIES AND FOUNDATIONS

programs or for the education of hiealth professionals, the second largest
expense category after support of schools and colleges.'*^ The largest
private charitable organization in the world is the Howard Hughes Medi-
cal Institute, with assets of over $6.4 billion.'*^ The W. K. Kellogg Founda-
tion, with assets of $4.2 billion, and the Robert Wood Johnson Founda-
tion, with assets of $2.6 billion, are two other prominent foundations
primarily interested in medical topics. The Rockefeller Foundation and
the Commonwealth Fund, established in 1918 by the Harkness family, are
two foundations that are historically important in funding aspects of the
U.S. health care system.'*^

FUNCTIONS OF HEALTH-RELATED FOUNDATIONS

The primary activity of a foundation, as noted in the previous section, is to
make grants to other nonprofit institutions. Foundations provide the
money to maintain and support institutions active in all functions of the
U.S. health care system and at one time were even active in performing
those functions themselves. Many foundations, for example, were ini-
tially established to provide patient care to the community's indigent. This
was usually accomplished by funding a local hospital or clinic, although
occasionally a foundation might have employed its own physicians to
provide patient care. On the national level, the Commonwealth Fund
funded the construction and maintenance of hospitals in some rural areas.
Through the use of demonstration projects, other foundations supported
the development of local health units, resulting in a concomitant im-
provement in the health of the surrounding population.

Over time, however, the involvement of foundations in direct patient
care has decreased. In many instances when clinics and demonstration
projects begun by a foundation proved to be beneficial, governmental
agencies developed the programs further. The Commonwealth Fund's
support of rural hospitals, for example, served as a model for federal
involvement in rural hospital construction with the Hill-Burton Act of
1946.'*5 The great remaining challenge in patient care — providing patient
care to the indigent or uninsured — is, however, beyond the resources of
even the richest foundations. Only a few foundations still fund innovative
demonstration programs in patient care, while most have shifted their
emphasis to health promotion or policy analysis.

Many of the resources that foundations once committed to direct
patient care have instead been spent on funding health promotion. Health
promotion itself has always been an important function of health founda-
tions. The eradication of hookworm in the South, for example, was primar-

FUNCTIONS OF HEALTH-RELATED FOUNDATIONS 65

ily a result of the sanitary efforts of the Rockefeller Foundation.'*^ More
recently, the Robert Wood Johnson Foundation and the Kaiser Foundation
have sponsored reporting on health care issues in the news media.

Foundations have historically had a major influence on biomedical
research. Early in this century, before the funding of biomedical research
was an accepted governmental function, foundations played an important
role in the scientific advance of medicine.'*^ Of course, the scale of founda-
tion support for both is small in comparison to governmental support. In
1989, for example, the Howard Hughes Medical Institute expended $197
million for biomedical research and private foundations another $82
million, whereas the NIH spent over $6.7 billion on health research and
development.'*^ Nevertheless, the contribution to biomedical research of
foundations like the Hughes is important. The Howard Hughes Medical
Institute, for example, provided seed money to support early efforts to
map portions of the human genome; only after their efforts helped build
support for the project could NIH get budgetary authority for the project
and establish the National Center for Human Genome Research.'*^ Other
foundations have given similar support to early fundamental work in the
basic life sciences.

Medical education is the area where foundations have perhaps had the
greatest influence. No foundation maintains its own medical school, and
the funding of training for individuals is limited. But foundations have
initiated a number of studies that have fundamentally changed the nature
of medical education in this country. For example, the Flexner report on
medical education (I9I0), which set out standards for modern medical
education in the United States, was funded by the Carnegie Foundation;
and the Rockefeller Foundation, through its General Education Board,
provided the funds that enabled a number of universities to implement
the recommendations embodied in the report. More recently, foundations
have supported studies on reform of medical school curricula. The Alfred
P. Sloan Foundation and the Josiah P. Macy Jr., Foundation in particular
have worked to increase educational opportunities for minorities in
health care fields.

In sum, foundations, like federal, state, and local agencies, provide
funding to purchase equipment and to construct, renovate, or expand
health care facilities; provide operating expenses or emergency funds;
support research; and educate health personnel through scholarships,
in-service education programs, on-the-job training, and exhibits. The
importance of foundations and the reason why their records are of
particular interest to historians is the pioneering role played by founda-
tions in all these areas. Foundations have historically had the flexibility to

66 HEALTH AGENCIES AND FOUNDATIONS

respond quickly to innovative ideas through the development of pilot
studies or demonstration projects. Successful approaches have then been
replicated on a broad scale, usually by a governmental agency.

THE RECORDS OF FOUNDATIONS

As with any institutional archives, foundation records document the
activities of the sponsoring organization. In addition, the records of health
foundations contain important information about individuals and other
groups and organizations. As Kenneth W. Rose noted, foundation records
may contain "important and often difficult-to-find information about a
variety of other institutions and organizations which too often disappear
without leaving any paper trail of their own. Since applicants for financial
support have to explain themselves, their backgrounds, and their needs to
their founders, foundation records are rich in the details of the histories of
other organizations. "5°

Unfortunately, Rose's survey of the records of all foundations suggests
that foundation records may be at risk. Of the 1,000 largest foundations
contacted for the survey, only 394 foundations chose to respond. Of those
394, only 43 (35 percent) had deposited their records in either an in-
house or external archives. The situation is even worse for foundations
that fund health care activities. Of the 140 foundations identified in the
survey as having a historical interest in health care, only 21(15 percent)
have formal internal or external archives programs. Six of these 21 are
found at the Rockefeller Archives Center; without the efforts of this one
repository, the picture would be even more bleak.

Many of the foundations that have not established formal internal or
external archives programs did report that archival records are found in
the general records of the foundation. Yet the completeness of these
records is in question. The Josiah Macy, Jr., Foundation, for example, one
of the most important foundations in the history of health care in this
country, reported having administrative and correspondence files only
since 1976, although it was founded in 1930. Other foundations impor-
tant to the development of health care, including the W. K. Kellogg
Foundation, the Alfred P. Sloan Foundation, and the Pew Charitable
Trusts, did not grant permission to have their responses to the survey
published in the volume, suggesting that they are unwilling to allow
researchers access to their records.

Fortunately, the work of Rose and others at the Rockefeller Archives
Center is an important first step in alerting foundations to the importance
of their records, and the center itself is an excellent model of a well-run
foundation archives. Since the publication of the survey, other founda-

NOTES 67

tions interested in health care have either deposited records in external
repositories or have established their own archives programs. The Albert
and Mary Lasker Foundation, for example, deposited the records relating
to the Lasker Award, the premier American award for medical research, in
the National Library of Medicine. Perhaps more important, the People-to-
People Foundation, Inc., the sponsor of Project HOPE, has established an
internal archives at its headquarters in Millwood, Virginia. With the
assistance of a National Historical Publications and Records Commission
grant, the foundation has organized its 381 cubic feet of records and
published a guide to its holdings. The guide is a model for other founda-
tions interested in establishing archives. ^^ One hopes that the Rockefeller
Archives Center's example, the People-to-People Foundation's guide, and
this volume, will encourage more foundations to establish active archival
programs.

NOTES

1. Professional and voluntary associations also perform many of the same
funaions as health care agencies and foundations. Their contributions are
considered in Chapter 6.

2. The term "agency" frequently has a specific meaning for federal, state, and
local governments, designating a governmental unit at a distinrt level in the
government hierarchy. In this chapter it is used generically to refer to any
governmental unit (department, agency, office, branch, division, etc.).

3. National Center for Health Statistics, Health: United States, 1991, and Prevention
Profile (Hyattsville, Md.: National Center for Health Statistics, 1991), 274.

4. Ibid., 277.

5. Charles Brecher, "The Government's Role in Health Care," in Anthony R.
Kovner and contributors. Health Care Delivery in the United States, 4th ed. (New
York: Springer Publishing Company, 1990), 297.

6. The lack of consistency in agency functions from state to state was one of the
driving forces behind the creation of the RLIN Seven States Project, which
tried to provide access to archival collections according to functional criteria
rather than by office of origin. On the Seven States Project and its functional
organization, see David Bearman, "Archives and Manuscript Control with
Bibliographic Utilities: Opportunities and Challenges," American Archivist 52
(Winter 1989): 26-39; Robert Sink, "Appraisal: The Process of Choice,"
American Archivist 53 (Summer 1990): 452-58; and Research Libraries Group,
Government Records in the RUN Database: An Introduction and Guide (Mountain
View, Calif.: Research Libraries Group, 1990).

7. Robert Straus, Medical Care for Seamen: The Origin of Public Medical Service in the
United States (New Haven: Yale University Press, 1950). Other discussions of
the origins of the Marine Hospital Service and its mandate to treat sailors are

68 HEALTH AGENCIES AND FOUNDATIONS

found in Bess Furman, A Profile of the United States Public Health Service.
1798-1948 (Bethesda, Md.: National Library of Medicine, 1973) and Ralph
Chester Williams, The United States Public Health Service, 1798-1950
(Washington, D.C.: Commissioned Officers Association of the United States
Public Health Service, 1951).

8. A Common Thread of Service: An Historical Guide to HEW (Washington, D.C.:
Department of Health, Education, and Welfare, 1973).

9. The categorical institutes constituting the National Institutes of Health and
located on the Bethesda campus of NIH are devoted to the following subjects:
Aging; Alcohol Abuse and Alcoholism; Allergy and Infectious Diseases;
Arthritis and Musculoskeletal and Skin Diseases; Cancer; Child Health and
Human Development; Deafness and Other Communication Disorders; Drug
Abuse; Dental Research; Diabetes and Digestive and Kidney Diseases; Eyes;
General Medical Sciences; Heart, Lung and Blood; Mental Health;
Neurological Disorders and Stroke; and Nursing Research. The National
Institute of Environmental Health Sciences, also a component part of the NIH,
is located in Research Triangle Park, North Carolina.

10. Several efforts are under way to document the human genome project,
supported by funds from the National Center for Human Genome Research at
NIH and the National Science Foundation. The Beckman Center for the
History of Chemistry has begun one such effort, and the bioethics library at
Georgetown University has begun another.

1 1 . Mark Walter, "Pharmaceuticals: An Industry Ripe for Automation," in The
Seybold Report on Publishing Systems 22{\2) (March 8, 1993), 3-12.

12. National Center for Health Statistics, Health: United States, 1991, 294, 297.

13. Brecher, "Government's role," 309.

14. Professional standards review organizations and their impact on hospitals are
discussed in more detail in Chapter 2.

1 5. Brecher, "Government's Role," 311.

16. Joel Howell, "Preserving Patient Records to Support Health Care Delivery,
Teaching, and Research," in Nancy McCall and Lisa A. Mix, eds.. Designing
Archival Programs to Advance Knowledge in the Health Fields (Baltimore: Johns
Hopkins University Press, 1994).

1 7. The United States Cadet Nurse Corps and Other Federal Nurse Training Programs
(Washington, D.C.: Public Health Service, 1950), 78. See also Philip A.
Kalisch and Beatrice J. Kalisch, The Federal Influence and Impact on Nursing
(Hyattsville, Md.: Bureau of Health Professions, Division of Nursing, 1980)
(NTIS doc. HRP-0900636).

18. Lauren LeRoy and Philip R. Lee, Deliberations and Compromise: The Health
Professions Educational Assistance Act of 1976 (Cambridge, Mass.: Ballinger, 1977).

1 9. Randy Shilts, And the Band Played On: Politics, People, and the AIDS Epidemic
(New York: St. Martin's Press, 1987), 54.

20. Federal Records Act, 44 U.S. Code 3101.

2 1 . An overview of the programmatic activities and expenditures of each state
health agency is provided in the Public Health Foundation's annual survey of
public health agencies.

NOTES 69

22. Public Health Foundation, Public Health Agencies 1991: An Inventory of Programs
and Block Grant Expenditures (Washington, D.C.: Public Health Foundation,
1991), 1.

23. Ibid., 3.

24. The increased incidence of antibiotic-resistant tuberculosis in the United
States may lead to the revival of tuberculosis sanatoria.

25. In some other states, such as Georgia, hospitals are operated by separate
hospital authorities outside of the supervision of the state health agency.
Public Health Agencies 1991, 7.

26. Arizona, the last state to join the Medicaid program, signed on in 1982.

27. NIH Data Book: Basic Data Relating to the National Institutes of Health (Bethesda,
Md.: National Institutes of Health, 1991), 2.

28. An interesting analogy from the world of physics is found in Utah, where
much of the recent work on cold fusion was funded by the state government.

29. Committee on the Records of Government, Report (Washington, D.C.:
Committee on the Records of Government, 1985), 71.

30. Ibid., 20. On the poor state in general of state archives, see also Lisa B. Weber,
ed.. Documenting America : Assessing the Condition of Historical Records in the States
(Atlanta: Conference of the National Historical Publications and Records
Commission Assessment and Reporting Grantees, 1984).

31. Roland M. Baumann, "The Administration of Access to Confidential Records
in State Archives: Common Practices and the Need for a Model Law,"
American Archivist 49 (1986): 361-363.

32. In addition to the Baumann work cited above, see also McCall and Mix,
Designing Archival Programs.

33. C. A. Miller et al., "A Survey of Local Public Health Departments and Their
Directors," American Journal of Public Health 67 (October 1977): 931-99.

34. Public Health Agencies 1991, 1.

35. Haven Emerson, Local Health Units for the Nation (New York: Commonwealth
Fund, 1945).

36. H. G. Jones, Local Government Records: An Introduction to Their Management,
Preservation, and Use (Nashville, Tenn.: American Association for State and
Local History, 1980), 19.

37. Ibid., 136.

38. Bruce W. Dearstyne, The Management of Local Government Records: A Guide for
Local Officials (Nashville, Tenn.: American Association for State and Local
History, 1988), 110-1.

39. William G. Le Furgy, The Records of a City: A Guide to the Baltimore City Archives
(Baltimore, Md.: City Archives and Records Management Office, 1984), 36,
and John Daly, Descriptive Inventory of the Archives of the City and County of
Philadelphia (Philadelphia: Department of Records, 1970).

40. Ibid., 37; telephone conversation with David Weinberg, Philadelphia City
Archives, 27 June, 1993.

41. National Data Book of Foundations, 1991 (New York: Foundation Center, 1991),
v. The Foundation Center, a nonprofit organization founded and supported
by foundations "to provide a single authoritative source of information on

70 HEALTH AGENCIES AND FOUNDATIONS

foundation giving," is the best source of information on foundations (also
called philanthropic foundations, charitable trusts, trusts, charitable
corporations, and sometimes funds). See the Foundation Directory (New York:
Foundation Center, 1992), xxi-xxxii.

42. National Guide to Funding in Health, 2nd ed. (New York: Foundation Center,
1989), V, and Ruth Kovacs, ed.. Foundation Grants Index 1993, 21st ed. (New
York: Foundation Center, 1992), xii-xiii.

43. The Howard Hughes Medical Institute is not technically a foundation under
the tax code but instead is a medical research organization. Because its
activities and purpose are so similar to those of foundations, it is considered
with foundations in this chapter.

44. Robert J. Glaser, "The Impact of Philanthropy on Medicine and Health,"
Perspectives in Biology and Medicine 36 (1992): 46-56. This source provides a
useful historical introduction to the activities of several major foundations in
support of health care.

45. A. McGhee Harvey and Susan Abrams, For the Welfare of Mankind: The
Commonwealth Fund and American Medicine (Baltimore: Johns Hopkins
University Press, 1986).

46. John Ettling, The Germ of Laziness: Rockefeller Philanthropy and Public Health in
the New South (Cambridge: Harvard University Press, 1981).

47. Barbara G. Rosenkrantz and Peter Buck, Introduction, in Philanthropic
Foundations and Resources for Health: An Anthology of Sources (New York:
Garland Publishing, 1990): xi-xix.

48. NIH Data Book 1991,2.

49. George F. Cahill, Jr., and Diane R. Hinton, "Howard Hughes Medical Institute
and Its Role in Genomic Activities," Genomics 5 (November 1989): 952-54;
and Robert Mullan Cook-Deegan, "The Human Genome Project: The
Formation of Federal Policies in the United States, 1986-1990," in Kathi E.
Hanna, ed.. Biomedical Politics (Washington, D.C.: National Academy Press,
1991), 99-175.

50. Kenneth W. Rose, The Availability of Foundation Records: A Guide for Researchers
(North Tarrytown, N.Y.: Rockefeller Archives Center, 1990), IV-2-IV-3. See
also Darwin H. Stapleton and Kenneth W. Rose, eds.. Establishing Foundation
Archives: A Reader and Guide to First Steps (Washington, D.C.: Council on
Foundations, 1991).

5 1 . Chuck Hill and Anne Muchoney, eds., A Guide to the Project HOPE Archives
(Millwood, Va.: People-to-People Foundation, 1991).

SELECT ANNOTATED BIBLIOGRAPHY

Several general guides to the U.S. health care system present good overviews of
the functions, activities, and roles of federal, state, and local health agencies.
Among the best are Anthony R. Kovner and contributors. Health Care Delivery
in the United States (New York: Springer Publishing Company, 1990); Florence

SELECTED ANNOTATED BIBLIOGRAPHY 7 1

A. Wilson and Duncan Neuhauser, Health Services in the United States (Cam-
bridge, Mass.: Ballinger, 1985); and Milton I. Roemer, Ambulatory Health
Services in American: Past, Present, and Future (Rockville, Md.: Aspen Systems
Corporation, 1981 ), which also contains a good overview of patient care
aaivities of disease-specific foundations. An excellent compilation of essays
on the government's role in formulating health policy is Theodore J. Litman
and Leonard S. Robins, Health Politics and Policy (Albany, N.Y.: Delmar Pub-
lisher, 1991).

The best history on the origins of the Public Health Service (and hence federal
involvement with health care) remains that by Robert Straus, Medical Care for
Seamen: The Origin of Public Medical Service in the United States (New Haven: Yale
University Press, 1950). The most recent history is Fitzhugh Mullan, Plagues
and Politics: The Story of the United States Public Health Service (New York: Basic
Books, 1989). Recent historical studies of other federal health agencies in-
clude Victoria Harden, Inventing the NIH: Federal Biomedical Research Policy,
1887-1937 (Baltimore: Johns Hopkins University Press, 1986); Elizabeth
Etheridge, Sentinel for Health: A History of the Centers for Disease Control
(Berkeley and Los Angeles: University of California Press, 1992); and Alice
Sardell, The U.S. Experiment in Social Medicine: The Community Health Center
Program, 1965-1986 (Pittsburgh: University of Pittsburgh Press, 1988).

The classic work on local health units is Haven Emerson, Local Health Units for the
Nation: A Report (New York: Commonwealth Fund, 1945; reprinted by Arno
Press, 1977). In 1973 a team at the University of North Carolina began an
important project to survey the activities and organization of local health
agencies. A good example of their work is C. A. Miller et al., "A Survey of
Local Public Health Departments and Their Directors," American Journal of
Public Health 67 (1977), 931-39. An excellent model history that focuses on
the activities of a local health department is John Duffy, A History of Public
Health in New York City, 1625-1866 (New York: Russell Sage Foundation,
1968-[74]).

The standard work on the structure and organization of foundations is Frank
Emerson Andrews, Philanthropic Foundations (New York: Russell Sage Foun-
dation, 1956). The value of the archives of philanthropic foundations, includ-
ing health-related foundations, has been argued by David C. Hammack in
"Private Organizations, Public Purposes: Nonprofits and Their Archives,"
Journal of American History 76 (1989): 181-91. Good histories of the health
activities of important foundations include A. McGehee Harvey and Susan L.
Abrams, For the Welfare of Mankind: The Commonwealth Fund and American
Medicine (Baltimore: Johns Hopkins University Press, 1986); E. Richard
Brown, Rockefeller Medicine Men: Medicine and Capitalism in America (Berkeley
and Los Angeles: University of California Press, 1979); and John Ettling, The
Germ of Laziness: Rockefeller Philanthropy and Public Health in the New South
(Cambridge: Harvard University Press, 1981).

CHAPTER 4

Biomedical Research Facilities

PAUL G.ANDERSON

Biomedical research facilities are units of the U.S. health care system
devoted primarily to scientific investigations in medicine or other modes
of therapeutic treatment, or to studies of the basic composition and
functions of the human body. This chapter reviews the major types of
biomedical research institutions and their activities. As shown in Table
l-I, biomedical research institutions are inextricably involved with most
functions of the health care system. The signature function of research
may not readily be distinguished from other principal functions. Many
kinds of investigative units, for example, are involved in patient care.
Their programs often contribute a vital part to the education (particularly
postgraduate training) of health care professionals. Indirectly their influ-
ence extends still further: biomedical research findings are an essential
ingredient in health promotion and policy formulation, and they make
possible the manufacture and marketing of products and services worth
billions of dollars annually.

Institutions in the United States devoted to biomedical research num-
ber in the thousands and include programs in the basic sciences, such as
molecular biology and biophysics, as well as in the clinical sciences, such
as cardiology and surgery. Units that conduct programs dedicated to
developing refinements in biomedical technology within larger institu-
tions belong equally to this category. The concept of biomedical research
also includes investigations in allied health fields, such as dental medicine,
nursing, and pharmacology, and in behavioral sciences, such as psychol-
ogy and sociology.^ In this chapter, the term will be used in its broadest
sense.

74 BIOMEDICAL RESEARCH FACILITIES

Specialty institutions devoted to biomedical research fields are identi-
fied by a welter of generic terms, some clearly denoting a particular
function or size, others seemingly devoid of meaningful association. The
jargon of the National Institutes of Health (NIH), the largest of the Public
Health Service branches of the Department of Health and Human Ser-
vices, for example, speaks of "BIDs" — bureaus, institutes, and divisions.^
There are also many federal research agencies bearing the name center.
Institutions outside the government are designated by these same terms,
but many others are used as well. The nonprofit sector recognizes numer-
ous research academies, clinics, consortiums, departments, groups, foundations,
laboratories, programs, and units. The commercial sector adds companies and
corporations.

Unmistakable from even a casual analysis of this segment of the U.S.
health care system is the fact that independent biomedical research units
are far outnumbered by comparable organizations that are subdivisions of
larger bodies. Fewer than one in ten are without some form of parent
body. Throughout the country, there is a proliferation of specialty units
within governmental agencies, hospitals, universities, and commercial
companies. This is not to say that independent biomedical research insti-
tutions are a declining phenomenon. There are today, as there have been
for decades, many new and vital organizations of this description. At
present, however, the trend favors the development of large, conglomer-
ate medical enterprises.^

Another general characteristic of research institutions, and one that is
related to the frequency of their affiliated or subordinate status, is that as a
rule they are neither quite as visible nor as permanent as other kinds of
organizations in the U.S. health care system. Most U.S. hospitals, for
example, take as part of their mission to be known as permanent commu-
nity assets and often assiduously cultivate their public image through
media advertising and other, more subtle public relations campaigns.
Educational institutions also desire visibility to attain objectives such as
the recruitment of students and the maintenance of alumni and commu-
nity support. Health industry firms routinely spend millions of dollars
annually to encourage the public to trust and use their products. By
contrast, a public profile is deemed unnecessary, if not undesirable, for
most specialty research organizations. Such units are established when
intellectual motivation and funding opportunities come together, and this
generally happens with far less fanfare than is heard from institutions that
directly serve the public. When all their projects conclude or funding is
exhausted, most research organizations, both public and private, can
relatively swiftly disburse their property assets and disband.

TYPES OF BIOMEDICAL RESEARCH INSTITUTIONS

FIGURE 4-1 Dr. George H. Bishop conduas research on sensory mechanisms of
skin in the Neurophysiology Laboratory, McMillan Hospital-Oscar Johnson Insti-
tute, Washington University, St. Louis, 1946. Source; Washington University School of
Medicine Library, St. Louis

TYPES OF BIOMEDICAL RESEARCH INSTITUTIONS

The federal government has long established and operated biomedical
research agencies. Every state of the union also funds agencies that
conduct investigations in health-related fields. Completing the picture are
varieties of investigative units that are both private and nonprofit and also
many that are run for profit. Both federal and profit-making units tend to
be unambiguous concerning control and funding. The investigatory
branches of the Department of Health and Human Services, for example,
operate totally on congressional appropriations. Their work is performed
ostensibly in the public interest, and significant findings are generally
divulged as soon as it is feasible. Commercial biomedical firms usually
conduct research out of corporate revenues; findings from their laborato-
ries are proprietary and disseminated according to marketing strategies.

The factors of control and funding are often more complicated in the
cases of state agencies and of private, nonprofit biomedical research
institutions. A large proportion of institutions in both categories depend

76 BIOMEDICAL RESEARCH FACILITIES

on complicated and multilayered funding systems extending across state
lines. Various federal grant programs enable state, local, and private
nonprofit organizations to form special units for biomedical research.
Private foundations and corporate sponsors also play a central role in
sustaining nonprofit investigative organizations, both within and apart
from governmental control. All of this is carried on in the public interest
or, from a different perspective, in the interest of science and health.'^

Private philanthropy accounts for what most closely approximates a
legal definition of a "typical" biomedical research organization. This
definition is found in a section of the Internal Revenue Code concerning
the eligibility of such units to receive private donations. According to the
code, an organization is a medical research organization [if it is] directly
engaged in the continuous active conduct of medical research in conjunc-
tion with a hospital. "5 Under the strictest possible interpretation, the law
would appear to address only those units that are subordinate sections of
major health care delivery facilities. The phrase "in conjunction with a
hospital," however, is generally taken to include many different levels of
association with clinical institutions, among them purely intellectual and
collegial connections. A broad interpretation permits wholly independent
organizations engaged in health sciences research to receive donations
under the code.^ Many research units, furthermore, are eligible recipients
of charitable contributions and gifts by virtue of being part of educational
institutions.^

FEDERAL BIOMEDICAL RESEARCH LABORATORIES

The federal government operates several hundred specialized biomedical
research components. These are parts of the agencies already reviewed in
broader perspective in Chapter 3. The greatest number are grouped under
the egis of the Public Health Service of the Department of Health and
Human Services. They include the institutes and centers that compose the
NIH, the divisions of the Substance Abuse and Mental Health Services
Administration, and the Centers for Disease Control. They all are com-
monly referred to as intramural research laboratory units (i.e., operating
within the "walls" of the federal government), to draw a distinction
between them and the extramural research program offices operated by
many of the same institutes and divisions, in which money is sent "be-
yond the walls." Many specialized biomedical research institutes and
divisions are also to be found within the departments of Agriculture,
Defense, Energy, and Veterans Affairs.^

Federal agencies set national standards not only because they are

TYPES OF BIOMEDICAL RESEARCH INSTITUTIONS 77

sources of funding, but also because they serve, at least in principle, as
flagships in their respective investigative fields. At the very least, they
have been centers where scientists across the country gained formative
experiences and made important associations. This leadership function
was particularly significant during the halcyon early years of the NIH
(roughly the late 1940s through the early 1960s). In his autobiography.
For the Love of Enzymes, the biochemist Arthur Kornberg recalls how young
scientists typically exchanged positions at the NIH for appointments at
other institutions, or vice versa, in the course of their careers.^ Competi-
tion between the NIH and the world outside Bethesda for candidates to fill
junior posts and postdoctoral fellowships continues to renew and
strengthen these same connections. Mutual reinforcement, moreover, is
perpetuated through the experiences of members of hundreds of review
panels that convene at the NIH as a part of the annual grant-funding
process.

Specialization renders it impossible to represent any one federal
laboratory unit as typical of all that the government operates. The mam-
moth NIH campus in Bethesda houses the largest concentration of intra-
mural research programs. There, to cite but one example, are located the
laboratories of the Digestive Diseases Branch, Intramural Research Divi-
sion, of the National Institute of Diabetes and Digestive and Kidney
Diseases, one of the thirteen National Institutes of Health. This unit boasts
two sections, devoted respectively to gastroenterology and to liver dis-
eases, where scientists conduct experiments on the physiology and bio-
chemistry of digestive disorders. A prominent example of NIH laboratories
located outside Bethesda are the units administered by the Gerontology
Research Center of the National Institute of Aging, in Baltimore. A wide
range of investigations on the aging process and age-related disorders are
conducted at the center's facilities.

Military medicine embraces numerous fields of applied biomedical
research. The Letterman Army Institute of Research in San Francisco, for
example, is devoted to problems related to battlefield trauma and defenses
against biological and chemical weapons. The Diving Medicine Depart-
ment of the Naval Medical Research Institute in Bethesda specializes in
studies of decompression sickness, the use of anesthesia and other drugs
below the ocean's surface, and the long-term effects of contaminants on
divers. The Department of Veterans Affairs, in addition to maintaining
cooperative research contracts with medical centers throughout the
United States, operates its own Medical Research Service at departmental
headquarters in Washington, D.C., to investigate clinical problems espe-
cially prevalent in Veterans Administration hospitals.

78 BIOMEDICAL RESEARCH FACILITIES

HOSPITAL- OR UNIVERSITY-AFFILIATED RESEARCH INSTITUTIONS

"Affiliated status" in this context covers both integral research units of
hospitals and universities and research institutions that maintain coopera-
tive arrangements with hospitals and universities. They are commonly
located within both state-supported and private, nonprofit medical cen-
ters. Federal extramural funding, private philanthropy, and clinically
generated revenues have contributed to make equivalent units in both
ownership categories remarkably similar.

An example of an integral unit is the Bockus Research Institute in
Philadelphia. Bockus is a part of the Graduate Hospital Research Center,
which in turn is affiliated with the University of Pennsylvania (although
not owned by the university). The institute specializes in research in
cardiovascular physiology. An example of an institution with a more
collateral relationship with a hospital complex is the Brain Research
Center, an independent, nonprofit organization affiliated with the George
Washington University School of Medicine and located at Children's
National Medical Center in Washington, D.C. Research there concentrates
on the role of neuropeptides in the nervous systems of children, and the
center is currently running experiments in the treatment of autistic
and self-injurious behavior. Not all hospital-affiliated research units,
however, conduct laboratory experiments. The Sid W. Richardson Insti-
tute for Preventive Medicine of the Methodist Hospital in Houston, for
example, specializes in epidemiological studies of chronic lung and
heart diseases. Among its objectives are the analysis of health insurance
claims and employee absentee data to evaluate preventive medicine
programs.

The overwhelming majority of biomedical research institutions func-
tion within a single facility, but there are numerous exceptions. The
Affiliated Children's Arthritis Centers of New England, for example, is a
research organization comprised of a network of fifteen tertiary pediatric
centers located throughout the region and based at the Floating Hospital
of New England Medical Center in Boston. The organization conducts a
series of programs on childhood rheumatic diseases, including clinical and
health management research, and community education courses and
workshops.

Private hospitals that house research institutes number in the hun-
dreds. These special branches are located throughout the United States,
though virtually all are found in major metropolitan areas. As noted in the
previous chapter, the economic and social realities of the U.S. health care
system make it difficult to operate large private hospitals outside urban
centers. This is doubly true for costly research units. The investigatory

TYPES OF BIOMEDICAL RESEARCH INSTITUTIONS 79

divisions of the Mayo Clinic in Rochester, Minnesota, are exceptions in
this regard. The Mayo Foundation continues to operate research programs
in private facilities, although with extensive government support. The
General Clinical Research Center at Mayo Foundation is located at St.
Mary's Hospital in Rochester and is funded by the NIH's General Clinical
Research Centers Program, which underwrites investigations in a wide
range of clinical specialties. Other Mayo research facilities are housed at
Rochester Methodist Hospital. More recently, the foundation has estab-
lished group practices in Jacksonville, Florida, and Scottsdale, Arizona. A
special satellite telecommunications system permits staff physicians at
these locations to participate in selected research programs centered in
Rochester. ^°

Academic medical centers have increasingly developed as the loca-
tions of choice for biomedical research. Minimal components for an
academic medical center are a hospital and a degree training program in at
least one branch of the health sciences, but this hardly suffices to describe
the massive conglomerates that have emerged under this bare description
in many large urban areas. ^^ As with hospitals and research units, a
hierarchical affiliation is not a necessity. Many institutions have been able
to devise cooperative arrangements and to derive other mutual benefits
from mere proximity. An outstanding example of this is the clustering of
biomedical research institutions in metropolitan Houston in the vicinity of
several universities and hospitals.

The biomedical research units at Boston University are typical of
special investigatory divisions that have developed under the umbrellas of
academic medical centers throughout the United States: the Aphasia
Research Center, the Arthritis Center, the Center for Psychiatric Rehabili-
tation, the General Clinical Research Center, the Gerontology Center, the
Health Policy Institute, the Hubert H. Humphrey Cancer Research Center,
the Human Bioenergetics Laboratory, the Laboratory of Neurophysiology,
the Marine Program, the Robert Dawson Evans Memorial Department of
Clinical Research, and the Whitaker Cardiovascular Institute. Major uni-
versity medical centers such as Boston University's are, in general, more
intellectually diverse than those connected to hospitals without graduate
degree programs in the health sciences. Many extend beyond biomedicine
proper to allied fields in biology, bioengineering, and the social sciences.
Boston University, for example, maintains a year-round research program
at the facilities of the Marine Biological Laboratory in Woods Hole,
Massachusetts. The fact that Boston University is privately owned has no
bearing on the array of research units that it maintains or the kinds of
investigations in which they engage. Numerous large state universities
support comparable numbers and varieties of investigatory bodies.

80 BIOMEDICAL RESEARCH FACILITIES

INDEPENDENT NONPROFIT BIOMEDICAL RESEARCH INSTITUTIONS

A select number of private, nonprofit agencies occupy enormously influ-
ential positions at the centers of the experimental life sciences, each with
numerous links to the world of clinical practice as well. Particularly
illustrative of institutions in this rank are three of the oldest in the United
States — the Carnegie Institute of Washington, the Cold Spring Harbor
Laboratory in Cold Spring Harbor, New York, and the Marine Biological
Laboratory in Woods Hole, Massachusetts.

The Carnegie Institute of Washington is a private organization with
centers in several cities. In terms of biomedical research, the most notable
of these centers is the Department of Embryology, founded in 1 9 14, and
located in Baltimore. The department's general research agenda is to
study the "mechanism of differentiation, growth, and morphogenic pro-
cesses coordinating transformation of an egg into a functional adult." The
institute also operates the Carnegie Laboratories of Embryology, Davis
Division, located at the University of California, Davis, specializing in
investigations in embryonic development of the human brain. The divi-
sion is operated under contract by the university.

The Cold Spring Harbor Laboratory, founded in 1890, is a nonprofit
research organization affiliated with ten sponsoring universities but gov-
erned by its own board. It boasts a research staff numbering in the
hundreds, some of whom are active in fields only tangentially related to
the human health sciences. The laboratory has long been among the
leading centers of work in genetics and molecular biology in the United
States. Cancer investigations are another important part of its program.

Founded in 1888, the Marine Biological Laboratory is among the most
venerable of the private independent research institutions. Despite the
name, the laboratory is not exclusively devoted to the study of marine life
but is renowned for research conducted on cell biology, neurobiology, and
other areas with a human focus. The laboratory is particularly well known
for its summer institute, where scientists in biomedical and related disci-
plines from around the world lease space to further their research projects.
In addition to the arrangement with Boston University's Marine Program,
the laboratory also houses a year-round research program of the Univer-
sity of Pennsylvania.

Some independent biomedical research institutions have small staffs
and limited research budgets. Their programs may, nevertheless, be far-
reaching and ambitious. The Center for Human Genetics, a nonprofit
laboratory in Bar Harbor, Maine, for example, has only one permanent
staff scientist. The center investigates genetic approaches to understanding
and treating a variety of birth defects and congenital debilities. The Center

TYPES OF BIOMEDICAL RESEARCH INSTITUTIONS 8 1

for the Study of Anorexia and Bulimia is a nonprofit division of tfie
Institute for Contemporary Psycfiotherapy in New York City and conducts
studies on the prevalence, demography, etiology, and treatment of these
eating disorders. Its operation is funded almost completely by clinic
income. One of the best known centers for research in human sexuality is
the Masters and Johnson Institute, in St. Louis. Its program includes the
study of conceptive, contraceptive, and human sexual physiology, psy-
chology, and endocrinology.

Some independent research units specialize in fields and treatments
traditionally eschewed by major medical centers. The Acupuncture Re-
search Institute, for example, is a private, nonprofit research organization
in Monterey Park, California, devoted to the ancient Chinese healing art.
It sponsors clinical conferences and seminars at the Queen of Angels
Hollywood Presbyterian Medical Center and at Los Angeles International
University. Another example is the Laban/Bartenieff Institute of Move-
ment Studies, Inc., in New York City, which investigates applications of a
form of physical therapy with roots outside any of the natural sciences.
Rudolf Laban (1879-1958), an Austrian dancer and choreographer, for-
mulated a series of principles for the understanding of body movement
that were applied to therapy by a disciple, Irmgard Bartenieff (1900-
1981). The institute claims that these principles have applications to
psychotherapy, fitness, and sports training.

BIOMEDICAL RESEARCH AND DEVELOPMENT COMPANIES OR
DIVISIONS OF COMPANIES

All profit-making enterprises in biomedical fields necessarily engage to
some degree in research. Although the health industries in the United
States are the subject of Chapter 7, many varieties of specialty research
units within the commercial sector of the contemporary health care
system will be discussed here. The similarities and close ties that exist
between them and nonprofit institutions are noteworthy. Advanced work
in the fields of cellular or molecular biology and genetics, for example,
relies on intimate professional contacts between investigators, on one
side, and suppliers of apparatus, drugs, and reagents, who are themselves
scientists, on the other. ^^

Life Technologies, Inc., of Gaithersburg, Maryland, is typical of many
small research and development companies that have emerged to supply
NIH laboratories and extramural scientific institutions with instruments
and materials relating to DNA technology and advanced clinical diagnos-
tics. The company conducts its own research in areas such as restriction
enzymes, eukaryotic transcription systems, and hepatitis B hybridization.

82 BIOMEDICAL RESEARCH FACILITIES

Synergen, Inc., of Boulder, Colorado, is an example of a firm oriented
toward fields outside the health professions (e.g., applications of microor-
ganisms in enhanced oil recovery) that has discovered applications of its
research to clinical medicine (e.g., the treatment of lung disease). Some
companies have been established by nonprofit institutions to exploit the
commercial potential of biomedical research. A prominent example is
Salk Institute Biotechnology Industrial Associates, Inc., of San Diego,
which conducts research under contract with several larger firms, among
them Phillips Petroleum, in selected areas of cell biology and genetics.

RESEARCH PARTNERSHIPS BETWEEN COMMERCIAL COMPANIES AND
NONPROFIT INSTITUTIONS

Recent decades have witnessed extraordinary developments in partner-
ships between commercial companies and nonprofit institutions. A trend-
setting event in this area was the $23 million contract awarded to Harvard
Medical School by the Monsanto Company in 1974 to fund cancer
research. ^^ The essence of this and subsequent agreements, distinguishing
them from totally commercial research ventures, is that industrial firms
agreed to underwrite investigatory programs using the facilities and staffs
of nonprofit institutions in return for a share in the rights to lucrative
discoveries.^"^

Major partnerships might have developed before the 1970s had there
not been a perception on the part of industry that if nonprofit organiza-
tions were recipients of federal grants or contracts and private money, all
rights to discoveries would fall in the public domain. A lawsuit that has
become known as the Gator- Ade case led to an important clarification of
this matter. A University of Florida researcher discovered a formula for a
soft drink demonstrably beneficial to athletes. After the university de-
clined to file for a patent, the scientist contracted in 1 969 with the Stokley
Van Camp Company to produce the beverage. Gator- Ade proved profita-
ble, whereupon the university belatedly filed suit to claim all royalties.
The case, settled out of court, inspired the passage of Public Law 96-5 1 7 in
1980, giving nonprofit institutions and small businesses the right to retain
title to inventions resulting from government grants and contracts. The
legislation has opened the door to scores of joint agreements between
nonprofit research organizations and small commercial biotechnology
firms.

The 1980s witnessed the advent of several multi-million-dollar con-
tracts between academic medical centers and large chemical or pharma-
ceutical companies which are noteworthy.'^ Massachusetts General Hos-
pital, the largest Boston teaching hospital associated with Harvard Univer-

FUNCTIONS AND ACTIVITIES OF BIOMEDICAL RESEARCH INSTITUTIONS 83

sity, was foremost among institutions of its kind to establish industrial
partnerships. The German chemical firm Hoechst AG signed a contract
with Massachusetts General in 1980 to create a $68 million molecular
biology center. In 1989, the hospital announced an $85 million contract
with Shiseido Co., Ltd., of Japan to support a center for research on skin
and skin diseases. In the following year, a $36.8 million agreement was
reached between the hospital and the pharmaceutical giant Bristol-Myers
Squibb to establish a cardiovascular research unit.

Among universities with large research-oriented medical centers,
Washington University in St. Louis set precedents for attracting huge
corporate contracts. In 1981 the university agreed with Mallinckrodt, also
of St. Louis, to undertake a $3.8 million research project focusing on
hybridomas, artificially created cells that produce antibodies useful in the
treatment of a variety of diseases. The following year, the university
joined with another St. Louis chemical firm, Monsanto, to study cellular
communications, particularly proteins and peptides that affect the im-
mune system. Originally calling for $23.5 million in corporate support,
subsequent renewals of the pact have augmented the total committed to
nearly $100 million, earning it the distinction of being to date the most
extensive research collaboration ever funded between an American com-
pany and an American university. ^^

Agreements such as these have aroused considerable controversy.
Critics warned that the profit motive and the restrictions placed by the
contracts on dissemination of findings and the rights to discoveries could
corrupt academic medicine beyond redemption. ^^ Spokespersons for the
parties involved have responded by praising their agreements as model
collaborative programs, contending that the rights, licenses, and royalties
that academic investigators reserve for their corporate sponsors constitute
a reasonable price for underwriting their work.^^ There is reason to expect
that major academic-industrial partnerships will continue and expand in
the future.

FUNCTIONS AND ACTIVITIES OF BIOMEDICAL RESEARCH
INSTITUTIONS

Most early medical researchers in the United States were physicians who
worked in relative isolation to discover new treatments or new knowl-
edge of the human body. William Beaumont (1785-1853), to cite a
well-known example of a pioneer investigator, conducted experiments on
digestive physiology in his home on an isolated army post in the 1820s,
focusing his attention on a single patient. To observe here that

84 BIOMEDICAL RESEARCH FACILITIES

Beaumont's world disappeared long ago is an understatement. The stark
differences between biomedical research then and now underscore why
today few research programs are possible without elaborate planning and
support. The activities outlined here apply equally to investigations in
hospitals, educational institutions, and programs of independent research
institutions.

The functions and activities of biomedical research units are compli-
cated and diverse. Nevertheless, they can be classified into a relatively few
basic categories. The range of activities composing the research function is
unquestionably central; patient care and education are secondary func-
tions. Not only the core function but also certain activities composing the
institutional administration function deserve archival scrutiny. Before
experimentation begins, efforts must be organized to secure funding and
recruit personnel. All during the operating lifetime of the unit, work is
performed not only by a scientific elite but also by employees who acquire
and manage the equipment, facilities, and materials. The training of junior staff
members and students may be objectives requiring substantial attention
and expenditures. Activities such as these represent more than a string of
peripheral events, for they are the background to the research process in
which investigations are proposed and justified, and results dissemi-
nated.^^

BASIC, CLINICAL, AND APPLIED BIOMEDICAL RESEARCH

Biomedical research is typically dedicated to the pursuit of basic scientific
or clinical knowledge. Rephrasing the definition with which this chapter
began, the difference between basic and clinical research is the difference
between studies of the functions and composition of the human body, on
one hand, and investigations in medicine or other modes of therapeutic
treatment, on the other. Some observers would see this difference as a
health sciences version of the dichotomy common to all intellectual
endeavors — distinguishing fundamental work from applied. Others dis-
cern nuances between the concepts of clinical and applied research and
between therapeutic and nontherapeutic investigation. Merely having
patients tested, we are reminded, is not enough to make the project
practical or useful. ^°

Many distinctions between basic and clinical sciences are more theo-
retical than real. An ever-expanding and overlapping array of research
subfields encompasses all areas of biomedical research. The basic biomedi-
cal sciences may still be known in part by academic names such as
anatomy, biochemistry, genetics, microbiology, pharmacology, and physi-
ology, all of which are subjects in the classic medical education curricu-

FUNCTIONS AND ACTIVITIES OF BIOMEDICAL RESEARCH INSTITUTIONS 85

lum. The identity of clinical sciences is reinforced by counterparts among
common hospital services (e.g., internal medicine, surgery, anesthesiol-
ogy, obstetrics/gynecology, ophthalmology, otolaryngology, neurology,
psychiatry, and radiology). But beneath the intellectual matrix corre-
sponding to the services and departments of clinical and educational
institutions there is much overlap and constant change.

The 1980s and 1990s have witnessed increasing concentration on
molecular and cell biological research engaged in by scientists of various
departmental affiliations. Contemporary biomedicine is now conducted
and expressed, as Kornberg phrased it, "in a common language of chemis-
try."^^ The three following examples illustrate crossovers from basic to
clinical research. Certain projects to discover new treatments for epilepsy
draw on the expertise of biochemists and pharmacologists in testing
anticonvulsion agents; work on growth inhibitory factors by immunolo-
gists and zoologists has contributed to the effectiveness of agents inhibit-
ing the rejection of transplanted organs; and studies of how molecules are
distributed among distinctive cell regions have proved to have important
applications to understanding the functions of photoreceptors in the
human retina, and to yield new forms of treatment to restore impaired
vision. 2^

Applied research programs in engineering and physics continually
produce advances in testing and diagnostic equipment, which offer broad
applications for biomedical programs. Radiology and surgery are among
the fields that most frequently benefit from new technology, such as
magnetic resonance imaging, positron emission tomography, and video-
guided laparoscopic surgery. New synthetic materials for implants and
prostheses are frequently introduced from chemical and engineering
laboratories outside biomedicine. Every discipline of biomedical research
has profited from technologies as various as electron microscopy, chemi-
cal microbalances and microsensors, lasers, and microchips, to name but a
few. Many innovations open up new avenues for diagnostic and thera-
peutic investigations at the same time that they themselves are undergo-
ing further testing and refinement. ^^

In all of biomedical research, and particularly among institutions in
the nonprofit sector, collaboration regularly extends beyond institutional
walls. The science writer Michael Spector described the interaction suc-
cinctly: "Researchers for the NIH, universities, and private businesses
routinely join together in their attempts to develop a drug, for example, or
to understand the nature of a scientific problem. Groups form and dissolve
constantly, based on scientific predilection and research needs. ILeading
scientists] benefit tremendously from these new protean arrange-
ments."^"* Biomedical scientists may aspire to unique credit for major

86 BIOMEDICAL RESEARCH FACILITIES

discoveries but generally acknowledge their dependence on colleagues.
Meetings of professional societies, the review process for grant applica-
tions and for publication of findings, and improved technologies in medi-
cal informatics all encourage collaboration.

RESEARCH FUNCTION: FUNDING

In the 1960s and 1970s, the federal government accounted for about 60
percent of biomedical research funding, and industry accounted for 25 to
30 percent. These relative proportions of funding changed in the 1980s as
industry increased its funding, especially in the areas of biotechnology and
pharmaceutical research. Of the $22.6 billion spent on biomedical re-
search in 1990, roughly 46 percent was funded by industry, 44 percent by
the federal government, and 10 percent by private nonprofit foundations
and other sources. ^^ Industry and the federal government tend to fund
different types of biomedical research. Whereas industry tends to focus on
funding applied research in private laboratories, the federal government
concentrates its funding on basic biomedical research projects in academic
institutions and federal laboratories. As funding resources dwindle, how-
ever, governmental funding priorities may shift toward applied research.

Securing research funding requires the detailed communication of
methods, objectives, and costs involved in the proposed investigations.
Projects that are unsponsored — that is, projects that are supported by the
internal revenues of an organization — must at very least be justified and
budgeted to a degree sufficient to satisfy the scrutiny of the sponsoring
medical center's overall management. Major governmental grants or
contracts require lengthy applications, followed by periodic reports, au-
dits, and other communications to funding agencies. Support from private
foundations may require less paperwork than the NIH or other federal
grant endowments, but they, too, entail extensive administrative prepara-
tions and oversight. Commercial ventures generally involve, in addition,
extensive legal arrangements.^^

Association with a larger organization can provide a research unit
with crucial assistance in maintaining its program over time. Institutional
links help to establish and promote the credentials of research programs
and expedite financial operations. Universities and hospitals, for example,
routinely negotiate blanket agreements with funding agencies covering all
their research subsidiaries. As a result, the number of staff directly in-
volved with grants administration and employed within the individual
research units is minimized. Despite controversy over "excessive" admin-
istrative overhead charged at certain institutions (as in the widely publi-
cized case of Stanford University), basic formulas for determining indirect

FUNCTIONS AND ACTIVITIES OF BIOMEDICAL RESEARCH INSTITUTIONS 87

costs incurred by extramural research units have been followed for dec-
ades. Many large research centers have established committees to monitor
the situation and avoid possible abuses.

Competition for funding can be fierce among colleagues at competing
institutions or even at the same institution. In the 1980s, the chance of
being funded by the NIH decreased from 32 percent to 24 percent of
submitted applications, for three reasons: (1) each grant cost more, (2)
project awards covered a longer period of time, and (3) the number of
high-quality applications increased. ^^

Senior scientists play a significant role in regulating the system
through participation in various aspects of the peer review process.
Through study sections, the formal panels summoned to advise the NIH,
or through less formal advisory work on behalf of foundations, partici-
pants help determine who receives funding. This is generally a rigorous,
time-consuming, and often contentious process. ^^

STAFFING OF BIOMEDICAL RESEARCH INSTITUTIONS

Recruitment of qualified personnel is another basic activity through
which a biomedical research program is organized and justified. The
process may start with the selection of an individual to head the unit.
Normally, the director is a senior scientist, perhaps the individual who
pioneered or first achieved major successes in the chosen field of investi-
gations. A unit has an enormous advantage if it is headed by someone
knowledgeable in all aspects of operations, who is known and respected
by colleagues throughout the discipline, and who commands the trust of
the institution's backers. There is, however, no foregone conclusion that
the most productive investigators available would be willing to assume
executive command. Many capable scientists are philosophically opposed
to devoting precious time and energy to administrative duties and take
pains to eschew such appointments. The direction of large research organ-
izations may, therefore, be entrusted to individuals who have chosen
managerial or entrepreneurial goals over direct involvement in scientific
discovery. 2^

Formal academic training is obviously a basic consideration in the
recruitment of the scientific staff. A doctoral degree has long been the
basic credential for employment and advancement as a full professional in
biomedical research institutions. Clinical research units may require in-
vestigators to have an M.D. degree. For work in one of the basic sciences,
a Ph.D. or Sc.D. degree in a relevant discipline may be preferred. Recog-
nizing the importance of both tracks of graduate education to careers in
advanced biomedical research, many institutions seek candidates with

88 BIOMEDICAL RESEARCH FACILITIES

combined doctorates, particularly graduates of a recognized university
Medical Science Training Program, sponsored by funds from the NIH.^°
Still more significant, fiowever, is tfie reputation of the university where
an individual studied, the reputation of advisors and mentors, and
whether significant scientific experience was acquired through postdoc-
toral fellowships or residencies.^^

The work of visiting and part-time professional staff is a significant
factor at many biomedical research institutions. Researchers in these
categories are often as numerous as the regular, full-time investigators. At
academic medical centers, this may result from joint staff appointments to
hospital services and teaching departments. Independent institutions
have traditionally attracted the participation of visiting researchers during
the summer, when professorial scientists are relieved of their teaching
responsibilities at academic medical centers.

Various numbers of technicians, clerical staff, and other, less skilled
workers are ranked below the professional investigators in the chain of
command. Technicians may range from individuals knowledgeable and
experienced enough to perform complicated assignments to untrained
laboratory assistants hired to wash glassware and clean animal cages.
Hiring, supervision, and other aspects of personnel management are
major responsibilities of institutional administrations, just as in any organ-
ization, but in the case of research units employee performance evalua-
tions are likely to focus on scientific contributions and specialized judg-
ments that are unique to the field.

Despite obvious differences among employee classifications, it is im-
portant to observe that hierarchical ranking may not be as rigid at bio-
medical research units as in most health care delivery facilities and schools.
Research units can be as pragmatic as industrial firms in rewarding and
promoting talented individuals. Investigative experience, particularly a rec-
ord of productive contributions to publishable discoveries, is what ulti-
mately counts the most in establishing a research career. It is very common
in biomedical science for research teams to recognize the contributions of
junior members, and in many instances technicians have been promoted to
professional status in recognition of expertise acquired on the job.

The risk of job instability due to dependence on grant or contract
support is problematic for all employees of biomedical research institu-
tions. A sudden demand for qualified personnel created when grant
money becomes available may be followed by layoffs when grants lapse.
Professional investigators as well as technicians are sometimes inconven-
ienced by short-term positions, but the former presumably have a
stronger commitment to their work and ultimately a greater chance of
gaining permanent employment.'^

FUNCTIONS AND ACTIVITIES OF BIOMEDICAL RESEARCH INSTITUTIONS 89

MANAGING LABORATORIES AND OTHER RESEARCH SETTINGS

Laboratories are the most typical settings for biomedical research. Their
size, the types of equipment used, and the number of personnel employed
vary to such a degree that little generalization is possible. Many kinds of
analysis require close physical proximity to clinical examination rooms or
operating rooms, and therefore the laboratories must be situated within a
hospital or medical center. In other fields of research, investigations focus
on nonliving substances, microorganisms, or laboratory animals that can
be acquired and manipulated without connection to clinical activity.

The formats employed for recording and analyzing data likewise vary
enormously. No single technological advance has necessarily rendered
obsolete paper laboratory notebooks or clinical case files. New software
products, however, are constantly being marketed to capture and manip-
ulate raw data. For every research specialty, there is an ever expanding
array of calculating, computing, monitoring, and testing equipment, all
with digitalized data output. Computer graphics programs, many inte-
grated with word-processing software, routinely record and store the
graphic and tabular results of experiments or trials online.

Scientific laboratory apparatus, along with equipment for the clinical
examinations that investigators may share with hospital colleagues, is
usually expensive. Once acquired, it may be complicated or dangerous to
operate. Interaction between investigators and manufacturers and suppli-
ers can be complex. In fields where the research is at the cutting edge of
technology, scientists themselves sometimes become inventors. This phe-
nomenon was perhaps more pronounced in decades past, before the
advent of microchip-regulated electronics. Even today, however, as con-
sumers in the relatively tiny market for expensive machinery, major
laboratories exercise the power to demand customized equipment. Proper
security arrangements for hazardous and controlled substances and mea-
sures for their safe and legal disposal require sizable investments at many
kinds of laboratories. Biomedical research institutions are also significant
consumers of high-priced multipurpose items, such as computer hard-
ware. Biomedical information transfer and biostatistics have become
crucial services of large medical centers, demanding correspondingly large
outlays for mainframe data processing equipment and network lines, not
to mention the specialists to maintain and operate them.^^

LABORATORY ANIMAL MANAGEMENT

Laboratory animal management is a significant area of specialization
within biomedical research. A wide variety of animal species, from pri-
mates to E. coli, are used in experimentation. The archetypal research

90 BIOMEDICAL RESEARCH FACILITIES

subject may be the guinea pig, although more frequent and extensive uses
are made of rats and mice. Several mutant strains of rodent genera (e.g.,
the nude mouse) have been specially bred and marketed for laboratory
purposes. The experimental use of higher animals, such as cats, dogs, and
monkeys, is also widespread in nearly all disciplines. This is the most
costly aspect of operations, because it requires extensive space for cages,
systems for sanitary feed handling and cleaning of the pens, and the
services of veterinarians.

Contemporary procedures and regulations governing animal experi-
mentation have been profoundly affected by criticism or opposition from
groups ranging frorh antivivisectionists to animal liberation partisans.
Humane societies have worked to stiffen ordinances regulating the sale of
impounded dogs and cats to laboratories and have demanded legislative
or police investigation of certain research institutions. The U.S. Depart-
ment of Agriculture, which is charged with enforcing animal welfare
legislation, has repeatedly revised regulations concerning facilities, proce-
dures, and oversight. Committees for the governance of animal experi-
mentation are now mandatory. Biomedical research institutions across
the country have in recent years expanded and upgraded their animal
care facilities.

CONDUCTING CLINICAL TRIALS

Procedures for formal clinical trials are essential to the work of a substan-
tial proportion of biomedical research institutions. Most often these are
employed as means for studying the effectiveness of new drugs, but many
other objectives are possible, including investigations of various elements
significant in diet, fitness, genetic makeup, and social behavior. Depend-
ing on the nature of the study, an experimental laboratory may or may
not be directly involved. Some kinds of clinical trials or aspects of large
projects are entrusted to commercial testing companies. Federal regula-
tions, however, require hiring a statistical and clerical staff trained to
conduct surveys of sizable subject populations. Friedman and colleagues
and Spicker have provided comprehensive definitions of clinical trials.^'*
They indicate that every well-designed study requires a protocol incorpo-
rating written agreements between investigators, subjects, and a scientific
group selected to monitor response variables. Each trial should be con-
structed as a means of grappling with a primary question for which there
are reasonable expectations of verifiable conclusions. The study popula-
tion is a subset of a general population defined by specific eligibility
criteria, out of which the group of subjects actually studied is selected.
Nearly all investigations of this sort require a control group with which the

FUNCTIONS AND ACTIVITIES OF BIOMEDICAL RESEARCH INSTITUTIONS 9 1

group receiving the new intervention can be compared. Proper calcula-
tion of the size of the respective groups is essential to ensure the statistical
means of recognizing significant differences in the data.

Effective designs for clinical trials incorporate standard means for
avoiding elements of bias. Some subjects participating in drug tests, for
example, may be asked to receive the experimental substance, rather than
the placebo. To allow such a choice to be made by the subject, however,
could produce seriously skewed data. Minimal standards for a scientific
trial, therefore, hold that it be "single blind." The researchers, for their
part, usually need to demonstrate that they have not favored one group of
subjects over another in administering the experimental substance. In a
double-blind trial, neither subjects nor investigators know which inter-
vention is administered. In a triple-blind study, not even the group
monitoring responses is aware of each intervention assignment.

The agreements with subjects that are essential to conducting a clini-
cal trial are supposed to follow the principle of informed consent. Re-
search applications of informed consent developed implicitly over centu-
ries within general medical ethical and legal precepts. They received,
however, specific articulation at the Nuremberg trials, in the court's
judgment against the Nazi concentration camp investigators. United States
V. Karl Brandt. That decision remains the benchmark for mandating efforts
toward free and enlightened decisions on the part of clinical research
subjects. ^5 Gaining informed consent from subjects of biomedical research
is consequently one of the most elaborate and costly steps of a screening
process. Warnings have regularly been voiced over the years that many
investigators neglect their responsibilities in this matter to one degree or
other. ^^ The federal government has responded by issuing increasingly
lengthy regulations governing these interactions. Chief among them is the
mandate to establish institutional review boards or human subjects com-
mittees. In theory, institutional review boards are charged with scrutiniz-
ing research proposals for the protection of human subjects at any institu-
tion funded by the Department of Health and Human Services. ^^

In certain areas of clinical research, formal clinical trials and formal
applications of informed consent do not apply. Many new surgical inter-
ventions, most pathology research, and various kinds of experimental
psychiatric treatments are in this category. Some forms of clinical investi-
gations, furthermore, are entirely retrospective, involving the study of
inactive medical records. Much epidemiological research, for example,
requires permission from hospital management for secondary analysis of
data not originally created for general knowledge. Whatever the design
and scope of the problem under investigation, some form of rigorous
control is required to reach valid scientific conclusions.

92 BIOMEDICAL RESEARCH FACILITIES

PATIENT CARE IN BIOMEDICAL RESEARCH INSTITUTIONS

A prerequisite for conducting clinical trials in most instances is that a
biomedical research institution offer clinical care services. Although some
subjects participate in research investigations for reasons not related to
their own health, substantially more are attracted after having first sought
treatment as patients. This is one of several facets of the connections
between hospitals and research units that were alluded to earlier in this
chapter. Depending on the treatment specialty, a research institution itself
may function as a hospital or may offer only outpatient services. All
requirements for hospital or clinic licensing and other regulations that are
discussed in Chapter 2 apply to biomedical research institutions that treat
patients. Patient care services of independent biomedical research institu-
tions are subject to the same centripetal forces of the U.S. health care
system that have linked together originally autonomous hospitals as
medical centers. Institutions may affiliate or merge services voluntarily to
control costs or acquire new facilities. There also have been instances in
which internal reorganization has been forced upon research units by
third-party payers to simplify billing procedures.'^

EDUCATIONAL ACTIVITIES OF BIOMEDICAL RESEARCH INSTITUTIONS

Biomedical research institutions also engage in educational activities, both
informal and formal. Informal educational activity is necessitated by the
fact that scientific investigations are highly specialized, employing sophis-
ticated concepts and the latest equipment. The junior staff need to be
educated regarding the use of equipment and handling of hazardous
materials. Research units affiliated with academic medical centers and
teaching hospitals may also play significant roles in formal educational
programs. A unit could operate, for example, as a specially funded section
of a basic science department at a medical school, with all the senior staff
holding academic appointments. Students might be involved in projects in
fulfillment of elective course work or perhaps as summer employees.
Postdoctoral fellows render significant contributions to research pro-
grams, with their employment often underwritten by federal grants. (For
further information on the role of research programs in health profession-
als' education, see Chapter 5.)

COMMUNICATION AND MARKETING OF BIOMEDICAL RESEARCH
FINDINGS

Most biomedical research, particularly in the nonprofit sector, is intended
to produce publishable findings. The quality of the publication as a rule is

FUNCTIONS AND ACTIVITIES OF BIOMEDICAL RESEARCH INSTITUTIONS

FIGURE 4-2 Psychologist Joanna Grant Nicholas studies communication skills
of hearing-impaired children at Central Institute for the Deaf, St. Louis, 1993.
Source: Central Institute for the Deaf, St. Louis, Marcus Kosa, photographer

important to investigators, and a respected refereed scientific journal is
the medium of choice in most cases. The writing and editorial revision that
take place before a manuscript'^ is submitted for publication are often a
painstaking process. Large research institutions may employ professional
writers and editors to facilitate this process. As organizational activities,
such services are likely to come under administrative purview, but unlike
the activities considered previously in this chapter, they are primarily
focused on the end products of research rather than on beginnings.

Scientific journals in the main are published either by professional
associations or by commercial firms. A significant number, however, are
published directly by research institutions. An even more common varia-
tion is for a professional association to appoint an editor-in-chief and an

94 BIOMEDICAL RESEARCH FACILITIES

editorial board, who then may draw on the resources of a research unit.
Neurology, for example, the chief official organ of the American Academy
of Neurology, has since its inception been edited by a series of distin-
guished investigators in the field, who oversee editorial operations.

An essential ingredient in editing a scientific journal is peer review of
the most promising submissions. Editors normally send each manuscript
to at least two experts in the field for them to judge the quality and
potential of the work. Rarely do reviewers have the opportunity to test
fully the methods and findings described, so their reactions are never
foolproof, but overall the process provides an effective means of quality
control. The identities of reviewers are generally kept confidential, and
their critiques may be moderated by the editors before they render
decisions about publication. The exchanges involved can be an important
part of the work of a research institution.'^^ (For more information on
publishing in the medical field, see Chapter 7.)

Avenues of scientific communication less formal than refereed jour-
nals may also be important to research units. Bulletins and newsletters are
commonly devoted to such purposes as interstaff news (a particular
consideration if the unit operates in decentralized facilities or employs
substantial numbers of visiting or temporary staff) and fund raising.
Conferences, seminars, and symposia are frequently chosen means for
disseminating information or airing common problems among colleagues.
Many research institutions employ public relations personnel to tout
achievements to media and directly to the general public. All these and
other efforts require a significant investment of the unit's resources.

Biomedical research institutions may produce marketable inventions
worth in the aggregate millions of dollars annually as products or by-
products of their investigations. Certain major medical centers generate
enough patentable findings to warrant hiring staffs of patent attorneys to
manage the situation. This is beyond the means, however, of most smaller
nonprofit institutions. Independent research units do have the option of
contracting with patent management organizations, the largest of which
are also equipped to handle product marketing.'^^

DOCUMENTATION OF BIOMEDICAL RESEARCH INSTITUTIONS

The work of archivists in scientific fields other than biomedicine to
document what is termed "discipline history" has significant applications
here. The concept of discipline history originally developed out of concern
for preserving landmark records in the physical sciences and engineering.
The primary goal has been to ensure adequate documentation of subject

DOCUMENTATION OF BIOMEDICAL RESEARCH INSTITUTIONS 95

areas through joint efforts of archivists in several institutions. One of the
most effective demonstrations of archival cooperation of this nature has
been coordinated by the Center for the History of Physics of the American
Institute of Physics (AIP) in fields such as high-energy physics, space
science, and geophysics.'^^

If we ignore for a moment the obvious differences between physics
and biomedicine and compare specific programs in these two disciplines,
we find many similarities. Like biomedical units, institutions devoted to
research in physics have many different missions and profiles, ranging
from federal governmental agencies to commercial ventures. As in bio-
medicine, the contributions of nonprofit units are very strong. These
institutions include both state-supported and private bodies, some univer-
sity-affiliated, others independent. A combination of federal grant pro-
grams and private philanthropy enables them to conduct similar investi-
gatory programs. To round out the list of similarities, much of the research
performed in physics laboratories has a direct impact on biomedicine.
Investigations in isotope analysis, applications of laser techniques, spect-
roscopy, and ultrasonics are but a few of these areas. Many examples of
close collegial interaction between physicists and biomedical researchers
could be cited at any large academic medical center.

THE HUMAN GENOME INITIATIVE: A MODEL SUBJECT FOR DISCIPLINE
HISTORY

It is not appropriate here to discuss how receptive all research institutions
in physics may be to the model established by the AIP other than to
observe that it appears to work most effectively in the world of megapro-
jects supported primarily by governmental agencies and consortia. There
are areas of biomedical research that lend themselves equally well to
discipline history projects, and for similar reasons. Among the most likely
current subjects is the Human Genome Project, a worldwide research
effort that has the goal of mapping the entire structure of human DNA and
determining the location of the estimated 100,000 human genes. Funded
through the NIH and the Department of Energy, a substantial portion of
the research is being conducted in the laboratories of these two agencies.
In the grandest tradition of extramural programs, the NIH portion of the
appropriation is shared with (at this writing) seven major centers located
at universities throughout the United States. Other related program assis-
tance is available to smaller research teams, with additional money pro-
vided for training grants, technology development, and international
collaboration."^^

The objectives of the Human Genome Project in a sense are inherently

96 BIOMEDICAL RESEARCH FACILITIES

archival. This is particularly clear from one part of the NIH project, which
is to establish and operate a National Center for Biotechnology Informa-
tion (NCBI) within the National Library of Medicine. NCBI has the
particular mission of creating automated systems for knowledge about
molecular biology, biochemistry, and genetics and of pursuing research in
biological information handling. NCBI is currently conducting investiga-
tions with genome research centers and libraries throughout the country
about the feasibility of transmitting mapping data online. The Human
Genome Project also offers opportunities for archival development
through a small portion (3 percent) of the budget allocated to address
ethical, legal, and social considerations. Arguing that the full implications
of the project on society cannot be understood unless appropriate records
on a wide range of issues are collected and retained, at least two private
organizations have begun discipline history studies on genome research.'*^
Currently, the most comprehensive effort in this regard is being
mounted by the Chemical Heritage Foundation, an organization spon-
sored by the American Chemical Society and the Society of Chemical
Engineers (and openly modeled on the AIP). The CHF project, titled
BIMOSI, or Biomolecular Sciences Initiative, is interested not only in
genome research but in all important investigations pertaining to molecu-
lar biology. At this writing, the staff of BIMOSI have begun to advise
researchers and their organizations about what to preserve and where,
and how to conduct oral histories. A somewhat more limited documenta-
tion project is under way at the National Center for Bioethics Literature, of
the Kennedy Institute of Ethics at Georgetown University, focusing on the
ethical, legal, and social implications of human genome research. Histori-
ans and archivists involved in both projects acknowledge the enormity of
their respective undertakings, in particular challenges related to the diver-
sity of interests of individual researchers and their parent institutions.'^^

OBSTACLES TO DOCUMENTATION PLANNING FOR BIOMEDICAL
RESEARCH INSTITUTIONS

The opportunity that has developed for a discipline history project on
genome research is unusual among biomedical research fields. The combi-
nation of factors — novelty, urgency, international collaboration, and
above all, the generous public funding of the project — is more characteris-
tic of the great crash programs in nuclear physics than any recent field of
medical investigation. It is worth examining here why there were no
comparable calls for discipline history centers to address earlier national
mandates for biomedical research, such as the "wars" declared on cancer
from the 1930s through the I980s.'*6

DOCUMENTATION OF BIOMEDICAL RESEARCH INSTITUTIONS 97

The differences are at least fourfold. First, as already noted, there is
the proliferation of biomedical research institutions in the United States.
Consider, for example, a hypothetical history center for cancer oncology.
Counting only the units that truly specialize in problems and issues
relating to malignancies, one would have to deal not with seven major
centers, as with the Human Genome Project, but perhaps seven times
seventy. '^^ For better or worse (and certainly, in the case of cancer, there
have been many arguments to the effect that the proliferation of research
institutions has resulted in much duplication and waste), the extramural
grant system and private philanthropy have never concentrated their
funding eggs in only a few baskets.

Second, there is the general issue of confidentiality of clinical data.
Essentially, this is an area governed by the same constraints involving
patient records discussed in Chapter 2. Research units within hospitals
and academic medical centers are required to safeguard the identities of
study subjects as completely as they do the identities of regular patients.
For this reason, they normally deny outside researchers (or anyone else)
access to clinical data that they have generated or augmented for investi-
gative purposes.'*^

A third difference reflects the enormous contributions of private,
profit-making research institutions to every biomedical field. Competition
alone dictates that information about their proprietary discoveries not be
shared with other organizations or individuals, at least until the data no
longer have market value. Companies that have developed new drugs for
the treatment of cancer (or HIV infections, or any other focus of a health
crisis) find themselves under great pressure to justify decisions about the
costs, marketing, and distribution of their products. They are certain,
therefore, to be armed with policies concerning what they will dissemi-
nate to the public and what they will withhold.

A fourth difference is more a matter of philosophy and custom than
legal substance. This relates to the traditional reliance on refereed journals
as the primary medium for reporting — and preserving the historical re-
cord of — biomedical discoveries in the academic sector. For most biomedi-
cal scientists, journals are the true archives: at best, they convey succinctly
the nature of discoveries, discuss their implications, and provide necessary
directions for replicating the experiments. Unlike findings from projects in
sciences and technologies that are comYnissioned for national security
operations or commercial enterprises, most investigations in medicine and
allied fields are intended to produce publishable results. Despite fierce
competition among scientists for the attention of editors and review
panels of the most respected journals, findings of most reputable health
science projects appear sooner or later in print."*^ It is no accident that the

98 BIOMEDICAL RESEARCH FACILITIES

titles of well over one hundred biomedical serial publications representing
a wide range of investigative fields begin with variations of the term
"archives."

The narrow implication of this tradition is that special repositories for
original research data are unnecessary. Several indications, however,
point to a greater realization within the biomedical research community
than in the past that measures must be taken to preserve documentation
generated by significant projects. Hedrick in 1985 offered an extensive
summary of these issues. ^o They include wider opportunities for verifica-
tion, refutation, or refinement of original results; the chance for replica-
tions with multiple data sets; encouragement of new questions and multi-
ple perspectives employing the original data; the creation of new data sets
through data file linkages; reductions in the incidence of faked and
inaccurate results; dissemination of knowledge about analytic techniques
and research designs; and the provision of expanded resources for training
of future scientists. Other authors address the possibility that some re-
searchers who have been supported by public funding may be compelled
to preserve and share their data with others. ^^

CURRENT ARCHIVAL COVERAGE OF BIOMEDICAL RESEARCH
INSTITUTIONS

Archival repositories located throughout the United States hold extensive
records of biomedical research. These records, however, almost exclu-
sively pertain to scientific investigations conducted at hospitals, federal
government-operated laboratories, and educational institutions. (See
Chapters 2, 3, and 5 for examples of major collections in these respective
categories.) Documentation of the functions of specialized biomedical
research units, by contrast, is located in relatively few repositories. In-
stances mainly reflect the academic connections of the principal investiga-
tors; an example is papers of distinguished scientists preserved in univer-
sity archives. Individual prominence has also led to the placement of
relevant collections in certain general repositories, among them the Li-
brary of Congress, the National Library of Medicine, the Smithsonian
Institution, the American Philosophical Library (Philadelphia), and the
State Historical Society of Wisconsin (Madison). The records of the Gen-
eral Education Board of the Rockefeller Foundation in the Rockefeller
Archive Center are important for their coverage of early twentieth-
century foundation support of biomedical research institutions. Rarely
has an independent nonprofit institution in the fields examined here
established its own archives, as is the case with the Cold Spring Harbor
Laboratory. The commitment to archives or discipline history on the part

NOTES 99

of specialty profit-making biomedical research enterprises is, at this writ-
ing, an unknown. A patient, persistent, and long-term investigation by a
discipline history group dedicated to biomedical research, along the lines
of the AIP or the Chemical Heritage Foundation, could yield important
information. ^2

NOTES

1. Various directories of biomedical research organizations follow significantly
different criteria in the selection and arrangement of their listings. The
Encyclopedia of Medical Organizations and Agencies (EMOA), 3rd ed. (Detroit: Gale
Research, 1990), for example, lists more than 2,500 research organizations,
including approximately 700 U.S. government research centers and programs
and approximately 1,800 university-related and other nonprofit institutions
outside of federal agencies. Entries in EMOA are divided into 69 biomedical
specialty areas, all but two of which are the focus of at least one research
center in the United States. The Research Centers Directory (RCD,) 16th ed.
(Detroit: Gale Research, 1991) covers university research centers and other
nonprofit research organizations in both the United States and Canada but
does not list the federal government agencies of either country. "Medical and
Health Sciences," the third of seventeen sections, contains almost 2,000
entries. An additional 1,000 institutions that are devoted to the basic
biomedical and behavioral sciences may be found listed in three other
sections of RCD. Commercial research institutions in the United States, which
do not appear in either of the publications just mentioned, account for about
1,800 of the entries in The Biotechnology Directory (1991 ed., J. Coombs and Y.
R. Alston, New York: Stoclcton Press, 1990).

2. Donald S. Fredrickson, "Biomedical Research in the 1980s," New England
Journal of Medicine 304 ( 1 98 1 ) : 5 1 3 .

3. Biomedical research institutions in these respects are typical of a much larger
web of institutions that cut across government, nonprofit, and industrial
lines. See Louis Galambos and Joseph Pratt, The Rise of the Corporate
Commonwealth: U.S. Business and Public Policy in the Twentieth Century (New
York: Basic Books, 1988), and Louis Galambos, ed.. The New American State:
Bureaucracies and Policies Since World War II (Baltimore: Johns Hopkins
University Press, 1987).

4. Robert Q. Marston, "Influence of NIH Policy Past and Present on the
University Health Education Complex," in H. Hugh Fudenberg and Vijaya L.
Melnick, eds.. Biomedical Scientists and Public Policy (New York: Plenum Press,
1978); Robert J. Glaser, "The Impact of Philanthropy on Medicine and
Health," Perspectives in Biology arid Medicine 36 (1992): 46-56; and George F.
Cahill, "The Role of Foundations in the Future of Medicine," Clinical and
Investigative Medicine 9, no.4 (1986): 273-77.

5. Internal Revenue Code 170A-9(b)(l)(iii).

1 00 BIOMEDICAL RESEARCH FACILITIES

6. Barbara J. Kirschten, "Obtaining Tax-Exempt Status for Medical Research
Organizations," Tax Management, Estates, Gifts, and Trusts Journal 15 (1990):
28-32.

7. Internal Revenue Code 170A-9(b)(l)(ii).

8. For official listings and program statements, see The United State Government
Manual (Office of the Federal Register, National Archives and Records
Administration, annual). See also Alice K. Dustira, "The Funding of Basic and
Clinical Biomedical Research," in Roger J. Porter and Thomas E. Malone,
eds.. Biomedical Research: Collaboration and Conflict of Interest (Baltimore: Johns
Hopkins University Press, 1992), 33-56.

9. Arthur Kornberg, For the Love of Enzymes: The Odyssey of a Biochemist
(Cambridge: Harvard University Press, 1989), 1-8, 29-31, 79-83, 121-34.

10. Information drawn in part from an information bulletin, "Mayo Graduate
School of Medicine . . . Postdoctoral Research Fellowship Programs" (Mayo
Clinic and Foundation, Rochester, Minn., 1991).

1 1 . Rosemary Stevens, In Sickness and in Wealth: American Hospitals in the Twentieth
Century (New York: Basic Books, 1989). For more information on academic
health centers, see Joan D. Krizack, "The Context for Documentation
Planning in Academic Health Centers," in Nancy McCall and Lisa A. Mix,
eds.. Designing Archival Programs to Advance Knowledge in the Health Fields
(Baltimore: Johns Hopkins University Press, 1994).

12. Christopher C. Vaughn et al., "The Contribution of Biomedical Sciences and
Technology to U.S. Economic Competitiveness," in Porter and Malone,
Biomedical Research, 57-76.

1 3. Wayne Biddle, "A Patent on Knowledge: Harvard Goes Public," Harper's, July
1981, 22-26, and Bernard D. Reams, University-Industry Research Partnerships
(Westport, Conn.: Quorum Books, 1986), 105.

14. Paul G. Waugaman and Roger J. Porter, "Mechanisms of Interactions
between Industry and the Academic Medical Center," in Porter and Malone,
Biomedical Research, 93-1 18.

15. Reams, University-Industry Research Partnerships, 105-326, devotes extensive
coverage to selected contracts.

16. Waugaman and Porter, "Mechanisms of Interactions," 1 1 1-14.

17. Richard S. Ross, "Academic Research and Industry Relationships," Clinical
and Investigative Medicine 9 (1986): 268-72, and Thomas W. Langfitt et al., eds..
Partners in the Research Enterprise: University-Corporate Relations in Science and
Technology (Philadelphia: University of Pennsylvania Press, 1983).

18. Reams, University-Industry Research Partnerships, 123-24, 146.

19. Joan K[rizack] Haas, Helen Willa Samuels, and Barbara Trippel Simmons,
Appraising the Records of Modern Science and Technology: A Guide (Cambridge:
Massachusetts Institute of Technology, 1985), although not addressing
biomedical research directly, is a substantial guide to understanding the
process and stages of scientific investigations. See especially the Table of
Scientific and Technological Activities and Their Records, 20.

20. Howard H. Hiatt, America 's Health in the Balance: Choice or Chance? (New York:
Harper & Row, 1 987), 1 56-6 1 , and William Paton, Man and Mouse: Animals in

NOTES 101

Medical Research (New York: Oxford University Press, 1984), 23-24.
Bioethicists in particular draw distinctions between therapeutic and
nontherapeutic research (or between validated and nonvalidated praaices).
See Thomas A. Mappes and Jane S. Zembaty, Biomedical Ethics, 3rd ed. (New
York: McGraw-Hill, 1991), 204-9. For the concept of clinical research placed
into international perspective, see Jacques Genest, "Modern Concept of the
Organization of Clinical Research," Clinical and Investigative Medicine 9 (1986):
256-60.

21. Quoted by James B. Wyngaarden in "The Role of Government Support in
Biomedical Research," Clinical and Investigative Medicine 9 (1986): 265-68.

22. Washington University, Division of Biology and Biomedical Sciences, Faculty
Research (catalog), 1992-1993, 1992.

23. For a broad archival survey of industries of the kind involved here, see Bruce
H. Bruemmer and^heldon Hochheiser, The High-Technology Company: A
Historical Research and Archival Guide (Minneapolis: Charles Babbage Institute,
University of Minnesota, 1989).

24. Michael Spector, "The Case of Dr. Gallo," New York Revievi' of Books, 15 Aug.
1991, 52.

25. Robert F. Jones, American Medical Education: Institutions, Programs, and Issues
(Washington, D.C.: Association of American Medical Colleges, 1992), 21.

26. Gerald F. Anderson and Catherine M. Russe, "Biomedical Research and
Technology Development," Health Affairs 6 (1987): 85-92.

27. Jones, American Medical Education, 22.

28. Philip Abelson, "Mechanisms for Evaluating Scientific Information and the
Role of Peer Review," Journal of the American Society for Information Science 41
(1990): 216-22, and Susan Crawford, Loretta Stucki, "Peer Review and the
Changing Research Record," ibid., 223-28.

29. Virginia P. White, Handbook of Research Laboratory Management (Philadelphia:
ISl Press, 1988), 18-20.

30. Carl Frieden and Barbara J. Fox, "Career Choices of Graduates from
Washington University's Medical Scientist Training Program," Academic
Medicine 66, no.3 (1991): 162-64.

31. White, Research Laboratory Management, 46-58.

32. Waneta C. Tuttle et al., "Considerations of Managing Large-Scale Clinical
Tx\a\s," Journal of the Society of Research Administrators 2\, no. 2 (1989): 13-
22.

33. It does not always follow that well-funded investigations use the best
equipment. A National Science Foundation study in the early 1980s revealed
that less than 20 percent of existing apparatus used in academic research in
the biological and medical sciences was state of the art. Many buildings and
laboratory facilities erected in the early days of NIH funding (the late 1940s to
the early 1960s), moreover, urgently need modernization. See E. Jill Hurt,
ed.. Health Policy Agenda for the American People {Chicago: Health Policy Agenda
for the American People, 1987), 2: 1 57.

34. Laurence M. Friedman, Curt D. Furberg, and David L. DeMets, Fundamentals
of Clinical Trials (Littleton, Mass.: PSG, 1985); Stuart F. Spicker, The Use of

1 02 BIOMEDICAL RESEARCH FACILITIES

Human Beings in Research: With Special Reference to Clinical Trials (Boston:
Kluwer, 1988); and Tuttle et al., "Large-Scale Clinical Trials."

35. Paul Appelbaum, Charles W. Lidz, and Alan Meisel, Informed Consent: Legal
Theory and Clinical Practice (New York: Oxford University Press, 1987), 211-
19; Ruth Faden, Tom L. Beauchamp, and Nancy M. P. King, A History and
Theory of Informed Consent (New York: Oxford University Press, 1 986), 1 5 1-87;
and David J. Rothman, Strangers at the Bedside: A History of How Law and
Bioethics-Transformed Medical Decision Making (New York: Basic Books, 1 99 1 ).

36. David L. Wheeler, "Informed Consent Questioned in Research Using
Humans," Chronicle of Higher Education, 4 Dec. 1991, A 14.

37. Code of Federal Regulations, Title 45, pt. 46, Protection of Human Subjects,
revised March 8, 1983. The portions of the Code that specify how institutional
review boards (IRBs) are to be established and operated include the following:
"Each IRB shall have at least five members, with varying backgrounds to
promote complete and adequate review of research activities commonly
conducted by the institution. The IRB shall be sufficiently qualified through
the experience and expertise of its members, and the diversity of the
members' backgrounds including consideration of the racial and cultural
backgrounds of members and sensitivity to such issues as community
attitudes, to promote respect for its advice and counsel in safeguarding the
rights and welfare of human subjects." A subsequent part of the same seaion
of the regulation indicates that each IRB shall include "at least one member
whose primary concerns are in nonscientific areas (45 CFR 46. 1 07) ." See also
Applebaum et al.. Informed Consent, 219-28.

38. Two institutions at the Washington University Medical Center illustrate
situations of this nature: Barnard Free Skin and Cancer Hospital, a research
hospital in St. Louis that was originally independent, merged with the
university in 1950 and lost its autonomy in patient care four years later, when
it moved to the medical center campus. Barnard now functions as an
endowed research and treatment program of the university medical school
and Barnes Hospital, the center's principal teaching hospital. In 1992,
Mallinckrodt Institute of Radiology, the clinical treatment arm of the
university's radiology department, transferred most of its patient services at
Barnes Hospital to the hospital administration in the interests of simplifying
billing procedures, as required by Medicare and commercial insurers.

39. Archival readers are advised that the research world ineluctably uses the term
manuscript almost exclusively in this context.

40. Arnold S. Relman, "Medical Research, Medical Journals, and the Public
Inieresi," Journal of the Society of Research Administrators 2\, no. 2 (1989): 7-12;
Abelson, "Evaluating Scientific Information"; and Crawford and Slucki,
"Peer Review."

41. White, 1988, 140^7.

42. Joan Warnow-Blewetl, "Saving the Records of Science and Technology: The
Role of a Discipline History Center," Science and Technology Libraries 7 (1987):
29-40; "The Role of a Discipline History Center, Part II: Promoting Archives

NOTES 1 03

and Research in Science and Technology," Science and Technology Libraries 9
(1988-89): 85-102. See also AIP, AIP Study of Multi-Institutional Collaborations:
Phase I: High Energy Physics (New York: AIP, Center for History of Physics,
1992) issues of the AIP History Newsletter, 1989-present, that describe a long-
term study of interinstitutional collaborations in physics and allied sciences.

43. U.S. Department of Health and Human Services, U.S. Department of Energy,
Understanding Our Genetic Inheritance, the U.S. Human Genome Project: The First
Five Years, FY I99I-I995 (Washington, D.C.: Government Printing Office,
1990); and John Beatty and Elizabeth E. Sandager, "Documenting the
Human Genome Project: Challenges and Opportunities," draft report. History
of Science Society, 1992.

44. U.S. Department of Health and Human Services, Understanding Our Genetic
Inheritance, and unpublished communication with David Lipman, NCBI, and
Susan Crawford, Washington University School of Medicine Library.

45. The Chemical Heritage Society publishes a quarterly newsletter. Chemical
Heritage (formerly The Beckman Center for Chemistry News); unpublished
communication with Susan Lindee and Elizabeth E. Sandager, Chemical
Heritage Foundation; Doris Mueller Goldstein, National Reference Center for
Bioethics Literature, Georgetown University, 1990-1991; Elizabeth E.
Sandager, "Report on Los Alamos Exploratory Site Visit," on behalf of the
Chemical Heritage Foundation, unpublished, 1992. Other prominent efforts
to document the human genome project are led and coordinated by Victoria
A. Harden of the NIH Historical office.

46. For a comprehensive account of the "cancer wars," see James T. Patterson,
The Dread Disease: Cancer and Modern American Culture (Cambridge: Harvard
University Press, 1987).

47. The actual total, suggested by EMOA and RCD, would fall between 400 and 500.

48. Brian Jay Yolles, Joseph C. Connors, and Seymour Grufferman, "Obtaining
Access to Data from Government-Sponsored Medical Research," New England
Journal of Medicine 315 (1986): 1669-72.

49. Relman, "Medical Research, Medical Journals, and the Public Interest."

50. Terry E. Hedrick, "Justifications for and Obstacles to Data Sharing," in
Stephen E. Fienberg, Margaret E. Martin, and Miron L. Straf, eds.. Sharing
Research Data (Washington, D.C.: National Academy Press, 1985), 123-47.
See also Jane Williams, "The Importance of Preserving Scientific Data," in
McCall and Mix, eds.. Designing Archival Programs.

51. Joe Shelby Cecil and Eugene Griffin, "The Role of Legal Policies in Data
Sharing," in Fienberg et al.. Sharing Research Data; Cecil and Robert Boruch,
"Compelled Disclosure of Research Data: An Early Warning and Suggestions
for Psychologists," Law and Human Behavior 12 (1988): 181-89; and Yolles
et al., "Obtaining Access to Data."

52. David Bearman and John T. Edsall, eds.. Archival Sources of the History of
Biochemistry and Molecular Biology: A Reference Guide and Report (Boston:
American Academy of Arts and Sciences, 1980), is still the most complete
guide to existing archival collections from biomedical research institutions.

1 04 BIOMEDICAL RESEARCH FACILITIES

SELECT ANNOTATED BIBLIOGRAPHY

Abelson, Philip. "Mechanisms for Evaluating Scientific Information and the Role
of Peer Review." Journal of the American Society for Information Science 41
(1990): 216-22. Examines the effects of the "publish or perish" syndrome on
research publication and discounts reports of widespread fraud.

American Institute of Physics, Center for History of Physics. AIP Study of Multi-
Institutional Collaborations, Phase I: High-Energy Physics. New York: American
Institute of Physics, 1992. An enormously valuable model for any scientific
discipline history project; divided into reports (no. 1: "Summary and Recom-
mendations"; no. 2: "Documenting Collaborations"; no. 3: "Catalog of Se-
lected Historical Materials") by various authors, principally Joan Warnow-
Blewett (see also below).

Bearman, David, and John T. Edsall, eds. Archival Sources of the History of Biochemis-
try and Molecular Biology: A Reference Guide and Report. Boston: American
Academy of Arts and Sciences, 1980. A classic survey of archival holdings in
key biomedical sciences.

Bruemmer, Bruce H., and Sheldon Hochheiser. The High-Technology Company: A
Historical Research and Archival Guide. Minneapolis: Charles Babbage Institute,
University of Minnesota, 1989. Describes the research function and its activi-
ties in high-technology companies.

Cahill, George F. "The Role of Foundations in the Future of Medicine." Clinical
and Investigative Medicine 9, no. 4 (1986): 273-77. Sees a slow decline in
philanthropic support for biomedical research, made up in part by academic-
private sector contracts.

Frederickson, Donald S. "Biomedical Research in the 1980s." Nevi' England Journal
of Medicine 304 (1981): 509-17. The title notwithstanding, a good short
history of biomedical research before the decade began.

Friedman, Lawrence M., et al. Fundamentals of Clinical Trials, 2nd ed. Littleton,
Mass.: PSG Publishing Co., 1985. A comprehensive and clearly written intro-
duction to a basic methodology.

Fudenberg, H. Hugh, and Vjaya L. Melnick, eds. Biomedical Scientists and Public
Policy. New York: Plenum Press, 1978. A collection of essays on problems and
issues in public funding of research.

Haas, Joan K[rizack], Helen Willa Samuels, and Barbara Trippel Simmons. Ap-
praising the Records of Modern Science and Technology: A Guide. Boston: Massa-
chusetts Institute of Technology, 1 985. An overview of documentation gener-
ated in the various stages of scientific and technological research (although,
with few specific references to biomedicine); well organized and illustrated.

Hedrick, Terry E. "Justifications for and Obstacles to Data Sharing." In Sharing
Research Data, edited by Stephen E. Fienberg, Margaret E. Martin, and Miron
L. Straf. Washington, D.C.: National Academy Press, 1985. Finds little reliable
information about scientific data sharing; advocates careful cost-benefit anal-
ysis.

Hiatt, Howard H. America's Health in the Balance: Choice or Chance? New York:

SELECT ANNOTATED BIBLIOGRAPHY 1 05

Harper & Row, 1987. Chapter 10, "Biomedical Research," advocates taxing
all health-related goods and services to fund scientific investigations.

Institute of Medicine, Division of Health Sciences Policy, Committee on the
Responsible Conduct of Research. The Responsible Conduct of Research in the
Health Sciences. Washington, D.C.: National Academy Press, 1989. Examines
issues related to biomedical research fraud; proposes ways of encouraging
ethical standards without stifling research freedom and creativity.

Langfitt, Thomas W., et al., eds. Partners in the Research Enterprise: University-
Corporate Relations in Science and Technology. Philadelphia: University of Penn-
sylvania Press, 1983. Proceedings of a national conference on university-
corporate relations in science and technology held at the University of Penn-
sylvania in 1982.

Porter, Roger J., and Thomas E. Malone, eds. Biomedical Research: Collaboration and
Conflict of Interest. Baltimore: Johns Hopkins University Press, 1992. Analyzes
problems of biomedical research funding, especially academic-industrial part-
nerships, from a university perspective.

Reams, Bernard D. University-Industry Research Partnerships. Westport, Conn.:
Quorum Books, 1986. An extensive historical and legal analysis, illustrated
by appendices containing the texts of four landmark contracts, three of which
concern biomedical research.

Relman, Arnold S. "Medical Research, Medical Journals, and the Public Interest."
Journal of the Society of Research Administrators 21(1 989) : 7-12. The former
editor of the New England Journal of Medicine discusses the mechanics of
peer-reviewed journals and argues that most substantive findings in biomedi-
cal research are published.

."What Is Clinical Research?" Clinical Research 9, no. 3 (1961): 516-18. A

brief historical review.

Ross, Richard S. "Academic Research and Industry Relationships." Clinical and
Investigative Medicine 9, no. 4 (1986): 269-72. Argues that, overall, academic-
industrial partnerships are worth the risks.

Rothman, David J. Strangers at the Bedside: A History of How Law and Bioethics

Transformed Medical Decision Making. New York: Basic Books, 1991. Chapter 5,
"New Rules for the Laboratory," explores problems in research ethics, espe-
cially involving human subjects, and bureaucratic responses from the NIH
and the Food and Drug Administration.

Strickland, Stephen P. The Story of the NIH Grants Programs. Lanham, Md.: University
Press of America, 1988. A short monograph in eleven chapters, covering
developments from Public Health Service-funded research in the 1 930s to NIH's
growing pains of the later 1960s, with a few cursory glances at events since then.

Swann, John P. Academic Scientists and the Pharmaceutical Industry: Cooperative
Research in Twentieth-Century America. Baltimore: Johns Hopkins University
Press, 1988. Traces cooperative biomedical research partnerships between
universities and industry back to the 1920s; includes classic case studies, such
as the collaboration of the Banting group at the University of Toronto with Eli
Lilly in the discovery of insulin.

1 06 BIOMEDICAL RESEARCH FACILITIES

Warnow-Blewett, Joan. "Saving the Records of Science and Technology: The Role
of a Discipline History Center." Science and Technology Libraries 7 (1987):
29-40; "The Role of a Discipline History Center, Part II: Promoting Archives
and Research in Science and Technology." Ibid. 9 (1988-89): 85-101. These
articles discuss the development of programs at the Center for the History of
Physics of the American Institute of Physics, especially strategies for selection
and archival placement of key research documentation. (See also citation
under American Institute of Physics.)

Wyngaarden, James B. "The Role of Government Support in Biomedical Re-
search." Clinical and Investigative Medicine 9, no. 4 (1986): 265-68. A brief
sketch of the "panorama of national support for health research and develop-
ment in the United States."

CHAPTER 5

Educational Institutions and
Programs for Health Occupations

NANCY McCALL AND LISA A. MIX

OVERVIEW OF INSTRUCTIONAL PROGRAMS
IN THE HEALTH FIELDS

A broad range of instructional programs provide students with the requi-
site knowledge, skills and credentials for occupations in the health fields.
Academic preparation for these occupations is designed to instill in stu-
dents specialized knowledge, problem-solving skills, and responsible
modes of professional conduct. The functions of these instructional pro-
grams are, therefore, to provide intellectual, technical, and practical train-
ing of the various disciplines.^ Although the programs focus on tradition
and established standards, they are not immutable. Each generation of
graduates brings a cycle of change through fresh insights and new ap-
proaches to their respective professions.

Instructional programs for occupations in the health fields occupy a
unique place in the U.S. educational system. Whereas the controls for
most instructional programs for other occupations are determined largely
by the institutions in which they are based, the controls for instructional
programs in the health fields are almost always defined outside their
immediate institutional setting. Because most institutional programs in
the health fields interface with practical training that involves patients and
human subjects, they are more tightly controlled by legislative bodies
(both state and national) and voluntary and professional associations.
Institutions with instructional programs for occupations in the health
fields must comply with a vast and complex array of external legislation,
regulatory requirements, and professional standards of various disciplines

107

1 08 EDUCATIONAL INSTITUTIONS AND PROGRAMS FOR HEALTH OCCUPATIONS

in the health professions and related sciences and also the biological
sciences/life sciences.

Because these outside controls change frequently and rapidly to
accommodate new developments in the health fields, they bring regular
and fast-paced change to instructional programs for health-related occu-
pations. Because instructional programs in the arts and humanities and
other related fields have fewer outside controls, they usually are not
compelled to adopt uniform requirements, revise curriculum, or reform
standards as often as instructional programs in the health fields. As a
result, the core requirements for instructional programs in these other
fields tend to vary on a national basis from institution to institution. By
contrast, the core requirements for instructional programs in the health
fields have greater uniformity throughout the country from institution to
institution. Because of the many external pressures to keep current,
instructional programs in the health fields are among the most pro-active
and highly energized programs in American higher education.

Instruction for occupations in the health fields occurs mainly in two
types of institutional setting^: educational institutions (colleges, universi-
ties, and postsecondary vocational institutions) and health care delivery
facilities. In many cases, reciprocal arrangements exist between these two
types of institution. In the instance of instructional programs that are
based at educational institutions, a significant portion of the clinical
teaching and training usually occurs in health care delivery facilities.
However, much of the teaching activities of instructional programs that
are based in health care delivery facilities are conducted at these institu-
tions. Usually, the faculty for these programs are from an affiliated educa-
tional institution. These joint programs entail considerable administrative
cooperation, both formal and informal. Because the records of these types
of program span two or more institutional settings, archivists from the
institutions involved should be prepared to collaborate in their documen-
tation planning efforts. Major sites that combine institutions of higher
education with health care delivery facilities are known as academic
medical centers or academic health centers. At these centers the functions
of health care delivery, education, and research are highly integrated. In
some instances interinstitutional archival programs have been established
at academic medical centers. For example, the archives of the Johns
Hopkins Medical Institutions encompass the university health divisions
(School of Medicine, University School of Nursing, School of Hygiene and
Public Health, Welch Medical Library) and the Johns Hopkins Hospital.

Educational degree programs and training certificate programs are the
two basic program tracks in the health fields. Degree programs are based
largely in educational institutions with practical training components in

OVERVIEW OF INSTRUCTIONAL PROGRAMS IN THE HEALTH FIELDS 1 09

health care delivery facilities. Training certificate programs may be based
in either educational institutions or health care delivery facilities. Certifi-
cate programs in educational institutions are usually affiliated with health
care delivery facilities, enabling students to receive practical training.

Degree programs are more comprehensive in terms of the amount of
intellectual preparation and extent of practical training than certificate
programs; they take longer for students to complete and are more costly
for institutions to run. The fee for tuition in degree programs is generally
significantly higher than in certificate programs.' However, the high
tuition costs of professional degree programs usually yield greater long-
term returns because graduates of these programs generally attain the
most autonomous and highly paid occupations in the U.S. health care
system, while graduates of certificate programs are usually limited to
subsidiary and lower-paid occupations.

Because most degree and certificate programs for occupations in the
health fields require both theoretical study and practical training, they are
most often conducted in dual settings — in educational institutions and in
health care delivery facilities. Theoretical studies are usually conducted at
educational institutions, while supervised practical training is held at
health care delivery facilities.

The practical training component is an especially critical part of
academic preparation for the health occupations. Learning how to per-
form many clinical and technical applications can only be accomplished
through the practice of doing. The experience of practical training also
affords students opportunities to apply problem-solving skills by confront-
ing the uncertainties of clinical practice in a supervised setting. Thus, in
the health fields learning by doing brings the concept of practice to the
formalism of higher education.

Instructional programs for occupations in the health fields are strin-
gently regulated and highly standardized at the program level rather than
at the institutional level. External forces from the public and private
sectors play a greater role than institutional policy in determining the
scope and standards of these programs. Professional educational and
health care associations in the private sector usually take the lead in
setting program standards and codes of professional conduct; legislative
bodies and governmental agencies, however, are primarily responsible for
adopting laws and regulations and for monitoring compliance to them.
The regulatory controls for instructional programs in the health fields
frequently contain special implications for archivists. Often they include
stipulations about the management and preservation of particular docu-
mentation. Although a central administration division such as the regis-
trar's office or academic affairs section usually administers institutional

1 1 EDUCATIONAL INSTITUTIONS AND PROGRAMS FOR HEALTH OCCUPATIONS

compliance with external regulatory controls, archivists frequently bear
responsibilities for managing the long-term retention and use of this
documentation. As part of their documentation planning efforts for in-
structional programs in the health fields, archivists need to work carefully
with registrars or other appropriate administrators to identify the docu-
mentation that must be designated for long-term preservation. Documen-
tation of the credentials earned by students at these institutions is of
particular importance.

A symbiotic relationship exists between these instructional programs
and current needs in the health fields. As requirements for occupational
practice change, corresponding changes are usually also made in the
curriculum of the programs. For instance as the Clinton administration
presses for more general practitioners, medical schools are re-assessing
their curriculum with this in mind. Many of the same professional associa-
tions, governmental agencies, and legislative bodies that regulate occupa-
tional practices in the health fields also regulate the instructional pro-
grams for these occupations. These external controls function as a means
of compelling the programs to keep pace with change. The literature
published by the professional associations and governmental agencies that
regulate occupations and instructional programs in the health fields is an
especially useful information resource for archivists. As a rule, it provides
specific details about program and occupational requirements at the same
time it presents an overview of the intellectual and technical scope of the
programs and occupations.

Because instructional programs in the health fields must constantly
revise and upgrade curricula and standards, they are among the most
forward-looking and innovative programs in postsecondary education.
They are incubators for new ideas in education as well as in health care
delivery and research. Much basic research in the health, life, and biologi-
cal sciences is conducted in conjunction with instructional programs, and
the programs are often testing grounds for new policies, practices, and
materials in the health fields.

TYPES OF INSTITUTION WITH INSTRUCTIONAL PROGRAMS FOR
OCCUPATIONS IN THE U.S. HEALTH CARE SYSTEM

The types of educational and training institution for occupations in the
U.S. health care system are as varied as the occupations that are part of it.
The two major types of institution, educational institutions and health
care delivery facilities, can be broken down into the following categories:

TYPES OF INSTITUTION WITH INSTRUCTIONAL PROGRAMS 111

Educational Institutions

• Universities

• Colleges (two-year and four-year)

• Vocational and technical schools

Health Care Delivery Facilities

• Hospitals

• Others (e.g., hospices, health maintenance organizations,
nursing homes)

EDUCATIONAL INSTITUTIONS

Instruction for health care occupations takes place in most types of
institutions of higher education, as well as in vocational and technical
institutions. Universities generally offer a broad range of programs,
through the doctoral degree in varying configurations of professional and
research fields; most universities give high priority to research. Colleges
offer associate and baccalaureate degrees in the liberal arts or occupational
fields; many two-year colleges provide a variety of certificate programs,
and four-year colleges often conduct master's degree programs in such
fields as nursing. Vocational and technical schools offer certificate programs
and, in some cases, associate of arts degrees, leading to employment in the
ancillary health care occupations.

Educational institutions with instructional programs for the health
care professions fall into two broad groups: general educational institu-
tions with specialized programs for the health occupations, and specialized
institutions geared specifically to instruction in health care occupations.
The most comprehensive example of a general educational institution is a
university. Universities may administer any combination of professional
schools (such as schools of medicine, nursing, public health, veterinary
medicine, and dentistry), graduate and undergraduate degree programs,
and paraprofessional training programs. Colleges are also general educa-
tional institutions that have instructional programs for health care occu-
pations. Thus, archivists of many educational institutions are responsible
for the records of instructional programs for health care occupations. The
records of some publicly supported educational institutions, however, are
sometimes under the jurisdiction of public archives.

Educational and training institutions that specialize in the health care
occupations include junior colleges, professional schools, and vocational
and technical schools. The Central Maine Medical Center School of Nurs-
ing and the Forsyth School for Dental Hygienists in Massachusetts are
examples of two-year colleges that train students specifically for health

112 EDUCATIONAL INSTITUTIONS AND PROGRAMS FOR HEALTH OCCUPATIONS

care occupations. Professional schools in chiropractic, nursing, pharmacy,
and optometry, as well as a few medical schools, exist as freestanding
professional schools or specialized institutions. Meharry Medical College
and the Philadelphia College of Osteopathic Medicine are examples of
freestanding medical schools and medical centers; the Massachusetts
College of Pharmacy and Allied Health Sciences and the Southern College
of Optometry are examples of schools for related and ancillary health
occupations; and the National Education Center, with locations around
the country, is an example of a vocational/technical school.

HEALTH CARE DELIVERY FACILITIES

Although their primary function is patient care, hospitals, and to a lesser
extent other health care delivery facilities, also play an important role in
educating individuals for occupations in the health fields. Some instruc-
tional programs for nurses, physician assistants, and technicians are hospi-
tal-based. Medical internship and residency programs are usually admin-
istered by hospitals, although the physicians in charge of those programs are
members of the medical school faculty. Most programs based in institutions
of higher education, such as those for medicine, nursing, and physical
therapy, include clinical experience in a hospital, clinic, or ambulatory care
facility. The parts of the curriculum that provide clinical experience for
medical students are referred to as clinical clerkships. Hospices, nursing
homes, and health maintenance organizations also serve as sites for stu-
dents' practical experience. Although these other health care delivery facili-
ties have traditionally played a lesser role than hospitals in training health
care professionals, the trend is beginning to reverse.

Administrative relationships between educational or training institu-
tions and health care delivery facilities vary. The Council of Teaching
Hospitals identifies three levels of affiliation between hospitals and medical
schools. Graduate indicates that the hospital is used by the school for
graduate training programs only (i.e., for interns, residents, and fellows who
have completed the M.D. degree). M^/or affiliation signifies that the hospital
is an important part of the teaching program of the medical school, is a
major unit in the clinical clerkship program for medical students, and
participates in any graduate medical education program of the medical
school. Limited affiliation with a medical school indicates that the hospital is
used in the school's teaching program only to a limited extent.'^ Almost all
limited affiliations are for instructing residents and fellows only. Most
medical schools have a major affiliation with one teaching hospital and have
graduate or limited affiliation with other hospitals. Table 5-1 shows the
intersection of institutions and degree programs.

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114 EDUCATIONAL INSTITUTIONS AND PROGRAMS FOR HEALTH OCCUPATIONS

HISTORICAL PERSPECTIVE

THE INSTITUTIONALIZATION OF EDUCATION IN THE HEALTH FIELDS

The institutionalization of education and training for occupations in the
health fields is a relatively recent phenomenon. For centuries, individual
apprenticeship was the primary means of preparation for these occupa-
tions. In the United States during the eighteenth and nineteenth centuries
the process of apprenticeship was gradually formalized under the aegis of
special courses and placed in institutional settings, mainly hospitals and
educational institutions. Preparation for the health occupations thus en-
tered the realm of higher education.

For most of the nineteenth century, medical, dental, pharmacy, and
veterinary schools were proprietary institutions that emphasized the prac-
tical elements of their professions. The faculty mainly included commu-
nity practitioners whose teaching activities were secondary to their prac-
tices. Teaching consisted for the most part of lectures to large numbers of
students. 5

As progressive new approaches to teaching and research in medicine
and the biological sciences evolved in Europe, many American medical
students and physicians traveled to European universities and research
institutes to study. When they returned, they brought a spirit of reform
and new ideas. Many of these European-trained physicians joined the
faculties of the leading medical schools and led the revision of curriculum
to incorporate more laboratory instruction, direct participation of students
in patient care under faculty supervision, and the teaching of new discov-
eries in bacteriology and other medical sciences. The widespread publicity
given to medical advances and discoveries in bacteriology made medical
students eager to learn about them. Popular demand for the most current
medical knowledge in conjunction with the introduction of higher educa-
tional standards gradually forced all medical schools either to adopt
curriculum reform or be faced with closure owing to declining enroll-
ments and rising expenses.^

Despite the promising beginning of nursing education with the intro-
duction of the Nightingale model, the rigor of the nursing curriculum
declined as hospitals assumed control of nursing schools. In hospital-
based schools the service needs of the hospital frequently took precedence
over formalized studies. In many instances nursing students became little
more than a source of cheap labor for the hospitals in which their schools
were based. ^

The introduction of European teaching models eventually helped to
raise the quality of medical, dental, pharmacy, and veterinary education
in the United States during the ninteenth century. The trend toward

HISTORICAL PERSPECTIVE 115

formalizing education in these fields was further enhanced at the turn of
the century. Various legislative movements that were directed toward
establishing more rigorous standards for health care practice sprang up at
both the state and national levels. The passage of new laws and regula-
tions covering practice in health care had great impact on instructional
programs.^

Hospitals, schools, colleges, and universities were compelled to im-
prove instructional programs to prepare students for licensing and certifi-
cation procedures. Institutions that produced poorly prepared graduates
who failed to obtain a license or certification for practice were eventually
affected economically by the loss of students. These institutions either had
to close or radically revise their educational and training procedures to
meet changing standards because prospective practitioners sought to
attend institutions that would best prepare them for licensing and board
certification. The tightening of licensing and certification procedures
eventually made the educational and training process much more com-
petitive.

Authority over professional education gradually passed to the profes-
sional societies. For example, the Council on Medical Education of the
American Medical Association (AMA) began to accredit medical schools in
1905. Subsequently, most states began to restrict licensure to practice
medicine to graduates of AMA-accredited schools. The council gradually
raised the standards for accreditation, which contributed to the drop in the
number of medical schools from over 160 in 1900 to 86 in 1920.^

The medical department of the College of Philadelphia was the first
American medical school to be established. Founded in 1765, it was based
largely on the model of the University of Edinburgh. ^o In 1821 the first
American school of pharmacy, the Philadelphia College of Pharmacy, was
founded. ^^ Formalized, institution-based dental education also had its
beginnings in the early part of the nineteenth century. In 1825 the first
dental school in North America was established in Bainbridge, Ohio;
however, the Baltimore College of Dental Surgery, which opened in 1840,
actually was the prototype for dental education in the United States.'^ In
1855 the Boston Veterinary Institute, the first veterinary college, was
established.^^ Toward the end of the nineteenth century, in 1873, the first
school of nursing in the United States was established at Bellevue Hospital
in New York City. An independent institution modeled after Florence
Nightingale's educational specifications, the Bellevue school was organ-
ized and administered by a board that had no ties to the hospital. ^"^ Public
health did not exist as a profession until the early part of the twentieth
century. Although public health courses had been an occasional part of
the curriculum of medical, nursing, and dental schools, the first formal-

116 EDUCATIONAL INSTITUTIONS AND PROGRAMS FOR HEALTH OCCUPATIONS

ized school of public health was established in 1916 at the Johns Hopkins
University through an appropriation from the Rockefeller Foundation.'^

EXPANSION OF EDUCATIONAL PROGRAMS IN THE HEALTH FIELDS

Both the number and the kinds of instructional programs for occupations
in the U.S. health care system have grown significantly since 1950.
Although their increase can be attributed partly to the overall growth in
higher education, it has largely resulted from the expansion of occupa-
tions within the health sciences and health care delivery and the need to
develop corresponding educational programs. The broadening of health
care delivery throughout the population, along with the rise of research in
the health sciences, has led to a general increase in the number of
personnel working in the health fields. Transformations in research and
patient care, especially the use of the team approach, have in turn
engendered many new occupations.

One hundred years ago, patient care consisted largely of the ministra-
tions of individual practitioners of widely varying qualifications. The
primary practitioners included physicians, nurses, midwives, apothecar-
ies, and even ministers and veterinarians. In urban areas with many
well-qualified practitioners, physicians led patient care activities, while
other types of practitioner assumed secondary roles. In remote rural areas
where trained physicians were scarce, however, midwives, nurses, apoth-
ecaries, and, in some instances, veterinarians frequently assumed the role
of the primary health providers. Most of these practitioners made house
calls and maintained offices in which they treated patients.

Today, by contrast, large teams of health care professionals are involved
in treating individual patients, requiring the site of patient care to be moved
from homes and practitioners' offices to hospitals and other health care
delivery facilities. Another factor in this shift to treating patients in hospitals
has been the ascending importance of the clinical laboratory in diagnosis
and treatments. Physicians need, for example, x-rays and blood chemistry
tests to properly diagnose and treat patients. A contemporary health care
delivery team includes as many as twenty or thirty highly specialized
workers from a variety of occupations. A physician specialist usually serves
as the "captain" of the team, which consists of other physician specialists,
nurses, technicians, therapists, and so on. New, specialized occupations in
nursing, technical assistance, and ancillary care have evolved largely in
conjunction with the expansion of diagnostic and therapeutic procedures,
the enactment of new social and economic policies, and new approaches to
the distribution of responsibility in patient care. Fundamental changes in
health care practice have led to the creation of criteria and standards for

HISTORICAL PERSPECTIVE 117

many of these new occupations. Events such as wars, civil unrest, and
national disasters have also contributed to changes in patient care. For
example, new modes of triage and emergency health services have been
developed in military interventions and rescue operations. In addition social
and economic factors, such as nursing shortages, have helped bring about
new health care occupations.

Scientific research in the health fields, like scientific research in
general, has evolved from the work of lone investigators in solitary
laboratory settings to large collaborative projects that are intra- and
interinstitutional, interdisciplinary, national, and international in scope. A
century ago leading scientists primarily worked alone or with a small staff
in one laboratory. Today scientists in the vanguard serve as principal
investigators of collaborative networks of research teams that span vari-
ous institutions and include a broad cross section of occupations. These
large-scale collaborative approaches have now become the norm for
research in the health fields.'^

The team approach to scientific research and patient care has special
implications for higher education. In the past fifty years, the introduction
of many new occupations in the health fields has had a major impact on
post-secondary educational institutions in the United States. At the same
time that existing postsecondary educational institutions have expanded
instructional programs to accommodate changing occupations in the
health fields, new types of specialized educational institutions have
evolved. The number of vocational schools specializing in the health
technologies and the number of community colleges with programs for
ancillary health occupations have greatly increased.

The AMA, the American Dental Association, and several specialty
societies have largely been responsible for initiating certificate and degree
programs in the new allied health occupations at a variety of institutions.
Professional organizations in the fields of radiology and pathology in
particular have taken the lead in developing certificate programs for allied
health personnel in their respective fields. Professional, undergraduate,
and graduate schools have introduced many more specialized degree
programs in the health fields at the bachelor's, master's and doctoral
degree levels.

Early in the twentieth century, educational institutions specializing in
the health fields also became more involved in research. In the post-
World War II years, the federal government, largely through the National
Institutes of Health, allocated vast and unprecedented amounts of funding
for conducting research and training research personnel in the health
fields. With the infusion of postwar funding came major new incentives
for research at educational institutions and health care delivery facilities.

118 EDUCATIONAL INSTITUTIONS AND PROGRAMS FOR HEALTH OCCUPATIONS

Institutions with instructional programs in the health fields expanded
both physically and intellectually to accommodate these funding opportu-
nities. Special components for research evolved at the departmental level
in the basic and applied clinical sciences divisions. Eventually these insti-
tutions became centers for research in addition to being centers for
education and patient care.

The factors that have been most responsible for altering the occupa-
tions in the health fields have also had the greatest influence on changing
educational institutions and instructional programs in the health fields.
Advances in science and technology, the rise of ancillary care, reliance on
technology in both research and patient care, the introduction of third-
party reimbursement for health services, heightened social and economic
concerns, grant and contractual funding for research, and tighter regula-
tory controls are among the key factors that have transformed not only
the occupations but also the instructional programs in the health fields.
These factors have contributed to the increase in and the diversity of
occupations and programs.

From the middle to the latter part of the twentieth century, develop-
ment in instructional programs has been commensurate with major
changes in the health care system. As the activities of health care have
expanded in scope and become more highly specialized, instructional pro-
grams have had to keep in close step. Programs in ancillary and technologi-
cal training have increased significantly over the past two decades. At the
same time, graduate specialization in the health, social, biological, and life
sciences has been on the rise. Within schools of nursing, dentistry, phar-
macy, and public health, programs now range from the paraprofessional to
the doctoral levels, and schools of medicine are establishing doctoral pro-
grams in some life and biological sciences fields. Many of these educational
institutions have also added programs in health policy, finance, and admin-
istration. In the latter part of the twentieth century, legislation and govern-
mental funding continue to have a significant impact on instructional
programs in the health fields. The passage of the Medicare Act in 1965
opened the door for many new occupations, and the equal opportunity
legislation of the past three decades has afforded many new educational
opportunities to ethnic minorities, women, the economically underprivi-
leged, and the physically challenged.

The complexities and costs of late twentieth-century health services
have led to demands for more intensive quality and cost controls. As a
result, several new disciplines have emerged in the following areas: health
policy and planning, health economics, health services research, and
health administration. These highly technical areas of specialization play
an increasingly important role in the activities of organizing, financing.

CLASSIFICATION OF OCCUPATIONS IN THE U.S. HEALTH CARE SYSTEM 119

and regulating the health fields. Various programs in these disciplines
have arisen at the master and doctoral levels in educational institutions
including schools of public health, business schools, and schools and
departments of public policy, economics, and administration.

The social sciences have also had a major impact upon the health
professions. In the past fifty years, many new occupations that emanated
from the social sciences have evolved in the health fields. Professional
specialization has largely occurred in the following areas: health behavior,
ethics, history of health care, social determinants of health, social analysis
of health care, environmental health, environmental engineering, occu-
pational health, international health, and health education. Archivists
need to be aware of the importance of documenting these educational
programs because these new disciplines are playing a strategic role in
shaping the present and future directions of the health fields. ^^

Despite the concentrated institutionalization of education and train-
ing in the health occupations, individual instructional programs are still
largely controlled by external forces — by professional, educational, and
medical associations, legislative bodies, and governmental agencies. As in
the earlier apprenticeship tradition, professional health associations func-
tion somewhat as the medieval guilds did in defining criteria and setting
standards for skilled work and ethics of practice; they establish the criteria
for each field's specialized educational requirements.^^ Legislative bodies
and governmental agencies represent the public interest by defining the
suitability of these programs and monitoring their compliance with edu-
cational standards and regulations.

Because the incorporation of instruction with patient care can in some
instances raise the cost of care, many health care delivery facilities have
resisted or severed affiliations with instructional programs and educa-
tional institutions. Health care reforms that emphasize cost containment
may require that new sources of funding be found for the practical
training of health care professionals.

CLASSIFICATION OF OCCUPATIONS IN THE U.S. HEALTH CARE
SYSTEM

The U.S. Department of Labor has defined sixteen broad areas in which
most health care occupations are clustered. (See Table 5-2.) Three basic
types of occupation can be found in each of these categories:

1 . Service occupations deal primarily with the delivery of technical and
clinical services.

1 20 EDUCATIONAL INSTITUTIONS AND PROGRAMS FOR HEALTH OCCUPATIONS

TABLE 5-2 Areas in which most of the health care occupations are clustered

Clinical laboratory services

Dentistry

Dietetics and nutrition

Education

Health information and communication

Health services administration

Medicine

Nursing

Pharmacy

Psychology

Science and engineering

Social work

Technical instrumentation

Therapeutic Services

Veterinary medicine

Vision care

Source: Data from U.S. Department of Labor, Employment and Training Administration; and
U.S. Department of Healtfi, Education, and Welfare, Health Resources Administration.
Health Careers Guidebook (Washington, D.C.: U.S. Department of Labor, 1979)

2. Educational and research occupations deal primarily with pedagogical
activities and scientific studies. In the health fields, education and
research are inextricably bound together. Researchers frequently
teach their area of specialization, and many educators also engage
in some aspect of clinical or scientific research.

3. Combined occupations involve the delivery of services in addition to
education and research and are represented mainly by faculty in
academic health centers, who are frequently engaged in patient
care as well as research and education.

According to classifications of the Department of Education, prepara-
tion for occupations in the U.S. health care system is concentrated primar-
ily in two broad educational fields — the health professions and related
sciences and the biological sciences/life sciences.'^ The health professions
and related sciences encompass the highly specific training programs for
service occupations as well as related research occupations. They include
groups of instructional programs that prepare individuals to provide

CLASSIFICATION OF OCCUPATIONS IN THE U.S. HEALTH CARE SYSTEM

121

FIGURE 5-1 A class in gross and microscopic anatomy for nursing students,
taught by Dr. Florence Sabin, the first woman to reach the rank of full professor in
the Johns Hopkins University School of Medicine, circa 1915. Source: Alan Mason
Chesney Medical Archives, Johns Hopkins Medical Institutions

patient care, or related research and support services, to individuals or
groups. ^° The category of biological sciences/life sciences programs in-
cludes instructional programs that describe the scientific study of living
organisms and their systems. Specialized programs in the biological and
life sciences prepare students mainly for occupations in basic scientific
research and education. Many of these basic science occupations are
directly or indirectly part of the U.S. health care system. By providing
basic instruction in the preclinical sciences, programs in the biological
sciences also play an important role in the curriculum of specialized
programs in the health sciences. Biological and life sciences programs
prepare students primarily for occupations in laboratory research. (See
Table 5-3 for a classification of fields in the health professions and related
sciences, and Table 5-4 for a classification of fields in the life sciences and
biological sciences.)

A dense network of controls and standards governs occupations in the
health fields. Occupations involving patient care or research with human

1 22 EDUCATIONAL INSTITUTIONS AND PROGRAMS FOR HEALTH OCCUPATIONS

TABLE 5-3 Classification of fields in the health professions and
related sciences

Chiropractic

Communication disorders sciences

Community health services

Dentistry

Heahh and medical administrative services

Health and medical aides and assistants

Health and medical diagnostic and treatment services

Health and medical laboratory technologies/technicians

Health and medical preparatory programs

Medical basic sciences

Medical clinical services

Medicine

Mental health

Nursing

Optometry

Ophthalmic/optometric services

Osteopathic medicine

Pharmacy

Podiatry

Public health

Rehabilitation/therapeutic sciences

Veterinary medicine

Miscellaneous health sciences and allied health services (acupuncture and oriental
medicine, medical dietetics, medical illustration, naturopathic medicine,
psychoanalysis)

Source: Data from Robert L. Morgan, E. Stephen Hunt, and Judith M. Carpenter, Classification
of Instructional Programs (Washington, D.C.: U.S. Department of Education, 1991)

subjects are the most tightly controlled and heavily regulated, from the
education and training phase through credcntialing and practice. Controls
are exerted largely through the following four means: ( 1 ) establishment of
criteria and standards for accrediting instructional programs, educational
institutions, and health care delivery facilities; (2) licensure, (3) certifica-
tion; and (4) regulations and legislation governing practice.

Accreditation is "the process by which an authorized agency or organi-

CLASSIFICATION OF OCCUPATIONS IN THE U.S. HEALTH CARE SYSTEM 1 23

TABLE 5-4 Classification of fields in the life and biological sciences

Anatomy

Biochemistry

Biology

Biological immunology

Biometrics

Biophysics

Biostatistics

Biotechnology

Botany

Cell and molecular biology

Cytology

Ecology

Embryology

Epidemiology

Evolutionary biology

Genetics, plant and animal

Immunology

Marine/aquatic biology

Microbiology/bacteriology

Molecular biology

Mycology

Neuroscience

Nutritional sciences

Parasitology

Pharmacology

Physiology

Plant physiology

Psychology

Radiation biology/radiobiology

Toxicology

Virology

Zoology

Source: Data from Robert L. Morgan, E. Stephen Hunt, and Judith M. Carpenter, Classification
of Instructional Programs (Washington, D.C.: U.S. Department of Education, 1990)

1 24 EDUCATIONAL INSTITUTIONS AND PROGRAMS FOR HEALTH OCCUPATIONS

zation evaluates and recognizes a program of study or an institution as
meeting certain predetermined qualifications or standards."^' Licensure is
"the process by which an agency of government grants permission to
persons meeting predetermined qualifications to engage in a given occu-
pation and/or to use a particular title; or, grants permission to institutions
to perform specified functions within their jurisdiction. "^-^ Certification is
"the process by which a nongovernmental agency or association grants
recognition to an individual who has met certain predetermined qualifica-
tions specified by that agency or association. "^^

The most comprehensive sets of legislation governing health care prac-
tice are the Medical Practice Acts of the several states. This is "legislation
valid within each state which defines and regulates the practice of medicine
including qualifications for licensure within its jurisdiction." In some states
the practice of physician's assistants, and other licensed health manpower is
also regulated by the medical practice act.-^^ In addition all states have
legislation entitled Nurse Practice Act, governing the practice of nursing.

Another factor that affects instructional programs is the eligibility of
the programs' graduates for third-party reimbursement and their ability to
qualify in the competition for research grant funding. Service and re-
search occupations that become ineligible for third-party reimbursement
or fail to qualify to obtain grant funding usually have difficulty surviving.
The pressure to meet professional standards for practice and to qualify for
research funding or reimbursement of services are among the major
economic forces that shape these instructional programs.

For the purpose of focusing this discussion, we have limited it to
occupations with two or more of the following characteristics:

• Inclusion in the U.S. Department of Labor's categorization of
occupations in the health fields (see Table 5-3);

• Existence of accredited instructional programs for the occupation;

• Recognition by legal, regulatory, and professional bodies of the right
to practice the occupation;

• Eligibility of the occupation for either direct or indirect third-party
reimbursement for services;

• Inclusion of the occupation on biomedical research teams; and

• Eligibility of the occupation for funding by research grants and
contracts.

Occupations in the U.S. health care system are hierarchical and highly
structured, ranging from the professional to the paraprofcssional. The
instructional programs for these occupations and the institutions in which
the programs are based are equally diverse. In addition the range of

THE ROLE OF ACCREDITATION IN DEFINING INSTRUCTIONAL PROGRAMS 125

credentials conferred by institutions with instructional programs is both
extensive and varied.

THE ROLE OF ACCREDITATION IN DEFINING INSTRUCTIONAL
PROGRAMS

In the United States, accreditation is a major process that links nearly all
instructional programs in the health fields. Accreditation occurs at both
the institutional and the program level. To be accredited, the institutions
and the specialized programs at them must meet the exacting standards of
official accrediting bodies. These bodies not only set criteria for accredita-
tion but also confer accreditation status on institutions and programs. In
the United States accreditation is voluntary in concept. Yet, because
accreditation status is tied directly to the eligibility to receive governmen-
tal and private funds, the pursuit of accreditation has become imperative
for the survival of institutions and programs. As a result, accreditation
standards play a large role in the design and administration of instruc-
tional programs for occupations in the health fields.

Accreditation requirements account in large part for the standardiza-
tion of instruction for specific occupations, which occurs primarily at the
program level rather than at the institutional level. Basic requirements for
specific degrees and training certificates are similar in all institutional
settings. Because of accreditation standards, the curricula of specialized
instructional programs tend to be both occupation- and discipline-specific.
For instance, as a result of highly standardized nationwide requirements
for nursing diploma programs, the types of core courses required for a
diploma are essentially the same in every R.N. program.

The 1993 edition of the Council of Postsecondary Accreditation Membership
Directory (the last edition before COPA voted itself out of existence)
includes fifty-five associations. Twelve of the associations are responsible
for institutional accreditation, the remaining forty-three are responsible
for accrediting specialized programs at institutions of postsecondary edu-
cation. Of the twelve associations that accredit institutions, ten are respon-
sible for accrediting institutions that have programs for occupations in the
health fields. (See Table 5-5.) Six of these associations for institutional
accreditation are regional associations. Thirty-three of the forty-three
associations that accredit specialized programs are devoted to programs
for occupations in the U.S. health care system. (See Table 5-6.) The
AMA's Committee on Allied Health Education and Accreditation serves as
an umbrella agency for nineteen review committees, each representing

1 26 EDUCATIONAL INSTITUTIONS AND PROGRAMS FOR HEALTH OCCUPATIONS

TABLE 5-5 Associations that accredit postsecondary educational institutions

National Associations

Accrediting Bureau of Health Education Schools

Career College Association
Accrediting Commission for Independent Colleges and Schools;
Accrediting Commission for Trade and Technical Schools

National Home Study Council

Accreditation Council for Continuing Medical Education

Regional Associations

Middle States Association of Colleges and Schools (Delaware, District of Columbia,
Maryland, New Jersey, New York, Pennsylvania, Puerto Rico, Virgin Islands)

New England Association of Schools and Colleges (Connecticut, Maine, Massa-
chusetts, New Hampshire, Rhode Island, Vermont)

North Central Association of Colleges and Schools (Arizona, Arkansas, Colorado,
Illinois, Indiana, Iowa, Kansas, Michigan, Minnesota, Missouri, Nebraska, New
Mexico, North Dakota, Ohio, Oklahoma, South Dakota, West Virginia, Wiscon-
sin, Wyoming)

Northwest Association of Schools and Colleges (Alaska, Idaho, Montana, Nevada,
Oregon, Utah, Washington)

Southern Association of Colleges and Schools (Alabama, Florida, Georgia, Ken-
tucky, Louisiana, Mississippi, North Carolina, South Carolina, Tennessee,
Texas, Virginia)

Western Association of Schools and Colleges (American Samoa, California, Guam,
Hawaii, Trust Territory of the Pacific)

Source: Data from Council on Postsecondary Education, COPA Membership Directory (Washing-
ton, D.C.:COPA, 1992)

professional organizations collaborating in the accreditation of programs
in designated allied health fields. ^^ (See Table 5-7.) The principal accredi-
tation group for schools of medicine is the Liason Committee on Medical
Education, a joint committee of the AMA and the Association of American
Medical Colleges. The Accreditation Council for Continuing Medical Edu-
cation, an arm of the AMA, accredits institutions to approve continuing
education credit hours.

Because programs for the health occupations are located in educa-
tional institutions and in health care delivery facilities, the accreditation of
health care delivery facilities also plays an important role in the accredita-
tion of instructional programs. The Joint Commission on Accreditation of
Healthcare Organizations (JCAHO) also participates in the accreditation of

THE ROLE OF ACCREDITATION IN DEFINING INSTRUCTIONAL PROGRAMS 1 27

TABLE 5-6 Associations that accredit specialized programs in the
health fields

Accrediting Bureau of Health Education Schools (medical assistant and medical
laboratory technician)

Accrediting Commission on Education for Health Services Administration

American Association for Counseling and Development

American Council on Pharmaceutical Education

American Dental Association (dentistry and dental auxiliary programs)

American Dietetic Association

American Medical Association

Committee on Allied Health Education and Accreditation
Liaison Committee on Medical Education (with AAMC)

American Optometric Association

American Osteopathic Association

American Physical Therapy Association

American Podiatric Medical Association

American Psychological Association

American Speech-Language-Hearing Association

American Veterinary Medical Association

Association of American Medical Colleges

Liaison Committee on Medical Education (with AMA)

Council on Accreditation of Nurse Anesthesia Educational Programs

Council on Chiropractic Education

Council on Education for Public Health

Council on Rehabilitation Education

Council on Social Work Education

National Accreditation Commission for Schools and Colleges of Acupuncture and
Oriental Medicine

National Confederation of State Medical Examining and Licensing Boards

National League for Nursing

Boards of Review for Baccalaureate and Higher Degree, Associate Degree,
Diploma, and Practical Nursing Programs

The Committee on Allied Health Education and Accreditation (CAHEA) functions as an
umbrella agency for nineteen review committees, each representing professional organiza-
tions collaborating in the accreditation of programs in designated allied health fields (see
Table 5-7)

Source: Data from Council on Postsecondary Education, COPA Membership Directory (Washing-
ton, D.C.: COPA, 1992)

1 28 EDUCATIONAL INSTITUTIONS AND PROGRAMS FOR HEALTH OCCUPATIONS

TABLE 5-7 Review committees under the AMA's Committee on Allied Health
Education and Accreditation

Accreditation Review Committee on Education for the Anesthesiologist's Assis-
tant

Committee on Accreditation of Specialist in Blood Bank Schools, American Asso-
ciation of Blood Banks

Joint Review Committee on Education in Cardiovascular Technology

Cytotechnology Programs Review Committee, American Society of Cytotech-
nology

Joint Review Committee on Education in Diagnostic Medical Sonography

Joint Review Committee on Education in Electroneurodiagnostic Technology

Joint Review Committee on Educational Programs for the EMT-Paramedic

National Accrediting Agency for Clinical Laboratory Sciences

Curriculum Review Board, American Association of Medical Assistants'
Endowment

Accreditation Review Committee for the Medical Illustrator

Council on Education, American Health Information Management Association

Joint Review Committee on Educational Programs in Nuclear Medicine Tech-
nology

Accreditation Committee, American Physical Therapy Association

Joint Review Committee for Ophthalmic Medical Personnel, Joint Commission on
Allied Health Personnel in Ophthalmology

Accreditation Committee for Perfusion Education

Accreditation Review Committee on Education for the Physician Assistant

Joint Review Committee on Education in Radiologic Technology

Joint Review Committee for Respiratory Therapy Education

Accreditation Review Committee on Education in Surgical Technology

Source: Data from Council on Postsecondary Education, COPA Membership Directory (Washing-
ton, D.C.: COPA, 1992)

instructional programs for occupations in the health fields. In addition, the
JCAHO makes specific recommendations for educational programs in the
following areas: child and adolescent health, diagnostic radiology services,
dietetic services, emergency services, infection control, library services,
medical records, medical staff, nursing services, pathology and medical
laboratory services, services for patient and family, pharmaceutical ser-
vices, physical rehabilitation services, radiation oncology services, respira-

IMPACT OF REGULATORY ENVIRONMENT ON INSTRUCTIONS L PROGRAMS 129

tory care services, social work services, special care units, and surgical and
anesthesia services. ^^

THE IMPACT OF THE REGULATORY ENVIRONMENT ON
INSTRUCTIONAL PROGRAMS

Regulatory requirements play a major role in shaping curricula and
defining programs. The regulatory activities that control programs and
institutions in many instances interact with the regulatory activities that
control the practice of occupations in the health fields. Knowledge of the
regulatory environment is particularly important because regulatory re-
quirements carry many stipulations regarding the generation, mainte-
nance, and disposition of documentation.

LICENSURE

State licensing boards in the health fields are the authoritative bodies that
grant permission to institutions to perform designated functions, and to
individuals to practice specific occupations and assume particular titles.
Each state has licensing boards in numerous health occupations. Licen-
sure is intended as a means of quality control for practicing in the health
occupations and operating health care deliver facilities. Meant to offer
society a measure of protection from incompetent practitioners and inade-
quate health care delivery facilities, licensure governs the rights of indi-
viduals to practice and of institutions to operate.

To ensure that graduates have smooth entry into the work force,
instructional programs for the health occupations adapt curricula to meet
standards for licensing in their particular state. Whereas certificate pro-
grams tend to address only the specific licensing requirements of the state
in which the program is located, degree programs usually aspire to meet
the national norm in licensing standards, affording their graduates more
professional mobility at the entry level. Most schools, however, have
instructional programs that go far beyond the minimum licensing require-
ments, and rarely do students from accredited institutions fail license
examinations. Because standards for licensure vary from one state licens-
ing board to another, efforts are under way to introduce standardized
licensing examinations for a number of occupations in the health fields.
Greater standardization should help normalize curricula and create
greater mobility for graduates.

Since 1915 the National Board of Medical Examiners has assumed a

1 30 EDUCATIONAL INSTITUTIONS AND PROGRAMS FOR HEALTH OCCUPATIONS

leadership role in providing testing services for licensing physicians. Its
mission includes preparing and administering high-caliber qualifying ex-
aminations; cooperating with state examining boards, state boards, and
other bodies involved in educating and evaluating personnel in the health
fields; engaging in ongoing research to assess the quality of education in
the health fields and to improve the precision of their assessment tech-
niques; and providing educational outreach regarding their testing meth-
odologies and procedures.

In recent years the National Board has engaged in cooperative projects
with other health professionals. Major instances of collaboration have
occurred with the National Commission on the Certification of Physician
Assistants and the National Council of State Boards of Nursing. ^^

CERTIFICATION

Although licensure is required by law, certification is a voluntary process
in the health fields. Specialty boards of professional organizations set
standards and regulate the certification process. Even though it is volun-
tary in concept, board certification is a widespread requirement for em-
ployment in the health occupations. By also setting standards for the
curricula and accreditation of instructional programs, specialty boards
have significantly influenced both specialized education and practice in
the health fields. Specialty boards determine length of training, scope, and
content of courses. Board certification, which is especially important for
advancement in academia, is also a significant factor in setting fee sched-
ules and in the third-party reimbursement process.

TYPES OF INSTRUCTIONAL PROGRAM

Programs for occupations in the U.S. health care system exist either as
freestanding institutions, as components of college or university systems,
or as divisions within professional schools. Universities and colleges pre-
pare students for many types of health care occupation through accredited
graduate or undergraduate degree programs. Typical graduates of these
programs are occupational therapists (who earn a bachelor's degree in
occupational therapy), physical therapists (who earn a bachelor's or a
master's degree in physical therapy), physician assistants (who earn a
bachelor's or master's degree or a professional certificate), and pharma-
cists (who earn either a bachelor's or doctor of pharmacy degree, depend-
ing on the area of pharmacy in which they intend to practice). Profes-

FUNCTIONS OF INSTITUTIONS THAT CONFER CREDENTIALS FOR OCCUPATIONS 131

sional schools in dentistry, medicine, and other fields require undergradu-
ate education as a prerequisite to admission. ^^

A considerable number of instructional programs, such as those pre-
paring physician assistants, physical therapy assistants, phlebotomists,
dental hygienists, and nurses, are offered as associate degree programs at
two-year community and junior colleges. Two-year community, junior,
and technical colleges as well as some specialized institutions also offer
degree and certificate programs for specialized clerical personnel and
technicians. In addition, two-year community colleges offer degree pro-
grams that prepare individuals for further training in one of the health
care occupations.

Specialized degree programs often exist within a professional school.
For example, some schools of public health offer, in addition to a master's
degree in public health, a master's degree in health administration, and
many physician assistant training programs are located in medical schools
or in schools of allied health. Some ancillary care workers, such as
radiologic technologists, receive training in specialized short-term training
schools and programs or at vocational technical institutions. These pro-
grams are either freestanding or based in a university, college, or hospital.
Another type of specialized program is the continuing education program,
now required by many health care professions as a condition of maintain-
ing licensure. Continuing education is discussed in detail later in this
chapter.

The records of institutions with instructional programs in the health
fields contain vital data and information that are regularly used by the
institutions, faculty, and students to meet evidential requirements for
accreditation, licensing, and certification. Archivists responsible for main-
taining the records of these institutions should give special consideration
to the various evidential uses of these records. They should also consider
the primary resource value of the vast range of records from these
institutions that may be viable for ongoing studies in the health, life,
biological, and social sciences in some areas of the humanities.

FUNCTIONS OF INSTITUTIONS THAT CONFER CREDENTIALS FOR
OCCUPATIONS IN THE U.S. HEALTH CARE SYSTEM

The primary function of a health educational or training institution is to
prepare individuals for occupations in the health care system. Closely
related to the education function are the functions of research and patient
care. At an academic health center, the three functions of education.

1 32 EDUCATIONAL INSTITUTIONS AND PROGRAMS FOR HEALTH OCCUPATIONS

biomedical research, and patient care are interdependent. Administration,
including financial management, human resource management, informa-
tion management, and facilities management, is also a function of educa-
tional institutions, just as it is a function of all institutions and organiza-
tions.

EDUCATION

Education for health care professionals may be divided into four levels:
undergraduate education, graduate education, postgraduate education,
and continuing education. Not every health care occupation requires all
four levels. The focus of most instructional programs is to prepare their
graduates to meet and maintain professional licensing requirements. At
graduation, an institution confers credentials on students, but this creden-
tialing alone does not enable an individual to practice. In nearly every
occupation involving patient care, program graduates must also obtain a
license or certificate before they are permitted to practice. Therefore, in
preparing students to practice nursing, medicine, or dentistry, for exam-
ple, an instructional program must impart high professional standards and
include a curriculum that will enable students to qualify for licensing or
certification.

Postgraduate education is required for practicing medicine and for
specialized practice in the fields of dentistry, nursing, optometry, phar-
macy, podiatry, and veterinary medicine. After graduation from medical
school, physicians must complete an internship, lasting one or two years,
in an accredited graduate medical education program. After the intern-
ship, physicians usually complete a residency in the specialty in which
they intend to practice.

Most physicians who practice a specialty seek certification by a spe-
cialty board, although board certification is not required for specialized
practice. Board certification helps to legitimize a specialist's practice by
ensuring that the physician meets certain qualifications and has the
credentials needed to obtain and maintain certification. Eighty-five per-
cent of physicians specialize in one of twenty-three specialties.-^^ Some
newer areas of specialization include preventive medicine, family medi-
cine, and community medicine. Dentists, nurses, optometrists, pharma-
cists, physician assistants, podiatrists, and veterinarians may also special-
ize. In most of the health care professions, licensing boards and state
governments require additional education and practical training for spe-
cialized practice.

Many health care professions require continuing education as a con-
dition of maintaining a license to practice. For example, in the medical

FUNCTIONS OF INSTITUTIONS THAT CONFER CREDENTIALS FOR OCCUPATIONS 133

profession, twenty-three states require continuing medical education
(CME) credits for re-registration of a physician's license to practice medi-
cine. Ten specialty boards require CME credits for recertification. Eight
state medical societies and seven specialty societies require CME credits as
a condition of membership.'*^

The role of the educational institution in continuing education is to
host or coordinate continuing education courses and to confer the credits.
The institution selects the speakers and determines the course content.
The courses and programs are often underwritten by a commercial ven-
ture such as a drug company.

Continuing education is designed to broaden the knowledge and
upgrade the skills of practitioners throughout the course of their careers.
Because of ongoing and extensive change in the health fields, continuing
education has evolved as a principal means of keeping graduates current
with the latest developments in their professions. In some instances the
accrual of continuing education credits is a requirement for maintaining
licensure and certification. A number of states have introduced legislation
that requires personnel in a range of occupations, including nursing and
medicine, to earn a stipulated number of continuing education credits per
year to maintain their licensing and certification to practice.

Overall, the quality of preparatory education in the health fields is still
considerably higher than that of the emerging area of continuing educa-
tion. More rigorous controls are in place for preparatory education than
for continuing education because no single mechanism exists to monitor
the quality of continuing education systems in the health fields. Evalua-
tion of continuing education is done on a voluntary basis and credits are
issued on verification of attendance. In recent years both federal agencies
and professional associations have become more actively involved in
setting standards for continuing education in an effort to improve its
overall quality.

Although continuing education is still largely a voluntary process, it is
rapidly expanding out of market demand. Even where legislation and
regulatory requirements do not require continuing education, enrollment
figures are high. Students voluntarily requesting evaluation of their
course work is a particularly significant characteristic of continuing educa-
tion programs offered by educational institutions.'^ The American College
of Physicians self-assessment exam is an example of physicians' need and
regard for self-evaluation. Personnel in the health occupations, especially
those at academic health centers, appear to be highly motivated by the
ongoing need to retool and to learn new skills and procedures. A clear
consensus exists among personnel in the health fields regarding the need
for relevant and high-caliber continuing education courses.

1 34 EDUCATIONAL INSTITUTIONS AND PROGRAMS FOR HEALTH OCCUPATIONS

In recent years professional associations, legislative bodies, and gov-
ernment agencies have entered the debate over controls and standards for
continuing education in the health fields, declaring that the relationship
between commercial sponsorship and continuing education is not
healthy. In 1990 the U.S. Senate's Committee on Labor and Human
Resources held hearings on the role of pharmaceutical companies in
continuing education. At about this time the AMA released guidelines on
gifts to physicians from industry. These guidelines were readily adopted
by the Pharmaceutical Manufacturers Association. In addition, the Ac-
creditation Council for Continuing Medical Education and the Food and
Drug Administration recently introduced guidelines designed to limit drug
companies' control of the content of the continuing education courses that
they fund.'^

RESEARCH

Research plays an integral role at institutions of higher education. Federal
research grants and contracts are a key source of funding for institutions of
higher education, particularly those involved with the health care system.
The need to obtain external support for research has changed the charac-
ter of educational institutions in the health fields — particularly medical
schools — over the past four decades. Entry into the competition for re-
search funding has forced these institutions to expand administrative
activities and set new institutional agendas. ^^ Because tuition for profes-
sional degree programs in the health fields usually falls short of true costs,
there is extensive cross subsidy of teaching from research funding and
patient care revenues. Research funding is used to pay the salaries of
faculty members, for the education of graduate students, and for equip-
ment, among other things. It has created a new set of loyalties for faculty,
who feel more obligated to their funding source (e.g., a governmental
agency, foundation, or corporation) than to their institution.''^ As a result,
confusion often exists at educational institutions over the ownership of
research records. The granting agencies, principal investigators, and the
institutions where the research activities are conducted share responsibil-
ity for the maintenance of these records. Because most grants are awarded
to institutions and not to individuals, however, the institutions have
ownership rights to any equipment purchased by grant funds and to the
products of research. Furthermore, because the institutions usually have
ownership rights over the physical research records and their intellectual
content, they may determine the policies governing retention and use of
these records. For instance, when principal investigators move to other

FUNCTIONS OF INSTITUTIONS THAT CONFER CREDENTIALS FOR OCCUPATIONS 135

institutions, they are usually required to deposit the original records at the
institution where the research was conducted and take copies with them.

In deciding which institutions and which research projects to fund,
funding agencies play a critical role in the fate of these institutions.
Although the awards are based on peer review, the decisions of these
agencies greatly influence what research is done, where it is done, and
who does it. Success or failure to obtain research funding may alter the
direction of instructional programs and may cause individual departments
to thrive or wither at an institution. At academic health centers in particu-
lar there is concern that the pre-eminence of the research function may
skew the direction of education and patient care.^^

In addition to conducting research, faculty at institutions of higher
education with instructional programs in the health sciences train stu-
dents for research occupations. A considerable amount of time, effort, and
money is put into training researchers. Individuals planning a research
career in the life and biological sciences usually seek a Ph.D. degree, which
could be earned from a program based in a medical school, a health
sciences school other than a medical school (e.g., a school of nursing or
public health), or a university. Those planning a research career in the
health sciences seek either a Ph.D or an M.D. degree. Some researchers
hold combined M.D. and Ph.D degrees, including graduates of Medical
Scientist Training Programs. Students who seek careers in public health
and areas such as health policy and theory also earn graduate level
degrees. (For a comprehensive discussion of research institutions and the
research function, see Chapter 4.)

PATIENT CARE

Educational institutions with instructional programs for health care occu-
pations are involved in patient care, usually through affiliation with a
health care delivery facility. Most instructional programs include a practi-
cal component that involves the student interacting with patients in a
supervised setting. The administrative relationship between an educa-
tional institution and a health care delivery facility determines the degree
to which the educational institution is also a health care delivery facility.
For example, in many academic health centers practicing physicians hold
appointments on the hospital staff and are faculty of the school of medi-
cine. The faculty's clinical professional activities provide revenue for the
school and educational opportunities for students. Where the organiza-
tional relationship is very close, administrative distinctions between the
educational institution and the health care delivery facility tend to blur. As

1 36 EDUCATIONAL INSTITUTIONS AND PROGRAMS FOR HEALTH OCCUPATIONS

a result, documentation of the activities of the facuhy and student trainees
may be generated in both the hospital and medical school.

INSTITUTIONAL ADMINISTRATION

Educational institutions and health care delivery facilities with instruc-
tional programs in the health fields have especially complex administra-
tive responsibilities because education in the health fields is densely
regulated. A significant portion of the budgets of these institutions is
devoted to administrative overhead, including salaries and the costs of
storage and management of evidential materials that must be retained for
legal and regulatory requirements.^^

In general, the chief sources of income for most institutions with
degree and certificate programs in the health fields (public, private, or
church-operated) include revenue from clinical services, research and
teaching grants, tuition, gifts, and endowments. Public- and church-
operated institutions receive operating appropriations from the bodies
that own them, and they obtain funding though the usual sources of
patient fees, grants, gifts, tuition, and endowments. Privately operated
institutions compete in both the private and public sector for funding.

The extensive collaboration between educational institutions and
health care delivery facilities in patient care, research, and teaching
account for many complexities over the jurisdiction of documentation.
Much of the collaboration is interdepartmental and also intra- and interin-
stitutional. Some collaborative activities are local and regional in nature,
but many are national or international in scope. Support for these activi-
ties usually comes from a wide variety of funding sources.

The administration of institutions with educational programs in the
health fields is largely decentralized yet strongly hierarchical, with a clear
distribution of responsibility and authority. Usually these institutions have
governing boards, a chief operating officer and central administrative staff,
and departmental chiefs with administrative staffs. Because of the impor-
tance of effective regulatory compliance, the administrative structure of
these institutions has been designed to distribute administrative responsibil-
ity to the appropriate location of activity. Whereas the institutions are legally
responsible for the administration of grants, they place direct responsibility
on the departments that receive the grants to administer them according to
the appropriate requirements. In turn the departments place the burden of
responsibility on the principal investigators to uphold the terms of their
award. These institutions emphasize individual responsibility in research as
well as in patient care and education.

THE ROLE OF ACADEMIC HEALTH CENTERS 1 37

At institutions with instructional programs in the health fields, the
individual departments have considerable power and authority. Scientific
departments generate funding through grants, patents, and technical
licensing; clinical departments generate revenue from fees for services. As
a result of their capacity to generate income, the clinical and scientific
departments have significant leverage with the central administration of
their institution.

THE ROLE OF ACADEMIC HEALTH CENTERS

Because of the need to integrate academic studies and research with
practical training, specialized centers have evolved that combine institu-
tions of higher education with health care delivery facilities. The academic
health center is the venue where these two types of institution come
together and where much of the education for the health professions
occurs. The three functions of education, research, and health care deliv-
ery (i.e., patient care and health promotion) converge at academic health
centers.

As defined by the Association of Academic Health Centers, an aca-
demic health center includes "a school of medicine (allopathic or osteo-
pathic), a teaching hospital, and at least one additional health education
program (structured as a school or college or functioning within other
units of the center)." An academic health center operates either as a
component of a university, as part of a state university system, or as a
freestanding institution.'^ The governance structures of academic health
centers vary greatly.

In one model, institutions are governed by a board and chief execu-
tive officer of the medical center to whom the hospital director, dean of
the school of medicine and deans of the other schools report. (Duke, the
University of Pennsylvania, and many state schools follow this model.) In
a second model, the school of medicine is part of a university that
contracts with several completely independent hospitals to provide teach-
ing facilities in clinical settings. (Harvard, Tufts, and some of the newer
state schools such as the medical schools at the University of South
Carolina follow this model.)

The central educational component at an academic health center is
the school of medicine. Almost all medical schools are part of academic
health centers.'^ Other components of academic health centers are, most
frequently, schools of dentistry and nursing. Schools of pharmacy, allied
health professions (such as medical technology, occupational therapy.

138

EDUCATIONAL INSTITUTIONS AND PROGRAMS FOR HEALTH OCCUPATIONS

physical therapy, and physician assistants), public health, optometry, and
veterinary medicine may also be part of an academic health center. As
well, academic health centers may offer graduate programs in health-
related scientific fields. '*°

In 1992 the Council of Teaching Hospitals recognized 123 academic
medical centers in the United States, and the Association of Academic
Health Centers (AAHC) counted 97 members. According to the 1992
Academic Health Centers Directory, approximately 60 percent of academic
health centers are publicly owned and 40 percent are private institutions.
All AAHC members are composed of one to seven schools or programs for
educating health care professionals; more than 75 percent have three or
more schools. Members own or are affiliated with between one and
twenty-seven hospitals, with the majority (about 63 percent) linked to
between two and five hospitals. The American Hospital Association's
annual statistical summary for 1990 (the 1991-1992 edition) identified
1,238 teaching hospitals, representing 19 percent of all U.S. hospitals. Of
these, about one third were government owned (18 percent state and
local, 12 percent federal) and the remainder were privately owned (67
percent not-for-profit, 3 percent for-profit).

FIGURE 5-2 A medical student study group at the Johns Hopkins University
School of Medicine, circa 1990. Source: Bill Dennisoii, photographer; the Alan Mason
Chesney Medical Archives of the Johns Hopkins Medical Institutions

THE ROLE OF ACADEMIC HEALTH CENTERS 1 39

AN ACADEMIC HEALTH CENTER: THE JOHNS HOPKINS MEDICAL
INSTITUTIONS

Like other academic health centers in the United States, the Johns
Hopkins academic health center was initially organized around a consor-
tium of professional schools, health care delivery facilities, and research
institutes for the purpose of integrating the health care delivery (patient
care and health promotion), education, and research functions. Recently,
however, Johns Hopkins and a growing number of other academic health
centers have opted to augment this consortium model to accommodate
fundamental changes in financing and health care delivery. To stabilize
the financial operations of its constituent institutions and to ensure their
cost-effectiveness, Johns Hopkins added a vareity of companies that
provide goods and services, including medical equipment, pharmaceuti-
cals, and home health services, to its consortium. Many of these compa-
nies are also incorporated to serve the public sector. As a result the
consortium includes a combination of for-profit and not-for-profit corpo-
rations, representing a notable departure from the predominantly non-
profit consortium model for academic health centers.

At Johns Hopkins the consortium does not constitute a single legal
entity. Unlike many academic health centers, the educational component
(the Johns Hopkins University) does not own the consortium's health care
delivery facilities. Thus, the educational component and the health care
delivery facilities operate as separate corporate entities within a consor-
tium that is dedicated to uniting the functions of education, patient care,
and research at its constituent institutions.

The Johns Hopkins academic health center is currently organized
around three corporate entities: the Johns Hopkins Health System Corpo-
ration, the Johns Hopkins Hospital, and the Johns Hopkins University.
The Health System includes a network of smaller corporations that are
either wholly-owned by the Health System Corporation or owned jointly
with either the Johns Hopkins Hospital or the Johns Hopkins University.
While most of these companies are not-for-profit corporations, several
have been created as for-profit corporations. The purpose of the Johns
Hopkins Health System is to provide an infrastructure of financial and
service support for patient care, education, and research in the consor-
tium.41

At Johns Hopkins the principal health care delivery facilities include
the Johns Hopkins Hospital, the Francis Scott Key Medical Center, the
Homewood Medical Center, and the Kennedy Krieger Institute. The
health divisions of the university include the School of Hygiene and Public
Health, the School of Medicine, the School of Nursing, and the Welch

1 40 EDUCATIONAL INSTITUTIONS AND PROGRAMS FOR HEALTH OCCUPATIONS

Medical Library. The Johns Hopkins consortium of educational institu-
tions, health care delivery facilities, and service corporations is one of the
largest, most diverse, and most highly specialized academic health centers
in the country.

The governance and administration of the Johns Hopkins academic
health center is atypical in that there is no overarching governance
structure and each of the corporate entities has its own chief executive
officer and individual governance and administrative structure. Thus the
Johns Hopkins Hospital, Health System, and University coexist as separate
corporations with their own boards of trustees and chief executive offi-
cers. There is, however, cross-representation from the different corpora-
tions on the boards and within the administrative structure of the various
organizations. For example, the president of the Hospital is also chief
executive officer of the Health System; and the president of the University
is chief executive officer of the health division of the University. Each of
the professional schools in the health divisions is administered by a dean
who reports to the president of the University. The director of the library
reports to the dean of the School of Medicine who also serves as the vice
president for the health divisions of the university. In addition, each of the
university's health divisions has a faculty advisory board and each health
care delivery facility has a medical staff advisory board.

OVERVIEW OF ARCHIVAL/RECORDS MANAGEMENT
PROGRAMS AT ACADEMIC HEALTH CENTERS

The scarcity of published information about archival and records manage-
ment programs at academic health centers led the Medical Archives of the
Johns Hopkins Medical Institutions to conduct two surveys. In 1987 the
staff sent questionnaires to 1 16 institutions designated as academic medi-
cal centers by the Council of Teaching Hospitals, and received completed
questionnaires from 78. A majority of the respondents (53) reported that
their institutions had repositories for historical records. In January 1988,
the Medical Archives staff conducted a follow-up telephone survey of
these 53 respondents. Although 40 institutions reported having archival
programs, only 14 reported having records management programs. Inter-
estingly, 13 institutions reported having both archival and records man-
agement programs, but in only four of these institutions were the two
programs jointly administered. The survey results indicated that two of
these joint programs were administered by university libraries, one by a
history of medicine department, and one by the central administration of
the medical center.'*^ A majority of the archivists and records managers

ISSUES IN DOCUMENTING INSTRUCTIONAL PROGRAMS IN THE HEALTH FIELDS 141

who were polled expressed alarm about the abundant production and
accumulation of documentation at their academic medical centers. They
were particularly concerned about the lack of archival and records man-
agement guidelines for the health fields. Many of them indicated the need
for appraisal guidance that focuses on the special characteristics of docu-
mentation from the health fields. Determining what documentation
should be selected and preserved seemed to be a priority in their work.

ISSUES IN DOCUMENTING INSTRUCTIONAL PROGRAMS IN THE
HEALTH FIELDS

Degree programs in the health fields are generally based in institutions of
higher education, and as such, their documentation falls under the pur-
view of their institutional archives. While there is a need for appraisal
guidance for documentation of these specific types of instructional pro-
grams, most colleges and universitites have an archival program in place.

Certificate and other non-degree programs, by contrast, are often
ephemeral, as are many of the institutions that conduct them because
they cannot appropriate sufficient funding. Those institutions that survive
often lack archival programs. The archives of defunct specialized institu-
tions are sometimes placed with the archives of their professional associa-
tions or accrediting bodies, which may themselves be deposited in large
repositories. For example, records from various midwifery programs are
located in the archives of the American College of Nurse-Midwives which
are deposited in the National Library of Medicine.

A number of legal and regulatory requirements contain stipulations
about the long-term retention of certain types of records from institutions
in the U.S. health care system. In general provisions are made for retain-
ing student records in both the degree and certificate programs. These
records are regularly used throughout the careers of graduates. When
graduates of these programs seek new licenses or admission to other
educational programs, the application process nearly always requires that
the degree- and certificate-granting institutions verify the graduates' aca-
demic credentials.

Granting agencies and philanthropic foundations are beginning to set
more stringent requirements for the long-term retention of research
documentation. In the meantime, insurance companies, professional as-
sociations, and federal and state agencies continue to impose many re-
quirements for the long-term retention of clinical documentation. Be-
cause academic health centers in particular receive capital from many
diverse yet highly regulated funding sources, they are obligated to follow

1 42 EDUCATIONAL INSTITUTIONS AND PROGRAMS FOR HEALTH OCCUPATIONS

varied requirements for the retention of fiscal documentation. As new
data and information management technologies are introduced to institu-
tions in the health fields, archivists at these institutions are challenged by
numerous technical issues in the preservation and long-term use of
institutional documentation.'*'

In summary, archivists at institutions with instructional programs in
the health fields face many complex problems associated with the selec-
tion, organization, preservation, and ongoing use of documentation at
their institutions. They need to be apprised of legal and regulatory re-
quirements and well-informed about the ethical, social, economic, scien-
tific, and technological issues associated with the institution's patient care,
education, and research functions. These issues are indeed formidable,
challenging archivists at these institutions to seek creative yet responsible
solutions for the selection and long-term management of institutional
documentation. Because of the need to plan carefully for the selection of
documentation to be preserved, it is important for archivists to have an
overview of the context of instructional programs at educational institu-
tions and health care delivery facilities. By comparing their programs with
others nationally, they will be able to identify the program's common and
unique features which will help them to set priorities regarding the
functions and activities selected for documentation. In concluding, our
hope is that this chapter will provide useful background information for
archivists as they develop documentation plans for institutions with in-
structional programs in the health fields.

ACKNOWLEDGMENTS

We are particularly grateful for the assistance of the following individuals
from Johns Hopkins in the preparation of this chapter: Louise Cavag-
naro — former vice president of the Johns Hopkins Hospital; Frances
Dukissis, administrative secretary — Medical Archives; Elizabeth Fee, pro-
fessor of health policy and managment — School of Hygiene and Public
Health; Mary E. Foy, assistant dean and registrar — School of Medicine;
Gloria Freeman, administrator for continuing education — School of Medi-
cine; Carol J. Gray, dean — School of Nursing; Edward Morman, director
of historical collections — Institute of the History of Medicine; Richard S.
Ross, dean emeritus — School of Medicine; Patricia Stephens, director of
scientific editing services — Welch Medical Library; and Arlowayne Swort,
former associate dean for academic affairs — School of Nursing. We also
extend special thanks to William G. Rothstein, professor of sociology —
University of Maryland, Baltimore County, for reading earlier drafts of

NOTES 1 43

this chapter, and to Helen W. Samuels, head of special collections at the
Massachusetts Institute of Technology, for sharing with us drafts of her
work Varsity Letters: Documenting Modern Colleges and Universities.

NOTES

1 . The functions that we ascribe to instructional programs in the health fields are
corollaries to the functions that Helen Willa Samuels ascribes to institutions of
higher education. In Varsity Letters: Documenting Modern Colleges and Universities
(Metuchen, N.J.: Scarecrow Press, 1992), Samuels states that institutions of
higher education embody the following seven funaions: ( I ) confer
credentials, (2) convey knowledge, (3) foster socialization, (4) condua
research, (5) sustain the institution (institutional administration), (6) provide
public service, and (7) promote culture.

2. The U.S. Department of Education uses the term instructional programs to
encompass educational and training programs.

3. In a personal communication with the authors, Arlowayne Swort (16 July
1993) noted that nursing programs have been especially costly to operate.
She cites studies done in the 1970s and 1980s that showed that some
hospital-based diploma nursing schools were more expensive than either
associate or bachelor's degree programs. The cost imbalances between the
hospital-based diploma programs and the nursing degree programs based in
educational institutions led to the eventual closing of many hospital-based
diploma programs. One probable explanation for the cost variables is insti-
tutional infrastructure. Because instruction for nursing as for other occu-
pations in the health fields is labor intensive and heavily regulated, the cost of
operating these programs is especially high. When clusters of these programs
are based in educational institutions, many basic administrative and instruc-
tional costs may be shared. By contrast, the stand-alone diploma programs
must assume the full brunt of administrative and instructional costs.

4. Council of Teaching Hospitals, Association of American Medical Colleges,
Committee Structure and Membership Directory 1991 (Washington, D.C.:
Association of American Medical Colleges, 1991).

5. William G. Rothstein, letter to the authors, 24 Jan. 1993.

6. Ibid.

7. William G. Rothstein, American Medical Schools and the Practice of Medicine: A
History (New York: Oxford University Press, 1987), 85-88.

8. Richard H. Shryock, Medical Licensing in America, 1650-1965 (Baltimore: Johns
Hopkins University Press, 1967).

9. William G. Rothstein, letter to the authors, 24 Jan. 1993.

10. James Bordley III and A. McGehee Harvey, Two Centuries of American Medicine:
1776-1976 (Philadelphia: W. B. Saunders, 1976), 10.

11. Edward Kremers (revised by Glenn Sonnedecker), Kremers and Urdang's
History of Pharmacy (Philadelphia: J. B. Lippincott, 1976), 227.

1 44 EDUCATIONAL INSTITUTIONS AND PROGRAMS FOR HEALTH OCCUPATIONS

12. Ruth Roy Harris, Dental Science in a New Age: A History of the National Institute of
Dental Research (Rockville, Md.: Montrose Press, 1989), 7-8.

1 3. Joseph Nathan Kane, Famous First Facts: A Record of First Happenings, Discoveries,
and Inventions in American History (New York: H. W. Wilson, 1981), 687.

14. Rothstein, American Medical Schools.

1 5 . Elizabeth Fee, Disease and Discovery: A History of the Johns Hopkins School of Public
Health, I9I6-I939 (Baltimore: Johns Hopkins University Press, 1987).

16. See AIP Study of Multi-Institutional Collaborations (New York: Center for History
of Physics/ American Institute of Physics, 1992) for a report on the findings of
this project, which aimed "to identify patterns of collaboration, define the
scope of the documentation problems, field-test possible solutions, and
recommend future actions to secure adequate documentation."

17. Elizabeth Fee, telephone conversation with the authors, October 1993.

18. For more information on professional associations, see Chapter 6.

19. Robert L. Morgan, E. Stephen Hunt, and Judith M. Carpenter, Classification of
Instructional Programs (Washington, D.C.: U.S. Department of Education,
1991 ) contains a comprehensive list of the subfields of the health, life, and
biological sciences.

20. Ibid., 169.

21. National Board of Medical Examiners, Committee on Goals and Priorities,
Evaluation in the Continuum of Medical Education: Report of the Committee on Goals
and Priorities of the National Board of Medical Examiners, (Philadelphia: National
Board of Medical Examiners, 1973).

22. Ibid., 87.

23. Ibid., 85.

24. Ibid., 87.

25. Council on Postsecondary Education, COPA Membership Directory
(Washington, D.C.: Council on Postsecondary Education, 1992).

26. The Joint Commission 1990 Accreditation Manual for Hospitals (Chicago: Joint
Commission on Accreditation of Healthcare Organizations, 1989), 318.

27. National Board of Medical Examiners, In Service to Medicine, 75th anniversary
publication (Philadelphia: National Board of Medical Examiners, 1990), I,
68-70.

28. U.S. Department of Labor, Occupational Outlook Handbook (Washington, D.C.:
U.S. Department of Labor, 1986).

29. Ibid.

30. American Medical Association, 799/ Continuing Medical Education Fact Sheet
(American Medical Association, Chicago, 1991).

31. Bordley and Harvey, American Medicine, 346.

32. Bonnie Davidson, "The New Ethical Climate of CME," Physicians' Travel and
Meeting Guide (May 1992): 44-48.

33. Rothstein, American Medical Schools, 255.

34. Ibid., 248.

35. Jeremiah A. Barondess, "The Academic Health Center and the Public Agenda:
Whose Three-Legged Stool?" Annals of Internal Medicine 115 (1991): 962-67.

36. David U. Himmelstein and Steffie Woolhandler, "Cost Without Benefit:

SELECT ANNOTATED BIBLIOGRAPHY 1 45

Administrative Waste in U.S. Health Care," New England Journal of Medicine
314, no. 7 (19xx): 411-45.

37. Association of Academic Health Centers, Directory (Washington, D.C.:
Association of Academic Health Centers, 1991).

38. Richard S. Ross, Letter to the authors, July 1993.

39. Rothstcin, American Medical Schools, 225-26.

40. Joan D. Krizack, "Assessing the Context for Archival Programs in the Health
Fields," in Nancy McCall and Lisa A. Mix, eds.. Designing Archival Programs to
Advance Knowledge in the Health Fields. (Baltimore: Johns Hopkins University
Press, 1994).

41. The Johns Hopkins Health System includes the following corporations:
Francis Scott Key Medical Center, the Johns Hopkins Medical Services
Corporation, Broadway Medical Management Corporation, the Johns
Hopkins Home Care Group, Dome Corporation, Broadway Services, Inc.,
Broadway Development Corporation, Johns Hopkins Pharmaquip, Inc.,
Johns Hopkins Home Health Services, Inc., Johns Hopkins Pediatrics-at-
Home, Inc., Kennedy Krieger Institute, and Wyman Park Medical Associates,
Inc.

42. Alan Mason Chesney Medical Archives, Johns Hopkins Medical Institutions,
"Results of the Follow-up Survey of Archives and Records Management
Programs at Academic Medical Centers" (unpublished). This survey was
conducted as part of The Johns Hopkins Records Project, funded by the
National Historical Publications and Records Commission.

43. See McCall and Mix, Designing Archival Programs for an in-depth study of how
archives in the health field should function.

SELECT ANNOTATED BIBLIOGRAPHY

ACADEMIC HEALTH CENTERS

Association of Academic Health Centers. Directory. Washington, D.C.: Association
of Academic Health Centers, 1991. Defines an academic health center; lists all
members of the Association of Academic Health Centers, giving the members'
component institutions and programs.

Barondess, Jeremiah A. "The Academic Health Center and the Public Agenda:
Whose Three-Legged Stool?" Annals of Internal Medicine 115 ( 1991 ): 962-67.
Discusses the relationship between education, research, and patient care at an
academic health center.

Council of Teaching Hospitals, Association of American Medical Colleges. Commit-
tee Structure and Membership Directory 1986. Washington, D.C.: Association of
American Medical Colleges, 1991. Lists all teaching hospitals in the United
States, giving demographic information; defines the relationships between
hospitals and schools of medicine.

Krizack, Joan D. "Assessing the Context for Archival Programs in the health
fields." in Designing Archival Programs in the Health Fields, edited by Nancy

1 46 EDUCATIONAL INSTITUTIONS AND PROGRAMS FOR HEALTH OCCUPATIONS

McCall and Lisa A. Mix. Baltimore: Johns Hopkins University Press, 1994.
Uses the academic health center as a case study for a functional approach to
documentation planning.
Munson, Fred C, and Thomas A. D'Aunno. The University Hospital in the Academic
Health Center: Finding the Right Relationship, vol. 2. Washington, D.C.: Associa-
tion of American Medical Colleges and Association of Academic Health
Centers, 1987. Discusses the relationship between teaching hospitals and
educational programs in the health fields.

ARCHIVES /DOCUMENTATION PLANNING

Samuels, Helen Willa. Varsity Letters: Documenting Modern Colleges and Universities
Metuchen, N.J.: Scarecrow Press, 1992. Takes a functional approach to
documenting educational institutions.

HEALTH OCCUPATIONS

Badasch, Shirley A., and Doreen S. Chesebro. The Health Care Worker: An Introduc-
tion to Health Occupations, 2nd ed. Englewood Cliffs, N.J.: Prentice-Hall, 1988.
Provides background information about occupations in the health fields,
giving educational requirements.

Morgan, Robert L., E. Stephen Hunt, and Judith M. Carpenter. Classification of
Instructional Programs, 1990 ed. Washington, D.C.: U.S. Department of Educa-
tion, 1991. Provides comprehensive lists of the components of educational
programs in the health, life, and biological sciences.

U.S. Department of Labor, Bureau of Labor Statistics. Occupational Outlook Hand-
book, Bulletin 2250, 1986-87 ed. Washington, D.C.: U.S. Department of
Labor, 1986. Provides Department of Labor designations for occupations in
the health fields and descriptions of the educational requirements.

U.S. Department of Labor, Employment and Training Administration, U.S. De-
partment of Health, Education, and Welfare, Health Resources Administra-
tion. Health Careers Guidebook, 4th ed. Washington, D.C.: U.S. Department of
Labor, 1979. Lists all health occupations according to category; gives a de-
tailed description of each occupation, including educational requirements,
the nature of the work, and the state of the job market.

HISTORY OF THE HEALTH FIELDS / EDUCATION IN THE HEALTH FIELDS

Bordley, James, III, and A. McGehee Harvey. Two Centuries of American Medicine:
1776-1976. Philadelphia: W. B. Saunders, 1976. Covers the development of
medical schools and education programs in the United States.

Fee, Elizabeth. Disease and Discovery: A History of the Johns Hopkins School of Public
Health. Baltimore: Johns Hopkins University Press, 1987. A history of the first
school of public health in the United States.

SELECT ANNOTATED BIBLIOGRAPHY 1 47

Harris, Ruth Roy. Dental Science in a New Age: A History of the National Institute of
Dental Research. Rockville, Md.: Montrose Press, 1980. Discusses the history of
dental education in the Unites States.

Kremers, Edward. Kremers and Urdang's History of Pharmacy, revised by Glenn
Sonnedecker. Philadelphia: J. B. Lippincott, 1976. A comprehensive history
of pharmacy in antiquity, the Middle Ages, Modern Europe and the United
States; it includes a chapter on the development of American educational
programs in the field of pharmacy.

Rothstein, William G. American Medical Schools and the Practice of Medicine: A History.
New York: Oxford University Press, 1987. A thorough history of medical
education in the Unites States, leading to a thoughtful analysis of the current
situation.

REGULATION

Joint Commission on the Accreditation of Healthcare Organizations. Accreditation
Manual for Hospitals. Chicago: Joint Commission on the Accreditation of
Healthcare Organizations, 1989. Addresses accreditation requirements for
hospitals. Issued annually.

National Board of Medical Examiners, Committee on Goals and Priorities. Evalua-
tion in the Continuum of Medical Education. Report of the Committee on Goals and
Priorities of the National Board of Medical Examiners. Philadelphia: National
Board of Medical Examiners, 1973. A comprehensive discussion of accredita-
tion, licensing, certification, and regulation in education for the health fields.

National Board of Medical Examiners. In Service to Medicine, 75th anniversary
publication. Philadelphia: National Board of Medical Examiners, 1990. Pro-
vides historical information about licensing in the health professions.

Young, Kenneth E., Charles M. Chambers, H. R. Kells, et al. Understanding Accredi-
tation. San Francisco: Jossey-Bass, 1983. A comprehensive discussion of the
accreditation process; explains how accreditation came into being, what it
entails today, the role of institutions, the role of accrediting bodies, and the
relationship between accreditation and regulation.

CHAPTER 6

Professional and Voluntary
Associations

JAMES G.CARSON

Professional and voluntary associations and organizations play a major
role in the U.S. health care system. Professional associations serve as the
collective voice of the various health professions, participate in and influ-
ence the regulation of those professions, and are a major force in educat-
ing and training health practitioners. Voluntary associations are signifi-
cantly involved in providing information to the public on health matters
as well as in funding biomedical research.

Gale's Encyclopedia of Medical Organizations and Agencies, the standard
reference in this area, lists approximately 5,000 such organizations func-
tioning at the international, national, and state levels.^ Not included in
this count are nearly 2,000 county medical societies^ and untold local
chapters of major national organizations such as the American Cancer
Society and the American Heart Association.

Professional associations, as the term suggests, are organized around the
concerns of particular health professions and draw their membership
exclusively or primarily from practitioners of those professions. Their
history in the United States dates to the founding of the first provincial
medical society in New Jersey in 1766.' Such organizations act as the
collective voice of the profession they represent. Their agendas commonly
include enhancing the position of their own profession within the larger
universe of health professions and in the eyes of governmental agencies
and the public at large. Additionally, they devote themselves to setting
requirements for licensure and maintaining standards for professional
practice; to encouraging research, innovation, and education; and to
legislative lobbying and similar "mutual protection" activities.'^ In terms

149

1 50 PROFESSIONAL AND VOLUNTARY ASSOCIATIONS

of the functions of the U.S. health care system as presented in this work,
professional associations are particularly active in two areas: education
and policy formulation and regulation. Activities such as publishing jour-
nals and offering continuing education programs for members are exam-
ples of the educational function. Professional associations implement the
policy formulation and regulation function through such activities as
standard-setting and legislative lobbying. Some professional associations
may also carry out activities in the realm of health promotion, and
virtually all are involved to some extent in providing their members with
practice-related products and services such as patient education brochures
and job placement services. (This activity is to be distinguished from the
U.S. health care system's function of providing goods and services, as
defined in Chapter 1.)

Voluntary associations are typically organized around some particular
disease, issue, or constituency other than a health profession. Examples
are the American Cancer Society, the Planned Parenthood Federation of
America, and New York City's Gay Men's Health Crisis. Depending on the
nature of a voluntary association, its membership may consist predomi-
nantly of lay persons, or it may be a mixture of both lay persons and
health professionals.

Voluntary health associations trace their beginnings in the United
States at least as far back as the 1861 founding of the Civil War Sanitary
Commission, devoted to promoting proper sanitation in Union Army
troop quarters and to improving medical treatment for sick and wounded
soldiers. 5 In peacetime, voluntary associations have made major contribu-
tions to the health of the American public by such means as promoting
public acceptance of programs to control the spread of communicable
diseases, initiating research projects, and sponsoring new health services
unavailable through normal public health channels.'' These purposes
coincide neatly with three of the six major functions of the U.S. health
care system: health promotion, biomedical research, and patient care.

In the latter part of the twentieth century, the health promotion
function is the most prominent of the three in the agendas of these groups.
The patient care activities of voluntary associations have largely been
taken over by other entities. However, a few voluntary associations do
participate directly in patient care — for example, by providing guide dogs
for blind people, as do the Lions Clubs, or by rendering first aid to victims
of disasters, as do Red Cross volunteers. A few other associations retain
more indirect roles in patient care by funding institutions, such as the
Shriners' burn institutes. The involvement of voluntary associations in the
research function falls somewhere between these two extremes. Volun-
tary associations are rarely directly involved in carrying out biomedical

TYPES OF PROFESSIONAL AND VOLUNTARY HEALTH ASSOCIATIONS 151

research (with the notable exception of the American Red Cross); it is not
unusual, however, for voluntary associations to fund laboratories at
universities or other institutions.

Associations may occasionally move between the "voluntary" and
"professional" poles over time, one example being the American Heart
Association, which was originally organized as a professional society and
later reorganized as a voluntary association.^ In fact, the formation of
associations is itself a typical aspect of professionalization. The medical
historian Richard H. Shryock noted the deleterious impact of squabbles
between practitioners on the esprit de corps of physicians in the early
ninteeenth century. Their responses to this state of affairs included agitat-
ing for improved medical education, promulgating and enforcing codes of
professional ethics, and founding medical societies to place the collective
weight of the profession behind these enterprises.^ In a more modern
example, the increasing professionalization of homeopathy is evident in
the movement toward a uniform professional certification process for
homeopathic practitioners and the consequent formation in late 1991 of
the Council for Homeopathic Certification.^

The distinction between professional and voluntary organizations
becomes somewhat fuzzy in areas of alternative medicine, which lack
clear-cut credentialing procedures to define practitioners. For the most
part, however, it remains useful to think of professional associations as
those organized around the practice of specific health professions and of
voluntary associations as those devoted to specific diseases, problems,
issues, and constituencies in the health care universe.

The remainder of this chapter presents a typology of professional and
voluntary health associations, with examples of each type. It then consid-
ers the functions of the health care system that involve associations and
discusses the associations' activities that carry out those functions. Follow-
ing these sections are two case studies: one of a professional association,
the Illinois State Medical Society, and the other of a voluntary association,
the American Heart Association. The concluding section gives a brief
overview of current archival and records management activities among
health associations.

TYPES OF PROFESSIONAL AND VOLUNTARY HEALTH
ASSOCIATIONS

The universe of professional and voluntary health associations can be
classified with reasonable accuracy into eight categories of concern or
emphasis:

152

PROFESSIONAL AND VOLUNTARY ASSOCIATIONS

1. the medical profession in general;

2. medical specialties;

3. specific diseases or other medical conditions;

4. specific therapies or medical techniques;

5. allied professions and activities;

6. parallel professions;

7. alternative schools of medical practice; and

8. special concerns and constituencies.

As shown in Table 6-1, some of these categories contain both professional
and voluntary associations, in the senses defined above; some include
only one or the other.

In addition, one must note the existence of a class of umbrella
organizations whose memberships consist of other organizations or insti-
tutions rather than of individuals. Some of these umbrella organizations
fit relatively comfortably into one of the eight categories listed above.
Examples include the Federation of Orthodontic Associations and the
Federation of Prosthodontic Organizations, both of which include dental
specialty associations; the Council of Medical Specialty Societies, whose
constituency is clear from its title; and the National Health Council, whose

TABLE 6-1 Types of U.S. health associations, with examples

Professional
Association

Voluntary
Association

General medical
Specialties
Diseases

Therapies/techniques
Allied professions
Parallel professions
Alternative schools
Special concerns

American Medical
Association

American College of
Cardiology

American Society of Trans-
plant Surgeons

American Medical Writers
Association

American Dental
Association

American Holistic Medical
Association

National Medical
Association

American Red Cross

American Heart
Association

Living Bank

National Health
Federation

Gay Men's Health Crisis

TYPES OF PROFESSIONAL AND VOLUNTARY HEALTH ASSOCIATIONS 1 53

constituency includes a variety of general health associations (both pro-
fessional and voluntary). Other umbrella associations consist of institu-
tions or organizations belonging to classes treated in other chapters of this
work. The National Association of Medical Equipment Suppliers, for
example, relates to the health industries; the American Hospital Associa-
tion and the Council of Teaching Hospitals relate to health care delivery
facilities; and the Association of American Medical Colleges, the National
Association of Health Career Schools, and the American Association of
Colleges of Nursing relate to educational institutions.

GENERAL MEDICAL PROFESSIONAL ASSOCIATIONS

The "arch-organization" under this rubric is the American Medical Asso-
ciation (AMA). Founded in 1847, the AMA exerted little influence during
its first fifty years and only began to assume its current influential position
after it was reorganized in 1901 into a confederation of state medical
societies. '° As currently constituted, the AMA is a professional guild
whose membership of approximately 300,000 comprises slightly less than
half of the M.D. physicians in the United States. (This proportion has
declined slightly in recent years with the proliferation of medical special-
ties and the resulting competition for membership from specialty socie-
ties.)

Complementing the AMA are 54 state' ^ and nearly 2,000 county
medical societies whose membership consists of physicians practicing in a
particular locality. The organization of the medical profession at this level
considerably predates the formation of the AMA, and these societies are
separate from the AMA. In a handful of states, however, membership in
the AMA is a prerequisite to membership in the county and state societies.

GENERAL MEDICAL VOLUNTARY ASSOCIATIONS

Undoubtedly the most notable organization in this category is the Ameri-
can Red Cross, which has a professional staff of 23,000, nearly 2,800 local
chapters, and 1.2 million trained volunteers. "The mission of the Ameri-
can Red Cross is to improve the quality of human life; to enhance
self-reliance and concern for others; and to help people avoid, prepare for,
and cope with emergencies. "'^ In furthering this mission, the Red Cross
engages in myriad activities, notably blood bank services and disaster
relief — the latter an activity that typically involves patient care in the form
of first aid. The Red Cross also has major commitments in the area of
health promotion through such activities as blood pressure screening, first
aid training, and AIDS information campaigns. Perhaps uniquely among

1 54 PROFESSIONAL AND VOLUNTARY ASSOCIATIONS

voluntary health organizations, the Red Cross also operates its own
biomedical research facility, the Jerome H. Holland Laboratory, concen-
trating on blood-related research.

MEDICAL SPECIALTIES— PROFESSIONAL ASSOCIATIONS

The professional associations in this category include about 80 specialty
societies of physicians practicing medical specialties such as cardiology
(American College of Cardiology), oncology (American Society of Clinical
Oncology), family medicine (American Academy of Family Physicians),
and the like.'^ These societies are similar in mission to the AMA, within
the limits imposed by the particular specialties. They tend to compete for
members with the AMA, which, as mentioned earlier, has lost member-
ship (in percentage terms) as medical specialties have proliferated in
number and complexity.

Alongside these societies exist numerous, generally smaller organiza-
tions devoted to subspecialties and interdisciplinary areas. Those related
to oncology, for example, number approximately twenty, including the
Society of Gynecologic Oncologists, the International Society for Preven-
tive Oncology, and the International Association for Comparative Re-
search on Leukemia and Related Diseases. Each major specialty features a
similar constellation of subspecialty and interdisciplinary associations.

The Council of Medical Specialty Societies also deserves brief mention
in this category. It is an umbrella organization founded in 1965 that now
includes twenty-four member societies organized "to provide a forum and
communications mechanism for the exchange of information . . . , to
identify and discuss public and professional issues of mutual interest or
concern, and to provide representation to appropriate organizations."''*

Related to the specialty societies but distinct from them are the
twenty-four certification boards organized under the American Board of
Medical Specialties. These certifying boards, consisting of outstanding
experienced practitioners, administer written and oral examinations in
the various specialties and subspecialties. In 1993, 39 specialty and 72
subspecialty certificates were offered by these boards.'^ Although the
members of a certifying board are likely to be members of appropriate
specialty societies, there is no formal structural connection between the
two.i^^

SPECIFIC DISEASES OR CONDITIONS— VOLUNTARY ASSOCIATIONS

This category includes such well-known organizations as the American
Heart Association, the American Cancer Society, and the March of Dimes,

TYPES OF PROFESSIONAL AND VOLUNTARY HEALTH ASSOCIATIONS

155

as well as others devoted to a wide range of disorders such as alcoholism,
Alzheimer's disease, and lupus erythematosus. These organizations typi-
cally include, in varying proportions, physicians, other health care profes-
sionals, and lay persons with a special interest in the disease or disorder in
question. A number of the major ones (e.g., the American Cancer Society)
are organized with state and local branches.^'' The American Heart Associ-
ation also has a network of fourteen scientific councils consisting primar-
ily of physicians practicing specialties related to its mission. These councils
represent the respective specialties in the association's decisions on allo-
cating grant support for research and in determining the content of the
organization's professional education activities and public education pro-
grams. ^^

Also deserving brief mention under this heading are the Shriners,^'^ a
fraternal organization with a special interest in children's health and in
burn research and treatment, and the 1.3 million-member Lions Clubs
International, a service association that takes a particular interest in
visually handicapped people^^ and funds goods and services such as
eyeglasses, guide dogs, mobile glaucoma-screening clinics, and vision
research.

FIGURE 6-1 Shelters provided by the American Red Cross after the San Francisco
earthquake in 1906. Source: American Red Cross, National Headquarters

1 56 PROFESSIONAL AND VOLUNTARY ASSOCIATIONS

SPECIFIC THERAPIES AND TECHNIQUES— PROFESSIONAL AND
VOLUNTARY ASSOCIATIONS

Organizations devoted to individual therapies and techniques are organ-
ized around a large number of entirely mainstream health activities, such
as organ transplantation and home health care; some less traditional but
increasingly accepted techniques, such as biofeedback and acupuncture;
and a handful of more controversial practices, such as cryonics (the
freezing of a person's body after death, in anticipation of a future cure for
the fatal disease) and Rolfing, a type of massage therapy. In the former
cases, the distinction between professional and voluntary associations is
generally clear. In the area of transplantation, for example, such profes-
sional associations as the Transplantation Society and the American Soci-
ety of Transplant Surgeons are complemented by voluntary ones, preem-
inently the Living Bank and Medic Alert's Organ Donor program. To take
an example from the opposite end of the spectrum, the Bay Area Cryonics
Society consists of "individuals interested in life extension through cryon-
ics. "^^ In such a case — lacking a precise definition of what constitutes a
"professional cryonicist"^^ — the distinction between professional and vol-
untary associations is difficult to draw with any degree of confidence.

ALLIED PROFESSIONS AND ACTIVITIES— PROFESSIONAL
ASSOCIATIONS

Organizations devoted to professions such as nursing, medical records
administration, and medical writing are included under this heading. The
larger organizations, such as the 200,000-member American Nurses Asso-
ciation,^^ perform for their respective constituencies a range of functions
similar to those of the AMA. Smaller organizations have less ambitious
agendas, such as the American Medical Writers Association, which boasts
3,500 members and whose program consists largely of publications, an
annual conference, and a thorough continuing education program.^"*

PARALLEL HEALTH PROFESSIONS— PROFESSIONAL ASSOCIATIONS

This category edges into the allied professions on the one hand and the
"alternative schools" on the other hand. It clearly includes, however, a
short list of professions: dentistry, optometry, pharmacy, and veterinary
medicine. In general, these professions are characterized by the fact that
their practitioners hold doctoral level academic degrees or have under-
gone a comparably rigorous pattern of professional training. Each of these
has a national professional organization, such as the American Dental

TYPES OF PROFESSIONAL AND VOLUNTARY HEALTH ASSOCL\TIONS 1 57

Association and the American Optometric Association, similar in structure
and function to the AMA. Both of these associations also have networks of
associated state and, in the case of the American Dental Association, local
organizations.

ALTERNATIVE SCHOOLS OF MEDICAL PRACTICE— PROFESSIONAL
ASSOCIATIONS

Again, there is some fuzziness of boundaries distinguishing alternative
schools from specialties or parallel professions. Nonetheless, some entities
clearly fall into the first category; among them are homeopathy, holistic
medicine, chiropractic, and naturopathy. Professional organizations in
this realm include, for example, the American Holistic Medical Associa-
tion, American Chiropractic Association, and American Association of
Naturopathic Physicians.

ALTERNATIVE SCHOOLS OF MEDICAL PRACTICE— VOLUNTARY
ASSOCIATIONS

Possibly the preeminent voluntary alternative medicine organization is
the National Health Federation, the stated mission of which is to promote
"individual freedom of choice in matters relating to health"^^ — which in
practice means freedom to choose alternative as well as traditional thera-
peutic approaches. Some alternative medicine organizations seem to
straddle the boundary between professional and voluntary. To take one
example, the National Center for Homeopathy carries out both the educa-
tional function and the policy formulation and regulation function typical
of professional associations, the former through its associated National
Center for Instruction in Homeopathy and Homeotherapeutics,^^ the
latter through the Council for Homeopathic Certification. ^^ On the other
hand, this organization also devotes itself to health promotion in a fashion
typical of a voluntary association. For example, its annual meeting is open
to the public, and it sponsors local study groups whose clientele consists
largely of lay persons. ^^

SPECIAL CONCERNS— PROFESSIONAL ASSOCIATIONS

The preeminent examples of this category are professional associations for
racial and ethnic minorities, such as the National Medical Association
(NMA), the professional society of African-American physicians. Founded
in 1895 and "[c]onceived in no spirit of racial exclusiveness, fostering no

1 58 PROFESSIONAL AND VOLUNTARY ASSOCIATIONS

ethnic antagonism, but born of the exigencies of the American Environ-
ment, the National Medical Association has for its object the banding
together for mutual cooperation and helpfulness the men and women of
African descent who are legally and honorably engaged in the practice of
medicine. "^^ Although the need for such a parallel professional associa-
tion has diminished somewhat in the ensuing years, the NMA continues
as a forum for the special professional concerns of African-American
physicians. Like the AMA, it publishes a journal and sponsors scientific
meetings and continuing medical education courses, although it focuses
on issues pertaining to economically disadvantaged and ethnic minority
patients. Other examples of this class of associations are the National Black
Nurses Association and groups of gay and lesbian physicians.

SPECIAL CONCERNS— VOLUNTARY ASSOCIATIONS

Organizations that include both health professionals and lay persons
organized around a topic of special concern compose this category. One
example is New York's Gay Men's Health Crisis, whose mission is "to
provide support services to people with AIDS, people with AIDS-Related
Complex (ARC) and the people who love and care for them; to [inform]
the public at large, individuals at high risk for human immunodeficiency
virus (HIV) infection, and health care professionals about AIDS; [and] to
advocate for fair and effective AIDS public policy and funding."^'' Other
similar groups include the Planned Parenthood Federation of America,
whose mission encompasses public information and public policy advo-
cacy related to contraception and reproductive health,^' and the National
Safety Council, whose mission is to "influence society to adopt safety and
health policies, practices and procedures that prevent and mitigate human
and economic losses arising from accidental causes and adverse occupa-
tional and environmental health exposures. "^^

TABLE 6-2 Role of health associations in the U.S. health care system

Health Biomedical

Association Patient Care Promotion Research

Professional — x —

Voluntary x XXX x

XXX, considerable involvement; x, minimal involvement; — , little or no involvement.

HEALTH CARE SYSTEM FUNCTIONS PERFORMED BY ASSOCIATIONS 1 59

HEALTH CARE SYSTEM FUNCTIONS PERFORMED BY
ASSOCIATIONS

As noted at the beginning of this chapter, professional and voluntary
associations were once heavily involved in research and patient care. In
the latter part of the twentieth century, however, three major functions of
the U.S. health care system are significantly advanced by health associa-
tions: promoting health and health awareness on the part of the general
public; educating and training health practitioners; and formulating policy
for, and regulating the practice of, the health professions. In general, the
professional associations are most concerned with the second and third of
these functions, education and policy formulation and regulation, while
health promotion looms larger on the agendas of the voluntary associa-
tions. A number of voluntary associations also carry out programs related
to the research function (typically by funding research programs or insti-
tutions); a few also carry out patient care activities. (See Table 6-2 for a
graphic representation of the role of health associations in the U.S. health
care system.)

HEALTH PROMOTION FUNCTION— PROFESSIONAL ASSOCIATIONS

The health promotion function includes activities aimed at promoting
health, such as fitness programs and informational campaigns. Though their
principal focus is elsewhere, professional associations are by no means
absent from this arena of activity. For example, the American Dental
Association's stated mission includes promoting the dental health of the
general public." To that end, the association provides most of the dental
health educational material used in the United States and sponsors the
National Children's Dental Health Month program.^"* Similarly, the Ameri-
can Optometric Association sponsors an allied organization, the American

Regulation/Policy Provision of Goods/

Education Formation Services

XXX XXX —

X — —

1 60 PROFESSIONAL AND VOLUNTARY ASSOCIATIONS

Foundation for Vision Awareness, which supports public information cam-
paigns focusing on the importance of comprehensive vision care.'^

HEALTH PROMOTION FUNCTION— VOLUNTARY ASSOCIATIONS

The health promotion function is easily the most visible province of the
voluntary associations. Often this function is carried out through public
information campaigns. The National Safety Council, for example, produced
media campaigns during 1991 focusing on water safety and the hazards of
garage door openers.'^ The council also produces booklets and other publi-
cations for use in workplace safety training programs. ^^ Health promotion
may also be carried out in instructional programs for the public, such as the
American Red Cross courses in first aid, cardiopulmonary resuscitation, and
similar topics, which serve an annual total of 7 million people.'^

Groups devoted to specific diseases also tend to focus largely on health
promotion. The American Council on Alcoholism emphasizes public in-
formation activities to promote the prevention and early diagnosis of the
disease and rehabilitation for its victims,'^ and the National Mental Health
Association serves as the central national source for informational materi-
als on mental health and mental illness. *° The American Cancer Society's
Cansurmount program trains volunteers with histories of cancer to pro-
vide functional and emotional support to cancer patients.'*^

Organizations devoted to non-mainstream therapeutic techniques
and alternative schools of medical practice also tend to focus considerable
effort on health promotion. Examples include the American Center for
the Alexander Technique, which promotes a "technique that enables
individuals to use their bodies with ease, grace, flexibility, and freedom
from strain, "*2 and the National Center for Homeopathy, whose stated
purpose is to "promote health through the use of homeopathic medi-
cine. '"^^ In such cases, one may be inclined to question which is being
promoted — the health of the public or the use of a particular technique or
therapeutic approach. No doubt the organizations themselves would an-
swer "both," as the above quotation from the National Center for Home-
opathy suggests. However, even associations concerned with more main-
stream therapies sometimes engage in promotional activities. A number of
those concerned with transplantation, for example, have promotional
programs designed to overcome public reluctance to donate organs.

EDUCATION FUNCTION— PROFESSIONAL ASSOCIATIONS

All the major types of professional association engage in educational
activities, including general medical associations, specialty societies, and

HEALTH CARE SYSTEM FUNCTIONS PERFORMED BY ASSOCIATIONS 161

groups dedicated to specific treatments, allied professions, parallel profes-
sions, and alternative schools of medical practice. In general, the initial
education for the health professions is delivered through academic institu-
tions such as medical and nursing schools, with appropriate practical
training in patient care settings such as teaching hospitals. Professional
associations are not heavily involved in this aspect of the education
function except that they typically participate in the regulation of educa-
tional programs by accreditation or similar processes. This is discussed
later as an aspect of the policy formulation and regulation function.

Professional associations have also assumed a considerable role in
activities designed to keep health practitioners abreast of developments in
their fields. These activities include publications, meetings, and continu-
ing professional education programs. Typically, health practitioners must
participate regularly in formal continuing professional education as a
requirement for retaining licensure to practice.

The AMA, for example, publishes the well-known Journal of the
American Medical Association, and 10 specialty journals. The AMA also
offers an ongoing program of continuing education for physicians at its
Chicago headquarters, and offers practical advice to its members through
its Practice Management Department. The American College of Cardiol-
ogy considers that "continuing medical education is the College's princi-
pal priority" and operates a wide variety of continuing education pro-
grams. These include more than thirty programs on specialized topics
offered annually at the college's Bethesda, Maryland, headquarters; a
similar number of extramural programs offered at sites throughout the
United States; and the annual Scientific Session, featuring over 1,000
reports of original research, lectures, and similar presentations.'*'^ The
Association of Surgical Technologists places special emphasis on training
practitioners to pass the national certifying examination in surgical tech-
nology.'*^

EDUCATION FUNCTION— VOLUNTARY ASSOCIATIONS

The education function is dominated by the professional associations,
since participants in this function are generally health professionals.
However, participation by voluntary organizations is not unknown. For
example, the Eye Bank Association of America, a voluntary association
focused on a particular therapy, operates a program to train technicians in
enucleating (removing) eyes for transplant.^^ The Epilepsy Foundation of
America supports professional as well as public education on epilepsy,
principally by funding fellowships in the medical and behavioral sci-
ences.'*'' Organizations devoted to alternative schools of medical practice

1 62 PROFESSIONAL AND VOLUNTARY ASSOCIATIONS

often are obliged to place great emphasis on education and training, since
they may well be the only avenues through which such training is
available. For example, the Himalayan International Institute of Yoga
Science and Philosophy of the U.S.A. "operates ... a graduate school,
which offers masters degrees in Eastern Studies and Comparative Psychol-
ogy."*^

POLICY FORMULATION AND REGULATION FUNCTION-
PROFESSIONAL ASSOCIATIONS

Most professional associations perform activities related to the policy
formulation and regulation function. Policy formulation involves coordi-
nating health care services within a specified region or jurisdiction on a
suprainstitutional level. In the nature of the case, activities aimed at
implementing this function fall primarily to government and quasi-gov-
ernmental agencies. However, associations do involve themselves indi-
rectly in this area, typically through legislative lobbying to influence
policy. The AMA, among its other activities, "represents the profession
before Congress and governmental agencies. '"^^ In the specific realm of
legislative lobbying, the AMA has in some years outspent all other organi-
zations. ^^ It has been joined in the lobbying trenches by other national
organizations such as the American Dental Association, American Nurses
Association, and American Hospital Association. ^^

Another type of policy activity in which professional associations
engage is the consideration and formal adoption of policy statements on
various issues by the membership, typically through resolutions of a
legislative body such as the AMA's House of Delegates. Although this
activity does not directly affect health care delivery policy as formulated
and enforced by governmental and quasi-governmental agencies, it
makes an association's views known and feeds them into the policy-
making process.

Professional associations also engage in nonlegislative regulation ac-
tivities, regulation being defined as the setting of standards for health
practitioners and institutions. The most important and noteworthy in-
stance of such activity is the participation of professional associations in
accrediting education programs. The AMA, for example, cooperates with
other entities to set standards for hospitals, residency programs, medical
schools, and continuing medical education courses^^; it also participates in
the accreditation process for nearly twenty allied health fields. The Ameri-
can Dental Association inspects and accredits dental schools as well as
schools for dental assistants, hygienists, and laboratory technicians.''^ The
American Nurses Association issues published standards for the profes-

HEALTH CARE SYSTEM FUNCTIONS PERFORMED BY ASSOCIATIONS 1 63

sion,^'* and the National Association for the Advancement of Psychoanaly-
sis and the American Boards for Accreditation and Certification (one
organization, its title notwithstanding) sets certification standards for
individual psychoanalysts and psychoanalytic therapists. ^^

One conspicuous regulatory activity — the certification of individual
medical specialists — is largely absent from the agendas of the professional
associations, since it is generally performed by a separate system of
specialty boards that have no formal connections with the specialty
societies. Another such activity, discipline for infractions of professional
standards, is usually carried out at the local level, by a state or county
medical society rather than the AMA.

POLICY FORMULATION AND REGULATION FUNCTION— VOLUNTARY
ASSOCIATIONS

As discussed earlier, policy formulation and regulation for health profes-
sions are carried out preeminently by professional associations in con-
junction with other entities such as governmental agencies. Voluntary
associations are not appreciably involved in many aspects of this function,
such as certifying practitioners and regulating training programs. Other
activities supporting this function are, however, sometimes found on the
agendas of voluntary associations. For example, the American Council on
Alcoholism lists, among its activities, supplying expert witnesses in state
and federal proceedings involving alcohol issues. ^^ The Epilepsy Founda-
tion of America provides expert testimony in federal and state legislative
proceedings and enters amicus briefs in court cases affecting individuals
with epilepsy. ^-^

A number of large voluntary associations are considerably active on
the legislative lobbying front. For example, the cigarette-smoking ban on
domestic airline flights is largely the result of a cooperative lobbying effort
by the American Heart Association, the American Cancer Society, and the
American Lung Association. ^^ The National Safety Council has joined
with the National Highway Traffic Safety Administration and the National
Transportation Safety Board in an effort to encourage the adoption of
state laws mandating suspension or revocation of driver's licenses of
persons found driving under the influence of drugs or alcohol. ^^

OTHER FUNCTIONS OF PROFESSIONAL AND VOLUNTARY
ASSOCIATIONS

As previously discussed, most of the functions of voluntary organizations
fall into the health promotion and education realms. However, a few such

1 64 PROFESSIONAL AND VOLUNTARY ASSOCIATIONS

associations are also involved in other health care system functions. These
include, to a small extent, patient care, and to a larger extent biomedical
research. A few voluntary associations do play a role in patient care by
funding goods and services for persons suffering from particular condi-
tions. One example is the mission of the Lions Clubs to aid visually
handicapped people, which involves providing eyeglasses, guide dogs,
and mobile glaucoma-screening clinics. Another example is found in New
York's Gay Men's Health Crisis and similar organizations devoted to
people with AIDS and HIV infection. The Gay Men's Health Crisis is
heavily involved in providing direct patient services, though these services
are for the most part complementary to medical treatment as such.
Services include meals-on-wheels programs, assistance with shopping
and household tasks, and legal and advocacy services. ^° A few other
voluntary associations also participate indirectly in providing patient care
by funding institutions, such as the Shriners' burn institutes. A more
direct role in patient care is taken by the Planned Parenthood Federation,
which has a network of over 900 health care delivery facilities.^ ^

Research grant programs are funded by a number of groups such as
the American Cancer Society and the American Heart Association. In
other cases — notably, again, the Lions and the Shriners — voluntary asso-
ciations sponsor research institutions focusing on their particular areas of
interest. One exceptional voluntary association, the American Red Cross,
operates its own biomedical research laboratory. The Jerome H. Holland
Laboratory for the Biomedical Sciences, in Montgomery County, Mary-
land, opened in 1987.^^

While many of the functions of professional organizations fall into the
education, regulation and policy formulation areas, brief mention should
be made of one additional distinctive function that is not a function of the
U.S. health care system per se: the provision of various membership services
to practitioners. Professional associations, including the American Dental
Association and the AMA, have become major providers of professional
liability and other types of insurance to their members. Many, if not most,
facilitate professional placement by publishing notices of available vacan-
cies and/or by operating formal placement services. Some also offer
nonprofessional group services, such as mutual funds and other invest-
ment opportunities. Finally, virtually every professional association mar-
kets patient information brochures and similar materials to its members.
This last activity may appear to straddle the functional boundaries be-
tween health promotion, patient care, and the provision of goods and
services, but it is too prominent to neglect.

The advocacy activities of special-constituency groups also deserve
brief notice in this category. To take an example, the National Black

HEALTH CARE SYSTEM FUNCTIONS PERFORMED BY ASSOCIATIONS 1 65

Nurses Association espouses the role of advocate for improved health care
in the African-American community. ^^ Although such activities bear
some resemblance to both education and health promotion, they are
focused on the awareness of issues rather than directly on the preserva-
tion or restoration of health, and hence deserve to be considered as
distinct from either of those functions.

Finally, both professional and voluntary associations must devote a
portion of their attention and resources to the administrative function.
Again, this is not a distinctive function of the U.S. health care system, but
refers to those dealings with people, property, and money that any
organization must carry on to survive. In general, these functions in
health associations appear similar to their counterparts in other types of
association. The organizational chart of the American College of Cardiol-
ogy, for example, reveals a group of administrative committees with titles
like "Budget, Finance and Investment," "Buildings, Grounds and Acqui-
sitions," "Strategic Planning," and so forth. ^"^ Their counterparts in the
American Heart Association's Chicago chapter include "Budget, Finance
and Audit," "Management Services," and "Long Range Planning. "^^
Both professional and voluntary associations also share such administra-
tive activities as maintaining membership data bases, planning and exe-
cuting conventions, and interviewing and hiring personnel. Many volun-
tary health associations also devote considerable resources to fund raising.
For example, the American Heart Association describes "revenue genera-
tion" as one of its three principal enterprises.

FUNCTIONS OF UMBRELLA ORGANIZATIONS

The functions carried out by the umbrella associations naturally vary with
their mission and constituency. In the main, however, they tend to cluster
in the realms of education and policy formulation and regulation (which
are also the two main areas of concern to the larger class of professional
associations catering to individuals). Examples of the education function
include management education programs for medical school deans and
teaching hospital directors offered by the Association of American Medical
Colleges,^^ the American Hospital Association's in-service education pro-
grams for hospital personnel,^^ and a series of executive development
seminars for new and aspiring deans of nursing offered by the American
Association of Colleges of Nursing. ^^ Examples of the regulation and
policy formulation function include the efforts of the National Health
Council to secure uniform standards of financial reporting for voluntary
health associations^^; the National Association of Health Career Schools,
which cooperates with governments and other organizations to maintain

1 66 PROFESSIONAL AND VOLUNTARY ASSOCIATIONS

appropriate standards and policies in the realm of health career training''^;
and the National Association of Medical Equipment Suppliers, whose
lobbying influence is hinted at by its stated interest in "support [ing]
legislation and regulations that are beneficial to the home health care
industry and provide incentives for suppliers to continue to serve Medi-
care/Medicaid beneficiaries."^'

In some cases one function is overwhelmingly emphasized, owing to
the special nature of an organization's mission. Such is the case, for
example, with the Joint Commission on Accreditation of Healthcare
Organizations (JCAHO), a policy-formulating and regulating body by its
nature. JCAHO unites the American Dental Association, American Col-
lege of Physicians, American College of Surgeons, American Hospital
Association, AMA, and the public at large to establish standards and
conduct accreditation programs for hospitals, mental health centers, hos-
pice programs, and similar health care institutions and organizations.^-^
The Association of American Medical Colleges demonstrates a similar
overwhelming emphasis on the education function; alongside its many
general activities in support of medical education, this association also
administers the Medical College Admissions Test, a near-universal re-
quirement for admission to medical school. '^^

CASE STUDIES

PROFESSIONAL ASSOCIATION CASE STUDY: ILLINOIS STATE MEDICAL
SOCIETY

A typical medical professional society, the Illinois State Medical Society
(ISMS) celebrated its sesquicentennial in 1990. Thus, its 1840 founding
antedated by seven years the organization of the AMA. ISMS is now
among the half-dozen or so "unified" state medical societies — that is,
concurrent membership in the AMA is required of ISMS members. In
1990, ISMS had a membership of about 18,000, a staff of nearly 200, and
an annual budget of approximately $6.4 million. The society states as its
mission "to unite the [Illinois] medical profession behind: (I) promoting
the science and art of medicine; (2) protecting public health; (3) elevating
the standards of medical education; and (4) informing the public and the
profession of the advancements in medical science and the advantages of
proper medical care."^"* The education and health promotion functions
emerge graphically from this mission statement; regulation and policy
formulation are (as will shortly become apparent) implicit in the purpose
of "promoting the science and art of medicine." (It should be noted that
the ISMS mission statement uses "promoting" in the sense of "advanc-

CASE STUDIES 167

ing" rather than the sense intended by the term "health promotion" as
used in this work).

Health Promotion Function Although it devotes most of its efforts to
policy formulation and education, the ISMS noted in its 1990 annual
report some health promotion activities, notably directed toward adoles-
cents and senior citizens. The society's AIDS and Adolescents program,
initiated in 1987, has sent more than 300 physicians into junior high and
high schools across the state to teach students about the transmission and
prevention of AIDS. The Partners for Health program, inaugurated in
1990, provides physician speakers to senior citizen facilities to make
presentations aimed at improving communication between physicians
and older patients.

Education Function Education activities loom larger than any other
single function in the reported 1990 programs of the ISMS. These activi-
ties included continuing professional education for practicing physi-
cians — for example, producing and distributing an instructional video
tape for physicians on HIV counseling and testing, and gathering and
distributing information to physicians on contractual relationships with
health maintenance organizations and preferred provider organizations.
The ISMS also assisted in funding medical education by raising and
contributing money to provide low-interest loans to medical students; and
it engaged in education-related research, conducting a study of the merits
of individualized continuing medical education programs.

Policy Formulation and Regulation Function The 1990 annual
report of the ISMS documented an active role for the organization in
influencing health care legislation in the state of Illinois. In 1990 the ISMS
was successful in securing passage of a bill providing immunity from civil
lawsuits to physicians who volunteer time in community-based free
medical clinics, and of another bill providing similar immunity to physi-
cians who notify spouses of a patient's positive HIV test. Also on the ISMS
legislative agenda were bills mandating Medicare assignment as a require-
ment for licensure of physicians, and providing for a "Canadian-style"
universal health care system, both of which the society opposed. Through
its Third Party Payment Processes Committee, the society worked with the
Illinois Department of Public Aid to improve access to prenatal care for
recipients of public aid; and its political action committee, IMPAC, for the
first time endorsed a candidate (the eventual winner) in Illinois's 1990
gubernatorial race. Society members were also involved in revising state
regulations affecting ambulatory surgical treatment centers and clinical

168

PROFESSIONAL AND VOLUNTARY ASSOCIATIONS

FIGURE 6-2 American Red Cross disaster relief services after the San Francisco

earthquake in 1989. Source: American Red Cross, National Headquarters

laboratories, and the society was authorized to accredit continuing medi-
cal education sponsors in the state of Illinois.

Membership Services Two noteworthy ancillary activities performed
by the ISMS are examples of typical membership services. The society first
considered the possibility of providing malpractice insurance in 1916, and
its subsidiary organization, the Illinois State Medical Inter-Insurance Ex-
change, is now the seventh largest medical malpractice insurer in the
United States. The society's biweekly newspaper, Illinois Medicine, while
serving as a general news and educational vehicle for the profession, is
also a principal advertising medium for job openings for physicians in
Illinois and the surrounding area.

VOLUNTARY ASSOCIATION CASE STUDY: AMERICAN HEART
ASSOCIATION

The American Heart Association (AHA) traces its beginnings to the found-
ing of the Association for the Prevention and Relief of Heart Disease in
New York City in 1915. This and similar groups in several other cities

CASE STUDIES 169

banded together to form the American Heart Association in 1924. At first
the association consisted primarily of physicians and other health profes-
sionals. By the late 1930s, the membership had become increasingly
interested in expanding its activities to reach the general public. Its first
grant funding for a public information program, on rheumatic fever, was
received from the American Legion in 1946. With this encouragement,
the association was reorganized as a voluntary association in 1948.^^ From
that time it began to involve lay persons with skills in fund raising, public
information, business management, communications, and community
organization.^^

The AHA's simple, straightforward mission statement is as follows:
"The mission of the American Heart Association is to reduce disability and
death from cardiovascular diseases and stroke." The AHA carries on three
principal activities in support of this mission: "cardiovascular research,
cardiovascular education, and revenue generation." In terms of the divi-
sion of functions used in this study, cardiovascular research corresponds
to the research function, and cardiovascular education embraces both the
education and the health promotion functions. The third activity, revenue
generation, represents the enormous nationwide effort conducted by the
association to raise funds for its other activities, largely through volunteer
solicitation of gifts from individuals. As of 1992, the association included
approximately 2,000 state and metropolitan affiliates, divisions, and
branches, and involved some 3.5 million volunteers.

A unique feature of the AHA organization, the fourteen councils have
a collective total of 18,200 members, primarily physicians and other
health professionals. Each council is devoted to a particular specialized
area. A few examples include councils on Cardiopulmonary and Critical
Care, Cardiovascular Nursing, and Epidemiology and Prevention. The
councils are represented on the AHA Research Committee, which over-
sees the allocation of research grants; the councils also give guidance to
the AHA's professional education and public information initiatives.

Health Promotion Function Given the general predominance of this
function in the programs of most voluntary associations, it is not surpris-
ing to find that the AHA supports a wide array of community programs to
reduce death and disability from heart and blood vessel diseases. These
programs focus on a variety of topics, including heart attack, high blood
pressure, rheumatic fever, stroke, congenital heart disease, nutrition,
smoking, and cardiopulmonary resuscitation. Specific examples include
Heart at Work, a program based in the workplace that was started in 1985
and focuses on risk factors and early warning signs of heart attack; an
extensive arsenal of informational packages for elementary and high

1 70 PROFESSIONAL AND VOLUNTARY ASSOCIATIONS

school audiences; and the Tobacco Free America Project, a cooperative
enterprise with the American Cancer Society and American Lung Associa-
tion. These programs collectively accounted for an expenditure of $55.9
million during the 1990-1991 fiscal year and reached nearly 25 million
people. During the same period, AHA-sponsored cholesterol screening
and blood pressure checks reached 1.3 million people.

The AHA also dispenses information to the public through print and
electronic media; over 3,700 inquiries from members of the media were
answered by the association's National Center during 1990-1991, while
thousands more were handled by local affiliates.

Education Function Perhaps reflecting its origins as a professional
society, the AHA continues to be invested in professional education to a
degree unusual for a voluntary association. Its 1990-1991 budget for this
purpose was $30 million. The annual AHA Scientific Sessions, begun in
1925, are "now one of the nation's largest gathering[s] of scientists,
physicians and other health professionals concerned about . . . cardiovas-
cular diseases. "^^ The association also publishes eight professional jour-
nals, including Arteriosclerosis and Thrombosis: A Journal of Vascular Biology,
Currents in Emergency Cardiac Care, and Heart Disease and Stroke, a journal
inaugurated in 1992 and targeted specifically at primary care physicians.

Policy Formulation and Regulation Function As noted earlier, the
involvement of voluntary associations in this function is somewhat lim-
ited, in comparison to the professional associations. The AHA is, however,
among those voluntary associations with active lobbying presences in
Washington, D.C. The AHA Office of Public Affairs was established in
1981 "to interact with Congress and federal regulatory agencies on such
issues as biomedical research funding, tobacco control and nutrition. "^^

Other Functions Not atypically for a major voluntary health associa-
tion, the AHA's indirect involvement in biomedical research is considera-
ble. In fact, the association provides more financial support for cardiovas-
cular research than any other nongovernmental body in the world,
primarily through fellowships for scientific investigators and grants-in-aid
for specific projects. The association made a major commitment to in-
creased research funding in the late 1980s, at least partly in response to
the decline in federal support for such research. The first three AHA-
Bugher Foundation Centers for Molecular Biology of the Cardiovascular
System were opened in 1986, with the support of the Henrietta B. and
Frederick H. Bugher Foundation, at Baylor University College of Medi-
cine, in Houston, Texas, the University of Texas Southwestern Medical

CURRENT ARCHIVAL/RECORDS MANAGEMENT PROGRAMS 171

Center, in Dallas; and Children's Hospital, in Boston. Three additional
centers (at Brigham and Women's Hospital, in Boston, Stanford Univer-
sity, and the University of California at San Diego) were added in 1991.

"Revenue generation," of course, is hardly a function unique to the
U.S health care system. However, since the AHA (with refreshing frank-
ness) identifies this as one of its major enterprises, it might be noted in
passing that the 1990-1991 income of the AHA reached $288.5 million.
Of this total, $235.7 million was received as contributions from the
general public. The AHA has also had significant success in attracting
research funding from pharmaceutical companies and philanthropic
foundations.

CURRENT ARCHIVAL/RECORDS MANAGEMENT PROGRAMS IN
HEALTH ASSOCIATIONS

Not surprisingly, archival coverage of professional and voluntary health
associations is spotty at best. Of approximately 2,800 individuals listed in
the most recent (1991) membership directory of the Society of American
Archivists, fifteen, or slightly more than one half of 1 percent, were
employed by health associations. In all but one case, the employing
associations were professional organizations such as the AMA and the
American Hospital Association.^^ Of the roughly forty associations men-
tioned at one point or another in this chapter, eight are definitely known
to have ongoing archival or records management programs. These include
the American Hospital Association, AMA, American Dental Association,
American Heart Association, American Optometric Association, Illinois
State Medical Society, American Red Cross, and Planned Parenthood
Federation. Most of these programs are operated on-site by personnel of
the respective associations. In two cases, however, the association records
are instead placed in external repositories: the records of the American
Red Cross are transferred to the National Archives of the United States,
and the records of the Planned Parenthood Federation are deposited in the
Sophia Smith Collection at Smith College, in Northampton, Massachu-
setts.^°

Several additional organizations — the American College of Cardiol-
ogy, the Transplantation Society, and Lions Clubs International — have
accumulated collections of historical materials, but it is not certain that
these collections are managed, organized, or added to in any systematic
fashion. Two additional associations, the American Academy of Family
Physicians and the American Academy of Pediatrics, were in the process
of beginning an archival program as of spring 1992. Thus, among the forty

1 72 PROFESSIONAL AND VOLUNTARY ASSOCIATIONS

or SO associations mentioned in this chapter, no more than one in four
appears to maintain any sort of archival or records management program.
If applied to the entire universe of perhaps 5,000 U.S. health associations,
this ratio is in all likelihood misleadingly optimistic, given the fact that
large and well-known associations are disproportionately represented
among those treated in this chapter.

Some of the programs just mentioned, notably those of the American
Dental Association, the American Optometric Association, and the Ameri-
can Hospital Association, are devoted to documenting the history of the
respective professions as well as of the associations themselves. Several
additional medical specialty societies identify themselves as maintaining
discipline history centers for their respective specialties. These include the
American Society of Anesthesiologists, American College of Physicians
(for internal medicine), American Association of Neurological Surgeons,
American College of Obstetrics and Gynecology, Oncology Nursing Soci-
ety, American Academy of Ophthalmology, American Academy of Oto-
laryngology, and American Psychiatric Association. It is not clear, how-
ever, that the discipline history activities of these societies are always
associated with an ongoing archival program comparable in scope to those
of, for example, the American Dental Association or the American Hospi-
tal Association.

An example of a professional association archives is the American
Medical Association Archives, located in the AMA headquarters building
in Chicago, where it is staffed by one full-time employee^' and holds
approximately 3,000 cubic feet of material. The AMA Archives systemati-
cally preserves record copies of association publications as well as the
official actions of the AMA House of Delegates and subsidiary committees
and councils. The archives' holdings also include audiovisual materials
prepared for public information purposes. However, it makes no consis-
tent effort to collect unpublished material that would document the
association's activities in the policy formulation and regulation realm, or
in other areas that do not inherently involve the dispensing of informa-
tion.

Among archival or records management programs in voluntary asso-
ciations, that of the American Heart Association appears to be one of the
best organized. The AHA employs one full-time records manager, sup-
ported by a budget of $3,850.^^ The program includes a written job
description for the records manager and a multipage manual for the
records management function that lists objectives for the program, char-
acteristics of records to be targeted for preservation, and a sampling of
types of record to be preserved. The reported holdings are approximately
50,000 documents, including annual reports, AHA journals and newslet-

CURRENT ARCHIVAL/RECORDS MANAGEMENT PROGRAMS 1 73

ters, by-laws, biographical materials, and numerous other types of docu-
ments.

These two examples are, as suggested above, highly atypical. Many
other health associations are small, shoestring operations, and it should
hardly be surprising to find that they lack the resources to place a high
priority on the systematic documentation of their operations. Others —
notably AIDS organizations — are growing explosively to meet expanding
need, but may well prefer to devote all their resources to their primary
missions rather than to documentation efforts. ^^ This interpretation seems
to be supported by one response to my request for information, that of the
Gay Men's Health Crisis, which sent an impressive total of twenty-six
pieces of AIDS information literature^'^ while passing over the issue of
archival/records management activities in complete silence. ^^

A related area of concern is the collecting of health association records
by repositories outside the associations themselves. This topic was
touched on briefly earlier in this section, with reference to the records of
the American Red Cross and the Planned Parenthood Federation, which
are deposited, respectively, in the National Archives of the United States
and the Sophia Smith Collection at Smith College. In these two cases, the
presence of the associations' records in the archives is the result of an
ongoing cooperative arrangement between association and repository.

In many other cases, however, health association records are collected
not under such continuing arrangements, but as a result of one-time
transfers to external repositories. A search of standard national biblio-
graphic resources for archival and manuscript collections revealed about
1 30 entries for health association records in external repositories — at first
blush, a mildly encouraging figure. ^^ However, the overwhelming major-
ity of these entries — 95 of 130 — represent collections from state and local
medical and specialty societies, deposited for the most part in university
libraries or local historical societies. ^^ Of the remaining thirty-five entries,
about twenty represent state and local voluntary association records,
from, for example, local Red Cross Chapters and the Wisconsin Lung
Association, also preponderantly in university and historical society col-
lections. Only about 1 5 entries represent national associations — ten pro-
fessional (e.g., the American Society for Clinical Investigation and the
American Association for Medical Systems and Informatics) and five
voluntary (e.g., the American Council on Alcohol Problems, the Associa-
tion for Voluntary Sterilization). Thus, at the national level, the collecting
of archival and manuscript material from health associations seems to be,
if anything, less commonplace among external repositories than among
the associations themselves.

It seems clear, then, that in the realm of health associations there is

1 74 PROFESSIONAL AND VOLUNTARY ASSOCIATIONS

need both for vastly increased documentation efforts and for shrewd
priority-setting in those efforts, which obviously must be selective in
terms of both organizations and functions targeted for documentation. It
is hoped that this chapter provides a framework for making these difficult
decisions.

ACKNOWLEDGMENTS

My first debt of gratitude is owed to Victoria A. Davis, who encouraged me
to continue her work on this project after her departure from the Ameri-
can Medical Association. I wish to thank the staffs of the AMA library and
the library systems of the University of Illinois at Chicago and Loyola
University of Chicago. For assistance in gaining access to these libraries, I
thank the late Ann Faulkner, formerly Assistant Dean of the Graduate
School at Loyola, and Karen Graves, formerly at the AMA, now acting
documents librarian at the University of Illinois at Chicago.

I also thank association staff members who went to considerable
trouble to provide me with information about their respective associa-
tions: Rebecca Rhine Gschwend, Council of Medical Specialty Societies;
Susan Lucius, American Heart Association (National Center); Lynn Gigli-
otti, American Heart Association of Metropolitan Chicago; Linda Hudson,
Illinois State Medical Society; Jerry Knoll, American Red Cross; Charlotte
A. Rancilio, American Optometric Association; Jennifer C. Wellman,
National Center for Homeopathy; Patrick F. Cannon, Lions Clubs Interna-
tional; Robert W. O'Brien, National Safety Council; Suzanne H. Howard,
American College of Cardiology; Patrick Giles, Gay Men's Health Crisis;
Gloria A. Roberts, Planned Parenthood Federation of America; Michelle
Armstrong, Association of Surgical Technologists; and J. Lee Dockerly,
American Board of Medical Specialties. I am also grateful to archival
consultant Cynthia Swank, of the Inlook Group, for information on the
Epilepsy Foundation of America, and to fellow author Peter Hirtle, of the
National Archives and Records Administration, for assistance with online
searching of the Research Libraries Information Network.

NOTES

L Encyclopedia of Medical Organizations and Agencies (Detroit: Gale Research, 1987
[2nd ed.j, 1990 [3rd ed.], and 1992 [4th ed.]) (hereafter cited as EMOA-2.
EMOA-3, and EMOA-4, respectively). The actual number of listings in EMOA
is over 12,000; however, this count includes government agencies, funding

NOTES 175

organizations, and research centers and institutes, all of which fall outside the
scope of this chapter.

2. Paul J. Feldstein, Health Associations and the Demand for Legislation: The Political
Economy of Health (Cambridge, Mass.: Ballinger, 1977), 28.

3. Paul Starr, The Social Transformation of American Medicine: The Rise of a Sovereign
Profession and the Making of a Vast Industry (New York: Basic Books, 1982), 40.

4. James M. Rosser and Howard E. Mossberg, An Analysis of Health Care Delivery
(New York: John Wiley & Sons, 1977), 33-34.

5. Page Smith, Trial by Fire: A People's History of the Civil War and Reconstruction
(New York: McGraw-Hill, 1982), 393-99.

6. Lloyd E. Burton and Hugh H. Smith, Public Health and Community Medicine
(Baltimore: Williams & Wilkins, 1970) 60. Quoted in Rosser and Mossberg,
Health Care Delivery, 29.

7. These events took place in 1924 and 1948, respectively. The American Heart
Association is discussed as a case study in a later section of this chapter.

8. Richard H. Shryock, The Development of Modern Medicine (Madison: University
of Wisconsin Press, 1979), 267, and Medicine in America: Historical Essays
(Bahimore: Johns Hopkins Press, 1966), 154, 157.

9. Homeopathy Today, April 1992 (Fairfax, Va.: National Center for Homeopathy),
21.

10. Starr, American Medicine, 91, 109. In 1901 the AMA House of Delegates was
established, with membership drawn primarily from representatives of the
state societies in proportion to the states' membership. This replaced the
previous haphazard system that gave undue influence to physicians who
lived near the sites of annual meetings. The change provided greater
continuity and authority in the AMA's own decision-making and gave rise to
dramatic increases in the state societies' membership and influence.

11. The count of 54 includes the 50 states plus "state-type" associations in the
Distria of Columbia, Guam, Puerto Rico, and the Virgin Islands.

12. "The American Red Cross: People Helping People" (American National Red
Cross, Washington, D.C.: 1989, Brochure). This information about the Red
Cross is drawn from recent publications provided by the organization itself.

13. Since medical specialties are, by definition, health professions, there are no
voluntary associations devoted to medical specialties as such.

14. Council of Medical Specialty Societies Mission Statement (Council of Medical
Specialty Societies, Lake Forest, 111. February 1992).

15. J. Lee Dockery, M.D., Executive Vice President, American Board of Medical
Specialties, telephone conversation with author, 2 Nov. 1993. The aaual
number of distinct subspecialties in which certificates are offered is somewhat
less than 72 because of overlap among the subspecialty certificates offered by
the 24 boards; for example, the boards in family practice, internal medicine,
and pediatrics all offer subspecialty certification in sports medicine.

16. Rebecca Rhine Gschwend, Acting Executive Vice President, Council of
Medical Specialty Societies, telephone conversation with author, 18 May
1992. Informal relationships between specialty certification boards and

1 76 PROFESSIONAL AND VOLUNTARY ASSOCIATIONS

specialty societies reportedly run the gamut from close cooperation to mutual
suspicion and antagonism.

1 7. This is both similar to and in contrast with the relationship between the AMA
and the state and local medical societies, which are separate but related
organizations, rather than "chapters" or "branches" of the AMA.

1 8. American Heart Association, American Heart Association Scientific Councils and
Journals (Dallas: American Heart Association, 1991), 1.

19. The full name of the Shriners is the Imperial Council of the Ancient Arabic
Order of the Nobles of the Mystic Shrine for North America.

20. EMOA-2, 758.

21. EMOA-2, 235. This organization is not listed in the third or fourth editions.

22. The Bay Area Cryonics Society did not respond to my request for a statement
of its views on this issue of definition.

23. EMOA-4, 644.

24. This information is drawn from recent brochures provided by the association.

25. EMOA-4, 23.

26. Advertisement for 70th annual summer instructional program. Homeopathy
Today, April 1992, 18.

27. Harry F. Swope, and Randall Neustaedter, "Council for Homeopathic
Certification moves ahead," Homeopathy Today, April 1992, 21.

28. National Center for Homeopathy, Homeopathy: Natural Medicine for the 21st
Century (Fairfax, Va.: National Center for Homeopathy, 1992), 7-8.

29. This statement, written in 1908 by Charles V. Roman, a past president of the
NMA, is carried on the title page of every issue of the NMA Journal.

30. "GMHC: First in the Fight Against AIDS" (Gay Men's Health Crisis, New York,
1992, Brochure).

31. "Mission and Policy Statements" (Planned Parenthood Federation of
America, New York, 1990), 2.

32. National Safety Council, Looking Toward Tomorrow: 1991 Report to the Nation
(Chicago: National Safety Council, 1991), 2.

33. "Connections: 1992 Member Services Guide" (American Dental Association,
Chicago, 1992), 4.

34. EMOA-4, 269.

35. "American Optometric Association: A Look Behind the Logo" (American
Optometric Association, St. Louis, Mo., 1992, Brochure).

36. National Safety Council, Looking Toward Tomorrow, 14-15.

37. Ibid., 5-6.

38. "The American Red Cross: People Helping People" (American National Red
Cross, Washington, D.C., 1989, Brochure).

39. EMOA-4, 859.

40. EMOA-4, 546.

41. EMOA-3, 373.

42. Encyclopedia of Associations, 23rd ed. (Detroit: Gale Research, 1989), 1344.

43. Letter from Jennifer C. Wellman, National Center for Homeopathy, to the
author, 3 April 1992.

NOTES 1 77

44. "American College of Cardiology 1992 Fact Sheet" (American College of
Cardiology, Bethesda, Md., 1992).

45. EMOA-4, 884.

46. EMOA-4, 967.

47. Letter from Cynthia G. Swank to Joan Krizack, 19 Oa. 1992.

48. EMOA-2, 96. This organization is not listed in the third or fourth editions.

49. EMOA-4, 4.

50. Feldstein, Health Associations, 27. In 1965 the AMA spent more money
opposing Medicare during the first three months of the year than any other
lobbying organization spent during the entire year!

51. Feldstein, Health Associations, passim.

52. EMOA-4, 4.

53. EMOA-4, 269.

54. EMOA-4, 644.

55. EMOA-4, 544.

56. EMOA-4, 859.

57. Letter from Cynthia G. Swank to Joan Krizack, 19 Oct. 1992.

58. American Heart Association, American Heart Association History 1992 (Dallas,
Tex.: American Heart Association, 1992), 14.

59. National Safety Council, Looking Toward Tomorrow, 13.

60. The First Ten Years: Gay Men 's Health Crisis 1990-1991 Annual Report (New York:
Gay Men's Heahh Crisis, 1992), 3-7.

61. Planned Parenthood Federation of America, A Tradition of Choice: 1991 Service
Report (New York: Planned Parenthood Federation of America, 1991), 5.

62. American National Red Cross, The American Red Cross Biomedical Research and
Development Report, 1991 (Washington, D.C.: American National Red Cross,
1991).

63. EMOA-4, 649.

64. "American College of Cardiology Organizational Chart for Board and
Committees" (American College of Cardiology, Bethesda, Md., 1991).

65. "American Heart Association of Metropolitan Chicago Organizational Struc-
ture" (American Heart Association of Metropolitan Chicago, Chicago, 1991).

66. EMOA-4, 71.

67. EMOA-4, 459.

68. EMOA-4, 643.

69. EMOA-4, 23.

70. EMOA-4, 22.

71. EMOA-4, 415.

72. EMOA-4, 19.

73. EMOA-4, 7.

74. Letter from Linda Hudson, Vice President for Communications, Illinois State
Medical Society, to the author, 5 Feb. 1992. All information given about the
Illinois State Medical Society in this section is based on material provided by
the society itself.

75. This development coincided almost exactly with the founding of the

1 78 PROFESSIONAL AND VOLUNTARY ASSOCIATIONS

American College of Cardiology (ACC) in 1949; the ACC and AHA now have
a number of joint committees and task forces.

76. American Heart Association, History 1992, 1. All information about the AHA in
this section is drawn from recent publications provided by the association itself.

77. American Heart Association, History 1992, 6.

78. Ibid.

79. The single voluntary association represented is the American Alliance of
Health, Physical Education, Recreation and Dance, headquartered in Reston,
Virginia.

80. Part of the rationale for this procedure is that the Sophia Smith Collection also
holds the papers of early birth control advocate and Planned Parenthood
founder Margaret Sanger.

8 1 . AMA Archives staff are also responsible for answering public inquiries on
current AMA policies, so the proportion of time devoted to archival funaions is
lower than the 1 FTE figure might suggest. In addition, as of November 1993 the
AMA was engaged in significant cutbacks of its library and archival operations,
so this description of the archives' operations may soon be outdated.

82. This figure presumably excludes the incumbent's salary and benefits.

83. It should be noted, however, that AIDS documentation projects are being
carried out at the University of California at San Francisco and by volunteer
archivists Kathryn Hammond Baker, Stanley Moss, and Nancy Richard at
AIDS Action Committee in Boston.

84. Gay Men's Health Crisis reports that in 1991 it distributed exactly 1,468,256
such pieces (as well as 1 , 342, 317 condoms) . One hopes that, at least, GMHC is
preserving sample copies of its literature, as well as the periodic "AIDS Fact
Sheet" from which the above statistics are drawn.

85. However, the Gay Men's Health Crisis has successfully negotiated with the
New York Public Library to house their records.

86. The sources consulted include the National Union Catalog of Manuscript
Colleaions (NUCMC) and the online databases of the Research Libraries
Information Network (RLIN) and Online Computer Library Center (OCLC).
The total of 1 30 excludes duplicate entries for the same collection in more
than one source.

87. A very high proportion of these records represent New York State and are
held by the New York Academy of Medicine; the Downstate Medical Center,
Brooklyn; and the Cornell University Archives. Probably there are other
states whose medical societies are comparably well documented but that have
not benefited from grant funding to support the entry of cataloging
information into national databases, as has been the case in New York.

SELECT ANNOTATED BIBLIOGRAPHY

There appears to be no single book-length treatment of the history and role of
health care associations, either professional or voluntary. A brief overview of
the subject appears in James M. Rosser and Howard E. Mossberg, An Analysis

SELECT ANNOTATED BIBLIOGRAPHY 179

of Health Care Delivery (New York: John Wiley & Sons, 1977), 29-35. For an
article-length treatment of a single specialty see Bertram Slaff, "History of
Child and Adolescent Psychiatry Ideas and Organizations in the United States:
ATwenlieih-CentuvY Review," Adolescent Psychiatry 16 (1989): 31-52.

The legislative lobbying activities of selected health associations, including the
American Medical Association, American Dental Association, American
Nurses' Association, and American Hospital Association, are treated in Paul J.
Feldstein, Health Associations and the Demand for Legislation: The Political Econ-
omy of Health (Cambridge, Mass.: Ballinger, 1977).

The American Medical Association has been the subject of at least three book-
length historical works, namely James G. Burrow, AMA: Voice of American
Medicine (Baltimore: Johns Hopkins Press, 1963), Frank D. Campion, The
AMA and U.S. Health Policy Since 1940 (Chicago: Chicago Review Press, 1984);
and Morris Fishbein, A History of the American Medical Association, 1847 to 1947
(Philadelphia: W. B. Saunders Co. 1947).

The field is littered with histories of state, local, and specialty societies, of variable
quality and length. A small and arbitrary sample includes James Gilliam
Hughes, American Academy of Pediatrics: The First 50 Years (Evanston, 111.:
American Academy of Pediatrics, 1980); Joseph Roy Jones, History of the
Medical Society of the State of California (Sacramento: Historical Committee of
the Sacramento Society for Medical Improvement, 1964); and Leonard A.
Lewis, "The History of the American Society for Dermatologic Surgery and Its
Impaa on the Specialty of Dermatology," Journal of Dermatologic Surgery and
Oncology 16, no. 11 (1990): 1054-56.

Among voluntary associations, the American Cancer Society seems to be unique
in having been the subject of a book-length history: Walter Sanford Ross,
Crusade: The Official History of the American Cancer Society (New York: Arbor
House, ca. 1987). A few articles (again, greatly varied in both length and
quality) have been devoted specifically to archives and archival activities of
health organizations. These include T. A. Appel, "The Archives of the Ameri-
can Physiological Society," Physiologist 27 , no. 3 (1984), 131-32; Linda Cox,
Geraldine Hutner, and Robin Kennett, "Creating the Archives," New Jersey
Medicine 85, no. 9 (1985), 734-53; Robert S. Sparkman, "The Collection and
Preservation of the Archives of the Southern Surgical Association," Annals of
Surgery 207, no. 5 (1988), 533-37; and Manfred Waserman, "A Catalogue of
the Manuscripts and Archives of the Library of the College of Physicians of
Philadelphia, by Rudolf Hirsch" [essay review]. Transactions and Studies of the
College of Physicians of Philadelphia 5, no. 4 (1983), 385-87.

The standard reference on current health associations and organizations is Encyclo-
pedia of Medical Organizations and Agencies, 4th ed. (Detroit: Gale Research,
1992).

CHAPTER 7

Health Industries

JAMES J. KOPP

Providing the goods and services that support the U.S. health care system
is the principal function of one of the largest and most profitable compo-
nents of the U.S. health care system, the health industries. This "medical
industrial complex," as it has been labeled,^ supports the other compo-
nents of the health care system by inventing, developing, and distributing
such goods as drugs and medical equipment and by providing a broad
range of services from laundering to computing. The health industries not
only provide the foundation of the health care system, but also are a
dominant force in the world of corporate America. In 1991 five of the
twenty-five most profitable U.S. companies were in the health industries.-^

The for-profit nature of most of the health industries sets them apart
from the other institutions and organizations examined in this book. Like
other components of the U.S. health care system, these industries play a
significant role in helping people — saving lives and improving the quality
of life. Because these industries are driven by the profit motive, however,
the emphasis on getting a better product or service to market faster and
with as low an overhead as possible is the measure of success and even of
survival. This chapter examines the for-profit industries that compose the
medical industrial complex.^

Health industries can be broadly grouped into two categories: those
that manufacture and distribute goods to the medical marketplace and
those that provide health-related services to physicians, hospitals, other
health care providers, and the general consumer. The two major types of
manufacturers and distributors of health care goods are pharmaceutical
companies, and medical supplies and equipment companies. Pharmaceu-

181

1 82 HEALTH INDUSTRIES

tical companies, such as Eli Lilly and Company, Merck & Co., and Bristol-
Myers Squibb, develop and manufacture drugs and related products and
deliver and provide support for these goods. Medical supplies and equip-
ment manufacturers, such as Johnson & Johnson (which also manufac-
tures pharmaceuticals) and Baxter International, are responsible for the
design, manufacture, delivery, and support of a wide range of products,
including surgical and medical instruments, x-ray equipment, contact
lenses, and snakebite kits. A third type of industry, often overlooked in
examinations of the medical industrial complex but of significant impor-
tance in the delivery and support of health care in the late twentieth
century, is medical publishing. Medical publishers range from companies
that publish in all disciplines, such as McGraw-Hill, to companies that
focus solely on scientific and medical literature, such as Gower Medical
Publishing. Academic and association presses are other important players
in medical publishing, but they are often less profit driven than the
commercial publishing houses.

The service segment of the health industries is vast. The largest and
most influential service industry in the United States is the health insur-
ance industry. By the late 1980s over 86 percent of the civilian population
in the United States (more than 205 million Americans) was protected by
one or more forms of health care insurance. Health insurance companies
are a large part of the profit-making segment of the U.S. health care
system. Other types of service industries include firms that support the
health industries and other elements of the health care system, such as
drug testing companies, which perform clinical trials for pharmaceutical
manufacturers, and private independent laboratories, which perform
analyses for hospitals and physicians. Health care industries that provide
services also include a broad array of other enterprises such as hospital
management firms, food services, laundry services, computing centers,
and architecture and building consultants. An example of a service indus-
try is ARA Services, which started as a supplier of vending machines in
hospital waiting rooms and is now one of the largest food service compa-
nies in the United States as well as a leading provider of uniforms, linens,
and other services to hospitals and nursing homes. Another example is
American Medical Buildings, which develops, designs, and supervises
construction of medical buildings and clinics.

This chapter examines the largest sector within each of the two broad
categories of health industries, the goods providers and the service provid-
ers. Pharmaceutical companies are examined as an example of a goods
manufacturing industry; the medical supplies and equipment industry
and medical publishing are examined in less detail. In the service sector,
the health insurance industry is discussed. The examination of pharma-

PHARMACEUTICAL COMPANIES 1 83

ceutical companies and health insurance providers begins with a historical
overview of each industry, providing a foundation for discussing the
industry's functions. These functions are explored, and similarities and
differences are highlighted.

PHARMACEUTICAL COMPANIES

The pharmaceutical industry, considered the most profitable major manu-
facturing sector since the late nineteenth century, is a large and powerful
component of the U.S. economy and of the U.S. health care system's
health industries."^ There are over 500 pharmaceutical manufacturers in
the United States and several have annual sales of over $5 billion, led in
1991 by Bristol-Myers Squibb, with sales over $11 billion, and Merck &
Co., with sales of $8.6 billion. Merck and Bristol-Myers Squibb also
ranked fourth and fifth in total profits for all U.S. corporations in 1991.^

TYPES OF PHARMACEUTICAL COMPANIES

Pharmaceutical companies can be classified into four broad groupings
according to the type of drugs they produce and how the drugs are
distributed. These groupings are^:

• ethical companies

• "over-the-counter" (OTC) companies

• generic companies

• "start-up" biotechnology and experimental companies

As for other aspects of the health industries, the distinctions between
these groups have blurred in recent years. Companies that originally
focused on one type of drug have broadened their focus to include other
types.

Ethical companies are research-based drug companies that market
their products to health care providers and delivery facilities. The term
"ethical" was first used in the early twentieth century and was meant to
denote honest. It subsequently came to apply to medicines that were not
publicly advertised.^ Examples of ethical companies are Eli Lilly and
Company, Merck & Co., and the Upjohn Company. OTC companies are
marketing-based companies that sell products directly to the consumer.
Bristol-Myers Squibb and Warner-Lambert are examples of OTC compa-
nies (although both also have prescription drug divisions). Generic com-
panies also are marketing-based companies which on patent expiration
convert proprietary products to generic drugs and sell them to health care

1 84 HEALTH INDUSTRIES

providers and delivery facilities. Examples of these companies are Mylan
Laboratories, Quad Pharmaceuticals, and Bolar Pharmaceutical Com-
pany. The biotechnology and experimental companies within the phar-
maceutical industry are research-based companies that use new tech-
niques, in particular genetic engineering and structure-based design, to
develop new products. Amgen, Biogen, and Vertex are examples of these
types of companies.

HISTORY

Some pharmaceutical companies have their roots in centuries-old tradi-
tions. Merck & Co., for example, traces its antecedents to 1668, when
Friedrich Jacob Merck purchased an apothecary in Darmstadt, Germany.^
Several American firms started in the first half of the nineteenth century,
and many others were founded later in the 1800s. The history of the
pharmaceutical industry itself, however, is little more than a century old,
its growth and development coinciding with the rise of scientific medicine
in the late nineteenth century and the simultaneous emergence of en-
trepreneurial tendencies in the U.S. health care system. The formation of
the American pharmaceutical industry was influenced by such factors as
the public health movements of the period, initial efforts at government
regulation, scientific breakthroughs such as the discovery of salvarsan
(used in the treatment of protozoan infections), changes in the educa-
tional system that produced scientists to work in this growing economy,
and even the chain drugstore movement.

Some scholars argue that the pharmaceutical industry did not evolve
into its modern form until World War II, when the focus of the industry
shifted from drug manufacturing to drug innovation. This transformation
took place in part because of the discovery of the therapeutic powers of
drugs such as the sulfonamides in the 1930s and the increased demand for
drugs during World War II. After penicillin was released for civilian use in
1945, the rate of drug innovation increased dramatically. The first half of
the 1940s saw 67 new drugs introduced into the U.S. market; by the last
half of the 1950s, this number had reached 248."^

The history of the pharmaceutical industry following World War II is
dominated by a rapid increase in scientific research and development
efforts, but other factors also played large roles. One factor was govern-
mental regulation of therapeutic drug manufacturing. Although govern-
mental control of drugs generally dates back to the 1906 Pure Food and
Drug Act, the focus of the 1906 act was largely on food adulteration and
abuse and less on drug regulation.'^ It was not until 1938, when a new
Food, Drug, and Cosmetic Act was passed, that more emphasis was

PHARMACEUTICAL COMPANIES 185

placed on drug regulation. The 1938 act, a result in part of the deaths
associated with inadequately tested new drugs such as sulfanilamide,
called for premarketing testing of drugs. However, this legislation failed to
provide an adequate regulatory agency, as the legal powers of the Food
and Drug Administration (FDA) were considered "somewhat ambigu-
ous."^^ It was not until the early 1960s when another tragedy, precipi-
tated by the use of thalidomide, led to the strengthening of the regulatory
powers of the 1938 act.^^ The 1962 amendments "empowered the FDA to
specify the testing procedure a manufacturer must use to produce accept-
able information for evaluating the NDA [new drug application]."'^ These
amendments also required for the first time that manufacturers provide
proof of the efficacy as well as safety of new drugs. Although the 1962
amendments have left a trail of controversy in the thirty years since their
passage, they have continued to serve as the basis for drug regulatory
actions. In the 1980s, largely as a result of the acquired immunodeficiency
syndrome (AIDS) epidemic, substantial rethinking of the federal regula-
tory role and of specific policies was initiated and certain changes were
proposed. One result was that in May 1987, the FDA adopted a new rule
that allowed the release of experimental drugs to individuals with AIDS
and other serious diseases before final approval of the drugs. Azidothy-
midine (AZT), shown to be an effective drug against the human immu-
nodeficiency virus, was one of the first drugs released in this manner.'"^

Governmental control of the release of new drugs is not the only
aspect of regulation that is significant in the pharmaceutical industry. The
FDA has also become increasingly involved in economic aspects of the
pharmaceutical industry, including pricing, marketing, and competition.
The Federal Trade Commission monitors economic aspects of the pharma-
ceutical industry, such as the industry's high return on equity and also
controls the advertising of OTC drugs. '^

These concerns about the pharmaceutical industry highlight another
major area of the development of the industry in the post-World War II
period: economic growth and the competition, diversification, and consol-
idation that resulted from this growth. The extent of this growth can be
demonstrated in a number of ways but perhaps none more dramatic than
the seventeenfold increase in sales of prescription drugs in the thirty years
following the end of World War II. In addition to the fact that there were
more drugs in the marketplace as a result of effective research and
development efforts, events such as the passage of Medicare and Medicaid
legislation in the mid-1960s made it easier and often cheaper for Ameri-
cans to receive drug treatment. Increased advertising, especially on televi-
sion, contributed to this growth in drug sales. Even cultural and societal
changes, ranging from such factors as an increase in stressful white collar

186

HEALTH INDUSTRIES

FIGURE 7-1 Dr. Randolph T. Major (center), Merck vice president and scientific
director, meets in 1949 with Dr. Selman A. Waksman (left), in whose Rutgers
University laboratory streptomycin was discovered, and with Sir Alexander Flem-
ing, nobel laureate and discoverer of penicillin. Source: Merck & Co., Inc., Whitehouse
Station, N.J.

occupations to the civil, political, and social upheavals that affected
Americans in the postwar decades, may have played a part in the eco-
nomic growth of the industry. As Walter Measday noted in 1977, "It may
be a commentary on our society that shipments of tranquilizers alone
today exceed the entire output of the industry in 1939 by a wide mar-
gin. "'^

The industry's growth led to significant and often brutal competition.
According to David Schwarfzman, two competitive strategies are available
to a pharmaceutical manufacturer: cutting prices or seeking innova-
tions.'^ Both tactics have been used in the pharmaceutical industry over
the past forty years to obtain a larger market share and to seek a more
favorable profit margin.

The economic growth of the pharmaceutical industry also led to
diversification and consolidation among companies involved in producing

PHARMACEUTICAL COMPANIES 1 87

drugs for the U.S. health care system. In similar fashion to other compo-
nents of the U.S. health care system, pharmaceutical companies have
increasingly become economically and organizationally parts of larger
institutions dealing with a variety of products and services. The Upjohn
Company had its origins in the late nineteenth century as the Upjohn Pill
and Granule Company with the manufacture of pills as its primary focus.
However, like other long-standing American drug-producing firms such
as Lilly and SmithKline, in the post- 1950 period Upjohn began to diversify
into such areas as agricultural and aerospace products. The diversification
at Lilly, which began pill manufacturing in 1876, included agricultural
products, which by the 1980s accounted for 30% of sales, and cosmetics,
which represented 10% of sales. ^^ In the late twentieth century, other
leading research-based drug manufacturers, such as American Home
Products, emerged as pharmaceutical giants after years of producing a
variety of other consumer products, some of which were health related. In
another aspect of economic diversification, the leading pharmaceutical
companies have become international in scope, combining with estab-
lished foreign companies or extending their own sales and manufacturing
operations beyond U.S. boundaries.

The development of the pharmaceutical industry in the twentieth
century focuses on research, innovation, and the swift delivery of prod-
ucts to the marketplace. In these characteristics, it is similar to the other
health industries discussed in this chapter. Similarly, the impact of regula-
tory agencies on health industries has become a major factor in the
post-World War II period. All these factors have an impact on the profita-
bility of these industries, which is, of course, the most critical measure of
their success.

HEALTH INDUSTRY FUNCTIONS

As noted at the outset of this chapter, the primary function of the health
industries in the U.S. health care system is the provision of goods and
services (see Table 7-1), which is composed of several activities: research
and development, marketing and sales, and production and distribution.
In addition, certain health industries are minimally involved in the health
promotion function and all engage in institutional administration.'^ (See
Table 7-2.) Most of these functions comprise specific activities within each
type of health industry, and these are discussed below. Institutional
administration, which is common to all the health industries, is discussed
briefly here for the sake of convenience. Although the discussion is brief,
the importance of the administration function in the health industries
should not be overlooked.

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CORPORATE MANAGEMENT IN THE HEALTH INDUSTRIES

As expected with for-profit businesses, the function of corporate manage-
ment is a major one in the health industries. The principal activities within
this function include:

governance
fiscal management
personnel management
operations management
facilities management
external relations

The nature and extent of each activity within each health industry depend
on the product or service, the size of the industry, and such factors as the
role of the industry in relation to broader corporate structures (e.g., parent
companies, subsidiaries, etc.).

FUNCTIONS OF THE PHARMACEUTICAL INDUSTRY

In addition to the common function of institutional administration noted
above, the pharmaceutical industry is involved in research and develop-
ment, marketing and sales, production and distribution, and health pro-
motion. Each of these functions is examined below.

Research and Development in the Pharmaceutical Industry As is

evident from the historical overview provided earlier, research is a critical
function of the pharmaceutical industry. It is, in effect, the lifeblood of the
industry. In many ways, the research efforts of pharmaceutical companies
are at the center of patient care in the United States. As Schnee and
Caglarian noted, "The primary purpose of pharmaceutical research is to
aid in the prevention, diagnosis, and treatment of disease and general
promotion of health. "^^ Three specific activities are included within the
research function in the pharmaceutical industry: research, testing, and
regulatory submission and approval.

Research Pharmaceutical companies are involved in both basic and
applied drug research. ^^ In the past two decades, the trend has been to
focus less on basic research and more on applied research. ^^ Part of the
reason for this development is that the costs of basic research have
skyrocketed since the 1960s, and the financial return on investment in
basic research has not been as great as in the two decades following World
War II. Another reason for the decline in basic research activity is that
there is a limit to the new drugs that can be discovered. New chemical

PHARMACEUTICAL COMPANIES 191

entities, the essence of new drug discoveries, are rare, and after the surge
of discovery and development in the 1940s and 1950s (when over 3,500
new products and dosage forms were introduced) it became necessary to
move into other areas of innovation. Such areas include development of
duplicate products, compounded products, and alternate dosage forms. ^^
In the 1970s and 1980s, pharmaceutical companies increasingly put a
greater emphasis on these latter categories of drug innovation.

Testing In all types of drug research, a wide range of methods of drug
testing is undertaken, including toxicology tests and clinical studies. Al-
though most drug research takes place within pharmaceutical companies
at their own expense, some aspects of this testing, such as clinical trials
(the investigation of the effects of a drug administered to human subjects),
are undertaken on contract by laboratories and other for-profit organiza-
tions outside the companies. As noted in Chapter 4, a number of multimil-
lion dollar contracts between academic medical centers and pharmaceuti-
cal companies were signed in the 1980s. In fact, the pharmaceutical
industry has a substantial history of cooperative research with American
universities, beginning in the 1920s and 1930s with such collaborative
efforts as those between Abbott Laboratories and pharmacologists at the
University of Wisconsin. ^'^

Regulatory Submission and Approval Drug testing wdthin the phar-
maceutical companies is a direct result of regulatory stipulations placed on
these companies by federal legislation. Thus the activity of preparing a
new drug for submission to the FDA is an integral activity. The process of
regulation does not apply only to the actual submission of a proposed new
drug; governmental controls also exist for most aspects of premarketing
testing, from preclinical (animal) to clinical testing. The entire process of
bringing a drug to market, from innovation to marketing, is tightly woven
with regulatory guidelines and mandates.

Marketing and Sales in the Pharmaceutical Industry In the phar-
maceutical industry, the marketing and sales function is composed of the
separate activities of marketing research and planning, advertising, and
sales (or, in the industry's terminology, detailing). ^5 a study by the
Congressional Office of Technology Assessment found that the pharma-
ceutical industry's marketing and advertising costs average about $10
billion per year.^^

Marketing Research and Planning Marketing research and planning
is in itself a business within the business of the pharmaceutical industry.

1 92 HEALTH INDUSTRIES

Pharmaceutical companies as well as outside firms undertake extensive
research and analysis of physician needs and prescribing behavior, which
provides information used to devise strategies to develop and market
products. ^^

Advertising Advertising is key to the marketing strategies of pharma-
ceutical companies. Several hundred million dollars are expended annu-
ally in the United States on drug advertising. Again, depending on the type
of company, the nature and extent of advertising varies. Ethical compa-
nies traditionally have advertised strictly to health care providers, primar-
ily through professional journals. In recent years, appeals by ethical
companies aimed directly at lay consumers have appeared in television
and magazine advertising, the method most often used by OTC compa-
nies. These ads, however, generally are not for specific products but are
used to promote corporate visibility and goodwill for the industry. Some
medical publishers, returning to tactics used in the nineteenth century,
are producing books that contain pharmaceutical advertising interspersed
with the text.^^ Free samples distributed to physicians and then passed on
to patients are used not only as a form of informal clinical evaluation of a
product but also as an effective means of promoting the product. Expendi-
tures for samples approximate those for journal advertising among the
leading pharmaceutical companies. Other promotional campaigns, such
as giveaways of pens, pads, and notebooks advertising the company and
its products, are also used by the pharmaceutical companies. In recent
years the FDA and several medical societies have sought to place restric-
tions on these giveaways. ^^

Sales (Detailing) Depending on the type of pharmaceutical company
(see Types of Pharmaceutical Companies, above), the scope of sales varies,
but the focus is generally the same: introducing new products, new
dosages, and new medical uses as well as selling existing products. Phar-
maceutical companies employ sales representatives to call on physicians,
hospital pharmacists, wholesalers, and other health care providers. Com-
panies also use direct mail campaigns, telemarketing, and, of course,
media advertising to sell their products.

Production and Distribution in the Pharmaceutical Industry Pro-
duction of goods in the pharmaceutical industry is largely driven by the
two functions of research and development and marketing and sales.
After new products are developed and approved, production is the next
step. The role of marketing and sales, however, plays an equally (and

MEDICAL SUPPLIES AND EQUIPMENT MANUFACTURERS 1 93

some might argue more) important role in production of goods. In a
for-profit corporation, the demand for the product (often largely influ-
enced by marketing and sales activity) clearly guides production. Conse-
quently, the general function of corporate management comes into play
in the production process as the various activities of fiscal management,
materials management, and even plant management may determine
production quotas and directions.

Distribution of products in the pharmaceutical industry depends on
the type of company involved. Ethical companies distribute primarily to
health care providers, whereas OTC companies focus on consumers. In
each case, wholesalers play an important role as the conduit for indirect
drug sales.

Health Promotion in the Pharmaceutical Industry "The business
of the drug industry is human health," as David Siskind noted in 1978,^°
and therefore health promotion is an integral function of pharmaceutical
companies, although one that is of less importance than the other func-
tions discussed earlier in this chapter. Insofar as much of the focus of the
pharmaceutical industry is on health care providers, the preponderance of
health promotion by the industry is directed toward physicians and others
who decide what drugs should be used. Thus, health promotion in the
pharmaceutical industry is largely an "educational effort" (the preferred
term of the industry) aimed at practicing physicians. ^^ Most of this "edu-
cation" takes place in the advertising and sales effort of the companies.
Nevertheless, promotional advertisements directed at consumers have
begun to appear on television and in magazines. In addition, some phar-
maceutical companies, in response to the rise in drug abuse and the AIDS
epidemic, are sponsoring promotional campaigns tied in to increasing
public awareness of these issues.

MEDICAL SUPPLIES AND EQUIPMENT MANUFACTURERS

Medical supplies and equipment manufacturing is a large and diverse
component of the medical industrial complex. The spectrum of products
generated by this industry ranges from Band-Aids to high technology
equipment. The 1976 Medical Device Amendments (Public Law 94-295)
to the Federal Food, Drug, and Cosmetic Act defined a medical device as
"any instrument, apparatus, or similar or related article that is intended to
prevent, diagnose, mitigate, or treat disease or to affect the structure or
function of the body."^^

1 94 HEALTH INDUSTRIES

The range of this industry is vast. Nearly 3,000 manufacturing estab-
lishments are registered with the Bureau of Medical Devices of the FDA,
and these companies produce items that fall into more than 160 Standard
Industrial Classification codes. The bulk of these products fall into six
major categories: surgical and medical instruments; surgical appliances
and supplies, dental equipment and supplies, x-ray apparatus and tubes,
electromedical equipment, and ophthalmic goods. ^^

In 1991 three companies dominated the sales in the U.S. medical
supplies and equipment market — Johnson & Johnson, with $12.4 billion
in sales, Baxter International, with $8.9 billion, and Abbott Laboratories,
with $6.8 billion. Johnson & Johnson also was the fourteenth highest
profit earning company in 1991 and of the top twenty-five corporations in
profit earnings had the largest percentage increase in profit from 1990 to
1991 (28 percent). 54

MEDICAL SUPPLIES AND EQUIPMENT MANUFACTURERS' FUNCTIONS

The functions of medical supplies and equipment manufacturers are
similar to those of the pharmaceutical companies. Research and devel-
opment, marketing and sales, and production and distribution are the
primary functions; health promotion is a secondary function. Although
the medical supplies and equipment manufacturers do not undertake
biomedical research as do the pharmaceutical companies, they do rely
on research in such areas as engineering and product development to
strengthen their position in the marketplace and bring marketable
products to consumers as quickly as possible. As in the pharmaceutical
industry, competition is keen in the areas of innovation and product
delivery. Regulatory submission and approval, although not as strin-
gent as in the pharmaceutical industry, still play a major role in the
medical supplies and equipment industry. Within the marketing and
sales function, activities similar to those of the pharmaceutical industry
can be found in medical supplies and equipment manufacturers. Mar-
keting research and planning, advertising, and sales are important.
Production is driven by market needs and corporate directions. Distri-
bution and support services are a large part of the industry, with the
support service aspect being perhaps more prominent in the medical
equipment industry than in the pharmaceutical industry, owing to the
need for technical support for equipment and other devices. As with
the pharmaceutical companies, health promotion in the form of "edu-
cating" is a function of the medical supplies and equipment industry,
which similarly targets the health care providers to whom products are
sold.

INSURANCE COMPANIES 1 95

MEDICAL PUBLISHING

Recording medical advances, knowledge, and information is an aspect of
the U.S. health care system as old as the profession itself. The industry of
medical publishing might be said to date from the eighteenth century
when publishers of medical journals first appeared regularly in Europe
although scientific and medical books had been published for centuries. In
the two centuries since that time, medical publishing has become a critical
and central part of the U.S. health care system. After World War II, and
especially beginning in the 1960s, the volume of medical publishing
increased at a dramatic rate. The information explosion characteristic of
other fields was no less evident in health care. Expansion of the medical
publishing industry to include data base creation and distribution is a
phenomenon of the computer revolution, and the National Library of
Medicine's production of MEDLINE in the 1960s was one of the earliest
developments in this area. CD-ROM publications first appeared in the
1980s, and the first electronic medical journal appeared in 1992. '^

The two dominant functions of the medical publishing industry are
the marketing and sales and the production and distribution of goods.
Unlike the other industries examined thus far, there is no direct involve-
ment in research or health promotion. The publishing industry's goods,
however, are indispensable to the operation of the U.S. health care system
as a whole and to research in particular.

INSURANCE COMPANIES

The health insurance industry, like the other health industries discussed
in this chapter, is a big business in America. Joseph Califano, in his
analysis of the "profitable acolytes" of American health care, remarked
that "the commercial insurance companies and the Blues are the money
changers, particularly in the temples of hospital care."^^ Two U.S. health
insurance companies, Aetna Life & Casualty and CIGNA, had sales in
excess of $18 billion in 1991. ^^

TYPES OF HEALTH INSURANCE

There are four predominant forms of health insurance coverage in the
United States:'^

• private for-profit (commercial insurance companies)

• private nonprofit (Blue Cross and Blue Shield)

1 96 HEALTH INDUSTRIES

• nonprofit prepayment plans (HMOs, PPOs)

• government funded programs (Medicare and Medicaid)

Within these types of insurance providers there are four basic types of
health insurance:

• hospitalization

• surgery

• regular medical expenses

• major medical expenses

Hospitalization insurance includes normal and necessary hospital ex-
penses such as the cost of the hospital room and meals, use of the
operating room, x-ray and laboratory fees, and some medicines and
supplies. Surgical insurance covers the cost of operations, up to certain
limits. Regular medical expense policies also pay for doctors' services
other than surgical treatment, either in the hospital or elsewhere. Major
medical policies protect the insured against catastrophic charges, generally
paying most costs — up to a total ranging from $10,000 to as much as
$250,000 — above an initial deductible amount that is paid by the policy
holder.39

HISTORY

Despite the tremendous volume of business in the health insurance
industry, the industry itself is a relatively recent development on the
American health care scene. Although there are nineteenth-century prec-
edents for health insurance coverage, primarily associated with fraternal
orders and industries such as lumber and mining, health insurance on an
individual or national basis was not widely accepted or desired in the
nineteenth century. The American Medical Association (AMA), in fact,
long condemned the concept of "contract practices.'"**^ The passage of a
National Insurance Act in Great Britain in 1911, combined with increasing
costs for medical care, caused Americans in the Progressive Era to become
interested in compulsory health insurance. For a variety of reasons,
however, including wavering support from the AMA and U.S. involve-
ment in World War I, interest in compulsory health insurance had largely
subsided by the end of the second decade of the century. By 1925 the New
York State Medical Society reported that health insurance was "a dead
issue in the United States.'"*'

Although the spirit of compulsory health insurance was subdued for
over a decade, the basis for a revival in interest in and support for health
insurance continued to develop. From the 1 9 1 Os to the 1 940s, workmen's
compensation was the most common form of health insurance in America

INSURANCE COMPANIES 1 97

and helped to keep the notion of some type of medical assistance alive.
The Depression years of the 1930s created the appropriate mood for
addressing the issue of health insurance for workers and the needy.
During these years several hospitals began experimenting with hospital
prepayment or insurance plans. One of the most influential of these was
the Baylor University Hospital plan, considered to be the precursor of the
Blue Cross movement.'*^ The success of the Baylor plan attracted the
interest of other hospitals, and by 1937 twenty-six such plans were in
operation. During that year the American Hospital Association and the
AMA's House of Delegates began approving such plans, and the Health
Service Plan Commission (later the Blue Cross Commission) was organ-
ized.

In the late 1930s surgical-medical plans were also being developed;
the first was the California Physicians Service in 1939. This led to the
organization in 1946 of the Blue Shield Medical Care Plans, Inc. (later
Blue Shield Commission). Even the AMA became supportive of health
insurance and created its own Associated Medical Care Plan. The medical
profession had come to see the advantages of health insurance, particu-
larly the economic ones (e.g., regular payments). A key step forward for
health insurance came through litigation when in 1948 the Supreme
Court ruled that health insurance benefits could be included in collective
bargaining.

By the early 1950s, a majority of Americans had purchased health
insurance of some type.'^^ From the 1950s to the mid-1960s, the health
insurance industry saw continuous growth. In the mid-1960s, the health
insurance industry, as well as the health care industry as a whole, changed
even more dramatically with the enactment of Medicare and Medicaid
legislation. As Ronald Numbers points out, "In 1967, just two years after
the passage of Medicare, third parties for the first time paid more than half
of the nation's medical bills. '"^^ This historic watershed set the stage for
further growth of the health insurance industry as it developed into a
multibillion dollar institution in the following decades.

From the late 1970s to the late 1980s the health insurance market
changed significantly. In the 1970s the marketplace was dominated by
commercial insurers and Blue Cross/Blue Shield plans. A decade later the
predominance of commercial insurers and the "Blues" had been eroded
by the fact that many employers were self-insured and by the significant
growth of preferred provider organizations and health maintenance or-
ganizations. One result of this change in the health insurance market was
increased competition among health insurers. This trend is likely to foster
further change in the health insurance industry in the coming decade, as is
the rekindling of the debate over national health insurance.'^^

198

HEALTH INDUSTRIES

FIGURE 7-2 A group production manager (left) watches a process operator as he
examines a sample of the active ingredient for PROSCAR, a drug for treating
benign prostatic hyperplasia, in a sterile glove box, 1991 . Source: Merck & Co., Inc.,
Whitehouse Station, N.J.

FUNCTIONS OF THE HEALTH INSURANCE INDUSTRY

The primary function of the health insurance industry in the U.S. health
care system is to provide insurance coverage. The institutional functions
within the health insurance industry are similar to those in the pharma-
ceutical and medical equipment and supply manufacturers, although the
definition and dimensions of these functions differ in the service industry
of health insurance.

INSURANCE COMPANIES 1 99

Research and Development in the Health Insurance Industry

Much of the research done by insurance companies is sociological and
economic (examining the demographics and statistics of the U.S. society
and economy) rather than biomedical, as in the case of pharmaceutical
companies. Although insurance companies are interested in basic re-
search and sponsor significant amounts of such research, the type of
research undertaken by the industry itself is largely applied. Other aspects
of the research function, as discussed for the goods manufacturers, do not
apply to the health insurance companies.

Marketing and Sales in the Health Insurance Industry As with the
pharmaceutical companies examined earlier, the marketing and sales
function in the health insurance industry can be broken down into the
separate activities of

• marketing research and planning

• advertising

• sales

Marketing research and planning in the health insurance industry, as
noted above, center largely on sociological and economic areas. As with
the pharmaceutical companies, this activity is a business in itself.
Advertising is a major activity of the health insurance companies,
although, because of increasing participation in group plans, direct
advertising to the consumer for health insurance is not as prominent as
with other types of insurance coverage (e.g., automobile insurance).
Sales in the health insurance industry generally follow along the lines
of sales in the other industries discussed earlier. The difference is that a
large portion of the insurance covering Americans is not sold directly to
the consumer but is marketed through employers or outgroup buyers.
Although the insurance salesperson remains a fixture of American
society, the emphasis of these individuals has shifted away from health
insurance to other types of insurance coverage (such as life, automo-
bile, and mortgage insurance).

Production and Distribution in the Health Insurance Industry As

a service industry, insurance involves no production of goods, distinguish-
ing this industry from the pharmaceutical and medical suppliers and
equipment manufacturers. Distribution and support services in the health
insurance industry include such activities as claims reviews and process-
ing of payments.

200 HEALTH INDUSTRIES

Health Promotion in the Health Insurance Industry Health insur-
ance companies play a strong role in health promotion, as it is in their best
interest that their clients remain healthy. Primarily as an offshoot to
advertising and marketing campaigns, health insurance companies pro-
duce items, such as pamphlets on industrial safety and video tapes on child
care, as a way to make the public aware of good health practices as well as
of the services the insurance companies offer.

RECORDS OF HEALTH INDUSTRIES

As noted at the outset of this chapter, the for-profit nature of the health
industries is an important characteristic of this segment of the U.S. health
care system. It is also a dominant factor in the documentation issues
within these industries. Documentation generated within any component
of the U.S. health care system is preserved principally for purposes of
recording the history and functions of the respective institutions. Within
the health industries, however, the relationship of this documentation to
the ongoing viability of the organization is more critical. Within the
documentation generated by the health industries lies the very success
(and potential failure, from a for-profit standpoint) of the organization.

Each function of the health industries, as examined in this chapter,
produces records that hold varying degrees of corporate secrets, strategies,
and perhaps skeletons. Issues such as corporate security and litigation
present challenges to the maintenance and availability of these materials.
The nature of the documentation, from fiscal records to research data, is
sensitive and potentially a liability to the companies. The plethora of data
gathered in the research process presents a dichotomous management
situation. On the one hand, as Samuels pointed out in relation to the
pharmaceutical companies, "The industry values information and recog-
nizes the need for long-term access for scientific, regulatory, and manage-
ment purposes.'"*^ On the other hand, these records are sensitive, for
personal as well as corporate reasons, and close control of the documents
is critical. Because of this, some companies may have initiated records
retention policies that emphasize records destruction rather than records
retention.'*'^ Such policies are counter to archival practices and, as early as
the 1960s, led to a push among archivists for companies to retain com-
pany records chronicling the success and failures of a company's history. '^^

Largely as a result of this situation, the overall status of documenting
the health industries is unclear. John Swann noted that "few drug compa-
nies maintain archives (or admit they do)."'^^ An examination of the
standard archival directories and reference tools supports Swann's assess-

NOTES 201

ment of the state of archives in the pharmaceutical industry as well as the
other industries examined in this chapter. 5*^ The few entries that exist for
the pharmaceutical industry in the Research Libraries Information Net-
work (RLIN) are generally for the personal papers of researchers who
worked for a leading pharmaceutical company, or pharmaceutical com-
pany records from the late nineteenth and early twentieth centuries that
are now housed at a college or university. There are even fewer indica-
tions of records programs in the other health industries examined in this
chapter. One interesting exception is that the records of several Silicon
Valley medical equipment companies (predominantly "high tech" com-
panies in such areas as medical imaging) are held at the Silicon Valley
Information Center. These, too, however, are the "public records" of the
companies, typically including press releases, quarterly and annual re-
ports, and Securities and Exchange Commission (10-K) reports. ^^

On the positive side, a number of archivists or records managers in the
health industries are listed in the SAA Directory. This seeming discrepancy
only reaffirms the speculation that the industries examined here may
have documentation programs in place but do not report such activities to
the standard directories, largely for proprietary and business reasons.
Without a thorough survey of the industries in question, a task beyond the
scope of this study, it is difficult to assess the total nature of documenta-
tion. However, as with other components of the U.S. health care system, it
is very likely that an increased documentation effort among the health
industries is warranted.

NOTES

1. Stanley Wohl, The Medical Industrial Complex (New York: Harmony Books,
1984), 1.

2. "Corporate Scoreboard," Business Week, 16 March 1992, 65. The five
companies are Merck & Co., Bristol-Myers Squibb, Johnson & Johnson,
American Home Products, and Eli Lilly and Company.

3. Some types of health industries, notably health insurance providers such as
Blue Cross/Blue Shield, are nonprofit and will not be discussed in detail here.
On the other hand, portions of other institutions of the U.S. health care sys-
tem are for-profit, such as some hospitals and nursing homes (see Chapter 2).

4. Jonathan Liebenau, Medical Science and Medical Industry: The Formation of the
American Pharmaceutical Industry (Baltimore: Johns Hopkins University Press,
1987), vii.

5. D. J. De Rezno, ed., Pharmaceutical Manufacturers in the United States (Park
Ridge, N.J.: Noyes Data, 1987), iii; "Corporate Scoreboard," Business Week, 16
March 1992, 65, 74.

202 HEALTH INDUSTRIES

6. Helen W. Samuels, "Documenting Modern Chemistry: The Historical Task of
the Archivist," (manuscript), 13-14.

7. (Liebenau, Medical Science and Medical Industry, 1 37, n. 18). This definition of
ethical companies has changed in the 1990s as advertising aimed at the
consumer has increasingly been used by traditional ethical companies. Still,
the products are prescription drugs that are sold to pharmacies and not to the
consumer.

8. Gary D. Nelson, Pharmaceutical Company Histories, vol. 1 (Bismarck, ND:
Woodbine Publishing, 1983), 79.

9. Meir Statman, Competition in the Pharmaceutical Industry: The Declining
Profitability of Drug Innovation (Washington, D.C.: American Enterprise
Institute for Public Policy Research, 1983), 4-6.

10. Jerome E. Schnee, "Governmental Control of Therapeutic Drugs: Intent,
Impact, and Issues," in Cotton M. Lindsay, ed.. The Pharmaceutical Industry:
Economics, Performance, and Government Regulation (New York: John Wiley &
Sons, 1978), 9. For precedents to the 1906 act, see Mitchell Okun, Fair Play in
the Marketplace: The First Battle for Pure Food and Drugs (DeKalb, 111.: Northern
Illinois University Press, 1986) and John B. Blake, ed.. Safeguarding the Public:
Historical Aspects of Medicinal Drug Control (Baltimore: Johns Hopkins Press,
1970).

11. Schnee, "Therapeutic Drugs," 10.

12. Thalidomide was found to cause severe malformations in limbs of developing
fetuses. The impact of the thalidomide episode is chronicled by Henning
Sjostrom and Robert Nilsson, Thalidomide and the Power of the Drug Companies
(Baltimore: Penguin, 1972).

13. Schnee, "Therapeutic Drugs," II.

14. Mary Graham, "The Quiet Drug Revolution," Atlantic, January 1991, 34-40.

15. Walter J. Campbell, "The Emerging Health Care Environment: Seleaed
Issues," in Lindsay, Pharmaceutical Industry , 135-136.

16. Walter S. Measday, "The Pharmaceutical Industry," in Walter Adams, ed..
The Structure of American Industry, 5th ed. (New York: Macmillan Publishing
Co., 1977), 255.

17. David Schwartzman, Innovation in the Pharmaceutical Industry (Baltimore:
Johns Hopkins University Press, 1976), 103.

18. Lilly's gross sales in 1985 were $3.27 billion, with $1.78 billion of that being
pharmaceutical products. De Renzo, Pharmaceutical Manufacturers, 94. See also
David Tucker, The World Health Market: The Future of the Pharmaceutical Industry
(New York: Facts on File Publications, 1984), 24-25.

19. The categorization here is adopted from Califano, who characterizes the
primary activities of the pharmaceutical companies as "to invent, patent, and
market drugs," and Samuels, who lists the functions of the pharmaceutical
companies as "research and development, testing of drugs, toxicology tests,
clinical studies, regulatory submissions and approval, marketing and sales,
corporate management." Joseph A. Califano, Jr., America's Health Care
Revolution: Who Lives? Who Dies? Who Pays? (New York: Random House, 1986),
124; Samuels, "Documenting Modern Chemistry," 16-17.

NOTES 203

20. Jerome E. Schnee and Erol Caglarian, "The Changing Pharmaceutical
Research and Development Environment," in Lindsay, Pharmaceutical
Industry, 9 1 .

2 1 . For a general discussion of the distinaion between applied and basic research,
see Chapter 4.

22. Schwartzman, Pharmaecutical Industry, 29.

23. Schnee and Caglarian, "Pharmaecutical Environment," 93.

24. John P. Swann, Academic Scientists and the Pharmaceutical Industry: Cooperative
Research in Twentieth-Century America (Baltimore: Johns Hopkins University
Press, 1988), 4.

25. Gilbert D. Harrell, "Pharmaceutical Marketing," in Lindsay, Pharmaceutical
Industry, 69.

26. Constance Sommer, "Drug Firms Profits Exceed Other Industries, Report
Says," Boston Globe, 26 Feb. 1993, 18. This figure is about $2 billion more than
the industry spends annually to develop new drugs.

27. Harrell, "Pharmaceutical Marketing," 72.

28. See "Whittle and Drug Companies Team Up for Medical Books," Publishers
Weekly, 17 May 1991, 44.

29. See Elisabeth Rosenthal, "Drug Companies' Profits Finance More Promotion
Than Research," New York Times, 21 Feb. 1993, 1, 26.

30. David A. Siskind, "Contributions of the Pharmaceutical Industry to Improved
Health," in Lindsay, Pharmaceutical Industry, 41.

31. Measday, "Pharmaecutical Industry," 269.

32. Federal Policies and the Medical Device Industry (Washington, D.C.: U.S.
Congress, Office of Technology Assessment, OTA-H-230, October 1984), 4.

33. 1987 Census of Manufactures (Washington, D.C.: U.S. Department of
Commerce, Bureau of the Census, 1989), 1-2.

34. "Corporate Scoreboard," Business Week, 16 March 1992, 74, 65.

35. Mark Sexton, "AMPA and STM Discuss Medical Publishing Future,"
Publishers Weekly, 13 April 1990, 40; "First Electronic Medical Journal to
Debut in 1992," Library Journal 1 Nov. 1991: 32.

36. Califano, America's Health Care Revolution, 124.

37. "Corporate Scoreboard," Business Week, 16 March 1992, 79.

38. Source Book of Health Insurance Data, 1989 (Washington, D.C.: Health Insurance
Association of America, [1989]), 7.

39. Malpractice insurance, which has played an increasingly large role in the
economics of health care since World War 11, is not treated here as "health
insurance," but it is an important segment of the insurance industry and the
U.S. health care system.

40. Ronald L. Numbers, "The Third Party: Health Insurance in America," in
Judith Walzer Leavitt and Ronald L. Numbers, eds.. Sickness and Health in
America: Readings in the History of Medicine and Public Health (Madison:
University of Wisconsin Press, 1978), 139.

41. Numbers, "Third Party," 139-141. Also see his Almost Persuaded: American
Physicians and Compulsory Health Insurance. 19 12-1920 (Baltimore: Johns
Hopkins University Press, 1978).

204 HEALTH INDUSTRIES

42. Ibid., 142. Also see Odin W. Anderson, Blue Cross Since 1929: Accountability and
the Public Trust (Cambridge, Mass.: Ballinger, 1975), 18.

43. Numbers, "Third Party," 145.

44. Ibid., 147.

45. H. E. Freeh and Paul B. Ginsburg, "Competition Among Health Insurers,
Revisited," Journal of Health Politics, Policy and Law 13 (1988): 279-91. See also
Freeh and Ginsburg, "Competition Among Health Insurers," in Warren
Greenberg, ed.. Competition in the Health Sector: Past, Present, and Future
(Germantown, Md.: Aspen Systems, 1978), and Banks McDowell,
Deregulation and Competition in the Insurance Industry (New York: Quorum
Books, 1989).

46. Samuels, "Documenting Modern Chemistry," 18.

47. The case of E. I. du Pont de Nemours & Co., although not falling into the
health industries, provides an example of this type of practice. See David A.
Hounshell, "Interpreting the History of Industrial Research and
Development: The Case of E. I. du Pont de Nemours & Co.," Proceedings of the
American Philosophical Society 134 (1990): 387^07. Such a policy at DuPont,
according to Hounshell was "designed ostensibly to protect the company" but
"comes at an extraordinary high cost: corporate amnesia." [405]

48. See Helen L. Davidson, "The Indispensability of Business Archives," American
Archivist 30 (1967): 593-97, which is based on her experience at the Eli Lilly
and Company Archives, and Davidson, "Selling Management on Business
Archives," ARMA Quarterly 33 (1969): 15-19, which discusses the types of
records to preserve for a firm involved in functions comparable to those
discussed in this chapter. An even older report, also based on the Eli Lilly and
Company Archives, is Irene M. Strieby, "All the King's Horses . . . ," Special
Libraries 50 (1959): 425-34. Another argument in favor of businesses
maintaining their own archives is John Teresko, "Should You Keep An
Archives?" Industry Week 188, 15 March 1976, 36-39.

49. Swann, Scientists and Industry, 8.

50. The 1988 edition of the National Historical Publications and Records
Commission's Directory of Archives and Manuscript Repositories in the United States
includes only two pharmaceutical entries (Abbott Laboratories and E. R.
Squibb & Sons). The health insurance industry has only one entry, that for
Blue Cross of California.

5 1 . Some of the companies included are Adac Laboratories, Circadian, Cooper
Biomedical, Rasor Associates, and Sierra Scientific.

SELECT ANNOTATED BIBLIOGRAPHY

No single comprehensive study exists for the broad field of health industries, but
many examinations of heahh care in the late twentieth century include
discussions of this important segment of the U.S. health care system. One
useful source is Joseph A. Califano, Jr., America's Health Care Revolution: Who

SELECT ANNOTATED BIBLIOGRAPHY 205

Lives? Who Dies? Who Pays? (New York: Random House, 1986). Also of use are
Stanley Wohl, The Medical Industrial Complex (New York: Harmony Books,
1984) and Barbara Ehrenreich and John Ehrenreich, The American Health
Empire: Power, Profits, and Politics (New York: Random House, 1970).

A number of general studies of the pharmaceutical industry are of note. Jonathan
Liebenau in Medical Science and Medical Industry: The Formation of the American
Pharmaceutical Industry (Baltimore: Johns Hopkins University Press, 1987)
provides an overview of the development of the industry up to the 1 930s with
a focus on Philadelphia firms. A work edited by Cotton M. Lindsay, The
Pharmaceutical Industry: Economics, Performance, and Government Regulation
(New York: John Wiley & Sons, 1978), includes several essays on various
aspects of the industry. Another essay, "The Pharmaceutical Industry," by
Walter S. Measday, in Walter Adams, ed.. The Structure of American Industry,
ed. 5 (New York: Macmillan, 1977), is still of value. A general reference
source on the industry is D. J. De Rezno, Pharmaceutical Manufacturers in the
United States. For an international focus on the industry, see Robert Ballance,
Janos Pogany, and Helmut Forstner, The World's Pharmaceutical Industry: An
International Perspeaive On Innovation, Competition, and Policy (Brookfield, Vt.:
Edward Elgar, 1992).

The medical supplies and equipment industry is less well represented in published
works. R. D. Peterson and C. R. MacPhee, Economic Organization in Equipment
and Supply (Lexington, Mass.: Lexington Books, 1973), is an older treatment
of the broad area of this industry. Various government reports on this
industry are of more value, including Federal Policies and the Medical Device
Industry (Washington, D.C.: U.S. Congress, Office of Technology Assessment,
1984). Studies of specific products are available, such as Manuel Trajtenberg,
Economic Analysis of Product Innovation: The Case ofCT Scanners (Cambridge:
Harvard University Press, 1990).

For a general overview of the medical publishing industry, see Judith S. Duke, The
Technical, Scientific, and Medical Publishing Market (White Plains, N.Y.: Knowl-
edge Industry Publications, 1985).

The health insurance industry is perhaps the most widely written about health
care industry. Almost any daily newspaper or weekly magazine contains
some item on this industry. The standard reference book on health insurance
statistics is the annually published Source Book of Health Insurance Data (Wash-
ington, D.C.: Health Insurance Association of America). Economic aspeas of
the industry are discussed in Banks McDowell, Deregulation and Competition in
the Insurance Industry (New York: Quorum Books, 1989). Ronald L. Numbers,
Almost Persuaded: American Physicians and Compulsory Health Insurance, 1912-
1920 (Baltimore: Johns Hopkins University Press, 1978) provides historical
background to the issue of health insurance in the United States.

A work focusing on the archival aspeas of business records, including pharmaceu-
tical companies, is Bruce Bruemmer and Sheldon Hochheiser, The High-
Technology Company: A Historical Research and Archival Guide (Minneapolis:
Charles Babbage Institute, Center for the History of Information Processing,
University of Minnesota, 1989).

CHAPTER 8

Documentation Planning and
Case Study

JOAN D. KRIZACK

Documentation planning is strategic planning for archives. It is an active
process that defines, within an institution or organization, which func-
tions and programs or activities will be documented and to what extent. It
also defines the purpose or purposes for which records will be collected:
institutional operations,^ historical research, or, in the case of certain
health care institutions, biomedical research. Documentation planning
specifies the goals of documentation and outlines methods of attaining the
goals. The product of documentation planning is a plan that is more
specific than a traditional collecting policy. Grounded in institutional,
interinstitutional, and system analyses, the plan identifies specific record
series for preservation. Documentation plans are not static; they should be
revised regularly to reflect changes in the institution and the larger system
of which it is part.^

Documentation planning is accomplished in two stages: analysis and
selection. The first stage consists of three layers of analysis: ( 1 ) an institu-
tional analysis, (2) a comparison of the institution with others of the same
type (regionally and nationally),^ and (3) an analysis of the relationship of
the institution to its broader context, in this case the U.S. health care
system. The selection stage consists of making decisions at three levels: ( 1 )
the function/activity level,* (2) the department or subdivision level, and
(3) the record series level.

The order in which the first two levels are addressed depends on
whether the function is the administration function or a function of a
specific type of institution. For example, a hospital's administration func-
tion may be broken down into activities (i.e., governance, external rela-

207

208 DOCUMENTATION PLANNING AND CASE STUDY

tions, fiscal management, operations management, facilities manage-
ment, and human resources management). Then the archivist identifies
the departments and records series that document these activities. All of
the remaining functions (i.e., patient care, health promotion, education,
and research), however, are documented in each of the medical and
ancillary departments. For these functions, the first level of decision-
making is the department or subdivision level, the second level is the
function level, and the third level is the record series level.

STAGE ONE: ANALYSIS

INSTITUTIONAL ANALYSIS

The basis of documentation planning is an analysis of the institution, its
relation to other institutions or organizations of the same type, and its
place in the larger environment in which it operates. These internal and
external analyses require some time and effort, but they provide a strong
foundation for formulating effective documentation plans and performing
other archival activities, such as processing and reference.
Institutional analysis consists of five elements:

1. Understanding the institution's mission and defining its functions;

2. Determining whether the institution is freestanding or part of a
larger organization (i.e., determining who owns and controls the
institution);

3. Understanding how the institution interacts with other
institutions, both public and private;

4. Becoming familiar with the institution's history and culture; and

5. Understanding institutional constraints.

Understanding the institution's mission and defining its functions involve
identifying the institution's purpose and the broad categories of activities
in which it engages. Here it is important to compare the institution's
functions with the functions of the U.S. health care system as a whole (see
Table 1-1 ), to identify any functions of the institution that are not health
care system functions, and to understand each function's relative impor-
tance. A good sense of the institution's mission and functions should
emerge from reading its mission statement, bylaws, and recent annual
reports. It may also be necessary to peruse management literature related
to the type of institution you are documenting to define appropriate
functions. This functional analysis is vital to the documentation planning
process because it provides a broad overview of the institution and

STAGE ONE: ANALYSIS 209

because it is the first and most general level at which documentation
decisions are made.

The second element of the institutional analysis is determining
whether the institution is freestanding or part of a larger organization or
corporation. This is particularly important because it affects where rele-
vant records are likely to be found and who is responsible for their
preservation. If the institution is part of a larger body, the archivist must
understand its relation and the relation of other subordinate entities to the
parent body. This information is necessary if archivists are to have a more
complete picture of their own institutions and to determine where, out-
side of the home institution, significant documentation is likely to reside.
Some archivists responsible for institutional records will, of course, be
working for the larger organization or corporation. If this is the case, they
still need to be concerned about preserving selected records of the subor-
dinate institutions.

Identifying other institutions, public and private, with which your
institution interacts and understanding the nature of the interaction is the
third element of the institutional analysis. In today's complex society,
institutions and organizations are linked to one another through coopera-
tive agreements, funding arrangements, and governmental regulation.
These interconnections, which are becoming more frequent and complex
in the face of national health care reform, affect the types of record
produced, their uniqueness, and their location. By exploring these inter-
institutional relationships, archivists may find they need not preserve
certain record series because those series are being preserved by another
institution. Carrying this idea further, archivists may use the information
gleaned from the analysis to initiate cooperative collecting agreements.

The fourth element of the institutional analysis is becoming familiar
with the institution's history and culture. Understanding the institution's
history enables the archivist to determine whether its functions and their
relative importance have changed over time and provides a basis for
comparison with other institutions of the same type, which is the next step
in the analysis stage of documentation planning. This element of institu-
tional analysis is easily accomplished if a historical volume or a series of
historical essays has been written. Otherwise, basic information on the
institution's founding, its development, and significant events in its past
may be gathered from in-house publications such as annual reports and
newsletters, local histories, and other sources.

Institutional culture may be defined as the values, beliefs, and as-
sumptions of an institution. Institutional culture is not necessarily appar-
ent from the records that institutions generate, yet a grasp of the culture is
essential to a well-crafted documentation plan. Archivists can begin to

210 DOCUMENTATION PLANNING AND CASE STUDY

understand their institutions' values, beliefs, and assumptions by discuss-
ing with appropriate administrators both the formal and the informal
channels through which policy is formulated and information is commu-
nicated, by acquiring an understanding of how the institution perceives
itself and treats its employees, and by learning about the institution's
physical environment, employee activities (such as sports competitions
and Christmas parties), rituals (service awards), and symbols (logo or
seal). 5

Understanding institutional constraints is the final element of the
institutional analysis. Whether the institution is financially sound and has
adequate personnel and space is obviously important, because these
factors will directly affect the resources available for a records program
and therefore the program's scale. If a hospital, for example, is located in
the middle of a city where space is costly and there is little room for
expansion, the archives program will likely not be assigned adequate
on-site storage space. The financial soundness of an institution may be
determined by consulting recent annual profit/loss statements (often
published in institutional annual reports) or by talking with the institu-
tion's chief financial officer. The head of human resources and the institu-
tion's facilities planner will be able to provide the information on person-
nel and space resources.

COMPARISON WITH OTHER INSTITUTIONS OF THE SAME TYPE

The second step in the analysis stage of documentation planning applies
the institutional analysis to a broader level, using it to compare a specific
institution with other institutions of the same type regionally and nation-
ally. Because such a comparison exposes the usual and unusual aspects of
an institution, it is invaluable in formulating the institution's documenta-
tion plan. The comparison should be made in terms of the institution's
mission, functions, range of activity, size, and significant "first" or "only"
accomplishments. Reading institutional histories, if available, and statisti-
cal compilations (for example, the American Hospital Association's an-
nual report of hospital statistics) is useful for making interinstitutional
comparisons. The lists of institutional types presented in Chapters 2
through 7 may be used to compare health care institutions of various
types with their peers. Archivists may also wish to consult their institu-
tion's public affairs department, which will be attuned to the special
qualities of the institution; however, archivists should keep in mind that
this department's mission is to portray the institution in the best light
possible.

STAGE TWO: SELECTION 211

RELATION TO THE U.S. HEALTH CARE SYSTEM

Broadening the analysis even further, archivists should acquire a general
understanding of the U.S. health care system and how their type of
institution or organization fits into it. This final layer of analysis, called
field analysis, provides the perspective necessary for archivists to place
their institutions in a societal context.

An understanding of these three layers of context — institutional,
peer, and systemwide (in other words, understanding the institution, its
place among similar institutions, and its relationship to the health care
system as a whole) — provides a solid foundation on which to build a
documentation plan.

STAGE TWO: SELECTION

Once the three layers of analysis have been completed, the documenta-
tion plan may be drafted. This is accomplished in four steps:

1 . defining the core record series,

2. conducting a retrospective analysis of existing historical materials,

3. conducting departmental studies, and

4. identifying significant record series for archival preservation.

Core record series are the basic series around which archivists should
shape their collections.^ As the foundation of archival collections, core
record series are the minimum documentation that should be preserved to
document broadly the functions and activities of an institution. Defining
the core record series entails first subdividing the institutional administra-
tion function into categories of activities. For example, a hospital's admin-
istration function, and probably the administrative function of other types
of institution as well, might be subdivided into the following categories of
activities: governance, external relations, fiscal management, operations
management (line activities), facilities management, and human resource
management. The administration function is emphasized at this point
because by documenting it, an archivist can gain a general overview of the
institution and all its functions.

Next, the administrative departments and offices that have significant
responsibilities for these activities are listed, along with the important
record series that they generate.^ Archivists should consult the most
recent organizational chart, institutional telephone directory, and depart-
mental and institutional annual reports, for example, to be sure they have
not overlooked any significant organizational units. It is likely that some

212 DOCUMENTATION PLANNING AND CASE STUDY

organizational units, such as purchasing, will not produce any core re-
cords series; if this is the case, they will not appear on the core list. It is
important for archivists to begin formulating the list theoretically, but also
to work from the reality of what record series are actually created.
Although virtually every institution creates annual reports, which are
important sources of information and should be part of the core record
series, other significant record series may be less obvious.

Some core record series may document more than one function, but
they should be listed only under their primary function and the office
where the (or an) original is found to avoid confusion and repetition.
When the listing of core record series is complete, it should contain only
those record series that are necessary to document a function or activity at
a general level. (See Table 8-1 for the core record series of Children's
Hospital, Boston.)

If the institution already has an archival program in existence or has a
cache of historical materials, the archivist needs to conduct a retrospective
analysis of existing historical collections to determine generally how well
the collections document the institution's functions. Depending on the
extent of the records and the complexity of the institution, the archivist
may decide to conduct a more specific collection analysis based on the
activities and projects that support the institution's functions. Such an
analysis is performed by examining all collections and deciding which
functions (and then possibly which activities or projects) the collections
document, and how well they document the functions over what period
of time.^ The results of this analysis will be more impressionistic than
scientific, but they will enable the archivist to assess the collection's
strengths and weaknesses, which will be useful information when the
documentation plan is written. This information may also lead the archi-
vist to try to locate care record series that are incomplete or missing.

If the institution has no existing archival program, then the archivist
should determine whether noncurrent records are stored in a central
location. At this point the institution's records manager should be con-
sulted. The purpose of reviewing these noncurrent record series is to
determine how well they document the institution's functions, activities,
or projects and which of them should be preserved in the archives. This
analysis should also include an assessment of significant record series that
have been lost or destroyed (if they can be identified) and the functions
they would have documented. Again, this analysis will inform the docu-
mentation plan.

The next step in the selection process involves studying the institu-
tion's medical departments and other nonadministrative units. The func-
tions other than institutional administration (i.e., patient care, health

STAGE TWO: SELECTION 213

TABLE 8-1 Children's Hospital's core records series

All Functions (function level)

All departments, and other organization units (organizational unit level)

Annual reports of the department/unit (record series level)

Departmental committee minutes

Departmental organization charts

Departmental policy and procedure manuals

Departmental publications (e.g., newsletters, brochures, updates)

Photographs, films, slides, etc., of department staff, interiors, and events

Institutional Administration (function level)
External Relations (activity level)

CEO's office (organizational unit level)

Correspondence file (record series level)
Department of Development and Public Affairs

Official institution publications {The News, Children's Today, Children's World,

Inside Children 's, Pediatric Views)
Photograph/slide files
Press releases

Promotional videotapes of Children's Hospital
Governmental and Community Relations Office
Correspondence file

Fiscal Management

Vice President for Finance's office
Annual profit/loss statements
Audited financial reports (institutional)

Operations Management
Research Administration

Investigator profiles (annual compilation of institutional research activity)
Committee minutes (Enders Faculty Council Steering, Awards, Education,
Facilities, Research Computing, and Technology Transfer)
Vice President of Medical Affairs' Office
Medical staff bylaws
Medical staff correspondence file
Medical staff directories

Minutes of medical staff standing committees (Cardiopulmonary Resuscita-
tion Committee, Clinical Investigation, Credentials, Disaster Control, Ethics
Advisory, Infection Control, Medical Records, Medical Staff Executive,
Nutrition Advisory, Oncology, Pharmacy, Quality Improvement, Radiation
Safety, Senior Appointments, Special Care Units [Multidisciplinary Inten-
sive Care Unit, Cardiac ICU and Newborn ICU], Tissue, and Transfusion)
Rules and regulations of the medical staff
Vice President for Operations' Office
Resident Handbooks

Facilities Management
CEO's Office
Property deeds

(continued)

214 DOCUMENTATION PLANNING AND CASE STUDY

TABLE 8-1 Children's Hospital's core records series (continued)

Facilities Management (continued)
Engineering office

Blueprints for building(s)
Facility Planning office

Planning reports

Photographs/slides of buildings

Correspondence file
Vice President for Operations

Correspondence file

Human Resource Management
CEO's office

Professional staff correspondence
Communications

Children's Hospital telephone directories
Human Resources

Employee handbook

Hospital policy and procedure manuals

Governance
CEO's office

Annual or periodic reports of CEO

Articles of incorporation

Charter

Constitution and bylaws

Minutes of medical center/hospital standing committees (Audit, Develop-
ment, Executive, Facility Planning, Finance, Investment, and Patient Care
Assessment)

Organizational charts

Patient Care

Admitting, Emergency Services, and Operating Room
patient logs (currently online)

Development and Public Affairs office

Directory of Medical Staff and Ambulatory Programs

Medical Records Department
Disease index (online after 1979)
Patient records index (online after 1979)

Department of Laboratory Medicine
Laboratory handbooks

Health Promotion
Health Information Department
Occasional publications

Education
Human Resources
Training Handbook

STAGE TWO: SELECTION

215

FIGURE 8-1 Operating room in Children's Hospital, Boston, 1932.
dren's Hospital Archives

Source: Chil-

promotion, education, and biomedical research) are emphasized from this
point forward. The selection process now changes from that used to
identify the core record series: the organizational units become the first
level of selection, after which come the function/activity level and then
the record series level. This process is appropriate because in most of the
U.S. health care system's institutions the patient care, health promotion,
education, and biomedical research activities are inextricably linked at the
departmental level. The first step is to list the medical and other nonad-
ministrative departments. These units may be subdivided as necessary.
For example, at Children's Hospital some of the medical departments are
subdivided into divisions and subdivisions. (See Table 8-2.) Then the
archivist conducts a study of each organizational unit, talking with the
unit's head or another designated representative and the individuals
responsible for managing the unit's records to better understand how it is
organized and what it does. Through this process the archivist gathers
background information and determines what core record series the
department generates (e.g., departmental annual reports, minutes of
departmental committees, photographs and other audiovisual materials,
departmental newsletters or other publications, departmental policy and

216 DOCUMENTATION PLANNING AND CASE STUDY

TABLE 8-2 Departments or services engaging in patient care, health
promotion, biomedical research, and educational activities

Medical Departments

Anesthesia

Cardiology and Cardiovascular Surgery

Dentistry

Medicine

Adolescent and Young Adult Medicine

Emergency Medicine

Endocrinology

Gastroenterology and Nutrition (one program)

Clinical Gastroenterology and Nutrition
General Pediatrics (eleven programs)

Child Development Unit

Clinical Pediatrics Program

Community and Support Services

Comprehensive Child Health

Developmental Evaluation Center

Family Development Program

Martha Eliot Health Center

Medical Diagnostic Programs

Pediatric Group Associates

Pharmacology-Toxicology Program

Services to Handicapped Children
Genetics (one program)

Clinical Genetics
Hematology and Oncology
Immunology (four programs)

Allergy

Dermatology

Clinical Immunology

Rheumatology
Infectious Diseases
Nephrology
Newborn Medicine
Pulmonary Medicine (one program)

Cystic Fibrosis Research Laboratories
Inpatient Services (eight programs)

Blackfan Service (school-aged children)

Bone Marrow Transplantation Service

Clinical Research Center Service

Janeway Service (adolescents)

Medical Intensive Care Service

Neonatal Intensive Care Service

(continued)

STAGE TWO: SELECTION 217

TABLE 8-2 Departments or services engaging in patient care, health
promotion, biomedical research, and educational activities

(continued)

Inpatient Services (eight programs) (continued)
Oncology Service
Rotch Service (infants and toddlers)

Neurology

Neurosurgery

Ophthalmology

Orthopaedic Surgery
Sports Medicine

Otolaryngology and Communication Disorders
Communication Enhancement Center

Pathology

Psychiatry
Psychology

Radiation Therapy

Radiology
Nuclear Medicine

Surgery
Gynecology
Plastic Surgery
Urology

Other Nonadministrative Departments /Units

Department of Laboratory Medicine

Information Service

Nursing

Nutrition and Food Service

Pastoral Care

Patient Activities

Pharmacy

Physical Therapy

Quality Improvement

Respiratory Therapy

Social Work

Utilization Review

Volunteers

218 DOCUMENTATION PLANNING AND CASE STUDY

procedure manuals). The archivist then identifies for preservation any
additional record series that best document the department.^

It is possible to decide not to document a particular division or
subdivision beyond the information contained in department-level rec-
ords. If, however, a division or subdivision is identified for further docu-
mentation, it is necessary for the archivist to meet with the division head
to identify record series for preservation. I found medical department
chiefs helpful in identifying those divisions and subdivisions significant
enough to be documented beyond the general level of information pro-
vided by records at the department level.

The selection process will assuredly not progress as smoothly as
suggested here. There may be times when records must be appraised
before the documentation plan has been completed because a department
is moving or an individual is retiring or has died, and there may be times
when a deparment head refuses to cooperate in the documentation
planning process. Although documentation plans are formulated from the
top down, the planning process also involves simultaneously working at
the unit level from the record series up. There is no specific formula that
can be used, but the archivist's ability to move from conceptualization to
archival reality and back again is essential to crafting a good plan.

At this point, if the institution is limiting its collecting scope to archival
records, the documentation plan is complete. If, however, the institution
wishes to acquire manuscript materials (papers of individuals and records
of outside organizations) or artifacts to complement its archival records,
then the documentation plan should conclude with detailed selection
criteria for manuscripts and artifacts. These criteria are part of a traditional
collecting policy.

DOCUMENTATION PLANNING: PRACTICAL ASPECTS

The first part of this chapter defined a documentation plan and described
the components of the planning process: background analysis and selec-
tion. The remainder of this chapter describes the practical aspects of
documentation planning and provides an example of a portion of a
documentation plan, that formulated for Children's Hospital, Boston.

ADMINISTRATIVE FOUNDATION

Building institutional support at various levels is critical to successful
documentation planning. After the archivist enlists the support of her or
his immediate supervisor, the next step is to gain the active support of the

DOCUMENTATION PLANNING: PRACTICAL ASPECTS 219

institution's chief executive officer (CEO) for the program. In fact, it is
helpful if the archivist sends out a letter, over the CEO's signature, to all
departments explaining the documentation planning project and request-
ing their cooperation. To gain CEO support, however, it may first be
necessary to have the support of other administrators, such as vice presi-
dents, legal counsel, department heads, and laboratory directors. Realisti-
cally, in some institutions it may not be possible to obtain the support of
key administrators. In that case, gather whatever support you can while
you keep trying to win the support of the other institutional leaders. The
worst case is that you may have to wait for top-level support until the
administration changes.

ARCHIVES COMMITTEE

While the archivist is securing the authority to carry out the documenta-
tion planning project, the archives committee is assembled. The commit-
tee should consist of records creators, users, and preservers: the archivist,
the records manager (who may be the same individual as the archivist),
the librarian, key administrators from each functional area, historians of
medicine or other historical researchers interested in topics documented
by the institution's records, a representative from the institution's legal
department, and a trustee or overseer. If the CEO or executive vice
president can be enlisted to serve on the committee, so much the better.
Others may be added to the team as appropriate. In the case of a hospital
that engages in biomedical research, for example, a physician, the medical
records specialist, and a biomedical researcher should be recruited to serve
on the committee. Although the archivist will effectively chair the com-
mittee, it is important that another committee member be the nominal
chair. Someone with greater institutional influence will usually be more
effective in accomplishing the committee's goals. In the hospital setting, a
senior staff physician or vice president is an appropriate archives commit-
tee chair.

DOCUMENTATION PLAN ARTICULATION

The heart of the documentation planning process is writing the documen-
tation plan. As mentioned earlier, the plan specifies what will be docu-
mented within each department and identifies specific record series that
will be preserved in the archives. Once information on existing historical
collections and/or noncurrent record series has been accumulated, the
archivist engages in additional analytical work, classifying the medical and
other nonadministrative departments and their subunits. The next steps

220 DOCUMENTATION PLANNING AND CASE STUDY

are to understand departmental functions and activities, and finally to
identify the record series that document their functions.

After selected record series have been designated to come to the
archives, the documentation plan is complete. For institutions or organi-
zations founded before the post-World War II "information explosion"
the archives committee may wish to select a date before which all or
virtually all records will be kept. It should be emphasized that the archivist
begins formulating the documentation plan theoretically, but as the re-
cords are reviewed, the plan will be revised as necessary to reflect the
reality of what records are actually generated. Annual notices should be
sent to organizational units to remind them of their agreement to send
specified material to the archives, and completed plans should be re-
viewed and updated every few years or when departments are merged or
disbanded.

The archives committee should also decide whether the papers of
individuals, the records of other organizations, and artifacts should be
sought to complement the archival collection. If manuscript material and
artifacts are to be collected, the documentation plan should specify which
individuals and/or types of organization should be solicited, taking into
consideration strengths and weaknesses of the archival collections. Mem-
bers of the archives committee will undoubtedly be helpful in identifying
individuals whose papers should be preserved.

In the hospital settings in which there is no records management
program, I have found it useful to have the archives program part of the
development and public affairs department rather than a function of the
hospital library. This is because development and public affairs staff
members have a broad understanding of the institution and how it
operates. They have their fingers on the pulse of the institution, under-
stand individual personalities, and can provide valuable advice on how to
accomplish documentation planning goals. There is, however, the danger
that the development and public affairs staff will view the archives solely
in terms of fund-raising and public relations activities.

CASE STUDY: CHILDREN'S HOSPITAL, BOSTON

INSTITUTIONAL ANALYSIS

Element 1: Mission and Functions The original mission of Children's
Hospital, as stated by the Board of Managers in 1869, was threefold: "The
medical and surgical treatment of the diseases of children. The attainment
and diffusion of knowledge regarding the diseases incident to childhood.

CASE STUDY: CHILDREN'S HOSPITAL, BOSTON 221

The training of young women in the duties of nursing. "^° The hospital's
current bylaws expand and clarify this mission:

The mission of Children's Hospital is to provide excellent health care to
children and, in support of this mission, to be the leading source of
research and discovery, seeking new approaches to the prevention,
diagnosis and treatment of childhood diseases as well as to educate the
next generation of leaders in child health.

In the nearly 125 years since the mission was first articulated, the institu-
tion's basic functions of patient care, biomedical research, and education
have remained the same. Patient care is now clearly stated as the primary
function, health promotion and community outreach activities play a
prominent role in the institution, and although the school of nursing
closed in 1978, the hospital still considers the education of nurses, physi-
cians, technicians, and others as one of its primary functions. Children's
Hospital is therefore involved in four of the six functions of the U.S. health
care system. Additionally, like all institutions. Children's Hospital engages
in institutional administration, a function that includes a range of activi-
ties necessary to keep the institution running: governance, external rela-
tions, fiscal management, operations management, facilities manage-
ment, and human resource management. These activities tend to be
similar in institutions of all types.

As the current mission statement makes clear, the primary function of
Children's Hospital is patient care. The hospital is a tertiary care facility
and provides the full range of services from standard, noncritical care
through specialized care and experimental treatment of infants, children,
and adolescents with extremely complex and virtually unique medical
conditions. The hospital is organized into fourteen clinical departments
with nineteen divisions that are further subdivided into twenty-seven
programs. Children's Hospital also offers more than 100 outpatient pro-
grams. Health promotion is closely allied to its patient care activities.
Although not explicitly stated in its mission statement, the Children's
Hospital bylaws (1989) emphasize health promotion through prevention.
The bylaws state that among its purposes are "to instruct, supervise, and
train [health care professionals] in the care, treatment, and prevention of
diseases . . . and to determine new and improved methods for the
treatment and prevention of diseases, and to disseminate information
about such matters."

Children's Hospital is the largest pediatric research facility in the
world and stands fourth among all independent hospitals in research
funding from the National Institutes of Health. ^^ The John F. Enders
Pediatric Research Laboratories at Children's Hospital house more than

222 DOCUMENTATION PLANNING AND CASE STUDY

500 researchers, and in 1992 the hospital was awarded $34 million for
research ($23 million from federal sources, $4 million from the Howard
Hughes Medical Institute, $3 million from industry, $3 million from
foundations, and the remainder from other sources, including the Com-
monwealth of Massachusetts). From fiscal years 1987 through 1992,
research funding continued to grow, despite the increasing scarcity of and
competition for research dollars, especially from the federal government.

Children's Hospital is the primary Harvard Medical School teaching
hospital for pediatrics, but its educational activities are not limited to
training physicians. In addition to internships, residencies, and postgradu-
ate programs for physicians, several departments also offer advanced
training programs for doctoral and postdoctoral students in the medical
sciences. The departments of Anesthesia, Cardiology and Cardiovascular
Surgery, and Medicine, for example, organize complete courses taught by
staff members. In other departments, including Orthopaedics and Neuro-
surgery, staff members present pediatric aspects within general courses on
their specialties. The hospital plays an important role in educating pediat-
ric nurse clinicians. The Department of Nursing is affiliated with twenty
academic institutions throughout the United States and provides educa-
tion at the baccalaureate, master's, and doctoral levels.

Children's Hospital also offers, among other programs, internships in
dietetics, social service, pastoral care, and clinical psychology; residencies
in pharmacy and hospital administration; formal on-the-job training pro-
grams for electrocardiograph technicians, housekeeping aides, respiratory
therapy technicians, and surgical technicians; affiliated programs in physi-
cal therapy with Boston University, Simmons College, and Northeastern
University, and in radiologic technology with Northeastern; informal
on-the-job training for laboratory technicians, unit secretaries, industrial
engineers, and autopsy attendants; and continuing education to meet the
recertification criteria of many health professions. Nearly every adminis-
trative and medical department at Children's Hospital is involved in
providing educational experiences for students who will be future health
care professionals.

Element 2: Institutional Control Children's Hospital is considered a
freestanding institution by the National Association of Children's Hospi-
tals and Related Institutions (NACHRI), although it is formally part of a
holding company. Children's Medical Center. Children's Medical Center
comprises Children's Hospital, the Children's National Research Institute
(which is currently inactive, but may be activated in the future to provide
organizational structure for research activities conducted by the Hospital),

CASE STUDY: CHILDREN'S HOSPITAL, BOSTON 223

Children's Extended Care Center (Groton, Massachusetts), Fenmore Re-
alty Corporation (a nonprofit corporation formed to acquire income-
producing real estate), Longwood Associates, Inc. (a for-profit subsidiary
that manages the Medical Center's real estate development), and the
Longwood Corporation (a nonprofit corporation owning real property for
the benefit of its nonprofit parent). The hospital runs two satellites: the
Martha Eliot Health Center (Jamaica Plain, a suburb of Boston), a neigh-
borhood clinic, and the Children's Hospital Specialty Care Center (Lexing-
ton, Massachusetts), an outpatient referral facility. The Children's Hospi-
tal League, a subsidiary of the hospital, is a nonprofit corporation operated
by volunteers; it plans and conducts various fund-raising events for the
hospital's benefit.

The Children's Medical Center is governed by a board of fifteen
trustees that is identical to the hospital's board. The standing committees
of the Children's Medical Center are the Audit Committee, Development
Committee, Executive Committee, Facility Planning Committee, Finance
Committee, Investment Committee, and Patient Care Assessment Com-
mittee. (It should be noted that the standing committees of all institutions
or organizations change with regularity.)

Element 3: Interactions with Other Institutions Children's Hospi-
tal is linked to many other institutions in carrying out activities related to
patient care. As examples, it has joint programs with Beth Israel Hospital,
Brigham and Women's Hospital, Dana-Farber Cancer Institute, Judge
Baker Children's Center, Massachusetts General Hospital, and the New
England Deaconess Hospital. In biomedical research it has joint programs
with Aga Khan University in Karachi, Pakistan; Harvard University's
Department of Biochemistry and Molecular Biology; the Massachusetts
Institute of Technology National Magnet Laboratory; the Whitehead Insti-
tute in Cambridge, Massachusetts; and Digital Equipment Corporation. In
research funding joint programs include those with the National Institutes
of Health, the Howard Hughes Medical Institute, the American Health
Association, and the Commonwealth of Massachusetts, among others. In
education it shares programs with Harvard Medical School (twenty-five
courses were listed in the 1991-1992 catalogue that third- and fourth-
year medical students could take at Children's Hospital), Boston English
High School, Bunker Hill Community College, Simmons College, and
most Boston teaching hospitals. Joint programs in administration include
those with the Massachusetts Hospital Association, NACHRI, and the
Medical Area Service Corporation, which provides transportation, pur-
chasing, and other services to institutions in the Longwood Medical Area,

224 DOCUMENTATION PLANNING AND CASE STUDY

and with accreditation and regulatory organizations such as the Joint
Commission on Accreditation of Healthcare Organizations and the Occu-
pational Safety and Health Administration.

Because it is located in the Longwood Medical Area, which is home to
six health care delivery facilities, ^^ Harvard Medical School, Harvard
School of Public Health, Harvard School of Dental Medicine, Harvard's
Francis A. Countway Library of Medicine, the Forsyth Dental Center
School for Dental Hygienists, and the Massachusetts College of Pharmacy
and Allied Health Sciences, every conceivable kind of affiliation, formal or
informal, has developed between Children's Hospital and the surrounding
medical community over the years. Much of this interaction had been
intended to improve care for patients, but with increased frequency joint
programs are coming into existence for education at all levels, and for
biomedical research. Because Children's interinstitutional connections
are extensive and complex and represent all four of the institution's
functions, they will be investigated in more detail at the organizational
unit level.

Element 4: History and Culture Children's Hospital was chartered by
the legislature of the Commonwealth of Massachusetts in 1869. Its his-
tory, from the hospital's founding through the early 1980s, has been
recorded in two books and a pamphlet. From my reading of these histori-
cal works and serial publications of the Development and Public Affairs
Department, certain facts that helped to shape the documentation plan
began to emerge. For example:

The nation's first pediatric radiology department was established at

Children's Hospital in 1900.

In 1903 the informal ties to Harvard Medical School were formalized;

hospital chiefs of service from this time on hold positions at Harvard.

In 1914 Children's Hospital was one of the first U.S. hospitals of any

type to create an independent physical therapy department.

In 1938 Dr. Robert Gross performed the world's first successful

surgical procedure to correct a cardiovascular defect, laying the

foundation for modern cardiac surgery.

In 1947 Children's Hospital made the transition to Children's Medical

Center, becoming the first pediatric medical center in the country.

From the perspective of documentation planning, one of the most
important points that becomes clear is that the health care delivery,
biomedical research, and education functions arc closely integrated. Pa-
tient care has always been the primary function of Children's; biomedical
research, mentioned prominently in the original mission statement of the

CASE STUDY: CHILDREN'S HOSPITAL, BOSTON 225

hospital, was the second function, with education following closely. It is
important to note that when research at Children's Hospital came into its
own in the early 1920s it did so within the existing departmental struc-
ture, rather than as a separate department or organization devoted to
biomedical research. The implications for documentation planning are
clear: because the health care delivery, biomedical research, and educa-
tion functions are integrated, it is expedient to plan to document these
functions within selected hospital departments or divisions instead of as
isolated functions. At the same time, it is important to have an overview of
the functions and to think functionally when devising the documentation
plan. The exception is the institutional administration function which
operates separately from the other functions and is therefore documented
independently.

From the vantage point of an employee. Children's Hospital's institu-
tional culture is readily apparent. The institution has a strong sense of
tradition and is proud of its history. For example, an annual lecture on the
history of the institution has been given for many years and is well-
attended. Employees at all levels are conscious of Children's leadership
role in pediatric medicine and are proud of being part of what they
consider a special enterprise. The hospital is compassionate both to its
employees, who are valued, and to its patients, who receive a remarkably
high level of care. On occasion, for example. Children's Hospital has found
funding to pay transportation costs to Boston for a dying child's grandpar-
ents. The culture of Children's Hospital is also permeated with ambition;
individuals are personally ambitious, and the institution is ambitious for
children, believing that with hard work all barriers to pediatric health can
be overcome.

The culture of Children's Hospital may be summed up in the words of
George H. Kidder, chairman of the Children's Hospital Board of Trustees:
"Children's is about people, and being mindful of the human side of this
place is the key to guiding it into the future. Building solid, supportive,
and trusting relationships is the way to ensure that this hospital fulfills its
mission of providing the finest care to children." ^^ Supporting this tradi-
tion of compassion and trust is Children's logo — a nurse closely holding a
child.

Element 5: Institutional Constraints The hospital's operating budget
for fiscal year 1992 was $255.3 million, and it ended the year with a
favorable balance of $24.5 million. The hospital gained $7.7 million from
patient care operations and $28 million from favorable prior year adjust-
ments. However, $11. 2 million was used to refinance debt.

Viewed over a seven-year period (FY 1986-1992), the institution's

226 DOCUMENTATION PLANNING AND CASE STUDY

financial situation is strong. Audited surpluses were recorded for the
entire period, ranging from a low of $0.2 million in 1989 to a high of $24.5
million in 1992. Also, after experiencing four years (1986-1989) of
negative cash flow, the hospital reported significant positive cash flow in
FY 1990-1992. The period of negative cash flow is accounted for by the
construction costs for two buildings that were added to improve facilities
for in-patient care and research.

It should also be noted that the Commonwealth of Massachusetts
adopted new hospital finance legislation (Chapter 495) on December 31,
1991. This law deregulates hospital revenues, allowing hospitals to nego-
tiate discounts with managed care organizations and insurers. At the same
time, the legislation significantly reduced Children's reimbursement from
the Commonwealth for bad debts and free care. The long-term implica-
tions for Children's Hospital, while not altogether clear, are optimistically
viewed by its administration. In addition it is not clear how the Clinton
administration's health care reforms, which emphasize competition and
managed care, will affect Children's. The hospital is already planning how
to change to remain competitive in the new environment.

COMPARISON OF CHILDREN'S HOSPITAL WITH OTHER CHILDREN'S
HOSPITALS, NATIONALLY AND REGIONALLY

There are 149 freestanding children's hospitals in the United States
and 42 that are part of a larger organization.^"^ Of the freestanding
institutions, 45 are children's general hospitals comparable to Children's
Hospital. In New England there are only 2 other freestanding children's
general hospitals: Newington (Connecticut) Children's Hospital and
Hasbro Children's Hospital in Providence, Rhode Island. There is one
listing for a New England children's hospital that is not freestanding:
the Floating Hospital for Infants and Children at New England Medical
Center.

These statistics, together with the fact that Children's Hospital is the
largest pediatric research facility in the country, clearly indicate that the
hospital is close to being a unique institution within New England. (It is
also the only freestanding children's hospital in the country to have a
full-time professional archivist.)

ANALYSIS OF CHILDREN'S HOSPITAL'S RELATIONSHIP TO THE U.S.
HEALTH CARE SYSTEM

This analysis involves reading through Chapter 1, "An Overview of the
United States Health Care System," and Chapter 2, "Health Care Delivery

STAGE TWO: SELECTION

227

FIGURE 8-2 Dental operating room in Children's Hospital, Boston, 1992.
Source: Development and Public Affairs Office, Children's Hospital

Facilities," to gain a perspective on the U.S. health care system and the role
of hospitals within it. These chapters also help point out the types of
relationship a hospital might have with other institutions and organizations
that are part of the U.S. health care system and indicate some of the changes
in the system that can be expected with the advent of health care reform.

STAGE TWO: SELECTION

WHY WILL RECORDS BE COLLECTED?

The Archives Committee decided that archival materials would be col-
lected primarily for institutional operations and historical research pur-
poses. Secondarily, they will be collected for biomedical research pur-
poses.^' The implication is that research data may not always be main-
tained in the hospital's archives; however, the archivist will attempt to
find an appropriate repository for research data that is not housed in the
archives.

The Archives Committee also decided that documenting the medical
components of Children's Medical Center (the Hospital and Children's

228 DOCUMENTATION PLANNING AND CASE STUDY

Specialty Care Center) would take precedence over documenting the real
estate components of the Medical Center.

SELECTION: FUNCTION LEVEL

This is the most general level — the level where the selection process
begins. Of the five functions of Children's Hospital (patient care, health
promotion, biomedical research, education, and institutional administra-
tion) the Archives Committee agreed to emphasize the administration and
biomedical research functions. Administration will be emphasized be-
cause of the institution's virtually unique position in New England, be-
cause by documenting administrative activities thoroughly, all of the
other functions will be documented generally, and because documenting
the administrative function will be helpful in carrying out current hospital
administrative activities. Biomedical research will be another focus of the
documentation plan because of Children's position as the largest pediatric
research facility in the world and because the institution has significant
accomplishments in this area. The documentation plan will also focus on
health promotion because it is an area of activity that is gaining in
importance owing to the federal government's emphasis on cost contain-
ment and managed care.

Patient care will be documented by virtue of the fact that Children's
Hospital has retained all of its patient records and logs since it opened in
1869. This decision was made before the documentation planning effort
began. ^^ Patient care is also documented in the multitude of articles
written about patients and published in the various official publications
originating in the Development and Public Affairs Office and constituting
the recommended core documentation. Education is more difficult to
document because much of it is done in conjunction with other (usually
educational) institutions that have archival programs where the bulk of
the documentation resides. The Francis A. Countway Library of Medicine,
for example, hold materials documenting aspects of the classroom educa-
tion of Harvard medical students who received clinical training at Chil-
dren's. For this reason, the documentation plan will place slightly less
emphasis on education.

SELECTION: ORGANIZATIONAL UNIT LEVEL

The first step is to identify the medical and other nonadministrative
departments, indicating their divisions, subdivisions, and programs as
appropriate. Table 8-2 outlines the territory to be documented. Originally
I thought that with the Archives Committee's help I would be able to

DEPARTMENT OF ANESTHESIA DOCUMENTATION PLAN 229

designate certain departments that would be documented only by the core
documentation (i.e., departmental annual reports; minutes of departmen-
tal committee meetings; photographs of departmental staff, events, and
interiors; departmental policy and procedure manuals; and department
publications, such as newsletters and brochures). After talking with the
Archives Committee, it became clear to me that this approach would not
work at Children's Hospital because everyone thinks that his or her
department is important and worthy of being fully documented in the
Hospital Archives. Although all medical departments will be documented,
not all of the departmental divisions and subdivisions will be documented
beyond the level of documentation residing in the department chief's files.
The Anesthesia Department was the first to be studied for documenta-
tion possibilities. One reason for this was purely practical — the associate
chief of the department was a member of the Archives Committee and
sympathetic to the documentation planning process. Other reasons were
that the Anesthesia Department was not well documented in existing
archival records and that the department is relatively small and not
complex, thus providing a good starting point. As a first step, I did
background research by rereading the sections of the hospital histories
devoted to the anesthesia department and reading through the last five
years of departmental annual reports. Then I met with the chief, the
associate chief, the clinical director of the Pain Treatment Service (which is
one of three department subdivisions that the associate chief recom-
mended be documented more fully), and the department administrator. I
used the questions and topics listed in Table 8-3 as the basis of the
meeting. (The questions in Table 8-4 may be used as a basis for developing
documentation plans for administrative departments.) The documenta-
tion plan for the Department of Anesthesia was reviewed by the three
physicians and the department administrator who were interviewed. The
final report was signed and dated by the department chief and the
archivist and distributed to appropriate people within the department.

DEPARTMENT OF ANESTHESIA DOCUMENTATION PLAN

DEPARTMENTAL ORGANIZATION

The department is organized into four divisions and one subdivision, all of
which are among the largest such programs in the country:

• cardiac anesthesia

• multidisciplinary intensive care unit (MICU)

• division of respiratory therapy

230 DOCUMENTATION PLANNING AND CASE STUDY

TABLE 8-3 Checklist of questions and topics for medical departnnentai
analysis

1. Is the department organized into divisions/sections?

2. Describe the patient care (inpatient and outpatient) activities of the
department.

3. Describe the health promotion activities of the department.

4. Describe the teaching (predoctoral, resident, fellow, technologist, continuing
education, etc.) activities of the department.

5. Describe the research (clinical and basic) activities of the department.

6. What are the departmentwide committees?

7. What is unusual about the department?

8. What is most important to document about the department?

9. What record series are needed in documenting this?

10. Describe the electronic records systems in place.

1 1 . Does the department generate:

a. Annual reports?

b. Departmental newsletters, patient brochures, information sheets, or other
publications?

c. Photographs or other audiovisual materials?

d. Committee minutes?

e. Policy and procedure manuals?

f. Departmental organization charts?

g. Records of teaching activities?
h. Records of research aaivities?

i. Patient records other than ofhcial medical records?

12. Has a departmental history been written?

13. Are there caches of departmental records that are not being used for current
operations? If yes, where are they located?

• operating room

• pain treatment service

The department has several committees: Clinical Competence, Educa-
tion, Fellowship Selection, Quality Assurance, and Research.

PATIENT CARE

The department is one of the largest pediatric anesthesia departments in
the world, and its services are used for every possible type of pediatric

DEPARTMENT OF ANESTHESIA DOCUMENTATION PLAN 23 1

TABLE 8-4 Checklist of questions and topics for administrative department
analysis

1. Is the department organized into divisions/sections?

2. What are the departmental functions?

3. Does the department operate special programs?

4. What are the departmentwide committees?

5. What is unusual about the department?

6. What is most important to document about the department?

7. What record series are needed to document this?

8. Describe the electronic records systems in place.

9. Does the department generate:

a. Annual reports?

b. Departmental newsletters, patient brochures, information sheets, or other
publications?

c. Photographs or other audiovisual materials?

d. Committee minutes?

e. Policy and procedure manuals?

f. Departmental organization charts?

g. Records of teaching activities?
h. Records of research activities?

i. Patient records other than official medical records

10. Has a departmental history been written?

1 1 . Are there caches of departmental records that are not being used for current
operations? If yes, where are they located?

operation and for many procedures done outside the operating rooms,
such as diagnostic radiology and radiation therapy.

TEACHING

The department has what is probably the largest anesthesiology training
program in the United States, educating residents and fellows and provid-
ing continuing education programs for physicians. Residents from Beth
Israel Hospital, Brigham and Women's Hospital, University Hospital, St.
Elizabeth's Hospital, Massachusetts General Hospital (MGH), and occa-
sionally others rotate through Children's for two to three months. At any
given time, the department has about fifteen residents. Fellows come for
between six months and three years to become specialized in pediatric
anesthesiology and/or pediatric critical care medicine. The department is

232 DOCUMENTATION PLANNING AND CASE STUDY

involved with two continuing education programs — an anesthesia review
course with MGH, and the Harvard Medical School Department of Anes-
thesia's review course.

RESEARCH

The department engages in a significant amount of research, publishing
over 100 papers per year. It participates in the Harvard Anesthesia Center
Research Grant (HACRG), which is run out of MGH. The program, which
has been funded by NIH for more than 20 years, trains anesthesiologists in
research. Participation in the HACRG program may lead to a Ph.D. from
Harvard or MIT.

Other research is organized by division, and all faculty are encouraged
to engage in research activities. Cardiac Anesthesia engages in clinical
studies and conducts basic research in conjunction with the Department of
Cardiology and Cardiovascular Surgery; the Multidisciplinary Intensive
Care Unit engages in clinical and basic research involving critically ill
patients; operating room staff do clinical research; the Pain Treatment
Service has its own laboratory and engages in clinical and basic research
studies.

PAIN TREATMENT SERVICE

Established in 1986, the Pain Treatment Service is the first multidisciplin-
ary children's pain service in the world. Its primary staff is composed of
anesthesiologists, psychologists, nurses, and physical therapists. Annu-
ally, 2,000 children (in-patients and outpatients) are treated for postoper-
ative pain and pain associated with cancer. The patient records and
shadow patient files of the service are computerized and never purged.

RECORD SERIES IDENTIFIED FOR PRESERVATION IN THE ARCHIVES

All functions:

• Department annual reports (published in "Reports of the
Departments"; currently have 1976-1992)

• Department chief's correspondence files

Patient Care:

• Clinical Competence Committee minutes

• Quality Assurance Committee minutes

• Pain Treatment Service brochures

DEPARTMENfT OF ANESTHESIA DOCUMENTATION PLAN 233

• Pain Treatment Service pain management protocols

• Pain Treatment Service patient handouts (e.g., on pediatric cancer
pain)

Education

• Annual syllabi of review courses

• Calendar of daily lectures and seminars (issued monthly)

• Education Committee minutes

• Educational manuals for trainees (produced by each division)

• Fellowship Selection Committee minutes

• Staff, resident, and fellow lists

• Trainee and staff file

Research

• Pain Treatment Service correspondence file

• Research Committee minutes

• Staff bibliography (in department's annual reports)

Health promotion

The department does not engage in health promotion activities

Other

Photographs of staff and fellows (taken annually)
Final budget performance reports
Main Operating Room
Anesthesia Laboratory
Pain Service

DOCUMENTATION PLANNING: A METHODOLOGY FOR SPECIALIZED
APPLICATION

The documentation plan for Children's Hospital Anesthesia Department is
an application of the documentation planning process to a particular
department in a specialized hospital. The plan is not meant to be a plan for
all anesthesia departments in all hospitals, but illustrates the documenta-
tion planning processes of analysis (institutional, interinstitutional, and
field) and selection (at the function/activity, department/program, and
record series levels). The process was designed to be translated to other
hospital organizational units and to the other institutions and organiza-
tions composing the U.S. health care system.

On an even more general level, the documentation planning process
can be applied to institutions and organizations outside of the U.S. health
care system, such as state or local government institutions, arts organiza-

234 DOCUMENTATION PLANNING AND CASE STUDY

tions, and labor organizations. To develop documentation plans for insti-
tutions or organizations that are not part of the U.S. health care system,
archivists will first need to develop field analyses, such as this book
provides for health care, for the larger systems of which these other
institutions and organizations are a part.

NOTES

1. "Institutional" may also be read as "organizational" throughout this chapter.

2. Documentation planning is an intrainstitutional approach to selection;
documentation strategy is an interinstitutional approach. See Helen Willa
Samuels, "Who Controls the Past?" American Archivist 49 (Spring 1986):
109-24. It is my belief that if documentation strategies are possible, they are
only so after the institutions involved have formulated documentation plans.

3. In some cases it may also be appropriate to examine the community context.
For example, when documenting a hospital in a large urban setting, it is
important to compare the hospital to others in and around the city.

4. Functions may be subdivided into subfunctions or activities as the case
requires. For example, in this book health care delivery has been divided into
patient care and health promotion in an attempt to emphasize health
promotion, which otherwise might not be appropriately documented.

5. Cynthia G. Swank, "Organizational Culture and Its Role in the Creation,
Survival and Use of Records: A Case Study" (Paper delivered at the Bentley
Historical Collections Symposium, July 1990).

6. The idea of core documentation is adapted from the library world's concept of
core collection. See, for example, Samuels, "Who Controls the Past?" 1 13-14.

7. Invoices for office supplies and other "housekeeping" records, for example,
are not significant record series for the purpose of documentation planning.

8. See Judith E. Endelman, "Looking Backward to Plan for the Future:
Collection Analysis for Manuscript Repositories," American Archivist 50
(Summer 1987): 340-53. Endelman's approach could be adapted to an
institutional archives.

9. It took me seven or eight hours from start to finish to devise the
documentation plan for the Children's Hospital Anesthesia Department.

10. The Children's Hospital: 1869-1939 (no publisher, n.d.), 9.

1 1. "Independent" is the operative word. Many hospitals are affiliated with a
university, and their research funding is reported as part of the research
funding of the parent institution.

12. The six are Beth Israel, Brigham and Women's, Children's, New England
Deaconess, Dana-Farber Cancer Institute, and Joslin Diabetes Center.

1 3. Children 's World: Year in Reviev^' 1991, 5.

14. All statistics in this section are taken from Listing of Freestandinc] Children's
Hospitals in the United States compiled by the National Association of Children's
Hospitals and Related Institutions (NACHRI). NACHRI's source was the 1991

NOTES 235

edition of the American Hospital Association Guide to the Health Care Field which
was based on the American Hospital Association's 1990 annual survey.

15. It should be noted that Nancy McCall and Lisa Mix, editors of Designing
Archival Programs to Advance Knowledge in the Health Fields (Bahimore: Johns
Hopkins University Press, 1994), recommend that preserving material for
biomedical research purposes be a primary function of health-related
archives; however. Children's Hospital was not ready to commit the
necessary resources.

16. For an excellent discussion of the secondary uses of official patient records
and appraisal considerations for patient records, see Joel D. Howell,
"Preserving Patient Records to Support Health Care Delivery, Teaching, and
Research," in Nancy McCall and Lisa Mix, eds.. Designing Archival Programs to
Advance Knowledge in the Health Fields (Baltimore: Johns Hopkins University
Press, 1994).

APPENDIX A

Selected Landmarks in the History of
Health Care in the United States

1756 Oldest U.S. hospital, Pennsylvania Hospital (Philadelphia),

founded.

1760 First physician licensing statute enacted in New York City.

1765 First medical school in the United States, Medical School of
the College of Philadelphia, founded.

1 766 First colonial, later state, medical society founded in New
Jersey.

1772 New Jersey act regulating medical practice; colonial, later

state, board of medical examiners adopted by New Jersey.

1790s Local boards of health organized in Baltimore, Boston,

Philadelphia, and New York City.

1798 Marine Hospital Service established by Congress. (Now the

U.S. Public Health Service.)

1 805 First formally organized medical library founded in Boston.

1812 New England Journal of Medicine precursor founded. (Now

the oldest U.S. medical journal.)

1836 Library of the Surgeon General's Office established,

forerunner of the National Library of Medicine.

1842 First use of ether anesthesia by Crawford Long, M.D., in

Georgia.

1846 First public demonstration of ether anesthesia at the
Massachusetts General Hospital, Boston.

1847 American Medical Association founded.

1851 Female Medical College of Pennsylvania (Philadelphia)

founded, world's first medical college for women.

237

238 SELECTED LANDMARKS IN THE HISTORY OF HEALTH CARE

1855 First state health department established in Louisiana.

1861 First voluntary health association, the Civil War Sanitary

Commission, founded in New York City.

1872 American Public Health Association formed.

1873 First three U.S. schools of nursing founded, in Boston, New
Haven, and New York City.

1879 National Board of Health established, first organized

medical research program of the federal government.
1881 American Red Cross founded by Clara Barton.

1887 Charles Mayo, M.D., and his sons established a practice in

Rochester, Minnesota, that evolved into the first large
medical group practice, the Mayo Clinic.

1891 National Confederation of State Medical Examining and
Licensing Boards founded.

1892 Anti-Tuberculosis Society of Philadelphia founded.

1893 Johns Hopkins University School of Medicine founded;
offered first formal progressive clinical education of
physicians.

1896 X-ray technique used in the United States.

1899 American Hospital Association founded.

1901 Rockefeller Institute for Medical Research founded; first
American institute devoted wholly to biomedical research.

American Medical Association reorganized as a federation
of state medical societies.

1902 Parke, Davis & Company (Detroit) began first American,
commercially operated research laboratory.

1906 Pure Food and Drug Act passed; became the basis for

federal regulation of foods and drugs.
1910 Abraham Flexner's report, "Medical Education in the

United States and Canada," published, changing the shape

of medical education.

1913 American College of Surgeons founded.

1917 First medical specialty board formed, American Board of
Ophthalmology.

1918 First federal grants given to states for public health services.

1929 Blue Cross started at Baylor University (Dallas, Texas).

1930 National Institute of Health (NIH) created, (now called
National Institutes of Health)

1935 Social Security Act passed.

1937 Health Service Plan Commission organized. (Later called
the Blue Cross Commission.)

National Cancer Institute of NIH established.

1938 Federal Food, Drug, and Cosmetic Act passed, increasing
drug regulation.

APPENDIX A 239

1942 First health maintenance organization formed. Kaiser

Permanente Health Plan. Rhode Island became first state to
enact a health insurance law.

1 944 Public Health Service Act passed, extending to all NIH

institutes the authority to award research grants to
nonfederal agencies.

1946 Hill Burton hospital planning and construction legislation

passed to improve population/bed ratios, especially in rural
areas.

Blue Shield Medical Care Plan organized. (Later called the
Blue Shield Medical Care Commission.)

1946 Communicable Disease Center established in Atlanta,

Georgia. (Now called Centers for Disease Control and
prevention.)

1950 National Science Foundation established.

1951 Joint Commission on Accreditation of Hospitals formed.
(Now called Joint Commission on Accreditation of
Healthcare Organizations.)

1953 Department of Health, Education, and Welfare established

as a cabinet level agency. (Now the Department of Health
and Human Services.)

1962 Amendments to the Food, Drug, and Cosmetic Act passed,
which empowered FDA to specify testing procedures for
evaluating new drug applications.

1963 Health Professions Educational Assistance Act legislated to
support medical schools and health-related educational
institutions.

1964 Nurse Training Act legislated to support nurse training.
National Library of Medicine began MEDLARS, the first
computerized system for searching medical literature.

1965 Medicare (medical health insurance for citizens over 65)
and Medicaid (medical assistance program for the indigent)
legislation passed.

Regional Medical Programs Act passed, establishing
regional cooperation in health care planning.

1966 Allied Health Professions Personnel Act legislated to
support training of allied health workers.

1968 Health Manpower Act legislated to support training health

professionals.

1970 Occupational Safety and Health Act (OSHA) passed,

regulating health hazards in the workplace.

National Institute of Alcohol Abuse and Alcoholism
established.

1972 Social Security Act Amendments passed, creating

professional service review organizations.

240 SELECTED LANDMARKS IN THE HISTORY OF HEALTH CARE

1973 Health Maintenance Organization Act passed, providing
funding for model HMO projects.

1974 National Institute on Aging established within NIH.

1975 Rhode Island became first state to enact a catastrophic
health insurance program.

1976 Health Care Financing Administration established.

1981 Acquired immunodeficiency syndrome (AIDS) first
recognized.

1982 Health Resources and Services Administration established.
Orphan Drug Aa passed.

Professional Standards Review Organizations transformed
into Peer Review Organizations.

1983 Diagnosis-related groups (DRGs) instituted as method of
Medicare reimbursement.

1987 FDA adopted rule allowing release of experimental drugs

(e.g., azidothymidine) to individuals with AIDS and other
serious diseases.
Source: Data from Joellen Beck Watson Hawkins and Loretta Peirfedeici Higgins,
Nursing and the American Heatlh Care Delivery System (New York: Tiresias,
1982), 58-60; Theodor J. Litman and Leonard S. Robins, Health Politics and
Policy (Albany, N.Y.: Delmar, 1991), 395-41 1; and Florence A. Wilson and
Duncan Neuhauser, Health Services in the United States (Cambridge, Mass.:
Ballinger, 1985), 289-91.

APPENDIX B

Health-Related Discipline
History Centers

The following list of repositories collecting manuscripts in various fields
within the history of health care is meant to be used to devise cooperative
collecting arrangements and to locate appropriate respositories in which
to house collections. Institutional archives are not listed.

Anesthesiology

Wood Library-Museum of Anesthesiology

515 Busse Highway

Park Ridge, IL 60068-3189

708/825-5586

Dentistry

American Dental Association