Pergamon

International Journal for Quality in Health Care, VoL 8, No. 4, pp. 401-407,1996
Copyright 1996 Avtdii Donabediui, Published by Eljevier Science Ltd. All righti reserved
Printed in Great Britain
1353-4505/96 $15.00+0.00

The Effectiveness of Quality Assurance

AVEDIS DONABEDIAN

Presented on May 30th, 1996, at the Closing Ceremony of the 13th International Conference of the IntcrnationaJ Society for
Quality in Health Care, Jerusalem. The author reserves copyright.

401

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The organizers of this conference intended,

from the very first, to adopt as its theme: "The
Impact of Quality Interventions in Health Care"
and, indeed, we have heard the strains of this
theme in its many variations, like the enticing
notes of a magic flute, all these many days.
What more appropriate ending to the conference I thought, when asked to be your farewell speaker, than a few parting words about
"The Effectiveness of Quahty Assurance". What
easier, I went on to think, since this is a subject I
have studied and written about during the more
than thirty years of my professional life [1,2].
How hasty I was! How reckless! How foolish!
Soon you shall see why.
As the enormity of my task sank in, I stripped
it to its bare essentials. I shall speak, I decided,
only about one form of quality assurance: that
which consists of obtaining information about
performance and, based on an analysis of
performance in any given situation, leads to
modification in behavior: directly, through educational and motivational activities, and indirectly, through adjustments in system design.
Furthermore, I would have in mind, I decided,
only clinical care, lopping off all other aspects of
organizational performance less central to the
patient-practitioner transaction.
But even when so restricted, the subject
presents some serious difficulties: in definition,
in conceptualization, in documentation, and in
presentation.
"Effectiveness" is itself no simple concept. It is
to be visualized as a process in a series of steps:
introduction; implantation; implementation;
modification in behavior; and finally, consequent progress toward health and health-related
objectives. It is likely that many of the factors
that influence the effectiveness of quahty assur-

ance act continuously throughout this progression. It is also likely that at each stage some
factors are more influential than others, and that
at some points new factors emerge to become
critical. For example, early in the progression,
the nature of the intervention and the receptivity
to it are dominant factors. At the transition from
behaviors to outcomes, the ability to harness
most effectively the technology of health care is
the more critical variable. Yet, what comes
before prefigures what is to come later; and
anticipation of what is to come influences what
happens at preceding steps.
A similar pattern of modulation and reverberation runs through the many layers of the
health care system. At the most general level,
there are the societal factors that surround,
shape, and profoundly influence the functioning
of the health care enterprise. That enterprise is
itself differentiated into layers and segments:
layers such as the institution, the department,
the work group, and the individual, and segments such as the professional and administrative. At each of these levels and in each of these
segments, distinctive forces may influence
whether or not quahty assurance will be
adopted, the form it will take, and how effectively it will be implemented.
The large number of quality assurance interventions, separately and in combination, add
another set of complexities to the task at hand.
So does the imperfect state of our knowledge
about the effects of these interventions. True
enough, there is an extensive literature to draw
upon. But much of it is anecdotal; it merely
describes what was done, and what seemed to
have been accomplished, only in specific locations, during short periods of time. There are
very few controlled studies. For example, of the
more than 6,000 reports on continuing education gathered by Davis and associates, only 99

402

contexts, and the interventions appropriate to

each of these.
In such a study a theory of effectiveness would
help, but I know of no such theory. There are,
rather, many theories and many competing
perspectives. The health care enterprise may be
seen as a culture, or a set of cultures, to which the
quality assurance effort must adapt, or which
may have to be modified if quality assurance is to
flourish. Or the health care enterprise may be
seen, in a somewhat related fashion, as a system
of social interactions in which the example,
approval and support of significant others
govern behavior. Therefore, it is to this network
of social exchanges that quality assurance must
be linked [4]. Alternatively, the health care
enterprise is endowed with a considerable
degree of rationality, so that information and
knowledge rule and it is through these that
quality assurance must act [5]. Or, perhaps,
behavior in the health care system is rational in
still another way, that of self-seeking calculation,
the advantages sought being economic, social, or
professional. Quality assurance must, therefore,
aim to contribute to these interests or, at least,
not to harm them. Contrariwise, behavior in the
health care system may not be as rational as one
would like to believe. Rather, it may be governed
in part by a variety of psychological and
emotional needs, aspirations, and fears [6]. Or,
possibly, the health care system is a network of
communications, vertical and horizontal; or it is
a system of power relationships, or superordination and subordination; or it is all of the
aforementioned and other things besides.
In the absence of a unifying theory, one takes
refuge in eclectic formulations that draw on
several perspectives. The most dominant of
these formulations today goes under the name
of "total quality management" or some variant
of it.
I have before me two reports. One is of an
effort to reduce mortality from coronary artery
bypass surgery in several States in Northern
New England. It flies the banner of "TQM",
uses its concepts and methods, speaks its
languageand it succeeds. In this case, as in
many others, TQM works [7].
The second enterprise, this one in not too-faraway New York State, has the same objectives,
but it is conceived and operated by a governmental agency with awsome powers of retribu-

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were deemed worthy of further analysis. Of

these, only two thirds reported a change in
behavior, and even fewer spoke of changes in
outcomes. Furthermore, the changes observed
were often limited to a few of the process and
outcome variables studied, they were small,
difficult to quantify, and of indeterminate clinical significance [3].
Even rarer than well-designed studies of single
interventions are assessments of variants of such
methods. Rarer still, to the point of nonexistence, are studies that set out to test competing, theory-based strategies of quality assurance.
To present this empirical material, even after
rigorous pruning, would be impossible in a talk
such as this and if presented, it would lead to the
almost foregone conclusion that: every reasonably established method in the armamentarium
of quality assurance has been shown to work in
some situations. Precertification and secondopinions work. Reminders, feedback, profiling,
benchmarking, guidelines, protocols, indicators,
detailing, continuing education in its various
formsthey all work. Quality circles, quality
improvement teams and similar group efforts
work. Financial incentives work; professional
incentives too. So do regulatory interventions,
administrative controls and professional interventions. They all work. Yet no one method is
demonstrably superior in every situation, or in
most.
One response to this uncertainty is to use a
combination of methods, hoping that a cumulative effect, or even a synergy, may emerge.
Fortunately, the methods at hand do fall into
reasonable constellations or sequences that
promise mutual reinforcement. Guidelines,
feedback, professional persuasion and continuing education form one such sequence. There
could also be an interaction between external
regulatory requirements and internal administrative or professional initiativesan interaction that is mutually supportive rather than
antagonistic.
Another response to the current uncertainty
in choosing what method is best is to postulate
that effectiveness depends not on the method
alone, but on an interaction between the
method and the situation in which it is to be
implemented. One looks, therefore, for a kind
of fit between method and situation. The study
of effectiveness becomes, then, a study of

A. Donabcdian

The effectiveness of quality assurance

in new directions, willing to take justifiable

risks [9].
What is not clear is how the appropriate
cultural change is to be achieved. Perhaps it
occurs, partly, through the play of external
forces: such as governmental pressure, professional aspirations, consumer demand, the play
of market forces, and so on. All these imply a
manifest or subtle threat to the organization; it
must adapt or possibly perish.
Perhaps the factor most often mentioned as a
feature of a culture, as well as a modifier of it, is
leadership: leadership in every sphere of a society
and every level of an organization. The chief
executive is a leader; so is the head of a clinical
unit; so is a manager; so must be someone in the
quality improvement team.
Leadership is often associated with positions
of authority; the ability to exercise authority, to
influence careers, to reward or censure, is an
important adjunct to it, even if kept in the
background. Power relationships are a factor
not to be ignored in the adoption and conduct of
quality assurance. But other attributes of leadership matter equally, if not more: the ability to
persuade, to motivate, to inspire trust, to set a
personal example of commitment to and personal participation in the quality assurance enterprise. Furthermore, most clinicians would like to
see in charge of the quality assurance apparatus
one of their own; a clinician senior in rank and of
unquestioned competence.
In part, this preference is related to still
another contextual factor, that of sponsorship.
In clinical practice, sponsorship by the relevant
professional association (of physicians, nurses,
and so on) confers legitimacy on the quality
assurance effort as a whole, and more so on the
particular guidelines and criteria that pertain to
the details of clinical work. It is a resource
assiduously to be sought.
Both leadership and sponsorship imply an
underlying structure of socially organized relationships. In addition to these, formal organization of the health care enterprise is an almost
necessary requirement for the institution and
operation of quality assurance activities. Formal
organizations provide the arena within which
cultural change takes place and where leadership
is exercised. They have the means to set the goals
of performance, to investigate success or failure,
to identify causative factors and to take appro-

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tion, held in check, but unmistakable. It is

traditional, pragmatic. TQM is beyond its ken.
Yet, it also worksat least as well, perhaps
better [8].
Can one make sense of all this? Do you see,
now, the problem I have faced?
Fortunately, despite all the uncertainties I
have portrayed, there are certain themes that
run constantly throughout the literature on
"effectiveness", themes partly founded on
empirical evidence, partly on theory-based
expectations, and partly on informed speculation. It is to these themes that I now turn.
To introduce at least a semblance of order into
my presentation, I shall divide these themes,
rather arbitrarily, into "Contextual" and
"Operational".
The context subsumes the general properties
of the situation into which quality assurance is
to be introduced and in which it is to operate.
These properties may support or handicap
quality assurance, or they may only support it
in some forms, under restricted conditions.
Among the contextual factors, one encounters
at the onset, the notion of "culture", which
includes what one believes and values, how
reality is seen and interpreted, how one is to
behave and how things are to be done. All
these are manifested in how important quality
is regarded to be, how it is defined, who is to
be responsible for it, and through what
mechanisms. The role of government is critical
to these matters, as is the role of the health
professions, of the organizations that finance
and provide care and of consumers, in association or individually.
In a step down from the more general to the
more particular, one often speaks of the culture
within an organizationthe microcosm where
the issues I have just mentioned come into play.
It is often said that some forms of quality
assurance amount to a "thought revolution",
one that requires a corresponding cultural
change. Some features of that change appear in
the clear assumption of responsibility for quality
in the highest reaches of an organization, the
diffusion of that responsibility throughout all its
parts and layers, a corresponding empowerment
of personnel and a less authoritarian form of
governance. Furthermore, organizations are
distinguished into some that resist change and
others that seek to learn, are ready to strike out

403

404

1. There is a demonstrable, consequential,

legitimate need
The awareness of need may derive, as I have
already implied, from the play of external forces,
or it may be self-generated, or the two may
interact. But, no matter how prompted, the need
must be regarded as important and clinically
relevant. Often, a reasonable first step is an
organized effort, through group discussion, to
identify needs, and set them in an agreed-upon
order of priority. In general, trivialization is
deadly, but sometimes one must seize upon
something relatively unimportant that a clinical
unit wishes to have done, hoping in that way to
demonstrate the potential of the quality assurance enterprise to help and to succeed.
In order to be demonstrable and credible,
what is needful must be documented with data
data of unimpeachable provenance and quality.
Moreover, the inference to be drawn from the
data must, themselves, be persuasive and compelling. Comparisons may be made with normative standards of acceptable legitimacy, either
professionally approved or self-generated. Parti-

cipation in the formulation of such guidelines

and standards is said to enhance compliance. It
is said, moreover, that comparison with the
actual performance of peers or of similar
institutions tends to be more compelling, and
some believe that setting precise, measurable
goals in advance, especially concerning outcomes of care, is powerfully motivating, if the
goals fail to be achieved [12,13].
The manner of presenting data is also important. More effective than written transmittal is
the opportunity to explain and discuss the
findings and their interpretation, and even more
so if individual performance is discussed in
private with a trusted and respected senior
colleague [14].
A genuine conviction that performance needs
to be improved is the indispensable first step in
the process of quality assurance.
2. Something can be done to meet the need
What should follow upon a conviction that
something needs to be improved is at least a
reasonable expectation that improvement can be
made. Loosely, this falls under the now popular,
even alluring, rubric of "empowerment".
Empowerment applies at all levels in an
organization: executive, managerial and operational. It applies, in particular, to the quality
assurance directorate. This is empowered by the
appointment of a chief of considerable stature
and authority, who belongs in the highest
reaches of an organization, where one can
participate in and influence, all decisions that
significantly impinge on quality. The directorate
is also empowered by having at its disposal the
necessary resources: human and material. These
include the requisite varieties and levels of
expertise. They also include time. Nothing
vitiates a quality assurance enterprise, revealing
its marginality in an organization, more than its
being delegated to persons of relatively little
authority, or conducted as an add-on to existing
responsibilities, in one's own free time.
These observations apply, as well, to groups
or teams that undertake, or are asked to undertake, quality improvement tasks. Quality
flourishes if everyone is alert to opportunities to
improve it, can communicate these, can suggest
how improvements are to be made, and can
expect serious consideration, leading to action,

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priate action. Within organizations, the

networks of informal communication and interpersonal influence are concentrated and potentiated, offering thereby a ready vehicle for the
processes of quality assurance. When the organizational nexus is underdeveloped, or virtually
absent, as in the private practice of ambulatory
care, some new organizational structure, formal
or informal, is usually needed to allow physicians to recruit resources, develop expertise, and
offer mutual support in the effort to improve
performance [10].
Let me now turn to my second category:
namely, the "operational" factors that influence
effectiveness. To help me present these in some
order, I shall assume, guided by more general
models of health behavior, a rather crude
progression of steps, as follows [11].
(1) There is a demonstrable, consequential,
legitimate need.
(2) Something can be done to meet the need.
(3) That which will be done, or is done, is the
right thing, done in the right way.
(4) There are demonstrable, useful results,
free of unforeseen, harmful consequences.
I shall go through these steps in order.

A. Donabedian

The effectiveness of quality assurance

where appropriate. Thus, one fosters a sense of
optimism, even of adventure, in an organization.
If not, one can expect cynicism at first, and later
an apathetic resignation in those who remain,
while the best depart.
The necessary next step, therefore, is that
action be taken but not any action, only actions
that are reasonable and approved.
3. That which will be done, or is done, is the right
thing, done in the right way

service to patients is a compelling professional

goal, the model of governance proposed is an
established feature of professional life, and the
methods to be employed are largely epidemiological, with some compatible extensions [15].
In most cases, it is best, it seems to me, to
emphasize continuities rather than disjunctions,
where possible extending quality assurance
activities already present in many health care
institutions. But that principle does not hold if
what already exists is, itself, externally imposed,
discordant, discredited, and demonstrably ineffective. It is better, then, to offer as a replacement
not another unfamiliar incursion, but, rather, a
return to the purer, more authentic traditions of
the health care professions.
Much of what seems new in quality assurance
is, in fact, eminently traditional. Professionals
wish to monitor their own work, led by one of
their own whom they trust and respect. They
prefer to study patterns of performance rather
than to search for individual miscreants. They
would much rather look for causes of failure in
underlying processes and structure, than in
professional malfeasance. If there are failures in
knowledge, judgment, or skill, they would want
these to be corrected by education and retraining, not punishment. Furthermore, education
would be more effective if specifically directed at
discrete, verified needs, conducted in person by
respected colleagues, and reinforced, where
possible, by individual consultation and advice.
All this is persuant to congruence with
professional norms. But it also serves a second
principle, that of "ownership". Professional
sponsorship and leadership are one prerequisite
to ownership. And so is personal participation in
the quality assurance enterprise: in setting its
goals, in constructing its criteria and standards,
in carrying out its processes and, where possible,
implementing the changes that it prescribes.
Through "ownership", two other related
principles are also served. These are "relevance"
and "utility". The purposes and consequences of
quality assurance must berelevantto the life and
work of those who engage in it, or are to be
consumers, so to speak, of its findings and
consequences. It operates in the domains these
consumers recognize as their own, where they
work, where they exercise responsibility, where
they can bring about change. Ideally, the quality
assurance enterprise will do what its consumers

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Expectations of what interventions, what

disturbances in the accustomed life of an
organization, quality assurance is likely to
make, are perhaps the major determinant of
how warmly it is likely to be received when
proposed, or how obstinately opposed. Later,
the very first actions taken can justify what was
hoped for, or either confirm or begin to allay the
fears that almost any change in the established
order is certain to arouse. At every step, thereafter, with each new undertaking, the need to
gain approval recurs, except that past events,
one hopes, have gradually built up trust, and
fostered an inclination to cooperate.
Much of what makes quality assurance interventions acceptable can be made to fall under the
rubric of "congruence", which is the degree of fit
between the interventions envisaged, and what I
earlier called "culture": the culture of the
organization as a whole or, of the subcultures
of its partsamong the latter, that of the health
care professions being the most compelling.
At the very least, one aims for a compatibility
with professional ideals, or, better still, a
reinforcement of these. A clear commitment to
quality, as professionals understand the term,
rather than cost-saving mainly, is a necessary
bond. So is the resolve to advance the welfare of
patients, to reinforce professional responsibility,
and to serve the need for professionals to know,
and continue to learn. It helps if what is
proposed is familiar in rationale and method. It
is less disturbing if the concepts and methods of
quality assurance are seen to resemble those of
the scientific method, which professionals
respect, or of clinical problem-solving, in which
they are daily engaged. If could be disturbing to
ask professionals to adopt concepts and methods ostensibly borrowed from the industrial
sector. And it is unnecessary to do so, since

405

406

4. There are demonstrable, useful results, free of

unforeseen, harmful consequences
The credibility of the quality assurance enterprise hinges on one thing above all else; that
something is done as a consequence of its
activities, and that this something is demonstrably useful. Let me call this, somewhat fancifully,
the principle of "fruition".
What could be more persuasive than to
experience, first hand, the benefits of quality
assurance? What could more demonstrably
confirm an organization's commitment to it?
On the contrary, what could be more destructive
to the entire effort than to observe that quality
assurance is a tissue of ostentatious pronouncements, or merely busy-work: onerous, boring,
unrewarding and useless.
Even worse, would be to experience the
undesirable consequences that one has feared
from the start, among them: dilution of professional responsibility, distortion of professional
judgment, stereotyping of practice, discouragement of innovation, legal hazard and an ambience of fearfulness that leads to resistance,

evasion, concealment and ultimate demoralization.

These dire prognostications are most often, of
course, only the hobgoblins summoned forth by
the timid, or the merely manipulative, to justify
opposition to legitimate quality assurance initiatives. But, sad experience has also shown that,
under perverse forms of intervention, such fears
can materialize. Therefore, at every step, they
are assiduously to be guarded against.
It is now time to end, but on a more hopeful
note.
To my mind, the most important single
condition for success in quality assurance is the
determination to make it work. If we are truly
committed to quality, almost any reasonable
method will work. If we are not, the most
elegantly constructed of mechanisms will fail.
We shall leave this place, I know, determined
to hold the stewardship of quality as a sacred
trust. Once again, we dedicate ourselves to that
high calling.
It is also fitting that, as we leave this city, we
offer thanks for its hospitality, and pray earnestly for peace to reign within it. Permit me,
therefore, to do so now, in the words of the sweet
psalmist himself, first as he spoke, and then in
translation [16]:

tofia, ftec

Pray for the peace of Jerusalem : they shall prosper that

love thee.
Peace be within thy walls,
and prosperity within thy
palaces.
For my brethren and companions' sakes, I will now say,
Peace be within thee.
Because of the house of the
LORD OUT God I will seek thy
good.
And now, dear friends, farewelland God
bless us all.

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would want to see done in the first place,

generate information they would like to have,
aim for effects they would want to see realized. In
short, it is useful.
Sometimes, quality assurance is useful in
solving discrete problems that have troubled a
clinical unit. At other times, it serves individual
aspirations, for example by revealing and
rewarding meritorious performance, otherwise
unnoticed. Sometimes, an entire profession,
nursing for example, is offered new opportunities for personal self-expression and growth, as
well as an avenue to professional recognition
even power. Whenever such utilities are manifest, participation in quality assurance is not
only welcomed, it is avidly sought.
To summarize, the quality assurance enterprise, if it is to flourish, should conform to the
cultural imperatives of those it wishes to
influence. But quality assurance is also a force
capable, of itself, to bring about a gradual
change in that culture, so that, in time, a greater
congruence can emerge. Therefore, the quality
assurance enterprise must be in for the long haul.
It must be persistent, consistent, meticulously
fair, and it must show results.

A. Donabedian

The effectiveness of quality assurance

Acknowledgements: I wish to thank Dr. Richard

Baker who not only helped me locate references but,
also, by sharing his own ideas, shaped some of my
thinking as well.

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Ann Arbor: Health Administration Press, 1986.
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Quality Health Care 1993; 1: 9-16.
16. Psalm 122, verses 6-9.

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1. Donabedian A, A guide to medical care administration, Volume 11, Medical care Appraisal.
American Public Health Association, 1969. See
pages 116-121 on "Implementation", and pages
122-151 on "Effectiveness".
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assurance. Part II, pages 59-128 in R H Palmer,
A Donabedian and G J Povar, Striving for
quality in health care: an inquiry into policy and
practice, Ann Arbor: Health Administration
Press, 1991.
3. Davis D A, Thomson M A, Oxman A D and
Haynes B, Changing physician performance: a
systematic review of the effect of continuing
medical education strategies. Journal of the American Medical Association 1995; 274: 700-705.
4. Mittman B S, Tonesk X and Jacobson P D,
Implementing clinical guidelines: social influence
strategies and practitioner behavior change.
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5. Batalden P and Stoltz P K, A framework for
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6. Robertson N, Baker R and Hearnshaw H,

407

iHlmatiomUoumalfor QmOiXjfaHtetth Cart, VoL 9, No. 4, pp. 311-312,1997

O 1997 Hjevfer Sconce Ltd. Allrighunaencd
Printed in Gnat Briuin

Pergamon

ERRATA
B. Ottosson, I. R. HaDberg, K. Axebson and L. Loven: Patients Satisfaction with Surgical Care Impaired by Cuts in
Expenditure and After Interventions to Improve Nursing Care at a Surgical Clinic. Int J Qual Health Care 9:43-53.
It is regretted that errors were made in Table 3 of the- above article. The corrected table is as follows:

Often
1993
1994

Seldom
1993
1994

Not at all
1993
1994

p-value

10.2
10.3

15.0
22.2 '

29.1
32.5

45.7
35.0

0.1

1.6
0.9

11.2
11.3

87.2
86.1

0.8

1.7

1.6
1.7

0.8
2.5

4.7
5.9

92.9
89.8

0.4

0.8
0.9

2.4
3.4

18.1
23.9

78.7
71.8

0.2

60.9
54.3

25.2
29.3

12.2
12.9

1.6
3.5

0.3

41.6
38.1

17.6
17.7

3.2
6.2

4.0
3.5

0.9

Anxiety before examination/treatm.

#

Experience of embarrassment

Anxiety regarding professional secrecy

Needing someone to talk to without finding anyone

There is someone to talk to about the examin./treatm.

There is someone to talk to about their personal

situation

Quite often
1993
1994

D not applicable 1993 = 33.6%; 1994 = 34.5%

Internal drop-out 1-10 respondents
# 11-15 respondents

311

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TABLE 3. Respondents' experience of tbelr personal contact with nursing staff. Comparisons between 1993 (n -131) and
1994 (n -128) as measured by the Mum-Whitney U-test (%)

312

Errata

ERRATUM
A. Donabedian: The Effectiveness of Quality Assurance. Int J Qual Health Care 8:401-407.
It is regretted that in publishing the above article, a passage of text was inadvertently printed upsidedown. The publishers would Uke to apologise for any embarrassment this error may have caused to
Professor Donabedian, and for any inconvenience to readers of the Journal. The correct version of the
text is given below:

Pray for the peace of Jerusalem. : they shall prosper that

love thee.
Peace be within thy walls,
and prosperity within thy
i

For my brethren and companions' sakes, I will now say,

Peace be within thee.
Because of the house of the
LORD our God I will seek thy
good.

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The English translation is as follows: