EDITORIALS 161

Patient safety Safety brings with it a further dimen-

................................................................................... sion, one that many clinical teams have
long struggled with. Safety is a systems

What is the role of healthcare issue. As knowledge advances and new

technologies are deployed in the work-
place, many undesired and unantici-
managers in delivering safe care? pated risks and consequences result.
Although, disappointingly, some of the
A Hutchinson, P Barach literature still refers to “medical error”
and “human error”, deep questioning
................................................................................... related to adverse events will usually
identify underlying systemic causes.6 7
To what extent should healthcare boards be held accountable Healthcare organisations are complex
for clinical practice at the institutions they govern? and are almost always under pressure, so
the chance of failing to provide an

W
hen the State of New York clinical practice at the institutions they element of care, or providing the wrong
Department of Health recently govern? Should boards be leading the one, is always there if human activity is
commissioned three quality charge to improve the safety and quality left unsupported by systems which can
improvement projects the topics seemed, of patient care? take up routine tasks, provide infor-
at first sight, to be like many other qual- The involvement of chief executives, mation, support decisions, and force
ity projects before them. Each clinical finance directors, and board members safer functions.
topic is aimed at preventing recognised may be where patient safety pro- Do support systems work? Evidence
complications of interventions and each grammes have the edge over on guideline implementation suggests
has an evidence base: perioperative use “traditional” quality improvement pro- that there are no easy fixes when it
of beta blockers in non-cardiac surgery, grammes, for safety looks at quality from comes to effecting change in clinical
prevention of thromboembolism, and the other end of the telescope. Of course, behaviour.7 But case studies on safety
surgical antimicrobial prophylaxis. Each every safety project should recognise the and system re-engineering from the
group of hospitals that won the competi- hard work of clinical teams who improve Institute of Healthcare Improvement in
tion to run the projects has developed an care by increments (sometimes over the United States9 and from the National
evidence-based standard of care. Imple- many years). But the safety perspective Health Service modernisation
mentation of each clinical standard challenges the whole organisation. The programme10 have demonstrated real
might be thought to run the risk that safety approach says that those people gains by engaging managers and by
taking the evidence into practice may who are not receiving evidence-based using systems approaches to quality and
suffer from the usual barriers.1 This all care represent a safety challenge. The safety. Additionally, much of the research
seems routine, so what is new? people who are not receiving thrombo- on improving the quality and safety of
The differences, and the enhanced embolism prophylaxis or who have had a prescribing suggests that systematising
opportunities for success, lie in the myocardial infarction and been dis- the process can lead to substantial
context of the projects which are part of charged from hospital without aspirin improvements.11
an initiative that aims to change practice are at risk. Some will suffer an adverse Quality used to be considered the pre-
and improve outcomes and, hence, im- event as a result of not receiving neces- serve of clinical teams. Sometimes this
prove safety. Each of the topics repre- sary advice or intervention. was because of defensiveness and a wish
sents a type of adverse event regularly to remain separate from management,
reported in the New York State Patient “Safety looks at quality from the sometimes because management was
Occurrence Reporting and Tracking Sys- other end of the telescope” uninterested, more often because each
tem (NYPORTS).2 Topic related pre- side did not recognise each other’s role.
implementation adverse event data are Gaining the attention of hospital and However, moving towards a culture of
already available on the NYPORTS sys- primary care organisation chief execu- safety is at the heart of the ethical
tem for each participating hospital, and tives and boards, sometimes for the first imperative of changing health care.
post-implementation data will be used to time, brings with it a recognition that This places new requirements on
assess the effectiveness of the implemen- quality of care is as much their responsi- healthcare organisations for even the
tation package. These post-intervention bility as it is that of clinical teams.3 introduction of clinical governance
data relate to important short term out- Leape4 has referred to this as “reciprocal meant that healthcare organisations
comes such as intraoperative or postop- responsibility”. Clinical teams take care were more concerned with risk manage-
erative myocardial infarction, deep ve- to provide professional care under the ment than the more positive and encom-
nous thrombosis or embolic events, and circumstances in which they work. In passing concept of safety. Furthermore,
wound infections, together with associ- turn, employers, managers and health every healthcare organisation faces sig-
ated mortality, morbidity, and costs. service funding bodies have a responsi- nificant safety and quality challenges
Something else is different. Senior bility to provide the circumstances, that cannot all be fixed at once. Clinical
hospital executives are required to be skills, people and equipment with which and managerial partnership is required
part of the project team, which means safe care can be delivered. This includes to set priorities and to support a culture
that they—as well as the clinical team attention to the safety climate of the of safe and effective practice.
members—have explicit responsibility organisation, perhaps through what The concept of safety as part of quality
for delivering better and therefore safer Weick and colleagues5 have characterised improvement enlarges the “quality enve-
care. All this raises intriguing questions as the “process of mindful organising”, lope”. Engaging senior management,
about the accountability role of boards in which there is a preoccupation with funding agencies, and healthcare profes-
and management in delivering safe care. the likelihood of failure and a reluctance sionals with the safety agenda through a
In the post Enron and WorldCom age, to simplify interpretations. This constant growing recognition of reciprocal re-
where boards are increasingly being sense of unease might help to explain sponsibility and a focus on systems as
encouraged to ask tough questions of the how some organizations are able to sus- well as people is the new dimension. It
companies they govern, should health- tain high risk repeated encounters with- just might work.
care boards be held accountable for out suffering adverse events. Qual Saf Health Care 2003;12:161–162

www.qshc.com
162 EDITORIALS

..................... interventions to improve professional practice. 7 Dekker S. The field guide to human error
Can Med Assoc J 1995;153:1423–31. investigations. Aldershot: Ashgate, 2002.
Authors’ affiliations 2 New York State Patient Occurrence 8 Grimshaw J, Russell IT. Effect of guidelines
A Hutchinson, School of Health and Related Reporting and Tracking System on medical practice: a systematic review of
Research (ScHARR), University of Sheffield, (NYPORTS). http://www.health.state.ny.us/ rigorous evaluations. Lancet
Sheffield S1 4DA, UK nysdoh/ (accessed 26 March 2003).
1993;342:1317–22.
P Barach, Department of Anesthesia and 3 Mohr J, Abelson, H, Barach P. Leadership
strategies in patient safety. J Qual Manage 9 Institute of Healthcare Improvement.
Critical Care, University of Chicago, Chicago, IL htp://www.ihi.org/conferences/natforum/
60637, USA Health Care 2002;11:69–78.
4 Leape L. Reciprocal accountability: an handouts/M20_Chessare.pdf (accessed 1
overlooked dimension of safety. Alliance April 2003).
Correspondence to: Professor A Hutchinson,
School of Health and Related Research 2002; November, 24–6. 10 National Health Service.
5 Weick KE, Sutcliffe KM, Obstfeld D. htp://www.modernnhs.nhs.uk/scripts
(ScHARR), Sheffield S1 4DA, UK;
Organising for high reliability: processes of (accessed 1 April 2003).
allen.hutchinson@sheffield.ac.uk collective mindfulness. Res Organisational 11 Bates DW, Cohen M, Leape LL, et al.
Behav 1999;21:81–123. Reducing the frequency of errors in medicine
REFERENCES 6 Woods DD, Cook RI. Nine steps to move using information technology. J Am Med Infor
1 Oxman AD, Thompson MA, Davis DA, et al. forward from error. Cognition Technol Work
Assoc 2001;8:299–308.
No magic bullets: a systematic review of 2002; 4: 137–44.

Patient safety system elements—human, information

................................................................................... and hardware—notions embodied in
crew resource management (CRM). The

Aviation safety: a model for health result is a “culture of safety”.

It is generally acknowledged that our

care?
health care does regularly violate this dic-
tum. Resulting corrective efforts are often
focused at the “sharp edge” of the health
W Rutherford care process—the level of patient
interface with the provider. This is under-
...................................................................................
standable in our medical culture which
It is time to rethink the institutions and processes through which subliminally suffuses students in their
earliest days of medical school with the
health care is delivered if a “culture of safety” is to be notion that “if I know enough, am smart
achieved. enough, work hard enough, I will not
make mistakes”. However, profound ad-
“Patient safety” has become a prominent procedures have been deployed actively verse effects result from this mis-
topic in the medical lexicon since the to prevent induced harm, often quite understanding of human behavior and
Institute of Medicine in 1999 released its aside and in addition to the purpose of human performance. They include strong
landmark report “To Err Is Human”.1 the enterprise. We in health care give lip psychological incentives—to add to legal
Much of the ensuing discussion sur- service to this moral imperative with the ones in our “system”—for concealment,
rounding an individual patient’s well familiar admonition “first do no harm”. denial, and transfer of “blame” for the
being treats “safety” as though it were a How well do we respect it in our inevitable errors which do occur. Efforts
palpable, concrete entity which some- attitudes, processes and procedures? Do focused at this sharp edge do not, and
how can be created by command, manu- we know what we are doing? cannot, accomplish the command to do
facture, or spontaneous generation. Alas, Another contemporary industry no harm; neither can a single soldier win
it is neither so simple nor so tangible, nor exists which shares with health care a war nor an individual star constitute a
is it accomplished by “doing what we some important attributes—high stakes; basketball team. There are too many other
always do, but doing it better”. We must potentially lethal technology; primary forces and players involved. It is impera-
rethink the institutions and processes participants who are strong willed, inde- tive that we look to the overall systems of
through which health care is offered. pendent, and quick to slip into autocratic delivering health care.
If danger can be defined as the behavior; a history and tradition of When we do, we find that there is no
probability of incurring injury or death deference to these key autocrats; work “system”. Health care is delivered by a
as a result of participating in, or being done in small, highly interdependent vast cottage industry which is populated
subjected to, a given activity or behavior, groups with little outside oversight or by dispirited providers2 serving an
safety is the inverse—that is, the likeli- supervision. It has changed its behavior increasingly disrespectful consumer,3
hood of emerging unharmed from the to enhance safety. financed by reluctant governmental and
same behavior. In the first instance it is a The airline industry has developed private “third parties” and preyed upon
relative term since life itself is a high risk processes and disciplines with respect to by a politically well connected parade of
phenomenon of finite duration. Life per- safety (no favorable claims are made plaintiffs’ attorneys. A condition has
mits no absolute safety. By definition, about this industry’s business acumen) been created wherein an “industry” sup-
patients are confronting some high- which can be instructive, even though ported by the most elegant new science
lighted element of life’s background risk not directly transplantable, to health and technology—and consuming great
when they enter themselves into the care. Over the last 30 years three wealth—has grasped defeat from the
healthcare web. Those who seek care do simultaneous and often interacting jaws of victory. It seems to have lost its
so with the hope that they can find relief, trends can be identified: (1) increasing sense of purpose.
all the while assuming that, in so doing, system transparency (the threshold for
they do not expose themselves to new reporting of untoward “events” has been “Health care is delivered by a vast
danger. Creating the environment where lowered), (2) increasing standardization cottage industry populated by
this assumption is justified is the chal- of procedures (the autonomy of the dispirited providers . . .”
lenge for patient safety activists. operator has been curtailed while pre-
In many potentially hazardous indus- serving his authority), and (3) increas- It is impossible to hear physicians’ dis-
tries specific attitudes, processes, and ing efficiency in extracting value from all cussions of similar cases and not be

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EDITORIALS 163

astounded (and appalled) by the practice volume of data from an appropriately confront the problems patients bring to
they describe. The efficacy of so many managed study would quickly offer us, and the ones we bring to them.
therapeutic regimes is so doubtful as to guidance as to the most effective prac- Qual Saf Health Care 2003;12:162–163
cause many therapeutic choices to be tices. We want evidence-based practice;
made by ill supported opinion. There is a let’s generate good evidence. .....................
literature so confused and confusing that The process of organizing and imple- Author’s affiliation
some common symptom constellations menting such an initiative would eventu- W Rutherford, 9660 Wolf Road, Geneseo,
appear likely to receive about as many ally involve medical administration, edu- IL 61254, USA; bill_rutherford@msn.com
therapeutic interventions as there are cation and practice at all levels, thus
practitioners consulted. Do all of them potentially restoring a sense of common REFERENCES
1 Kohn LT, Corrigan JM, Donaldson MS, eds.
work? Do any of them work? purpose among diffuse and competing To err is human: building a safer health
Very well defined evidence-based elements of the industry. Importantly, system. Institute of Medicine, Committee on
guidelines exist for treating several such a program could help bridge the Quality of Health Care in America.
Washington, DC: National Academy Press,
conditions—for example, asthma and expanding gap between the expertise in 1999.
hypertension.4 5 Yet surveys indicate that medical center ivory towers and the far 2 Career Center for Employers. Hospitals
in fewer than 20% of patients is the distal branches of the healthcare appara- and health networks. NEJM Career Center for
Employers 2001;75 (www.nejmjobs.org/rpt,
treatment for these diseases meeting the tus. 2003).
standards of the guidelines.6 7 There is no single notion—simple or 3 Marcus LJ, Dorn BC. Renegotiating health
Well designed, carefully conducted grand—that will create a culture of safety care. AMNews 17 June 2002.
4 National Asthma Education and
clinical studies separate effective from for health care. No proclamations can fix Prevention Program (NAEPP). Guidelines
ineffective regimens. Web based data the ills or grow a mature effective provider for the diagnosis and management of asthma.
collection could convert the existing dif- of care. But there are clues as to the direc- Expert Panel Report 2. NIH Publication No
97-4051. Bethesda, MD: National Institutes of
fuse practice into a powerful clinical tion in which we should start. Knowledge Health, 1997 (updated 2002).
study. Acceptable competing treatment must be squeezed from the enterprise. 5 National Institutes of Health (NIH). The
protocols for common clinical conditions Errors must be reported to permit engi- Sixth Report of the Joint National Committee
on Prevention, Detection, Evaluation and
would be identified. Individual practi- neering similar future errors out of a sys- Treatment of High Blood Pressure (JNC VI).
tioners in this new practice environment tem. Treatment regimens must be vali- NIH Publication No 98-4080. Bethesda, MD:
could select one (as they often say they dated or abandoned; effective ones must National Institutes of Health, 1998.
6 National Center for Health Statistics.
do) and apply it consistently. Providers be delivered dependably to all who need Asthma prevalence, health care use and
could report results of their real-world them, even when that means public edu- mortality 2000–2001. Hyattsville, MD:
interventions simultaneously with the cation to recruit those at silent risk. National Center for Health Statistics, US
DHHS, Division of Data Services
medical record keeping and billing in- Many conflicting pressures converge on (http://www.cdc.gov/nchs/products/pubs/
puts in a well designed practice software health care. The industry seems to have pubd/hestats/asthma/asthma.htm, January
suite. This could provide a good start neglected the potentials of a collective 2003).
towards identifying effective best prac- 7 Meissner I, Whisnant JP, Sheps SG, et al.
assertive pursuit of efficacy and safety in Detection and control of high blood
tices. This has been the norm in treating favor of a somewhat diffuse defence pressure in the community: do we need a
pediatric leukemia patients for the last against these many assaults. The profes- wake-up call? Hypertension
20 years.8 Their results would enter the sions and their patient public could 1999;34:466–71.
8 Simone JV, Lyons J. The evolution of cancer
database along with others using the greatly benefit from initiatives that look care for children and adults. J Clin Oncol
same and competing regimens. The large toward new paradigms which realistically 1998;16:2904–5.

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