Journal of Critical Care (2005) 20, 2 – 5

Evolution of Health Services Research for Critical Care

Brief history of patient safety culture and science

Roy Ilan MDa,*,
Robert Fowler MDCM, MS(Epi), FRCP(C)a,b

a
Department of Critical Care Medicine, Sunnybrook & Women’s College Health Sciences Centre, University of Toronto,
Toronto, Ontario, Canada M4N 3M5
b
Division of General Internal Medicine, Department of Medicine, Sunnybrook & Women’s College Health Sciences Centre,
University of Toronto, Toronto, Ontario, Canada M4N 3M5

Keywords:
Abstract The science of safety is well established in such disciplines as the automotive and aviation
Safety;
industry. In this brief history of safety science as it pertains to patient care, we review remote and recent
Critical care;
publications that have guided the maturation of this field that has particular relevance to the complex
Error;
structure of systems, personnel, and therapies involved in caring for the critically ill.
Intensive care
D 2005 Elsevier Inc. All rights reserved.

Patient safety has become a focus of clinical care and
research in recent years. However, the potential for medical
care to cause harm, has been appreciated throughout the
history of medicine. The term primum non nocere (first, do
no harm) is attributed by some historians to Galen and was
introduced to American and British medical culture by
Worthington Hooker in 1847 [1]. Florence Nightingale
noted, bIt may seem a strange principle to enunciate as the
very first requirement in a hospital that it should do the
sick no harmQ [2]. At the beginning of the 20th century,
Dr Harvey Cushing, a pioneer in surgery and neurosurgery,
published detailed descriptions of harm caused to his
patients secondary to his own performance [3].
The Institute of Medicine defines medical errors as bthe
failure of a planned action to be completed as intended or
the use of a wrong plan to achieve an aim [4].Q The terms
errors of execution (failure of a planned action to be
completed as intended) and errors of planning (the use of a
wrong plan to achieve an aim) are related to this definition.
The concepts of errors of omission (not doing something
T Corresponding author. Tel.: +1 416 480 6100 7428, + 1 416 480 6100
4522; fax: +1 416 480 4999.
E-mail address: roy.ilan@sw.ca (R. Ilan).
that ought to be done) and errors of commission (doing the
wrong thing) are familiar to clinicians and relate to
outcomes as well. Other systems of classification define
errors as failures at the systems level that include human,
organizational, and technical constraints on performance,
whether there are adverse consequences or not [5]. A close
call, or near miss, is an event that almost leads to patient
harm, but is avoided because of luck or timely interception.
The common denominator of interventions to improve
patients’ safety is the striving toward freedom from
accidental injury. The field of critical care medicine is
relatively new. Given the complexity of treatments and
diversity of interventions offered in intensive care units,
attention to patient safety culture and science is particularly
relevant for care of the critically ill [4,6]. In this article, we
review recent select publications that have helped to inform
the culture and science of patient safety.
1. A recent history of safety science outside
clinical medicine
Guarnieri M. Landmarks in the history of safety. J Safety
Res 1992;23:151-8.

0883-9441/$ – see front matter D 2005 Elsevier Inc. All rights reserved.
doi:10.1016/j.jcrc.2005.02.003
Brief history of patient safety culture and science
By the mid-19th century, the association of alcohol with
accidents served to reinforce an idea that had deep roots in
Western thinking: people were responsible for their own
safety and the victim shared the guilt for his or her injury
[7]. This belief was furthered by industrial accident records
indicating that for more than 90% of baccidents,Q the
employee was at fault, and the remaining cases were
unpreventable acts of God. In the early 1900s, insurance
company–sponsored research raised 2 concepts: the first
was that safety promotion was cost-effective; the second
was that accidents had psychological causes. Psychologists
believed that accidents were caused by mental errors, thus,
the safety expert was trained to look for psychological
problems. This approach dominated the science of safety for
almost 50 years, but lost its popularity when a key
component of safety psychology theory could not by
proven—a personality type that fit the accident-prone
definition could not be demonstrated. Guarnieri describes
the 1963 discovery by 2 independent scientists, William
Haddon and JJ Gibson, that the amount of energy delivered
to the body and the degree of damage ensued were directly
proportional and that injury prevention depended on control
of energy. This theory provided the basis for the automobile
safety standards. Coinciding with this development were
similar improvements in aviation safety, changes that
dramatically influenced the risk of loss of life in this area
and have been an inspiration for recent years’ efforts in
improving safety in medicine [8].
Safety scientists have subsequently advocated against
using the term accident and instead concentrated on the
process of the injury rather than associating blame to any
one party. Haddon and Gibson’s work shifted the focus of
research from behavioral psychology to engineering and
epidemiology. It facilitated the collaboration of engineering
and medicine, bringing a logical framework to apply
physics to injury control and prevention. This resulted in
modeling systems leading to injury and incorporating
accurate data into these models through use of sensors on
cars, gloves, shoes, hard hats, sports equipment, eyewear,
and others. This work has had an effect on the language of
safety: the word accident has nearly disappeared from the
modern scientific and engineering lexicon. It is estimated
that as a results of Haddon’s work on automobile safety
standards, at least 50 000 fatalities and hundreds of
thousands of serious injuries were prevented in just
the 10 years after their initial investigations. This work
has both enormous direct and indirect consequences on
the care of both trauma patients and critically ill patients
in general.
2. A systematic approach to safety in medicine
Leape LL, Bates DW, Cullen DJ, et al. Systems analysis
of adverse drug events. ADE Prevention Study Group.
JAMA 1995;274:35-43.
3
Several authors have investigated the incidence of
adverse events in hospitalized patients. The aim of this
study was to identify and evaluate the systems failures
that underlie errors causing adverse drug events and
potential adverse events [9]. This investigation was among
the first to demonstrate rigorous methods toward under-
standing root contributing factors, which then allow the
development of btreatmentsQ for preventable adverse drug
events. In a prospective cohort study, actual and potential
drug-related injuries were identified over a 6-month period
in nonobstetric, adult patients admitted to intensive care
units. The errors found were investigated promptly by
a multidisciplinary team that included physicians, nurses,
pharmacists, and systems analysts together with those
involved. The underlying systems failures were identified,
and ideas were generated as to how systems could be
redesigned to reduce the failures. During this study,
334 errors were detected as the causes of 264 preventable
adverse drug events and potential adverse drug events.
Sixteen major bsystems failuresQ were identified as the
underlying causes of the errors. The most common were a
failure in dissemination of drug knowledge to physicians
(29%) and inadequate availability of patient information
(18%). Seven systems failures accounted for 78% of the
errors, including drug knowledge dissemination, dose, and
identity checking, patient information availability, order
transcription, allergy defense, and medication order
tracking. All of the errors tracked could be improved by
better information systems. The authors mentioned that
hospital personnel, who willingly participated in the
detection and investigation of drug use errors, were able
to identify underlying systems failures. Given the type of
the most common systems failures, the authors conclude
that changes to improve dissemination and display of drug
and patient data would make errors in the use of drugs
less likely. The widespread promotion of both computer-
ized physician order entry and presence of a pharmacist
on rounds in the intensive care unit stems directly from
this work.
3. An audit of the current state of patient
safety in North America
Kohn LT, Corrigan JM, Donaldson MS, eds. To err is
human: building a safer health system. Washington (DC):
National Academy Press; 2000.
Although not the first publication in recent years to
systematically address patient safety in medicine, this
report of the Institute of Medicine bTo err is human:
building a safer health systemQ has aroused an enormous
response [4]. The report is a systematic review of the
medical literature on the potential for harm in modern
medicine. It estimates that 44 000 to 98 000 patients die
every year because of medical error in the United States
alone. The report explores the causes of the problem and
4 R. Ilan, R. Fowler
provides recommendations addressed to several levels
of intervention:
! The US Congress was advised to create a Center for
Patient Safety, which would set goals, track progress,
develop knowledge, and facilitate legislation.
! The development of a nationwide standardized
reporting system to organize and analyze events that
may compromise patient safety.
! Health-care organizations and health professionals are
advised to have performance standards and expect-
ations focused toward patient safety. They are
directed to establish patient safety programs and
implement practices proven to improve patient safety.
! The Food and Drug Administration is instructed to
increase attention to the safe use of drugs in both
premarketing and postmarketing processes.
The report also summarizes changes required to mini-
mize and prevent injury secondary to errors, including
improving awareness of the public and health professionals
to the problem; aligning payment systems and the liability
system so they encourage safety improvements; developing
training and education programs that emphasize the
importance of safety; and creating a culture of safety within
health-care organizations.
This report sets a goal of reducing error related mortality
in the United States by 50% over a 5-year period. A number
of legislative and regulatory initiatives to document errors
and to search for solutions have been started. Several
subsequent prominent publications have resulted, including
the report of the Quality Interagency Coordination Task
Force, which listed more than 100 action items to be
addressed by federal agencies [10]. Many of these recom-
mendations have been directed toward common practices in
intensive care units [11].
4. The evidence for change in patient safety
culture and practice
Shojania KG, Duncan BW, McDonald KM, et al, eds.
Making health care safer: a critical analysis of patient safety
practices. Rockville (Md): Agency for Healthcare and
Research Quality; 2001.
The Agency for Healthcare Research and Quality
commissioned the University of California at San Fran-
cisco –Stanford University Evidence-based Practice Center
to critically review the existing evidence on practices
relevant to improving patient safety [11]. Patient safety
practices were defined as those that reduce the risk of
adverse events related to exposure to medical care. Based on
preliminary surveys of the literature and expert consultation,
79 practices were identified for review. Most focused on
hospitalized patients, but some involved nursing home or
ambulatory patients.
The source for data included observational studies,
clinical trials, and systematic reviews in the peer-reviewed
medical and relevant non–health-care literature. Using a
predefined consensus technique, the practices were ranked
according to the strength of evidence.
Among all interventions, a list of the 11 practices with
the greatest evidence were identified for widespread
implementation. The focus and relevance of these inter-
ventions to critically ill patients are striking:
! Appropriate use of prophylaxis to prevent venous
thromboembolism in patients at risk.
! Use of perioperative h-blockers in appropriate
patients to prevent perioperative morbidity and
mortality.
! Use of maximum sterile barriers while placing central
intravenous catheters to prevent infections.
! Appropriate use of antibiotic prophylaxis in surgical
patients to prevent postoperative infections.
! Asking that patients recall and restate what they have
been told during the informed consent process.
! Continuous aspiration of subglottic secretions to
prevent ventilator-associated pneumonia.
! Use of pressure relieving bedding materials to prevent
pressure ulcers.
! Use of real-time ultrasound guidance during central-
line insertion to prevent complications.
! Patient self-management for warfarin to achieve
appropriate outpatient anticoagulation and prevent
complications.
! Appropriate provision of nutrition, with a particular
emphasis on early enteral nutrition in critically ill and
surgical patients.
! Use of antibiotic-impregnated central venous cathe-
ters to prevent catheter-related infections.
The authors conclude that an evidence-based approach
can help identify practices that are likely to improve patient
safety. They call for further research upon the evidence of
safety practices tested in limited settings and of promising
practices drawn from industries outside health care.
5. Summary
In this review, we have summarized a few important
milestones in the relatively new science of safety in
medicine, an important component of the more general
endeavor of quality assurance in medicine. As with any new
field, there are still controversies about basic issues, for
instance, the definition and the extent of the term safety. Is
safety about injuries from care that are caused by errors that
may be reduced with specific safety systems solutions, or is
it about adverse events of medical treatment, which require
advances in medical science? Should safety science be
concerned chiefly with the investigation of bpreventableQ
adverse events — a distinction that can be very difficult to
Brief history of patient safety culture and science
judge — or should we focus on adverse events regardless of
perceived preventability and strive to eliminate them
through a combination of safety science (error reduction
and recovery) combined with advances in clinical sciences?
In our efforts to improve the safety of critically ill patients,
should we apply only evidence-based practices or also yet
unproved practices that make inherent sense and might
improve patient safety [12]? We can be certain that
increasing emphasis will be placed on patient safety for
all patients, and that patient safety has particular relevance
to the complex structure of systems, personnel, and
therapies involved in caring for the critically ill.
References
[1] Hooker W. Physician and patient. New York (NY)7 Baker and
Scribner; 1847.
[2] Nightingale F. Notes on hospitals. London7 Parker and Son; 1859.
[3] Pinkus RL. Mistakes as a social construct: an historical approach.
Kennedy Inst Ethics J 2001;11:117 - 33.
5
[4] Kohn KT, Corrigan JM, Donaldson MS, editors. To err is human:
building a safer health system. Washington (DC)7 Committee on
Quality of Health Care in America, Institute of Medicine, National
Academy Press; 1999.
[5] McNutt RA, Abrams R, Aron DC, for the Patient Safety Committee.
Patient safety efforts should focus on medical errors. JAMA 2002;
287:1997 - 2001.
[6] Bion JF, Heffner JE. Challenges in the care of the acutely ill. Lancet
2004;363:970 - 7.
[7] Guarnieri M. Landmarks in the history of safety. J Safety Res 1992;
23:151 - 8.
[8] Wu AW, Pronovost P, Morlock L. ICU incident reporting systems.
J Crit Care 2002;17:86 - 94.
[9] Leape LL, Bates DW, Cullen DJ, et al. Systems analysis of adverse
drug events. ADE Prevention Study Group. JAMA 1995;274:35 - 43.
[10] Doing what counts for patient safety: federal actions to reduce medical
errors and their impact. Report of the Quality Interagency Coordina-
tion Task Force (QuIC) to the President. 2000, February.
[11] Shojania KG, Duncan BW, McDonald KM, et al, editors. Making
health care safer: a critical analysis of patient safety practices.
Rockville (Md)7 Agency for Healthcare and Research Quality; 2001.
[12] Leape LL, Berwick DM, Bates DW. What practices will most improve
safety? Evidence-based medicine meets patient safety. JAMA 2002;
288:501 - 7.