To Err is Human

To Err is Human
Prof. Dr. H. Erdal Akalın, FACP, FRCP, FIDSA
Istanbul, Turkey
• Cancer patient, 18, critical after drug injection blunder. Daily
News 2001; 24 Jan.
• A young patient with leukemia is dying, not from his disease,
but from an erroneous intrathecal injection of vincristine,
intended for intravenous use.
• 13 identical cases over the past 15 years.
• The hospital apologizes and two doctors are suspended,
pending investigation.
Donald Berwick, Not again! BMJ 2001; 322:247-48.
High Profile Deaths from Medical Errors
• Betsy Lehman was the health reporter for the Boston Globe. She received
a 10- fold overdose of chemo at Dana Farber and died.
• Josie King was recovering from burns when she died of dehydration and a
failure to monitor her pain medications at Johns Hopkins.
• Jesica Santillan died of ABO incompatibility when the surgeons and staff at
Duke failed to check her blood type prior to transplant.
• Sebastian Ferrero received an overdose of growth hormone at his
outpatient pediatric clinic and died.
All have foundations in their names and their families work with the schools
and hospitals on patient safety efforts. Do we really need to wait for a tragic
case in order for us to improve safety for our patients?
Is There a Problem?
• To Err is Human, IOM 1999
• Crossing the Quality Chasm, IOM 2001
• The President’s Advisory Commission on Consumer
Protection and Quality in the Health Care Industry, 1998
• Healthy People 2010, US DHHS, 2000
• How good is the quality of health care in the United
States? Milbank Q 1998
• Priority areas for national action, Transforming
healthcare quality, IOM 2003
• Patient safety, Achieving a new standard for care, IOM
2004
Institute of Medicine, Priority areas for national action: Transforming health care quality, 2003
Physicians vs Community, USA, Turkey
USA
Physicians (831)
Community (1207)
35%
42%
Turkey
Physicians (462)
Community (6354)
69%
10%
Blendon, et al. N Eng J Med 2003; 347:1933-40
Çakmakçı M, Akalın E, Patient safety in Turkey and World, 2010.
International
“Commonwealth Fund International Survey”
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USA
Canada
Australia
New Zeland
Germany
UK
34%
30%
27%
25%
23%
22%
C Schoen, Taking the pulse of health care systems: Experiences of patients with health problems
in six countries, Health Affairs 2005; November issue.
Preface
• To Err Is Human: Building a Safer Health System. The title of
this report encapsulates its purpose. Human beings, in all
lines of work, make errors. Errors can be prevented by
designing systems that make it hard for people to do the
wrong thing and easy for people to do the right thing.
• In health care, building a safer system means designing
processes of care to ensure that patients are safe from
accidental injury. When agreement has been reached to
pursue a course of medical treatment, patients should have
the assurance that it will proceed correctly and safely so they
have the best chance possible of achieving the desired
outcome.
William C. Richardson, Ph.D., Chair, November 1999
First Studies
• Brennan, Troyen A.; Leape, Lucian L.; Laird, Nan M., et al.
Incidence of adverse events and negligence in hospitalized
patients: Results of the Harvard Medical Practice Study I. N
Engl J Med. 324:370–376, 1991.
• Leape, Lucian L.; Brennan, Troyen A.; Laird, Nan M., et al. The
Nature of Adverse Events in Hospitalized Patients: Results of
the Harvard Medical Practice Study II. N Engl J Med.
324(6):377–384, 1991.
• Thomas, Eric J.; Studdert, David M.; Burstin, Helen R., et al.
Incidence and Types of Adverse Events and Negligent Care in
Utah and Colorado. Med Care forthcoming Spring 2000.
• Two large studies, one conducted in Colorado and
Utah and the other in New York, found that adverse
events occurred in 2.9 and 3.7 percent of
hospitalizations, respectively.
• In Colorado and Utah hospitals, 6.6percent of
adverse events led to death, as compared with 13.6
percent in New York hospitals.
• In both of these studies, over half of these adverse
events resulted from medical errors and could have
been prevented.
• When extrapolated to the over 33.6 million admissions to U.S.
hospitals in 1997, the results of the study in Colorado and
Utah imply that at least 44,000 Americans die each year as a
result of medical errors.
• The results of the New York Study suggest then number
maybe as high as 98,000.
• Even when using the lower estimate, deaths due to medical
errors exceed the number attributable to the 8th-leading
cause of death.
• More people die in a given year as a result of medical errors
than from motor vehicle accidents (43,458), breast cancer
(42,297), or AIDS (16,516).
IHI Global Trigger Tool Reveals Highest
Harm Rate
• The rate of adverse events was higher than previously
reported
• adverse events occurred in 33.2 percent of hospital
admissions (range: 29–36 percent) or 91 events per 1,000
patient days (range: 89–106).
• Some patients experienced more than one adverse event; the
overall rate was 49 events per 100 admissions (range: 43–56).
• Older patients, longer LOS, higher case mix, experienced most
adverse events
Classen DC, et al. Health Affairs. 30:4 (2011): 581–589
“Serious or potentially serious medication errors in the care
of 6.7 out of every 100 patients”.
Bates et al., JAMA 1995; 274:29-34
The terms: Error and Adverse event
• An error is defined as the failure of a planned
action to be completed as intended (i.e., error of
execution) or the use of a wrong plan to achieve
an aim (i.e., error of planning).
• An adverse event is an injury caused by medical
management rather than the underlying
condition of the patient. An adverse event
attributable to error is a “preventable adverse
event.”
Patient Safety Dictionary “Errors”
• Failure of a planned action to be completed as
intended or use of a wrong plan to achieve an aim; the
accumulation of errors results in accidents. (Kohn et
al.);
• Failure to complete a planned action as intended, or
the use of an incorrect plan of action to achieve a given
aim. (NHS);
• The failure of a planned action to be completed as
intended or the use of a wrong plan to achieve an aim.
Errors can include problems in practice, products,
procedures, and systems. (QuIC)
National Patient Safety Foundation, July 2003, www.npsf.org/
• Errors of commission: doing the wrong thing
• Errors of omission: not doing the right thing
• Errors of execution: doing the right thing
incorrectly
National Patient Safety Foundation, July 2003, www.npsf.org/
Major Challenges
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Medication errors (medication safety)
Surgical errors
Diagnostic errors
Errors due to system failure
Other (such as HAIs)
Human Factors
• Physical demands: fatigue, illness, substance abuse, stress
• Skill requirements: inexperience, fear, procedural shortcuts
• Mental workload: boredom, cognitive shortcuts, reliance on
memory
• Team dynamics: stress, shift work
• Device design: equipment/programs
• Environment: fixed: lighting, heat, unnatural workflow space;
controllable: noise, interruptions, motion, clutter
Traditional Approach to Error
Personal responsibility and theory of
“bad apples"
• Error is a character flaw
• Focus on the incident and the individual
• Punishment and Remediation
New Approach
• Patient safety: the prevention of healthcare errors,
and the elimination or mitigation of patient injury by
healthcare errors
• Medical error: an unintended healthcare outcome
caused by a defect in the delivery of care to a patient
National Patient Safety Foundation, July 2003, www.npsf.org/
“We can’t change the human condition,
but we can change the conditions under
which humans work.”
Prof James Reason
Pioneers in Patient Safety
• “Every system is perfectly designed to achieve the
results it gets.”
Don Berwick—former CEO of IHI
• “Incompetent people are, at most, 1% of the
problem. The other 99% are good people trying to do
a good job who make very simple mistakes and it's
the processes that set them up to make these
mistakes.”
Lucian Leape—Harvard School of Public
Health
Patient Safety Approach to Error
• Humans will err despite their best efforts, knowledge and
motivation. Therefore goal of Patient Safety is not to eliminate
human error, but to create safe systems to prevent them from
reaching the patient.
• Context of error is more important than the participant. Ask
“How did it happen” not “Who did it’?
• Assumes good intentions, ability, motivation and knowledge
• Systems or processes that depend on perfect human
performance are fatally flawed.
• Most adverse events result from a cascade of failures in a
flawed system
Culture Change
• Definition of culture: “the way we do business”
• Behaviors define culture—what you do, not say
• Culture is a manifestation of internalized
assumptions, shared beliefs and practices
• Culture is made up of understandings we share as to
how to act—usually unspoken but passed down
Culture of Safety
• Focuses on creating a safe system in which to work
• Strikes a balance between flattening hierarchy and
effective teamwork with a recognized leader
• Strives for high reliability with members preoccupied
with failure
• Creates an environment where both patients,
physicians, staff are treated with dignity and respect
– Right thing to do
– Keeps patients safer
Steps to Achieving Patient Safety and
High Reliability
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Address Strategic Priorities, Culture, and Infrastructure
Engage Key Stakeholders
Communicate and Build Awareness
Establish, Oversee, and Communicate System-Level Aims
Track/Measure Performance Over Time, Strengthen Analysis
Support Staff and Patients/Families Impacted by Medical Errors
Align System-Wide Activities and Incentives
Redesign Systems and Improve Reliability
Leadership Guide to Patient Safety, IHI, 2006
Patient Safety Strategies
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Strongly encouraged
Preoperative checklists and anesthesia checklists to prevent
operative and postoperative events
Bundles that include checklists to prevent central line–
associated bloodstream infections
Interventions to reduce urinary catheter use, including
catheter reminders, stop orders, or nurse-initiated removal
protocols
Bundles that include head-of-bed elevation, sedation
vacations, oral care with chlorhexidine, and subglottic
suctioning endotracheal tubes to prevent ventilatorassociated pneumonia
Hand hygiene
Ann Intern Med. 2013;158:365-368.
• The do-not-use list for hazardous abbreviations
• Multicomponent interventions to reduce
pressure ulcers
• Barrier precautions to prevent health care–
associated infections
• Use of real-time ultrasonography for central line
placement
• Interventions to improve prophylaxis for venous
thromboembolisms
Ann Intern Med. 2013;158:365-368.
Consequences of Medical Errors/Patient Safety
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Mortality and morbidity
Length of stay
Discomfort to patients and care takers
Legal issues
Pronovost et al. Defining and measuring patient safety. Crit Care Clin 2005; 21:1-19.
How to Improve Patient Safety?
• Evidence-based clinical practice
– Guidelines, Critical pathways, Bundles, Check-lists
• Culture change
– Accountability
• Education and training
• Behavioral change
– Being open-Saying SORRY when things go wrong!
Agency for Healthcare Research and Quality, 2001
Prof. Peter Davey
Thank you!
The IOM Quality Chasm Series
• To Err Is Human: Building a Safer Health System, 2000
• Crossing the Quality Chasm, 2001
• Leadership by Example: Coordinating Government Roles in Improving
Health Care Quality, 2002
• Fostering Rapid Advances in Health Care: Learning From Systems
Demonstrations, 2002
• Priority Areas for National Action: Transforming Health Care Quality, 2003
• Health Professions Education: A Bridge to Quality, 2003
• Patient Safety: Achieving a New Standard for Care, 2003
• Keeping Patients Safe: Transforming the Work Environment of Nurses,
2004
• Quality Through Collaboration: The Future of Rural Health Care, 2004
• Preventing Medication Errors: Quality Chasm Series, 2006
• Improving the Quality of Health Care for Mental and Substance-Use
Conditions: Quality Chasm Series, 2006