Principles of Patient SafetyAn Overview

Richard T. Griffey, MD, MPH

Assistant Professor, Emergency Medicine

Mary Z. Taylor, JD
Director of Patient Safety

Washington University School of Medicine

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Learning Objectives
What is the case for patient safety?
Adverse Events/Medical errors
System Design and Human Factors
Adverse Event Reporting
Culture of Safety
Disclosure of Adverse Events
What you can use these principles in your work

Definitions
Patient Safety
- Absence of preventable harm: avoidance of errors
in clinical care resulting in injury to our patients
Quality Care
- Best possible care: optimizing the likelihood of
health outcomes desired by patients, families and
clinicians

Incidence of adverse events and negligence in hospitalized patients

Results of the Harvard Medical Practice Study I (1991)
TA Brennan, LL Leape, NM Laird, L Hebert, AR Localio, AG Lawthers,
JP Newhouse, PC Weiler, and HH Hiatt

30,121 patients; 51 acute care hospitals in New York

Rates of Adverse Events (AE) by age, sex and specialty.

Adverse events in 3.7% of hospitalizations

27% resulting from negligence
58% preventable (errors)
13.6% resulted in death
Conclusion: There is a substantial amount of injury to patients from medical
management, and many injuries are the result of substandard care.
The Harvard Study was the first major attempt to quantify medical harm. It was
limited to professional liability claims and was the first to create a sense of the
magnitude of the problem.
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HarmScope of the Problem

More than 1 million preventable adverse
events occur in the US each year
An estimated 44,000-98,000 people die in
hospitals each year from preventable
medical errors

Institute of Medicine. 1999. To Err is Human: Building a safer health system.

Many mark the release of To Err is Human by the Institute of Medicine as the first major
study in patient safety and an attempt to offer ideas on what can be done in prevention.
The IOM took the Harvard study and extrapolated its findings to create the often quoted
44,000 98,000 statistic.
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Scope of the Problem

what if they all happened at once?
Extrapolated to annual hospital admissions
(33.6M)between 44,000 and 98,000 deaths/year
or 1 jumbo jets per day falling from the sky
Leape LL. Error in medicine. JAMA. 1994 Dec 21;272(23):1851-7

Total national costs estimated between $17 and $29

billion for preventable adverse events
Brennan TA, Leape LL, Laird NM, Hebert L, Localio AR, Lawthers AG, Newhouse JP, Weiler PC, Hiatt HH. Incidence
of adverse events and negligence in hospitalized patients. Results of the Harvard Medical Practice Study I. N
Engl J Med. 1991 Feb 7;324(6):370-6.

Yearly Attributable Deaths

45,000
40,000
35,000
30,000
25,000
20,000
15,000
10,000
5,000
0
MVA

Breast Cancer

AIDS

Medical Errors

Even using the lower number from the IOM study, Medical Errors killed more
Americans than car accidents and breast cancer. There is no indication that
the annual rate of deaths from errors decreased since 1999.
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AHRQ 2001

2011 Study Shows 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: 2936 percent) or 91 events per 1,000 patient days (range:
89106).
Some patients experienced more than one adverse event; the
overall rate was 49 events per 100 admissions (range: 4356).
Older patients, longer LOS, higher case mix, experienced most
adverse events

Classen DC, et al. Health Affairs. 30:4 (2011): 581589

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High Profile Deaths from Medical Errors

Chemotherapy overdose

Betsy Lehman, 39
Dana Farber

Dehydration and oversedation

ABO compatibility
checking error-- transplant

Josie King, 18 months

Johns Hopkins
Growth hormone
overdose

Jesica Santillan, 17
Duke
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Sebastien Ferrero, 3
U. Florida

High Profile Deaths from Medical Errors

Weve been talking about the numbers of people who die from errors. But its
important to maintain the focus on individual patients.
Betsy Lehman was the health reporter for the Boston Globe. She received a 10fold 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?

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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

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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

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Why Are We Quick to Blame?

Clinicians value personal judgment and responsibility

We like to have attribution/causality
We maintain an illusion of autonomy
If we can blame someone we can move on and dont
have to look a the entire processIts just human
error or It happens, its a known complication.

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Pioneers in Patient Safety

We cant change
the human
condition, but
we can change
the conditions
under which
humans work.

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James Reasons Swiss cheese Model

Some holes due
to active failures

Hazards

Other holes due to

latent system factors

Harm

Successive layers of defenses, barriers, & safeguards

No single individual error (active error) is sufficient to cause an accident
The majority of medical errors are caused by faulty systems, processes and
conditions that lead people to make mistakes or fail to prevent them
Latent conditions = system faults that increase the probability of individuals making
errors
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Pioneers in Patient Safety

DonBerwickformer CEOofIHI,nowheadofCMS
Every system is perfectly designed to achieve
the results it gets.

LucianLeapeHarvardSchoolofPublicHealth
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.

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Why has it taken so long to make things safer?

We fail to treat the delivery of healthcare as a science
Most errors dont harm patients/failure to capture and learn
-no harm, no foul usually brings a sigh of relief, not action
Need to overcome the culture of medicine which expects
perfection instead of expecting error and planning for it
-get away from the idea that your own effort drives everything
-healthcare is a team sport: overwhelming evidence that diverse input
improves outcomes

Some of us still believe smart people, working hard, will not

make mistakes
We map the human genome and transplant hearts and lungs,
but we dont wash our hands
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Medical Errors
Bad news

Errors are inevitable

Good news

Errors fall into predictable patterns

Communication

Planning

Execution

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Strong But Wrong

Once a decision is made,
natural tendency is to
defend it

Contradictory data is often

discounted or ignored

Problem often detected at

shift change fresh eyes,
or when a new person
enters a room
This tendency is prevalent among experienced clinicians who have
developed effective routines. It can also be common among newer clinicians
who don t have a history of experiences to draw from, a mature frame of
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reference. .

Human Factors
Examines activity by way of component tasks and
considers it in terms of:
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

We know errors result when these factors are violated

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Human Factors Principles

Avoid reliance on memoryseven digits is our max
Decrease reliance on vigilance
Increase verbal feedback/structured communication
Standardize what you can, and only that; use
protocols & checklists wisely
Use constraints and forcing functions to create a
safety net to save you from yourself
Reduce handoffs and standardize content
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When the posted speed limit is 65mph, how fast do you drive? What impacts your speed?
Time of day?
Whether its a speed trap?
Are you late picking up kids from daycare?
Is the weather bad?
Even the best intentioned are pressed to step over known safety precautions in medicine, resulting
in practice creep.
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Reliability and Safety

Expectations of Healthcare
Is it sufficient to achieve thrombolysis/PCI in MI
within 60 minutes 60% of the time?
Is it OK to eliminate 90% of the NICU BSIs?
What if we do the correct operation 99% of the time?
ATM example: Change in design reduced defect
rate 1,000 foldincreased reliability/reduced cost
Hard Stop: Most banks changed their design to release your card first,
then your money, so the card isnt retained. You cant leave it behind.

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Aviation Safety as a ModelHigh Reliability

Aviation industry admitted they were going to be
tired, make mistakes, do the wrong thing
As large commercial planes crashed the publics
attention was focused
Became pre-occupied with failure
o

Standardized communication between team members

Flattened hierarchy but recognized leadership

Created safe environments, free from distraction during critical steps

Developed reporting and investigation infrastructure

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How Do We Respond to Errors?

Report them

WUSM Employees use the WUSM Event Reporting System

http://ers.wusm.wustl.edu

BJC Employees use the BJC System (icon on desktops)

SAFEline

Call 7-SAFE (7233) and leave a message

Submit cases to Departmental QI or M&M process

Transparency with each other safely telling lessons learned

Ask What happened not Who did it?
Give a full explanation to patients/families of adverse events
Ask Who else can learn from this?generalize lessons
Involve patients and families 25in safety efforts

Traditional Voluntary Reporting in Hospitals

Lost Opportunities to Learn
Key Findings:
9 Hospital staff did not report 86% of events to incident reporting systems
9 Physician accounted for less than 2% of reports
Hospital Incident Reporting Systems Do Not Capture Most Patient Harm. January
2012 OEI-06-09-00091

Low physician reporting is problematic. It hinders the ability to identify and

mitigate risks. Physicians view health care through a unique lens, which allows
them to identify certain types of hazards and certain contributing factors better
than others.
Noble, DJ, Pronovost, Underreporting of Patient Safety Incidents Reduces Health
Cares Ability to Quantify and Accurately Measure Harm Reduction P. J Patient Saf 2010; 6:24

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Culture
Definition of culture: the way we do business
Behaviors define culturewhat 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 actusually unspoken but passed down

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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

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Just CulturePersonal Responsibility

A fair and just culture establishes the mechanisms to
appropriately apportion responsibility

Human error, At-risk behavior, Reckless Behavior

A just culture is one in which individuals are held

accountable for their actions, but not for system
flaws

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The algorithm helps you walk through an event to determine what actions need be taken:
system change, counseling, discipline. It recognizes that personal responsibility must be
paired with system change.
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Communication of Adverse Events to Patients

When harm occurs:

Consult with all those

involved to establish facts

If error contributed to harm:

Give family a prompt

explanation of what occurred

Give a compassionate &

truthful explanation and say
you are sorry

Express regret and

compassion for what they are
experiencingsay sorry

Tell them what you are

doing to prevent it from
happening again

Discuss the medical needs

going forwardshort and
long term effects of injury

Identify who will be their

contact for future
discussions

Document the error and the

discussions in the record

For more information on Disclosure, go http://patientsafety.wusm.wustl.edu

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Patient Safety in Action

What Can You Do?

Recognize your role on the team:

Solicit wide and independent input/Solicit discordant views

Develop a shared mental model that is verbalized and identify when the
plan needs to shift
Be approachable

Be preoccupied with failureobserve the systems

Communicate using best practices:

SBAR, Closed loop

communication, Standard handoff language, Stop the Line

When things go wrong, learn:

What happened?
Why?
What did you do to reduce risk of it happening again?
How do you know it worked?
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Thetypeofthinkingthatgotusintotheseproblems
willnotbethetypeofthinkingthatwillgetusout.
AlbertEinstein

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Conclusions
We want patient care to be safe, effective, and centered on the
patients needs and wants
We come to work, as do our colleagues, to do the best job
possible. We acknowledge that our systems of care are often
unreliable
We know that it almost always takes many failures to create
patient harm
Patient Safety is not a belief, it is something you dolearn
basic patient safety skills and techniques to prevent harm to
patients

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Acknowledgements
Institute for Healthcare Improvement Patient Safety Executive
Curriculum
University of Michigan Medical Center
Harvard Medical School Risk Management Foundation
Washington University School of Medicine Patient Safety
Curriculum authors:

Chris Carpenter, MD
James Duncan, MD
Richard Griffey, MD
Nikoleta Kolovos, MD
Brian Nussenbaum, MD;
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