1Principles of Patient SafetyAn Overview

Richard T. Griffey, MD, MPHAssistant Professor, Emergency Medicine

Mary Z. Taylor, JDDirector of Patient Safety

Washington University School of Medicine

2Learning 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

3Definitions

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

PresenterPresentation Notes

What is quality care?

4Incidence 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 YorkRates of Adverse Events (AE) by age, sex and specialty.

Conclusion: There is a substantial amount of injury to patients from medical management, and many injuries are the result of substandard care.

Adverse events in 3.7% of hospitalizations 27% resulting from negligence 58% preventable (errors) 13.6% resulted in death

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.

5HarmScope 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.

6Scope of the Problemwhat 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.

7Yearly Attributable Deaths

05,000

10,00015,00020,00025,00030,00035,00040,00045,000

MVA Breast Cancer AIDS Medical Errors

AHRQ 2001Even 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.

8The 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

2011 Study Shows IHI Global Trigger Tool Reveals Highest Harm Rate

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

9High Profile Deaths from Medical Errors

Sebastien Ferrero, 3U. Florida

Josie King, 18 monthsJohns Hopkins

Jesica Santillan, 17Duke

Betsy Lehman, 39Dana Farber

Chemotherapy overdose

Dehydration and oversedation

ABO compatibilitychecking error-- transplant Growth hormone

overdose

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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 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?

High Profile Deaths from Medical Errors

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Traditional Approach to Error

Error is a character flaw Focus on the incident and the individual Punishment and Remediation

Personal responsibility and theory of bad apples"

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

Pioneers in Patient Safety

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James Reasons Swiss cheese Model Some holes dueto active failures

Successive layers of defenses, barriers, & safeguards

Hazards

Other holes due tolatent system factors

Harm

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

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.

DonBerwickformer CEOofIHI,nowheadofCMS

LucianLeapeHarvardSchoolofPublicHealth

Every system is perfectly designed to achieve the results it gets.

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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 reference. .

PresenterPresentation NotesThis tendency is prevalent among experienced, senior clinicians, who have developed effective routines. It is also common among newer clinicians who don t have a history of experiences to draw from.

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Human Factors

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

Physical demands: fatigue, illness, substance abuse, stressSkill requirements: inexperience, fear, procedural shortcutsMental workload: boredom, cognitive shortcuts, reliance on memoryTeam dynamics: stress, shift workDevice design: equipment/programsEnvironment:

fixed: lighting, heat, unnatural workflow spacecontrollable: 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.

PresenterPresentation Notes

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Reliability and SafetyExpectations 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 costHard 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 failureo Standardized communication between team memberso Flattened hierarchy but recognized leadershipo 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 in safety efforts

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Traditional Voluntary Reporting in Hospitals Lost Opportunities to Learn

Key Findings:9 Hospital staff did not report 86% of events to incident reporting systems9 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

Give family a prompt explanation of what occurred

Express regret and compassion for what they are experiencingsay sorry

Discuss the medical needs going forwardshort and long term effects of injury

If error contributed to harm: Give a compassionate &

truthful explanation and say you are sorry

Tell them what you are doing to prevent it from happening again

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 ActionWhat 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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Thetypeofthinkingthatgotusintotheseproblemswillnotbethetypeofthinkingthatwillgetusout.

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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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;

Acknowledgements

Slide Number 1Learning ObjectivesDefinitionsSlide Number 4HarmScope of the Problem Scope of the Problemwhat if they all happened at once?Slide Number 7Slide Number 8High Profile Deaths from Medical ErrorsHigh Profile Deaths from Medical ErrorsTraditional Approach to ErrorPatient Safety Approach to Error Why Are We Quick to Blame? Slide Number 14James Reasons Swiss cheese Model Pioneers in Patient SafetyWhy has it taken so long to make things safer?Medical ErrorsStrong But WrongHuman FactorsHuman Factors PrinciplesSlide Number 22Reliability and SafetyExpectations of HealthcareAviation Safety as a ModelHigh Reliability How Do We Respond to Errors? Traditional Voluntary Reporting in Hospitals Lost Opportunities to Learn Culture Culture of SafetyJust CulturePersonal ResponsibilitySlide Number 30Communication of Adverse Events to PatientsPatient Safety in ActionWhat Can You Do?Slide Number 33ConclusionsSlide Number 35