Principles of Patient Safety An Overview

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1 Principles of Patient Safety An Overview Richard T. Griffey, MD, MPH Assistant Professor, Emergency Medicine Mary Z. Taylor, JD Director of Patient Safety Washington University School of Medicine 1

2 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 2

3 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 3

4 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. 4

5 Harm Scope 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 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. 5

6 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 ½ jumbo jets per day falling from the sky Leape LL. Error in medicine. JAMA Dec 21;272(23): 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 Feb 7;324(6):

7 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 AHRQ 2001

8 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: percent) or 91 events per 1,000 patient days (range: ). 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):

9 High Profile Deaths from Medical Errors Chemotherapy overdose Betsy Lehman, 39 Dana Farber ABO compatibility checking error-- transplant Dehydration and oversedation Growth hormone overdose Josie King, 18 months Johns Hopkins Jesica Santillan, 17 Duke 9 Sebastien Ferrero, 3 U. Florida

10 High Profile Deaths from Medical Errors We ve been talking about the numbers of people who die from errors. But it s 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? 10

11 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 11

12 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 12

13 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 don t have to look a the entire process It s just human error or It happens, it s a known complication. 13

14 Pioneers in Patient Safety We can t change the human condition, but we can change the conditions under which humans work. 14

15 James Reasons Swiss cheese Model Some holes due to active failures Hazards Harm Other holes due to latent system factors 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 15

16 Pioneers in Patient Safety Don Berwick former CEO of IHI, now head of CMS Every system is perfectly designed to achieve the results it gets. Lucian Leape Harvard School of Public Health 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. 16

17 Why has it taken so long to make things safer? We fail to treat the delivery of healthcare as a science Most errors don t 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 don t wash our hands 17

18 Medical Errors Bad news Errors are inevitable Good news Errors fall into predictable patterns Communication Planning Execution 18

19 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 19

20 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 20

21 Human Factors Principles Avoid reliance on memory seven 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 21

22 When the posted speed limit is 65mph, how fast do you drive? What impacts your speed? Time of day? Whether it s 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. 22

23 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 fold increased reliability/reduced cost Hard Stop: Most banks changed their design to release your card first, then your money, so the card isn t retained. You can t leave it behind. 23

24 Aviation Safety as a Model High Reliability Aviation industry admitted they were going to be tired, make mistakes, do the wrong thing As large commercial planes crashed the public s attention was focused Became pre-occupied with failure o o 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 24

25 Report them How Do We Respond to Errors? WUSM Employees use the WUSM Event Reporting System 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 25 in safety efforts

26 Traditional Voluntary Reporting in Hospitals Lost Opportunities to Learn Key Findings: Hospital staff did not report 86% of events to incident reporting systems Physician accounted for less than 2% of reports Hospital Incident Reporting Systems Do Not Capture Most Patient Harm. January 2012 OEI 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 Care s Ability to Quantify and Accurately Measure Harm Reduction P. J Patient Saf 2010; 6:24 26

27 Culture 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 27

28 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 28

29 Just Culture Personal 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 29

30 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. 30

31 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 experiencing say sorry Discuss the medical needs going forward short and long term effects of injury 31 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

32 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 failure observe 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? 32

33 The type of thinking that got us into these problems will not be the type of thinking that will get us out. Albert Einstein 33

34 Conclusions We want patient care to be safe, effective, and centered on the patient s 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 do learn basic patient safety skills and techniques to prevent harm to patients 34

35 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; 35

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