1. 2016/7/81 Patient Safety Introduction Adapted from VA National Center for Patient Safety www.patientsafety.gov

2. 2016/7/8 Adapted from VA National Center for Patient Safety www.patientsafety.gov 2 Objectives Understand the definition and scope of patient safety Become familiar with the epidemiology of adverse events in healthcare Build a good foundation for understanding the systems approach to patient safety Understand the role of close calls Learn about high reliability organizations Understand the basics of how to prevent, eliminate, and/or reduce adverse events and hazards

3. 2016/7/8 Adapted from VA National Center for Patient Safety www.patientsafety.gov 3 One or More Subsections Will Be Covered Subsection #1: Definition and Scope of Patient Safety Subsection #2: Patient Safety Epidemiology Subsection #3: Systems Approach to Patient Safety Subsection #4: Reducing harm by identifying and controlling hazards Subsection #5: High reliability organizations Subsection #6: Intro to Patient Safety Tools

4. 2016/7/8 Adapted from VA National Center for Patient Safety www.patientsafety.gov 4 Subsection #1: Definition and Scope of Patient Safety Definitions of error, adverse event, and patient safety; and why they matter Scope of patient safety –What we call it –System focus, not individual –What we measure –What we hope to achieve

5. 2016/7/8 Adapted from VA National Center for Patient Safety www.patientsafety.gov 5 Patient safety is the identification and control of hazards that could cause harm to patients Patient safety is the prevention of harm or injury to patients Is Patient safety a euphemism for medical error? –Not really - medical error is poorly defined and often a euphemism for blaming an individual Patient safety is about providing a safe environment in which to practice. “How can there be quality healthcare if it isn’t safe?” What is patient safety?

6. 2016/7/8 Adapted from VA National Center for Patient Safety www.patientsafety.gov 6

7. 2016/7/8 Adapted from VA National Center for Patient Safety www.patientsafety.gov 7 Is this Semantics? What do you call the following? –Wrong leg is amputated –Wrong medication is dispensed –Diagnosis is “too late” to save patient with meningitis –You almost go into the wrong room to do a lumbar puncture Hold judgment, but consider –Incidence and prevalence vary widely in major journals –Our focus is reducing harm to the patient

8. 2016/7/8 Adapted from VA National Center for Patient Safety www.patientsafety.gov 8 Working definitions of patient safety, errors, and adverse events VA: Adverse events are untoward incidents, therapeutic misadventures, iatrogenic injuries or other adverse occurrences directly associated with care or services provided within the jurisdiction of a medical center, outpatient clinic or other facility. Adverse events may result from acts of commission or omission (e.g., administration of the wrong medication, failure to make a timely diagnosis or institute the appropriate therapeutic intervention, adverse reactions or negative outcomes of treatment, etc.). Your Definitions? “Out of the box”: human error is irrelevant! –Who done it? Does that really matter? –Spectrum of human performance

9. 2016/7/8 Adapted from VA National Center for Patient Safety www.patientsafety.gov 9 Subsection #2: Patient Safety Epidemiology How many adverse events? How many close calls? Inpatient vs outpatient? Very dependent on definitions and methodology

10. 2016/7/8 Adapted from VA National Center for Patient Safety www.patientsafety.gov 10 Causes of death in US – all ages year 2000 1. Heart disease: 710,760 2. Chronic, low respiratory disease: 122,000 6. Diabetes: 69,301 8. Alzheimer’s: 49,558 9. Motor vehicle accidents: 41,994 *IOM (2000): Annual patient deaths attributed to medical error in US hospitals: 44,000-98,000 Estimated cost: $17 - $50 billion ** HealthGrades Report (2004): 191,000 deaths/yr Estimated cost: $6.3 billion/yr

11. 2016/7/8 Adapted from VA National Center for Patient Safety www.patientsafety.gov 11 And consider the research evidence… Retrospective studies (Brennan, et al, 1991)) –2-4% of hospitalizations –10-40% including close calls Cross-sectional (Ely, et al 1995) –50% with survey of Family Practice docs 2-20 years experience Prospective studies (Gopher, 1991; Andrews, 1999) –ICU observation: 1.7 events/patient/day –Internal Medicine rounds: 50% of all admitted patients with 1-10 events

12. 2016/7/8 Adapted from VA National Center for Patient Safety www.patientsafety.gov 12 96 - 98% Reliability in Hospitals? What would 99.9% reliability mean? –1 hour of unsafe drinking water every month –2 unsafe plane landings per day at O’Hare Airport in Chicago –16,000 pieces of mail lost every hour –22,000 checks deducted from the wrong bank account each hour –20,000 incorrect prescriptions every year –500 incorrect operations each week *Multiply above numbers by 20 to 40X ~ Hospital Reliability

13. 2016/7/8 Adapted from VA National Center for Patient Safety www.patientsafety.gov 13 More evidence of the problem Samore paper in JAMA on medical devices –0.1% or 17%? –Depends on what question you are asking? Your personal or family’s experience with adverse events? –One survey found 50% had significant story –Your experience asking residents to tell a story?

14. 2016/7/8 Adapted from VA National Center for Patient Safety www.patientsafety.gov 14 Subsection #3: Systems Approach to Patient Safety Systems model examples Systems versus Person-Focused No accountability?

15. 2016/7/8 Adapted from VA National Center for Patient Safety www.patientsafety.gov 15 It’s usually the system! (from UW-Madison Systems Engineering Initiative in Patient Safety)

16. 2016/7/8 Adapted from VA National Center for Patient Safety www.patientsafety.gov 16 What is the difference between focusing on the person and focusing on the system? Person approach –Focus on individuals –Blaming individuals for forgetfulness, inattention, or carelessness, poor production –Methods: poster campaigns, writing another procedure, disciplinary measures, threat of litigation, retraining, blaming and shaming –Target: Individuals System approach –Focus on the conditions and environment in which individuals work –Building fault tolerance in a system of work to reduce harm or mitigate its effects –Methods: creating better system –Targets: System (team, tasks, workplace, organization, physical environment)

17. 2016/7/8 Adapted from VA National Center for Patient Safety www.patientsafety.gov 17 No fault system or blame free environment? NO, not necessarily. –In the VA, intentionally unsafe acts are excluded from safety –Accountability systems have a place and are in place –Without individual accountability you cannot have safety or quality – “Just Culture” It does mean you should analyze the system to look for problems before jumping to the conclusion that it was somebody’s “fault”.

18. 2016/7/818 Subsection #4: reducing harm by identifying and controlling hazards Focus on the System

19. 2016/7/8 Adapted from VA National Center for Patient Safety www.patientsafety.gov 19 What is a hazard? In healthcare, a HAZARD is anything in the clinical environment that poses a risk for harm to a patient or provider. In medicine we call hazards risk factors. Example: compressed-air tubing with IV-type connector

20. 2016/7/8 Adapted from VA National Center for Patient Safety www.patientsafety.gov 20 Why focus on hazards and harm? In medicine, if we want to reduce the incidence of a disease we –Look for risk factors –Explore how they contribute to the disease –Develop solutions to reduce or eliminate the risk factor or mitigate its effects on the patient. In safety, if we want to reduce adverse events, we –Look for hazards –Analyze how they contribute to the adverse events – Develop solutions to reduce or eliminate the hazard.

21. 2016/7/8 Adapted from VA National Center for Patient Safety www.patientsafety.gov 21 Hazard is a “pre-close call” Bone cement expiration date is “hidden” on the larger, unseen surfaces of the flat packaging

22. 2016/7/8 Adapted from VA National Center for Patient Safety www.patientsafety.gov 22

23. 2016/7/8 Adapted from VA National Center for Patient Safety www.patientsafety.gov 23 How do you identify safety hazards? Proactive techniques, such as Healthcare Failure Mode and Effect Analysis (preventive medicine) –Focused upon complex work units in a health system OR, Pharmacy, ED, Ambulatory Clinic Eg. HFMEA on outpatient pharmacy in public health system in MA –Accomplished prior to implementing new software or new devices Reactive techniques, such as Root Cause Analysis (RCA) (acute care medicine) –Based on reports of close calls –Based on reports of adverse events Eg. RCA on inpatient anticoagulation protocol

24. 2016/7/8 Adapted from VA National Center for Patient Safety www.patientsafety.gov 24 How do you control hazards? CONTROL THEM so that they cannot do harm To control hazards, we prefer to follow the safety engineering “hierarchy of hazard control” –Eliminate hazard –Guard against hazard –Train to avoid hazards –Warn against hazard Effectiveness

25. 2016/7/8 Adapted from VA National Center for Patient Safety www.patientsafety.gov 25 Subsection #5: High reliability organizations Main theoretical construct in safety literature Learning organizations that make “everything everybody’s business” Lessons learned from industry –Nuclear Power –Aviation

26. 2016/7/8 Adapted from VA National Center for Patient Safety www.patientsafety.gov 26 Patient Safety Challenges Medicine Views Errors as Failings Which Deserve Blame - Fault –Train and blame mentality pervades –Corrective Actions Focus on Individual No Blood No Foul Philosophy –Many in health care ignore or downplay close calls –Is experience the best teacher? Who pays the tuition for learning from experience of managing complications?

27. 2016/7/8 Adapted from VA National Center for Patient Safety www.patientsafety.gov 27 A More Productive Approach People Don’t Come to Work to Hurt Someone or Make a Mistake Systems Issues > Individual’s Fault or Problem Common vulnerabilities that can be found and fixed for EVERYONE, not just one person/place

28. 2016/7/8 Adapted from VA National Center for Patient Safety www.patientsafety.gov 28 Awareness and Shame May be Largest Hurdles 1999 Survey at VA and Private Healthcare Organizations –Only 27% Agreed that Errors were a Serious Problem –49% “Ashamed” by Error 1999 IOM report concurs

29. 2016/7/8 Adapted from VA National Center for Patient Safety www.patientsafety.gov 29 Multi-Causal Theory “Swiss Cheese” diagram (Reason, 1991)

30. 2016/7/8 Adapted from VA National Center for Patient Safety www.patientsafety.gov 30

31. 2016/7/8 Adapted from VA National Center for Patient Safety www.patientsafety.gov 31 “Culture of Safety” and “High Reliability Organizations” Safety is always on the “agenda” – especially for top management Embrace information from close calls and hazard analysis Communication up and down the “food chain” If you are not sure it is safe, it is not safe

32. 2016/7/8 Adapted from VA National Center for Patient Safety www.patientsafety.gov 32 Empirical Evidence that Culture and Attitudes are Key Effective system fixes with evidence meet resistance from frontlines –Sign the site for wrong-site surgery –High concentration potassium removed from wards Root cause analyses keep finding the issues –Communication between various disciplines –Failure to “speak up” when something looks “out of whack”

33. 2016/7/8 Adapted from VA National Center for Patient Safety www.patientsafety.gov 33 Close calls and high reliability organizations Close calls 10-100 times > adverse events Noting them and dealing with them is a marker for HRO, culture of safety People more willing to analyze and delve into close calls (less shame?)

34. 2016/7/8 Adapted from VA National Center for Patient Safety www.patientsafety.gov 34 Subsection #6: Intro to Patient Safety Tools Example: Root Cause Analysis (RCA)

35. 2016/7/8 Adapted from VA National Center for Patient Safety www.patientsafety.gov 35 Discussion of VA and affiliate university safety programs Root cause analysis (RCA) –What happened, why did it happen, what can be done? –Triggered from actual events and close calls with “severe” potential –In VA, protected from discovery and confidential Close call reporting –In VA, when in doubt, call and talk to your patient safety manager Standards or goals of national organizations (e.g., JCAHO) –Dangerous abbreviations, patient mix-ups, free-flow IV pumps, etc.

36. 2016/7/8 Adapted from VA National Center for Patient Safety www.patientsafety.gov 36 Many impediments to adequate analysis of adverse events

37. 2016/7/8 Adapted from VA National Center for Patient Safety www.patientsafety.gov 37 Three related concepts Human error is a symptom of trouble deeper in the system (it is the starting point, not the end) To explain failure, do NOT try to find where people went wrong Find how people’s assessment and action made sense at the time, given the circumstances that surrounded them

38. 2016/7/8 Adapted from VA National Center for Patient Safety www.patientsafety.gov 38 Conclusions Patient Safety is focused on the system and not the individual –We are not interested in: Who done it? Patient Safety is proactive with a focus to prevent patient harm We are interested in: What happened? How did it happen? Why did it happen? What are we going to do to prevent it from happening again? And, how are we going to measure whether or not our interventions are working?