Building Safer Systems

1. Building Safer Systems ASA

2. Without data, you are just another person with an opinion. ASA

3. Safety • Safety is not a specific thing. • In complex organizations, safety is created by people as they do their work. • There are strategies and designs that favor safe performance. ASA

4. Safety is Produced by SocioTechnical Systems “The problem is not bad people; the problem is that the system needs to be made safer.” ….“preventing errors and improving safety require a systems approach….” “….this higher level of quality cannot be achieved by further stressing current systems of care… Trying harder will not work.” IOM 2001 “….healthcare organizations must develop a systems orientation to patient safety….” “Safety is a characteristic of systems and not of their components. Safety is an emergent property of systems.” “Reducing risk and ensuring safety require greater attention to systems that help prevent and mitigate errors.”

5. HRO’s: High Reliability Organizations: Characteristics • Process auditing and other active searches (eg, equip testing) for possible failures. • High quality standards • Risk perception: examining even small but unexpected events. • Command and control: • Fluid decision-making (flex hierarchy) • Formal rules and procedures (but flexible) • Constant training Karlene Roberts, 2005 ASA

6. Safety in Medicine: Needed Changes • Specify limits to maximum performance. [How many cases should we do?] • Decrease individual autonomy: • Regulations – the minimum necessary • Teamwork • specialization • Fatigue, overtime, excessive work schedules, staff shortages, stress. Amalberti R, 2005 ASA

7. Accident Models ASA

8. Some holes due to active failures hazards Other holes due to latent conditions (resident pathogens) losses This model is being increasingly criticized as an example of how to understand accidents. It is too static; the defects are often transient; and the whole system is more dynamic than the model suggests. Successive layers of defenses, barriers, and safeguards ASA

9. Sequential accident models inevitably lead to a root cause, which is the basis of the root cause analysis. The search for a root cause (often a human), tends to perpetuate the blame-the-person outcome. It also suggests that eliminating a root cause will solve the problem. ASA

10. Systemic (not sequential) accident model A detailed inquiry finds multiple parallel factors that led to the event considered to be the root cause. ASA

11. Systemic Accident Model Before the accident. ASA

12. Systemic Accident Model Retrospective analysis might suggest that the outcome of the actions taken was predictable. We have not completely escaped blame-&-train. ASA

13. System Features ASA

14. Aviation has achieved a 10-6 rate of injurious accidents. Surgery is said to have a 10-4 rate. ASA

15. Training Experience High/low volume System Features “In the medical arena, the most common system failure is in education. The person at the sharp end (eg, the surgeon) did not know enough or was not experienced enough to make the correct judgment or action.” VA Hernia Trial: 85% of participating surgeons were still climbing the learning curve. Who is responsible? ASA

16. 25,400 Business as usual 2015 438 1960 Our Goal The Evolution ofAviation Safety1965 - 2004 Airplanes in service Departures 2004 17.5 Million 19,077 2004 Hull loss accidentsper year Accident Rate / Million Departure Millions of departures Hull loss accident rate 1965 1975 1985 1995 2005 2015 ASA Year Boeing 2004 Statistical Data – May 2005

17. System Features Teams in Aviation & Medicine • Improved safety in commercial aviation, stemmed from better aircraft, better system designs, automation, and rule-making. • Work in aviation and medicine is done by teams. • Aviation: CRM reduced cockpit hierarchy, and communication improved. Moved on the LOSA & TEM. • Medicine is practiced by teams, and team development is now a major issue. That leads to CRM; better communication; and observational studies of surgical work (LOSA). ASA

18. System Features Importance of Teams in Surgical Performance Error Management in Pediatric Cardiac Surgery: Carthey, J et al (unpublished) Multicenter study of neonatal arterial switch operation in GB. 173 ASO’s observed by experts in error management. Errors defined as major or minor, and compensated or uncompensated. The total number of minor errors in a case, whether compensated or not, was directly related to the chances that a major error would not be corrected, and a serious complication or death would result. Minor errors and uncompensated major errors and deaths were less common with stable teams. ASA

19. High nurse turnover Nurse Dissatisfaction O.R. Vicious Cycle SPD dysfunctional Nurse less able Random case assignments Equipment missing Surgeon angry O.R. tension mounts Performance drop Case more difficult Flow interrupted Dysfunctional team. ASA

20. System Features Hypothetical staffing pattern during a four-hour case. Nurses, surgeon, and anesthesiologists can be a different mix several times per hour. No stable teams; communication affected; information lost. ASA

21. Bottom Line: Seek harmony to preserve teams and avoid unsafe behaviors. How the surgeon acts is key. System Features O.R. Communication – A Team Activity Lingard L et al. Communication failures in the O.R. Qual Saf Health Care 2004;13:330. Lingard L et al. Getting teams to talk. Qual Saf Health Care 2004;14:340 Lingard L et al. Team Communications in the O.R.: Patterns and sites of tension. Acad Med 2002;77:232. ASA

22. Loose coupling Tight coupling System Features An Important Failure Mode: Tight Coupling Tight coupling connects parts of the system so rigidly that actions at one place are immediately transmitted throughout. Prediction and control become harder, and accidents increase. In systems-talk, this is “going solid.” ASA

23. System Features Everyday Examples of Tight Coupling • No hospital beds • No ICU beds • Overbooked IR schedule • Shortage of surgical instruments: cases delayed • Inadequate resources to staff O.R. cases • Lengthy queues for operations. Elective surgery in off hours. • Long queues for routine outpatient appointments. Examples of failing to set production limits that match production capacity. ASA

24. SBAR (or SCAP) Read-back Face-to-face Hand-off IT (van Eaton) Checklists Standardized orders System Features The Useful Concept of Gaps Complexity creates gaps in care, where information can be lost. Every transition in care constitutes a gap. The increasing fragmentation of medical care is producing more gaps. Information loss at gaps can be decreased by handoff routines and checklists. HANDOFFS CHECKLISTS & ETC. ASA

25. Pre-op planning O.R. scheduling Admission scheduling Night before checklist Pre-op checklist (briefing) Post-op care checklist Admission and pre-op orders Postop orders Transition orders Discharge orders Discharge instructions System Features Checklists & Standardized Orders Orders Checklists As many as 11 checklists between evaluation in the clinic and discharge from the hospital. ASA

26. Referring MD Surgical Patient Flowchart Patient Surgeon Start Clinic Prepare Nurses PreOp O.R. Suite Nurses Operation O.R. Nurses O.R. Nurses Anesthesia1 R.R. Surgical Ward Nurses Nurses System Features Anesthesia2 Home ASA

27. Referring MD 1. 11. Patient Surgeon 1. 2. Clinic 2. ·Eleven handoffs ·Eight procedural subsystems 3. 3. Prepare 4. 4. Nurses 5. PreOp 5. O.R. Suite Nurses Operation 9.&10. O.R. Nurses O.R. Nurses 6. 6. Anesthesia1 R.R. 7. 7. Surgical Ward Nurses 8. 8. Nurses System Features Anesthesia2 Home ASA

28. Communication deficits during the operation -- lost information. Poorly synchronized multitasking that delayed case progress. Hand-offs during inappropriate times -- information loss. Counting protocol delayed case and of questionable quality. Circulating nurses performed retrieval errands too often. Christian CK, Zinner MJ, Dierks MM: A prospective study of patient safety in the operating room. Surgery 2006;139:159. Observational study of O.R. systems during general surgery cases. System Features ASA Good work: LW

29. Christian CK, Zinner MJ, Dierks MM: A prospective study of patient safety in the operating room. Surgery 2006;139:159. • Demonstrates how investigations done in the O.R. by surgeons can detect system faults. • And eliminate unsafe practices. • And presumably, improve efficiency. • The findings of this study could probably be replicated in most large hospitals. • As surgeons troubleshoot O.R. systems, surgeons require a share of administrative authority to implement the changes . System Features ASA

30. Conclusions • Progress in understanding • The systems nature of safety • The nature of surgical systems • System faults that affect safety • And how to fix them • Surgeons must be directly involved in 1) O.R. administration and 2) observational studies of the surgical system to bring about the required changes. ASA

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32. “To Err is Human. . . Or Is It? ACS Efforts – Error Prevention and Patient Safety Thomas R. Russell, MD, FACS April 20, 2006 ASA

33. Omnibus per artem fidemque prodesse ASA

34. The American College of Surgeons “Dedicated to improving the care of the surgical patient and to safeguarding standards of care in an optimal and ethical practice environment.” ASA

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36. Institutes of Medicine Three reports, starting with To Err Is Human: Building a Safer Health System, published in 2000. • Demonstrate that our current health care system neither controls spending nor ensures access to quality care • Clarion call for all to reevaluate their role • Quality • Cost ASA

37. To Err Is Human • Shift from saving lives by preventing errors to implementing evidence-based practices to improve quality • Domain of effectiveness of service, test or therapy to create better outcomes – i.e. “statistical lives” ASA

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39. Correct Diagnosis Proper Staging Proper Risk Assessment Disease Treatment Proper Treatment Best evidence Best technology Best technique Proper Outcome Survival No complications Disease cured Symptoms relieved Function restored Death with dignity ACS is working in all these areas Quality Surgical Care ASA

40. Quality Surgical Care • Structure • Process • Outcomes ASA

41. Education ASA

42. ACGME/ABMS Core Competencies • Medical Knowledge • Patient Care • Interpersonal and Communication Skills • Professionalism • Practice-based Learning and Improvement • Systems-based Practice ASA

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45. Practice-Based Learning & Improvement American College of Surgeons Case Logging System ASA

46. Closed Claims Project • A standardized collection of reviews of claims involving surgical mishaps from records kept by liability insurance companies • 461 claims reviewed to date • Purpose – to identify common problems and develop best practices and protective systems to improve patient safety ASA

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49. Education Program for Accreditation of Educational Institutes • Will serve as regional sites where surgeons may learn new procedures, emerging technologies, and rarely performed procedures ASA

50. ACS Efforts to Enhance Education in Surgical Skills ASA