1. © The Johns Hopkins University and The Johns Hopkins Health System Corporation, 2011 Learning From Defects Exercise Revisited Armstrong Institute for Patient Safety and Quality David A. Thompson DSc, MS, RN Associate Professor

2. Comprehensive Unit-based Safety Program (CUSP) 1.Educate staff on science of safety 2.Identify defects 3.Assign executive to adopt unit 4.Learn from one defect per quarter 5.Implement teamwork tools 2 We are here! Armstrong Institute for Patient Safety and Quality

3. Learning Objectives To understand the difference between first order and second order problem solving To address each of the 4 questions in learning from defects –What happened, why, what will you do to reduce risk, and how do you know it worked? 3 Armstrong Institute for Patient Safety and Quality

4. ICUs are High Risk Areas 17% of ICU patients suffer serious adverse events 1 1.7 errors per patient day: 29% potentially serious 2 85,000 errors every day 24,650 potentially life threatening On average, every patient admitted suffers a potentially life threatening error – Based on 55,000 daily, 5 million annually 4 1. Andrews LB, Stocking C. An alternative strategy for studying adverse events in medical care. The Lancet. 1997;349(9048):309-313. 2. Donchin Y, Gopher D, Olin M, et al. A look into the nature and causes of human errors in the intensive care unit. Critical Care Medicine. 1995;23(2):294-300. Armstrong Institute for Patient Safety and Quality

5. Assessing Defects Staff Safety assessment –Please describe how you think the next patient in your unit/clinical area will be harmed. Adverse event reporting systems Sentinel events Complications Infection rates Mortality and morbidity conference Claims data 5 Armstrong Institute for Patient Safety and Quality

6. Hazard/Defect? You Know It When You See It Armstrong Institute for Patient Safety and Quality 6

7. A Medication Error Story 63 year old man with sternal infection transferred to the ICU Allergy to Penicillin noted in chart Treatment includes Piperacillan 25 minutes after dose, patient arrests Antibiotic reaction regarded as likely trigger 7 Armstrong Institute for Patient Safety and Quality

8. A Medication Error Story Reason 8 Armstrong Institute for Patient Safety and Quality

9. 9

10. Defect? Armstrong Institute for Patient Safety and Quality 10

11. Defect? Armstrong Institute for Patient Safety and Quality 11

12. 12 Armstrong Institute for Patient Safety and Quality

13. Impact of ICU Nurse Staffing on Outcomes* Fewer ICU nurses associated with increased LOS risk of pulmonary complications Pulmonary insufficiency Reintubation of trachea Pneumonia 13 *Pronovost PJ, Dang D, Dorman T, et al. Intensive care unit nurse staffing and the risk for complications after abdominal aortic surgery. Eff Clin Pract. 2001;4:199- 206. Armstrong Institute for Patient Safety and Quality

14. Impact of Pharmacist on Outcomes* Pharmacist participation on daily rounds in the ICU associated with 66% reduction in adverse drug events (ADEs) ADEs reduced 10.4/1000 pt days to 3.5 Prevent one ADE every 143 patients 14 Leape *Leape LL, Cullen DJ, et al. Pharmacist participation on physician rounds and adverse drug events in the intensive care unit. JAMA.1999;282(3):267-270. Armstrong Institute for Patient Safety and Quality

15. Problem Solving* First Order –Recovers for that patient yet does not reduce risks for future patients –Example: You go get the supply or you make do Second Order –Reduces risks for future patients by improving work processes –Example: You create a process to make sure line cart is stocked 15 *Tucker AL, Edmondson AC. Why Hospitals Don’t Learn from Failures: Organizational and Psychological Dynamics that Inhibit System Change. California Management Review, 2003 ;45(2):55-72. Armstrong Institute for Patient Safety and Quality

16. © The Johns Hopkins University and The Johns Hopkins Health System Corporation, 2011 What is a Defect? Anything you do not want to have happen again

17. 4 Questions to Learn from Defects What happened? Why did it happen? What will you do to reduce the chance it will recur? How do you know that you reduced the risk that it will happen again? 17 Armstrong Institute for Patient Safety and Quality

18. What Happened? Reconstruct the timeline and explain what happened Put yourself in the place of those involved, in the middle of the event as it was unfolding Try to understand what they were thinking and the reasoning behind their actions/decisions Try to view the world as they did when the event occurred 18 Reason J. Human Error. Cambridge, UK: Cambridge Univ Pr; 1990. Armstrong Institute for Patient Safety and Quality

19. What Happened? Talk about and understand what happened Complete the “What Happened?” section of the Learning from Defects tool. 19 Armstrong Institute for Patient Safety and Quality

20. Why did it Happen? Develop lenses to see the system (latent) factors that lead to the event Often result from production pressures Damaging consequences may not be evident until a “triggering event” occurs Reason J. Human Error. Cambridge, UK: Cambridge Univ Pr; 1990. 20 Armstrong Institute for Patient Safety and Quality

21. Why did it Happen? Review the list of factors that contributed to the incident and check off those that negatively contributed and positively contributed to the defect Negative contributing factors are those that harmed or increased risk of harm for the patient Positive contributing factors limited the impact of harm 21 Armstrong Institute for Patient Safety and Quality

22. Why did it Happen? Complete the contributing factors section Items may positively contribute, negatively contribute, or not apply (n/a) These are examples but you may identify factors that are not listed, if so, write down 22 Armstrong Institute for Patient Safety and Quality

23. Why did it Happen? Review the list of contributing factors and identify the most important factors related to this event. Rate each contributing factor on its importance to this event and future events. 23 Armstrong Institute for Patient Safety and Quality

24. What will you do to reduce the risk? Safe design principles –Standardize what we do Eliminate defects –Create independent checks –Make it visible Safe design applies to technical and team work 24 Armstrong Institute for Patient Safety and Quality

25. Rank Order of Error Reduction Strategies Forcing functions and constraints Automation and computerization Standardization and protocols Checklists and double check systems Rules and policies Education / Information Be more careful, be vigilant 25 Armstrong Institute for Patient Safety and Quality

26. Strength of Interventions 26 Weaker ActionsIntermediate ActionsStronger Actions Double CheckChecklists/ Cognitive AidArchitectural/physical plant changes Warnings and labelsIncreased Staffing/Reduce workload Tangible involvement and action by leadership in support of patient safety New policy, procedure, or memorandum RedundancySimplify the process/remove unnecessary steps Training and/or educationEnhance Communication (read- back, SBAR etc.) Standardize equipment and/ or process of care map Additional Study/analysisSoftware enhancement/modifications New device usability testing before purchasing Eliminate look alike and sound- a-likes Engineering Control of interlock (forcing functions) Eliminate/reduce distractions Adapted from John Gosbee, MD, MS Human Factors Engineering Remember sometimes a weaker action is your only option. Armstrong Institute for Patient Safety and Quality

27. What will you do to reduce the risk? Review the 2-5 most important contributing factors Brainstorm Interventions –Develop an intervention to defend against the 2-5 most important contributing factors –Identify the strongest interventions that are feasible. –Identify a metric that you can use to measure the impact of the intervention Rate each intervention for its ability to mitigate the contributing factor and the teams belief that the intervention will be implemented and executed 27 Armstrong Institute for Patient Safety and Quality

28. What will you do to reduce the risk? Select top interventions (2 to 5) and develop intervention plan Assign person and task follow-up date 28 Armstrong Institute for Patient Safety and Quality

29. How do you know risks were reduced? Did you create a policy or procedure (weak)? Do staff know about policy or procedure? Are staff using the procedure as intended? –Behavior observations, audits Do staff believe risks were reduced? 29 Armstrong Institute for Patient Safety and Quality

30. How do you know risks were reduced? Once interventions have been implemented complete the “Describe Defect” and “Interventions” portion of section IV of the Learning from Defect Tool. Distribute to staff to rate: –The effectiveness of the implementation –How effective the intervention has been at reducing reoccurrence of the defect 30 Armstrong Institute for Patient Safety and Quality

31. Summarize and Share Findings Summarize findings (Case Summary – Appendix F) Share within your organizations Share de-identified findings with others in collaborative (pending institutional approval) 31 Armstrong Institute for Patient Safety and Quality

32. Unit Environment: availability of device. The appropriate size sheath for a transvenous pacing wire was not a stocked device. Pacing wires and matching sheathes packages separately… increases complexity. Regular training and education, even if infrequently used, of all devices and equipment. Infrequently used equipment/devices should still be stocked in the ICU. Devices that must work together to complete a procedure should be packaged together. Label wires and sheaths noting the appropriate partner for this device. ACTIONS TAKEN TO PREVENT HARM IN THIS CASE The bedside nurse taped together the correct size catheter and wire that were stored in the supply cabinet. In addition, she contacted central supply and requested that pacing wires and matching sheaths be packaged together. Knowledge, skills & competence. Care providers lacked the knowledge needed to match a transvenous pacing wire with appropriate sized sheath. Medical Equipment/Device. There was apparently no label or mechanism for warning the staff that the IJ Cordis sheath was too big for the transvenous pacing wire. CASE IN POINT: An African American male ≥ 65 years of age was admitted to a cardiac surgical ICU in the early morning hours. The patient was status-post cardiac surgery and on dialysis at the time of the incident. Within 2 hours of admission to the ICU it was clear that the patient needed a transvenous pacing wire. The wire was Threaded using an IJ Cordis sheath, which is a stocked item in the ICU and standard for PA caths, but not the right size for a transvenous pacing wire. The sheath that matched the pacing wire was not stocked in this ICU since transvenous pacing wires are used infrequently. The wire was threaded and placed in the ventricle and staff soon realized that the sheath did not properly seal over the wire, thus introducing risk of an air embolus. Since the wire was pacing the patient at 100%, there was no possibility for removal at that time. To reduce the patient’s risk of embolus, the bedside nurse and resident sealed the sheath using gauze and tape. Safety Tips:  Label devices that work together to complete a procedure  Rule: stock together devices need to complete a task SYSTEM FAILURES: OPPORTUNITIES for IMPROVEMENT:

33. Fellow DefectInterventions 1Unstable oxygen tanks on bedsOxygen tank holders repaired or new holders installed institution-wide 2Nasoduodenal tube (NDT) placed in lungProtocol developed for NDT placement 3Medication look-alikeEducation, physical separation of medications, letter to manufacturer 4Bronchoscopy cart missing equipmentChecklist developed for stocking cart 5Communication with surgical services about night coverage White-board installed to enhance communication 6Inconsistent use of Daily Goals rounding toolGained consensus on required elements of Daily Goals rounding tool 7Variation in palliative care/withdrawal of therapy orders Orderset developed for palliative care/withdrawal of therapy 8Inaccurate information by residents during roundsDeveloping electronic progress note 9No appropriate diet for pancreatectomy patientsDeveloping appropriate standardized diet option 10Wrong-sided thoracentesis performedEducation, revised consent procedures, collaboration with institutional root-cause analysis committee 11Inadvertent loss of enteral feeding tubePilot testing a ‘bridle’ device to secure tube 12Inconsistent delivery of physical therapy (PT)Gaining consensus on indications, contraindications and definitions, developing an interdisciplinary nursing and PT protocol 13Inconsistent bronchoscopy specimen laboratory ordering Education, developing an order set for specimen laboratory testing Critical Care Fellowship Program* 33 *Berenholtz SM, Hartsell TL, Pronovost PJ. Learning From Defects to Enhance Morbidity and Mortality Conferences. Am J Med Qual. 2009;24(3):192-5.

34. Key Lessons Focus on systems… not people Prioritize Use safe design principles Go mile deep and inch wide rather than mile wide and inch deep Pilot test Answer the 4 questions 34 Armstrong Institute for Patient Safety and Quality

35. Action Plan Review the Learning from Defect tool with your team Review defects in your unit Select one defect per month/quarter to learn from Post the stories of risks that were reduced Share with others 35 Armstrong Institute for Patient Safety and Quality

36. References Andrews LB, Stocking C. An alternative strategy for studying adverse events in medical care. The Lancet. 1997;349(9048):309-313. Donchin Y, Gopher D, Olin M, et al. A look into the nature and causes of human errors in the intensive care unit. Critical Care Medicine. 1995;23(2):294-300. Leape LL, Cullen DJ, et al. Pharmacist participation on physician rounds and adverse drug events in the intensive care unit. JAMA. 1999;282(3):267-270. Pronovost PJ, Dang D, Dorman T, et al. Intensive care unit nurse staffing and the risk for complications after abdominal aortic surgery. Eff Clin Pract. 2001;4:199-206. Tucker AL, Edmondson AC. Why Hospitals Don’t Learn from Failures: Organizational and Psychological Dynamics that Inhibit System Change. California Management Review, 2003 ;45(2):55-72. Reason J. Human Error. Cambridge, UK: Cambridge Univ Pr; 1990. Bagian JP, Lee C, et al. Developing and deploying a patient safety program in a large health care delivery system: you can't fix what you don't know about. Jt Comm J Qual Improv. 2001;27:522-32. Pronovost PJ, Holzmueller CG, et al. A practical tool to learn from defects in patient care. Jt Comm J Qual Patient Saf. 2006;32(2):102-108. Pronovost PJ, Wu Aw, et al. Acute decompensation after removing a central line: practical approaches to increasing safety in the intensive care unit. Ann Int Med. 2004;140(12):1025-1033. Vincent C. Understanding and responding to adverse events. New Eng J Med. 2003;348:1051-6. Wu AW, Lipshutz AKM, et al. The effectiveness and efficiency of root cause analysis. JAMA 2008;299:685-87. Berenholtz SM, Hartsell TL, Pronovost PJ. Learning From Defects to Enhance Morbidity and Mortality Conferences. Am J Med Qual. 2009;24(3):192-5. 36 Armstrong Institute for Patient Safety and Quality