SIA Root Cause Analysis

1. SIA Root Cause Analysis Lessons learned from Reviewing Program RCA’s Linda Ohler. MSN, RN, CCTC, FAAN QAPI and Regulatory Manager, George Washington University, D.C Cassandra Smith Fields. MSN, MBA, RN Administrative Director Transplant, Phoenix Children’s Hospital, Phoenix, AZ Tim Stevens. BSN, RN, CCTC Transplant Administrator, Providence Sacred Heart Medical Center & Children’s Hospital, Spokane, WA

2. Objectives Differentiate Root Cause Analysis from Morbidity and Mortality Reports Describe three challenges in defining and implementing RCAs in transplant programs Analyze the demonstration of a Root Cause Analysis

3. Agenda Overview Root Cause Analysis (RCA) and SIA evaluation RCA’s in the hospital and the transplant center Sample RCA Tools Case Study Other Methods for RCA Performance Improvement Tools

4. OVERVIEW

5. Motto for Root Cause Analysis • If you lose the patient or lose the graft….do not lose the lesson Thomas E. Hamilton Director, Survey & Certification Centers for Medicare & Medicaid Services

6. What’s in a Name? Morbidity and Mortality Review Surgeon Summary Case Review Causal Analysis Root Cause Analysis

7. RCA & SIA Evaluation

8. What does CMS ask for in an SIA? • Review the program’s causal analysis of patient deaths and graft failures during the most recent 36-months. The in-depth analysis should include at a minimum:

9. SIA RCA Requirements • The factors associated with these deaths and graft failures as well as an analysis of other adverse events that the Independent Peer Review Team considers relevant to the causal analysis of the graft or patient survival outcomes data • Review the transplant program’s own analysis of the root causes of the deaths or graft failures to evaluate the thoroughness and comprehensiveness of the analysis and the identification of all systemic factors, including, but not limited to, human factors, technical issues, equipment factors, communications systems, and policies and procedures missing or not followed • Evaluation of any trends or patterns in the factors associated with the deaths or graft failures

10. RCA Contributing Factors • Analysis of program activities across all three phases (pre, during, and post) of transplantation including: • Staffing levels and training: Numbers and skills across disciplines sufficient to adequately meet the needs of patients; • Patient selection criteria: The content, its application and efficacy, and the program’s adherence to its selection criteria; • Donor selection criteria: The content, its application and efficacy, and the program’s adherence to donor selection criteria; • Wait-list management: Effectiveness of policies and procedures, obtaining updated evaluations, routine candidate follow-up, and review of candidate status changes;

11. RCA Contributing Factors • Surgical protocols: Effectiveness of protocols and systems to develop policies and protocols (i.e. are there effective systems to research and base practices on current practice evidence); • Multi-disciplinary care: Evaluate if care is provided in a multi-disciplinary manner allowing input from all specialty areas during all three phases of transplantation and including but not limited to – transplant surgeons, physicians, transplant coordinators, transplant administrator(s), nurse(s), social worker(s), dietitian(s) and pharmacist(s) and other important disciplines such as anesthesia and cardiology; • Program’s policies and procedures: Analysis of program policies, procedures, and protocols to identify possible opportunities for improvement; and, • Post-transplant follow-up: Assess whether post-transplant follow-up care is provided in a safe, timely, and effective manner.

12. Contributing Factors by Discipline

13. Contributing Factors

14. RCA’s in the hospital and the transplant center

15. The Alphabet Soup Sentinel Events Adverse Events Safety Event Near Miss Serious Safety Event

16. Start at the beginning

17. COP’s for Transplant • X102 (b) Standard: Adverse Events • A Transplant Center must establish and implement written policies to address and document adverse events that occur during any phase of an organ transplantation case. These policies must address the process for the identification, reporting, analysis, and prevention of adverse events • (Interpretive Guideline) Adverse event means an untoward, undesirable, and usually unanticipated event that causes death or serious injury, or the risk therof

18. The Big 4 Serious medical complications or death caused by living donation Unintentional transplantation or organs of mismatched blood types Transplantation of organs to unintended recipients Unintended transmission of infectious disease to a recipient

19. X103 • (2) The transplant center must conduct a thorough analysis of and document any adverse event • Interpretive Guideline: A “thorough analysis” is expected to include (but are not limited to): • A description of the key facts of the event..the severity of the event, and how the patient was affected • A review of whether or not similar events have occurred • An analysis of related systems and processes that contributed to the events occurrence..Human Factors, Environment, Equipment, Policies, Procedures, Organizational

20. X104 And must utilize the analysis to effect changes in the transplant center’s policies and practices to prevent repeat incidents

21. Focused QAPI goes on to ask the following: Are there written adverse event (AE) policies and procedures specific to transplant? Are AE’s evaluated according to policies and procures? Can transplant staff describe what is meant by an adverse event (AE) in transplant? Can transplant staff explain how and/or to whom they report an adverse event (AE)? Does the hospital/program employ methods, in addition to staff incident reporting, to identify possible adverse events? Can the program provide evidence that adverse events identified through staff reports are being addressed?

22. Focused QAPI continued: • Does the written AE policy address the following communication and reporting structures?: • For each organ type • Staff reporting and communication methods within the transplant program and hospital • Process for disclosure of AEs to the patient/family • Process and timeline for reporting adverse events to required public, state and federal agencies • Is there evidence that the transplant program has adopted policies supporting a non-punitive approach to staff reporting of events and situations they consider unsafe?

23. Focused QAPI continued: • Does the written policy address/categorize the severity of events that are tracked and analyzed? • Does the program have a defined analysis method/process for AE? • Who • What • Actions taken to prevent similar events • Method for follow up • Describe which method(s) will be utilized to analyze AE? • Has the program/hospital conducted any causal analyses in the past 24 months? • Did the analysis of the adverse event address all appropriate areas across the continuum of care?

24. Now ask yourself the following: Is death and graft loss within the first year an Adverse Event? Should these events be subject to the same level of analysis as the Big 4? If you are subject to an SIA – how will you ensure that your deaths and graft losses have a “root cause analysis”

25. Then do your research: What is your organization’s Safety Event, or Incident Reporting Policy? Read the definitions

26. Common Definitions Safety Event: A deviation from generally accepted practice or process that includes near misses, precursor safety events and serious safety events Near Miss: A deviation in generally accepted practice that passes through error detection barriers and does not reach the patient because it is caught by a detection barrier designed into the system or by change or barrier not designed into the system, sometimes referred to as a Good Catch or Close Call

27. Common Definitions Continued Precursor Safety Event: A deviation from generally accepted practice or process that reaches the patient and causes no harm, no detectable harm, minimal temporary harm or minimal permanent harm Serious Safety Event: A deviation from generally accepted practice or process that reaches the patient and causes harm that includes moderate temporary harm, severe temporary harm, moderate permanent harm, severe permanent harm and death

28. Common Definitions Continued Sentinel Event: An unexpected occurrence involving death or major permanent loss of limb or loss of function (including recognized complications) such as serious sensory, motor, physiological or psychological injury, or the risk thereof, not related to the natural course of the patient’s illness or underlying condition and not present on admission, requiring continued treatment or lifestyle change

30. Tools to analyze and review events Apparent Cause Analysis: A limited investigation of an event that may be performed instead of a root cause analysis that identifies inappropriate acts and detects weaknesses in systems and processes and results in implementation of remedial corrective actions Common Cause Analysis: An aggregating analysis of safety events to identify process or cultural problems leading to events. The goal is to identify elements that contributed to the known events and select behavior-based expectations and error prevention techniques for staff to reduce human error and safety events

31. Tools Continued Protected Case Review: A conference held under case review protection where a case is presented and discussed for the purpose of education and system improvement Root Cause Analysis: Process for identifying the factors that underlie variation in performance that focuses primarily on systems and processes, not on individual performance. The analysis identifies potential improvements in theses processes or systems that would tend to decrease the likelihood of such events in the future or determines, after analysis, that no such improvement opportunities exist

33. RCA’s allow us to: • Implement a corrective action • Track the change • Determine if the change is effective • Demonstrate the effective change is sustainable • Establish a system to prevent the problem from occurring again

34. Challenges with using RCA’s Hospital policy often prescribes when an RCA methodology can be utilized Done in accordance with Joint Commission guidance and hospital policy – very labor intensive and time consuming Requires the time and effort of hospital resources

35. Morbidity and Mortality • Morbidity refers to the state of being diseased or unhealthy within a population • Mortality is the term used for the number of people who die within a population • A retrospective review of a case evaluating the physiologic and pathologic causes of either death or illness • M&Ms report on a single case • Discussion among colleagues • States what you think may have happened • Usually does not involve a comprehensive data analysis

36. RCA’s for transplant May or may not be a sentinel event Should always be more than an M&M Utilizes components of the RCA methodologies May not require reporting to TJC Is not discoverable Must be doable

37. Suggestions • The Big 4 • Sentinel Events and referred to Hospital for full RCA • Hedge on transmission of disease? • Death of a transplant recipient in the OR • Serious Safety Event • Quality will direct methodology – probably protected case review or some level of RCA • Death or graft loss within the first year post transplant • Serious Safety Event? • Defined Apparent Cause Analysis tool specific to transplant with MDT review

38. Be Reasonable • UCLA • Liver • Expect 27 graft losses in adults and 4 in peds • Expect 16 patient deaths in adults and 1.5 in peds • Kidney • Expect 12 graft losses in adults and .79 in peds • Expect 3.7 patient deaths in adults and 0 in peds • Heart • Expect 3.42 graft losses in adults and .56 in peds • Expect 2.97 patient deaths in adults and .62 in peds • Lung • Expect 5.62 graft losses in adults • Expect 4.98 patient deaths in adults • Plus pancreas and intestine

39. If your Observed Events are increasing • Before you become O>E • Start converting the graft losses and/or death analysis to a more robust RCA process • If you are going to flag • Go back and do the more robust RCA process on all graft losses and/or deaths in the cohort • Always, always • Track your events in QAPI and evaluate for trends

40. Root Cause Analysis

41. What are the goals of RCA? • Determine the best approach to preventing adverse events • Not a tool for punishment of individuals • Avoid culture of blame • Build a culture of safety. • Identify what can be done to prevent the adverse event or near miss from occurring again • Measure and track outcomes based on changes made.

42. Important concepts in RCA Avoid culture of blame Focus on systems issues Lessons learned: if you lose the patient/graft, do not lose the lesson

43. Three Common Mistakes: Assuming! Assuming you know what the problem is without seeing what is actually happening. Assuming you know how to fix a problem without finding out what is causing it. Assuming you know what is causing the problem without confirming it.

44. Demonstration of an RCA

45. The Joint CommissionROOT CAUSE ANALYSIS AND ACTION PLAN FRAMEWORK TEMPLATE Template has 24 analysis questions Provides a template for answering the analysis questions Aids organizing the steps in a root cause analysis. Not all questions will apply in every case and there may be findings that emerge during the course of the analysis. Be sure however to enter a response in the “Root Cause Analysis Findings” field for each question # For each finding continue to ask “Why?” and drill down further to uncover why parts of the process occurred or didn’t occur when they should have. Significant findings that are not identified as root causes themselves have “roots”.

47. Case Report • September 2010 • 35 year old mother of 3, healthy until this event. Allergies to Vancomycin and Heparin. • Two weeks after birth of third child she experience severe chest pain and was taken to a local hospital • Diagnosis was dissection of 3 coronary arteries • Put on by pass but could not come off • Placed on Impella pump and transferred to a hospital with a heart transplant program. • 9/12 Implanted with BiVad • Required 51 units of PRBCs, 3 units platelets and cryo and 14 units of FFP • 9/23 Listed for heart transplantation

48. Time Line • 9/24/2010 Began vaginal bleeding • 9/27 D& C done followed by bilateral uterine artery embolization, intrauterine balloon and partial hysterectomy on 10/16 • 11/26 discharged home, Bilirubin 4.6 • 1/18/2011 admitted for fibrin in pump, on heparin, discharged in 11 days on Coumadin • 2/2 admitted for anemia, GI bleed, Coumadin adjusted • 2/15 admitted for fibrin in pump • 4/18 admitted for GI Bleed • 5/9 admitted for GI bleed • 8/18 admitted for GI bleed, 3 units PRBC • 12/15 admitted for GI bleed • 3/30/2012 Bilirubin rising 7-8, Renal insufficiency, PRA 98% Heart offer. Donor and recipient crossmatch negative • 3/31/2012 transplant (12 hours in surgery)

49. Time Line • Heart transplant complications • 31 units PRBC, 8 Cryo, 60 platelets, 19 FFP • 15 minutes of circulatory arrest • Induced hypothermia • Difficulty extracting VAD due to adhesions • 3rd chest surgery in 18 months • Wound dehiscence, muscle flap • Dialysis required starting on day 4 post op • Day 9 developed multiple DVTs, positive urine culture • Hypotensive, required vasopressors • Developed dry gangrene of both feet • Day 26 trached/respiratory failure • MSOF • 6 weeks post transplant CT of head revealed CVA • Patient expired

50. Most pertinent TJC questions