Root Cause Analysis

1. Root Cause Analysis Konrad C. Nau, MD Professor and Chair WVU Dept Family Medicine-Eastern Division

2. Objectives 1) Understand importance of systems-based thinking when adverse events occur in medicine 2) Learn three approaches to Root Cause Analysis 3) Understand common pitfalls encountered when approaching patient safety issues

3. What is Root Cause Analysis? • Process for identifying contributing/ causal factors that underlie variations in performance associated with adverse events or near-miss/close calls • Process that features interdisciplinary involvement of those closest to and/or most knowledgeable about the situation

4. “Unintended injury to patients resulting from a medical intervention, which includes any action by healthcare workers, including clerical and maintenance staff.” Institute of Medicine “An unexpected occurrence involving death or serious physical or psychological injury or risk thereof.” Joint Commission Adverse and Sentinel Events

5. Near-Miss Events • When two planes nearly collide, they call it a “near miss.” It’s a NEAR HIT. • A collision is a “near miss.” BOOM! “Look, they nearly missed!” George Carlin The Absurd Way We Use Language<www.georgecarlin.com>

6. Where Did it Come From? • Derivative of Failure Mode Effect Analysis (FMEA) – US Military(1949) to determine effect of system and equipment engineering failures • FMEA use by NASA for Apollo space program (1960s) • US Auto Industry FMEA Standards implemented (1993)

7. Why involve residents in RCA? • Residents know what happens at the microprocess level • Residents are future leaders in healthcare • Residents are either team members or as implementer of key action plans • Resident/Fellow Participation in Patient Safety Activities - Baseline • Analysis of National RCA database (many caveats) • Residents as RCA team members < 30 (< 0.1%) • All physicians ~ 15%! • edward.dunn@med.va.govwww.patientsafety.gov

8. Overview of RCA Steps • Charter an inter-disciplinary team (4-6 people) • Those familiar and un-familiar with the process • Flow diagram of “what happened?” • Triggering questions to expand this view • Site visits and simulation to augment • Interviews with those involved or those with similar job • Resources (articles - NPSF, online databases) • Root cause/contributing factors developed • Five rules of causation to guide/push the team deep enough • Cause and Effect Diagram, etc

9. Five Causal Rules - Marx • Rule 1 - Causal Statements must clearly show the "cause and effect" relationship. • When describing why an event has occurred, you should show the link between your root cause and the bad outcome • each link should be clear to the RCA Team and others.

10. Five Causal Rules - Marx • Rule 2 - Negative descriptors (e.g., poorly, inadequate) are not used in causal statement • To force clear cause and effect descriptions (and avoid inflammatory statements), we recommend against the use of any negative descriptor that is merely the placeholder for a more accurate, clear description • “The Resident Manual was poorly written” vs • “OnCall start and stop times are not documented in policy”

11. Five Causal Rules - Marx • Rule 3 - Each human error must have a preceding cause. • It is the cause of the error, not the error itself, which leads us to productive prevention strategies. • “Joe ordered heparin and the patient bled out” vs • “Joe order heparin because he was unaware of a history of active Peptic Ulcer Disease in the pt.”

12. Five Causal Rules - Marx • Rule 4 - Each procedural deviation must have a preceding cause. • Procedural violations are like errors in that they are not directly manageable. Instead, it is the cause of the procedural violation that we can manage.

13. Five Causal Rules - Marx • Rule 5 - Failure to act is only causal when there was a pre-existing duty to act. • A doctor's failure to prescribe a medication can only be causal if he was required to prescribe the medication in the first place. • The duty to perform may arise from standards and guidelines for practice; or other duties to provide patient care.

14. NCPS RCA Model • A rigorous,legally protected and confidential approach to answering: - What happened?(event or close call) What happened that day? What usually happens? (norms) What should have happened? (policies) - Why did it happen? - What are we going to do to prevent it from happening again? (actions/outcomes) - How will we know that our actions improved patient safety? (measures/tracking)

15. Methods of RCA • Questioning to the Void • Event & Causal Factor Analysis • Safeguard Analysis

16. Questioning to the Void • A systematic approach of asking questions: • How is it that? • What do we know about . . .? • In Japan, called the Five Whys.

17. Questioning to the Void • Toyota says ask why 5 times • Keep going until your answer to why is: • I don’t know • I don’t care • It fell because of gravity. • Why is there gravity? • (I don’t care)

18. Event & Causal Factor Analysis Work order written for Oxygen Maintenance Shuts off oxygen Staff reports Patients are Gasping. Staff thinks oxygen cut off Staff not briefed Valves not Labeled Wrong Valve Closed

19. The Bidirectional RCA Process • Work backward chronologically from event to see what happened • Work forward chronologically to clarify and learn (Paradies)

20. Cause and effect are same thing 1 2 3 4 5 A continuum of causes Gano

21. Safeguard Analysis SOURCE VICTIM SAFEGUARDS

22. Steps in Safeguard Analysis • Identify potential or actual source of an event and identify the actual or potential victim. • Identify safeguards currently in place and determine effectiveness. • Develop plan to strengthen weak safeguards. • Identify/deploy new safeguards.