Maximizing Failure Mode & Effects Analysis As An Effective Risk Management Tool

1. Sandra Thompson Administrator, Quality Resources/Compliance Laurens County Health Care System Clinton, SC Thursday, May 31, 2012 Maximizing Failure Mode & Effects Analysis As An Effective Risk Management Tool

2. Discuss establishing a “Culture of Safety” • Describe the linkage between and importance of FMEA to RM • Identify the TJC FMEA requirements • Discuss the basics of failure mode and effects analysis • Identify tools and resources for further information & study Today’s Goals

3. 1995: “The year that medicine went to Hell in a handbasket” - Dennis O’Leary, JCAHO President, 9/01 • Tampa: Wrong site surgery • Dana Farber: Chemo event • Martin Memorial: Anesthesia event • These events helped drive a consensus for change A growing concern for patient safety….

4. Imperative driven by IOM reports • “To Err is Human” – 1999 • “Crossing the Quality Chasm” – 2000 • Culture of Safety is owned by ALL • Not physicians, Administration, or a single department • Requires new tools, new thinking, new information not traditionally utilized in healthcare • FMEA, RCA, Six Sigma, Lean, Systems Engineering, ???? “Culture of Safety”

5. Root cause analysis • Lean • Forcing functions (poke yoke) • Standardization (5S) • Customer focus (value stream mapping) • Front-line staff involvement (observation – “going to the gemba”, spaghetti diagrams) • Push/pull systems (patient flow) • High-reliability organizations • “Going for Zero” • Electronic health record • Proactive risk assessment • Healthcare FMEA! New Tools/New Thinking

6. Tools of Change Proactive Proactive Risk Assessment (FMEA, HFMEA) Automation, Computerization Standardization Forcing Functions Protocols, Pre-Printed Orders Checklists Least Effective Most Effective Effectiveness Scale Rules & Double-Checking Information Inspection HFMEA is a proactive means of assessing & decreasing risk in your organization! Education Auditing Reactive

7. FMEA • Failure Mode & Effect Analysis • Traditionally used in industry • Looks at a device or a component • HFMEA • Healthcare Failure Mode & Effect Analysis • Looks at a process FMEA vs. HFMEA

8. Process developed by VA Pt. Safety Center • Online tutorial at: • http://www.patientsafety.gov/CogAids/HFMEA/index.html#page=page-1 HFMEA

9. Do you take actions to prevent yourself from being late to work? Yes or No • Do you “take the shortcut” when you see traffic building up in a familiar place? Yes or No • Do you try to distinguish “big problems” from “little problems”? Yes or No • Do you see the possibility of eliminating some problems, but need a better way to show that to people? Yes or No Failure mode & effect analysis

10. Failure • When process begins to produce undesired results/effects • Failure Mode • Weakness/vulnerability in any part of process • Chain of events that has potential to cause safety problem Failure/Failure Mode

11. Assists RMs to favorably impact the patient care environment • Another tool in the box of RM strategies to understand and reduce medical error • Assists RMs & others in driving change before it can do harm • Proactively forecasts potential failures • Applies risk /loss control techniques to those potential failures Risk Management Perspective

12. What philosophy ? • “Blame free” vs. “Just Culture” • Do we see systems or individuals? • Are the right tools & resources available for the job? • What is an incident to be reported at your facility? • Close call/near miss/”good catches”? • Only adverse events (e.g., “harm”)? • Sentinel events? • Where do willfully unsafe acts fit in? Disruptive behavior? Where to Start: Foundation

13. Design/redesign incident reporting systems to capture near misses • Predictive – show patterns around a process – 100:10:1 • Rich source of information • Reward/encourage near miss reporting • Follow up on near misses and trend • Don’t forget the narrative! Important details found here • Close the loop – report back to staff on trends, patterns noted, solicit suggestions for improvement Where to Start: Foundation

14. Must filter the tidal wave! Where to Start: Foundation

15. Where to Start: Foundation For each reported incident:

16. Where to Start: Foundation

17. Apply the risk management equation • Severity x Frequency = RISK • What resources per level of risk? • Examine trends/patterns Culture of Safety: Foundation

18. Sources: • Your incident report data • Loss runs/claims data • Brainstorm list of HR processes for your organization • Consider physical resources, environment, staffing, etc. • Worker’s Compensation reports • Literature • Sentinel Event Alerts • Infection Control data • IHI • Joint Commission • Organizational strategic quality goals/objectives Getting Started: Select a High-Risk Process

19. Multidisciplinary group who have hands-on experience with the selected process/procedure • Include physicians! • RM role • May be multifaceted • CAUTION: Leader/Facilitator Assemble a Team

20. ABSOLUTE MUST: • Direct observation of process (Lean) • Tools: • “Process Mapping” vs. Flowcharting • Fishbone (Cause & Effect Diagram) • Current State Stream Maps (Lean) • Differentiate - need TWO maps! • “The way things were intended to work” • “The way things are actually working” Diagram the Process

21. Process Mapping Process Step Process Step Process Step Process Step 1 2 3 4 Medication ordered Auto electronic transfer to Pharmacy system Pharmacy fills scipt; sends to floor Nurse administers Sub-Processes Sub-Processes Sub-Processes Sub-Processes Sub-Processes • Dummy terminal • B. PCs • Check drug allergies • Check drug interactions • Check proper dosages • Orders labs • Order sent to auto dispensing • Automatically fills orders checked • Drugs pulled and script filled • Med cart filled • Cart sent to floor • Log on to laptop • Medcart • Medications scanned • Patient band scanned • Medication given to pt. • Pt. record updated • Dummy terminal • B. PCs

22. Compare “ideal” vs. “reality” • May be multiple failure modes – list all • Each failure mode can have multiple possible effects • Tool: Brainstorming • Ask: • What could fail with this step? (i.e., failure modes) • Why would this failure occur? (i.d., causes) • What could happen if this failure occurred? (i.e., effects) Identify Potential Failure Modes

23. Assess risk – severity/probability • Tools: • Fishbone (C&E) Diagram • Hazard Scoring Matrix (HFMEA) Assess Failure Modes-Identify Causes

24. Decision (proceed or stop) • If score 8 or higher & decision to stop, document rationale • Tools: • Decision Tree (HFMEA) • HFMEA Worksheet • Develop action plan for change • Include outcome measures, management concurrence Additional Steps

25. Concerns re: discoverability • Could provide potent evidence for plaintiff if all potential failures not addressed & mishap occurs involving that failure point • Follow current procedures under state law relative to peer review protection • Must be produced under guidance of medical staff & reviewed in “medical staff committee” • Include “disclaimer” on document • Seek guidance from legal counsel Protecting the Process

26. Seek support from senior leadership • Executive/Administrative Sponsor? • Include physicians • Physician Champion • Seek out trained facilitator OR get training in facilitation • Important to open communication • Involve front-line staff; give them ownership • Look for best practices already identified for the process being assessed Remember…..

27. Questions?

28. VA Center for Patient Safety • HFMEA Toolkit • http://www.patientsafety.gov/CogAids/HFMEA/index.html#page=page-1 • Institute for Healthcare Improvement • Online tool for conducting FMEA; can be shared • Tutorials, journal articles • Completed examples • http://www.ihi.org/knowledge/Pages/Tools/FailureModesandEffectsAnalysisTool.aspx Resources

29. http://www.patientsafety.gov/SafetyTopics/HFMEA/FMEA2.pdf • http://psnet.ahrq.gov/resource.aspx?resourceID=1531 http://www.patientsafety.gov/SafetyTopics/HFMEA/HFMEAIntro.pdf • http://intranet.uchicago.edu/quality/FailureModesandEffectsAnalysis_FMEA_1.pdf • http://www.patientsafety.gov/SafetyTopics/HFMEA/HFMEA_JQI.pdf Other Resources