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Healthcare Failure Mode and Effect Analysis SM. Edward J. Dunn, MD, MPH VA National Center for Patient Safety edward.dunn@med.va.gov www.patientsafety.gov. Location in our VA NCPS Curriculum Toolkit. Content Patient Safety Introduction Human Factors Engineering HFMEA ppt & exercise.
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Healthcare Failure Mode and Effect AnalysisSM Edward J. Dunn, MD, MPH VA National Center for Patient Safety edward.dunn@med.va.govwww.patientsafety.gov
Location in our VA NCPS Curriculum Toolkit • Content • Patient Safety Introduction • Human Factors Engineering • HFMEA ppt & exercise • Instructor Preparation • Swift and Long Term Trust • “Selling the Curriculum” • Etc… • Alternative Education Formats • Pt Safety Case Conference (M&M) • Pt Safety on Rounds (Modulettes) • HFMEA participation • Etc…
Why use prospective analysis? • Aimed at prevention of adverse events • Doesn’t require previous bad experience (patient harm) • Makes system more robust • JCAHO requirement
JCAHO Standard LD.5.2Effective July 2001 Leaders ensure that an ongoing, proactive program for identifying risks to patient safety and reducing medical/health care errors is defined and implemented. • Identify and prioritize high-risk processes • Annually, select at least one high-risk process • Identify potential “failure modes” • For each “failure mode,” identify the possible effects • For the most critical effects, conduct a root cause analysis
Who uses failure mode effect analysis? • Engineers worldwide in: • Aviation • Nuclear power • Aerospace • Chemical process industries • Automotive industries • Has been around for over 40 years • Goal has been, and remains, to prevent accidents from occurring
Healthcare Version - HFMEASM • Combines: • Traditional Failure Mode Effect Analysis • Hazard Analysis and Critical Control Point • VA Root Cause Analysis • Adapted and Tested in Healthcare Settings • 163 VA hospitals (with some success) • Still a complex process/time commitment (see NIH)
The Healthcare Failure Mode Effect Analysis Process Step 1- Define the Topic Step 2 - Assemble the Team Step 3 - Graphically Describe the Process Step 4 - Conduct the Analysis Step 5 - Identify Actions and Outcome Measures
Does this hazard involve a sufficient likelihood of occurrence and severity to warrant that it be controlled? (e.g. Hazard Score of 8 or higher) NO Is this a single point weakness in the NO process? YES (e.g. failure will result in system failure) (Criticality) YES YES Does an Effective Control Measure exist for the STOP identified hazard? NO Is the hazard so obvious and readily YES apparent that a control measure is not warranted? (Detectability) NO PROCEED TO HFMEA STEP 5 HFMEATM Decision Tree
“Blow-up” of One Line Failure Mode: 3B1a - Crucial Alarm Ignored and Patient Decompensated Failure Mode Cause Action Outcome Measure Severity Frequency
Interdisciplinary team Develop flow diagram Systems focus Actions & Outcome measures Scoring matrix (severity/probability) Triage questions, cause & effect diag., brainstorming Preventive v. reactive Analysis of Process v. chronological case Choose topic v. case Prospective (what if) analysis Detectability & Criticality in evaluation Emphasis on testing intervention HFMEA & RCA Differences Similarities