Presentation on theme: "Healthcare Failure Mode and Effect AnalysisSM"— Presentation transcript:
1 Healthcare Failure Mode and Effect AnalysisSM Edward J. Dunn, MD, MPHVA National Center for Patient SafetyHFMEA may remain part of this ppt or may be part of another – like alternative teaching formats
2 Location in our VA NCPS Curriculum Toolkit ContentPatient Safety IntroductionHuman Factors EngineeringHFMEA ppt & exerciseInstructor PreparationSwift and Long Term Trust“Selling the Curriculum”Etc…Alternative Education FormatsPt Safety Case Conference (M&M)Pt Safety on Rounds (Modulettes)HFMEA participationEtc…
3 Why use prospective analysis? Aimed at prevention of adverse eventsDoesn’t require previous bad experience (patient harm)Makes system more robustJCAHO requirementNCPS developed HFMEA to give facilities a tool that could be used to proactively evaluate our systems before an adverse event or close call occurs. Proactive analysis gives us the opportunity to get upstream of adverse events and close calls. The point is to take an objective look at our systems without guilt and shame being a factor as they sometimes are in retrospective analysis of an adverse event. When done correctly a prospective analysis will identify system vulnerabilities in many parts of the process that when corrected will make our systems more robust and fault tolerant.The new JCAHO Patient Safety Standards include a requirement for prospective analysis. NEXT SLIDE
4 JCAHO Standard LD.5.2 Effective 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 processesAnnually, select at least one high-risk processIdentify potential “failure modes”For each “failure mode,” identify the possible effectsFor the most critical effects, conduct a root cause analysisThe JCAHO Standard LD.5.2, which can be found in the Hospital Accreditation Program Standards, requires Leaders to ensure that there is an ongoing and proactive program for identifying risks to patient safetyComponents of the program include identifying and prioritizing high risk processes, selecting at least one of these high risk processes each year, and performing a prospective analysis on the process. The goal is to identify failure modes and their effects and implement corrective actions.JCAHO doesn’t come out and use the term Failure Mode Effect Analysis but they do talk in terms of failure modes and their effects.
5 Who uses failure mode effect analysis? Engineers worldwide in:AviationNuclear powerAerospaceChemical process industriesAutomotive industriesHas been around for over 40 yearsGoal has been, and remains, to prevent accidents from occurringFMEA has been in used for over 40 years in a number of industries to evaluate products and processes for making products. In the traditional FMEA multidisciplinary teams, with a clearly identified scope of work. Each identified failure mode is scored using a 10 point scale, for Severity, Occurrence and Detection. These 3 numbers are then multiplied together to create the Risk Priority Number. When all of the RPNs are known the team picks a cutoff and then corrects everything that has scored higher. Once the team is finished and corrections are made the process is repeated. The definitions used in the process are very general in nature. The top or worst score is a 10 and for severity this is anything that could result in death or injury….
6 Healthcare Version - HFMEASM Combines:Traditional Failure Mode Effect AnalysisHazard Analysis and Critical Control PointVA Root Cause AnalysisAdapted and Tested in Healthcare Settings163 VA hospitals (with some success)Still a complex process/time commitment (see NIH)
7 The Healthcare Failure Mode Effect Analysis Process Step 1- Define the TopicStep 2 - Assemble the TeamStep 3 - Graphically Describe the ProcessStep 4 - Conduct the AnalysisStep 5 - Identify Actions and Outcome Measures
9 HFMEATM Decision Tree Does this hazard involve a sufficient likelihood of occurrence and severity towarrant that it be controlled?(e.g. Hazard Score of 8 or higher)Is the hazard so obvious and readilyapparent that a control measure is notwarranted?(Detectability)STOPNOYESPROCEED TO HFMEASTEP 5Does an Effective Control Measure exist for theidentified hazard?Is this a single point weakness in theprocess?(e.g. failure will result in system failure)(Criticality)HFMEATM Decision Tree
13 Failure Mode: 3B1a - Crucial Alarm Ignored and Patient Decompensated “Blow-up” of One LineFailure Mode: 3B1a - Crucial Alarm Ignored and Patient DecompensatedFailure ModeCauseActionOutcome MeasureSeverityFrequencyIgnored alarm (desensitized)CatastrophicFrequentReduce unwanted alarms by: changing alarm parameter to fit patient physiological condition and replace electrodes with better quality that do not become detachedUnwanted alarms on floor are reduced by 75% within 30 days of implementation
14 HFMEA & RCA Differences Similarities Preventive v. reactive Analysis of Process v. chronological caseChoose topic v. caseProspective (what if) analysisDetectability & Criticality in evaluationEmphasis on testing interventionInterdisciplinary teamDevelop flow diagramSystems focusActions & Outcome measuresScoring matrix (severity/probability)Triage questions, cause & effect diag., brainstorming