The Basics Of Healthcare Failure Mode And Effect Analysis

The Basics of HealthcareFailure Mode and EffectAnalysisVideoconference Coursepresented byVA National Center for Patient Safety1

What is Failure Mode andEffect Analysis?Failure Mode and Effect Analysis(FMEA) is a systematic method ofidentifying and preventing productand process problems before theyoccur.2

Why Use FMEA? Aimed at prevention of tragedy Doesn’t require previous badexperience or close call Makes system more robust Fault tolerant3

Course ObjectivesBy the end of the course, participants will: Understand the purpose of Healthcare FMEA Have a conceptual understanding of the stepsof the Healthcare FMEA process Know how to choose an appropriate topic foranalysis Be able to successfully address the JCAHO2001 proactive risk assessment standard4

Failure Mode & Effect Analysis Do you take actions to prevent yourself frombeing late to work?Yes or No Do you “take the shortcut” when you see trafficbuilding 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 someproblems, but need a better way to show that topeople?Yes or No5

Failure Mode & Effect AnalysisYour answers indicate that you arealready applying some of theprinciples of Failure Mode andEffect Analysis (FMEA) to preventproblems in day-to-day life.6

Who uses FMEA? Engineers worldwide in:¾Aviation¾Nuclear power¾Aerospace¾Chemical process industries¾Automotive industries Has been around for over 30 years Goal has been, and remains today, toprevent accidents from occurring7

Rationale for FMEA in HealthcareHistorically Accident prevention has not been aprimary focus of hospital medicine Misguided reliance on “faultless”performance by healthcareprofessionals Hospital systems were not designed toprevent or absorb errors; they justreactively changed and were nottypically proactive8

Rationale for FMEA in HealthcareIf FMEA were utilized, the followingvulnerabilities might have beenrecognized and prevented: Major medical center power failureMRI Incident – ferromagnetic objectsBed rail and vail bed entrapmentMedical gas usage9

JCAHO Standard LD.5.2Effective July 2001Leaders ensure that an ongoing,proactive program for identifyingrisks to patient safety and reducingmedical/health care errors isdefined and implemented.10

Intent of LD.5.2The organization seeks to reduce the risk ofsentinel events and medical/health caresystem error-related occurrences byconducting its own proactive risk assessmentactivities and by using available informationabout sentinel events known to occur in healthcare organizations that provide similar careand services. This effort is undertaken so thatprocesses, functions and services can bedesigned or redesigned to prevent suchoccurrences in the organization.11

Intent of LD.5.2 (continued)Proactive identification and management ofpotential risks to patient safety have the obviousadvantage of preventing adverse occurrences,rather than simply reacting when they occur.This approach also avoids the barriers tounderstanding created by hindsight bias and thefear of disclosure, embarrassment, blame, andpunishment that can arise in the wake of anactual event.12

JCAHO Standard LD.5.2 Identify and prioritize high-riskprocesses Annually, select at least one high-riskprocess Identify potential “failure modes” For each “failure mode,” identify thepossible effects For the most critical effects, conduct aroot cause analysis13

JCAHO Standard LD.5.2 Redesign the process to minimize therisk of that failure mode or to protectpatients from its effects Test and implement the redesignedprocess Identify and implement measures ofeffectiveness Implement a strategy for maintaining theeffectiveness of the redesigned processover time14

Healthcare FMEA DefinitionsHealthcare Failure Mode & EffectAnalysis (HFMEA):(1) A prospective assessment thatidentifies and improves steps in aprocess thereby reasonably ensuringa safe and clinically desirableoutcome.(2) A systematic approach to identify andprevent product and process problemsbefore they occur.15

Healthcare FMEA DefinitionsEffective Control Measure:A barrier that eliminates or substantiallyreduces the likelihood of a hazardousevent occurring.16

Healthcare FMEA DefinitionsHazard Analysis:The process of collecting and evaluatinginformation on hazards associated withthe selected process. The purpose ofthe hazard analysis is to develop a listof hazards that are of such significancethat they are reasonably likely to causeinjury or illness if not effectivelycontrolled.17

Healthcare FMEA DefinitionsFailure Mode:Different ways that a process or subprocess can fail to provide theanticipated result.18

HFMEA and the RCA ProcessSimilarities Interdisciplinary Team Develop Flow Diagram Focus on systems issues Actions and outcomemeasures developed Scoring matrix(severity/probability) Use of Triage/Triggeringquestions, cause & effectdiagram, brainstormingDifferences Process vs. chronologicalflow diagram Prospective (what if)analysis Choose topic forevaluation Include detectabilityand criticality inevaluation Emphasis on testingintervention19

HFMEA Points OutSystem/Process VulnerabilitiesABCIdentified processissue;focus for intervention20

Reason’s Model of AccidentsProductionPressuresLack ofZero faultProcedurestoleranceMixedPunitive Messages anrmlo/Pio eam idu ronlPsosPCiv nviTefdMAoInEVAVHPrDEFENSESAccident21

Process Design & OrganizationalChange Process ty TestingSimplificationFail-safe designsReduce Reliance onMemory & VigilanceSimplifyStandardizeChecklistsForcing FunctionsEliminate Look and SoundalikesSimulateLooser coupling of systems Organizational¾ Increase Constructive Feedbackand Direct Communication¾ Teamwork¾ Drive Out Fear¾ Leadership Commitment22

The Healthcare Failure Modesand Effects ProcessStep 1- Define the TopicStep 2 - Assemble the TeamStep 3 - Graphically Describe the ProcessStep 4 - Conduct the AnalysisStep 5 - Identify Actions and OutcomeMeasures23

Healthcare FMEA ProcessSTEP 1Define the Scope of the HFMEA alongwith a clear definition of theprocess to be studied.24

Healthcare FMEA ProcessSTEP 2Assemble the Team –Multidisciplinary team with SubjectMatter Expert(s) plus advisor25

Healthcare FMEA ProcessSTEP 3 - Graphically Describe the ProcessA. Develop and Verify the Flow Diagram (thisis a process vs. chronological diagram)B. Consecutively number each process stepidentified in the process flow diagram.C. If the process is complex identify the areaof the process to focus on (manageablebite)26

Healthcare FMEA ProcessSTEP 3 - Graphically Describe the ProcessD. Identify all sub processes under each blockof this flow diagram. Consecutively letterthese sub-steps.E. Create a flow diagram composed of the subprocesses.27

Healthcare FMEA ProcessSTEP 4 - Conduct a Hazard AnalysisA. List Failure ModesB. Determine Severity & ProbabilityC. Use the Decision TreeD. List all Failure Mode Causes28

Healthcare FMEA ProcessSTEP 5 - Actions and Outcome MeasuresA. Decide to “Eliminate,” “Control,” or“Accept” the failure mode cause.B. Describe an action for each failure modecause that will eliminate or control it.C. Identify outcome measures that will be usedto analyze and test the re-designed process.29

Healthcare FMEA ProcessSTEP 5 - Actions and Outcome MeasuresD. Identify a single, responsible individual bytitle to complete the recommended action.E. Indicate whether top management hasconcurred with the recommended actions.30

Forms & Tools¾Forms¾Worksheets¾Hazard Scoring Matrix¾Decision Tree31

Healthcare FMEA ProcessStep 1. Select the process you want to examine.Define the scope (Be specific and include a cleardefinition of the process or product to be studied).This HFMEA is focused on32

Healthcare FMEA ProcessStep 2. Assemble the TeamFMEA NumberDate StartedDate CompletedTeam Members 1.4.2.5.3.6.Team LeaderAre all affected areas represented?YES / NOAre different levels and types of knowledge represented on the team? YES / NOWho will take minutes and maintain records?33

HFMEA WorksheetHFMEA Subprocess step name and titleHFMEA Step 4 - Hazard AnalysisActionTypeActions or Rationale(Control,for StoppingAccept,Eliminate)Outcome ingle PointWeakness?Haz ScorePotential CausesSeverityFirst Evaluate failuremode beforedetermining potentialcausesProbabilityFailure Mode:Existing ControlMeasure ?Decision Tree AnalysisPersonResponsibleHFMEA Step 5 - Identify Actions and OutcomesScoring34

HFMEA Decision TreeThe HFMEA DecisionTree Does this hazard involve a sufficientlikelihood of occurrence and severity towarrant that it be controlled?(e.g. Hazard Score of 8 or higher)NOYESIs this a single point weakness in theprocess?(e.g. failure will result in system failure)(Criticality)NOYESDoes an Effective Control Measure exist for theidentified hazard?YESSTOPNOIs the hazard so obvious and readilyapparent that a control measure is notwarranted?(Detectability)YESNOPROCEED TO HFMEASTEP 535

HFMEA Decision Tree1. Does this hazard involve asufficient likelihood of occurrence andseverity to warrant that it becontrolled?(e.g. Hazard Score of 8 or higher)YESNO36

HFMEA Decision Tree2. Is this a single point weaknessin the process?(e.g. failure will result in systemfailure)(Criticality)NOYES37

HFMEA Decision Tree3. Does an Effective ControlMeasure exist for the identifiedhazard?YESNOSTOP38

HFMEA Decision Tree4. Is the hazard so obvious andreadily apparent that a controlmeasure is not warranted?(Detectability)YESNOSTOPPROCEED39

Hazard AnalysisSEVERITY RATING:Catastrophic Event(Traditional FMEA Rating of 10 - Failure couldcause death or injury)Patient Outcome:Death or major permanentloss of function (sensory, motor, physiologic, orintellectual), suicide, rape, hemolytic transfusionreaction, Surgery/procedure on the wrong patientor wrong body part, infant abduction or infantdischarge to the wrong familyVisitor Outcome: Death; or hospitalization of 3or more.Staff Outcome: * A death or hospitalization of 3or more staffEquipment or facility: **Damage equal to ormore than 250,000Fire: Any fire that grows larger than an incipientMajor Event(Traditional FMEA Rating of 7 – Failure causes ahigh degree of customer dissatisfaction.)Patient Outcome:Permanent lessening of bodilyfunctioning (sensory, motor, physiologic, orintellectual), disfigurement, surgical interventionrequired, increased length of stay for 3 or morepatients, increased level of care for 3 or morepatientsVisitor Outcome: Hospitalization of 1 or 2 visitorsStaff Outcome: Hospitalization of 1 or 2 staff or 3or more staff experiencing lost time or restrictedduty injuries or illnessesEquipment or facility: **Damage equal to ormore than 100,000Fire: Not Applicable – See Moderate andCatastrophic40

Hazard AnalysisSEVERITY RATING:Moderate Event(Traditional FMEA Rating of “4” – Failure canbe overcome with modifications to theprocess or product, but there is minorperformance loss.)Minor Event(Traditional FMEA Rating of “1”– Failure wouldnot be noticeable to the customer and wouldnot affect delivery of the service or product.)Patient Outcome: Increased length of stay orincreased level of care for 1 or 2 patientsVisitor Outcome: Evaluation and treatment for1 or 2 visitors (less than hospitalization)Staff Outcome: Medical expenses, lost time orrestricted duty injuries or illness for 1 or 2 staffEquipment or facility: **Damage more than 10,000 but less than 100,000Fire: Incipient stage‡ or smallerPatients Outcome: No injury, nor increasedlength of stay nor increased level of careVisitor Outcome: Evaluated and no treatmentrequired or refused treatmentStaff Outcome: First aid treatment only with nolost time, nor restricted duty injuries nor illnessesEquipment or facility: **Damage less than 10,000 or loss of any utility without adversepatient outcome (e.g. power, natural gas,electricity, water, communications, transport,heat/air conditioning).Fire: Not Applicable – See Moderate andCatastrophic41