Healthcare Failure Mode and Effect AnalysisSM Edward J. Dunn, MD, MPH VA National Center for Patient Safety edward.dunn@med.va.gov www.patientsafety.gov HFMEA may remain part of this ppt or may be part of another – like alternative teaching formats

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 NCPS 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

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 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 The 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 safety Components 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.

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 FMEA 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….

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

HFMEATM Hazard Scoring Matrix Probability Severity Catastrophic Major Moderate Minor Frequent 16 12 8 4 Occasional 9 6 3 Uncommon 2 Remote 1

HFMEATM Decision Tree 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) Is the hazard so obvious and readily apparent that a control measure is not warranted? (Detectability) STOP NO YES PROCEED TO HFMEA STEP 5 Does an Effective Control Measure exist for the identified hazard? Is this a single point weakness in the process? (e.g. failure will result in system failure) (Criticality) HFMEATM Decision Tree  

ICU Alarm Example

ICU Alarm Example

ICU Alarm Example

Failure Mode: 3B1a - Crucial Alarm Ignored and Patient Decompensated “Blow-up” of One Line Failure Mode: 3B1a - Crucial Alarm Ignored and Patient Decompensated Failure Mode Cause Action Outcome Measure Severity Frequency Ignored alarm (desensitized) Catastrophic Frequent Reduce unwanted alarms by: changing alarm parameter to fit patient physiological condition and replace electrodes with better quality that do not become detached Unwanted alarms on floor are reduced by 75% within 30 days of implementation

HFMEA & RCA Differences Similarities 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 Interdisciplinary team Develop flow diagram Systems focus Actions & Outcome measures Scoring matrix (severity/probability) Triage questions, cause & effect diag., brainstorming