FMEA - Failure Mode & Effects Analysis Of Healthcare Processes


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FMEA - Failure Mode & Effects Analysis Of Healthcare Processes

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  • Slide 24 (of 34) states an analytic formula for indexing criticality failure modes. There is a problem with using multiplication to satisfy this kind of calculation.

    The process outlined in the rest of the slides suggests ranking the Criticality Indices (CI) from greatest to least, and attacking them in sequence. The following example will cause the formula to fail - giving a false positive.

    Assume two conditions exist, which need to be ranked with regard to one another.

    The first condition has values for frequency, severity, and probability of 20, 80, and 0.7.
    The second condition values are respectively 80, 20, and 0.7.

    The products for CI are identical, where 80 x 20 x 0.7 = 20 x 80 x 0.7 = 112. [arithmetic commutativity rule for addition and multiplication]

    However, I suggest that the first condition is more critical, due to the consequence severity. Yet, they're equivalently scored. How does one discern between them, if the CI is the decision variable?

    Is the 'frequency of occurrence' also expressed as a probability? If so, then try this example - instead of swapping the first and second term values, swap the first and third. The same error occurs! The more severe condition is masked by the CI calculation.

    Now, introduce the next difficulty with the formula... Low 'probability of detection' (regardless of the 'frequency of occurrence' and 'severity') results in low CI. Isn't the ranking by magnitude (greatest to least) supposed to place the really important problems at the TOP of the list? The 'D' term should be multiplicatively inverted (e.g. such as 1 - D, 'probability of NOT detecting') to have the correct effect for 'severity'.

    Isn't there a method of relation between these characteristics which isn't reliant upon products?
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FMEA - Failure Mode & Effects Analysis Of Healthcare Processes

  1. 1. Guidelines for Conducting Failure Mode and Effects Analysis of Healthcare Processes Copyright 2008 Cardinal Health Inc. or one of its subsidiaries. All rights reserved.
  2. 2. Joint Commission  Patient Safety Standards <ul><li>Ongoing, proactive program for identifying risks and reducing unanticipated adverse events and safety risks to patients is defined and implemented (PI.3.20) </li></ul><ul><ul><li>At least one high-risk process assessed annually </li></ul></ul><ul><ul><li>A failure mode and effects analysis is performed and the criticality of effects on patients determined </li></ul></ul><ul><ul><li>The process is redesigned to minimize risk </li></ul></ul><ul><ul><li>Redesigned process is implemented and monitored for effectiveness </li></ul></ul>PROPRIETARY
  3. 3. Failure Mode & Effects Analysis (FMEA) <ul><li>Engineering process </li></ul><ul><li>Used extensively in the airline and automobile industries </li></ul><ul><li>Main applications: </li></ul><ul><ul><li>Quality & safety of goods/services </li></ul></ul><ul><ul><li>Safety of processes </li></ul></ul><ul><li>Application to healthcare is recent </li></ul>PROPRIETARY
  4. 4. Definition of FMEA <ul><li>Systematic analysis of a process </li></ul><ul><li>Identifies </li></ul><ul><ul><li>ways process might fail (failure modes) </li></ul></ul><ul><ul><li>effects or results of failures </li></ul></ul><ul><ul><li>possible causes of failures </li></ul></ul><ul><li>Actions are taken to reduce potential for failure </li></ul><ul><ul><li>prevent or minimize possibility of occurrence </li></ul></ul><ul><ul><li>minimize consequences of failure </li></ul></ul><ul><li>An ongoing process of improvement </li></ul>PROPRIETARY
  5. 5. FMEA vs. Root Cause Analysis <ul><li>FMEA </li></ul><ul><ul><li>Proactive technique </li></ul></ul><ul><ul><li>Identifies and addresses problems before they occur </li></ul></ul><ul><ul><li>Incorporates some features of RCA </li></ul></ul><ul><li>Root Cause Analysis (RCA) </li></ul><ul><ul><li>Retrospective technique </li></ul></ul><ul><ul><li>Used to address problems after they occur </li></ul></ul><ul><ul><li>FMEA may be used during RCA to identify actions for improvement </li></ul></ul>PROPRIETARY
  6. 6. Objectives of FMEA in Healthcare <ul><li>To proactively identify and reduce risk points in healthcare processes that may negatively impact outcomes for patients, caregivers, and healthcare organizations. </li></ul><ul><li>Additional benefits: </li></ul><ul><ul><li>Increase effectiveness </li></ul></ul><ul><ul><li>Increase efficiency </li></ul></ul><ul><ul><li>Cost avoidance </li></ul></ul>PROPRIETARY
  7. 7. Obstacles <ul><li>Resistance to change </li></ul><ul><li>Lack of personnel time to participate in FMEA </li></ul><ul><li>Lack of resources to implement improvement strategies </li></ul><ul><li>Reluctance to replace immediate, convenient systems with safer, but more time-consuming ones </li></ul><ul><li>Lack of support from leadership </li></ul>PROPRIETARY
  8. 8. FMEA Process <ul><li>Choose a process </li></ul><ul><li>Form a team </li></ul><ul><li>Analyze the process </li></ul><ul><li>Identify strategies for improvement </li></ul><ul><li>Implement strategies </li></ul><ul><li>Evaluate effectiveness of actions taken </li></ul>PROPRIETARY
  9. 9. Choose a Process <ul><li>High-risk or error-prone processes </li></ul><ul><li>New processes/procedures </li></ul><ul><ul><li>In planning stage </li></ul></ul><ul><ul><li>After implementation </li></ul></ul><ul><li>Use of equipment </li></ul><ul><li>New or renovated facility design </li></ul><ul><li>Other aspects of healthcare system </li></ul><ul><ul><li>including non-clinical processes </li></ul></ul>PROPRIETARY
  10. 10. What to Analyze High-Risk Medications <ul><li>Anticoagulants </li></ul><ul><li>Chemotherapy agents </li></ul><ul><li>Insulin </li></ul><ul><li>Lidocaine </li></ul><ul><li>Midazolam </li></ul><ul><li>Parenteral calcium </li></ul><ul><li>Parenteral magnesium </li></ul><ul><li>Parenteral narcotics </li></ul><ul><li>Parenteral potassium </li></ul><ul><li>Parenteral NaCl>0.9% </li></ul><ul><li>Vasoactive agents </li></ul><ul><li>Neuromuscular blockers </li></ul>PROPRIETARY
  11. 11. What to Analyze Error-prone Procedures <ul><li>Examples </li></ul><ul><ul><li>Dose calculations and measurements </li></ul></ul><ul><ul><li>Telephone/oral transmission of orders </li></ul></ul><ul><ul><li>Handwritten and pre-printed orders </li></ul></ul><ul><ul><li>Choosing proper items from storage locations </li></ul></ul><ul><ul><li>Use of infusion control devices </li></ul></ul>PROPRIETARY
  12. 12. What to Analyze Changes in Processes/Procedures <ul><li>Examples </li></ul><ul><ul><li>New or changed medication use processes </li></ul></ul><ul><ul><li>New diagnostic procedures </li></ul></ul><ul><ul><li>New or changed treatment protocols </li></ul></ul><ul><ul><li>Formulary drug reviews </li></ul></ul><ul><ul><li>Policy and procedure development </li></ul></ul>PROPRIETARY
  13. 13. What to Analyze Incidents/High-risk processes reported in the literature <ul><li>Examples </li></ul><ul><ul><li>ISMP Medication Safety Alert! </li></ul></ul><ul><ul><li>Hospital Pharmacy </li></ul></ul><ul><ul><li>American Journal of Health-System Pharmacy </li></ul></ul><ul><ul><li>American Journal of Nursing </li></ul></ul><ul><ul><li>Journal of Healthcare Risk Management </li></ul></ul>PROPRIETARY
  14. 14. What to Analyze Incidents/High-risk processes reported by healthcare organizations and regulatory agencies <ul><li>Such as </li></ul><ul><ul><li>JC (Sentinel Event Alerts. </li></ul></ul><ul><ul><li>FDA ( </li></ul></ul><ul><ul><li>USP ( </li></ul></ul><ul><ul><li>ASHP ( ) </li></ul></ul><ul><ul><li>NCCMERP ( ) </li></ul></ul><ul><ul><li>NAHQ ( ) </li></ul></ul><ul><ul><li>NPSF ( ) </li></ul></ul>PROPRIETARY
  15. 15. What to Analyze Incidents/High-risk processes identified at your facility <ul><li>Through </li></ul><ul><ul><li>voluntary reporting of incidents </li></ul></ul><ul><ul><li>observation of high-risk processes </li></ul></ul><ul><ul><li>review of patient medical records </li></ul></ul><ul><ul><li>surveys of practitioners and patients </li></ul></ul><ul><ul><li>performance improvement data </li></ul></ul><ul><ul><li>evaluation of missing/unadministered doses </li></ul></ul>PROPRIETARY
  16. 16. Form a Team <ul><li>Most effective when conducted by a multidisciplinary team </li></ul><ul><li>Include all disciplines involved in the process being analyzed </li></ul><ul><li>Helpful Tip : </li></ul><ul><ul><li>A team of ten or fewer members is generally the most effective and efficient </li></ul></ul>PROPRIETARY
  17. 17. Form a Team <ul><li>Team composition </li></ul><ul><ul><li>Pharmacists </li></ul></ul><ul><ul><li>Nurses </li></ul></ul><ul><ul><li>Physicians </li></ul></ul><ul><ul><li>Risk Managers </li></ul></ul><ul><ul><li>Others such as </li></ul></ul><ul><ul><ul><li>Pharmacy technicians  Unit secretaries </li></ul></ul></ul><ul><ul><ul><li>Materials management  Dieticians </li></ul></ul></ul><ul><ul><ul><li>Information systems  Laboratory </li></ul></ul></ul><ul><ul><ul><li>Radiology  Respiratory therapy </li></ul></ul></ul>PROPRIETARY
  18. 18. Analyze the Process <ul><li>Understand the process </li></ul><ul><ul><li>Track process from beginning to end </li></ul></ul><ul><ul><li>A process flow diagram is a helpful tool </li></ul></ul><ul><li>Identify potential failure modes at each step in process </li></ul><ul><li>Identify the effects of each potential failure </li></ul><ul><li>Identify any checks/controls that increase likelihood of detection </li></ul>PROPRIETARY
  19. 19. Analyze the Process <ul><li>Helpful Tips : </li></ul><ul><ul><li>Ensure that the project is manageable </li></ul></ul><ul><ul><li>For complex processes focus on an area in the process </li></ul></ul><ul><ul><li>Develop flow diagrams of sub processes in the chosen area </li></ul></ul><ul><ul><li>Use a system of numbering or lettering for process and sub process steps </li></ul></ul>PROPRIETARY
  20. 20. Analyze the Process <ul><li>Helpful Tips : </li></ul><ul><ul><li>Process flow diagrams can be prepared in advance </li></ul></ul><ul><ul><li>The team then reviews the diagram and makes necessary revisions </li></ul></ul><ul><ul><li>A time saver for complex processes </li></ul></ul>PROPRIETARY
  21. 21. Analyze the Process <ul><li>Prioritize failure modes by estimating </li></ul><ul><ul><li>Probability of each failure occurring </li></ul></ul><ul><ul><li>Severity of effects of each failure </li></ul></ul><ul><ul><li>Probability of each failure being detected </li></ul></ul><ul><li>Estimates made </li></ul><ul><ul><li>Using ranking scales </li></ul></ul><ul><ul><li>Considering documented reports from the literature and from the hospital’s incident reporting system </li></ul></ul>PROPRIETARY
  22. 22. Analyze the Process <ul><li>Helpful Tips : </li></ul><ul><ul><li>Ranking scales should be meaningful to the team and to the process under analysis </li></ul></ul><ul><ul><li>Keep the scales simple </li></ul></ul><ul><ul><li>Develop definitive criteria for each ranking score </li></ul></ul><ul><ul><li>Ranking scales are a qualitative assessment tool used to prioritize areas of focus </li></ul></ul>PROPRIETARY
  23. 23. Example Severity Ranking Scale PROPRIETARY
  24. 24. Analyze the Process <ul><li>Calculate Criticality Index (CI) for each failure mode </li></ul><ul><li> CI= O X S X D </li></ul><ul><li>where: </li></ul><ul><ul><li>O = frequency of occurrence ranking score </li></ul></ul><ul><ul><li>S = severity of effects ranking score </li></ul></ul><ul><ul><li>D = probability of detection ranking score </li></ul></ul><ul><ul><li>Criticality Index is sometimes referred to as the </li></ul></ul><ul><ul><li>Risk Priority Number (RPN) </li></ul></ul>PROPRIETARY
  25. 25. Analyze the Process <ul><li>Assign priority ranking for each failure mode in decreasing order of CI </li></ul><ul><ul><li>Also may want to assign priority to those with high severity scores even though CI is low </li></ul></ul><ul><li>Helpful Tips : </li></ul><ul><ul><li>Keep clear, detailed documentation </li></ul></ul><ul><ul><li>Worksheets or forms can be helpful in recording and compiling ideas and ranking scores as the analysis proceeds </li></ul></ul>PROPRIETARY
  26. 26. Analyze the Process <ul><li>Identify root causes of potential failure modes </li></ul><ul><ul><li>Critical to identify all root causes </li></ul></ul><ul><li>Helpful Tips : </li></ul><ul><ul><li>Begin with failure modes with highest CI values </li></ul></ul><ul><ul><li>Address remaining failure modes later in descending order </li></ul></ul><ul><ul><li>Solutions to failures with highest CI values may be solutions to less significant failures </li></ul></ul><ul><ul><li>Cause & effect (fishbone) diagram is a helpful tool </li></ul></ul>PROPRIETARY
  27. 27. Identify Strategies for Improvement <ul><li>Identify actions that could reduce the CI </li></ul><ul><li>Include actions that: </li></ul><ul><ul><li>decrease likelihood of occurrence </li></ul></ul><ul><ul><li>decrease the severity of effects </li></ul></ul><ul><ul><li>increase probability of detection </li></ul></ul><ul><li>Helpful Tip : </li></ul><ul><ul><li>Don’t reinvent the wheel! Look at strategies implemented or recommended by other organizations </li></ul></ul>PROPRIETARY
  28. 28. Identify Strategies for Improvement <ul><li>Decide which strategies can be implemented </li></ul><ul><ul><li>Factors to consider: </li></ul></ul><ul><ul><ul><li>Likelihood that failure will be prevented </li></ul></ul></ul><ul><ul><ul><li>Likelihood of a long-term vs. short-term solution </li></ul></ul></ul><ul><ul><ul><li>Reliability of strategy/action (i.e., will it always work) </li></ul></ul></ul><ul><ul><ul><li>Impact on other processes, resources, schedules </li></ul></ul></ul><ul><ul><ul><li>Practicality </li></ul></ul></ul><ul><ul><ul><li>Barriers to implementation </li></ul></ul></ul><ul><ul><ul><li>Cost of implementation </li></ul></ul></ul><ul><ul><ul><li>Time needed to implement </li></ul></ul></ul><ul><ul><ul><li>How improvement can be measured </li></ul></ul></ul>PROPRIETARY
  29. 29. Types of Strategies for Improvement <ul><li>Redundancies </li></ul><ul><li>Fail-Safes </li></ul><ul><li>Eliminate item or procedure </li></ul><ul><li>Limit use or access </li></ul><ul><li>Location </li></ul><ul><li>Appearance </li></ul><ul><li>Tactile clues, special packaging </li></ul><ul><li>Warning signs, labels </li></ul><ul><li>Technology </li></ul><ul><li>Audible alarms </li></ul><ul><li>Protocols, procedures </li></ul><ul><li>Documentation </li></ul><ul><li>Education </li></ul><ul><li>Minimize/eliminate possibility of error </li></ul><ul><li>Minimize consequences of error </li></ul>PROPRIETARY Cohen MR, Senders J, Davis NM, Hosp Pharm 1994, 29:319-24, 326-28, 330
  30. 30. Implement Strategies for Improvement <ul><li>Develop an action plan </li></ul><ul><li>Develop process and outcome measures, as appropriate </li></ul><ul><li>Complete baseline measures of key processes as necessary </li></ul><ul><li>Implement action plan </li></ul><ul><li>Helpful Tip : </li></ul><ul><ul><li>Conduct a pilot test in a selected area before facility-wide implementation </li></ul></ul>PROPRIETARY
  31. 31. Evaluate Effectiveness of Actions <ul><li>Recalculate CIs of failure modes </li></ul><ul><li>Conduct process/outcome measures and reassess key processes and compare to baselines </li></ul><ul><li>Improvement shown if reduction in CI values, favorable process/outcomes measures, and improvement over baseline measures </li></ul><ul><li>If improvement not demonstrated, continue with FMEA </li></ul><ul><li>Continue to improve the process even if improvement is shown </li></ul>PROPRIETARY
  32. 32. Resources <ul><li>JC Failure Mode and Effects Analysis in Healthcare: Proactive Risk Reduction , 2007 </li></ul><ul><li>VA National Center for Patient Safety (NCPS) </li></ul><ul><ul><li> </li></ul></ul><ul><li>JC Perspectives on Patient Safety </li></ul><ul><li>Cohen MR, ed. Medication Errors . APhA, 2007 </li></ul>PROPRIETARY
  33. 33. Resources <ul><li>Hospital Pharmacy , April 1994 – 3 articles </li></ul><ul><li>McNally, Page, Sutherland. Am J Health-Syst Pharm . 1997; 54:171-7 </li></ul><ul><li>Fletcher CE. J Nur Admin . 1997; 27(12):19-26 </li></ul><ul><li>Barker D, et al. J Healthc Risk Manage . 2002; 22:9-12. </li></ul>PROPRIETARY
  34. 34. Question and Answer Session