1. Using failure modes and effects analysis to evaluate “home meds” failures in surgical patients Fred M. Blanchard, Pharm.D. Virginia Commonwealth University Patient Safety Fellowship Program May 1, 2003

2. Purpose Introduce FMEA methodology Introduce FMEA methodology Incorporate FMEA into Performance Improvement and Patient Safety Efforts Incorporate FMEA into Performance Improvement and Patient Safety Efforts Apply FMEA and evaluate “home meds” failures Apply FMEA and evaluate “home meds” failures

3. Methods Establish a team Establish a team FOCUS PDSA FOCUS PDSA FMEA Training FMEA Training FMEA FMEA Define, Prioritize, Measure Failures Define, Prioritize, Measure Failures Intervene Intervene Re-measure Re-measure

4. “Home Meds” Team Dale Bosiger, Pre-op Education Dale Bosiger, Pre-op Education Debra Coulter, PACU Debra Coulter, PACU Lynn Harris, Surgicare Lynn Harris, Surgicare Nadine Gilmore, Pharmacy Nadine Gilmore, Pharmacy Linda Lange, Nursing Policy and Procedure Linda Lange, Nursing Policy and Procedure Sherry Payne, Orthopedic Unit Sherry Payne, Orthopedic Unit Randall Puckett, Pharmacy Randall Puckett, Pharmacy Kim Woodley, Quality Support Services (PI) Kim Woodley, Quality Support Services (PI) Fred Blanchard, Pharmacy Fred Blanchard, Pharmacy

5. FMEA Originally intended for prospective identification of failures Originally intended for prospective identification of failures Applied retrospectively as a stand alone process in the healthcare environment Applied retrospectively as a stand alone process in the healthcare environment Also applied as a tool in FOCUS PDSA Also applied as a tool in FOCUS PDSA

6. PI and FMEA Similarities FOCUS PDSA FOCUS PDSA Find a Challenge Find a Challenge Organize a Team Organize a Team Clarify Process Clarify Process Understand the Variation & Select a Process Understand the Variation & Select a Process P-D-S-A P-D-S-A FMEA FMEA Define Topic Assemble Team Describe Process Hazard Analysis Action/Outcome Measures

7. Graphic Description of Process

8. Subsystem Steps and Causes

9. Failure Mode 2g1 Nurse transcription from patient form to assessment sheet is illegible 2g1 Nurse transcription from patient form to assessment sheet is illegible

10. Failure Analysis

11. Potential Cause 2g1(e) Form not suitable for writing complete medication instructions including drug, strength, route, and frequency 2g1(e) Form not suitable for writing complete medication instructions including drug, strength, route, and frequency

12. Hazard Analysis 2g1(e) Severity = Major Severity = Major Probability = Frequent Probability = Frequent Hazard Score = 12 Hazard Score = 12

13. Decision Tree 2g1(e)

14. Action Type Control Control Accept Eliminate

15. Action and Outcome Measures Measure “error” rates at baseline Measure “error” rates at baseline Develop a new form; combine steps Develop a new form; combine steps Perform a trial Perform a trial Measure post intervention “error” rates Measure post intervention “error” rates

16. PREOPNURSEADMITRECORDPREOPNURSEADMITRECORD OLDFORMOLDFORM {{

17. Baseline Measure of Current Process Retrospectively reviewed 94 charts-all same day surgeries over a three week period Retrospectively reviewed 94 charts-all same day surgeries over a three week period

18. Baseline Measurements Before Charts with “Home Meds” documented pre-op 94% Charts with any order to renew “Home Meds” post-op 69% Post-op “Home Meds” order “qualified” 84% Post-op “Home Meds” orders “complete” 34% Post-op orders that were clarified 44% Average number of “Home-Meds” pre-op 5.7 Average number of “Home Meds” renewed post-op 2.7 Drug, Strength, Frequency, Route info pre-op 91% Drug, Strength, Frequency, Route info post-op 98% Discrepancies post-op 22%

19. RESUMEHOMEMEDSFORMRESUMEHOMEMEDSFORM NEWFORMNEWFORM {

20. Post Intervention Utilization of Combined Home Meds Form Retrospectively reviewed 51 charts-all same day surgeries over a two week period Retrospectively reviewed 51 charts-all same day surgeries over a two week period New form used by nursing staff 45 times (88%) New form used by nursing staff 45 times (88%) New form used by nursing and physician staff 35 times (78%) New form used by nursing and physician staff 35 times (78%)

21. Results BeforeAfter Charts with “Home Meds” documented pre-op 94%100% Charts with any order to renew “Home Meds” post-op 69%100% Post-op “Home Meds” order “qualified” 84%100% Post-op “Home Meds” orders “complete” 34%100% Post-op orders that were clarified 44%0% Average number of “Home-Meds” pre-op 5.76.3 Average number of “Home Meds” renewed post-op 2.74.9 Drug, Strength. Frequency, Route info pre-op 91%99% Drug, Strength, Frequency, Route info post-op 98%99% Discrepancies post-op 22%0%

22. Discussion Advantages of using FMEA in the context of FOCUS PDSA Advantages of using FMEA in the context of FOCUS PDSA Identification of failures Identification of failures Greater depth of analysis Greater depth of analysis Improved prioritization of selected processes Improved prioritization of selected processes Limitations Limitations Time consuming Time consuming Reserve for critical processes Reserve for critical processes

23. Discussion Home Meds Reorder Process Home Meds Reorder Process Combining pre-op medication history with post-op order set: Combining pre-op medication history with post-op order set: Reduced process variation Reduced process variation Improved pre-op documentation Improved pre-op documentation Increased frequency of post-op renewal Increased frequency of post-op renewal Improved the completeness of post-op orders Improved the completeness of post-op orders Reduced calls to clarify orders Reduced calls to clarify orders Increased probability that meds taken at home were continued post-op Increased probability that meds taken at home were continued post-op Reduced the number of post-op order discrepancies Reduced the number of post-op order discrepancies