1. FMEA Applied to the Phenomenon of Retained Objects After Surgery Project Managers Dr. Joan Burtner and Dr. Laura Moody Mercer University School of Engineering

2. IIE/ASQ 'Quality Drives Lean' Conference Oct 2006 Dr. Joan Burtner, PresenterSlide 2 Presentation Overview Introduction Introduction Motivation for the Study Motivation for the Study Healthcare Failure Modes and Effects Analysis Case Study Healthcare Failure Modes and Effects Analysis Case Study Typical Results Typical Results Select Recommendations Select Recommendations Questions/Comments Questions/Comments

3. IIE/ASQ 'Quality Drives Lean' Conference Oct 2006 Dr. Joan Burtner, PresenterSlide 3 Introduction To Err is Human – Call for action with respect to reducing medical errors To Err is Human – Call for action with respect to reducing medical errors Case study courses at Mercer University School of Engineering emphasize real- world projects Case study courses at Mercer University School of Engineering emphasize real- world projects Clients: MD and RN responsible for administering Quality programs at a hospital in the southeast Clients: MD and RN responsible for administering Quality programs at a hospital in the southeast

4. IIE/ASQ 'Quality Drives Lean' Conference Oct 2006 Dr. Joan Burtner, PresenterSlide 4 What is an FMEA? Failure Modes and Effects Analysis Failure Modes and Effects Analysis “FMEA is a team-based problem-solving tool intended to help users identify and eliminate, or reduce the negative effects of, potential failures before they occur in systems, subsystems, product or process design, or the delivery of a service.” The Certified Quality Engineer Handbook, page 233 “FMEA is a team-based problem-solving tool intended to help users identify and eliminate, or reduce the negative effects of, potential failures before they occur in systems, subsystems, product or process design, or the delivery of a service.” The Certified Quality Engineer Handbook, page 233 CQE Body of Knowledge (Reliability and Risk Management) CQE Body of Knowledge (Reliability and Risk Management)

5. IIE/ASQ 'Quality Drives Lean' Conference Oct 2006 Dr. Joan Burtner, PresenterSlide 5 What is a Healthcare FMEA? Motivation for the HFMEA Motivation for the HFMEA Joint Commission on the Accreditation of Healthcare Organizations (JCAHO) Standard LD.5.2 requires facilities to select at least one high-risk process for proactive risk assessment annually Joint Commission on the Accreditation of Healthcare Organizations (JCAHO) Standard LD.5.2 requires facilities to select at least one high-risk process for proactive risk assessment annually FMEA vs HFMEA FMEA vs HFMEA HFMEA combines the detectability and criticality steps of a traditional FMEA HFMEA combines the detectability and criticality steps of a traditional FMEA HFMEA uses a hazard score in place of the risk priority number (RPN) that is associated with a traditional FMEA HFMEA uses a hazard score in place of the risk priority number (RPN) that is associated with a traditional FMEA Hazard Score obtained from the Hazard Matrix Table developed by the Department of Veteran’s Affairs National Center for Patient Safety Hazard Score obtained from the Hazard Matrix Table developed by the Department of Veteran’s Affairs National Center for Patient Safety

6. IIE/ASQ 'Quality Drives Lean' Conference Oct 2006 Dr. Joan Burtner, PresenterSlide 6 Project Timeline 2005-2006 Preliminary research Preliminary research Journal articles and books Journal articles and books Materials provided by southeastern hospital Materials provided by southeastern hospital Operating room observations Operating room observations Process flow and documentation Process flow and documentation High-Level High-Level Detailed counting procedures Detailed counting procedures Healthcare Failure Modes and Effects Analysis Healthcare Failure Modes and Effects Analysis Consultation with MD and RN Consultation with MD and RN

7. IIE/ASQ 'Quality Drives Lean' Conference Oct 2006 Dr. Joan Burtner, PresenterSlide 7 Project Team Clients: Upper level administrators at a southeastern hospital Clients: Upper level administrators at a southeastern hospital Chief Quality Officer (Physician) Chief Quality Officer (Physician) Performance Improvement Coordinator of Surgical Services (Registered Nurse) Performance Improvement Coordinator of Surgical Services (Registered Nurse) Faculty at Mercer University Faculty at Mercer University Dr. Joan Burtner – Certified Quality Engineer Dr. Joan Burtner – Certified Quality Engineer Dr. Laura Moody – Human Factors Engineer Dr. Laura Moody – Human Factors Engineer Students enrolled at Mercer University Students enrolled at Mercer University Industrial Engineering Seniors Industrial Engineering Seniors Industrial Management Seniors Industrial Management Seniors

8. IIE/ASQ 'Quality Drives Lean' Conference Oct 2006 Dr. Joan Burtner, PresenterSlide 8 Preliminary Research Factors associated with retained objects Factors associated with retained objects Emergency surgery Emergency surgery Unplanned change in surgical procedure Unplanned change in surgical procedure Patient obesity (higher mean body-mass- index) Patient obesity (higher mean body-mass- index) Most likely causes for discrepancies in counts Most likely causes for discrepancies in counts Intensity/complexity of the environment Intensity/complexity of the environment Non-standardized methods for performing counts Non-standardized methods for performing counts Poor communication among the Operating Room (OR) team members Poor communication among the Operating Room (OR) team members

9. IIE/ASQ 'Quality Drives Lean' Conference Oct 2006 Dr. Joan Burtner, PresenterSlide 9 Site-Specific Observations Forms used by southeastern hospital Forms used by southeastern hospital Qualitative assessment of process Qualitative assessment of process  Two people have to witness the count for it to be valid  Lap sponges are mainly lost in cases with obese people and/or abdominal surgeries  Sponges will do more damage to the patient than instruments if left inside the body, due to decomposition

10. IIE/ASQ 'Quality Drives Lean' Conference Oct 2006 Dr. Joan Burtner, PresenterSlide 10 Healthcare FMEA Step #1 Define the process that will be examined and define the scope Define the process that will be examined and define the scope Process - Counting of surgical tools and sponges prior to, during and after operations Process - Counting of surgical tools and sponges prior to, during and after operations Goal - Provide client with possible recommendations for performing this task that will attempt to prevent surgical tools and sponges from being left inside patients Goal - Provide client with possible recommendations for performing this task that will attempt to prevent surgical tools and sponges from being left inside patients

11. IIE/ASQ 'Quality Drives Lean' Conference Oct 2006 Dr. Joan Burtner, PresenterSlide 11 Healthcare FMEA Step #2 Assemble the Team Assemble the Team ISE Students ISE Students ISE Professors ISE Professors IDM Students IDM Students MD MD RN RN Expertise Expertise Subject-matter Subject-matter Process Improvement Process Improvement

12. IIE/ASQ 'Quality Drives Lean' Conference Oct 2006 Dr. Joan Burtner, PresenterSlide 12 Healthcare FMEA Step #3 Graphically represent the process Graphically represent the process Two flows generated Two flows generated High-Level process flow High-Level process flow Detailed counting procedure process flow Detailed counting procedure process flow Only partial graphics will be presented due to proprietary reasons Only partial graphics will be presented due to proprietary reasons

13. IIE/ASQ 'Quality Drives Lean' Conference Oct 2006 Dr. Joan Burtner, PresenterSlide 13 Healthcare FMEA Step #4 Conduct a hazard analysis Conduct a hazard analysis Define potential failures at each step in each process Define potential failures at each step in each process Define causes for failures at each step in process Define causes for failures at each step in process Assign severity rating: Assign severity rating: catastrophic, major, moderate, minor catastrophic, major, moderate, minor Determine probability score Determine probability score Determine hazard score Determine hazard score Eliminate, control, or accept failure mode Eliminate, control, or accept failure mode Actions for eliminate or control Actions for eliminate or control Who is responsible? Who is responsible?

14. IIE/ASQ 'Quality Drives Lean' Conference Oct 2006 Dr. Joan Burtner, PresenterSlide 14 Process Flow and Documentation High-Level Process High-Level Process Highlights overall operating room procedures Highlights overall operating room procedures Reviewed and approved by RN Reviewed and approved by RN Detailed Counting Procedures Detailed Counting Procedures Highlights the specific counting procedures for sponges, sharps, and instruments Highlights the specific counting procedures for sponges, sharps, and instruments Reviewed and approved by RN Reviewed and approved by RN

15. IIE/ASQ 'Quality Drives Lean' Conference Oct 2006 Dr. Joan Burtner, PresenterSlide 15 High-Level Process Flow Excerpt Is there a shift change? Yes 6) Completion of surgical procedure 3a) Possible introduction of additional equipment No 1) Equipment kits are brought into the OR 2) Sterile table is prepared for operation by scrub nurse 3) Pre-surgical count of instruments and sponges is conducted 4) Incisions are made 5a) Change in end-of- shift nurse 5b) Possible change in surgeon 5c) Possible addition of new surgical staff members

16. IIE/ASQ 'Quality Drives Lean' Conference Oct 2006 Dr. Joan Burtner, PresenterSlide 16 Sponge Decision Tree Excerpt Is the sponge count exactly the same as the package label states? Yes Are only X-ray detectable sponges being used? Use sponges that are not X-ray detectable only for dressings. Yes No

17. IIE/ASQ 'Quality Drives Lean' Conference Oct 2006 Dr. Joan Burtner, PresenterSlide 17 Healthcare Analysis Worksheet Healthcare Analysis Worksheet 1 Process Step 2 Potential Failure Mode 3 Potential Cause 4Severity 5Probability 6 Hazard Score 7 Decision (Proceed or Stop) 8 Action (Eliminate, Control or Accept) 9 Description of Action 10 Outcome Measure 11 Person responsible 12 Management Concurrence

18. IIE/ASQ 'Quality Drives Lean' Conference Oct 2006 Dr. Joan Burtner, PresenterSlide 18 Sterile Table Preparation Example Sterile Table Preparation Example 1 2) Sterile table is prepared for operation by scrub technician 2 Sterile table is not set up exactly the same by every nurse 3 There is no standard procedure 4 Moderate Severity 5 Frequent Occurrence 6 Hazard Score = 8 (Hazard Scoring Matrix) 7 Decision : Stop 8 Action : Control 9 Initiate standard procedure for sterile table setup 10 Percent of nurses conforming to new procedure 11 Nursing administrator 12 Management concurrence undetermined at this point

19. IIE/ASQ 'Quality Drives Lean' Conference Oct 2006 Dr. Joan Burtner, PresenterSlide 19 Results (High-Level) Accept Accept Step 1 - Equipment is brought into the operating room Step 1 - Equipment is brought into the operating room Control Control Step 3 - Pre-surgical count of the sponges and instruments Step 3 - Pre-surgical count of the sponges and instruments Eliminate Eliminate Step 6 - Completion of surgical process Step 6 - Completion of surgical process Instruments, sponges, or sharps are left inside of a patient Instruments, sponges, or sharps are left inside of a patient

20. IIE/ASQ 'Quality Drives Lean' Conference Oct 2006 Dr. Joan Burtner, PresenterSlide 20 Results (Detailed Counting Procedures) Accept Accept Step 2a - Sponges are not completely separated during the count Step 2a - Sponges are not completely separated during the count Control Control Step 11 - Object has left sterile field, circulator must retrieve and verify with the scrub nurse Step 11 - Object has left sterile field, circulator must retrieve and verify with the scrub nurse Eliminate Eliminate Step 10 - The scrub nurse continually counts needles during the procedure Step 10 - The scrub nurse continually counts needles during the procedure

21. IIE/ASQ 'Quality Drives Lean' Conference Oct 2006 Dr. Joan Burtner, PresenterSlide 21 Recommendations for Future Review FMEA worksheets Review FMEA worksheets Institute recommendations and test Institute recommendations and test Continue to monitor process flow periodically Continue to monitor process flow periodically Revise as necessary Revise as necessary

22. IIE/ASQ 'Quality Drives Lean' Conference Oct 2006 Dr. Joan Burtner, PresenterSlide 22 The project managers would like to acknowledge the exceptional efforts of the members of the student team as well as the professionalism of our community partners at a hospital in the southeast. Acknowledgements

23. IIE/ASQ 'Quality Drives Lean' Conference Oct 2006 Dr. Joan Burtner, PresenterSlide 23 Questions or Comments? Dr. Joan Burtner ASQ Certified Quality Engineer Associate Professor of Industrial Engineering Mercer University Macon, GA (478) 301-4127 Burtner_J@Mercer.edu