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FMEA Applied to the Phenomenon of Retained Objects After Surgery. Project Managers Dr. Joan Burtner and Dr. Laura Moody Mercer University School of Engineering. Presentation Overview. Introduction Motivation for the Study Healthcare Failure Modes and Effects Analysis Case Study
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FMEA Applied to the Phenomenon of Retained Objects After Surgery Project Managers Dr. Joan Burtner and Dr. Laura Moody Mercer University School of Engineering
Presentation Overview • Introduction • Motivation for the Study • Healthcare Failure Modes and Effects Analysis Case Study • Typical Results • Select Recommendations • Questions/Comments Dr. Joan Burtner, Presenter
Introduction • 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 • Clients: MD and RN responsible for administering Quality programs at a hospital in the southeast Dr. Joan Burtner, Presenter
What is an FMEA? • 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 • CQE Body of Knowledge (Reliability and Risk Management) Dr. Joan Burtner, Presenter
What is a Healthcare FMEA? • 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 • FMEA vs HFMEA • 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 • Hazard Score obtained from the Hazard Matrix Table developed by the Department of Veteran’s Affairs National Center for Patient Safety Dr. Joan Burtner, Presenter
Project Timeline 2005-2006 • Preliminary research • Journal articles and books • Materials provided by southeastern hospital • Operating room observations • Process flow and documentation • High-Level • Detailed counting procedures • Healthcare Failure Modes and Effects Analysis • Consultation with MD and RN Dr. Joan Burtner, Presenter
Project Team • Clients: Upper level administrators at a southeastern hospital • Chief Quality Officer (Physician) • Performance Improvement Coordinator of Surgical Services (Registered Nurse) • Faculty at Mercer University • Dr. Joan Burtner – Certified Quality Engineer • Dr. Laura Moody – Human Factors Engineer • Students enrolled at Mercer University • Industrial Engineering Seniors • Industrial Management Seniors Dr. Joan Burtner, Presenter
Preliminary Research • Factors associated with retained objects • Emergency surgery • Unplanned change in surgical procedure • Patient obesity (higher mean body-mass-index) • Most likely causes for discrepancies in counts • Intensity/complexity of the environment • Non-standardized methods for performing counts • Poor communication among the Operating Room (OR) team members Dr. Joan Burtner, Presenter
Site-Specific Observations • Forms used by southeastern hospital • 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 Dr. Joan Burtner, Presenter
Healthcare FMEA Step #1 • Define the process that will be examined and define the scope • 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 Dr. Joan Burtner, Presenter
Healthcare FMEA Step #2 • Assemble the Team • ISE Students • ISE Professors • IDM Students • MD • RN • Expertise • Subject-matter • Process Improvement Dr. Joan Burtner, Presenter
Healthcare FMEA Step #3 • Graphically represent the process • Two flows generated • High-Level process flow • Detailed counting procedure process flow • Only partial graphics will be presented due to proprietary reasons Dr. Joan Burtner, Presenter
Healthcare FMEA Step #4 • Conduct a hazard analysis • Define potential failures at each step in each process • Define causes for failures at each step in process • Assign severity rating: • catastrophic, major, moderate, minor • Determine probability score • Determine hazard score • Eliminate, control, or accept failure mode • Actions for eliminate or control • Who is responsible? Dr. Joan Burtner, Presenter
Process Flow and Documentation • High-Level Process • Highlights overall operating room procedures • Reviewed and approved by RN • Detailed Counting Procedures • Highlights the specific counting procedures for sponges, sharps, and instruments • Reviewed and approved by RN Dr. Joan Burtner, Presenter
High-Level Process Flow Excerpt 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 No 5a) Change in end-of-shift nurse 5b) Possible change in surgeon 5c) Possible addition of new surgical staff members Dr. Joan Burtner, Presenter
Sponge Decision Tree Excerpt Are only X-ray detectable sponges being used? Yes No No Use sponges that are not X-ray detectable only for dressings. Dr. Joan Burtner, Presenter
Healthcare Analysis Worksheet Dr. Joan Burtner, Presenter
Sterile Table Preparation Example Dr. Joan Burtner, Presenter
Results (High-Level) • Accept • Step 1 - Equipment is brought into the operating room • Control • Step 3 - Pre-surgical count of the sponges and instruments • Eliminate • Step 6 - Completion of surgical process • Instruments, sponges, or sharps are left inside of a patient Dr. Joan Burtner, Presenter
Results(Detailed Counting Procedures) • Accept • Step 2a - Sponges are not completely separated during the count • Control • Step 11 - Object has left sterile field, circulator must retrieve and verify with the scrub nurse • Eliminate • Step 10 - The scrub nurse continually counts needles during the procedure Dr. Joan Burtner, Presenter
Recommendations for Future • Review FMEA worksheets • Institute recommendations and test • Continue to monitor process flow periodically • Revise as necessary Dr. Joan Burtner, Presenter
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 Dr. Joan Burtner, Presenter
Questions or Comments?Dr. Joan BurtnerASQ Certified Quality EngineerAssociate Professor of Industrial EngineeringMercer University Macon, GA(478) 301-4127Burtner_J@Mercer.edu Dr. Joan Burtner, Presenter