1. Final Report Briefing Retained Foreign Object Performance Improvement Team Presented April 3, 2007

2. : GOAL : Eliminate the sentinel event of retained foreign objects (RFO)

3. Team Leader Dr. John Skibber Team Members Dr. Miguel Rodriguez-Bigas Dr. Ara Vaporciyan Dr. Peter Pisters Dr. Bharat Raval Judith Gerst Rolando Ramirez Susan Terrell Lisa McMillian

4. Team Members (cont.) Nadine Turner Pamela Bennett Tammy Campbell Aloma Smith Irvin Serra Ronald Portley Recorder/Coordinator Steven Foster Administrative Assistance Melina Scarborough Technical Consultant Jim Vinci, Holland and Davis, LLP

5. TIMELINE: Start date - Oct 2006 Scheduled completion date – Feb. 28, 2007 Actual completion date – Mar. 30, 2007 TIME CONSIDERATIONS: Complexity of task Change in team leadership Technology exploration

6. METHODOLOGY 1. Chartered by Dr. Burke 2. Action plan developed 3.Team tasking list developed 4. Statistics gathered A. Existing reports B. Ad Hoc 5. Regulations acquired 6.Policies & mandates acquired 7.Benchmarking completed 8.Interim reports to OR Committee

7. 9. “As-Is” Process mapped A. Flowchart B. Responsibility Assignment Matrix 10. Root Cause Analysis conducted 11. Best practices considered 12. Value Stream Map completed based on all data gathered and discovered using the process improvement methodology METHODOLOGY (Cont.)

8. 13. Prioritized all solutions 14. Categorized the solutions for the approving authority. METHODOLOGY (Cont.)

9. MAJOR FINDINGS 1.New adjunctive sponge and instrument counting technologies are not fully matured 2.Inadequate infrastructure in information technology to support, monitor and improve existing process 3. Current scheduling system does not support preparation of OR cases and patient safety

10. MAJOR FINDINGS (Cont.) 4. Need for surgical staff training in Crew Resource Management to ensure a safe working environment 5. Current policies for both medical staff & nursing have substantial gaps that result in poor adherence and practice 6. Excessive instruments and disposables are delivered to the OR in a manner that adds to distractions and impairs patient safety

11. PROCESS DEVELOPMENT Institutional Policy Volume IV, Book B, Compliance Program, Ch. 4, Policy & Procedure Development & Review, Policy IV.B.4.01 Policy, practice & compliance efforts in the OR and PE must be generated in a coordinated manner. Must include all stakeholders: Nursing Anesthesiology Surgery PE Support Services

12. PROCESS DEVELOPMENT CONT’D Generation of policies or improvement efforts without input from all stakeholders reduces patient safety & contributes to an unsafe environment & culture. This policy compliance will be required as we begin to address the solutions proposed in this report. Operating Room policy should not be generated in a single discipline only.

13. PROCESS FOR SELECTING SOLUTIONS All solutions considered Determined pros and cons Prioritized Categorized Recommendation

14. SOLUTION FOCUS 1.Patient Safety 2.Use of crew resource management principles for safety in the OR 3.Use of technology to support a defined process of counting by OR personnel for sponges and instruments 4.Fostering a collegial working relationship among those involved in the OR 5.Develop IT systems to support continuous performance, quality and safety improvement 6.Close gaps between existing policies, improve compliance to policy, and competency assessment

15. RECOMMENDED PROCESS (1 of 4)

16. RECOMMENDED PROCESS (2 of 4)

17. RECOMMENDED PROCESS (3 of 4)

18. RECOMMENDED PROCESS (4 of 4)

19. RECOMMENDED SOLUTIONS 1.Adopt the new counting process developed by the RFO Team (Appendix M) that governs the counting process and RFOs 2. Develop a comprehensive, competency based training program for the Perioperative Enterprise to include surgeons, PAs, anesthesiologists, nursing, assistants, techs, and radiologists as it relates to counting

20. RECOMMENDED SOLUTIONS 3. Circulating nurse should not be interrupted to do additional tasks: A. Provide adequate support staff in OR to eliminate disruptions during count B. Emphasize accuracy in preference card, schedule and patient consents C. Consider OR communication options that will reduce distraction and obtain Executive Team support (export to ACB) 4. Charter an Implementation Team to implement the recommendations of the Team that have been vetted through the OR Committee and approved by the OR Executive Team

21. RECOMMENDED SOLUTIONS 5A. Establish an Oversight Team to consider recommendations, make modifications and perform a semi-annual review of the counting processRFO prevention 5A. Establish an Oversight Team to consider recommendations, make modifications and perform a semi-annual review of the counting process and RFO prevention 5B. Continue instrument reduction efforts 7A. Develop a standardized nomenclature of all instruments and disposals across the count sheet, Perioperative Enterprises training and radiology library 7B. There must be an on-going assessment, evaluations and enforcement of the counting policy 9. Attending surgeon will be notified of first incorrect count per new process

22. RECOMMENDED SOLUTIONS 10. Institute Crew Resource Management training for all OR personnel 11. Only faculty radiologist will read x-rays with regards to retained foreign objects, including after normal duty hours. A test for an RFO should be considered a critical test. 12. Develop a policy that lists all procedures where counts must be done. The policy will be vetted with the OR Committee & Surgical Chairs prior to sending to OR Executive Team 13A. Develop a standardized nomenclature of operative procedures that ties in with the Scheduling Performance Improvement Team recommendations

23. RECOMMENDED SOLUTIONS 13B. Eliminate the occurrence of intimidations by surgeons, by enforcing the OR Behavior Policy approved by the Medical Practice Committee 15A. Needles, guide wires, and blades will be counted using ACB OR as “best practice” site 15B. The counting sub-process will be standard for both the ACB and the Main OR 17A. Retained Foreign Object is defined as when the patient is re-anesthetized and/or taken back to the OR to remove the RFO. A "Near Miss" is any miscount in the OR that is reconciled in the OR.

24. RECOMMENDED SOLUTIONS 17B. Establish a standard policy of notification after film is read as mapped in the radiology sub process 19. Adopt the standardized system on how instruments and supplies are arranged on back table 20. Create radiology library of foreign body instruments (materials) 21A. Use standardized whiteboard to improve communications in the OR (consider electronic whiteboard)

25. RECOMMENDED SOLUTIONS 21B. An incorrect count report has been implemented by nursing in the electronic medical record and should be part of the OR medical record and transparent for continuous quality improvement 23. Consider trial evaluation of Clear Count's system with wand to augment the counting process 24. Attempt to keep surgeon and nurses together as a team when possible 25. Eliminate cut items to the greatest extent possible. Look at smaller types of items that could be substituted. If an item is cut, exceptional care must be taken to reconstruct during count

26. RECOMMENDED SOLUTIONS 26. Anesthesia should be responsible and accountable for their gauze sponges and instruments. There should be no cross use between surgical and anesthesia team. This will require an anesthesia policy supported with education. 27. Surgeon or designee documents their understanding that all count results are correct or incorrect in the operative report 28. Surgeons should be included in nursing competencies evaluation

27. RECOMMENDED SOLUTIONS 29. The Director for the Perioperative Enterprise Support Team will determine how to best document and track case cart shortages and their reconciliation 30. All instruments except "retractors" will be out of tray

28. SOLUTION CATEGORIZATION

29. Necessity Recommended Team Will require a disciplined approach in engineering organizational change IMPLEMENTATION TEAM

30. RECOMMENDED IPT

31. OR Committee reviews the Team’s recommended solutions and if it does not agree, add its addendum to the final report OR Executive Team accepts and approves the final report Charter the Implementation Planning Team (IPT) Continued support to the IPT : REQUEST THE FOLLOWING :

32. DISCUSSION