1. Universal Protocol Guide Mount Auburn Hospital Department of Quality and Safety Instructions: > or back < navigation buttons.

2. Goals of this guide This guide is designed to help all physicians who do invasive procedures at Mount Auburn Hospital: Understand the rationale behind the universal protocol Correctly perform all of its elements

3. Contents Case example What is the universal protocol? Background The impact of errors What does the universal protocol involve? What procedures fall under the protocol Pre-op verification Site marking The “time out” Barriers Quiz

4. How well do you know the universal protocol? Please take this brief quiz The answers will be discussed at the end of this module Disclaimer: The case described is a composite based upon cases in the public domain

5. Bob Jones’ knee replacement Bob Jones is an 80 year old retired engineer with bilateral knee osteoarthritis. His right knee is more severely damaged and symptomatic. He meets with Dr. Smith, his orthopedic surgeon, and they agree upon the need for surgery.

6. Bob Jones’ knee replacement: In the holding room The nurse in the holding room greets Mr. Jones and initiates the pre-operative verification checklist. Dr. Smith’s history and physical indicate that he plans to do a left knee replacement. The nurse checks with Mr. Jones who is fairly certain that he had agreed with Dr. Smith on a right knee replacement. The patient signed an informed consent for a right knee replacement.

7. Which of the following actions should now be initiated? a) The nurse should assume the history and physical are incorrect and allow the patient to proceed into the OR b) The nurse should notify Dr. Smith of the discrepancies c) Dr. Smith should review his notes and the films, and re-confirm the decision with the patient d) Dr. Smith should insert a correction into the H & P with his signature, date and time e) b, c, and d

8. Bob Jones knee replacement: In the holding room Dr. Smith reviews his notes and the films, and re-confirms with Mr. Jones the plan for right knee replacement. He marks his initials on the patient’s right mid-tibia with an arrow pointing upward toward the right knee. He then marks “No” on the left knee.

9. Which of the following actions should now be initiated? a) No action need be taken b) The markings on the right tibia and left knee should be scrubbed off c) Dr. Smith should re-mark the right knee, “Yes” d) Dr. Smith should re-mark his initials directly at the incision site on the right side only e) b and d

10. Bob Jones knee replacement: In the operating room Mr. Jones is brought into the OR. The OR is set up for a left knee replacement. The circulator nurse verifies the patient’s identification with the anesthesiologist after which Mr. Jones is given general anesthesia. His blood pressure drops moderately below his baseline.

11. Bob Jones knee replacement: In the operating room Dr. Smith enters the OR and begins to prep and drape the left knee. His favorite music is playing on the radio. The scrub technician is not yet in the room. The circulating nurse is at the computer with her back to the patient. She initiates the “time out” stating the patient’s name, planned procedure, site, position and equipment present. Dr. Smith makes his incision in the left knee. When Mr. Jones’ BP stabilizes, the anesthesiologist looks up and questions which knee is being replaced.

12. Which elements of the “time out” were performed incorrectly? a) The “time out” was not initiated by the surgeon b) The entire team was not present c) The stated procedure was not cross- checked with the informed consent d) The site marking was not visualized and verbally confirmed by the team e) a, b, c, and d f) b, c, and d

13. What is the universal protocol? Guidelines to assure that the correct surgery and invasive procedures are done on the correct person, on the correct side and site These guidelines apply to invasive procedures anywhere in the hospital

14. Background The universal protocol was developed by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) in 2003 in collaboration with numerous professional organizations Effective July 1, 2004, compliance with the protocol has been required of all JCAHO accredited institutions

15. Background Wrong body part or site: 76% of cases Wrong patient: 13% of cases Wrong procedure: 11% of cases By specialty: Orthopedic/podiatric: 41% of cases General surgery: 20% Neurosurgery: 14% Urologic surgery: 11% The rest were dental/oral maxillofacial, cardiovascular- thoracic, ear-nose-throat, and ophthalmologic surgery http://www.jointcommission.org/SentinelEvents/SentinelEventAlert/sea_24.htm JCAHO’s 2001 root cause analyses of 126 cases reported to them:

16. Background Factors contributing to increased risk for wrong-site surgery: –Emergency procedure –Unusual physical characteristics (morbid obesity, physical deformity) –Unusual time pressures to begin or complete procedure –Unusual equipment or set-up in the OR –Multiple surgeons involved in the case –Multiple procedures being performed during a single surgical visit

17. Background CRICO experience: analysis of 40 cases of wrong-site surgery Data from malpractice claims 1985-2003 and surgical loss observations 1994-2004 –38% (15 cases) wrong vertebral level or wrong-side laminectomy of the spine –62% (25 cases) non-spine 12 wrong side 12 wrong site – no laterality, 8 involving multiple structures, 4 involving multiple lesions 1 wrong patient Kwaan MR, et al. Arch Surg.2005;141:353-358

18. What does the universal protocol include? The protocol includes 3 steps: 1.Pre-operative verification to confirm correct Patient Procedure Site/side 2.Site marking 3.“Time out” immediately before beginning the procedure

19. What procedures fall under the universal protocol guidelines? Any invasive procedure that involves puncture or incision of the skin, insertion of an instrument, or foreign materials Not included under the protocol are routine procedures such as venipuncture, placement of simple IV’s, NG tubes, and Foley catheters

20. Pre-operative verification What: A process to ensure that all relevant documents and studies –Are available –Have been reviewed –Are consistent with each other –Are consistent with the patient’s and team’s understanding of the intended procedure and site When: This step begins with the decision to do the procedure and continues through all settings and interventions in the pre-op preparation of the patient, up to and including the “time out.”

21. Site marking essentials Mark all cases involving: –Right or left laterality –Multiple structures (e.g. joints of fingers or toes) –Multiple levels (spinal procedures) The person performing the procedure should do the site marking The mark must be: –Unambiguous (initials only) –On the exact surgical site only –Visible after patient is prepped and draped

22. Site marking essentials When? –Before moving patient into the room where procedure will be performed –Before the patient is sedated to the point at which s/he cannot be meaningfully involved Patient involvement –The marking should occur with patient involvement –If the patient is unable to participate, whoever has authority to provide informed consent should participate

23. Site marking FAQ’s How do you mark lateral procedures when done through a natural body orifice, endoscope, laparoscope or cystoscope? –The skin overlying the relevant structure or organ should be marked and visible after draping to indicate the correct side

24. Site marking FAQ’s What is the recommended procedure for marking spinal surgery cases? –Pre-op: initial the specific level (cervical, thoracic or lumbar) –Intra-op: mark the precise inter-space using standard intra-operative radiographic marking technique

25. Site marking examples (1) Left wrist ganglionPIP joint

26. Site marking examples (2) Right shoulder Left hernia

27. Site marking examples (3) Right elbow Right hip

28. Site marking examples (4) L2 L3 L4 L5 L4 laminectomyLeft eye surgery

29. Site marking examples: Correct or incorrect? Left 4th distal interphalangeal joint

30. Site marking examples: Correct or incorrect? Left 4th distal interphalangeal joint IncorrectCorrect

31. The “time out” What: A pause to verify that –Patient identification has been confirmed –Surgeon’s articulation of procedure, site and side agree with informed consent –Site marking is clearly visible –Correct implant, prosthesis, special equipment is in the room When: Immediately before starting the procedure Where: In the location where the procedure is to be done

32. The “time out” Who: –The “time out” must involve the entire team that will be present during the initial surgical incision –At Mount Auburn Hospital, the surgeon initiates the “time out” Unanimous agreement among the team that all questions or concerns are resolved is required in order for the case to begin

33. The “time out” The “time out” is a conversation, not a checklist It is a time when each person who has responsibility for the outcomes of a procedure takes a moment to reflect on whether every aspect of the protocol has been followed, and the chance of error minimized The “time out” is the team’s final fail-safe prior to surgery

34. Video: The “time out” at Mount Auburn Video Instructions: Turn computer speaker and volume ON and mouse click on the embedded video below to play. If you are outside the hospital or cannot play the embedded video click on the link to the video stream below or from the Physician Education webpage. Click Here for Video Stream of the "Time Out" at Mount Auburn

35. Barriers It won’t happen to me –It could One more external regulation –Maybe so, but it might protect you and the patient Someone else’s responsibility to initiate –It’s yours and everyone’s “I must be mistaken, it’s probably ok” –If you’re uneasy, speak up

36. Quiz What are the 3 steps of the universal protocol? Describe 5 essential features of a correct site marking Describe 5 essential features of a correctly performed “time out” What’s your role in the “time out?”

37. Bob Jones, revisited Bob Jones and Dr. Smith have agreed upon a right knee replacement. The nurse in the holding room discovers a discrepancy between Dr. Smith’s H & P, the informed consent, and the patient’s understanding. Which of the following actions should now be initiated? a) The nurse should assume the history and physical are incorrect and allow the patient to proceed into the OR b) The nurse should notify Dr. Smith of the discrepancies c) Dr. Smith should review his notes and the films, and re- confirm the decision with the patient d) Dr. Smith should insert a correction into the H & P with his signature, date and time e) b, c, and d

38. Bob Jones, revisited Bob Jones and Dr. Smith have agreed upon a right knee replacement. The nurse in the holding room discovers a discrepancy between Dr. Smith’s H & P, the informed consent, and the patient’s understanding. Which of the following actions should now be initiated? a) The nurse should assume the history and physical are incorrect and allow the patient to proceed into the OR b) The nurse should notify Dr. Smith of the discrepancies c) Dr. Smith should review his notes and the films, and re- confirm the decision with the patient d) Dr. Smith should insert a correction into the H & P with his signature, date and time e) b, c, and d

39. Take homes Pre-operative verification ensures that the correct patient is receiving the correct procedure on the correct site and side. The purpose of pre-op verification is to ensure that all relevant documents and studies –Are available –Have been reviewed –Are consistent with each other –Are consistent with the patient’s and team’s understanding of the intended procedure and site

40. Take homes If inconsistencies are noted during the pre-op verification process, the procedure site and side should be –Verified by the surgeon and patient –The verified site/side should be correctly and consistently documented, and –Correctly communicated to the staff setting up the OR room, implants, and equipment

41. Bob Jones, revisited Dr. Smith re-confirms with Mr. Jones the plan for right knee replacement. He marks his initials on the right mid-tibia with an arrow pointing upwards to the right knee. He then marks “No” on the left knee. a) No action need be taken b) The markings on the right tibia and left knee should be scrubbed off c) Dr. Smith should re- mark the right knee, “Yes” d) Dr. Smith should re- mark his initials directly at the incision site on the right side only e) b and d

42. Bob Jones, revisited Dr. Smith re-confirms with Mr. Jones the plan for right knee replacement. He marks his initials on the right mid-tibia with an arrow pointing upwards to the right knee. He then marks “No” on the left knee. a) No action need be taken b) The markings on the right tibia and left knee should be scrubbed off c) Dr. Smith should re- mark the right knee, “Yes” d) Dr. Smith should re- mark his initials directly at the incision site on the right side only e) b and d

43. Take homes The operative site should be marked –With the physician’s initials only –By the person performing the procedure –With the patient’s (or surrogate’s) involvement –Directly over the incision site –And visible after draping Do not: –Use “Yes” or “No” –Mark the non-operative site

44. Bob Jones, revisited Dr. Smith enters the OR and begins to prep and drape the left knee. The scrub technician isn’t in the room. The circulating nurse is at the computer with her back to the patient. She initiates the “time out” stating the patient’s name, planned procedure, site, position and equipment present. Dr. Smith makes his incision in the left knee. The anesthesiologist looks up and questions which knee is being replaced. a) The “time out” should have been initiated by the surgeon b) The entire team was not present c) The stated procedure was not cross-checked with the informed consent d) The site marking was not visualized and verbally confirmed by the team e) a, b, c, and d f) b, c, and d

45. Bob Jones, revisited Dr. Smith enters the OR and begins to prep and drape the left knee. The scrub technician isn’t in the room. The circulating nurse is at the computer with her back to the patient. She initiates the “time out” stating the patient’s name, planned procedure, site, position and equipment present. Dr. Smith makes his incision in the left knee. The anesthesiologist looks up and questions which knee is being replaced. a) The “time out” should have been initiated by the surgeon b) The entire team was not present c) The stated procedure was not cross-checked with the informed consent d) The site marking was not visualized and verbally confirmed by the team e) a, b, c, and d f) b, c, and d

46. Take homes The “time out” –Is initiated by the surgeon –Must take place with the entire team present immediately before the planned procedure –Includes verification that Patient identification has been confirmed Surgeon’s articulation of procedure, site and side agree with informed consent Site marking is clearly visible Correct implant, prosthesis, special equipment is in the room

47. Credits Teaching module: –Created by Beth A. Lown, MD and G. Tracey Phillips, RN. Video Credits: –Created by Susan Abookire, MD Time Out players: –Susan Abookire, MD –Jay Connor, MD –Larry Mambrino, MD –Leslie Schneiderhan RN, CNS –Arthur Dayton CRNA –Judy Friedlich RN, Circulating Nurse –Laura Hastie ST - Scrub Technologist –Laura Dow ST - Patient Technical Support: –N.R. Chandrasekar, MD –Al Ghilardi Orthopedic First Assistant

48. Verification of Training Please complete the brief online verification of training using the link on the Physician Education page or click here: Universal Protocol Online Quiz

49. Questions? Contact the Mount Auburn Hospital Department of Quality and Safety Extension: 5073 Back to Beginning