U P DAT E Quarterly Update: What Might Be the Impact of Using Evidence-Based Best Practices for Preventing Wrong- Site Surgery? John R. Clarke, MD The mysterious two-year cycle of wrong-site surgery reports continues, with the second Editor, Pennsylvania Patient Safety Advisory lowest quarterly total to date (see Figure). As usual, this quarterly report has been Clinical Director, Pennsylvania Patient Safety Authority updated to include any belated additions and corrections from previous quarters. Professor of Surgery, Drexel University Two near-miss reports submitted to the Pennsylvania Patient Safety Authority exemplify the value of preventive measures. The first, a good catch, highlights the value of the time-out. The second shows how the problems of rationally addressing remote access to the operative site, such as with laparoscopic or endovascular surgery, has been resolved within one facility. A patient’s incorrect leg was prepped and draped for surgery. The error was noticed during time-out; no incision was made. The patient’s leg was not marked in pre-op. The nurse did not check to ensure leg was marked prior to taking the patient to the OR [operating room]. During the “time out,” it was noted that incorrect leg was prepped and draped. The drapes were taken down; the patient’s correct leg was prepped and draped. A new time-out was completed and all documents were rechecked. A patient’s surgical consent read “right femoral angiogram.” The patient stated we were operating on the left leg. The patient and doctor spoke and signed a new consent for the correct leg. The new consent read “left leg angiogram via right groin approach.” The patient, doctor, and a witness agreed and signed the new consent. This article examines the possible impact of each previously proposed best practice principle for preventing wrong-site surgery.1,2 Authority analysts did a subjective analysis of the narratives of the 444 wrong-site surgery reports from June 28, 2004, through June 30, 2011, to identify possible best practice principles for reducing risk suitable for Figure. Pennsylvania Patient Safety Authority Wrong-Site Surgery Reports by Quarter NUMBER OF REPORTS 30 25 23 23 21 21 20 19 19 19 18 17 17 16 16 16 16 16 16 16 16 15 15 14 14 13 13 11 11 11 10 9 8 Scan this code 5 with your mobile MS11392 device’s QR Reader to access 0 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 the Authority's wrong-site surgery 2004 2005 2006 2007 2008 2009 2010 2011 prevention toolkit. REPORTS BY QUARTER Vol. 8, No. 3—September 2011 Pennsylvania Patient Safety Advisory Page 109 ©2011 Pennsylvania Patient Safety Authority U P DAT E each scenario. One or more principles may Table. Possible Impact of Best Practice Principles for Preventing Wrong-Site Surgery be effective independently or in combina- POSSIBLE BEST PRACTICE NUMBER OF PERCENTAGE tion for each scenario. The narrative was IMPACT PRINCIPLE* REPORTS (N = 431) too sparse to give any clues about specific 1 6. Provider verifies 312 72% best preventive practices for 13 of the 444 reports, leaving 431 reports that were ana- 2 17. All engaged 310 72 lyzed further. The results of a subjective 3 15. Reference mark 300 70 analysis of the possibility for each principle 4 19. Voice concerns 292 68 to help prevent the wrong-site surgery are 5 12. Circulator verifies 286 66 presented in the Table. The possibility of multiple principles helping individually or 6 14. Stop activities 280 65 collectively was present for most of the nar- 7 10. Confirm mark 248 58 ratives assessed. (A flowchart detailing this 8 11. Mark with provider’s 237 55 subjective analysis is available exclusively initials on the Authority’s website.) 9 2. Site on history and 192 45 The most common best practice prin- physical ciple considered was the provider (the 10 13. Time out for each 173 40 surgeon doing the procedure or the procedure anesthesiologist doing the block) verify- 11 1. Site on schedule 158 37 ing the information in the documents and the mark with the patient. This was 12 3. Site on consent 151 35 considered a preventive measure when the 13 16. Active responses 110 26 narrative suggested that the provider had 14 21. Verify with images 61 14 not taken active responsibility before the 15 18. Provider empowers 59 14 time-out to ensure that the information that was the basis of the procedure was 16 5. Access office records 44 10 correct. This scenario was considered pos- 17 9. Provider resolves 26 6 sible in 312 of the 431 reports (72%). discrepancies The information about the correct site 18 20. Address concerns 11 3 that might have prevented the provider 19 4. Reconcile discrepancies 9 2 from making a wrong-site error was likely 20 7. Ask active questions 8 2 present on the schedule, the history and 21 8. Two identifiers 6 1 physical examination, the consent, the office records (on occasion), and/or the Other 8 preoperative imaging studies (on occa- Unknown 13 sion). Confirming the correct site marking * See “Identified Best Practices Principles for Preventing Wrong-Site Surgery” in this article. with the patient and initializing the mark is proof of that verification. ureter, and 1 resection of the wrong rib. Best practice includes a radiograph after Of the remaining 119 narratives, the use The distribution in the subset of 53 was surgical exposure of the operative site, using of intraoperative imaging verification for similar. In the subset, no other best practice markers that do not move, with a radiolo- location of the target anatomic structure principles for preventing wrong-site surgery gist’s reading, in addition to the surgeon’s. was the next most common best practice were identified in 49 of the 53 reports. Two of the narratives indicated a correct principle, considered a possible preventive reading from a radiologist after the fact. measure in 53 of the remaining reports. Consideration of intraoperative imaging There were very few connections between verification for location of the correct Use of the same principles to prevent level for spinal surgery is part of the North wrong-side ureteral stenting was supported this best practice principle and the other American Spine Society Clinical Care with evidence in the March 2010 Pennsyl- 20. Overall, 61 of the 431 reports (14%) Checklist for Safety to Prevent Wrong-Site vania Patient Safety Advisory.4 were considered to possibly benefit from this best practice: 46 wrong-level spinal Surgery (see “Identified Best Practices Prin- For the remaining 66 narratives, the next surgeries, 14 stents placed in the wrong ciples for Preventing Wrong-Site Surgery”).3 most common best practice principles Page 110 Pennsylvania Patient Safety Advisory Vol. 8, No. 3—September 2011 ©2011 Pennsylvania Patient Safety Authority that were considered as possible preven- in the prepped and draped surgical field — Regrasping an adjacent left-side tive measures involved doing a proper during the time-out, considered in 43 of anatomic structure after localizing time-out (Principles 12 through 20). these remaining 66 narratives. the intended right-side anatomic The best practice principles for a proper The addition of considering proper verifi- structure time-out were considered for 48 of these cation of the patient’s information by the Three other unusual situations were remaining narratives. The best practice circulating nurse, in an additional 4 nar- considered additional factors among the principles, chronologically, are as follows: ratives, and empowering team members 426 patients with one or more identified — The circulating nurse verifies the to speak up identified these 48 remaining best practice principles: failure to correctly patient’s information when bring- narratives for which best practice prin- map a sentinel node, loss of right-left ing the patient into the OR. This ciples for time-outs might be maximally orientation intraoperatively, and incorrect verification makes the nurse inde- effective for preventing wrong-site surgery. stereotactic settings. pendently informed about what the Of the remaining 18 narratives, the The original analysis by the Authority in physician should be doing during the remaining best practice principles that 2007 showed that the two basic reasons procedure. Ideally, the other team were considered were the expectation that wrong-site surgery occurs are misin- members are informed by the physi- the appropriately specific information formation in the patient’s records and cian during a preoperative briefing about the operation and the site of the misperception in the operating room.5 before the final time-out. operation would be available for verifica- This subjective analysis of 444 narratives — Formal time-outs should be done for tion on all critical documents, including of wrong-site surgery to consider the pos- each invasive procedure, including the operative schedule, the history and sible impact of 21 best practice principles preoperative radiological proce- physical examination, and the informed to prevent the specific events revealed dures for breast and other cancer consent. If the information is not available four areas of focus for preventing these procedures, anesthetic blocks, and from the history and physical examination errors and preventing wrong-site surgery. second procedures under the same in the facility’s medical record, it should Chronologically, they are as follows: anesthetic. The report narratives be available from the surgeon’s office frequently stated that a time-out records. Critical radiology and pathology 1. Use best practice principles to ensure had not been done. The need for a reports should be available, as should specific patient information is avail- formal time-out was considered for images, where appropriate, for proper veri- able for team members so they can 109 wrong-site anesthetic blocks and fication of all the patient’s information by verify all the information necessary to 3 wrong-site radiological procedures multiple team members before the patient prevent wrong-site surgery before the before definitive surgery. enters the operating room. patient enters the operating room. — The members of the team involved Ensuring patient information adequate 2. The provider performing any proce- in the procedure should bring inde- to inform team members for a proper dure should engage in the verification pendent knowledge to the time-out, verification was considered the best prac- of the patient’s information with the should be engaged in the time-out, tice principle for 13 of the remaining 18 patient before the patient enters the and should speak for the benefit narratives. The need for information from operating room to ensure an accurate of the patient and provider if their the history and physical examination was understanding while preparing the knowledge differs from that of any considered a common possible source of pre- patient for the procedure, during the other member of the team. Engage- venting wrong-site surgery for 12 of the 13 time-out, and during the procedure. ment means more than witnessing a narratives, with information from the office 3. Use best practice principles to ritual. Engagement means stopping records or consent the possible source for 1. inform and engage all team members other activities to focus on the verifi- Only five wrong-site narratives involved in the time-out process. cation of information. It means each unusual situations not covered by the best 4. Use imaging confirmation intra- team member communicating his or practice principles that have been identified: operatively where recommended, her understanding of the information specifically for spinal surgery. — Two vascular access devices placed being verified, not passively support- in less preferred arteries instead of Providers interested in preventing wrong- ing another person’s understanding. more preferred veins site surgery may wish to consider the Joint It means addressing concerns. Commission Center for Transforming — An operation based on an incor- The most common single practice prin- Healthcare Wrong Site Surgery Proj- rectly dictated pathology report ciple considered for a proper time-out ect: Reducing the Risk of Wrong Site — A selective abortion with multiple Surgery.6 was explicitly referencing the site marking fetuses Vol. 8, No. 3—September 2011 Pennsylvania Patient Safety Advisory Page 111 ©2011 Pennsylvania Patient Safety Authority U P DAT E IDENTIFIED BEST PRACTICES PRINCIPLES FOR PREVENTING WRONG-SITE SURGERY Except as noted, the evidence base for the following abridged Principle 11. Mark with provider’s initials. The site should be best practices principles was described in the December 2010 marked by the provider’s initials. Pennsylvania Patient Safety Advisory.1 Principle 12. Circulator verifies. All information that should be Principle 1. Site on schedule. The correct site of the operation used to support the correct patient, operation, and site, including should be specified when the procedure is scheduled. the patient’s or family’s verbal understanding, should be veri- fied by the circulating nurse upon taking the patient to the OR. Principle 2. Site on history and physical. The correct opera- tion and site should be noted on the record of the history and Principle 13. Time-out for each procedure. Separate formal physical examination. time-outs should be done for separate procedures, including anesthetic blocks, with the person performing that procedure. Principle 3. Site on consent. The correct operation and site should be specified on the informed consent. Principle 14. Stop activities. All noncritical activities should stop during the time-out. Principle 4. Reconcile discrepancies. Anyone reviewing the schedule, consent, history and physical examination, or reports Principle 15. Reference mark. The site mark should be vis- documenting the diagnosis, should check for discrepancies ible and referenced in the prepped and draped field during the among all those parts of the patient’s record and reconcile any time-out. discrepancies with the surgeon when noted. Principle 16. Active responses. Verification of information Principle 5. Access office records. The surgeon should bring during the time-out should require an active communication of copies of supporting information uniquely found in the office specific information, rather than a passive agreement, and be records to the surgical facility the day of surgery. verified against the relevant documents. Principle 6. Provider verifies. All information that should be Principle 17. All engaged. All members of the operating team used to support the correct patient, operation, and site, includ- should verbally verify that their understanding matches the infor- ing the patient’s or family’s verbal understanding, should be mation in the relevant documents. verified by the nurse and surgeon before the patient enters the Principle 18. Provider empowers. The surgeon should spe- operating room (OR). cifically encourage operating team members to speak up if Principle 7. Ask active questions. All verbal verification should concerned during the time-out. be done using questions that require an active response of spe- Principle 19. Voice concerns. Operating team members who cific information, rather than a passive agreement. have concerns should not agree to the information given in the Principle 8. Two identifiers. Patient identification should always time-out if their concerns have not been addressed. require two unique patient identifiers. Principle 20. Address concerns. Any concerns should be Principle 9. Provider resolves discrepancies. Any discrepan- resolved by the surgeon, based on primary sources of informa- cies in the information should be resolved by the surgeon, tion, to the satisfaction of all members of the operating team based on primary sources of information, before the patient before proceeding. enters the OR. Principle 21. Verify with images. Verification of spinal level, Principle 10. Confirm mark. The site should be marked by rib resection level, or ureter to be stented should require radio- a healthcare professional familiar with the facility’s marking logical confirmation, using a stable marker and readings, by policy, with the accuracy confirmed both by all the relevant both a radiologist and the surgeon. information and by an alert patient, or patient surrogate if the patient is a minor or mentally incapacitated. (continued on page 113) Page 112 Pennsylvania Patient Safety Advisory Vol. 8, No. 3—September 2011 ©2011 Pennsylvania Patient Safety Authority (continued from page 112) radiographs on two occasions and, most certainly, by a post- operative computed tomography scan on a third occasion. An Evidence for “Best Practice” 21 error identified by fluoroscopy was corrected midprocedure. The remaining error was detected by the radiography technician. The North American Spine Society Clinical Care Checklist for The analysis suggested that urologists should follow the same Safety to Prevent Wrong-Site Surgery includes consideration principles as vertebral surgeons by obtaining an intraoperative of an intraoperative radiograph during surgery, after surgical imaging study to confirm proper stent placement, with the inter- exposure of the operative site, using markers that do not move, pretation documented at the time. Pregnant patients could have to confirm the vertebral level to be operated on. It also includes ultrasound imaging.3 consideration of radiologist’s reading, in addition to the sur- geon’s reading.2 Notes 1. Quarterly update: the evidence base for best practices for An analysis of wrong-side ureteral stents revealed 20 reports, preventing wrong-site surgery [online]. Pa Patient Saf Advis accounting for 6% of all 357 wrong-site surgery reports sub- 2010 Dec [cited 2011 Jul 17]. Available from Internet: mitted to the Pennsylvania Patient Safety Authority as of the end http://patientsafetyauthority.org/ADVISORIES/ of 2009.3 Six stents were placed on the wrong side despite spe- AdvisoryLibrary/2010/dec7(4)/Pages/151.aspx. cific reference to doing a time-out. The reports suggested that wrong-side ureteral stenting might have occurred because the 2. North American Spine Society. Sign, mark & x-ray (SMaX): prevent wrong-site surgery [online]. [cited 2011 Jul 17]. intervention on the wrong side occurred after the operation had Available from Internet: http://www.spine.org/Pages/ begun, rather than initially, and that the side of the instrumented PracticePolicy/ClinicalCare/SMAX/Default.aspx. ureter may have been known only to the surgeon visualizing the landmarks, not to the other members of the OR team, who had 3. Quarterly update on the Preventing Wrong-Site Surgery limited views of the procedure, if any. A review of the reports Project: digging deeper [online]. Pa Patient Saf Advis showed that the failure to do intraoperative imaging was cited 2010 Mar [cited 2011 Jul 17]. Available from Internet: as a contributing factor in one report. Patients were returned http://patientsafetyauthority.org/ADVISORIES/ to the OR to correct errors documented by intraoperative AdvisoryLibrary/2010/Mar7(1)/Pages/26.aspx. NOTES 1. Pennsylvania Patient Safety Authority. AdvisoryLibrary/2010/dec7(4)/ patientsafetyauthority.org/ADVISORIES/ Principles for reliable performance of Pages/151.aspx. AdvisoryLibrary/2010/Mar7(1)/Pages/ correct-site surgery [online]. [cited 2011 3. North American Spine Society. Sign, 26.aspx. Jul 17]. Available from Internet: mark & x-ray (SMaX): prevent wrong-site 5. Clarke JR, Johnston J, Finley ED. http://patientsafetyauthority.org/ surgery [online]. [cited 2011 Jul 17]. Avail- Getting surgery right. Ann Surg 2007 EducationalTools/PatientSafetyTools/ able from Internet: http://www.spine. Sep;246(3):395-405. PWSS/Pages/principles.aspx. org/Pages/PracticePolicy/ClinicalCare/ 6. Joint Commission Center for Transform- 2. Quarterly update: the evidence base for SMAX/Default.aspx. ing Healthcare. Reducing the risk of best practices for preventing wrong-site 4. Quarterly update on the preventing wrong site surgery [online]. [cited 2011 surgery [online]. Pa Patient Saf Advis wrong-site surgery project: digging Jul 15]. Available from Internet: http:// 2010 Dec [cited 2011 Jul 17]. deeper [online]. Pa Patient Saf Advis www.centerfortransforminghealthcare. Available from Internet: http:// 2010 Mar [cited 2011 Jul 17]. Available org/UserFiles/file/CTH_WSS_Story patientsafetyauthority.org/ADVISORIES/ from Internet: http:// board_final_2011.pdf. Vol. 8, No. 3—September 2011 Pennsylvania Patient Safety Advisory Page 113 ©2011 Pennsylvania Patient Safety Authority