U P DAT E Quarterly Update on Wrong-Site Surgery: Facilities with Barriers to Best Practices May Experience More Wrong- Site Surgeries John R. Clarke, MD There were 11 reports of wrong-site surgery submitted to the Pennsylvania Patient Editor, Pennsylvania Patient Safety Advisory Safety Authority for the third quarter of 2012, plus one late report of wrong-site surgery Clinical Director, Pennsylvania Patient Safety Authority Professor of Surgery, Drexel University for the first quarter of 2012, resulting in an unenviable total of 503 since reporting began June 28, 2004. Anesthesia blocks represented 4 of the 11 wrong-site procedures in the operating room (OR) this quarter. However, the reports this quarter matched the fourth-lowest number of reports in a quarter since statewide reporting began (see Figure). During this quarter, Pennsylvania ORs went—for the fourth time—for more than a month without any reports of wrong- site surgery; the 39-day hiatus was the second-longest period since statewide reporting began. The period was bracketed by two wrong-site anesthesia blocks. Pennsylvania surgeons went 76 days without a wrong-site procedure. The rolling two-year average (49 per year) of wrong-site surgeries set a new low (see Figure). The Authority knows the best practices to prevent wrong-site surgery.1 When provid- ers follow these best practices, they can eliminate wrong-site surgery.2 And, as will be discussed below, providers who resist following best practices may experience more wrong-site surgeries than those who implement them. The results of following—or not following—best practices are illustrated by reports from this quarter. Two events involving anesthesia were reported during the quarter. One was a near miss that was caught during a time-out for the block. The other was an adverse event with no preoperative verification of the documents, no reference to the surgeon’s mark, and no time-out. A patient [was scheduled] for right ACL [anterior cruciate ligament] surgery. The anesthesiologist was preparing to perform nerve block on left leg. . . . The time-out was initiated and the block was performed on the correct side. The anesthesia provider identified the patient, introduced herself, did the H&P [history and physical], then went over the anesthetic plan with the patient: a block with IV [intravenous] sedation. The provider obtained the patient’s consent and asked what side was to have surgery. The patient said—and pointed to—his right shoulder. The provider then prepared to place the IV. . . . The provider asked again what side was having surgery. The patient said right. The provider then [went somewhere] to gather the ultra- sound and the items needed to place the block. When she returned, the patient’s left shoulder was out of the gown and his right shoulder was in the gown. The provider pro- ceeded to prep the left shoulder while discussing how the block worked with the patient’s companion. At that point, the provider’s supervisor arrived. The provider put her gloves on and proceeded to block the wrong shoulder. The following is another example of wrong-site surgeries this quarter that were associ- ated with providers not following known best practices,1 in this case, not referencing a visible site marking during the time-out. Patient consented for repair of right inguinal hernia. The Universal Protocol was com- Scan this code pleted for the right side. The time-out was completed for the right. . . . The patient was with your mobile marked preoperatively by the surgeon, but the marking was not visible after draping was device’s QR reader to access completed. The surgery proceeded as usual until the surgeon asked for a left-side mesh. the Authority's At that time, it was noted they were doing a left inguinal hernia. wrong-site surgery However, several near-miss reports this quarter illustrate that other providers are paying prevention toolkit. attention to best practices and catching potential problems. Vol. 9, No. 4—December 2012 Pennsylvania Patient Safety Advisory Page 145 ©2012 Pennsylvania Patient Safety Authority U P DAT E Figure. Pennsylvania Patient Safety Authority Wrong-Site Surgery Reports by Academic Year NUMBER OF REPORTS 80 70 Apr to Jun 21 19 60 Jan to Mar 8 16 11 50 14 9 Oct to Dec 17 21 16 10 11 Jul to Sep 40 16 14 19 11 30 13 15 17 17 16 13 11 20 15 23 23 10 19 16 17 16 16 12 11 MS12713 0 2004-05 2005-06 2006-07 2007-08 2008-09 2009-10 2010-11 2011-12 2012-13 ACADEMIC YEAR The value of preoperative verification: for posterior cervical reduction and A recent article surveyed all payments The preoperative screening depart- stabilization perched facet left C5/6. for surgical malpractice reported to the ment caught that the patient’s Surgeon agreed with level of fusion National Practitioners Data Bank from surgical reservation, OR schedule, but stated, after reviewing the MRI its inception in 1990 to 2006.3 Operating and consent stated “RIGHT” foot [magnetic resonance image], the lat- on the wrong body part was the source surgery. [But] when the patient was erality would be the right side. Initial of 3.21% of surgically related malpractice called for preoperative information, consent was established based on . . . payments in the United States during that he stated “LEFT” and the H&P dis- reading of radiological studies, which time. Eliminating this preventable occur- cussed “LEFT.” The surgeon’s office read left-sided fracture. The surgeon rence would, in theory, single-handedly was called and verified the correct reviewed the MRI . . . prior to proce- reduce surgically related malpractice pay- side was LEFT. A new reservation dure and determined the right facet ments by 3%. Evidence accumulates that was obtained; the OR schedule was was fractured, not the left. . . . The implementing best practices to prevent corrected according to the reservation, procedure was carried out according wrong-site surgery would achieve that and a new consent was sent by the to MRI review, and right side con- objective.2,4-7 Yet, implementation has office. firmed the fracture intraoperatively. not occurred in all Pennsylvania surgical After procedure, the surgeon spoke facilities. The value of verification during the with a radiologist, who also reviewed time-out: films and confirmed a fracture to the When consent was read out loud right facet. for OR time-out, the consent read Page 146 Pennsylvania Patient Safety Advisory Vol. 9, No. 4—December 2012 ©2012 Pennsylvania Patient Safety Authority PROVIDERS WHO RESIST and respondents from facilities that only READINESS FOR CHANGE FOLLOWING BEST-PRACTICE did endoscopies or infertility treatments. From prior analysis of facilities that STANDARDS MAY EXPERIENCE The 24 facilities describing successful self-corrected, experience with the MORE WRONG-SITE SURGERY implementation reported 1 wrong-site collaborations to prevent wrong-site sur- THAN THOSE WHO IMPLEMENT surgery among the 14 hospitals (7%) and gery,2,5 and review of the descriptions of THEM none in the 10 ASFs in the previous aca- the barriers and successful strategies for demic year (July 2011 to June 2012). The implementation of best practices,8 the The Authority has previously published 8 facilities describing barriers to imple- Authority has identified four essential the results of a survey of facilities to mentation reported 1 wrong-site surgery elements for successful implementation of identify the barriers to implementation among the 4 hospitals (25%), and none in standards to prevent wrong-site surgery: and the strategies for successful imple- mentation of the Authority’s 21 potential the 4 ASFs. The difference was not statisti- 1. Leadership. The chief executive recommendations to prevent wrong-site cally significant, given the small numbers. officers are willing to empower surgery.8 The sample size was expanded to the last the nurses to enforce the facility’s two years, consistent with the Authority’s best-practice policies and provide The survey divided the 21 potential two-year empirical cycle and rolling aver- resources to improve systems and recommendations into six major goals age. The 24 facilities describing successful educate providers, including (1, 2, 3A, 3B, 4, and 5), with a total of implementation reported 1 wrong-site physicians. eight proposed measurement standards (1, 2A, 2B, 3A, 3B, 4A, 4B, and 5). For surgery among the 14 hospitals (7%) and 2. Manpower. Identified champions, each of the eight measurement standards, 1 in the 10 ASFs (10%) over the prior ideally a leading surgeon, anesthe- respondents for the facilities were asked two-year cycle (July 2010 to June 2012). siologist, and OR nurse, have the to describe barriers to implementation of Of the 8 facilities describing barriers to authority, time, and resources to the recommendations that would prevent implementation, 1 of the 4 hospitals work with providers to change sys- the facilities from meeting the standard(s) (25%) reported 2 wrong-site surgeries (1 tems so that they meet best-practice for the goal. They were asked to describe each year), and 2 wrong-site surgeries were goals in a way that acknowledges any strategies they had used for success- reported among the 4 ASFs (50%). The realistic concerns of providers. ful implementation. Seventy facilities difference was statistically significant by 3. Information. Near-miss events are responded. Physician behavior was cited the chi-square test (p < 0.05) for the group captured and analyzed for quality most commonly as a barrier to implemen- as a whole, but not for either type of facil- improvement, policy and system tation, followed by difficulty accessing ity individually, perhaps again given the changes, and education. accurate information prior to the patient’s small numbers. 4. Time. Improving systems to meet the arrival in the preoperative holding area. The Authority was reluctant to take the goals of evidence-based best practice Elements of successful strategies for analysis back beyond the two-year cycle. It without significant compromise to implementation included leadership, was confident that the barriers were still workflow and educating providers empowerment, improved access to infor- existent but suspicious that the successful about making the improvements mation, education, and monitoring of strategies had not yet been implemented. takes time, typically about six compliance.8 The Authority suspects that the high months. Since the survey, the Authority has iden- probability of wrong-site surgery among The Authority can help facilities by tified 24 facilities (14 hospitals and 10 the facilities describing barriers (3 of 8) providing information about reported ambulatory surgical facilities [ASFs]) that was likely due to reporting bias. Two of events, providing checklists and other described only processes for successful the facilities describing barriers and expe- tools for improvement, and providing implementation of the standards and 8 riencing wrong-site surgery, including one educational resources. (See http://patient- facilities (4 hospitals and 4 ASFs) that with 2 events in 2 years, described barriers safetyauthority.org/EducationalTools/ described only barriers that prevented preventing them from meeting 5 of the 8 PatientSafetyTools/PWSS/Pages/home. the facilities from meeting the standards. standards each, suggesting a high level of aspx for a complete listing.) Excluded from the analysis were respon- frustration. Facility leaders can make a commit- dents from facilities that listed both, The results suggest that persistent barriers ment to implement evidence-based best single respondents responsible for mul- to the implementation of evidence-based practices and policies and procedures to tiple facilities, anonymous respondents, best-practice standards may be associated prevent wrong-site surgery, use appropri- with more wrong-site surgeries. ate checklists to aid compliance, achieve Vol. 9, No. 4—December 2012 Pennsylvania Patient Safety Advisory Page 147 ©2012 Pennsylvania Patient Safety Authority U P DAT E consistent compliance with those policies The surgeon should mark the site, do it in The Authority concurs that an alert and procedures, and monitor for and the pre-op/holding area, and do it in an patient or caregiver participating in the review all wrong-site events, including, at approved manner:10 time-out is a logical substitute for a site least, critical near misses.2,9 — “Mark in the pre-op/holding area mark—since the site mark is, itself, a sur- performed by the surgeon using a rogate for the verbal participation of an COMPARISON OF THE single-use surgical skin marker with a alert patient in the time-out—but that the AUTHORITY’S 21 EVIDENCE- consistent mark type (e.g., surgeon’s patient’s response should be confirmed by BASED BEST PRACTICES TO initials) placed as close as anatomi- all the relevant information, as it would PREVENT WRONG-SITE SURGERY cally possible to the incision site.” be if the site were being marked. AND THE JOINT COMMISSION’S — “Mark the site for every procedure; Another Joint Commission solution was 29 MAIN CAUSES AND if not possible, document why a site- to “perform a pre-operative briefing in SOLUTIONS FOR WRONG-SITE mark was not performed.” the operating room with patient involve- SURGERY — “Do not move patient to the operat- ment, if possible, to verify patient identity, ing room before surgeon has marked procedure site, and side, along with other The Joint Commission Center for Trans- critical elements that need to be verified forming Healthcare Wrong-Site Surgery the site.” and addressed but are not part of the Project identified 29 main causes of — Document why site was marked in Time Out process.” wrong-site surgeries and their targeted a nonapproved manner “even if a solutions.10 The Authority compared the wrong site surgery event has not The Authority supports the use of a solutions with its 21 evidence-based best occurred.” preoperative briefing, such as that in the practices to prevent wrong-site surgery.1 The Authority has no specific evidence WHO Surgical Safety Checklist,11 when There was overlap between the 29 main supporting the surgeon marking the site the patient enters the OR, prior to the solutions identified by the Joint Commis- but agrees that the surgeon is the optimal final time-out. The elements in that brief- sion and the 21 best practices identified provider for confirming that the site is ing should be those that need time to by the Authority for most of the causes marked accurately in a place that will be address before the incision is made, such and best practices for prevention. visible in the prepped and draped field. as the availability of blood. The elements The Authority will further explore the sites in the time-out should be those that need The Authority’s 21 evidence-based best confirmation just as the incision is being practices for the prevention of wrong-site at particular risk for wrong-site surgery. made, such as the location of the site surgery do not include the following spe- The Authority realizes that its evidence- mark in the prepped and draped field cific points that were identified and tested based best-practice principle #10 had an and the administration of prophylactic by the Joint Commission’s Robust Process implicit assumption that the site would antibiotics. The Authority has a suggested Improvement methods:10 be marked before the patient enters the merger of the Joint Commission’s Univer- — Limit schedulers accepting verbal OR or procedure room. It has modified sal Protocol and the WHO Surgical Safety requests for surgical bookings instead its principle to make that assumption Checklist.12 The Association of periOpera- of written documents by limiting explicit, as follows: tive Nurses has also merged the two into a “entry points for primary documen- — 10. The site should be marked by a Comprehensive Surgical Checklist.13 tation . . . to a single fax number.” healthcare professional familiar with The Joint Commission’s targeted solu- — “Confirm the presence and accuracy the facility’s marking policy, with the tions did not address the evidence-based of primary documents critical to the accuracy confirmed both by all the value of four of the Authority’s evidence- verification process prior to the day of relevant information and by an alert based best-practice principles: supporting surgery.” [italics added] patient, or patient surrogate if the information from the surgeon’s office The Authority concurs with the general patient is a minor or mentally inca- (#5), doing the preoperative verification principle of written documentation col- pacitated; the site should be marked before the patient enters the OR (#6), lected and reconciled prior to the day of before the patient enters the OR. verification by the circulating nurse upon surgery and emphasizes that the site of the As an alternate to the site mark, when taking the patient to the OR (#12), and procedure is a critical piece of informa- needed, the Joint Commission says that the need for intraoperative verification of tion that needs documentation. facilities should “confirm identification of spinal level, rib resection level, or ureter patient by all team members using patient to be stented (#21). armband, patient speak back, or patient caregiver if patient has been sedated.” Page 148 Pennsylvania Patient Safety Advisory Vol. 9, No. 4—December 2012 ©2012 Pennsylvania Patient Safety Authority NOTES 1. Pennsylvania Patient Safety Authority. 6. Quarterly update: the evidence base for 10. Joint Commission Center for Trans- Principles for reliable performance of best practices for preventing wrong-site forming Healthcare. Reducing the risk correct-site surgery [online]. 2011 Dec surgery. Pa Patient Saf Advis [online] of wrong site surgery [online]. 2012 [cited 2012 Oct 15]. http:// 2010 Dec [cited 2012 Oct 15]. http:// Feb [cited 2012 Oct 15]. http://www. patientsafetyauthority.org/ patientsafetyauthority.org/ centerfortransforminghealthcare.org/ EducationalTools/PatientSafetyTools/ ADVISORIES/AdvisoryLibrary/2010/ assets/4/6/CTH_WSS_Storyboard_ PWSS/Documents/principles.pdf. dec7(4)/Pages/151.aspx. final_2011.pdf. 2. Clarke JR. Quarterly update: what might 7. Clarke JR. Quarterly update: what might 11. Clarke JR. Editorial: WHO Surgical be the impact of using evidence-based be the impact of using evidence-based Safety Checklist. Pa Patient Saf Advis best practices for preventing wrong-site best practices for preventing wrong-site [online] 2008 Sep [cited 2012 Oct 15]. surgery? Results of objective assessments surgery? Pa Patient Saf Advis [online] http://patientsafetyauthority.org/ of facilities’ error analyses. Pa Patient Saf 2011 Sep [cited 2012 Jun 25]. http:// ADVISORIES/AdvisoryLibrary/2008/ Advis [online] 2011 Dec [cited 2012 Oct patientsafetyauthority.org/ Sep5(3)/Pages/74.aspx. 15]. http://patientsafetyauthority.org/ ADVISORIES/AdvisoryLibrary/2011/ 12. Pennsylvania Patient Safety Authority. ADVISORIES/AdvisoryLibrary/2011/ sep8(3)/Pages/109.aspx. Possible integration of actions to satisfy dec8(4)/Pages/144.aspx. 8. Clarke JR. What keeps facilities from Joint Commission Universal Protocol and 3. Orosco RK, Talamini J, Chang DC, et implementing best practices to prevent WHO Surgical Safety Checklist [online]. al. Surgical malpractice in the United wrong-site surgery? Barriers and strategies 2011 [cited 2012 Oct 15]. http:// States, 1990-2006. J Am Coll Surg 2012 for overcoming them. Pa Patient Saf Advis patientsafetyauthority.org/ Oct;215(4):480-8. [online] 2012 Nov 20 [cited 2012 Nov 20]. EducationalTools/PatientSafetyTools/ 4. Quarterly update on the Preventing http://patientsafetyauthority.org/ PWSS/Documents/crosswalk.pdf. Wrong-Site Surgery Project. Pa Patient Saf ADVISORIES/AdvisoryLibrary/Pages/ 13. Association of periOperative Registered Advis [online] 2010 Jun [cited 2012 Oct Home.aspx. Nurses. Comprehensive surgical checklist 15]. http://patientsafetyauthority.org/ 9. Clarke JR. Quarterly update on prevent- [online]. 2010 Apr [cited 2012 Oct 15]. ADVISORIES/AdvisoryLibrary/2010/ ing wrong-site surgery. Pa Patient Saf http://www.aorn.org/Clinical_Practice/ Jun7(2)/Pages/65.aspx. Advis [online] 2012 Mar [cited 2012 Oct ToolKits/Correct_Site_Surgery_Tool_ 5. Pelczarski KM, Braun PA, Young E. Hos- 15]. http://patientsafetyauthority.org/ Kit/Comprehensive_checklist.aspx. pitals collaborate to prevent wrong-site ADVISORIES/AdvisoryLibrary/2012/ surgery. Patient Saf Qual Healthc 2010 mar;9(1)/Pages/28.aspx. Sep-Oct;7:20-6. Vol. 9, No. 4—December 2012 Pennsylvania Patient Safety Advisory Page 149 ©2012 Pennsylvania Patient Safety Authority PENNSYLVANIA PATIENT SAFETY ADVISORY This article is reprinted from the Pennsylvania Patient Safety Advisory, Vol. 9, No. 4—December 2012. The Advisory is a publication of the Pennsylvania Patient Safety Authority, produced by ECRI Institute and ISMP under contract to the Authority. Copyright 2012 by the Pennsylvania Patient Safety Authority. This publication may be reprinted and distributed without restriction, provided it is printed or distributed in its entirety and without alteration. Individual articles may be reprinted in their entirety and without alteration provided the source is clearly attributed. This publication is disseminated via e-mail. To subscribe, go to http://visitor.constantcontact.com/ d.jsp?m=1103390819542&p=oi. To see other articles or issues of the Advisory, visit our website at http://www.patientsafetyauthority.org. Click on “Patient Safety Advisories” in the left-hand menu bar. THE PENNSYLVANIA PATIENT SAFETY AUTHORITY AND ITS CONTRACTORS The Pennsylvania Patient Safety Authority is an independent state agency created by Act 13 of 2002, the Medical Care Availability and Reduction of Error (“Mcare”) Act. Consistent with Act 13, ECRI Institute, as contractor for the Authority, is issuing this publication to advise medical facilities of immediate changes that can be instituted to reduce Serious Events and Incidents. For more information about the Pennsylvania Patient Safety Authority, see the Authority’s An Independent Agency of the Commonwealth of Pennsylvania website at http://www.patientsafetyauthority.org. ECRI Institute, a nonprofit organization, dedicates itself to bringing the discipline of applied scientific research in healthcare to uncover the best approaches to improving patient care. As pioneers in this science for more than 40 years, ECRI Institute marries experience and indepen- dence with the objectivity of evidence-based research. More than 5,000 healthcare organizations worldwide rely on ECRI Institute’s expertise in patient safety improvement, risk and quality management, and healthcare processes, devices, procedures and drug technology. The Institute for Safe Medication Practices (ISMP) is an independent, nonprofit organization dedicated solely to medication error prevention and safe medication use. ISMP provides recommendations for the safe use of medications to the healthcare community including healthcare professionals, government agencies, accrediting organizations, and consumers. ISMP’s efforts are built on a nonpunitive approach and systems-based solutions. Scan this code with your mobile device’s QR reader to subscribe to receive the Advisory for free.