U P DAT E Time-Out! Wrong-Site Surgery Update Wrong-site surgery continues to occur in Pennsylvania (see “Event Examples”). This EVENT EXAMPLES update focuses on knowledge about doing a time-out effectively. It also addresses a query about the value of reviewing imaging studies in the operating room (OR). Edited versions of two recent reports show the importance of a properly Updated wrong-site surgery reports are shown in the Figure. In the most recent quarter, conducted time-out: six (32%) were wrong-site anesthetic blocks. Wrong-site surgery events seem to follow a A patient was an add-on to the OR puzzling multiyear cycle. A yearly cycle could be explained by the seasonal variation in schedule for a RIGHT side procedure. operating volumes or by the learning curve in academic medical centers. For a multi- The patient was brought to the OR; year cycle, one can only speculate that events increase attention and lack of events sign-in procedure was followed; time- diminishes attention—and that the memory of events and the attention to prevent- out was started and the surgeon left ing another event lasts at least a year. If a multiyear cycle is real and the speculation the room. Staff completed the time-out without him, but when he returned to proves valid, the implication is that prevention of wrong-site surgery requires continued the room, they did a complete time-out attention to detail, not just system improvements, and that one must see continuous all over again. Everyone agreed on improvement for a minimum of two years to be sure the improvement is real. the RIGHT side. The patient was not positioned in any manner that empha- sized the laterality. The tech and the TIME-OUT surgeon were talking but the circulator did not hear the conversation. The Evidence-Based Best Practices surgeon was viewing real-time images The Pennsylvania Patient Safety Authority has established, from prior studies, prin- with the tech. The procedure was com- ciples that should be followed during a time-out:1 pleted without event. The circulating nurse and CRNA [certified registered All noncritical activities should stop during the time-out. In 31 observations of the time- nurse anesthetist] took the patient to out processes in 10 facilities that had wrong-site surgery and 4 facilities that had none, the recovery room. The surgeon was noncritical activities stopped in 9% of the cases in facilities that had wrong-site surgery and in the recovery room talking to the recovery room nurse about the case. 75% of the cases in facilities that had none, a statistically significant difference (p < 0.001). The circulator overheard him say we The site mark should be visible and referenced in the prepped and draped field dur- did the LEFT side. She said you mean ing the time-out. In a year-long, prospective comparison of 97 near-miss reports, in RIGHT side and he said no, LEFT. The nurse reminded him that he had which the potential error was caught before the skin was punctured, and 44 wrong-site signed off on RIGHT. The patient was surgeries, using a common event analysis form,2 the time-out was done after the patient rolled, confirming LEFT side was done. was prepped and draped in 88% of the near-miss events and in 64% of the wrong-site The nurse said she could not hear the surgery events, a statistically significant difference (p < 0.01); the mark was visible in discussion between the surgeon and tech. The tech did admit he knew that 87% of the near-miss events and in 69% of the wrong-site surgery events, a statistically RIGHT was agreed upon but he did significant difference (p < 0.05). In recent, unpublished comparisons—in a second not alert anyone. … It appears initially region of Pennsylvania—of 169 observations of compliance with the Universal Protocol that only the tech knew that the doctor in 12 facilities that had wrong-site surgery and 6 facilities that had none, the time-out was doing the LEFT side instead of the was done after the patient was prepped and draped in 85% of the cases in facilities that RIGHT. The tech did not make anyone else on the OR team aware of this but had wrong-site surgery and in 100% of the cases in facilities that had none, a statisti- clearly documented LEFT side on the cally significant difference (p < 0.01). documentation form postprocedure. Verification of information during the time-out should require an active communication The patient’s incorrect leg was of specific information, rather than a passive agreement, and be verified against the prepped and draped for surgery. The relevant documents. In 169 observations of compliance with the Universal Protocol in error was noticed during time-out, and no incision was made. The patient’s 12 facilities that had wrong-site surgery and 6 facilities that had none, all documents leg was not marked in pre-op. The were verified during the time-out in 66% of the cases in facilities that had wrong-site nurse did not check to ensure the leg surgery and 86% of the cases in facilities that had none, a statistically significant differ- was marked prior to taking to OR. Dur- ence (p < 0.05); critical diagnostic test results or imaging studies were verified during ing time-out, it was noted that incorrect the time-out in 73% of the applicable cases in facilities that had wrong-site surgery and leg was prepped and draped. The drapes were taken down. The patient’s 100% of the applicable cases in facilities that had none, a statistically significant differ- correct leg was prepped and draped. ence (p < 0.01). A new time-out was completed and all All members of the operating team should verbally verify that their understanding documents were rechecked. matches the information in the relevant documents. In the year-long, prospective com- parison of 97 near-miss reports, in which the potential error was caught before the skin Page 80 Pennsylvania Patient Safety Advisory Vol. 8, No. 2—June 2011 ©2011 Pennsylvania Patient Safety Authority Figure. Pennsylvania Patient Safety Authority Wrong-Site Surgery Reports by Quarter Time-Out Survey Results Hospitals that do surgery and ambulatory NUMBER surgical facilities (ASFs) in Pennsylvania OF REPORTS recently cooperated with the Authority to 30 complete a new survey on the conduct of time-outs. Surveys were forwarded to the OR managers of the 151 acute care, com- 25 24 23 munity, and children’s hospitals and the 21 21 247 ASFs in the commonwealth. 20 19 19 19 Responses were received from 58 hospitals 18 17 17 (38%) and 94 ASFs (also 38%), for a total 16 16 16 16 16 16 16 15 15 of 152 responses. Among the hospitals 15 14 14 responding, 32 (55%) had reported a 13 13 11 11 11 wrong-site surgery event. Among the 10 ASFs, 23 (24%) had reported a wrong-site surgery event. The difference between the 7 experience with wrong-site surgery between 5 the responding hospitals and ASFs was significant by Chi-square test (p = 0.001). MS11242 The difference is consistent with the fact 0 that 110 hospitals had reported wrong-site 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 surgery events before the time of the sur- 2004 2005 2006 2007 2008 2009 2010 2011 vey (73% of all hospitals doing surgery), REPORTS BY QUARTER whereas only 63 ASFs had reported wrong- site surgery (26% of all ASFs). Responses were received from 32 hospitals that had was punctured, and 44 wrong-site surger- prospective comparison of 97 near-miss reported wrong-site surgery (29%) and ies, using a common event analysis form,2 reports, where the potential error was 23 ASFs that had reported wrong-site the nurse, the surgeon, and the anesthesia caught before the skin was punctured, surgery (37%). This difference in survey provider were all involved in 98% of the and 44 wrong-site surgeries, using a com- response rates was not statistically signifi- near-miss events and in 88% of the wrong- mon event analysis form,2 operating team cant. Nevertheless, the survey results were site surgery events, a statistically significant members raised concerns in 79% of analyzed separately for hospitals and ASFs, difference (p < 0.05). the near-miss events and in 22% of the rather than combined, because of the dif- The surgeon should specifically encour- wrong-site surgery events, a statistically ferences between the two types of facilities. age operating team members to speak significant difference (p < 0.001). Because some ASFs specialize in proce- up if concerned during the time-out. The Any concerns should be resolved by the dures that may be less likely to result in statewide comparison of policies and pro- surgeon, based on primary sources of wrong-site surgery (e.g., endoscopies), cedures in 37 facilities that had wrong-site information, to the satisfaction of all secondary analyses were done to look for surgery and 96 facilities that had none3 members of the operating team before differences between hospitals and ASFs showed that including an explicit request proceeding. In the year-long, prospec- that had reported wrong-site procedures by the surgeon for operating team mem- tive comparison of 97 near-miss reports, and, therefore, did procedures that were bers to speak up if concerned during the in which the potential error was caught at risk for wrong-site errors. time-out was cited in 40% of the facilities before the skin was punctured, and that had wrong-site surgery and 76% of 44 wrong-site surgeries, using a com- Most time-outs were led by the circulat- the facilities that had none, a statistically mon event analysis form,2 the surgeon ing nurses. The circulation nurses led significant difference (p < 0.05). addressed concerns that were raised in the time-outs in 86% of the responding 82% of the near-miss events and in 40% hospitals and 73% of the responding Operating team members who have con- of the wrong-site surgery events, a statisti- ASFs. Surgeons led the time-outs in 9% of cerns should not agree to the information cally significant difference (p < 0.001). the responding hospitals and 10% of the given in the time-out if their concerns responding ASFs; anesthesia providers, in have not been addressed. In the year-long, Vol. 8, No. 2—June 2011 Pennsylvania Patient Safety Advisory Page 81 ©2011 Pennsylvania Patient Safety Authority U P DAT E 3% and 6%, respectively; and scrub tech- facilities responding: 43% of the hospitals practices shows that improvements in nicians, in 2% and 11%, respectively. The and 35% of the ASFs. The difference was time-out protocols can be made in the differences between hospitals and ASFs not statistically significant, although it was following: were not statistically significant. These significantly lower for the subset of ASFs — Specifically referencing the site mark- findings were also valid for the subsets that had wrong-site surgery than for hos- ing during the time-out that had reported wrong-site procedures. pitals that had wrong-site surgery (53% of — Including the specific location of the The site markings were referenced during hospitals, 26% of ASFs, p = 0.05). procedure and, possibly, the position the time-out in 82% of the responding The documents used for verifying the of the patient under the drapes dur- hospitals and 73% of the responding responses during the time-outs varied (see ing the time-out ASFs; the difference was not statistically Table 2). In particular, pathology reports — Considering active responses to significant. were not likely to be checked in any facili- single elements needing verification All facilities, without exception, verified ties. Imaging and pathology reports were during the time-out the patient’s identity during the time-out. significantly less likely to be checked — Having all members of the OR team Almost all verified the procedure (100% during the time-out in ASFs than in hos- engage in responding during the of hospitals and 99% of ASFs). The side pitals, although the differences held up time-out or specific location was verified by all only for imaging reports in facilities that had reported wrong-site procedures. Diane Rydrych, of the Minnesota Depart- hospitals, but only by 84% of ASFs, a ment of Health, and Kathleen Harder, statistically significant difference (p = 0.05 There were no consistent significant dif- PhD, of the University of Minnesota, by Chi-square). However, this difference ferences in how time-outs were conducted have observed time-outs in facilities across disappeared for facilities that had reported among hospitals and among ASFs that Minnesota and made a number of rec- wrong-site procedures (100% of hospitals had and had not reported wrong-site sur- ommendations for Minnesota facilities,4 and 96% of ASFs), suggesting the differ- gery. Therefore, comparisons can be made including the following: ence may be due to the types of procedures only against the previously established done (e.g., endoscopies). Only 55% of evidence-based best practices. 1. The operating team uses a “time- hospitals and 20% of ASFs included the out towel” or other visual aid to A comparison of the results of this survey cover the Mayo stand before the patient’s position under the drapes (e.g., of current time-out practices with previ- supine, prone) in the time-out. This procedure. ously established evidence-based best difference between hospitals and ASFs was statistically significant (p = 0.001) and Table 1. Results of Survey of Time-Out Protocols persisted in the subset of facilities reporting WHO RESPONDS DURING AMBULATORY wrong-site procedures. YOUR TIME-OUTS? HOSPITAL SURGICAL FACILITY P* Information about the patient, procedure, Surgeon 98% 98% — and site was verified a single item at a time according to 22% of hospitals and Circulating nurse 93 77 0.01 an almost identical 26% of ASFs, whereas Anesthesia provider 100 82 0.001 the majority of facilities accepted a single Scrub technician 90 73 0.05 response to verify all the information * Chi-square test presented. Not all facilities required all OR team Table 2. Results of Survey of Time-Out Protocols members to respond. These exemptions WHAT SOURCES ARE USED TO AMBULATORY were more common in ASFs (see Table 1). VERIFY VERBAL RESPONSES? HOSPITAL SURGICAL FACILITY P* The differences persisted for anesthesia Consent 100% 99% — providers and scrub technicians in the History and physical 70 63 — subset of facilities reporting wrong-site Operating room schedule 72 69 — procedures. Imaging studies 75 24 0.001 Active communication of information, Pathology report 24 11 0.05† rather than passive agreement, was expected for verification responses by a minority of * Chi-square test † See text for qualification Page 82 Pennsylvania Patient Safety Advisory Vol. 8, No. 2—June 2011 ©2011 Pennsylvania Patient Safety Authority 2. The surgeon initiates the time-out information he or she knows. The minimize the confirmation bias that immediately before the incision. anesthesia professional reads the sometimes happens when team mem- 3. All team members cease activity patient’s name, medical record bers defer to the surgeon and are except to ventilate the patient. number, and procedure from the reluctant to correct misinformation. 4. The circulating nurse reads the per- anesthesia record. The scrub tech 6. For multiple procedures, a time-out tinent information out loud to the states the procedure he or she is is done before each procedure. team, using source documents. set up for, visualizes the site mark, 7. Other information addressed during and states where it is located. The the time-out is minimal and, if pos- 5. Each member of the team inde- surgeon states the patient’s name, sible, is addressed earlier, during a pendently provides the pertinent complete procedure, and site from preoperative briefing. information out loud from the memory. The surgeon goes last to A structured analysis of interviews of surgeons, OR nurse managers, and OR nurses in a hospital in Australia5 identi- EVALUATING TIME-OUT PROTOCOLS OR SCRIPTS fied multiple reasons for “ambivalent The following rubric can be used to evaluate examples available from the compliance” with time-outs. Among the Pennsylvania Patient Safety Authority, as well as facility-specific time-out proto- important findings are that (1) the cols or scripts: surgeons are included in the development of time-out protocols to achieve surgeon The time-out protocol was developed with input from and approval of ownership and to avoid exclusively nurse- providers representing all roles in the time-out. driven protocols, and (2) the surgeons are A program is available for educating all providers involved in time-outs, educated about time-outs. The time-out protocol expects that the time-out will be done after the The UPMC Health System in Pittsburgh patient is prepped and draped and just before the procedure is begun. recently had surgeons, anesthesiologists, The time-out protocol expects all providers to stop noncritical activities and OR staff develop a uniform time-out to participate in the time-out. for the system that would be consistent The time-out protocol allows for flexibility in posing and responding to with both the Joint Commission’s Univer- the information requested in the time-out protocol, so that the empha- sal Protocol6 and with the World Health sis is on engaging the participants, not on rote memorization. Organization’s Safe Surgery Checklist,7 The time-out protocol expects that the information verified will include the which the system wished to introduce into patient’s identity, the procedure, the site identified by the site marking, and the ORs. One item the providers added to the site identified by any imaging or pathology studies. The protocol may the time-out script was a mention of the include verification of the patient’s position under the drapes. patient’s position (personal communica- The time-out protocol expects individual responses to individual questions tion). This addition addresses one of the by the leading provider for each role in the operating room (OR) team. two main causes of wrong-site surgery: disorientation in the operating room The time-out protocol requires that all responses to questions be in the when a patient is not in the conventional active voice, that is, that they transmit information, not just agreement supine position. (The other main cause is with information. misinformation.)8 The time-out protocol requires that any site marking be specifically pointed out by the surgeon during the time-out. The Reading Hospital SurgiCenter at Spring Ridge, in Wyomissing, Pennsylva- The time-out protocol expects that the information communicated in all nia, produced a video, in response to a responses be checked against all documents that could be used to verify near-miss event, that shows how to apply that information. the components of the Universal Proto- The time-out protocol should stipulate that the operating surgeons col, including the time-out. The facility should explicitly empower other OR team members to speak up if uses the video for staff education and is concerned. monitoring compliance with the Universal The time-out protocol permits any OR team member to put a hold on Protocol monthly. The video is described noncritical activities until any concerns have been reconciled. and available online through the website of Outpatient Surgery Magazine9 and, for Vol. 8, No. 2—June 2011 Pennsylvania Patient Safety Advisory Page 83 ©2011 Pennsylvania Patient Safety Authority U P DAT E Pennsylvania facilities, is available through indicated otherwise. Wrong-site arthrosco- — 2 craniotomies on the wrong side the Authority’s PassKey website. pies, ureteroscopies, and spinal procedures — 2 wrong-side intraabdominal pro- Other time-out scripts were published in were not automatically included. The cedures that might have benefited a previous Pennsylvania Patient Safety Advi- report had to specifically suggest that a from localization of the lesions on sory article.10 (See “Evaluating Time-Out preoperative review of the imaging study imaging studies, one involving a Protocols or Scripts.”) might have corrected an information error. computed tomography (CT) scan Wrong-site emergencies were not included. showing ovarian pathology and The Authority would like to receive time- Reviewing imaging studies might have one involving an magnetic reso- out protocols meeting these qualifications been helpful in preventing information nance imaging scan showing renal to post on the Authority’s Preventing errors in other reports; some descriptions pathology Wrong-Site Surgery web page. were too sparse to make any inference. — 1 vascular procedure on the wrong leg Reviewing images in the OR might have — 1 dental surgical procedure THE ROLE OF IMAGING STUDIES corrected information errors leading to — 1 incorrect localization of a foreign IN WRONG-SITE SURGERY 42 wrong-site procedures, as follows: body A query about the importance of review- Nine reports indicated that errone- — 14 instances of stenting of the wrong ing imaging studies in the OR as a step in ous information in available imaging ureter preventing wrong-site surgery prompted studies led to wrong-site surgery. Four — 7 wrong-site orthopedic procedures, analysis of the 415 wrong-site surgery involved incorrect interpretations before including one hip replacement, one reports in the Authority’s wrong-site sur- spinal surgery. Two involved incorrect hip fracture, one sacral fixation, and gery database through 2010. interpretations of sinus lesions on CT four fixations of finger injuries The analysis did not assume that imaging — 6 operations at the wrong spinal scans. One was misleading ultrasound studies would have been reviewed by anes- site, four at the wrong level, and two documentation of a breast lesion. One thesiologists to prevent wrong-site blocks. on the wrong side was a misleading radiographic interpreta- Unless otherwise stated, colon lesions tion of kidney stones. One resulted from — 5 operations on the wrong lung for were assumed to have been localized interpreting the wrong patient’s films in localized pathology by colonoscopy. Wrong-site procedures the OR. — 3 wrong-site breast procedures, in- addressing lung lesions and fractures were The analysts concluded that there is a net cluding two on the wrong side assumed to have benefited from review of benefit to reviewing imaging studies in and one at the wrong site on the images unless the description of the event the OR before surgery. correct side NOTES 1. Quarterly update: The evidence base 4. Minnesota Department of Health. Time- 8. Insight into preventing wrong-site sur- for best practices for preventing wrong- out process in Minnesota [online]. 2008 gery. Pa Patient Saf Advis [online]. site surgery. Pa Patient Saf Advis Sep [cited 2011 May 5]. Available from 2007 Dec [cited 2011 May 5]. [online] 2010 Dec [cited 2011 May 5]. Internet: http://www.health.state.mn.us/ Available from Internet: http:// Available from Internet: http://www. patientsafety/ae/wsssummaryfs.pdf. patientsafetyauthority.org/ patientsafetyauthority.org/ 5. Gillespie BM, Chaboyer W, Wallis M, ADVISORIES/AdvisoryLibrary/2007/ ADVISORIES/AdvisoryLibrary/2010/ et al. Why isn’t ‘time out’ being imple- dec4(4)/Pages/109b.aspx. Dec7(4)/Pages/151.aspx. mented? An exploratory study. Qual Saf 9. Heiser A, Ertel P. Wrong-site surgery 2. Blanco M, Clarke JR, Martindell D. Health Care 2010 Apr;19(2):103-6. video hits home. Outpatient Surg Wrong site surgery near misses and 6. Joint Commission. The universal [online]. 2011 Jan [cited 2011 May 5]. actual occurrences. AORN J 2009 Aug; protocol for preventing wrong-site, Available from Internet: http://www. 90(2):215-2. wrong-procedure, and wrong-person outpatientsurgery.net/issues/2011/01/ 3. Quarterly update on the preventing surgery [poster online]. [cited 2011 May safety. wrong-site surgery project. Pa Patient Saf 5]. Available from Internet: http:// 10. Quarterly update on the preventing Advis [online] 2008 Jun [cited 2011 www.jointcommission.org/assets/1/18/ wrong-site surgery project. Pa Patient Saf May 5]. Available from Internet: UP_Poster.pdf. Advis [online] 2009 Mar [cited 2011 http://patientsafetyauthority.org/ 7. World Health Organization. Safe surgery May 5]. Available from Internet: ADVISORIES/AdvisoryLibrary/2008/ saves lives. [cited 2011 May 5]. Available http://patientsafetyauthority.org/ Jun5(2)/Pages/69.aspx. from Internet: http://www.who.int/ ADVISORIES/AdvisoryLibrary/2009/ patientsafety/safesurgery/en. Jun6(2)/Pages/69.aspx. Page 84 Pennsylvania Patient Safety Advisory Vol. 8, No. 2—June 2011 ©2011 Pennsylvania Patient Safety Authority PENNSYLVANIA PATIENT SAFETY ADVISORY This article is reprinted from the Pennsylvania Patient Safety Advisory, Vol. 8, No. 2—June 2011. The Advisory is a publication of the Pennsylvania Patient Safety Authority, produced by ECRI Institute and ISMP under contract to the Authority. Copyright 2011 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 nearly 40 years, ECRI Institute marries experience and independence 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.