U P DAT E Quarterly Update on Wrong-Site Surgery: Trying to Hold the Gains John R. Clarke, MD Thirteen wrong-site procedures were reported to have occurred in Pennsylvania operat- Editor, Pennsylvania Patient Safety Advisory ing suites during the most recent reporting quarter (January through March), of which Clinical Director, Pennsylvania Patient Safety Authority nine were reported to have occurred during March alone. Three of the procedures were Professor of Surgery, Drexel University hand operations at the wrong site. Three were lumbar spine operations done at the wrong level. Another two were wrong-site pain blocks; one illustrates the importance of using all relevant documents, as well as the patient, to verify the site marking: [After the] time-out was done, the nurse noticed that the surgeon injected local lidocaine into the patient’s left mid-back and placed needles in the left mid-back in preparation of the transforaminal injection. The nurse questioned the surgeon regarding the proper side. The procedure was stopped. The surgeon verified that the correct side was the right; the needles were removed, and the procedure was then performed on the right T-12 area as scheduled. During the investigation of the event, the surgeon stated that during the mark- ing process he asked the patient if the left side was the correct side. He stated that the patient did not dispute this, so he proceeded to mark the patient for a left thoracic pro- cedure. As the nurse read the consent during time-out, the surgeon did not recognize that the marking was incorrect and proceeded with the procedure according to the marking. Two patients had multiple procedures that were more than they consented for. In both cases, the extra procedures were commonly paired with the consented procedures. Presumably, the surgeons were on autopilot and the operating room staffs were not maintaining situational awareness. One other patient had a graft harvest taken from the wrong site, illustrating the importance of having the harvest site specified in all the relevant documents. One procedure was done on the wrong patient due to a complica- tion with the identification process. The one wrong-site anesthesia block done this quarter was an intra-articular injection done by the operating surgeon, showing the importance of including any block in a time-out and referencing the mark during the time-out: In OR [operating room], circulating RN [registered nurse] prepped an unshaven, unmarked left leg. During the “time-out” the surgeon injected block medication into the left knee. The consent listed the right leg. The right knee had been shaved before the operation and marked by both patient and surgeon in pre-op. Once aware of the injec- tion to the wrong site, the process stopped. Confirmation was made that the right leg was the accurate side. The patient was re-prepped and re-draped. Surgery on the accu- rate site was completed. Near-miss reports from this quarter also illustrate the importance of the principles associated with avoiding wrong-site surgery.1 The correct site of the operation should be specified when the procedure is scheduled: OR schedule listed incorrect site of surgery. Schedule stated ORIF [open reduction internal fixation] of left hip. The correct site was right [hip]. The OR consent was correct, x-rays were correct, and site identification was also correct. The correct operation and site should be specified on the informed consent: Scan this code with your mobile Patient presented to OR with both signed anesthesia consent and procedure consent. device’s QR reader Upon reading consent, noticed that site (right vs. left) was not specified on consent. This to access the was noticed before time-out. Informed physician, who confirmed that left side was the Authority's toolkit correct side by showing the MRI [magnetic resonance imaging] study on the computer as on this topic. well as showing that he had marked the left side. Physician indicated he would correct the consent. Page 76 Pennsylvania Patient Safety Advisory Vol. 10, No. 2—June 2013 ©2013 Pennsylvania Patient Safety Authority 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 9 Oct to Dec 50 14 17 21 16 10 11 Jul to Sep 40 16 14 19 11 30 13 15 17 17 16 13 13 11 20 15 6 10 23 23 16 19 17 16 16 12 11 MS13237 0 2004-05 2005-06 2006-07 2007-08 2008-09 2009-10 2010-11 2011-12 2012-13 ACADEMIC YEAR When reading OR consent upon it was right foot. OR schedule and ID [identification] band placed as time-out, the RN noticed no right documentation from doctor’s office such, and drops started. After dose of or left side noted in surgery consent. all state left foot. Doctor notified. meds, it was discovered by comparison Time-out was stopped until clarified. All information, including the patient’s with her chart that she was to be Patient consented for open gastric understanding, should be verified before having surgery on left eye. Patient still bypass. Patient scheduled for the patient enters the operating room: stated right eye. Confirmation with laparoscopic possible open gastric surgeon’s [office] chart confirmed left Patient admitted to pre-op for left foot eye was indeed to be operated on. bypass. Doctor’s H&P [history and surgery. Schedule, H&P, consent, and physical] states laparoscopic bypass. scheduling sheet all have wrong site Patient identification should always be Patient stated laparoscopic gastric listed. Patient is scheduled to have done with two unique patient identifiers: bypass when brought into the room. left foot surgery, and all documents Wrong patient was taken to OR Open [gastric bypass] consent noted state right. New documents created room. Error realized, and patient during time-out. Doctor [resolved] with correct site of surgery. OR, returned to pre-op. Correct patient discrepancy. surgeon, and scheduler notified of then taken for procedure. Anyone reviewing the information should change. Clinical manager contacted [regarding] errors in documentation All information, including the patient’s check for discrepancies and reconcile any noted with the surgeon: and potential for wrong-site surgery. understanding, should be verified by each provider caring for the patient. The site Consent, OR schedule, and H&P During preparation for eye surgery should be marked, with the accuracy state left foot. Patient informed upon admission, the patient stated nurse while doing phone assessment she was having surgery on right eye. Vol. 10, No. 2—June 2013 Pennsylvania Patient Safety Advisory Page 77 ©2013 Pennsylvania Patient Safety Authority U P DAT E confirmed by both the relevant informa- [This was a] near miss/good catch 22-Month Follow-Up tion and the patient: by the OR team. Patient re-prepped Sixteen facilities volunteered to resur- Patient scheduled for open reduction and re-draped to the correct site with vey their policies with evidence-based and internal fixation of left distal the site marking visible within the practices to prevent wrong-site surgery femur fracture. Verified with patient, sterile field. 22 months after participating in the consent, provider, and anesthesia Other sources of misinformation: Authority’s second collaboration to that surgery was planned for the left prevent wrong-site surgery.2 Twelve were Patient consent was for left hip, but leg. Anesthesia mark [a band around hospitals and four were ambulatory surgi- grease board stated right hip. [The the ankle] was on the right leg. The cal centers. information was] reviewed with the operative site [had been] marked by surgeon, and left hip is the correct Of 97 potential elements in policies the surgeon, and [the patient had] operative site. that would prevent wrong-site surgery a traction pin. A regional block was by adhering to evidence-based practices, administered to the left femoral area. Tumor board registrar contacted 9 were found in the same number of pathology office to inform them that Surgical site was marked incorrectly. policies after 22 months, 57 were found in consent, anesthesia pre-op evaluation, The incorrect side was on the request more policies, and 31 were found in fewer and intra-op documentation all refer for services and the schedule. The policies. However, the changes for the to left mastectomy; specimen ID in consent and H&P were correct. 16 facilities were statistically significant, OR record indicates specimens are The surgeon was called . . . and the by chi-square test, for only three policy from the right breast. Surgeon called correct site was marked. elements; all three were improvements to confirm the left side should have (see Table 1). The site should be marked before any been [labeled] on all specimens. Cor- procedure: rections to all path reports were made. Five facilities had wrong-site surgery during the 22-month period, and 11 had Patient for surgery on his right ankle. And if you’re not part of the solution, no wrong-site surgery. One policy element Physician did not go in to see patient you’re part of the problem: was found significantly more commonly and mark site [before] anesthesiologist Operating surgeon spoke with assis- in the 11 facilities that did not experience . . . put in popliteal block. tant over the phone and instructed wrong-site surgery during that period (8 of Information communicated during the him to proceed with case by marking 11) than in the 5 that did (1 of 5), by chi- time-out should be verified against the the patient and performing the time- square test (p = 0.05): relevant documents: out. Time-out completed. Recorded — Does the policy or procedure require [The patient] presented for right knee in chart that operating surgeon that the surgeon obtain consent for arthroscopy. Consent states right, as [was] not present for time-out. Upon surgery from the patient or legal rep- well as H&P. Left knee was painted, arrival, operating surgeon asked if resentative prior to or at the time of cleansed, and draped. Incorrect side time-out was complete. OR staff scheduling the procedure? was realized during the time-out replied yes; RN stated we should repeat it now that you are present. Of the nine facilities with that policy ele- process, and correct knee operated on. ment, five had added the element after Operating surgeon refused, stated The site mark should be visible and that the presence and participation of the collaboration project ended; all five referenced in the prepped and draped the assistant is sufficient. RN noti- were facilities that experienced no wrong- field during the time-out: fied OR manager and charge nurse. site surgery in the interim. The patient was scheduled for right Seventeen sites volunteered to resurvey eye procedure. The right eye was A LOOK AT THE SUSTAINABILITY their compliance with evidence-based marked by the surgeon as the correct OF USING EVIDENCE-BASED practices to prevent wrong-site surgery site and confirmed by patient; the BEST PRACTICES TO PREVENT 22 months after participating in the consent documented the right eye. WRONG-SITE SURGERY Authority’s second collaboration to [The patient] was taken into the prevent wrong-site surgery.2 Twelve were OR; the right eye [was] prepped by Thanks to the generous cooperation of hospitals and five were ambulatory surgical circulator, and the left eye was draped participating facilities, the Pennsylvania centers; one of the five was part of one of by surgical tech. [It was] discovered by Patient Safety Authority has been able to the hospital systems, adhering to the same the OR team prior to initiating the follow up from two past collaborations policies. Ten observations were used for time-out that wrong site was draped. on the use of evidence-based practices to each site, for a total of 170 observations. prevent wrong-site surgery.1 Page 78 Pennsylvania Patient Safety Advisory Vol. 10, No. 2—June 2013 ©2013 Pennsylvania Patient Safety Authority Compliance with evidence-based practices had subsequent wrong-site surgery in the Authority’s initial collaboration to to prevent wrong-site surgery showed a and 81% of sites that had no sub- prevent wrong-site surgery.3 statistically significant decrease, by chi- sequent wrong-site surgery, for an Of 15 policies assessed by the four hospi- square test, 22 months after participating overall compliance of 83%. Twenty- tals at both at baseline (the end of the col- in their collaboration to prevent wrong- two months later, compliance had laboration project) and 48 months later, site surgery for three best practices (see decreased to 79% among the sites 7 remained universally consistent with Table 2). that had wrong-site surgery during evidence-based best practices. One became Compliance with evidence-based practices the interval and increased to 98% universally consistent: the requirement to prevent wrong-site surgery showed a among the sites that had no wrong- to include the exact description of the statistically significant increase, by chi- site surgery during the interval, for site when scheduling an operation. One square test, over the 22 months after an overall increase in compliance became more consistent: the requirement finishing their collaboration to prevent to 93%. to conduct separate time-outs for sepa- wrong-site surgery for four best practices rate procedures. One became net more (see Table 3). 48-Month Follow-Up consistent: the requirement to remove Four hospitals volunteered to resurvey patient information from the room with Five sites had wrong-site surgery during their policies and compliance with the 22-month period; 12 sites had no the patient. Two were less consistent with evidence-based practices to prevent wrong- evidence-base best practices than reported wrong-site procedures. Three evidence- site surgery 48 months after participating based best practices were currently at baseline: verification and reconciliation observed significantly more commonly at the 12 sites that did not experience wrong- Table 1. Policy Elements Found in Significantly More of 16 Facilities 22 Months after site surgery than at the 5 that did, by chi- Finishing a Collaboration Project to Prevent Wrong-Site Surgery square test (see Table 4). POLICY ELEMENT NO. OF NO. OF P= Compliance with two evidence-based FACILITIES, FACILITIES, best practices was associated with both MAR 2011 JAN 2013 a change over time and a difference Does the policy or procedure require that 6 13 0.05 between sites with and without wrong-site the surgeon state that other members of the operating team speak up if their surgery during the 22-month interval: understanding of the situation is different 1. At the end of the collaboration proj- than the one stated in the time-out? ect to prevent wrong-site surgery, the When an operation is done at the level of 3 12 0.001 site was marked, with the accuracy a particular vertebra or rib, does the policy or procedure require that the identity of the confirmed by images when relevant, vertebra or rib be verified by fluoroscopy or at 100% of sites that had subsequent radiograph (x-ray)? wrong-site surgery and 97% of sites When an operation is done to stent a ureter, 2 10 0.01 that had no subsequent wrong-site does the policy or procedure require that the surgery, for an overall compliance of side of the ureter be verified by fluoroscopy, 98%. Twenty-two months later, com- radiology (x-ray), or ultrasound? pliance had decreased to 71% among the sites that had wrong-site surgery during the interval and was 100% Table 2. Decreased Compliance with Evidence-Based Best Practices at 17 Sites 22 Months after Finishing a Collaboration Project to Prevent Wrong-Site Surgery, among the sites that had no wrong- Based on 170 Observations site surgery during the interval, for PRACTICE COMPLIANCE, COMPLIANCE, P= an overall decrease in compliance MAR 2011 JAN 2013 to 82%. The site should be marked by the 82% 50% 0.001 2. At the end of the collaboration provider’s initials. project to prevent wrong-site surgery, The site should be marked, with the 98% 82% 0.01 information communicated during accuracy confirmed by images when the time-out was verified against the relevant. relevant documents (e.g., schedule, The surgical field should be prepped 99% 92% 0.01 consent, H&P) at 90% of sites that and draped prior to the time-out Vol. 10, No. 2—June 2013 Pennsylvania Patient Safety Advisory Page 79 ©2013 Pennsylvania Patient Safety Authority U P DAT E of all available relevant documents (1) at Three of the four hospitals observed com- (23 of 25, p < 0.001) 48 months the time of scheduling and (2) prior to pliance both at baseline and 48 months later. The improved compliance was arriving in the preoperative holding area. later. For each practice, they observed a in concordance with the improve- Three had been reported as universally cumulative average of 25 operations at ment to a universally consistent consistent at baseline but not at baseline and 23 operations 48 months requirement to include the exact 48 months: (1) informing patients that all later. The compliance averaged 90% over- description of the site when schedul- providers will be asking for identification, all at baseline and 93% 48 months later. ing an operation. (2) marking the site after verification with Only two practices showed statistically 2. Radiographic verification of the spinal all relevant documents, and (3) written significant differences, by chi-square test, level intraoperatively improved from verification of the correct spinal level by between the two observations: 55% (11 of 20) during the baseline at a radiologist as part of the intraoperative 1. Including the schedule in the preoperative the end of the collaboration project verification. Because of the small sample verification improved from 45% (9 of to 100% (7 of 7, p < 0.05) size, no changes were tested for statistical 20) during the baseline at the end 48 months later. The difference in significance. of the collaboration project to 92% the percentage of opportunities (20 of 25 = 80% versus 7 of 23 = 30%) is significantly different Table 3. Improved Compliance with Evidence-Based Best Practices at 17 Sites (p < 0.001 by chi-square test), 22 Months after Finishing a Collaboration Project to Prevent Wrong-Site Surgery, suggesting that the samples for this Based on 170 Observations subset may have been collected PRACTICE COMPLIANCE, COMPLIANCE, P = differently in the two time periods. MAR 2011 JAN 2013 The site should be marked, with the 96% 99% 0.05 Interpretation of the Results of accuracy confirmed by all relevant the Follow-Up Surveys documents. The results of follow-up surveys of Separate formal time-outs should 85% 99% 0.01 policies and compliance with evidence- be done for separate procedures, including anesthesia blocks. based practices to prevent wrong-site surgery in facilities that participated Information communicated during the 83% 93% 0.01 time-out should be verified against the in collaborations to prevent wrong-site relevant documents (e.g., schedule, surgery showed interesting patterns, as consent, history and physical). described in this section. The surgeon actively participates in the 94% 99% 0.05 The institution of policies and improved time-out. compliance continued in some facilities after completion of their participation in Table 4. Current Compliance with Evidence-Based Best Practices at 5 Sites with Wrong-Site a collaboration to prevent wrong-site Surgery versus 12 Sites without Wrong-Site Surgery during the 22 Months since Finishing a surgery. Three policy elements were Collaboration Project to Prevent Wrong-Site Surgery, Based on 170 Observations found in significantly more facilities after PRACTICE COMPLIANCE, COMPLIANCE, P= 22 months (see Table 1). One policy ele- SITES WITH SITES WITHOUT ment, requiring the surgeon to get the con- WRONG-SITE WRONG-SITE sent prior to or at the time of scheduling SURGERY SURGERY the procedure, was added only in facilities The site should be marked, with the 71% 100% 0.01 that had no wrong-site surgery during the accuracy confirmed by images when 22-month period. Four evidence-based relevant. best practices were observed more fre- Information communicated during the 80% 98% 0.001 quently 22 months later (see Table 3). One time-out should be verified against the of those practices, verifying information relevant documents (e.g., schedule, consent, history and physical). against relevant documents, improved only in facilities that had no wrong-site surgery Information communicated during the 79% 98% 0.001 time-out should be verified against during the 22-month period. At least one diagnostic test results, images, and/or additional best practice was observed more pathology reports, if relevant. frequently 48 months later. Page 80 Pennsylvania Patient Safety Advisory Vol. 10, No. 2—June 2013 ©2013 Pennsylvania Patient Safety Authority Some policies and practices to prevent significantly more frequently over time Presumably, the best practices that were wrong-site surgery were no longer as were as follows: maintained were supported by policies prevalent at follow-up as they were at the — The site should be marked, with the and by systems that facilitated compliance. end of the collaboration (see Table 2). accuracy confirmed by all relevant They may have become good habits. Decreased compliance with one of these documents. Presumably, continued improvements in practices, confirming the accuracy of the compliance resulted from strengthening — Separate formal time-outs should be site marking with images when relevant, policies, reducing barriers to compliance, done for separate procedures, includ- was associated with wrong-site surgery and/or providing effective incentives for ing anesthesia blocks. during the 22 months before follow-up. compliance. — Information communicated dur- The policies to prevent wrong-site surgery ing the time-out should be verified Presumably, decreased compliance over that were significantly more prevalent against the relevant documents time resulted from persistence of behavior after completion of the collaboration were (e.g., schedule, consent, H&P). that did not match best practice. The as follows: failure to maintain compliance may be — The surgeon actively participates in — The surgeon states that other mem- the time-out. associated with resistance to the practice, bers of the operating team should And, at 48-months, as follows: continued barriers, ineffective incentives, speak up if their understanding of lack of enforcement, and/or absence of the situation is different than the — The schedule should be included in monitoring and feedback. one stated in the time-out. the preoperative verification. The best practices that were observed The results of the follow-up surveys of — When an operation is done at the facilities that had participated in collabo- level of a particular vertebra or rib, significantly less frequently over time were as follows: rations to prevent wrong-site surgery dem- the identity of the vertebra or rib onstrate continued improvement in the should be verified by fluoroscopy or — The site should be marked by the presence of policies and compliance with radiograph (x-ray). provider’s initials. evidence-based best practices. Most poli- — When an operation is done to stent — The site should be marked, with the cies and best practices were maintained. a ureter, the side of the ureter should accuracy confirmed by images when Compliance with some best practices be verified by fluoroscopy, radiology relevant. decreased, suggesting the need for peri- (x-ray), or ultrasound. — The surgical field should be prepped odic monitoring and feedback. Facilities — The surgeon should obtain consent and draped prior to the time-out. committed to preventing wrong-site sur- for surgery from the patient or legal All other best practices were maintained gery should persist in efforts to adopt and representative prior to or at the time over 22 to 48 months—or at least compli- comply with best practices. of scheduling the procedure. ance varied in ways that were not statisti- The facilities that volunteered to These results suggest prolonged negotia- cally significant. participate in the repeat surveys are tions with surgeons on the medical staff Continued improvement in the presence commended for their dedication to the to accept some policies affecting them. of policies and compliance with evidence- project to prevent wrong-site surgery in Compliance with evidence-based practices based best practices to prevent wrong-site Pennsylvania. to prevent wrong-site surgery increased surgery was more common than decreased Acknowledgments over time after the collaboration for adherence to best-practice policies. Miranda Minetti, BS, and Edward Finley, BS, some practices and decreased for others. The underlying patterns for the observed Pennsylvania Patient Safety Authority, contributed The best practices that were observed with the conduct of the survey and with the changes over time can only be conjectured. collection of the data, respectively. NOTES 1. Pennsylvania Patient Safety Authority. 2. Clarke JR. Quarterly update: what ADVISORIES/AdvisoryLibrary/2011/ Principles for reliable performance might be the impact of using dec8(4)/Pages/144.aspx. of correct-site surgery [online]. evidence-based best practices for 3. Pelczarski KM, Braun PA, Young E. 2010 Dec [cited 2013 Apr 25]. preventing wrong-site surgery? Results Hospitals collaborate to prevent wrong- http://patientsafetyauthority.org/ of objective assessments of facilities’ site surgery. Patient Saf Qual Health EducationalTools/PatientSafetyTools/ error analyses. Pa Patient Saf Advis 2010 Sep-Oct;7:20-6. PWSS/Documents/principles.pdf. [online] 2011 Dec [cited 2013 Apr 25]. http://patientsafetyauthority.org/ Vol. 10, No. 2—June 2013 Pennsylvania Patient Safety Advisory Page 81 ©2013 Pennsylvania Patient Safety Authority PENNSYLVANIA PATIENT SAFETY ADVISORY This article is reprinted from the Pennsylvania Patient Safety Advisory, Vol. 10, No. 2—June 2013. The Advisory is a publication of the Pennsylvania Patient Safety Authority, produced by ECRI Institute and ISMP under contract to the Authority. Copyright 2013 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. 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