U P DAT E Quarterly Update: What Might Be the Impact of Using Evidence-Based Best Practices for Preventing Wrong-Site Surgery? Results of Objective Assessments of Facilities’ Error Analyses John R. Clarke, MD Pennsylvania healthcare facilities reported 11 wrong-site surgeries to the Pennsylvania Editor, Pennsylvania Patient Safety Advisory Patient Safety Authority during the most recent reporting quarter, which is an increase Clinical Director, Pennsylvania Patient Safety Authority Professor of Surgery, Drexel University from the previous quarter, but matches the third lowest quarterly number of event reports (see Figure). This update includes any belated additions and corrections from previous reporting quarters; specifically, the identification and deletion of a second, duplicate event report of a wrong-site surgery in the first quarter of 2006, resulting in minor adjustments to previous totals for the seven reporting years (June 2004 through September 2011). Successful efforts to decrease wrong-site surgeries—reported previously by the Health Care Improvement Foundation Partnership for Patient Care wrong-site surgery collaboration (73%),1 by the Veterans Health Administration medical team training program (25%),2 and by a recent, unpublished, wrong-site surgery collaboration of facilities in a second region of Pennsylvania (0 events during operating room (OR) procedures in more than 1 year)— continue with an article in this issue of the Pennsylvania Patient Safety Advisory about the Minnesota Time Out.5 NEAR-MISS REPORTS Some recent reports of wrong-site near misses illustrate the value of assessing near-miss events. Figure. Pennsylvania Patient Safety Authority Wrong-Site Surgery Reports by Quarter NUMBER OF REPORTS 30 25 23 23 21 21 20 19 19 19 17 17 17 16 16 16 16 16 16 16 16 15 15 14 14 13 13 11 11 11 11 10 9 8 5 Scan this code MS11624 with your mobile device’s QR 0 reader to access 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 Q3 the Authority's 2004 2005 2006 2007 2008 2009 2010 2011 wrong-site surgery prevention toolkit. REPORTS BY QUARTER Page 144 Pennsylvania Patient Safety Advisory Vol. 8, No. 4—December 2011 ©2011 Pennsylvania Patient Safety Authority Incorrect Specimen Labeling such as described in the September OBJECTIVE ASSESSMENTS OF THE Two near-miss reports of incorrect label- 2011 Advisory.5 At least three ear- IMPACT OF EVIDENCE-BASED ing of specimens illustrate the importance lier reports have been found in the reporting system since July 2004: BEST PRACTICES TO PREVENT of following good practices to prevent WRONG-SITE SURGERY mislabeled pathology specimens. The left knee was prepped for surgery. The OR schedule, patient consent, The best practice principles for preventing The specimen requisition sheet and the patient verification, and physician wrong-site surgery have been identified,6 specimen container were incorrectly marking all listed the right knee. The updated, and supported by their evidence labeled with another patient’s name error was discovered during the time- base.5,7 Collaborative efforts with the and number. The physician was noti- out. The right knee was prepped Health Care Improvement Foundation fied and correctly identified and labeled and draped, and the procedure Partnership for Patient Care to upgrade the specimen requisition sheet and the was performed. compliance with the best practice specimen container for this patient. principles were effective in reducing A patient was intubated, prepped A pathologist, while reading slides wrong-site surgeries in 30 facilities in the and draped; the time-out was per- on the case, discovered that the Philadelphia area.1 A similar, unpublished formed and team realized wrong wrong laterality was put on both the collaborative effort in facilities in a second leg. The patient was reprepped and specimen container and slip (left/ region of Pennsylvania resulted in redraped. [Staff] continued with the right)—[laterality was] right on both, 0 wrong-site surgeries in facility ORs dur- correct-site surgery. and it should have been left. ing OR procedures in more than 1 year. A The OR staff initially draped the subjective analysis of the narratives of all All paperwork, especially preprinted wrong leg before a knee arthroscopy wrong-site surgery reports from June 28, labels, from the previous patient should procedure. The error was caught dur- 2004, through June 30, 2011, to determine be cleared before bringing another patient ing the time-out process. The correct the potential impact of each evidence- into the OR. The site of the specimen leg was draped, and the procedure based best practice principle was published should be verified by the surgeon before completed by the surgeon. in the September 2011 Advisory.5 The fol- the specimen leaves the room. 3. Near-miss situations resulting in lowing is an objective assessment of the Critical Near Misses cancellation of the procedure. These impact of each evidence-based best practice events have been reported approxi- principle, based on the error analysis The Authority received a report of a mately once per year. They occurred forms completed by facilities’ patient safety patient scheduled for removal of a ureteral when the patient’s understanding officers (PSOs). stent from the wrong-side. As it turned out for the patient, there was only one was different than the documented Since August 2007, the Authority has stent and the correct stent was removed. information, when drops were put asked each PSO who submits a report of in the wrong eye, and when an a wrong-site surgery to use a standardized The World Health Organization High incorrect consent could not be cor- error analysis form when doing the root- 5s project has identified three near-miss rected because the patient had been cause analysis.8,9 These standardized error situations as critical near misses that sedated. The Authority would not analysis forms provide a structure for a necessitate root-cause analyses:4 include cancellation of a procedure complete assessment of all evidence-based 1. Procedures that are done correctly based on identification that the best practice principles that might be defi- despite incorrect information, such as patient was the wrong patient as a cient, rather than just focus on the specific described in the event report above. near miss that fell into this critical causes of the reported event. The forms However, the Authority would not category, just any cancellation affect- include yes/no questions relating to the include doing the correct procedure ing the patient who was supposed to evidence-based best practice principles to on the wrong patient as a critical get the procedure, based on identifi- prevent wrong-site procedures. Questions near miss; the Authority would con- cation of the wrong patient, wrong did not relate to three evidence-based best sider operating on the wrong patient procedure, or wrong site. practice principles: (1) the correct opera- as a wrong-site procedure, even if the Treating critical near misses as seriously tion and site is recorded on the history patient received a medically appropri- as wrong-site events should help maintain and physical examination (principle 2), ate procedure. awareness of the constant risk of wrong- (2) all information is verified by the 2. Errors caught by the last step of the site events. Universal Protocol, the time-out, (continued on page148) Vol. 8, No. 4—December 2011 Pennsylvania Patient Safety Advisory Page 145 ©2011 Pennsylvania Patient Safety Authority U P DAT E Table. Deficiencies of Evidence-Based Best Practice Principles in Error Analyses of Wrong-Site Operative Procedures UN- % YES % YES OF % NO OF EVIDENCE-BASED BEST PRACTICE ASSESSMENT* YES NO KNOWN NA OR NO YES/NO YES/N0 PRINCIPLE† The correct site was specified on the 80% 9% 2% 9% 89% 90% 10% 1. The correct site of the operation schedule. should be specified when the procedure is scheduled. The name of procedure(s) was stated 80% 13% 6% 1% 93% 86% 14% 3. The correct operation and site correctly on the consent. The correct should be specified on the informed site/side/level/digit was clearly consent. stated on the consent. The person obtaining the scheduling 61% 5% 15% 19% 67% 94%‡ 6% 4. Anyone reviewing the schedule, information verified the information consent, history and physical ex- provided from the surgeon’s office. amination, or reports documenting the diagnosis, should check for dis- crepancies among all those parts of the patient’s record and reconcile any discrepancies with the surgeon when noted. All information from the surgeon’s 78% 5% 6% 11% 83% 93% 7% 5. The surgeon should have records was available in the operating supporting information uniquely suite for verification against primary found in the office records at the sources of information. surgical facility on the day of surgery. A member of the operating room 83% 8% 6% 3% 91% 91% 9% 6. All information that should be (OR) staff performed the preoperative used to support the correct patient, reconciliation. operation, and site, including the patient’s or family’s verbal understanding, should be verified by the nurse and surgeon before the patient enters the OR. 6A. RN should verify preoperatively. Preoperative verification against 67% 17% 6% 9% 84% 80% 20% 6B. Surgeon should verify the consent and patient records was preoperatively. done by the surgeon prior to the time-out. Verification of patient’s information 91% 8% 2% 0% 98% 92% 8% 6C. All information, including about full name, date of birth, patient’s information, should be procedure, and correct site or side, verified preoperatively. if any, was done with identification (ID) band, consent, schedule, and surgeon’s documents in the patient’s record. All information was verified by the 78% 16% 6% 0% 94% 83% 17% 6A, 6C. RN should verify all registered nurse (RN) preoperatively. information. All information was verified by the RN 63% 29% 9% 0% 91% 69% 31% 6A, 6B, 6C. The RN and the surgeon and the surgeon preoperatively. should verify all information. The patient was asked to state his 78% 13% 6% 2% 91% 86% 14% 7. All verbal verification should be or her full name, date of birth, done using questions that require procedure, and correct site or side, an active response of specific if any. information, rather than a passive agreement. The patient identified by stating full 95% 2% 3% 0% 97% 98% 2% 8. Patient identification should name and date of birth was verified by always require two unique patient preoperative RN using patient name identifiers. and date of birth on ID band. Page 146 Pennsylvania Patient Safety Advisory Vol. 8, No. 4—December 2011 ©2011 Pennsylvania Patient Safety Authority Table. Deficiencies of Evidence-Based Best Practice Principles in Error Analyses of Wrong-Site Operative Procedures (continued) UN- % YES % YES OF % NO OF EVIDENCE-BASED BEST PRACTICE ASSESSMENT* YES NO KNOWN NA OR NO YES/NO YES/N0 PRINCIPLE† The surgeon reconciled any 1% 5% 4% 91% 5% 95%‡ 5% 9. Any discrepancies in the discrepancies using original information should be resolved documents. by the surgeon, based on primary sources of information, before the patient enters the OR. Marked properly with verification. 34% 41% 7% 18% 75% 56%‡ 44% 10. The site should be marked by a healthcare professional familiar with the facility’s marking policy, with the accuracy confirmed both by all the relevant information and by an alert patient or patient surrogate if the patient is a minor or mentally incapacitated. The operative site was marked with 31% 40% 5% 24% 71% 43% 57% 11. The site should be marked by the the physician’s initials. provider’s initials. The time-out was done in the OR. 81% 16% 2% 0% 98% 83% 17% 13. Separate formal time-outs should be done for separate procedures, including anesthetic blocks, with the person performing that procedure. The incision was made after the 61% 6% 2% 31% 67% 91% 9% 14. All noncritical activities should time-out. stop during the time-out. The operative site marking was visible 53% 22% 2% 23% 74% 71% 29% 15. The site mark should be visible during the time-out. and referenced in the prepped and draped field during the time-out. Verification in the time-out included 50% 21% 24% 5% 71% 70% 30% 16. Verification of information verification of correct patient, with during the time-out should require identification with ID wristband and an active communication of specific chart, and verification of procedure information, rather than a passive and site. agreement, and be verified against the relevant documents. The time-out involved the surgeon, 70% 19% 5% 6% 88% 79% 21% 17. All members of the operating anesthesia provider, nursing staff, and team should verbally verify that surgical technician. their understanding matches the information in the relevant documents. A member of the operating team 8% 50% 2% 41% 57% 50%‡ 50% 19. Operating team members who raised a specific concern about have concerns should not agree to possible wrong-site surgery at any the information given in the time- point before the incision, when the out if their concerns have not been time-out verification or site mark were addressed. questionable. The surgeon responded to a specific 10% 3% 2% 84% 13% 97%‡ 3% 20. Any concerns should be resolved concern a member of the operating by the surgeon, based on primary team voiced about possible wrong-site sources of information, to the surgery. satisfaction of all members of the operating team before proceeding. Written interpretation of intraoperative 27% 14% 6% 53% 41% 85%‡ 15% 21. Verification of spinal level, rib images relevant to the case were resection level, or ureter stented available in the OR within the time should require radiological needed to make intraoperative confirmation, using a stable marker decisions. and readings by both a radiologist and the surgeon. * Total number of responses is 129 for each assessment. † Best practice principles 2, 12, and 18 were not assessed. ‡ “Yes” responses, when compared to “No” responses, include “NA” responses. Vol. 8, No. 4—December 2011 Pennsylvania Patient Safety Advisory Page 147 ©2011 Pennsylvania Patient Safety Authority U P DAT E (continued from page 145) B. Verification and reconciliation of the The error analyses revealed that the sur- relevant information and marking of geons did not do preoperative verification circulating nurse upon taking the the site by the person doing the pro- with comparison against relevant written patient to the OR (principle 12), and cedure on the day of surgery before information in 20% of wrong-site pro- (3) the surgeon specifically empowers the patient enters the OR (principles cedures, whereas the preoperative nurse team members to speak up if concerned 6 through 11). did not perform verification in 9%. This (principle 18). Each deficiency in best difference in deficiencies of preoperative C. A properly done time-out, meaning practice principles that is identified may verification between surgeons and nurses one that actively engages all members be causal, incidental, or contributory to was statistically significant by chi-square of the operating team, references the the reported event. This impact analysis test (X2 = 6.29, p < 0.05). The verifica- site mark in the prepped and draped focuses on the deficiencies identified by tion failed to include all relevant patient field, and empowers all members of the questions in the systematic review of information in 8% of procedures and did the team to speak up if concerned evidence-based best practice principles. not require the patient to verbalize the (principles 12 through 20). As of the end of June 2011, the Authority information in an active voice (“My name D. When appropriate, intraoperative is . . . .”) in 14%. The net effect was that has received 129 completed error analysis verification of the anatomic site, the preoperative nurse failed to do verifi- forms assessing deficiencies of evidence- specifically for spinal surgery, rib cation, against all relevant information, based best practice principles associated resections, and ureteral stenting. Such according to 17% of analyses; and veri- with wrong-site OR procedures. These error verification requires proper localiza- fication by two providers, the nurse and analysis forms represented 51% of all 254 tion of the site by imaging studies, physician, using all relevant information, wrong-site procedures during that time. All ideally with independent confirma- was deficient in 31% of analyses. Best questions were answered in all forms. tion by both the surgeon and an practice principles with good compliance The results (see Table) are presented in imaging specialist (principle 21). and minimal deficiencies included the the numerical order of the evidence-based A. Preoperative verification of the surgeon reconciling discrepancies when best practice principles and grouped completeness and accuracy of all the they were identified, deficient in only 5% according to the four key groups of best information relevant to the operation of analyses, and using two identifiers, the practice principles identified by the (principles 1 through 5). least common deficiency, at 2%. subjective analysis of the narrative of all wrong-site surgery reports:5,10 The completeness and accuracy of the Marking the site properly, including veri- information on the consent, regarding the fying the location against relevant patient A. Preoperative verification of the exact procedure and the exact site of the information as well as the patient’s completeness and accuracy of all the procedure, were deficient in 14% of the understanding, was deficient in 44% of information relevant to the operation analyses of 129 wrong-site events. The cor- the analyses of wrong-site events in which (principles 1 through 5). At mini- rect site was not specified on the schedule marking the site was applicable. When mum, this information includes according to 10% of the analyses. Infor- marking the site was applicable, the sur- the following: mation from the surgeons’ records that geon’s initials were used in only 43% of — Schedule might have been useful for verification the analyses, the word “yes” in 41%, and — Consent was not available in 7%. Early reconcili- other, unspecified notations, if any, in the — History and physical examina- ation, before the day of surgery, was not remainder of the analyses. tion, including office notes if done for 6%, not including patients for C. A properly-done time-out, meaning relevant whom early reconciliation was not pos- one that actively engages all members of — Laboratory results sible. The completeness and accuracy of the operating team, references the site information on the history and physical mark in the prepped and draped field, — Imaging studies examination was not assessed. and empowers all members of the team — Pathology reports, if relevant B. Verification and reconciliation of the to speak up if concerned (principles 12 Optimally, this information is all verified through 20). relevant information and marking of the to be complete and accurate before the site by the person doing the procedure Failure to do a time-out in the OR was day of elective surgery. Ideally, it would be on the day of surgery before the patient reported in 17% of the analyses of known to be complete and accurate before enters the OR (principles 6 through 11). wrong-site events. The surgeon apparently leaving the surgeon’s office. Page 148 Pennsylvania Patient Safety Advisory Vol. 8, No. 4—December 2011 ©2011 Pennsylvania Patient Safety Authority did not wait for the time-out before mak- surgeon, encouraging team members to subjective analysis of the report narra- ing the incision in 9%. speak up if concerned, was not assessed. tives.5 All four groups of best practice The site marking was not visible in the D. When appropriate, intraoperative principles would address deficiencies prepped and draped field during the time- verification of the anatomic site, specifi- commonly found in the error analyses of out according to 29% of the analyses. cally for spinal surgery, rib resections, wrong-site operative procedures: Verification did not include checking and ureteral stenting. Such verification 1. Preoperative verification information about the patient (identity, requires proper localization of the site by 2. Verification and marking of the site procedure, and site) against the written imaging studies, ideally with independent by the person doing the procedure information in 30% of the analyses. The confirmation by both the surgeon and an on the day of surgery before the time-out did not involve all members of imaging specialist (principle 21). patient enters the OR the operating team in 21%. Deficiencies of intraoperative verification 3. Properly done time-outs, engaging As a result, information was not correct of the anatomic site, when appropriate, all members of the operating team, or the site mark was not visible during the were reported in 15% of analyses. referencing the site mark in the time-out and team members failed to raise The objective assessment of the impact prepped and draped field, and the concerns according to 50% of the analy- of following evidence-based best practice surgeon empowering all members of ses. However, a concern was raised and principles to prevent wrong-site surgery, the team to speak up if concerned the surgeon failed to respond in only 3% using information from uniform error 4. Intraoperative verification of the of analyses. Specific empowerment by the analyses of 129 wrong-site operative pro- anatomic site, when indicated, by cedures, supports the previously reported imaging studies NOTES 1. Pelczarski KM, Braun PA, Young E. Hos- 5. Clarke JR. Quarterly update: what might 8. Blanco M, Clarke JR, Martindell DP. pitals collaborate to prevent wrong-site be the impact of using evidence-based best Wrong site surgery near misses and surgery. Patient Saf Qual Health 2010 practices for preventing wrong-site surgery? actual occurrences. AORN J 2009 Aug; Sep-Oct:20-6. [online]. Pa Patient Saf Advis 2011 Sep 90(2):215-8, 221-2. 2. Neily J, Mills PD, Eldridge N et al. [cited 2011 Nov 4]. Available from Inter- 9. Pennsylvania Patient Safety Authority. Incorrect surgical procedures within and net: http://patientsafetyauthority.org/ Wrong-site surgery error analysis form outside of the operating room: a follow-up ADVISORIES/AdvisoryLibrary/2011/ [online]. 2010 Aug [cited 2011 Nov 4]. report. Arch Surg 2011 Jul 18. [epub ahead sep8(3)/Pages/109.aspx. Available from Internet: http:// of print]. 6. Pennsylvania Patient Safety Authority. patientsafetyauthority.org/ 3. Rydrych D. Success in preventing wrong- Principles for reliable performance of EducationalTools/PatientSafetyTools/ site procedures in Minnesota with the correct-site surgery [online]. 2010 Dec PWSS/Pages/wss_error_analysis.aspx. Minnesota Time Out [online]. Pa Patient [cited 2011 Nov 4]. Available from Inter- 10. Pennsylvania Patient Safety Authority. Saf Advis 2011 Dec [cited 2011 Dec 1]. net: http://patientsafetyauthority.org/ Associations for key best practice prin- Available from Internet: http:// EducationalTools/PatientSafetyTools/ ciples in a potential impact analysis of 431 patientsafetyauthority.org/ADVISORIES/ PWSS/Pages/principles.aspx. wrong-site procedures [online]. 2011 Sep AdvisoryLibrary/2011/dec8(4)/Pages/ 7. Quarterly update: the evidence base for [cited 2011 Nov 10]. Available from Inter- home.aspx. best practices for preventing wrong-site net: http://patientsafetyauthority.org/ 4. Croteau, Rick (Joint Commission Inter- surgery [online]. Pa Patient Saf Advis 2010 EducationalTools/PatientSafetyTools/ national). Personal communication with: Dec [cited 2011 Nov 4]. Available from PWSS/Pages/p_associations.aspx. John R. Clarke. 2011 Nov 4. Internet: http://patientsafetyauthority.org/ ADVISORIES/AdvisoryLibrary/2010/ dec7(4)/Pages/151.aspx. Vol. 8, No. 4—December 2011 Pennsylvania Patient Safety Advisory Page 149 ©2011 Pennsylvania Patient Safety Authority PENNSYLVANIA PATIENT SAFETY ADVISORY This article is reprinted from the Pennsylvania Patient Safety Advisory, Vol. 8, No. 4—December 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. 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