Pennsylvania Patient Safety Advisory Quarterly Update on the Preventing Wrong-Site Surgery Project Three years have passed since the first definitive Figure. Pennsylvania Patient Safety Authority article from the Pennsylvania Patient Safety Authority Wrong-Site Surgery Reports by Academic Year, on wrong-site surgery at the end of June 2007.1 When 2004 to 2010 compared to the first three years of reporting, the NUMBER number of events during the more recent three years OF REPORTS has doggedly persisted (see Figure). During the first 100 year of focus (2007 to 2008), the number of reported 90 events increased to near a previous high, perhaps 80 73 72 because of increased awareness and standardization 70 around the National Quality Forum definitions.2 60 56 59 60 57 After that initial focus on wrong-site surgery, the 50 number of events has decreased each year. However, 40 the Commonwealth of Pennsylvania still averages 30 more than one report per week.* 20 Numerous studies, available on the Authority’s Pre- MS10406 10 venting Wrong-Site Surgery Project Web page,3 have 0 identified evidence-based best practices for prevent- 2004-2005 2005-2006 2006-2007 2007-2008 2008-2009 2009-2010 ing wrong-site surgery. Of the 14 events for this last reported quarter (April 1, 2010, through June 30, REPORTS BY ACADEMIC YEAR (July 1 through June 30) 2010), 4 (29%) were repetitions of wrong-site anes- thetic blocks. Best practices for preventing wrong-site anesthetic blocks were discussed in the December recommended marking the insertion site, especially 2009 and March 2010 issues of the Pennsylvania Patient since the procedure involved a femoral nerve block Safety Advisory,4,5 initiating the recent description of completed in the supine position and a sciatic nerve evidence-based best practices for specific procedures.† block completed in the prone position. The patient was to have a block on the right The importance of properly following the Universal hand. The block was done on left side by the Protocol6 is reinforced by the following reports: anesthesiologist. . . . The right side was then Two patients with the same name were operated on marked and a second block was completed. by the same surgeon the same day. The surgeon oper- The patient was scheduled for right eye surgery. . . . ated on the first patient, thinking she was the second As the nurse was preparing to prep the patient, he patient. Fortunately for the patients, both had the noticed the surgeon blocking the left eye. An official same operation, but the Authority considers this event time-out had not been done at this time. . . . wrong-patient surgery. Two patient identifiers are nec- essary for proper identification prior to surgery. One facility that reported a wrong anesthesia block in the previous quarter submitted additional infor- The Authority received a report that illustrated mation to share its recommendations for system reasons for following the Universal Protocol other improvement: than preventing wrong-site surgery: The time-out was performed with two anesthesiolo- [After the anesthetic was injected, but] before gists and another individual. The patient confirmed the incision was made, the surgeon realized that that the right leg was the operative site, although the consent stated the “index finger.” The surgery the patient was to have surgery on the left leg. The was cancelled, and rescheduled. The consent was anesthesiologist inserted a catheter in the right groin. incorrect. The injected anesthetic was on the correct When the surgeon saw the catheter, she informed the side, correct site (middle finger). anesthesiologist that the patient was having surgery The surgeon had started the intended procedure on the left leg. The anesthesiologist removed the cath- when he or she realized that the consent did not cover eter and placed a new catheter on the left side. the correct operation. The incorrect consent would The facility’s root-cause analysis indicated that, have been identified with proper preoperative verifica- although a time-out had been done, the anesthesiolo- tion of the documents, including the documents in gist did not mark the site prior to the time-out. The the verification of the site marking, and doing a time- anesthesiologists rely on sites marked by surgeons, out before any localized anesthetic procedure. but this mark had not yet been made. The facility Can the “time-out” work? An ambulatory surgical facility reported a save attributed to this last step in * As usual, this update includes any belated additions and correc- the Universal Protocol: tions from previous quarters. † All report narratives have been edited to remove identifying The OR [operating room] staff initially draped the information. wrong leg before knee arthroscopy procedure. The Page 102 REPRINTED ARTICLE - ©2010 Pennsylvania Patient Safety Authority Vol. 7, No. 3—September 2010 Pennsylvania Patient Safety Advisory error was caught during the time-out process. The care unit], the parent said the lesion removed was the correct leg was draped and the procedure completed incorrect lesion. by the surgeon. The surgeon did not see the patient preoperatively. The The recent description in the Advisory of evidence- site was marked after the patient was in the OR. based best practices for specific procedures also The site was marked without verifying it with all the included spinal surgery,4 pain management proce- documents and the patient or surrogate. The surgeon dures,5 ureteral stenting,5 and hand surgery.5 Reports did not properly respond to concerns raised by OR in this quarter include problems with two other staff (by reconciling the discrepancies using the infor- specific types of procedures: (1) surgery on the wrong mation from all the documents and the patient scar, skin lesion, or subcutaneous lesion, and or surrogate). (2) procedures involving the wrong device. When operating on skin and subcutaneous lesions Surgery on Scars, Skin Lesions, and that could be present in multiple sites, extra care is Subcutaneous Lesions needed to ensure that the intended sites are identi- fied, marked, and operated on. The patient may not Of the 375 total reports of wrong-site surgery, be a perfect source of information, in part because 13 reports (3.5%) involved visible scars, melan- the lesions may be on a part of the body that is not omas, moles, or other skin lesions, or palpable subcu- visible or palpable. Marks should identify the lesions taneous lesions. Five involved pediatric patients and as accurately and unambiguously as possible. In addi- their parents. tion to the standard evidence-based practices for These events resulted from the presence of multiple preventing wrong-site surgery in general, the following visible or palpable candidate sites. In four events, are proposed for skin and subcutaneous lesions: the surgeons referenced the wrong incisional scar in 1. The person doing the surgery should mark the patients with multiple prior procedures. In another correct lesion as accurately and unambiguously five reports, the surgeons excised nearby similar as possible. lesions instead of the intended lesions. In three other events, different pigmented lesions were widely 2. Precise, detailed, accurate preoperative excised instead of the intended melanomas. In one, a documents should be maintained to verify the scar was removed instead of a subcutaneous lesion. location of the operative site. Seven reports cited issues with the information for 3. A mirror and/or a patient advocate should identifying or marking the sites. The patients or par- be used, if necessary, to assist the patient in ents were cited six times, including twice when the participating in the site verification and marking. information was noted to be correct and twice when it was not. Incorrect office notes were also cited once. Procedures Involving the Wrong Device No other documents were mentioned as a source of Ten reports of procedures (2.7%) involved a device information. In fact, two reports indicated that prop- other than the one intended. (This analysis excludes erly collected consents were not part of the verifica- procedures involving insertion of correct devices tion processes and another two events indicated that with the wrong specifications, such as the wrong- information from the patients was not sought. diopter intraocular lens implant, which can be The site identification and markings were noted to due to different error mechanisms.7,8) Seven of have been done by the surgeons four times (three the ten reports involved the insertion of a vascular described as incorrectly), by residents twice, and a access device other than the one intended. One nurse once; one anesthesia provider correctly identi- report involved enteric feeding tubes. One involved fied a site. When mentioned, most sites were marked tympanoplasty tubes, and one involved a nerve by circles. Three reports indicated that the wrong simulator and cardiac pacemaker. Four of the reports lesions were marked. Another two events were associ- specifically noted that the patients had major, long- ated with extra circles. Another report suggested that term medical problems. the mark was not close to the lesion. Of the seven reports involving the wrong vascular The following report illustrates multiple high-risk access device, five reports indicated confusion behaviors known to be associated with wrong-site between subcutaneous venous access ports and surgery: Hickman or Broviac intravenous catheters (three one way and two the other). One report indicated Preoperatively, the parent identified the left chest as confusion between a dialysis catheter and an intended the site of the lesion to the nursing staff. In the OR, port and another confusion between a dialysis the surgeon was marking a left neck lesion as the site catheter and an intended arteriovenous fistula. for removal and the nursing staff stated that the site was incorrect site per the parent. The surgeon said Three of the reports identified errors. One incorrect that the office notes indicated that the left neck was procedure was due to a scheduling error. One report correct and continued to remove the left neck lesion. cited a failure to do a time-out. One event involved When the patient was in the PACU [postanesthesia an incision for a different device, immediately Vol. 7, No. 3—September 2010 REPRINTED ARTICLE - ©2010 Pennsylvania Patient Safety Authority Page 103 Pennsylvania Patient Safety Advisory corrected, due to a mental error by the surgeon after evidence-based best practices to prevent wrong-site the time-out. surgery. Those requests should also be made to the Insertion of the correct vascular access device from Authority office or the regional PSL. among all the potential options appears to be the Notes most common challenge involving insertion of 1. Doing the “right” things to correct wrong-site devices. Vascular access devices are adjuncts to surgery. PA PSRS Patient Saf Advis [online] 2007 Jun treatment of major, long-term medical problems. [cited 2010 Aug 7]. Available from Internet: http:// The surgeon is usually in a supportive role. The www.patientsafetyauthority.org/ADVISORIES/ patient may have had many of the different options AdvisoryLibrary/2007/jun4(2)/Pages/29b.aspx. in the past. To supplement the general evidence- based practices for preventing wrong-site surgery, the 2. National Quality Forum. Serious reportable events in following refinements are proposed for procedures healthcare—2006 update. Washington DC: National Quality Forum; 2007. involving the insertion of a device, when the device is not part of a controlled specialty inventory: 3. Pennsylvania Patient Safety Authority (Authority). Preventing wrong-site surgery [patient safety tool 1. The specific device should be mentioned on collection online]. [cited 2010 May 3]. Harrisburg the schedule, the consent, and the surgeon’s (PA): Authority. Available from Internet: http:// preoperative evaluation of the patient. This www.patientsafetyauthority.org/EducationalTools/ information should be checked for its presence PatientSafetyTools/PWSS/Pages/home.aspx. and agreement with all the documents in the preoperative verification. 4. Quarterly update on the preventing wrong-site surgery project: improving, but still room for 2. The specific device should be mentioned during perfection. Pa Patient Saf Advis [online] 2009 Dec the time-out. [cited 2010 Aug 7]. Available from Internet: http:// 3. The specific device should be called out when www.patientsafetyauthority.org/ADVISORIES/ delivered onto the operative field. AdvisoryLibrary/2009/Dec6(4)/Pages/141.aspx. 5. Quarterly update on the preventing wrong-site surgery Resources, Consultation, and Other Education project: digging deeper. Pa Patient Saf Advis [online] The Authority’s Preventing Wrong-Site Surgery Web 2010 Mar [cited 2010 Aug 7]. Available from Internet: page has been reorganized for easier navigation of its http:// www.patientsafetyauthority.org/ADVISORIES/ many resources. They include self-assessment tools, AdvisoryLibrary/2010/Mar7(1)/Pages/26.aspx. sample forms and checklists, educational posters and 6. Joint Commission. Revised Universal Protocol; some videos, illustrative figures and tables, patient-educa- changes are effective immediately. Joint Commission tion brochures, and online information at other sites.3 Online 2009 Sep 9 [cited 2010 Aug 7]. Available The Authority has an on-site consultation program from Internet: http://www.jointcommission.org/ for Pennsylvania facilities that wish to analyze their NR/rdonlyres/25D5EC4D-F17C-4DCB-B0D2- vulnerabilities for wrong-site surgery, particularly 8967EE48D5F1/0/jconlineSept909.pdf. following a wrong-site event (or a close call) in a 7. Focusing on eye surgery. PA PSRS Patient Saf Advis surgical suite. Those interested in taking advantage [online] 2005 Mar [cited 2010 Aug 7]. Available from of this program should contact the Authority office Internet: http:// www.patientsafetyauthority.org/ or their regional patient safety liaison (PSL). The ADVISORIES/AdvisoryLibrary/2005/Mar2(1)/ Authority’s PSLs will assist facilities in assessing their Pages/12.aspx. policies and procedures, measuring staff compliance, 8. Still not seeing clearly—a second look at intraocular and doing a thorough analysis of any events using the lens implant events. Pa Patient Saf Advis [online] resources developed by the Authority.3 2008 Jun [cited 2010 Aug 7]. Available from Internet: Pennsylvania facilities in need can also request a http:// www.patientsafetyauthority.org/ADVISORIES/ Webinar to educate OR and surgical staff about AdvisoryLibrary/2008/Sep5(3)/Pages/106.aspx. Page 104 REPRINTED ARTICLE - ©2010 Pennsylvania Patient Safety Authority Vol. 7, No. 3—September 2010 PENNSYLVANIA PATIENT SAFETY ADVISORY This article is reprinted from the Pennsylvania Patient Safety Advisory, Vol. 7, No. 3—September 2010. The Advisory is a publication of the Pennsylvania Patient Safety Authority, produced by ECRI Institute and ISMP under contract to the Authority. Copyright 2010 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 Web site 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 Web An Independent Agency of the Commonwealth of Pennsylvania site 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.