Pennsylvania Patient Safety Advisory Quarterly Update on the Preventing Wrong-Site Surgery Project: Improving, but Still Room for Perfection The latest update from the Pennsylvania Patient Figure 1. Pennsylvania Patient Safety Authority Safety Authority’s reporting system database contin- Wrong-Site Surgery Reports by Quarter ues to show an encouraging decrease in the number NUMBER of reports of wrong-site surgery (see Figure 1, which OF REPORTS includes adjustments for late reports from previous 30 quarters). The number of reports for the third quarter of 2009 was the second lowest quarterly total ever 25 24 (the previous quarter’s total was the lowest), and was 23 21 the lowest-ever total for a third quarter, during which 20 20 19 19 20 the resident training cycle traditionally starts. The 17 17 total number of reports for the past six months (16) 16 16 15 15 15 15 15 14 is lower than the previous average for three-month 13 periods (16.9). 11 11 10 10 The trend toward fewer reports of wrong-site surgery 6 reinforces the Authority’s belief that the advice devel- 5 oped from the Preventing Wrong-Site Surgery Project MS09517 is useful. As further evidence, the regional collabora- 0 tive to prevent wrong-site surgery that was sponsored Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 by the Health Care Improvement Foundation again 2004 2005 2006 2007 2008 2009 reported no wrong-site surgeries since the first quar- REPORTS BY QUARTER ter, meaning that the participating facilities have had no such events in more than seven months. The collaborative’s time without wrong-site surgery now who asked the patient which knee was to be operated exceeds 97% of its previous event-free intervals. on. The patient stated “left.” The anesthesiologist per- formed the nerve block on the left side. The patient Anesthetic Blocks was taken to the OR for the right-knee surgery and The 10 reports received in the third quarter all it was determined the nerve block was done on the described problems previously addressed by the wrong side. Authority. In particular, four events, like three of the Whereas wrong-site blocks constituted 20% of the six reported last quarter, were wrong-site anesthetic wrong-site events in the first six months of data blocks (all reports have been edited for contextual reporting to the Authority, they accounted for 44% deidentification): of wrong-site events in the most recent six months A patient was scheduled for a surgical procedure of of reporting (see Figure 2), suggesting that the imple- left hand under axillary block. The anesthesiologist mentation of best practices to prevent wrong-site blocked the right arm. The correct arm, left, was blocks lags behind other efforts to prevent wrong-site marked appropriately. The error was discovered by surgery (the p value for the linear regression is 0.06, the anesthesiologist after initiating the block. just above the cutoff for statistical significance). Doing a formal time-out before an anesthetic block could A patient was brought to the OR [operating room] potentially eliminate about 27% (92 of 337) wrong- after being identified by the attending surgeon. The site errors in the surgical suite. However, based on the informed consent was reviewed. Prior to the time-out data from the Preventing Wrong-Site Surgery Project, identifying the eye to be operated on, a peribulbar a time-out before an anesthetic block does not elimi- block was inadvertently performed on the right eye by nate the need to do a time-out just before the start of the surgeon; the left eye was marked. The error was the surgical procedure, with the site marking visible in realized by the surgeon. The left eye then was blocked, the prepped and draped surgical field, as illustrated by sterilely prepared, and draped in the usual manner. two other reports from this quarter. The time-out was performed. The patient consented [to] and verbally affirmed A patient was scheduled for left cervical injection. procedure on L side lumbar area. The patient was The time-out was done prior to procedure, and all brought to the OR. The time-out was conducted with parties, including the patient, verified the procedure all members of surgical team present. All members was to be done on the left side. The physician injected agreed. The patient was moved onto table and posi- the right side. He did not mark the site. The patient tioned in the prone position. The patient tolerated asked after the procedure why the right was injected the procedure well and was transferred to the PACU rather than the left. [postanesthesia care unit]. The physician met the A patient was admitted for surgery [on the right patient and staff in PACU and explained he had knee]. The patient was seen by the anesthesiologist, done the procedure on the wrong side. Vol. 6, No. 4—December 2009 REPRINTED ARTICLE - ©2009 Pennsylvania Patient Safety Authority Page 141 Pennsylvania Patient Safety Advisory Figure 2. Percentage of Wrong-Site Surgery Reports That Describe Wrong-Site Anesthesia Blocks PERCENTAGE 60 55% 50% 50 47% 42% 40% 40% 40 35% 35% 33% 30 29% 31% 25% 27% 27% 20 20% 14% 10 15% 14% 13% MS09516 7% 6% 0 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 2004 2005 2006 2007 2008 2009 REPORTS BY QUARTER The side (left) was marked by the surgeon. When with the anesthesia provider just before any anesthetic block the perineal area is the operative site, the hand is and that another time-out be done with the surgeon just marked by the surgeon after checking consent, read- before the incision, unless the surgeon performs the ing note, and confirming with patient. The hand is anesthetic block and incision in continuity after the left undraped during procedure for confirmation of surgical field has been prepped and draped. side. In this procedure, the doctor did not place the mark on the hand; he marked it on the forearm. The Spinal Surgery patient was taken to the OR and positioned on table. Wrong-level spinal surgery continues to represent The surgeon made the incision without a formal roughly 10% of the wrong-site surgery events reported time-out. The surgeon asked which side. Without to the Authority. This quarter, the Authority received rechecking consent or site marking, the nurse stated two reports. Also, two parties requested that the the right side. The doctor [explored right side]. There Authority give suggestions on how to avoid this prob- was no evidence of pathology noted. Rechecked note. lem, which cannot be solved just by following the Completed procedure on left. Universal Protocol, because the site (level) verification The 2010 revision of the Joint Commission’s Uni- occurs intraoperatively. The North American Spine versal Protocol does not help the confusion, in the Society (NASS) suggests an intraoperative imaging Authority’s opinion, about when to do the time-out. study, after surgical exposure of the operative site, The 2009 version states that the time-out should using markers that do not move, to confirm the be done before the start of anesthesia; the 2010 ver- vertebral level to be operated on, with a radiologist’s sion reverts to stating that the time-out should be interpretation as well as the surgeon’s.2 done before the incision.1 Based on multiple studies The Authority advises the following, which summa- from the Preventing Wrong-Site Surgery Project,* the rizes its findings and the NASS checklist: Authority strongly advises that a formal time-out be done 1. Note the level on the schedule and on the con- * The Pennsylvania Patient Safety Authority has a Web page sent form. devoted to educational tools for preventing wrong-site surgery (avail- 2. Have relevant existing imaging studies available in able at http://www.patientsafetyauthority.org/EducationalTools/ PatientSafetyTools/PWSS/Pages/home.aspx). Its resources include the OR. all the Authority’s publications on the subject, including self- assessment tools, sample forms and checklists, educational posters 3. As always, the surgeon should include in the pre- and videos, illustrative figures and tables, and patient education operative time-out an explicit empowerment for brochures, as well as links to information from other Web sites. team members to speak up if concerned. Page 142 REPRINTED ARTICLE - ©2009 Pennsylvania Patient Safety Authority Vol. 6, No. 4—December 2009 Pennsylvania Patient Safety Advisory 4. Conduct an intraoperative imaging time-out: following a wrong-site event (or a close call). Requests a. Localize the desired site with an immobile radi- can be made by contacting the Authority office or the opaque marker, such as a needle in the bone regional Patient Safety Liaison. The Authority clinical or a Kocher clamp on the spinous process. specialists will assist facilities in assessing their policies and procedures, measuring staff compliance, and con- b. Obtain and read an imaging study that con- ducting a thorough analysis of any events. firms the site exactly. The Authority remains committed to eliminating c. Have the imaging study also officially read by wrong-site surgery. a radiologist before proceeding. Notes The Authority developed an addendum to the “Wrong-Site/-Side Surgery Error Analysis Form” that 1. Joint Commission. Revised Universal Protocol; some addresses wrong-level spine surgery and that is now changes are effective immediately. Joint Commission on the Authority’s Web site. Facilities should consult Online 2009 Sep 9 [cited 2009 Oct 26]. Available these additional questions when wrong-level spinal from Internet: http://www.jointcommission.org/ surgery has been done. NR/rdonlyres/25D5EC4D-F17C-4DCB-B0D2- 8967EE48D5F1/0/jconlineSept909.pdf. The Wrong-Site Surgery Consultation Program 2. North American Spine Society. Sign, mark & x-ray The Authority has begun an on-site consultation pro- (SMaX): a checklist for safety [online]. 2001 [cited 2009 gram for Pennsylvania facilities that wish to analyze Oct 26]. Available from Internet: http://www.spine.org/ their vulnerability for wrong-site surgery, particularly Documents/SMaXchecklist.pdf. Vol. 6, No. 4—December 2009 REPRINTED ARTICLE - ©2009 Pennsylvania Patient Safety Authority Page 143 PENNSYLVANIA PATIENT SAFETY ADVISORY This article is reprinted from the Pennsylvania Patient Safety Advisory, Vol. 6, No. 4—December 2009. The Advisory is a publication of the Pennsylvania Patient Safety Authority, produced by ECRI Institute and ISMP under contract to the Authority. Copyright 2009 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 https://www.papsrs.state.pa.us/ Workflow/MailingListAddition.aspx. 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.