Pennsylvania Patient Safety Advisory Quarterly Update on the Preventing Wrong-Site Surgery Project Where is the Sense of Urgency? and the verification of the perioperative documents. Wrong-site surgery is a “never event,” and now it is Misperception problems require attentive (rather also a procedure for which hospitals and ambulatory than automatic) behavior by multiple members of the surgical facilities will probably not get reimbursement operating team, acting redundantly, to reliably catch (if they ever did). The Centers for Medicare & Med- the errors. icaid Services intends to add wrong procedures and Past studies have shown that physician behavior is crit- procedures on wrong body parts and wrong patients ical to preventing wrong-site surgery.5 Physicians catch to its list of unreimbursed preventable conditions.1 potential errors by seeing their patients and reviewing The latest update from PA-PSRS shows that another their records before the patients enter the operating 20 wrong-site surgeries were reported during the room (OR). However, physicians are major contribu- third quarter of 2008 (see Figure). Minor adjustments tors to wrong-site errors that first arise in the OR. have been made in previous quarters to reflect new Improvement in the efforts to prevent wrong-site information. Altogether, Pennsylvania facilities have surgery requires both improvement in the accuracy reported 286 wrong-site surgeries in 51 months, or of information in the preoperative scheduling and about one every five to six days. Overall, about 27% documentation systems and improvement in provider of wrong-site procedures were anesthesia blocks or involvement in the process. Reliability that depends other preliminary invasive procedures, 63% involved on human behavior requires redundancy, meaning a failure of the Universal Protocol for the principal everyone on the patient care team must make the procedure, and 10% were wrong-level spinal pro- patient’s safety his or her personal responsibility—not cedures that could only be caught by radiographic the responsibility of someone else. confirmation of the spinal level during the initial sur- gical exposure of the operative site. Preliminary Results of a One-Year Analysis The Joint Commission has recognized the persistence of Wrong-Site Errors in Pennsylvania Using of wrong-site surgery nationally,2 noticed a decrease in a Common Analysis Form compliance with the Universal Protocol time-out (most From August 2007 through August 2008, facilities in recently in ambulatory care centers from 94% in 2003 Pennsylvania used a common analysis form to analyze to 83% in 2008),3 and issued more explicit directions 44 wrong-site surgeries and 97 near misses. PA-PSRS for the conduct of the Universal Protocol in 2009.4 analysts thank the facilities that took the time to com- Wrong-site surgery happens every week in Pennsyl- plete the common assessment form and contribute to vania and, by extrapolation, every day in the United the statewide initiative to prevent wrong-site surgery. States. It happens despite knowing how it happens A complete analysis of the differences between near- and what keeps it from happening.5,6 Misinforma- miss wrong-site errors that are caught and those that tion problems can be prevented by a robust design go on to actual occurrences will be published in the of the information system supporting scheduling future. The following are preliminary conclusions based on comparisons of wrong-site surgeries to near Figure. PA-PSRS Wrong-Site Surgery Reports by misses. Quarter ■ Reports of near misses were more likely to identify NUMBER errors in scheduling, errors on the consent form, OF REPORTS and discrepancies between the patient’s under- 30 standing and the written documents. ■ Reports of near misses were more likely to mention 25 24 the use of multiple identifiers during preoperative 21 verification and the use of the identification wrist- 20 20 20 20 19 19 band during the time-out. 17 16 14 15 15 15 16 ■ The surgeon was more frequently involved in the 15 13 preoperative verification process in reported near 11 11 misses than reported wrong-site surgeries. (This 10 11 observation is consistent with the observations in a previously reported retrospective analysis authored 5 by PA-PSRS analysts.5) 0 ■ Near-miss reports more frequently indicated Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 that the time-out was done after the patient was 2004 2005 2006 2007 2008 prepped and draped and that the operative site REPORTS BY QUARTER mark was visible during the time-out. Page 142 REPRINTED ARTICLE - ©2008 Pennsylvania Patient Safety Authority Vol. 5, No. 4—December 2008 Pennsylvania Patient Safety Advisory ■ Near-miss reports indicated participation in the wrong-site errors based on misinformation (rather time-out of more members of the OR team. than misperceptions of right and left) are corrected ■ The operating surgeon was more likely to encour- before the patient enters the OR. Informational age members of the team to speak up if concerned errors should be corrected before the patient reaches during the time-out and to respond to concerns the OR, freeing up the very busy operating team to raised in reported near misses than in reported worry only about errors of misperception due to right- wrong-site surgeries. left confusion, confirmation bias, and other causes. Because of the successful use of the common analysis Before a panel on OR safety at the 2008 Clinical form for wrong-site surgery, near misses, and actual Congress of the American College of Surgeons, the occurrences in Pennsylvania, the wrong-site error author asked the surgeons in the audience whether analysis form has been posted on the Pennsylvania they would see their preoperative patients in the hold- Patient Safety Authority’s Preventing Wrong-Site Sur- ing area if they were not required to do so and, if so, gery Web page.6 PA-PSRS analysts encourage anyone why. Of 29 respondents, 27 said they would; 2 said faced with a wrong-site surgery near miss or occur- they would not. Time constraint was the common rence in his or her facility to use the form to aid in reason for not seeing patients. One of the 27 surgeons the analysis. now sees patients in the holding area because of a previous experience of performing a wrong-site sur- Multiple Wrong-Site Surgeries of the Same gery associated with the practice of not seeing patients Type at Multiple Facilities before they entered the OR the day of the surgery. PA-PSRS analysts looked at the 64 facilities that had Altogether, the 27 surgeons gave 51 reasons for volun- reported more than one wrong-site surgery since tarily seeing their patients in the holding area. These reporting began in June 2004; 25 had some simi- reasons were grouped into several categories. The larities within their multiple reports of wrong-site most common reasons cited were to provide psycho- surgery, suggesting a problem with the facility’s system logical support for the patient: to reassure patients or with an individual provider’s behavior. Of those and their families and decrease their anxiety (12), to 25 facilities, 21 had multiple reports of problems affirm the surgeons’ rapport with their patients within that also occurred multiple times at other facilities, the context of the doctor-patient relationship (7), to suggesting system problems rather than individual convey caring and concern for their patients (3), and provider problems. The problems that occurred multi- to address concerns or questions of patients or their ple times at each of multiple facilities were as follows: families (5). More than two-thirds (19) of the surgeons ■ Local anesthesia blocks, nerve blocks, regional gave one or more reasons related to psychological sup- blocks, periorbital blocks, nerve root injections, port of patients and their families as their rationale for epidural injections, and other injections were done seeing patients in the holding area. at the wrong site 40 times in 17 facilities that made Two other groups of reasons were related to acquiring this wrong-site error more than once. information. One group of reasons was associated ■ Other wrong-site errors associated with eye surgery with the review of information to avoid treating occurred four times in two facilities. patients based on incorrect information from faulty memories: to review information relevant to the ■ Wrong-site ureteral procedures occurred four times patient and procedure (11), to specifically check in two facilities. information while the patient was still alert (1), to ■ Cervical spine fusions, other spinal fusions, and check documents such as the consent form (2), and other spinal procedures were done at the wrong to mark the site (1). About half (14) the surgeons gave vertebral level 16 times in five facilities that made the opportunity to refresh their memories by review- this wrong-site error more than once. ing information as a reason for seeing patients in the These results suggest that the greatest potential for holding area. The other information-related reason system improvement to prevent wrong-site surgery is cited was a desire to see whether patients’ conditions adherence to the Universal Protocol for preliminary had changed since they had last been seen, which anesthetic procedures4 and strengthening of the might alter or even lead to cancellation of the pro- system for radiographic confirmation of the correct cedure. Interest in checking for changes in patients’ vertebral level during spinal surgery.7 conditions (4) added another two surgeons to those who visited patients in the holding area to acquire Rationale for Surgeons to See Patients in information from alert patients before bringing them the Preoperative Holding Area, Rather Than into the OR. Initially Greeting Them in the OR Other reasons centered around the surgeons’ sense As noted above, a significant contributor to physi- of the standard of care: visiting the patient preopera- cian behavior that prevents wrong-site surgery is the tively was part of the doctor-patient relationship, as surgeon’s practice of participating in the preoperative noted above (7), represented best medical care (1), verification of written documents with awake patients was a safe practice (3), or was safer than not visiting in the preoperative holding area so that potential the patient, based on personal experience (1). About Vol. 5, No. 4—December 2008 REPRINTED ARTICLE - ©2008 Pennsylvania Patient Safety Authority Page 143 Pennsylvania Patient Safety Advisory 40% of the surgeons indicated their belief that visit- ing patients in the holding area was, for them, the Enter the Time-Out in the OR Competition standard of care. Does your facility have a particularly good script Surgeons appear to be motivated to see patients in the for the time out in the operating room (OR)? If so, preoperative holding area. For 93% of the surgeons please enter the Time-Out in the OR competition. surveyed, the reasons fell into one or both of the fol- Here’s what you have do: lowing categories: Write down your script for a Time-Out in the 1. Providing psychological support to the patient OR for Mary Jones’ (MR# 007) Left Total Hip Replacement as if it were a Shakespearean play. and/or family For example: 2. Reviewing and updating information Circulating nurse: “Time-out. We are These positive motivations may encourage compli- doing a left total hip replacement on ance with the most recent revisions of the Universal Mary Jones, medical record number 007; Protocol.4 is that right?” Surgeon: “Right.” Setting the Patients’ Expectations Anesthesia provider: “Agree.” Properly following the Universal Protocol involves Submit the script in a Word document or its elec- asking a preoperative patient the same questions tronic text equivalent to JClarke@ecri.org. repeatedly. Prompted by reports of hospitals that have informed patients about what to expect as a The entries will be posted for peer review and comments. The winning entries will be determined consequence of following the Universal Protocol, by a vote of your peers, posted on the Pennsylva- the Pennsylvania Patient Safety Authority has devel- nia Patient Safety Authority Web site, and profiled oped a brochure that surgeons or facilities can give in an upcoming issue of the Advisory. to preoperative patients so that they understand why This is your opportunity to share your expertise so many providers ask the same questions. Surgeons with others. and facilities can download the brochure from the Pennsylvania Patient Safety Authority’s Preventing Wrong-Site Surgery Web page.6 They can add their Notes logos or contact information to personalize the bro- 1. Onigman M. CMS to add surgical errors to ‘never event’ chure to their environment. list [online]. 2008 Dec 4 [cited 2008 Dec 5]. Available Ongoing Projects to Prevent Wrong-Site from Internet: http://iafaw.blogspot.com/2008/12/ cms-to-add-surgical-errors-to-never.html. Surgery 2. Joint Commission. Statement and persistence of the This issue of the Advisory contains a review of the problem [online]. 2008 Nov 24 [cited 2008 Dec 5]. Avail- literature addressing the sterility of site marking and able from Internet: http://www.jointcommission.org/ the potential for cross-contamination with use of AccreditationPrograms/Office-BasedSurgery/ markers on multiple sites. The review also looks at Standards/09_FAQs/NPSG/Universal_Protocol/ the performance of site markers with various skin General/Statement+and+Persistence+of+the+Problem. prep solutions. Because the literature on this latter htm. topic is inconclusive, PA-PSRS analysts will be survey- 3. Joint Commission. National Patient Safety Goal compli- ing the experiences of Pennsylvania facilities that use ance trends by program: ambulatory care accreditation surgical site markers with their skin prep solutions. program (January 1, 2003- June 30, 2008) [online]. [cited Pennsylvania Patient Safety Officers are encouraged 2008 Dec 5]. Available from Internet: http://www. to help their OR managers to complete the survey jointcommission.org/NR/rdonlyres/AA3A3F66-ADFE- when it is distributed in the near future. Also, others 4330-A58D-D17728D9C3BD/ are encouraged to tell PA-PSRS analysts about their 0/08_npsg_2nd_quarter_ahc.pdf. experiences using site markers (see the contact infor- 4. Joint Commission. 2009 standards frequently asked mation below). questions: Comprehensive Accreditation Manual for Two submissions have been made to the Time-Out Hospitals (CAMH) [online]. 2008 Nov 24 [cited 2008 in the OR Competition mentioned in the previous Dec 5]. Available from Internet: http://www.joint- issue of the Advisory. The contest remains open to commission.org/AccreditationPrograms/Hospitals/ more entries (see “Enter the Time-Out in the OR Standards/09_FAQs/. Competition”). 5. Clarke JR, Johnston J, Finley ED. Getting surgery right. The Pennsylvania Patient Safety Authority is com- Ann Surg 2007 Sep;246(3):395-405. mitted to preventing wrong-site surgery. Comments, 6. Pennsylvania Patient Safety Authority. Preventing wrong- suggestions, and specific inquiries are welcome from site surgery [toolkit online]. [cited 2008 Dec 5]. Available facilities with particular problems or questions con- from Internet: http://www.psa.state.pa.us/psa/cwp/ cerning wrong-site surgery. Communications should view.asp?a=1293&q=448010. be directed to John Clarke, MD, FACS, clinical 7. North American Spine Society. Sign, mark & x-ray director of the Pennsylvania Patient Safety Reporting (SMaX): a checklist for safety [online]. 2001 [cited 2008 System at ECRI Institute, by telephone at (610) 825- Dec 5]. Available from Internet: http://www.spine.org/ 6000 or by e-mail at JClarke@ecri.org. Pages/PracticePolicy/ClinicalCare/SMAX/Default.aspx. Page 144 REPRINTED ARTICLE - ©2008 Pennsylvania Patient Safety Authority Vol. 5, No. 4—December 2008 PENNSYLVANIA PATIENT SAFETY ADVISORY This article is reprinted from the Pennsylvania Patient Safety Advisory, Vol. 5, No. 4—December 2008. The Advisory is a publication of the Pennsylvania Patient Safety Authority, produced by ECRI Institute and ISMP under contract to the Authority as part of the Pennsylvania Patient Safety Reporting System (PA-PSRS). Copyright 2008 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 “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 PA-PSRS program, 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 PA-PSRS program or the Pennsylvania Patient Safety An Independent Agency of the Commonwealth of Pennsylvania Authority, see the Authority’s Web 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.