Pennsylvania Patient Safety Advisory Improvement in Preventing Wrong-Site Surgery! Traction or Transient? The latest update from the Pennsylvania Patient Figure. Pennsylvania Patient Safety Authority Safety Authority’s reporting system database shows Wrong-Site Surgery Reports by Quarter an encouraging decrease in the number of reports of NUMBER wrong-site surgery for the third consecutive quarter OF REPORTS (despite adjustments for late reports) to an all-time 30 low of six reports (see Figure). This is the most sus- tained statewide decrease in wrong-site surgery events 25 24 22 to date. Furthermore, a regional collaborative to 20 20 21 20 19 19 prevent wrong-site surgery that began in March 2008 17 18 reported zero wrong-site surgeries during the second 16 15 16 15 14 15 15 13 13 quarter of 2009, meaning facilities participating in 11 11 the collaborative have reported only two events in 10 more than seven months and none in more than four 6 months. The collaborative’s time without wrong-site 5 surgery exceeds 95% of its previous event-free inter- vals. The Authority continues to monitor wrong-site 0 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 surgeries and plans to replicate the collaborative in 2004 2005 2006 2007 2008 2009 another region. REPORTS BY QUARTER The six reports during the second quarter of 2009 all described problems previously addressed by the Authority: from the time-out and performed a left YAG laser capsulotomy for posterior capsule opacification. ■ One report described a wrong-site surgery based At the end of the procedure, the doctor realized an on an incorrect side listed on the schedule. The error had been made and then performed the correct Authority advocates checking the accuracy of the procedure on the patient’s left eye. Investigation of site on the schedule by reconciling the schedule the event revealed that the surgeon had two patients with the history and physical, physician order, and scheduled back-to-back that afternoon: the first for consent. a capsulotomy and the second for an iridotomy. The ■ Three reports described wrong-site anesthesia patients were taken to the [operating room (OR)] out blocks without referencing the site mark. Many of order due to their arrival time. Even though the wrong-site procedures are wrong-site anesthesia nurse identified the patient correctly and performed blocks that could be prevented by a formal time- a time-out correctly indicating a left iridotomy proce- out before such procedures. dure, the surgeon “pulled rank” and insisted on doing a left capsulotomy, which was originally the first pro- ■ One report described doing the time-out before cedure on the schedule that day. prepping the patient. The wrong site was then prepped. The Authority advises doing the time-out The facility identified two problems: (1) the lack of after prepping and draping, with the site mark vis- situational awareness about the change in the OR ible in the field. schedule and (2) the use of hierarchy to resolve a ■ One report, edited for contextual deidentification, conflict. The Authority’s analysts also identified the is described in full because it includes many causes failure of the surgeon to see the patient before the of wrong-site surgery. (The reader is encouraged patient entered the OR to verify the correct informa- to take a moment to list as many causes he or she tion, the failure to verify information with the patient, can and then compare those causes with the causes reliance on memory rather than documentation, that the Authority’s analysts identified.) the failure to reconcile conflicting information, the failure to have office records available for reference, The patient arrived for ordered left YAG laser iri- the failure to empower the nurse, and the failure to dotomy for glaucoma. The patient was identified and satisfactorily address a concern raised by a member of prepped for this procedure. When the surgeon arrived, the operating team. the nurse performed a time-out using the original phy- sician order and the consent, both indicating that the Although Pennsylvania facilities are reporting fewer patient was to undergo a left YAG laser iridotomy wrong-site surgeries, one of the above reports was for glaucoma. The doctor informed the nurse that from a facility that had never previously reported a the nurse was wrong. The nurse showed the doctor wrong-site procedure in the five years of mandatory the original order and consent signed by the patient reporting to the Authority, despite a large volume of in the office. The doctor insisted the patient was to surgery. Its report is an example that facilities must have left YAG laser capsulotomy for posterior capsule always be aware of the possibility that the next case opacification. The doctor overruled the information may involve wrong-site surgery. Page 104 REPRINTED ARTICLE - ©2009 Pennsylvania Patient Safety Authority Vol. 6, No. 3—September 2009 Pennsylvania Patient Safety Advisory If surgical facilities are to hold their gains in consis- 15. All members of the operating team should ver- tently performing correct-site surgery, the following bally verify that their understanding matches the principles for reliable performance of correct-site sur- information in the relevant documents. gery, identified by the Authority during its Preventing 16. The surgeon should specifically encourage oper- Wrong-Site Surgery Project, should be consistently ating team members to speak up if concerned followed: during the time-out. 1. The correct site of the operation should be speci- 17. Operating team members who have concerns fied when the procedure is scheduled. should not agree to the information given in the 2. The correct operation and site should be time-out if their concerns have not been addressed. noted on the record of the history and physical 18. Any concerns should be resolved by the surgeon, examination. based on primary sources of information, to the 3. The correct operation and site should be specified satisfaction of all members of the operating team on the informed consent. before proceeding. 4. Anyone reviewing the schedule, consent, history 19. Verification of spinal or rib level should require and physical examination, or reports document- radiological confirmation, using a stable marker ing the diagnosis, should check for discrepancies and readings by both a radiologist and the surgeon. among all those parts of the patient’s record and 20. All paperwork and labels for a patient in an OR reconcile any discrepancies with the surgeon should be cleared before the next patient arrives. when noted. 21. Information identifying surgical specimens 5. The surgeon should bring copies of supporting should be verified with the surgeon via active information uniquely found in the office records communication of specific information, rather to the surgical facility the day of surgery. than a passive agreement. 6. All information that should be used to support the Survey on Surgical Site Marking Pens and correct patient, operation, and site, including the Techniques patient’s or family’s verbal understanding, should be verified by the nurse, anesthesia provider, and In July 2009, the Authority’s analysts distributed a surgeon before the patient enters the OR. survey, through Patient Safety Officers (PSOs), for OR managers in Pennsylvania hospitals and ambula- 7. All verbal verification should be done using ques- tory surgical facilities to share their good and bad tions that require an active response of specific experiences using various marking pens with various information, rather than a passive agreement. skin preparation agents. OR managers were asked to 8. Patient identification should always require two report the visibility of their markers with their vari- unique patient identifiers. ous skin preparations and to relay any complaints 9. Any discrepancies in the information should be from patients. resolved by the surgeon, based on primary sources Within three weeks, the Authority received 106 of information, before the patient enters the OR. responses of facility experiences. The results of the 10. The site should be marked by a healthcare profes- survey are available in two tables on the Authority’s sional familiar with the facility’s marking policy, Web site.* Table 1 lists experiences according to the with the accuracy confirmed both by all the markers, and Table 2 lists experiences according to relevant information and by an alert patient, or the skin preparation agents. (Although respondents patient surrogate if the patient is a minor or men- were not asked to list multiple products, some did; tally incapacitated. hence, the number of evaluations exceeded the actual number of survey responses.) Experiences are 11. All information that should be used to support reported for visibility of the mark after skin prepara- the correct patient, operation, and site, including tion and for patient complaints about the marks. the patient’s or family’s verbal understanding, Cardinal Health markers were almost always reported should be verified by the circulating nurse upon to be visible with no patient complaints, although taking the patient to the OR. the specific Cardinal Health products were not listed 12. Separate formal time-outs should be done for in the reports. Viscot Medical Precision surgical skin separate procedures, including anesthetic blocks, markers received comparable reports, albeit with fewer with the person performing that procedure. 13. The site mark should be visible and referenced in the prepped and draped field during the time-out. * The Pennsylvania Patient Safety Authority has a Web page devoted to educational tools for preventing wrong-site surgery 14. Verification of information during the time- (available at http://www.patientsafetyauthority.org/Educational- out should require an active communication Tools/PatientSafetyTools/PWSS/Pages/home.aspx). Its resources include all the Authority’s publications on the subject, including of specific information, rather than a passive self-assessment tools, sample forms and checklists, educational agreement, and be verified against the relevant posters and videos, illustrative figures and tables, patient-education documents. brochures, and online information available from other Web sites. Vol. 6, No. 3—September 2009 REPRINTED ARTICLE - ©2009 Pennsylvania Patient Safety Authority Page 105 Pennsylvania Patient Safety Advisory experiences and one comment that the ink needs a time-out script that identify the patient, procedure, adequate time to dry. and side or site of the procedure. Implants avail- Only 3 of the 106 facilities reported surgeons’ con- ability, antibiotic administration, allergies, and other cerns about the sterility of marks in a prepped surgical additions to the Universal Protocol not related to pre- field. In a prior review, the Authority reported no venting wrong-site surgery have been eliminated from documented concerns in the medical literature regard- the time-out scripts. Elements of the time-out that ing the sterility of single-use marking pens.1 involve confirmation or documentation not based on conversation have also been eliminated. Please send The Time-Out Script Competition your reviews and comments on any or all components of any or all scripts electronically to the editor at The Authority has posted five entries for the Time- jclarke@ecri.org. Please ensure comments are linked Out in the OR Script Competition online at http:// to specific scripts by their numbers. This is your www.patientsafetyauthority.org/EducationalTools/ chance to help shape robust scripts for time-outs. PatientSafetyTools/PWSS/Pages/scripts.aspx. The Authority remains committed to decreasing The first round of open-ended review and comment and eventually eliminating wrong-site surgery. The remains active for all who wish to participate. The Authority welcomes any comments, suggestions, and Pennsylvania Patient Safety Advisory editors appreciate specific inquiries from facilities with specific prob- the review comments submitted to date. The edi- lems or questions concerning wrong-site surgery. For tors may publish some of the critiques during the example, PSOs at facilities that experience wrong-site second round but will not identify any reviewers. The surgery could contact the Authority to assist in root- reviews may make a general comment on any script cause analysis. Communications should be directed or comment on any parts of any scripts, positively or to: John Clarke, MD, FACS, clinical director of the negatively, but should specifically consider at least Pennsylvania Patient Safety Authority, at ECRI Insti- three issues: (1) compliance with the time-out ele- tute, by telephone at (610) 825-6000 or by e-mail at ments of the Universal Protocol intended to prevent jclarke@ecri.org. wrong-site surgery, (2) active participation of all the important members of the operating team, and (3) Note efficiency. Efficiency will be defined as the length of 1. Surgical site markers: putting your mark on patient time involved in performing the script. As mentioned safety. Pa Patient Saf Advis [online] 2008 Dec [cited in the March 2009 issue of the Advisory, the time 2009 Aug 4]. Available from Internet: http:// should ideally be less than 90 seconds. Please note www.patientsafetyauthority.org/ADVISORIES/ that the script competition includes only the parts of AdvisoryLibrary/2008/Dec5(4)/Pages/130.aspx. Page 106 REPRINTED ARTICLE - ©2009 Pennsylvania Patient Safety Authority Vol. 6, No. 3—September 2009 PENNSYLVANIA PATIENT SAFETY ADVISORY This article is reprinted from the Pennsylvania Patient Safety Advisory, Vol. 6, No. 3—September 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.