R E V I E W S & A N A LY S E S Comments from Pennsylvania Medical Professional Societies on the Pennsylvania Patient Safety Authority’s Potential Recommendations to Prevent Wrong-Site Surgery and the Authority’s Responses John R. Clarke, MD Potential recommendations to prevent wrong-site surgery were sent to 27 medical pro- Editor, Pennsylvania Patient Safety Advisory fessional societies in Pennsylvania for comment.* These recommendations were based Clinical Director, Pennsylvania Patient Safety Authority Professor of Surgery, Drexel University on the Authority’s 21 Principles for Reliable Performance of Correct-Site Surgery1 (see “Principles for Reliable Performance of Correct-Site Surgery”). The evidence base for these recommendations has been presented in the past and is available from the Authority.2 The potential impact of each recommendation on reduc- ing wrong-site surgeries in Pennsylvania has also been presented.3 Medical professional societies in Pennsylvania were asked to comment on the accept- ability, feasibility, and cost of each of the 21 recommendations. Twelve medical profes- sional societies responded to the request for comments, including among them seven surgically-related specialty societies and two general medical provider societies. No organization commented that any of seven recommendations were unacceptable, not feasible, or costly. Those recommendations were recommendations 1, 2, 3, 7, 8, 17, and 20 (see “Prin- ciples for Reliable Performance of Correct-Site Surgery”). Six other recommendations also did not receive comments that they were unacceptable but did receive comments about feasibility or costs. — One organization thought that reconciling discrepancies (recommendation 4) would not be feasible because of difficulties reaching the surgeons. One organiza- tion thought that additional manpower might be needed. In response, the Authority notes that reconciliation must occur sometime preoperatively. — Three organizations thought that having information available that was unique to the office records (recommendation 5) was not feasible and was costly because of the lack of integration between the surgeons’ records and the operating facili- ties’ records. One organization thought that it could be easily achieved by faxing the supporting documents to the preoperative suite. The Authority agrees with the proposed solution. — One organization thought that having both the nurse and the surgeon verify the patient’s information preoperatively (recommendation 6) was not feasible. In response, the Authority reiterates the strong evidence that the surgeon’s preoperative verifica- tion is one of the most important actions for preventing wrong-site surgery.2 Preoperative verification by the surgeon provides both a double check of the information used for the final time-out and a reminder for the surgeon of the correct information about that patient in preparation for his or her participation in the final time-out. — Two organizations thought that having the circulating nurse verify all information before taking the patient to the OR (recommendation 12) was costly because of the nursing time involved. In response, the Authority reiterates the importance of mak- ing sure all patient information is correct before the patient enters the OR.2 — One organization thought that separate time-outs for separate procedures (rec- ommendation 13), including anesthetic blocks, was time consuming, although Scan this code another organization commented that it required minimal additional time. The with your mobile device’s QR reader to access *As of the date of publication, all recommendations in this supplement issue of the Pennsylvania the Authority's Patient Safety Advisory are to be considered potential recommendations to prevent wrong-site wrong-site surgery surgery. prevention toolkit. (continued on page 18) Page 16 Pennsylvania Patient Safety Advisory Vol. 9, Suppl. 1—November 20, 2012 ©2012 Pennsylvania Patient Safety Authority PRINCIPLES FOR RELIABLE PERFORMANCE OF CORRECT-SITE SURGERY The following principles for reliable performance of correct-site surgery, identified by the Pennsylvania Patient Safety Authority during its Preventing Wrong-Site Surgery Project, should be consistently followed. 1. The correct site of the operation should be specified when the procedure is scheduled. 2. The correct operation and site should be noted on the record of the history and physical examination. 3. The correct operation and site should be specified on the informed consent. 4. Anyone reviewing the schedule, consent, history and physical examination, or reports documenting the diagnosis should check for discrepancies among all those parts of the patient’s record and reconcile any discrepancies with the surgeon when noted. 5. The surgeon should have supporting information uniquely found in the office records at the surgical facility on the day of surgery. 6. All information that should be used to support the correct patient, operation, and site, including the patient’s or family’s verbal understanding, should be verified by the nurse, anesthesia provider, and surgeon before the patient enters the operating room (OR). 7. All verbal verification should be done using questions that require an active response of specific information rather than a pas- sive agreement. 8. Patient identification should always require two unique patient identifiers. 9. Any discrepancies in the information should be resolved by the surgeon, based on primary sources of information, before the patient enters the OR. 10. The site should be marked by a healthcare professional familiar with the facility’s marking policy, with the accuracy con- firmed both by all the relevant information and by an alert patient, or patient surrogate if the patient is a minor or mentally incapacitated. 11. The site should be marked by the provider’s initials. 12. All information that should be used to support the correct patient, operation, and site, including the patient’s or family’s verbal understanding, should be verified by the circulating nurse upon taking the patient to the OR. 13. Separate formal time-outs should be done for separate procedures, including anesthetic blocks, with the person performing that procedure. 14. All noncritical activities should stop during the time-out. 15. The site mark should be visible and referenced in the prepped and draped field during the time-out. 16. Verification of information during the time-out should require an active communication of specific information, rather than a passive agreement, and be verified against the relevant documents. 17. All members of the operating team should verbally verify that their understanding matches the information in the relevant documents. 18. The surgeon should specifically encourage operating team members to speak up if concerned during the time-out. 19. Operating team members who have concerns should not agree to the information given in the time-out if their concerns have not been addressed. 20. Any concerns should be resolved by the surgeon, based on primary sources of information, to the satisfaction of all members of the operating team before proceeding. 21. Verification of spinal level, rib resection level, or ureter to be stented should require radiological confirmation, using a stable marker and readings by both a radiologist and the surgeon. Source: Pennsylvania Patient Safety Authority. Principles for reliable performance of correct-site surgery [online]. 2010 Dec [cited 2012 Jun 25]. http://patientsafetyauthority.org/EducationalTools/PatientSafetyTools/PWSS/Documents/principles.pdf. Vol. 9, Suppl. 1—November 20, 2012 Pennsylvania Patient Safety Advisory Page 17 ©2012 Pennsylvania Patient Safety Authority R E V I E W S & A N A LY S E S (continued from page 16) Authority agrees with the comment that Six recommendations received com- — One organization had strong objec- the time is minimal. ments about acceptability and about tions to the recommendation that feasibility or costs. the site mark be visible in the — One organization thought that the — One organization did not agree prepped and draped field during definition of “noncritical” activities that surgeons should be responsible the time-out (recommendation 15), that should be stopped during the for resolving discrepancies in the stating that, during eye surgery, time-out (recommendation 14) was patient’s information, using primary only the eye itself is visible. The not specific, making compliance sources of information, before the recommendations of the American difficult. In response, the Authority patient enters the operating room Academy of Ophthalmology Wrong- agrees that the definition of “noncritical” (recommendation 9) and thought Site Task Force4 include marking activities is unstated. At this time, it rec- that having the surgeon do it was not the site “if only one eye is to have ommends facilities include lists of exempt feasible. However, the organization surgery,” suggesting the mark be “critical” activities in their policies in lieu may have misunderstood what infor- placed “around the eye” (meaning of a uniform definition for all facilities. mation needed to be resolved using near, not surrounding). The recom- Two recommendations received com- mendations further state that “if it is primary sources, saying “license, ments that they were unacceptable customary for the surgeon to put a passport” may not be available. but did not receive specific com- towel over the patient’s forehead in The recommendation refers to the ments about feasibility or costs. the operating room prior to placing patient’s medical record.2 Another — Two organizations did not agree organization thought this recom- of the clear surgical drape, it may be that the site should be marked with mendation was not feasible, because beneficial for the identifying mark the provider’s initials (recommenda- surgeons may run multiple operating to be placed on the cheek rather tion 11), one arguing that the initials rooms. In response, the Authority reiter- than the forehead. In this way, the are sometimes illegible, and both ates the strong evidence that the surgeon’s surgeon can visualize the identifying proposing that other institutionally reconciliation of discrepancies is one of mark immediately before placing the consistent methods should be accept- the most important actions for preventing surgical drape.” able. No organization commented wrong-site surgery.2 In response to the concerns, an analyst that the recommendation was not from the Authority sampled the cover- — One organization did not agree feasible or was costly. In response, age of ophthalmic surgery drapes and that the site should be marked by a the Authority notes that the evidence observed marking and time-out procedures healthcare professional familiar with favoring the use of initials to mark the during three cataract procedures in an the facility’s marking policy, with the site is based on a single analysis2 and is ambulatory surgical facility. 3M™ accuracy confirmed both by all the willing to consider an alternative to this Steri-Drape™ ophthalmic drapes with relevant information and by an alert evidence-based best practice recommenda- apertures ranged in aperture size from patient or patient surrogate (recom- tion if evidence is presented supporting 17.7 x 6.7 cm to 5.7 x 2.9 cm.5 The mid- mendation 10), offering a more the alternative. size drapes used in the three procedures stringent requirement that the mark- — One organization did not agree ing be done by the attending surgeon observed allowed the surgical site marks, that the surgeon should specifically or resident. One organization placed in the vicinity of the brows, to be encourage operating team members thought that the recommenda- visible through the Steri-Drapes in the to speak up if concerned during the tion was not feasible under certain apertures. It was the opinion of the ana- time-out (recommendation 18) on circumstances, such as for emergen- lyst that surgical site marks placed near the premise that such a statement cies or court-appointed consents. the boney prominences surrounding the “conveys the false impression that In response to the concerns about the orbit—in the vicinity of the brow, cheek- a) without it, teammates would not feasibility of confirmation of the mark bone, or lateral bridge of the nose—could speak and b) other times are not under certain circumstances, the Author- be visible in a prepped and draped field safe to voice concern.” In response, ity agrees that unusual circumstances (see Figure). The Authority reviewed the the Authority reiterates the very clear may need to be covered by the facility’s 30 reports of wrong-side eye surgery; eight evidence that explicit empowerment is marking policy, including the use of other reports (27%) specifically mentioned that observed significantly more—almost twice healthcare providers as patient surrogates the correct eye had been marked prior to as often—in analyses of near-miss events if necessary. the wrong-side procedure. than wrong-site events.2 Page 18 Pennsylvania Patient Safety Advisory Vol. 9, Suppl. 1—November 20, 2012 ©2012 Pennsylvania Patient Safety Authority Figure. Eye Drape Shows Space for Site Marking communication and verification against documents does not mean that a surgeon in sterile attire goes through the patient’s chart. It means that the surgeon responds to a question such as “Which side is the surgery on?” instead of “The surgery is on the left side. Do you agree?” The veri- fication against the documents does not have to be done by each provider who is giving an active response but can be done by a single provider who is receiving the responses. — One organization did not think that the recommendation that operating team members who have concerns should not agree to the information given in the time-out if their concerns have not been addressed (recommendation 19) should be included. However, the recommendation may have been misunderstood; the organization Photo courtesy of Shutterstock. All rights reserved. stated that it “would not include it in any form.” No reasons were given. The Authority does not agree with the reiterates the evidence that in a compara- In response, the Authority reiterates the American Academy of Ophthalmology tive analysis of wrong-site events and very strong evidence that concerns are Wrong-Site Task Force that marking need near-miss events, wrong-site events were raised in near-miss events and not in only be done when one eye is involved. significantly more likely to not have had wrong-site events.2 On logical grounds, one could not distin- the site mark visible in the prepped and guish an unmarked eye during the start draped field.2 — One organization did not agree that of a bilateral procedure from the wrong verification of spinal level, rib resec- — Two organizations did not agree eye during a unilateral procedure. Confu- tion level, or ureter to be stented that verification of information dur- sion between unilateral and bilateral should require radiological confirma- ing the time-out should require an surgery may have contributed to wrong- tion, including readings by both a active communication, rather than site surgery, as described in this report. radiologist and the surgeon (recom- a passive agreement, and be veri- mendation 21), although no reason OR nurse drew up proper fied against the relevant documents was given. Three organizations drugs . . . for eye block. The (recommendation 16). One thought raised concerns about the cost of doctor gave injection in . . . the that passive agreement should be radiological confirmation, especially right eye, then asked nurse for sufficient. One organization thought by a radiologist. In response to the com- more block—which he then gave that the recommendation was not ments of organizations and the results in the . . . left eye. possible because “a gowned/gloved of the survey of facilities,6 the Authority One other organization thought surgeon will not be able to reference — concludes that the potential standard for that having the site mark visible in relevant documents.” In response, the recommendation 21 should be modified. the prepped and draped field was Authority notes that active responses The potential modification to the mea- not feasible, but this organization are required of patients and should be surement standard for recommendation gave no reason. In response to general required of providers for the same rea- 21 is as follows: comments about having the site mark sons. The latter organization may have misunderstood the recommendation. 100% of imaging studies be visible in the prepped and draped Verification of information by active have documentation that the field during the time-out, the Authority Vol. 9, Suppl. 1—November 20, 2012 Pennsylvania Patient Safety Advisory Page 19 ©2012 Pennsylvania Patient Safety Authority R E V I E W S & A N A LY S E S anatomic site is correct by the physician, unless no second Acknowledgments operating surgeon before the physician can be made available Theresa V. Arnold, DPM, and Edward Finley, BS, of the Pennsylvania Patient Safety Authority, procedure is done and have and the imaging study cannot be developed and disseminated the survey and documentation that the ana- transmitted to a second physi- collected the data. tomic site is correct before the cian within a reasonable time.6 procedure is done by a second NOTES 1. Pennsylvania Patient Safety Authority. wrong-site surgery? Pa Patient Saf Advis root_VJ3G0N3T7Ngv/ Principles for reliable performance [online] 2011 Sep [cited 2012 Jun 25]. vroot_3LPG2VJGS7ge/ of correct-site surgery [online]. http://patientsafetyauthority.org/ gvel_NL72KXQND0gl/theme_ 2011 Dec [cited 2012 Jun 25]. ADVISORIES/AdvisoryLibrary/2011/ ca_en_healthcare_3_0/command_ http://patientsafetyauthority.org/ sep8(3)/Pages/109.aspx. AbcPageHandler/output_html. EducationalTools/PatientSafetyTools/ 4. American Academy of Ophthalmology. 6. Clarke JR. What keeps facilities PWSS/Documents/principles.pdf. Recommendations of American from implementing best practices to 2. Pennsylvania Patient Safety Academy of Ophthalmology Wrong- prevent wrong-site surgery? Barriers Authority. The evidence base for the Site Task Force [online]. 2008 Nov and strategies for overcoming principles for reliable performance [cited 2012 Jun 25]. http://one.aao. them. Pa Patient Saf Advis [online] of the Universal Protocol [online]. org/ce/practiceguidelines/patient_ 2012 Nov 20 [cited 2012 Nov 20]. 2011 Dec [cited 2012 Jun 25]. content.aspx?cid=d0db838c-2847- http://patientsafetyauthority.org/ http://patientsafetyauthority.org/ 4535-baca-aebab3011217. ADVISORIES/AdvisoryLibrary/ EducationalTools/PatientSafetyTools/ 5. 3M. 3MTM Steri-DrapeTM ophthalmic Pages/Home.aspx. PWSS/Documents/u_principles.pdf. surgical drapes with aperture 3. Clarke JR. Quarterly update: what [online]. [cited 2012 Jun 25]. http:// might be the impact of using evidence- products3.3m.com/catalog/ca/en001/ based best practices for preventing healthcare/-/node_GSK2P6WVVFbe/ Page 20 Pennsylvania Patient Safety Advisory Vol. 9, Suppl. 1—November 20, 2012 ©2012 Pennsylvania Patient Safety Authority PENNSYLVANIA PATIENT SAFETY ADVISORY This article is reprinted from the Pennsylvania Patient Safety Advisory, Vol. 9, Suppl. 1—November 20, 2012. 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