R E V I E W S & A N A LY S E S Wrong-Site Orthopedic Operations on the Extremities: The Pennsylvania Experience John R. Clarke, MD INTRODUCTION Editor Emeritus, Pennsylvania Patient Safety Advisory Clinical Director Emeritus, Wrong-site procedures (procedures done on the wrong side, wrong body part, or Pennsylvania Patient Safety Authority wrong patient, or the wrong procedure) occurred once for every 63,603 procedures in Professor of Surgery, Drexel University Pennsylvania in 2010-2011.1 The probability of performing a wrong-site procedure is reportedly 25% for orthopedic surgeons2 and 21% for hand surgeons.3 PIAA, formerly ABSTRACT the Physician Insurers Association of America, reported medical liability averaging The Pennsylvania Patient Safety Authority $133,047 for wrong-site orthopedic procedures in 2008 US dollars.4 analyzed 83 wrong-site extremity proce- Since June 28, 2004, the Commonwealth of Pennsylvania has required all hospitals dures within the domain of orthopedic and ambulatory surgical facilities to report all medical errors involving patients, includ- surgery reported over a nine-year period, ing all wrong-site procedures, to the Pennsylvania Patient Safety Authority.5 The Joint representing 15% of the 541 reports of Commission implemented its Universal Protocol July 1, 2004.6 wrong-site operating room procedures in Over the first nine years of reporting (July 2004 through June 2013), the Authority Pennsylvania hospitals and ambulatory received 541 reports of wrong-site procedures in the operating rooms (ORs) of surgical facilities from July 2004 through Pennsylvania hospitals and ambulatory surgical facilities.7 Since June 2007, the June 2013. The most common body Authority has focused efforts on a program to prevent wrong-site procedures in ORs.8 parts involved were the hand (6% of all The program to prevent wrong-site surgery has identified 21 evidence-based best 541 reports), the knee (5%), and the foot practices to prevent wrong-site surgery, from indicating the site of the surgery when (3%). All 34 wrong-site hand procedures scheduling the procedure to doing intraoperative verification of vertebral levels for spi- were initiated at the wrong site on the cor- nal surgery (see “Principles for Reliable Performance of Correct-Site Surgery” online at rect hand; 12 involved operating on an http://patientsafetyauthority.org/EducationalTools/PatientSafetyTools/PWSS/Pages/ adjacent finger, and 9 involved making an principles.aspx).9 Although identification of these best practices was not sufficient to incision for a carpal tunnel release instead reduce wrong-site surgery, collaborative efforts with facilities to implement the practices of an intended trigger finger release. has resulted in a 37% reduction of wrong-site procedures.1,10,11 Most (92%) of the 25 wrong-site knee procedures were performed on the wrong Given the number of wrong-site procedures analyzed, the Authority has been able to knee. The 14 wrong-site foot procedures discern differences in the relative importance of best practices and nuances in best were a mix of both the wrong foot and the practices within different specialty areas—for example, anesthetic blocks,12 procedures wrong site on the correct foot. Overall, for pain relief,12 stenting of the ureters,12 spinal operations,13,14 and excisions of skin and 18 wrong-site procedures on the legs subcutaneous lesions.15 Because procedures on the hand and on the knee are among involved the injection of local anesthetic the seven most common procedures to be done at the wrong site and represent 11% of into the knee joint or foot at the beginning all wrong-site procedures in the OR,7,16 the Authority undertook an analysis looking for of the procedure; 13 of them were done specific information about causes of wrong-site surgery and possible preventive steps without the benefit of a proper time-out. for extremity procedures typically done by orthopedic surgeons. The following marking and time-out prac- tices might have prevented specific types METHODS of wrong-site extremity procedures: (1) mark Using a combination of search terms, including event location, event type, and key- the site close to the planned incision words in the narratives, all potential wrong-site procedures in Pennsylvania ORs are and reference it during all steps leading identified weekly in reports to the Pennsylvania Patient Safety Reporting System. The up to the incision, and (2) do separate potential events are reviewed separately by two patient safety analysts to identify actual time-outs for separate procedures on the wrong-site procedures. The National Quality Forum definitions of wrong-site proce- same patient. (Pa Patient Saf Advis 2015 dures are used;17 specifically, the procedure begins when the skin is punctured, even if Mar;12[1]:19-27.) corrected intraoperatively. Relocation of the operative site to the correct site resulting from recommended intraoperative radiographic verification, such as with vertebral surgery, is not considered a wrong-site procedure. Scan this code Discrepancies in the reviews of potential wrong-site procedures are resolved by a with your mobile combination of follow-up questions to the reporting facilities and/or discussion until device’s QR reader consensus is reached. The wrong-site procedures are then classified as to type of to access the wrong-site error, type of procedure, and compliance or noncompliance with the Authority's toolkit 21 evidence-based best practices for preventing wrong-site surgery.9 on this topic. Vol. 12, No. 1—March 2015 Pennsylvania Patient Safety Advisory Page 19 ©2015 Pennsylvania Patient Safety Authority R E V I E W S & A N A LY S E S Procedures not done in hospital ORs Included were procedures involving feet The analysis presents the results of the or ambulatory surgical facilities are (including toes), ankles, tibias and fibulas, classifications of the wrong-site OR excluded from this analysis. Because the knees, femurs, hips, pelvic bones, shoul- extremity procedures within the domain usual causes are different, the Authority ders, humeri, elbows, forearms, wrists, of orthopedic surgery and identifies com- excludes wrong implants, such as a left and hands (including digits). mon patterns. knee implant incorrectly inserted during a The collection and analysis of the infor- correct right knee replacement, from the mation reported through the Pennsylvania RESULTS analysis even though wrong implants meet Patient Safety Reporting System is man- Of the 541 reports of wrong-site pro- the National Quality Forum definition of dated by Pennsylvania law.5 Because the cedures in Pennsylvania hospital and wrong procedure.17 Pennsylvania law prohibits identification ambulatory surgical facility ORs in the For this analysis, all wrong-site procedures of individual patients or providers in nine years from July 2004 through June classified as procedures on the extremi- the reports,5 it is impossible to confirm 2013, 83 (15%) were extremity-related pro- ties were considered. The following were the specialty of the providers. All of the cedures within the domain of orthopedic then excluded from the cohort: anesthesia procedures could have been done by surgery (see Table 1). The most common blocks done by anesthesia providers, orthopedic surgeons, although some parts of the extremities involved were the vascular procedures, insertions of implant- may have been done by plastic surgeons hand (6% of all reports), the knee (5%), able medical devices (such as delivery or general surgeons doing hand surgery, and the foot (3%). systems), and excisions of skin and subcu- neurosurgeons doing peripheral nerve Three wrong-side hip procedures were taneous lesions. surgery, or podiatrists. identified: one was for the repair of a hip Table 1. Wrong-Site Operating Room Procedures of the Extremities within the Domain of Orthopedic Surgery in Pennsylvania Hospitals and Ambulatory Surgical Facilities, July 2004 through June 2013, by Body Area AREA WRONG-SITE % OF WRONG WRONG WRONG WRONG WRONG WRONG PROCEDURES TOTAL SIDE SITE LEVEL SITE PROCEDURE PATIENT GENERAL UNSPECIFIED Foot 14 2.6 7.5* 5.5 0 0 1 0 Ankle 2 0.4 2 0 0 0 0 0 Knee 25 4.6 23 1 0 0 1 0 Femur 1 0.2 0 1 0 0 0 0 Hip 3 0.6 3 0 0 0 0 0 Hand 34 6.3 0 19 0 2 13 0 Elbow 4 0.7 0 3 0 0 1 0 Total extremity 83 15.3 35.5 29.5 0 2 16 0 Spine 74 13.7 10.5 † 0 63.5 0 0 0 Procedures in 211 39.0 125 36 1 0 42 7 other surgical domains Blocks by 115 21.3 113 1 0 0 1 0 anesthesia professionals Procedures for 58 10.7 44 0 7 1 4 2 pain relief Grand total 541 100.0 328 66.5 71.5 3 63 9 * One procedure was done at the wrong site of the wrong foot. † One procedure was done on the wrong side of the wrong spinal level. Page 20 Pennsylvania Patient Safety Advisory Vol. 12, No. 1—March 2015 ©2015 Pennsylvania Patient Safety Authority fracture, one for a total hip replacement, Of the 19 procedures at the wrong site, correctly in 7 of the 12 and that the correct and one for an injection into the hip joint 6 procedures (4 involving the wrong site was stated in 6 of the 7 prior to the inci- for pain relief. All three just involved vio- finger and 2 confusing fingers and meta- sion being made at a wrong site. Time-outs lation of the skin and were identified in carpals) mentioned pins, K wires, or open were not done according to two reports, the OR, with the correct procedure then reductions and fixation of fractures or and the surgeon began to operate before or being performed. dislocations. during the time-out in another three. Of the four wrong-site elbow procedures, Of the other 13 reports classified as start- Problems with site markings and time- three involved the wrong part of the ing or completing the wrong procedure, outs are illustrated by these contextually correct elbow and one involved a wrong 9 stated that an incision was made for deidentified reports: procedure. a carpal tunnel release instead of an 48-year-old scheduled for left trigger Two wrong-side ankle procedures intended trigger finger release. Two of thumb release. Left arm site marked were identified, and both involved those carpal tunnel releases were com- per policy. Left hand positioned on arthroscopies. pleted before the error was detected. OR table and draped. Hand posi- Making an incision for a carpal tunnel tioned by assistant for left carpal One wrong-site procedure involved operat- release when the intended procedure was ing on the wrong end of the femoral shaft tunnel. Time-out called by circulat- a trigger finger release was the second ing nurse, noting procedure: trigger to remove hardware. most common wrong-site error made for thumb release on left hand. Procedure Wrong-site procedures on the hand, knee, extremity procedures within the domain started with a 2 cm incision of the and foot were analyzed in detail for patterns. of orthopedic surgery, behind wrong-knee skin for a carpal tunnel [release]. injections (see below). This one scenario represented 26% of all wrong-site hand Patient scheduled for release of a OR Procedures on the Hand procedures and 11% of all wrong-site trigger finger of the right hand. Wrong-site hand procedures were the Consent indicated the same. Site was most common wrong-site extremity-related extremity procedures within the domain of orthopedic surgery. It was also the marked by the surgeon. The area was procedures (n = 34) within the domain of prepped. During the prep, site mark orthopedic surgery (see Table 1) and were subject of a case report in the New England Journal of Medicine. Another two of the 18 washed off with the alcohol. The the fourth most common type of wrong- surgeon proceeded to do a carpal tun- site procedures overall. four remaining reports also stated that an incision was made for a carpal tunnel nel [release], then realized he was to All of the reported wrong-site hand pro- release instead of the intended procedure. do a trigger finger [release]. . . . The cedures were incisions made at the wrong surgeon told the staff he was think- site on the correct hand, when the site was Failure to follow evidence-based best ing about a patient he had done the specified in the report. (Two reports pro- practices9 for two steps of the Universal previous day. The surgeon said the vided no detailed information beyond the Protocol6 (marking the site and doing a time-out had been done. report of an operation at the wrong site.) time-out) was cited in multiple reports of wrong-site hand procedures. Patient brought to the OR for open Of the 32 reports providing information reduction and pin fixation realign- for analysis (see Tables 2 and 3), 19 were Site markings were mentioned in 11 re- ment of a middle phalanx fracture classified as procedures that were started ports, with suboptimal practices men- of the left long finger. The left long or done at wrong sites. The other 13 were tioned in 8 of the 11. Examples of finger was marked with an “X” classified as starting or completing the suboptimal site marking practices included between the first and second knuckles wrong procedure. marks made remote from the site (on the preoperatively by the surgeon. Time- Of the 19 procedures at the wrong site, arm, on the forearm), made in areas that out completed, with all parties in the 12 involved operating on an adjacent could be confused with the operative site room participating and confirming. finger. Another five wrong-site procedures (the palm), made ambiguously (“X,” below Consent read by the nurse. Surgeon involved remote digits (one), fingers ver- the incision site), not done, washed off by then marked an incision line on sus metacarpals (two), palm versus wrist the skin prep, and done in the OR rather left, fourth finger. Surgeon asked for (one), and anterior versus posterior wrist than before entering the OR. scalpel and made skin incision on (one). Two other reports described the Time-outs were mentioned in 17 reports. the fourth finger. The assistant ques- sites in nonanatomic terms. They were noted to have been done before tioned the surgeon about the finger beginning the operation in 12 of the 17, marked with an “X.” with specific mention that they were done Vol. 12, No. 1—March 2015 Pennsylvania Patient Safety Advisory Page 21 ©2015 Pennsylvania Patient Safety Authority R E V I E W S & A N A LY S E S Table 2. Reports of Procedures on the Wrong Site of the Correct Hand, as Reported to the Pennsylvania Patient Safety Authority July 2004 through June 2013 REPORT VERIFICATION SITE MARK STERILE DRAPED HAND TIME-OUT INCOMPLETE/ WRONG SITE PREP POSITIONED COMPLETE ADJACENT 1 Yes Confusion during Done correctly, Incomplete Yes marking of [correct] stating correct finger procedure and site 2 “Below incision site” Yes Yes Yes Incomplete Yes 3 “X” on middle finger Done correctly, Incomplete Yes stating correct procedure and site 4 On correct finger, in Incomplete Yes addition to pin fixation of distal interphalangeal joint 5 Forearm, not finger Incomplete Yes 6 Yes Yes Incomplete Yes 7 Done correctly, Incomplete Yes stating correct procedure and site 8 Incomplete Yes 9 Yes Palm Yes Yes Started incision Incomplete No prior to time-out 10 Marked patient in OR Started incision Incomplete No during time-out 11 Not done Yes Incomplete No 12 Done correctly Incomplete No 13 Done correctly, Complete Yes stating correct procedure and site 14 Complete Yes 15 Complete Yes 16 Complete Yes 17 Complete No 18 Yes Yes Yes Incomplete Not specified 19 Yes Incomplete Not specified Note: Blank cells indicate that this information was not available in the report. Patient here for release of a right review with the patient. . . . The OR Procedures on the Knee ring trigger finger. Nurse attending circulating RN confirmed the proce- Wrong-site procedures on the knee were patient and did not perform the surgi- dure with the patient in the pre-op the most common wrong-site procedures cal pause right away. Surgeon then area as well. Patient taken to OR of the legs, the second most common marked the patient and started an and prepped and draped. Prior to wrong-site extremity procedures within incision on the right thumb as the final time-out, the surgeon nicked the domain of orthopedic surgery, and nurse read the consent. Surgeon real- the right palm in preparation for a the seventh most common type of wrong- ized the incision was [supposed] to be carpal tunnel release. The circulating site procedures overall, behind anesthetic on the right ring finger. RN told the surgeon to stop, and the blocks, spinal operations, procedures for Surgeon marked the right palm in correct procedure was discussed pain relief, hand procedures, eye proce- the pre-op area during the procedure and completed. dures, and stenting of the ureters. Page 22 Pennsylvania Patient Safety Advisory Vol. 12, No. 1—March 2015 ©2015 Pennsylvania Patient Safety Authority Table 3. Reports of Wrong Procedures on the Correct Hand, as Reported to the Pennsylvania Patient Safety Authority July 2004 through June 2013 REPORT VERIFICATION SITE MARK STERILE DRAPED HAND TIME-OUT INCOMPLETE/ PROCEDURE PROCEDURE PREP POSITIONED COMPLETE STARTED/ PLANNED DONE 1 Correct digit Yes Yes Done Incomplete Carpal tunnel Trigger finger correctly, (injection) release release stating correct procedure and site 2 Arm Yes Yes For carpal Done Incomplete Carpal tunnel Trigger finger tunnel release correctly, release release stating correct procedure and site 4 Yes Yes Incomplete Carpal tunnel Trigger finger release release 4 Not done Incomplete Carpal tunnel Trigger finger release release 5 Incomplete Carpal tunnel Trigger finger release release 6 Yes Incomplete Carpal tunnel Trigger finger release release 7 Not done Incomplete Carpal tunnel Trigger finger release release 8 Washed off Yes Yes Complete Carpal tunnel Trigger finger by prep release release 9 Complete Carpal tunnel Trigger finger release release 10 Complete Carpal tunnel Tenosyno- release vectomy 11 Started Incomplete Carpal tunnel Excision of incision prior release ganglion to time-out 12 Scheduling error Incomplete Excision of Excision of without proper cyst from mass from verification tendon finger tip sheath 13 Complete De Quervain A1 pulley tendon release release Note: Blank cells indicate that this information was not available in the report. Most of the 25 wrong-site knee procedures anesthetic into the joint of the wrong and two reports did not specify the type of were performed on the wrong side. One knee at the beginning of the procedure. surgery on the knee (see Tables 4 and 5). surgeon lost intraoperative orientation This one type of wrong-site event con- and positioned an anterior cruciate recon- stituted 60% of all the wrong-site knee Wrong-Side Injections of Local struction of the correct knee in a direction procedures, 18% of all wrong-site extrem- Anesthetic into the Knee Joint appropriate for the opposite knee. One ity procedures within the domain of The narrative reports of 8 of the 15 in- patient had the wrong arthroscopic proce- orthopedic surgery, and 3% of all wrong- jections of local anesthetic into the joint dure done on the correct side. Of the site OR procedures. Another six reports of the wrong knee mentioned that the 23 knee procedures on the wrong side, involved arthroscopy of the wrong knee, correct knee had been marked. The 15 reported the injection of local Vol. 12, No. 1—March 2015 Pennsylvania Patient Safety Advisory Page 23 ©2015 Pennsylvania Patient Safety Authority R E V I E W S & A N A LY S E S Table 4. Reports of Wrong-Knee Injection, as Reported to the Pennsylvania Patient Safety Authority July 2004 through June 2013 REPORT SITE MARK LEG HOLDER TOURNIQUET STERILE PREP DRAPED TIME-OUT 1 Wrong leg Not Yet 2 Wrong leg Before putting leg in leg holder 3 Yes Wrong leg Before putting leg in leg holder 4 Wrong leg Wrong leg Not Yet 5 Not Yet 6 Wrong leg Not Yet 7 Yes Wrong leg Wrong leg Not Yet Not Yet 8 Not Yet 9 Yes 10 Yes Not Yet 11 Yes Wrong leg Wrong leg 12 Yes Not Yet 13 Yes Wrong leg Wrong leg During 14 Yes Yes 15 No detailed information provided Note: Blank cells indicate that this information was not available in the report. Table 5. Reports of Wrong-Knee Operation, as Reported to the Pennsylvania Patient Safety Authority July 2004 through June 2013 REPORT SITE MARK LEG HOLDER TOURNIQUET STERILE PREP DRAPED TIME-OUT PROCEDURE 1 Wrong leg Correct procedure not Not completed followed 2 Wrong leg Wrong leg Done correctly, stating Not completed correct side 3 Wrong leg Wrong leg Wrong leg Not completed 4 Yes Wrong leg Not Done Completed 5 Yes Wrong leg Wrong leg Yes Completed 6 Yes Done correctly, stating Completed correct side 7 No detailed information provided Completed 8 No detailed information provided Completed Note: Blank cells indicate that this information was not available in the report. injections occurred after the wrong knee preparation according to one report. The final time-out according to one report, was put in the leg holder according to injection was done after the wrong knee and after a final time-out according to three reports and after the tourniquet was was draped according to one report and one report. put on the wrong leg according to three before any draping according to one other One pathway to this problem is described reports (see Table 4 for the relationships report. According to two reports, a time- in this contextually deidentified report: of events reported for each wrong-knee out was done before the wrong knee was injection). The injections were done after put in the leg holder. The wrong-knee Patient was interviewed in the hold- the wrong knee was prepped accord- injections were done before final time- ing area and verbally confirmed the ing to five reports and before any skin outs according to six reports, during the limb and permit. When the patient was in the OR, one more check was Page 24 Pennsylvania Patient Safety Advisory Vol. 12, No. 1—March 2015 ©2015 Pennsylvania Patient Safety Authority done: asked patient, “Left knee, elevated the left leg for the proce- This contextually deidentified report correct?” Patient answered, “Right.” dure. Nurse prepped and draped the describes the situation: Tourniquet cuff put on right knee. knee. During the time-out, no one The patient consented to the removal Physician injected right knee while recognized that the wrong leg had of a left heel bone spur and a right prepping. Nurse asked to do a time- been prepared. The procedure was bunionectomy. He had identical out. Time-out done, at which time performed on the incorrect leg. [Ana- pathologies in both feet. The patient it was noted the permit was for the lyst note: Possible confirmation bias was identified, the time-out was done, left knee and the right knee had following the physician’s elevation of and the surgical sites were marked been prepared and injected with 1% the wrong leg.] appropriately with the patient supine. lidocaine. The patient was turned prone, remov- OR Procedures on the Foot ing the site markings from the visual Wrong-Side Knee Operations The 14 wrong-site procedures done on feet field, and the procedures were per- The narrative reports of three of the eight represented a diverse group of problems: formed in the reverse. wrong-side knee operations mentioned 7 procedures were done on the wrong Problems resulting from asymmetric that the correct knee had been marked. foot, 1 was done on both the wrong foot procedures on different feet are also Again, the operations occurred after the and a different part of the foot (great toe described in two other contextually de- wrong knee was put in the leg holder instead of fifth toe), 5 were done on an identified reports, including one more of according to one report, after the tourni- adjacent structure on the correct foot, and the above injections into the wrong foot: quet was put on the wrong leg according 1 was an incorrect procedure done at the to two reports, and after the wrong knee correct location. The patient was injected with local was prepped and draped according to anesthetic in the left 1st metatar- Of the seven procedures done on the three reports (see Table 5). sal area, and he should have been wrong foot, three were injections into the injected in the right 1st metatarsal A time-out was not done according to wrong foot, all caught before the planned area. He was then injected in the one report and was not done correctly procedure was done. correct right 1st metatarsal area and according to one other report. A time- This contextually deidentified report is the correct left heel. out was done unremarkably according to illustrative: one report, and two reports specifically Patient was scheduled for fusion of mentioned that the correct side was stated 3 mL of bupivacaine 0.5% mixed toes two through five on the left foot during the time-out prior to the wrong- with 3 mL of lidocaine 1% were and matricectomy of the fifth toe on knee operation. injected into the patient’s left foot the right foot. Surgeon verified and by the surgeon. The circulating nurse marked the sites in the pre-op holding Two contextually deidentified reports noticed the surgeon injecting the area. Patient was taken to the OR. describing wrong-side knee procedures are wrong foot and told him the correct Procedures were confirmed [and per- as follows: operative site was the right foot. . . . formed]. In the recovery room [after OR schedule lists operation as right No attempt had been made by the the procedures were completed], it knee arthroscopy. OR consent and surgeon prior to this occurrence to was discovered that the matricectomy H&P [history and physical] state left position, place a tourniquet, prep, had been done on the left great toe knee arthroscopy. Patient identified or drape the correct operative site. A instead of the right fifth toe. . . . The left knee as site of surgery. The left time-out had not been done before patient stated that he wondered why knee was marked. Time-out documen- this occurrence happened. the surgeon marked the great toe, but tation indicated left knee as site of Four procedures were done on the wrong he did not say anything. surgery. Arthroscopy performed on the foot, and none was recognized until after Five patients had procedures on structures right knee. [Analyst note: Possible that the procedure was complete. Two of these adjacent to the correct structure. Three the room was set up for right knee patients had both symmetrical pathology involved operating on the second toe arthroscopy based on the schedule.] and were being operated on in the prone instead of the third toe and were identi- A [patient] was admitted for right position. One of the two was also having fied and corrected in the course of the knee arthroscopy. Patient properly two different procedures done on the procedure. The other two involved meta- identified; site properly marked; and two feet. tarsals; one was corrected and one was patient brought to OR. Physician completed at the incorrect site. Vol. 12, No. 1—March 2015 Pennsylvania Patient Safety Advisory Page 25 ©2015 Pennsylvania Patient Safety Authority R E V I E W S & A N A LY S E S One patient had an incorrect procedure supine. Two wrong-site procedures of the to doing wrong-site hand procedures. One performed as the result of scheduling the foot were with the patient prone. surgeon had to wait for a missing antibi- procedure incorrectly. Another common cause of misperception otic to be infused after the time-out. The is confirmation bias, the psychological other surgeon consulted his office records DISCUSSION process of being attentive to information between the time-out and grabbing the that confirms existing beliefs and ignor- wrong finger to begin the operation. Three predominant anatomic locations— hands, knees, and feet—represented 88% ing information that contradicts them.20 The presence of trauma was not suf- of all wrong-site extremity procedures Confirmation bias was inferred as a pos- ficient to preclude wrong-site surgery for within the domain of orthopedic surgery. sible factor in the analysis of 16 reports one fractured hip, one fractured meta- The nature and causes of wrong-site indicating a misleading setup for the proce- carpal, fractured finger phalanges of two extremity procedures vary with the ana- dure: 1 release of a trigger finger positioned patients, and one dislocated distal inter- tomic locations of the procedures. for a carpal tunnel release, 1 application phalangeal joint. of a tourniquet on the wrong leg for foot There were no wrong-site shoulder opera- Most wrong-site knee procedures (92%) surgery, 1 fixation of a hip fracture prepped tions. However, 11 of the 115 wrong-site were wrong-side procedures. All 34 hand and draped on the wrong side, and 13 reports anesthesia blocks done by anesthesi- procedures were on the correct hand but of wrong-knee surgery. The wrong-side set- ologists (10%) were blocks of the wrong involved a wrong site or wrong procedure. ups for the 13 knee procedures (see Tables 4 shoulder. The narrative of one suggests Wrong-site foot procedures were a mix of and 5) included putting the wrong leg in that the site had not been marked by the both. No procedures were performed on the leg holder (four times), putting the surgeon (“Block was done on left . . . right the wrong patient. tourniquet on the wrong leg (five times), side was then marked.”). In addition, the Surgeons performed 19 wrong-site injec- prepping the wrong knee prior to the narrative for a leg block stated that the tions in the OR before the scheduled intra-articular injection (four times), and site of the operation had not been previ- procedure: 15 intra-articular injections prepping and draping the wrong knee (four ously marked, although it did not state into wrong knees, 3 local anesthetics into times). Four wrong-site event narratives the planned operation. wrong feet, and 1 local anesthetic into (one for the hand, one for the hip, and two the wrong site on the correct hand. Eight for the knee) noted a proper time-out had The analysis of information in the patient reports specifically noted that the surgical been done after the incorrect setup, with safety reporting system has to be incident- site had been marked. Thirteen of the 18 three of the four specifically mentioning based, rather than rate-based, because lower-extremity injections appear to have that the correct site was stated in the time- the relevant information for procedures been done without the benefit of a proper out process. without errors is not available to the time-out, and one was done after an unre- Authority. The analyses were based on More than one out of every four wrong- information submitted in the narratives of markable time-out. Seven of the site hand procedures consisted of making the events. An analysis of root-cause analy- 13 were specifically noted to have been an incision for a carpal tunnel release ses might be more informative. done before the time-out, one before the when the intended procedure was a trig- surgeon entered the room, two before Nevertheless, the patterns identified by ger finger release, suggesting a common the prep, one during the time-out, and the case analyses suggest practices to pre- risk factor. Excluding the one report of two after a time-out conducted before vent specific extremity procedures within the patient being positioned for a carpal the (wrong) leg was positioned in the leg the domain of orthopedic surgery from tunnel release mentioned above, possible holder. being done at the wrong site, in addition factors are automated behavior and dis- The Authority has identified that mis- traction. One of the narratives, mentioned to the general 21 principles9 that have information in the documents used for above, said the surgeon was thinking been effective in reducing wrong-site sur- verification prior to surgery and misper- about another patient. The Authority’s gery in all OR procedures.1,10,11 They are as ception by the surgeon in the OR are 21 evidence-based best practices to prevent follows (in chronological order): the two major causes of wrong-site proce- wrong-site surgery9 include the practice of 1. To minimize the risk of a wrong-site dures.19 Positioning the patient prone can having the surgeon state the correct infor- anesthesia block, mark the operative elicit misperception with right-left confu- mation, rather than just agree with the site before the anesthesiologist does sion. Most orthopedic procedures on stated information, to avoid automated the block. the extremities are done with the patient behavior. Two narratives specifically men- 2. Make the site marking as close to the tioned distractions of the surgeons prior incision as possible and reference it Page 26 Pennsylvania Patient Safety Advisory Vol. 12, No. 1—March 2015 ©2015 Pennsylvania Patient Safety Authority during the positioning of the extrem- incision, such as a preoperative intra- procedure instead of a single time-out ity, the application of any tourniquet, articular injection of the knee. referencing the multiple procedures and the prepping and draping of the 4. Have the surgeon state the procedure and sites. operative site, as well as during the and site, rather than agree to the Acknowledgments final time-out just prior to the incision. stated procedure and site, to minimize Theresa V. Arnold, DPM, manager of clinical This appears to be especially important the risks of automated behavior. analysis, and Edward Finley, BS, data analyst, for hand procedures, where the entire both of the Pennsylvania Patient Safety Authority, 5. When doing separate procedures provided ongoing analytical help. hand is in the operative field. on the same patient, do separate 3. Do a separate time-out for any injec- time-outs immediately before each tion not done in continuity with the NOTES 1. Clarke JR. Quarterly update on prevent- 9. Pennsylvania Patient Safety Authority. 15. Quarterly update on the preventing ing wrong-site surgery. Pa Patient Saf The evidence base for the principles for wrong-site surgery project. Pa Patient Saf Advis [online] 2012 Jun [cited 2014 Jan reliable performance of the Universal Advis [online] 2010 Sep [cited 2014 Jan 24]. http://patientsafetyauthority.org/ Protocol [online]. 2012 [cited 2014 Jan 24]. http://patientsafetyauthority.org/ ADVISORIES/AdvisoryLibrary/2012/ 24]. http://patientsafetyauthority.org/ ADVISORIES/AdvisoryLibrary/2010/ Jun;9(2)/Pages/69.aspx EducationalTools/PatientSafetyTools/ Sep7(3)/Pages/108.aspx 2. Canale ST. Wrong-site surgery: a prevent- PWSS/Documents/u_principles.pdf 16. Quarterly update: progress in preventing able complication. Clin Orthop Relat Res 10. Clarke JR. Quarterly update: what might wrong-site surgery in Pennsylvania. Pa 2005 Apr;(433):26-9. be the impact of using evidence-based Patient Saf Advis [online] 2011 Mar [cited 3. Meinberg EG, Stern PJ. Incidence of best practices for preventing wrong-site 2014 Jan 24]. http://patientsafety wrong-site surgery among hand surgeons. surgery? Results of objective assessments authority.org/ADVISORIES/Advisory J Bone Joint Surg Am 2003 Feb;85- of facilities’ error analyses. Pa Patient Saf Library/2011/mar8(1)/Pages/39.aspx A(2):193-7. Advis [online] 2011 Dec [cited 2014 Jan 17. National Quality Forum. Serious reportable 24]. http://patientsafetyauthority.org/ events in healthcare—2006 update. A con- 4. Quarterly update on preventing wrong- ADVISORIES/AdvisoryLibrary/2011/ sensus report. Washington (DC): National site surgery project. Pa Patient Saf Advis dec8(4)/Pages/144.aspx Quality Forum; 2007. [online] 2008 Sep [cited 2014 Jan 24]. http://patientsafetyauthority.org/ADVI 11. Pelczarski KM, Braun PA, Young E. Hos- 18. Ring DC, Herndon JH, Meyer GS. Case SORIES/AdvisoryLibrary/2008/Sep5(3)/ pitals collaborate to prevent wrong-site records of The Massachusetts General Pages/103.aspx surgery. Patient Saf Qual Health 2010 Sep- Hospital: case 34-2010: a 65-year-old Oct:20-6. woman with an incorrect operation on 5. 2002 Pa. Laws 154, No. 13. Medical Care Availability and Reduction of Error 12. Quarterly update on the preventing the left hand. N Engl J Med 2010 Nov (MCARE) Act. Also available at http:// wrong-site surgery project: digging deeper. 11;363(20):1950-7. patientsafetyauthority.org/PatientSafety Pa Patient Saf Advis [online] 2010 Mar 19. Clarke JR, Johnston J, Blanco M, et al. Authority/Governance/Documents/ [cited 2014 Jan 24]. http://patientsafety Wrong-site surgery: can we prevent it? Adv act_13.pdf authority.org/ADVISORIES/ Surg 2008;42:13-31. AdvisoryLibrary/2010/Mar7(1)/ 6. Joint Commission. Facts about the Uni- 20. Reason J. Safety in the operating theatre— Pages/26.aspx versal Protocol [online]. 2014 [cited 2014 part 2: human error and organisational Jan 24]. http://www.jointcommission. 13. Clarke JR. Quarterly update: what body failure. Qual Saf Health Care 2005 org/facts_about_the_universal_protocol parts and procedures are associated Feb;14(1):56-60. with wrong-site surgery? Pa Patient Saf 7. Clarke JR. Quarterly update on wrong- Advis [online] 2013 Mar [cited 2014 Jan site surgery: areas to focus attention. Pa 24]. http://patientsafetyauthority.org/ Patient Saf Advis [online] 2013 Dec [cited ADVISORIES/AdvisoryLibrary/2013/ 2014 Jan 24]. http://patientsafety Mar;10(1)/Pages/34.aspx authority.org/ADVISORIES/Advisory Library/2013/Dec;10(4)/Pages/142.aspx 14. Quarterly update on the preventing wrong-site surgery project: improving, but 8. Pennsylvania Patient Safety Authority. still room for perfection. Pa Patient Saf Preventing wrong-site surgery [web page]. Advis [online] 2009 Dec [cited 2014 Jan [cited 2014 Jan 24]. http://patientsafety 24]. http://patientsafetyauthority.org/ authority.org/EducationalTools/Patient ADVISORIES/AdvisoryLibrary/2009/ SafetyTools/PWSS/Pages/home.aspx Dec6(4)/Pages/141.aspx Vol. 12, No. 1—March 2015 Pennsylvania Patient Safety Advisory Page 27 ©2015 Pennsylvania Patient Safety Authority PENNSYLVANIA PATIENT SAFETY ADVISORY This article is reprinted from the Pennsylvania Patient Safety Advisory, Vol. 12, No. 1—March 2015. The Advisory is a publication of the Pennsylvania Patient Safety Authority, produced by ECRI Institute and ISMP under contract to the Authority. Copyright 2015 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 website 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 An Independent Agency of the Commonwealth of Pennsylvania website 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 more than 40 years, ECRI Institute marries experience and indepen- dence 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. 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