Wrong-Site Orthopedic Operations on the Extremities: The Pennsylvania Experience

​Authors
John R. Clarke, MD Editor Emeritus, Pennsylvania Patient Safety Advisory Clinical Director Emeritus,
Pennsylvania Patient Safety Authority
Professor of Surgery, Drexel University

Abstract

The Pennsylvania Patient Safety Authority analyzed 83 wrong-site extremity procedures within the domain of orthopedic surgery reported over a nine-year period, representing 15% of the 541 reports of wrong-site operating room procedures in Pennsylvania hospitals and ambulatory surgical facilities from July 2004 through June 2013. The most common body parts involved were the hand (6% of all 541 reports), the knee (5%), and the foot (3%). All 34 wrong-site hand procedures were initiated at the wrong site on the correct hand; 12 involved operating on an adjacent finger, and 9 involved making an incision for a carpal tunnel release instead of an intended trigger finger release. Most (92%) of the 25 wrong-site knee procedures were performed on the wrong knee. The 14 wrong-site foot procedures were a mix of both the wrong foot and the wrong site on the correct foot. Overall, 18 wrong-site procedures on the legs involved the injection of local anesthetic into the knee joint or foot at the beginning of the procedure; 13 of them were done without the benefit of a proper time-out. The following marking and time-out practices might have prevented specific types of wrong-site extremity procedures: (1) mark the site close to the planned incision and reference it during all steps leading up to the incision, and (2) do separate time-outs for separate procedures on the same patient.

Introduction

Wrong-site procedures (procedures done on the wrong side, wrong body part, or wrong patient, or the wrong procedure) occurred once for every 63,603 procedures in 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 the Physician Insurers Association of America, reported medical liability averaging $133,047 for wrong-site orthopedic procedures in 2008 US dollars.⁴

Since June 28, 2004, the Commonwealth of Pennsylvania has required all hospitals and ambulatory surgical facilities to report all medical errors involving patients, including all wrong-site procedures, to the Pennsylvania Patient Safety Authority.⁵ The Joint Commission implemented its Universal Protocol July 1, 2004.⁶ Over the first nine years of reporting (July 2004 through June 2013), the Authority received 541 reports of wrong-site procedures in the operating rooms (ORs) of Pennsylvania hospitals and ambulatory surgical facilities.⁷ Since June 2007, the Authority has focused efforts on a program to prevent wrong-site procedures in ORs.⁸ The program to prevent wrong-site surgery has identified 21 evidence-based best practices to prevent wrong-site surgery, from indicating the site of the surgery when scheduling the procedure to doing intraoperative verification of vertebral levels for spinal surgery (see “Principles for Reliable Performance of Correct-Site Surgery").⁹ Although identification of these best practices was not sufficient to reduce wrong-site surgery, collaborative efforts with facilities to implement the practices has resulted in a 37% reduction of wrong-site procedures.^1,10,11

Given the number of wrong-site procedures analyzed, the Authority has been able to discern differences in the relative importance of best practices and nuances in best practices within different specialty areas—for example, anesthetic blocks,12 procedures for pain relief,12 stenting of the ureters,12 spinal operations,13,14 and excisions of skin and subcutaneous lesions.¹⁵ Because procedures on the hand and on the knee are among the seven most common procedures to be done at the wrong site and represent 11% of all wrong-site procedures in the OR,^7,16 the Authority undertook an analysis looking for specific information about causes of wrong-site surgery and possible preventive steps for extremity procedures typically done by orthopedic surgeons.

Methods

Using a combination of search terms, including event location, event type, and keywords in the narratives, all potential wrong-site procedures in Pennsylvania ORs are identified weekly in reports to the Pennsylvania Patient Safety Reporting System. The potential events are reviewed separately by two patient safety analysts to identify actual wrong-site procedures. The National Quality Forum definitions of wrong-site procedures are used;¹⁷ specifically, the procedure begins when the skin is punctured, even if 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.

Discrepancies in the reviews of potential wrong-site procedures are resolved by a combination of follow-up questions to the reporting facilities and/or discussion until consensus is reached. The wrong-site procedures are then classified as to type of wrong-site error, type of procedure, and compliance or noncompliance with the 21 evidence-based best practices for preventing wrong-site surgery.⁹   

Procedures not done in hospital ORs or ambulatory surgical facilities are excluded from this analysis. Because the usual causes are different, the Authority excludes wrong implants, such as a left knee implant incorrectly inserted during a correct right knee replacement, from the analysis even though wrong implants meet the National Quality Forum definition of wrong procedure.¹⁷

For this analysis, all wrong-site procedures classified as procedures on the extremities were considered. The following were then excluded from the cohort: anesthesia blocks done by anesthesia providers, vascular procedures, insertions of implantable medical devices (such as delivery systems), and excisions of skin and subcutaneous lesions.
Included were procedures involving feet (including toes), ankles, tibias and fibulas, knees, femurs, hips, pelvic bones, shoulders, humeri, elbows, forearms, wrists, and hands (including digits).

The collection and analysis of the information reported through the Pennsylvania Patient Safety Reporting System is mandated by Pennsylvania law.5 Because the Pennsylvania law prohibits identification of individual patients or providers in the reports,⁵ it is impossible to confirm the specialty of the providers. All of the procedures could have been done by orthopedic surgeons, although some may have been done by plastic surgeons or general surgeons doing hand surgery, neurosurgeons doing peripheral nerve surgery, or podiatrists.

The analysis presents the results of the classifications of the wrong-site OR extremity procedures within the domain of orthopedic surgery and identifies common patterns.

Results

Of the 541 reports of wrong-site procedures in Pennsylvania hospital and ambulatory surgical facility ORs in the nine years from July 2004 through June 2013, 83 (15%) were extremity-related procedures within the domain of orthopedic surgery (see Table 1). The most common parts of the extremities involved were the hand (6% of all reports), the knee (5%), and the foot (3%).

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 Procedures	% of Total	Wrong Side	Wrong Site General	Wrong Level	Wrong Site Unspecified	Wrong Procedure	Wrong Patient
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 other surgical domains	211	39.0	125	36	1	0	42	7
Blocks by anesthesia professionals	115	21.3	113	1	0	0	1	0
Procedures for pain relief	58	10.7	44	0	7	1	4	2
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.		​	​	​	​	​	​	​

Three wrong-side hip procedures were identified: one was for the repair of a hip fracture, one for a total hip replacement, and one for an injection into the hip joint for pain relief.

All three just involved violation of the skin and were identified in the OR, with the correct procedure then being performed.

Of the four wrong-site elbow procedures, three involved the wrong part of the correct elbow and one involved a wrong procedure.

Two wrong-side ankle procedures were identified, and both involved arthroscopies.

One wrong-site procedure involved operating on the wrong end of the femoral shaft to remove hardware.   

Wrong-site procedures on the hand, knee, and foot were analyzed in detail for patterns.

OR Procedures on the Hand

Wrong-site hand procedures were the most common wrong-site extremity-related procedures (n = 34) within the domain of orthopedic surgery (see Table 1) and were the fourth most common type of wrong-site procedures overall.

All of the reported wrong-site hand procedures were incisions made at the wrong site on the correct hand, when the site was specified in the report. (Two reports provided no detailed information beyond the report of an operation at the wrong site.) Of the 32 reports providing information for analysis (see Tables 2 and 3), 19 were classified as procedures that were started or done at wrong sites. The other 13 were classified as starting or completing the wrong procedure.

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 Prep	Draped	Hand Positioned	Time-Out	Incomplete/ Complete	Wrong Site Adjacent
1	Yes	Confusion during marking of [correct] finger	​	​	​	Done correctly, stating correct procedure and site	Incomplete	Yes
2	​	"Below incision site"	Yes	Yes	Yes	​	Incomplete	Yes
3	​	"X" on middle finger	​	​	​	Done correctly, stating correct procedure and site	Incomplete	Yes
4	​	On correct finger, in addition to pin fixation of distal interphalangeal joint	​	​	​	​	Incomplete	Yes
5	​	Forearm, not finger	​	​	​	​	Incomplete	Yes
6	​	​	Yes	Yes	​	​	Incomplete	Yes
7	​	​	​	​	​	Done correctly, stating correct procedure and site	Incomplete	Yes
8	​	​	​	​	​	​	Incomplete	Yes
9	Yes	Palm	Yes	Yes	​	Started incision prior to time-out	Incomplete	No
10	​	Marked patient in OR	​	​	​	Started incision during time-out	Incomplete	No
11	​	Not done	​	​	​	Yes	Incomplete	No
12	​	​	​	​	​	Done correctly	Incomplete	No
13	​	​	​	​	​	Done correctly, stating correct procedure and site	Complete	Yes
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. ​ ​ ​				​	​	​	​	​

 

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  Prep	Draped	Hand Positioned	Time-Out	Incomplete/ Complete	Procedure Started/ Done	Procedure Planned
1	​	Correct digit	Yes	Yes	​	Done correctly, stating correct procedure and site	Incomplete (injection)	Carpal tunnel release	Trigger finger release
2	​	Arm	Yes	Yes	For carpal tunnel release	Done correctly, stating correct procedure and site	Incomplete	Carpal tunnel release	Trigger finger release
4	​	​	Yes	Yes	​	​	Incomplete	Carpal tunnel release	Trigger finger release
4	​	​	​	​	​	Not done	Incomplete	Carpal tunnel release	Trigger finger release
5	​	​	​	​	​	​	Incomplete	Carpal tunnel release	Trigger finger release
6	​	​	​	​	​	Yes	Incomplete	Carpal tunnel release	Trigger finger release
7	​	​	​	​	​	Not done	Incomplete	Carpal tunnel release	Trigger finger release
8	​	Washed off by prep	Yes	​	​	Yes	Complete	Carpal tunnel release	Trigger finger release
9	​	​	​	​	​	​	Complete	Carpal tunnel release	Trigger finger release
10	​	​	​	​	​	​	Complete	Carpal tunnel release	Tenosyno- vectomy
11	​	​	​	​	​	Started incision prior to time-out	Incomplete	Carpal tunnel release	Excision of ganglion
12	Scheduling error without proper verification	​	​	​	​	​	Incomplete	Excision of cyst from tendon sheath	Excision of mass from finger tip
13	​	​	​	​	​	​	Complete	De Quervain tendon release	A1 pulley release
Note: Blank cells indicate that this information was not available in the report. ​ ​ ​ ​ ​						​	​	​	​

Of the 19 procedures at the wrong site, 12 involved operating on an adjacent finger. Another five wrong-site procedures involved remote digits (one), fingers versus metacarpals (two), palm versus wrist (one), and anterior versus posterior wrist (one). Two other reports described the sites in nonanatomic terms.

Of the 19 procedures at the wrong site, 6 procedures (4 involving the wrong finger and 2 confusing fingers and metacarpals) mentioned pins, K wires, or open reductions and fixation of fractures or dislocations.   

Of the other 13 reports classified as starting or completing the wrong procedure, 9 stated that an incision was made for a carpal tunnel release instead of an intended trigger finger release. Two of those carpal tunnel releases were completed before the error was detected. Making an incision for a carpal tunnel release when the intended procedure was a trigger finger release was the second most common wrong-site error made for extremity procedures within the domain of orthopedic surgery, behind wrong-knee injections (see below). This one scenario represented 26% of all wrong-site hand procedures and 11% of all wrong-site extremity procedures within the domain of orthopedic surgery. It was also the subject of a case report in the New England Journal of Medicine.¹⁸ Another two of the four remaining reports also stated that an incision was made for a carpal tunnel release instead of the intended procedure.

Failure to follow evidence-based best practices9 for two steps of the Universal Protocol6 (marking the site and doing a time-out) was cited in multiple reports of wrong-site hand procedures.

Site markings were mentioned in 11 reports, with suboptimal practices mentioned in 8 of the 11. Examples of suboptimal site marking practices included marks made remote from the site (on the arm, on the forearm), made in areas that could be confused with the operative site (the palm), made ambiguously (“X,” below the incision site), not done, washed off by the skin prep, and done in the OR rather than before entering the OR.

Time-outs were mentioned in 17 reports. They were noted to have been done before beginning the operation in 12 of the 17, with specific mention that they were done correctly in 7 of the 12 and that the correct site was stated in 6 of the 7 prior to the incision being made at a wrong site. Time-outs were not done according to two reports, and the surgeon began to operate before or during the time-out in another three.

Problems with site markings and time-outs are illustrated by these contextually deidentified reports:

48-year-old scheduled for left trigger thumb release. Left arm site marked per policy. Left hand positioned on OR table and draped. Hand positioned by assistant for left carpal tunnel. Time-out called by circulating nurse, noting procedure: trigger thumb release on left hand. Procedure started with a 2 cm incision of the skin for a carpal tunnel [release].

Patient scheduled for release of a trigger finger of the right hand. Consent indicated the same. Site was marked by the surgeon. The area was prepped. During the prep, site mark washed off with the alcohol. The surgeon proceeded to do a carpal tunnel [release], then realized he was to do a trigger finger [release]. . . . The surgeon told the staff he was thinking about a patient he had done the previous day. The surgeon said the time-out had been done.

Patient brought to the OR for open reduction and pin fixation realignment of a middle phalanx fracture of the left long finger. The left long finger was marked with an “X” between the first and second knuckles preoperatively by the surgeon. Time-out completed, with all parties in the room participating and confirming. Consent read by the nurse. Surgeon then marked an incision line on left, fourth finger. Surgeon asked for scalpel and made skin incision on the fourth finger. The assistant questioned the surgeon about the finger marked with an “X.”

Patient here for release of a right ring trigger finger. Nurse attending patient and did not perform the surgical pause right away. Surgeon then marked the patient and started an incision on the right thumb as the nurse read the consent. Surgeon realized the incision was [supposed] to be on the right ring finger.

Surgeon marked the right palm in the pre-op area during the procedure review with the patient. . . . The circulating RN confirmed the procedure with the patient in the pre-op area as well. Patient taken to OR and prepped and draped. Prior to final time-out, the surgeon nicked the right palm in preparation for a carpal tunnel release. The circulating RN told the surgeon to stop, and the correct procedure was discussed and completed.

OR Procedures on the Knee

Wrong-site procedures on the knee were the most common wrong-site procedures of the legs, the second most common wrong-site extremity procedures within the domain of orthopedic surgery, and the seventh most common type of wrong-site procedures overall, behind anesthetic blocks, spinal operations, procedures for pain relief, hand procedures, eye procedures, and stenting of the ureters.

Most of the 25 wrong-site knee procedures were performed on the wrong side. One surgeon lost intraoperative orientation and positioned an anterior cruciate reconstruction of the correct knee in a direction appropriate for the opposite knee. One patient had the wrong arthroscopic procedure done on the correct side. Of the 23 knee procedures on the wrong side, 15 reported the injection of local anesthetic into the joint of the wrong knee at the beginning of the procedure. This one type of wrong-site event constituted 60% of all the wrong-site knee procedures, 18% of all wrong-site extremity procedures within the domain of orthopedic surgery, and 3% of all wrong-site OR procedures. Another six reports involved arthroscopy of the wrong knee, and two reports did not specify the type of surgery on the knee (see Tables 4 and 5).

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 followed	Not completed
2	​	​	​	Wrong leg	Wrong leg	Done correctly, stating correct side	Not completed
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 correct side	Completed
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. ​ ​			​	​	​	​	​

Wrong-Side Injections of Local Anesthetic into the Knee Joint

The narrative reports of 8 of the 15 in-jections of local anesthetic into the joint of the wrong knee mentioned that the correct knee had been marked. The injections occurred after the wrong knee was put in the leg holder according to three reports and after the tourniquet was put on the wrong leg according to three reports (see Table 4 for the relationships of events reported for each wrong-knee injection). The injections were done after the wrong knee was prepped according to five reports and before any skin preparation according to one report. The injection was done after the wrong knee was draped according to one report and before any draping according to one other report. According to two reports, a time-out was done before the wrong knee was put in the leg holder. The wrong-knee injections were done before final time-outs according to six reports, during the final time-out according to one report, and after a final time-out according to one report.

One pathway to this problem is described in this contextually deidentified report:

Patient was interviewed in the holding area and verbally confirmed the limb and permit. When the patient was in the OR, one more check was done: asked patient, “Left knee, correct?” Patient answered, “Right.” Tourniquet cuff put on right knee. Physician injected right knee while prepping. Nurse asked to do a time-out. Time-out done, at which time it was noted the permit was for the left knee and the right knee had been prepared and injected with 1% lidocaine.

Wrong-Side Knee Operations

The narrative reports of three of the eight wrong-side knee operations mentioned that the correct knee had been marked. Again, the operations occurred after the wrong knee was put in the leg holder according to one report, after the tourniquet was put on the wrong leg according to two reports, and after the wrong knee was prepped and draped according to three reports (see Table 5).

A time-out was not done according to one report and was not done correctly according to one other report. A time-out was done unremarkably according to one report, and two reports specifically mentioned that the correct side was stated during the time-out prior to the wrong-knee operation.

Two contextually deidentified reports describing wrong-side knee procedures are as follows:

OR schedule lists operation as right knee arthroscopy. OR consent and H&P [history and physical] state left knee arthroscopy. Patient identified left knee as site of surgery. The left knee was marked. Time-out documentation indicated left knee as site of surgery. Arthroscopy performed on the right knee. [Analyst note: Possible that the room was set up for right knee arthroscopy based on the schedule.]

A [patient] was admitted for right knee arthroscopy. Patient properly identified; site properly marked; and patient brought to OR. Physician elevated the left leg for the procedure. Nurse prepped and draped the knee. During the time-out, no one recognized that the wrong leg had been prepared. The procedure was performed on the incorrect leg. [Analyst note: Possible confirmation bias following the physician’s elevation of the wrong leg.]

OR Procedures on the Foot

The 14 wrong-site procedures done on feet represented a diverse group of problems: 7 procedures were done on the wrong foot, 1 was done on both the wrong foot and a different part of the foot (great toe instead of fifth toe), 5 were done on an adjacent structure on the correct foot, and 1 was an incorrect procedure done at the correct location.
Of the seven procedures done on the wrong foot, three were injections into the wrong foot, all caught before the planned procedure was done.

This contextually deidentified report is illustrative:

3 mL of bupivacaine 0.5% mixed with 3 mL of lidocaine 1% were injected into the patient’s left foot by the surgeon. The circulating nurse noticed the surgeon injecting the wrong foot and told him the correct operative site was the right foot. . . . No attempt had been made by the surgeon prior to this occurrence to position, place a tourniquet, prep, or drape the correct operative site. A time-out had not been done before this occurrence happened.   

Four procedures were done on the wrong foot, and none was recognized until after the procedure was complete. Two of these patients had both symmetrical pathology and were being operated on in the prone position. One of the two was also having two different procedures done on the two feet.

This contextually deidentified report describes the situation:

The patient consented to the removal of a left heel bone spur and a right bunionectomy. He had identical pathologies in both feet. The patient was identified, the time-out was done, and the surgical sites were marked appropriately with the patient supine. The patient was turned prone, removing the site markings from the visual field, and the procedures were performed in the reverse.

Problems resulting from asymmetric procedures on different feet are also described in two other contextually de-identified reports, including one more of the above injections into the wrong foot:

The patient was injected with local anesthetic in the left 1st metatarsal area, and he should have been injected in the right 1st metatarsal area. He was then injected in the correct right 1st metatarsal area and the correct left heel.

Patient was scheduled for fusion of toes two through five on the left foot and matricectomy of the fifth toe on the right foot. Surgeon verified and marked the sites in the pre-op holding area. Patient was taken to the OR. Procedures were confirmed [and performed]. In the recovery room [after the procedures were completed], it was discovered that the matricectomy had been done on the left great toe instead of the right fifth toe. . . . The patient stated that he wondered why the surgeon marked the great toe, but he did not say anything.

Five patients had procedures on structures adjacent to the correct structure. Three involved operating on the second toe instead of the third toe and were identified and corrected in the course of the procedure. The other two involved metatarsals; one was corrected and one was completed at the incorrect site.

One patient had an incorrect procedure performed as the result of scheduling the procedure incorrectly.

Discussion

Three predominant anatomic locations—hands, knees, and feet—represented 88% of all wrong-site extremity procedures within the domain of orthopedic surgery. The nature and causes of wrong-site extremity procedures vary with the anatomic locations of the procedures.

Most wrong-site knee procedures (92%) were wrong-side procedures. All 34 hand procedures were on the correct hand but involved a wrong site or wrong procedure. Wrong-site foot procedures were a mix of both. No procedures were performed on the wrong patient.

Surgeons performed 19 wrong-site injections in the OR before the scheduled procedure: 15 intra-articular injections into wrong knees, 3 local anesthetics into wrong feet, and 1 local anesthetic into the wrong site on the correct hand. Eight reports specifically noted that the surgical site had been marked. Thirteen of the 18 lower-extremity injections appear to have been done without the benefit of a proper time-out, and one was done after an unremarkable time-out. Seven of the 13 were specifically noted to have been done before the time-out, one before the surgeon entered the room, two before the prep, one during the time-out, and two after a time-out conducted before the (wrong) leg was positioned in the leg holder.

The Authority has identified that misinformation in the documents used for verification prior to surgery and misperception by the surgeon in the OR are the two major causes of wrong-site procedures.¹⁹ Positioning the patient prone can elicit misperception with right-left confusion. Most orthopedic procedures on the extremities are done with the patient supine. Two wrong-site procedures of the foot were with the patient prone.

Another common cause of misperception is confirmation bias, the psychological process of being attentive to information that confirms existing beliefs and ignoring information that contradicts them.20 Confirmation bias was inferred as a possible factor in the analysis of 16 reports indicating a misleading setup for the procedure: 1 release of a trigger finger positioned for a carpal tunnel release, 1 application of a tourniquet on the wrong leg for foot surgery, 1 fixation of a hip fracture prepped and draped on the wrong side, and 13 reports of wrong-knee surgery. The wrong-side setups for the 13 knee procedures (see Tables 4 and 5) included putting the wrong leg in the leg holder (four times), putting the tourniquet on the wrong leg (five times), prepping the wrong knee prior to the intra-articular injection (four times), and prepping and draping the wrong knee (four times). Four wrong-site event narratives (one for the hand, one for the hip, and two for the knee) noted a proper time-out had been done after the incorrect setup, with three of the four specifically mentioning that the correct site was stated in the time-out process.

More than one out of every four wrong-site hand procedures consisted of making an incision for a carpal tunnel release when the intended procedure was a trigger finger release, suggesting a common risk factor. Excluding the one report of the patient being positioned for a carpal tunnel release mentioned above, possible factors are automated behavior and distraction. One of the narratives, mentioned above, said the surgeon was thinking about another patient. The Authority’s 21 evidence-based best practices to prevent wrong-site surgery⁹ include the practice of having the surgeon state the correct information, rather than just agree with the stated information, to avoid automated behavior. Two narratives specifically mentioned distractions of the surgeons prior to doing wrong-site hand procedures. One surgeon had to wait for a missing antibiotic to be infused after the time-out. The other surgeon consulted his office records between the time-out and grabbing the wrong finger to begin the operation.

The presence of trauma was not sufficient to preclude wrong-site surgery for one fractured hip, one fractured metacarpal, fractured finger phalanges of two patients, and one dislocated distal interphalangeal joint.

There were no wrong-site shoulder operations. However, 11 of the 115 wrong-site anesthesia blocks done by anesthesiologists (10%) were blocks of the wrong shoulder. The narrative of one suggests that the site had not been marked by the surgeon (“Block was done on left . . . right side was then marked.”). In addition, the narrative for a leg block stated that the site of the operation had not been previously marked, although it did not state the planned operation.   

The analysis of information in the patient safety reporting system has to be incident-based, rather than rate-based, because the relevant information for procedures without errors is not available to the Authority. The analyses were based on information submitted in the narratives of the events. An analysis of root-cause analyses might be more informative.

Nevertheless, the patterns identified by the case analyses suggest practices to prevent specific extremity procedures within the domain of orthopedic surgery from being done at the wrong site, in addition to the general 21 principles9 that have been effective in reducing wrong-site surgery in all OR procedures.^1,10,11 They are as follows (in chronological order):

1. To minimize the risk of a wrong-site anesthesia block, mark the operative site before the anesthesiologist does the block.
2. Make the site marking as close to the incision as possible and reference it during the positioning of the extremity, the application of any tourniquet, and the prepping and draping of the operative site, as well as during the final time-out just prior to the incision. This appears to be especially important for hand procedures, where the entire hand is in the operative field.
3. Do a separate time-out for any injection not done in continuity with the incision, such as a preoperative intra-articular injection of the knee.
4. Have the surgeon state the procedure and site, rather than agree to the stated procedure and site, to minimize the risks of automated behavior.
5. When doing separate procedures on the same patient, do separate time-outs immediately before each procedure instead of a single time-out referencing the multiple procedures and sites.

Acknowledgments

Theresa V. Arnold, DPM, manager of clinical analysis, and Edward Finley, BS, data analyst, both of the Pennsylvania Patient Safety Authority, provided ongoing analytical help.

Notes

1. Clarke JR. Quarterly update on preventing wrong-site surgery. Pa Patient Saf Advis [online] 2012 Jun [cited 2014 Jan 24].             http://patientsafety.pa.gov/ADVISORIES/Pages/201206_69.aspx
2. Canale ST. Wrong-site surgery: a preventable complication. Clin Orthop Relat Res 2005 Apr;(433):26-9.
3. Meinberg EG, Stern PJ. Incidence of wrong-site surgery among hand surgeons. J Bone Joint Surg Am 2003 Feb;85-A(2):193-7.
4. Quarterly update on preventing wrong-site surgery project. Pa Patient Saf Advis [online] 2008 Sep [cited 2014 Jan 24].             http://patientsafety.pa.gov/ADVISORIES/Pages/200809_103.aspx
5. 2002 Pa. Laws 154, No. 13. Medical Care Availability and Reduction of Error (MCARE) Act. Also available at http://www.legis.state.pa.us/cfdocs/legis/li/uconsCheck.cfm?yr=2002&sessInd=0&act=13
6. Joint Commission. Facts about the Universal Protocol [online]. 2014 [cited 2014 Jan 24]. http://www.jointcommission.org/standards_information/up.aspx
7. Clarke JR. Quarterly update on wrong-site surgery: areas to focus attention. Pa Patient Saf Advis [online] 2013 Dec [cited 2014 Jan 24]. http://patientsafety.pa.gov/ADVISORIES/Pages/201312_142.aspx
8. Pennsylvania Patient Safety Authority. Preventing wrong-site surgery [web page]. [cited 2014 Jan 24; link no longer available]. http://patientsafety.pa.gov/pst/Pages/Wrong%20Site%20Surgery/hm.aspx?psapst=Wrong-Site Surgery#
9. Pennsylvania Patient Safety Authority. The evidence base for the principles for reliable performance of the Universal Protocol [online]. 2012 [cited 2014 Jan 24]. http://patientsafety.pa.gov/pst/Pages/Wrong%20Site%20Surgery/u_principles.aspx
10. Clarke JR. Quarterly update: what might be the impact of using evidence-based best practices for preventing wrong-site surgery? Results of objective assessments of facilities’ error analyses. Pa Patient Saf Advis [online] 2011 Dec [cited 2014 Jan 24]. http://patientsafety.pa.gov/ADVISORIES/Pages/201112_144.aspx
11. Pelczarski KM, Braun PA, Young E. Hospitals collaborate to prevent wrong-site surgery. Patient Saf Qual Health 2010 Sep-Oct:20-6.
12. Quarterly update on the preventing wrong-site surgery project: digging deeper. Pa Patient Saf Advis [online] 2010 Mar [cited 2014 Jan 24]. http://patientsafety.pa.gov/ADVISORIES/Pages/201003_26.aspx
13. Clarke JR. Quarterly update: what body parts and procedures are associated with wrong-site surgery? Pa Patient Saf Advis [online] 2013 Mar [cited 2014 Jan 24]. http://patientsafety.pa.gov/ADVISORIES/Pages/201303_34.aspx
14. Quarterly update on the preventing wrong-site surgery project: improving, but still room for perfection. Pa Patient Saf Advis [online] 2009 Dec [cited 2014 Jan 24]. http://patientsafety.pa.gov/ADVISORIES/Pages/200912_141.aspx
15. Quarterly update on the preventing wrong-site surgery project. Pa Patient Saf Advis [online] 2010 Sep [cited 2014 Jan 24]. http://patientsafety.pa.gov/ADVISORIES/Pages/201009_108.aspx
16. Quarterly update: progress in preventing wrong-site surgery in Pennsylvania. Pa Patient Saf Advis [online] 2011 Mar [cited 2014 Jan 24]. http://patientsafety.pa.gov/ADVISORIES/Pages/201103_39.aspx
17. National Quality Forum. Serious reportable events in healthcare—2006 update. A consensus report. Washington (DC): National Quality Forum; 2007.
18. Ring DC, Herndon JH, Meyer GS. Case records of The Massachusetts General Hospital: case 34-2010: a 65-year-old woman with an incorrect operation on the left hand. N Engl J Med 2010 Nov 11;363(20):1950-7.
19. Clarke JR, Johnston J, Blanco M, et al. Wrong-site surgery: can we prevent it? Adv Surg 2008;42:13-31.
20. Reason J. Safety in the operating theatre—part 2: human error and organisational failure. Qual Saf Health Care 2005 Feb;14(1):56-60.

Supplemental Material

Self-Assessment Questions 

Learning Objectives
  

• Identify high-risk areas of the body prone to wrong-site procedures.
• Recall ways the surgical mark can help prevent wrong-site surgery.
• Recognize when two time-outs would be indicated for an orthopedic operation on the extremity in the OR.
• Select ways of verbally confirming information that are high-risk and low-risk for wrong-site surgery.

Questions

The following questions may be useful for internal education and assessment. You may use the following examples or come up with your own questions.

1. In Pennsylvania, in the nine years between July 2004 and June 2013, wrong-site orthopedic operations were performed on all extremity parts except:
1. The foot
2. The knee
3. The shoulder
4. The hand
2. Which of the following errors is most commonly involved in wrong-site hand procedures?
1. Operating on the wrong patient
2. Operating on the wrong hand
3. Doing the wrong procedure at the correct location
4. Doing a carpal tunnel release instead of the intended trigger finger release
3. Which of the following errors is most commonly involved in wrong-site knee procedures?
1. Operating on the wrong patient
2. Operating on the wrong knee
3. Doing the wrong procedure on the correct knee
4. Injecting anesthesia into the wrong knee joint as a prelude to the operation
4. Which of the following errors is most commonly associated with injecting anesthesia into the wrong knee as a prelude to the operation?
1. Not marking the operative site
2. Putting the tourniquet on the wrong leg
3. Draping the wrong leg
4. Not doing a time-out before the injection
5. There is no need to mark the site for an open repair of a fracture.
1. True
2. False
6. Which of the following interventions is most effective for preventing wrong-site hand surgery?
1. Ensuring the accuracy of the information when scheduling the procedure
2. Having the patient point to the correct site of operation before being prepped and draped
3. Marking the site as close to the incision as possible and referencing it during the time-out
4. Fully stating the procedure and site during the time-out

Question 7 refers to the following scenario:

The patient was interviewed in the holding area preoperatively and verbally stated the correct limb and procedure in agreement with the consent. The correct knee was marked. After the patient was taken to the OR, the circulating nurse asked the patient, “Left knee, correct?” Patient answered, “Right.” The resident put a tourniquet cuff on right knee. The surgeon injected the right knee while prepping. The circulating nurse asked to do a time-out. During the time-out, it was noted that the consent was for the left knee and the right knee had been prepared and injected with 1% lidocaine.

7. Which of the following statements is most likely true:
1. The circulating nurse made the best effort possible to elicit confirmatory information, but the patient gave incorrect information in response.
2. The members of the OR team were aware of the site mark during their preparation of the patient in the OR.
3. A separate time-out is not indicated under the Universal Protocol for an injection of local anesthetic in the knee prior to an arthroscopy.
4. The site mark was referenced in the prepped and draped field during the time-out.
5. An injection of local anesthetic in the wrong knee prior to an arthroscopy meets the definition of a wrong-site procedure.