The mysterious two-year cycle of wrong-site surgery reports continues, with the second lowest quarterly total to date (see Figure). As usual, this quarterly report has been updated to include any belated additions and corrections from previous quarters.
Figure. Pennsylvania Patient Safety Authority Wrong-Site Surgery Reports by Quarter
Two near-miss reports submitted to the Pennsylvania Patient Safety Authority exemplify the value of preventive measures. The first, a good catch, highlights the value of the time-out. The second shows how the problems of rationally addressing remote access to the operative site, such as with laparoscopic or endovascular surgery, has been resolved within one facility.
A patient’s incorrect leg was prepped and draped for surgery. The error was noticed during time-out; no incision was made. The patient’s leg was not marked in pre-op. The nurse did not check to ensure leg was marked prior to taking the patient to the OR [operating room]. During the “time out,” it was noted that incorrect leg was prepped and draped. The drapes were taken down; the patient’s correct leg was prepped and draped. A new time-out was completed and all documents were rechecked.
A patient’s surgical consent read “right femoral angiogram.” The patient stated we were operating on the left leg. The patient and doctor spoke and signed a new consent for the correct leg. The new consent read “left leg angiogram via right groin approach.” The patient, doctor, and a witness agreed and signed the new consent.
This article examines the possible impact of each previously proposed best practice principle for preventing wrong-site surgery.1,2 Authority analysts did a subjective analysis of the narratives of the 444 wrong-site surgery reports from June 28, 2004, through June 30, 2011, to identify possible best practice principles for reducing risk suitable for each scenario. One or more principles may be effective independently or in combination for each scenario. The narrative was too sparse to give any clues about specific best preventive practices for 13 of the 444 reports, leaving 431 reports that were analyzed further. The results of a subjective analysis of the possibility for each principle to help prevent the wrong-site surgery are presented in the Table. The possibility of multiple principles helping individually or collectively was present for most of the narratives assessed. (See an
online-exclusive flowchart detailing this subjective analysis.)
Number Of Reports ||
(N = 431)|
|1|| 6. Provider verifies ||312||72%|
|2||17. All engaged||310||72|
|3||15. Reference mark||300||70|
|4||19. Voice concerns||292||68|
|5||12. Circulator verifies||286||66|
|6||14. Stop activities||280||65|
|7||10. Confirm mark||248||58|
|8||11. Mark with provider's initials||237||55|
|9|| 2. Site on history and physical||192||45|
|10||13. Time out for each procedure||173||40|
|11|| 1. Site on schedule||158||37|
|12|| 3. Site on consent||151||35|
|13||16. Active responses||110||26|
|14||21. Verify with images||61||14|
|15||18. Provider empowers||59||14|
|16|| 5. Access office records||44||10|
|17|| 9. Provider resolves discrepancies||26||6|
|18||20. Address concerns||11||3|
|19|| 4. Reconcile discrepancies||9||2|
|20|| 7. Ask active questions||8||2|
|21|| 8. Two identifiers||6||1|
| ||Other ||8|| |
| ||Unknown||13|| |
* See "Identified Best Practices Principles for Preventing Wrong-Site Surgery" in this article. |||||
The most common best practice principle considered was the provider (the surgeon doing the procedure or the anesthesiologist doing the block) verifying the information in the documents and the mark with the patient. This was considered a preventive measure when the narrative suggested that the provider had not taken active responsibility before the time-out to ensure that the information that was the basis of the procedure was correct. This scenario was considered possible in 312 of the 431 reports (72%).
The information about the correct site that might have prevented the provider from making a wrong-site error was likely present on the schedule, the history and physical examination, the consent, the office records (on occasion), and/or the preoperative imaging studies (on occasion). Confirming the correct site marking with the patient and initializing the mark is proof of that verification.
Of the remaining 119 narratives, the use of intraoperative imaging verification for location of the target anatomic structure was the next most common best practice principle, considered a possible preventive measure in 53 of the remaining reports. There were very few connections between this best practice principle and the other 20. Overall, 61 of the 431 reports (14%) were considered to possibly benefit from this best practice: 46 wrong-level spinal surgeries, 14 stents placed in the wrong ureter, and 1 resection of the wrong rib. The distribution in the subset of 53 was similar. In the subset, no other best practice principles for preventing wrong-site surgery were identified in 49 of the 53 reports.
Consideration of intraoperative imaging verification for location of the correct level for spinal surgery is part of the North American Spine Society Clinical Care Checklist for Safety to Prevent Wrong-Site Surgery (see “Identified Best Practices Principles for Preventing Wrong-Site Surgery”).3 Best practice includes a radiograph after surgical exposure of the operative site, using markers that do not move, with a radiologist’s reading, in addition to the surgeon’s. Two of the narratives indicated a correct reading from a radiologist after the fact.
Use of the same principles to prevent wrong-side ureteral stenting was supported with evidence in the
Pennsylvania Patient Safety Advisory.4
For the remaining 66 narratives, the next most common best practice principles that were considered as possible preventive measures involved doing a proper time-out (Principles 12 through 20). The best practice principles for a proper time-out were considered for 48 of these remaining narratives. The best practice principles, chronologically, are as follows:
The circulating nurse verifies the patient’s information when bringing the patient into the OR. This verification makes the nurse independently informed about what the physician should be doing during the procedure. Ideally, the other team members are informed by the physician during a preoperative briefing before the final time-out.
Formal time-outs should be done for each invasive procedure, including preoperative radiological procedures for breast and other cancer procedures, anesthetic blocks, and second procedures under the same anesthetic. The report narratives frequently stated that a time-out had not been done. The need for a formal time-out was considered for 109 wrong-site anesthetic blocks and 3 wrong-site radiological procedures before definitive surgery.
The members of the team involved in the procedure should bring independent knowledge to the time-out, should be engaged in the time-out, and should speak for the benefit of the patient and provider if their knowledge differs from that of any other member of the team. Engagement means more than witnessing a ritual. Engagement means stopping other activities to focus on the verification of information. It means each team member communicating his or her understanding of the information being verified, not passively supporting another person’s understanding. It means addressing concerns.
The most common single practice principle considered for a proper time-out was explicitly referencing the site marking in the prepped and draped surgical field during the time-out, considered in 43 of these remaining 66 narratives.
The addition of considering proper verification of the patient’s information by the circulating nurse, in an additional 4 narratives, and empowering team members to speak up identified these 48 remaining narratives for which best practice principles for time-outs might be maximally effective for preventing wrong-site surgery.
Of the remaining 18 narratives, the remaining best practice principles that were considered were the expectation that the appropriately specific information about the operation and the site of the operation would be available for verification on all critical documents, including the operative schedule, the history and physical examination, and the informed consent. If the information is not available from the history and physical examination in the facility’s medical record, it should be available from the surgeon’s office records. Critical radiology and pathology reports should be available, as should images, where appropriate, for proper verification of all the patient’s information by multiple team members before the patient enters the operating room.
Ensuring patient information adequate to inform team members for a proper verification was considered the best practice principle for 13 of the remaining 18 narratives. The need for information from the history and physical examination was considered a common possible source of preventing wrong-site surgery for 12 of the 13 narratives, with information from the office records or consent the possible source for 1.
Only five wrong-site narratives involved unusual situations not covered by the best practice principles that have been identified:
Two vascular access devices placed in less preferred arteries instead of more preferred veins
An operation based on an incorrectly dictated pathology report
A selective abortion with multiple fetuses
Regrasping an adjacent left-side anatomic structure after localizing the intended right-side anatomic structure
Three other unusual situations were considered additional factors among the 426 patients with one or more identified best practice principles: failure to correctly map a sentinel node, loss of right-left orientation intraoperatively, and incorrect stereotactic settings.
The original analysis by the Authority in 2007 showed that the two basic reasons wrong-site surgery occurs are misinformation in the patient’s records and misperception in the operating room.5
This subjective analysis of 444 narratives of wrong-site surgery to consider the possible impact of 21 best practice principles to prevent the specific events revealed four areas of focus for preventing these errors and preventing wrong-site surgery. Chronologically, they are as follows:
Use best practice principles to ensure specific patient information is available for team members so they can verify all the information necessary to prevent wrong-site surgery before the patient enters the operating room.
The provider performing any procedure should engage in the verification of the patient’s information with the patient before the patient enters the operating room to ensure an accurate understanding while preparing the patient for the procedure, during the time-out, and during the procedure.
Use best practice principles to inform and engage all team members in the time-out process.
Use imaging confirmation intraoperatively where recommended, specifically for spinal surgery.
Providers interested in preventing wrong-site surgery may wish to consider the Joint Commission Center for Transforming Healthcare Wrong Site Surgery Project: Reducing the Risk of Wrong Site Surgery.6
Pennsylvania Patient Safety Authority. Principles for reliable performance of correct-site surgery [online]. [cited 2011 Jul 17]. Available from Internet:
Clarke JR, Johnston J, Finley ED. Getting surgery right.
Ann Surg 2007 Sep;246(3):395-405.
Identified Best Practices Principles for Preventing Wrong-Site Surgery
Except as noted, the evidence base for the following abridged best practices principles was described in the
Pennsylvania Patient Safety Advisory.1
Principle 1. Site on schedule.The correct site of the operation should be specified when the procedure is scheduled.
Principle 2. Site on history and physical.The correct operation and site should be noted on the record of the history and physical examination.
Principle 3. Site on consent.The correct operation and site should be specified on the informed consent.
Principle 4. Reconcile discrepancies.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.
Principle 5. Access office records.The surgeon should bring copies of supporting information uniquely found in the office records to the surgical facility the day of surgery.
Principle 6. Provider verifies.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 and surgeon before the patient enters the operating room (OR).
Principle 7. Ask active questions.All verbal verification should be done using questions that require an active response of specific information, rather than a passive agreement.
Principle 8. Two identifiers.Patient identification should always require two unique patient identifiers.
Principle 9. Provider resolves
discrepancies.Any discrepancies in the information should be resolved by the surgeon, based on primary sources of information, before the patient enters the OR.
Principle 10. Confirm mark.The site should be marked by a healthcare professional familiar with the facility’s marking policy, with the accuracy confirmed both by all the relevant information and by an alert patient, or patient surrogate if the patient is a minor or mentally incapacitated.
Principle 11. Mark with provider’s initials.The site should be marked by the provider’s initials.
Principle 12. Circulator verifies.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.
Principle 13. Time-out for each procedure.Separate formal time-outs should be done for separate procedures, including anesthetic blocks, with the person performing that procedure.
Principle 14. Stop activities.All noncritical activities should stop during the time-out.
Principle 15. Reference mark.The site mark should be visible and referenced in the prepped and draped field during the time-out.
Principle 16. Active responses.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.
Principle 17. All engaged.All members of the operating team should verbally verify that their understanding matches the information in the relevant documents.
Principle 18. Provider empowers.
The surgeon should specifically encourage operating team members to speak up if concerned during the time-out.
Principle 19. Voice concerns.Operating team members who have concerns should not agree to the information given in the time-out if their concerns have not been addressed.
Principle 20. Address concerns.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.
Principle 21. Verify with images.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.
Evidence for “Best Practice” 21
The North American Spine Society Clinical Care Checklist for Safety to Prevent Wrong-Site Surgery includes consideration of an intraoperative radiograph during surgery, after surgical exposure of the operative site, using markers that do not move, to confirm the vertebral level to be operated on. It also includes consideration of radiologist’s reading, in addition to the surgeon’s reading.2
An analysis of wrong-side ureteral stents revealed 20 reports, accounting for 6% of all 357 wrong-site surgery reports submitted to the Pennsylvania Patient Safety Authority as of the end of 2009.3 Six stents were placed on the wrong side despite specific reference to doing a time-out. The reports suggested that wrong-side ureteral stenting might have occurred because the intervention on the wrong side occurred after the operation had begun, rather than initially, and that the side of the instrumented ureter may have been known only to the surgeon visualizing the landmarks, not to the other members of the OR team, who had limited views of the procedure, if any. A review of the reports showed that the failure to do intraoperative imaging was cited as a contributing factor in one report. Patients were returned to the OR to correct errors documented by intraoperative radiographs on two occasions and, most certainly, by a postoperative computed tomography scan on a third occasion. An error identified by fluoroscopy was corrected midprocedure. The remaining error was detected by the radiography technician. The analysis suggested that urologists should follow the same principles as vertebral surgeons by obtaining an intraoperative imaging study to confirm proper stent placement, with the interpretation documented at the time. Pregnant patients could have ultrasound imaging.3