The latest update from the Pennsylvania Patient Safety Authority’s reporting system database shows 12 wrong-site surgeries reported during the first quarter of 2009 (see Figure). Encouraging trends remain. The Southeastern Pennsylvania regional collaborative to prevent wrong-site surgery that began in March 2008 had one wrong-site anesthetic procedure reported among 30 facilities in February 2009 after a three-month hiatus from wrong-site procedures and an eight-month hiatus from wrong-site anesthetic blocks. The three-month hiatus is better than the 90th percentile for the time between reports for this group of hospitals. The Authority will continue to monitor the progress and continues to plan to replicate the initiative in another region.
Figure. Pennsylvania Patient Safety Authority
Wrong-Site Surgery Reports by Quarter
Of the 12 facilities that reported a wrong-site surgery event to the Authority this quarter, eight had reported wrong-site surgery previously—a total of 23 previous reports, for an average of almost three previous reports per repeat reporter. The cumulative 31 wrong-site surgery reports from these eight facilities represent almost exactly 10% of all wrong-site surgery reports in the Authority’s database.
Because of the lower-than-average number of reports of wrong-site surgery statewide this quarter, all the reports, edited for contextual deidentification, are described below. Analytical commentary follows the reports to emphasize principles that have been mentioned in previous Pennsylvania Patient Safety Advisory articles describing the results from the Authority’s Preventing Wrong-Site Surgery Project.*
* The Pennsylvania Patient Safety Authority has a Web page devoted to educational tools for preventing wrong-site surgery. Its resources include all the Authority’s publications on the subject, including self-assessment tools, sample forms and checklists, educational posters and videos, illustrative figures and tables, patient-education brochures, and online information available from other Web sites.
The surgeon and the surgery team met with patient preoperatively. Discussion ensued between the patient and the surgeon about the skin lesion to be removed. The result of the discussion indicated that a particular lesion was to be removed. The lesion in question was circled and marked in front of the patient, family, and nurses in the preoperative area. The consent forms were not verified. The location on the consent indicated another location. The patient proceeded to the operating room (OR). The “time-out” procedure was performed. Verbiage during the time-out was miscommunicated. All the pre-, intra- and postoperative documentation was filled out according the consent form. Upon entering the recovery room, the family questioned the location of the dressing. The nurses were alerted, and corrective action began.
Commentary. On analysis, this event had two prime causes:
- The surgeon based the site marking on personal memory of the patient and the patient’s input, which the surgeon misinterpreted. The surgeon did not refer to the documents when marking the site. The family did not comment because they did not appreciate that the mark was a mark to indicate the site of the incision. The site mark should always be reconciled with all the pertinent documents. The results from the Preventing Wrong-Site Surgery Project have shown that this reconciliation needs to include the consent, the history and physical examination, and the schedule at a minimum.
- The consent was not referenced during the timeout. All information used in the time-out should be verified using the written records.
The patient was in the OR for excision of a subcutaneous lesion. The area had been marked preoperatively. The lesion was removed uneventfully. Postoperatively, the patient stated that the mass the patient expected to be removed had not been removed. The physician examined the area and found a second subcutaneous lesion superior to the suture line that had not been previously identified. This mass could only be appreciated with the patient in certain positions, and when the site was marked it was not seen.
Commentary. According to follow-up information captured through the Authority’s Wrong-Site/-Side Surgery Error Analysis Form, the surgeon did not involve the patient in any of the site verification process before marking the site. (A public version of this analysis form is available from the Authority.) The results from the project have shown the importance of verifying the site with all the pertinent documents and with the patient.
The patient’s site marking was placed where it was not easily seen after the patient was positioned for a biopsy. The other side was imaged; an incidental finding of a suspicious area was biopsied. The surgeon proceeded with scheduled biopsy on the correct side after it was noted that the wrong side had been done initially.
Commentary. Results from the project make it clear that the marks should be visible when the patient is prepped and draped and the physician is poised to start the procedure. This was the fourth wrong-site surgery report from this facility.
A patient [was scheduled] for right epidural injection. The time-out was performed after the patient was positioned and before the procedure was started, stating right-sided procedure was to be performed. The surgeon marked the lumbar region, but not the side. The surgeon injected local anesthetic into left-sided subcutaneous tissues, stopped, and switched to the right side. The procedure was NOT performed on wrong side; local anesthetic only was initiated on wrong side.
Commentary. According to the National Quality Forum definition of serious reportable events, this was a wrong-side procedure, because the skin was punctured on the wrong side.
As described in the follow-up information from the Authority’s error analysis form, the time-out was done correctly. The subsequent error about side was noted by the patient, who was awake during the procedure.
The patient was admitted to the surgery area prior to having a procedure on the left leg and was to have a femoral nerve block. The surgeon marked the left leg as the operative site. In the preoperative area, the anesthesiologist verified the side of the block with the patient and performed a right femoral nerve block. The patient asked when [the anesthesiologist] was going to do the side [the patient] was to have surgery on, and [the anesthesiologist] realized the wrong leg had been blocked. [The anesthesiologist] proceeded to perform the block on the left leg, and the patient went to surgery.
Commentary. Wrong-site surgery includes localized anesthetic blocks. The results of the Authority’s wrong-site surgery project show the need to follow the Joint Commission’s Universal Protocol for each separate procedure, including a time-out before an anesthetic block. According to follow-up information from the Authority’s error analysis form, the anesthesiologist did not follow the Universal Protocol for this case. This was the third wrong-side anesthetic block reported by this facility.
The patient [was identified], and the history and physical examination information and consent were obtained from parent. The (R) leg was marked for the procedure. The (L) leg was cleaned and prepped with the parent present. The parent then left the holding area, and the patient was sedated for the procedure. The (L) popliteal nerve block was successfully completed without incident. Upon completion of this block, it was noted that the operation was to be on the (R) leg. The attending surgeon was notified. The parent was notified by the physicians. It was decided to block the (R) leg and proceed with the surgery. The (R) popliteal . . . nerves were blocked without incident.
Commentary. In the follow-up with the error analysis form, the facility attributed this wrong-side error to the patient lifting up the wrong leg just before the anesthesiologist began the procedure. The anesthesiologist did not check for the site mark. The results from the project have shown the importance of referring to the site marking just before starting the procedure. This was the sixth wrong-site surgery report—and the second report of a wrong-side anesthetic block—from this facility.
Wrong side paravertebral block. Initially had left-sided placement of the catheter and then had a right-sided placement as well.
Commentary. According to follow-up with the error analysis form, the anesthesiologist was disoriented as a result of being distracted while doing the procedure. The anesthesiologist had marked the site, but the mark was not visible during the procedure. It is the presence of a verified mark as a reference point, not the effect of marking on memory, that is important. Another member of the team questioned the side, but not until after the procedure had been done. This was the fourth wrong-site operative procedure reported by this facility. Two of three prior reports involved surgeons injecting local anesthetics into wrong sites before the time-outs.
Reports 8 and 9
A patient was scheduled for a procedure on the right eye. The patient was given all preprocedure drops in the right eye. The surgeon arrived, identified the patient, and marked the right eye. The surgeon did the procedure and, at conclusion, realized that the incorrect eye had been treated. The patient has the same pathology in both eyes. Both eyes need treatment, but the right eye was scheduled for that day.
Nursing discovered when comparing documentation to physical verification that the left knee was injected instead of the right knee. The physician was notified and verified the incorrect knee was injected. The error was disclosed. . . . both knees were arthritic. . . .
Commentary. Comparisons of wrong-site surgery reports and near-miss reports for the Preventing Wrong-Site Surgery Project have proven that bilateral pathology is a patient risk factor that increases the possibility of wrong-site surgery, as illustrated in the two reports above. With bilateral pathology, the need to verify the site with the documents is essential.
A case was scheduled as a left-sided spinal procedure. The patient was marked on the left side. The consent, schedule, and the patient all agreed it was the left side. The left side was mentioned in the time-out. After the incision was closed, but before the patient had woken up, the surgeon realized that the procedure had been done on the right side. The instruments were still sterile, so the patient was reprepped, redraped, and the incision was opened. The surgeon then did the procedure on the left side, as scheduled.
Commentary. The correct location of spinal surgery within a spinal segment is difficult because it can only be confirmed radiographically (for the correct level) or by intraoperative observation of the internal anatomy (for the correct side). A formal intraoperative confirmation of the side by the assistant or scrub tech would be helpful to prevent events like this one.
According to follow-up information from the error analysis form, a clue in this case was where the surgeon was standing, which was the right side of the table. The scrub technician noticed that the surgeon was on the wrong side of the table, but did not speak up. Analyses done for the wrong-site surgery project have shown that wrong-site errors are more likely to be prevented when the surgeon explicitly empowers team members to speak up if they are concerned.
This was the sixth wrong-site surgery report from this facility.
The patient was to undergo a diskectomy. Under fluoroscopy, the surgeon removed another disk as well. The surgeon had difficulty visualizing the disk spaces. . . . entered and removed one disk thinking it was the other.
Commentary. Based on analysis of prior reports for the project, the radiographic localization of the correct disk space should be verified by both the operating surgeon and a radiologist to ensure that the location is correct. This was the fourth wrong-site surgery report from this facility.
The patient was seen at the office for pain of the right elbow, requiring surgical intervention. On the day of surgery, the patient presented complaining of pain greater on the lateral side. The surgeon chose to change the surgery and performed a right lateral elbow procedure. The consent, however, was signed for a right medial elbow procedure and was not changed. The pathology report supports pathology on the lateral side. Upon review of the chart and discussion of the case with the surgeon and the medical director, it is determined that this Serious Event should have been reported as a wrong-site surgery.
Commentary. Decisions are sometimes made preoperatively to change the procedure that was originally scheduled. However, these changes should be carefully documented in the pertinent documents. The facility’s decision to call this event wrong-site surgery because the actual procedure was not the originally intended procedure, despite being acceptable medical care, is commendable. Its position prevents the possibility of postoperative rationalization, such as occurred with a previous report from an earlier quarter:
Patient with lesions of the hip underwent wide excision with myocutaneous flap of the left hip lesion. The consent form identified the right side. The surgical site verification was completed in [the special procedure unit] with the right side identified and marked by the physician and the patient; the right side identified in the holding area and during the final time-out. The patient was confused regarding which side was to be done during the final time-out. Otherwise the right [side] was confirmed by all. The patient was turned over for the procedure and the surgeon operated on the left side. When brought to his attention, the surgeon stated he discussed doing smaller lesion first with patient in his office and that it is the left side. When questioned about why all verifications and documentations stated right, the surgeon indicated he meant the left and operated on correct side.
The Authority has received reports of decisions made intraoperatively to change the procedure based on the observed internal pathology. For instance, a computed tomography scan or ultrasound report might indicate a large cyst originating from the right ovary, but on exploration, the cyst proves to be originating from the left ovary. These events would not be considered wrong-site procedures.
Survey on Surgical Site Marking Pens and Techniques
The Authority analysts are disseminating a survey, to be communicated through the Patient Safety Officers of Pennsylvania hospitals and ambulatory surgical facilities, in which OR managers can share their good and bad experiences using various marking pens and techniques for marking surgical sites. Others will be encouraged to also contribute by downloading the survey from the Authority’s Web site and submitting their experiences to the editor at email@example.com.
The Time-Out Script Competition
The Authority has received five entries for the Time-Out in the OR Script Competition. The scripts
are posted on the Authority’s Web site.
For the first round, the Advisory editors will accept open-ended review and comment from all who wish to do so. The editors may publish some of the critiques in the second round, but will not identify any reviewers. The reviews may make a general comment on any script or comment on any parts of any scripts, positively or negatively, but should specifically consider at least three issues: (1) compliance with the time-out elements of the Universal Protocol intended to prevent wrong-site surgery, (2) active participation of all the important members of the operating team, and (3) efficiency. Efficiency will be defined as the length of time involved in performing the script. As mentioned in the March 2009 issue of the Advisory, the time should ideally be less than 90 seconds. Please note that the Time-Out in the OR Script Competition includes only the parts of a time-out script that identify the patient, procedure, and side or site of the procedure. Implants availability, antibiotic administration, allergies, and other additions to the Universal Protocol not related to preventing wrong-site surgery have been eliminated from the time-out scripts. Elements of the time-out that involve confirmation or documentation not based on conversation have also been eliminated. Please send your reviews and comments on any or all components of any or all scripts electronically to the editor at firstname.lastname@example.org. Please make sure you link comments to specific scripts by their numbers. This is your chance to help shape robust scripts for time-outs.
The Authority remains committed to preventing wrong-site surgery and welcomes any comments, suggestions, and specific inquiries from facilities with specific problems or questions concerning wrong-site surgery. Communications should be directed to John Clarke, MD, FACS, clinical director of the Pennsylvania Patient Safety Authority, by telephone at (610) 825-6000 or by e-mail at email@example.com.