Sixteen wrong-site procedures were reported in Pennsylvania operating suites this quarter, resulting in a total of 46 for the year (July 2012 through June 2013), the lowest for any academic year since reporting began and the third lowest for any consecutive 12-month period, although this last quarter equaled the historical median (see the Figure). Nevertheless, the numbers are far below the historical highs of 76 for an academic year and 82 for a consecutive 12-month period.Figure. Pennsylvania Patient Safety Authority Wrong-Site Surgery Reports by Academic Year
|Anesthetic Blocks By Anesthesia Providers||115||21|
|Spinal Surgery—Wrong Level||65||12|
|Ear, Nose, And Throat Surgery||19||4|
The types of procedures were, as usual, ones previously identified as common among wrong-site procedures (see Table 1). Four were wrong-site spinal procedures, and one was a wrong-site pain procedure for pain management. Three were wrong-site regional blocks, and another was a wrong-site local anesthetic block. Two were wrong-site ureteral stents. Two were wrong-site hand procedures. At least one of the hand procedures was related to not putting the mark as close as possible to the incision site on the hand, as follows:
The forearm was marked and initialed, and surgery was planned for right ring finger. The finger was not marked. The incision was made on the right middle finger. . . . Immediately identified, and surgery completed without incident on the ring finger.
One of the other three procedures was associated with not having the most up-to-date information in the patient’s record when the patient changed her mind about the preferred procedure:
The patient had originally signed a consent in the surgeon’s office for a [laparoscopic] tubal ligation. The consent and H&P [history and physical] were faxed to the preadmission area. Three weeks later, she changed her mind to an Essure procedure. The new consent and amended H&P were faxed to the preadmission area. On the day of surgery, the chart contained the original consent (for the tubal ligation) and the amended H&P. . . . The [laparoscopic] tubal ligation was completed.
Near-miss reports received this quarter also illustrate a multitude of weaknesses in facilities’ processes for preventing wrong-site surgery and the importance of repeated verifications.
Scheduling error resulting in an incorrect room setup:
The staff noted that the consent was different from the scheduled procedure. The room was set up again, and the correct procedure was completed.
Wrong patient transported to the preoperative holding area:
The OR [operating room] nurse aide brought the right chart but the wrong patient to the OR holding area. The OR holding area nurse discovered this during the patient interview. The correct patient was [then] brought to the OR holding area.
The patient arrived to the holding area. The anesthesia consult sheet was incorrectly stamped with the wrong patient’s name. The paperwork was then corrected.
A consent form was on this patient’s chart for a bilateral cervical branch block. During the time-out process, the patient informed staff that she was here for a radiofrequency ablation (RFA). At this time, we discovered that another patient’s consent form had been mislabeled with this patient’s identification label. A new, written consent was obtained, and the patient had the RFA completed.
Patient arrived in the holding area. The OR schedule and x-ray reading stated left knee. The surgeon’s consult and accompanying note stated right knee. The surgeon was notified. The consult and accompanying note were corrected by the surgeon.
A patient was scheduled for right leg surgery; both the OR schedule and the consent stated right leg, but the patient’s procedure was to be done on the left leg. The discrepancy was discovered in preoperative assessment. The patient was seen by the attending, a new consent was obtained, and the site was marked.
A patient was admitted to the preoperative area for closed reduction of the right distal radius. All paperwork, including signed consent, stated left. The patient verbalized left arm on the preoperative phone call. . . . All the paperwork sent from the office was incorrect. . . . OR staff was notified of the correct surgical procedure to be performed.
A patient admitted for right arm surgery. The H&P stated left arm. All other surgical paperwork stated right arm, which was correct. . . . The patient verified the correct site of the surgery during the preoperative phone call. The consent and schedule were accurate. The H&P was revised with the correct site of surgery.
Wrong laterality on the consent was identified after anesthesia induction. The physician discovered the error and the need to change the laterality [on the consent] while reviewing films.
A patient was scheduled for left pyelogram and ureteral stent. The preoperative H&P read left-sided stone. . . . The consent was for left pyelogram, extraction of left ureteral stone, and insertion of left ureteral stent. The patient stated he was having a stone removed from his penis. After the patient was anesthetized . . . ,the surgeon stated this is the right side. Hard stop done. The computed tomography scan was pulled and showed right ureteral stone. . . . [Emergency department] note showed right stone. Progress note stated right stone.
During the time-out, the physician disagreed with the operative site as per the consent, H&P, and entire chart’s [indication of] operative site as left. X-rays were reviewed. Correct site of right was verified. Correct consent was obtained.
These last three reports also underscore the need for the surgeon to verify and reconcile all relevant information before the patient enters the OR.
Incorrect marking of the site of the procedure:
During the time-out, it was noticed that the patient was marked with an L on the right side and an R on the left side. This was corrected.
A patient was scheduled for an open reduction and internal fixation of left mid-shaft femur fracture. It was verified with patient consent, provider, and anesthesia that surgery was planned for the left leg. The anesthesia mark was on the right leg. The [correct] operative site was marked [by the surgeon] and by traction pins. Anesthesia reported a regional block was administered to the left femoral area. Surgical team and patient all verified that surgery was to be on the left leg.
Patient had preoperative needle localization and sentinel node [injection] on the left (correct side). Surgeon marked the patient at the bedside in preoperative holding on the right side. . . . Registered nurse discovered the incorrect side had been marked by the surgeon.
Note that the surgeon was marking the patient after the needle localization and isotope injection. The best practice would be for the surgeon to mark the operative site (correctly) before any ancillary procedure in order to provide a landmark for the other physicians.
The patient was in the OR for a craniotomy on the left. The physician marked the right side. Staff noticed this and it was corrected. The patient had the procedure as planned on the correct side.
Wrong knee was marked by the surgeon in the holding room. Patient was asked which knee and if it was marked, and the patient stated the wrong knee had been marked.
The preceding is an additional report in the database of the patient not telling the physician that the mark was in an incorrect location.
Patient transported to the wrong OR:
Patient [brought] to my OR by the anesthesia providers. I checked the operative permit, which was for a bronchoscopy. Room was set up for sinus surgery. We brought in the proper instrumentation and equipment for the [patient’s] procedure. This patient was originally scheduled for OR #15. The sign hanging on the patient’s stretcher was OR #15.
Patient taken from holding area by anesthesia provider to OR #11, when patient was scheduled to be in OR #12. Staff interviewed the patient in OR #11 and identified that the wrong patient was brought to their OR.
Tourniquet applied to the wrong limb:
Thigh tourniquet applied to incorrect leg. It was removed and applied to correct leg.
Surgery started before the time-out was done:
Surgical procedure started before a time-out was performed. When discovered, the team was notified and told to STOP. . . . Second time-out was performed.
Several sheets of another patient’s labels were found on this patient’s chart. Almost mislabeled his specimens with her labels but noticed the mistake (wrong labels) while labeling the specimens.
Recently, Bixenstine et al. reported that 9.5% of surgical specimens were labeled incorrectly with patient identifiers and that 23.8% were labeled incorrectly regarding laterality.1
The Risk of Wrong-Site Surgery
The Pennsylvania Patient Safety Authority has calculated that wrong-site surgery occurred once for every 63,603 OR procedures in Pennsylvania in 2010-2011, the last academic year for which statistics were available.2 The rate is also the best performance since measurement began. While the rate puts wrong-site surgery into the category of relatively rare events, the volume of procedures in a facility or surgeon’s practice predicts a significant likelihood of an event occurring over time. Table 2 illustrates the probability of an event occurring in a facility or practice as a function of the number of procedures performed.
Potential Areas for Improvement in Compliance with the Authority’s Goals for Preventing Wrong-Site Surgery*
In partnership with the Hospital and Healthsystem Association of Pennsylvania and the Pennsylvania Hospital Engagement Network (PA-HEN), the Authority has engaged 27 hospitals and ambulatory surgical facilities in a third collaborative effort to prevent wrong-site surgery. This collaboration is funded by the Partnership for Patients initiative established by the Center for Medicare and Medicaid Innovation (also known as the Innovation Center).
Facilities in the collaboration were given the opportunity to participate in on-site observations and evaluations of their compliance and practices related to the recommended evidence-based best practices to prevent wrong-site surgery. The evaluations were based on compliance with the Authority’s goals and measurement standards3 associated with the 21 proposed recommendations to prevent wrong-site surgery.4
Eleven facilities requested on-site observations. The observations consisted of one-day visits with review and discussions of the facilities’ policies with the staff and independent observations of activities related to the Universal Protocol in the preoperative holding areas and the ORs by two observers. The observers were escorted, and the reason for observing was announced to those being observed. Attempts were made to observe cases most likely to be associated with wrong-side, wrong-part, or wrong-level surgery. The number of observations for each measurement standard varied by facility and observer. The observers reached consensus on their observations prior to exit interviews with surgeons and anesthesia providers, OR administrators and staff, and invited administrators.
Observations at nine of the facilities were done by the same two-person observation team (the authors). The aggregate results of these nine observations are presented to identify possible opportunities for improvement in compliance with the measurement standards for preventing wrong-site surgery in Pennsylvania.
Compliance with the measurement standards for the goals for preventing wrong-site surgery is presented in Table 3. Results of the observations of compliance with each goal are presented qualitatively: always, mostly, sometimes, or never. When no opportunities to observe compliance were present, observations were marked as not applicable.
|A = Always, M = Mostly, S = Sometimes, N = Never, NA = Not Applicable|||||||||||||||||||
|Measurement Standards And Goals||Facility|||||||||||||||||
|The schedule, history and physical, and consent are complete and correct, and all such documents are consistent prior to the day of surgery.|||||||||||||||||||
|The schedule, history and physical, and consent are present, complete, correct, and in agreement on initial verification when the patient arrives in the preoperative holding area on the day |
|The physician doing the procedure properly verifies the information and properly marks the site prior to the patient entering the operating room.|||||||||||||||||||
|The physician doing the procedure verifies and reconciles the patient's understanding, the schedule, the history and physical, |
the consent, and any other relevant information prior to the patient entering the operating room.
|The physician doing the procedure marks the site, if indicated by the procedure, with the physician's initials prior to the patient entering the operating room.||M||M||M||M||S||A||S||M||M|
|All members of the operating room team give primary attention to the time-out and participate with active-voice responses.|||||||||||||||||||
|The surgeon, the anesthesia professional, the circulating nurse, and the scrub technician each respond with active voices to questions or statements in the time-out script directed to each |
|The physician doing the procedure points out the site mark in the prepped and draped field to the other members of the operating room team during the time-out.|||||||||||||||||||
|If the presence of a mark is indicated by the procedure, the initials can be seen in the prepped and draped field.||S||S||M||S||M||M||M||S||M|
|The physician doing the procedure points out the site mark in the prepped and draped field.||S||S||S||S||N||S||N||S||N|
|Members of the operating room team are told that they can speak up during the time-out if they have concerns and that those concerns will be addressed in the best interest of the patient.|||||||||||||||||||
|The physician doing the procedure actively empowers the other members of the operating team to speak up if concerned during the time-out.||N||N||N||N||N||N||N||N||N|
|If a member of the operating team stops the procedure because he or she has concerns, those concerns are addressed.||NA||NA||NA||NA||NA||NA||NA||NA||NA|
|When intraoperative verification by an imaging study is indicated, the properly executed intraoperative imaging study is read by the operating room surgeon—and a radiologist or other qualified physician, if available in the facility—to verify the correct anatomic location before doing the procedure.|||||||||||||||||||
|If intraoperative verification by an imaging study is indicated, the physicians document that the imaging studies verify that the anatomic site is correct before the procedure is done.||A||A||A||A||NA||NA||N||A||S|
Spinal procedures were available for observation in seven of the nine facilities on observation days. The physicians consistently used intraoperative imaging to verify that the anatomic site was correct before doing the procedure in five of the seven facilities (71%); for example, in one facility, one surgeon used fluoroscopy to document every step of the procedure and the others followed the recommendations of the North American Spine Society.5 One of the two surgeons in another facility took a plain radiograph before the procedure to verify the bony landmarks and then did intraoperative orientation from them. The physician at one of the other seven facilities did not verify the information preoperatively, did not consistently mark the site, did not reference the exact location during the time-out, and did not document the site during intraoperative imaging.
The surgeon, anesthesia professional, circulating nurse, and scrub technician were generally attentive during the time-out in seven of nine facilities (78%), responding in active voice to questions or statements directed to them. This was observed consistently in four facilities and most of the time in three others. It was only sometimes observed in two.
Eight facilities (89%) mostly had complete descriptions of the patients’ correct procedures and locations on the schedules, the patients’ H&Ps, and their consents verified when the patients arrived in the preoperative holding areas on their days of surgery. This standard was only sometimes observed in one facility.
Likewise, the physicians doing the procedures generally marked the sites, when indicated, with their initials prior to the patients entering the ORs at seven of nine facilities (78%). Proper site markings were consistently observed at one facility and observed most of the time at six facilities. Proper site markings were only sometimes observed at two.
The physicians doing the procedures verified and reconciled the patients’ understandings, the schedules, the H&Ps, the consents, and any other relevant information prior to the patients entering the ORs most of the time in five facilities (56%) and some of the time in four facilities.
The observers also noted that the marks could be seen in the prepped and draped fields most of the time in five facilities (56%) and some of the time in four facilities. There was no consistency in compliance with these two measurement standards.
The physicians doing the procedures were sometimes observed to point out the site marks in the prepped and draped fields during the time-outs in three facilities and were never observed to point out the site marks in six.
The physicians doing the procedure were never observed to actively empower the other members of the operating team to speak up if concerned during the time-outs.
The observers concluded from the aggregate results that the facilities in the collaboration that invited outside observation had many similar opportunities to improve compliance with the measurement standards for preventing wrong-site surgery in Pennsylvania—and that it was reasonable to extrapolate that the remaining facilities in the collaboration, and even the remaining facilities in Pennsylvania, might benefit from systematic efforts to improve compliance as well.
In particular, although attentiveness by the surgeon and other members of the operating team during the time-out has become a successful habit associated with the time-out script, explicit empowerment of the operating team by the surgeon has not, despite being shown to be associated with avoiding wrong-site surgery.6
Pointing out the site marks in the prepped and draped fields during the time-outs was also infrequently observed, despite it being the rationale for marking the site in the first place.6
There was substantial opportunity for improvement in compliance with two of the measurement standards: physician verification prior to the patient entering the OR and the visibility of the mark in the prepped and draped field.
Compliance was generally observed in these facilities for verification of the completeness and accuracy of the patient’s documents preoperatively, marking of the site by the physician doing the procedure, active participation in the time-out by members of the operating team, and intraoperative imaging to verify the anatomic site of spinal procedures.
Based on the documented opportunities for improvement in this sample, facilities should consider looking attentively at the measurement standards.
* The observations and analyses upon which this information is based were in part funded and performed under contract number HHSM-500-2012-00022C, entitled “Hospital Engagement Contractor for Partnership for Patients Initiative.”
The authors and the Pennsylvania Patient Safety Authority thank the PA-HEN collaboration project leaders, staff, and administrators at the hospitals that invited the Authority to observe their practices to prevent wrong-site surgery.
Bixenstine PJ, Zarbo RJ, Holzmueller CG, et al. Developing and pilot testing practical measures of preanalytic surgical specimen identification defects. Am J Med Qual 2013 Jul-Aug;28(4):308-14.