Pa Patient Saf Advis 2015 Mar;12(1):41-4.
Quarterly Update on Wrong-Site Surgery: Do You Really Want to Wake the Patient Up and Start Over?
Healthcare Executive/Administrator; Nurse; Other Licensed Professionals; Physician
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Authors
John R. Clarke, MD
Editor Emeritus, Pennsylvania Patient Safety Advisory
Clinical Director Emeritus, Pennsylvania Patient Safety Authority
Professor of Surgery, Drexel University

Fifteen reports of wrong-site surgery in Pennsylvania operating rooms (ORs) during the fourth quarter of 2014 represents a continued regression in the first half of the academic year from the nadir of 2012, despite continued progress in the first quarter of the academic year noted in the last update (see the Figure). The majority of reports involved injections or spinal procedures, including four wrong-side paravertebral pain blocks, two wrong-level spinal procedures, two wrong-side preoperative regional blocks by anesthesiologists, and one wrong-side local anesthetic injection by the surgeon prior to the formal time-out. The majority of all 611 wrong-site procedures in Pennsylvania operating suites since July 2004 have been anesthetic blocks by anesthesiologists and surgeons (170), wrong-level spinal procedures (75), or pain management procedures (68)—the persistent top three wrong-site operating suite procedures by type.


Figure. Pennsylvania Patient Safety Authority Wrong-Site Surgery Reports by Academic Year
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Some of the problems, such as the role of confirmation bias and the importance of referencing the site mark, are illustrated by the following contextually deidentified report:

Patient was placed in pre-op holding area for placement of right femoral nerve block before right ankle surgery. Equipment was brought into the holding area and happened to be placed in an orientation consistent with performing a left femoral nerve block (ultrasound on patient’s right side). Anesthesiologist was standing on patient’s left side when time-out was performed with CRNA. CRNA left to obtain sedation while anesthesiologist drew up medications necessary for block on counter behind patient. After drawing up drugs, anesthesiologist proceeded to prep and drape the wrong side. Block was performed without incident. Following completion of block, the patient’s covers (which were covering from thigh down) were pulled back to assess adequacy of block when surgical signature was noted on the contralateral ankle.

Another Criterion for Intraoperative Site Verification

Some fractures need intraoperative verification of their location before internal fixation, as illustrated by the following wrong-site surgery report:

Surgeon prepped right foot and after completing the time-out, using flouro to locate the fracture of the 3rd metatarsal and marking it, she placed the first piece of hardware into the metatarsal. After viewing the x-ray when done with the first piece of hardware, the surgeon noted that she had done the 2nd metatarsal. The 3rd was then done as planned.


Intraoperative verification of the location of some fractures by imaging studies prior to internal fixation needs to be added to the current list of procedures needing intraoperative site verification:

  • Spinal level prior to spinal surgery
  • Location of ureteral stent after placement
  • Rib number prior to resection

Critical Near Misses

Near-miss reports continue to demonstrate vulnerability to risks for wrong-site surgery and the importance of safeguards to minimize those risks. In particular, three patients had to be awakened from sedation or anesthesia because of the failure to reconcile information during the preoperative visits by the surgeons—information that could have been reconciled by the surgeons during their verifications of the documents prior to marking the sites:

Patient presented for an arteriovenous graft. During the time-out, it was noted that the informed consent form specified right side and the OR schedule indicated left. At the time of the time-out, the patient was under anesthesia and unable to clarify information. Next of kin unavailable. Patient awakened from anesthesia, and procedure completed after laterality confirmed.

Surgeon obtained consent in holding area. Both patient and surgeon agreed that it was the left knee, and the left knee was marked appropriately. Staff in the area heard the verification. The patient was [then] sedated and taken to the operating room. The circulating RN during the time-out noted the consent said right. The time-out was stopped. The patient was awakened. She verified the site was the left, along with her husband. The consent was corrected. The patient was sedated again, and the procedure started without issue.

Procedure was cancelled after patient was intubated and asleep. Surgeon assessed patient and stated, “Inflammation at operative site.” Discovered before doing the time-out.

Another report illustrates the confusion that can be sown from an improperly scheduled operation:

Patient was scheduled for surgery: “ORIF Right Proximal Tibia/Fibula.” OR informed x-ray and anesthesia of the scheduled case. Anesthesia went up to see the patient . . . [and became] aware that the patient did not have a right proximal tib/fib fracture. The patient had a left proximal humeral fracture. Anesthesia checked the consent. The surgical consent was for “ORIF Left Proximal Humerus.” Because the case was scheduled incorrectly, the incorrect instrumentation was picked. This was a near miss, and it caused a lot of confusion between multiple departments (OR, x-ray, ICU, anesthesia, central supply) and the patient.

Contrast those patient experiences with these good catches by other providers helping to make sure the surgeon’s patient got the correct procedure at the correct location:

Patient seen in preadmission testing area for surgery workup. [Identified] OR reservation from doctor’s office had wrong side.

Consent for above-knee amputation had incorrect side listed. Identified by floor nurse and corrected prior to OR.

Patient transferred via ED from another hospital for surgical emergency. Patient was to be evaluated and stabilized in ED and then taken to OR. Consent for OR and anesthesia printed out by charge nurse. Right before consents were signed, the nurse noticed the wrong patient’s name and information were printed out on the consents. Correct stickers applied. Anesthesia and surgeon informed, and consents then signed by patient with correct labels on consent forms.

During morning briefing, it was discovered that case was scheduled incorrectly. Case booked as exploratory laparotomy, right colon resection. Surgeon said case is laparoscopic right colectomy. Patient consent and H&P [history and physical] reflected open procedure. Surgeon notified [to clarify].

Order written: needle localization right breast mass @ 6:00. Reports and films reviewed by radiologist prior to procedure identified site to be localized as atypical area on stereotactic biopsy films, not benign mass at 6:00 diagnosed by previous sono core biopsy. Verified with doctor. Diagnostic mammogram done per procedure to identify correct marking clip to be localized.

More near-miss reports point to lack of compliance by surgeons marking the sites with verification of information from both documents and the patients in the preoperative holding area:

Patient came to operating room without having side/site marked. Surgeon notified and came to mark patient prior to block and prior to surgery.

Surgeon spoke with patient in pre-op area and initialed [patient] at base of hand. In pre-op, circulator verified with patient what surgery she was to have: “My third finger.” Upon doing time-out in OR, surgeon realized it was patient’s 4th digit that had contracture (not third). Patient already received general anesthesia, so surgeon spoke with patient’s family and corrected consent to reflect 4th digit. Correction witnessed, and [surgeon] proceeded to release 4th digit contracture.

Patient consented for right inguinal hernia repair. Consent consistent with H&P. Patient also verbally confirmed procedure. Patient brought to OR and induced for surgery. Upon skin prep, it was noticed that the surgeon did not mark laterality pre-op. This was discussed with the surgeon. Surgeon stated he didn’t mark patients for this procedure as he made midline incisions and would check the other side for a hernia and repair it if necessary. Department policy states procedures with laterality are to be marked by the surgeon prior to arrival to operating room suite. Patient would not have been consented for left hernia repair had one been present.

Patient for surgery on left leg. Site not marked by surgeon. Surgeon notified; stated to nurse, “This is abuse. I was just here and you said there was nothing more to be done.” Nurse reminded surgeon that the missing site mark was discovered during the pre-op huddle.

The following is another report of a surgeon being noncompliant with procedures to minimize the risk of wrong-site surgery to the potential detriment of his or her own patient:

Patient brought into room and positioned on bed. Nurse noticed laparoscopy equipment was not working. Patient prepped [by surgeon] while nurse troubleshot laparoscopy equipment. Nurse told surgeon to wait while she was fixing the equipment. While she was doing so, the surgeon proceeded with making the incision before time-out [was done]. Time-out complete after incision was made. All components to time-out were agreed upon by the OR team. OR tech and nurse discussed with the surgeon about procedure prior to incision, but not as a formal team. Entire team spoken to in regard to proper procedure and priorities and methods to handle the situation differently.

Other reports indicate an overreliance on the time-out to catch information errors that could more conveniently and safely be caught preoperatively, by the surgeon or others, before the patient is brought into the OR:

While doing the time-out, it was discovered that the [patient’s chart did not have a signed] surgical consent. Doctor’s office was contacted to fax a copy of the surgical consent, which the patient had previously signed, from the office.

Patient scheduled for procedure “Incision and Drainage of Left Buttock” in operating room. Upon time-out completion, surgical consent stated “Incision and Drainage”; no location or side/site noted on consent. Consent updated through confirmation with surgeon and patient’s wife.

[Pediatric] patient admitted to OR for treatment of left forearm fracture. During surgical time-out, after patient was asleep, wrong site noted on surgical consent. X-rays and chart reviewed and confirmed left forearm as planned operative site. Parents were informed of inaccurate consent. Consent was changed to correct site. Father initialed change, and his initials were witnessed.

Patient was going to the OR for L3-4 microdiscectomy, and case was scheduled as being on the right side. Time-out stated as a left-side case. Consent that was completed in the office by patient and surgeon was noted as right, but the narrative note from that day clearly spells out the left lateral foraminal stenosis. Case was completed on the correct side of left.

RN performed the time-out, stating the procedure to include right breast lumpectomy with sentinel lymph node biopsy on right and left breast lumpectomy. Another RN took over the case. Upon obtaining the specimen from the left breast, the new RN saw that the consent did not include the procedure to the left breast. RN was present during the pre-op discussion between surgeon, the patient, and her sister when they discussed including left breast biopsy in the procedure. Surgeon added the left breast lumpectomy to the consent at the end of the procedure; deviation from established protocol.

However, some informational discrepancy could only have been caught in the OR:

Patient was prepped and draped for a left nephrectomy. Surgeon halted the surgery due to inconsistency with radiology films that were displayed in the operating room. The charge nurse and administrators were then notified of the situation. Surgeon reevaluated radiology films and report and determined that incorrect films were placed in patient’s records. Surgeon spoke with the patient’s family, evaluated all available patient information, and determined that the left kidney was the correct kidney.

The time-out, the critical last step in the Universal Protocol, can be compromised by inappropriate handoffs, as illustrated by this report:

CRNA was relieved for a break minutes before the time-out. . . . One of the elements of the time-out is [asking,] “Are the antibiotics given?” Two grams of Ancef were ordered, and [the relief CRNA] reported to the entire team that none had been documented and that she did not have any in her Pixis in the room. I went to the Pixis in the core, retrieved the 2 grams, and gave the patient the 2 grams at [8:30 a.m.] and the procedure began. When [the original CRNA] returned from her break, I asked her to reverify the time the Ancef was given, and she reported that she had given the patient 2 grams at [about 8:10 a.m.]. The patient had received a double dose.

Several reports of identification problems in this past quarter illustrate the continued possibility of wrong-patient surgery despite the occurrence of only nine surgical procedures on the wrong patient since July 2004:

Wrong patient registered. Two different patients with the same name in the system, one DOB [in December and the other in October of the same year].

Nursing floor printed off and placed wrong H&P on the patient’s chart. Physician discussed incorrect medical issues with the patient, based on the wrong H&P’s information. Anesthesia did the preoperative evaluation based on misinformation. All issues were corrected prior to patient going to OR.

Patient was sent from floor to PACU to check in for pre-op procedure. Patient was sent with wrong patient’s chart. Floor unit called and made aware. Patient’s correct chart brought to PACU at that time. While looking through patient’s chart, which was the correct chart, the wrong patient’s H&P was placed on the chart. The wrong antibiotic dose was sent to PACU with patient. Surgeon made aware. Anesthesia staff and OR nursing made aware. All incorrect patient documentation removed from chart, and the antibiotic administered by anesthesia was the correct medication and dose.

Patients were identical twins presenting for same procedure, which was insertion of ear tubes. Anesthesia provider brought in second scheduled [twin] patient, thus deviating from OR schedule. Upon completion of the first timeout, it was discovered that the incorrect patient was brought to the room.

Conclusion

Surgeons, anesthesiologists, and pain management specialists would all benefit from doing a proper preoperative verification of the site, using both the documents and the patient as sources for verification. Those doing the procedures would also benefit from being fully engaged in the time-out process with all other members of the OR team, who are fully engaged in making sure the patient gets the correct procedure at the correct site.

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