HospitalInspections.org

Based on interview and document review, the Quality Assurance Program failed to ensure corrective actions specific to surgical time outs and surgical counts were implemented and monitored to ensure patient safety.


Findings include:


Review of the April 2013 Quality Performance Monitoring report for Universal Protocol /TIME-OUT revealed 5 out of 8 surgeons were non-compliant with the protocol following the wrong sided surgery that occurred on 3/25/13. There was no documentation to indicate how or if these findings were addressed.


Interview with the Chief Medical Officer and Chief of Surgery on 5/22/13 indicated they were not aware of this audit or the findings.


Review of the Safety Event Summary and Follow-up History report (QUANTROS) for Patients #9 and #25 revealed a report of incorrect surgical counts and failure to obtain an x-ray as required per facility policy. There was no documentation to indicate how or if these findings were addressed.

Based on findings from interview, medical record review and document review surgical services are not provided in accordance with acceptable standards of practice as it relates to conducting surgical time outs to ensure the correct patient, procedure, site and laterality during surgical procedures which resulted in a wrong sided procedure being performed on Patient #1 on 3/25/13.


Findings include:

Interview with the Vice President Surgical Services on 5/20/13 revealed that surgeons eligible for "block time" utilize Form 359 to schedule their surgical cases. This form is faxed to the surgical scheduler from the physician's office.

Review of Form 359 dated 3/25/13 revealed operative side as "right" and procedure scheduled as ankle arthroscopy with possible ligament reconstruction.

During interview with the Operating Room Administrative Clerk on 5/22/13 at 8:45am it was noted that the surgical site was incorrectly entered as "Left" for the patient's surgery scheduled for 3/25/13.

Review of Operating Schedule dated 3/25/13 revealed operative procedure was documented as "left arthroscopy ankle/personeal brevis exploration possible ligament reconstruction."

Review of operative consent dated 3/25/13 revealed procedure as "right ankle arthroscopy, drilling osteochondrial defect, ligament reconstruction, peroneal tendon reconstruction, related procedures."

Review of the patient's medical record under "Operative Screens" dated 3/25/13 at 10:27am revealed "TIME OUT" taken prior to procedure stated operative side is on RIGHT, correct site marked with initials with agreement by team.

During interview with the Operating Room Nurse on 5/22/13 at 9:00am it was noted that on 3/25/13 the room/equipment was set up according to the operative schedule, which stated surgical side as being LEFT. After setting up the room, the nurse stated she interviewed the patient in the pre-operative holding area and reviewed the site marking and surgical consent which both indicated the RIGHT side. The patient was then taken to the Operating Room where a "Time Out" was done prior to incision; however, the wrong side was prepped and draped because of the room being set up for a LEFT sided surgery prior to the patient interview in the pre-op holding area. The attending surgeon was not present during the "Time Out" procedure; however, the Physician Assistant was present. The Physician Assistant proceeded with the surgery on the LEFT side. While charting, the nurse cross referenced the surgical schedule with the surgical consent and realized the error. The error was immediately announced to the operative team and the procedure was stopped. The nurse then left the room to notify the attending surgeon of the error. The attending surgeon presented to the room and the correct side was prepped, draped and procedure completed.

Interview with the Vice President of Surgical Services on 5/21/13 at 10:05am revealed that at the time of the incident, "extenders" (Physician Assistants) were allowed to participate in the "Time Out" procedure without the attending physician being present in the Operating Room.

Review of Policy and Procedure titled "Universal Protocol for all Consented Invasive Procedures," revision date 7/2012 revealed under Section IV Procedure the following: "ALL team members must communicate actively, clearly, and ongoing about scheduling, consent, marking, and/or appropriate equipment/supplies. All involved staff are responsible for verifying the correct patient, procedure, anatomical side when applicable." Under Team Responsibilities the policy revealed the following: "Immediately prior to the incision or start of procedure, all staff present will step back, take a "Time Out" for 30-60 seconds to verbally confirm the patient, procedure, site/side, position, availability of implants and necessary studies."

Review of Safety Event Summary and Follow-up History report (QUANTROS) for the event dated 3/25/13 revealed the operating room nurse reported that the case was on the schedule for a left ankle arthroscopy with a ligament repair. The room was set up for a left ankle. The operating room nurse saw the patient prior to the procedure and verified with the patient that the right ankle was to be operated on and the attending surgeon's initials were observed on the right ankle. During the time out prior to the procedure it was verbally stated that it was the right. The surgical team did not notice that the left leg was prepped for surgery. Incision occurred on the left leg and 25 minutes into the procedure it was discovered that the consent was for the right leg.

Based on interview, medical record review and document review the facility did not ensure the Physician Assistant providing care to Patient #1 was under the direct supervision of the physician.


Findings include:


Review of Department of Orthopaedic Surgery Appointment/Reappointments Credentialing file for the Physician Assistant revealed under General Departmental Privileges for Physician Assistants the following: "Performing as first or second assistant during an operation. Limited to Direct or Personal Supervision."

Review of the Medical Dental Staff Bylaws dated December 2012 revealed under Allied Health Professionals that Dependent/Supervision is a requirement for Physician Assistants.

During interview with the Operating Room Nurse on 5/22/13 at 9:00am it was noted that on 3/25/13 the attending surgeon was not present during the "Time Out" procedure; however, the Physician Assistant was present. The Physician Assistant proceeded with the surgery on the LEFT side. While charting, the nurse cross referenced the surgical schedule with the surgical consent and realized the error. The error was immediately announced to the operative team and the procedure was stopped. The nurse then left the room to notify the attending surgeon of the error. The attending surgeon presented to the room and the correct side was prepped, draped and procedure completed.

Review of the attending surgeon's Operative Report dated 3/25/13 noted that despite the mark being on the appropriate right lower extremity and consent was for a right sided surgery, the surgical schedule had indicated a left-sided surgery. As a result, the left lower extremity was prepped and draped. The joint line on the left side was isolated and insufflated with normal saline. A 4 mm incision to the skin was made, and dissected down to the joint with a hemostat and a camera was placed into the joint. It was at that point in time where the camera was being inserted into the joint that the realization of the wrong-sided surgery was made.

Review of Safety Event Summary and Follow-up History report (QUANTROS) for the event dated 3/25/13 indicated incision occurred on the left leg and 25 minutes into the procedure it was discovered that the consent was for the right leg.

Based on medical record and document review the facility has not ensured that follow-up on incorrect surgical counts is conducted in accordance with facility policy in 2 out of 25 records reviewed.(Patient #s 9 and 25)


Findings include:


Review of the Surgical Case Record for Patient #9 dated 3/24/13 at 2:20am under COUNTS revealed the sharps count was incorrect and that an x-ray had not been taken.


Review of Safety Event Summary and Follow-up History report (QUANTROS) dated 3/24/13 for Patient #9 revealed the following: "Upon checking the needle count nearing the end of the case the count was off by 2. We were over 2 needles." The attending surgeon was made aware and x-ray was declined.

Review of Safety Event Summary and Follow-up History report (QUANTROS) dated 4/18/13 for Patient #25 revealed the following: "This is a report of an off count. There were 5 more laps on the field then on the count sheet."

Review of the medical record for Patient #25 indicated no documentation was present to indicate an x-ray was taken following the incorrect count.

Review of Policy and Procedure titled "Counting of Sponges, Sharps, Instruments and Miscellaneous Items" dated 11/2012 revealed under INCORRECT COUNT the following: "If a sponge, sharp or instrument is missing, or more are counted at the first count, the item must be found or declared not in the wound. This is accomplished by the following method: (A) The RN Circulator will inform the surgeon of an incorrect count. Wound closure is stopped and wound will be examined by the operating surgeon to determine if a sponge or sharp is present. (B) The scrub and circulator will recount the items in question, both on and off the field. (C) The RN Circulator will notify the Unit Manager or charge nurse, who will send additional help into the room. (D) When the search of the wound and the search of the room are completed and the item is not found, a x-ray will be taken before the wound is closed. (E) Reading of the x-ray will be done by the radiologist. (F)If the item is not found, the RN Circulator must write document in QUANTROS the search, x-ray, and result of the x-ray."