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BAPTIST MEDICAL CENTER 111 DALLAS STREET SAN ANTONIO, TX 78205 May 4, 2017
VIOLATION: OPERATING ROOM POLICIES Tag No: A0951
Based on review of medical records, interviews, and review of hospital policies and protocols, the hospital failed to enforce policies governing surgical care to ensure the achievement of high standards of patient care. Staff failed to follow the Post-Procedural Verification process in the hospital's Universal Protocol/Time Out Policy that could have potentially prevented patient #18 from having to undergo a second surgical procedure to remove the fallopian tubes and ovaries that had been left in her body during a prior surgical procedure. The hospital also failed to adopt, implement and enforce a policy that would identify all personnel on surgical cases including scrub techs and circulating nurses because it could not be determined through documentation whether or not the scrub tech had been given lunch relief during a procedure performed on patient #18.

Findings Included:

A review of portions of the medical record beginning on 04/25/17 in the conference room for patient #18 related to surgical procedures performed on 02/28/17 revealed the following in part:

1. A consent was signed by the patient on 02/28/17 at 0945 for a "Robotic Assisted Laparoscopic Bilateral Salpingooophorectomy, Lymph Node Sampling, Omentectomy, Cytology, Mediport Placement."

2. A Universal Protocol/Safety Checklist included a section entitled, "Time Out Immediately Prior to Start of Procedure" that was signed and dated 2-28-17 at 1138. The procedure was listed as Robotic BSO, LNS, Omentectomy, Cytology, Mediport.

3. An intraoperative record listed one scrub tech, counts by the circulator with that one scrub tech and one specimen identified as pelvic washings.

During an interview on 05/04/17 at 1:55 p.m. in the conference room, S1 confirmed the above findings. During further interview on 05/04/17 at 2:40 p.m., S1 confirmed that lunch relief for the scrub tech was not documented and confirmed it is not on the operating room log but thinks there was lunch relief. S1 was asked about a tracking mechanism for case assignments. According to S1, "They write on a white board and it is erased at the end of the day." S1 confirmed there is no tracking mechanism, and stated, "If the circulator doesn't write it on the intra-operative record, we have lost it."

During a telephone interview on 05/04/17 at 2:15 p.m., S2 was asked about lunch relief documentation for the scrub tech but S2 could not recall if a scrub tech came in or not to give lunch relief to the scrub tech and stated, "I may have omitted" the documentation.

4. A Universal Protocol/Safety Checklist that included a section entitled, "Post-Procedural Verification Immediately After The Procedure" was signed and dated 02-28-17 at 1335. The form stated it was, "To be completed in the procedure area or at the bedside for bedside procedures" and in part that "The procedure team verbally confirms the following with the team:"

The name of the procedure recorded
The specimen(s) is labeled with the patient's name, account number and source (or not
applicable)

During an interview on 04/26/17 at 1:28 p.m. in the conference room, S1 confirmed that the post-procedure verification that would have taken place from that procedure to the next procedure was over-looked. It was signed but not done.

During a telephone interview on 05/04/17 at 2:15 p.m., regarding the Post-Procedural Verification, S2 stated, "Stuff we normally do like the post-surgical time out (post-procedure
verification) got missed" and "The time out at the end of the case is informal."

5. An Immediate Post-op Note created on 02/28/17 at 13:47 by P1 listed the following procedures performed:

Robotically assisted laparoscopic bilateral salpingo-oophorectomy
Laparoscopic pelvic and aortic lymph node sampling Omentectomy/Minilaparotomy
Mediport Insertion under Fluoroscopy

An Addendum on 02/28/17 at 14:56 made to the Immediate Post-op Note stated:

"Patient was taken immediately back to OR, after obtaining consent from her husband to remove her tubes and ovaries. These structures had been surgically ligated and placed in the cul de sac during the surgery but not removed at the conclusion of the lymph node dissection. After placing the patient under GETA a second time, the abdomen was reinsufflated and the tubes and ovaries were found in the posterior cul de sac and then removed; they had been labeled left and right with cautery during the initial dissection."

6. An Operative Report dictated on 03/01/17 at 08:24 by P1 revealed in part the following:

DATE OF PROCEDURE: 02/28/2017

"The patient was awakened and taken to Recovery in stable condition. At this point, I realized that I had not taken out the ovaries shortly after moving the patient to Recovery. I then reconsented the patient via her husband as she had just waking up from anesthesia, also verbally consented the patient when she was a little more awake."

"We took the patient back and she was given another dose of antibiotics. Both adnexa were placed in EndoCatch bags and removed sequentially through the 12 mm port."

During a telephone interview on 05/04/17 at 3:13 p.m., P1 confirmed that he got to the recovery room, was going over the operative summary and at that point he realized not taking out the ovaries.

A review of the hospital policy number RM-PS-04, entitled, "Hand-Off Communication," last reviewed and effective "07/11" revealed that it stated the following in part:

PURPOSE:
To provide a safe patient environment through a consistent process to communicate important information about a patient's plan of care.

Hand-off communication will occur whenever there is a transfer of patient care to a different level of care or to another unit and whenever there is a transfer of a patient's care from one provider to another provider.

2. Transfer of Patient's Care:
a. Transferring a patient's care includes, but is not limited to the following:
(2) Temporary responsibility for staff leaving the unit for a short time (e.g., lunch or other breaks, etc.)

A review of hospital policy number RM-PS-08, entitled, "Universal Protocol/Time Out Policy," last reviewed, "02/13" and effective, "04/13," revealed that it stated in part the following:

PURPOSE
To establish a uniform Baptist Health System (BHS) policy and procedure to conform to the Universal Protocol and WHO Safety Checklist.

POLICY
A. The Universal Protocol/Time Out policy applies to:

3. Any invasive procedure involving informed consent and puncture or incision of the skin or insertion of an instrument or foreign material into the body, including but not limited to:
h. Laparoscopic surgical procedures
o. Invasive procedures

PROCEDURE
C. The Pre-Procedural Verification process "Time Out" and Post-Procedural Verification process are required for all invasive procedures.

D. Step 4: Post-Procedural Verification

1. Must occur in the procedure setting IMMEDIATELY after completion of the procedure.

2. Will involve ALL members of the healthcare team. In surgical areas the circulating nurse is responsible for initiating the Post-Procedural Verification. The Post-Procedural Verification includes verification of:

a. The name of the procedure recorded. Since the procedure may change or expand during the course of the procedure it should be confirmed with the team exactly what procedure was done.

c. The specimen(s) is labeled with the patient's name, account number and specimen description including any orienting marks (or not applicable). Confirmation of critical specimen information prevents laboratory errors.

3. Any member of the healthcare team has the responsibility to stop-the-line if the Post-Procedural Verification is not completed.

4. If variation/disagreement during the Post-Procedural Verification occurs all processes must stop until resolution is obtained.

REFERENCES

World Alliance for Patient Safety, Implementation Manual Surgical Safety Checklist (First Edition), World Health Organization

According to The World Health Organization (WHO) Surgical Safety Checklist (First Edition) at http://www.who.int/patientsafety/safesurgery/tools_resources/SSSL_Checklist_finalJun08.pdf?ua=1, a sign out section is to be completed before the patient leaves the operating room that the nurse verbally confirms with the team, "How The Specimen Is Labeled."

According to an Association of Operating Room Nurses (AORN) Comprehensive Surgical Checklist dated June 2016 at https://www.aorn.org/surgicalchecklist there is a sign out before the patient leaves the operating room and the RN confirms, "Name of Operative Procedure" and "Specimens identified and labeled."