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Based on interview and record review, the hospital failed to comply with the Condition of Participation for Surgical Services as evidenced by:

1. The hospital failed to follow its policy and procedure (P&P) titled, "Universal Protocol" when, staff began a surgical procedure on the wrong surgery site. (Refer to A951)

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of quality health care in a safe environment.

Based on interview and record review, the facility failed to follow its Policy and Procedure (P&P) titled, "Universal Protocol" for one of 30 sampled patients (Patient 20). When surgical staff who participated in a surgical procedure were not present during the site marking, and entire duration of final timeout (an immediate pause by the medical team to confirm the correct patient, procedure, and site). This failure resulted in the start of a surgical procedure on the wrong surgical site.

Findings:

During a review of Patient 20's "Operative Report" dated, 10/22/24, Report indicated, "Procedure performed: Left endoscopic [a procedure using a tool to look inside the body] medial maxillectomy [procedure to remove part of your maxilla (bone) nearest to your nose and adjoining teeth] for resection of [removal of] dentigerous cyst [fluid-filled sac that forms around the crown of an unerupted permanent tooth] Left partial ethmoidectomy [removal of infected tissue and bone in the ethmoid sinuses]". Report indicated, "Surgeon: [Ear Nose and Throat (ENT) Surgeon A] . . . Assistant (s): [Medical Doctor (MD) B.] Report indicated, "Procedure details: The surgery began on the right with an uncinectomy. [removal of the uncinate process: a thin hook-like structure of the wall of the lateral nasal cavity] . . .The uncinate was removed. . .within one minute of initiating the procedure, it was understood that the cyst was on the contralateral [opposite] side. As a result, the remainder of the surgery was performed on the left. . . I was physically present and directly participated in all portions of the above procedure." Signed by ENT A.

During a review Patient 20's "Consent to Operation", dated 10/19/24, Consent indicated, "Operation or procedure: Left endoscopic maxillary antrostomy [procedure to clear sinus opening]".

During an interview on 12/18/24, at 11:54 a.m., with Senior Quality Consultant (SQC) C, SQC stated, "If a new staff member came in [to operating room] who was not present during the timeout then a new one should have been performed".

During an interview with ENT A on 12/18/24, at 4:22 p.m., ENT A stated, "I was present during the second time out for my procedure. The site marking was done by me in pre-op. I marked the left side near the jaw. The resident [MD B] performed the initial start of the procedure. [MD B] was not present during the timeout for this procedure, typically they are present during the timeout, but [MD B] was elsewhere". ENT A stated, "I was not present during the initial start of the procedure, when I came back in, [MD B] told me she started on the right side, then realized it was the incorrect side and started on the left side". ENT A stated, he took over the procedure when he returned to the room.

During an interview with MD B on 12/18/24, at 4:34p.m., MD B stated, "I was present at the very end of the second time out". MD B stated, "I saw they marked the left jaw". MD B stated, "[ENT A] and I had a verbal communication, start on the left maxillary". MD B stated, "I started on the right side, I removed the tissue of the uncinate process to visual where I needed to go, after that first step, I realized it was the wrong side, because there was no blood from the prior procedure. I let everyone know that it was the wrong side, then I started on the correct side, then [ENT A] took over the rest of the procedure".

During a review of the facility's P&P titled, "Universal Protocol" dated 2022 , the P&P indicated, "The purpose of this policy is to provide a process to reduce the risk of wrong patient, wrong procedure, and/or wrong site surgery and procedures. Universal protocol is applicable to all invasive procedures and non-invasive procedures with more than minimal risk to the patient, and excludes procedures that do not require informed consent. . . Procedure: B. Marking the operative or procedure site 2. The site will be marked by the person who is ultimately accountable for the procedure and will be present during the procedure. . . D. Final Verification-Time out 1. The Time Out is initiated by the LIP/APP [Licensed individual practitioner/Advanced practice provider] who will make the initial incision, puncture, or perform the procedure. . .2. All immediate members of the procedure team are to participate in the time-out process".