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Based on document review, and interview, it was determined that the hospital failed to comply with the Condition of Participation, 42 CFR 482.51 Surgical Services.

Findings include:

1. The hospital failed to ensure that the required resources were available prior to taking patient to the operating room and inducing anesthesia, per hospital policy. See A-951.

Based on document review and interview it was determined that for 1 (Pt. #2) of five patients medical record reviewed for surgery, the hospital failed to ensure that the required materials for the surgical procuedure were readily available prior to taking patient to the operating room and inducing anesthesia, per hospital policy.

Findings include:

1. On 6/11/2025, the hospital's 'Loaner Tray' (template 4/12/2023 B.) policy included, " ...III. Definitions: ...Loaner Trays: surgical instruments/implants that are not owned or housed in [hospital] ...IV. Policy: ...All loaner instruments must be received, logged, decontaminated, and sterilized in the sterile processing department (SPD) prior to scheduled procedure ...1. ...trays shall arrive at the site for validation by 9:00 a.m., no less than 48 hours prior to the day before the scheduled procedure ...". The hospital reviewed the policy on 10/22/2024, however no revisions were made.

2. On 6/11/2025, the hospital's 'Universal Protocol for Procedural Safety' (10/24/2022) policy included, " ...V. Procedure: A. Pre-procedure verification process ...5. The elements of pre-procedure verification may include but is not limited to: ...e. Requested implants, devices or equipment are available ...E. Implant Verification: 1. Use of a separate implant verification process supports focused team communication and reduces surgical/procedural errors". The hospital reviewed the policy on 5/07/2025, however no revisions were made.

3. On 6/12/2025, the clinical record of Pt. #2 was reviewed. Pt. #2 was scheduled for an elective surgical procedure: Cervical 5-6 Disc Replacement (surgery of the spine) on 8/12/2024. The clinical record including the following:

- The Orthopedic Surgeon's (MD #4) 'Clinical Notes' on 8/12/2024 at 7:30 AM included, " ...Upon [MD #4] arriving at the operating room [Pt. #2] was undergoing anesthesia. That is when [MD #4] began [MD #4's] preoperative checklist, going over instruments, the microscope, the setup of the room, as well as the implants that would be needed. It was at that point that [MD #4] realized that the implants were not available and the rep (vendor representative) was not present ...[MD #4] called the rep and it was impossible to get this type of cervical disc replacement instrument into the hospital within a reasonable amount of time ...it would have taken about 30 minutes to an hour to deliver [implant] to the hospital and likely another 3-4 hours of sterile processing. This is certainly not a safe amount of time to be under anesthesia waiting. The surgery had not started, and no incision had been made yet. Therefore [the surgical team] decided to reverse anesthesia and [MD #4] followed up with [Pt. #2] in the postoperative holding area to explain what happened. The rep should have been made aware of this surgical procedure. Secondly, [MD #4] believe that all instrumentation and implants should be acknowledged prior to the patient entering the room. Lastly, [MD #4] did go to the surgical coordinator/scheduler and ensured that we had ordered the proper implants and correctly filled out the order for the surgery and that was deemed to be done correctly."

4. On 6/11/2025, the hospital's 'Patient Safety Event Form' (8/12/2024) included, " ...Pt. #2 ...Event type: Surgery/Procedure/Anesthesia ...Main OR ... Event summary: A spine case was cancelled this morning, there was no vendor rep that is going to support the case. [Pt. #2] was already intubated when the team and the surgeon found out there was no vendor support. [Pt. #2] was woken up, extubated and recovered in the PACU (Post-Anesthesia Care Unit) ...Reviewer summary: The vendor was not able to confirm. The rep that is listed in case check was transferred to another department. Team member coaching provided. Reported in safety huddle. Referred to Patient Relations. Risk Management for review ...Safety Event Classification: ...No harm ...".

5. On 6/11/2025, the hospital's internal analysis in regard to Pt. #2's incident was reviewed. The analysis indicated that the opportunity for improvement was that the vendor was not present, an inadequate process, and that the team will review the case check process prior to procedures and determine if the Vendor is present prior to the timeout. The hospital provided two staff meeting attestations that included discussion of the hospital's Time Out and Sign Out process on 2/04/2025 and discussion of vendors not moving supplies on 3/04/2025. The analysis did not include supporting documentation of case check review nor further review of hospital processes nor identified opportunities for improvement and indicated that the safety event was closed on 8/30/2024.

6. On 6/16/2025, the hospital's surgical 'Case Check' for 8/12/2024 indicated that a vendor was requested for Pt. #2's surgery on 8/07/2024, without response. The "Case Check" did not indicate that additional requests were made to the Vendor.

7. On 6/12/2025 at approximately 9:08 AM, an interview with the Anesthesiologist Resident (MD #5) was conducted. MD #5 stated that Pt. #2's Anesthesiology team was given the 'all clear' (procedure set-up is complete and ready for patient) and Pt. #2 was brought to the OR and anesthesia was induced. MD #5 stated that the Surgeon (MD #4) realized that during the surgical team's 'Time Out', the Vendor nor the surgical implant was not present. MD #5 stated that the surgery was canceled at that time, anesthesia was reversed, and Pt. #2 went to PACU for recovery.

8. On 6/12/2025 at approximately 9:23 AM, an interview with the Surgeon (MD #4) was conducted. MD # 4 stated that MD #4 entered the OR for surgical procedure and during the Time-Out process with the surgical staff, MD #4 realized that the Vendor rep was not present nor the cervical implant. MD #4 stated that the request for the Vendor was sent, and it appeared as the rep did not accept. MD #4 stated that the case should not have been scheduled. MD #4 stated that MD #4 was not made aware that the Vendor did not accept nor that the implant would not be available for the procedure.

9. On 6/12/2025 at approximately 9:48 AM, an interview with the OR Circulator (E #18) was conducted. E #18 stated that prior to a patient entering the OR, the room should be setup with all required equipment, including implants. E #18 stated that prior to surgery, the Charge Nurse tried to contact the rep, but the surgical team had not received information about the rep's time of arrival. E #18 stated no recollection of a change in hospital practice/process in the OR since Pt. #2's event, however the team double checks that all equipment and the Vendor rep, if required, is available prior to a patient entering the OR.

10. On 6/12/2025 at approximately 10:05 AM, an interview with the Surgical Technician (E #20) was conducted. E #20 stated that E #20 provided set-up for Pt. #2's surgical case. E #20 stated that trays were set-up as identified on the preference card (list that indicates equipment/supplies needed for specific case). E #20 stated that the preference card includes the list of trays needed, but not implants. E #20 stated that the OR Circulator and the Surgeon communicate to determine readiness of a patient being transferred to the OR. E #20 stated that if a vendor rep is required for a case, the rep should be in the OR prior to the patient's arrival. E #20 stated that the vendor rep did not arrive for Pt. #2's case and the surgery was canceled.

11. On 6/12/2025 at approximately 12:28 PM, an interview with the Sterile Processing Department Manager (E #24) was conducted. E #24 stated that the Pt. #2's vendor tray was not received prior to Pt. #2's scheduled surgery date on 8/12/2024.
12. On 6/16/2025 at approximately 10:13 AM, an interview with Assistant Clinical Manager (E #16) and the Director of Surgical Services (E #17) was conducted. E #16 stated that there are no supporting documents of the education that was provided to staff in regard to vendor verification of equipment. E #17 stated that the hospital's Universal Protocol policy is followed for pre-procedural verification and that there is currently a new tracking system for vendor trays. E #16 and E #17 had no additional documentation to provide in regard to the hospital's follow-up to Pt. #2's safety event.