Bringing transparency to federal inspections
Tag No.: A0951
Based on document review and interview, for 2 of 9 surgical records (Pts. #8 and #11) reviewed, the hospital failed to ensure that documentation of the timeout (safety check) process included all members of the healthcare team.
Findings include:
1. The hospital's policy titled, "Universal Protocol" (effective 05/2025), was reviewed on 12/03/2025 and required, "...Time-out - the verification process using active, oral communication. This process confirms that the correct patient is receiving the correct procedure at the correct site. A time-out is always performed immediately prior to starting an invasive procedure in the location where the procedure will be performed. It involves all healthcare members, including physicians, who are assisting/performing the procedure... Time-Out/Final Verification: a. Conduct a final verification of the correct patient, procedure, site and, as applicable, implants. b. Final verification is conducted in the location where the procedure will be performed, before stating the invasive procedure or making the incision. It must involve all participants of the team and uses active communication... The Time-out is documented in the patient intra-operative record..."
2. The clinical record of Pt. #8 was reviewed on 12/03/2025. Pt. #8 had an EGD (endoscopy - examination of upper digestive tract) on 11/10/2025 with monitored anesthesia care (MAC). The timeout documentation, dated 11/10/2025 at 1:01 PM, included the surgeon, nurse, and technician; however, lacked inclusion that the anesthesia provider was present.
3. The clinical record of Pt. #11 was reviewed on 12/03/2025. Pt. #11 had a colonoscopy (examination of lower digestive tract) on 11/11/2025 with MAC. The timeout documentation, dated 11/11/2025 at 5:33 PM, included the surgeon, nurse, and technician; however, lacked inclusion that the anesthesia provider was present.
4. An interview was conducted with the GI Lab Manager (E#10) on 12/04/2025, at approximately 11:00 AM. E#10 stated that the timeout must be completed in the procedure room before the patient is given any anesthetic or sedating medications. E#10 stated that the whole team must be present and includes the surgeon, nurse, technician and the anesthesia provider if MAC is used. E#10 stated that only CRNAs (nurse anesthetists) or anesthesiologists may administer MAC.