HospitalInspections.org

Based on interview and document review, the facility did not ensure that surgical services were provided in accordance with acceptable standards of practice. Specifically, the facility did not ensure that there were policies and procedures developed, in accordance with standards of practice, for maintaining, monitoring, and addressing, in an emergency situation, the temperature and humidity levels in the facility's operating rooms (ORs). The lack of these policies and procedures does not ensure the health and safety of patients undergoing surgery.

See Findings in Tag A0951.

Based on interview and document review, the facility did not ensure that their policies and procedures pertaining to temperature and humidity to be monitored and maintained within the operating room (OR) environment, emergency response in the case of an abnormal temperature/humidity increase within the OR environment, and immediate use steam sterilization (IUSS) and the IUSS of implants, were developed in accordance with acceptable standards of practice.

Findings include:

-- Review of the facility's after action report (AAR), titled "OR & SPD Humidity Incident," dated 9/26/2024, revealed there was elevated humidity, above 60 percent (%) relative humidity, in the facility's ORs and sterile processing department (SPD) on 9/26/2024 for approximately 2 and a half hours, before surgical cases had started that day. This compromised the sterility of almost all of the clean sterile supplies stored in those areas, which were then disposed of by facility staff. The AAR also revealed that there was confusion on what standards to follow for maintaining and monitoring temperature and humidity in the ORs and SPD. The date set for reviewing and implementing new facility policies and procedures concerning this incident was 3/1/2025 and the status stated "ongoing."

-- Review of the facility's policy and procedure titled, "Installing & Maintaining Protected Environments," effective date 7/1/2022, revealed that it lacked information on a specified temperature or humidity range that the ORs had to be maintained at, how the temperature and humidity levels would be monitored, or an acceptable standard of practice that the policy and procedure referenced. Also, there wasn't a specific policy or procedure for emergency response in the case of abnormal temperature/humidity increase within the OR environment, or reference to an acceptable standard of practice.

-- Per interview of Staff N, OR Staff, on 3/10/2025 at 3:00 pm, they are not aware of a facility policy and procedure in place for emergency response in the case of abnormal temperature/humidity increase within the OR environment.

-- Per interview of Staff K, OR Staff, on 3/10/2025 at 10:35 am, during the facility's OR and SPD humidity incident on 9/26/2024, there was a lot of confusion and none of the staff knew what to do.

-- Per interview of Staff J, OR Staff, on 3/10/2025 at 10:00 am, Staff J recalled the humidity being elevated on 9/26/2024. Staff J felt the staff did not know what to do. They started to re-sterilize the OR trays because the filters inside the trays were wrinkled. Over 4000 trays had to be redone.

-- Per interview of Staff L, OR Staff, on 3/10/2025 at 11:25 am, Staff L recalled there was an issue with the chiller in September in the middle of the night. It was almost foggy in the OR. Staff L went to the facility to assist staff. They were opening trays in the core and finding them compromised. Surgeries had started, but there was a lot of mixed messaging on how to proceed. Many surgeries were cancelled that day. The staff was upset and voiced their concerns. Staff didn't know what to do. There was an issue with the leadership in SPD at that time.

-- Per interview of Staff G, SPD Staff, on 3/10/2025 at 9:45 am and 3/11/2025 at 1:15 pm, they stated that the facility utilized One Tray Sealed Sterilization Containers for IUSS instead of having sterilizers for IUSS in the clean sterile core of the ORs. They also stated they were unsure whether there was a facility policy and procedure concerning IUSS, the IUSS of implants, or the One Tray Sealed Sterilization Containers.

-- Review of the facility's sterilization and disinfection policies and procedures on 3/11/2025 revealed that there wasn't a policy and procedure for IUSS, the IUSS of implants, or the One Tray Sealed Sterilization Containers, based on an acceptable standard of practice.

-- During interview of Staff C, Physical Plant Director, on 3/4/2025 at 11:45 am, they confirmed that a new policy and procedure has not been reviewed and implemented yet for the monitoring of temperature/humidity levels in the ORs and SPD or for emergency response in the case of abnormal temperature/humidity increase within the OR environment.

Based on document review, medical record (MR) review, and interview, 1) in 10 of 10 MRs (Patient #1 - Patient #10), the anesthesia consent forms lacked the name of the specific provider performing the anesthesia service and the signature of the anesthesiologist was not legible. Additionally, the hospital's policy and procedure lacked instruction to staff to document the name of the provider administering anesthesia on the consent. 2) In 4 of 10 MRs (Patient #1, Patient #2, Patient #3, and Patient #9) the surgical and/or the anesthesia consent forms lacked documentation of date and/or time the patients signed the consent. 3) In 1 of 10 MRs (Patient #4) the surgical consent form contained abbreviations. 4) In 1 of 10 MRs (Patient #5) the surgical consent contained a word that had been crossed out. This lack of documentation does not portray the actual care provided to the patient.

Findings regarding (1) include:

-- Review of Patient #1's MR revealed, their anesthesia consent form dated 9/26/2024 at 8:16 am, lacked documentation of the name of the specific provider that provided anesthesia services to the patient and the anesthesia provider's signature was not legible.

-- Review of Patient #2's MR revealed, their anesthesia consent form dated 3/6/2025 at 10:38 am, lacked documentation of the name of the specific provider that provided anesthesia services to the patient and the anesthesia provider's signature was not legible.

-- Review of Patient #3's MR revealed, their anesthesia consent form dated 2/14/2025 at 12:17 pm, lacked documentation of the name of the specific provider that provided anesthesia services to the patient and the anesthesia provider's signature was not legible.

-- Review of Patient #4's MR revealed, their anesthesia consent form dated 2/25/2025 at 7:11 am, lacked documentation of the name of the specific provider that provided anesthesia services to the patient and the anesthesia provider's signature was not legible.

-- Review of Patient #5's MR revealed, their anesthesia consent form dated 1/10/2025 at 9:25 am, lacked documentation of the name of the specific provider that provided anesthesia services to the patient and the anesthesia provider's signature was not legible.

-- Review of Patient #6's MR revealed, their anesthesia consent form dated 2/28/2025 at 7:08 am, lacked documentation of the name of the specific provider that provided anesthesia services to the patient and the anesthesia provider's signature was not legible.

-- Review of Patient #7's MR revealed, their anesthesia consent form dated 2/24/2025 at 10:28 am, lacked documentation of the name of the specific provider that provided anesthesia services to the patient and the anesthesia provider's signature was not legible.

-- Review of Patient #8's MR revealed, their anesthesia consent form dated 3/10/2025 at 9:40 am, lacked documentation of the name of the specific provider that provided anesthesia services to the patient and the anesthesia provider's signature was not legible.

-- Review of Patient #9's MR revealed, their anesthesia consent form dated 9/26/2024 at 12:10 pm, lacked documentation of the name of the specific provider that provided anesthesia services to the patient and the anesthesia provider's signature was not legible.

-- Review of Patient #10's MR revealed, their anesthesia consent form dated 9/26/2024 at 7:39 am, lacked documentation of the name of the specific provider that provided anesthesia services to the patient and the anesthesia provider's signature was not legible.

-- Review of the facility's policy and procedure titled "Procedure, Site, Location, & Patient Identification Verification," revised 10/2023, lacked instruction to staff to identify the provider who would be providing the anesthesia to the patient during their procedure.

Findings regarding (2) include:

-- Review of the facility's facility's policy and procedure titled "Procedure, Site, Location, & Patient Identification Verification," revised 10/2023, indicated consent documentation must include the patient, witness, and licensed practioner's signature, date, and time the consent was obtained.

-- Review of Patient #1's MR revealed the surgical consent, dated 9/26/2024, lacked the time the patient signed the consent. The anesthesia consent, dated 9/26/2024, lacked the date and time the patient signed the consent.

-- Review of Patient #2's MR revealed the anesthesia consent, date 3/6/2025, lacked the date and time the patient signed the consent.

-- Review of Patient #3's MR revealed the anesthesia consent, dated 2/14/2025, lacked the date and time the patient signed the consent.

-- Review of Patient #9's MR revealed the anesthesia consent, dated 9/26/2024, lacked the date and time the patient signed the consent.

Findings regarding (3) include:

-- Review of the facility's facility's policy and procedure titled "Procedure, Site, Location, & Patient Identification Verification," revised 10/2023, indicated consent documentation should have no acronyms or abbreviations, except spinal levels.

-- Review of Patient #4's MR revealed the surgical consent form indicated the procedure being performed was a robotic assisted laparoscopic right partial nephrectomy, possible right radical nephrectomy with TAP block. TAP was not spelled out (transversus abdominis plane - numbs the nerves of the anterior abdominal wall).

Findings regarding (4) include:

-- Review of the facility's facility's policy and procedure titled "Procedure, Site, Location, & Patient Identification Verification," revised 10/2023, indicated if consent documentation is altered or illegible, it must be redone and re-signed by all parties.

-- Review of Patient #5's MR revealed the surgical consent contained a word that had been scribbled over. No new consent was obtained.

-- During interview of Staff O, Regulatory Director, on 3/11/2025 at 3:30 pm, they acknowledged the above findings.