HospitalInspections.org

Based on medical record review and staff interview, it was determined the hospital failed to ensure patients received care in a safe setting for 1 of 6 patients (Patient #3) whose medical records were reviewed. This caused Patient #3 to experience prolonged anesthesia time due to hospital error and without a documented benefit to the patient. This had the potential to affect all patients receiving services at the hospital. Findings include:

Patient #3 was a 61 year old female who had surgery, a lumbar fusion, on 8/20/25. The operative note stated, "While preparing to perform diskectomy, my scrub tech notified me that there was biological material [tissue fragment] within the trials [surgical instrument]. Therefore, back table was contaminated and we elected to abort the procedure and send the materials back to central processing for appropriate cleansing and sterilization. I had a discussion with Dr. [name], the director of anesthesiologist [sic], who felt that she would be fine in the lateral position and so I packed the wound with betadine-soaked 4x4s and placed drapes over the wound ... I then left the room and then came back once the instruments were prepared ... There were no complications. The patient tolerated the procedure well." There was nothing documented regarding whether the risks of keeping Patient #3 under anesthesia for several extra hours outweighed the benefit.

The Director of Perioperative Services was interviewed on 9/04/25 beginning at 10:32 AM. He stated when they discussed whether to keep Patient #3 under anesthesia, they were aware it would take about 3 hours to reprocess the surgical instruments.

A document titled, "Perioperative Case Times," for Patient #3 was provided. It showed the anesthesia start time was 7:04 AM, the procedure start time was 8:10 AM, and the bioburden was discovered at 8:23 AM. The case was restarted at 12:00 PM. Patient #3 was under anesthesia from 8:23 AM to 12:00 PM while the instruments were reprocessed.

The anesthesia note from the procedure was reviewed. It showed the anesthesia was started at 7:04 AM on 8/20/25. It showed a significant decrease in Patient #3's blood pressure between 1:15 PM and 1:35 PM, and another decrease in blood pressure at about 2:05 PM. The anesthesia concluded at 2:42 PM.

Patient #3's CRNA was interviewed on 9/04/25 beginning at 12:09 PM by phone and Patient #3's record was reviewed with him. He stated when they flipped Patient #3 to the prone (facedown) position, he could not obtain a blood pressure from her arterial line or any of her 4 limbs. He stated he then pushed some pressers (medication to raise blood pressure). He said at that point the arterial line started to read her blood pressure. He said he voiced concern about the significant presser support Patient #3 needed and continuing the surgery. He stated he and the Supervising Anesthesiologist decided to abort the case. When asked what the benefit to keeping Patient #3 under anesthesia was while the dirty surgical instruments were reprocessed, he stated there was no real benefit and keeping her asleep was not preferred. He said he was unsure if it was safe to close her as the incision had already been made.

Due to Patient #3's significant hypotension during surgery, potentially due to her prolonged anesthesia time, her surgery was not able to be completed on 8/20/25. She had a second surgery on 8/27/25. She stayed in the hospital from 8/20/25 to 8/31/25. It was unclear if the prolonged anesthesia time while waiting on the surgical instruments was beneficial to Patient #3.

The Director of Quality was interviewed on 9/04/25 beginning at 12:33 and confirmed there were no documented benefits to keeping Patient #3 under anesthesia while the surgical instruments were reprocessed.

It was unclear what the benefit there was to keeping Patient #3 under anesthesia while the instruments were reprocessed. Additionally, it was unclear why Patient #3's physician documented she "tolerated the procedure well," and, "there were no complications" when the procedure had to be aborted prior to completion due to extreme hypotension.

The hospital failed to ensure patients received care in a safe setting.

Based on observations and interview it was determined, the facility failed to maintain a clean and sanitary environment to avoid sources and transmission of infection. This failure had the potential to impact all patients receiving surgery in the hospital placing patients at risk for infection. Findings include:

On 9/02/25 at 2:13 PM during a tour of the sterile processing area it was noted the commercial cart washer, located inside an area referred to as "prep and pack," was observed with a white substance accumulated on the front of the doors running from the top of the doors to the bottom in several different columns. A sterile processing staff member was asked about the white substance and responded that it was difficult to clean, and the vendor was the one who maintains the cart washer.

On 9/04/25 at 11:30 AM a cleaning log or cleaning schedule was requested for the cart washer from the Director of Compliance. Surveyors were informed that a cleaning log was not available. It was unclear when or how the cart washer was cleaned. The Director of compliance confirmed that the cart washer should be regularly cleaned and that a cleaning schedule would be developed going forward.

The facility failed to maintain a clean and sanitary environment.

Based on CDC guideline review, Instructions for Use, observation, interview and record review, the facility failed to ensure adherence to its infection control policies and procedures by allowing a physician to utilize IUSS for a surgical instrument outside of emergency circumstances. Additionally, the facility failed to follow recognized standards of practice for reprocessing of surgical instruments. Findings include:

1. The hospital failed to ensure IUSS was used for emergency situations only.

A facility policy titled "Immediate Use Steam Sterilization," dated 2/02/23, stated that IUSS is to be used only in emergency situations and outlined the following criteria:

"Patient is on the OR table and the instrument is needed as soon as possible."

"Instrument is one of a kind."

"No alternatives exist except to utilize IUSS."

This policy was not followed.

Furthermore, the facility did not provide evidence of documented reeducation or corrective action for the physician following the incident, which is inconsistent with the facility ' s own infection control protocols and staff accountability standards. Findings Include:

Patient #6 was a 68-year-old male who underwent shoulder surgery on 6/16/25.

The hospital provided a list of all instances of IUSS use over the past year. One entry from June noted: " ...the rep brought 1 tray [instrument tray] and there wasn't enough time between cases to process [instruments] per standard protocol."

Review of the incident report revealed that Patient #6 was moved into the OR while the surgical instruments intended for his procedure had not yet completed sterile processing. The narrative stated this was done to "appease" the physician, who was described as being on a "war path."

The Sterile Processing Department Manager was interviewed on 9/3/25 beginning at 3:30 PM. He confirmed he was present during the incident and stated the instrument was put through IUSS based on the physician's insistence, who did not want to disrupt his surgical schedule.

The Vice President of Quality was interviewed and confirmed that the Chief Medical Officer had spoken to the physician regarding the misuse of IUSS, emphasizing that it is intended for emergencies-not for convenience. However, when asked for documentation of reeducation or corrective action, he stated there was none.

The hospital failed to appropriately document reeducation or retraining for the physician and permitted the use of IUSS for convenience. This failure to enforce infection control standards and staff accountability placed future patients at risk for surgical site infections.

2. Proper precleaning guidelines for surgical instruments were not followed.

a. A CDC document titled, "Sterilizing Practices," reviewed 9/09/25, stated, "Surgical instruments are generally presoaked or prerinsed to prevent drying of blood and tissue." This guideline was not followed.

Observations of the SPD were conducted on 9/02/25 beginning at 2:13 PM. A sign was visualized which stated dirty surgical instruments were to be sprayed with Blu62.

The Medline website (https://www.medline.com/product/Blu62-Pretreatment-Instrument-Detergent/Z05-PF132640), accessed 9/09/25, was reviewed for the specifications for Blu62 Pretreatment Instrument Detergent. It stated, "Formulated to begin the cleaning process and prevent drying and pitting of bioburden on surgical instruments."

Observations conducted on 9/02/25 beginning at 2:13 PM included observations of dirty instruments being cleaned in the decontamination room. There was a cart full of used surgical instruments waiting to be cleaned. Observed on top of the tray were 3 containers each containing multiple surgical instruments which were visibly soiled with dried blood. They were observed with the Sterile Processing Technician who agreed they were not kept moist.

The hospital failed to ensure surgical instruments were kept moist between use in the OR and decontamination.

b. Observations conducted on 9/02/25 beginning at 2:13 PM included observations of dirty instruments being cleaned in the decontamination room. The Sterile Processing Technician was observed doing the pre-cleaning of surgical instruments. There were 2 blue buckets and one red bucket for cleaning and rinsing of the instruments. The Sterile Processing Technician was observed placing enzymatic cleaner and water in the red bucket.

When asked what the correct ratio of enzymatic cleaner to water was, The Sterile Processing Technician said the machine pumped the correct amount of enzymatic cleaner and they filled the water to the handle on the blue bucket. She confirmed the water measurement was only applicable to the blue bucket and the water was not properly measured in the red bucket, creating the incorrect concentration of enzymatic cleaner to water.

The facility failed to follow proper precleaning guidelines for surgical instruments.



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