HospitalInspections.org

According to observation, DEA.gov website review, and staff interview, it was determined the facility failed to ensure Drugs listed in Schedules II, III, IV, and V of the Comprehensive Drug Abuse Prevention and Control Act of 1970 were kept locked within a secure area. This created potential for unauthorized access to opiate and benzodiazepine medications. Findings include:

According to the DEA.gov website (https://www.dea.gov/drug-information/drug-scheduling accessed 8/07/24), "Schedule II drugs, substances, or chemicals are defined as drugs with a high potential for abuse, with use potentially leading to severe psychological or physical dependence. These drugs are also considered dangerous. Some examples of Schedule II drugs are: ... hydromorphone (Dilaudid) ... fentanyl."

Observations were conducted in the pharmacy area on 7/29/24 at 10:00 AM. In the pharmacy, a "pass through" window was observed. It was a wall of cubbies which was accessible from the pharmacy, and also on the outside of the pharmacy via a double locked cupboard. There was a box of anesthesia medications which were placed in each individual cubby. The Pharmacist stated this was where CRNAs checked out anesthesia medications for the day, including fentanyl and dilaudid.

Additional observations were conducted of the pass through window on 7/29/24 at 11:41 AM. The pass through window was observed from the side anesthesia providers had access to. There was one set of cupboard doors which were opened via an RFID badge lock. Surveyor requested the pharmacist open the main cupboard door. When the main cupboard door was opened, surveyor visualized 8 additional cubbies which were also locked by an RFID badge system, only to be opened by the anesthesia provider which it belonged to. The surveyor was able to open one of the 8 cubbies which was unlocked, and visualized a black box containing anesthesia medication. The pharmacist present for the observation confirmed the individual cubby should have been locked.

Scheduled anesthesia medications were not kept locked within the secure area, creating potential for unauthorized access of medications.

Based on observation, review of AORN guidelines, and staff interview, it was determined the facility failed to maintain a functional and sanitary environment for patients receiving care at the facility. This had the potential to impact all patients receiving services at the facility and placed patients at an increased risk for infections to occur. Findings include:

1. The facility failed to follow AORN guidance related to maintaining a sterile enviroment during construction.

AORN guidelines 2022 edition under the section titled "Design and Maintenance" subsection 10.4.2 stated, "Place barriers (EG, solid fiberboard or sheet rock walls, sealed plastic walls between the surgical suite and maintain them at all times." This recommendation was not followed. An example includes:

The surgical areas were toured on 7/29/24 beginning at 11:00 AM, in the presence of the surgical manager, DON, and Infection Preventionist. One area observed was the sterile storage area that contained sterile supplies to be used in surgery. The area had a water leak found on 7/21/24 and was undergoing construction during the observation. An approximately 4-foot high by 15-foot long section of wall separating the sterile supply area and the hall had been removed. The plastic that was utilized to contain the construction had several holes including around the light switch and at the seams around the door frame on both sides of the wall. The side of the wall into the hallway appeared to have positive pressure meaning what was inside the wall was potentially being pushed into the hallway. The removed section of wall was directly opposite an operating room that was not sealed from the construction area and that was currently in use.

During the tour the Infection Preventionist confirmed and visualized the holes in the plastic and immediately placed plastic tape over the breaks in the plastic.

A second tour of the sterile supply area was conducted the following day on 7/30/24 beginning at 9:45 AM. An additional floor to ceiling plastic wall was in place and the hallway was blocked off to traffic.

The facility failed to maintain a sanitary environment.

2. The facility failed to ensure terminal cleaning was conducted during construction projects in the surgical areas.

AORN guidelines 2022 edition under the section titled Environmental cleaning subsection 9.1 through 9.4 stated, "Perform cleaning of environmental surfaces to remove dust and debris ... Perform terminal cleaning before equipment and supplies are place in the area where the construction renovation, repair, demolition or disaster remediation has been completed ... if flooding or water related emergency occurs, including sewage intrusion, inspect the area for water damage and implement a cleaning and disinfection process ... Perform a terminal cleaning of affected areas when condensation is observed on surfaces." These guidelines were not followed. An example includes:

The sterile supply room was identified by the Facilities Maintenance Manager to have a water leak in the wall on 7/21/24. The wall in the sterile supply was opened and the water leak was subsequently fixed that same day. An outside construction company began with the water remediation on 7/25/24 and was ongoing during the survey. The sterile supply room contained a large quantity of surgical supplies that were used in the facilities OR's. There was no hospital documentation of the area being terminally cleaned including supplies evaluated for dust and debris after the water intrusion and during the construction project.

Surveyors requested cleaning logs for the sterile supply area. The DON provided a checklist of monthly duties for the month of July 2024. The checklists were not dated when the individual tasks were performed. The section titled "check for outdates and wipe down:" for the "Supplies in sterile storage" had not been completed at time of survey.

The Infection Preventionist was interviewed on 7/31/24 beginning 9:45 AM. She confirmed there were no logs of the sterile supply area being terminally cleaned in July.

The facility failed to maintain a sanitary environment.

Based on review of AORN standards, observation, review of surgery schedule, and staff interview, it was determined the facility failed to ensure surgical services were provided in accordance with acceptable standards of practice for 1 of 10 ORs (OR #3) in the facility. Additionally, the facility failed to maintain a functional and sanitary enviroment in the surgical area. Failure to maintain surgical services in accordance with acceptable standards of practice put all patients receiving surgical care at the facility at risk of a negative outcome due to inadequate OR cleaning and maintenance, and potential for injury. Findings include:

1. According to AORN Guidelines for Perioperative Practice 2022 Edition page 111 Section 12.2 for design and maintenance of ORs stated, "Maintain the integrity of structural surfaces (eg doors, floors, walls, ceilings, cabinets) and have surfaces repaired when damaged." This guideline was not followed. Examples include:

Observations in the surgical areas, and ORs, were conducted on 7/30/24 beginning at 8:45 AM with the DON of perioperative services, RN Surgical Manager, and a Perioperative RN. There were 10 ORs in the surgical area, some of which had new epoxy floors, and some of which were a rubber tile system. In OR 3 there were multiple patched areas where the rubber floor had been repaired previously. Problems with the floor in OR 3 included but were not limited to the following issues:

- There was tape holding tiles together in areas where the tile had split
- There were cracks in the rubber tiles where the bare concrete floor was exposed
- There was adhesive residue on the floor where tape had been removed and replaced
- There were multiple areas where the rubber floor had lifted from the concrete forming a raised bubble, with potential for tripping when walking or moving patient gurneys over the raised area

It was unclear how the floor in OR 3 could be properly cleaned, both terminally and between surgical cases. This compromised the sterile environment in OR #3.

The surgical schedule was reviewed. It showed surgical cases in OR 3 were performed until 7/29/24, the same day the survey started.

The DON of Perioperative Services, RN Surgical Manager, and another Perioperative RN were present for the observations of OR 3 on 7/30/24 at 8:45 AM and were interviewed during the observations. The RN Surgical Manager was asked how long the floors had been broken and she said, "as long as I can remember." She stated the heavy gurneys and surgical equipment rolling on the floor over time caused the floor to break. They confirmed the broken floor was not suitable for patient use in the sterile OR environment.

The DON of Perioperative Services was interviewed during additional surgical observations on 7/31/24 at 10:50 AM. He stated floors in ORs 1 and 5 thru 10 had been replaced with epoxy flooring. He stated floors in ORs 2 thru 4 had not been replaced. He stated Monday 7/29/24 was the last day OR 3 was used for surgical cases and was closed until the floors could be replaced.

The CEO was interviewed on 7/30/24 at 2:17 PM. She stated for 13 years the floors in the ORs had been a problem.

The facility failed to ensure surgical services were provided in accordance with acceptable standards of practice, putting all patients receiving services in OR 3 at risk of a negative outcome.

2. Refer to A - 0749 as it relates to failure of the infection control program to maintain a clean and sanitary environment in the operative area.

The cumulative effects of these negative systemic practices impeded the ability of the hospital to provide surgical services in a safe and sanitary manner.