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Based on observation, record review and interview the facility failed to ensure surgical services were well-organized appropriate to the scope of services offered, and failed to maintain high standards of medical practice and patient care when:

A. Observation on 7/30/24 revealed damaged vinyl floor and an open pass-through window between clean and dirty areas in the sterile processing department. (Cross Refer to A 0941)

B. Observations on 7/31/24 revealed damaged vinyl floor and a closed pass-through window between clean and dirty areas in the sterile processing department. (Cross Refer to A 0941)

C. Infection control /environmental rounds were not being consistently completed in the sterile processing department. (Cross Refer to A 0941)

D. No humidity readings were documented for January 2024 through June 2024 for the sterile processing department. For the operating room, when temperature and humidity readings were out-of-range, there were no documented actions. (Cross Refer to A 0951)

E. The facility did not maintain a policy regarding the operation of the pass-through window (separates clean from dirty) located in the sterile processing department, to include air exchange requirements. (Cross Refer to A 0951)

The facility's failure to provide surgical services (sterilization procedures) in accordance with acceptable standards for conditions of temperature, humidity, air exchange, and pressures potentially impacted appproximately 900 surgical patients per month.

Based on observation, record review and interview the facility failed to ensure sterile processing services were organized appropriate to the scope of services offered, when:

A. Observations on 7/30/24 revealed damaged vinyl floor and an open pass-through window between clean and dirty areas. A follow-up observation on 7/31/24 revealed the pass-through window was closed.

B. Infection control /environmental rounds were not being consistently completed in the sterile processing area.

Findings were:

A. Observations throughout the sterile processing department on 7/30/24 revealed:

-numerous divots to the vinyl flooring; areas of gouges; missing tile; rust; and rippling/buckling were present. The flooring in the surgical processing department was damaged and could not be cleaned.

- a pass-through window between the decontamination (dirty) and the sterile processing room (clean) where instruments were cleaned, sterilized and stored, was open. A label at the top of the window stated, "Please keep closed when not in use." The open window allowed air movement from the dirty side to the clean side, allowing for cross-contamination and contamination of sterile packaging.

A follow-up observation on the morning of 7/31/24, in the sterile processing department, revealed the pass-through window was now closed. A tag attached to the broken piece read, "missing piece snapped" (no date, initials, or time was recorded).

Review of policy, Title: BSA OR Sterile Packaging, approval date 3/2023, documented in part:
"Storage and Processing
...Packaging
Perform packaging in an area intended, designed, and equipped for sterilization packaging..."

Review of the facility "Annual Infection Prevention Plan 2024,"documented in part:,
"The hospital reduced the risk of infections associated with medical equipment, devices, and supplies
BSA implements infection prevention and control activities when doing the following:
1. Cleaning and disinfecting medical equipment, devices, and supplies.
2. Sterilizing medical equipment, devices, and supplies.
3. Disposing of medical equipment, devices, and supplies.
4. Storing medical equipment, devices, and supplies."

In interview on the morning of 7/31, staff #13 stated, " ... damage to the flooring with the rippling/buckling of the vinyl on the floor, and tear in the vinyl appear to be multiplying daily."

Interviews with Staff #s 13, 14, and 15 on the afternoon of 7/30/24, in the facility conference room, revealed when surveyor inquired about condition of pass-through window, staff replied that the pass-through window had remained open for 1 to 2 years. Staff also replied:
- "Cameras and lenses get sat up there (on the window counter) and they go to be wrapped and processed."
- "Director of Surgical Services (Staff #22) says she reports it, nothing happens."

In interview on the afternoon of 7/30/24, in a facility conference room, Staff #1, Director of Quality, Patient Safety, Infection Prevention and Compliance, when asked about the pass-through window stuck in the open position, stated: "It has not been brought to my attention. Took prevention piece (became for responsible for infection prevention) in February of this year. Cross contamination might be an issue if airflow is pushing contamination out into clean area. I can see where that might be an issue, but I would need more information." When asked what the plan was, going forward, Staff #1 stated, "Make sure window is closed. Need to at least have that (window) closed."

B. Review of the "Infection Prevention Plan 2024, documented in part, "The hospital has a method for communicating responsibilities for preventing and controlling infection to licensed independent practitioners, staff, visitors, patients, and families ... Infection Prevention rounds ..."

When asked for documentation of infection control/environment rounds the hospital performed in the sterile processing department, none were provided except for a round on 4/17/24.

Based on interview, observation and record review, the facility failed to ensure policies maintained high standards of medical practice and patient care when:

A. No humidity readings were documented for January 2024 through June 2024 for the surgical processing department. For the operating room, when temperature and humidity readings were out-of-range, there were no documented actions.

B. The facility did not maintain a policy regarding the operation of the pass-through window (separates clean from dirty) located in surgical processing department, to include air exchange requirements.

Findings:

A. Review of facility spreadsheet for out-of-range temperature and humidity dated January 2024 through June 2024 revealed no humidity documentation for the Sterile Processing department.

In interview on the morning of 7/31/24, Staff #22, Director of Surgical Services, reported Staff #20, Director of Facilities, "owns" the temperature and humidity policy and Staff #22 was unable to find any data related to the sterile processing department.

Review of facility spreadsheet dated January 2024 through June 2024 revealed when temperature and humidity in the Operating Rooms (ORs) were out-of-range, there were no documented actions taken, if any.

Facility policy titled "Temperature and Humidity Policy for Operating Rooms" effective date 3/20/22, stated in part, "Policy: The following applies to the surgical procedure rooms and sterile processing rooms:
Recommended temperature ranges are between 68°F and 75°F. BSA will program the temperature settings for procedure rooms and the processing room to operate in that range...

2. The recommended humidity range is between 20% and 60%.
...Procedure:
1. The clinical person responsible for opening the surgical suites for the day shall review temperature and humidity readings for the procedure rooms and for the reprocessing room daily, prior to the initiation of procedures. This information is provided via email from our building automation system.
2. When the temperature is found to be outside of the recommended ranges, he/she can adjust the thermostat or call Facility Services Dispatch ..."

B. Observation of sterile processing department on 7/30/24 revealed a pass-through window between the decontamination (dirty) and the sterile processing room (clean) where instruments were cleaned, sterilized and stored, was open. A label at the top of the window stated, "Please keep closed when not in use." The open window allowed air movement from the dirty side to the clean side, allowing for cross-contamination and contamination of sterile packaging.

In interview on the afternoon of 7/30/24, in a facility conference room, Director of Quality, Patient Safety, Infection Prevention, and Compliance (Staff #1), when asked about the pass-through window, stated: "It has not been brought to my attention. Took prevention piece in February of 2024. Cross-contamination might be an issue if airflow is pushing contamination out or into clean area. I can see where that might be an issue, but I will need more information."

An observation on the morning of 7/31/24, in the sterile processing department, revealed the pass-through window was now closed. A tag attached to the broken piece read, "missing piece snapped" (no date, initials, or time was recorded).

In an interview on the morning of 7/31/24, in a facility conference room, Staff #22 (Director of Surgical Services) revealed the facility did not monitor air exchange in the sterile processing department.

The facility was asked to provide manufacturer instructions and a policy for the operation of the pass-through window in the sterile processing department. No policy or manufacturer instructions were provided.

In an article sponsored by Steris, titled "Keeping Air Pressure in Control" found at: https://university.steris.com/article-pdfs/CHL285_May_June.pdf, states: " ... Policies and procedures establish when ... pass-through windows can be open, and in some cases, how far a passthrough window can be opened. It is important that limitations are identified, staff are trained, and procedures are enforced when it comes to these processes.
...Sterilizer Equipment room: Pressure: Positive; ACH (Air Changes Per Hour): 10...
Conclusion
Air management is a crucial function of infection control and prevention because it helps control cross contamination and disease transmission. Facilities must establish engineering controls and processes, and monitor rooms to ensure that air flows in the correct direction."