HospitalInspections.org

Based on observation, staff interview, and review of facility documents, it was determined that the facility failed to ensure: 1.) the flow of contaminates to clean areas are minimized by a physical barrier by adhering to recommended airflow pattern in accordance with CDC guidelines; 2.) the floors in the sterile processing department are kept clean, with terminal cleaning records kept, in accordance with facility policy; and 3.) the external surfaces of the automated washers in the sterile processing department (SPD) are cleaned and disinfected daily in accordance with manufacturer instructions for use.

Findings include:

1. Reference: Centers for Disease Prevention and Control (CDC) Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008 Update: May 2019 states, "... Physical Facilities - The central processing area(s) ideally should be divided into at least three areas: decontamination, packaging, and sterilization and storage. Physical barriers should separate the decontamination area from the other sections to contain contamination on used items. In the decontamination area, reusable contaminated supplies (and possibly disposable items that are reused) are received, sorted, and decontaminated. The recommended airflow pattern should contain contaminates within the decontamination area and minimize the flow of contaminates to the clean areas. The American Institute of Architects recommends negative pressure and no fewer than six air exchanges per hour in the decontamination area (AAMI [Association for the Advancement of Medical Instrumentation] recommends 10 air changes per hour) and 10 air changes per hour with positive pressure in the sterilizer equipment room. ..."

On 07/08/25 at 10:35 AM, during a tour of the Sterile Processing Room, an open pass-through window leading from the decontamination room was observed. On the window was a sign stating, "Keep Window Closed at All Times." This finding was confirmed with Staff (1), S4, and S5.

2. On 07/09/25 at 10:30 AM, a tour of the Sterile Processing Room was conducted in the presence of S1, S4, and S5. In front of the washers, the white floors were observed with multiple black scratches, scuff marks, and brownish colored residue, inside and around a long seam extending to the washer. Along the base of the washers, thick brown colored residue was observed. S5 stated that the floors are cleaned by Environmental Services [EVS].

At 10:53 AM, an interview was conducted with S7. S7 stated that the floors are swept and mopped each day during the afternoon shift. He/she further stated that "once a week we do terminal cleaning, which includes high dusting and wall washing" and that a scrubber machine is used to clean inside the black scratches. A request was made to view the terminal cleaning logs of the sterile processing room, or any documentation that the floors are being cleaned. S7 stated that they did not keep logs at this time. At 1:15 PM, during an interview with S14, he/she stated the brownish residue observed in and around the floor seam is a filler used to repair the gap in the flooring.

At 3:16 PM, S1 confirmed that there was no terminal cleaning log. Upon request, S1 provided the facility's EVS policy for cleaning the Sterile Processing Department (SPD) area, titled, "[name of company] 9.05 - Sterile Processing; Managing Department(s): Environmental Services," Date Issued 10/01/24, which stated, "Policy Statement: Sterile Processing is one of the most critical areas of the hospital. Extreme care must be taken to ensure the following schedule is carried out rigorously and in accordance with departmental procedures. ... Daily Routine Cleaning ... Note: Terminal Cleaning Logs should be kept for record keeping. ..."

3. On 07/09/25 at 10:30 AM, during a tour of the Sterile Processing Room in the presence of S1, and S5, the Getinge automated washers were observed with visible streak marks, white splatter marks, and discolored areas. S5 stated that the SPD staff are responsible for cleaning the washers, and that the outside of the washer is wiped down weekly. Upon request, S5 was unable to provide documentation of the weekly washer cleaning. A request was made to review the instructions for use (IFU) for the washer.

Review of the "Getinge 86-Series User Manual" provided by S1 stated, "... 4. Maintenance ... 4.1 Daily Inspection: the following points are performed as part of a daily inspection of the machine: Clean the outer parts of the machine (see section 4.2.5 Cleaning the exterior) ... 4.2.5 Cleaning the exterior ... The front and side panels can be cleaned and disinfected with an alcohol-based cleaning agent or medical spirit. The operator panel is cleaned in the same way. Remove stains from metal parts with an ordinary cleaner for stainless steel. ..."

These findings were confirmed on 07/10/25 during exit conference with S1, S2, S3, and S14.