HospitalInspections.org

Based on observations and documentation review during a survey conducted from November 28-December 01, 2011, the volume of deficiencies issued to the Hospital for non compliance with the 2000 Edition of the Life Safety Code, and deficiencies generated relating to the physical plant, it is determined the hospital failed to ensure the safety of patients, staff and the public. Therefore, the condition is not met. See A722, K056 and K069.

Based on observation and staff interview, it was determined the hospital failed to maintain
adequate facilities to ensure endoscopic equipment is decontaminated, disinfected and stored in a manner which is in compliance with minimum construction standards. This has the potential to adversely affect the safety of all patients by not having endoscopic equipment appropriately disinfected and stored prior to procedures.

Findings include:

1. During a tour of the hospital endoscopy instrument processing area on 11/28/11 at approximately 3:40 p.m., it was noted that the procedures used for cleaning contaminated instruments and storage of disinfected instruments does not eliminate the potential for cross contamination. It was observed there are two endoscope procedure rooms (procedure rooms #3 and #4). Both procedure rooms have exit doors into a corridor. The Operating Room (OR) Manager who was present during the observations stated the contaminated instruments are transported from each procedure room, through a common corridor and into the processing room. The processing occurs in a small room (approximately five (5) feet by ten (10) feet) which is located between the two procedure rooms. The door from the corridor entering into the processing room is on the five (5) feet side of the processing room. There are no other doors entering or exiting the small processing room. She stated the initial decontamination and the high level disinfection occurs in the same small room. The processing room was observed to have no separations or barriers between the decontamination and disinfection areas. During the observations of the processing room on 11/28/11 at approximately 3:40 p.m., it could not be determined that a negative pressure and a minimum ten (10) air exchanges per hour was met as required for a decontamination room. The cleaning of instrumentation does not allow the flow from the contaminated area to a clean area without the potential for droplet contamination due to the close proximity of the decontamination sink and the automatic processing unit used for disinfections and the lack of a physical barrier between the clean and contaminated areas.

2. The OR Manager stated the disinfected instruments are stored in a clean closet which is located in the corridor near the two procedure rooms. She stated the disinfected instruments are transported out of the processing room through the same door which is used to bring the contaminated instruments into the processing room. Observations of the area on 11/28/2011 at approximately 3:40 p.m. confirmed the hospital is transporting contaminated and disinfected instruments through the same door way of the processing room. It was observed there is only one door available to enter and exit the processing room. The hospital ' s process of transporting contaminated instruments through the same door as the disinfected instruments does not meet the minimum construction standards and creates potential for cross contamination of all instruments used for procedures for all patients.

3. These findings were discussed with the OR Manager and Facility Manager during the tour of the operating room area at approximately 3:42 p.m., on 11/28/11. Both agreed that the processing and storage of instruments was not being done to meet the minimum requirements.


Guidelines for Design and Construction of Health Care Facilities
7.7.A.5 Endoscopy suite requirements
9.9 Endoscopy Suite
9.9.B Instrument Processing Room(s)
9.9.B1. Dedicated processing room(s) for cleaning and disinfecting instrumentation must provided. In an optimal situation, cleaning room(s) should be located between two procedure rooms. However, one processing room may serve multiple procedure rooms. Size of the cleaning room(s) is dictated by the amount of equipment to be processed.

Cleaning rooms should allow for the flow of instrumentation from the contaminated area to the clean area, and finally, to storage. The clean equipment rooms, including storage, should protect the equipment from contamination.

9.9.B2.he decontamination room should be equipped with the following:
a. Utility sink(s), as appropriate to the method of decontamination used. This may require soaking sink(s), rinse sink(s), automated cleaning device(s), or a combination.
b. One freestanding handwashing station.
c. Work counter space(s).
d. Space and plumbing fixtures for automatic endoscope cleaners, sonic processor, and flash sterilizers(where required).
e. Ventilation system. Negative pressure shall be maintained and a minimum of 10 air changes per hour shall be maintained. A hood is recommended over the work counter. All air should be exhausted to the outside to avoid recirculation within the facility.
g. Floor covering monolithic and joint free.

Note: The cleaning area shall allow for the flow of instruments from the contaminated area to the clean assembly area and then to storage. A physical barrier shall be provided to prevent droplet contamination on the clean side. Clean equipment rooms, including storage, should protect the clean equipment from contamination.

Based on observation and staff interview, it was determined the hospital ' s infection control program failed to ensure endoscopic instruments are processed in a manner in accordance with accepted standards of practice. This has the potential to adversely affect the safety of all patients by not having endoscopic equipment appropriately disinfected and stored prior to procedures.

Findings include:

1. During a tour of the hospital operating room (OR) #1 on 11/28/11 at approximately 1:50 p.m., a processing substance for high level disinfection of instruments (Cidex OPA) was observed being used for processing instruments in the OR room and in between surgical procedures for multiple patients. The initial gross decontamination procedure for instruments is being performed in the operating room and the instruments are placed in the tub of Cidex OPA in the OR room to perform high level disinfection. The instruments are then removed from the tub of Cidex OPA and used for the next procedure for a different patient. Failure to remove the instruments from the operating room to perform the decontamination and high level disinfection creates a potential for cross contamination and fails to meet the minimum requirements for processing of instruments.

2. These findings were discussed with the OR Manager and Facility Manager during the tour of the operating room area at approximately 3:42 p.m., on 11/28/11. They concurred with the findings.