HospitalInspections.org

Cross refer to:

C0222
C0225

Based on staff interview and a review of facility documentation, the hospital failed to ensure that preventive maintenance of the steam sterilizer was performed on a scheduled basis by qualified personnel, using the sterilizer manufacturer's service manual as a reference.

Findings were:

During a tour of the facility on the morning of 4/20/16 with the Risk Manager and Staff #25, the individual responsible for sterile processing at the hospital, the manual for the facility's steam sterilizer included was requested. Staff #25 stated she wasn't sure a manual existed. The Risk Manager stated, "We could probably get it online." This indicated the sterile processing and other hospital staff were unaware of the manufacturer's recommended maintenance for the steam autoclave. Thus, no documented preventive maintenance had been performed on the machine, and there was no way to ascertain what the manufacturer's recommendations for preventive maintenance were.

The above findings were confirmed with Staff #25 and the Risk Manager during the tour of the facility on the morning of 4/20/16. These findings were again confirmed in an interview with the hospital administrator and other administrative staff on the afternoon of 4/20/16 in the facility meeting room.

Based on observation, interview and record review the facility failed to ensure a clean and orderly environment. This deficient practice had the possibility to cause harm in all patients.

Findings were:

A tour of the hospital on the morning of 4/20/16 with the Risk Manager, ED Manager and Chief Nursing Officer revealed the following:

Emergency Department
An unsecured canister of oxygen in the equipment supply area behind the nurses station.

Patient Room #18 (ready for patient use)
The restroom call light ended approximately 36" above the floor.
There was an unidentified sticky residue on the exterior of the patient supply stand drawer which was approximately 6" x 6".

Patient Room #19 (ready for patient use)
The restroom call light ended approximately 36" above the floor.
The plastic bed frame had chipped plastic approximately 1 ½" x ½" which made thorough cleaning impossible.

Basement Medical Records Room
A room in the basement housed numerous boxes of the hospital's patient records. The administrator identified the records as being from the Emergency Department for the years 2004-2013 and inpatient records from 2004-2009. It was impossible to ascertain by observation exactly which records were housed there as the entire floor of the room was completely underwater. In some areas, the water was as much as 2" deep. Cardboard boxes of records that weren't on shelves had been stored on flats to raise them above the water. The room smelled of mold. When the Risk Manager and Chief Nursing Officer were asked, they agreed the room had a strong smell of mold.

Basement Clean Supply Rooms
Patient care supplies were stored in two basement closets on open shelves. The floors were not clean and in one of the closets, there was an approximate 24" x 24" opening into the crawl space above the closet. The light of this closet did not function. The closet included shoulder immobilizers, rib belts, pelvic traction belts, and finger splints among other supplies available for patient use. The opening in the ceiling allowed debris, moisture and pests to freely enter the closet. The two closets were directly across the hall from the flooded, moldy medical records room.

Nurses Station IV Solutions Room
The small room housing various patient supplies behind the nurses station, including IV solutions, had an external door which the Risk Manager stated was no longer in use. Below the door and among the shelves of supplies was an area approximately 24" x 24" of standing water which was 1/2" to 1" deep. The room contained 21 external shipping boxes holding patient supplies. A number of the boxes were shelved above unpacked supplies on lower shelves which were ready for patient use.

Activity Director's Office
The office of the Activity Director was between two areas of the nurses station. To reach the IV solutions room, the office had to be passed through. In the doorway of the office, there was carpeting which had come loose and was floppy and slightly rolled across the doorway. It posed a likely danger of tripping.

Main Patient Supply Room
A small former patient room served as the hospital's main patient supply room. The ceiling tiles of this room had several large holes over patient supplies. The holes allowed access of dirt, debris and pests over the supplies which were identified by the Risk Manager as ready for patient use. Around the light was an approximate 6" diameter water stain circle. Once ceiling tiles are exposed to moisture, there is a possibility of mold and crumbling in the tile.

The above findings were confirmed with Staff #25, the ED Manager, the Chief Nursing Officer and the Risk Manager during the tour of the facility on the morning of 4/20/16. These findings were again confirmed in an interview with the hospital administrator and other administrative staff on the afternoon of 4/20/16 in the facility meeting room.

Based on a review of documentation, a tour of the facility and staff interviews, the facility failed to ensure that patient instruments were sterilized in accordance with regulatory requirements for sterile processing for hospitals in the State of Texas as delineated in 25 TAC §133.41(v). The facility had no written policies related to the sterile processing of instruments, and was not following state requirements. This placed patients at risk for infection due to improper or inadequate sterilization practices.

Findings were:

A review of the personnel record for staff member #25, the individual identified as responsible for sterile processing for the facility, revealed this employee had not completed any specialized training for the sterile processing of instruments.

In an interview with staff #25 during a tour of the facility on the morning of 4/20/16, she stated she had never received any training in sterile processing. She said, "I was kind of thrown into it about 5 years ago." When asked if the appropriate mechanical and chemical indicators were being implemented and monitored to ensure instruments were adequately sterilized, she stated, "I don't know what those are. We only use the autoclave about once every 3 months." She stated she was performing biological indicator testing and pointed to a box of Attest 126P biological indicators. The expiration date on the indicators was August 2009. She stated the sterilizer had no print-out as "There's no tape in the machine" and that there were no documented performance records which included mechanical indicators for sterilizer loads. Staff #25 stated, "I don't know whether this machine reaches the right temperature." The manual for the facility's steam sterilizer included was requested. Staff #25 stated she wasn't sure a manual existed. The Risk Manager stated, "We could probably get it online." This indicated the sterile processing and other hospital staff were unaware of the manufacturer's recommended maintenance for the steam autoclave. Thus, no documented preventive maintenance had been performed on the machine, and there was no way to ascertain what the manufacturer's recommendations for preventive maintenance were. In addition, the sterile processing of patient instruments and equipment was performed without knowledge of the manufacturer's instructions for the use of the machine.

Facility policy entitled Infection Control C/S, Department: Central Supplies/Autoclaving, last reviewed 3/23/16, included the following:
"F. Indicator tape must be used on all items to be sterilized. Tapes are checked after sterilization ...
2. Packing will be considered unsterile (compromised) when certain events occur: ...
h. Absence of external or internal indicators ...
7. Sterilization Cycle ...
A. For safety reasons, only adequately instructed persons may operate the sterilizer.
B. Instruction must be on had [sic] (hand) at all times for references.
C. Proper temperatures and exposure times must be knows [sic]..."

The CDC Guidelines for Disinfection and Sterilization in Healthcare Facilities, 2008, available at http://www.cdc.gov/hicpac/Disinfection_Sterilization/13_0Sterilization.html includes the following:
"...the steam cycle is monitored by mechanical, chemical, and biological monitors. Steam sterilizers usually are monitored using a printout (or graphically) by measuring temperature, the time at the temperature, and pressure. Typically, chemical indicators are affixed to the outside and incorporated into the pack to monitor the temperature or time and temperature. The effectiveness of steam sterilization is monitored with a biological indicator containing spores of Geobacillus stearothermophilus (formerly Bacillus stearothermophilus). Positive spore test results are a relatively rare event and can be attributed to operator error, inadequate steam delivery or equipment malfunction.
Portable (table-top) steam sterilizers are used in outpatient, dental, and rural clinics. These sterilizers are designed for small instruments, such as hypodermic syringes and needles and dental instruments. The ability of the sterilizer to reach physical parameters necessary to achieve sterilization should be monitored by mechanical, chemical, and biological indicators."

The above findings were confirmed with Staff #25 and the Risk Manager during the tour of the facility on the morning of 4/20/16. These findings were again confirmed in an interview with the hospital administrator and other administrative staff on the afternoon of 4/20/16 in the facility meeting room.

Cross refer to:

C0308

Based on observation, interview and record review the facility failed to ensure a clean and orderly environment. This deficient practice had the possibility to cause harm in all patients.

Findings were:

A tour of the facility on the morning of 4/20/16 with the Risk Manager, ED Manager and Chief Nursing Officer revealed a room in the hospital basement which housed numerous boxes of the hospital's patient records. The administrator identified the records as being from the Emergency Department for the years 2004-2013 and inpatient records from 2004-2009. It was impossible to ascertain by observation exactly which records were housed there as the entire floor of the room was completely underwater. In some areas, the water was as much as 2" deep. Cardboard boxes of records that weren't on shelves had been stored on flats to raise them above the water. The room smelled of mold. When the Risk Manager and Director of Nursing were asked, they agreed the room had a strong smell of mold. A thorough examination of the condition of the records was impossible as the floor was underwater.

In an interview with the facility administrator on the afternoon of 4/20/16 in her office, she stated, "We had that hard rain last night and we think some of the runoff got into that room." When it was mentioned that the room had a strong smell of mold, she stated, "Well, there was also something a while back where some pipes burst above the records in the ceiling. I'm not really sure what the issue is."

The above findings were confirmed with the Risk Manager and Chief Nursing Officer during the tour of the facility on the morning of 4/20/16. These findings were again confirmed in an interview with the hospital administrator and other administrative staff on the afternoon of 4/20/16 in the facility meeting room.