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Based on observation, interview and record review, the facility Infection Control Program failed to maintain a sanitary environment in one of 19 main operating rooms, failed to ensure that surgical instruments were adequately sterilized for 2 out of 20 random observations of sterilized surgical instrument packages (peel packs), and failed to ensure that instances of inadequately sterilized surgical instruments were consistently monitored per facility policy, resulting in the potential for transmission of infections, with the potential to effect all patients receiving surgery at the facility. Findings include:

On 1/30/17 at 1030, during an observation of a surgery in the main Operating Room (OR) unit with Chief Financial Officer Staff A, the OR Program Coordinator, Staff N and the OR Educator, Staff M, the following concerns were observed in OR #12. The Radiology viewing board had flecks of dried particulate matter on the frame. When queried, Staff N stated that the board was no longer used and would be scheduled for removal. The arm rests on the operating table had multiple layers of tape remnants on the sides. When queried, Staff N stated that it should have been removed during cleaning, and that OR staff should use cleanable reusable straps instead of tape. The footrest pad in use on the operating table had multiple cracks in the vinyl covering, exposing the underlying padding. When queried, Staff M stated that the footrest pad was not cleanable in that condition and needed to be replaced. The Intravenous (IV) fluid pole in use had flecks of dried matter on the top of the base. When queried, Staff N stated that Environmental Services staff may not be responsible for cleaning the IV pole as it might be considered Anesthesia Department equipment. When queried, Staff N was unable to say conclusively which department was responsible for cleaning the IV pole. The electrical outlet pillar was observed to have streaks and raised flecks of tan matter on the surface where the plugs were. When queried, Staff M stated, " It needs to be cleaned. "

On 1/30/17 at 1515, the Cardiac Catheterization Department was toured with the Director of the Cardiac Catheterization Department, Staff J. During an observation of packages of autoclaved (sterilized) surgical instruments (peel packs) in their Inventory Room with Staff J, two peel packs were observed to contain hinged surgical instruments that were autoclaved (sent through the sterilizer) in the locked (clamped shut) position. Staff J confirmed that the two hinged surgical instruments were a needle driver and a hemostat, and that sterilization was not adequate as the sterilization process could not effectively treat the surfaces locked together. Staff J stated that the inadequately sterilized hinged surgical instruments would have been noticed when they were inspected by the surgical technician per the facility policy when the procedure room was being set up , and then removed from service before they ever reached the patient.

On 1/31/17 at 1400, review of the facility policy entitled, " Surgery Suite Cleaning, dated 10/15/16, noted the following instructions to Environmental Services personnel:
1. " Between case cleaning: Wash the lights and furniture. " There was no mention of who was responsible for cleaning of the electrical socket pillar, IV poles or vertical surfaces.
2. " Terminal Nightly Cleaning: Damp wipe all non-electrical equipment and furniture in the room, top to bottom. " There was no mention of who was responsible for cleaning of the electrical socket pillar, IV poles or vertical surfaces.

On 1/31/17 at 1415, review of the facility policy entitled, "Cleaning and Disinfection Guidelines, dated 9/6/16 revealed the following statements, "Medical equipment will be decontaminated and processed by disinfection or sterilization procedures according to the Center for Disease Control and Prevention's (CDC) Guideline for Disinfection and Sterilization in Health Care Facilities, 2008 Association of Operating Room Nurses (AORN), the Association for Professionals in Infection Control and Epidemiology (APIC), the Association for the Advancement of Medical Instrumentation (AAMI ... "

On 2/1/17 at 1000, review of the CDC guideline paper entitled, "Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008", revealed the following statements, "Medical devices that have contact with sterile body tissues or fluids are considered critical items. These items should be sterile when used because any microbial contamination could result in disease transmission. Such items include surgical instruments, biopsy forceps, and implanted medical devices. "

A facility policy on sterilization of hinged surgical instruments was requested but not received by exit.



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On 01/30/17 at approximately 1000 during the initial tour of 3 Webber South Unit, Staff I, was observed setting up a sterile field in obstetrics operating room #4. During observation and interview, Staff I was asked if in the last 3 months, she had found any inadequately sterilized or bioburden contaminated instruments, during the process of setting up the sterile field. Staff I responded "yes I did, about 3 weeks ago I found a dirty Bladder Blade (large heavy stainless steel blade). "Staff I was further queried in regards to what procedure she followed for reporting inadequately sterilized or bioburden contaminated instruments, she replied "I told my charge Nurse (Staff O)."

On 01/30/17 at approximately 1020 during an interview with manager, Staff O, she was queried as to the above incident. She stated that she "followed the policy, took pictures and made out a MIDAS report."

On 01/31/17 at approximately 1400,during an interview with the Infection Control Coordinator (Staff D) she stated she was "unaware of this incident." It was determined that this stated incident could not be found or traced and no MIDAS reporting was found.

On 01/31/17 at approximately 1420, during review of the facility policy titled, "Event Reporting" undated, it was determined that if an event is determined, then it must be reported in the MIDAS system, so the event can be followed up through the Infection Control or Quality process and a RCA (Root Cause Analysis) can be completed. The policy states for each MIDAS report, there must be a corresponding root cause analysis report, and a corrective action plan.