HospitalInspections.org

44712


Licensure Reference Number
9-006.14B


Based on observation, interview and record review, the facility failed to maintain a complete inventory of all facility equipment used in the care of patients and failed to provide ongoing preventative maintenance in accordance with manufacturer specifications for 2 of 12 sampled pieces of medical equipment.

Findings include:

Interview with Maintenance Director and Chief Nursing Officer on 5/12/21 at 2:00 pm revealed no inventory list was maintained by facility staff, as the facility contracted with a vendor who was responsible for logging all equipment and any information needed would be provided by "name of service technician", who comes onsite to log new equipment and provide preventive maintenance. Facility did not have any department specific equipment inventory to track preventive maintenance.


A. Tour of surgery suite on 5/11/2021 at 10:00 am revealed a machine #306 used for leak testing of endoscopes and colonoscopes (for viewing upper and lower gastrointestinal tracts). Surveyor requested preventive maintenance information for 12 devices used in the facility. Asset Snapshots with safety inspection/ schedule needs, were provided by the contracted vendor with 10 devices having current inspection reports. Preventative Maintenance Log or Asset Snapshot for #306 Olympus CLV-U40 was last inspected on 4/21/2016. Under the activity column it read, "deleted" (machine taken out of preventive inspection activity). During same surgical tour on 5/11/2021, surgery nurse stated machine #306 was currently being used for leak testing the scopes.


B. Tour of Outpatient clinic rooms on 5/11/2021 at 09:00 am revealed a monitor #366 used for obtaining vital signs. Surveyor requested preventive maintenance information for 12 devices used in the facility. Asset Snapshots with safety inspection/ schedule needs, were provided by the contracted vendor with 10 devices having current inspection reports. Preventative Maintenance Log or Asset Snapshot for #366 Fukuda Denshi was last inspected on 12/4/2019. The sheet in the master bio-electronic log book for medical monitor #366 was blank for last inspection or next inspection due date. The client summary activity report last completed inspection on 12/4/2019. The prior four years the medical monitor #366 was inspected annually in December 2015 through the last inspection of December 2019.

Based on a review of policies and procedures, a tour of surgical services, and staff interviews the facility failed to ensure compliance with their infection control program by following its policies and procedures, methods to prevent and control potential transmission of infections by:
A) Failing to maintain the Autoclave Sterilization Machine (a machine used to sterilize surgical instruments and devices for surgery to kill microorganisms by subjecting the items to temperatures between 250 degrees- 275 degrees Fahrenheit) logs in accordance with the facility policy and the AAMI (Association for the Advancement of Medical Instrumentation-the standard that provides the guidelines for the use, care and processing of medical devices.);
B) Not having hand sanitizer in surgery mounted on the wall or in the cabinet as per the hand hygiene policy for hand sanitizing;
C) Not using a closed containment device for IUSS (Immediate Use Steam Sterilization-procedure to sterilize an item in the shortest possible time to be available for use in the surgery).

Findings are:

A. A tour of the surgery suites and the sterile processing area on 5/11/21 from 8:50 AM to 10:15 AM with the Director of Surgery (RN M) revealed that the facility staff run weekly biological testing (A test system containing viable microorganisms with a defined resistance to a specific sterilization process. They help monitor whether the necessary conditions were met to kill a specified number of microorganisms for a given sterilization process.) and Bowie Dick testing (A Bowie Dick test is a standard operational test that demonstrates proper air removal from their pre-vacuum autoclave chamber. It is primarily useful for testing pre-vacuum cycles that are sterilizing wrapped goods or packs.) daily on the days the facility has surgery. Each load of instruments and devices contained chemical indicators as per manufacturer recommendations. There were no organized logs available for review. The strips from the biological, chemical and bowie dick testing were kept in a drawer in the processing area.

An interview with RN M on 5/11/21 at 10:00 AM revealed, that the tests are run but logs are not maintained.

Review of the undated policy titled "STERILIZATION-ALL METHODS" revealed:
-Documentation
Perioperative personnel will complete documentation to reflect activities related to all methods of sterilization.
*Sterilization records will be maintained according to and in compliance with local, state, and federal regulations.
*Every sterilization cycle and modality will be documented and will include:-load identification; -exposure parameters;-the operator's name or initials; and -results of physical, chemical and biological monitors.

Review of the AAMI ST79:2017-Standard 13.3.3 Sterilizer records: The process critical parameters (time and temperature) provided on the recording chart, printer, or tape should be reviewed, signed, and dated by the operator to indicate an acceptable cycle. For each sterilization cycle, the following information should be recorded: a( the load number; b) the specific contents of the lot or load, including quantity, department, and a specific description of the items (e.g., towel packs, type/name of instrument sets); c) the exposure time and temperature, if not provided on the sterilizer recording chart;d) operator identification; e (the results of biological testing, if applicable; f) the results of Bowie-Dick testing, if applicable; g) the response of the CI (chemical indicators) placed in the PCD (process challenge device-an item designed to constitute a defined resistance to a sterilization process and used to assess performances of the process.) if applicable; and h) any reports of inclusive or nonresponsive Cls found later in the processed devices.

B. A tour of the surgery suites area on 5/11/21 from 8:50 AM to 10:15 AM with RN M revealed that the surgery suite entrance's and the surgery suites lacked a wall mounted device to provide hand sanitizer or a bottle of hand sanitizer in the cabinet for hand hygiene. There was only a small sample size bottle on the anesthesia cart.

An interview with RN M on 5/11/21 at 10:00 AM verified the surgery suite entrance's and the surgery suites lacked having hand sanitizer readily available.

Review of the undated policy titled "HAND HYGIENE" revealed:
-INDICATIONS FOR USING AN ALCOHOL BASED HAND RUB, ANTIMICROBIAL SOAP OR PLAIN SOAP AND WATER:
*If hands are not visibly soiled for routine decontamination; *When entering the room; *Before having direct contact with patients; *Before donning sterile gloves when inserting a central line; *Before inserting indwelling urinary catheters, peripheral vascular catheters, or other invasive devise that do not require a surgical procedure; *After contact with a patient's intact skin; *After contact with bodily fluids or excretions, mucous membranes, non-intact skin, and wound dressings if hands are not visibly soiled; *If moving from a contaminated-body site to a clean-body site during patient care; *After contact with inanimate objects (e.g. medical equipment) in the immediate vicinity of the patient; *After removing gloves; * When exiting room.

C. A tour of the sterile processing area on 5/11/21 from 8:50 AM to 10:15 AM with RN M revealed that the facility did not follow their policy for IUSS (Immediate Use Steam Sterilization-procedure to sterilize an item in the shortest possible time to be available for use in the surgery).

An interview with RN M on 5/11/21 at 10:00 AM revealed, The process for IUSS was described as putting items into an open pan, running for a cycle according to the manufacturer and then using the sterile handles to take the pan out of the autoclave.
Review of the undated policy titled "STERILIZATION-IMMEDIATE USE STEAM STERILIZATION" revealed:
-Procedure
The following steps will be followed for ISSN of items to be used in the perioperative setting:
*The device manufacturer's written instructions for use (IFU) include instructions for IUSS; *The device manufacturer's written IFU for cleaning, cycle type, exposure times, temperature settings, and drying times are available and followed; *Items are placed in a containment device that has been validated for IUSS and cleared by the US Food & Drug Administration for this purpose.; * Items are placed in a containment device in a manner that allows steam to contact all instrument surfaces.; *The containment device manufacturer's written IFU are followed.; *Packaging and wrapping are not done unless the sterilizer and packaging are designed and intended for this use.; * Items are used immediately and not stored for later use or held from one procedure to another; *Measures are taken to prevent contamination during transfer to the sterile field.

Review of the AAMI ST79:2017-Standard 10.2.3 Immediate use steam sterilization (IUSS) should not be used for purposes of convenience or as a substitute for sufficient instrumentation. Instrument inventories should be sufficient to meet anticipated surgical volume and to ensure that there is enough time to complete all critical elements of reprocessing. IUSS should be kept to a minimum and should be used only in urgent clinical situations. Items processed by IUSS should be a) decontaminated as specified; b) placed in a rigid sterilization container system that is intended for the cycle parameters to be used; c) used immediately & not stored for later use or held from one procedure to another; and
d) identified as IUSS. RATIONALE: Rigid sterilization container systems protect the sterilized item from environmental contaminants during transfer from the sterilizer chamber to the point of use.