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Based on observation, interview, and record review, the facility failed to implement an effective infection prevention program. The facility failed to:

1. ensure Neonatal ICU staff moved dirty equipment to a dedicated cleaning space prior to disassembly/cleaning of patient care equipment such as GE Care Station Isolettes.
2. ensure the humidity water was changed every 7 days per manufacturer specifications for Neonatal ICU Care Station Isolettes.
3. establish a process to ensure equipment contaminated in isolation rooms would he handled in a manner to prevent cross-contamination and transfer of microorganisms to other staff, patients or surfaces.
4. ensure that the facility competency-based checkoff training for staff cleaning of the GE Care Station Isolettes followed established infection control policies and manufacturer specifications.

Findings included:
Observation in the 3rd Floor Neonatal Intensive Care Unit (NICU) on 6/4/24 at 10:30 am. Unit Secretary Staff ID # 66 showed surveyor and leadership team where she had cleaned the GE Care Station Isolette. She showed a clinical bed space, adjacent to Isolation Room 337A, with a sink and counter space, immediately outside of Isolation Room 337A. There was Patient ID #3 noted to be in the room with isolation signage on the door. The sink utilized for equipment cleaning process was located outside Room 337A and other clinical patient rooms and was noted to be the sink utilized to wash hands for staff who exited the isolation room and adjacent patient rooms.

Interview with Unit Secretary Staff ID # 66 on 5/4/24 at 11:00 am. She verbalized that cleaning and disinfecting neonatal ICU isolettes is a part of her role on the unit. She verbalized there was no dedicated space for cleaning that has been designated by the facility. She verbalized that she used the "purple wipes" and pointed to the "Super Sani Cloth" wipes for cleansing. She stated that units which required "deep cleansing" which she identified as units with visible soiling or staining from blood, dried milk, etc would have removable components "soaked in water in a basin" prior to cleansing. She verbalized there was not a process in place to identify if the Isolette had been in an isolation room prior to cleansing and there were no differences to cleaning process based on patient's isolation status.

Interview with NICU Nurse Manager Staff ID #59 on 6/4/24 at 2:30 pm. She reviewed the GE CareStation User Manual. She confirmed the facility unit based staff, were performing Isolette changes every 2 weeks or at discharge (if sooner). She was not aware that the manufacturer recommendations for changing the water reservoir were to be performed weekly (every 7 days). She confirmed this was not being completed. She reviewed the user manual for GE Carestation Isolettes. This included maintenance, cleaning and disinfection manufacturer recommendations. She confirmed that the removable parts of the Isolette such as tubing management grommets, canopy seals, porthole gaskets and fan had instructions to soak. She was unable to confirm what they should be soaked in, the dwell time for soaking and what/if they should be rinsed prior to drying and re-installation. She confirmed the facility does not have a dedicated space where devices are relocated to for the cleansing and disinfection process. She provided a competency checklist which was used by facility unit-based education staff for verifying competency of staff who perform these roles. She confirmed the facility did not have a procedural policy for cleaning and disinfecting Isolette units. She confirmed the competency checklist did not follow the manufacturer recommendations seen in the IFU (Instructions for Use).

Interview with Infection Control Practitioner Staff ID # 70 on 6/4/24 at 3:15 pm. She confirmed there was no infection control audits or observations related to cleansing and disinfecting of equipment in the NICU that she was aware of. She was asked infection control process related to cleansing of medical equipment and devices. She stated that infection control recommends that the staff follow manufacturers recommendations. She stated that each piece of equipment has its own "IFU" (Instructions for Use). She stated that they should utilize products based on recommendations. She stated that proper "contact time" is an important part of the efficacy for different products. She confirmed that soiled equipment cleaning/disassembly should not be occurring in clinical areas. In addition, she reviewed the NICU Giraffe Omnibed Cleaning Checklist with surveyor. She confirmed there was no instructions or information related to what products should be used for cleaning, no contact or dwell time, no instructions for what agent should be used for "soaking" removable plastic parts and dwell time for soaking, etc.

Record Review of the facility's "Standard and Transmission-Based Precautions" policy, last reviewed 02/26/2024, stated " ...Policy 1. Standard Precautions: All healthcare providers and healthcare personnel shall practice standard precautions in the care of all patients. Standard precautions apply to (1) blood; (2) all body fluids, secretions and excretions except sweat, regardless of whether or not they contain visible blood; (3) non-intact skin; and (4) mucous membranes. Standard precautions are designed to reduce the risk of transmission of micro-organisms from both recognized and unrecognized sources of infection in healthcare settings ....d) Patient care equipment ... ii. Reusable patient care equipment should be cleaned and reprocessed according to manufacturer guidelines between patient uses ... v. Soiled equipment should be handled in a manner which prevents cross contamination to the skin, mucous membranes, and clothing; and transfer to microorganisms to other patients or surfaces."

Record Review of the facility's "Infection Prevention and Control Program Plan CY 2024", last reviewed 1/17/2024, stated "5.7 Responsibilities of the Hospital Epidemiologist and the Infection Prevention and Control staff shall include, but not limited to, the following: ...5.7.3 Establish a process for ongoing review and evaluation of all aseptic, isolation, sterilization, disinfection, food safety, and sanitation practices. This shall also include the evaluation of equipment and supplies used for sterilization, disinfection, cleaning, and decontamination processes." It further stated " ...6.3.3 The following are IPC activities which have been selected for implementation during this year: 6.3.3.1 Process surveillance activities: ...6.3.3.1.4 Appropriate cleaning and disinfection of reusable patient care equipment requiring high-level disinfection and sterilization (semi-critical and critical equipment). 6.3.3.1.5. Appropriate cleaning and disinfection of non-critical patient care equipment."

Record Review of the manufacturer's GE Giraffe OmniBed Carestation User Manual provided by Nursing Director Staff ID # 58 stated "Chapter 7: Maintenance, Cleaning and Disinfection. The following schedule lists the minimum frequencies for cleaning and disinfection. Water Reservoir. Minimum frequency Every 1 week. The humidity reservoir should be cleaned and disinfected weekly and when humidity use is discontinued. ... Cleaning and Disinfecting Method Recommendations. The following table indicates which ports may be cleaned or disinfected with each method.
Method: Wipe with a disinfecting cloth. Parts: All components with the exception of the tubing management grommets, porthole gaskets, and canopy seals.
Method: Soak. Parts: Tubing management grommets, canopy seals, porthole gaskets and fan.
Method: Steam sterilize. Parts: Water Reservoir
Method: Wipe. Parts: All device surfaces and components to remove visible debris prior to disinfection."
It further stated "Preparing to Clean and Disinfect the Device. To prepare the device for cleaning and disinfecting: 1. Gather PPE per clinical protocol. 2. Obtain recommended solutions. 3. Move the device to a work area where youhave adequate space to completely disassemble parts. Note: All parts to ne cleaned and disinfected, included rail mounted options, should be placed in an area separate from the area where clean parts are placed.4. Put on PPE per clinical protocol ..."

Record Review of the facility's "Giraffe Omnibed Cleaning Checklist", undated, stated "Process:
1. Choose correct cleaning solution
2. Ensure all residue has been removed from the inner and outer isolette
3. Spray and wipe the outside of the isolette, moving from top to bottom. Allow appropriate soak time for cleaning solution
4. Partially raise the top of the bed
5. Clean the inside cover
6. Once finished cleaning the inside cover, raise the roof completely
7. Remove and soak all plastic bumpers (4 large portholes, 2 long, 8 small corner pieces)
8. Clean the inside and outside of the two side panels, ensuring to separate the interior wall from the outer wall. Allow for appropriate soak time. Once finished, lower the side panels
9. Clean and lower the end panel, allowing for appropriate soak time
10. Clean and remove the following base pieces, allowing for appropriate soak time. Make sure the place the clean pieces in a clean location:
11. Mattress
12. Clear mattress base
13. Bed warmer (make sure to unplug)
14. Catch tray
15. First base
16. Second base
17. Third base (make sure to appropriately release the spring clips)
18. Fourth base
19. Remove and clean the spindle, allowing for appropriate soak time
20. Clean the main base, allowing for appropriate soak time
21. Replace the spindle
22. Clean the soaking plastic items and allow to air dry while reassembling the bed
23. Rebuild the base, making sure the pieces lock into place
24. Raise the sidewalls (x3)
25. Remove and clean the water reservoir and container, allowing for appropriate soak time
26. Clean the interior of the drawer, allowing for appropriate soak time
27. Sign the "cleaned by" label and adhere to the bed "
Cleaner: Meets Cleaning Guidelines Does Not Meet Guidelines
Signature: ________________________ Date: __________________
Validator Signature: ________________ Date: __________________"