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Based on interview, record review, and review of facility policies and procedures the facility failed to have a policy and procedure in place to notify the infection control department when a patient Endobronchial ultrasound (EBUS) scope tested positive for bacteria after the scope had been cleaned and disinfected. This failure affected eleven patients.

Failure to have a defined policy for staff to follow puts patients at risk for possible infection when an endoscope tests positive for a bacterial organism and the endoscope is continuing to be used despite testing positive for bacteria.
References:
Association for Professionals in Infection Control and Epidemiology (APIC) re: Docket No. FDS-2015-N-0722; Gastroenterology and Urology Devices Panel meeting on reprocessing of duodenscopes and other endoscopes read in part:
"Each facility should develop and implement a comprehensive quality control program for reprocessing duodenoscopes and endoscopic ultrasound scopes. This program should include written procedures for monitoring training and program adherence. It should also include standard documentation of equipment tests, processes, and quality monitors used during the reprocessing procedure. Any duodenoscope suspected of being associated with a patient infection should be taken out of service. A process including validation of cleaning sterilization must be conducted before the scope is returned to service".

Findings include:

1. Review of facility policies and procedures entitled " Endoscopy Scope Reprocessing "; policy #86100-PCS-154, draft dated 6/23/2016; stated under "Purpose: To create uniform standards for endoscope reprocessing that will minimize occurrences of infectious complications. Specific equipment responsibilities are handled by select number of trained scope reprocessors ' acting collaboratively to achieve the uniform standard".
The policy did not specify what staff should do if a culture came back positive after the scope had been cleaned and disinfected.

Prior to the above draft policy the facility did not have any type of policy on the processing of the EBUS scopes. There was no policy since there were no national guidlines on how to process the EBUS scopes for routine culturing and processing.

2. The EBUS scope had tested positive intermittently for the bacteria "Enterobacter-cloacae " since 3/2/2016. Each time the scope tested positive for bacteria the scope was cleaned and disinfected and recultured again for the presence of bacteria.

The infection control department was notified on 5/16/2016 about the EBUS scope testing positive for the bacteria "Enterobacter cloacae". At that time the EBUS scope was taken out of service on 5/16/2016 by the infection control department. The scope was sent for an evaluation to a third party vendor to examine the scope.

The infection control department discovered literature from the national Association for Professionals in Infection Control and Epidemiology (APIC) that high level disinfection does not provide enough log reduction of organisms to allow for a margin of safety. As a result the Spalding classification would change for scope reprocessing to require sterilization.

It was determined by the infection control department the EBUS scope was not safe to return to service and should be retired.

3. On 8/3/2016 at 11:30 AM the Infection Control Program Director (Staff #1) was interviewed by Surveyor #1. Staff #1 verified the above findings. Staff #1 stated prior to the incident the endoscopy department would get positive culture results but now the results were reported to the infection control department as well as the endoscopy department.

ITEM #1 - PERSONAL PROTECTIVE EQUIPMENT

Based on observation, the hospital failed to implement policies and procedures designed to prevent exposure to infectious agents during the processing of medical equipment.

Failure to follow personal protective equipment per recommended practice puts patients and staff at risk of infection.

Reference: The Centers for Disease Control and Prevention bulletin titled "Example of Safe Donning and Removal of Personal Protective Equipment", dated 3/2010, stated in part: "GOWN: Fully cover torso from neck to knees, arms to end of wrist, and wrap around the back."

Findings:

On 8/3/2016 at 9:50 AM, Surveyor #2 observed a Respiratory Therapy Assistant (Staff #7) reprocess a bronchoscope. S/he failed to tie the gown at the back, allowing the straps to drag across the floor and the gown to move forward, potentially leading to cross contamination of the staff ' s uniform or other areas of the reprocessing suite.

ITEM #2 - REPROCESSING OF NON-CRITICAL MEDICAL EQUIPMENT

Based on observation, document review, and policy and procedure review, the hospital failed to follow manufacturer ' s instructions for use for cleaning non-critical medical and hospital equipment.

Failure to follow manufacturer's instruction for use places patients and staff at risk for infections.

Findings:

1. The hospital policy titled " Moist Heat " with Hydrocollators states in part, " 2. Maintenance: d. The inside of the unit is to be cleaned monthly or more frequently if the water becomes cloudy. "

The manufacturer ' s instructions for use indicate that the units need to be cleaned every 2 weeks, meaning the policy does not follow manufacturer ' s recommendations.

2. On 8/3/2016 at 1:50 PM in the physical therapy unit, Surveyor #2 inspected the cleaning logs for the Hydrocollators (Chattanooga). There was a gap in the recorded cleanings between April and July 2016, meaning the cleanings for May and June were either not performed or documented.

ITEM #3 - OPERATING ROOM CLEANING

Based on observation, the hospital failed to ensure that surgical staff properly disinfected equipment during between case cleanings.

Failure to ensure standard cleaning practices are followed places patients at risk for increased infection/illness.

Findings:

On 8/3/2016 at 1:10 PM, Surveyor #2 observed a between case cleaning of an operating room. A Registered Nurse (RN) (Staff #8)) cleaning cords from a piece of equipment bunched multiple cords during cleaning rather than wiping down each individual cord. This practice does not ensure that the entire surface of the equipment is contacted with disinfectant.

Item #4 - DIETARY

Based on observation, the hospital failed to implement policies and procedures to assure compliance with the Washington State Retail Food Code (246-215 WAC).

Failure to properly implement the requirements of the food code puts patients at risk of acquiring foodborne illness.

Findings:

During a tour of the hospitals dietary department on 8/3/2016 between 2:00 PM and 3:00 PM, Surveyor #2 made the following observations:

1. Surveyor #2 used a thin-stem thermometer to measure the temperature of items in a hot holding unit for room service orders. Roasted Potatoes measured at 120 degrees Fahrenheit, below the required hot holding temperature of 135 degrees Fahrenheit.

Reference: Washington State Retail Food Code, WAC 246-215-03525 (1) (b)

2. Blood from thawing beef had leaked from the storage pan containing it and began drying on the floor of the walk-in refrigerator. Non-food-contact surfaces of equipment must be kept free of food residues.

Reference: Washington State Retail Food Code, WAC 246-215-04600 (3)

3. A sanitizer bucket was being stored in a handwashing sink at the front end food service area. Hand sinks must be dedicated for handwashing.

Reference: Washington State Retail Food Code, WAC 246-215-05270 (2)

4. An espresso station in the cafeteria did not have a dedicated hand sink on location and the nearest hand sink was not within 25 feet.

Reference: Washington State Retail Food Code, WAC 246-215-05255 (2)

5. The espresso station had a hand sanitizer station present for hand hygiene, but this method does not allow employees to wash their hands according to the procedure outlined in the retail food code.

Reference: Washington State Retail Food Code, WAC 246-215-02305 (2)


ITEM #5 HOUSEKEEPING

Based on interview and review of infection control documents, the hospital failed to ensure that staff members follow environmental policy for cleaning patient rooms when the patient is in isolation.

Failure to follow hospital policy for environmental cleaning in the patient care area puts patients, staff, and visitors at risk of exposure to communicable diseases.

Findings:

1. On 8/3/2016 at 10:00 AM, Surveyor #3 interviewed a member of the environmental services staff (Staff #9) about their process for cleaning isolation rooms. When the surveyor asked if the process included removal of privacy curtains, the staff member indicated that unless soiled, the curtains remained in the room, but staff sprayed them with disinfectant spray.

2. On 8/3/2016 at 1:00 PM, Surveyor #3 reviewed the hospital's infection control program. In the hospital's infection control committee meeting minutes dated 5/18/2016, the minutes indicated that criteria for curtain changes after patient discharge included curtains that were soiled, damaged, or used in an isolation room.

2. On 8/3/2016 at 10:00 AM, Surveyor #3 interviewed a member of the environmental services staff (Staff #9) about their process for cleaning isolation rooms. When the surveyor asked if the process included removal of privacy curtains, the staff member indicated that unless soiled, the curtains remained in the room, but staff sprayed them with disinfectant spray.

3. On 8/3/2016 at 1:00 PM, during review of the infection control program, Surveyor #3 asked a member of the infection control program (Staff #2) about the discrepancy in information between the infection control minutes and the staff interview. Staff Member #2 explained that the curtain policy is undergoing revision, but that staff had been instructed to remove curtains from isolation rooms at discharge.