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BELOIT HEALTH SYSTEM 1969 W HART RD BELOIT, WI 53511 July 11, 2018
VIOLATION: INFECTION CONTROL Tag No: A0747
Based on observation, interview and record review, the hospital failed to have effective monitoring of sanitary conditions to avoid transmission of pathogens, in 2 of 2 surgical areas (Operating room suites and Sterile Processing Department).

Findings include:

1) The hospital failed to ensure that surgical instruments were cleaned per hospital policy and manufacturer's instructions, in 1 of 2 areas (Sterile processing). (A0749)

2) The hospital failed to ensure that sanitary conditions were maintained in 2 of 3 operating rooms observed (Operating rooms 2 and 3). (A0749)

The cumulative effects of these surgical and environmental infection control failures resulted in the hospital's inability to promote the health and safety of their patients.
VIOLATION: INFECTION CONTROL OFFICER RESPONSIBILITIES Tag No: A0749
Based on observation, interview and record review, the hospital failed to ensure that surgical instruments were cleaned per hospital policy and manufacturer's directions, in 1 of 2 areas (Sterile Processing); and failed to ensure that OR (operating room) sanitation was maintained to prevent the spread of pathogens, in 2 of 3 OR suites (OR's #2 and 3).

Findings include:

1) The 7/11/18 record review of hospital "Policystat ID 73, last revised 9/2015, Steps for Cleaning and Processing of Instruments and Supplies" stated under "Policy:
... II. Cleaning is preliminary to disinfection and sterilization. It is the process used to free a surface of soiled contamination. Cleaning operations have three major objectives.
A) removal of visible soiled contamination.
B) removal of invisible soil pathogens.
C) removal of as many harmful microorganisms as possible.
D) soaking to remove gross soiled contamination and make washing easier.
III. Washing may be done manually or mechanically. Cleanliness is essential for proper sterilization. After gross soil has been cleaned from items, they may be placed into the ultrasonic cleaner for deep cleaning. Items that may not withstand the ultrasonic action should be washed with the appropriate detergent and brushes. All items shall be cleaned while being held under water to prevent aerosolization of contaminated fluids.
IV. All items washed with detergent shall be rinsed in accordance with the manufacturer's instructions for use, or if unavailable, in clear water to remove soap residue that may cause discoloration and pitting of instrument surfaces."

Hospital "Policystat ID 08, last revised 9/2017, Instruments- Care and Cleaning", stated under "Policy: Instruments, needles, syringes, basins, trays and other precision items are to be cleaned in accordance with the manufacturer's instructions for use...". Under "Procedure: I. Cleaning procedure: A. Manual wash in warm detergent solution 125 Fahrenheit using a stiff bristle brush. B. Give particular attention to serrations, hinges, locks and teeth. Allow 30 seconds per instrument; 12 seconds to wash and 18 seconds to dry... D. Rinse the instrument thoroughly in hot running water. E. Rinse a second time."

Hospital "Policy stat ID 11, last revised 9/2015, Decontamination- Receiving and Handling" stated under "I. All items, disposable and non-disposable, received from all areas shall be handled appropriately by discarding them or preparing them for reuse. All soiled items are received in the decontamination area. I.G. Follow the manufacturer's instructions for use. As applicable, rinse any non-mechanical items in cold water and place in any enzyme detergent soak...".

Observations in the hospital's main SPD (sterile processing department) on 7/10/18 from 12 p.m. through 2 p.m. revealed the following:
At 12:08 p.m. observations were made of Technician L, cleaning surgical instruments used in a total knee replacement surgery case. L was not observed to submerge the tray of surgical instruments into the Prolystica enzyme cleaner solution that was prepared in the sink to the left of the instrument case tray sitting on the sink ledge . L stated "we do not sit the trays into the solution because the case carts trays are too big for the sink". L was observed to swish, brush and rinse each surgical instrument before putting it into another case tray to the right of the sink with the enzyme cleaner in it. The observation revealed in 3 of 6 surgical tweezers cleaned, Technician L did not use the surgical brush to clean the metal "V" joint of the tweezers. When asked about this cleaning on 7/10/18 at 12:12 p.m., L stated "I did a visual inspection of the joint and flushed it (with water)". L was observed to pick a large (approximately 6 inch) tweezer off the top of the instrument tray that L had just cleaned. Upon inspection L wiped finger of gloved hand into the "V" joint removing an approximate 1 millimeter sized yellow debris particle. After the batch of surgical instruments were washed, brushed and put into the tray to the left of the enzyme cleaner sink, L used a measuring cup to scoop up 2 cups of the enzymatic cleaning solution out of the sink, that had just been used to clean these surgical instruments and pour it over the tray of instruments that L had just brushed and cleaned.

During interview with VP of MA (Vice President of Medical Affairs) A, and VP of NS (Vice President of Nursing Services) on 7/10/18 at 4:15 p.m., the observations with L were shared, A stated "that shouldn't have happened".

The 7/10/18 record review of the enzymatic surgical instrument cleaner used by the hospital stated on the label "Prolystica 2x concentrate enzymatic presoak and cleaner for manual and automatic washing is for removal of a broad range of soils on surgical instruments and medical devices in the manual cleaning process... Consult the manufacturer's recommended reprocessing instructions to determine any additional procedures necessary to clean their particular medical device. Medical devices should be sterilized or disinfected by appropriate means in a separate subsequent step.
Directions: Manual /Ultrasonic applications: Fill sink or basin with warm water to appropriate level to fully immerse surgical instruments. Dilute chemistry: 1/8 to 1/2 fluid ounce per gallon of warm water... Clean for a minimum of 1-5 minutes. Cleaning times should be longer with dried on proteinaceous materials... After cleaning all surfaces should be rinsed with warm water. Solution should be discarded daily or when visibly soiled."

2) Hospital "Policy stat ID 96, last revised 11/2014, Environmental cleaning", stated under "3. Terminal cleaning of each operating and procedure room shall be completed daily... Unused rooms should be cleaned once during each 24 hour period... Spot wash all walls... Clean and disinfect all were horizontal surfaces... Clean floor making sure the bed is moved and the floor is washed underneath; move all furniture to the center of the room and continue cleaning the floor...".

Hospital "Policy stat ID 83, last revised 11/2014, Terminal Cleaning Checklist", stated under "Policy: The ORs (operating rooms) are to be terminally cleaned and a checklist is to be completed by the cleaning crew or centers support staff every night. The areas cleaned will be inspected by the OR staff assigned to each room prior to the start of cases the following day. This is to ensure the tasks have been completed and the appropriate level of terminal cleaning and disinfection has taken place by those involved in the cleaning process." On the "OR terminal clean competency", it stated "performance criteria: ...9. Clean and disinfect walls, doors and baseboards. 10. Clean and disinfect vents... 21. Clean and disinfect floor, a) using microfiber mop and floor cleaner/disinfectant, start mopping at the edges of the room, working your way to the entrance door...".

Observations on 7/10/18 at 8:30 a.m. of operating rooms 2 and 3 revealed that floor baseboards in each room had a large build-up of greasy brownish black debris extending around the entire baseboard surface of the rooms. In OR (operating room) 3, when a dry paper towel was used against this surface to the left of the OR entrance door, it brought up blackish colored grease and dust. The ventilation outlet vent (blowing air into the room) on the wall of OR 3 was covered with beige dust on the surface of it's metal slats. An anesthesia stool in OR 3 had a small tear on it's vinyl seat surface, exposing cotton batting, which could not be effectively cleaned /disinfected. The wall, adjacent to the entrance door of inside operating room 2, revealed a hole with missing and crumbled drywall plaster which exposed the metal grid underneath. This hole was approximately 6 inches long by 1 and 1/2 inches wide.

During interview with Director of SPD (sterile processing) G at 3:30 p.m. on 7/10/18, G stated "a work order was put in some time ago, but the wall has not been fixed yet". G agreed that non-intact surfaces could not be cleaned/disinfected.

The 7/10/18 record review of an engineering department work order # 6, created on 6/28/18 at 1:19 p.m., revealed repairs to the wall had been requested by SPD.