HospitalInspections.org

Based on records review, and interview, the facility failed to ensure patients received care in a safe setting, as evidenced by the facility's failure to ensure that staff demonstrated the competency and skill necessary to oversee and manage equipment maintenance, citing 4 of 4 staff (Personnel #8, #9, #13, and #14) who did not have documented evidence that they demonstrated the competency and skill to test hemodialysis equipment for endotoxins and colony counts.

Findings:

In an interview on 06/09/20 at 1:50 PM, the Senior HR Generalist (Personnel #12) stated that there was no documented evidence that Pesonnel #8, #9, #13, and #14 demonstrated the competency or the skill to draw water samples for testing endotoxin and colony count levels on the facility's 3 portable reverse osmosis machines and 5 hemodialysis machines.

Based on record review and interview, the facility failed to monitor and follow manufacturer's recommendation for disinfection procedure for 2 of 2 Reverse Osmosis (RO) machines (RO machines #HSW-002519 dated 04/09/18 - 06/19/19 and 01/13/20 - 06/05/20 and #HSW-002477 dated 04/19/18 - 08/18/19 and 01/13/20 - 06/05/20) in that, disinfection logs did not show documented evidence facility staff checked for residual or clearance of the Hydrogen Peroxide/Peroxyacetic Acid (PAA) Peracidin disinfectant post disinfection or prior to use for patients' dialysis treatments. This practice placed all dialysis patients at risk for harm for potential chemical adverse reaction and/or cross contamination.

Findings:

A review of the facility's Policy & Procedure, AmeriWater Section 5, Disinfecting the System MRO1 Manual, 98-0144 Rev. G, included, " ...CAUTION...Exposure to PAA concentrate or solution may cause severe chemical burns...27...allow the machine to run...WARNING...Do not connect to any dialysis machine at this time...the water quality may register good, but it is possible that some residual PAA solution is still in the system...all of the disinfecting solution MUST be co completely flush out...29. After the ...has run for ...allow to run for an additional ...begin to test for the presence of PAA with residual test strips ...at all water outlet points ...30 ...Periodically test for the presence of residual PAA at the ends of the Reject Hose, Product Water hose and the Product Water Sample port ...until less than 3 parts per million (PPM) of the PAA is detected by the residual test strips ...WARNING ...continue rinsing and testing with test strips until all test strips show negative result ...to ensure that there is less than 3 PPM ...disinfecting solution ...31. Record the stop time on the Log to have a record of how long it takes for the disinfecting solution to completely rinse out. Place a check mark on the log to verify that residual PAA tested negative ..."


A review of the facility's Reverse Osmosis (RO) machines #HSW-002519 dated 04/09/18 - 06/19/19 and 01/13/20 - 06/05/20 and #HSW-002477 dated 04/19/18 - 08/18/19 and 01/13/20 - 06/05/20 included, " ...disinfected column with staff initials ...filter changed with dates and staff initials ...comments ...Peracidin disinfection ..."


The facility's RO machines (RO machines #HSW-002519 dated 04/09/18 - 06/19/19 and 01/13/20 - 06/05/20 and #HSW-002477 dated 04/19/18 - 08/18/19 and 01/13/20 - 06/05/20) disinfection logs did not show documented evidence facility staff checked for residual or clearance of the Hydrogen Peroxide/Peroxyacetic Acid (PAA) Peracidin disinfectant post disinfection or prior to use for patients' dialysis treatments, as per manufacturers directions for use.


On 06/09/20 at 1:45 PM, the Infection Prevention Manager (personnel #10) and the Senior Human Resources (HR) Generalist (personnel #12) confirmed in an interview the facility's RO machines disinfection logs did not show documented evidence facility staff checked for residual or clearance of the Hydrogen Peroxide/Peroxyacetic Acid (PAA) Peracidin disinfectant post disinfection or prior to use for patients' dialysis treatments, as per manufacturers directions for use.