Department of Health & Human Services

Centers for Medicare & Medicaid Services
Form Approved

OMB No. 0938-0391
Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number 012508 (X3) Date Survey Completed 12/12/2019
Name of Provider or Supplier Birmingham East Dialysis Street Address, City, State 1105 East Park Drive, Birmingham, AL
For information on the provider's plan to correct this deficiency, please contact the provider or the state survey agency.
(X4) ID Prefix Tag Summary Statement of Deficiencies

(Each deficiency should be preceded by full regulatory or LSC identifying information)
V0250 DIALYS PROPORT-MONITOR PH/CONDUCTIVITY
CFR(s): 494.40(a)

5.6 Dialysate proportioning: monitor pH/conductivity It is necessary for the operator to follow the manufacturer's instructions regarding dialysate conductivity and to measure approximate pH with an independent method before starting the treatment of the next patient.


This STANDARD is not met as evidenced by:
Based on observations, review of facility procedures and interviews, it was determined the staff failed to: 1. Follow facility procedure for monitoring dialysate conductivity prior to treatment initiation. 2. Follow facility procedure for disinfection of the Phoenix XL meter. This affected 2 of 2 observations conducted to observe staff perform the conductivity using the Phoenix meter including Patient Identifier (PI) # 11 and had the potential to negatively affect all patients dialyzing in this facility. Findings include: Facility Procedure: Measuring Conductivity, Temperature and/or pH using the Phoenix Conductivity Meter Procedure Number: 2-08-01G Revision Date: April 2019 Materials required: ... Dialysis quality water Notes: Dialysis quality water should be obtained fresh same day of use prior to use with this procedure... Procedure... 3. Pull the syringe plunger and draw solution through the cell... observe the reading on the meter display... 5. Expel sample solution into sink or waste container. 6. Rinse the cell and syringe interior by drawing dialysis quality water through the cell filling the syringe. Expel and discard water". Facility Procedure: Phoenix XL Meter Disinfection, Calibration Verification and Storage Procedures Procedure Number: 2-08-04 A Revision Date: October 2018 Procedure: ...3. Draw a 1% bleach solution through the measurement module and into the syringe.... 4. Allow 1% bleach solution to remain in instrument for 10 minutes... 5. Expel the bleach solution. Thoroughly rinse the 1% bleach solution from the syringe and measurement module by rapidly flushing with dialysis quality water at least three times. Document disinfection step on the pHoenix XL meter log... 6. Test for residual bleach. After the bleach disinfection, equipment should not be used until results from residual bleach test have reached a level of less than 0.5 ppm (parts per million). Document the residual bleach test on the pHoenix XL log. 1. During the flash tour of the facility conducted on 12/10/19 at 8:15 AM, the surveyor observed the Reverse Osmosis (RO) water on the Tri-Station was labeled 12/9/19. The staff failed to ensure the dialysis quality water was obtained fresh same day of use prior to use... In an interview conducted on 12/10/19 at 9:30 AM, Employee Identifier (EI) # 9, Facility Administrator (FA) # 2, confirmed the above findings. 2. An observation was conducted on 12/10/19 at 10:35 AM to observe EI # 5, Patient Care Technician (PCT), prepare the dialysis machine for PI # 11 at station 9. EI # 5 failed to rinse the phoenix meter with dialysis quality water before obtaining a dialysate sample. EI # 5 checked the conductivity with the phoenix meter, cleaned the meter, replaced the meter to the clean area. EI # 5 failed to rinse the cell and syringe with dialysis quality water after use. In an interview conducted on 12/12/19 at 11:30 AM, EI # 1, Facility Administrator, who confirmed the above findings. 22965 3. An observation was conducted on 12/10/19 at 11:30 AM to observe EI # 5, PCT, prepare the dialysis machine at station # 12. EI # 5 failed to rinse the pHoenix meter with dialysis quality water before obtaining a dialysate sample for testing EI # 5 failed to rinse the cell and syringe with dialysis quality water after checking the conductivity and ph of Station 12 dialysis machine. An interview was conducted on 12/12/19 at 9:50 AM with EI # 1 who confirmed the staff failed to follow policy and procedures on the use of pHoenix meters.