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 012306 (X3) Date Survey Completed 06/24/2021
Name of Provider or Supplier Childrens Hospital Of Alabama Esrd Street Address, City, State 1600 7th Avenue South, 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 the pHoenix XL User's Guide, facility procedure and interviews, it was determined the facility failed to ensure the staff rinsed the pHoenix meters with RO (reverse osmosis) water after use. This affected 2 of 2 observations for unsampled patients, Patient Identifier (PI) # 6 and PI # 7, and this had the potential to negatively affect all patients who dialyzed at this facility. Findings include: pHoenix XL User's Guide Pages: 15-17 F. Taking Measurements A. Sample Directly from the Hemodialysis delivery system: 1. Connect to Dialysis Machine ...6. Close the valve, disconnect from the dialysis system, and record the readings. 7. See Final Steps on Page 17. Final steps: 1. Press the Menu button to deactivate the hold feature and begin normal measurements... 2. Rinse the sample cup/tube thoroughly with treated water when finished. Rinse the cell meter and syringe interior thoroughly with treated water prior to storage. Phoenix XL Meter Dialysate Testing Departmental Procedure No. 18372 Last Revised/Reviewed 03/08/19 V11. Procedure The conductivity and pH of Dialysate will be checked before every dialysate treatment... F. Once testing is complete; discard the used solution... G. The instrument will turn off automatically... H. Rinse the cell, syringe interior, and sampling cup/tube thoroughly with RO water after use. I. Keep cell filled with RO water during use. J. Pack with Neo-care....at the end of use... 1. An observation was conducted on 6/23/21 at 11:25 AM to observe Employee Identifier (EI) # 5, Registered Nurse (RN), prepare the dialysis machine for PI # 6 at station 8. EI # 5 performed conductivity and pH testing, and placed the meter on the counter. After testing was complete, EI # 5 failed to rinse the pHoenix meter thoroughly with dialysis quality water. 2. An observation was conducted on 6/23/21 at 11:45 AM to observe EI # 7, RN, perform conductivity and pH testing at station 5 prior to arrival of an unsampled patient, PI # 7. After testing was complete, EI # 7 failed to rinse the pHoenix meter thoroughly with RO water. An interview was conducted on 6/24/21 at 10:00 AM with EI # 6, Biomedical Supervisor, who verified the staff failed to follow the pHoenix XL User's Guide and facility procedure and rinse the pHoenix meter with RO water after each use.