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 852587 (X3) Date Survey Completed 02/07/2025
Name of Provider or Supplier Fresenius Kidney Care Richmond County Street Address, City, State 2556 Tobacco Road Suite A, Hephzibah, GA
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)
V0175 CFC-WATER & DIALYSATE QUALITY
CFR(s): 494.40



This CONDITION is not met as evidenced by:
Based on observation, staff interviews, a review of the facility's Policy and Procedures (P&P), a review of the manufacturer's Directions for Use (DFU), and a review of the Association for the Advancement of Medical Instrumentation (AAMI) for "Dialysate for hemodialysis" (ANSI/AAMI RD52: 2004), it was determined that the facility failed to ensure that there was a safe environment for all patients, as evidenced by the failure of two of two Patient Care Technicians, (PCT AA and PCT BB) observed, to independently verify the hemodialysis machine's dialysate pH (potential of Hydrogen- a measurement that can determine the acidity or alkalinity of a solution), at Station (S), (S7), during preparation and initiation of hemodialysis treatments of two of two patients, (P), (P#5 and P#2), on 2/5/25 and 2/6/25, respectively. This deficient practice had the potential to negatively affect the health and safety of P#2, P#5 and the other 17 patients, (P#1, P#3, P#9, P#10, P#11, P#12, P#13, P#14, P#15, P#16, P#17, P#18, P#19, P#20, P#21, P#22, and P#23), whose dialysate or dialysis bath (the fluid that the hemodialysis machine proportions from bicarbonate concentrate, acid concentrate and treated water used to exchange solutes with the blood in a dialysis filter), concentration prescriptions were different from the facility's standard dialysate, which was 2 Potassium / 2.5 Calcium. Complications as minor as nausea and fatigue or as severe as metabolic acidosis (a decrease in pH that could cause rapid breathing, confusion, dizziness, shortness of breath, and chest pain) could result if dialysate composition is incorrect. The facility census was 37. Cross Reference: V 250 - Failure of the facility to ensure that PCTs AA and BB, independently test the machine's dialysate pH when the dialysate concentration was changed and when the dialysate in a jug was replaced due to low contents.