Statement of Deficiencies

Statement of Deficiencies	(X1) Provider/Supplier/CLIA Identification Number 852569	(X3) Date Survey Completed 07/23/2025
Name of Provider or Supplier Dialysis Center Of Athens	Street Address, City, State 210 Hawthorne Park, Athens, 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)

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 observation, staff interviews, a review of the manufacturer's Directions for Use (DFU), a review of facility Policies and Procedures (P&P), and a review of the Association for the Advancement of Medical Instrumentation's (AAMI's) "American National Standard 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 in-center hemodialysis (ICHD) patients as evidenced by failure of two of two Patient Care Technicians (PCTs - PCT AA and PCT BB) observed, to correctly verify the hemodialysis (HD) machine's final dialysate conductivity (ability of the dialysate to conduct electricity) and pH (acidity), according to the manufacturer's DFU and facility's P & P. This failure had the potential to negatively affect the health and safety of five of five patients who were receiving hemodialysis treatment at Stations (S) 1, S2, S4, S6, and S7 at the time of observation. Incorrect dialysate composition can lead to a range of complications, from mild symptoms such as nausea and fatigue to more serious conditions like metabolic acidosis (a decrease in blood pH that may cause rapid breathing, confusion, dizziness, shortness of breath, or chest pain). And if conductivity is out of the acceptable range, the effectiveness of the dialysis treatment may be reduced, and impair patient treatment, alter electrolyte and fluid balance, and lead to serious health consequences. The facility census was 10. Findings include: During observation in the Patient Treatment Room on 7/23/25 between 5:00 a.m. and 6:40 a.m., the following was revealed: - At 5:10 a.m., PCT AA was observed entering the Dialysate Preparation room to obtain the Myron L Ultrameter II 6P (a portable, multi-parameter water quality meter, used to measure conductivity, pH...). - PCT AA was observed at 5:14 a.m., verifying the machine's final dialysate conductivity and pH at S7, using the Myron L Ultrameter II 6P. PCT AA obtained a dialysate sample from the machine and proceeded to fill the Ultrameter with the sample once, then immediately read the results. - PCT AA was observed at 5:27 a.m., verifying the machine's final dialysate conductivity and pH at S16, using the Myron L Ultrameter II 6P. PCT AA repeated the same incorrect procedure as mentioned above. - PCT BB was observed at 5:30 a.m., verifying the machine's final dialysate conductivity and pH at S2, using the Myron L Ultrameter II 6P. PCT BB obtained a dialysate sample from the machine and proceeded to fill the Ultrameter with the sample twice, then immediately read the results. -During an interview on 7/23/25 at 6:00 a.m. PCT BB stated that, depending on whether the Ultrameter readings were out of range, she might have used multiple samples; however, she usually used only two samples before reading and recording the pH and conductivity results. -During an interview on 7/23/25 at 6:35 a.m., PCT AA stated that she typically collected a sample and filled the Ultrameter twice before reading the results. PCT AA also stated that the facility used the same Ultrameter to check the Bicarbonate levels prior to the first patient treatment. -A review of the manufacturer's DFU on the "Myron L Ultrameter (Trademark) II 6P", showed the following: Page 9-10 V. SPECIFIC RECOMMENDED MEASURING PROCEDURES A. Measuring Conductivity & Total Dissolved Solids (TDS) 1. Rinse cell cup 3 times with sample to be measured. (This conditions the temperature compensation network and prepares the cell.) 2. Refill cell cup with sample. 3. Press COND or TDS. 4. Take reading. C. Measuring pH (6PFCE) 1. Remove protective cap by rotating while grasping and pulling up. 2. Rinse pH/ORP sensor well and conductivity cell cup 3 times with sample to be measured. Shake out each sample to remove any residual liquid. 3. Refill both sensor well and cell cup with sample. 4. Press pH. 5. Note value displayed -Failure to properly rinse the Myron L Ultrameter II 6P prior to checking the dialysate pH and conductivity can lead to inaccurate readings from the residue from the bicarbonate mixed with the dialysate, which can result in false high or low readings for both pH and conductivity. A review of facility Policy: E-Tec-203 titled, "Ultrameter (Trademark) Model 6P Procedure", stated: 5. Procedure A. Daily Use- Dialysate Testing 1. Rinse the Ultrameter' s conductivity and pH sensors three (3) times using dialysate from the blue Hanson port of the dialysis machine. 2. Refill the sensor with the dialysis. 3. Press COND to measure conductivity. 4. Press pH to measure dialysate pH. According to ANSI/AAMI RD52: 2004, Section 5.6, "Dialysate Proportioning", 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. - The Director of Operations (DO) was notified of the above findings on 7/23/25 at 7:18 a.m.