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 852539 (X3) Date Survey Completed 06/10/2021
Name of Provider or Supplier Eatonton Kidney Center Street Address, City, State 103 N Washington Avenue, Eatonton, 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)
V0403 PE-EQUIPMENT MAINTENANCE-MANUFACTURER'S DFU
CFR(s): 494.60(b)

The dialysis facility must implement and maintain a program to ensure that all equipment (including emergency equipment, dialysis machines and equipment, and the water treatment system) are maintained and operated in accordance with the manufacturer's recommendations.


This STANDARD is not met as evidenced by:
Based on a review of facility records and staff interviews, it was determined that the facility failed to follow the manufacturer's guidelines for the maintenance of the Neo2 Meter (a precision test instrument that measures the conductivity, temperature, pH (test for acidity) of liquids, such as dialysate solution used with hemodialysis delivery systems and may also be used to test the pH and conductivity of acid and sodium bicarbonate dialysate concentrates and water used in hemodialysis applications). This failure had the potential to negatively affect the health and safety of all 10 in-center hemodialysis patients that dialyze at the facility. Findings include: A review of facility records revealed that the last date of the annual calibration of the Neo2 Meter was not available. The only record found was a request for calibration dated 7/26/17. The manufacturer's recommendation was for the Meter to be returned for maintenance annually to keep the Meter in good repair. According to the biomed technician (BMT) on 6/8/21 at approximately 3:00 p.m., he stated that the Neo2 Meter was calibrated in 2019 but was not sure of the date and he could not provide a documented evidence of the certificate of calibration. The Administrative Assistant could not find the documentation, except a request form for calibration dated 7/26/17. The Administrative Assistant, on 6/9/21 at approximately 3:00 p.m., gave this surveyor a copy of the facility's request to Mesa Labs (Manufacturer) for calibration of Neo2 Meter dated 7/26/17 and stated that, that was all the documentation she could find.