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)
V0180 BACT CONVENT DIALYSATE-MAX & ACTION LEVELS
CFR(s): 494.40(a)

4.3.2.1 Bacteriology of conventional dialysate: max & action limits Conventional dialysate should contain a total viable microbial count lower than 200 CFU/mL and an endotoxin concentration of lower than 2 EU/mL. The action level for the total viable microbial count in conventional dialysate should be 50 CFU/mL and the action level for the endotoxin concentration should be 1 EU/mL. If levels exceeding the action levels are observed in the dialysate, corrective measures, such as disinfection and retesting, should promptly be taken to reduce the levels.


This STANDARD is not met as evidenced by:
Based on a review of facility records, the Association for the Advancement of Medical Instrumentation (AAMI) standards, and staff interviews, it was determined that the facility failed to promptly take actions for dialysate microbial (bacterial) levels that exceeded the AAMI standards, to ensure that the water used to prepare dialysate was safe for all 10 in-center hemodialysis patients who were dialyzing at this facility. This failure had the potential to negatively affect the health and safety of all 10 patients who were under the care of this facility. Findings include: A review of AAMI recommendations revealed that because 48 hours can elapse between sampling water to determine microbial contamination and receiving results, and because bacterial proliferation can be rapid, corrective actions must be initiated promptly, before levels exceed the recommended maximum levels of 200 CFU/ml of total viable microbial count and 2 EU/mL of endotoxin concentration. It was also recommended that the water and distribution system be disinfected promptly any time the levels of bacteria or endotoxin exceeds the action levels. "Promptly" would be met if action is taken within 48 hours of receiving the results of testing. Action includes disinfecting the system, repeating cultures and notifying the Medical Director of the results. A review of chemical and microbiological monitoring logs which included 12 months (6/2020 - 5/2021) of chemical analysis, microbiological testing of water and dialysate, and monitoring of the water distribution system revealed the following: 1. Microbiology report for Hemodialysis machine #2 on 6/8/20 dialysate LAL test (Limulus Amebocyte Lysate, is a test for the determination of bacterial endotoxins) result was 1.40 EU/mL (Endotoxin Units per milliLiter). There was no documentation that the equipment was removed out of service or that it was promptly disinfected. There was no documentation of a re-draw of the dialysate culture of machine #2 until 6/29/20. There was no documentary evidence that the Medical Director (MD) was notified of this action level culture results within 24 hours of review and no documentation in the Quality Assessment and Performance Improvement (QAPI) that the abnormal results were discussed with plans of correction in order to avoid recurrence. During a discussion with the Biomed Technician (BMT) on 6/8/21 at approximately 2:30 p.m., he stated that a plan of correction (POC) for the out of range culture results was not discussed during their QAPI meeting and the Administrative Assistant confirmed that there was no documentation of the out of range results with a POC in the QAPI meeting minutes. A review of the facility's policy and procedure (P&P) titled, "Dialysate Water Microbiology and Endotoxin Sampling" with no date of creation, effectivity nor revision, stated: LAL Endotoxin: Action Level >/= 1.000 EU/mL 2. If the microbiology count/endotoxin concentration exceeds the action threshold, take corrective action. - If this 1st result to exceed the action threshold, retake sample as soon as possible (2 days or 1 week the latest) - If this is the 2nd result to exceed the action threshold, contact person responsible for dialysis water quality assurance (e.g. biomed, renal tech, nursing unit), if not already notified. - If this is the 3rd (or more) results to exceed the action threshold, it is likely that biofilm is present in the water treatment and must be removed. Contact the water treatment system vendor for guidance. Retest the system or DI tanks. The facility's P & P regarding the action level for culture results that were out of range did not satisfy the recommendations of AAMI.