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 012515 (X3) Date Survey Completed 04/20/2023
Name of Provider or Supplier Fresenius Medical Care Opelika Street Address, City, State 2609 Village Professional Drive, Suite 2, Opelika, 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, manufacturer's instructions for use for the Myron L D-6 Meter, and interviews, it was determined the facility failed to ensure staff rinsed the Myron L D-6 Meter with clean water after dialysate testing. This affected two of two observations of preparation of the hemodialysis (HD) machine prior to treatment initiation and had the potential to negatively affect all patients who dialyze at the facility. Findings include: Myron L Company Digital Dialysate Meter Operation Manual 16 February 16 page 11 ...V1. After Using the Dialysate Meter A. Maintenance of the Conductivity Cell Rinse out the conductivity cell with clean water... 1. An observation was conducted on 4/18/23 at 10:03 AM with EI (Employee Identifier) # 6, CCHT (Certified Clinical Hemodialysis Technician), and EI # 4, RN (Registered Nurse) to observe conductivity and pH (potential of hydrogen) testing using the Myron L D-6 Meter at station 11. EI # 6 tested the dialysate, read the conductivity results 13.7, pH 6.9, and EI # 4 verified the results. EI # 6 discarded the dialysate solution into the dirty sink and EI # 6 and EI # 4 exited the testing station. EI # 6 failed to rinse the Myron L meter with clean water after use per manufacturer's directions. There was no clean water at the dirty sink. An interview was conducted on 4/18/23 at 10:40 AM with EI # 1, Director of Operations, who confirmed staff failed to follow the Myron L meter directions for dialysate testing. 41624 2. An observation was conducted on 4/18/23 at 11:31 AM with EI # 5, CCHT, and EI # 4, RN to observe conductivity and pH testing using the Myron L D-6 Meter at station 15. EI # 5 tested the dialysate, read the conductivity results 13.8, pH 7.0, and verified by EI # 4. EI # 5 discarded the dialysate solution into the dirty sink and EI # 5 and EI # 4 exited the testing station. EI # 5 failed to rinse the Myron L meter with clean water after use per manufacturer's directions. There was no clean water at the dirty sink. An interview was conducted on 4/18/23 at 10:40 AM with EI # 1 who confirmed staff failed to follow the Myron L meter directions for use for dialysate testing.