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 012512 (X3) Date Survey Completed 11/17/2022
Name of Provider or Supplier Fmc Dialysis Services Selma Street Address, City, State 905 Medical Center Parkway, Selma, 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)
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 review of policy and procedure, Digital Dialysate Meter Operation Manual, the Clinical Log Readings Report, observations and interviews with the staff it was determined the facility failed to: 1. Perform the PH (Potential Hydrogen) and conductivity testing daily on one of two Myron L D-6 meters present in the dialysis facility 2. Ensure all supplies for use on the dialysis floor were not expired. Findings include: Myron L D6 Meter Maintenance Procedure Published Date: 9/1/22 Reference Number: 64380 Procedure: 2. Enter date of meter verification 3. Enter time of daily verification 4. At the beginning of the day, check conductivity, TDS (total dissolved solutes) (442), and pH solutions for expiration dates... 5. Measure a sample of 14.00 mS (MilliSiemens) Conductivity solutions... Document value and continue with verification. 6. Measure a sample of 3000 TDS (442) solution... Compare results with acceptable range... and document value and continue with verification. 7. Measure a sample of 7.00 pH solution... compare results with acceptable range...document value and continue with verification... 8. Measure a sample of 4.00 pH buffer solution...compare results with acceptable range...document and continue with verification... 9. Measure a sample of 10.00 pH buffer solution...compare results with acceptable range...document value and continue with verification... 10. At the end of the day the pH sensor well must be filled with pH sensor storage solution... 11. Enter initial of staff member performing verification. 12. Enter any comments. Documentation: Daily verifications will be documented on Myron L D6 Daily Verification Form. Calibrations will be documented on Myron L D6 Calibration Form... Digital Dialysate Meter Operation Manual Myron L Company February 18, 2016 Policy: B. Calibration Intervals: If using the Dialysate Meter to check Dialysate concentrations, you should check the calibration of the pH and Conductivity functions at the beginning and the end of each work day or more often if required by the clinics internal procedures. Then recalibrate if indicated... XI. Calibration Intervals A. Suggested Calibration Intervals: Checking Dialysate: Conductivity: Check against standard conductivity solutions. Frequency: At the beginning and end of each work day. Check cell cup cleanliness: At the beginning and end of each work day. pH: Check against standard buffer solution. Frequency: At the beginning and end of each work day. Check sensor well cleanliness: At the beginning and end of each work day... Facility Policy: Storage of Supplies Date: 4/5/21 Version: 2 Policy: Supplies must be rotated First in-First Out (FIFO) to ensure products maintain quality and do not expire. Appropriately dispose of items that have reached the expiration date. 1. Review of the FKC (Fresenius Kidney Care) Clinical Log Readings Report dated 9/20/22 to 11/15/22 revealed documentation for the Myron L D 6 meter # D605924. Further review revealed no documentation for the Myron L D6 Meter D609988 for the two months requested and the meter D609988 was currently being used on the dialysis floor and in the water room. An interview was conducted on 11/17/22 at 9:05 AM with Employee Identifier (EI) # 2, Bio Technician, who confirmed the machine numbers were entered wrong in the computer system and there is no documentation for the meter D609988 for the daily meter checks. 2. An observation was conducted on 11/15/22 at 9:05 AM on the dialysis floor. During the observation a pack of 67 red top blood tubes was found on the dialysis counter and had expired on 9/30/22. An interview was conducted on 11/17/22 at 10:00 AM with EI # 1, Clinic Manager who confirmed the blood tubes were expired and had been removed from the dialysis floor.