Summary:
Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) Recertification Survey was completed on October 21, 2025. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) (a)(1) Maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: A review of 2023 - 2025 Maintenance Logs confirmed that testing personnel failed to perform preventative maintenance as specified by the manufacturer. THE FINDINGS INCLUDE: 1. A review of p. 68 of the Global 240/ 720 Analyzer User Manual listed the required preventiative maintenance schedule as follows: USER DEFINED MAINTENANCE DAILY: - Cleaning the working plane - Washing of cuvettes MONTHLY: - Washing distilled water reservoir 6 - 12 MONTHS: - Replace reading cuvettes (every 6 - 12 months) - Replace photometer lamp (2000h or every 12 months) - Replace sampling needle (every 12 months) - Replace needle cleaner (every 6 months) PREVENTIVE MAINTENANCE BY QUALIFIED PERSONNEL - Replace the piston/ glass syringe (every 12 months) - Replace dryer shump (every 12 months) - Replace kit tubes (every 24 - 36 months) 2. A review of the Maintenance Logsheet, currently in use, confirmed that the laboratory performed only the cleaning of the working plane and the washing of the distilled water reservoir. 3. An exit interview, with the Laboratory Director and General Supervisor, on October 21, 2025, at 1:00pm confirmed testing personnel failed to perform all of the preventative maintenance as specified by the manufacturer. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --