Summary:
Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on July 29, 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: D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on maintenance records review and staff interviews, the laboratory failed to perform and document ALL equipment maintenance checks as required by the instrument manufacturer from August 2023 and July 2025. Findings: 1. QA documents review revealed that Humidity checks were not recorded for the Diatron Pictus 500 Chemistry analyzer from August 2023 - July 2025. Per manufacturer, the Diatron Pictus 500 should operate at a relative humidity (RH) range of 35% - 85%. 2. An interview with the laboratory director at approximately 12:20 PM confirmed no documentation of relative humidity from August 2023 through July 2025. D5781