Summary:
Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on August 24, 2023. 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) 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: (1) Water quality. (2) Temperature. (3) Humidity. (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 document review and interview with the staff, it was determined the laboratory failed to document accurate Relative Humidity (RH) on each day of testing as required by the Cryostat manufacturer from 2021 to June 2023. Findings: 1. The review of maintenance records revealed that the laboratory failed to document Relative Humidity (RH) accurately on each day of testing using the Avantik QS 12 Cryostat as required. According to the instrument manufacturer, (RH) normal range is ( 0 - 60%), but (RH) was above 60% at least once each month from April 2021 to June 2023. 2. Monthly Quality Assurance (QA) review by the laboratory director did NOT initiate a