Summary:
Summary Statement of Deficiencies D0000 A recertification survey was performed on April 30, 2024. The facility was found to be NOT in compliance with all applicable CLIA requirements for specialties /subspecialties for 42 CFR. 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 observation, document review, and staff interview, the laboratory failed to ensure the relative humidity (RH %) was monitored and documented as required by the Leica CM 1510S manufacturer. Findings: 1. Observation during the laboratory tour on 4/30/24 at 1:25 p.m. revealed the lack of a hygrometer in the laboratory. 2. Review of the RH logs revealed the lab failed to monitor and document the RH % on the days of testing from 6/1/21 to 4/30/24 (185 of 185 days). 3. Interview with the MOHS technician in the laboratory on 4/30/24 at 1:25 p.m. confirmed the RH % was not monitored or documented for the aforementioned dates. 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 --