Summary:
Summary Statement of Deficiencies 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 surveyor observation, record reviewed and confirmed through an interview with the Practice Manager (PM) and MOHS Manager (MM), the laboratory failed to define and correctly document temperature conditions for the proper operation of the Advantik QS12 Cryostat as evidenced by the following: 1. Record review on 7/1/2024 at 10:00 AM of the laboratory's 'Hematoxylin and Eosin' maintenance logs which contain the day of use Cryostat temperatures revealed: a. The acceptable temperature range is -24 to -30 degrees Celsius. b. The recorded temperatures for March 2024 through June 2024 were out of range for 6 of 7 days when the Cryostat was in use. c. The temperature was not recorded for 1 of 7 days when the Cryostat was in use from March 2024 through June 2024. 2. Record review on 7/1/2024 of the laboratory's 'Cryostat Maintenance' procedure revealed: "The cryostat should be in the 24 to 30 degree Celsius range." The procedure does not contain the minus signs before the acceptable temperature range. 3. Record review on 7/1/2024 of the laboratory's 'Quarterly QA Checklist' signed by the laboratory Director on 6/20/2024 revealed:, the section that states, "When humidity or temperature checks were out of range,