Summary:
Summary Statement of Deficiencies D0000 The initial survey was performed on 02/20/2024. The laboratory was found in compliance with a standard-level deficiency cited. The findings were reviewed with the laboratory director and histotechnologist during an exit conference performed at the conclusion of the survey. 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 a review of records and interview with the histotechnologist, the laboratory failed to ensure the temperature was maintained as required for the Avantik QS12 Cryostat for four of nine days of patient testing reviewed in March of 2023. Findings include: (1) On 02/20/2024 at 11:00 am the histotechnologist stated the laboratory prepared frozen sections of tissues obtained during Mohs surgical procedures using the Avantik QS12 Cryostat. The sections were then reviewed microscopically; (2) A review of the temperature records for the area where the cryostat was maintained and temperature logs for patient testing performed during March of 2023 identified the following: (a) The defined acceptable temperature range, as stated in the records was -23 to -32 degrees Celsius; (b) For four of nine days of patient testing (March 15,22,27,29), the temperature was documented as -22 degrees Celsius. (3) The records were reviewed with the histotechnologist who stated on 02/20/2024 at 11:00 am, the temperature reading was not acceptable on the days of testing as stated above. 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 --