Summary:
Summary Statement of Deficiencies D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on a direct observation of laboratory equipment, a review of cryostat records, and an interview with the Mohs lead on 11/1/2024, the laboratory failed to perform maintenance as required by the manufacturer for the Avantik QS12 cryostat. The findings include: 1. A direct observation in the laboratory identified an Avantik QS12 cryostat. 2. A review of the cryostat records identified that the laboratory failed to have a maintenance log and document maintenance of the cryostat since beginning testing in February 2024. 3. An interview with the Mohs lead on 11/1/2024 at 9:57 am confirmed the lack of maintenance documentation for the Avantik QS12 cryostat. 4. The laboratory reports performing 1200 Mohs slide examinations annually. 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 --