Summary:
Summary Statement of Deficiencies D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) (b)(2)(i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (b)(2)(ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on the surveyor's review of the laboratory's policy/procedure, preventive maintenance (PM) documentation, six patient records and an interview with the medical assistant (MA); it was determined that the laboratory failed to follow an established policy and procedure in place for the PM as defined by the manufacturer, with at least the frequency recommended for the laboratory's equipment prior to patient testing. The findings include: 1.The laboratory failed to provide PM documentation for the years 2023 and 2024 for the microscope used at the facility according to manufacturer's requirements, to be performed annually. 2. The surveyor reviewed six Mohs patient records from January 13, 2023 to August 15, 2025. Two out of six (23-013 and 25-013) were missing entries for the cryostat PM. 3. No