Summary:
Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on lack of documentation, record review, and interview with the MOHS Technologist (MT) the laboratory failed to verify the accuracy of MOHS testing twice annually. Findings: 1. Record review of the laboratory's proficiency testing documentation for 2023 and 2024 on 1/15/2025, revealed no documentation for the twice annual verification of Mohs testing. 2. Record review of the laboratory's Proficiency Testing policy on 1/15/2025 revealed: "Semi-Annually, The tech or Risk Manager will send two cases containing the original slides... send it our for a microscopic examination by a Board Certified Dermatopathologist... Results of each Proficiency Test will be entered in a log and kept in the laboratory management manual, as part of it's permanent records." 3. Interview with the MT on 1/15/2025 at 10:00am confirmed the findings above. 4. The laboratory performs 962 tests annually in the specialty of Pathology. 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. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- This STANDARD is not met as evidenced by: Based on record review and interview with the laboratory MOHS Technologist (MT) the laboratory failed to assure function checks were within the laboratory's established limits before patient testing. Findings include: 1. Record review on 1/15/25 of 2024 and 2025 Cryostat temperature logs revealed the following: a. Temperature ranges, top of page: -21C to -25C and, lower on the page, -21*C to -26*C. b. The temperature states, "Notify director of any problems with the machine and document." c. The cryostat was noted as having temperatures lower than the established ranges on testing days 2024: 8 of 19 January, 12 of 13 February, 8 of 9 March, 13 of 14 April, 9 of 12 May, 7 of 11 June, 5 of 12 November, 4 of 11 December, and 2025: 3 of 5 January. Temperatures were lower than established ranges 2024: 4 of 11 June, 3 of 13, 2 of 15 September. 3. Interview with the MT on 1/15/2025 at 9:30am confirmed the above findings. The MT stated that the lab director had been made aware of the temperature variations but no