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 the lack of the laboratory's policies & procedures, review of six (6) random patients Mohs reports, quality control records, proficiency testing records, and interview with the laboratory staff on September 14, 2021 at approximately 11:45 a. m.; it was determined that the laboratory failed to verify, at least twice annually, the accuracy of its Mohs test for the years 2019 and 2020 for two (2) out of three (3) Mohs testing diagnosing physicians. The findings included: 1. The laboratory did not have any documentation showing that it had verified its Mohs test accuracy for the years 2019 and 2020 for two (2) out of three (3) Mohs surgeons performing slide reading and providing patients' diagnosis. Therefore, the accuracy of the laboratory's test results to the patients for Mohs procedure, cannot be assured. 2. The laboratory staff affirmed on 09/14/2021 at approximately 11:45 a.m., that the laboratory did not have any record to verify its Mohs test accuracy for the years 2019 and 2020 for two (2) out of three (3) Mohs testing physicians. 3. The laboratory's testing declaration form signed by the laboratory director, stated that the laboratory performs 120 Histopathology Mohs tests annually. 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. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- This STANDARD is not met as evidenced by: Based on the laboratory's procedure manual, lack of documentation, and interview with the laboratory staff (LS), it was determined that the laboratory failed to perform and document maintenance and calibration of the microscopes as defined by the manufacturer and with at least the frequency specified by the manufacturer for the laboratory equipment. The findings included: 1. The laboratory's standard operating procedure (SOP) indicates that annual maintenance and calibration by a contracted equipment service according to manufacturer's requirements be performed on two microscopes used in the laboratory (Olympus BH2 and Premiere microscopes). 2. The LS confirmed on 09/14/2021 at approximately 11:30 a.m. that the laboratory failed to follow SOP for maintenance and calibration of the microscope for the years 2019 and 2020. 3. According to the annual test volume declared by the laboratory on 09/14 /2021; the laboratory performs approximately 140 tests annually. D6082 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(1) The laboratory director must ensure that testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services for all aspects of test performance, which includes the preanalytic, analytic, and postanalytic phases of testing. This STANDARD is not met as evidenced by: Based on the failure to establish and follow a peer review policy for the verification at least twice annually the accuracy of the Mohs procedure for the years 2019 and 2020 (D5217), and the lack of preventive maintenance documentation for the microscopes for the years 2019 and 2020 (D5429); it was determined that the laboratory director failed to ensure that testing systems developed and used for each the Mohs tests performed in the laboratory provide quality laboratory services for all aspects of test performance, which includes the preanalytic, analytic, and postanalytic phases of testing. -- 2 of 2 --