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 three (3) randomly chosen patients' Mohs reports, three (3) Histopathology slides, quality control records, peer review records, and interviews with the laboratory director (LD) and office manager (OM) on August 24, 2022 at approximately 12:15 p.m.; it was determined that the laboratory failed to verify, at least twice annually, the accuracy of its Mohs and Histopathology tests for the years 2020 and 2021 for two (2) out of two (2) Mohs and Histopathology testing diagnosing physicians. The findings included: 1. The laboratory did not have any documentation showing that it had verified its Mohs and Histopathology tests' accuracy for the years 2020 and 2021 for two (2) out of two (2) Mohs surgeons and dermatopathologists performing slide reading and providing patients' diagnosis. Therefore, the accuracy of the laboratory's test results for patients for Mohs and Histopathology procedures, cannot be assured. 2. The LD and OM confirmed at approximately 12:45 p.m., that the laboratory did not have any record to verify its Mohs and Histopathology test accuracy for the years 2020 and 2021 for two (2) testing physicians. 3. The laboratory's testing declaration form signed by the laboratory director, stated that the laboratory performs 500 Histopathology and Mohs tests annually. D5391 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- identified in the preanalytic systems specified at 493.1241 through 493.1242. This STANDARD is not met as evidenced by: Based on the surveyors' interviews with the laboratory director (LD) and the laboratory's office manager (OM) and record review of pre-analytic, analytic, and postanalytic remedial action records on August 24, 2022; the laboratory failed to establish written policies and procedures for an ongoing quality assessment mechanism to monitor, assess, and when indicated, correct problems identified in the laboratory's systems. Findings included: 1. According to laboratory LD and OM, during preanalytic, analytic, and postanalytic review of patients' processed Mohs and Histopathology slides, if a patient specimen was received or a report was issued that did not meet the laboratory's criteria for acceptability, a description as to why the specimen or report did not meet the laboratory's criteria for acceptability would be documented, appropriate