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 review of laboratory policies, verification of accuracy records and interview with histology technician (HT #1) and laboratory director (LD) 10/21/21, the laboratory failed to verify the accuracy of the Potassium Hydroxide (KOH)/Wet Prep and the Mart 1 Immunostain at least twice annually in 2019, 2020 and 2021, a period of approximately 3 years in which verification of accuracy was not performed. 1. The laboratory failed to verify the accuracy of the KOH/Wet Prep at least twice annually in 2019, 2020 and 2021. Review of laboratory policy "General Laboratory Quality Systems" revealed under section 6 "PROFICIENCY TESTING POLICY...For Provider-Performed Microscopies, the laboratory will either be enrolled in proficiency testing or will perform split-specimen testing with another laboratory or between providers." Review of verification of accuracy (proficiency testing) records for the KOH/Wet Prep test revealed no documentation of a twice annual verification of accuracy in 2019, 2020 or 2021, either by being enrolled in proficiency testing or performing split-specimen testing with another laboratory or between providers. Exit interview with HT #1 and LD at approximately 3:00 p.m. confirmed the laboratory failed to verify the accuracy of the KOH/Wet Prep testing at least twice annually in 2019, 2020 and 2021. 2. The laboratory failed to verify the accuracy of the Mart 1 Immunostain at least twice annually in 2019, 2020 and 2021. Review of laboratory policy "Quality Assessments" under section "Analytic Systems #2. "...some type of proficiency program is required." and under "Section V: Proficiency Testing ... Meeting CLIA Requirements When No Commercial Proficiency Testing Service is available...one of the four following methods should be used for bi-annual quality assessment to verify the accuracy of test results." Review of verification of accuracy Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- (proficiency testing) records revealed no documentation of a twice annual verification of accuracy in 2019, 2020 and 2021 by either of the four methods under "Section V: Proficiency Testing...". Exit interview with HT #1 and LD at approximately 3:00 p.m. confirmed the laboratory failed to verify the accuracy of the Mart 1 Immunostain at least twice annally in 2019, 2020 and 2021. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)