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 2-year verification records for the calendar year 2022 and an interview with the clinical manager, the laboratory failed to perform 2-year verification for KOH slides in the calendar year 2022 for the three providers who perform PPMP testing. FINDINGS: 1. The clinical manager confirmed on March 27, 2023, at approximately 2:00 P.M. that the laboratory failed to verify and document the accuracy of interpretation of KOH slides at least twice per year in calendar year 2022. a. Approximately ten patient samples were tested for KOH for the calendar year 2022. 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)