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 a surveyor review of the twice per year verification records and an interview with the office manager, the laboratory failed to verify the accuracy of fungal cultures at least twice per year for calendar year 2018. Findings include: 1. On September 12, 2019 at approximately 10:00 AM the office manager confirmed surveyor's finding that the accuracy of fungal culture testing was verified once on 11/29/18. The laboratory's twice a year verification policy states: "Two times yearly 5 specimens are sent to another CLIA approved lab for verification". No other record of verification was available for review. 2. Approximately 70 patients' samples were tested and reported for fungal cultures in calendar year 2018. 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)