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 lack of lack of the twice-annual verification records and an interview with the laboratory testing personnel, the laboratory has never verified the accuracy of the urine colony count testing at least twice per year. FINDINGS: On December 11, 2018, at approximately 11:45 AM the laboratory testing personnel confirmed that twice annual verification to verify the accuracy of urine colony count twice annually has never been performed. The testing personnel stated that they have never been told by their regulatory agency that they needed to perform this task or to perform proficiency test if necessary. Approximately 115 patient samples were tested and reported for colony counts during the last two years. 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)