Summary:
Summary Statement of Deficiencies D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on a lack of laboratory quality control (QC) records and an interview with the laboratory testing person, the laboratory failed to test QC material for the Siemen' 10 SG Urine reagent strip. Findings Include: It was confirmed by the laboratory testing person on December 12, 2019, at approximately 12:30 PM that the laboratory failed to follow the manufacturer's instruction for the Siemens 10 SG Urine reagent strips which state QC material is to be performed when a new bottle is opened. Approximately 660 patient tests were performed for urinalysis and results reported during that time. 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)