Summary:
Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on record review and staff interview, laboratory (lab) personnel failed to sign the attestation form for 1 of 1 chemistry proficiency testing (PT) event in 2023. Findings include: 1. Review on 8/29/2023 of PT records from 2023 revealed the lab had enrolled in PT through College of American Pathologists (CAP) and had completed 1 PT event as of the survey date for urine drug screen (UDS) testing (CAP event UDS-B 2023) . Review of the PT attestation form revealed no signatures from the testing personnel or from the laboratory director. 2. Interview on 8/29/2023 at 9:55 a.m. with Testing Personnel confirmed the above finding. 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)