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 lack of documentation and interview with staff, the laboratory failed to verify urinalysis test accuracy at least twice annually for 2 of 2 years of testing reviewed (February 2019 to February 2021). The laboratory performed approximately 3000 urinalyses per year. Findings include: 1. The laboratory lacked documentation microscopic urinalysis accuracy at least twice annually in 2019 and 2020. The laboratory lacked documentation for 1 of 2 accuracy checks in 2019 and 2020. 2. In an interview with the lead medical assistant on 02/11/2021 at approximately 1:30 P. M. the medical assistant confirmed microscopic urinalysis twice annual verification of test accuracy was not documented for 2019 and 2020. 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)