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 ensure they verified the accuracy of semen analysis at least twice annually in 2017. The laboratory performed approximately 250 post vasectomy analysis per year for the presence or absence and motility of semen. Findings include: 1. The laboratory failed to document they checked post vasectomy semen analysis accuracy twice in 2017. 2. In an interview conducted on 08/13/2018 at approximately 10:00 A.M. staff stated they did not have documentation to verify sperm counts and motility testing accuracy at least twice annually in 2017. 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)