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 review of the laboratory's proficiency testing (PT) result reports, and interview with the laboratory staff, it was determined that the laboratory failed to verify, at least twice annually, the accuracy of the semen viability and motility counts. The findings included: a. The laboratory performed sperm count in an IVF laboratory. b. The laboratory elected to enroll with AAB (American Association of Bioanalysts) PT program to verify the accuracy of the sperm motility and sperm viability. c. The laboratory obtained scores of 50 % for Motility and Viability, repectively in S1 2022 AAB PT event, which was unsatisfactory performance. d. The laboratory performs Motility and Viability counts in approximately 42 patient specimens monthly. e. The laboratory staff affirmed (8/23/2022 @ 10:05 am) that the laboratory obtained 50% for Motility and Viability counts in S1, 2022 AAB PT which was unsatisfactory performance. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on review of the laboratory's procedure manual, and interview with the laboratory staff, it was determined that the laboratory director failed to review the Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- procedures and approve, sign and date it. The findings included: a . There was no current laboratory director's signature on the laboratory's procedure manual -- 2 of 2 --