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 surveyor review of proficiency testing records and interview with a technical consultant, the laboratory has not verified the accuracy of semi-quantitative sperm counts twice annually. Findings include: 1. Review of proficiency testing records from 2018 and 2019 showed the laboratory did not verify the accuracy of semi-quantitative sperm counts using proficiency samples. 2. Interview with staff A, a technical consultant, on February 4, 2020 at 2:00 PM confirmed the laboratory reports semi-quantitative sperm counts as part of their post-vasectomy semen analysis. Further interview confirmed the laboratory did not verify the accuracy of the test twice annually. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --