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 list of tests performed, lack of documentation, and interview with the laboratory director at 2:24 PM on 11/20/2019, the laboratory failed to verify the accuracy for post vasectomy sperm count. Findings are: 1. Review of the laboratory's list of tests performed revealed the laboratory performing post vasectomy sperm count testing for the past 2 years. 2. No documentation could be presented through proficiency testing or laboratory comparison to verify the accuracy of this testing. 3. Interview with the laboratory director revealed the laboratory had not enrolled the laboratory in proficiency testing or had comparison testing performed for this analyte. 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 --