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 College of American Pathologists (CAP) proficiency testing records and interview with the laboratory staff it was determined that; the laboratory failed to at least twice annually, the laboratory must verify the accuracy of Anti- Sperm (IgA) procedure it performs that is not included in subpart I of this part. The findings included: a. Based on review and the lack of documentation for Anti-Sperm (IgA) tests. b. The laboratory performs approximately twenty five (25) Anti Sperm (IgA) tests from 2017 to 2019. c. The laboratory staff confirmed (10/21/2019, 14:45) that the laboratory failed to at least twice annually verify the accuracy of the Anti- Sperm (IgA) tests. 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 --