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 procedures and laboratory and proficiency testing (PT) records and interview with a technical consultant (Staff A), the laboratory did not verify the accuracy of the post-vasectomy semen analysis motility testing twice annually in two of the last two years. Findings include: 1. Review of the "Post- Vasectomy Semen Analysis" procedure, effective date 12/12/2023, showed testing personnel evaluate patient post-vasectomy semen samples for the presence of spermatozoa and for motility. 2. Review of PT records from 2024 and 2025 showed no evidence the laboratory evaluated PT samples for spermatozoa motility. 3. Review of laboratory quality assessment records for the last two years showed no evidence the laboratory verified the accuracy of motility evaluation on post-vasectomy semen samples twice annually. 4. Interview with Staff A on June 10, 2025, at 1:00 PM confirmed the laboratory did not verify the accuracy twice annually of the spermatozoa motility evaluation included in the post-vasectomy semen analysis. 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 --