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 twice year verification records, the current, approved standard operating procedures, as well as interview with the office manager (OM), the laboratory failed to perform twice year slide verification for the calendar years 2022 and 2023. FINDINGS: 1. Verification was performed and documented for December 15th, 2022, and October 24th, 2023. There was no documentation of second verification performed for 2022 and 2023. 2. This is contrary to instructions indicated in the twice year verification procedure. 3. It was noted that the laboratory successfully performed twice year verification prior to 2022. 4. The OM confirmed the findings on May 15th, 2024, at 2:30 P.M. 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 --