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 a review of the laboratory's test menu, lack of documentation, and staff interviews, the laboratory failed to verify the accuracy of 2 out of 38 tests using liquid chromatography-mass spectrometry (LC-MS) for toxicology confirmation at least twice a year in 2023. The findings include: 1. A review of the test menu revealed that the laboratory's LC-MS analytes included Ethyl Glucuronide (ETG) and Ethyl Sulfate (ETS). 2. No verification of accuracy documents were available for ETG or ETS testing in 2023. 3. An interview with the general supervisor on 08/20/2024 at 4:00 p. m. confirmed that the laboratory did not verify the accuracy of ETG or ETS testing in 2023. 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 --