Summary:
Summary Statement of Deficiencies D0000 The Eurofins Donor & Product Testing, LLC laboratory was found to be out of compliance with the regulations of the Clinical Laboratory Improvement Amendments of 1988 (42 C.F.R. part 493) upon completion of the recertification survey performed on February 26, 2026. The following standard-level deficiencies were cited: 493.1451 Technical supervisor responsibilities . D6128 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) (b)(9) Thereafter, evaluations must be performed at least annually unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individuals performance must be reevaluated to include the use of the new test methodology or instrumentation. This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the Technical Supervisor (TS) failed to complete a comprehensive competency evaluation at least annually for one of eight testing personnel (TP) in 2024. Findings are as follows: 1. The laboratory performed non-waived Microbiology, Immunology, and Immunohematology testing as confirmed by the General Supervisor (GS) during a tour of the laboratory at 9:17 a.m. on 2/26/26. 2. Annual competency assessments were required for all testing personnel as established in the Ensuring Competency for Eurofins DPT Personnel procedure found in MediaLab software. 3. A 2024 annual competency assessment was not found for TP8 during review of laboratory competency assessment records. The laboratory was unable to provide the missing records upon request. 4. In an interview at 2:15 p.m. on 2/26/26, the GS confirmed the above finding. . 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 --