Summary:
Summary Statement of Deficiencies D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) (e)(11) Ensure that prior to testing patients specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results; This STANDARD is not met as evidenced by: Based on record review and interviews with Testing Personnel #1 (TP1) and the Laboratory Director (LD), the LD failed to ensure TP1 received documented training prior to testing and reporting results on patient samples in the specialty of Chemistry. Findings include: 1. Record review on 3/16/2026 of the Personnel file for TP1, hired 12/2025, revealed TP1 did not have documented training on the AU480 Chemistry analyzer prior to testing patient samples. 2. Staff interview on 3/16/2026 at 11:00 AM with TP1 and the LD confirmed the above findings. TP1 stated, "I know I had it, but it must have been misplaced." 3. The laboratory performs 96,000 tests annually in the specialty of Chemistry. 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 --