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 staff interview the laboratory director failed to ensure testing personnel (TP) received documented training prior to reporting results on patient samples in the specialty of Hematology. Findings include: 1. Record review on 5/26/2026 of the laboratory's TP records revealed 1 of 1 new TP did not have documented training records. 2. Record review on 5/26/26 of the laboratory's, 'Lab Personnel Education and Training Policy' revealed, "Prior to any testing of patient samples, lab personnel must be appropriately educated and trained. 3. Staff interview with the TP #1 on 5/26/2026 at 9:15 AM confirmed the above TP did not have documented training records and are reporting out patient test results in the specialty of Hematology. 4. The laboratory performs 420 Hematology tests annually. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) (b)(9) Thereafter, evaluations must be performed at least annually This STANDARD is not met as evidenced by: Based on record review and staff interview the Technical Consultant (TC) failed to ensure testing personnel (TP) received annual competency assessment in the specialty of Hematology. Findings include: 1. Record review on 5/26/2026 of the laboratory's Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- 2024, 2025 and 2026 to date TP records revealed: a. 2 of 2 TP did not receive annual competency assessment in 2024. b. Review of documentation for the 2 of 2 TP indicated above identified a record with a typed date of 12/8/2023 referencing a lapse in competency assessment. The same document indicates the individual was deemed competent to perform CBC testing during the period of 10/2024 through 12/2024; however, the document was signed by the laboratory director on 12/8/2023. c. The documentation did not include evidence of a