Summary:
Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of the laboratory's proficiency testing policy, review of the laboratory's American Proficiency Institute's (API) proficiency testing records from 2025 and 2026, and staff interview, the laboratory failed to ensure testing personnel signed the attestation statements for 6 of 6 proficiency testing events. The findings included: 1. The laboratory's policy titled "Proficiency Testing" (approved on 09/01 /2024) stated: "The attestation statement shall be signed and dated by testing personnel and the Lab Director at the time of testing." 2. A review of the laboratory's American Proficiency Institute's proficiency testing records from 2025 (Microbiology Events 1, 2 and 3) and 2026 (Microbiology Events 1, 2, and 3) determined the attestation statements provided the following instructions: "SIGNATURES REQUIRED - For all PT results an attestation statement must be signed by the testing personnel and the laboratory director..." 3. Further review of the proficiency testing records determined testing personnel names were printed in the same handwriting on 6 of 6 attestation statements. There were no testing personnel signatures on the statements. The events without signatures were: 2025 Microbiology event 1 2025 Microbiology event 2 2025 Microbiology event 3 2026 Microbiology event 1 2026 Microbiology event 2 2026 Microbiology event 3 4. The technical consultant confirmed the findings after his review of the records on 10/15/2026 at 900 hours in the break room. D5783