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 record review, staff interview, and policy review, the laboratory failed to ensure testing personnel signed the attestation statement for 1 of 12 (3rd Event 2025 Chemistry Core) American Proficiency Institute (API) proficiency testing events reviewed from 2025 and 2026. Findings include: 1. Reviewed at 10:10 a.m. on 05/21 /26, the 3rd Event 2025 Chemistry Core API proficiency testing records failed to include an attestation statement signed by the testing personnel. 2. During an interview at 10:14 a.m. on 05/21/26, a Technical Consultant (#1) confirmed testing personnel had not signed the attestation statement for the 3rd Event 2025 Chemistry Core API proficiency testing. 3. Reviewed the morning of 05/21/26, the policy "Laboratory Policy: Proficiency Testing Policy," dated 07/15/24, stated, ". . . The staff member who performed the testing is responsible for entering and signing off on results. Complete and sign the Attestation Statement. . . ." 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 --