Summary:
Summary Statement of Deficiencies D0000 The validation survey was performed on 08/18/2025. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the director of laboratory services at the conclusion of the survey. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory manager, the laboratory director failed to attest that, at the time of testing, proficiency testing samples were tested in the same manner as patient specimens as required under Subpart H for two of eight proficiency testing events reviewed in 2024 and 2025. Findings include: (1) On 08/18/2025 at 11:00 am, a review of 2024 and 2025 proficiency testing events identified attestation statements had been signed after the graded evaluations were completed by the proficiency testing program for two of eight events reviewed: (a) First event 2024 Chemistry Core - The graded evaluation was completed on 01/18/2024 and the attestation statement had not been signed by the laboratory director until 01/18/2024; (b) Third event 2024 Chemistry Core - The graded evaluation was completed on 09/07/2024 and the attestation statement had not been signed by the laboratory director until 09/07/2024. (2) The records were reviewed with the laboratory director who stated on 08/18/2025 at 11:00 am the attestation statements had not been signed timely as stated above. 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 --