Summary:
Summary Statement of Deficiencies D0000 A validation survey was performed on January 20, 2026 by the State of Michigan Licensing and Regulatory Affairs Department. The laboratory was found to be out of compliance with CLIA regulations (42 CFR Part 493, Laboratory Requirements) for standard-level deficiencies. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: . Based on record review and interview with the technical supervisor, the laboratory failed to establish and follow its competency assessment policy for one (technical supervisor/testing personnel #1) of eight total testing personnel listed on Form CMS- 209. Findings include: 1. A review of the laboratory's "Competency Testing of Laboratory Personnel" policy revealed a section stating, "Failure to pass competency testing will result in the notification of the laboratory director or designee and disciplinary/