Summary:
Summary Statement of Deficiencies D0000 A recertification survey was performed on September 4, 2025 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 the following condition-level deficiencies: 493.1215 Condition: Hematology. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director. 493.1409 Condition: Laboratories performing moderate complexity technical consultant. D5024 HEMATOLOGY CFR(s): 493.1215 If the laboratory provides services in the specialty of Hematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1269, and 493. 1281 through 493.1299. This CONDITION is not met as evidenced by: . Based on record review and interviews, the laboratory failed to establish test procedures to include specimen labeling, a step-by-step procedure for performing Complete Blood Count (CBC) testing, CBC reportable ranges, and CBC critical values (refer to D5403), failed to perform and document daily maintenance for its Medonic M-series hematology analyzer (refer to D5429 A), failed to perform and document monthly maintenance for its Medonic M-series hematology analyzer (refer to D5429 B), failed to follow its control procedures to test three control materials each day of testing (refer to D5441), failed to perform