Summary:
Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) Recertification Survey was completed on February 25, 2026. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: A review of the current Laboratory Procedure Manual confirmed that the procedure manual failed to contain procedures for all tests, assays, and examinations performed by the laboratory or procedures as required by CLIA regulations. THE FINDINGS INCLUDE: 1. A review of current Laboratory Procedure Manual confirmed that the following procedures were not available: a. Complete Blood Cell Count Procedure, b. Down Time Procedure c. Maintenance Procedure d. Personnel Procedure e. Quality Control Procedure f. Quality Assurance Procedure g. Safety Procedure 2. An exit interview, with the Laboratory Director and Testing Personnel, on February 25, 2026, at 1:15pm confirmed that the procedure manual failed to contain procedures for all tests, assays and examinations performed by the laboratory or procedures as required by CLIA regulations. 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 --