Summary:
Summary Statement of Deficiencies 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: Based on the lack of an accessible procedure manual on May 13, 2025 and interview with the laboratory director, the laboratory failed to ensure a written procedure manual was available for testing and examining specimens. Findings: 1. The laboratory could not provide or access the laboratory procedure manual during the course of the inspection. 2. Interview with the laboratory director on May 13, 2025 at 12:15 PM confirmed, the laboratory failed to ensure the procedure manual was available to laboratory personnel on day of inspection. 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 --