Summary:
Summary Statement of Deficiencies D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) (d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on a review of the laboratory procedure manual, lack of documentation, and interviews with laboratory staff, the laboratory director failed to approve, sign, and date all the laboratory procedures. Survey findings include: A. During a review of the laboratory procedures, it was determined the laboratory director failed to sign the procedure manual and individual policies. B. In an interview at 12:50 on 10/21/2025, Technical Consultant (TC) as listed on the 209 form, confirmed the laboratory director's written approval of the laboratory procedures was not available. 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 --