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 review of Standard Operating Procedures (SOPs) as well as interview with the Testing Personnel (TP), the laboratory failed to document approval and date of approval of the procedures by the current Laboratory Director (LD) before use. FINDINGS: 1. There was no documentation of LD review, approval, and date of approval for the in-use Optum Medical Care, PC policies and procedures. 2. The TP confirmed the findings on September 1, 2026, at approximately 3:30 P.M. 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 --