Summary:
Summary Statement of Deficiencies D5407 PROCEDURE MANUAL CFR(s): 493.1251(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 record review and interview with the Office Manager, the laboratory failed to have the procedure manual signed by the Laboratory Director prior to laboratory testing of patient specimens. Findings include: 1. Record review of the laboratory's procedure manual revealed that the procedure manual had not been signed by the Laboratory Director before patient testing. 2. In an interview on 12/06/2018 at 01:30 PM, the Office Manager confirmed the procedure manual had not been signed by the Laboratory Director. 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 --