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 a review of laboratory procedures and an interview of laboratory personnel, the laboratory failed to document the approval of the current laboratory director on all procedures. Findings: 1. A review of the two procedure manual binders provided by the laboratory revealed that none of the procedures were signed by the current laboratory director. 2. An interview of the testing person on 06/20/2018 at 10:05 AM confirmed the above finding. 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 --