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: Through a review of the laboratory's policies and procedures and through interviews with laboratory staff, it was determined the laboratory failed to have the laboratory director approve, sign, and date procedures. Survey findings follow: A. A review of the laboratory's procedures revealed that none of the procedures were signed and dated by the director indicating his review and approval. The laboratory became a compliance lab on 2/28/2017. B. In an interview at 3:17 pm on 2/13/2018, the laboratory supervisor confirmed the lack of director's approval and signature of the procedures in use by the laboratory. 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 --