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, procedures and interviews with laboratory staff, it was determined the Laboratory failed to have the Laboratory Director approve, sign, and date procedures. As evidenced by: 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 05/01/2017. B. In an interview at 10:30 am on 03/15/2018, 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 --