Summary:
Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on record review and interview with the Laboratory Manager, the laboratory failed to have policies and procedures that were specific to their laboratory for 2 out of 2 years (2016-2017) reviewed. Findings Included: Review of policies and procedures (signed by the Laboratory Director 08/31/17) reveals another laboratories name on all policies. During an interview on 02/19/18 at 12:00 PM the Laboratory Manager confirmed that the name on the policies belonged to the parent laboratory and that the name of the actual laboratory where testing was performed was not on any policies or procedures. 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 --