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 surveyor's review of the laboratory's procedure manual and an interview and confirmed with the laboratory director, the laboratory failed to have a procedure manual that is up-to-date and accurate and the laboratory director failed to approve (sign and date) the laboratory procedure manual. FINDINGS: 1. The procedure manual was last signed and dated on January 15, 2016. 2. The current procedure manual still lists the previous technical component laboratory's name, EastGene. The laboratory's current technical component laboratory is PathGenix Diagnostics. 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 --