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 record review and staff interviews, the laboratory failed to provide documentation that the Laboratory Director approved, signed and dated the procedure manuals. Findings: Review of the procedure manuals showed that the laboratory failed to provide documentation that the Laboratory Director approved, signed and dated the procedure manuals. The most recent signature in the procedure manual was signed and dated 8/09/13 for all procedures except one which was signed but not dated by the laboratory director and was signed and dated by all other personnel in February and March of 2015. During an interview on 4/13/17 at 10:10 AM, Mohs Technician A stated that the laboratory director had signed the procedure in 2017, but did not know where the form was located. 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 --