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 direct observation the laboratory failed to have procedures approved, via signature and date, by the current Laboratory Director before use. All patients tested at this lab have the potential to be affected. Findings Include: 1. Review of the laboratory's manual, on 8/23/18 at 9:20 am, found 10 out of 17 policies and procedures were not approved, via signature and date, by the lab director. 2. Review of the laboratory's manual, on 8/23/18 at 9:20 am, found no coversheet was used for the lab director to approve the manual or track changes to policies and 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 --