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 review of the procedure manual and interview, the laboratory did not ensure that the procedures used by the laboratory staff were signed and dated by the current laboratory director. Findings: 1. The laboratory laboratory director was changed in the federal data base after the previous recertification survey on 08/22/2019. Review of the policy and procedure manuals show that the new laboratory director had not approved (signed and dated) the policies and procedures used by the laboratory staff. 2. During the survey on 04/26/2022 at 10:45 AM the laboratory manager confirmed that all the policy and procedure manuals had not been approved by the current laboratory director. 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 --