Summary:
Summary Statement of Deficiencies D6107 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(15) The laboratory director must specify, in writing, the responsibilities and duties of each consultant and each supervisor, as well as each person engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or result reporting and whether supervisory or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on proficiency testing record review and an interview with the laboratory general supervisor, the laboratory director failed to delegate in writing, the responsibility to the general supervisor to document the handling and reporting of proficiency testing (PT) and signing of the attestation forms. Findings: 1. Based on the College of American Pathologist (CAP) PT record review, the laboratory director failed to sign the attestation statements since the first event in 2016. 2. Based on the laboratory's general supervisor responsibility policy, the laboratory director failed to specify in writing, the delegation of duty to the general supervisor for signing the attestations forms from CAP. 3. An interview on February 26, 2018 at 2:30 PM, with the general supervisor, confirmed the general supervisor responsibility policy failed to include the responsibility of signing the attestation forms for proficiency testing. 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 --