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 procedure manual review and interview with the Office Manager, the laboratory failed to have job descriptions in the procedure manual. Findings included: During the review of the procedure manual, it was found that there were no job descriptions for the clinical consultant, technical supervisor, general supervisor, and testing personnel. During an interview on 05/01/2018 at 09:00 AM, the Office Administrator confirmed there were no job descriptions in the procedure manual. 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 --