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: Through a review of the form CMS-209, a review of the laboratory personnel records, lack of documentation, and an interview with laboratory staff, it was determined the laboratory director failed to give written authorization for testing personnel to perform testing without direct supervision. Survey findings include: A. The form CMS-209, which was completed by the laboratory, lists three Testing Personnel (Employees #4, #5, and #6 as listed on the form). B. In a review of personnel records for the testing personnel it was determined that three of three personnel lacked written authorization to perform testing without direct supervision. C. In an interview, at 10:14 on 7/17 /2019, Employee #6 (who is listed as both a Testing Personnel and General Supervisor) confirmed that the three Testing Personnel listed on the CMS-209 lack the written authorization to test signed by the 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 --