Summary:
Summary Statement of Deficiencies D6032 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(14) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(14) Specify, in writing, the responsibilities and duties of each consultant and 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 results reporting, and whether consultant or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Through a review of personnel records, and interview with laboratory staff, it was determined the laboratory director failed to give written authorization for two of three testing personnel identified on the CMS 2009 form to perform moderately complex laboratory tests. Survey findings follow: A. A review of personnel records, revealed there was no signed authorization to perform moderately complex complete blood counts for testing personnel identified as numbers one and two on the form CMS-209. B. Upon request, the laboratory could not provide a signed authorization to perform Complete Blood Count testing for the testing personnel identified as numbers one and two on the CMS 209 form. C. In an interview on 7/11/19 at approximately 11:45 AM, the laboratory staff, identified as number four on the CMS 209 form, confirmed that the laboratory failed to have a signed authorization to perform moderately complex Complete Blood Counts for the testing personnel identified as numbers one and two on the CMS 209 form. 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 --