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 for four of four testing personnel listed on the form CMS 209, lack of documentation, and interviews with laboratory staff, it was determined the laboratory director failed to give written authorization to one of four testing personnel who perform Complete Blood Counts (CBC). Survey findings follow: A. A review of personnel records for four of four testing personnel revealed that testing personnel #4, (as listed on form CMS-209) had no written authorization to perform CBC testing without direct supervision. B. During an interview, at 10:30 a.m. on 8/16/2022, laboratory employee #2 (as listed on the form CMS-209) confirmed that written authorizations to test were not available for testing personnel #4. 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 --