HAR §11-110.1-7. (2) Is certified as a clinical laboratory under 42 C

F.R. part 493 subpart A; and (3) Remits applicable fees. (b) A person applying for an initial class I clinical laboratory permit and renewal shall complete application forms provided by the department. The application shall include at a minimum: (1) Name and address of the clinical laboratory where laboratory testing is performed; (2) Name and address of the owner of the clinical laboratory; (3) Name of the laboratory director; (4) Name of the laboratory consultant if the laboratory director is not a clinical laboratory director or medical technologist licensed by the State; and (5) List of tests and methodologies and annual test volume to be performed by the laboratory. (c) The laboratory director of a class I clinical laboratory shall: (1) Be accessible to the laboratory and provide onsite, telephone, or electronic consultation as needed; (2) Visit the laboratory at least two times per year; (3) Approve all laboratory tests performed in the laboratory and have written protocols available for all testing personnel; (4) Prior to patient testing, provide training to testing personnel and document the personnel's competency to perform tests accurately and reliably; (5) Ensure specimens for laboratory testing are properly collected; (6) Ensure control materials meet the laboratory's and, as applicable, the manufacturer's test system criteria for acceptability before reporting patient test results; (7) Ensure patient test results are reported accurately and in a timely manner; and (8) Ensure all federal, state, and county safety regulations are followed. 110.1-9 27.63