HAR §11-110.1-8. Requirements for a class II clinical laboratory permit

(a) A person intending to operate a clinical laboratory may apply for a class II permit if the laboratory: (1) Is not located in a licensed clinical laboratory; (2) Is maintained by a licensed medical facility for performing tests solely on the facility's patients; (3) Performs only waived, PPMP tests, or POCTs or a combination of these tests; (4) Is certified as a clinical laboratory under 42 C.F.R. part 493 subpart A; and (5) Remits applicable fees. (b) A person applying for an initial class II permit or 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; 110.1-10 67 63 §11-110.1-8 (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 approximate annual test volume to be performed by the laboratory. (c) The laboratory director of a class II 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. (d) The laboratory director of a class II clinical laboratory may delegate the laboratory director's duties in writing to the laboratory's laboratory consultant. (e) The department may inspect the laboratory for initial approval and renewal of a class II permit. A clinical laboratory with a class II permit shall allow the inspection of its premises, records, materials, equipment, and methodology, by a representative of the department at any time during the laboratory's working hours. The department may accept the on-site inspections of the College of American Pathologists, Joint Commission on Accreditation of Healthcare 110.1-11 2763