HAR §11-110.1-9. Requirements for a clinical laboratory license

(a) A person intending to operate a clinical laboratory may apply for a clinical laboratory license if the laboratory: (1) Is certified as a clinical laboratory under 42 C.F.R. part 493; (2) Performs moderate or high complexity tests or both, in addition to any combination of waived, PPMPs, or POCTs; and (3) Remits applicable fees. (b) A person applying for an initial clinical laboratory license or renewal of a clinical laboratory license shall complete application forms provided by the department and submit the applicable fee. The application shall include at a minimum: (1) Name and address of the clinical laboratory where clinical laboratory testing is performed; (2) Name and address of the owner of the clinical laboratory; (3) Name of the clinical laboratory director licensed by the State; (4) Names of testing personnel and their Hawaii clinical laboratory personnel license numbers, if required for the laboratory tests they are performing; (3) A list of tests and methodologies and annual test volume to be performed by the laboratory. (c) The department may inspect the laboratory for initial approval and renewal of its clinical laboratory license. A licensed clinical laboratory 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 110.1-12 2763 §11-110.1-9 inspections of the College of American Pathologists, Joint Commission on Accreditation of Healthcare Organizations, U.S. Department of Health and Human Services Centers for Medicare and Medicaid Services, and other agencies, provided that these agencies have standards that are substantially equal to or more stringent than the requirements of this section. [Eff JUL 05 2007] (Auth: HRS §§321-11, 321-11.5, 321-13) (Imp: HRS §§321-11, 321-11.5, 321-13) §11-110.1-10 Licensed clinical laboratory; clinical laboratory director's responsibilities. (a) The director of a licensed clinical laboratory shall be responsible for: (1) The technical and scientific operation of the laboratory, including the selection and supervision of test procedures, reporting of results, continuous application of quality control procedures, and active participation in the operations to the extent necessary to assure compliance with the rules and directives of the department; (2) The proper performance of all tests in the laboratory; and (3) The technical supervision of qualified laboratory personnel. (b) Commensurate with the scope and complexity of the services provided, the clinical laboratory director shall ensure that the staff is qualified, sufficient in number, and receives in-service training to maintain competency to perform test procedures and to report test results promptly and proficiently. (c) If the clinical laboratory director is absent for more than thirty days, the associate clinical laboratory director or, if there is none, a person whose qualifications are satisfactory to the department shall assume the responsibilities of the laboratory director. (d) When a clinical laboratory director's employment is terminated for any reason, the owner of the clinical laboratory shall notify the department within fourteen days of the termination of employment. [Eff JUL 05 2007] (Auth: HRS §§321-13, 321-14) (Imp: HRS §§321-13, 321-14) 110.1-13 2763