Haw. Code R. § 11-110.1-7 - Requirements for a class I clinical laboratory permit

(a) A person intending to operate a clinical laboratory may apply for a class I permit if the laboratory:

(1) Performs only waived or provider performed microscopy procedures, or both, pursuant to 42 C.F.R. part 493 subpart A, on its premises;

(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.

(d) The laboratory director of a class I 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 its class I permit. A clinical laboratory with a class I 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 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 subparts 1 and 2 of this chapter.

Notes

Haw. Code R. § 11-110.1-7

[Eff JUL 05 2007] (Auth: HRS §§ 321-11, 321-13) (Imp: HRS §§ 321-11, 321-13)