Hawaii

Hawaii Department of Health, Clinical Laboratories. 
https://health.hawaii.gov/statelab/files/2013/07/sld-lic-har.pdf

(1) 11-110.1-1 Purpose. The purpose of this chapter is to protect the health, welfare, and safety of the public by establishing minimum licensure standards for clinical laboratories and clinical

laboratory personnel:

(a) “Laboratory consultant” means a clinical laboratory director or medical technologist licensed under this chapter.

“Moderate complexity tests” means laboratory tests categorized as moderate complexity pursuant to 42 C.F.R. part 493 subpart A.

“High complexity tests” means laboratory tests categorized as high complexity pursuant to 42 C.F.R. part 493 subpart A.

(b) “Laboratory acceptable to the department” means a clinical laboratory licensed by the department or licensed by another state whose requirements are equal to or more stringent than the requirements of this chapter, a clinical laboratory certified pursuant to the Clinical Laboratory Improvement Amendments of 1988, 42 C.F.R. part 493, a clinical laboratory certified under 21 C.F.R. parts 600-680, or a clinical laboratory acceptable to the U. S. Department of Health and Human Services.

(c) 11-110.1-6 Requirements for a clinical laboratory permit or license.   

      (1) No person shall establish, conduct, maintain, or operate a clinical laboratory in the State without a valid and effective clinical laboratory permit or license issued by the department.

     (2) An application shall be submitted for each address in which clinical laboratory tests are performed.

     (3) The following laboratories shall be exempt from the requirements of subsection (b); (see link above).

     (4) Application forms for licensure may be obtained by request from the state laboratories division, department of health.

     (5) The clinical laboratory personnel licenses are:

           (i) Clinical laboratory director;

           (ii) Medical technologist (clinical laboratory scientist);

           (iii) Clinical laboratory specialist;

           (iv) Cytotechnologist; and

           (v) Medical laboratory technician (clinical laboratory technician).

      (6) Every applicant for a clinical laboratory personnel license shall provide documents verifying education, training, and employment experience  requested on the application form.

      (7) The specific education, training, and experience requirements for clinical laboratory personnel licenses may be waived by the director if the applicant presents evidence to the satisfaction of the director that the applicant’s combination of education, training, and experience is substantially equivalent to the specific clinical licensure requirements.

      (8) All applications for original licensure shall be approved or denied no later than sixty calendar days following the date that the application is complete with all required documents verifying education, training, experience and full payment of all required fees. All applications for license renewal or restoration shall be approved or denied no later than sixty calendar days following receipt of a completed renewal or restoration application and the full payment of all required fees.

      (9) All clinical laboratory personnel licenses shall expire on January 31 of each odd-numbered year.

      (10) All valid clinical laboratory personnel licenses in effect immediately prior to the effective date of this subchapter shall remain in effect until their renewal dates.”

Application: https://www.cms.gov/Medicare/CMS-Forms/CMS-Forms/downloads/cms116.pdf

To apply for a CLIA certificate of waiver, applicants must complete Form CMS116 and Form 1513.

Application forms should be mailed to State of Hawaii Department of Health Office of Health Care Assurance.

Notices to pay CLIA fees for an initial CLIA certificate are mailed about 2 weeks after the CLIA application is accepted by Hawaii Department of Health’s office. Once paid, the biennial CLIA certificate is in effect for 2 years, starting from the date the application is accepted by our office. 

(d) “Laboratory specialty” means clinical chemistry, hematology, immunohematology, microbiology, immunology, cytology, cytogenetics, histocompatibility, molecular biology and other specialties recognized by a certifying agency acceptable to the department.

Online Access to CLIA Certificates

CMS is now making CLIA certificates available online at no cost via the QCOR Lookup Tool.  All certificates generated after September 27, 2023 should be available for download.  Click HERE to access the Tool and choose “CLIA Laboratory Lookup” from the left menu bar (2nd option from the top).  When you click the entry for the laboratory, a box containing the laboratory information and a link to the certificate will pop up in a new window.