STAND. COM. REP. NO. 527

Honolulu, Hawaii

RE: S.B. No. 602

S.D. 1

Honorable Ronald D. Kouchi

President of the Senate

Thirty-Second State Legislature

Regular Session of 2023

State of Hawaii

Sir:

Your Committee on Health and Human Services, to which was referred S.B. No. 602 entitled:

"A BILL FOR AN ACT RELATING TO HEALTH,"

begs leave to report as follows:

The purpose and intent of this measure is to:

(1) Establish permitting and education requirements for pharmacists performing certain diagnostic tests or tests waived pursuant to the Clinical Laboratory Improvement Amendments of 1988 (CLIA); and

(2) Expand the definition of "practice of pharmacy" to include the performance of certain diagnostic or CLIA-waived tests.

Your Committee received testimony in support of this measure from the Board of Pharmacy, University of Hawai‘i at Hilo, Walgreen Co., Hawai‘i Pharmacists Association, Times Pharmacy, and two individuals. Your Committee received testimony in opposition to this measure from Clinical Labs of Hawaii.

Your Committee finds that the coronavirus disease 2019 pandemic highlighted the critical need to address health care testing accessibility and streamline unnecessary administrative regulations. While pharmacists possess the skills and knowledge necessary to perform diagnostic and CLIA-waived tests, which are non-technical and present a low risk for erroneous results, pharmacists' scope of practice under existing state law does not explicitly authorize performance of these tests. To clarify this ambiguity, this measure amends pharmacists' scope of practice to explicitly include the ordering and performance of certain diagnostic-related and CLIA-waived tests.

Your Committee has amended this measure by:

(1) Clarifying that, unless otherwise authorized by law, no pharmacist shall order, or perform the collection of specimens for, certain diagnostic-related and CLIA-waived tests without first obtaining a permit;

(2) Clarifying that, before ordering, or performing the collection of specimens for, certain diagnostic-related and CLIA-waived tests, the pharmacist shall have completed certain training;

(3) Clarifying the definition of "practice of pharmacy" to include ordering certain tests and performing the collection of specimens for certain tests authorized or approved by the United States Food and Drug Administration;

(4) Amending section 1 to reflect its amended purpose;

(5) Inserting an effective date of December 31, 2050, to encourage further discussion; and

(6) Making technical, nonsubstantive amendments for the purposes of clarity and consistency.

As affirmed by the record of votes of the members of your Committee on Health and Human Services that is attached to this report, your Committee is in accord with the intent and purpose of S.B. No. 602, as amended herein, and recommends that it pass Second Reading in the form attached hereto as S.B. No. 602, S.D. 1, and be referred to your Committee on Commerce and Consumer Protection.

Respectfully submitted on behalf of the members of the Committee on Health and Human Services,

________________________________

JOY A. SAN BUENAVENTURA, Chair