STAND. COM. REP. NO. 2051

Honolulu, Hawaii

, 2023

RE: S.B. No. 602

S.D. 2

H.D. 1

Honorable Scott K. Saiki

Speaker, House of Representatives

Thirty-Second State Legislature

Regular Session of 2023

State of Hawaii

Sir:

Your Committee on Consumer Protection & Commerce, to which was referred S.B. No. 602, S.D. 2, entitled:

"A BILL FOR AN ACT RELATING TO HEALTH,"

begs leave to report as follows:

The purpose of this measure is to:

(1) Require pharmacists to obtain a permit and complete appropriate training to order or perform the collection of specimens for certain diagnostic-related tests and tests waived pursuant to the federal Clinical Laboratory Improvement Amendments of 1988; and

(2) Amend the scope of practice of pharmacy to authorize pharmacists to order or perform the collection of specimens for such tests described in paragraph (1).

Your Committee received testimony in support of this measure from the University of Hawai‘i at Hilo, Board of Pharmacy, Walgreen Co., CVS Health, Hawai‘i Pharmacists Association, and seven individuals. Your Committee received testimony in opposition to this measure from the Hawaii Medical Association and Clinical Laboratories of Hawaii. Your Committee received comments on this measure from the Department of Health.

Your Committee finds that, as a result of the COVID-19 pandemic, the federal Public Readiness and Emergency Preparedness Act (PREP Act) granted pharmacists the independent authority to order and collect Clinical Laboratory Improvement Amendments (CLIA) waived tests, such as PCR tests for COVID-19 testing. Pharmacists have been performing these tests pursuant to the PREP Act and, as a result, have the skill, experience, and training to perform these tests. However, the authorization granted by the PREP Act is set to expire in 2024.

Your Committee further finds that CLIA-waived tests are simple, easy to use tests that are non-technical in nature and are meant to be performed by lay persons in a non-clinical setting. CLIA-waived tests pose little to no risk to patients experiencing adverse health effects from these tests and they can easily be performed at home or in a pharmacy setting. This measure ensures that pharmacists in the State continue to be empowered to perform CLIA-waived tests.

Your Committee has amended this measure by:

(1) Deleting the authority for pharmacists to perform certain diagnostic-related tests;

(2) Explicitly specifying the CLIA-waived tests for which pharmacists may order, perform, and report the results;

(3) Requiring pharmacists to report test results to an adult patient's primary care physician or a minor patient's pediatrician;

(4) Requiring pharmacists to follow all applicable state laws and rules regarding the reporting of communicable diseases;

(5) Changing the effective date to June 30, 3000, to encourage further discussion; and

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

As affirmed by the record of votes of the members of your Committee on Consumer Protection & Commerce that is attached to this report, your Committee is in accord with the intent and purpose of S.B. No. 602, S.D. 2, as amended herein, and recommends that it pass Second Reading in the form attached hereto as S.B. No. 602, S.D. 2, H.D. 1, and be placed on the calendar for Third Reading.

Respectfully submitted on behalf of the members of the Committee on Consumer Protection & Commerce,

____________________________

MARK M. NAKASHIMA, Chair