STAND. COM. REP. NO. 95-22

Honolulu, Hawaii

, 2022

RE: H.B. No. 1667

H.D. 1

Honorable Scott K. Saiki

Speaker, House of Representatives

Thirty-First State Legislature

Regular Session of 2022

State of Hawaii

Sir:

Your Committee on Health, Human Services, & Homelessness, to which was referred H.B. No. 1667 entitled:

"A BILL FOR AN ACT RELATING TO HEALTH,"

begs leave to report as follows:

The purpose of this measure is to:

(1) Clarify that a pharmacist-in-charge of a pharmacy may sign off on applications to perform Clinical Laboratory Improvement Amendments waived tests; and

(2) Clarify that pharmacists may order and perform certain Clinical Laboratory Improvement Amendments waived tests.

Your Committee received testimony in support of this measure from the University of Hawaii at Hilo, Walgreen Co., Hawai‘i Health & Harm Reduction Center, Times Pharmacy, Hawai‘i Pharmacists Association, CVS Health, Hep Free Hawaii, and seven individuals. Your Committee received comments on this measure from the Department of Health and Board of Pharmacy.

Your Committee finds that under existing Department of Health regulations, pharmacies that perform Clinical Laboratory Improvement Amendments waived tests are required to partner with a clinical laboratory director to sign-off on the application to perform the tests. This signatory requirement places Hawaii in a minority of states that still have this requirement. Most states instead allow the pharmacist‑in‑charge of a pharmacy to sign applications for the purpose of authorizing Clinical Laboratory Improvement Amendments waived testing.

Your Committee has amended this measure by:

(1) Specifying that a pharmacist, rather than the pharmacist-in-charge of a pharmacy, may serve as the director of a laboratory to order and perform Clinical Laboratory Improvement Amendments waived tests;

(2) Clarifying that pharmacists may order and perform all Clinical Laboratory Improvement Amendments waived tests that are approved or authorized by the U.S. Food and Drug Administration;

(3) Changing the effective date to July 1, 2060, to encourage further discussion; and

(4) 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 Health, Human Services, & Homelessness that is attached to this report, your Committee is in accord with the intent and purpose of H.B. No. 1667, as amended herein, and recommends that it pass Second Reading in the form attached hereto as H.B. No. 1667, H.D. 1, and be referred to your Committee on Consumer Protection & Commerce.

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

____________________________

RYAN I. YAMANE, Chair