STAND. COM. REP. NO. 2935

Honolulu, Hawaii

RE: S.B. No. 2592

S.D. 2

Honorable Ronald D. Kouchi

President of the Senate

Thirty-First State Legislature

Regular Session of 2022

State of Hawaii

Sir:

Your Committee on Commerce and Consumer Protection, to which was referred S.B. No. 2592, S.D. 1, 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) Define "clinical laboratory director" to include certain physicians, licensed clinical laboratory scientists, and pharmacists; and

(2) Amend the definition of "practice of pharmacy" to include the ordering and performing of certain Clinical Laboratory Improvement Amendments-waived tests.

Your Committee received testimony in support of this measure from the Hawai‘i-American Nurses Association, Walgreen Co., CVS Health, Hawai‘i Pharmacists Association, and six individuals. Your Committee received testimony in opposition to this measure from the Department of Health, Clinical Labs of Hawai‘i, and seven individuals. Your Committee received comments on this measure from the Board of Pharmacy and American Society for Clinical Laboratory Science Hawai‘i.

Your Committee finds that certain tests waived under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) 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. Pharmacies across the country perform CLIA-waived tests to provide easy and convenient access to important patient health care information. There is little to no risk of patients experiencing adverse health effects from CLIA-waived tests, as they can easily be performed in any non-laboratory setting, including at home or at a pharmacy.

Your Committee additionally finds that, over time, pharmacists have become more accessible and the scope of their practice has expanded, making access to health care more convenient for patients. Pharmacists possess the skills and knowledge to perform CLIA-waived tests in accordance with specific policies, procedures, and protocols developed collaboratively by health professionals. Hawai‘i is the only state that requires additional credentialing as a clinical laboratory director, which creates regulatory barriers to testing that do not exist elsewhere in the nation at a time when there is already significant strain on the State's health care system. Accordingly, this measure will remove barriers to promote access to safe and effective health care services.

Your Committee has amended this measure by:

(1) Clarifying the definition of "clinical laboratory director" to include advanced practice registered nurses for clinical laboratory tests or examinations classified as waived under the CLIA; and

(2) 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 Commerce and Consumer Protection that is attached to this report, your Committee is in accord with the intent and purpose of S.B. No. 2592, S.D. 1, as amended herein, and recommends that it pass Third Reading in the form attached hereto as S.B. No. 2592, S.D. 2.

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

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ROSALYN H. BAKER, Chair