2024 -- S 2603

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LC005334

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     STATE OF RHODE ISLAND

IN GENERAL ASSEMBLY

JANUARY SESSION, A.D. 2024

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A N   A C T

RELATING TO HEALTH AND SAFETY -- LABORATORIES

     Introduced By: Senators Felag, and DiPalma

     Date Introduced: March 01, 2024

     Referred To: Senate Health & Human Services

     It is enacted by the General Assembly as follows:

     SECTION 1. Chapter 23-16.2 of the General Laws entitled "Laboratories" is hereby

amended by adding thereto the following section:

     23-16.2-15. Performance of certain laboratory services upon request.

     (a) A clinical laboratory may perform a clinical laboratory service (including accepting a

specimen or assignment for examination and rendering a report), that it is otherwise allowed to

perform, upon the request of the person on whom the service is to be performed and render a report

directly to the person, where the service is for the same purpose as a test or collection device that

has been approved or cleared by the Food and Drug Administration of the United States Department

of Health and Human Services for sale or distribution to the public on a direct or over-the-counter

basis without a prescription from a qualified health care practitioner.

     (b) The department of health shall promulgate rules and regulations for direct-to-consumer

laboratory testing, and shall create patient guidelines to inform patients of this service by December

1, 2024.

     (c) A company performing direct-to-consumer laboratory testing as described in this

section shall present a copy of the department of health guidelines to a patient for each testing order.

     (d) A patient shall complete an attestation form that states that the patient has received and

reviewed the department of health guidelines on direct-to-consumer laboratory testing.

     SECTION 2. This act shall take effect upon passage.

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EXPLANATION

BY THE LEGISLATIVE COUNCIL

OF

A N   A C T

RELATING TO HEALTH AND SAFETY -- LABORATORIES

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     This act would allow a patient to receive a report containing the results of direct to

consumer laboratory testing, in certain circumstances. The department of health (DOH) would

promulgate rules, regulations, and guidelines for patients regarding such testing by December 1,

2024.

     This act would take effect upon passage.

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