Rhode Island Code of Regulations
Title 216 - Department of health
Chapter 60 - Laboratories and Medical Examiner
Subchapter 05 - State Laboratory
Part 4 - Clinical Laboratories and Stations (216-RICR-60-05-4)
Section 216-RICR-60-05-4.3 - General Requirements

Universal Citation: 216 RI Code of Rules 60 05 4.3

Current through September 18, 2024

A. It shall be unlawful for any person, corporation or other form of business entity to perform clinical laboratory services on specimens collected in this state or to own, conduct or maintain a clinical laboratory or station in this state without a license pursuant to the requirements of the Act, and this Part, unless exempt in accordance with R.I. Gen. Laws § 23-16.2-3 as follows:

1. A laboratory maintained by a hospital licensed under R.I. Gen. Laws Chapter 23-17, or by food preparation or processing establishments performing analysis to determine the quality of their own products, or by a licensed physician or group of licensed physicians who make the tests referred to in R.I. Gen. Laws § 23-16.2-2 personally and solely in connection with the treatment of their own patients; however, an independent laboratory which makes the tests on its own responsibility for a single physician or group of physicians is subject to the Act; and

2. Any temporary or ad hoc health promotion screening program conducted for the general public which offers generally accepted mass screening procedures; provided the health promotion or screening program is conducted pursuant to a permit issued in accordance with rules and regulations pertaining to Permits for Screening Programs (Part 20-10-1 of this Title).

B. A clinical laboratory or station shall represent itself in its advertisements, publications, or other forms of communication, as providing only those services for which it is licensed and shall not advertise in a manner which tends to mislead the public.

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