Rhode Island HB 5367: AN ACT RELATING TO HEALTH AND SAFETY -- LABORATORIES (Restores provisions of chapter 16.2 of title 23 as well as all of chapter 16.3 of title 23, which were repealed or deleted in the 2015 Budget Act, relating to definitions, licensing, and the operation of medical laboratories.)

Bill Text

2019 -- H 5367
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LC001315
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S T A T E O F R H O D E I S L A N D
IN GENERAL ASSEMBLY
JANUARY SESSION, A.D. 2019
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A N A C T
RELATING TO HEALTH AND SAFETY -- LABORATORIES
Introduced By: Representatives Carson, Bennett, and Blazejewski
Date Introduced: February 08, 2019
Referred To: House Health, Education & Welfare

It is enacted by the General Assembly as follows:
SECTION 1. Sections 23-16.2-2, 23-16.2-6 and 23-16.2-7 of the General Laws in 1
Chapter 23-16.2 entitled "Laboratories" is hereby amended to read as follows: 2
23-16.2-2. Definitions. 3
When used in this chapter: 4
(1) "Analytical laboratory" means a facility for the biological, microbiological, chemical, 5
physical, and radiochemical examination of potable water, nonpotable water or other 6
environmental matrices. 7
(2) "Clinical laboratory" means a facility for the biological, microbiological, serological, 8
chemical, immunohematological, hematological, radiobioassay, cytological, pathological, or 9
other examination of materials derived from the human body for the purposes of providing 10
information for the diagnosis, prevention, or treatment of any disease or impairment of or the 11
assessment of the health of human beings. 12
(3) "Director" means the director of the department of health. 13
(4) "Persons" means any individual, firm, partnership, corporation, company, association, 14
or joint stock association. 15
(5) "Station" means a facility for the collection, processing, and transmission of the 16
materials described in subdivisions (1) and (2) for the purposes described in subdivisions (1) and 17
(2). 18
(6) "Certification" means the determination by the department of health that an analytical 19

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laboratory is capable of performing specific tests or analyses of environmental samples in 1
accordance with the requirements of the regulations promulgated pursuant to this chapter. 2
(7) "Clinical laboratory test" or "laboratory test" means a microbiological, serological, 3
chemical, hematological, radiobioassay, cytological, immunological, or other pathological 4
examination that is performed on material derived from the human body, the test or procedure 5
conducted by a clinical laboratory that provides information for the diagnosis, prevention, or 6
treatment of a disease or assessment of a medical condition. 7
(8) "Nationally recognized certification examination" means an appropriate examination, 8
as determined by the director, covering both academic and practical knowledge, including, but 9
not limited to, those offered by the American Society of Clinical Pathologists (ASCP), American 10
Medical Technologists (AMT), National Credentialing Agency (NCA), or the American 11
Association of Bioanalysts Board of Registry (AAB), and including any appropriate categorical 12
or specialty examinations. 13
23-16.2-6. Issuance or denial of license. 14
Not less than thirty (30) days from the time any application for the license is received, the 15
director shall grant the application and issue a license to maintain a laboratory or station if the 16
director shall be satisfied that the applicant complies with the rules and regulations promulgated 17
in accordance with this chapter establishing standards for the qualifications of personnel and 18
adequacy of equipment and facilities. The standards for qualification of personnel who perform 19
clinical laboratory tests shall require, as a minimum, successful completion of a nationally 20
recognized certification examination. Notwithstanding this requirement, the director may 21
establish, by regulation, alternative criteria for individuals who previously qualified under federal 22
regulatory requirements, such as 42 C.F.R. § 493.1433 of the March 14, 1990 federal register, or 23
other criteria that may be established to have met the requirements of this chapter. shall include 24
provisions for minimum standards of professional education or experience, as determined by the 25
director. The director may provide for the examination of applicants to determine their 26
qualifications. Notwithstanding the preceding statements in this section, upon payment of any 27
applicable license fees, the director may grant immediate licensure to any clinical laboratory 28
licensed as a clinical laboratory in another state and certified under the Clinical Laboratory 29
Improvement Act of 1988, when the clinical laboratory has been asked to perform a clinical 30
laboratory service which is not offered by any other clinical laboratory then licensed in this state. 31
23-16.2-7. Suspension and revocation of license. 32
(a) The department of health may revoke or suspend the license or specific certification 33
of any laboratory or station for conduct by or chargeable to the laboratory or stations as follows: 34

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(1) Failure to observe any term of the license or specific certification issued under 1
authority of this chapter by the department of health;