2020 -- H 7815
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LC004683
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STATE OF RHODE ISLAND
IN GENERAL ASSEMBLY
JANUARY SESSION, A.D. 2020
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AN ACT
RELATING TO HEALTH AND SAFETY -- LABORATORIES
Introduced By: Representatives Carson, and Blazejewski
Date Introduced: February 26, 2020
Referred To: House Health, Education & Welfare
It is enacted by the General Assembly as follows:
1 SECTION 1. Sections 23-16.2-2, 23-16.2-6 and 23-16.2-7 of the General Laws in Chapter
2 23-16.2 entitled "Laboratories" are hereby amended to read as follows:
3 23-16.2-2. Definitions.
4 When used in this chapter:
5 (1) "Analytical laboratory" means a facility for the biological, microbiological, chemical,
6 physical, and radiochemical examination of potable water, nonpotable water or other environmental
7 matrices.
8 (2) "Clinical laboratory" means a facility for the biological, microbiological, serological,
9 chemical, immunohematological, hematological, radiobioassay, cytological, pathological, or other
10 examination of materials derived from the human body for the purposes of providing information
11 for the diagnosis, prevention, or treatment of any disease or impairment of or the assessment of the
12 health of human beings.
13 (3) "Director" means the director of the department of health.
14 (4) "Persons" means any individual, firm, partnership, corporation, company, association,
15 or joint stock association.
16 (5) "Station" means a facility for the collection, processing, and transmission of the
17 materials described in subdivisions (1) and (2) for the purposes described in subdivisions (1) and
18 (2).
19 (6) "Certification" means the determination by the department of health that an analytical
 1 laboratory is capable of performing specific tests or analyses of environmental samples in
2 accordance with the requirements of the regulations promulgated pursuant to this chapter.
3 (7) "Clinical laboratory test" or "laboratory test" means a microbiological, serological,
4 chemical, hematological, radiobioassay, cytological, immunological, or other pathological
5 examination that is performed on material derived from the human body, the test or procedure
6 conducted by a clinical laboratory that provides information for the diagnosis, prevention, or
7 treatment of a disease or assessment of a medical condition.
8 (8) "Nationally recognized certification examination" means an appropriate examination,
9 as determined by the director, covering both academic and practical knowledge, including, but not
10 limited to, those offered by the American Society of Clinical Pathologists (ASCP), American
11 Medical Technologists (AMT), National Credentialing Agency (NCA), or the American
12 Association of Bioanalysts Board of Registry (AAB), and including any appropriate categorical or
13 specialty examinations.
14 23-16.2-6. Issuance or denial of license.
15 Not less than thirty (30) days from the time any application for the license is received, the
16 director shall grant the application and issue a license to maintain a laboratory or station if the
17 director shall be satisfied that the applicant complies with the rules and regulations promulgated in
18 accordance with this chapter establishing standards for the qualifications of personnel and adequacy
19 of equipment and facilities. The standards for qualification of personnel who perform clinical
20 laboratory tests shall require, as a minimum, successful completion of a nationally recognized
21 certification examination. Notwithstanding this requirement, the director may establish, by
22 regulation, alternative criteria for individuals who previously qualified under federal regulatory
23 requirements, such as 42 C.F.R. § 493.1433 of the March 14, 1990 federal register, or other criteria
24 that may be established to have met the requirements of this chapter shall include provisions for
25 minimum standards of professional education or experience, as determined by the director. The
26 director may provide for the examination of applicants to determine their qualifications.
27 Notwithstanding the preceding statements in this section, upon payment of any applicable license
28 fees, the director may grant immediate licensure to any clinical laboratory licensed as a clinical
29 laboratory in another state and certified under the Clinical Laboratory Improvement Act of 1988,
30 when the clinical laboratory has been asked to perform a clinical laboratory service which is not
31 offered by any other clinical laboratory then licensed in this state.
32 23-16.2-7. Suspension and revocation of license.
33 (a) The department of health may revoke or suspend the license or specific certification of
34 any laboratory or station for conduct by or chargeable to the laboratory or stations as follows:
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 1 (1) Failure to observe any term of the license or specific certification issued under authority
2 of this chapter by the department of health;
3 (2) Failure to observe any order made under authority of this chapter or under the statutory
4 authority vested in the department of health;
5 (3) Engaging in, aiding, abetting, causing, or permitting any action prohibited under this
6 chapter;
7 (4) Failing to observe any regulations promulgated by the department of health.
8 (b) Whenever the director shall have reason to believe that any laboratory or station, for
9 the maintenance of which the director has issued a license or specific certification as provided for
10 in § 23-16.2-4, is being maintained in violation of the rules and regulations provided in § 23-16.2-
11 5, the director may, pending an investigation and hearing, suspend for a period not exceeding thirty
12 (30) days, any license or specific certification issued under authority of this chapter and may, after
13 due notice and hearing, revoke the license or specific certification if the director finds that the
14 laboratory or station is being maintained in violation of the rules and regulations. The holder of a
15 license shall upon its revocation promptly surrender the license or specific certification to the
16 director.
17 (c) The director may revoke or suspend the license, or may impose appropriate fines as
18 promulgated in regulation, of any laboratory or station that does not ensure that all personnel meet
19 the requirements of this chapter.
20 SECTION 2. Title 23 of the General Laws entitled "HEALTH AND SAFETY" is hereby
21 amended by adding thereto the following chapter:
22 CHAPTER 16.5
23 MEDICAL LABORATORY SCIENCE PRACTICE
24 23-16.5-1. Short title.
25 This chapter shall be known and may be cited as the "Medical Laboratory Science Practice
26 Act".
27 23-16.5-2. Declaration of policy and statement of purpose.
28 It is declared to be a policy of the state that the practice of medical laboratory science by
29 health care professionals affects the public health, safety, and welfare and is subject to control and
30 regulation in the public interest. It is further declared that medical laboratories and medical
31 laboratory science practitioners provide essential services to practitioners of the healing arts by
32 furnishing vital information which may be used in the diagnosis, prevention, and treatment of
33 disease or impairment and the assessment of the health of humans. The purpose of this chapter is
34 to provide for the better protection of public health by establishing minimum qualifications for
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 1 medical laboratory science practitioners, and by ensuring that medical laboratory tests are
2 performed with the highest degree of professional competency by those engaged in providing
3 medical laboratory science services in the state.
4 23-16.5-3. Definitions.
5 The following words and terms when used in this chapter have the following meaning
6 unless otherwise indicated within the context:
7 (1) "Accredited medical laboratory program" means a program planned to provide a
8 predetermined amount of instruction and experience in medical laboratory science that has been
9 accredited by one of the accrediting agencies recognized by the United States Department of
10 Education.
11 (2) "Board" means the medical laboratory science board appointed by the director of health.
12 (3) "Department" means the Rhode Island department of health.
13 (4) "Director" means the director of the Rhode Island department of health.
14 (5) "Limited function test" means a test conducted using procedures which, as determined
15 by the director, have an insignificant risk of an erroneous result, including those which:
16 (i) Have been approved by the United States Food and Drug Administration for home use;
17 (ii) Employ methodologies that are so simple and accurate as to render the likelihood of
18 erroneous results negligible; or
19 (iii) The director has determined, pose no reasonable risk of harm to the affected patient if
20 performed incorrectly.
21 (6) "Medical laboratory" or "laboratory" means any facility or office in which medical
22 laboratory tests of either an analytical or clinical nature are performed.
23 (7) "Medical laboratory science practitioner" or "one who engages in the practice of
24 medical laboratory science" means a health care professional who performs medical laboratory
25 tests or who is engaged in management, education, consulting, or research in medical laboratory
26 science, and includes laboratory directors, supervisors, medical laboratory scientists
27 (technologists), specialists, and technicians working in a laboratory, but does not include persons
28 employed by a medical laboratory to perform supportive functions not related to direct performance
29 of laboratory tests and does not include medical laboratory trainees. Provided, however, nothing
30 contained in this chapter shall apply to a medical perfusionist engaged in the testing of human
31 laboratory specimens for extracorporeal functions, which shall include those functions necessary
32 for the support, treatment, measurement, or supplementation of the cardiopulmonary or circulatory
33 system of a patient.
34 (8) "Medical laboratory scientist" and/or "technologist" means a person who performs
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 1 medical laboratory tests pursuant to established and approved protocols requiring the exercise of
2 independent judgment and responsibility, maintains equipment and records, performs quality
3 assurance activities related to test performance, and may supervise and teach within a medical
4 laboratory setting.
5 (9) "Medical laboratory technician" means a person who performs laboratory tests,
6 pursuant to established and approved protocols, which require limited exercise of independent
7 judgment and responsibility, maintains equipment and records, and performs quality assurance
8 activities related to test performance.
9 (10) "Medical laboratory test" or "laboratory test" means a microbiological, serological,
10 chemical, hematological, radiobioassay, cytological, immunological, or other pathological
11 examination which is performed on material derived from the human body, the test or procedure
12 conducted by a medical laboratory which provides information for the diagnosis, prevention, or
13 treatment of a disease or assessment of a medical condition.
14 23-16.5-4. Exceptions.
15 This chapter shall not apply to:
16 (1) Any person performing medical laboratory tests within the scope of their practice and
17 for which they are licensed, pursuant to any other provisions of the general laws.
18 (2) Medical laboratory science practitioners employed by the United States government or
19 any bureau, division, or agency of the United States government, while in the discharge of their
20 official duties.
21 (3) Medical laboratory science practitioners (clinical laboratory scientists) employed by
22 the state of Rhode Island or any bureau, division, or agency of the state, while in the discharge of
23 their official duties.
24 (4) Medical laboratory science practitioners engaged in teaching or research, provided that
25 the results of any examination performed, are not used in health maintenance, diagnosis, or
26 treatment of disease.
27 (5) Students or trainees enrolled in a medical laboratory science education program;
28 provided that, these activities constitute a part of a planned course in the program that the persons
29 are designated by title such as intern, trainee, or student, and the persons work directly under the
30 supervision of an individual licensed by this state to practice laboratory science.
31 (6) Individuals performing limited function tests.
32 23-16.5-5. License required.
33 (a) No person shall practice medical laboratory science or hold themself out as a medical
34 laboratory science practitioner in this state, unless they are licensed pursuant to this chapter.
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 1 (b) All persons who were engaged in the practice of medical laboratory science on July 1,
2 1992, who are certified by or eligible for certification by an agency approved by the department of
3 health, and who have applied to the department of health on or before July 1, 1994, and have
4 complied with all necessary requirements for the application, may continue to perform medical
5 laboratory tests until July 1, 1995, unless the application is denied by the department of health, or
6 the withdrawal of the application, whichever occurs first.
7 (c) Persons not meeting the education, training, and experience qualifications for any
8 license described in this chapter may be considered to have met the qualifications providing they
9 have:
10 (1) Three (3) years acceptable experience between January 1, 1986 and January 1, 1996
11 and submit to the department of health the job description of the position which the applicant has
12 most recently performed, attested to by their employer and notarized; or
13 (2) No less than twelve (12) years acceptable experience prior to 1993 and submits to the
14 department of health the job description of the position which the applicant has most recently
15 performed, attested to by their employer and notarized on or before December 1, 2001.
16 (d) After December 1, 2001, no initial license shall be issued until an applicant meets all
17 of the requirements under this chapter, and successfully completes a nationally recognized
18 certification examination, such as NCA, DHHS, ASCP, state civil service examination, or others
19 including appropriate categorical and specialty exams. Provided, however, that the provisions of
20 this subsection shall not be available to any individual who has been previously denied a license as
21 a medical laboratory science practitioner by the department of health.
22 23-16.5-6. Administration.
23 (a) There is created within the division of professional regulation of the department of
24 health, a medical laboratory advisory board which shall consist of seven (7) members who have
25 been residents of the state for at least two (2) years prior to their appointment, and who are actively
26 engaged in their areas of practice. The director of the department of health, with the approval of
27 the governor, shall make appointments to the board from lists submitted by organizations of
28 medical laboratory science practitioners and organizations of physicians and pathologists.
29 (b) The board shall be composed of:
30 (1) One physician certified by the American Board of Pathology or American Board of
31 Osteopathic Pathology;
32 (2) One physician who is not a laboratory director nor a pathologist;
33 (3) Four (4) medical laboratory science practitioners, one of whom is a non-physician
34 laboratory director, one of whom is a medical laboratory scientist (technologist), and one of whom
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 1 is a medical laboratory technician, whom, except for their initial appointments, hold active and
2 valid licenses as medical laboratory science practitioners in this state, and one of whom is a medical
3 laboratory science practitioner, not falling in one of the first three (3) categories; and
4 (4) One public member who is not associated with nor has a financial interest in the practice
5 of medical laboratory science.
6 (c) Board members shall serve for a term of three (3) years, and until their successors are
7 appointed and qualified, except that the initial appointments, which shall be made within sixty (60)
8 days after July 1, 2020, shall be as follows:
9 (1) One pathologist, one non-physician laboratory director, and one medical laboratory
10 scientist, shall be appointed to serve for three (3) years;
11 (2) One public representative and one non-pathologist physician, shall be appointed to
12 serve for two (2) years; and
13 (3) The remaining two (2) members shall be appointed to serve for one year.
14 (d) The membership of the board shall receive no compensation for their services.
15 (e) Whenever a vacancy shall occur on the board by reason other than the expirat