2016 -- H 7447

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LC004103

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     STATE OF RHODE ISLAND

IN GENERAL ASSEMBLY

JANUARY SESSION, A.D. 2016

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A N   A C T

RELATING TO HEALTH AND SAFETY - LABORATORIES

     

     Introduced By: Representatives Serpa, Ackerman, Regunberg, Fellela, and Hearn

     Date Introduced: February 03, 2016

     Referred To: House Health, Education & Welfare

     It is enacted by the General Assembly as follows:

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     SECTION 1. Sections 23-16.2-2, 23-16.2-6 and 23-16.2-7 of the General Laws in

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Chapter 23-16.2 entitled "Laboratories" are hereby amended to read as follows:

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     23-16.2-2. Definitions. [Effective January 1, 2016.] -- When used in this chapter:

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      (1) "Analytical laboratory" means a facility for the biological, microbiological, chemical,

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physical, and radiochemical examination of potable water, nonpotable water or other

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environmental matrices.

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      (2) " Clinical laboratory" means a facility for the biological, microbiological, serological,

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chemical, immunohematological, hematological, radiobioassay, cytological, pathological, or

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other examination of materials derived from the human body for the purposes of providing

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information for the diagnosis, prevention, or treatment of any disease or impairment of or the

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assessment of the health of human beings.

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      (3) "Director" means the director of the department of health.

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      (4) "Persons" means any individual, firm, partnership, corporation, company,

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association, or joint stock association.

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      (5) "Station" means a facility for the collection, processing, and transmission of the

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materials described in subdivisions (1) and (2) for the purposes described in subdivisions (1) and

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(2).

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      (6) "Certification" means the determination by the department of health that an analytical

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laboratory is capable of performing specific tests or analyses of environmental samples in

 

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accordance with the requirements of the regulations promulgated pursuant to this chapter.

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      (7) "Medical laboratory test" or "laboratory test" means a microbiological, serological,

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chemical, hematological, radiobioassay, cytological, immunological, or other pathological

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examination that is performed on material derived from the human body, the test or procedure

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conducted by a medical laboratory that provides information for the diagnosis, prevention, or

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treatment of a disease or assessment of a medical condition.

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      (8) "Nationally recognized certification examination" means an appropriate examination,

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as determined by the director, covering both academic and practical knowledge, including, but

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not limited to, those offered by the American Society of Medical Pathologists (ASCP), American

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Medical Technologists (AMT), National Credentialing Agency (NCA), or the American

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Association of Bioanalysts Board of Registry (AAB), and including any appropriate categorical

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or specialty examinations.

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     23-16.2-6. Issuance or denial of license. [Effective January 1, 2016.] -- Not less than

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thirty (30) days from the time any application for the license is received, the director shall grant

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the application and issue a license to maintain a laboratory or station if the director shall be

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satisfied that the applicant complies with the rules and regulations promulgated in accordance

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with this chapter establishing standards for the qualifications of personnel and adequacy of

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equipment and facilities. The standards for qualification of personnel who perform medical

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laboratory tests shall require, as a minimum, successful completion of a nationally recognized

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certification examination. Notwithstanding this requirement, the director may establish, by

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regulation, alternative criteria for individuals who previously qualified under federal regulatory

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requirements, such as 42 CFR § 493.1433 of the March 14, 1990 federal register, or other criteria

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that may be established to have met the requirements of this chapter. shall include provisions for

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minimum standards of professional education or experience, as determined by the director. The

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director may provide for the examination of applicants to determine their qualifications.

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Notwithstanding the preceding statements in this section, upon payment of any applicable license

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fees, the director may grant immediate licensure to any medical laboratory licensed as a medical

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laboratory in another state and certified under the Medical Laboratory Improvement Act of 1988,

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when the medical laboratory has been asked to perform a medical laboratory service which is not

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offered by any other medical laboratory then licensed in this state.

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     23-16.2-7. Suspension and revocation of license. [Effective January 1, 2016.] -- (a)

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The department of health may revoke or suspend the license or specific certification of any

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laboratory or station for conduct by or chargeable to the laboratory or stations as follows:

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      (1) Failure to observe any term of the license or specific certification issued under

 

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authority of this chapter by the department of health;

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      (2) Failure to observe any order made under authority of this chapter or under the

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statutory authority vested in the department of health;

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      (3) Engaging in, aiding, abetting, causing, or permitting any action prohibited under this

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chapter;

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      (4) Failing to observe any regulations promulgated by the department of health.

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      (b) Whenever the director shall have reason to believe that any laboratory or station, for

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the maintenance of which the director has issued a license or specific certification as provided for

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in § 23-16.2-4, is being maintained in violation of the rules and regulations provided in § 23-16.2-

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5, the director may, pending an investigation and hearing, suspend for a period not exceeding

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thirty (30) days, any license or specific certification issued under authority of this chapter and

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may, after due notice and hearing, revoke the license or specific certification if the director finds

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that the laboratory or station is being maintained in violation of the rules and regulations. The

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holder of a license shall upon its revocation promptly surrender the license or specific

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certification to the director.

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      (c) The director may revoke or suspend the license, or may impose appropriate fines as

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promulgated in regulation, of any laboratory or station that does not ensure that all personnel

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meet the requirements of this chapter.

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     SECTION 2. Title 23 of the General Laws entitled "HEALTH AND SAFETY" is hereby

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amended by adding thereto the following chapter:

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CHAPTER 16.5

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MEDICAL LABORATORY SCIENCE PRACTICE

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     23-16.5-1. Short title. -- This chapter shall be known and may be cited as the "Medical

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Laboratory Science Practice Act".

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     23-16.5-2. Declaration of policy and statement of purpose. -- It is declared to be a

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policy of the state that the practice of medical laboratory science by health care professionals

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affects the public health, safety, and welfare and is subject to control and regulation in the public

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interest. It is further declared that medical laboratories and medical laboratory science

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practitioners provide essential services to practitioners of the healing arts by furnishing vital

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information which may be used in the diagnosis, prevention, and treatment of disease or

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impairment and the assessment of the health of humans. The purpose of this chapter is to provide

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for the better protection of public health by providing minimum qualifications for medical

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laboratory science practitioners, and by ensuring that medical laboratory tests are performed with

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the highest degree of professional competency by those engaged in providing medical laboratory

 

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science services in the state.

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     23-16.5-3. Definitions. -- The following words and terms when used in this chapter have

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the following meaning unless otherwise indicated within the context:

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     (1) "Accredited medical laboratory program" means a program planned to provide a

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predetermined amount of instruction and experience in medical laboratory science that has been

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accredited by one of the accrediting agencies recognized by the United States Department of

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Education.

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     (2) "Board" means the medical laboratory science board appointed by the director of

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health.

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     (3) "Department" means the Rhode Island department of health.

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     (4) "Director" means the director of the Rhode Island department of health.

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     (5) "Limited function test" means a test conducted using procedures which, as determined

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by the director, have an insignificant risk of an erroneous result, including those which:

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     (i) Have been approved by the United States Food and Drug Administration for home

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use;

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     (ii) Employ methodologies that are so simple and accurate as to render the likelihood of

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erroneous results negligible; or

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     (iii) The director has determined pose no reasonable risk of harm to the patient if

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performed incorrectly.

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     (6) "Medical laboratory" or "laboratory" means any facility or office in which medical

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laboratory tests of either an analytical or clinical nature are performed.

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     (7) "Medical laboratory science practitioner" or "one who engages in the practice of

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medical laboratory science" means a health care professional who performs medical laboratory

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tests or who is engaged in management, education, consulting, or research in medical laboratory

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science, and includes laboratory directors, supervisors, medical laboratory scientists

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(technologists), specialists, and technicians working in a laboratory, but does not include persons

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employed by a medical laboratory to perform supportive functions not related to direct

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performance of laboratory tests and does not include medical laboratory trainees. Provided,

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however, nothing contained in this chapter shall apply to a medical perfusionist engaged in the

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testing of human laboratory specimens for extracorporeal functions, which shall include those

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functions necessary for the support, treatment, measurement, or supplementation of the

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cardiopulmonary or circulatory system of a patient.

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     (8) "Medical laboratory scientist" and/or "technologist" means a person who performs

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medical laboratory tests pursuant to established and approved protocols requiring the exercise of

 

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independent judgment and responsibility, maintains equipment and records, performs quality

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assurance activities related to test performance, and may supervise and teach within a medical

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laboratory setting.

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     (9) "Medical laboratory technician" means a person who performs laboratory tests

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pursuant to established and approved protocols which require limited exercise of independent

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judgment and responsibility, maintains equipment and records, and performs quality assurance

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activities related to test performance.

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     (10) "Medical laboratory test" or "laboratory test" means a microbiological, serological,

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chemical, hematological, radiobioassay, cytological, immunological, or other pathological

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examination which is performed on material derived from the human body, the test or procedure

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conducted by a medical laboratory which provides information for the diagnosis, prevention, or

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treatment of a disease or assessment of a medical condition.

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     23-16.5-4. Exceptions. -- This chapter shall not apply to:

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     (1) Any person performing medical laboratory tests within the scope of their practice and

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for which they are licensed pursuant to any other provisions of the general laws.

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     (2) Medical laboratory science practitioners employed by the United States government

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or any bureau, division, or agency of the United States government while in the discharge of the

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employee's official duties.

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     (3) Medical laboratory science practitioners engaged in teaching or research, provided

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that the results of any examination performed are not used in health maintenance, diagnosis, or

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treatment of disease.

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     (4) Students or trainees enrolled in a medical laboratory science education program

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provided that these activities constitute a part of a planned course in the program, that the persons

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are designated by title such as intern, trainee, or student, and the persons work directly under the

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supervision of an individual licensed by this state to practice laboratory science.

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     (5) Individuals performing limited function tests.

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     23-16.5-5. License required. -- (a) No person shall practice medical laboratory science

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or hold themself out as a medical laboratory science practitioner in this state unless they are

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licensed pursuant to this chapter.

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     (b) All persons who were engaged in the practice of medical laboratory science on July 1,

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1992, who are certified by or eligible for certification by an agency approved by the department

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of health, and who have applied to the department of health on or before July 1, 1994, and have

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complied with all necessary requirements for the application, may continue to perform medical

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laboratory tests until July 1, 1995 unless the application is denied by the department of health, or

 

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the withdrawal of the application, whichever occurs first.

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     (c) Persons not meeting the education, training, and experience qualifications for any

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license described in this chapter may be considered to have met the qualifications providing they

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have:

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     (1) Three (3) years acceptable experience between January 1, 1986 and January 1, 1996

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and submit to the department of health the job description of the position which the applicant has

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most recently performed attested to by their employer and notarized; or

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     (2) No less than twelve (12) years acceptable experience prior to 1993 and submits to the

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department of health the job description of the position which the applicant has most recently

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performed attested to by their employer and notarized on or before December 1, 2001.

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     (d) After December 1, 2001, no initial license shall be issued until an applicant meets all

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of the requirements under this chapter, and successfully completes a nationally recognized

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certification examination, such as NCA, DHHS, ASCP, state civil service examination, or others

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including appropriate categorical and specialty exams. Provided, however, that the provisions of

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this subsection shall not be available to any individual who has been previously denied a license

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as a medical laboratory science practitioner by the department of health.

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     23-16.5-6. Administration. -- (a) There is created within the division of professional

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regulation of the department of health a medical laboratory advisory board which shall consist of

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seven (7) persons who have been residents of the state for at least two (2) years prior to their

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appointment, and who are actively engaged in their areas of practice. The director of the

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department of health, with the approval of the governor, shall make appointments to the board

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from lists submitted by organizations of medical laboratory science practitioners and

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organizations of physicians and pathologists.

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     (b) The board shall be composed of:

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     (1) One physician certified by the American Board of Pathology or American Board of

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Osteopathic Pathology;

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     (2) One physician who is not a laboratory director and is not a pathologist;

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     (3) Four (4) medical laboratory science practitioners, one of whom is a non-physician

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laboratory director, one of whom is a medical laboratory scientist (technologist), and one of

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whom is a medical laboratory technician, whom, except for their initial appointments, hold active

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and valid licenses as medical laboratory science practitioners in this state, and one of whom is a

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medical laboratory science practitioner not falling in one of the first three (3) categories; and

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     (4) One public member who is not associated with or financially interested in the practice

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of medical laboratory science.

 

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     (c) Board members shall serve for a term of three (3) years, and until their successors are

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appointed and qualified, except that the initial appointments, which shall be made within sixty

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(60) days after July 1, 2016, shall be as follows:

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     (1) One pathologist, one non-physician laboratory director, and one medical laboratory

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scientist, shall be appointed to serve for three (3) years;

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     (2) One public representative and one non-pathologist physician, shall be appointed to

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serve for two (2) years; and

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     (3) The remaining members shall be appointed to serve for one year.

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     (d) The membership of the board shall receive no compensation for their services.

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     (e) Whenever a vacancy shall occur on the board by reason other than the expiration of a

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term of office, the director of the department of health with the approval of the governor shall

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appoint a successor of like qualifications for the remainder of the unexpired term. No person shall

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be appointed to serve more than two (2) successive three (3) year terms.

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     23-16.5-7. Duties and powers of the medical laboratory advisory board. -- In addition

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to any other power conferred upon the board pursuant to this chapter, the board shall recommend

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to the director:

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     (1) Rules and regulations for the implementation of this chapter including, but not limited

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to, regulations that delineate qualifications for licensure of medical laboratory science

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practitioners as defined in this chapter, specify requirements for the renewal of licensure,

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establish standards of professional conduct, and recommend on the amendment or on the repeal

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of the rules and regulations. Following their adoption, the rules and regulations shall govern and

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control the professional conduct of every person who holds a license to perform medical

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laboratory tests or otherwise engages in the profession of medical laboratory science;

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     (2) Standard written, oral, or practical examinations for purposes of licensure of medical

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laboratory science practitioners as provided for in §23-16.5-5;

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     (3) Rules and regulations governing qualifications for licensure of specialists in those

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medical laboratory science specialties that the board may determine in accordance with §23-16.5-

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8(c);

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     (4) Rules and regulations governing personnel performing tests in limited function

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laboratories;

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     (5) A schedule of fees for applications and renewals;

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     (6) Establish criteria for the continuing education of medical laboratory science

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practitioners as required for license renewal;

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     (7) Any other rules and regulations necessary to implement and further the purpose of

 

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this chapter.

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     23-16.5-8. Standards for licensure. -- (a) Medical laboratory scientist (technologist). -

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The department of health shall issue a medical laboratory scientists license to an individual who

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meets the qualifications developed by the board, including at least one of the following

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qualifications:

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     (1) A baccalaureate degree in medical laboratory science (medical technology) from an

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accredited college or university whose curriculum included appropriate medical education;

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     (2) A baccalaureate degree in biological, chemical, or physical science from an accredited

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college or university, and subsequent to graduation has at least twelve (12) months of appropriate

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medical education in an accredited medical laboratory science program;

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     (3) A baccalaureate degree which includes a minimum of thirty-six (36) semester (or

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equivalent) hours in the biological, chemical, and physical sciences from an accredited college or

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university plus two (2) years of full-time work experience including a minimum of four (4)

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months in each of the four (4) major disciplines of laboratory practice (medical chemistry,

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medical microbiology, hematology, immunology/immunohematology);

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     (4) A baccalaureate degree consisting of ninety (90) semester (or equivalent) hours,

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thirty-six (36) of which must be in the biological, chemical, or physical sciences, from an

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accredited college or university, and appropriate medical education in an accredited medical

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laboratory science program; or

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     (5) A medical laboratory scientist (technologist) who previously qualified under federal

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regulatory requirements such as 42 CFR §493.1433 of the March 14, 1990 Federal Register or

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other regulations or criteria which may be established by the board.

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     (b) Medical laboratory technician. - The department of health shall issue a medical

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laboratory technician's license to an individual who meets the qualifications promulgated by the

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board, including at least one of the following qualifications:

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     (1) An associate degree or completion of sixty (60) semester (or equivalent) hours from a

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medical laboratory technician program (MLT or equivalent) accredited by an agency recognized

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by the United States Department of Education that included a structured curriculum in medical

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laboratory techniques;

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     (2) A high school diploma (or equivalent): and

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     (i) Completion of twelve (12) months in a technician training program such as CLA

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(ASCP) medical laboratory assistant (American Society of Clinical Pathologists), [CLA) (ASCP)]

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in an accredited school and medical laboratory technician-certificate (MLT-C) programs

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approved by the board; or

 

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     (ii) Successful completion of an official military medical laboratory procedure course of

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at least fifty (50) weeks duration and has held the military enlisted occupational specialty of

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medical laboratory specialist (laboratory technician); or

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     (3) A medical laboratory technician who previously qualified under federal regulatory

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requirements such as 42 CFR §493.1441 of the March 14, 1990 Federal Register which meet or

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exceed the requirements for licensure set forth by the board.

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     (c) Medical histologic technician. - The department of health shall issue a medical

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histologic technician license to an individual who meets the qualifications promulgated by the

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board, including at least one of the following:

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     (1) An associate degree or at least sixty (60) semester hours (or equivalent) from an

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accredited college or university to include a combination of mathematics and at least twelve (12)

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semester hours of biology and chemistry, and successful completion of an accredited program in

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histologic technique or one full year of training in histologic technique under the supervision of a

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certified histotechnologist or an appropriately certified histopathology supervisor with at least

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three (3) years experience.

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     (2) A high school diploma (or equivalent) and two (2) years full-time acceptable

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experience under the supervision of a certified/licensed medical histologic technician at a licensed

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medical laboratory in histologic technique.

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     (d) Cytotechnologist. - The department of health shall issue a cytotechnologist license to

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an individual who meets the qualifications promulgated by the board including at least one of the

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following:

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     (1) A baccalaureate degree from an accredited college or university with: twenty (20)

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semester hours, thirty (30) quarter hours of biological science; eight (8) semester hours, twelve

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(12) quarter hours of chemistry; three (3) semester hours, four (4) quarter hours of mathematics;

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and successful completion of a twelve (12) month cytotechnology program.

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     (2) A baccalaureate degree from an accredited college or university with: twenty (20)

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semester hours, thirty (30) quarter hours of biological science; eight (8) semester hours, twelve

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(12) quarter hours of chemistry; three (3) semester hours, four (4) quarter hours of mathematics;

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and five (5) years full-time acceptable medical laboratory experience including cytopreparatory

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techniques, microscopic analysis, and evaluation of the body systems within the last ten (10)

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years. At least two (2) of these years must be subsequent to the completion of the academic

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component and at least two (2) years must be under the supervision of a licensed physician who is

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a pathologist, certified, or eligible for certification, by the American Board of Pathology in

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anatomic pathology or has other suitable qualifications acceptable to the board.

 

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     (3) A cytotechnologist who previously qualified under federal regulatory requirements

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such as 42 CFR §493.1437 of the March 14, 1990 Federal Register.

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     (e) The board shall recommend standards for any other medical laboratory science

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practitioners specializing in areas such as nuclear medical technology, radioimmunoassay,

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electron microscopy, forensic science, molecular biology, or similar recognized academic and

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scientific disciplines with approval of the director of the department of health.

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     23-16.5-9. Waiver of requirements. -- The board shall recommend regulations

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providing procedures for waiver of the requirements of §23-16.5-8 for all applicants who hold a

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valid license or its equivalent issued by another state; provided that the requirements under which

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that license or its equivalent was issued, meet or exceed the standards required by this chapter

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with the approval of the director. The board may also recommend regulations it deems

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appropriate with respect to individuals who hold valid licenses or their equivalent in other

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countries.

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     23-16.5-10. Licensure application procedures. -- (a) Licensure applicants shall submit

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their application for licensure to the department of health upon the forms prescribed and furnished

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by the department of health, and shall pay the designated application or examination fee.

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     (b) Upon receipt of application and payment of a fee, the department of health shall issue

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a license for a medical laboratory scientist or technologist, a medical laboratory technician, or an

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appropriate specialty license to any person who meets the qualifications specified in this chapter

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and the regulations promulgated under this chapter.

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     (c) The board may recommend a procedure for issuance of temporary permits to

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individuals otherwise qualified under this chapter who intend to engage in medical laboratory

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science practice in this state for a limited period of time not to exceed eighteen (18) months.

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     (d) The board may recommend a procedure for issuance of provisional licenses to

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individuals who otherwise qualify under this chapter but are awaiting the results of certification

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examinations. A provisional license so issued shall be converted to a license under the provisions

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of §23-16.5-8 or expire not more than twelve (12) months after issuance. At the discretion of the

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board, the provisional license may be reissued at least one time with the director's approval.

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     23-16.5-11. Licensure renewal. -- (a) Licenses issued pursuant to this chapter shall

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expire on a date and time specified by the department of health.

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     (b) Every person licensed pursuant to this chapter shall be issued a renewal license every

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two (2) years upon:

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     (1) Submission of an application for renewal on a form prescribed by the department of

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health and payment of an appropriate fee recommended by the board; and

 

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     (2) Proof of completion, in the period since the license was first issued or last renewed, of

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at least thirty (30) hours of continuing education courses, clinics, lectures, training programs,

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seminars, or other programs related to medical laboratory practice which are approved or

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accepted by the board; or proof of re-certification by a national certification organization that

5

mandates an annual minimum of fifteen (15) hours of continuing education, such as the National

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Certification Agency for Medical Laboratory Personnel.

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     (c) The board may recommend any other evidence of competency it shall deem

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reasonably appropriate as a prerequisite to the renewal of any license provided for by this chapter,

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as long as these requirements are uniform as to application, are reasonably related to the

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measurement of qualification, performance, or competence, and are desirable and necessary for

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the protection of the public health.

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     23-16.5-12. Disciplinary requirements. -- The board may make recommendations to the

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director of the department of health pertaining to the issuance, renewal, or revocation of a license,

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or suspension, placement on probation, censure, or reprimand of a licensee, or any other

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disciplinary action that the board may deem appropriate, including the imposition of a civil

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penalty, for conduct that may result from, but not necessarily be limited to:

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     (1) A material misstatement in furnishing information to the department of health;

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     (2) A violation or negligent or intentional disregard of this chapter, or of the rules or

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regulations promulgated under this chapter;

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     (3) A conviction of any crime under the laws of the United States or any state or territory

21

of the United States which is a felony or which is a misdemeanor, an essential element of which

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is dishonesty, or of any crime which is directly related to the practice of the profession;

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     (4) Making any misrepresentation for the purpose of obtaining registration or violating

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any provision of this chapter;

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     (5) Violating any standard of professional conduct adopted by the board;

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     (6) Engaging in dishonorable, unethical, or unprofessional conduct of a character likely to

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deceive, defraud, or harm the public;

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     (7) Providing professional services while mentally incompetent, under the influence of

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alcohol or narcotic or controlled dangerous substance that is in excess of therapeutic amounts or

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without valid medical indication;

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     (8) Directly or indirectly contracting to perform medical laboratory tests in a manner

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which offers or implies an offer of rebate, fee-splitting inducements or arrangements, or other

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unlawful remuneration; or

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     (9) Aiding or assisting another person in violating any provision of this chapter or any

 

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rule adopted under this chapter.

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     23-16.5-13. Hearing requirements -- Procedure. -- (a) The proceedings for the

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revocation, suspension or limiting of any license may be initiated by any person, corporation,

4

association, or public officer or by the board by the filing of written charges with the board, but

5

no license shall be revoked, suspended, or limited without a hearing before the board within sixty

6

(60) days after the filing of written charges in accordance with the procedures established by the

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board. A license may be temporarily suspended without a hearing for the period not to exceed

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thirty (30) days upon notice to the licensee following a finding by the board that there exists a

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significant threat to the public health and approved by the director.

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     (b) Any appeal from the action of the board shall be in accordance with the provisions of

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chapter 35 of title 42 ("the administrative procedures act").

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     23-16.5-14. Roster of licenses. -- The department of health shall maintain a roster of the

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names and addresses of persons currently licensed and registered under the provision of this

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chapter, and of all persons whose licenses have been suspended or revoked within the previous

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year.

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     23-16.5-15. Receipts. -- The proceeds of any fees collected pursuant to the provisions of

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this chapter shall be deposited as general revenues.

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     23-16.5-16. Severability. -- If any provision of this chapter or the application of any

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provision to any person or circumstance shall be held invalid, that invalidity shall not affect the

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provisions or application of this chapter which can be given effect without the invalid provision

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or application, and to this end the provisions of the chapter are declared to be severable.

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     SECTION 3. 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 restore certain provisions of chapter 16.2 of title 23 as well as all of

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chapter 16.3 of title 23, which were repealed or deleted in the 2015 Budget Act, 2015 H 5900

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Substitute A as amended. These provisions pertain to definitions, licensing, and the operation of

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medical laboratories.

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     This act would take effect upon passage.

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