2015 -- H 6340

========

LC002919

========

     STATE OF RHODE ISLAND

IN GENERAL ASSEMBLY

JANUARY SESSION, A.D. 2015

____________

A N   A C T

RELATING TO HEALTH AND SAFETY

     Introduced By: Representative Patricia A. Serpa

     Date Introduced: June 24, 2015

     Referred To: House Finance

     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

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

     23-16.2-2. Definitions. --When used in this chapter:

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

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

environmental matrices.

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

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

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

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

assessment of the health of human beings.

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

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

or joint stock association.

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

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

(2).

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

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

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

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

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

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

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

treatment of a disease or assessment of a medical condition.

     (8) “Nationally recognized certification examination” means an appropriate examination,

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

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

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

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

or specialty examinations.

     23-16.2-6. Issuance or denial of license. -- Not less than thirty (30) days from the time

any application for the license is received, the director shall grant the application and issue a

license to maintain a laboratory or station if the director shall be satisfied that the applicant

complies with the rules and regulations promulgated in accordance with this chapter, establishing

standards for the qualifications of personnel and adequacy of equipment and facilities. The

standards for qualification of personnel who perform clinical laboratory tests shall require, as a

minimum, successful completion of a nationally recognized certification examination.

Notwithstanding this requirement, the director may establish, by regulation, alternative criteria for

individuals who previously qualified under federal regulatory requirements, such as 42 CFR §

493.1433 of the March 14, 1990 federal register, or other criteria which may be established to

have met the requirements of this chapter. shall include provisions for minimum standards of

professional education or experience, as determined by the director. The director may provide for

the examination of applicants to determine their qualifications. Notwithstanding the preceding

statements in this section, upon payment of any applicable license fees, the director may grant

immediate licensure to any clinical laboratory licensed as a clinical laboratory in another state and

certified under the Clinical Laboratory Improvement Act of 1988, when the clinical laboratory

has been asked to perform a clinical laboratory service which is not offered by any other clinical

laboratory then licensed in this state.

     23-16.2-7. Suspension and revocation of license. – (a) The department of health may

revoke or suspend the license or specific certification of any laboratory or station for conduct by

or chargeable to the laboratory or stations as follows:

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

LC002919 - Page 2 of 13

authority of this chapter by the department of health;

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

statutory authority vested in the department of health;

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

chapter;

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

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

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

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

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

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

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

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

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

certification to the director.

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

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

meet the requirements of this chapter.

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

amended by adding thereto the following chapter:

CHAPTER 16.3

CLINICAL LABORATORY SCIENCE PRACTICE

     23-16.3-1. Short title. -- This chapter shall be known and may be cited as the "Clinical

Laboratory Science Practice Act".

     23-16.3-2. Declaration of policy and statement of purpose. -- It is declared to be a

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

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

interest. It is further declared that clinical laboratories and clinical laboratory science practitioners

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

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

assessment of the health of humans. The purpose of this chapter is to provide for the better

protection of public health by providing minimum qualifications for clinical laboratory science

practitioners, and by ensuring that clinical laboratory tests are performed with the highest degree

of professional competency by those engaged in providing clinical laboratory science services in

LC002919 - Page 3 of 13

the state.

     23-16.3-3. Definitions. -- The following words and terms when used in this chapter have

the following meaning unless otherwise indicated within the context:

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

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

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

Education.

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

health.

     (3) "Clinical laboratory" or "laboratory" means any facility or office in which clinical

laboratory tests are performed.

     (4) "Clinical laboratory science practitioner" or "one who engages in the practice of

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

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

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

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

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

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

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

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

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

cardiopulmonary or circulatory system of a patient.

     (5) "Clinical laboratory scientist" and/or "technologist" means a person who performs

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

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

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

laboratory setting.

     (6) "Clinical laboratory technician" means a person who performs laboratory tests

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

judgment and which are performed under the personal and direct supervision of a clinical

laboratory scientist (technologist), laboratory supervisor, or laboratory director.

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

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

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

LC002919 - Page 4 of 13

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

treatment of a disease or assessment of a medical condition.

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

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

     (10) "Limited function test" means a test conducted using procedures which as

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

which:

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

use;

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

erroneous results negligible; or

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

performed incorrectly.

     23-16.3-4. Exceptions. -- This chapter shall not apply to:

     (1) Any person performing clinical laboratory tests within the scope of his or her practice

and for which he or she is licensed pursuant to any other provisions of the general laws.

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

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

employee's official duties.

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

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

treatment of disease.

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

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

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

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

     (5) Individuals performing limited function tests.

     23-16.3-5. License required. -- (a) No person shall practice clinical laboratory science or

hold himself or herself out as a clinical laboratory science practitioner in this state unless he or

she is licensed pursuant to this chapter.

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

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

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

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

LC002919 - Page 5 of 13

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

the withdrawal of the application, whichever occurs first.

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

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

have:

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

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

most recently performed attested to by his or her employer and notarized; or

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

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

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

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

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

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

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

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

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

     23-16.3-6. Administration. -- (a) There is created within the division of professional

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

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

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

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

from lists submitted by organizations of clinical laboratory science practitioners and

organizations of physicians and pathologists.

     (b) The board shall be composed of:

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

Osteopathic Pathology;

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

     (3) Four (4) clinical laboratory science practitioners, at least one of whom is a non-

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

one of whom is a clinical laboratory technician, and who, except for the initial appointments, hold

active and valid licenses as clinical laboratory science practitioners in this state and one of whom

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

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

LC002919 - Page 6 of 13

of clinical laboratory science.

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

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

(60) days after July 1, 1992, shall be as follows:

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

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

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

serve for two (2) years; and

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

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

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

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

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

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

     23-16.3-7. Duties and powers of the clinical laboratory advisory board. -- In addition

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

to the director:

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

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

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

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

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

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

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

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

laboratory science practitioners as provided for in § 23-16.3-5;

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

clinical laboratory science specialties that the board may determine in accordance with § 23-16.3-

8(c);

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

laboratories;

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

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

practitioners as required for license renewal;

LC002919 - Page 7 of 13

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

this chapter.

     23-16.3-8. Standards for licensure. -- (a) Clinical laboratory scientist (technologist). -

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

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

qualifications:

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

accredited college or university whose curriculum included appropriate clinical education;

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

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

clinical education in an accredited clinical laboratory science program;

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

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

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

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

microbiology, hematology, immunology/immunohematology); or

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

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

accredited university, and appropriate clinical education in an accredited clinical laboratory

science program.

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

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

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

     (b) Clinical laboratory technician. - The department of health shall issue a clinical

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

board, including at least one of the following qualifications:

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

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

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

laboratory techniques;

     (2) A high school diploma (or equivalent): and (i) Completion of twelve (12) months in a

technician training program such as CLA (ASCP) clinical laboratory assistant (American Society

of Clinical Pathologists), [CLA) (ASCP)] in an accredited school and medical laboratory

technician-certificate (MLT-C) programs approved by the board; or (ii) Successful completion of

LC002919 - Page 8 of 13

an official military medical laboratory procedure course of at least fifty (50) weeks duration and

has held the military enlisted occupational specialty of medical laboratory specialist (laboratory

technician); or

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

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

exceed the requirements for licensure set forth by the board.

     (c) Clinical histologic technician. - The department of health shall issue a clinical

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

board, including at least one of the following:

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

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

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

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

certified histotechnologist or an appropriately certified histopathology supervisor with at least

three (3) years experience.

     (2) High school graduation (or equivalent) and two (2) years full-time acceptable

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

clinical laboratory in histologic technique.

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

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

following:

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

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

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

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

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

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

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

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

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

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

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

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

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

LC002919 - Page 9 of 13

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

such as 42 CFR § 493.1437 of the March 14, 1990 federal register.

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

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

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

scientific disciplines with approval of the director of health.

     23-16.3-9. Waiver of requirements. -- The board shall recommend regulations

providing procedures for waiver of the requirements of § 23-16.3-8 for all applicants who hold a

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

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

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

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

countries.

     23-16.3-10. Licensure application procedures. -- (a) Licensure applicants shall submit

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

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

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

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

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

and the regulations promulgated under this chapter.

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

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

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

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

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

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

of § 23-16.3-8 or expire not more than twelve (12) months after issuance. At the discretion of the

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

     23-16.3-11. Licensure renewal. -- (a) Licenses issued pursuant to this chapter shall

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

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

two (2) years upon:

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

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

LC002919 - Page 10 of 13

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

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

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

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

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

Agency for Medical Laboratory Personnel.

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

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

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

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

the protection of the public health.

     23-16.3-12. Disciplinary requirements. -- The board may recommend to the director of

health issuance, renewal, or revocation of a license, or suspension, placement on probation,

censure, or reprimand of a licensee, or any other disciplinary action that the board may deem

appropriate, including the imposition of a civil penalty, for conduct that may result from, but not

necessarily be limited to:

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

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

regulations promulgated under this chapter;

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

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

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

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

any provision of this chapter;

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

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

deceive, defraud, or harm the public;

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

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

without valid medical indication;

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

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

unlawful remuneration; or

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

LC002919 - Page 11 of 13

rule adopted under this chapter.

     23-16.3-13. Hearing requirements -- Procedure. -- (a) The proceedings for the

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

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

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

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

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

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

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

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

chapter 35 of title 42.

     23-16.3-14. Roster of licenses. -- The department of health shall maintain a roster of the

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

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

year.

     23-16.3-15. Receipts. -- The proceeds of any fees collected pursuant to the provisions of

this chapter shall be deposited as general revenues.

     23-16.3-16. Severability. -- If any provision of this chapter or the application of any

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

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

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

     SECTION 3. This act shall take effect upon passage.

========

LC002919

========

LC002919 - Page 12 of 13

EXPLANATION

BY THE LEGISLATIVE COUNCIL

OF

A N   A C T

RELATING TO HEALTH AND SAFETY

***

     This act would restore certain 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, 2015 H 5900

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

clinical laboratories.

     This act would take effect upon passage.

========

LC002919

========

LC002919 - Page 13 of 13