SECTION 1. Chapter 13 of the General Laws, as appearing in the 2012 Official Edition, is hereby amended by inserting after section 108 the following sections:-
(a) There shall be a board of registration of clinical laboratory professionals which shall consist of 9 members appointed by the governor who have been residents of the Commonwealth for at least two years prior to their appointment. Three members of the board shall be licensed physicians certified as pathologists by the American Board of Pathology or American Board of Osteopathic Pathology. One member of the board shall be a non-physician laboratory director. Two members of the board shall be licensed clinical technologists, under the provisions of sections 264 to 271 of chapter 112, except in cases of members originally appointed to the board. One member of the board shall be a licensed clinical technician, under the provisions of sections 264 to 271 of chapter 112, except in cases of members originally appointed to the board. One member of the board shall be an educator in the clinical laboratory sciences from an educational
program accredited by the National Accrediting Agency for Clinical Laboratory Sciences, or its successor. One member of the board shall be a representative of the public subject to section 9B.
(b) Board members shall serve for a term of three years and until successors are appointed and qualified, except that the initial appointments shall be as follows:
One pathologist, one non-physician laboratory director, and one clinical technologist shall be appointed to serve for three years; one public representative shall be appointed to serve for two years; and the remaining members shall be appointed to serve for one year.
(c) Whenever a vacancy shall occur on the board by reason other than the expiration of a term of office, a successor of like qualifications shall be appointed by the governor for the remainder of the unexpired term. No person shall be appointed to serve for more than two successive 3-year terms.
(d) The members of the board shall be public employees for the purposes of chapter 258 for all acts or omissions within the scope of their duties as board members. The members of the board shall serve without compensation; provided, however, that each member shall be reimbursed for actual expenses reasonably incurred in the performance of duties as a member or on behalf of the board.
(e) A member may be removed by the governor for neglect of duty, misconduct or malfeasance or misfeasance in office after a written notice of the charges against him and an opportunity to be heard.
Section 110. The board shall have the following powers and duties:
(a) to promulgate regulations and adopt such rules as are necessary to regulate clinical laboratory professionals;
(b) to establish administrative procedures for processing applications 47 for licenses and license renewals and to hire or appoint such agents as are appropriate for processing applications for licenses and license renewals;
(c) to receive, renew, approve or disprove applications for licensing, renewal and reinstatement and to issue those licenses;
(d) to define by regulation the appropriate standards for education and experience necessary to qualify for licensing, including, but not limited to, continuing professional education requirements for clinical laboratory professionals; provided that such standards shall be no less stringent than those adopted by the American Society for Clinical Pathology, or its successor, and for the conduct and ethics which shall govern the practice of clinical laboratory personnel; (e) to establish standards of supervision for students or persons in training to become qualified to obtain a license in the occupation or profession it represents;
(f) to deny, suspend, or revoke a license or otherwise discipline licensees for violations of licensure provisions under section 264 to 271 of chapter 112.
(g) to summarily suspend the license of a licensee who poses an imminent danger to the public provided that a hearing shall be afforded to the licensee within 7 days of an adverse action by the board to determine whether such action is warranted; and
(h) to perform such other functions and duties as may be required to carry out this section.
SECTION 2. Said chapter 13 is hereby further amended by inserting after the word “therapists” in section 9 subsection (a) the following words:- and the board of registration of clinical laboratory professionals.
SECTION 3. Chapter 112 of the General Laws is hereby amended by adding the following sections:-
Section 264. As used in sections 264 to 271, inclusive, the following words shall, unless the context requires otherwise, have the following meanings:-
“Accredited program”, an educational program accredited by the National Accrediting Agency for Clinical Laboratory Science, or its successor.
“ASCP”, American Society for Clinical Pathology, a national agency for certification and recertification of clinical laboratory professionals, or its successor.
“Board”, the board of registration of clinical laboratory professionals.
“Clinical laboratory”, a laboratory facility as defined under chapter 111D.
“Clinical laboratory test”, an exempt, simple, or complex laboratory test as defined in chapter111D.
“Clinical laboratory technologist”, an individual who performs clinical laboratory tests pursuant to established and approved protocols requiring the exercise of independent technical judgment subject to the supervision, control, responsibility, and direction of the clinical laboratory director.
“Clinical laboratory technician”, an individual who performs tests pursuant to established and approved protocols which require limited exercise of independent technical judgment and which are performed under the supervision, control, responsibility, and direction of the clinical laboratory director or subordinate appointed by such director.
“Independent technical judgment”, the performance or conduct of clinical laboratory tests and assumption of responsibility for determination of the validity of clinical laboratory test results without intervention by or the supervision of another health care provider authorized by law to assume responsibility for the conduct and validity of clinical laboratory tests.
“Licensed clinical laboratory professional”, a trained health care professional who performs clinical laboratory tests according to his or her qualifications, and includes clinical laboratory technologists and technicians, but does not include persons employed by a clinical laboratory to perform supportive functions not related to the direct performance of laboratory tests.
“Provisional licensed clinical laboratory personnel”, a person with a provisional license issued under section 267.
Section 265. An application for original license or license renewal shall be made on forms approved by the board and accompanied by the appropriate fee. The fee for original licenses and renewals shall be determined by the secretary of administration and finance. An applicant for original license shall be sworn and shall furnish satisfactory proof that the person is at least 18 years old, of good moral character and has met the educational and professional experience requirements prerequisite to licensure.
Section 266. An applicant for registration as clinical laboratory professional shall have:
(a) successfully completed a clinical laboratory science education program approved by the National Accrediting Agency for Clinical Laboratory Sciences, or its successor, and satisfied certification requirements promulgated by ASCP; or
(b) earned at least an associate degree in the chemical or biological sciences and completed such experience as may be required by the board.
Section 267. A person who meets the qualifications for licensure may, between the date of filing an application for licensure and notification by the board, perform clinical laboratory tests as a provisional licensed clinical laboratory personnel upon filing an approved application with the board and payment of a fee to be determined by the secretary of administration and finance. A provisional license will cease immediately upon notification from the board that an application has been denied.
Section 268. No person shall hold himself out as a clinical 138 laboratory professional unless that person is licensed in accordance with section 110 of chapter 13. Nothing in this section shall be construed to prevent or restrict the practice, service, or activities of:
(a) any person licensed in the Commonwealth under any other Act from engaging in the practice for which the person is licensed;
(b) a pathologist, cytotechnologist, or histologist;
(c) an individual trained as a phlebotomist;
(d) clinical laboratory professionals employed by the United States government or any bureau, division, or agency of that government while in the discharge of that person’s official duties;
(e) clinical laboratory educators engaged in teaching or research, provided that the results of any test performed are not used in health maintenance, diagnosis, or treatment of disease;
(f) students or trainees enrolled in an accredited program;
(g) individuals performing solely limited function tests;
(h) persons in the Commonwealth to provide service as part of an ongoing emergency or disaster relief effort.
Section 269. The board may deny or refuse to renew a license or, after a hearing pursuant to section 110 of chapter 13, revoke, suspend or cancel the license or otherwise discipline a licensee upon satisfactory proof to a majority of the board that the person has:
(a) obtained or attempted to obtain a license by fraud or deception;
(b) been convicted of a felony under state or federal law or committed any other offense involving moral turpitude;
(c) been adjudged mentally ill or incompetent by a court of competent jurisdiction;
(d) used illicit drugs or intoxicating liquors to the extent which adversely affects that person’s performance;
(e) engaged in unethical or unprofessional conduct including, but not limited to, willful acts, reckless disregard for patient safety or gross negligence in the course of professional practice;
(f) violated any lawful order, rule or regulation rendered or adopted by the board; or
(g) been refused issuance or been disciplined in connection with a license issued by any other state or country.
Section 270. Whoever, not being lawfully authorized to perform clinical laboratory tests who performs or attempts to perform clinical laboratory tests shall be punished by a fine of not less than one hundred nor more than one thousand dollars or by imprisonment for not less than one month nor more than one year, or both.
Section 271. The board shall maintain a roster of the names and addresses of persons licensed and registered under the provision of this Act, and of all persons whose licenses have been suspended, revoked, or cancelled.
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