84R11876 MAW-F
By: Lucio S.B. No. 1383
A BILL TO BE ENTITLED
AN ACT
relating to the licensing and regulation of medical laboratory
science professionals; providing penalties; imposing fees.
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
SECTION 1. Subtitle M, Title 3, Occupations Code, is
amended by adding Chapter 703 to read as follows:
CHAPTER 703. MEDICAL LABORATORY SCIENCE PROFESSIONALS
SUBCHAPTER A. GENERAL PROVISIONS
Sec. 703.001. SHORT TITLE. This chapter may be cited as the
Medical Laboratory Science Practice Act.
Sec. 703.002. PUBLIC POLICY; LEGISLATIVE PURPOSE. (a) The
legislature declares as a policy of this state that:
(1) the practice of medical laboratory science by
health care professionals affects the public health, safety, and
welfare and is subject to control and regulation in the public
interest; and
(2) medical laboratories and medical laboratory
science professionals provide essential services to health care
professionals by furnishing vital information that may be used in
the diagnosis, prevention, and treatment of diseases or impairments
and the assessment of human health.
(b) The purpose of this chapter is to ensure better
protection of the public health by:
(1) requiring minimum qualifications for medical
laboratory science professionals; and
(2) ensuring that medical laboratory tests are
performed with the highest degree of professional competency by
individuals engaged in providing the services in this state.
Sec. 703.003. DEFINITIONS. In this chapter:
(1) "Advisory committee" means the Medical Laboratory
Science Advisory Committee.
(2) "Categorical medical laboratory scientist" means
an individual licensed under this chapter to perform medical
laboratory scientist services in one major practice area of a
laboratory under the supervision, control, and responsibility of a
laboratory director.
(3) "CLIA" means the federal Clinical Laboratory
Improvement Amendments of 1988 (42 C.F.R. Part 493).
(4) "Commission" means the Texas Commission of
Licensing and Regulation.
(5) "Department" means the Texas Department of
Licensing and Regulation.
(6) "Executive director" means the executive director
of the department.
(7) "Independent technical judgment" means the
performance of clinical laboratory tests and assumption of
responsibility for determining the validity of clinical laboratory
test results without intervention by or the direct supervision of a
health care professional.
(8) "Laboratory director" means a person who meets the
requirements of a laboratory director under CLIA.
(9) "Medical laboratory" means a facility in which a
medical laboratory test is performed for diagnosis, prevention, or
treatment of disease or impairment or assessment of human health.
(10) "Medical laboratory scientist" means an
individual who uses independent technical judgment in the
performance of tests and procedures under the supervision, control,
and responsibility of a laboratory director.
(11) "Medical laboratory scientist services" means:
(A) the use of independent technical judgment in
the performance of medical laboratory tests;
(B) the establishment and implementation of
protocols, quality assessment, method development and selection,
equipment selection and maintenance, and all activities related to
the pre-analytic, analytic, and post-analytic phases of medical
laboratory testing under the supervision, control, and
responsibility of a laboratory director; and
(C) the direction, supervision, consultation,
education, and performance of research functions related to medical
laboratory testing.
(12) "Medical laboratory technician" means an
individual licensed under this chapter to perform medical
laboratory technician services.
(13) "Medical laboratory technician services" means
the performance of medical laboratory tests in accordance with
established and approved protocols that require the limited
exercise of independent technical judgment and are performed under
the supervision of a medical laboratory scientist, laboratory
supervisor, or laboratory director.
(14) "Medical laboratory test" means a
microbiological, serological, chemical, biological,
hematological, immunological, immunohematological, immunoassay,
cytochemical, or genetic test or procedure performed on material
derived from or existing in a human body that provides information
for the diagnosis, prevention, or monitoring of a disease or
impairment or assessment of a medical condition. The term includes
the pre-analytic, analytic, and post-analytic phases of testing.
(15) "Point-of-care testing" means analytical patient
testing activities provided at a health care facility but performed
outside the central medical laboratory facilities that do not
require permanent dedicated space, including testing using
analytical instruments at a temporary patient care location.
(16) "Practice of medical laboratory science" means
practice by an individual who manages, supervises, educates,
consults, researches, or performs medical laboratory testing or
technical procedures in a medical laboratory. The term does not
include an activity that constitutes the practice of medicine or
the activities of a person performing only clerical duties or other
duties not directly related to the performance of medical
laboratory testing.
(17) "Waived test" means a simple laboratory
examination or procedure that, under a federal interpretation of
CLIA, employs a simple and accurate methodology that renders the
likelihood of erroneous results negligible or poses no reasonable
risk of harm to the patient if performed incorrectly.
Sec. 703.004. EXEMPTIONS. This chapter does not apply to:
(1) a physician licensed to practice medicine in this
state;
(2) an individual licensed under another law of this
state and engaged in health care services within the scope of the
license holder's licensed practice;
(3) an individual engaged in the practice of medical
laboratory science in the employ of the federal government or a
federal bureau, division, or agency and in the discharge of the
employee's official duties;
(4) an individual engaged in the practice of medical
laboratory science and engaged exclusively in research, provided
that the results of an examination performed are not used in health
maintenance, diagnosis, or treatment of disease;
(5) an intern, student, or trainee enrolled in a
medical laboratory science education program, provided that:
(A) the activities constitute a part of a planned
course in the program;
(B) the individual is designated by title as an
intern, student, or trainee; and
(C) the individual works directly under an
individual licensed by this state to practice medical laboratory
science or an individual exempt from this chapter under Subdivision
(4);
(6) an individual solely performing waived or
provider-performed microscopy tests under CLIA;
(7) an individual performing point-of-care testing
categorized under CLIA as moderate complexity in an acute care
facility, if the facility complies with the following requirements:
(A) in the laboratory, a laboratory director is
responsible for:
(i) designing and providing or supervising
the training programs for the point-of-care testing personnel;
(ii) supervising and monitoring the quality
assurance and quality control activities of the testing site;
(iii) assisting in the selection of
technology;
(iv) reviewing the results of proficiency
testing and recommending corrective action, if necessary; and
(v) monitoring the continued competency of
the testing personnel; and
(B) processes are in place at the facility and
are acceptable to the department to ensure and document the
continued competency of the point-of-care testing personnel;
(8) an individual solely performing histopathology
testing or performing or interpreting the results of molecular
testing on histological specimens, as described by CLIA;
(9) an individual solely performing or interpreting
cytology testing, including the performance or interpretation of
molecular testing on cytological specimens, as described by CLIA,
provided that this chapter may not be construed as a limitation on
the scope of work permitted under CLIA for qualified
cytotechnologists;
(10) a medical laboratory assistant who performs
non-testing pre-analytical duties, including processing specimens,
accessioning, loading specimens into analyzers, or preparing
specimens for referral testing;
(11) an individual solely performing or interpreting
histocompatibility testing for transplantation services;
(12) an individual solely performing or interpreting
testing by mass spectrometry, provided the individual has a
bachelor's degree in a chemical science and meets the CLIA
requirements for testing personnel performing high complexity
testing; or
(13) an individual performing testing on
plasmapheresis specimens in a laboratory regulated by the federal
Food and Drug Administration.
Sec. 703.005. APPLICATION OF SUNSET ACT. The Medical
Laboratory Science Advisory Committee is subject to Chapter 325,
Government Code (Texas Sunset Act). Unless continued in existence
as provided by that chapter, the advisory committee is abolished
and this chapter expires September 1, 2027.
SUBCHAPTER B. POWERS AND DUTIES
Sec. 703.051. RULES. (a) The commission shall adopt rules
to administer this chapter and as necessary to protect the public
health, safety, and welfare, including rules on:
(1) the qualifications to obtain a license under each
category of medical laboratory science professional;
(2) the renewal of a license;
(3) standards of professional conduct;
(4) authorization or approval of nationally
recognized and validated certification examinations for medical
laboratory science professionals; and
(5) criteria for the continuing education of medical
laboratory science professionals as required for license renewal.
(b) The commission by rule shall prescribe the activities
that may be performed by each category of license holder under this
chapter.
(c) The commission by rule may exempt a medical laboratory
science professional who is employed by a certification agency
approved by the executive director from licensing and continuing
education fees.
(d) This chapter may not be construed as providing the
department, commission, or executive director authority to:
(1) regulate the activities of a physician who is
directing a clinical laboratory; or
(2) establish by rule an academic, educational, or
testing requirement that is not expressly prescribed or required by
this chapter.
Sec. 703.052. FEES. The commission by rule shall establish
and collect reasonable and necessary fees in amounts sufficient to:
(1) cover the costs of administering this chapter; and
(2) provide reasonable funding for medical laboratory
personnel education.
Sec. 703.053. DEPARTMENT POWERS AND DUTIES. (a) The
department may authorize disbursements necessary to implement this
chapter, including disbursements for office expenses, equipment
costs, and other necessary facilities.
(b) The department may examine any criminal conviction or
guilty plea of an applicant for issuance or renewal of a license,
including by obtaining any criminal history record information
authorized by law.
Sec. 703.054. PERSONNEL. The department may employ
personnel necessary to administer this chapter.
Sec. 703.055. REGISTRY OF LICENSE HOLDERS. (a) The
department shall maintain a registry of the name and address of each
individual licensed under this chapter and each individual whose
license has been suspended or revoked.
(b) The department shall post the registry on the
department's Internet website and make copies of the registry
available to the public on request.
Sec. 703.056. CONSUMER INTEREST INFORMATION. (a) The
department shall prepare information of consumer interest
describing:
(1) the functions performed by the department under
this chapter; and
(2) the rights of a consumer affected by this chapter.
(b) The information must describe the procedure by which a
consumer complaint is filed with and resolved by the department.
(c) The department shall make the information available to
the public.
SUBCHAPTER C. MEDICAL LABORATORY SCIENCE ADVISORY COMMITTEE
Sec. 703.101. ADVISORY COMMITTEE. (a) The Medical
Laboratory Science Advisory Committee is an advisory body to the
department and executive director.
(b) The advisory committee consists of nine members
appointed by the department as follows:
(1) three members who are medical laboratory science
professionals who are not physicians, at least one of whom is a
medical laboratory scientist and at least one of whom is not a
laboratory director;
(2) three members who are pathologists certified by
The American Board of Pathology, the American Osteopathic Board of
Pathology, or another certification board the department
determines has certification requirements at least as stringent as
those of The American Board of Pathology or the American
Osteopathic Board of Pathology;
(3) one member who is a physician and is not a
laboratory director or pathologist;
(4) one member who is a medical laboratory science
educator and is not a physician; and
(5) one public member.
(c) The department may make appointments to the advisory
committee from lists submitted by organizations of medical
laboratory science professionals and organizations of physician
pathologists.
(d) Chapter 2110, Government Code, does not apply to the
advisory committee.
Sec. 703.102. TERMS; VACANCIES. (a) Members serve
staggered six-year terms and until their successors are appointed
and qualified.
(b) A vacancy shall be filled for the remainder of the
unexpired term in the same manner as an original appointment.
(c) A member may not serve more than two consecutive terms.
Sec. 703.103. PUBLIC MEMBER ELIGIBILITY. A member who
represents the public may not be:
(1) an officer, director, or employee of an individual
regulated under this chapter;
(2) an individual required to register as a lobbyist
under Chapter 305, Government Code; or
(3) an individual related to an individual described
by Subdivision (1) or (2) within the second degree by affinity or
consanguinity.
Sec. 703.104. COMPENSATION; REIMBURSEMENT. A member of the
advisory committee serves without compensation. If authorized by
the department, an advisory committee member is entitled to
reimbursement for actual and necessary expenses incurred in
performing the functions of the advisory committee, subject to the
General Appropriations Act.
Sec. 703.105. MEETINGS. The advisory committee shall meet
annually and may meet at other times at the call of the executive
director.
Sec. 703.106. ADVISORY COMMITTEE DUTIES. The advisory
committee shall provide advice and recommendations to the
department and executive director on technical matters relevant to
the administration and enforcement of this chapter, including
certification agency approval, licensing standards and
qualifications, renewal requirements, standards of professional
conduct, and continuing education requirements.
SUBCHAPTER D. LICENSE REQUIREMENTS
Sec. 703.151. LICENSE REQUIRED. Except as provided by
Section 703.004, an individual may not perform or offer to perform
medical laboratory tests or represent that the individual is a
medical laboratory science professional unless the individual
holds an appropriate license issued under this chapter.
Sec. 703.152. APPLICATION REQUIREMENTS. (a) An applicant
for a license under this chapter must:
(1) submit to the department a completed application
on a form prescribed by the executive director;
(2) submit to the department any other information
required by rule;
(3) demonstrate to the satisfaction of the department
the qualifications required by this chapter and by rule;
(4) demonstrate the applicant's honesty,
trustworthiness, and integrity; and
(5) pay the application fee.
(b) The department shall issue the appropriate license to
each individual who meets the qualifications required by this
chapter and by rule.
(c) The department may conduct an examination of any
criminal conviction of an applicant, including obtaining any
criminal history record information authorized by law.
(d) Criminal history record information obtained by the
department may not be released or disclosed to any person except on
court order or with the written consent of the applicant who is the
subject of the criminal history record information.
Sec. 703.153. MEDICAL LABORATORY SCIENTIST. An applicant
for a medical laboratory scientist license must:
(1) hold at least a bachelor's degree from a regionally
accredited college or university;
(2) have successfully completed the medical
laboratory experience or training required by rule;
(3) be certified by a nationally recognized
certification organization approved by the executive director;
(4) pay the application fee and license fee; and
(5) comply with any other requirements established by
rule.
Sec. 703.154. CATEGORICAL MEDICAL LABORATORY SCIENTIST. An
applicant for a categorical medical laboratory scientist license
must:
(1) hold at least a bachelor's degree from a regionally
accredited college or university;
(2) have successfully completed the medical
laboratory experience or training required by rule;
(3) be certified by a nationally recognized
certification organization approved by the executive director;
(4) pay the application fee and license fee; and
(5) comply with any other requirements established by
rule.
Sec. 703.155. MEDICAL LABORATORY TECHNICIAN. (a) An
applicant for a medical laboratory technician license must:
(1) hold at least an associate degree from a
regionally accredited college or university;
(2) have successfully completed the medical
laboratory experience or training required by rule;
(3) be certified by a nationally recognized
certification organization approved by the executive director;
(4) pay the application fee and license fee; and
(5) comply with any other requirements established by
rule.
(b) The department shall accept as satisfying the
requirement of Subsection (a)(1) evidence that the applicant has:
(1) successfully completed a course in procedures for
a military laboratory of not less than 50 weeks in length; and
(2) served as a medical laboratory specialist or
laboratory technician in the military.
Sec. 703.156. TEMPORARY LICENSE. (a) The commission by
rule may establish a procedure for issuance of temporary licenses
to individuals under this chapter who intend to engage in the
practice of medical laboratory science in this state for a limited
period not to exceed six months.
(b) Unless otherwise noted on the license, a temporary
license is valid for not more than six months after the date of
issuance and may be renewed once.
Sec. 703.157. PROVISIONAL LICENSE. The department may
issue a provisional license under this chapter to an applicant who
holds a license in another state, submits a proper application, and
pays the required fees if the department determines that the
applicant is licensed in a state in which the requirements for
issuance of the license are at least as stringent as the
requirements under this chapter and by rule. A provisional license
under this section is valid for not more than 90 days.
Sec. 703.158. LICENSE TERM AND RENEWAL. (a) A license
issued under this chapter expires on the second anniversary of the
date of issuance. The commission by rule may adopt a system under
which licenses expire on various dates during the year.
(b) A license holder may renew the license by paying the
required renewal fee and:
(1) successfully completing at least 10 hours each
year of continuing education courses, clinics, lectures, training
programs, seminars, or other programs related to medical laboratory
practice that are approved or accepted by the executive director;
or
(2) successfully completing recertification by a
national certifying organization recognized by the executive
director that mandates at least 10 hours each year of continuing
education for recertification.
(c) The commission by rule may require additional evidence
of competency to practice medical laboratory science as reasonably
appropriate as a prerequisite to the renewal of any license under
this chapter if the requirements are:
(1) uniformly applied;
(2) reasonably related to the measurement of
qualification, performance, or competence; and
(3) desirable and necessary for the protection of the
public health.
SUBCHAPTER E. LICENSE DENIAL AND DISCIPLINARY ACTION
Sec. 703.201. GROUNDS FOR DISCIPLINARY ACTION. The
executive director may refuse to issue or renew, revoke, or suspend
a license, place on probation, censure, or reprimand a license
holder, or take any other disciplinary action, including the
imposition of a civil penalty under Section 703.202 or the
imposition of an administrative penalty under Section 703.204, the
department considers appropriate for:
(1) a material misstatement in furnishing information
to the department;
(2) a violation or negligent or intentional disregard
of this chapter or a rule adopted under this chapter;
(3) a conviction for any crime under the laws of the
United States or any state of the United States that is a felony or a
misdemeanor, an essential element of which is dishonesty, or of any
crime that is directly related to the practice of the profession;
(4) a misrepresentation made to obtain a license;
(5) a violation of any standard of professional
conduct adopted by the commission;
(6) dishonorable, unethical, or unprofessional
conduct of a character likely to deceive, defraud, or harm the
public;
(7) the provision of professional services while
mentally incompetent or under the influence of alcohol, a narcotic,
or a controlled dangerous substance that is in excess of
therapeutic amounts or without valid medical indication;
(8) directly or indirectly contracting to perform
medical laboratory tests in a manner that offers or implies an offer
of rebate, fee-splitting inducements or arrangements, or other
remuneration;
(9) aiding or assisting another individual in
violating any provision of this chapter or a rule adopted under this
chapter; or
(10) a misrepresentation with regard to the existence
or category of license or other certification or professional
qualification held in connection with any employment application.
Sec. 703.202. CIVIL PENALTY. (a) A person who violates
this chapter or a rule adopted under this chapter is liable to this
state for a civil penalty of not more than $500 for each violation.
(b) The amount of the penalty shall be based on:
(1) the seriousness of the violation;
(2) the history of previous violations;
(3) the amount necessary to deter a future violation;
and
(4) any other matter that justice may require.
(c) The attorney general may sue to collect a civil penalty
under this section. In the suit the attorney general may recover,
on behalf of the state, the reasonable expenses incurred in
obtaining the penalty, including investigation and court costs,
reasonable attorney's fees, witness fees, and other expenses.
Sec. 703.203. HEARINGS; ADMINISTRATIVE PROCEDURE. (a) If
the department proposes to deny a license or take disciplinary
action against a license holder, the license holder is entitled to a
hearing.
(b) The proceedings relating to a license denial and
disciplinary action by the department under this chapter are
governed by Chapter 2001, Government Code. A hearing under this
chapter shall be conducted by the State Office of Administrative
Hearings.
Sec. 703.204. ADMINISTRATIVE PENALTY. (a) The commission
or executive director may impose an administrative penalty on an
individual licensed under this chapter who violates this chapter or
a rule or order adopted under this chapter.
(b) The amount of the penalty may not exceed $500. Each day
a violation continues or occurs is a separate violation for the
purpose of imposing a penalty. The amount shall be based on:
(1) the seriousness of the violation, including the
nature, circumstances, extent, and gravity of the violation;
(2) the economic harm caused by the violation;
(3) the history of previous violations;
(4) the amount necessary to deter a future violation;
(5) efforts to correct the violation; and
(6) any other matter that justice may require.
(c) The individual may stay enforcement during the time the
order is under judicial review if the individual pays the penalty to
the court clerk or files a supersedeas bond with the court in the
amount of the penalty. An individual who cannot afford to pay the
penalty or file the bond may stay enforcement by filing an affidavit
in the manner required by the Texas Rules of Civil Procedure for a
party who cannot afford to file security for costs, except that the
department may contest the affidavit as provided by those rules.
(d) The attorney general may sue to collect the penalty.
(e) A proceeding to impose an administrative penalty is
subject to Chapter 2001, Government Code.
SUBCHAPTER F. TRANSITIONAL LICENSING
Sec. 703.251. TEMPORARY PROVISION; LICENSING. (a) This
subchapter expires September 1, 2021. The department may not issue
a license under this subchapter after August 31, 2019.
(b) The department shall issue a license to a qualified
applicant under this subchapter who:
(1) submits to the department the information required
by rule, including, as applicable:
(A) the job description of the medical laboratory
position the applicant most recently held and a sworn statement by
the applicant's employer attesting to the applicant's job
description; or
(B) proof that the applicant is certified by a
nationally recognized certification agency approved by the
executive director; and
(2) pays the application and licensing fee.
Sec. 703.252. MEDICAL LABORATORY SCIENTIST. To qualify for
a license under this subchapter as a medical laboratory scientist,
an applicant must:
(1) be currently certified to perform medical
laboratory scientist services by a certification agency approved by
the executive director; or
(2) have performed the duties of a medical laboratory
scientist for at least three years during the five years preceding
the date of application.
Sec. 703.253. CATEGORICAL MEDICAL LABORATORY SCIENTIST. To
qualify for a license under this subchapter as a categorical
medical laboratory scientist, an applicant must:
(1) be currently certified to perform medical
laboratory scientist services in one major practice area by a
certification agency approved by the executive director; or
(2) have performed the duties of a categorical medical
laboratory scientist for at least three years during the five years
preceding the date of application.
Sec. 703.254. MEDICAL LABORATORY TECHNICIAN. To qualify
for a license under this subchapter as a medical laboratory
technician, an applicant must:
(1) be currently certified to perform medical
laboratory technician services by a certification agency approved
by the executive director; or
(2) have performed the duties of a medical laboratory
technician for at least three years during the five years preceding
the date of application.
Sec. 703.255. EFFECT OF LICENSE. The holder of a license
issued under this subchapter is entitled to practice to the same
extent as the holder of a license under Subchapter D.
Sec. 703.256. RENEWAL. A license issued under this
subchapter expires on the second anniversary of the date of
issuance. Notwithstanding the qualifications for an initial
license under Section 703.153, 703.154, or 703.155, the license may
be renewed as a license under Section 703.158.
SECTION 2. As soon as possible after the effective date of
this Act, the Texas Department of Licensing and Regulation shall
appoint the members of the Medical Laboratory Science Advisory
Committee in accordance with Chapter 703, Occupations Code, as
added by this Act. In making the initial appointments, the
department shall designate:
(1) three members for terms expiring February 1, 2017;
(2) three members for terms expiring February 1, 2019;
and
(3) three members for terms expiring February 1, 2021.
SECTION 3. The Texas Commission of Licensing and Regulation
and the executive director of the Texas Department of Licensing and
Regulation, as appropriate, shall adopt the rules, standards,
procedures, and fees necessary to implement Chapter 703,
Occupations Code, as added by this Act, not later than August 31,
2016.
SECTION 4. Notwithstanding Chapter 703, Occupations Code,
as added by this Act, an individual engaged in the practice of
medical laboratory science is not required to hold a license under
that chapter to engage in the practice of medical laboratory
science before September 1, 2017.
SECTION 5. This Act takes effect September 1, 2015.