81R6033 YDB-D
By: Lucio S.B. No. 775
A BILL TO BE ENTITLED
AN ACT
relating to the licensing and regulation of clinical laboratory
science professionals; providing penalties.
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. CLINICAL LABORATORY SCIENCE PROFESSIONALS
SUBCHAPTER A. GENERAL PROVISIONS
Sec. 703.001. SHORT TITLE. This chapter may be cited as the
Clinical 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 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; and
(2) clinical laboratories and clinical 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 impairment
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 clinical
laboratory science professionals; and
(2) ensuring that clinical 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 board" means the Clinical Laboratory
Science Advisory Board.
(2) "Categorical clinical laboratory scientist" means
an individual licensed under this chapter to perform clinical
laboratory scientist services in one major practice area of a
laboratory.
(3) "Clinical laboratory" means a facility in which a
clinical laboratory test is performed.
(4) "Clinical laboratory science professional" means
an individual licensed under this chapter to practice clinical
laboratory science.
(5) "Clinical laboratory scientist" means an
individual licensed under this chapter to perform clinical
laboratory scientist services. The term includes a medical
technologist.
(6) "Clinical laboratory scientist services" means:
(A) the performance of clinical 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 clinical
laboratory testing; and
(C) the direction, supervision, consultation,
education, and performance of research functions related to
clinical laboratory testing.
(7) "Clinical laboratory specialist in cytogenetics"
means an individual licensed under this chapter to perform
cytogenetic testing, including culturing, harvesting, staining,
microscopy, and chromosome analysis, and to direct, supervise,
consult, educate, and perform research functions related to
clinical laboratory testing.
(8) "Clinical laboratory specialist in
histocompatibility" means an individual licensed under this
chapter to perform histocompatibility testing by molecular and
serological techniques and to direct, supervise, consult, educate,
and perform research functions related to clinical laboratory
testing.
(9) "Clinical laboratory specialist in molecular
biology" means an individual licensed under this chapter to perform
each aspect of molecular analysis, including recombinant DNA
technology, polymerase chain reaction, and hybridization
techniques and to direct, supervise, consult, educate, and perform
research functions related to clinical laboratory testing.
(10) "Clinical laboratory technician" means an
individual licensed under this chapter to perform clinical
laboratory technician services. The term includes a medical
laboratory technician.
(11) "Clinical laboratory technician services" means
the performance of clinical laboratory tests in accordance with
established and approved protocols that require the limited
exercise of independent judgment and are performed under the
supervision of a clinical laboratory scientist, laboratory
supervisor, or laboratory director.
(12) "Clinical laboratory test" means a
microbiological, serological, chemical, biological,
hematological, immunological, immunohematological, radiobioassay,
cytochemical, cytobiological, or biophysical 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 clinical condition.
The term includes the pre-analytic, analytic, and post-analytic
phases of testing.
(13) "Commissioner" means the commissioner of state
health services.
(14) "Department" means the Department of State Health
Services.
(15) "Executive commissioner" means the executive
commissioner of the Health and Human Services Commission.
(16) "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.
(17) "Practice of clinical laboratory science" means
practice by an individual who manages, supervises, educates,
consults, researches, or performs clinical laboratory testing or
technical procedures in a clinical laboratory. The term does not
include the activities of a licensed physician or of a person
performing only clerical duties or other duties not directly
related to the performance of clinical laboratory testing.
(18) "Trainee" means an individual who has not
fulfilled the educational requirements to take an approved
nationally recognized certification examination or who is in the
process of obtaining full-time comprehensive experience under
supervision.
(19) "Waived test" means a simple laboratory
examination or procedure that, under the United States Food and
Drug Administration's interpretation of the Clinical Laboratory
Improvement Amendments (42 C.F.R. Part 493), 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) an individual licensed under the laws of this
state and engaged in health care services within the scope of the
license holder's licensed practice;
(2) an individual engaged in the practice of clinical
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;
(3) an individual engaged in the practice of clinical
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;
(4) a student or trainee enrolled in a clinical
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, trainee, or student; and
(C) the individual works directly under an
individual licensed by this state to practice clinical laboratory
science or an individual exempt from this chapter under Subdivision
(3);
(5) an individual solely performing waived or
provider-performed microscopy tests under the Clinical Laboratory
Improvement Amendments (42 C.F.R. Part 493); or
(6) an individual performing tests categorized under
the Clinical Laboratory Improvement Amendments (42 C.F.R. Part 493)
as non-waived point-of-care testing, but only if the acute care
facility complies with the following requirements:
(A) in the laboratory, a clinical laboratory
scientist or individual who qualifies as a laboratory director
under the Clinical Laboratory Improvement Amendments (42 C.F.R.
Part 493) 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.
Sec. 703.005. APPLICATION OF SUNSET ACT. The Clinical
Laboratory Science Advisory Board is subject to Chapter 325,
Government Code (Texas Sunset Act). Unless continued in existence
as provided by that chapter, the advisory board is abolished and
this chapter expires September 1, 2021.
[Sections 703.006-703.050 reserved for expansion]
SUBCHAPTER B. EXECUTIVE COMMISSIONER, COMMISSIONER, AND
DEPARTMENT POWERS AND DUTIES
Sec. 703.051. RULES. (a) The executive commissioner shall
adopt rules necessary to administer this chapter, including rules
on:
(1) the qualifications for licensure under each
category of clinical laboratory science professional;
(2) the renewal of licensure;
(3) standards of professional conduct for each
category of clinical laboratory science professional;
(4) authorization or approval of nationally
recognized, validated, criterion-based certification examinations
for clinical laboratory science professionals; and
(5) criteria for the continuing education of clinical
laboratory science professionals as required for license renewal.
(b) The executive commissioner by rule shall prescribe the
activities that may be performed by each category of license holder
under this chapter.
Sec. 703.052. FEES. The commissioner shall establish and
collect reasonable and necessary fees in amounts sufficient to
cover the costs of administering this chapter.
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,
guilty plea, or deferred adjudication of an applicant for issuance
or renewal of a license, including by obtaining any criminal
history record information permitted 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 addresses of
each individual licensed under this chapter and each individual
whose license has been suspended or revoked in the preceding year.
(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.
[Sections 703.057-703.100 reserved for expansion]
SUBCHAPTER C. CLINICAL LABORATORY SCIENCE ADVISORY BOARD
Sec. 703.101. ADVISORY BOARD. (a) The Clinical Laboratory
Science Advisory Board is an advisory body to the department and
executive commissioner.
(b) The advisory board consists of seven members appointed
by the governor as follows:
(1) four members who are licensed clinical laboratory
science professionals, with at least one who is not a physician
laboratory director and at least one who is a clinical laboratory
scientist;
(2) one member who is a physician certified by the
American Board of Pathology, the American Board of Osteopathic
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 Board of
Osteopathic Pathology;
(3) one member who is a physician and is not a
laboratory director or pathologist; and
(4) one public member.
(c) The governor may make appointments to the advisory board
from lists submitted by organizations of clinical laboratory
science professionals and organizations of physician pathologists.
(d) Chapter 2110, Government Code, does not apply to the
advisory board.
Sec. 703.102. TERMS; VACANCIES. (a) Members serve
staggered three-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 board serves without compensation. If authorized by the
commissioner, an advisory board member is entitled to reimbursement
for actual and necessary expenses incurred in performing the
functions of the advisory board, subject to the General
Appropriations Act.
Sec. 703.105. MEETINGS. The advisory board shall meet
twice annually and may meet at other times at the call of the
commissioner.
Sec. 703.106. ADVISORY BOARD DUTIES. The advisory board
shall provide advice and recommendations to the department and
executive commissioner on technical matters relevant to the
administration and enforcement of this chapter, including
examination approval, licensing standards and qualifications,
renewal requirements, standards of professional conduct, and
continuing education requirements.
[Sections 703.107-703.150 reserved for expansion]
SUBCHAPTER D. LICENSE REQUIREMENTS
Sec. 703.151. LICENSE REQUIRED. (a) Except as provided by
Section 703.004, an individual may not perform or offer to perform
clinical laboratory tests or represent that the individual is a
clinical laboratory science professional unless the individual
holds an appropriate license issued under this chapter.
(b) The executive commissioner by rule may establish the
qualifications and licensing requirements for additional
categories of clinical laboratory license professionals as the
executive commissioner determines necessary to protect the public
health and safety.
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 commissioner;
(2) submit to the department any other information
required by department rule;
(3) demonstrate to the satisfaction of the
commissioner the qualifications required by this chapter and
department 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 department rule.
(c) The department may conduct an examination of any
criminal conviction of an applicant, including obtaining any
criminal history record information permitted by law.
Sec. 703.153. CLINICAL LABORATORY SCIENTIST. An applicant
for a clinical laboratory scientist license must:
(1) hold a baccalaureate degree from a regionally
accredited college or university;
(2) have successfully completed the clinical
laboratory experience or training required by department rule;
(3) be certified by a nationally recognized
certification organization approved by the executive commissioner;
(4) pay the application fee and license fee; and
(5) comply with any other requirements established by
department rule.
Sec. 703.154. CATEGORICAL CLINICAL LABORATORY SCIENTIST.
An applicant for a categorical clinical laboratory scientist
license must:
(1) hold a baccalaureate degree from a regionally
accredited college or university;
(2) have successfully completed the clinical
laboratory experience or training required by department rule;
(3) be certified by a nationally recognized
certification organization approved by the executive commissioner;
(4) pay the application fee and license fee; and
(5) comply with any other requirements established by
department rule.
Sec. 703.155. CLINICAL LABORATORY TECHNICIAN. An applicant
for a clinical laboratory technician license must:
(1) hold at least an associate degree from a
regionally accredited college or university;
(2) have successfully completed the clinical
laboratory experience or training required by department rule;
(3) be certified by a nationally recognized
certification organization approved by the executive commissioner;
(4) pay the application fee and license fee; and
(5) comply with any other requirements established by
department rule.
Sec. 703.156. CLINICAL LABORATORY SPECIALIST IN MOLECULAR
BIOLOGY. An applicant for a clinical laboratory specialist in
molecular biology license must:
(1) hold a baccalaureate degree from a regionally
accredited college or university;
(2) have successfully completed the clinical
laboratory experience or training required by department rule;
(3) be certified by a nationally recognized
certification organization approved by the executive commissioner;
(4) pay the application fee and license fee; and
(5) comply with any other requirements established by
department rule.
Sec. 703.157. CLINICAL LABORATORY SPECIALIST IN
CYTOGENETICS. An applicant for a clinical laboratory specialist in
cytogenetics license must:
(1) hold a baccalaureate degree from a regionally
accredited college or university;
(2) have successfully completed the clinical
laboratory experience or training required by department rule;
(3) be certified by a nationally recognized
certification organization approved by the executive commissioner;
(4) pay the application fee and license fee; and
(5) comply with any other requirements established by
department rule.
Sec. 703.158. CLINICAL LABORATORY SPECIALIST IN
HISTOCOMPATIBILITY. An applicant for a clinical laboratory
specialist in histocompatibility license must:
(1) hold a baccalaureate degree from a regionally
accredited college or university;
(2) have successfully completed the clinical
laboratory experience or training required by department rule;
(3) be certified by a nationally recognized
certification organization approved by the executive commissioner;
(4) pay the application fee and license fee; and
(5) comply with any other requirements established by
department rule.
Sec. 703.159. TEMPORARY LICENSE. (a) The executive
commissioner by rule may establish a procedure for issuance of
temporary licenses to individuals otherwise qualified under this
chapter who intend to engage in the practice of clinical laboratory
science in this state for a limited period not to exceed one year.
(b) Unless otherwise noted on the license, a temporary
license is valid until the first anniversary of the date of issuance
and may be renewed once at the discretion of the commissioner.
Sec. 703.160. 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 department rule.
Sec. 703.161. LICENSE RENEWAL. (a) A license issued under
this chapter expires on the second anniversary of the date of
issuance.
(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 clinical
laboratory practice that are approved or accepted by the
department; or
(2) successfully completing recertification by a
national certifying organization recognized by the department that
mandates at least 10 hours each year of continuing education for
recertification.
(c) The executive commissioner by rule may require
additional evidence of competency to practice clinical laboratory
science as the executive commissioner considers 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.
[Sections 703.162-703.200 reserved for expansion]
SUBCHAPTER E. LICENSE DENIAL AND DISCIPLINARY ACTION
Sec. 703.201. GROUNDS FOR DISCIPLINARY ACTION. The
department 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 executive commissioner;
(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
clinical 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 may be conducted by a hearings officer designated by the
commission.
Sec. 703.204. ADMINISTRATIVE PENALTY. (a) The
commissioner 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) A proceeding to impose an administrative penalty is
subject to Chapter 2001, Government Code.
SECTION 2. As soon as possible after the effective date of
this Act, the governor shall appoint the members of the Clinical
Laboratory Science Advisory Board in accordance with Chapter 703,
Occupations Code, as added by this Act. In making the initial
appointments, the governor shall designate:
(1) three members, including a pathologist member, a
nonphysician laboratory director member, and a clinical laboratory
scientist member, for terms expiring February 1, 2013;
(2) two members, including the public member and a
nonpathologist physician member, for terms expiring February 1,
2012; and
(3) two members for terms expiring February 1, 2011.
SECTION 3. As soon as possible after the effective date of
this Act, the executive commissioner of the Health and Human
Services Commission shall adopt the rules, standards, procedures,
and fees necessary to implement Chapter 703, Occupations Code, as
added by this Act, and Section 5 of this Act.
SECTION 4. Notwithstanding Chapter 703, Occupations Code,
as added by this Act, an individual engaged in the practice of
clinical laboratory science is not required to hold a license under
that chapter to engage in the practice of clinical laboratory
science before September 1, 2011.
SECTION 5. Notwithstanding Chapter 703, Occupations Code,
as added by this Act, the Department of State Health Services shall
issue a license to a qualified applicant under this section who:
(1) applies for a license under this section not later
than September 1, 2011;
(2) submits to the department the information required
by department rule;
(3) submits to the department the job description of
the position the applicant most recently performed and a sworn
statement by the applicant's employer attesting to the applicant's
job description;
(4) has at least three years of acceptable experience,
in the preceding five years, in the applicable practice of clinical
laboratory science;
(5) is certified by or eligible for certification by a
nationally recognized certification agency approved by the
department; and
(6) pays the application and licensing fee.
SECTION 6. This Act takes effect September 1, 2009.