Bill Text: TX SB805 | 2011-2012 | 82nd Legislature | Introduced

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Bill Title: Relating to the licensing and regulation of medical laboratory science professionals; providing penalties.

Sponsorship: Partisan Bill (Democrat 1)

Status: (Introduced - Dead) 2011-04-05 - Left pending in committee [SB805 Detail]

Download: Texas-2011-SB805-Introduced.html

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82R3528 SLB-F
By: Lucio S.B. No. 805

A BILL TO BE ENTITLED
AN ACT
relating to the licensing and regulation of medical 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. 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.
(3) "CLIA" means the federal Clinical Laboratory
Improvement Amendments (42 C.F.R. Part 493).
(4) "Commissioner" means the commissioner of state
health services.
(5) "Department" means the Department of State Health
Services.
(6) "Executive commissioner" means the executive
commissioner of the Health and Human Services Commission.
(7) "Laboratory director" means a person who meets the
requirements of a laboratory director under CLIA.
(8) "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.
(9) "Medical laboratory assistant" means an
individual who may assist in the performance of medical laboratory
tests and procedures under the supervision of a laboratory
director.
(10) "Medical laboratory science professional" means
an individual licensed under this chapter to practice medical
laboratory science.
(11) "Medical laboratory scientist" means an
individual who assists in the performance of tests and procedures
under supervision by a laboratory director.
(12) "Medical laboratory scientist services" means:
(A) 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; and
(C) the direction, supervision, consultation,
education, and performance of research functions related to medical
laboratory testing.
(13) "Medical laboratory technician" means an
individual licensed under this chapter to perform medical
laboratory technician services.
(14) "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 judgment and are performed under the
supervision of a medical laboratory scientist, laboratory
supervisor, or laboratory director.
(15) "Medical laboratory test" means a
microbiological, serological, chemical, biological,
hematological, immunological, immunohematological,
radioimmunoassay, 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.
(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 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 the activities of a licensed physician or of a person
performing only clerical duties or other duties not directly
related to the performance of medical 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 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) 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;
(2) 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;
(3) 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;
(4) 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
(3);
(5) an individual solely performing waived or
provider-performed microscopy tests under CLIA;
(6) 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 medical laboratory
scientist or 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;
(7) an individual solely performing histopathology
testing, as described by CLIA;
(8) an individual solely performing or interpreting
cytology testing, including the performance or interpretation of
molecular testing on cytological specimens, as described by CLIA;
or
(9) 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.
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, 2023.
[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 medical laboratory science professional;
(2) the renewal of licensure;
(3) standards of professional conduct for each
category of medical laboratory science professional;
(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 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 executive 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 or
guilty plea 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.
(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. 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 commissioner.
(b) The advisory committee consists of nine members
appointed by the executive commissioner as follows:
(1) three members who are licensed medical laboratory
science professionals, with at least one who is not a physician
laboratory director and at least one who is a medical laboratory
scientist;
(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
(5) one public member.
(c) The executive commissioner 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 executive commissioner, 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
commissioner.
Sec. 703.106. ADVISORY COMMITTEE DUTIES. The advisory
committee 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. 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 commissioner;
(2) submit to the department any other information
required by rule;
(3) demonstrate to the satisfaction of the
commissioner 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 permitted by law.
(d) Criminal history record information obtained by the
department may not be released or disclosed to any person except on
court order, with the written consent of the applicant that is the
subject of the criminal history record information, or as provided
by Section 411.110, Government Code.
Sec. 703.153. MEDICAL LABORATORY SCIENTIST. An applicant
for a medical laboratory scientist license must:
(1) hold at least a baccalaureate 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 commissioner;
(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 baccalaureate 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 commissioner;
(4) pay the application fee and license fee; and
(5) comply with any other requirements established by
rule.
Sec. 703.155. MEDICAL LABORATORY TECHNICIAN. 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 commissioner;
(4) pay the application fee and license fee; and
(5) comply with any other requirements established by
rule.
Sec. 703.156. TEMPORARY LICENSE. (a) The executive
commissioner 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 at the discretion of the
commissioner.
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.
Sec. 703.158. LICENSE RENEWAL. (a) A license issued under
this chapter expires on the second anniversary of the date of
issuance. The executive commissioner 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
commissioner; or
(2) successfully completing recertification by a
national certifying organization recognized by the executive
commissioner 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 medical 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 703.159-703.200 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
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
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.
[Sections 703.205-703.250 reserved for expansion]
SUBCHAPTER F. TRANSITIONAL LICENSING
Sec. 703.251. TEMPORARY PROVISION; TRANSITIONAL LICENSING.
(a) This subchapter expires September 1, 2015. The department may
not issue a transitional license under this subchapter after August
31, 2013.
(b) The department shall issue a transitional 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 commissioner; and
(2) pays the application and licensing fee.
Sec. 703.252. MEDICAL LABORATORY SCIENTIST. To qualify for
a transitional license under this subchapter as a medical
laboratory scientist, an applicant must:
(1) be currently certified as a medical laboratory
scientist by a certification agency approved by the executive
commissioner;
(2) have met the education requirements of Section
703.153 and have performed the duties of a medical laboratory
scientist for at least three years during the five years preceding
the date of application;
(3) have been engaged in the full-time education of
medical laboratory practitioners for at least two years during the
five years preceding the date of application; or
(4) have performed the duties of a medical laboratory
scientist for at least five years preceding the date of
application.
Sec. 703.253. CATEGORICAL MEDICAL LABORATORY SCIENTIST. To
qualify for a transitional license under this subchapter as a
categorical medical laboratory scientist, an applicant must:
(1) be currently certified as a categorical medical
laboratory scientist by a certification agency approved by the
executive commissioner;
(2) have met the education requirements of Section
703.154 and have performed the duties of a categorical medical
laboratory scientist for at least three years during the five years
preceding the date of application;
(3) have been engaged in the full-time education of
medical laboratory practitioners for at least two years during the
five years preceding the date of application; or
(4) have performed the duties of a categorical medical
laboratory scientist for at least five years preceding the date of
application.
Sec. 703.254. MEDICAL LABORATORY TECHNICIAN. To qualify
for a transitional license under this subchapter as a medical
laboratory technician, an applicant must:
(1) be currently certified as a medical laboratory
technician by a certification agency approved by the executive
commissioner;
(2) have met the education requirements of Section
703.155 and have performed the duties of a medical laboratory
technician for at least three years during the five years preceding
the date of application; or
(3) have performed the duties of a medical laboratory
technician for at least five years preceding the date of
application.
Sec. 703.255. EFFECT OF TRANSITIONAL LICENSE. The holder
of a transitional 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 transitional 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
transitional license may be renewed under Section 703.158.
SECTION 2. Section 411.110(a), Government Code, is amended
to read as follows:
(a) The Department of State Health Services is entitled to
obtain from the department criminal history record information
maintained by the department that relates to:
(1) a person who is:
(A) an applicant for a license or certificate
under the Emergency Medical Services Act (Chapter 773, Health and
Safety Code);
(B) an owner or manager of an applicant for an
emergency medical services provider license under that Act; or
(C) the holder of a license or certificate under
that Act;
(2) an applicant for a license or a license holder
under Subchapter N, Chapter 431, Health and Safety Code;
(3) an applicant for a license, the owner or manager of
an applicant for a massage establishment license, or a license
holder under Chapter 455, Occupations Code;
(4) an applicant for employment at or current employee
of:
(A) the Texas Center for Infectious Disease; or
(B) the South Texas Health Care System; [or]
(5) an applicant for employment at, current employee
of, or person who contracts or may contract to provide goods or
services with:
(A) the vital statistics unit of the Department
of State Health Services; or
(B) the Council on Sex Offender Treatment or
other division or component of the Department of State Health
Services that monitors sexually violent predators as described by
Section 841.003(a), Health and Safety Code; or
(6) an applicant for a license or a license holder
under Chapter 703, Occupations Code.
SECTION 3. As soon as possible after the effective date of
this Act, the executive commissioner of the Health and Human
Services Commission 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 executive commissioner shall designate:
(1) three members for terms expiring February 1, 2013;
(2) three members for terms expiring February 1, 2015;
and
(3) three members for terms expiring February 1, 2017.
SECTION 4. 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, not later than March 1,
2012.
SECTION 5. 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, 2012.
SECTION 6. This Act takes effect September 1, 2011.