84R11874 NC-F
By: Lucio S.B. No. 1662
A BILL TO BE ENTITLED
AN ACT
relating to requiring the registration of medical laboratory
science professionals; providing an administrative penalty;
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 REGISTRY
SUBCHAPTER A. GENERAL PROVISIONS
Sec. 703.001. SHORT TITLE. This chapter may be cited as the
Medical Laboratory Science Professionals Registry Act.
Sec. 703.002. PUBLIC POLICY; LEGISLATIVE PURPOSE. (a) The
legislature declares as a policy of this state that medical
laboratory science professionals provide essential services to
health care professionals by furnishing vital information that may
be used in the diagnosis and treatment of diseases.
(b) The purpose of this chapter is to ensure better
protection of the public by:
(1) requiring certain laboratory professionals to be
registered by this state;
(2) ensuring that updated information about
registered laboratory professionals is available to state agencies
and other interested parties; and
(3) enabling the collection of workforce data that
does not currently exist.
Sec. 703.003. DEFINITIONS. In this chapter:
(1) "CLIA" means the federal Clinical Laboratory
Improvement Amendments of 1988 (42 C.F.R. Part 493).
(2) "Commissioner" means the commissioner of state
health services.
(3) "Department" means the Department of State Health
Services.
(4) "Executive commissioner" means the executive
commissioner of the Health and Human Services Commission.
(5) "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.
(6) "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 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.
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 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 participating in a
medical laboratory science program, provided that:
(A) the activities constitute a part of a planned
course in the program; and
(B) the individual is designated by title as an
intern, student, or trainee;
(6) an individual solely performing
provider-performed microscopy tests under CLIA;
(7) an individual who performs non-testing
pre-analytical duties, including processing specimens,
accessioning, loading specimens into analyzers, or preparing
specimens for referral testing;
(8) an individual solely performing waived tests under
CLIA;
(9) an individual solely performing point-of-care
testing;
(10) an individual solely performing histopathology
testing;
(11) an individual solely performing cytologic
testing;
(12) an individual solely performing or interpreting
histocompatibility testing for transplantation services;
(13) an individual solely performing analytical
chemical procedures, including mass spectrometry; or
(14) an individual solely performing testing on blood
products for pharmaceutical use under guidelines of the United
States Food and Drug Administration.
Sec. 703.005. RULES. The executive commissioner shall
adopt rules to implement this chapter.
SUBCHAPTER B. REGISTRATION
Sec. 703.051. REGISTRATION REQUIRED. A person is required
to register with the department under Section 703.052 if the person
performs a medical laboratory test in a medical laboratory that is
certified by CLIA or is granted deemed status under rules adopted by
CLIA.
Sec. 703.052. MEDICAL LABORATORY SCIENCE PROFESSIONALS
REGISTRY. (a) The department shall maintain a registry of persons
described by Section 703.051. The executive commissioner shall
adopt rules prescribing the information a person must provide to
register. The department shall issue a registration to a person who
submits the required information.
(b) Information collected under this section must be:
(1) collected electronically on a standardized form;
(2) aggregated into a database; and
(3) made available to the public, provided that
confidential information is protected.
(c) A registration under this chapter expires on the second
anniversary of the date the registration is issued and may be
renewed as provided by rules adopted under this chapter.
(d) The department may charge a fee for a registration under
this chapter in an amount sufficient to cover the costs of
administering this chapter.
SUBCHAPTER C. ENFORCEMENT
Sec. 703.101. ADMINISTRATIVE PENALTY. (a) The
commissioner may impose an administrative penalty on the owner of a
medical laboratory who employs an individual who:
(1) is required by Section 703.051 to register with
the department under this chapter; and
(2) is not registered with the department.
(b) The amount of the penalty may not exceed an amount set by
the commissioner. 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) any 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 owner of the medical laboratory may stay enforcement
during the time the order is under judicial review if the person
pays the penalty to the court clerk or files a supersedeas bond with
the court in the amount of the penalty. A person 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 that 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. (a) A person is not required to submit the
information required by Section 703.052, Occupations Code, as added
by this Act, before September 1, 2016.
(b) A person is not required to register under Section
703.051, Occupations Code, as added by this Act, and the
commissioner of state health services may not impose an
administrative penalty under Section 703.101, Occupations Code, as
added by this Act, before December 1, 2016.
SECTION 3. (a) Except as provided by Subsection (b) of
this section, this Act takes effect September 1, 2015.
(b) Sections 703.051 and 703.101, Occupations Code, as
added by this Act, take effect December 1, 2016.