Bill Text: TX SB1662 | 2015-2016 | 84th Legislature | Introduced
Bill Title: Relating to requiring the registration of medical laboratory science professionals; providing an administrative penalty; imposing fees.
Spectrum: Partisan Bill (Democrat 1-0)
Status: (Introduced - Dead) 2015-03-23 - Referred to Health & Human Services [SB1662 Detail]
Download: Texas-2015-SB1662-Introduced.html
84R11874 NC-F | ||
By: Lucio | S.B. No. 1662 |
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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. |