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.