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
  relating to requiring the registration of medical laboratory
  science professionals; providing an administrative penalty;
  imposing fees.
         SECTION 1.  Subtitle M, Title 3, Occupations Code, is
  amended by adding Chapter 703 to read as follows:
         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
               (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
               (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
               (9)  an individual solely performing point-of-care
               (10)  an individual solely performing histopathology
               (11)  an individual solely performing cytologic
               (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.
         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
  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.
         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.