81R29094 YDB-D
By: Gattis H.B. No. 2294
Substitute the following for H.B. No. 2294:
By: Coleman C.S.H.B. No. 2294
A BILL TO BE ENTITLED
AN ACT
relating to the establishment of the undiagnosed disease registry.
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
SECTION 1. Subtitle D, Title 2, Health and Safety Code, is
amended by adding Chapter 82B to read as follows:
CHAPTER 82B. UNDIAGNOSED DISEASE REGISTRY
Sec. 82B.001. SHORT TITLE. This chapter may be cited as the
Undiagnosed Disease Reporting Act.
Sec. 82B.002. DEFINITIONS. In this chapter:
(1) "Clinical laboratory" means an accredited
facility in which:
(A) tests are performed identifying findings of
anatomical changes; and
(B) specimens are interpreted and pathological
diagnoses are made.
(2) "Executive commissioner" means the executive
commissioner of the Health and Human Services Commission.
(3) "Health care facility" means:
(A) a general or special hospital as defined by
Chapter 241;
(B) an ambulatory surgical center licensed under
Chapter 243;
(C) an institution licensed under Chapter 242; or
(D) any other facility, including an outpatient
clinic, that provides diagnosis or treatment services to patients
with an undiagnosed disease that results in death.
(4) "Physician" has the meaning assigned by Section
151.002, Occupations Code.
Sec. 82B.003. APPLICABILITY OF CHAPTER. This chapter
applies to records of cases of undiagnosed diseases that result in
death on or after January 1, 2010.
Sec. 82B.004. REGISTRY REQUIRED. The department shall
maintain for this state an undiagnosed disease registry for
undiagnosed diseases that result in death or other cases the
executive commissioner by rule requires to be included in the
registry.
Sec. 82B.005. CONTENT OF REGISTRY; SAMPLES. (a) The
undiagnosed disease registry must be a central data bank of
accurate, precise, and current information that medical
authorities agree serves as an invaluable tool in the early
recognition, prevention, cure, and control of undiagnosed
diseases.
(b) The undiagnosed disease registry must include:
(1) a record of the cases of undiagnosed diseases that
result in death in this state; and
(2) information concerning undiagnosed disease cases
the department considers necessary and appropriate for the
recognition, prevention, cure, or control of undiagnosed diseases.
(c) The undiagnosed disease registry may include cases of
undiagnosed diseases that do not result in death.
(d) The department shall store samples of tissues
corresponding to individual registry records that may be of future
benefit to medical professionals.
Sec. 82B.006. EXECUTIVE COMMISSIONER POWERS. To implement
this chapter, the executive commissioner may:
(1) adopt rules the executive commissioner considers
necessary;
(2) execute contracts the executive commissioner
considers necessary;
(3) receive the data from medical records of cases of
undiagnosed diseases that are in the custody or under the control of
clinical laboratories, health care facilities, and physicians to
record and analyze the data directly related to the diseases;
(4) compile and publish statistical and other studies
derived from the patient data obtained under this chapter to
provide, in an accessible form, information that is useful to
physicians, other medical personnel, and the general public;
(5) comply with requirements as necessary to obtain
federal funds in the maximum amounts and most advantageous
proportions possible;
(6) receive and use gifts made for the purpose of this
chapter; and
(7) limit undiagnosed disease reporting activities
under this chapter to specified geographic areas of this state to
ensure optimal use of funds available for obtaining the data.
Sec. 82B.007. REPORTS. (a) The department shall submit an
annual report to the legislature on the information obtained under
this chapter.
(b) The department, in cooperation with other undiagnosed
disease reporting organizations and research institutions, may
publish reports the department determines are necessary or
desirable to carry out the purpose of this chapter.
Sec. 82B.008. DATA FROM MEDICAL RECORDS; TISSUE SAMPLES.
(a) To ensure an accurate and continuing source of data concerning
undiagnosed disease, each clinical laboratory, health care
facility, and physician shall furnish to the department or its
representative, on request, data that the executive commissioner
considers necessary and appropriate and that is derived from each
medical record pertaining to a case of an undiagnosed disease that
is in the custody or under the control of the clinical laboratory,
health care facility, or physician. The department may not request
data that is more than three years old unless the department is
investigating a possible undiagnosed disease cluster.
(b) A clinical laboratory, health care facility, or
physician shall furnish the data requested under Subsection (a) in
a reasonable format prescribed by the department and within six
months of the patient's death or treatment for an undiagnosed
disease unless a different period is prescribed by the United
States Department of Health and Human Services.
(c) The data required to be furnished under this section
must include patient identification, symptoms, tests conducted,
and any other information the department requires.
(d) The department may access medical records that would
identify cases of undiagnosed diseases, establish characteristics
or treatment of undiagnosed diseases, or determine the medical
status of any identified patient from the following sources:
(1) a health care facility or clinical laboratory
providing screening or therapeutic services to a patient related to
an undiagnosed disease; or
(2) a physician providing treatment to a patient with
an undiagnosed disease.
(e) The executive commissioner shall adopt procedures that
ensure adequate notice is given to the clinical laboratory, health
care facility, or physician before the department accesses data
under Subsection (d).
(f) The data required to be furnished under this section may
be shared with undiagnosed disease registries of clinical
laboratories or health care facilities subject to the
confidentiality provisions in Section 82B.009.
(g) Each clinical laboratory, health care facility, and
physician shall furnish to the department or its representative, on
request, any available tissue samples that the executive
commissioner considers necessary.
Sec. 82B.009. CONFIDENTIALITY. (a) Reports, records, and
information obtained under this chapter are confidential and are
not subject to disclosure under Chapter 552, Government Code, are
not subject to subpoena, and may not otherwise be released or made
public except as provided by this section or Section 82B.008(f).
The reports, records, and information obtained under this chapter
are for the confidential use of the department and the persons or
public or private entities that the department determines are
necessary to carry out the intent of this chapter.
(b) Medical or epidemiological information may be released:
(1) for statistical purposes in a manner that prevents
identification of individuals, clinical laboratories, health care
facilities, or physicians;
(2) with the consent of each person identified in the
information; or
(3) to promote undiagnosed disease research,
including release of information to other undiagnosed disease
registries and appropriate state and federal agencies, under rules
adopted by the executive commissioner to ensure confidentiality as
required by state and federal laws.
(c) A state employee may not testify in a civil, criminal,
special, or other proceeding as to the existence or contents of
records, reports, or information concerning an individual whose
medical records have been used in submitting data required under
this chapter unless the individual consents in advance.
(d) Data furnished to an undiagnosed disease registry or an
undiagnosed disease researcher under Subsection (b) or Section
82B.008(f) is for the confidential use of the undiagnosed disease
registry or the undiagnosed disease researcher, as applicable, and
is subject to Subsection (a).
Sec. 82B.010. IMMUNITY FROM LIABILITY. The following
persons subject to this chapter that act in compliance with this
chapter are not civilly or criminally liable for furnishing the
information required under this chapter:
(1) a health care facility or clinical laboratory;
(2) an administrator, officer, or employee of a health
care facility or clinical laboratory;
(3) a physician or employee of a physician; and
(4) an employee of the department.
Sec. 82B.011. EXAMINATION AND SUPERVISION NOT REQUIRED.
This chapter does not require an individual to submit to any medical
examination or supervision or to examination or supervision by the
executive commissioner or the executive commissioner's
representatives.
SECTION 2. (a) Not later than December 1, 2009, the
executive commissioner of the Health and Human Services Commission
shall adopt the rules and procedures required to establish the
undiagnosed disease registry under Chapter 82B, Health and Safety
Code, as added by this Act.
(b) Not later than January 1, 2010, the Department of State
Health Services shall establish the undiagnosed disease registry
under Chapter 82B, Health and Safety Code, as added by this Act.
(c) Notwithstanding Chapter 82B, Health and Safety Code, as
added by this Act, a clinical laboratory, health care facility, or
physician is not required to report the data required under Chapter
82B until January 1, 2010.
SECTION 3. This Act takes effect September 1, 2009.