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.