BILL ANALYSIS
Senate Research Center C.S.S.B. 284
81R13056 YDB-D By: Nelson
Committee Report (Substituted)
AUTHOR'S / SPONSOR'S STATEMENT OF INTENT
There are currently no federal or state laws requiring tissue procurement organizations to be federally accredited.
C.S.S.B. 284 strengthens the accreditation requirements for tissue transplantation and procurement companies and requires more stringent documentation for the transport of bodies and body parts.
RULEMAKING AUTHORITY
Rulemaking authority previously granted to the Anatomical Board of the State of Texas (board) is modified in SECTION 2 (Section 691.031, Health and Safety Code) of this bill.
Rulemaking authority is expressly granted to the executive commissioner of the Health and Human Services Commission in SECTION 3 (Section 692.005, Heath and Safety Code) of this bill.
SECTION BY SECTION ANALYSIS
SECTION 1. Amends Subchapter B, Chapter 691, Health and Safety Code, by adding Section 691.0225, as follows:
Sec. 691.0225. INFORMED CONSENT DOCUMENT. Requires the Anatomical Board of the State of Texas (board) to develop an informed consent document to inform a person making a gift of a decedent's body or anatomical specimen for purposes of education or research of the risks and benefits associated with donation. Requires the board to make the document available on the board's Internet website.
SECTION 2. Amends Section 691.031(a), Health and Safety Code, as follows:
(a) Requires the board to adopt rules to ensure that a label with certain language is affixed to the container in which the body or anatomical specimen is transported; and each person who has control or possession of a body or anatomical specimen satisfactorily completes the information required on a chain-of-custody form prescribed by the board, maintains a copy of the form for the person's records, and transfers the form to any other person to whom control or possession of the body or anatomical specimen is transferred.
SECTION 3. Amends Section 692.005, Health and Safety Code, by adding Subsections (d) and (e), as follows:
(d) Prohibits a qualified tissue procurement organization from acting as a donee for a gift of a body or body part under this section unless the organization has provided the Health and Human Services Commission (HHSC) a copy of the organization's accreditation by the American Association of Tissue Banks, the Eye Bank Association of America, or another accreditation organization approved by HHSC.
(e) Authorizes the executive commissioner of HHSC to adopt rules as necessary to administer this section.
SECTION 4. Requires the board, not later than January 1, 2010, to adopt the rules and form required under Section 691.031(a), Health and Safety Code, as amended by this act; and develop the informed consent document required under Section 691.0225, Health and Safety Code, as added by this Act.
SECTION 5. (a) Provides that, notwithstanding Section 692.005, Health and Safety Code, as amended by this Act, a qualified tissue procurement organization is not required to be accredited under Section 692.005(d), Health and Safety Code, as added by this Act, on the effective date of this Act, but must comply with this section.
(b) Requires a qualified tissue procurement organization that is accredited on the effective date of this Act to submit proof of accreditation to HHSC as required under Section 692.005(d), Health and Safety Code, as added by this Act, not later than March 1, 2010.
(c) Requires a qualified tissue procurement organization that is not accredited on the effective date of this Act to:
(1) submit proof to HHSC that the organization has applied for accreditation not later than March 1, 2010; and
(2) submit proof to HHSC that the organization is accredited as required by Section 692.005(d), Health and Safety Code, as added by this Act, not later than March 1, 2011.
SECTION 6. Effective date: September 1, 2009.