| (a) Purpose. This section establishes a program to
award funding for an unrelated donor umbilical cord blood bank in
Texas.
(b) Funding objectives. The funding awarded pursuant
to this section is intended to improve public health in Texas through
obtaining efficiently delivered services for gathering and retaining
unrelated umbilical cord blood from live births for the primary purpose
of making the cord blood available for transplantation purposes.
(c) Definitions. The following words and terms, when
used in this section, have the following meanings, unless the context
clearly indicates otherwise:
(1) Blood bank--A facility that:
(A) obtains a human umbilical cord blood donation from
an unrelated donor;
(B) is licensed, certified, or accredited as a blood
bank, blood and tissue center, laboratory, or other health care facility
and is authorized by:
(i) state and/or federal law, rule, or regulation;
(ii) the American Association of Blood Banks; and
(iii) International Organization of Standardization
to collect, process, and preserve human umbilical cord blood donations;
and
(C) is operated in compliance with professionally recognized
standards regarding quality and safety of collection of human umbilical
cord blood donations, including the American Association of Blood
Banks and International Organization of Standardization.
(2) Commission--The Texas Health and Human Services
Commission or its designee.
(3) Contractor--The recipient of the funding awarded
under this section.
(4) Donation--Human umbilical cord blood obtained from
an unrelated donor and resulting from a live birth.
(5) Services--Umbilical cord blood collection, storage,
preservation, and/or processing services provided by a blood bank.
(6) Unrelated donor--A person who:
(A) is legally authorized or competent;
(B) voluntarily provides a donation; and
(C) is not related by affinity or consanguinity (as
determined under Chapter 573, Texas Government Code) to the recipient
of the donation.
(7) Unrelated Donor Umbilical Cord Blood Bank Program
or Program--The Contractor-operated public blood bank program that
provides for gathering and retaining umbilical cord blood for transplantation
to recipients who are unrelated to the blood donors.
(d) General conditions of the funding. The funding
awarded pursuant to this section, and any extension, continuation,
or addition to such funding, is subject to:
(1) the availability of appropriated state funds;
(2) an award process as established by the commission;
(3) the requirements of Chapter 531, Texas Government
Code, and any administrative rules adopted thereunder, including Chapter
391 of this title (relating to Purchase of Goods and Services by the
Texas Health and Human Services Commission);
(4) the requirements of the contract executed by the
commission with the Contractor as required under subsection (f) of
this section; and
(5) an audit by the commission, the State Auditor's
Office, or an entity approved by the commission of the Contractor's
performance of the services or compliance with applicable auditing
standards and State and federal law;
(e) Applicant eligibility criteria. To be eligible
for the funding awarded under this section, a blood bank must, at
a minimum, demonstrate:
(1) the ability to establish, operate, and maintain
an unrelated donor umbilical cord blood bank in Texas and to provide
related services, including experience operating similar facilities
in this state.
(2) possession of an appropriate, current license,
certification, or certificate of good standing to operate as a blood
bank from the American Association of Blood Banks and International
Organization of Standardization;
(3) a plan to continue the operation of the unrelated
donor umbilical cord blood bank beyond the term of the contract required
by subsection (f) of this section, including an appropriate financial
plan;
(4) the financial stability and resources sufficient
to ensure the achievement of the funding objectives and operation
of the unrelated donor umbilical cord blood bank;
(5) appropriate skills, qualifications, financial resources,
and experience necessary to perform the services and provide the deliverables
(both of which are specified in the contract entered under subsection
(f) of this section) in an efficient and cost-effective manner, with
the highest degree of quality and responsiveness within the context
of the requirements of the contract; and
(6) policies relating to non-discrimination regarding
the selection and treatment of donors and recipients of donations
on the basis of race, sex, national origin, or ability to pay.
(f) Contract. The Contractor must enter into a contract
with the commission that requires, among other things, the Contractor
to:
(1) operate and maintain an unrelated donor umbilical
cord blood bank in this state in accordance with standards described
in subsection (c)(1) of this section;
(2) gather, collect, and preserve umbilical cord blood
from live births only;
(3) comply with any financial or reporting requirements
imposed on the Contractor specified in the contract; and
(4) comply with all applicable federal and state laws
and their implementing regulations.
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