Texas Administrative Code
Title 1 - ADMINISTRATION
Part 15 - TEXAS HEALTH AND HUMAN SERVICES COMMISSION
Chapter 351 - COORDINATED PLANNING AND DELIVERY OF HEALTH AND HUMAN SERVICES
Subchapter A - GENERAL PROVISIONS
Section 351.701 - Unrelated Donor Umbilical Cord Blood Bank Program
Universal Citation: 1 TX Admin Code ยง 351.701
Current through Reg. 49, No. 38; September 20, 2024
(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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