SECTION 351.701. Unrelated Donor Umbilical Cord Blood Bank Program

(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.

Source Note: The provisions of this §351.701 adopted to be effective August 5, 2003, 28 TexReg 5987; amended to be effective June 22, 2016, 41 TexReg 4435