1. (a) Purpose. This section implements and is adopted in accordance with the requirements of House Bill 3572 enacted by the 77th Texas Legislature (Acts 2001, 77th Leg., R.S., ch. 1198, at 2574), which authorizes the Health and Human Services Commission to implement a program to award a grant for the establishment of an unrelated donor umbilical cord blood bank in Texas.

2. (b) Grant objectives. The grant awarded pursuant to this section is intended to improve public health in Texas through:

   1. (1) the establishment of an umbilical cord blood bank to serve unrelated donors and recipients;
   2. (2) operation of such services for a minimum period of eight years from the date of the grant award; and
   3. (3) the support and promotion of medical and scientific research opportunities resulting from the operation of an unrelated donor umbilical cord blood bank.

3. (c) Definitions. The following words and terms, when used in this section, have the following meanings, unless the context clearly indicates otherwise:

   1. (1) Blood bank--A facility that:

      1. (A) obtains a human umbilical cord blood donation from an unrelated donor; and is either
      2. (B) licensed, certified, or accredited as a blood bank, blood and tissue center, laboratory, or other health care facility that is authorized by state and/or federal law, rule or regulation to collect, process, and preserve human umbilical cord blood donations; or

      3. (C) operated in compliance with professionally recognized standards regarding the quality and safety of collection of human umbilical cord blood donations, including, but not limited to:

         1. (i) the American Association of Blood Banks or the American Association of Tissue Banks;
         2. (ii) the American Society of Blood and Marrow Transplanters;
         3. (iii) the Center for Biologics Evaluation and Research of the United States Food and Drug Administration;
         4. (iv) the Foundation for Accreditation of Hematopoietic Cell Therapy;
         5. (v) the International Society for Cellular Therapy;
         6. (vi) the Joint Commission for Accreditation of Health Organizations; or
         7. (vii) the Cord Blood Transplantation Study sponsored by the National, Heart, Blood, and Lung Institute of the National Institutes of Health.
   2. (2) Commission--The Health and Human Services Commission.
   3. (3) Donation--Human umbilical cord blood obtained from an unrelated donor and resulting from a live birth.
   4. (4) Grant--The funding assistance authorized by House Bill 3572 enacted by the 77th Texas Legislature (Acts 2001, 77th Leg., R.S., ch. 1198, at 2574) and awarded pursuant to this section for the sole purpose of establishing an unrelated donor umbilical cord blood bank program in Texas.
   5. (5) Grantee--The recipient of the grant awarded under this section.
   6. (6) Services--Umbilical cord blood collection, storage, preservation, and/or processing services provided by a blood bank.

   7. (7) Unrelated donor--A person who:

      1. (A) is legally authorized or competent;
      2. (B) voluntarily provides a donation; and
      3. (C) is not related by affinity or consanguinity (as determined under Chapter 573, Government Code) to the recipient of the donation.

4. (d) General conditions of the grant. The grant awarded pursuant to this section, and any extension, continuation, or addition to such grant, are subject to:

   1. (1) the availability of appropriated state funds;
   2. (2) a competitive award process as established by the commission;
   3. (3) the requirements of the Uniform Grant and Contract Management Standards Act, Chapter 783, Government Code and the rules and standards adopted by the Office of the Governor in accordance with Chapter 783, Government Code, and codified at Title 1, Texas Administrative Code. Sections 5.141, et seq.;
   4. (4) the requirements of the contract executed by the commission with the grantee as required under subsection (f) of this section; and
   5. (5) audit by the commission, the State Auditor's Office, or an entity approved by the commission of the grantee's performance of the services or compliance with the rules and standards adopted by the Office of the Governor in accordance with Chapter 783, Government Code, and codified at Title 1, Texas Administrative Code. Sections 5.141, et seq.

5. (e) Applicant eligibility criteria. A blood bank may apply for the grant awarded under this section and must, at a minimum, demonstrate:

   1. (1) the ability to establish, operate, and maintain an unrelated donor umbilical cord blood bank in Texas and to provide related services, including, but not limited to:

      1. (A) experience operating similar facilities in this state;
      2. (B) affiliation or agreements with research institutions or other similar blood banks and facilities to conduct related research or improve the accessibility of umbilical cord blood services in Texas;
   2. (2) possession of an appropriate, current license, certification, or certificate of good standing to operate as a blood bank;
   3. (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. (4) the financial stability and resources sufficient to ensure the achievement of the grant objectives and operation of the unrelated donor umbilical cord blood bank;
   5. (5) appropriate donor and recipient management plans, protocols, including long-term management plans where clinically appropriate;
   6. (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;

   7. (7) a quality improvement process or mechanism to:

      1. (A) identify problems relating to the delivery of the services;
      2. (B) measure and document improvement in the delivery of the services, and
      3. (C) provide appropriate monitoring of patient outcomes, to the degree permitted under state and federal law and the informed consent of donors and recipients of donations.

6. (f) Contract. The grantee must enter into a contract with the commission that requires, among other things, that the grantee:

   1. (1) operate and maintain an unrelated donor umbilical cord blood bank in this state in accordance with standards described in subsection (c)(1)(C) of this section;
   2. (2) operate the blood bank at least until the eighth anniversary of the effective date of the contract;
   3. (3) gather, collect, and preserve umbilical cord blood only from live births;
   4. (4) comply with any financial or reporting requirements imposed on the grantee specified in the contract; and
   5. (5) comply with all applicable federal and state laws, as amended, and their implementing regulations.
7. (g) Expiration. This section expires August 31, 2004.

Source Note:The provisions of this §351.701 adopted to be effective August 5, 2003, 28 TexReg 5987.