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RULE §1.451Autologous Adult Stem Cell Banks

(a) This section implements Title 12, Health and Safety Code, Chapter 1003.

(b) Autologous Adult Stem Cells are cells taken from a person to be transplanted into that same person.

(c) Autologous Adult Stem Cell Bank is any facility that stores autologous adult stem cells for use in treatment or research.

(d) An entity should apply the following criteria when establishing or operating an autologous adult stem cell bank in this state.

(e) The governing body:

  (1) shall be responsible for the organization, management, control, staffing, and operation of the facility;

  (2) shall be formally organized in accordance with a written constitution and bylaws, which clearly set forth the organizational structure and responsibilities; and

  (3) shall adopt, be responsible for, and ensure that operating and ethics policies and procedures are implemented and enforced.

(f) The facility shall use current scientific standards for the collection, storage, manipulation and use of adult stem cells.

(g) The facility shall ensure that services are provided in a safe and effective manner in compliance with all applicable state and federal laws and regulations.

(h) The facility shall adopt and implement an effective, ongoing, quality assessment and performance improvement program to monitor and evaluate the collection, storage, manipulation and use of adult stem cells.

(i) An autologous adult stem cell bank operating in this state shall file, on a department form, the following information:

  (1) the bank's physical and mailing address and other contact information as specified;

  (2) the owner, principle and/or supervising physician.

(j) The information may appear on the department's public web site. The information is not an endorsement by the department and may not be used in advertising by the stem cell bank, its parent or agent.

Source Note: The provisions of this §1.451 adopted to be effective December 3, 2012, 37 TexReg 9514

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