Connecticut General Statutes (Last Updated: November 2, 2019) |
Volume 6. |
Title 19a. Public Health and Well-Being |
Chapter 368a. Department of Public Health |
Sec. 19a-32s. Board's authority to enter into contracts re collection and transportation of umbilical cord blood units.
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(a) In order to achieve the umbilical cord blood collection goals of the program, the board shall, commensurate with available funds appropriated for the administration of the program, contract with one or more entities that have demonstrated the competence to collect and transport umbilical cord blood units in compliance with all applicable federal law and who meet all other requirements prescribed in this section. The board shall contract to establish or designate not less than two umbilical cord blood collection centers at fixed locations in the state. Any such fixed location collection center shall be located at a birthing hospital with three thousand seven hundred fifty or more births per year and where a disproportionate share of such births involve women from minority populations. The board shall, to the extent practicable, encourage the collection of units of umbilical cord blood at other nonfixed locations in the state as is practicable.
(b) Any contract entered into pursuant to subsection (a) of this section shall: (1) Use a competitive process that identifies the best proposals submitted by applicant entities to achieve the collection and research objectives of the program; and (2) provide that (A) the state retains an interest in any umbilical cord blood collected in the state commensurate with its investment in the program, (B) income received by the board as a result of the contract shall be used to ensure that the umbilical cord blood collection program shall be self-sustaining not later than July 1, 2020, (C) any units of umbilical cord blood deemed unsuitable for transplantation shall be returned to the state for use in biological or medical research, and (D) any entity with whom the board contracts shall provide quarterly reports to the board that include, but are not limited to, information concerning: (i) The total number of umbilical cord blood units collected, (ii) the number of collected units deemed suitable for transplant, (iii) the number of collected units deemed suitable for research only, and (iv) the clinical outcomes of any transplanted units. Reports provided to the board pursuant to this subsection shall not include personally identifiable information.
(c) Any entity seeking to enter into a contract with the board shall, at a minimum, be in compliance with the requirements of the federal Food and Drug Administration pertaining to the manufacture of clinical-grade cord blood stem cell units for clinical indications.
(d) Any medical facility or research facility performing services on behalf of the board, pursuant to a contract entered into pursuant to subsection (a) of this section, shall comply with, and be subject to, state and federal law concerning the protection of medical information and personally identifiable information contained in, or obtained through, the umbilical cord blood collection inventory.
(e) For purposes of this section and section 19a-32r, the board shall not be considered a state contracting agency, as defined in subdivision (28) of section 4e-1.
(P.A. 11-160, S. 5.)
History: P.A. 11-160 effective July 13, 2011.