(1) On or after July 1, 2025, a gamete agency, gamete bank, or fertility clinic shall not operate as a gamete agency, gamete bank, or fertility clinic in Colorado, or match or provide gametes or embryos to recipients in Colorado, without having first obtained a license from the department. The license is conditioned on compliance with the applicable standards, requirements, and other provisions of this article 57 and its implementing rules. (2) (a) A gamete agency, gamete bank, or fertility clinic shall submit an annual application and fee for a license to operate on the form and in the manner prescribed by the department. (b) (I) On or before January 1, 2025, the state board shall promulgate rules establishing a schedule of fees of not more than five hundred dollars per year, subject to annual adjustment for inflation, based on the annual percentage change in the United States department of labor's bureau of labor statistics consumer price index for Denver-Aurora-Lakewood for all items paid by all urban consumers, or its applicable predecessor or successor index, to help meet the direct and indirect costs of administration and enforcement of this article 57. A gamete agency, gamete bank, or fertility clinic that is a nonprofit organization is exempt from such fees. (II) The department shall assess and collect, from each gamete agency, gamete bank, or fertility clinic that is applying for licensure pursuant to this section, a fee in accordance with the fee schedule established by the state board pursuant to subsection (2)(b)(I) of this section. (III) The department shall transmit fees collected pursuant to this section to the state treasurer, who shall credit the money to the gamete agency, gamete bank, or fertility clinic fund created in section 25-57-112. (IV) Fees collected pursuant to this subsection (2) may be used by the department to provide technical assistance and education to the public and to gamete agencies, gamete banks, or fertility clinics related to the provision of and compliance with Colorado law, in addition to regulatory and administrative functions. The department may contract with private entities to assist the department in providing technical assistance and education but not in providing regulatory or administrative functions. (3) (a) (I) The department shall investigate and review each original application and each renewal application for a license to operate as a gamete agency, gamete bank, or fertility clinic. The department shall require all applicants to submit information in the original and renewal application process to document compliance with licensing requirements. Subject to available appropriations, the department may, as it deems necessary, perform on-site inspections or complaint investigations of a gamete agency, gamete bank, or fertility clinic located outside of Colorado. The department shall determine an applicant's compliance with this article 57, and the rules adopted pursuant to this article 57, for the collection and provision of gametes from donors who are unknown to a recipient at the time of the donation before issuing a license. (II) The gamete agency, gamete bank, or fertility clinic shall submit in writing, in a form prescribed by the department, a corrective action plan detailing the measures it will take to correct any violations found by the department as a result of inspections undertaken pursuant to this subsection (3). The department shall conduct a follow-up inspection to ensure implementation of the corrective action plan. (III) When investigating or reviewing the records of a gamete agency, gamete bank, or fertility clinic located outside of Colorado, the department shall investigate and review only the records pertaining to donors whose gametes or embryos were matched or provided to recipients in Colorado. (b) The department shall not retain any identifying information about donors, recipients, or donor-conceived persons, and shall keep confidential all health-care information or documents obtained or viewed during an inspection or investigation of a gamete agency, gamete bank, or fertility clinic pursuant to subsection (3)(a) of this section. All records, information, or documents so obtained are exempt from disclosure pursuant to sections 24-72-204 and 25-1-124. (4) Except as otherwise provided in subsection (5) of this section, the department shall issue or renew a license to operate as a gamete agency, gamete bank, or fertility clinic when it is satisfied that the applicant or licensee is in compliance with the requirements set forth in this article 57 and the rules promulgated pursuant to this article 57. Except for provisional licenses issued in accordance with subsection (5) of this section, a license issued or renewed pursuant to this section expires one year after the date of issuance or renewal. The department shall suspend or revoke a license in accordance with section 24-4-104. (5) The department may issue a provisional license to operate as a gamete agency, gamete bank, or fertility clinic to an applicant for the purpose of operating as a gamete agency, gamete bank, or fertility clinic for a period of ninety days if the applicant is temporarily unable to conform to all of the standards required pursuant to this article 57. As a condition of obtaining a provisional license, the applicant shall show proof to the department that significant good faith attempts are being made to conform and comply with the applicable standards required pursuant to this article 57. The department may issue a second provisional license, for a like term and fee, to effect compliance. A further provisional license shall not be issued for the current year after the second issuance. (6) (a) It is a violation of this article 57 for any person, corporation, or other entity to operate as a gamete agency, gamete bank, or fertility clinic in Colorado without a valid license or in violation of the terms and conditions of a license. The department may revoke or not renew the license in accordance with the procedures set forth in section 24-4-104 of a licensed gamete agency, gamete bank, or fertility clinic that fails to adhere to the terms and conditions of its license and the standards and requirements established by rule pursuant to this article 57. (b) The department may assess a civil penalty of not more than twenty thousand dollars, adjusted annually for inflation, based on the annual percentage change in the United States department of labor's bureau of labor statistics consumer price index for Denver-Aurora- Lakewood for all items paid by all urban consumers, or its applicable predecessor or successor index, for each day the person is in violation of this article 57. The assessed penalty accrues from the date the department finds that the person, corporation, or entity is in violation of this article 57. The department shall assess, enforce, and collect the penalty in accordance with article 4 of title 24 and credit the money to the general fund. Enforcement and collection of the penalty occurs following the decision reached in accordance with procedures set forth in section 24-4- 105.
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