5 Colo. Code Regs. § 1005-6-2

Current through Register Vol. 47, No. 24, December 25, 2024

Section 5 CCR 1005-6-2 - Definitions

A. Assisted reproduction: method of causing pregnancy other than sexual intercourse. The term includes:

a. intrauterine or intracervical insemination;

b. donation of gametes or embryos;

c. in-vitro fertilization and transfer of embryos; and

d. intracytoplasmic sperm injection.

B. Department: the Colorado Department of Public Health and Environment.

C. Donor: individual who produces eggs or sperm collected by a gamete agency, gamete bank, or fertility clinic or whose eggs or sperm is used to create an embryo received by a gamete agency, gamete bank, or fertility clinic for use in assisted reproduction by a recipient who is unknown to the donor of the gametes at the time of donation. A donor and a recipient parent or parents are "unknown" to each other if a gamete agency, gamete bank, or fertility clinic introduced or initiated the match or connection between the donor and recipient parents, and the donor and recipient parent or parents do not mutually exchange identifying information. The term "donor" only applies to the regulation of gamete agencies, gamete banks, or fertility clinics pursuant to article 57 and does not apply for the purposes of determining parentage.

D. Donor-conceived person: an individual of any age who was born as a result of assisted reproduction using gametes from a donor unknown to the recipient parent or parents at the time of donation.

E. Family: For the purposes of counting families established in this licensure program, a "family" is a unit of one or more parents and the children they parent. This includes new partners of anyone already parenting a child conceived with donor gametes. This definition only applies to these rules.

F. Fertility clinic: entity or organization located in Colorado that performs assisted reproduction medical procedures and receives donor gametes for a recipient and the recipient and gamete donor are unknown to each other at the time of donation.

G. Gamete: unfertilized oocytes or sperm.

H. Gamete agency: oocyte or sperm donor matching agency that:

a. Matches gamete donors with recipients; and

b. Matches the potential recipients and gamete donors who are unknown to each other at the time of donation; and

c.

I. Is located within Colorado; or

II. Is located outside of Colorado and matches intended recipients located in Colorado during the matching process with gamete donors.

I. Gamete bank: entity or organization that

a. collects gametes from a donor or receives embryos; and

b. provides gametes or embryos to a recipient parent or parents or the recipient parent's medical provider when the recipient and donor are unknown to each other at time of donation, and

c.

(I) is located within Colorado or

(II) provides gametes or embryos to a recipient parent or parents located in Colorado.

J. Identifying information: donor's full name; donor's date of birth; donor's permanent, and, if different, current address or other contact information at the time of donation, or, if different, the donor's current address or other contact information or both as retained by the gamete agency, gamete bank, or fertility clinic.

K. Matches or matches gametes: means the process of matching a donor with a recipient in Colorado. A "match" is made by a gamete agency, and a match is considered made when an intended recipient parent selects a specific potential donor, or agrees to receive a specific potential donor's gametes, prior to the collection of the gametes.

a. For recipients who already have a child from a donor, the recipient is considered to be already "matched" with that donor when requesting additional samples.

L. Medical history: information regarding present physical illness of donor; past illness of donor; and social, genetic, and family medical history pertaining to donor's health.

a. For the purpose of these rules, "family medical history" must include a detailed 3-generation family history to the extent possible. Donors who are adopted and those who are unable to provide any family history information about their genetic relatives should be considered on a case-by-case basis.

M. Mental health professional: a person who is certified or licensed pursuant to article 245 of title 12 or an out-of-state professional who is a licensed psychiatrist, clinical psychologist, or professional counselor.

N. Recipient or recipient parent: a person who receives donor gametes or embryos as an intended parent from a gamete agency, gamete bank, or fertility clinic for use in assisted reproduction for the purpose of conceiving a child.

O. Recipients in Colorado: people within Colorado, regardless of their residency, receiving the goods or services described in this rule that require a license. This does not include Colorado residents who leave Colorado to receive services.

P. State board: the Colorado State Board of Health.

5 CCR 1005-6-2

47 CR 20, October 25, 2024, effective 11/14/2024