Virginia Regulatory Town Hall

Proposed Text

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Action:
Repeal Sections Pertaining to HIV Testing of Gamete Donors
Stage: Fast-Track
 
12VAC5-90-230

Part XII
Human Immunodeficiency Virus (HIV) Testing of Gamete Donors (Repealed)

12VAC5-90-230. Definitions. (Repealed.)

The following words and terms, when used in this part, shall have the following meanings unless the context clearly indicates otherwise:

"Artificial insemination" means instrumental placement of semen into the vagina, cervical canal, or uterus of a recipient.

"Donor" means an individual who is unrelated by marriage to the recipient and who contributes sperm or ova used in the following procedures: treatment of infertility by artificial insemination; in vitro fertilization; gamete intrafallopian tube transfer; zygote intrafallopian tube transfer or any other gamete, zygote, or embryo transfer; or other intervening medical technology using sperm or ova.

"Embryo" means the product of a fertilized ovum prior to the eighth week of development inside a uterus.

"Gamete" means either sperm or ova.

"Gamete intrafallopian tube transfer" means placement of harvested ova and sperm into the fallopian tube or tubes of a recipient.

"HIV-1" means the retrovirus causing the human immunodeficiency virus infection, type 1.

"HIV-2" means the retrovirus causing the human immunodeficiency virus infection, type 2.

"In vitro fertilization" means placement of a zygote or embryo that has been fertilized outside the body into the uterus of a recipient.

"Zygote" means a fertilized ovum prior to cell cleavage.

"Zygote intrafallopian tube transfer" means placement of a zygote or zygotes into the fallopian tube or tubes of a recipient.

12VAC5-90-240

12VAC5-90-240. Excluding donors with high risk factors. (Repealed.)

A. Practitioners using gametes for the treatment of infertility by transfer of such gametes to a recipient shall interview all gamete donors at the time of donation in order to screen for high risk behavior indicating potential exposure to HIV-1 and HIV-2.

B. Any gamete donor reporting infection with HIV-1 or HIV-2 or any of the following risk factors shall be excluded from donating:

1. Men who have had sex with another man within the preceding five years.

2. Persons who have injected drugs for a nonmedical reason in the preceding five years, including intravenous, intramuscular, and subcutaneous injections of recreational or illegal drugs.

3. Persons with hemophilia or related clotting disorders who have received human derived clotting factor concentrates.

4. Persons who have had sex in exchange for money or drugs in the preceding five years.

5. Persons who have had sex in the preceding 12 months with any person described in subdivisions 1 through 4 of this subsection or with any person suspected of being infected with HIV-1 or HIV-2.

6. Persons who have been exposed within the last 12 months to known or suspected HIV-1 or HIV-2 infected blood through percutaneous inoculation (e.g., needle stick) or through contact with an open wound, nonintact skin, or mucous membrane.

7. Current inmates of correctional systems, including jails and prisons, and individuals who have been confined in jail or incarcerated in prison for more than 72 consecutive hours during the previous 12 months.

8. Persons who have had or have been treated for syphilis or gonorrhea during the preceding 12 months.

9. Persons who within 12 months of donation have undergone acupuncture, ear or body piercing or tattooing in which sterile procedures were not used or where it is unknown if sterile procedures were used.

10. Persons who choose to defer from donation whether or not they report any of the above potential exposures to HIV-1 or HIV-2.

12VAC5-90-250

12VAC5-90-250. Storage of semen pending negative HIV tests. (Repealed.)

Semen specimens from donors shall be stored and withheld from use for at least 180 days following donation and used only if the donor tests negative for serum antibodies for HIV-1 and HIV-2 on enzyme-linked immunosorbent assay or blood HIV-1 and HIV-2 by polymerase chain reaction at least 180 days after donation.

12VAC5-90-260

12VAC5-90-260. Use of ova after negative HIV tests. (Repealed.)

Ova shall be used only if the donor tests negative for serum antibodies to HIV-1 and HIV-2 on enzyme-linked immunosorbent assay or blood HIV-1 and HIV-2 by polymerase chain reaction at the initiation of the cycle during which the ova are harvested.

12VAC5-90-270

12VAC5-90-270. Notifying recipients of option to delay transfer. (Repealed.)

Practitioners using ova, embryos, or zygotes for the treatment of infertility or other medical technology involving the transfer of ova, embryos, or zygotes to a recipient shall notify these recipients of the option for having donor ova fertilized and the resultant zygotes frozen and then transferred to the recipient only if the ova donor is negative for serum antibodies for HIV-1 and HIV-2 on enzyme-linked immunosorbent assay or blood HIV-1 and HIV-2 by polymerase chain reaction at least 180 days after donation.