Annex E of the Cells, Tissues, and Organs for Transplantation and Assisted Reproduction: General Requirements CSA Standard "Exclusionary Criteria for Risk Factors Associated with HIV, HBV, and HCV"

• This annex is an excerpt from "CAN/CSA Z900.1-03 Cells, Tissues, and Organs for Transplantation and Assisted Reproduction: General Requirements", Annex E, published by the Canadian Standards Association, March 2007. The Canadian Standards Association is responsible for the content of the excerpt.
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Annex E (normative)

Exclusionary Criteria for Risk Factors Associated
with HIV, HBV, and HCV

Note: This Annex is a mandatory part of this Standard.

E.1

The exclusionary criteria for donation of cells, tissues, or organs shall include the following risk factors associated with HIV, HBV, and HCV:

1. men who have had sex with another man in the preceding five years;
2. persons who report nonmedical intravenous, intramuscular, or subcutaneous injection of drugs in the preceding five years;
3. persons with hemophilia or related clotting disorders who have received human-derived clotting factor concentrates;
4. persons who have engaged in 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 persons described in Items a) to d) or with a person known or suspected to have HIV, clinically active HBV, or HCV;
6. persons who have been exposed in the preceding 12 months to known or suspected HIV-, HBV-, and/or HCV-infected blood through percutaneous inoculation 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 incarcerated for more than 72 consecutive hours during the previous 12 months;
8. persons who within 12 months of donation have undergone tattooing, ear piercing, or body piercing in which shared instruments were used; and
9. persons who have had close contact within 12 months preceding donation with another person having clinically active viral hepatitis (e.g., living in the same household, where sharing of kitchen and bathroom facilities occurs regularly).

E.2

Exclusionary criteria for evaluating pediatric donors shall include the following:

1. children meeting any of the exclusionary criteria listed in Clause E.1;
2. children born to mothers with HIV infection or to mothers who meet the behavioural or laboratory exclusionary criteria for adult donors (regardless of their HIV status) unless HIV infection can be definitely excluded in the child by meeting the following criteria: children older than 18 months of age who are born to mothers with risk for HIV infection, who have not been breast-fed within the last 12 months, and whose HIV antibody tests, physical examination, and medical records do not indicate evidence of HIV infection; and
3. children less than 18 months of age who are born to mothers with or at risk for HIV infection, or who have been breast-fed (by these mothers) within the past 12 months.

March 2007
(Replaces p. 57, January 2003)