[Federal Register Volume 61, Number 213 (Friday, November 1, 1996)]
[Notices]
[Pages 56548-56549]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-28064]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Clarification of Human Immunodeficiency Virus Screening Practices 
for Organ Donors

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services.

ACTION: Notice.

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SUMMARY: In 1994, the Centers for Disease Control and Prevention (CDC) 
published revised guidelines for preventing transmission of human 
immunodeficiency virus through transplantation of human tissue and 
organs.\1\ The guidelines were developed to minimize the risk of HIV 
transmission to transplant recipients while maintaining the 
availability of suitable donor organs/tissue. In developing the 
document, CDC sought assistance from public and private health 
professionals, including expert consultants involved in organ/tissue 
transplantation, to ensure that the diverse circumstances surrounding 
transplants were considered. Reports from the organ procurement and 
transplantation community have indicated that, in attempts to ensure 
the highest level of safety, the guidelines have been interpreted in a 
way which has further compromised the already limited supply of human 
organs. The purpose of this notice is to clarify the recommendations 
concerning the use of organs from potential donors who test HIV-
antibody negative but who have behavioral risk factors for HIV 
infection. The provisions in this notice apply only to screening of 
organ donors; they do not apply to screening of tissue, blood, or other 
donors.

    \1\ CDC. Guidelines for preventing transmission of human 
immunodeficiency virus through transplantation of human tissue and 
organs. MMWR 1994;43(No. RR-8).

FOR FURTHER INFORMATION CONTACT: Martha F. Rogers, M.D., Division of 
HIV/AIDS Prevention, CDC, Mailstop E-45, 1600 Clifton Road, Atlanta, GA 
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30333, telephone 404-639-6130.

SUPPLEMENTARY INFORMATION: The prevention of HIV transmission from 
transplantation of human organs is based primarily on two 
considerations: (a) careful screening of potential donors for behaviors 
that place them at high risk of acquiring HIV infection; and (b) HIV-
antibody testing of blood samples obtained from the potential donor. 
According to the 1994 guidelines, potential donors who test HIV-
antibody negative but have one or more behavioral exclusionary criteria 
may be accepted as donors if

    The risk to the recipient of not performing the transplant is 
deemed to be greater than the risk of HIV transmission and disease 
(e.g., emergent, life-threatening illness requiring transplantation 
when no other organs/tissues are available and no other lifesaving 
therapies exist). In such a case, informed consent regarding the 
possibility of HIV transmission should be obtained from the 
recipient.\1\

    CDC recognizes the life-extending and -enhancing properties of 
organ transplantation. Therefore, when a potential organ donor tests 
HIV-antibody negative but has behavioral risk factors for HIV 
infection, the decision to accept an organ for transplantation should 
be made after consideration of the relevant risk factors for the 
individual recipient and with recognition of the very low incidence of 
HIV transmission in such situations. CDC recognizes the need for 
transplant centers, not organ procurement organizations, to deal with 
matters of patient consent in this setting.
    In accepting an organ for transplantation, transplant teams should 
assess immediately the medical and

[[Page 56549]]

social information available from the organ procurement organization 
regarding the potential donor. In the context of the current organ 
shortage, transplant teams are encouraged to accept and transplant 
organs from medically appropriate donors who test HIV-antibody negative 
but have behavioral risk criteria for HIV infection after the 
transplant teams have discussed the risks and benefits with potential 
recipients and/or their families. As recommended in the 1994 
guidelines, organ transplant recipients should be tested for HIV 
infection three months after their organ transplant.

    Dated: October 23, 1996.
Claire Broome,
Deputy Director, Centers for Disease Control and Prevention (CDC).
[FR Doc. 96-28064 Filed 10-31-96; 8:45 am]
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