Improvements in donor screening, serologic testing, reporting and investigating suspected donor-derived disease transmission have improved organ and tissue safety. The risk of acquiring an infection from an organ or tissue transplant is thought to be very low. However, the risk for transmission of infectious pathogens, such as viruses, bacteria, fungi and protozoa/parasites, remains and requires continued vigilance.
Multiple organizations play a role in organ and tissue safety. CDC provides expertise and assistance investigating potential transmission of infections from organs or tissues. CDC investigates suspected disease transmission, assisting state and local health departments, especially when the investigation is multistate. CDC reference laboratories help identify the transmitted pathogens provide additional testing capabilities that may not be otherwise available. CDC disease detectives assist the healthcare community in tracing back diseased organs to the original donor in order to identify who else may have received contaminated organs and/or tissue. Findings from investigations help inform regulatory decisions and guidance on reducing the risk of infectious transmissions through organ and tissue.
The Health Resources and Services Administration (HRSA) is a government agency that provides oversight of organ recovery and transplantation through the Organ Procurement and Transplantation Network (OPTN), established by Congress under the National Organ Transplant Act of 1984.
- The United Network for Organ Sharing (UNOS) is a private, non-profit organization that operates the OPTN under contract with HRSA. OPTN data is collected on all deceased and living donors, organ candidates and organ recipients. OPOs and transplant hospitals must be members of the OPTN to participate in organ recovery and transplantation, and are expected to follow OPTN policies.
The Centers for Medicare and Medicaid Services (CMS) is a government agency that establishes performance standards for transplant centers and OPOs to determine certification or recertification. The ability to receive Medicare reimbursement is linked to meeting CMS performance standards.
The Association of Organ Procurement Organizations (AOPO) is a national, non-profit organization that offers a voluntary accreditation service to its 58 OPO institutional members located within the United States and its territories to help ensure compliance with federal regulations and AOPO standards. AOPO also provides services such as education and advocacy for its members.
The Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) is a government agency that regulates human tissue, including ocular tissue, for transplantation. Regulations cover all tissue banks that are involved in the recovery, processing, storage and/or distribution of tissue. Only healthcare facilities that participate in the recovery, processing or distribution of tissue for transplantation are also required to follow FDA tissue regulations.; All tissue and eye banks must be registered with the FDA and follow these regulations.
The American Association of Tissue BanksExternal, a professional, non-profit scientific and educational organization, provides an accreditation program for transplant tissue banks. Accreditation is mandatory for maintaining status as an AATB institutional member. Currently, more than 125 tissue banks are accredited based on compliance with AATB’s Standards for Tissue Banking. These Standards include requirements harmonized with applicable FDA External regulations and guidance.
The Eye Bank Association of AmericaExternal is a national, non-profit organization that provides an accreditation service for its 83 U.S. and 12 international member eye banks ensuring compliance with EBAA published medical standards. Accreditation is mandatory for active membership in the EBAA. EBAA Medical Standards define minimum standards of practice in the recovery, preservation, processing, storage, and distribution of ocular tissue for transplantation, and are endorsed by the American Academy of Ophthalmology. Medical standards include requirements to maintain eye bank compliance with applicable FDAExternal regulations.