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Donor Management

Community-based Donor Standard: This standard only allows donors who permanently reside within the defined Donor Recruitment Area of the plasma center to donate at that center. The standard helps to maintain a steady and reliable donor population and supply of quality plasma.

Cross Donation Management Standard : Plasma donors may misunderstand the reasons for limiting the number of times that they can donate per week. Infrequently, a donor may attempt to donate more often than is allowed. While these are rare occurrences, it is necessary to take measures to protect the health of the donor and minimize the risk of cross donation. This standard addresses the potential risk of cross donation.

Donor Education Standard: It is important that donations are collected from a low-risk donor population. This standard requires new donors to engage in an educational program and follow-up assessment regarding HIV/AIDS and activities that place them at risk for HIV/AIDS. The educational program also encourages donors to lead a healthy lifestyle. Those potential donors, who acknowledge being involved in defined high-risk behaviors, are deferred from donating.

National Donor Deferral Registry Standard: This standard helps ensure that donors deferred for reactive test results do not donate in other facilities. Any individual who tests reactive for HIV, HBV or HCV must be entered into a national database (the National Donor Deferral Registry) used by all IQPP-certified centers in the U.S. All individuals presenting themselves for the first time are checked against the NDDR®. Those who have previously been deferred for reactive test results at any participating facility can quickly be identified and rejected utilizing this computerized database.

Qualified Donor Standard: Potential donors must pass two separate medical screenings and testing for HIV, HBV and HCV on two different occasions. Only after satisfactory screenings and negative test results does that person become a Qualified Donor. If a donor does not return within six months, that person loses his/her Qualified Donor status and must qualify again. This standard means that plasma from a one-time-only donor (even when all test results are negative) cannot be used for further manufacture. The standard results in committed donors and eliminates the risk that so-called "test-seekers" are accepted.

Viral Marker Standard: It is important that donations are collected from a low-risk donor population. This standard focuses on that element. Each center is obliged to report its viral marker rates for HIV, HBV and HCV in the donor population. The center's rates are compared to the industry average. Alert limits are set to take into account the number of annual donations. If a center exceeds the limit for any of these viruses or the aggregate, the center will implement corrective actions that will bring the center into compliance with the standard.

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