Talecris owns or contracts with plasma donation centers located in communities throughout the United States. Each center must meet Talecris Biotherapeutics' strict specifications for all aspects of the plasma collection process.
Each plasma donation center is inspected three to six times each year by various Federal and State regulatory agencies and organizations, as well as by Talecris Biotherapeutics' quality assurance department.
First-time Donor
Every first-time donor undergoes an extensive screening program:
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Medical Exam |
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Medical History |
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Check against the National Donor Deferral Registry (NDDR) |
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Two sequential screening and serological viral tests are conducted within a six-month period:
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Human immunodeficiency virus (HIV) |
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Hepatitis B (HBV) |
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Hepatitis C (HCV) |
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Repeat Donations Required
For additional safety, Talecris holds a donor's plasma until the donor returns for a second donation.
If a donor does not return to the center in 60 days, the donor's plasma is destroyed. This repeat donation requirement has increased plasma safety dramatically.1,2
References:
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1. |
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Remington KM, Petteway SR Jr. Comprehensive Pathogen Safety Management for Plasbumin. Pediatr Crit Care Med. 2001;2(suppl):S23-S27.
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Council of Europe, Public Health Committee. Human Plasma for Fractionation.1998. Resolution AP-CSP (98) 11.
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