Plasma is the liquid component of blood collected through plasmapheresis, where the plasma is separated and the remaining blood cells are returned to the donor. This collected plasma is a raw material for creating life-saving plasma protein therapies, which treat serious conditions like hemophilia and immune deficiencies. Plasma donation centers operate under a strict regulatory framework established by the U.S. Food and Drug Administration (FDA). These federal guidelines govern every aspect of the collection process, including how frequently an individual can donate.
Why Donor Safety Requires Frequent Monitoring
Tracking the frequency of donations is a fundamental requirement to safeguard the donor’s health. Plasmapheresis removes large volumes of plasma, which contains important proteins and water. Frequent removal can temporarily deplete these proteins, particularly immunoglobulins, potentially lowering a donor’s ability to fight off infections.
Because of this risk, the FDA permits a donor to undergo plasmapheresis no more than once in any two-day period, and a maximum of twice within a seven-day period. Centers also perform screenings before each donation to measure total protein levels and hematocrit. Monitoring these biological markers is a direct method of preventing hypoproteinemia or anemia caused by excessive donation.
National Systems for Tracking Donor History
Plasma centers know if a donor has recently visited another facility, even one operated by a competing company. This knowledge is possible due to a centralized, industry-wide database established specifically to prevent individuals from donating too often, a practice known as cross-donation. The Plasma Protein Therapeutics Association (PPTA) developed and maintains this system.
This database is called the Cross Donation Check System (CDCS). Every time a donor presents at a participating center, their personal identifying information is entered into the CDCS to check for recent donations at any other center connected to the network. The system works in near real-time to flag any individual attempting to donate before the federally mandated 48-hour waiting period has passed. The core purpose of the CDCS is to minimize the risk of a donor exceeding the maximum allowable frequency, which could compromise their health.
The CDCS helps the entire industry adhere to the strict federal requirements for donation frequency. This shared data system ensures that the safety rules remain consistent regardless of which corporate entity collects the plasma. This centralized tracking mechanism makes it virtually impossible to successfully donate at one center and then immediately attempt to donate at a different center. This cross-center monitoring provides an essential layer of protection for the donor population.
What Happens When Donation Limits Are Exceeded
When the CDCS detects a recent donation at another facility, the donor is immediately refused for that day’s procedure. This refusal is a direct consequence of the system flagging a violation of the required time interval between donations. The individual is then subject to a temporary deferral until the required period has elapsed.
Attempting to bypass the frequency rules can lead to more serious consequences beyond a single refusal. If a donor is found to be intentionally cross-donating, they may face a permanent deferral from all plasma donation centers connected to the system. This action is taken because the centers must comply with FDA regulations, and allowing repeated over-donation could result in regulatory penalties. The deferral process is ultimately a safety measure designed to protect the donor from the physiological risks associated with excessive plasma removal.