Plasma donation is a process where the liquid portion of blood, plasma, is collected while red blood cells and other components are returned to the donor. This valuable component is used to create therapies for individuals with various medical conditions, including immune deficiencies and bleeding disorders. Regulatory bodies and donation centers classify donors as “new” or “returning” based on specific criteria to ensure the safety and quality of plasma-derived medicinal products.
Understanding “New” Plasma Donor Criteria
An individual is classified as a “new” plasma donor if they have never donated before or if a significant amount of time has passed since their last donation. Initial eligibility requires donors to be at least 18 years old and weigh a minimum of 110 pounds. Potential donors undergo a comprehensive screening process, including a detailed medical history, a physical examination, and blood tests for transmissible viruses like HIV and hepatitis, to ensure their health and plasma safety.
During screening, vital signs are measured, and a blood sample is taken to assess hematocrit and protein levels. Donors must also provide valid identification, proof of address, and their Social Security number. This process establishes a baseline health profile before their first donation.
How Long “New” Donor Status Lasts
The duration a donor is considered “new” is determined by regulatory testing and safety protocols. Federal regulations require ongoing testing and monitoring. Plasma collected during initial donations may be held in quarantine for a minimum of 60 days. This hold period allows for subsequent negative test results to confirm the donor’s eligibility and the plasma’s safety.
A donor achieves “qualified donor” status after completing a certain number of donations with consistently negative test results within a specified timeframe. Until these conditions are met, initial plasma units are not released for manufacturing therapeutic products. This ensures that only plasma from thoroughly screened and repeatedly tested donors enters the supply chain, prioritizing patient safety.
Becoming a Returning Donor and Ongoing Frequency
Once a donor meets the criteria for “qualified” status, they become a “returning” donor. This means their plasma can be used for manufacturing therapies without the extended quarantine period applied to initial donations. Returning donors can donate plasma more frequently than whole blood donors due to the body’s rapid ability to replenish plasma. Federal regulations permit donations up to twice within a seven-day period, with at least 48 hours between donations.
Before each subsequent donation, returning donors undergo a “mini” health screening. This abbreviated process includes a review of their health questionnaire, a check of their vital signs, and a finger-prick blood test to re-evaluate hematocrit and protein levels. While less extensive than the initial screening, these regular checks are important for monitoring the donor’s ongoing health. Additionally, returning donors are required to have a full physical examination at least once a year to maintain their eligibility.
Resetting Donor Status
A previously qualified returning donor may be reclassified as “new” or require full re-screening under certain circumstances. This typically occurs after a significant lapse in donation activity. If a donor is unable to provide a sample for required periodic testing for over six months, they must be processed as a new donor upon their return.
This reclassification necessitates repeating the comprehensive medical history, physical examination, and initial blood tests. The purpose of resetting donor status after a prolonged absence is to re-evaluate the donor’s health and confirm continued eligibility, as their medical status or exposure risks may have changed. The re-screening process ensures all safety standards are upheld for plasma collection.