Plasma donation involves collecting the liquid portion of blood (plasma) for manufacturing medical treatments. A donor’s status, whether “new” or “returning,” is a classification used by collection centers. This designation influences initial donation volume limits, medical screening requirements, and the payment structure. Federal regulations govern donor classification to ensure donor health and product safety.
Establishing Donor Status for the First Time
Becoming a plasma donor begins with a screening process to establish eligibility. This requires a medical history interview, a physical examination by licensed or supervised personnel, and blood tests for infectious diseases and protein levels. Federal guidelines specify the physical examination must occur no more than one week before the first procedure.
The “New Donor” status is established only after successfully completing this screening and the first successful donation. This procedure sets the baseline health metrics against which future donations are measured. Once the first donation is completed, the donor transitions from an applicant to a documented “Repeat Donor.”
The Time Frame That Reclassifies a Returning Donor
The definition of a “lapsed” donor after a break is determined by federal health guidelines, which mandate specific re-screening procedures. The U.S. Food and Drug Administration (FDA) requires that a donor who does not return for necessary periodic testing for a period exceeding six months must be processed as a new donor upon their return. This six-month lapse triggers a full reset of the donor’s status.
When a donor returns after this six-month benchmark, they must undergo the entire initial screening process again, including a new physical examination and a complete medical history review. This requirement ensures that the donor’s current health status meets all safety standards before they continue donating. Although the six-month period is the regulatory standard for re-screening, individual plasma centers may also use this reclassification to re-enroll the donor in a “new donor” compensation program for a limited time.
This reclassification is necessary because required monitoring tests, such as the total plasma protein determination, must be performed at least every four months for regular donors. Exceeding the six-month time limit necessitates the more rigorous “new donor” re-screening to confirm their continued suitability.
Distinguishing Status Rules from Donation Frequency Limits
The time frame for reclassifying a lapsed donor should not be confused with short-term donation frequency limits. Federal regulation strictly limits the frequency of donation to protect the donor’s health. Donors are permitted to donate no more than twice within any seven-day period.
A minimum of one calendar day must pass between donations to allow the body to recover and replenish fluid volume. These short-term frequency limits apply universally, focusing on immediate biological recovery. The long-term six-month status rules focus on maintaining current health and safety documentation.