Source Plasma Donor Laboratory Suitability Criteria (BioLife Plasma Centers)
BioLife Plasma centers use donor suitability criteria that include key pre-donation blood tests such as hemoglobin and total serum protein. These criteria align with U.S. FDA expectations for plasmapheresis donor suitability. [1] BioLife also performs a pre-donation medical screening that includes a blood sample on the day of donation. [2]
Hemoglobin and Hematocrit Thresholds
- Hemoglobin must be ≥12.5 g/100 mL of blood. [1]
- If the microhematocrit method is used, a hematocrit value of 38% is equivalent to 12.5 g/100 mL hemoglobin. [1]
Total Serum Protein Threshold
- Total serum protein must be no less than 6.0 g/100 mL. [1]
- Donors with quantitative total protein results <6.0 mg/100 mL are deferred until repeat testing shows acceptable values. [1]
Blood Pressure and Vital Parameters Used Alongside Laboratory Tests
- Blood pressure must be within normal limits, with a systolic range of 90–180 mmHg and a diastolic range of 50–100 mmHg considered normal. [1]
- Pulse rate of 50–100 beats per minute with regular rhythm is the recommended normal range. [1]
Infectious Disease Testing Relevant to Donor Eligibility
- Donor suitability determination includes serologic testing for syphilis (STS). [1]
- Donors must be free of diseases transmissible by blood transfusion, with specific deferral rules described by FDA donor suitability expectations. [1]
Measurement Practices on Donation Day
- Hemoglobin/hematocrit and total serum protein are assessed as part of the day-of-donation suitability determination. [1]
- Weight must be at least 110 lb for donation suitability. [1]
BioLife-Specific Publicly Posted Eligibility Information
- BioLife states that a pre-donation medical screening includes vitals and a blood sample to ensure it is safe to donate that day. [2]
- BioLife publicly indicates that local staff determine individual eligibility after medical screening. [2]