COVID-19 Convalescent Plasma Program – Hospitals

While the product is a regular apheresis plasma unit, it is considered an “investigational” product when used for transfusion to COVID-19 patients. Hospitals bear the responsibility for research use of COVID-19 convalescent plasma.

If you have not already done so, you must decide how you are going to access the product. You have three main options (NOTE that all pathways allow your hospital to continue to work directly with LifeStream for product access).

  • US COVID-19 Expanded Access Program (Mayo Clinic National IRB)
    • This is likely the simplest and least cumbersome way to obtain the product.
    • Follow the directions on the site to register your facility, and the approval extends to all patients (individual informed consent supplied on the above page).
    • You will be required to complete simple paperwork after the transfusion for the study; see protocol for details.
    • Billing for products provided under the EAP will be done via BARDA.
  • Emergency Investigational New Drug Approval (eIND from FDA)
    • Approval to administer CCP under this eIND is patient-specific and limited to those who have severe or immediately life-threatening COVID-19.
    • The basic process is outlined here.
    • Each patient undergoing treatment requires an individual approval from FDA.
    • Providers must complete a simple form and get a confirmatory email from FDA (typically within 4-8 hours); faster turnaround may occur with phone approval.
    • Billing for products provided under local IRB will be billed directly to the hospital.
  • Local (independent) Investigational Review Board
    • You will need to follow your own IRB processes for transfusion of this product.
    • Please note that LifeStream is NOT required to collect this product under “research” conditions.
    • As a result, any additional tests or samples for donors referred by a hospital to LifeStream will be the responsibility of the hospital (LifeStream will not collect additional samples for your research use, in other words).
    • Billing for products provided under local IRB will be billed directly to the hospital.

Since the way the product is billed is different between these pathways, LifeStream will ask if your facility is participating in the Expanded Access Program at the time of shipping the product to you.

To prepare for program expansion and accepting convalescent plasma at your organization, please enter the following ISBT codes into your system as soon as possible:

Ordering COVID-19 Convalescent Plasma

Please contact LifeStream Hospital Services at 909-386-6829 or email covidplasma@LStream.org for more information. This product will not be available through routine electronic ordering system.

Hospital Pre-screening
  • Since this product is likely to be scarce, especially in the early days of collections, LifeStream can only support transfusion of products according to the criteria outlined in the Expanded Access Program protocol; please see page 5 of that document.
    • LifeStream asks that hospital transfusion services and their medical directors verify that products requested are being given to patients who meet the EAP inclusion criteria:
      • At least 18 years of age
      • Laboratory-confirmed diagnosis of infection with SARS-CoV-2
      • Admitted to an acute care facility for the treatment of COVID-19 complications
      • Severe or life-threatening COVID-19, or judged by the treating provider to be at high risk of progression to severe or life-threatening disease (NOTE: See the linked protocol, page 5, for the definition of “severe” and “life-threatening”)
  • ​LifeStream does not test donors or blood products for ACTIVE COVID-19 infection. 
  • LifeStream Blood Bank is now testing all successful blood donations for COVID-19 antibodies. Your antibody testing results reveal your potential to donate convalescent plasma, a powerful way to help those fighting COVID-19. The antibody test will indicate if the donor’s immune system has produced antibodies because of previous exposure to the virus. This is not a test that tells a person whether or not they have a current COVID-19 infection. If you are feeling unwell, please do not donate blood. For more info about antibody testing, click here.
  • LifeStream does NOT provide directed donations to specific facilities or patients. When a donor donates convalescent plasma on behalf of a hospital, we reserve some of the products from that collection for that hospital’s use. The hospital then decides how to distribute the product in their facility, based on their own criteria. We work with donors and hospitals to make this happen every day through this web page, and we are appealing to recovered COVID-19 patients throughout our area to contact us to arrange a convalescent plasma donation.

Will My Hospital Receive All of the Plasma from Donors I Refer to LifeStream?
  • If LifeStream successfully collects a plasma product from a donor referred by a hospital or provider associated with a hospital, we will reserve up to half of the plasma products collected from the donor’s first donation for that hospital’s use.
  • Most apheresis plasma collections result in three or four plasma units, approximately 200 mL each. If up to three units are collected from the donor’s first donation, one unit will be reserved for the referring hospital. If four units are collected, then two units will be reserved.
  • Please note: As mentioned above, this process is NOT a “directed donation.” LifeStream will not “tag” the unit with a potential recipient’s name, as this is the responsibility of the transfusing facility. ABO compatibility is also the responsibility of the transfusing facility.
For further questions, please email covidplasma@LStream.org, or call (909) 386-6837.
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