Who is eligible to donate COVID-19 convalescent plasma (CCP)?
Donors must meet all the required screening criteria for blood donation and the additional FDA criteria, as follows:
- Prior diagnosis of COVID-19 by either one of the following:
Complete resolution of symptoms at least 14 days prior to donation
Male donors, or female donors who have not been pregnant, or female donors who have been tested since their most recent pregnancy and results interpreted as negative for HLA antibodies
- A documented positive test result (e.g. nasal swab) at the time of illness OR
- A positive serological test for SARS-CoV-2 antibodies after recovery, if prior diagnostic testing was not performed at the time COVID-19 was suspected
SARS-CoV-2 neutralizing antibody titers, if available, of at least 1:160 or 1:80 may be considered acceptable
- Female donors with a history of pregnancy and no test for HLA antibodies will be tested to mitigate TRALI as a part of OneBlood’s processes
What is the directed donation process?
- The first step in the directed donation process is for the clinician to register donor and the patient on OneBlood's clinician referral page
- The registering clinician is required to attest to the donor's eligibility as outlined above and provide their contact information and license number
- A representative will contact the donor or clinician if any further details are needed
- OneBlood will assess and schedule a collection date and time with the donor to collect COVID-19 convalescent plasma (CCP)
- Potential donor will complete all routine donor screening procedures and be assessed for eligibility for donation
- Once the CCP has been collected, tested, manufactured, and patient compatibility has been confirmed, the unit with the patient-specific eIND/EAP number will be transported to the ordering hospital's blood bank/transfusion service
- A donor cannot be directed to more than one patient eIND/EAD number
- However, more than one donor may be referred to the same patient eIND/EAD number. In these instances, the first compatible unit that is successfully collected and processed will be matched with the patient eIND/EAP number and any additional collected units will be distributed according to order fulfillment logic outlined in OneBlood’s policy
Can I request COVID-19 convalescent plasma (CCP) without referring a donor?
Yes, HOWEVER to request CCP a service order needs to be created in BloodHub and the patient-specific eIND or EAP and patient blood type must be provided. Requesting CCP must follow standard blood product ordering procedures within your hospital. The order will be fulfilled in the order it was received and compatible product becomes available – similar to standard blood donation, this relies on donors registering for an allogeneic donation. OneBlood encourages you to direct donors and clinicians to oneblood.org/COVID-19 to begin the registration process.
What happens if I refer a donor, but do not have a patient identified to receive COVID-19 convalescent plasma (CCP)?
- Any donor that is referred without a receiving patient and their accompanying eIND or EAP number, will be providing their convalescent plasma to the allogeneic supply and the product will be used to fulfill the next order in the queue according to blood type compatibility
- The more allogeneic donors that self-register on the donor form, the greater the allogeneic supply, lessening dependence on the more time-consuming process of referred donation
How do I place a request for COVID-19 convalescent plasma (CCP)?
- Orders for CCP can be placed in BloodHub, consult with your hospital’s lab or blood bank staff as they will be able to assist in logging in and placing the order
- Orders must include a patient eIND or EAP number and the patient's blood type
- If you are arranging a referred donation for a specific patient, the initial intake steps still need to be completed at oneblood.org/COVID-19, in addition to placing an order in BloodHub
Does OneBlood have a comprehensive policy around the collection and distribution of COVID-19 convalescent plasma (CCP)?
OneBlood’s updated policy on CCP can be found here
Can you tell me the status of a donor’s collection or resulting COVID-19 convalescent plasma (CCP)?
- Once a collection has been completed, OneBlood cannot share the status of the resulting unit because that is protected donor information. The status of outstanding requests for CCP can be tracked in BloodHub. When a request for CCP is being actively filled, the BloodHub order will be updated to provide insight into order fulfillment and shipping.
Why can’t I order COVID-19 convalescent plasma (CCP) for stock to have in my hospital’s inventory?
- Overall availability of COVID-19 convalescent plasma (CCP) is in extremely short supply
- Supply at this time is, in large measure, available only in conjunction with directed donations
- CCP can only be released to patients under a patient-specific Emergency Investigational New Drug (eIND) or Expanded Access Program (EAP) patient number
- Orders for CPP must be placed with an eIND or EAP patient number and the patient’s blood type. Click here for OneBlood’s policy on CCP distribution