This process was originally done in the first phase of CCP collection.  I have updated it to include SARS-CoV-2 antibody testing.

Principle:

Due to the pandemic, we will initially MANUALLY collect an experimental, investigational-use-only plasma product from apheresis donors and treat it with Mirasol.  THIS IS A EMERGENCY INTERIM PROCESS UNTIL THE MEDINFO HEMATOS IIG PROCESSES ARE PREPARED AND VALIDATED.

Policy:

1. Good Manufacturing Practice applies:
   1. Manufacturers’ recommended processes for equipment and materials usage applies.
   1. All staff engaged in these processes must be competency assessed successfully.
2. Pre-Screening:
   1. Clinical staff will use the prescreening document to select donors for pre-donation screening.
3. Quarantine:
   1. All processes (day 0, day 1, day 2, and product modification and release) will be done in quarantine areas SEPARATE and DISTINCT from regular Transfusion Medicine activities.  This includes:
      1. Separate space and equipment must be provided.
         1. Equipment for this project may NOT be used for regular, non-quarantine processes
   2. Non-Transfusion Medicine staff will not be permitted in operational areas.
   3. Prospective donors will not be permitted in the processing, testing, storage, or blood bank work areas.
4. Donation Process:
   1. Day 0:  Registration, check donor deferral database, questionnaire, physical exam including arm check, and specimen collection using ISBT specimen labels
   2. Use latest manual donor questionnaire.
   3. Day 1:  Donor marker and immunohematology testing, review of results, accept or reject donor for actual plasmapheresis
   4. Day 2:  Collect manufacturer’s recommended volume of plasma (500 ml if < 80 kg, 600 ml if >= 80 kg), aliquot, pathogen-inactivate (Mirasol), freeze at minus 80C
5. Testing:
   1. Testing will be performed with regular blood donor specimens using ISBT specimen labels
   2. Testing must be done by donor-specific processes (not those for clinical patients)
      1. Exclude malaria and HTLV testing.
   3. Testing must be directly interfaced to Medinfo Hematos IIG donor module
   4. CCP COVID antibody testing:
      1. SARS-CoV-2 antibody testing to be performed to determine cut-off for donor eligibility for CCP collection.
      2. Use of donors with antibody levels below threshold is at the discretion of the treating clinician.
6. Processing:
   1. Aliquoting, pathogen-inactivation, and labelling may proceed if the pre-donation screening results are acceptable.
7. Storage:
   1. Long-term in minus 80C quarantine freezer
   2. Short-term at 1-6 C just after thawing in quarantine refrigerator
   3. Standard temperature monitoring and alarms apply
8. Labelling:
   1. The backup manual labelling process applies
   2. The ISBT specimen label will the donor unit number
      1. Outdate will be 6 years if the product is stored at -65C, 1 year if stored at -18C
9. Product Release:
   1. Orders must be on the PAPER requisition (old Blood Bank Order Form) with a patient prescription and signed by a physician designated to treat COVID patients.
      1. No orders in Cerner
   2. Thawing plasma at 37C upon receipt of order by Transfusion Medicine staff
   3. Signing out component to clinical unit by Transfusion Medicine Staff to locations treating COVID-19 patients.
10. Information Technology:  Medinfo Hematos IIG customized software to be implemented as soon as possible for all processes
11. Not covered:  Transfusion Medicine is NOT responsible for:
    1. Triage of request for convalescent plasma
    2. Pickup and transport of components

References:

1. Level 1-4 documents for donation, testing, processing, and release of blood components
2. COVID-19 Plasma Donor Prescreening Document, 8/4/20