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.
   2. 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)
   3. Testing must be directly interfaced to Medinfo Hematos IIG donor module
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:
      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
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

8/4/20