I prepared the following plan for a CCP program for HMC Qatar in March, 2020.  The workflow is divided into four (4) modules:

1. Registration/Interview/Physical Examination/Apheresis Collection
2. Donor Marker Testing and Immunohematology Testing
3. Production/Aliquoting/Pathogen-Inactivation/Storage
4. Product Thawing/Product Release

Module 1:

1. Collection/registration/screening must be in a separate area from regular blood and apheresis donations.
2. Donors must provide consent.
3. ISBT specimen labels must be used on each tube collected.
4. We need a minimum of two apheresis nurses, one for the registration/screening/post-donation observation and one for the actual apheresis procedure.
5. If there will be multiple serial donors, then we need a waiting area (each donor at least 2 meters apart).
6. Donor screening must be in sound-proof area so that other waiting donors cannot hear the interview/questionnaire process.
7. Amount that can be collected depends on body weight:  500 ml for <80 kg and 600 ml for >= 80 kg, collection may occur twice per week
8. Collection time includes 15 minutes for registration/interview/physical examination, 60-75 minutes and 15 minutes for cleanup/disinfection before the next case, approximately 2 hours per donation.
9. A post-donation observation area (minimum 15 minutes after collection) with apheresis nurse nearby in case of reactions is needed if there will be multiple donors.
10. Specimens will

Module 2:

1. Donor testing and donor immunohematology will be done with other donor specimens in our regular location

Module 3:

1. Apheresis collection must be processed and stored separately from regular blood/apheresis donations.
2. Processing will occur only after the results are shown to meet all criteria.
3. Pre-collection testing (test-only donation) would permit processing without waiting for results.
4. Storage at minus 80C may be for a minimum of six (6) years but this may be extended if needed.
5. All acceptable components will have a final ISBT label—no products without the ISBT label will be transfused.  The ISBT label indicates that the unit meets all donor criteria for convalescent plasma.

Module 4:

1. Product modification (thawing) and release (sign out from blood bank) must be in a separate area(s) from the regular hospital blood bank.
2. Release of convalescent plasma follows the same process as regular component release
3. Transfusion of convalescent plasma at the patient’s bedside follows same process as regular component transfusion
4. Nursing and other staff performing the transfusion must pass competency assessment.
5. Plasma will be transfused as ABO-identical or compatible unless low ABO-titer group A is used.
6. Plasma must be free of clinically significant antibodies

Workflow Considerations:

1. Donors must be restricted to the waiting, collection, or post-donation observation areas.
2. Donors must NOT pass through production, testing, or component release areas (just as they are currently restricted in the Blood Donor Center and HMC hospital blood banks/transfusion services).

Logistics:

1. Throughput is a maximum of 4 donors (2000 to 2400 ml plasma) per eight-hour shift with one apheresis nurse and one donor apheresis (Trima) machine.
2. The processes are scalable with additional staff and machines (e.g. with 3 machines and nurses, then 12 donors and 6000 to 7200 ml of plasma collected).
3. Thawing of 1-2 units of plasma takes up to one hour.  Contact the quarantine blood bank at least one hour before the desired pick-up time.
4. The four modules above can be in separate areas not adjacent to one another.  Modules 1, 3, and 4 must be quarantine areas where access is limited.  Module 2 can be performed with regular donor specimens using standard precautions.
5. We can provide training for transfusion of blood components and competency assessment to any location transfusing this product.

Information Technology:

1. All modules will be connected to the Medinfo Hematos IIG dedicated blood bank computer system.
2. All records of collection/production/testing/storage/modification/release will be stored therein.
3. All ordering of convalescent plasma components will be through Medinfo.
4. External test results (e.g. future antibody titering) can be added to the component information.
5. Links to the Hospital Information System (Cerner) may be considered after the Medinfo processes are fully functional.