The Workflow Obtaining Convalescent Plasma for the U.S. COVID-19 Expanded Access Program

Before starting the process, please review the protocol document to fully understand the requirements of this program.

How to enroll your patient(s) in the COVID-19 plasma treatment study

Detailed workflow

  1. COVID-19 patient is identified as a potential convalescent plasma recipient. Order ABO typing at this point so blood bank has a validated ABO type on the patient before the rest of the process starts.
  2. Register your site with Mayo Clinic using the Site Registration Form.
  3. Register as a local physician/PI with Mayo Clinic using the Physician/PI Registration and FDA 1572 Form.
  4. Obtain Patient consent and keep a signed copy at your local site.
  5. Register your patient using the Patient Enrollment Form.
    1. The treating Physician/PI certifies consent by selecting “yes” and entering the data.
    2. Submit the form.
    3. After submitting the form, a pop-up notification is generated in the form that:
      1. Verifies your patient is registered
      2. Indicates that Mayo Clinic authorizes you to order convalescent plasma for your patient from your hospital blood bank through your normal ordering processes (e.g., EPIC, etc.)
    4. You can email this confirmation to yourself for your records by filling in the email address and clicking “Send” in the pop-up notification.
  6. Physician places “Order Convalescent Plasma” for the specific patient to the hospital blood bank to order convalescent plasma from outside regular supplier per standard operating practices. The local physician/PI must work out this ordering process with their hospital blood bank, via the electronic health record, such as EPIC.

    For hospitals that do not have a regular blood supplier, Blood Centers of America (BCA), which operates a national resource sharing network, has implemented a toll-free number to help hospitals order convalescent plasma.

    Hospitals that need to order convalescent plasma from an outside provider, can contact:

    Phone: 844-633-3226 (844-NEEDABO)

    The federal program will reimburse regardless of the convalescent plasma blood bank source.

  7. Hospital blood bank places order with the outside supplier based upon the ABO type of the recipient.
  8. Hospital blood bank receives product from supplier, enters the units into inventory according to local standard operating processes and stores them in an area segregated for COVID-19 convalescent plasma products.
  9. Hospital blood bank informs recipient’s patient care team that convalescent plasma is available and ready to transfuse for the patient identified on the prior request (step 6), per local hospital’s standard processes and procedures.
  10. The physician/PI or designee places a transfusion order for the convalescent plasma per hospital’s blood product transfusion ordering process.
  11. The hospital blood bank thaws and issues the convalescent plasma after receiving the transfuse convalescent plasma order.
  12. Plasma unit is transfused at bedside and administered according to local hospital procedures.

    The initial data collection form should encompass the transfusion period(s) and the 4-hour window following transfusion. For additional information, visit our FAQs.

  13. Complete initial data collection form with (1) unit number and (2) patient medical record number. This report must be completed for every patient enrolled in the program, even if plasma is not ordered and/or the transfusion is not given, including the reasons why. This is a regulatory requirement. This form also includes reporting any Serious Adverse Events (SAEs) that occur at 4 hours post transfusion. This form must be filled out separately for each unit of plasma administered.
  14. Report any patient safety, expected or unexpected Serious Adverse Events (SAEs) that occur between 4 hour post-transfusion through 7 days using the Serious Adverse Event form. If you have an SAE, you must complete this form. This is a regulatory requirement.
  15. Complete the 7-day form. This form should be submitted in addition to the 4-hour post infusion form (and SAE form if there are any Serious Adverse Events) even if your patient passes away because the purpose of this form is to collect patient history. The day of transfusion is considered day zero.
  16. Complete the 30-day form if patient remains hospitalized.

    This form collects improvement outcomes, resolution of SAEs and documents newly developed events that have occurred after day 7 and up to 30 days. The 30-day form will be emailed to the local physician/PI and/or coordinator/other support staff. Basic information is prepopulated to save you time. If you reported that your patient passed away on the 7-day form you will not receive the email. If you reported that your patient was discharged on the 7-day form you will be able to indicate whether your patient was re-hospitalized. If your patient has since passed away or been discharged you will only be asked to provide the date and submit the form.