Before starting the process, please review the protocol document to fully understand the requirements of this program.
Quick reference guides
If you need assistance completing any of the required forms, see our quick reference guides.
- 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.
- Register your site with Mayo Clinic using the Site Registration Form.
- Register as a local physician/PI with Mayo Clinic using the Physician/PI Registration and FDA 1572 Form.
- Obtain Patient consent and keep a signed copy at your local site.
- Enroll your patient using the Patient Enrollment Form.
- The treating Physician/PI certifies consent on the Patient Enrollment Form by selecting “yes” and entering the data.
- Submit the form.
- After submitting the form, a pop-up notification is generated in the form that:
1. Verifies your patient is enrolled
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.)
- This confirmation will be emailed to the physician and any additional contacts provided on the Patient Enrollment Form. You will also receive a link to a unique patient dashboard that will be used throughout the study to access all additional forms and reports for the patient.
- The Medical History Form can be completed either after patient enrollment or after the initial transfusion but must be completed prior to the first SAE Report Form submission. The Medical History Form can be edited and updated.
- 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.
- Hospital blood bank informs recipient’s patient care team that convalescent plasma is available and ready to transfuse for the patient identified in step 5, per local hospital’s standard processes and procedures.
- The physician/PI or designee places a transfusion order for the convalescent plasma per hospital’s blood product transfusion ordering process.
- The hospital blood bank thaws and issues the convalescent plasma after receiving the “transfuse convalescent plasma” order.
- Plasma unit is transfused at bedside and administered according to local hospital procedures.
- Complete the Transfusion Form with (1) unit number and (2) patient medical record number utilizing the unique link to the patient dashboard. This report must be completed for every patient enrolled in the program that receives a transfusion. The Transfusion Form should encompass the transfusion period(s) and the 4-hour window following transfusion. For additional information, see the FAQs.
This form must be filled out separately for each unit of plasma administered (two units given within a 12-hour window can be submitted on a single Transfusion Report Form, view FAQ for more detailed explanation).
- Report any expected or unexpected Serious Adverse Events (SAEs) that occur within 7 days for each convalescent plasma transfusion administered through the EAP. If you have an SAE, you must complete this form. This is a regulatory requirement.
Each SAE reported must have an accompanying SAE Resolution Form to document whether the SAE did or did not resolve and when resolution occurred.
- Beginning seven days after the date of enrollment and then every seven days thereafter, complete the Weekly Rapid Patient Update and End of Study Form for each patient until one of the following occurs:
- Physician decides no plasma transfusion was required (if patient’s condition worsens, please fill out a transfusion form and then fill out the next Weekly Patient Rapid Update form in seven days)
- Patient was in hospital for ≥ 30 days after enrollment in the EAP
- Patient was discharged
- Patient passed away
- Once the end of study requirements are met (above) you will be able to complete the end of study information which is found in the Weekly Rapid Patient Update and End of Study Form to close out the study for each patient.