US EAP Data Collection Simplification FAQ

Last updated: July 18, 2020

What are the reporting requirements for the Expanded Access Program?

All reporting requirements are available through the Unique Patient Status Dashboard. After patient enrollment, please fill out the Medical History Form to provide additional pre-transfusion information. Within 24 hours of each convalescent plasma transfusion, please complete the Plasma Transfusion Form. If two transfusions are completed within 12 hours of each other, you may report them both on one form.

It is a regulatory requirement to report any Serious Adverse Events (SAEs) that occur within seven days of ANY transfusion on an SAE Report Form. When the SAEs resolve, complete the linked SAE Resolution Form as well. If no SAEs occur, the SAE Report Form will still appear in your Dashboard, but the form does not need to be completed.

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 decided no plasma transfusion was required (if conditions change and transfusion is given, 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 latest transfusion in the EAP
  • Patient was discharged
  • Patient passed away

If the patient passes away, which forms are required to be completed?

If the death occurs within seven days of any convalescent plasma transfusion, it is classified as a Serious Adverse Event and must be reported on an SAE Report Form in addition to the Weekly Rapid Patient Update and End of Study Form. If the death occurs outside of the seven-day window, only denote this on the Weekly Rapid Patient Update and End of Study Form.

What is the purpose of the simplified patient update forms?

Most patient follow-up forms have been simplified to capture only high priority data to reduce administrative burden on health care providers and administrative staff.

What happened to the data entered into previous versions of the forms?

Patient data that were entered into the previous versions of the forms are saved in our database and are still accessible by the Expanded Access Program team.

What is the Unique Patient Dashboard?

The Unique Patient Dashboard is a centralized location (Survey Queue) that provides a list of forms for each patient. You are automatically directed to the dashboard after Patient Enrollment and provided a unique link for each patient. At the dashboard, you can complete, edit and review all forms for the patient.

The link to each Unique Patient Dashboard is patient specific and accesses their Protected Health Information (PHI). Do NOT distribute the link, use the link for other patients, or share the link with unauthorized personnel. This link should be treated as PHI.

How are the Unique Patient Dashboard links distributed?

For patients that were migrated from the old system, the Unique Patient Dashboard links were sent after enrollment to the physicians and coordinators who were listed on the patient enrollment form.

For new patients, you will receive a Unique Patient Dashboard Link for each patient after enrollment in a confirmation email. You will also be redirected to the page where the URL is the Unique Patient Dashboard link and provided the link at the top of the completion screen after submitting the patient enrollment and medical history forms. Additionally, all follow-up, confirmation of completion and reminder emails sent to you will include patient data and the Unique Patient Dashboard Link.

The link to each Unique Patient Dashboard is patient specific and accesses their Protected Health Information (PHI). Do NOT distribute the link, use the link for other patients, or share the link with unauthorized personnel. This link should be treated as PHI.

What is the Survey Queue?

The survey queue is the list of available and completed forms in the Unique Patient Dashboard providing information about whether the forms have been completed.

The link to each Unique Patient Dashboard is patient specific and accesses their Protected Health Information (PHI). Do NOT distribute the link, use the link for other patients, or share the link with unauthorized personnel. This link should be treated as PHI.

Are all forms viewable on the homepage of the patient dashboard or will certain forms only populate based on other forms’ responses?

After completion of the Patient Enrollment Form, the following forms will appear: Medical History, Plasma Transfusion Form, Serious Adverse Event Form, Weekly Rapid Patient Update and End of Study Form, and Additional Contacts Form.

The Serious Adverse Event Resolution Form populates after each SAE Report Form is completed. Proceed immediately to the SAE Resolution Form regardless of whether the SAE has been resolved, as you may indicate the SAE is unresolved and return later to edit your response and provide resolution data. You must complete the SAE resolution forms in the order that you complete the SAE Report Forms as these forms are linked by the instance number in the Unique Patient Dashboard.

Will providers still receive confirmation emails and reminders?

Yes. Confirmation emails, reminders and alerts will be sent to all contacts on record for each patient. This includes the physician and optional coordinator that you provided on the Patient Enrollment Form, as well as the optional additional five contacts you provided on the Additional Contacts Form at the bottom of the Unique Patient Dashboard.

Where are Serious Adverse Events (SAEs) reported in the new system?

All Serious Adverse Events are reported using the SAE Report Form available on the Unique Patient Dashboard that may be completed multiple times for each patient. One SAE is reported per SAE Report Form.

Does the physician have to complete the Serious Adverse Event Form?

While the SAE Report may be filled out by support personnel, the SAE Report must be reviewed, signed and dated electronically by the physician.

What is the time frame for reporting Serious Adverse Events (SAEs)?

All Serious Adverse Events that occur within seven days of any convalescent plasma transfusion must be reported within 24 hours of occurrence. This is a regulatory requirement.

What should providers do if they see incorrect data displayed on their forms?

Providers may edit forms as necessary, if possible. If something is seen on a form that cannot be edited such as the Serious Adverse Event Form, email uscovidplasma@mayo.edu to notify the data team of the error.

What if I submit a form unintentionally or want to delete a reported form?

If you would like the form entirely deleted, that must be done by the US COVID plasma data team. Please contact us at uscovidplasma@mayo.edu with this request.

Can providers delete forms from the unique patient dashboard?

No, deletion of forms must be completed by the US COVID plasma data team at uscovidplasma@mayo.edu. Please contact us with your request.

Will all forms in the Expanded Access Program be available in the Unique Patient Dashboard?

No. The Site Registration Form and Physician Registration Form will remain separate and be accessible via the physician detailed workflow found on the www.uscovidplamsa.org webpage.

Are there any changes to the reporting of Serious Adverse Events (SAEs)?

All SAEs will now be reported via one SAE Report Form with one event per form. This is the only non-editable form in the Unique Patient Dashboard. Multiple SAEs can be reported using this form.

After submitting the SAE Report Form, you will have the option to download a PDF of your responses in the Unique Patient Dashboard. Afterwards, proceed immediately to the linked SAE Resolution Form (linked by the instance number that is displayed after the form, i.e., Serious Adverse Event Report - #1 which is linked to Serious Adverse Event Resolution - #1). On this SAE Resolution Form, you will see the SAE data provided on the linked SAE Report Form and have the opportunity to either provide resolution data or state that the SAE has not yet been resolved. This SAE Resolution Form is editable, so you may return to the form later to provide resolution data.

Information on reported SAEs will be viewable in the Unique Patient Dashboard under both the SAE Report Forms and SAE Resolution Forms.

What should providers do if they do not receive Unique Patient Dashboard Links for patients?

If you do not receive the Unique Patient Dashboard Link for a previously enrolled patient, contact uscovidplasma@mayo.edu to request that a Unique Patient Dashboard link be sent to you. However, only the contacts on record for a patient may request these links since they contain patient PHI. If you are not a contact on record, you may ask for the contacts on record for a patient and have them send an email requesting we add you to the record and distribute the Unique Patient Dashboard link.

How many contacts are permitted in the system? How are they added?

Seven total contacts can be added for each patient. This includes the physician and optional coordinator provided on the Patient Enrollment Form, as well as the optional additional five contacts provided via the Additional Contacts Form located at the bottom of the Unique Patient Dashboard.

Where can providers enroll new patients in the new system?

If a form appears in my Unique Patient Dashboard, do I have to complete it?

No. Many of the forms that appear in the Unique Patient Dashboard are provided for your opportunity to report if necessary. The appearance of the forms does not necessarily indicate a requirement that you fill the form out (e.g., only fill out the SAE Form if an SAE occurs).

Can multiple units of plasma be transfused to the same patient under the Expanded Access Program? How is this recorded?

Yes. If a patient receives multiple transfusions within 12 hours using blood from the same blood bank, providers can fill out one Plasma Transfusion Form for the transfusions.

If a patient receives multiple transfusions within 12 hours from different blood banks, or if the transfusions are more than 12 hours apart, separate Plasma Transfusion Forms must be completed.