COVID-19 Convalescent Plasma Emergency Use Authorization

Updated as of October 1, 2020

Convalescent Plasma Workflow - Updated

As of August 28, 2020 Baptist Health South Florida will no longer be participating in the Mayo Clinic Expanded Access Program.

The FDA has approved convalescent plasma for COVID-19 under an Emergency Use Authorization (EUA).

Nurse Navigators

This role will be discontinued as of October 1, 2020. The blood bank will continue to be responsible for tracking and documenting as appropriate on convalescent plasma cases.

Nurse Navigator Assignments:

• Edwina Brathwaite – Doctors Hospital, Mariners Hospital, South Miami Hospital and West Kendall Baptist Hospital

• Michelle Montero – Baptist Hospital of Miami, Homestead Hospital• Maureen Avella – Bethesda East and West Hospital, Boca Raton Regional Hospital

Provider Specific Workflow

Physician must review the Fact Sheet for Health Care Providers, identify a patient as a CCP hospitalized candidate, communicate and provide the patient/legally authorized representative (LAR) with the Fact Sheet for Patients and Parents/Caregivers, and place orders for CCP.

Cerner Pop-up: Provider Attestation - Updated

Provider Responsibilities – Updated as of 9.3.2020

As we all know, healthcare in the era of COVID-19 is an ever changing process. We received an additional update from the FDA on August 28, 2020 in regards to COVID-19 Convalescent Plasma. The FDA emergency use authorization (EUA) stipulates that blood suppliers utilize a specific test for COVID-19 antibodies and notify prescribing providers of the amount of antibody titers (whether high or low) in a particular unit of COVID-19 convalescent plasma. At this time blood suppliers have been given a transition period of up to 8 weeks to meet this expectation. Therefore, until the blood suppliers can meet the full EUA expectation, the FDA has advised that the current COVID-19 convalescent plasma being provided to patients be called “Investigational COVID-19 Convalescent Plasma” and that patients be notified of this.

Currently we ask that all providers who prescribe COVID-19 Convalescent Plasma discuss this with their patients/LAR. Additionally, we will be updating the “Authorization for Transfusion of Blood or Blood Components/Derivatives (SF-0001)” to include consenting for the blood product “Investigational COVID-19 Convalescent Plasma.” This authorization will still be obtained by the bedside RN.

Nursing Specific Workflow

Bedside RN Responsibilities

• Bedside RN reviews orders in the Power Plan in Cerner: “COVID 19 Convalescent Plasma Infusion_B” and obtains the Authorization for Transfusion of Blood or Blood Components and Derivatives (SF-0001, the current Blood Consent)

• Blood Bank will call the bedside RN when plasma is ready for pick up. Bedside RN will print the pick-up slip and present to the blood bank to pick up the plasma

• Follow Convalescent Plasma Transfusion Protocol in Cerner– Infuse plasma as per physician orders (refer to Blood Transfusion/Administration ,

Requisition, Specimen Collection, Issuing/Emergency/Massive Transfusion procedure) (Mosby’s)

– Document transfusion and any serious adverse events in EHR as per entity procedures

• Nursing documentation:– As part of the FDA criteria for the Convalescent Plasma EUA, hospitals and health

care providers must maintain records regarding the administration of convalescent plasma. This includes but is not limited to- patient name, age, disease manifestation, number of doses administered per patient, other drugs administered as well as serious adverse events and adverse reactions after transfusion of convalescent plasma including fatalities

Available Resources and Documents

SO-0275 COVID19 Convalescent Plasma Infusion Orders

W.I.N.K Convalescent Plasma Treatment for COVID-19

Fact Sheet for Patients and Parents/Caregivers

Available in English, Spanish and Creole

Fact Sheet for Health Care Providers

Letter of Authorization

Convalescent Plasma Donation Flyer

EBCC Coronavirus Intranet Site

• http://intranet.bhssf.org/en/departments-and-directories/ebcc/Pages/default.aspx

EBCC Coronavirus Internet Site

• Type “covid19” into the URL bar and press enter• This will take you directly to BHSF Coronavirus Resources including the Convalescent Plasma resources

For any questions please reach out to:

The EBCC TeamBHSFEBCC@baptisthealth.net

COVID-19 Convalescent Plasma Emergency Use AuthorizationConvalescent Plasma Workflow - UpdatedNurse NavigatorsProvider Specific WorkflowCerner Pop-up: Provider Attestation - UpdatedProvider Responsibilities – Updated as of 9.3.2020Nursing Specific WorkflowBedside RN ResponsibilitiesSlide Number 9SO-0275 COVID19 Convalescent Plasma Infusion OrdersW.I.N.K Convalescent Plasma Treatment for COVID-19Fact Sheet for Patients and Parents/CaregiversFact Sheet for Health Care ProvidersLetter of AuthorizationConvalescent Plasma Donation FlyerEBCC Coronavirus Intranet SiteEBCC Coronavirus Internet SiteSlide Number 18