AABB’s CCP collection protocol – 03 31 2020
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COVID-19 Convalescent Plasma Collection:
Donor Eligibility, Processing, Labeling, and Distribution
This COVID-19 Convalescent Plasma (CCP) collection protocol was prepared by AABB based on
information provided by members of the CCP Collection Working Group, in consultation with the FDA’s
Center for Biologics Evaluation and Research. The Convalescent Plasma Collection Overview
(Attachment A) and Convalescent Plasma Implementation Checklist (Form 1) supplement the protocol.
This document is intended to serve as an FDA reviewed protocol that will help ensure
CCP collections:
• • Are rapidly available under an acceptable set of collection, manufacturing, and distribution
practices.
• • Are well-coordinated locally and nationally to promote an adequate inventory and expanded
access to FDA approved patient treatment.
• • Meet FDA and AABB criteria required for: o allogeneic blood donations, including consent,
donor safety, and product safety, purity and potency.
• o eventual administration to a patient under an FDA approved IND.
•
• • Are distributed only to hospitals for use under an approved IND or a single patient
emergency IND.
• • Are collected and labeled as a licensed* FFP or PF24 blood component: o to expedite CCP
availability for treatment protocols by utilizing the existing component preparation processes
of licensed establishments, which represents the majority of collection establishments.
• o with attributes for antibodies to COVID-19 and the cautionary statement for administration
under IND only.
• o tie tags may be used for the cautionary statement and the receiving hospital’s IND number.
• o OR use the alternative to label the collection as apheresis convalescent plasma using the
appropriate ICCBBA code.
•
*Registered (not licensed) establishments will determine the steps required for labeling and distribution
of CCP collections, including the same attributes and cautions.
CCP requires an FDA approved IND for administration to a patient but does not require an IND for
collection, manufacturing, and distribution. [Refer to FDA’s March 24th Communication]
This protocol is acceptable for use by AABB-accredited blood collection facilities. Facilities not
accredited by AABB should consider alignment with AABB Standards to ensure consistency in CCP
collections. AABB may issue additional requirements, including data collection requirements, for blood
collectors providing CCP to hospitals for administration under approved INDs.

Before collecting CCP, blood collection establishments should consider
the following:
Preparation for a CCP collection program
• • Develop SOPs for CCP collection and component preparation based on the information
provided in this document and compliance with FDA regulations and AABB Standards. Identify
compliance strategies necessary for CCP collections.
• • Train staff on new SOPs, highlighting requirements that CCP collections meet all requirements
for allogeneic donations, as well as additional requirements which are unique to CCP, such as
documentation of testing for initial infection and recovery from infection (well and healthy on the
day of donation), inventory management to easily identify CCP units, segregation in storage,
shipping and labeling requirements, and distribution limited to hospitals with an approved IND.

 •

• Provide education to staff describing the unique properties of CCP and the patients needing
treatment with CCP.
AABB’s CCP collection protocol – 03 31 2020
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 •

• Discuss donor and staff safety and address concerns, providing information necessary to
understand that CCP donors are allogenic donors who are no longer ill and have tested negative
for COVID-19 before arriving at the donor center, whenever possible.
• Prepare the Blood Establishment Computer System and labeling processes: o Select
ICCBBA codes according to your collection process.
o Identify special attributes and required cautionary statement.
o Define limitations and criteria for distribution.
• Ensure recordkeeping procedures capture CCP donor eligibility and collection information,
as required for all allogeneic blood donors.

Donor Recruitment
Blood collection establishments should establish a donor recruitment plan for recovered COVID-19
donors suitable to local conditions to ensure the donor eligibility criteria are met and collections are
adequate for use with approved patient treatment nationally.
Coordinate with the available local resources:
• • Contact the public health departments, local hospitals, and health care providers that have
treated COVID-19 patients to develop a partnership to recruit recovered patients as volunteer
CCP donors.
• • Develop appropriate process and messaging whereby treating clinicians and public health
employees reach out to recovered patients already discharged from care and newly recovered
patients as they are discharged from care.
• • Encourage local partners to provide recovered patients with “hard copy” documentation for
both the patient’s initial positive diagnostic test AND a negative test for SARS-CoV-2 at the time
of recovery. This documentation must be provided to the blood collection establishment and may
be hand carried. Refer to donor eligibility.
• • Contact local media to deliver public service announcements requesting recovered COVID-19
patients contact blood collection establishments.
Donor Eligibility Criteria and Documentation – refer to FDA’s March 24th Communication, unless
otherwise noted:
• • Documentation of SARS-CoV-2 infection (diagnosis and recovery) as follows:
• o Prior diagnosis of COVID-19 by a laboratory test must be provided to the blood collection
establishment prior to collection. Written documentation is required and may be hand carried by
the potential donor.
• o Negative results for COVID-19 either from one or more nasopharyngeal swab specimens or by
a molecular diagnostic test from blood [if less than 28 days have elapsed since the donor’s last
symptom(s).] A partial list of available tests can be accessed at https://www.fda.gov/medicaldevices/emergency-situations-medical-devices/emergency-use-authorizations.
• Potential CCP donors who have been symptom free for 28 days or longer are eligible as
allogeneic donors under the precautionary measures in the FDA’s March 11th communication,
with documentation of prior diagnosis but do not require the negative test to confirm
recovery from infection. Donor recovery from COVID-19 prior to donation based on testing
and resolution of symptoms is necessary for: o the safety of other donors and staff
o as evidence that the potential donor is healthy and well on the day of donation, as required
by donor eligibility criteria [if less than 28 days have elapsed since the donor’s last
symptom(s).] FDA’s March 11th considerations do not include a negative test for COVID-19 for
such a donor if collected 28 days after the last symptom. However, a facility may elect to
apply more stringent criteria at any time.
• Donors must be male or females who are nulliparous or negative for HLA antibodies. This
TRALI risk mitigation strategy is consistent with AABB Standards for AABB accredited blood
collectors.

 • The CCP donor must meet all allogeneic blood donor eligibility criteria on the day of
donation.
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 •

• The CCP donor may donate plasma once every 28 days as permitted by allogeneic donor
eligibility criteria. Each medical director must determine when more frequent plasma donations
are appropriate and set a policy to support both donor safety and the availability of CCP.

Donor Collection – refer to FDA’s March 24th Communication, unless otherwise noted:
Prior to donation, donor consent must be obtained (e.g. the AABB Donor History Questionnaire).
• • Additionally, consent for investigational product testing is required if not already incorporated
in blood establishments standard consent form. Specific consent is required if samples for
research are to be collected and stored.
• • CCP will be collected by apheresis as a licensed FFP or PF24 component. Production from whole
blood can also be considered.
• • Blood collection establishments may follow their current policies for retrieval and quarantine.
Refer to FDA’s March 11th optional precautionary measures.
Convalescent Plasma Processing
• • Attachment A depicts the processing pathways available. Blood collection establishments
should follow existing SOPs for collection of licensed FFP and PF24.
• • CCP is an allogeneic collection for which all FDA regulations apply, including testing,
processing, storage, and traceability [Refer to the FDA’s March 24th Communication].
Convalescent plasma products should include a tie tag making it possible to identify the unit for
segregated storage of CCP inventory.
Labeling CCP as FFP or PF24 with attributes – refer to FDA’s March 24th Communication:
• • Blood collection establishments will collect apheresis plasma suitable as an FFP or PF24
component and distribute these units to hospitals.
• • The hospital’s issuance of the unit to a patient for treatment of COVID-19 must be done under
an established IND pathway and may include establishing an acceptable result on a SARS-CoV-2
antibody assay to qualify the unit for use as CCP.
• • Such a CCP collection would be labeled as FFP or PF24 with appropriate attributes and
cautionary statement.
The labeling of these licensed blood components must:
• • Include the attribute indicating the antibody test result for the collection: “This product
contains SARS-CoV-2 antibodies measured using an investigational assay” and the result may be
placed on the tie tag.
• • Include the cautionary statement, which may be placed on the tie tag, “Caution: New Drug-Limited by Federal (or United States) law to investigational use.”
• ISBT Product Codes as an attribute:
• o Use the appropriate ISBT product codes for convalescent plasma collections.
• o These are evolving and facilities should consult the ICCBBA website, at www.iccbba.org, for
current options.

Alternative Labeling of FFP or PF24 Collections as CCP units using ICCBBA codes:
Blood collection establishments may elect to label the product described above with the Convalescent
Plasma component name. Such a product would be unlicensed but could be shipped across state lines
for administration under an FDA approve IND (the IND number should appear on the tie tag). Refer to
the FDA’s March 24th Communication.
Label requirements and 4x4 Label Example:
• • Must include the statement “Caution: New Drug—Limited by Federal (or United States) law to
investigational use.”
• • SARS-CoV-2 antibody assay results if available.
• • Ensure FDA registration number replaced the license number and other appropriate
information for interstate shipping, if applicable.

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•

• Remove the reference to the Circular of Information.

Separate bag codes are not currently available. When splitting COVID-19 convalescent plasma
donations, use division codes. Information for labeling plasma products can be found in the United
States Industry Consensus Standard for the Uniform Labeling of Blood and Blood Components Using
ISBT 128.
Product Suitability – refer to FDA’s March 24th Communication:
• • All product suitability requirements apply, and the unit may only be released to a facility with
an approved IND.
• • Product volume will vary and does not determine dose at time of administration.

National Product Registry:
Following production of CCP, blood establishments should register products available for national use at
www.aabb.org/covid19registry.
RESOURCES – links to:
FDA Communications:
1. Investigational COVID-19 Convalescent Plasma - Emergency INDs – March 24, 2020
2. Updated Information for Blood Establishments Regarding the Novel Coronavirus Outbreak – March
11, 2020
3. Partial list of available tests: https://www.fda.gov/medical-devices/emergency-situations-medicaldevices/emergency-use-authorizations
4. Investigational COVID-19 Convalescent Plasma - Emergency INDs Frequently Asked Questions –
March 26, 2020
Other resources:
5. ICCBBA website: www.iccbba.org
6. United States Industry Consensus Standard for the Uniform Labeling of Blood and Blood Components
Using ISBT 128
7. Cerus website and package inserts for those who elect to implement PRT
8. ADDITIONAL RESOURCES will be posted on AABB’s COVID-19 Convalescent Plasma
Resources webpage as new information becomes available.
AABB’s CCP collection protocol – 03 31 2020
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 ATTACHMENT A
COVID-19 Convalescent Plasma Collection Overview
Prospective donor, ≥ 14 days well without symptoms, with written documentation of BOTH
positive diagnostic assay (onset) and negative clearance assay (recovery), referred to
collection facility by clinicians (local outreach per collection facility, national outreach per
blood orgs., public health department, professional societies, HHS et al)). Prescreening
with DHQ if possible.
Acceptable donor screening with DHQ, meeting all allogeneic criteria. Males or females who
are nulliparous or anti-HLA negative
Label and Distribute as licensed* FFP/PF24 OR alternative for CCP (ISBT-128 codes in
progress) with specific attribute (antibody positive with investigational test), cautionary
statement and FDA approved IND#, or expanded access/eIND**
PRT may be performed per local policy.
Other product types may be evaluated per local policy.
List units in national inventory database Online link at AABB
*Registered blood
Negative NP swab with EUA
establishments will
cleared molecular test if
determine steps necessary
not available from clinician
Repository storage/expanded
for distribution of CCP
access/eIND
collected as FFP or PF24
Hospitals with no local supply
with attributes and
can use FDA’s eIND link**
Positive COVID antibody at
cautionary statement.
Storage locally with export
specified
Donor plasmapheresis (vs.
availability
level with investigational
WB), including samples for
Distribute to transfusion
assay if available
COVID antibody if not done
service for use at hospital with
(predonation or with
predonation
FDA approved treatment
donation testing) AABB’s
Tubes to research
protocols with patient consent
CCP collection protocol – 03 31
repository. Additional
and outcome documentation as
2020
donor consent and
required.
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sampling plan.

AND/or

AND

 Form 1: COVID-19 Convalescent Plasma Implementation
Checklist
This checklist template should be modified to reflect the center’s policies
and processes.

Preparation

□

Develop overarching procedure for convalescent plasma using the guidance
provided in the document and Attachment A

□ Define product manufacturing workflow
□ ISBT code implementation
□ Product label creation
□ Staff training on new SOPs, donor eligibility, product segregation, shipping and
labeling requirements, and order management

□ Facilitate internal education for collection,
manufacturing, and distribution requirements
□ Process defined for recordkeeping of all steps (donor qualification through
distribution)

Donor Eligibility and Collections

□
□

Process defined for donor recruitment

Process defined for donor screening (allogeneic + additional requirements and
documentation)

□

Donor consent for collection and, if applicable, investigation/research

Convalescent Plasma Processing

□

Process defined for convalescent plasma manufacturing and storage, (pathogen
reduction, if performed)

□

Process defined for segregating convalescent plasma from other frozen
inventory

Labeling, Release and Distribution

□ Process defined to ensure products are labeled appropriately
□ Process defined to limit distribution to hospital with IND
□ Process defined for cGMP and Quality Assurance
□ Process defined for the receipt and fulfillment of customer orders for
convalescent plasma