FDA | Biologics Effectiveness and Safety (BEST)

Blood & Blood Products

The Center for Biologics Evaluation and Research (CBER) regulates the collection of blood and blood components used for transfusion or for the manufacture of pharmaceuticals derived from blood and blood components, such as clotting factors, and establishes standards for the products themselves. CBER also regulates related products such as cell separation devices, blood collection containers and HIV screening tests that are used to prepare blood products or to ensure the safety of the blood supply.

Most Recent Blood & Blood Products Assessments

Title

Date

COVID-19 Convalescent Plasma Surveillance Protocol

C19 Plasma Protocol 2020 (pdf)

12/14/2020

COVID-19 Convalescent Plasma Surveillance Protocol

Trends in Red Blood Cells Transfusions within the Biologics Effectiveness and Safety (BEST) Initiative Network, 2012-2018

AABB Trends RBC transfusions Abstract 2019 (pdf)

10/19/2019

ISBT 128, Information Standard for Blood and Transplant 128 Coding System, Transfusion, Blood, Blood Components, Apheresis, Leukocyte-reduction, LR, Irradiation (IR), transfusion, EHR, Electronic Health Records, Red Blood Cells, RBC, transfusion episode, unit levels, NBCUS, National Blood Collections & Utilization Survey

Advancing the Use of the ISBT-128 Coding System in Electronic Health Records to Monitor Blood Transfusion Prevalence in the United States

ISBT codes characterize transfusion rates Abstract 2018 (pdf)

10/13/2018

ISBT 128, Information Standard for Blood and Transplant 128 Coding System, Transfusion, Blood, Whole Blood, Blood Components, transfusion related adverse events, AE, EHR, Electronic Health Records, Red Blood Cells, Platelets, Plasma, Cryoprecipitate

Biologics Effectiveness and Safety (BEST) Initiative: Building the Infrastructure for a National Hemovigilance System to Monitor Transfusion-Related Adverse Events

ISBT codes characterize transfusion rates Poster 2018 (pdf)

10/13/2018

ISBT 128, Information Standard for Blood and Transplant 128 Coding System, Transfusion, Blood, Whole Blood, Blood Components, transfusion related adverse events, AE, hemovigilance system, Observational Medical Outcomes Partnership, OMOP, CDM, common data model, EHR, Electronic Health Records, Red Blood Cells, Platelets, Plasma, Infrastructure

Biologics Effectiveness and Safety (BEST) Initiative: Incorporating ISBT-128 Codes into OHDSI’s OMOP Common Data Model to Build A National Hemovigilance System to Monitor Transfusion-Related Adverse Events

Incorporating ISBT into BEST Abstract 2018 (pdf)

06/02/2018

ISBT 128, Information Standard for Blood and Transplant 128 Coding System, Transfusion, Blood, Whole Blood, Blood Components, transfusion related adverse events, AE, hemovigilance system, Observational Medical Outcomes Partnership, OMOP, CDM, common data model, EHR, Electronic Health Records, Red Blood Cells, Platelets, Plasma, Infrastructure