Submitted by Anna Razatos on
Terumo Supports a Biologically Derived Product Unique Identifier
Terumo Blood and Cell Technologies is a medical technology company. Our products, software and services enable customers to collect and prepare blood and cells to help treat challenging diseases and conditions. Our associates around the world believe in the potential of blood and cells to do even more for patients than they do today. Terumo Blood and Cell Technologies supports the addition of a Biologically Derived Product data element to the United States Core Data for Interoperability (USCDI). Addition of the Medical Product of Human Origin (MPHO) Unique Identifier to USCDI will enhance the industries’ ability to track blood utilization and will enable more efficient hemovigilance activities such as disease transmission tracing, transfusion reaction investigations and preventing the transfusion of an incompatible unit of blood. Including the existing ISBT-128 label information into the MPHO Unique Identifier will provide seamless traceability of a transfusion from the donor to the patient. This simple act can help improve the health outcomes for all transfused patients and especially sickle cell and other chronically transfused individuals.
Submitted by minigrrl on
Support for Biologically Derived Product
Inclusion of the Biologically Derived Product element in USCDI, including the use of ISBT-128 standard codes, is vital for public health, regulatory, and research activities related to biological product effectiveness and safety, including hemovigilance surveillance supported by CDC’s National Healthcare Safety Network (NHSN). Current tracking of adverse events related to biologically derived products (e.g., blood transfusion-associated adverse events) is hindered by lack of accurate identifiers for transfusions amenable to fully electronic extraction from the electronic health record. The capability of identifying biologically derived products using this identifier would facilitate automated reporting for transfusions/transplants, reduce burden of reporting on providers, and significantly improve accuracy of hemovigilance and other patient safety activities.
Ongoing surveillance for blood safety in the United States is conducted through the CDC’s National Healthcare Safety Network (NHSN) Hemovigilance (HV) module, which is part of the Biovigilance component of NHSN. The NHSN HV module captures several types of transfusion-associated adverse events as well as monthly totals of blood use, by component type, at participating facilities. This surveillance is used to track the incidence and prevalence of transfusion-associated adverse events with the goal of informing strategies to reduce such events and improve overall patient safety. In addition, CDC performs investigations and other studies as needed that do not currently make use of automated capture of electronic health records but are potential candidates for such automation in the future.
Lantana supports NHSN in hemovigilance surveillance and strongly recommends inclusion of a Biologically Derived Product in USCDI, including the use of ISBT-128 standard codes. A Biologically Derived Product data element would enable capture of individual blood components as well as adverse events for hemovigilance. Current tracking of adverse events in the NHSN HV module requires manual input of adverse events (including ISBT-128 codes for all implicated products), which can be burdensome and may not always yield complete information. Inclusion of a Biologically Derived Product element is vital for hemovigilance surveillance for multiple reasons, including reducing burden on providers by facilitating more automated reporting, improving overall participation in hemovigilance activities, and strengthening robustness and accuracy of reporting.
Inclusion of the Biologically Derived Product data element now is important for future consideration regarding how the standard will need to be expanded to meet the needs of hemovigilance and overall surveillance of biologically derived products in the future. It is vital that the USCDI engages with stakeholders in hemovigilance and other areas of surveillance of biologically derived products to ensure the standards are harmonized with the community-consensus definitions of adverse events, and to facilitate automated capture of essential safety information.
The Biologically Derived Product data element is relevant to all U.S. healthcare settings where blood transfusions, transplants, and other biological products are administered.
Use Case: https://www.cdc.gov/nhsn/biovigilance/blood-safety/index.html
In addition to the NHSN HV module, Lantana is leading work that relies on accurate information from electronic health records regarding identity of biologically derived products, https://www.lantanagroup.com/resources/blood-bank-ig/. This initiative is seeking to establish FHIR standards for blood product phenotyping. A biologically derived product element in USCDI is vital to support interoperability of data exchange to improve blood product inventory, facilitate safer transfusions, and contribute to more efficient adverse event reporting.
Additionally, Lantana is engaged on work led by IBM and FDA on adverse event reporting related to transfusions, which could benefit from inclusion of the Biologically Derived Product data element in USCDI: https://build.fhir.org/ig/HL7/fhir-icsr-ae-reporting/branches/main/index.html.