Submitted by barbee.whitaker on 2022-09-28 Promoting Biologically Derived Product Data Class to USCDI v4 For the past 3 years, the Center for Biologics Evaluation and Research (CBER) Biologics Effectiveness and SafeTy (BEST) Innovative Methods Initiative has been working on developing a FHIR-based solution to enhance the reporting and validation of adverse events associated with the use of biologics, often known as medical products of human origin (MPHO), in the US. The BEST team developed and balloted a FHIR IG (https://build.fhir.org/ig/HL7/fhir-icsr-ae-reporting/branches/main/index.html) to detail the process where adverse event (AE) individual case safety reports (ICSR) are generated from EHR data. The FHIR IG provides examples for vaccine AEs, using VAERS (Vaccine Adverse Event Reporting System), and Transfusion-related AEs (TRAEs), using FAERS (FDA Adverse Event reporting system) reports. For a TRAE report, accurate documentation of exposure (product type and time of encounter) is extremely critical to establish causality of events. The BEST FHIR IG uses the Biologically Derived Product (BDP) (https://www.hl7.org/fhir/biologicallyderivedproduct.html) FHIR resource (to provide product identifying ISBT-128 codes) to ascertain the accurate exposure for a TRAE. Working with our foundational data partner over the past 3 years, the BEST team has been able to obtain and use ISBT-128 codes captured in their EHR. CBER has submitted the BDP FHIR resource to the USCDI ONDEC, and it is currently at Level 2. The BDP data element submission has gained support from many stakeholders, including eHealth Exchange, Association for the Advancement of Blood & Biotherapies (AABB), American Society for Clinical Pathology (ASCP), America’s Blood Centers (ABC), International Council for Commonality in Blood Bank Automation (ICCBBA), and Terumo blood and cell technologies, as evidenced by their comments (https://www.healthit.gov/isa/uscdi-data-class/biologically-derived-product). To further the BDP data element to USCDI v4, CBER and the BEST team explored the availability of ISBT-128 data (typically resident in the hospital blood bank information system) with some collaborators. We approached 3 collaborating healthcare systems, 2 EPIC users and one CERNER user, and we were able to confirm the availability of ISBT-128 codes in their EHR systems. The evidence we collected (via emails, meetings, and redacted screenshots) confirms that the 2 EPIC users (each with a different blood bank Laboratory Information System (BB LIS)) receive and display ISBT-128 codes to their clinicians and patients. The CERNER user as well, using a third BB LIS, can capture and display the ISBT-128 codes in the EHR system. Based on the discussions with our collaborators, the core data needed (ISBT-128) to generate an accurate TRAE report, among many important use cases, is available in the EHR. Therefore, it would be feasible to implement BDP in USCDI v4. Also, including BDP in v4 will allow CBER to continue improving capability to report adverse events associated with biologics, and as mentioned earlier, will create the on-ramp for establishing a nationwide system that enables traceability of transplanted cells, tissues, and organs to ensure the safety of the recipients.