Material substance originating from a biological entity intended to be transplanted or infused into another (possibly the same) biological entity.

Comment

Promote Biological Derived Product Data Class in USCDI v5

Promote the Biologically Derived Product Data Class for patient safety reasons for the USCDI v5.

Product Code and Unique Identifier are the priority data elements in the Biologically Derived Product Data Class.

Product Code and Unique Identifier data elements are recorded in the documentation, having discrete elements will help with tracking reactions and improve patient safety.

Adding these data elements will inform clinical research and serious adverse event evaluations during clinical trials. The serious adverse event adjudication committee will have more information to understand the factors surrounding biological products which may provide insight into study drug adverse events and the relationship to a study drug.

Physician support for Biologically Derived Product data element

I strongly support the inclusion of biologically derived product data (BPD) in USCDA v4.  The inclusion of BPD in the USCDI will further enhance the ability of electronic medical records to support both traceability and biovigilance across the full spectrum of Medical Products of Human Origin (MPHO) by providing the ability to link key MPHO information in a standard manner to the recipient’s record.  We need this enhanced traceability to quickly track patients affected by infectious disease transmission, such as recently occurred with tuberculosis in bone grafts.  This will also allow for an enhanced hemovigilance system that tracks blood components and adverse effects from transfusion reactions.  Since transfusions are the most frequently performed medical procedure in the United States it is critical that we have secure means for tracking transfusions and the associated adverse events.

AABB Support for Biologically Derived Product Data Element

The Association for the Advancement of Blood and Biotherapies (AABB) continues to support the addition of a Biologically Derived Product data element to the USCDI. Interoperability in this area is aligned with the goals expressed in the January 2023 ONC Health IT Standards Bulletin of facilitating patient access, promoting health equity, reducing disparities, supporting underserved communities, and advancing public health data interoperability. For instance, a Biologically Derived Product data element has the potential to facilitate the ability of providers to have access to a patient’s transfusion history, regardless of where a previous transfusion occurred. This capability would help advance ONC’s goals by helping to prevent incompatible transfusions, supporting red blood cell antigen matching, and ultimately improving health outcomes for chronically transfused individuals, such as patients with sickle cell disease.  As another example, a Biologically Derived Product data element would support patients’ access to care because it could be used to assess whether the current supply of specific blood components is adequate to satisfy patients’ needs. It would also serve as a tool to advance hemovigilance capabilities and improve health outcomes for patients who receive blood transfusions. For example, it could help identify non-infectious complications, such as transfusion-associated circulatory overload (TACO), transfusion-related acute lung injury (TRALI), and transfusion of an incompatible unit of blood.

Continued ICCBBA support for inclusion of BDP data elements

ICCBBA continues to strongly support the inclusion of the Biologically Derived Product data elements in the USCDI.  We specifically support the MPHO Unique Identifier, Product Codes, Source Identifier, Division, and Processing Facility coding.

With the recent enhancements to the BiologicallyDerivedProduct Resource of HL7®FHIR® Standard (Release 5), these elements are now more readily accessible. The maturity of the data elements based on the ISBT 128 Standard, in use for decades, is clearly established.  In addition to these key elements of traceability being readily accessed from the bar codes or 2D Data Matrix symbols on an ISBT 128 label, they are also widely incorporated into blood product administration modules of multiple software platforms.

The inclusion of the Biologically Derived Product data elements in the USCDI will further enhance the ability of electronic medical records to support both traceability and biovigilance across the full spectrum of Medical Products of Human Origin (MPHO) by providing the ability to link key MPHO information in a standard manner to the recipient’s record.

Support for Biologically Derived Product in USCDI.v4

According to ONC Health IT Standards Bulletin of January 2023 (https://www.healthit.gov/sites/default/files/page/2023-01/Standards_Bulletin_2023-1.pdf ) Draft USCDI v4 will prioritize data elements that focus on patient care and facilitating patient access while promoting equity, reducing disparities, supporting underserved communities, integrating behavioral health data with primary care, and supporting public health data interoperability.

Inclusion of the BiologicallyDeriviedProduct (BDP) data class into the requirements for interoperability addresses ONC’s data priorities. Having a unique identifier and a product code for BDP allows health providers to better understand biologics exposure for underserved populations, including those with sickle cell disease who have received many transfusions (blood is a BDP) and who may have developed life threatening yet evanescent antibodies to future blood products, which is critical to ensure patient safety. Information about red blood cell antibodies is critical to the success of the Blood Cell Antibody Exchange, recognized by the HHS Secretary Becerra as one of the winners of the Secretary’s Equity Challenge and is described below (under the Assistant Secretary for Health (OASH): Blood Cell Antibody Exchange).

The Blood Cell Antibody Exchange project would benefit substantially by the inclusion of the BDP Data Class in USCDI v4 as the Secretary’s Challenge has a 2-year deadline (from 2022). FDA is are working with a group of federal agencies and volunteer providers organized through the HHS Office of the ASH (OASH) and the Advisory Committee for Blood and Tissue Safety and Availability (ACBTSA).

In addition to improving patient care in underserved communities, impacting health equity, and reducing disparities, including BDP in the USCDI v4 and eventually requiring interoperability of this data will support public health interfaces. Information about adverse events associated with biologics would be more easily and readily reported to FDA and other public health agencies for surveillance and potential post-market action on products ranging from blood and blood components, tissues, organs, and cells. BDP is required to accurately document exposure to these many biologics. To document this exposure, the BDP unique identifier and a product code are essential. We have established through a proof-of-concept in collaboration with 3 independent healthcare systems the availability of the data required to populate BDP FHIR resources, as we have noted in our previous comment dated 2022-09-28.

Assistant Secretary for Health (OASH): Blood Cell Antibody Exchange

Patients who receive blood transfusions are at risk of hemolytic transfusion reactions, and people of color are more likely to experience morbidity and mortality associated with reactions to the transfusion of blood products. Some of these reactions can be prevented through the improved sharing and interoperability of data.
Impact: People of Sub-Saharan and South Asian descent are more likely to be diagnosed with hemoglobinopathies such as sickle cell disease (SCD) and thalassemia, and structural racism and longstanding inequities in care for people with SCD have contributed to increased morbidity and mortality in adults with SCD. Reducing the danger from a routine part of care for SCD—blood transfusions— can help to address these disparities and improve outcomes for people living with SCD.
Proposed Solution: The creation of a national RBC antibody exchange with the support of blood bank information system (BBIS) vendors will increase the speed, accuracy, reliability, and security of transfusion history exchange. These factors will promote safety and efficiency in America’s blood banks.

Support for Biologically Derived Product Data Class in USCDI v4

I strongly support the inclusion of biologically derived product data in USCDI v4.  As a transfusion medicine physician and patient advocate, I believe this is a critical step in improving transfusion safety.  

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.  

Additional Interoperable Blood Bank Information System

FDA CBER can confirm that we received additional evidence of a fourth instance of interoperable EPIC/Blood Bank Information Systems that exchange Biologically Derived Product information, specifically ISBT-128 codes, between the Blood Bank Laboratory Information System and the transfused patient’s EPIC medical record (EPIC).

Level 2 Data Class: Biologically Derived Product

Level 2 Data Class: Biologically Derived Product

Level 2 Data Element: Product Code

Level 2 Data Element: Unique Identifier

Level 2 Data Element: Source Identifier

Level 2 Data Element: Division

Level 2 Data Element: Processing Facility

While IMO agrees that exchange of information regarding biological entities for transplants or blood products has importance, neither the technical specifications cited in the submission, nor the referenced terminologies are widely in use in ONC Certified HIT or implemented in clinical care.  

The FHIR Resource to support the submission as a Level 2 Data Class, Biologically Derived Product BiologicallyDerivedProduct (R5 Draft Ballot) is not in use in production environments. The use of ISBT 128 Product Codes for Medical Products of Human Origin required by the resource could be a significant roadblock to implementation as this code system is not widely used in ONC Certified HIT to support clinical care.  

IMO does not recommend that the proposal for Biologically Derived Product data class or data elements for inclusion in USCDI V3. While the use and exchange of ISBT 128 Product Codes for Medical Products of Human Origin between HIT has value in automation of NHSN reporting, this terminology is not required in regulation for ONC Certified HIT.  IMO supports the inclusion of ISBT 128 in future regulation for interoperability, and eventual inclusion in the USCDI.

 

Response to IMO

We thank IMO for providing their thoughts on the Biologically Derived Product data class submission. While we agree that the FHIR Resource Biologically Derived Product in R5 Draft Ballot is not widely used (because R5 is not yet in Normative status), the R4 version of the resource has been agreed to be raised to FMM Level 2, indicating implementation across a number of implementers that are capturing and exchanging this data in FHIR. The BDP resource will then be on its way to FMM Level 3, following a formal round of balloting with comments from implementers.

It is also important to note that the underlying data elements that are being proposed under the Biologically Derived Product data class have been mapped to ICCBBA ISBT data elements which are widely used in capturing and exchanging data around biologically derived products in the US and internationally. As noted in our submission, ISBT labeling is required for all blood and blood components, as well as various tissues and transplant products in the United States, in order to be accredited by accrediting organizations in the United States and many other countries. These accrediting organizations require their members to use ISBT 128 coding and labeling for cellular therapies and ocular tissue (AABB [https://www.aabb.org/news-resources/resources/cellular-therapies/isbt-128-for-cellular-therapy], the Foundation for the Accreditation of Cellular Therapy (FACT) [https://news.factwebsite.org/isbt-128-audit-tool-for-cellular-therapy-provides-additional-resource-for-verifying-labels/] and the Eye Bank Association of America (EBAA) [http://restoresight.org/wp-content/uploads/2016/01/ISBT-Webpage-Implementation-Guide-Use-of-ISBT-128-in-North-American-Eye-Banks-v130.pdf]). This results in these data elements being captured physically on all blood bags and blood components, as well as other biologically derived products.

As such, ISBT-related data elements are captured in blood banking, laboratory information systems (LIS), and pathology software used across providers in the United States, and are being exchanged in HL7 formats today [reference: https://www.iccbba.org/uploads/8b/eb/8beb16a5f9e2c0c420a3e5f099f49b03/RT042-ISBT-128-Data-References-for-use-in-Electronic-Messages.pdf], as well as for reporting to NHSN and to FDA for hemovigilance and product safety purposes. We believe that inclusion of this data class in the next version of USCDI will encourage providers to capture these data elements in FHIR format, rather than in older HL7 formats, in an effort to move towards a modern FHIR API-based exchange of these very important data elements for patient access, as well as for coordination of care.

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