ABC urges the Administration, Congress and industry stakeholders to promote the value blood components to patients, communities, and the healthcare system through the following actions:
Prioritize blood donation as a national imperative
- Establish partnerships that raise awareness about the need for consistent blood donation from a diverse community of donors;
- Address disproportionate reliance on type O donors through the implementation of utilization practices that benefit patients and promote a robust blood supply.
Recognize the vital role of blood components in health and wellness
- Explore pathways and reimbursement mechanisms to facilitate implementation of safety and technology measures when mandated by FDA or when market incentives otherwise do not exist.
- Implement a robust, national data platform for the collection and utilization of blood components to allow for analysis on the status of the blood supply and evidence-based decision making on its role in public health, preparedness, and response.
- Promote patient access to blood components throughout the healthcare system by removing barriers to care and ensuring appropriate reimbursement.
Reduce unnecessary and burdensome regulation
- Evaluate the infectious disease testing burden from prespecified health economic thresholds;
- Amend FDA regulations to maximize the gift of life. Currently, blood centers must discard an otherwise acceptable and safe blood donation if there is an error stemming from internal processes even if that error has no influence on the safety, purity, or potency of the donation;
- Finalize platelet bacterial contamination guidance that recognizes and addresses the potential impact on availability;
- Implement a rational, flexible approach to the regulation of plasma products. This includes harmonizing plasma freezing times with those required by manufacturers worldwide and advocating that the FDA give blood centers the ability to move plasma from transfusable to further manufacture as demanded by clinical need;
- Revise licensing regulations that prohibit distribution of products in interstate commerce that are acceptable for sale and use in the state of manufacture. These have undergone 100 percent quality control testing in process of licensure and this prohibition delays licensure and increases the costs of innovation;
- Eliminate the need to submit a BPDR (Blood Product Deviation Report) generated because of post donation information (PDI) that does not result in a recall.