Recommendations of the 48th ACBTSA Meeting, November 28-29, 2016

The Advisory Committee on Blood and Tissue Safety and Availability met on November 28-29, 2016, and voted unanimously in favor of the following recommendaion. (14 in favor, 0 against)

Whereas the Committee finds that:

• Blood is a public good, built on the altruism of non-remunerated donors.  Simple supply and demand economic principles do not fully address the societal value of this critical national resource.  Consequently, there are unique considerations with respect to sustainability of the blood system.
• Data previously submitted to this Committee, findings from the RAND Report and the 2015 NBCUS suggest that there is a decline in utilization likely causing a decline in collections. None of these sources has been able to fully capture the current situation and the dynamic implications to the blood system. There is an urgency that requires a near-term solution – the resiliency of the blood system is at risk.
• Although the blood system appears, from the outside, to be functioning today, we assess it as very fragile. Based on our experience, expertise and public comments received, the situation has worsened since the Committee last addressed this topic. As enumerated below, the blood system is subject to significant vulnerabilities that could manifest quickly and further threaten the sustainability of the blood system.
• Examples Include:
  • The ability to maintain resilience to respond to daily fluctuations in supply and demand,
  • Defining and developing the surge capacity to react to unique local and national disasters (including military needs)
  • Meeting patient requirements for advanced therapies (e.g., cardiac surgeries, sickle cell disease, bleeding disorders, cancer therapies, sand stem cell and solid organ transplantation)
  • Understanding the specific need for different blood components. Red blood cells, platelets, and plasma may be administered in completely different patient settings and select blood types and donors (e.g., O negative red blood cells and AB plasma) are in increasing demand,
  • Responding to emerging environmental and infectious disease threats
  • Inadequate payment for the true cost of blood collection, processing, testing and distribution
  • Insufficient dialogue between stakeholders, ACBTSA and the HHS Blood, Organ, Tissue Senior Executive Council
  • Shrinking donor pool, For example, donor selection criteria (i.e., iron deficiency considerations, hemoglobin thresholds, travel related, and infectious disease risks) and changing demographics

Therefore, the Committee recommends:

• Federal oversight should proactively address the competing forces within the blood system. This includes:
  • Ensuring appropriate financial remuneration for infrastructural support to maintain a sustainable and resilient blood supply
  • Collecting data in a timely manner to help to drive policy and resource utilization
  • Provide sufficient support for technological innovation with respect to resource sharing and institution of new safety measures as appropriate.
• Specific Recommendations:
  • Prioritize a review of these findings and develop policies to address the listed vulnerabilities in a timely and expeditious manner.
  • Examine models of risk based decision making to inform future public policy to include all stakeholders in the vein to vein process from donor to patients and their families, and including all intermediaries, (e.g., blood centers, hospitals, clinicians, medical device developers).
  • Develop mechanisms to encourage hospitals and blood centers to participate in data collection programs; this should include collection, utilization, and cost; the Secretary should convene a panel of stakeholders to suggest appropriate data elements.
  • Explore the potential for direct payment to blood centers to cover the costs of the infrastructure required to maintain adequate supplies for the public good.
  • Reduce regulatory uncertainty with respect to innovations to encourage investment in their development and implementation.