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AABB 2018 Advocacy Agenda

AABB 2018 Advocacy Agenda Diagram

AABB’s advocacy agenda is a working document. We update it annually as well as when new issues arise.

AABB is committed to advocating for policies that support two broad objectives: (1) ensuring that patients and healthcare providers have adequate, appropriate access to safe transfusion medicine and cellular therapies; and (2) enhancing patient and donor care and safety in transfusion medicine and cellular therapies.

The association advances these goals by focusing on the following priorities:

  • Promoting a sustainable U.S. blood system as a critical component of the healthcare system and emergency preparedness.

    Blood and blood components are irreplaceable essential medicines. Blood transfusions are medically necessary, predictable treatments for patients with chronic health conditions, such as anemia, gastrointestinal bleeding, infection, liver failure, hematological disorders, cancer and other illnesses, as well as for patients who lose blood during surgery or because of injury. In addition, blood components must be immediately available in emergencies for resuscitation, traumas, massive transfusion protocols and other critical treatments, such as for burn victims.

    Even though blood is a critical public health resource, the current U.S. blood system is fragile, and several existing trends and challenges threaten to disrupt the blood system. Changing medical practices, reduced blood utilization, a shrinking donor pool and consolidation throughout the health care system have stressed the blood community. Additionally, the blood sector faces mounting economic pressures from existing and emerging voluntary and mandatory safety measures, which are intended to protect the health of patients and donors but are costly to implement. These existing challenges limit the ability of the blood system to invest in research and development, adopt innovative technologies and maximize its potential for preparing for and responding to emerging infectious diseases, disasters and emergencies.

    Data related to the blood system - such as data on blood supply availability, operations and utilization – are essential for ensuring that the blood supply is stable and capable of responding to emerging infectious diseases, disasters and emergencies. The collection and analysis of timely, relevant data identify trends and are important for developing policies related to the sustainability of the blood supply and blood system.

    AABB advocates for policies that:

    • Support a stable blood supply that has sufficient capacity to respond to emerging infectious diseases, disasters and emergencies.
    • Encourage research related to transfusion medicine and blood availability.
    • Promote the collection, analysis and public reporting of data related to the blood system.

  • Promoting access to cellular therapies.

    Cellular therapies include both standard of care treatments, such as hematopoietic stem cell transplant for hematologic malignancies, as well as novel treatments for a wide variety of diseases or conditions. These constantly evolving, innovative therapies originate as human cells and are transplanted or infused to replace or repair damaged tissue or cells. Examples of these cells include hematopoietic stem cells, skeletal muscle stem cells, mesenchymal stem cells, lymphocytes, dendritic cells and pancreatic islet cells.

    AABB advocates for policies that:

    • Support patients’ access to safe, novel cellular therapies.
    • Foster research related to cellular therapies.
    • Advance a sustainable U.S. supply of high quality cord blood products.

  • Promoting adequate coverage and payment policies for transfusion medicine and cellular therapies.

    Unfortunately, flawed coverage and reimbursement policies can limit patients’ access to products and services, stifle research and development, and impede the adoption of new technologies. Medicare payment policy does not immediately capture costs associated with new technologies, and it takes years for payment rates to reflect increased costs to providers that result from new regulatory requirements.

    AABB advocates for policies that protect and improve Medicare coverage and reimbursement policies related to blood, blood products, transfusion medicine and cellular therapies.

  • Promoting policies that support the appropriate regulation and timely introduction of new products and safety technologies for transfusion medicine and cellular therapies.

    As biologics, blood, blood components and cellular therapies involve inherent risks – both infectious and non-infectious – that require ongoing vigilance and attention. New products and technologies, such as screening tests for emerging infectious diseases, pathogen reduction technology and rapid bacterial tests, are intended to protect the blood supply from infectious diseases and bacterial contamination. Similarly, as patients are offered a wide array of new cellular therapy treatments in various clinical settings, it is important to ensure that they are receiving high-quality, safe care. The regulatory systems applicable to blood and blood products, transfusion medicine and cellular therapies need to help protect patient and donor care and safety without stifling innovation or unnecessarily hindering patient access to quality care.

    AABB advocates for:

    • The use of evidence-based policymaking, which includes but is not limited to risk assessment.
    • Revising regulations and guidances that: (1) do not result in increased safety, (2) are duplicative, outdated, unnecessary or overly burdensome; (3) unnecessarily restrict access to products and technologies; and (4) stifle innovation.

  • Promoting policies that advance patient and donor care and safety in transfusion medicine and cellular therapies.

    Continuous data collection and analysis, evolving medical practices and ongoing quality assessment and improvement activities support patient and donor care and safety. For instance, AABB leads and strongly supports hemovigilance and biovigilance programs, which are critical to patient safety and donor health. The data collected through patient and donor hemovigilance efforts enables public and private stakeholders to monitor adverse reactions and incidents associated with blood collection and transfusion. These important data are used to identify trends, establish best practices and develop interventions that significantly improve patient and donor care and safety.

    As another example, patient blood management (PBM) is an evidence-based, multidisciplinary approach to optimize the care of patients who may need transfusion. PBM can reduce the need for blood transfusions and reduce healthcare costs, while ensuring that blood components are available for the patients who need them.

    AABB’s steadfast commitment to improving patient and donor care and safety in transfusion medicine and cellular therapies is exemplified by our role as a global leader in setting standards, accreditation, implementation of quality systems and education. AABB develops standards for blood banks and transfusion services, cellular therapies, perioperative services, relationship testing, immunohematology reference laboratories, molecular testing and PBM. AABB’s accreditation programs are aimed at improving the quality and safety of the activities covered by the standards. Additionally, AABB educates the transfusion medicine and cellular therapies community on current science and best practices that support patient and donor care and safety.

    AABB advocates for policies that:

    • Promote enhanced patient and donor care and safety, such as patient and donor hemovigilance programs.
    • Encourage the use of patient blood management as a means of improving the quality of patient care and potentially reducing healthcare costs.
    • Encourage research related to patient and donor care and safety.

February 2018