91¹ú²ú¾«Æ·

The 91¹ú²ú¾«Æ· (ASH) represents over 18,000 physicians, scientists, and medical trainees committed to the study of blood and treatment of blood-related diseases. ASH members include clinicians who specialize in treating children and adults with hematologic disorders and researchers who investigate the causes of disease and potential new promising treatments and therapies. Maintaining a safe and sufficient blood supply is vital to supporting public health. ASH is especially concerned with ensuring an adequate supply of safe blood and blood products – including red blood cells, platelets, plasma, and other blood components – when clinically justified for individuals with hematologic conditions. This includes individuals with blood cancers, hemophilia, thalassemia, and sickle cell disease (SCD) for whom blood transfusions, blood components, and plasma-derived therapies can prevent complications, offer a higher quality of life and even be lifesaving.

Blood is the one of the most frequently prescribed intravenous therapies in hospitals. Despite its critical importance, the blood supply is unstable, and the ongoing COVID-19 pandemic has exacerbated existing challenges and reinforced the need to invest in the security of the blood supply chain. ASH supports steps to ensure a safe and adequate blood supply and to further encourage donations from all healthy people capable of donation. Blood safety policies are complex, and many factors need to be considered when examining potential changes. Therefore, it is important for all stakeholders to explore potential evidence-based solutions with an intersectional approach that also provides patient safety.

ASH supports the following policy goals to support a strong blood supply:

1. CLINICAL MANAGEMENT: Identify best practices for more efficient blood utilization, and clinical management protocols to minimize the need for transfusion.
2. RESEARCH AND SURVEILLANCE: Encourage additional research to better inform donor policies and assure a safe and robust blood supply.
3. DONOR ELIGIBILITY CRITERIA: Safely maximize eligibility criteria and eliminate unwarranted biased exclusion of marginalized populations.
4. PUBLIC EDUCATION AND AWARENESS: Increase interest in donating blood and minimize barriers to blood donation.
5. ADEQUACY OF SUPPLY: Ensure that recipients of blood products have confidence in safety of the blood supply and are well informed about the benefits and risks of blood transfusion.

CLINICAL MANAGEMENT

The first element of ASH’s policy is to identify best practices for more efficient blood utilization and clinical management protocols to minimize the need for transfusion. This can help to reduce demand for blood and blood products if patients can be safely managed in other ways. For example, improving treatment of anemia and iron deficiency in multiple areas. Evidence suggests this can reduce the need for transfusion in pregnant people and those undergoing surgery.

The Society also supports implementation of transfusion management recommendations, such as from ASH's Choosing Wisely List and relevant ASH Guidelines. A number of these recommendations relate directly to blood and blood product usage. For example, ASH’s Choosing Wisely List recommends transfusing the minimum number of red blood cell (RBC) units necessary to relieve symptoms of anemia or to return a patient to a safe hemoglobin range. Furthermore, antifibrinolytic therapies (e.g. tranexamic acid) can reduce the amount of blood and platelets needed by both patients with hematologic malignancies and those undergoing various types of surgeries. In addition, ASH SCD Guidelines: Transfusion Support discuss when transfusion should be used to care for individuals with SCD.

RESEARCH AND SURVEILLANCE

ASH believes that complex blood safety policies should be based on sound and highly validated science, and the Society supports the adoption of new technologies and/or revised donor eligibility criteria policies with an intersectional approach that increase the potential pool of donors, reduce unwarranted discriminatory policies, and improve the safety and reliability of the blood supply, without an increased risk to end users. Continued funding of research in transfusion medicine is essential to advancing innovation and maintaining safety. Additionally, continued support for research is needed to better understand the clinical utility and safety of blood substitutes.

The Society encourages policymakers to sustain or expand research funding in this area. As an example, this would include support for the U.S. Food and Drug Administration’s Assessing Donor Variability and New Concepts in Eligibility (ADVANCE) study, national consortium performing the National Heart, Lung, and Blood Institute’s Recipient Epidemiology and Donor Evaluation Study (REDS-IV-P), individual investigators performing transfusion medicine research through R01 and PPG funding, and training new investigators in transfusion medicine research through K and T32 funding at the National Institutes of Health (NIH).

The Society also supports national databases and monitoring systems to help facilitate this research as well as general surveillance about the safety and adequacy of the blood supply. There is a critical need in the United States to establish and maintain a comprehensive federally funded blood supply tracking and redistribution system. The ability to identify and move blood around the country where needed quickly is paramount. This will help to guarantee an adequate blood supply is readily available during “normal” times and during public health emergencies. Additionally, developing nationwide databases and registries, such as a Red Blood Cell Alloantibody Database, will reduce unnecessary duplication of testing and increase the efficiency of providing appropriate blood products.

Finally, the Society also supports the Transfusion-Transmissible Infections Monitoring System (TTIMS) and calls for implementation of a national system capturing comprehensive, real-time hemovigilance data and patient outcomes to advance safety and innovation by promoting evidence-based policymaking, informing the development and adoption of new blood safety technologies, and enabling continuous practice and quality improvement by all blood provision organizations.

DONOR ELIGIBILITY CRITERIA

ASH supports efforts to safely maximize eligibility criteria, including revising donor deferral policies related to men who have sex with men (MSM). ASH supported the Food and Drug Administration (FDA) change in 2020 that reduced the donor deferral period from 12 to three months for MSM, as well as important work that is now occurring to collect the needed scientific evidence to further evaluate the current policy. ASH strongly supports this effort as a pathway to the establishment of donor-screening based on individual risk behaviors, not sexual or gender identity. The use of rational, science-based deferral periods must be applied fairly and consistently among all blood donors across the country, based on the latest scientific evidence. Public policy in this area should avoid unnecessary and discriminatory deferrals.

PUBLIC EDUCATION AND AWARENESS

During all times, and especially in public health emergencies, policymakers must support novel intersectional approaches to donor recruitment, increasing awareness of blood donation, and promoting diversity among blood donors. As an example, initially during the COVID-19 pandemic there was a tremendous response from donors, but that eventually waned, causing more blood shortages. Continuous, consistent, and coordinated messages about the need for donations are important throughout a public health emergency and during non-emergent periods, so blood is available should an emergency arise.

ASH supports efforts to increase interest in donating blood and minimize barriers to blood donation. Engaging and encouraging cross-stakeholder advocacy and awareness efforts can convey the importance of blood donation and why a robust blood supply is critical to patient care. One pressing challenge in recruiting new donors relates to the critical need to have a diverse blood supply. Unfortunately, recruitment of diverse donors is difficult. We are especially concerned about an adequate blood supply for individuals with SCD for whom transfusions are lifesaving and prevent complications. Since patients with SCD are at a very high risk of alloimmunization, providing prophylactic C, E, and K matched red cells must remain the standard of care, and this necessitates a diverse blood donor pool. Any public awareness efforts related to blood donation should utilize an intersectional lens to focus on recruitment of a diverse pool of donors and also be monitored for effectiveness.

Finally, ASH calls for programs and policies that will ensure safety for both donors and the end users of blood and blood products. For donors, this includes culturally sensitive and effective communication including education about how their donation causes iron deficiency and the steps they can take to prevent it. Recipients of blood products must be well informed – for example with development of education materials about blood transfusion practices and safety – so they can have confidence in the safety and adequacy of the blood supply.

ADEQUACY OF SUPPLY

As noted above, the COVID-19 public health emergency spotlighted the areas of risk for the blood supply. To address these challenges, there is a critical need in the United States to establish, maintain and fund a system that captures and makes available data on the national blood supply chain. This type of data system needs be sustainable; contain information from a maximum number of blood collection centers and institutions/individuals that utilize blood products; and provide useful data to the entire blood transfusion community. Ideally, this system would also track adverse reactions and transfusion challenges patients face, which would enhance the safety and efficacy of transfusion medicine practices in the United States.

Finally, to ensure that blood and plasma collection can continue during a public health emergency, these activities must be designated as “essential,” and these facilities and providers must be prioritized as health care entities that receive protective equipment.