Dear Admiral Giroir:
The Advisory Committee on Blood and Tissue Safety and Availability met on August 26-27, 2020 to hear presentations and discuss strategies for improving the blood community’s response to public health emergencies. The presenters shared their organizations’ experiences of responding to public health emergencies, highlighted strengths that can be built upon for future emergencies, identified weaknesses that threaten the safety and availability of the blood supply, and recommended actions to ensure our nation’s preparedness and patient care.
Challenges and Weaknesses to Be Addressed
The Committee learned that while previous threats from transfusion-transmitted bacterial, viral, and parasitic agents affected blood safety, the COVID-19 pandemic disrupted blood availability because of widespread cancellations of blood donations. Blood centers and hospitals highlighted that a lack of accurate, real-time information on blood supply and utilization affected informed decision making and patient care, particularly for patients who need surgical procedures that require large volumes of transfusion (for example, liver transplantation) and people who need regular transfusion (for example, people with sickle cell disease and cancer).
Additional challenges and weaknesses identified by the presenters include the following.
- Lack of coordination in national and local public messaging efforts about the status of blood supply and donation
- Significant concerns from blood donors and staff about the safety of the work environment
- Lack of existing stockpiles of critical blood supplies
- Lack of plans for addressing transportation logistics
- Significant financial impact of the pandemic on blood center operations
Strengths to Build Upon
Despite the challenges, the blood centers, in collaboration with government and industry, successfully managed the collection of regular blood products and COVID convalescent plasma (CCP) from recovered patients and began to create a CCP national stockpile. Tens of thousands of patients were treated with CCP resulting in reduced illness and prevention of deaths. The blood community attributed multiple factors as strengths in achieving the success, including
- National public awareness campaigns about blood shortage
- Collaboration between blood centers, hospitals, government agencies, and industry with defined outcomes
- Changes to regulatory requirements such as donor deferrals
- Blood centers’ rapid adjustments to their operations
The current COVID-19 pandemic presents an opportunity for informing future decisions about our nation’s blood safety and availability during public health emergencies. The presenters and the public proposed many recommendations covering the entire blood supply chain. To fully digest the information shared by the presenters and to make actionable recommendations, the Committee decided to form work groups to develop prioritized recommendations within 30-45 days.
Recommendations
On September 25, 2020, ACBTSA members met virtually to review, discuss, and fine-tune the recommendations developed by the work groups. After thorough discussion, the Committee members unanimously voted yes to approve the following recommendations.
Focus Area 1: Governance/Locus of Authority
Recommendation: Establish a defined locus of authority for national blood and plasma policy, the Assistant Secretary for Health, coordinating with FDA, CDC, NIH, HRSA, ASPR, CMS, DoD, VA, and those non-government organizations that provide and transfuse blood and plasma products, and develop and implement a National Blood Policy inclusive of all blood and plasma products.
Focus Area 2: National Disaster Planning/Business Community
Recommendation: Develop and fund a comprehensive national disaster plan for the blood and plasma supply and include in National Recovery Framework to assure coordination between private and government sectors at the Federal and State levels.
Some key issues concerning this recommendation include:
- Convene stakeholders from federal agencies, industry, and healthcare experts to develop plan, including what Congressional funding may be required to implement and support the plan.
- Ensure that blood and plasma donation, processing and product distribution are designated as critical infrastructure and essential services.
- Perform an independent after-action review of blood/plasma community and HHS response to pandemic, focusing on blood supply adequacy.
- Define role, gaps and needs in disaster response of the AABB Interorganizational Task Force on Domestic Disasters and Acts of Terrorism, and provide funding, as needed, to fill gaps.
- Examine adequacy of current agreements that support disaster response activities between the private and government sectors, such as with HHS, DOD
Focus Area 3: Supply Chain to Produce Blood Products
Recommendation: Develop policies and provide funding to strengthen the resiliency of the blood and plasma supply chain in order to ensure product availability to hospitals during national emergencies, to include:
- Ensure blood and plasma center employees are considered essential personnel and are federally recognized with the same designation as critical healthcare workers during national emergencies and have priority access to vaccines and to supplies that are critical for blood collection and manufacturing, including personal protection equipment (PPE).
- Appoint a representative from the blood and plasma industry to federal committees or task forces responsible for allocation of critical supplies and transportation and logistics resources during national emergencies and give priority access to transportation and delivery systems for blood and plasma centers to assure continued operations in situations where infrastructure is disrupted.
- Provide funding and assign a task force to establish a 6-month distributed national stockpile of key supplies and devices that are essential to maintain a safe and available blood supply. The storage process and resource sharing of the stockpile will be managed and coordinated by blood and plasma industry representatives, thereby ensuring currently in-use and in-dated supplies.
- Work with manufacturers of plastics, testing reagents and ancillary supplies to identify specific U.S. product codes that could be manufactured in alternative manufacturing plants and proactively work with the FDA on functional flexibility resulting in FDA approval to continue to supply products that are critical to the U.S. blood supply chain from these alternative manufacturing plants.
Focus Area 4: Blood and Plasma Donor Engagement, Growth, and Research
Recommendation 4.1: Fund social science research to generate efficient and effective strategies to engage and retain younger and more diverse blood and plasma donors.
- Support public awareness and sustainable donor engagement studies including implementation and translational science.
- Evaluate the effectiveness of monetary and non-monetary incentives.
- Evaluate the implementation of evidence-based interventions designed to engage and retain blood and plasma donors.
Recommendation 4.2: In partnership with FDA, examine and revise policies that could increase the availability of blood and plasma donors and products
Focus Area 5: Data Infrastructure Solutions
Recommendation: Establish, implement, and fund comprehensive, sustainable, minimally burdensome infrastructure that monitors and makes available real-time data on blood availability and utilization,
Building on current infrastructure and gap analysis, develop a plan for a hemovigilance and transfusion outcomes system and determine funding mechanism.
Key attributes of such an infrastructure include:
- Being rooted in legislation and/or regulation
- Promotes improved patient outcomes
- Ensures data confidentiality
- Minimizes reporting burden by key stakeholders
- Leverages existing electronic reporting platforms
- Captures data from the maximum number of blood centers and hospitals
Focus Area 6: Innovation
Recommendation 6.1: Establish a public-private partnership to proactively explore and develop policy solutions intended to encourage innovation, promote quality and efficiencies, and advance the continued safety and availability of the blood supply.
The goals of such a partnership applied to blood products could provide for the following:
- Utilize regulatory science in the development of new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated blood products.
- Benefit patients by speeding the rate of important new products reaching the market by developing sound scientific and policy approaches to reduce the size and duration of pre-market clinical trials.
- Reduce time and resources needed for product development, assessment, and review. Utilize methods to allow rapid implementation of alternative approaches to supply blood product needs as exemplified in the response to past emergency situations such as hurricane Maria, other natural disaster scenarios, or situations involving specific military product needs.
- Establish early dialogue and coordination of clinical and development efforts with CMS and other government agencies regarding reimbursement policies and decision making to speed reimbursement programs and align with real costs as exemplified in the convalescent plasma program and funding of new screening tests for emerging pathogens at blood centers.
- Increase early discussion and collaboration between product developers and providers, regulatory scientists and decision makers as exemplified in the INTERACT program approach used by FDA for medical products.
Recommendation 6.2: Establish training and education workshops to instruct the general healthcare community on appropriate approaches and processes to use for regulatory approvals for the use of blood products (existing and new) under EUA, EAP and other appropriate approval mechanisms.
Focus Area 7: Finance
Recommendation: Identify and secure stable funding sources and mechanisms to support the national blood system in order to cover (but not be limited to) the following initiatives:
- Innovation that has the potential to improve the safety, efficacy, or reliability of the blood supply.
- Creation of redundant capacity in the blood system to reduce risk of blood product or critical supply shortages.
- Implementation of new mandated regulatory requirements that improve blood safety.
- Urgent financial needs of blood centers during national emergencies (e.g., the CARES Act).
