ACBTSA August 27, 2020 - Meeting Summary

Call to Order

Jim Berger, Designated Federal Officer for the Advisory Committee on Blood and Tissue Safety and Availability (ACBTSA), conducted roll call (see Appendix for attendance). The meeting started with a quorum.

Recap of Day-1 Meeting

Dr. Jay Menitove summarized the Day-1 presentations and highlighted key messages and recommendations made by the presenters and panelists, including the following.

• Blood donation
  • Impact of the COVID-19 pandemic on blood collection organizations
  • Donor engagement during public health emergencies and in normal times
  • Strategies for stabilizing blood supply
  • Fund donor motivation research
  • Fund national blood donation campaigns

• Data
  • Lack of a "sight line" between blood center and hospital inventories
  • Establish and considerations for a real-time data collection system
• Supply chain
  • Lack of a relationship between blood centers and Personal Protection Equipment (PPE) vendors prior to the COVID-19 pandemic
  • Commercial flight cancellations negatively affected the transportation of supplies and blood samples (to testing labs)
  • Set up a stockpile for PPE and other critical supplies
  • Establish a single, dedicated national contingency/disaster plan
• Financial stress
  • Impact of the pandemic on blood centers (50% blood centers marginally profitable, others had net losses)
  • Transition of blood supply to commodity status strangled innovation
  • Provide stable funding for continuity and innovation (the pandemic increased costs)
  • Provide financial assistance (e.g., cash flow) during public health emergencies, if needed
• Policy
  • Lack of harmonization between local, state, and federal regulations
  • Establish guiding management (e.g., access to transportation)
  • Identify blood center staff as essential personnel
  • Blood supply logistics during emergencies coordinated by a volunteer-supported task force; Fund the task force and determine authority
• Regulations
  • "If testing is too complex, it is not cost effective"
  • Streamline regulations without compromising safety
    • Discontinue serologic testing and promote pathogen reduction technology (PRT) plus nucleic acid testing (NAT)
  • Support donor risk/qualification research
• COVID-19 convalescent plasma (CCP)
  • A success for patients and the blood community
  • Perform a "lessons learned" analysis

Jackie Fredrick, Chair of ACBTSA, encouraged the Committee members to think what recommendations they would propose in the following categories, which are in line with Dr. Menitove's summary.

• Blood donor engagement and growth
• Data infrastructure solutions
• Supply chain solutions
• Innovation/regulatory/public-private partnerships
• National disaster/Business continuity planning
• Financial needs
• Governance/locus of authority

Ms. Fredrick asked the Committee members also to think about how they would classify the recommendations as immediate (less than 2 years), mid-term (3-4 years), or long-term (>4 years) action.

In response to Mr. Jim MacPherson's question on providing "cash flow" assistance to blood centers if needed, Jim Berger confirmed that blood centers may qualify for small business loans. Ms. Fredrick also asked the Committee members to think about how the blood centers, as critical part of the national health infrastructure, could obtain assistance through the emergency relief funding similar to hospitals

Government Data Collection Systems for Transfusion Medicine and Blood Operations

The panelists representing the Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), and the National Institute of Health (NIH) first introduced their agencies' respective data collection systems and then answered questions from the Committee members.

FDA Data Collection Systems

Dr. Barbee Whitaker, Lead General Health Scientist from the Office of Biostatistics and Epidemiology of FDA's Center for Biologics Evaluations and Research, introduced FDA' blood safety monitoring systems, including the FDA Adverse Event Reporting System (FAERS), the Transfusion-Transmissible Infections Monitoring System (TTIMS), and the Biologics Effectiveness and Safety (BEST) Program.

FAERS

• A passive surveillance system that collects reports electronically from manufacturers, and through MedWatch from healthcare providers and the public.
• Current state: Fatalities associated with blood collection and transfusions must be reported as soon as possible. Expedited adverse event reports of serious and unexpected events must be submitted to FDA in 15 days. Non-expedited reports must be submitted quarterly if a product is less than 5 years old, otherwise annually.

TTIMS

• Launched in 2015, TTIMS collects data on about 60% U.S. blood donors.
• TTIMS is jointly funded by FDA, National Heart, Lung, and Blood Institute (NHLBI), and HHS Office of Assistant Secretary for Health (OASH), and it operates through a public-private partnership.
• Potential future directions: TTIMS can be expanded to 1) include additional infectious disease agents or other agents; and 2) conduct further research on donor behaviors, donor hemovigilance, donor subpopulations of interest, donation characteristics, and other potential risks.

BEST

• BEST is an active surveillance system that uses innovative approaches such as artificial intelligence to mine electronic health records and to establish automated adverse events reporting.
• It includes some claims data, and it better addresses specific Centers for Biologics Evaluation and Research (CBER) product needs and regulatory questions.
• Strengths:
  • Uses advanced computational methods
  • Automation may reduce clinician burden by identifying potential adverse events
  • Planned expansion to other electronic health records (EHRs) such as EPIC
  • Uses ISBT-128 codes to identify transfusion exposures
  • Lives covered: Currently 5-50 million EHR patient lives
  • Linkage of EHR-Claims data would improve longitudinality across different healthcare settings
• Weaknesses
  • Automation approaches are initially resource intensive
  • Implementation of automated adverse event reporting on larger scale will take many years
  • Accurate computable phenotypes of many transfusion reactions are difficult to develop and refine because they are complex conditions

CDC Blood Safety and Availability and Data Collections

Dr. Sridhar Basavaraju, Director of CDC's Office of Blood, Organ, and Other Tissue Safety, highlighted CDC's data collection efforts related to blood safety, including the National Blood Collection and Utilization Survey (NBCUS), the National Healthcare Safety Network (NHSN) Hemovigilance Module, and transfusion-transmitted infection investigational data.

NBCUS

• Intermittent national surveys of the U.S. blood collection centers and transfusing facilities since 1971
• The goal is to develop reliable estimates of blood collection and utilization
• NBCUS can monitor trends in collection and utilization (2019 data will be published in about a month) and also collect donor demographics (e.g., age)
• Future direction: capture data related to new events, consider adding new variables, revise the questionnaires (Federal Registry Notice will be published prior to the 2021 survey)

Dr. Basavaraju acknowledged that in public health emergencies, the overall use of NBCUS is limited because it is unable to capture real-time data; however, the tools have been used during Zika virus outbreak to quickly estimate blood collection and utilization in Puerto Rico and the data were used to quantify the need for blood importation.

NHSN Hemovigilance Module

• A web-based surveillance system implemented in 2010.
• Participating facilities report
  • Facility characteristics (e.g., setting, bed size, etc.) annually;
  • Adverse reactions monthly;
  • Total numbers of transfused components monthly; and
  • Transfusion process errors resulting in adverse reactions.
• Future direction:
  • Potential sentinel surveillance in select metropolitan areas
  • Continuous engagement with stakeholders to use the system to improve the practice of transfusion.

Dr. Basavaraju noted that in public health emergencies, NHSN is able to capture data in near real time. For example, during the current COVID-19 pandemic, the system has been modified to track COVID-19 convalescent plasma (CCP) and associated adverse reactions, and assess the impact of COVID-19 on blood utilization.

Dr. Basavaraju also introduced CDC's investigation efforts related to transfusion-transmitted infections and CDC's collaboration with FDA in determining contamination sources through bidirectional information sharing.

In summary, Dr. Basavaraju reiterated the following takeaways.

• The NBCUS is the most comprehensive national survey to measure blood collection and utilization; however, the data are not real-time.
• NHSN Hemovigilance Module collects monthly data on blood utilization and in standardized format for adverse reactions. Findings are consistent with other hemovigilance systems, and improved participation can provide more nationally representative data.
• CDC's transfusion-transmitted infection investigations provide valuable evidence related to prevention and interventions. Data collected by CDC are shared with relevant stakeholders to inform policy, regulatory, and safety interventions.

National Heart, Lung, and Blood Institute Supported Transfusion Research Databases and Responses to Emerging Infectious Diseases

Dr. Simone Glynn, Branch Chief of the Blood Epidemiology and Clinical Therapeutics Branch at NHLBI, introduced the databases of the Recipient Epidemiology and Donor Evaluation Study (REDS) program.

• The overall goal of the REDS research program is to improve the safety and availability of transfused blood products in the U.S. and worldwide.
• The REDS-III Vein-to-Vein research database allows the evaluation of the effect of blood donor and component characteristics on the recipient's clinical and laboratory outcomes.
• The REDS-IV-P Vein-to-Vein Research database is under development. Once completed, the datasets will be available through BioLINCC.

Dr. Glynn highlighted the following two REDS research studies

• REDS-III U.S. Natural History Cohort of Zika Virus RNA+ Blood Donors
• REDS -IV-P Epidemiology, Surveillance, and Preparedness of the Novel SARS-CoV-2 Epidemic (RESPONSE) study, which evaluates if SARS-CoV-2 poses a threat to the blood supply as a potential transfusion-transmitted pathogen

Stakeholder Presentations

Patient Perspective

Nathan Schaefer, Vice President of the National Hemophilia Foundation (NHF), shared NHF's and the American Plasma Users (APLUS) Coalition's advocacy efforts during the COVID-19 pandemic and highlighted APLUS's initiatives, including issuing a statement in support of FDA policy changes related to COVID and submitting comments in response to the Senate Health, Education, Labor, and Pensions (HELF) Committee's Request For Information asking for policy ideas regarding preparing for the next pandemic.

Mr. Schaefer shared his thoughts on what has worked well in response to the pandemic, pointed out areas that still need improvement, and made the following recommendations.

Recommendations

• Support evidence-based decisions in determining donor eligibility
• Reiterate the importance of patient input in all decisions
• Ensure that any national blood policy is inclusive of whole blood, blood components, and source and recovered plasma
• TTIMS should be a permanent, comprehensive program with dedicated funding, and it should transparently and publicly report data.
• Support awareness campaigns like those called for in the CARES Act
• Solicit patient stories/perspectives in all efforts

AABB: Strengths, Challenges, and Recommendations to Improve the Blood Community's Response to Public Health Emergencies

Debra BenAvram, Chief Executive Officer of AABB, highlighted the following foundational strengths of the blood community in response to the COVID-19 pandemic.

• Coordinated national messaging on the need for blood donations
• Collaboration related to changes in blood availability and utilization
• Innovation (e.g., CCP) facilitated by policymakers and a unique public-private partnership

Ms. BenAvram noted that the pandemic highlighted the following weaknesses, which jeopardized patient care and blood safety and availability.

• Lack of real-time data on the blood supply, utilization, and hemovigilance
• Threats to the blood system supply chain
• Risks related to blood collection activities (e.g., mobile blood drives)

Ms. BenAvram offered the following recommendations to build upon the strengths and address the weaknesses.

Recommendations

• Establish, implement, and fund a sustainable infrastructure that captures and makes accessible real-time data on blood availability and utilization, hemovigilance, and transfusion outcomes. The infrastructure should
  • Protect data confidentiality,
  • Minimize burdens,
  • Leverage existing platforms,
  • Capture data from maximum number of blood donor centers and hospitals, and
  • Be rooted in legislation.
• Develop effective donor awareness and engagement activities to strengthen the blood donor base. Such activities should
  • Work through a public-private collaboration;
  • Take a comprehensive, sustainable approach to blood donor awareness;
  • Explore multisector partnerships; and
  • Examine and revise policies that could increase the availability of blood components.
• Support 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. Examples include
  • Identify regulatory and reimbursement barriers that limit innovation or interfere with patient care
  • Explore patient-centered policy solutions that support better care for individuals, better health for populations, and lower costs
  • Proactively identify efficiencies and opportunities to improve clinical trials conducted during public health emergencies
  • Use information from the COVID-19 response to update preparedness plans for a future pandemic involving an emerging transfusion-transmissible virus

America's Blood Centers (ABC): COVID-19 Lessons Learned

Kate Fry, Chief Executive Office of the America's Blood Centers (ABC), shared similar observations regarding what worked well and what did not regarding the blood community's response to the COVID-19 pandemic. She offered the following recommendations.

Recommendations

• Continuous recruitment of donors
  • Need for continuous recruitment of donors, which is the number 1 challenge that blood centers face today
  • Promoting robust donor base must become national imperative, which is the single most effective tool we have to prepare for a disaster
  • Social science research is required to best understand a path forward
  • Public-private partnership is necessary to amplify reach of public awareness campaign
• National, near real-time monitoring system for the U.S. blood supply
  • Information, coordination, and implementation of strategy can only be properly deployed when necessary data are collected and readily available
  • Blood supply data, including blood usage, is neither currently systematically nor comprehensively collected
  • National databases, with reporting requirements linked to financial support
• Development and funding of a comprehensive national disaster plan for the blood supply
  • COVID-19 has shown that regional disaster planning is not sufficient
  • Must include not only traditional stakeholders but also other essential stakeholders (e.g., public health and nontraditional industry suppliers)
  • Full range of potential scenarios (e.g., transfusion-transmissible pathogens)
  • Must also prioritize how federal, state, and local agencies will work together in tandem with industry to maximize coordination and execution
  • Must include blood center alternative collection procedures
• Revise approval and fund pathways for novel products, tests, and technology
  • COVID-19 pandemic brought to light some limitations and opportunities
  • Any regulatory changes made in rapid succession must be accompanies by flexing of regulatory requirements that impede rapid implementation
  • More centralized role by federal government in pathogen reduction implementation

American Red Cross (ARC): COVID-19 Experience

Chris Hrouda, President of American Red Cross's Biomedical Services, shared American Red Cross's experience during the pandemic. He identified the following strengths.

Strengths

• Rapid implementation of enhanced safety measures to ensure the safety and confidence of donors and staff
• Increased visibility and public awareness, including local, state, federal, and medial support
• Effective operational responses to COVID-19, including effective internal strategies, rapid regulatory changes, strong industry partnerships, and effective communications with hospitals
• New product implementation (e.g., collecting, manufacturing, and distributing CCP)

Weakness and Challenges

• Blood drive cancellations
• Inefficient national outreach for CCP

• Absence of mechanisms to allow decision-making for the blood systems as a whole
• Changing local and state regulatory directives
• Managing the process of getting staff to be considered essential service employees at a state by state level
• Delaying or changing guidance around PPE caused difficulty
• Longstanding resource restraints limited the ability of blood providers and manufactures to introduce innovative approaches
• Blood providers may not fully understand blood donor motivation
• Absence of systems to monitor and report on industry-wide data

Recommendations

• Invest in the systems necessary to provide real-time data to support both blood centers and hospitals focused on available supply, demand forecasting, utilization, and hemovigilance
• Include blood collectors in the National Disaster Framework and clearly spelled-out in all Emergency Support Functions at the federal and state levels
• Work with industry and government partners to enhance our response planning to focus on large scale loss of sponsored blood drives, large scale loss of trained staff, and significant disruptions in transportation routes
• Evaluate innovative solutions to a more focused and productive industry wide donor engagement process
• Identify a stable funding mechanism to allow for the necessary investments to respond more effectively to future challenges

Department of Defense Stakeholder Statement

COL Audra Taylor, Division Chief of the Armed Services Blood Program (ASBP) at the Department of Defense (DoD), introduced ASBP, shared DoD's perspective regarding response to COVID-19 pandemic, and provided recommendations.

What Worked Well

• Initial collaboration with FDA, AABB, and the industry
• Participation in the joint statement to encourage blood donation
• Early and frequent communication with AABB CEAG facilitated coordination efforts
  • For example, with DoD being involved from the initial CEAG response, members of the CEAG were able to work quickly and efficiently when blood was needed to support the USNS Comfort that was deployed to the State of New York
• DoD's support in transporting blood supplies from the American Red Cross to the local hospital in Guam due to the flight restrictions on the island
• Weekly meeting hosted by AABB

COL Taylor highlighted the following challenges ASBP faced, which is consistent with what previous presenters have shared.

Challenges

• Vulnerability of staff exposure
• Decreased donor turn out for scheduled blood drives
• Frequent blood drive cancellations
• Uncertainty of PPE supply
• Adaption to how blood drives and collections take place with new social distancing and PPE measures
• Loss of population/trainee, which posed a huge impact on blood products
• Lack of required agreements in place for DoD procurement of blood products before the pandemic

Recommendations

• Implement holistic Emergency Response Plan across the DoD blood enterprise planning and responding
• Keep the ability to quickly identify, mobilize, and train additional medical support (identify resources ahead of time would be beneficial)
• Gain an understanding of how DoD is supported by HHS in domestic responses
• Identify and establish required agreements

Plasma Protein Therapeutics Association Stakeholder Statement

Amy C. Efantis, President and CEO of the Plasma Protein Therapeutics Association (PPTA), emphasized the lifesaving role of plasma protein therapies in treating a wide range of rare, chronic conditions related to plasma protein deficiencies. She shared that the COVID-19 pandemic has led to decline in plasma donations, and that plasma collections/donations are urgently needed.

Ms. Efantis shared similar observations regarding strengths and weaknesses, and she offered the following recommendations.

Recommendations

• Include patient voice to inform policy
• Streamline or exempt the Clinical Laboratory Improvement Agreements requirements for donor centers
• Evaluate donor behavioral risk categories for applicability (NAT testing/pathogen reduction)
• Study donor motivation to increase donor pool
• Expand/enhance TTIMS (or something similar system) to monitor the effect of changes

Public Comment

Dr. Richard Benjamin, Chief Medical Officer of CERUS, provided comments and proposed recommendations for improving the blood community's response to future public health emergencies. He urged the Committee to think if the community's response would be timely enough to protect the safety and availability of the blood supply should the next outbreak be transfusion-transmissible and asymptomatic individuals could present as blood donors.

Dr. Benjamin noted that existing technologies that are already in routine use (e.g., plasma pathogen reduction) will make a difference. He urged the community to be proactive because remaining reactive in adopting change is inadequate when facing emerging infectious diseases.

Using the French Transfusion Service's response to the 2014 Chikungunya outbreak as an example, Dr. Benjamin suggested instituting a similar three-pronged approach to ensuring supply continuity, including appropriate deferrals for symptomatic donors, testing, and pathogen reduction. He emphasized that to be prepared for future emergencies, processes for these approaches need to be in routine use now.

Dr. Benjamin urged the community to be proactive, to recognize the role of pathogen reduction in ensuring blood safety, and to support efforts to extend pathogen reduction to all blood products.

Future Considerations

Blood-Based Therapies for Patient Treatment: CCP and Other Immunotherapies

Dr. Michael Joyner, Principal Investigator of the FDA Expanded Access to Convalescent Plasma for the Treatment of Patients with COVID-19, shared what he learned from the Expanded Access treatment program and offered recommendations.

What Worked Well

• Community engagement, which was key to the Expanded Access Program (EAP) success
• Collaboration at all levels
• CCP scale up
• Data collection and reporting from the sites

Weaknesses

• Drop in blood collections during the pandemic
• Collection of convalescent plasma versus normal products for regular surgery
• Financial fragility of the blood collecting system
• Shifting from the in-series process to in-parallel implementation

Recommendations

• Develop a financial model that works best for the U.S. blood collection system (for example, a "utility" model that does not depend on distribution)
• Stockpile frozen blood products
• Support research and development program to extend platelet shelf life
• Establish a national research and development program on passive immunity
• Keep key infrastructure (e.g., convalescent plasma collection) "warm" for the next crisis, and embed randomized clinical trial capability in the infrastructure
  • Dr. Joyner suggested that HHS should consider commissioning a "white paper" and working with the academic team involved in the CCP program.

Dr. Joyner briefly reviewed the EAP program and explained the 30-day crude mortality results, which showed that patients who received high antibody-containing plasma within three days of diagnosis had lower mortality rate. Patients who received CCP treatment four or more days after diagnosis, however, did not show the same dose-dependent response. The result suggested that early treatment was critical, he noted.

Dr. Joyner stated that to prepare for the next pandemic, the community needs to develop countermeasures (e.g., taking passive immunity to the next level) that can be rapidly deployed against known and unknown pathogens of pandemic potential.

Innovation in Blood Products for the Future: Responding to Public Health Emergencies

Dr. John Holcomb, Professor of Surgery and Senior Scientist at the University of Birmingham's Center for Injury Science, briefly reviewed the epidemiology of injury. He pointed out that data on blood product availability, transfusions, and patient outcomes should be linked at the national level. He suggested leveraging and linking existing federal data collection programs to optimize patient outcome.

Dr. Holcomb noted that research funding for optimizing the use of blood products in bleeding patients is essential to improve outcomes, referencing previous studies including the PTOMMTT and PROPPR trials. He pointed out that how blood products are used in the civilian word impacts the Military and vice versa. He noted that studies have shown prehospital blood transfusion improves patient outcome, and reimbursement for both current prehospital blood products and reimbursement for new blood products is essential to improve survival.

Recommendations

Dr. Holcomb noted that actions are needed to address the following three topics.

• Reliable funding for current blood product utilization research and for new blood product development
• Platform for data sharing across multiple competing blood businesses.
• Prehospital billing process for current and new blood products

Dr. Holcomb noted that the above actions will help achieve the following.

• Data driven, nationwide, supply, demand, utilization, and outcomes
• Current and new blood products available on all ambulances and in all hospitals
• Military will deploy with blood products at all levels of care
• Quickly, dramatically, and cost effectively improve outcomes of all Military and civilian bleeding patients

Discussion

In response to Dr. Goodrich's question on approaches to ensuring rapid response, Dr. Joyner suggested a three or four-pronged strategy: keep certain infrastructure "warm," stockpile certain products, engage young people to donate, and look at improved financial reimbursement for blood centers starting with a "utility-like "model. He noted that a coordinated system with surge compacity built in is needed.

Dr. Holcomb suggested considering the emergency actions that have been proposed by all speakers that are being done every day around the world.

Dr. Paul Ness asked Dr. Holcomb's view on pathogen inactivation for platelets and even red blood cells.

Dr. Holcomb responded that when patients at a high risk of dying from bleeding, infectious disease is not a top concern given the low transmission rate. He noted that he is against of anything that affects the function of the blood products because everything needs to work right to save lives.

Dr. Joyner stressed the importance of further translational research on platelets.

Dr. Jed Gorlin commented that it is not clear that EHRs are currently set up for translational research.

Dr. Holcomb responded that EHRs are not optimal for understanding transfusion, but they could be. He suggested collaborating with FDA (e.g., the BEST program) to do research.

Dr. Joyner noted that he is trying to set up a synthetic control group for the EAP with some EHR vendors as well as large insurance claim organizations and hospital systems. He commented that EHR data mining is doable, and billing codes from the databased could be useful for cost estimates/studies.

In response to Ms. Fredrick's question on passive immunity and if CCP could be collected from people who are vaccinated with COVID vaccine (when it becomes available), Dr. Joyner explained that depending how robust the antibody response is, it is possible. He commented that the question reflects creative thinking and how to repurpose older ideas in modern context.

Mr. Jim MacPherson asked why there is so much controversy around the EAP and the Emergency Use Authorization (EUA) of CCP.

Dr. Joyner explained that FDA received a lot of Investigational New Drug Applications (INDs) in March 2020, and one idea was to have an EAP for consistency. The program took off, and as a result people begun to develop higher expectations beyond the original goal/objective of the program. Regarding EUA, Dr. Joyner explained that, CCP met the thresholds for EUA, which include addressing unmet medical need, reasonable safety profile, and at least some chances of efficacy/benefit. He pointed out that lack of understanding of the history, purpose, and objectives of an EAP, as well as the purpose and rules of EUA, may be a factor contributing to the controversy.

In response to Mr. MacPherson's follow up comment, Dr. Joyner pointed out the complexity of running randomized clinical trials (e.g., infrastructure and patient recruitment).

In response to Dr. John Holcomb's question on dose effectiveness and number of units, Dr. Joyner explained that there were no preclinical pharmacokinetic (PK) studies. He further explained that they have some data about volume, and there is indication that more volumes help; however they have to work through that in the context of antibody levels, size of the patient, and other issues.

Ms. Fredrick asked Dr. Holcomb to help make a suggestion around making available a system to deal with public health emergencies.

Dr. Holcomb responded that to him, everyday injuries are public health emergencies and working in the trauma world is the best way to be prepared. The best way to prepare for mass casualty in his view is to have the blood products prehospitally. He noted that it would expand the need for increased donation, expand the ability to respond, and improve outcome of everyday injuries.

Dr. Joyner suggested changing the mind set and transforming the current blood collection model to a surplus model.

Mr. Bill Block added that blood centers used to collect per demand for various reasons. He shared that after they changed from a distribution model to a collection model for CCP, the centers have ramped up CCP collections significantly.

Dr. Holcomb pointed out the need to have the ability to have the products on the shelf for mass casualties. He commented that dried blood products, the ability to have these products pre-hospital, and stockpiling dry products all need to be addressed.

Committee Discussion

Ms. Fredrick suggested the Committee develop specific and actionable recommendations, clarify the resources needed to accomplish the recommendations, and organize the recommendations in the following categories.

• Blood donor engagement and growth
• Data infrastructure solutions
• Supply chain solutions
• Innovation/regulatory/public-private partnerships
• National disaster/Business continuity planning
• Financial needs
• Governance/locus of authority

Clarifications

In response to Ms. Sally Caglioti's question about funding, Ms. Fredrick explained there is no specific amount of funding committed to by HHS or Congress. Mr. Jim Berger clarified that the SEC 209 report goes directly to Congress and in that report the agencies have the opportunity to identify the projects that they want supported. He explained that the ACBTSA recommendations are going the HHS, and it is up to HHS to decide what resources they have to provide support. He further explained that ACBTSA could recommend (in this report) that they have the opportunity to submit a report to Congress to identify preparedness response issues that they would like to be funded. He noted there is an opportunity to reach out to Congress directly. He suggested the Committee prioritize the recommendations.

Discussion

Following the clarifications, the Committee members discussed a range of topics that need to be addressed.

MacPherson pointed out several issues that need to be addressed and need to be on the list, including plans for CCP, coordination between organizations, stockpiles, and how to manage the coronavirus going forward even after the acute phase of the pandemic is over.

Mr. Berger responded that the Committee could recommend National Academy of Medicine conduct workshops, develop a report, and provide directions.

Dr. Susan Galel asked the Committee to take into consideration that a plan for the future needs to include assessment of risk and potential need for implementing testing rapidly. She also pointed out that regarding pathogen reduction, not all agents are susceptible to PRT technology and certain things (e.g., organs and cell therapies) cannot be pathogen reduced using current method. She pointed out that even in the context of pathogen reduction, there may be a need for testing to exclude high pathogen burden products and to potentially protect the safety of the recipient of tissue and organ transplants. She pointed out that even though testing does not appear to be needed for this pathogen (SARS-CoV-2), the situation might be different in another outbreak.

Mr. Perez explained that BCA's supply chain analysis includes all elements of the entire whole supply chain.

Dr. Elisa asked if Ms. Fredrick had considered legislation to establish a blood system to monitor donation/utilization.

Ms. Fredrick responded no, and she mentioned a few models that the Committee could consider, including the models/approaches used by the United Network for Organ Sharing, the NMDP, the American Society of Hematology, and the Tick-Borne Disease Working Group.

Mr. Jim MacPherson commented on the fragility of the blood system.

Ms. Fredrick suggested defining actionable recommendations to and work with HHS to make things happen.

Structure and number of recommendations

Jackie expressed her preference for organizing the recommendations based on the common/priority areas touched upon by all the presenters. She clarified that there is no limitation on how many recommendations the Committee can make, but the Committee will vote on all the recommendations at the end.

Prioritization

Dr. Uhl suggested prioritizing the list/categories and short-term actions.

The group discussed and debated the priorities. Different opinions were expressed. While some members suggested prioritizing areas that need funding, others suggested ranking the categories based on the urgency of the issues that need to be addressed.

Additional topic areas for recommendation

In additional to the big topic areas that Ms. Fredrick suggested, members of the Committee also pointed out additional areas and issues that need to be addressed, including

• Research on donor motivation
  • Find out what methods work and do not work regarding recruiting and keeping donors in the system
• Finance and business revenue of blood centers
• Data reporting
  • Dr. Daryl Kor noted that he did not hear much about mandatary data reporting. He commented that it is doable and infrastructure is already there.
  • Dr. Paul Ness added that NHSN seems to be working but is used by only about 10% of the hospitals because it is voluntary based. He suggested that perhaps all hospitals should be required to use it.
• Existing systems
  • Dr. Kor suggested having a broad lens to look at existing systems including those in and outside of the blood community.
  • Dr. Basavaraju pointed out that even if mandatory reporting is required only for emergency situations, it still takes time and effort to ramp up. He explained NHSN's data reporting features and how it could be modified.
  • Ms. Fredrick noted that the Committee members can suggest a path forward but they do not have to solve the issues individually.

Dr. Raymond Goodrich proposed the following recommendations through the chat box.

Provide for a system that provides real-time and universal data on availability and use of blood. Possibly invest in making the existing NBCUS system and adverse event monitoring systems operated by CDC capable of doing this.

Address methods to "keep the system warm" for introducing interventions, such as convalescent plasma, by defining processes and acceptable target performance goals (FDA) in times between pandemic rather than during. Perhaps this may be better education and definition of existing EUA and EAP processes and requirements. Perhaps it may mean definition of generic clinical formats.

Concerns, suggestions, and pathway forward

Due to time constraint, the Committee did not reach consensus over the priority order of the categories nor discuss the draft recommendations prepared by the Writing Committee based on the presentations and discussions during the meeting. Concerns were raised about the process. To develop well thought out recommendations, Committee members suggested 1) setting up subcommittees/work groups to draft recommendations, and 2) the Committee as a whole review, discuss, and vote on the recommendations at another meeting.

Mr. Berger confirmed the approach is acceptable. He reminded the Committee that for transparency, his office will need to post a Federal Registry Notice at least 15 days prior to the Committee's next meeting.

Mr. Scott Brubaker pointed out that many of the 2013 recommendations are similar to what have been discussed at this meeting.

Dr. Basavaraju suggested perhaps making a few concrete, specific recommendations that can be implemented.

New Business and Next Steps

At the end of the discussion, the Committee decided to form work groups to develop recommendations.

Motion and vote

Ms. Fredrick made a motion, Dr. Andrew Cap seconded the motion, and the Committee members unanimously approved the following outcome of the 51^st ACBTSA meeting.

Outcome of the 51^st ACBTSA Meeting

ACBTSA decided to develop prioritized, actionable recommendations within 30-45 days after this meeting. The Committee will schedule another meeting to review, discuss, and vote on the recommendations proposed by the work groups.

Next Step and Action Items

After further discussion, the Committee decided the following step-by-step plan.

• ACBTSA will form work groups and select chairs via email.
• The work groups will develop concise, prioritized, actionable recommendations that focus on actions that need to be taken in the next couple years and circulate their recommendations among ACBTSA members for input.
• ACBTSA will schedule another meeting to vote on those recommendations (approve or reject).

In response to Claudia's question on examples of previously funded recommendations, Mr. Berger explained that one example is the RAND report, which HHS funded based on previous recommendations.

Adjournment

The meeting was adjourned at 4:39 pm

Appendix A: 51^st ACBTSA Meeting: Day-2 Attendees

ACBTSA Members in Attendance (in alphabetical order)

Chair

Jacquelyn (Jackie) Frederick, MT (ASCP) SBB, MBA, Hon DB/DPH, Retired CEO, Versiti, Inc.

Public Members

Biree Andemariam, MD, Associate Professor, Department of Medicine, Neag Comprehensive Cancer Center, Division of Hematology/Oncology, University of Connecticut Health (UConn Health); Chief Medical Officer, Sickle Cell Disease Association of America, Inc.

Sally Caglioti, MS, MT (ASCP), President & CEO, Creative Testing Solutions

Andrew P. Cap, MS, MD, PhD, FACP, Colonel, Medical Corps, U.S. Army; Director of Research, U.S. Army Institute of Surgical Research; Hematology-Oncology Consultant to the U.S. Army Surgeon General; NATO Blood Panel Co-Chair; Professor of Medicine, Uniformed Services University; Hematology/Oncology/BMT Staff, San Antonio, Military Medical Center

Claudia S. Cohn, MD, PhD, Associate Professor of Laboratory Medicine and Pathology; Director, Blood Bank Laboratory; Associate Director, Clinical Laboratories, University of Minnesota; Chief Medical Officer, AABB

Raymond P. Goodrich, PhD, Executive Director, Infectious Disease Research Center, Office of the Vice President for Research; Professor, Department of Microbiology, Immunology and Pathology, Colorado State University

Elisa Gordon, PhD, MPH, Professor, Department of Surgery, Division of Transplantation; Center for Health Services and Outcomes Research, Institute for Public Health and Medicine; Center for Bioethics and Medical Humanities, Department of Medical Education, Feinberg School of Medicine, Northwestern University

Jed B. Gorlin, MD, MBA, Vice President and Medical Director, Memorial Blood Centers

Daryl Kor, MD, MSc, Professor of Anesthesiology; Director, Patient Blood Management Program, Mayo Clinic College of Medicine

Jim MacPherson, MS, MPh, President/CEO, MacPherson Strategies; President, Global Healing

Paul Ness, MD, Professor, Pathology and Medicine, Johns Hopkins University

David Perez, BA, Retired CEO, Terumo BCT

Representative Members in Attendance

AABB

Lynne Uhl, MD, Vice Chair, Division of Laboratory and Transfusion Medicine, Department of Pathology, Beth Israel Deaconess Medical Center; Associate Professor, Harvard Medical School

American Association of Tissue Banks

Matthew J. Kuehnert, MD, FACP, FIDSA, Chief Medical Officer, MTF Biologics

Association of Organ Procurement Organizations

Gary Marklin, MD, Chief Medical and Research Officer, Mid-America Transplant

Eye Bank Association of America

Bennie H. Jeng, MD, MS, Professor and Chair, Department of Ophthalmology and Visual Sciences, University of Maryland School of Medicine; Past member, Board of Directors, Eye Bank Association of America

Major Blood Supplier

Chris Hrouda, MT (ASCP), President, Blood Services, American Red Cross

Plasma Protein Fraction Community

Mary Gustafson, MS, MT (ASCP), SBB, Vice President, Global Regulatory Policy, Plasma Protein Therapeutic Association

Manufacturer/Supplier of Blood Donor Testing and Screening

Susan Galel, MD, Senior Director of Medical Affairs, Blood Screening, Roche Molecular Systems

Ex-Officio Members

Center for Disease Control and Prevention

Sridhar V. Basavaraju, MD, FACEP, CDR, USPHS, Director, Office of Blood, Organ, and Other Tissue Safety, Division of Healthcare Quality Promotion, Centers for Disease Control and Prevention

Centers for Medicare and Medicaid Services

Diane H. Corning, RN, JD, Health Insurance Specialist, Center for Clinical Standards and Quality, Clinical Standards Group, Centers for Medicare and Medicaid Services

Food and Drug Administration, Office of Blood Research and Review

Nicole Verdun, MD, Director, Office of Blood Research and Review, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration (Joined after roll call)

Food and Drug Administration, Office of Tissues and Advanced Therapies

Scott A. Brubaker, Director, Division of Human Tissues, Office of Tissues and Advanced Therapies, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration

Health Resources and Services Administration

Marilyn E. Levi, MD, Director, Division of Transplantation, Health Resources Services Administration

National Institutes of Health

Kathleen (Cathy) Conry Cantilena, MD, Acting Chief/Senior Research Physician, Department of Transfusion Medicine, Clinical Center, National Institute of Health

ACBTSA Members Absent from the Meeting

Matthew J. Keuhnert, MD, FACP, FIDSA, Chief Medical Officer, MTF Biologics

HHS Support Staff in Attendance

James (Jim) Berger, MS, MT (ASCP), SBB, Designated Federal Officer, Senior Advisor for Blood and Tissue Policy, Office of Infectious Disease and HIV/AIDS Policy, Office of the Assistant Secretary for Health, U.S. Department of Health and Human Services

Alice Tsai, MPH, Public Health Analyst, Office of Infectious Disease and HIV/AIDS Policy, Office of the Assistant Secretary for Health, U.S. Department of Health and Health and Human Services

Jordan Broderick, MA, Health Communication Specialist, Office of Infectious Disease and HIV/AIDS Policy, Office of the Assistant Secretary for Health, U.S. Department of Health and Health and Human Services

Allison Petkoff, ORISE Fellow, Office of Infectious Disease and HIV/AIDS Policy, Office of the Assistant Secretary for Health, U.S. Department of Health and Health and Human Services

Presenters and Panelists at the Day-2 Meeting (in the order of presentation)

Jay Menitove, MD, Retired CEO and Medical Director of the Community Blood Center-Kansas City

Barbee I Whitaker, PhD, Lead General Health Scientist, Office of Biostatistics & Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration

Sridhar V. Basavaraju, MD, FACEP, CDR, USPHS, Director, Office of Blood, Organ, and Other Tissue Safety, Division of Healthcare Quality Promotion, Centers for Disease Control and Prevention

Simone Glynn, MD, MSC, MPH, Chief, Blood Epidemiology and Clinical Therapeutics Branch, Division of Blood Disease and Resources, National Heart, Lung, and Blood Institute, National Institutes of Health

Nathan Schaefer, MSW, Vice President of Public Policy, National Hemophilia Foundation

Debra BenAvram, FASAE, CAE, Chief Executive Office, AABB

Kate Fry, MBA, CAE, Chief Executive Officer, America's Blood Centers

Chris Hrouda, President, Biomedical Services, American Red Cross

COL Audra L. Taylor, Division Chief, Armed Services Blood Program

Amy C. Efantis, President & CEO, Plasma Protein Therapeutics Association

Michael J. Joyner, MD, Department of Anesthesioloy and Perioperative Medicine, Mayo Clinic

John B. Holcomb, MD, FACS, Professor of Surgery, Senior Scientist, Center for Injury Science, University of Birmingham, Alabama