Recap of the 51st ACBTSA Meeting
Organization/Order of the Recommendations
Welcome and Roll Call
Ms. Jackie Fredrick, Chair of the Advisory Committee on Blood and Tissue Safety and Availability (ACBTSA), welcomed and thanked all Committee members for their continued work on developing recommendations after the 51st ACBTSA meeting (August 26-27, 2020).
Mr. Jim Berger, Designated Federal Officer for ACBTSA, conducted roll call (see Appendix for attendance). The meeting started with a quorum.
Purpose of the Meeting
Ms. Fredrick explained that the main purpose of today’s meeting is to discuss and vote on the recommendations developed by seven Work Groups made up of Committee members. Ms. Fredrick noted that she will submit the recommendations to the Assistant Secretary for Health once the Committee approves them.
Ms. Fredrick reminded all Committee members that the Committee needs to answer the following two questions.
- What recommendations should be made to the Assistant Secretary for Health to further improve the blood community’s response to public health emergencies and can be acted on in the next 2-4 years?
- What additional resources are required to act on the recommendations?
Recap of the 51st ACBTSA Meeting
Dr. Jay Menitove summarized the Day-1 presentations and highlighted key issues/topics addressed and recommendations made by the presenters and panelists.
Summary of Day-1 Meeting
Blood Donation
Main issues/topics discussed
- 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
Recommendations
- Fund donor motivation research
- Fund national blood donation campaigns
Data
Main issues/topics discussed
- Lack of real-time data on blood collection and utilization
Recommendations
- Establish and support a real-time data collection system
Supply Chains
Main issues/topics discussed
- 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)
Recommendations
- Set up a stockpile for PPE and other critical supplies
- Establish a single, dedicated national contingency/disaster plan
Financial Stress
Main issues/topics discussed
- 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
Recommendations
- 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
Main issues/topics discussed
- Lack of harmonization between local, state, and federal regulations
Recommendations
- Establish guiding management (e.g., access to transportation)
- Identify blood center staff as essential personnel
- Fund the AABB Interorganizational Task Force and determine authority
Regulations
Main issues/topics discussed
- Complexity of testing, cost-effectiveness
Recommendations
- Streamline regulations without compromising safety
- Support donor risk/qualification research
COVID-19 convalescent plasma (CCP)
Topics discussed
- Experience and success
Recommendations:
- Conduct a “lessons learned” analysis
Highlights of Day-2 Meeting
Dr. Menitove explained that during the second day of the 51st ACBTSA meeting, multiple stakeholder organizations, the public, and invited speakers made more recommendations, including recommendations on improving patient outcome.
Discussion of Recommendations
The Committee reviewed and discussed the recommendations in the following seven focus areas and addressed overlaps.
Focus Area 1: Supply Chain to Produce Blood Products
Ms. Sally Caglioti reviewed the recommendations and explained the rationale.
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:
- Assuring blood and plasma center employees are considered essential personnel and are federally recognized with the same designation as physicians and nurses during national emergencies
- Assuring blood and plasma center employees have priority access to vaccines and to supplies that are critical for blood collection and manufacturing, including PPE
- Appointing a representative from the blood and plasma industry to federal committees or task forces responsible for allocation of critical supplies and transportation resources during national emergencies
- Providing funding and assigning a task force to establish a 6-month 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
- Working 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
- Providing priority access to transportation and delivery systems for blood and plasma centers to assure continued operations in situations where infrastructure is disrupted
Discussion
Discussion of Bullet Point 4
The Committee members discussed the role of the task force and how the stockpile should be managed. Members generally agreed that it is important to have a system in place to ensure the availability of the supply. However, a few members pointed out that a centralized approach may not be the most effective solution to address supply chain issues, given that technologies continue to evolve and products need to be updated periodically. Committee members agreed that a task force (or a Working Group, a Committee) including supply chain experts is needed to develop recommendations to address the details, and that the stockpile needs to be current.
A few Committee members also pointed out that a task force (e.g., the AABB Interorganizational Task Force on Domestic Disasters and Acts of Terrorism) is already in place and has a role similar to what is described in the bullet. They raised concern that setting up another task force might be redundant.
Ms. Caglioti clarified that the group is not suggesting a centralized location for the stockpile, and that’s why they suggest a task force to address the issue. She noted that the bullet point can be incorporated into another recommendation.
The Committee also discussed if ongoing funding is needed. After a brief discussion, they decided not to discuss funding mechanisms in the recommendation.
Revised bullet 4
- 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.
Discussion of Bullet Points 1 and 2
The Committee members discussed designation categories, how they are determined and prioritized, and if they should call out physicians and nurses. They agreed to combine bullet points 1 and 2 and not call out physicians and nurses.
Combined/revised bullet point
- 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).
Discussion of Bullet Points 3 and 6
Ms. Fredrick suggested and other Committee members agreed to combine these two bullet points. Together they tweaked the wording.
Combined/revised bullet point
- Appoint a representative from the blood and plasma industry to federal committees or task forces responsible for allocation of critical supplies and transportation 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.
Focus Area 2: National Disaster Planning/Business Continuity
Mr. Jim MacPherson reviewed the recommendations and explained the rationale for the specific bullet points.
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 stakeholder experts to develop plan, including what Congressional funding may be required to implement and support the plan
- Assure 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
- Address accompanying logistics and transportation issues
- Include regular disaster exercises
Discussion
Mr. Jim MacPherson explained that the bullet points are step-by-step considerations for the recommendation.
Discussion of Bullet Point 2
The Committee members first discussed bullet point 2 and the potential overlap between this bullet point and the first bullet point of Focus Area 1 recommendation. Mr. MacPherson explained that the bullet point in this recommendation is more about infrastructure (including donation), whereas the first bullet point in Focus Area 1 recommendation is more about personnel.
The Committee members agreed to keep the bullet point as it.
Discussion of Bullet Point 3
Mr. MacPherson explained the rationale for the bullet point. No changes were made.
Discussion of Bullet Point 4
The Committee members discussed the differences between the task force mentioned in Focus Area 1 Recommendation (original bullet point 4) and the AABB Task Force highlighted in the 4th bullet point in Focus Area 2 Recommendation.
Ms. Fredrick and Ms. Caglioti explained that the AABB Task Force includes representatives from blood collection entities and functions as a coordinating center, whereas the one in Focus Area 1 Recommendation should include supply chain experts coming from the industry. They noted that the two are different.
To avoid confusion, a couple committee members suggested using a different name (e.g., a Committee or a Working Group) for “task force” in Focus Area 1 Recommendation.
The Committee members also discussed whether to keep this bullet point broad or specific. Different views were expressed. While some members suggested being specific, others expressed preference for keeping the bullet point as is and they pointed out that gaps need to be identified first if funding is requested.
Discussion of Bullet Point 1
The Committee discussed who would identify the gaps, who should develop the plan, and who should take the lead. Members pointed out that the stakeholder experts should include federal agency, industry, and healthcare experts.
Revised bullet point 1
- Convene stakeholders from the federal government, industry, and healthcare experts to develop a plan, including what Congressional funding may be required to implement and support the plan.
Discussion of Bullet Point 5
Mr. MacPherson explained the rationale. The Committee members agreed to keep the bullet point as is.
Discussion of Bullet Point 6
The Committee discussed and agreed to remove this bullet point because the topic is addressed in Focus Area 1 Recommendation.
Discussion of Bullet Point 7
The Committee agreed to remove this bullet point to keep the recommendation concise.
Focus Area 3: Blood and Plasma Donor Engagement, Growth, and Research
Dr. Jed Gorlin reviewed the recommendations and explained the rationale.
Recommendation 3.1: Fund social science research which will result in 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 3.2: In partnership with FDA, examine and revise policies that could increase the availability of blood and plasma donors and products
Discussion
A Committee member suggested replacing “which will result in” with “to generate” in Recommendation 3.1 because one does not know what science/research may result in. Others agreed.
Revised Recommendation 3.1: Fund social science research to generate efficient and effective strategies to engage and retain younger and more diverse blood and plasma donors.
The Committee members briefly discussed who would conduct the research and if they should call out the NIH. Dr. Gorlin expressed preference for not being specific.
The Committee members also briefly discussed if the second bullet point should include both effectiveness and safety. Ms. Fredrick and Mr. MacPherson noted that safety has been addressed. No changes were made to the bullet point.
Focus Area 4: Innovation
Dr. Ray Goodrich explained the rationale and reviewed the following two recommendations.
Recommendation 4.1: 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 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 4.2: 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.
Discussion
Dr. Goodrich noted that the first recommendation is about using a platform (a concept borrowed from the Medical Device Innovation Consortium model) to address innovation-related issues in blood, and the second recommendation is about education.
The Committee briefly discussed if Recommendation 3.2 and the second bullet point of Recommendation 4.1 are the same. Ms. Fredrick explained that Recommendation 3.2. is about donation and donor engagement and the second bullet point under Recommendation 4.1 is about robust products, and she suggested keeping both of them.
The Committee members also discussed if funding for research and testing should be included in Recommendation 4.1 (e.g., bullet point 4).
Dr. Nicole Verdun pointed out that a paradigm for funding diagnostic tests already exists (e.g., testing for Zika virus was funded by the government), and she suggested providing more details if the Committee members think there is still a gap.
After further discussion, the Committee decided to add “and funding new screening tests for emerging pathogens” after convalescent plasma programs in the fourth bullet point under Recommendation 4.1.
Revised bullet point 4
- 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 new screening tests for emerging pathogens at blood centers.
Focus Area 5: Governance/Locus of Authority
Ms. Fredrick reviewed the recommendation and explained the rationale. She noted that a clearly defined locus of authority for national blood and plasma policy would help drive innovation and ultimately improve patient outcome.
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.
A couple of members cautioned about the outcome and potential challenges/issues associated with implementation.
Ms. Fredrick explained that leaders from major blood and plasma collection organizations are supportive of the recommendation, and she expressed her view that a clearly defined locus of authority is needed.
A Committee member asked if the Recommendation intentionally leaves out “tissue.” Ms. Fredrick responded yes. She explained that the blood community and the plasma community share many common issues, as demonstrated by the COVID-19.
Dr. Matthew J. Kuehnert noted that tissue-related topics could be discussed at another meeting.
Focus Area 6: Data Infrastructure Solutions
Dr. Claudia Cohan reviewed the following recommendation.
Recommendation: Establish, implement, and support comprehensive, sustainable, minimally burdensome infrastructure that monitors and makes available real-time data on blood availability and utilization, hemovigilance, and transfusion outcomes.
Key attributes of such an infrastructure include:
- Being rooted in legislation
- 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
Discussion
The Committee members discussed hemovigilance and existing data collection systems that can be leveraged (e.g., CDC’s NHSN, NIH’s REDS programs, and FDA’s BEST) to improve patient outcomes.
The Committee members also discussed blood collection and utilization, and they debated if real-time data are needed. Different views were raised. While a couple of members commented that real-time data from hospitals are not needed most of the time unless there is an emergency (e.g., the COVID-19 pandemic), others pointed out that at the 51st ACBTSA meeting, the presenters and stakeholders clearly stated that real-time data are needed to ensure blood availability for patient care.
The Committee then discussed if a gap analysis for Hemovigilance should be conducted first, and if the Committee should recommend documenting gaps instead of setting up a new system.
Ms. Fredrick explained that a gap analysis has already been conducted in 2009 and a report of that analysis exists today, and she clarified that this recommendation suggests building upon existing systems, not building a new system.
Ms. Fredrick suggested breaking the recommendation into two recommendations: one on real-time data on blood availability and utilization, and the other one on hemovigilance. Other members agreed.
Revised Recommendation
- Establish, implement, and support 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 hemovigilance, and transfusion outcomes system and determine funding mechanisms
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 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.
Discussion
Ms. Fredrick reviewed the recommendation and explained that the recommendation and some of the bullet points may appear redundant; however, given the importance, she suggested grouping and place them together under Finance.
The Committee briefly discussed and agreed to add “(e.g., CARES Act)” at the end of the last bullet point.
Revised bullet point 4
- Urgent financial needs of blood centers during national emergencies (e.g., CARES Act).
Organization/Order of the Recommendations
In response to a question from Dr. Lynne Uhl, Ms. Frederick explained that the recommendations do not have to be submitted in the above order. She noted that the recommendation on national policy can be moved up based on Dr. Uhl’s suggestion.
Vote
After the Committee members have reviewed and discussed all of the recommendations, Mr. Jim Berger made a motion for the Committee to approve the recommendations. Dr. Kuehnert seconded the motion. The Committee members in attendance unanimously voted yes to approve the following recommendations.
Focus Area 1: 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:
- Assure 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 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
- Provid 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 2: National Disaster Planning/Business Continuity
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
- Assure 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: Blood and Plasma Donor Engagement, Growth, and Research
Recommendation 3.1: 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 3.2: In partnership with FDA, examine and revise policies that could increase the availability of blood and plasma donors and products
Focus Area 4: Innovation
Recommendation 4.1: 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 4.2: 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 5: 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 6: 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 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., Cares Act).
Closing Remarks and Adjournment
Ms. Fredrick thanked all Committee members for their work. She noted that after today’s meeting, she will send a letter, which will include a brief introduction and all of the recommendations, to ADM Giroir, Assistant Secretary for Health. She noted that she will share ADM Giroir’s feedback with the Committee as soon as she hears from him.
Mr. Jim Berger thanked all the Committee members and adjourned the meeting at 3:57 pm EST.
Appendix A: 52nd ACBTSA Meeting Attendance
ACBTSA Members in Attendance (in alphabetical order)
Chair
Jacquelyn (Jackie) Fredrick, MT (ASCP) SBB, MBA, Retired CEO, Versiti, Inc.
Public Members
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 (joined after roll call)
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 and Nebraska Community Blood Bank, Division of Innovative Blood Resources; Assistant Professor of Pediatrics and Laboratory Medicine, University of Minnesota
Daryl Kor, MD, MSc, Professor of Anesthesiology; Director, Patient Blood Management Program, Mayo Clinic College of Medicine
Jim MacPherson, MS, MPh, President and CEO, MacPherson Strategies
David Perez, BA, Retired CEO, Terumo BCT
Representative Members
AABB
Lynne Uhl, MD, Vice Chair, Division of Laboratory and Transfusion Medicine, Department of Pathology, Beth Israel Deaconess Medical Center; Associate Professor of Pathology, Harvard Medical School
American Association of Tissue Banks
Matthew J. Kuehnert, MD, FACP, FIDSA, Chief Medical Officer, MTF Biologics; Professor of medicine, Hackensack Merifian School of Medicine
Association of Organ Procurement Organizations
Gary Marklin, MD, Chief Medical and Research Officer, Mid-America Transplant
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
Jefferson M. Jones, MD, Division of Healthcare Quality Promotion, Centers for Disease Control and Prevention (Alternate for 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)
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
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
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.
Paul Ness, MD, Senior Director, Transfusion Medicine; Professor of Pathology, Medicine, and Oncology, Johns Hopkins University
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, Vice President, Global Regulatory Policy, Plasma Protein Therapeutic Association
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
HHS Support Staff in Attendance
James (Jim) Berger, MS, MT(ACSP) SBB, Designated Federal Officer, Senior Advisor for Blood and Tissue Policy, Office of HIV/AIDS and Infectious Disease Policy, Office of the Assistant Secretary for Health, U.S. Department of Health and Human Services
Alice Tsai, MPH, Office of Infectious Disease and HIV/AIDS Policy, Office of the Assistant Secretary for Health, U.S. Department of Health and Human Services
Allison Petkoff, Office of Infectious Disease and HIV/AIDS Policy, Office of the Assistant Secretary for Health, U.S. Department of Health and Human Services
Debbie Seem, Office of Infectious Disease and HIV/AIDS Policy, Office of the Assistant Secretary for Health, U.S. Department of Health and Human Services
