53rd Meeting August 17-18, 2021 - Meeting Summary

Chair Jackie Fredrick, MT (ASCP) SBB, MBA, Hon DB/DPH, welcomed the participants to the 53rd meeting of Advisory Committee on Blood and Tissue Safety and Availability. She expressed her appreciation for their commitment to serve the American people and appreciation for the staff who have assisted in the preparation for this meeting.

James Berger, MS, MT(ACSP) SBB, conducted the roll call. A quorum was met, allowing the meeting to move forward. Ms. Fredrick welcomed Barbara Bryant, the newest Advisory Board member and representative from the National Institutes of Health. She introduced the purpose of the meeting, which continues the work from August 2020 when the Committee developed nine recommendations to ensure critical blood and plasma products remain available for patients. This meeting will focus on supply chain resiliency (day one) and data collection and data infrastructure (day two). These issues for discussion today were selected from the original nine recommendations following planning Committee discussions.

During the meeting, we will hear about lessons learned from the blood systems' response to the COVID-19 public health emergency and identify strategies to strengthen and improve the national system around blood and plasma. In addition, the Committee is charged with identifying potential solutions and plans to back the two agenda items. Finally, the Committee should consider additional recommendations to define the role of blood and plasma donor centers in enhancing public health surveillance. She reviewed the questions for the Committee to examine during the meeting.

Mr. Berger introduced Assistant Secretary of Health Rachel L. Levine, MD, for opening remarks. Dr. Levine welcomed the experience and expertise of this Committee to inform the department on the current and impending blood and tissue-related issues to ensure a safe, robust, and efficient supply for patients in need.

Our country is facing the worst blood supply crisis since World War II, which has only been compounded by the pandemic. In an effort to address this challenging situation, Congress passed the Coronavirus Aid and Relief Economic Security Act (CARES). Included in this legislation is the National Blood and Plasma Awareness Campaign to encourage eligible Americans donate life-saving blood and plasma. The Office of the Assistant Secretary for Health (OASH) will implement the National Blood and Plasma Awareness Campaign. The challenges we face are not from the pandemic alone. It is critical to address immediate- and long-term challenges related to donation. This campaign also provides an opportunity to reach underserved communities.

The Committee submitted a comprehensive list of recommendations to the previous Assistant Secretary for HHS. I ask that you build on last year's recommendations to develop actionable next steps for the Department to consider. The ACBTSA will explore two important issues that have the potential to improve the blood industry and supply of blood products (e.g., an efficient supply of blood and blood products and data infrastructure that supports the surveillance and utilization needs of the blood industry).

Dr. Levine took a moment to recognize the contributions of the ACBTSA Chair, Jackie Fredrick, who will conduct her final meeting today. Her leadership on blood issues is exemplary. Ms. Fredrick please accept my personal commendation for your service to the Department and on behalf of our nation. Dr. Levine thanked everyone for their time and dedication to the ACBTSA and welcomes your guidance. She is committed to working with you on implementing the recommendations. Dr. Levine turned the meeting back to Ms. Fredrick to review the previous recommendations.

Purpose of the Meeting

Update and document lessons learned during the blood systems response to the current COVID-19 public health emergency for the purpose of identifying strategies for strengthening and improving the national system.
Further define potential solutions and plans for recommendations related to 1) required data collection infrastructure for real-time data collection and decision making for blood availability and utilization and 2) disaster preparedness for supply chain resiliency and access, and the role of national stockpiles for critical supplies.
Consider an additional recommendation to define the role of blood and plasma donor centers in enhancing public health surveillance for emerging infections as a critical data infrastructure solution.

Questions for the Committee

What is the current state of each critical system, its strengths, and its weaknesses?
What have we learned from the COVID-19 pandemic that can build a more resilient and responsive system to ensure availability and safety of blood and blood-derived products?
What are additional industry models that can inform our recommendations on how to strengthen the blood industry in these two critical priorities recommendations?
What is the role of government, industry, and the blood and plasma community in addressing and solving these critical issues?

Review of 2020 Recommendations

Ms. Fredrick reviewed the 2020 Recommendations and the recommendations from the Report to Congress on the adequacy of the national blood supply. The nine Advisory Committee recommendations, as well as the recommendations in the Congressional report provide an important framework for resiliency for a modern and robust blood and plasma network.

In Section 209 of the Report on Adequate Blood Supply of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act (PAHPAIA), Congress charged the Secretary of HHS to submit a report to Congress covering four aspects of blood and plasma transfusion: 1) recruitment of blood donors; 2) adequacy of blood supply; 3) transfusion monitoring system; and 4) additional measures for safety and innovation focused on the development, use, or implementation of new technologies, processes, and procedures to improve the safety and reliability of the blood supply. The report was submitted to a broad group of leadership in Congress and across HHS.

The recommendations made exclusively in the Advisory Committee include 1) to establish a locus of authority for the national blood and plasma policy, and 2) to develop and fund a national disaster plan for business continuity.

The recommendations made exclusively in the Congressional report include 1) funding to ensure that transfusion-dependent patient needs are met; 2) funding for studies to examine the predictive social and psychological factors that drive blood donation motivation and develop recommendations to design a program to attract and retain donors; 3) funding for research to evaluate paid and volunteer donor programs; and 4) funding for research to target, recruit, and engage blood donors for personalized medicine.

The Advisory Committee and Congressional Report both recommended 1) the development of policies to fund and strengthen resiliency in the supply chain to produce blood products; 2) a focus on donor recruitment to address the national blood supply crisis; 3) data infrastructure solutions to understand blood inventory and blood utilization; 4) innovation focused on public-private partnerships to create an entity to evaluate the innovation and investment needed to address blood and plasma supplies from production to patient; and 5) secure stable funding to support the national blood system.

The Congressional Report also addressed the possibility of expanding the Transfusion-Transmissible Infections Monitoring System (TTIMS) to 1) monitor other transmissible infections; 2) increase participation among blood centers; and 3) coordinate non-transfusion transmissible infection studies.

Public Comment

Mr. Berger opened the floor for public comments.

Mary Gustafson, Vice President of Global Regulatory Policy for Plasma Protein Therapeutics Association (PPTA)

The clinical need for plasma protein therapy has steadily increased, but plasma donation levels have struggled to meet this need even before the pandemic.
Mexican nationals have safely and reliably contributed to the global effort to collect plasma for life-sustaining and life-saving purposes. Denying their contribution will put American patients at risk. PPTA estimates a loss of as much as 4.5 million contributions annually, which equates in a loss of treatment for more than 30,000 immunotherapy treatments.
Plasma manufacturing is dependent on a complex global supply chain. Manufacturing in the U.S. cannot meet the need for U.S. patients. While capacity is growing, new facilities are expensive and take several years to complete.

Debra Ben Avram, Chief Executive Officer, American Association of Blood Banks (AABB)

AABB offers three suggestions:
- Ensure recommendations address opportunities to integrate solutions in the blood supply into all preparedness and response policies;
- Promote the critical role of the blood system by encouraging interagency collaboration on solutions that engage multiple sectors of the public health system; and
- Include the resources needed to establish, implement, and maintain each solution.
AABB is committed to working with the entire blood community to address the complex challenges that impact blood safety and availability. We offer our support and AABB's assistance in advancing these important efforts.

Whitney Green, Senior Vice President of Molecular Lab and Donor Screening, Roche Diagnostics

Roche supports the formation of a task force to review strategies and ensure availability of components critical for a safe and adequate blood and plasma supply.
The task force should be made up of key stakeholders, including blood and plasma customers, regulators, and suppliers who have expertise to review critical components needed.
Roche would welcome the opportunity to participate in this task force to share expertise and lessons learned during the pandemic.

John Miller, Chief Executive Officer, LIFELINE Blood Services and Board President of American Blood Centers (ABC)

We are supportive of a national data infrastructure to monitor collection and utilization.
Accurate and comprehensive data is necessary to predict the demand for blood components, assess the impact of regulatory changes, and changes in donor trends.
Coordinating inventory management will better serve patients.
Confidentiality and security of blood center information, financial support, and public-private partnership to streamline efforts will be important when looking at options at a national data infrastructure.
Blood centers must be included in the national stockpile of essential supplies (e.g., Personal Protective Equipment (PPE), disinfectant, and related medical laboratory testing supplies).

Nathan Schaefer, Vice President of Policy National Hemophilia Foundation (NHS)

Please keep the need for adequate plasma donation central in your work.
Please continue to incorporate meaningful patient input in your work. We ask that you include a patient representative on your Committee and keep this request in mind during your deliberations.
NHS stands ready to help the Committee and in our shared goals to ensure a safe and adequate blood and plasma supply.

Glen Michael Fitzpatrick, Chief Scientific Officer, Cellphire Therapeutics

All reports have recommended a locus of authority for national blood and plasma policy.
As you develop recommendations, please be aware of how blood, plasma, and platelets are described for the non-scientific community.
Data is essential to identify the supply and demand of components.
Advances in next-generation blood products could reduce need for blood donation and could improve blood safety.

Richard Benjamin, Chief Medical Officer, Ceres Corporation

Please consider the future threat from bloodborne pathogens and the threat to the blood supply.
Work with the Food and Drug Administration (FDA) to recognize the urgent need to lower the minimum dose of platelets to address the on-going challenge of platelet availability.
Create an automatic data collection scheme for blood utilization that could feed into the Centers for Disease Control and Prevention (CDC) healthcare safety network.

Common Definition of Supply Chain

Sally Caglioti, MS, MT (ASCP), President and CEO, Creative Testing Solutions, began the meeting discussion with a definition of the supply chain: the entire process of 'making' and transfusing blood and plasma products, which includes every stage of the process from the supply of raw materials (including donors) to component production, testing, distribution, and transfusion.

The components of the supply chain are unique (e.g., donors, employees, suppliers, logistics providers, and patients). During the pandemic, the supply chain and transport systems were disrupted, and critical pieces of equipment (e.g., PPE, reagents, and equipment) were in short supply. The system is further taxed by lack of succession planning for workforce, the limited number of suppliers, and the lack of contingency planning. Please think of these key stakeholders while determining ways to improve the supply chain for future events.

Ms. Fredrick opened the floor for comments.

C: (Ms. Gustafson) Blood and plasma share many similarities, but the two industries follow different paths once the donation has been received. Please keep in mind that these are two very different entities.

A: (Ms. Caglioti) Agreed. Much of the plasma production and fractionation actually occurs outside of the United States, which further complicates the conversation.

Q: (Dr. Goodrich) How has demand for these products changed during the pandemic?

A: (Dr. Uhl) At the height of the pandemic response (March through May), there was a significant decline (45%) in utilization in red cells and plasma, primarily because operating rooms were closed. During reopening, demand was high coupled with the decline in donors, which stressed supply.

Q: (Dr. Waeckerlin) What about logistics?

A: (Ms. Caglioti) Many in the blood and plasma community are dependent on the commercial airline industry. We are developing back-up plans using ground transportation, and we need to establish a network where we can drive products.

Lessons Learned from the COVID-19 Pandemic

Ms. Fredrick introduced the three speakers for this panel. Each of the speakers has led their organization during the COVID pandemic to ensure patients receive the care needed. A question and answer period will follow the speakers' presentations.

Inside A Pandemic: An Academic Medical Center's Response

Eric L. Conley, Executive Vice President, Froedtert Health System, President, Froedtert Hospital, provided an overview of his organization's response to the pandemic. At the beginning of the pandemic, the focus was on flattening the curve to take the burden off of healthcare system. Information was changing rapidly, which required an incident command system that was enterprise wide.

The first wave of the pandemic (March-May 2020) consisted of 24 operational periods. During this period, leadership created a surge plan to expand bed capacity (e.g., critical and accurate care) and workforce capacity (e.g., ambulatory care and operating room staff). We managed full ICUs and ECMOs with appropriate staff. The public health collaborative provided information and communication with partner hospitals regarding beds, staffing, and supplies. Communications through the incident command center were frequent during the pandemic to share information with staff. The stream-lined structure of the Incident Command Structure helped implement the Telemedicine platform in five days.

The institution remained in an incident command structure for recovery to take the opportunity to put operational efficiencies in place. During recovery, the institution began to shift focus, monitor inpatient and ambulatory volume growth, and evaluate staff burn out. By August 2020, the hospital was back to pre-COVID operations but with greater efficiencies, controlled access, and safety. The recovery command went back to 'reimagined' normal operations in September of 2020.

The needs identified for the future include consumer and digital experience, economic considerations, and rapid evolution of the care delivery model, health disparities and social justice, and expand support of staff and patients.

The hospitals were able to accommodate a higher level of patients during the second wave of the pandemic due to efficient operations and process improvements established earlier.

BCA's COVID-19 Experience

Bill Block, Chief Executive Officer and President, Blood Centers of America, Inc. (BCA), worked in collaboration with many organizations within the industry to make this experience possible. He focused on four key areas: 1) supply chain; 2) donor impact; 3) communication; and 4) data.

Blood centers worked collaboratively to collect COVID Convalescent Plasma (CCP). Biomedical Advanced Research and Development Authority (BARDA) provided funding to allow for the collection when the need was still uncertain. They also created a supply chain that was unique to blood centers. The supply chain challenges include cost increases for PPE (e.g., gloves, masks, gowns, and disinfectant), a vetting process for suppliers to perform rapid transactions, quick distribution of stockpile of product, and establish a cost-recovery model.

Communication was critical for interorganizational coordination to streamline efforts. These organizations examined opportunities to gather CCP as a bridge to vaccine availability. BARDA and Operation Warp Speed provided critical support to supply CCP to hospitals during the early months of the pandemic. The group used forecasting tools to stockpile CCP. At one point, the centers ramped up collection of 25,000 doses per week and distributing 24,000 doses per week.

Data is necessary to identify gaps. BCA developed a file format on data gathered daily for collection and distribution of product. The data was updated every 15 minutes. The infrastructure is in place and is now being used to understand the CCP in stock during the delta variant. Investments are being made to AI models and data (e.g., 7 million donors to evaluate trends). The Center is using a tool called Gold to identify potential CCP donor areas and target populations with educational marketing.

He proposed three requirements: 1) funding for a supply chain stockpile; 2) funding to accelerate a data analytics engine; and 3) establish a rapid reaction force.

The Canadian Experience

Graham Sher, MD, PhD, Chief Executive Officer, Canadian Blood Services (CBS), provided an overview of the healthcare system in Canada. The organization focuses on fresh blood products, plasma protein and related products, stem cells, organs and tissues, diagnostic services, and research and development. During the pandemic, Canadian hospital critical care capacity was stressed. The pandemic has been managed by each provincial and territorial government across the country. While the approaches were similar, the public policies differed (e.g., reopening plans, mask mandates, etc.), which added a hurdle for a nation-wide program.

CBS worked to mitigate risk to staff and donors and ensure the impact of each wave would not impact the supply of blood components. CBS set up a governance structure consisting of an executive level steering committee to establish working groups with dedicated subject matter experts. The committees met frequently to share information. Many changes were instituted quickly, including wellness checkpoints, mask mandates, physical distancing, enhanced cleaning, acrylic installations, and blood donation criteria. CBS chose to exceed local public health requirements and standardized these requirements across the country.

During the first wave of the pandemic, there was volatility in inventory of blood products, but this supply was stabilized with subsequent waves. The largest disruptive event resulted from an outbreak at a mid-sized production center. The rest of the national network moved product into that region of the country to support hospitals.

During the pandemic, collection was shifted from mobile sites to 35 permanent collection sites. Donors expressed high levels of confidence in the CBS protective measures. CBS partnered with hospitals and clinicians to understand demand and forecast future needs to make adjustments in the supply. CBS coordinated with the Alliance of Blood Operators to understand how each country managed supply issues.

The largest challenge with the supply chain challenge was with immunoglobulin product. The global plasma industry was experiencing shortages and production companies could not meet contractual committed volumes.

CBS began migrating all donor appointments to a digital platform before the pandemic, which has facilitated safety screening and donor flow. CBS continued to work closely with the transplant community and stem cell programs.

CBS worked to support employees to reduce burn out, increase resiliency, and provide financial security. It created an in-house app to manage positive COVID-19 cases to protect donors, employees, contractors, and volunteers.

Canadian vaccinations began slowly, but today 73 percent of the population is fully vaccinated. Vaccination is popular among employees, which will be mandated for all CBS employees with only medically-approved exemption accepted. CBS has been testing samples for seroprevalence to understand the rates in the country before and after availability of vaccines. The data was put into broad public health measures in the country. Canada did not stockpile CCP, except for three clinical trial studies. The positive benefit of CCP was not apparent and CBS has stopped collecting it.

CBS was focused on recovery in a post-pandemic world, which included building in resilience and agility to address future crises. This approach has enhanced strategic foresight through automation and digitization, the future of work, and products and services.

Question & Answer/Discussion

Ms. Fredrick opened the floor for questions.

Q: (Ms. Fredrick) You were successful moving from patients not seeking care to resuming normal functions. Can you comment on how you were able to bring back patients and engage new patients so you are now back to normal operations?

A: (Mr. Conley) There was fear and appropriate use of our healthcare system. Because of the fear, there was a reduction in care in the emergency room, which was being used as a primary care facility. The complexity of our patients showed that. We became operationally efficient as if we still had those patients coming in.

Q: (Ms. Fredrick) How important is your digital platform going forward?

A: (Mr. Conley) We are testing to see what it is like being digital to take care of patients at home. Can we do this for other patients, like chronic heart care?

Q: (Ms. Fredrick) How do we develop more granular and integrated data capabilities and best practices for cyber security?

A: (Dr. Sher) Cybersecurity is a huge issue. We had a robust program before the pandemic. This is also a recognition of not if but when, so what are our recovery capabilities (e.g., ransomware). We do regular penetration testing at all parts of the organization. Cybersecurity continues to be a big concern. We are sitting on key healthcare information. It is an area that we have invested more money into and will stay on top of and is an area of continued improvement.

A: (Mr. Conley) The more people we touch the more access points for a cyber breach. We play cyber-type games to look for weaknesses.

Q: (chat) I assume that for the pay-for-collection model that BARDA owns the inventory of CCP. Has that introduced any challenges or need for allocation? Who would be responsible for the allocation?

A: (Mr. Block) Contractually, we developed a plan to distribute product across the organization and have a resource-sharing program to get products anywhere it is needed. From an allocation standpoint, they wanted us to stockpile product in an area that was centralized in the country. This is where the bulk of long-term CCP was stored. We did set up some product in an excess freezer capacity across the country. We sent that first and then product from the centralized location. BARDA turned over the ownership of the product to us and allowed us to allocate it as needed.

Q: (Ms. Fredrick) Can you address employee vaccinations? How will this policy apply to vendors in your building?

A: (Mr. Conley) On November 1, we will require all employees to be vaccinated or in that process. Vendors will also be required to be vaccinated. There will be no exceptions for any folks coming in who touch patients. Everyone will be required to be vaccinated. We will allow for some exceptions with our employees.

A: (Dr. Sher) We have now made a determination that all employees need to be vaccinated as well as volunteers and contractors. The challenge for us is what to do for donors. If we mandate the vaccination of donors, then we may see a drop in donation rates. That is an area that we will continue to evaluate.

Q: (Ms. Fredrick) How did you develop the expertise to ensure quality and legitimacy of untested suppliers?

A: (Mr. Block) Before the pandemic, we have a supplier validation group to validate suppliers. We also have 200 contracts with suppliers across the globe and have a good sense as to which suppliers are legitimate in this portfolio. We have developed a third echelon of trusted sources in the industry to help us validate untested suppliers.

Q: (Ms. Fredrick) Does CBS plan to initiate a stockpile of critical supplies? If so, what level of inventory will you target? Who will fund the stockpiles?

A: (Dr. Sher) Yes. There is no single magical number based on availability of suppliers and the shelf life of product. We have increased inventory for all of our business essential supplies, and it has had an impact on working capital. This is an expensive undertaking with significant financial impacts on the organization. We drew down on working capital to fund the inventory that will be charged back to the government when the product is shipped to hospitals.

Identification and Prioritization of Key Risk Drivers for the Dutch Blood Supply

David Perez, Retired President & CEO, Terumo BCT, welcomed Dr. Janssen and Ms. Sasongko to the meeting. This work could help us understand how to develop a risk assessment and heat map to assess the U.S. blood supply.

Identification and Prioritization of Key Risk Drivers for the Dutch Blood Supply

Mart P. Janssen, PhD, Principal Investigator Transfusion Technology Assessment, Sanquin Research Amsterdam, The Netherlands, provided a brief overview of Sanquin blood establishment. Following a discussion about the impact on the aging population, we expected a demand for red blood cells. Instead, they found a decrease in demand. Previously, demography was used to forecast the demand for red blood cells. This held until about 1997. In 2016, an internal research examiner noted a need for a prediction model to understanding the main drivers for the change in blood use and determine the scenarios that will most likely change the requirement for the blood supply in the future. This required data. They applied a structural approach to gather this information.

Syeldy Langi Sasongko, MSc, PhD student, Transfusion Technology Assessment, Sanquin Research Amsterdam, The Netherlands, continued. In many high-income countries, there has been a persistent decline in red blood cells. For the Netherlands, this has been a decrease in need by 40% due to variations in different surgery techniques, pharmaceutical products, and rise of patient blood management. In order for blood bank management to forecast need, they needed to understand these trends. We used an approach called scenario development to 'see' the future by supporting strategic decision making to cope with uncertainties. We used the applied this step-wise approach to blood transfusion to prepare for alternate levels of future red blood cell demand. By identifying the main drivers and transformational factors, we could look to see how the factors influenced the future rather than focus on storylines of the future. This approach consisted of two steps.

For step 1, they identified the historical trends and drivers through a literature review and interviews. In this case, they identified lower transfusion thresholds, evidence-based medicine, surgical techniques and pharmacologic agents, and organizational changes. The transformation factors included social (e.g., demographics), technological (e.g., smart data, immuno-gene therapy), economic, environmental, political, and legal items (e.g., European Union (EU) laws).

Step 2 consisted of development sessions consisting of workshops of experts. They used a quality software (Meeting Sphere) to present results from Step 1 and gather the thoughts of experts and brainstorm other transformational factors that are not on the list to identify and rank opportunities or vulnerabilities as well as identify organizational actions to overcome these vulnerabilities. The resulting data consisted of more than 200 ideas that were consolidated into 10 themes that needed further clarification.

The ten themes were plotted on the importance-uncertainty matrix and then conducted focus groups to evaluate each theme and identify opportunities and threats to develop recommendations. For example, the blood supply organization (theme) requires the right leaders at the right place, an innovative process, and strong collaboration between hospitals and academic centers. The organization needs to be agile and flexible, contain multi-disciplinary research teams, and have a well-defined strategy and focus. Another theme, precision medicine, was also a critical-planning issue that required personalized advice for optimal personalized blood management. One of the most important measure identified was the need to continue to consult with hospitals on the need for products.

The pandemic, a highly uncertain event, disrupted the blood supply. The pandemic provided an opportunity window that allowed the organization to change. The blood supply organization was rated as a critical scenario driver. In terms of communication and digitization, we found that extensive and intensive communication happened internally and externally. There was also a change in social perceptions.

The work shows the results of a structured information collection process involving various stakeholders. The team has identified the main drivers that can be mapped on a risk matrix. The future risk and opportunities can be a starting point for developing mitigating actions or additional discussions. It is important to be as specific as possible from the beginning because this process is time consuming and labor intensive. With regard to ACBTSA, this scenario approach could be readily copied to obtain a broad range of input from stakeholders.

Question & Answer/Discussion

Q: (Mr. Perez) How did you choose this methodology? Is this a living process?

A: (Dr. Janssen) We started with an initial plan, and we realized along the way that we had to change things here and there. It is a labor-intensive exercise. We can use this information to see if there are new developments that are needed. Creating these lists is very informative for people to comment on. It should be a living document that you update every two to three years to ensure the information is useful.

Q: (Ms. Caglioti) It looks like a model you can apply to different scenarios? Is that true?

A: (Dr. Janssen) It is difficult to say if this is something that can be adapted to any question.

Q: (Susan Galel, MD, Senior Director of Medical Affairs, Blood Screening at Roche Molecular Systems) How did you prioritize the work? How did you get buy-in from your organization?

A: (Ms. Sasongko) Buy-in is difficult. The work that has been done has overlap with what we are facing during the pandemic. The mitigating factors that we proposed are the actions the organization ended up taking to be successful during the pandemic. We can now use the pandemic to create a bridge.

Q: (Mr. Goodrich) With regard to the experience in the Netherlands, to what extent is your situation unique as being a single-supplier of blood products to hospitals to control the supply-demand situation.

A: (Dr. Janssen) That is difficult to answer. We were lucky that COVID did not turn out to be transfusion transmissible. Independent of the way blood supply is structured, I am not sure if the national blood supply would be in a better position.

Q: (Mr. Goodrich) If commercialization was too broad to evaluate in the context of the analysis, how did the group respond to that suggestion that these innovations would reach public utility?

A: (Ms. Sasongko) One of the difficulties in specifying themes and mapping them out is that there is overlap and juxtaposition. On one hand the innovations that were coming into the field there was agreement. The wider commercialization theme was much less agreeable. There was consensus for a specific subset but not for the broader component of commercialization.

Q: (Ms. Fredrick) How did you use this methodology to create plans across organizations or sectors? Did you implement these plans? Who is the driver and has the authority over that?

A: (Dr. Janssen) Any further decisions outside of the assessment are out of our control. We want to identify the long-term drivers and their importance so we can prioritize mitigating measures. It is like a heat map. We assemble the information but from there it is like a kaleidoscope to open up the discussion.

A: (Ms. Sasongko) Sanquin has realized that using digitalization is a way to connect with donors, but it can also be a way to connect with customers to assess need. Although plans have not come forth from this project, there are tangible ways to use what we have done during the pandemic to meet future needs. In your context, it could be a software or digital platform to know the needs of your customers.

Q: (Jed Gorlin, MD, MBA, Innovative Blood Resources) I know that Sanquin struggles with diversity of the patient base. How did you engage stakeholders from diverse communities for feedback?

A: (Ms. Sasongko) What was interesting is that we have struggled with that, but COVID has provided a window of public recognition and has created more trust. Because our efforts have been so public, there is now an awareness and trust of our organization.

Panelist Discussion
Risk Management: Impact of the COVID-19 Pandemic

Panelists

Sally Caglioti, MT (ASCP) SBB

Bill Block, CEO and President, Blood Centers of America, Inc.

David R. Green, President/CEO, Vitalant

Eric Santiago-Justiniano, MBA, Vice President Operations, Fresenius Kabi Puerto Rico, Chief Financial Officer, Fenwal International, Inc., Vice President Operations, Fresenius Kabi Puerto Rico

Michael P. Angelastro, Director, Division of Pharmaceutical Countermeasures Infrastructure, Biomedical Advanced Research & Development Authority, Assistant Secretary for Preparedness & Response, U.S. Department of Health & Human Services

Claudia S. Cohn, MD, PhD, Professor of Laboratory Medicine and Pathology, University of Minnesota, Chief Medical Officer, AABB

Steven M. Frank, MD, Professor, Department of Anesthesiology/Critical Care Medicine, Director, Johns Hopkins Health System Blood Management Program, Director, Center for Bloodless Medicine and Surgery Johns Hopkins Medical Institutions

Mr. Perez introduced the panelists for the next session that brings together industry leaders to hear their thoughts on these issues. He noted that Mr. Angelastro has been called away for a pandemic-related meeting and will not be available to participate in the discussion.

Q: (Mr. Perez) We have heard a little about the national stockpile. What in your opinion in the need, value, and the management of a stockpile of critical product?

A: (Ms. Caglioti) This is a critical step toward a more robust supply chain for the country. We have to form some type of a stockpile whether it is government-funded or a public-private partnership. One of the limitations is the lack of suppliers. It is also cost ineffective to have more than one supplier so it is difficult to maintain a business continuity plan.

Q: (Mr. Perez) Given the size and scale of your organization, what are your thoughts on a national stockpile?

A: (Mr. Green) I agree with what Sally just laid out. The supply chain resiliency was shattered. It happened for a few reasons. Some of the requirements of the pandemic were items like masks, which we didn't use before the pandemic. The dual technology challenges are not only cost-prohibitive but the feasibility to transition from one platform to another is not easily done. There have to be business continuity solutions with the supply chain. In terms of the national stockpile, it is necessary for expendables, blood products, etc., but I would encourage us to consider the challenges of logistics during times of disaster. Large programs need to move product quickly and this is challenged during times of disaster. We need to develop a model that does some concentration of supplies in some nationally-controlled areas but other supplies with the blood operators.

A: (Mr. Block) The national stockpile is critical. We had one critical supplier for blood bags. They had to increase plasma bags by 400%, which diverted resources from other products. What a stockpile does is it gives you breathing room so you can correct and adjust during times of crisis. If you have a stockpile of 30-40 days on hand, it gives you flexibility. The fact that we used two different suppliers on machines gave us added flexibility. We also historically did not buy PPE. We need to make blood centers a priority in the health center.

Q: (Mr. Perez) What is your perspective on the national stockpile. What is your business continuity plan?

A: (Mr. Santiago) Our business continuity plan is not set to one type of crisis. We have dealt with fire, hurricane, and now a pandemic. Part of our contingency plan is to increase the inventory pipeline during the summer to prepare for hurricanes. During the pandemic, the level of demand skyrocketed overnight. We tried to ensure we could supply our customers. We invest in our employees to secure the overtime. We invest in our supplier to guarantee the stock of components to make product available to our end user. From that perspective, our BCP is not an extraordinary event or an accident. We plan. We discuss this extensively. It is part of our planning process. We also learned from other pandemics, including the bird flu from 2004, including the need for PPE.

Q: (Mr. Perez) As you are going through the pandemic, which data was most useful when you were making decisions? What were the holes in the data that you wished you had?

A: (Dr. Cohn) We had little data to go on. We knew what level of blood we wanted to keep in the inventory. We could speak to our local suppliers to determine if they could supply that level, but we heard nation-wide that there were shortages. There was no data to make long-range decisions. As the pandemic continued, blood suppliers began to share information more readily. I think there were many hospitals that felt like they were running blind.

A: (Dr. Frank) We get data from [unknown], and we have dashboards built for our blood management programs. Initially, our blood use across Johns Hopkins was down 30 percent due to cancelled elective surgeries (March-June 2020). As surgeries came back online toward the end of the summer, we began to see red cells coming back to baseline. Platelets came back slower and still remain below baseline. When we were at 40 percent of our par level, we sent out alert messages to trauma surgeons. Two percent of our patients (massively transfused) use 50 percent of our blood.

Q: (Mr. Perez) What data did you lack?

A: (Mr. Green) We have a modeling data management system to handle tracking of our production, inventory, and distribution throughout the enterprise. We had no visibility into what our hospitals customers were anticipating. We knew what they had and what they were going through. What we didn't have was their two-week forecast. If we knew how they were scheduling surgeries, we could input that data into our models to respond to those requirements. When we get to a certain level in our supply, we coordinate with our hospitals to triage their activities. Our biggest gap is between the blood operators and hospitals in forecasting need. We got a lot of our advanced reporting from the media. In many respects, that was our major source of information to factor into our planning models to anticipate demand. BCS did a marvelous job in managing CCP. We can do far better than what we have been doing as an industry. If we don't know where the need is, it is difficult to be responsive and support a sustainable national blood supply.

A: (Ms. Caglioti) We are further down in the supply chain. Our biggest issue was planning. In March and April, we had a decline in donations and had a four-week supply with no idea of what to expect. We didn't know if the blood centers were going to collect and the blood centers didn't know what hospitals would use.

Q: (Mr. Perez) Can you speak to the shortage of phenotype blood for patients with sickle-cell disease during the pandemic?

A: (Dr. Cohn) There is an overall shortage of blood. Overall, it was difficult getting donors. A community that was hard hit was the African American community. A community hard hit by COVID will not donate as much in the past, resulting in a shortage of phenotype-matched blood.

Q: (Mr. Perez) Can you speak to manufacturing in the Caribbean?

A: (Mr. Santiago) These are strategic services. We are talking about the Dominican Republic and Puerto Rico. It is difficult to just move a production center to another location (e.g., Dominican Republic to someplace else). The math doesn't work. We need to be sure the infrastructure of facilities are adequate and modern. The people who work at the facilities are properly trained to produce a high-quality product. We operate in these environments for economic reasons. We have to guarantee that we provide the product that is compliant with requirements. During the pandemic, we faced a reality that logistics became cumbersome. It is difficult to hire employees. Part of the formula requires training of employees to guarantee high standards to produce a quality product. It is important to have capable leadership, trained employees, and access to the market for the flow of products. Outside the DR and Puerto Rico, it is a very different perspective.

Q: (Mr. Perez) Can you comment on the ability to project surgical blood needs for two plus weeks? Can you also speak about mass transfusion?

A: (Dr. Frank) That is difficult. Elective surgeries have gone minimally invasive, and robotic surgeries have reduced the transfusion rate to almost zero. Two percent of patients use 50 percent of blood. At our institutions, these are trauma patients and transplant patients (e.g., liver transplant and ECMO). For example, we had one trauma victim who used 400 units. He survived and walked out the door. He used more blood than every hip replacement in all five hospitals in the Johns Hopkins health system in an entire year. The massive transfusion patients are the ones we are concerned about, and they are hard to predict. That is why we are interested in a futility rule. We gave 140 units of product to a patient who was not going to survive. The patient came up to the operating room without pulse or pressure and on high dose epi and nor-epi. We poured blood into the patient for five hours with intermittent return of pulse and pressure. I asked the surgeon if we could stop, but the surgeon said no that this patient had survivable injuries. This happened three times. The patient did not survive. When we presented this case in surgical M&M, the most senior surgeons said we should have stopped earlier based on the conditions. The next day the Red Cross put out a memo of a severe shortage of blood in the mid-Atlantic region.

Q: (Mr. Perez) What are the three biggest lessons learned during the pandemic?

A: (Mr. Block) There are three big areas where we think we can improve. 1) Supply chain resiliency - developing a stockpile and develop flexibilities. We want to work with suppliers to ensure flexibility and resilience in the supply chain. 2) Communications - we need communication across many disciplines, including clinical, organizational coordination, hospitals (there can be a disconnect), etc. 3) Data analytics - we need to shore up some gaps in the system. We can provide a good collection and distribution forecast by blood component, but we do not know when it is used by the hospital.

C: (Dr. Basavaraju) I have not seen a situation where a national stockpile would be a benefit. When dealing with CCP as a therapeutic, I am hesitant to try to get into discussions on how it was a success when I haven't seen any data on how it works. The outcome is uncertain.

Q: (Mr. Goodrich) I am hearing different things concerning stockpiling: products, blood components, vaccines, etc. that could be prioritized in the blood bank setting. What is it that you need to stockpile is an important issue to address? How would you determine the composition of the stockpile needs to be, like PPE, which is not commonly used? Getting on a list of being essential healthcare providers to get access to these materials is critical. With all of the planning that goes on, how would you determine the composition of the stockpile? If it is difficult to transition to one supplier to another, how do you choose the supplier? Most disasters are regional, but the pandemic was global. How do you address that? We need to get to a fundamental root assessment of supply availability.

A: (Mr. Block) We developed an early supply list based on current use not switching suppliers to withstand supply disruption. The stockpile is a critical element of the plan. We do need to develop national capacities.

C: (Dr. Galel) I was struck by the importance of uncertainty in Sanquin's presentation and how we need to take that into account in planning. The key word is resiliency. Stockpile plans are for what you are currently using, but it won't prepare you for the unknown. Stockpiles may be useful but may not address every issue. We need to identify areas of uncertainty and develop ways to respond to these issues. It may require regulatory flexibility (e.g., IND pathway). There may be other regulatory pathways that we need to respond resiliently to unanticipated needs.

Q: (Mr. Perez) What changes have you instituted at your organization since the pandemic?

A: (Ms. Caglioti) We need to enhance our business continuity planning. It would have been difficult to entertain all the things we needed that we have now experienced. We need to go through a disciplined approach to evaluate what is needed. Looking at every scenario (e.g., workforce, ransomware, natural disasters) and determining how to prepare for that. Going through that process to ensure we have a plan. We will find it is difficult to build stockpiles and business continuity plans, because we do not have the financial resources to do that. We are now looking at how to build additional capacity in our five laboratories (e.g., operate at 70 percent capacity). We need to focus on business continuity planning, expand relationships nationally, and increase visibility into our inventory.

A: (Mr. Green) In addition to the points raised by Sally, I would encourage us to 1) not make our business continuity and supply chain analysis a response to the pandemic. We operate that we produce 1.5 million red cell units annually. During a blood bag shortage, we had little help that resulted in cancelled surgeries and more. It was not a pandemic issue. It was just as catastrophic as the pandemic, which led to blood shortages throughout the service area. 2) Our heavy reliance on mobile blood drives really had to be cancelled out by a fixed site focus. We have to move to a direct donor engagement model. We will not return to a heavy reliance on mobile drives. A fixed site draw model is essential for long-term sustainability for a national blood network, but we have work to do with donor engagement and awareness to maintain and build a capable and sustainable blood system. 3) I also share concerns of cybersecurity. We need to maintain a protective posture and remain vigilant. 4) Finally, we need to consider the employee or staff mindset following the pandemic. There is no such thing as an entry-level position. We need to be mindful of economics of living wages for staff who are not looking for ladders of advancement. Many employees are also content working from home. There is a shift in employee expectations that is different from what it used to be.

Q: (Dr. Uhl) Locally is there an opportunity for blood centers who provide blood to certain hospital networks to develop incident command centers to anticipate blood need?

A: (Mr. Green) We have done that. but it is done in a case-by-case basis. Replicating that 100 times becomes problematic. We need an automated dashboard that would allow for close to real-time visibility of the blood status.

Q: (Dr. Uhl) Is there a need to encourage the FDA to take a proactive role of providing a pathway for alternate suppliers (non-U.S.-based)? Can we look forward rather than reacting?

A: (Ms. Caglioti) We work closely with the FDA. Many suppliers have alternate plants in other countries. We are in a global supply chain. Having better visibility in our entire supply chain will be critical if we want to establish any kind of safety stock.

C: (Ms. Gustafson) We heard early that there was a stockpile but these need to be maintained, rotated, etc. or else they are useless. The idea of limited vendors is a real problem. She touched on additional problems of employee turnover/expectations, supply chain, geographic issues of testing centers, etc.

C: (Dr. Ness) There are products that could be stockpiled (e.g., Hbox). We don't do that. That is something we need to think about with forward planning.

Q: (Mr. Perez) Can you speak to lessons learned from your experiences?

A: (Mr. Santiago) Our strategy is very direct. We are in-sourcing as much as we can to have supplies close to produce the material. We are consolidating about 90 percent of what we touch to one location (e.g., 'Made in USA' branding and faster shipping).

A: (Dr. Cohn) They key lesson that we learned is that it is not if but when there will be another pandemic. Can we use the lessons learned from this experience and apply them? We put in place a long-term shortage plan. Now we have a plan in place when we cannot get enough blood for several weeks. Part of the shortage plan is increased communication. We increase communication with our blood suppliers. We discuss inventories, surgery schedules, etc. It would be great if we could project further out. We also increased channels with the hospitals. We started daily huddles with high-blood use doctors to identify the number of patients and evaluate the blood inventory to meet their needs. We also started prospective auditing. It alerted the hospital that we were in a new place.

A: (Dr. Frank) The people involved with patient blood management (PBM) across the world are saying this is important. Simple campaigns have had a greater impact on overall blood use than any other intervention we have done ('Why Give Two' campaign, self-salvage, lower hemoglobin triggers, thromboelstography (TEG), homothermic, controlled hypotension). These are patient blood management approaches that are important.

C: (Dr. Waeckerlin) Box stores have a better handle on their inventory. We have a huge black hole. We have no idea what happens to the blood once it goes to the hospital. Maybe install smart refrigerators to control inventories to inform draw and distribution going forward.

Committee Discussion and Recommendation Formulation

A: (Ms. Caglioti) We can request funding to build back capacity into the blood industry infrastructure. Ten years ago, we were collecting 17 million donations in the United States every year, but the need for blood reduced. During that time, blood centers reduced their infrastructure. Over time, we have a much smaller donor base and infrastructure to support the need. We may have gone too far. We need to build back into our overall national plan to provide the extra capacity to use in the case of a natural disaster, ransomware attack, or pandemic.

A: (Mr. Block) I would love to work with a task force to reenforce supply chain resiliency (e.g., a stockpile of supplies, PPE, etc.) and include a plan to manage them. I would also encourage that you build more flexibility into the supply network. It is hard to attract innovation in our network (e.g., more suppliers).

A: (Mr. Green) We need to get to having a system with real-time data transparency for hospitals, blood operators, and vendors. Data will allow us to understand how to influence, streamline, and protect this critical resource.

A: (Dr. Cohn) We need a centralized locus of authority for a national policy. We are a fragmented system, and we need to work in a coordinated way that could extend to how to give advice on convalescent plasma. Most countries had a single critical trial for patients with COVID. We had over 50 and it was the only way to get our hands on CCP until the expanded protocol. We didn't come up with an answer on CCP quickly.

A: (Dr. Frank) We need to emphasize all of the methods of patient blood management to conserve blood, and we need to get our colleagues and ourselves to donate. Healthcare providers do not donate as much as they could.

A: (Mr. Santiago) One of the biggest challenges in manufacturing is to have a strong, formal forecasting process. We need an adequate line-of-sight. This requires a lot of information sharing. Leadership should come together periodically to discuss these issues, assess our errors, and develop new approaches.

Committee Discussion Summary and Vote

Ms. Caglioti reviewed the draft recommendations with the Committee to submit to the Assistant Secretary. We want to submit recommendations that are actionable and quantifiable.

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:

Charge an expert task force to include funding to ~~Provide funding and assign a task force to~~ perform a comprehensive risk assessment and business continuity plan and make recommendations for ensuring robustness of access to key supplies and devices that are essential to maintain a safe and available blood and plasma supply. The task force should include representatives from the blood and plasma industry, regulatory authorities, and manufacturers of plastics, testing reagents, and other critical supplies. The task force should explore options including the potential design of a stockpile as well as regulatory pathways to facilitate rapid approval of alternative manufacturing locations.
Ensure blood and plasma centers are assured critical infrastructure and funding. Further blood and plasma center employees and donors are considered essential personnel and federally recognized with the same designation as critical healthcare workers during national emergencies and have the priority access to vaccines, therapeutics, and to supplies that are critical for blood collection and manufacturing, including personal protection equipment (PPE).
Appoint a representatives 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 system for blood and plasma centers to assure continued operations in situations where infrastructure is disrupted.
Provide funding and assign a task force to perform a risk assessment and make recommendations for ensuring robustness of access to key supplies and devices that are essential to maintain a safe and available blood and plasma supply. The task force should include representatives from the blood and plasma industry, regulatory authorities, and manufacturers of plastics, testing reagents, and other critical supplies. The task force should explore options including the potential design of a stockpile as well as regulatory pathways to facilitate rapid approval of alternative manufacturing locations.

Ms. Caglioti noted the Committee are not experts on supply chain or risk assessment, but we ask for funding to assign a task force. She opened the floor for discussion.

C: (Dr. Ness) The supply chain discussion assumes the donors will continue to donate. This is a serious problem.

C: (Ms. Caglioti) There may be an entire meeting that focuses on the donors. Perhaps that is another topic to address at another time.

C: (Ms. Fredrick) Donor recruiting deserves its own meeting.

Q: (Mr. Perez) When it comes to funding, is there precedent for this?

A: (Mr. Berger) The Assistant Secretary for Health (ASH) can convene the Blood Organ and Tissue Senior Executive Council (BOTSEC), which is composed of HHS agencies, Department of Defense (DOD), and Department of Veterans Affairs (VA), to bring forward recommendations and decide what projects are best suited for support.

Q: (Mr. Perez) The last recommendation of a risk assessment will require outside resources to complete this task. Do we need to quantify and outline what we are asking for?

A: (Mr. Berger) The ASH would come back with specific questions on what is needed to support a requirement.

A: (Ms. Fredrick) Bullet point three is the most important and needs to be moved up. I would be more direct to charge an expert task force to include funding to develop a business continuity and risk assessment. You are looking for an expert task force across the supply chain and suppliers, and the business continuity planning needs to begin with the risk assessment. If we could get that started in what you have, it could be done in six months and report back to the ASH if you have the resources and funding.

C: (Ms. Caglioti) So we should move the third bullet to the first. We do not need to quantify the cost. We just need to recommend it and they will ask us what we need.

C: (Mr. Berger) HHS needs to decide the steps to take to make this happen.

C: (Ms. Caglioti) Once the risk assessment is done, the planning to mitigate the risk could include things like storage of frozen blood to create a stockpile and the funding for that would be a second ask.

C: (Mr. Berger) You could put out a Request for Information or put together a planning committee or a workshop to bring subject matter experts together to decide how this could be done.

Q: (Ms. Fredrick) Is this the process you used with the Rand Report?

A: (Mr. Berger) This was a different time when blood centers didn't communicate as well.

C: (Dr. Galel) This strengthens the need from what we heard from Mr. Santiago to improve solutions to improve resiliency. It is valuable to hear from suppliers what things might improve resiliency. I would include BARDA in this. I don't know if we name them specifically. There may be lessons learned that would be helpful to us.

Q: (Dr. Uhl) BARDA would be critical for this discussion to inform the conversation. Do we need or will we have an opportunity to define a timeline for this to take place or is this part of the back-and-forth once the recommendations have been presented?

A: (Mr. Berger) The timeline represents the urgency of the need. It is good to rank the recommendations on what needs to be done first.

C: (Dr. Uhl) So one, two, three, rather than a task force needs to be convened.

A: (Mr. Berger) That will help but it will be up to ASH on what can be funded.

C: (Dr. Gorlin) I was impressed by the Sanquin presentation. We do not want to plan for the last pandemic, so a broad risk-based, but also keep our focus narrow. Asking for resources for a more global risk assessment is warranted.

C: (Ms. Caglioti) We need to think of all of these things for the risk assessment.

Q: (Dr. Uhl) I am struggling with putting priority access to vaccines. That may be too narrow. Would we be better served to broaden it to general protection of healthcare workers in this area?

A: (Ms. Caglioti) We could say, 'priority access to vaccines, therapeutics, and supplies that are critical to blood collection.'

C: (Ms. Gustafson) The term was 'critical infrastructure' or 'essential healthcare workers' were buzz terms that might be used for continuity. We talk about workers but what about donors? Donors are the critical raw materials that we have to have.

Q: (Ms. Caglioti) Are you suggesting that we add blood donors to the recommendation?

A: (Ms. Gustafson) Blood and plasma donors need to be able to move to give a donation. We should take the directive and be forward thinking. I do not know if we have enough innovation to do without our donors, and we need to be able to ensure that workers and donors are available and recognized.

C: (Ms. Fredrick) Working closely with health systems, they were provided with critical infrastructure to operate and care for patients. Blood Centers didn't get the level of funding and protection that the rest of the healthcare system received. Blood Centers and plasma centers are assured of critical infrastructure funding to include and put this there. Hospitals had interesting ways to get liquidity to protect infrastructure and employees (e.g., from illness and compensation). You want to be in the CARES package in a way that is more consistent with the healthcare systems.

C: (Ms. Gustafson) The third bullet only has 'a representative from industry.' You need to include multiple representatives from the different groups.

A: (Ms. Caglioti) Maybe say 'appoint representatives from the blood and plasma industry?' That way if there is a need to appoint more than one, we can do that.

C: (Ms. Gustafson) Yes that is good.

Q: (Dr. Waeckerlin) Does it also make sense to ask us to come up with a broadband of implementing this?

A: (Ms. Caglioti) It may be difficult to come up with a number before we know what the task force will identify what is needed to do.

C: (Dr. Waeckerlin) It may be helpful to even have a broad estimate of what it will cost it may help it move forward to implementation.

C: (Ms. Caglioti) So the task force should provide a broad cost estimate of each risk mitigation plan. It could also include the number of subcommittees and subgroups to accomplish this task.

Q: (Ms. Caglioti) Say the ASH approves this, what is the next step?

A: (Mr. Berger) It depends on what BOTSEC suggests on how to address this recommendation.

A: (Ms. Fredrick) Dr. Levine will take this to BOTSEC and government will have experts in this area, and it might be some of the people on the task force will be experts from government who can add all of the aspects from the government.

Q: (Dr. Waeckerlin) Do the recommendations change if we are dealing with a pandemic if the agent is transfusion transmitted? Can we anticipate and plan for those changes now?

A: (Ms. Caglioti) The risk task force would consider this as a possible scenario. What do you think?

A: (Dr. Galel) That would be part of the risk assessment to plan for various scenarios. I do not think the recommendations would change.

C: (Ms. Gustafson) A risk assessment should consider all of the scenarios and forecasting.

C: (Ms. Fredrick) This fits in nicely in innovation. It needs to be in here but when we talk about building flexibility through innovation that it could be part of funding the innovation needed to elevate some of these threats.

C: (Mr. Perez) We might be able to tap into the innovation in the risk assessment. What is the risk of a lack of innovation?

C: (Ms. Caglioti) The task force would need to put this together a model for the United States.

Closing Remarks and Adjournment

Ms. Fredrick thanked the Committee for their thoughtful discussion around the recommendations. She suggested holding the vote on the recommendations until the vote on the data infrastructure recommendations. Mr. Berger concurred it would be good to provide additional time for people to consider these recommendations. Lauren Overman shared the draft recommendations with the Committee.

Ms. Fredrick thanked all of the members for their participation and input during the discussion. The meeting was adjourned at 5:30 p.m. Eastern.

ACBTSA SGE Members in Attendance (in alphabetical order)

Chair Jacquelyn (Jackie) Fredrick, MT (ASCP) SBB, MBA, Hon: DB/DPH
Sally Caglioti, MS, MT (ASCP)
Andrew Cap, MD, PhD
Claudia Cohn, MD, PhD
Raymond Goodrich, PhD
Jed B. Gorlin, MD, MBA
Jim MacPherson, MS, MPH
Paul M. Ness, MD
David Perez
Ron Waeckerlin, MD

ACBTSA Rep Members

Vice Chair Matthew J. Kuehnert, MD, FACP, FIDSA
Susan Galel, MD
Mary Gustafson, MS, MT (ASCP) SBB
Bennie H. Jeng, MD
Gary Marklin, MD
Lynne Uhl, MD

ACBTSA ex-officio Members

Sridhar V. Basavaraju, MD, FACEP, CDR, USPHS
Scott A. Brubaker
Barbara Bryant, MD
Rebecca Free, MD, MPH, LCDR, USPHS
Marilyn E. Levi, MD
Nicole Verdun, MD

Absent

Biree Andemariam, MD
Diane H. Corning, RN, JD
Elisa Gordon, PhD, MPH
J. Chris Hrouda, MT (ASCP)
Daryl Kor, MD, Msc

Wednesday, August 18, 2021 (Day 2)

Roll Call, & Call to Order

Ms. Fredrick welcomed the Advisory Committee to the second day of the 53rd meeting of the HHS Advisory Committee on Blood and Tissue Safety and Availability. She reminded the group to review the email containing the revised draft recommendations for supply chain resiliency. Mr. Berger conducted the roll call. A quorum was met, and the meeting was called to order. Ms. Fredrick turned the floor over to Vice Chair Matthew Kuehnert.

Dr. Kuehnert thanked Claudia Cohn, MD, PhD and Barbara Bryant, MD, and Chair Fredrick as well as the HHS staff who have assisted with the planning. He gave a quick overview of the agenda for the day before turning the floor over to Dr. Cohn.

Introduction and Outline the Goal

Dr. Cohn began by discussing an example of a high casualty event in Washington D.C. to evaluate access to the blood supply. The victims are taken to one of two hospitals. Neither hospital is aware of their neighbor's blood supply despite only being a few miles apart. Each hospital uses a different blood center. The information that is needed is not available. The AABB Interorganizational Disaster Task Force is activated and begins exploring options for distributing blood in the region. The Task Force's success depends on knowing who to call.

She revisited the event with a data infrastructure that is in place. The AABB Task Force is convened and has access to immediate, real-time information on the blood inventory as well as information about any adverse reactions to blood.

The current state of the blood industry includes: 53 blood centers in the United States and 90 hospitals with blood donor groups that supply the hospital system. Each hospital and blood center is aware of their own inventory, but no one is talking to anyone else to share data. The National Healthcare Safety Network (NHSN) is in place but is only used by a small number of hospitals due to burdensome reporting requirements. There is no requirement or incentive to participate in the NHSN.

The National Blood Collection and Utilization Survey (NBCUS) is conducted every two years. Data is collected and published by the CDC every other year, which produces data that is 2-3 years old. There is no real-time data. The Rand Report provided a single snapshot in time and does not capture blood supply volatility for planning purposes.

We propose a National Blood Data Collaborative, which would include 1) blood center data; 2) hospital transfusion data; 3) hemovigilance data; and 4) healthy donor data for public health surveillance. This is a big idea that will require collaborative work to accomplish. We have many of the fundamental pieces already established but in different groups.

The blood centers will input information on blood collected, location, and available. The hospitals will share the amount of blood transfused, wasted, and hemovigilance to inform blood safety and tie transfusions to outcomes. Blood donor data would provide information on public health surveillance, which has already been used as a source of information during the pandemic.

Dr. Cohn reviewed the agenda for the day. She outlined how an imagined centralized data repository would work. The system would need to be as automated to make it easy for people to use. This information could assist AABB Interorganizational Task Force, NHSN for hemovigilance data, and various systems that use surveillance system for public health. This is the 10,000-foot view of the network. Other people will need to develop uniform code and other logistics to ensure the different systems can talk to one another to keep this network going.

Revision of the EU Blood Legislation - Lessons from COVID

Dr. Kuehnert introduced Deirdre Fehily, PhD, Policy Officer, Substances of Human Origin, DG Santé, European Commission.

Dr. Fehily began with an evaluation of the EU legislation on substances of human origin, which gives EU the legal power to set high standards of quality and safety for blood, tissues, and cells (BTC).

The EU has adopted three acts of legislation: 1) blood and blood products (2002); 2) tissues and cells (2004); and 3) human organs for transplantation (2010). The EU evaluation was completed in 2017-2019 to see how the legislation was working across the 27 member states if it is it is still fit for purpose. Organ legislation was not included in the evaluation. The evaluation found the legislation was successful at providing protection but some weakness were found, including: 1) patients are not fully protected from avoidable risks (e.g., due to reflect changes and updates); 2) avoidable risks for BTC donors and for children born from donated eggs, sperm, or embryos; 3) divergent approaches to oversight cause unequal levels of safety and quality and barriers to the exchange of BTC across the EU; 4) BTC legislation lags behind innovation; and 5) EU vulnerable to interruptions in supply of some BTC.

The legislation is being revised to address the five shortcomings through publication of a roadmap, open public consultation (e.g., two surveys), and two studies to produce an impact assessment report. The report will determine which approach will be most effective, cost efficient, and with the lowest administrative burden. The aim is to publish the report by the end of the 2021 calendar year. One of the studies, contracted to ICF, is gathering evidence from an independent perspective to support the report. The second study, conducted by Deloitte, will explore the digital infrastructure to implement changes to support the new legislation. The Deloitte report is anticipated in 2023 or 2024. This window provides the time to develop the data infrastructure to support the framework for BTC.

The public consultation across the EU allowed for comment. One of the questions posed was how the stakeholders believe the COVID-19 pandemic influence their evaluation conclusion. They found that the stakeholders were influenced by the pandemic, specifically for the risk of shortages or sudden supply disruption.

Some proposals for future legislation under discussion include 1) routine monitoring of activity data resulting in mandatory reporting to address number of donations, distributed within the state, distributed between member states, and units imported or exported; 2) rapid notification of sudden drops in supply; 3) obligation to have emergency preparedness plans in place; and 4) other legal measures. Key stakeholders presented their position on the four topics. There was a high level of support for rapid notification and routine monitoring, as well as emergency preparedness plans. Harmonization of functions would help supply sufficiency. There was less support for export bans.

Routine monitoring of activity data principles proposed a critical dataset that should be harmonized for the whole of the EU and mandated in legislation. The mandated dataset could build on the core dataset for research in tissues and cells. The critical dataset can be used to inform citizens on the status of BTC, denominators for vigilance activities, identify interdependencies, and develop more sustainable supply. The published report looked at the data required, how the data should be updated, and who is accountable for data collection, verification, and dissemination for replacement tissues, hematopoietic cells, and medically-assisted reproduction. TRIP, the Dutch Hemovigilance Organization, carried out a parallel exercise for blood and plasma (January-March 2021). The report recommended a common data set with recommendations on how the data should be shared.

The Blood Supply Contingency and Emergency Plan (B-SCEP Project) develops emergency plans based on key risk scenarios, frameworks, interventions, and models. It also gathered stakeholder thoughts, which include more trust, collaboration and exchange, promotional donation campaigns, reduce waste, and investment in equipment, staff, and data infrastructure.

The expanded mandate for the European Center for Disease Prevention and Control will publish proposals to build a network of EU reference laboratories and a network for substances of human origins. At the moment there is one full-time person working on this topic, but will expand team to four soon.

The proposed amendment links the donor population to monitoring the spread of infectious diseases. The pandemic has highlighted that the 1) sufficiency of supply is important aspect of ensuring patient safety; 2) monitoring the supply situation is key to managing it; 3) a system of reporting and rapid notification is needed; 4) emergency preparedness planning is essential; and 5) legal requirement to install this approach.

Blood Donors as a Sentinel Population - Preparing for the Next Pandemic

Christian Erikstrup, MD, PhD, Chair Professor, Consultant, Department of Clinical Immunology, Aarhus University Hospital, Department of Clinical Medicine, Aarhus University, began his talk with basic facts about blood transfusion. Blood donors may help society with surveillance of infections to prepare for the next pandemic.

Transfusion medicine has helped teach about disease, including understanding Hepatitis B, HIV, West Nile virus, Zika virus, Hepatitis E, and Coxiella burnetti. Safety measures put into place to protect the blood supply means that the blood donors are not fully representative of the background population. The Scandinavian Transfusions and Donations database (SCANDAT) includes 1.5 million patients between 1968-2012. Patients' diagnosis of dementia were identified. Risk of disease was compared with recipients transfused with donors with disease and those without disease, showing no transmissible agent.

Blood donors provide a screen to gain new knowledge about infectious diseases for the past century. They propose screening a population (e.g., well defined, high, constant, with frequent infection) for an infection. The blood bank is suited for large-scale surveillance studies.

Are donors willing to participate in surveillance and biobank studies? Traditionally people donate blood for transfusion to help one or two patients. Today, they are asked to give access to blood samples and data, including questionnaires and four years of surveillance and research to benefit future patients. The sentinel surveillance monitors the rate of occurrence of specific conditions to assess the stability or change in health levels of a population. The study will also be used to understand SARS CoV-2.

Early in the pandemic, seroprevalence in blood donors were used to ascertain seroconversion for antibodies. This approach was useful early in the epidemic with low seroprevalence and low specificity of the assay in use.

To determine if donors are representative of the population, SCANDAT donors have 30 percent lower mortality than the background population. The health donor bias is similar to the healthy worker effect. The healthy donor effect is weaker for some diseases, like infections than other diseases, like heart disease.

Blood banks may deal with a healthy donor effect, but the donor population is more consistent than a random request from the larger background population. Additional surveys may be required through time to capture other information (e.g., co-morbidities, children, and the elderly).

The infection fatality rate in Denmark found to be ~1 percent in Danes younger than 69 but 5 percent in those older than 70. All blood donations have been tested for coronavirus from October 2020 to June 2021 with a very reliable assay. They recalculated the infection fatality rate for the first wave (March 2020) and second wave (December 2020). The infection rate was lower for healthy individuals without co-morbidities.

Sero-surveys were used to estimate missed infections. Even with a massive testing, about one-third of infections were missed. The model for serosurveillance requires an understanding of the lag period. Data to date suggests SARS CoV-2 seroprevalence lags PCR testing 4-5 weeks.

Other pandemics will likely occur. Blood donor biobanks provide an opportunity to prepare by providing public health surveillance. Multiple donations from an individual provide an opportunity to look for pathogens through time. The survey can also include questionaries for behavior or symptoms of previous infection. Some areas can match a database with health registers to get precise information if donors have been treated at a hospital.

This information can also be used to understand how other environmental factors, like air pollution, can affect the risk of respiratory tract infections. The next step is to increase data volume through a collaboration with Iceland. He proposes using blood donor biobanks for future preparedness plans.

Question & Answer/Discussion

Dr. Kuehnert opened the floor for questions. He began with a chat question about serologic testing and if it should be expanded to include new and emerging threat agents.

A: (Dr. Fehily) From our point-of-view, it is too early to say how this might work at the EU level. The legal proposal is still under discussion. We don't see it as something that would happen continuously but on a campaign basis.

Q: (Dr. Kuehnert) Michael Mina at Harvard proposed a global observatory and a concept of sero-epidemiological horizon scanning where you take blood donors and look at their profiles for antibodies to investigate change. Is the technology at the point where this could be implemented?

A: (Dr. Erikstrup) I do not know about the technology that Michael Mina is using. It is possible to do the seroprevalence surveys on the short notice, because of the pandemic urgency. Money is short, and it is hard to get funding for seroprevalence surveys where there is no pressing epidemic. I design research studies and then do it on a project level.

Q: (Dr. Kuehnert) Is there a group that discusses what should be looked at? How do you decide what to look at?

A: (Dr. Erikstrup) From the infections mentioned, they have started out as epidemics and even pandemics. It is the urgency that decides if funding is available.

A: (Dr. Fehily) It is important that topics like this are included in the mandate of organizations, like ECDC, then there is a basis for funding the work.

Q: (Dr. Kuehnert) In the U.S., the demographics have changed significantly. We have not seen as many minority donors. How do you account for these changes during pandemics if you are using this data for decision-making?

A: (Dr. Erikstrup) In Denmark, we have not seen a change in the demographic of our donors, but you would have to take that into account. Blood donor populations would be more constant than other populations, but blood surveys cannot stand alone. We can also define other sentinel populations, like all patients visiting hospital on Monday morning. When we compared our data to the national seroprevalence survey, they only did it in certain time points. What was reassuring even though population changed over time the data was similar.

Q: (Dr. Basavaraju) How are biobanks useful for emerging pathogens where there is no blood viremic phase? How much value is testing nucleic acid in blood to identify the pathogen? Even if you identify a virus, how do you know it is clinically relevant?

A: (Dr. Erikstrup) It is hard to give a general answer. It will depend on the agent in questions. COVID-19 is easy for us to track in the blood banks because people with mild symptoms or asymptomatic, so it makes sense to screen blood donors. Severe infections are another issue.

C: (Dr. Kuehnert) Most infections produce an antibody response. It can be tracked. It is a question of whether it will be tracked.

Q: (Dr. Goodrich) How do you see the results from this surveillance factoring into decisions at national and international levels of blood screening practices? How are you collaborating with other countries?

A: (Dr. Erikstrup) Our screening for COVID-19 has had next to no impact on our blood service. We collect the data and share it with the state sero-epidemiological institute for modeling. We haven't used it for blood safety reasons, because COVID-19 does not affect transfusion. There are other infections, like Hepatitis E, which is not relevant for the general citizen, but it is important for our recipients so it is important to know if donors are infected.

Q: (Mr. MacPherson) What you are proposing has been around a long time, and the problem has always been money. Patient-level data is very expensive. What is the real return on investment?

A: (Dr. Cohn) It is important to keep in mind. Vizient may provide a better way to address that question. It can help us also address blood availability and blood utilization. With emerging and infectious diseases and changes in blood usage, investigating how to improve the job with hemovigilance is worth doing. Perhaps we can convene as a Working Group to examine this further.

Q: (Dr. Kuehnert) Do you have further comments on how to adopt the common data set concept in the United States?

A: (Dr. Fehily) The data set is key when having conversations with authorities. The key is to get the data to the critical set of information. The digital infrastructure is provided centrally with the defined data set then the possibility for having variations or misinterpretations is lowered.

Q: (Dr. Kuehnert) How does data infrastructure happen? How do you manage when you have a patchwork of infrastructure to make it common?

A: (Dr. Fehily) It is the challenge. Deloitte is looking at the existing data gathering exercises in place and those that we are planning and those that we have proposed to see how they might interact. We are also getting stakeholders on board. To reduce burden of those involved, we want to avoid 27 member states putting together a data infrastructure by creating something centrally. That is the thinking currently but we are waiting on results from the Deloitte analysis.

Q: (Dr. Kuehnert) We have an incredible resource, but you cannot test everything. How do you handle sampling and what is stored in biobanks? How do you deal with informed consent in advance of the donation?

A: (Dr. Erikstrup) In the Danish blood survey, we keep an archive sample from all donations. In the sero-surveys, we ask the donor for consent to be tested for coronavirus antibodies. When we include donors, we ask for permission to do genetic research with a large number of aims and use their register data and plasma samples. We have used genetics in large sample sizes and also case-controlled approach. Our baseline samples are kept in an automated freezer. From 140,000 participants, we have 1.5 million plasma samples.

A: (Dr. Fehily) From our experience during the pandemic and CCP, we established a single database at the EU-level. There were various successes. One of the major challenges was the data protection regulation and the judgement from different states what informed consent needed to be.

A: (Dr. Erikstrup) Denmark had a hard time donating information to the study. Because of all of our possibilities to do register-based research, our lawyers interpret the law very vigorously. We were only able to provide the data if it were fully anonymized. We must deal with legal matters and data security.

Q: (Dr. Kuehnert) How do you store all of the plasma? How much freezer space do you have?

A: (Dr. Erikstrup) We keep our samples in commercial freezing houses at -20 °C.

C: (Dr. Ramsey) We did a review of literature on mass casualty events to learn about transfusion needs. There is a dearth of information for emergency planning. Getting data for both response and learning for planning would be valuable for hospitals and blood centers. It seems that blood supply has been sufficient. The issue is knowing where to send it.

Q: (Ms. Fredrick) How is the EU supporting the digital infrastructure build and the project team working on contingency planning? We might be looking for that type of support. Can you share the resources it has taken for those two project to completion?

A: (Dr. Fehily) The source of planning for the contingency program is the EU public health program. A new one starts in 2021. It covers all EU-wide projects on public health. I will have to get back to you on the amount. The digital infrastructure planning with Deloitte is also not at my fingertips. The amount has increased for the new program - EU4Health - indicating how the pandemic has changed the prioritization for health initiatives across the EU.

C: (Ms. Fredrick) When we were writing the Congressional Report, the benefit of collecting data on transfusion outcomes was raised. Although we do not know of many cases of large-scale situations where blood is not present, what became clear is that every physician treating sickle-cell patients that blood is not readily available. Platelets are not available when needed throughout our country. She quoted that according to the Red Cross 33% of hospitals did not have platelets and 36% of the trauma patients who died did not have the right kind of blood to transfuse.

C: (Dr. Cap) This is a major problem. If you aggregate the data too much, you can fool yourself into thinking you have adequate supply. You need hemostatic resuscitation as close to the point of injury. In south Texas, our work is centralized around San Antonio. It was not until we placed whole blood on helicopters that people are receiving the treatment needed. We need to do a better job providing products, developing new products, and putting products near the patients. Rural trauma mortality numbers are significantly higher than urban areas. We have a lot of work to do.

C: (Dr. Ness) Part of my concern yesterday on the supply chain on sustaining donor activities is that we are not looking at what is available in existing hospitals. Can we develop products at the hospital level or in a supply depot to meet acute crises? What is really available in the inventory needs to be carefully defined so the data is meaningful and easy for hospitals in a crisis situation to send blood to other locations?

C: (Dr. Cohn) The process needs to be refined. I think the information is important. We need to collect data in a uniform way (e.g., uniform codes). Cryopreserved platelets could be a way to extend distribution. We have a lot of room to improve.

AABB Interorganizational Task Force: U.S. Perspective on Blood Supply and Inventory Data

Leo DeBandi, Vice President, Analytics, Production and Inventory Planning, American Red Cross, began his talk with a brief history of the Task Force. Following 9/11, there was an unprecedented surge in blood donations, resulting in a surplus and some wastage. The Task Force was established to coordinate blood donations following disasters to ensure donations are collected accurately and clear and consistent messages are delivered to the public on the status of the nation's blood supply. The Task Force is comprised of representatives from the blood services, the associations, the commercial entities, as well as liaisons from government agencies. The Task Force works together to prepare for disasters to ensure inventories are in place and also acts as a mechanism to assess the needs for collection and transportation of blood.

AABB serves as the designated coordinating entity for the Task Force, which includes critical events assessment group, the American Blood Centers, the American Red Cross, Blood Centers of America, as well as liaisons from the armed services blood program and the HHS Office of the Assistant Secretary of Health (OASH). Additional members include the American Hospitals Association, College for American Pathologists, National Marrow Donor Program, Plasma Protein Therapeutics Association, and liaisons from the CDC and FDA.

In the event of an emergency, AABB convenes a subcommittee of the Task Force to ascertain the medical blood need based on estimates using pre-determined formulas and assessing availability of supply. The blood collector experiencing the disaster may submit a request to the Task Force for assistance. Findings are communicated with other members of the Task Force.

The current data provides the Task Force with information to address emergencies, but it is limited. Three organizations submit information on blood inventory: Blood Center of America, American Blood Centers, and the American Red Cross. Submissions are manual and not standardized. On any given day, some centers may not report the daily inventory level. The visibility does not reach the regional level and only accounts for red blood cells. Hospital data is not provided.

During disasters with warning (e.g., hurricane), blood centers try to move blood to the affected area, but events without warning are supplied by local hospitals with blood centers refilling the hospital supply.

The COVID-19 pandemic revealed the lack of timely, comprehensive data on the blood supply. This will strengthen the nation's preparedness abilities and improve the task force's ability to assure that blood is available to meet patient's needs. He pointed to the example of CCP as a mechanism that this is possible. This type of collaboration and coordination facilitate patient timely access to CCP. The Advisory Committee could learn from the CCP example.

The Assistant Secretary of Health (ASH), the Assistant Secretary for Preparedness and Response (ASPR), and other policymakers should ensure that blood collection establishments, the Task Force, and considerations related to the safety and availability of the blood supply are integrated into federal, state, and local pandemic and disaster preparedness and response policies. HHS should dedicate funding to support the Task Force's infrastructure and ensure the innovative support to meet the needs for the nation.

National Data Warehouse for Blood

Martin Grable, Executive Vice President, Chief Financial and Administrative Officer,

OneBlood, began by reviewing the recommendations in the Report to Congress, which provided key themes in the collection of real-time data to respond to public health emergencies. This requires investment and infrastructure.

The Working Group began in January 2020 and accounts for 62 percent of the blood supply, which is really only an estimate. The goal is to support all of the combined interest of the national blood supply. We are trying to establish a core data set from which to lay the foundation for an inclusive and collaborative data store. We want to be additive rather than disruptive. It is a project that is a work in progress. We want to perfect the foundation with the input of others, and modularity and extensibility are key pieces of that. The Report to Congress coalesced the long-standing concerns and articulated the consensus about the need for data. This need was amplified during the pandemic.

John Mass, Vice President Biomedical Services Business Systems, American Red Cross, continued. At the beginning of the pandemic, blood drives were cancelled affecting the inbound supply and changing the demand as surgeries were cancelled. As CCP was introduced, the need to understand inventory and demand increased.

The Working Group began by determining the simple datasets to combine information. The pilot study for CCP examined inventory, donor data, and SARS CoV-2 antibodies. We designed a simple data set for inventory that would be easy to automate to ensure timely downloads of data. The data loads were originally loaded manually with an eye toward automation. Also, the refresh was set to weekly.

The pilot study developed a geographic idea of where the product was located (e.g., work in progress, in stock, shipped) and the rate of change on a day-by-day basis. Early on, our ability to grow inventory was difficult. Once this started during the summer months, the inventory increased, but it became stressed at the end of the year across the country. After the inventory began to grow again in early spring, it was again drawn down as it was transformed into other products. We found strong correlation for our results in other external datasets (e.g., IHNE group). The pilot worked well. The group is now working on a second pilot to automate data loads. We are looking how to expand and define the governance.

Mr. Grable continued. The goal is to establish data governance to support a wide range of data management policies, as well as validation and compliance frameworks. We are also working to make the approach scalable, extensible for enterprise data, specialized workbenches for ingestion, insights, and reporting. In addition, we are working to improve objectivity and visibility, industry-wide, on donor demographics and blood product availability, tracking, and location. Finally, the reporting of blood availability across the national blood supply routinely as well as during times of disaster will support the AABB.

A key demonstration of success is to replicate the data for the National Blood Collection Utilization Survey (NBCUS). By capturing these core data elements, we could reproduce the NBCUS survey on the blood operator side in shorter time slices than is currently possible (e.g., near real-time data to highlight key issues). We are conforming to current programs to allow data to be integrated as necessary. Future efforts could focus on using historical data to make predictions.

To date, the group has assembled the right group of executives, operators, and data scientists. The CCP pilot has proven to be a successful prototype that has been expanded to include broader product and donor data. The data and focus of module one is donor data (de-identified), donation data, product inventory data, and distribution data. They are using ICPA coding for products in the system, which allows for objectification of other products at a more granular nature.

Question & Answer/Discussion

Q: (Dr. Kuehnert) Will this work be sustainable? What is the risk if there is a change in management that this work will be shelved?

A: (Mr. Mass) When we think about sustainability it is about cost and effort. If we cannot automate the data loads, it won't move forward. They key for us is automation and simplicity. With those two things, we believe it will be sustainable. After conversations with TTIMS, we worked through how we could make this as easy as possible. We are being very careful with how the data is being used. We are developing dashboards and consensus on who has access to them. This has also avoided the situations of mistrust in how data is being used.

A: (Mr. Grable) Governance and decision-making is key for a pilot. You need to have an entity that is distinct and separate. The pilot is a separate entity, like a 501(c)(3). The governance would require an operating committee. Importantly, the generation of data cannot be done by One Blood or American Red Cross. We have to be able to engender the confidence and trust of confidentiality and appropriate use of the data, which resides in the entity. We are not starting with a blank sheet of paper. We can demonstrate the ability and baseline requirements of governance and technology from which to work, and it is perfected when we bring others into the group.

Q: (Ms. Fredrick) You have 60 percent of blood supply. BCA has 40 percent. Together we have everything for effective public health emergencies and natural disasters. If we had all this data in one place and we had a public-private authorized structure that in times of public health emergencies or larger disaster could position the blood where needed, how would you see that working? Is it that government has a contract with you to produce data? We know there is blood out there but only individual CEOs have authority to release it.

A: (Mr. Mass) We have discussed this. In some ways, it is not an in-year term item. When you can skip the transparency, it does help everyone. A public-private effort would be very workable, like TTIMS. Moving product and creating a governance model around that would be a huge step in the right direction, but we would really have to dig in to figure out how that would work.

A: (Mr. DeBandi) When you look at a disaster and a response, the issue is who has the blood, where is it, and how much is there. The data from this type of model facilitates and enhances the ability to do that. The question is what is the mechanism to do that moving forward?

A:(Mr. Grable) Usually there is a willingness in the blood community to support one another. The question is if I give this up how do I replace it? It is in our collective national and our own interest to know what the blood supply today looks like. It will make it easier to know what you can contribute and still feel confident in meeting your own operational supply. We have designed this as inclusive and not exclusive. We envision that as this evolves it will be more broadly accepted. We wanted to flesh this out at the pilot level to solve some of the problems and increase confidence that this can be done cost effectively.

Q: (Dr. Cohn) How granular is the distribution data?

A: (Mr. Mass) In the pilot, we stopped at the state level. We have the data to the zip code, but we kept it at the state level as we working in parallel on some governance issues.

Q: (Dr. Cohn) Would super granular data be too complicated? What is a good level for your purposes?

A: (Mr. DeBandi) My recommendation for the pilot was keep it at the state level. We can move product at the state level as long as we know it is there.

A: (Mr. Grable) The structure that we are trying to establish could allow for hospital-collected data as well as DOD data. We thought about the different groups that would report out.

Q: (Dr. Kuehnert) Do you see blood centers as the main consumer of the data or do you see hospitals also participating?

A: (Mr. Mass) We wanted to make sure the pilot was producing value to the members. Once you get there, the information can be used by many different groups. You didn't need to pick up the phone to call people who were already low. This could be expanded to help what is going on from a hospital point-of-view. In pilot 2, we started looking at how to automate NCBUS-like data where we could extrapolate out what is happening in the industry overall.

A: (Mr. Grable) The other part of this is the donor side is equally important. We believe that ABC and BCA aggregated national data would be valuable to understand the changing demographics of collection. When we are making a case about what we know about our data, it would be important to have that founded in national-level data.

Q: (Dr. Kuehnert) How does this harmonize with NBCUS?

A: (Mr. Grable) It was more about making the data available. I am not sure we are all answering the questions in the same way. It would be good to have a consistent application of data to the questions. I believe it would be more reliable data.

C: (Dr. Basavaraju) This pilot does not have the same breadth of variables or same statistical precision as NCBUS to determine national estimates. The NCBUS has blood utilization information obtained from 3,000 hospitals. For the blood centers, the response rate is 90-95 percent and hospitals it is 75-85 percent. NCBUS is not intended to be real-time data. The NCBUS survey instrument has been largely unchanged in several decades.

A: (Mr. Grable) Our goal was not to replace NCBUS, only to answer the blood operator-based questions. We were only trying to facilitate the availability of that data and replicate some of the value of that data from a blood operator and donor model.

A: (Dr. Kuehnert) Is there a national tissue or skin inventory system? The answer is no. We know how many are distributed from tissue banks, but we have no idea how many were implanted. There is interest in skin for burn. In terms of inventory or what has been implanted, there is no template for blood in that area.

Q: (Dr. Kuehnert) Is the Assistant Secretary for Preparedness and Response (ASPR) on the task force?

A: (Mr. DeBandi) ASPR is not on the task force, but they are brought in as needed.

Q: (Ms. Fredrick) AABB made a strong position that all blood issues be integrated into all of the Federal- and state-wide disaster planning. Is it important for them to be present at the disaster task force or should someone be present in the ASPR planning? Would it not be better to have someone at the table early on during disasters?

A: (Mr. DeBandi) I will take that back to the team.

Recipient Hemovigilance: How to Enable and/or Encourage Hospitals to Provide Data

Hemovigilance in Massachusetts

Melissa Cumming, MS, CIC, Senior Epidemiologist, Healthcare-Associated Infections and Antibiotic Resistance Program Lead, Bureau of Infectious Disease and Laboratory Sciences,

Massachusetts Department of Public Health, began the presentation with a brief history of hemovigilance in Massachusetts.

The Massachusetts Department of Public Health (MDPH) Bureau of Healthcare Safety and Quality administers the clinical laboratory program and has regulatory authority for blood banks. The system began in the 1950s, which recorded information on paper, including total transfusion numbers and rare adverse reactions. This process held until the early 2000s.

Chester Andrzejewski, PhD, MD, FCAP, Director of System Blood Banking and Transfusion/Apheresis Medicine Services, Baystate Health, Assistant Professor, Department of Pathology, University of Massachusetts Medical School-Baystate, continued with engagement of stakeholders (e.g., Massachusetts Medical Society (MMS) and American Red Cross Medical Advisory Committee (ARC-MAC)). Beginning in the 1990s, MMS culled the transfusion committee. At that same time, the MAC expanded its membership and focus. It also brought in epidemiology experts. The focus was expanded to include transfusion recipient issues. There was also an effort to have the MDPH update the taxonomy of transfusion reactions. Also, the Board of Registration in Medicine, which was also interested in healthcare quality at the hospital level, was also interested in transfusion issues.

They returned to MDPH for on-going discussions to transition from a paper-based system to an electronic system. There was adoption of the National Healthcare Safety Network (NHSN) system in 2014. NHSN is the CDC broad-based tracking and response system to identify emerging and enduring threats across healthcare system. It is a secure, Internet-based surveillance platform managed by Division of Healthcare Quality Promotion (DHQD) at the CDC. The Biovigilance Component is one element of NHSH and is designed for transfusion staff in healthcare facilities to monitor recipient adverse reactions and quality control incidents.

Ms. Cumming continued that the hemovigilance module captures adverse transfusion reactions (e.g., 12-defined reaction types, immutability, and severity). Errors and accidents that lead to adverse reactions are a reporting option. It also includes denominator data (e.g., the number of units, aliquots, and discards of specified blood product transfused, as well as the number of patient samples collected and total cross-match procedures recorded).

The MDPH created a group within NHSN and requires all blood banks to join the group. The group can only read the data, not edit the data. Facilities can only view their own data. There are some build-in analytics. Participants can use their data to monitor adverse reactions and quality incidents in their own facilities and identify areas for prevention strategies. It also provides a way to compare their results to similar facilities.

Dr. Andrzejewski shared the number stakeholders (e.g., AABB, CDC, blood banks, ARC MAC, MDPH BHCSQ, MDPH Epidemiology, and hemovigilance champions) who assisted with these efforts.

Ms. Cummings continued. The group connected with blood bank supervisors, medical directors, and NHSN facility administrators at each hospital. It established a Technical Advisory Group (TAG) to engage early adopters. This is now a regulatory requirement in Massachusetts to replace the paper-based system. It provided time to train and educate contributors. It engaged with MABB and AABB for support and leveraged CDC support in outreach efforts.

There are challenges. Early challenges include Secure Access Management System (SAMS) approval process, which was found to be cumbersome. There was confusion around 'surveillance case definition' vs 'clinical case definition.' One may not impact the other. The time required for a facility to complete this reporting on a monthly basis was a concern. One of the more recent changes was the removal of the non-severe allergic reaction as a reporting requirement. Incident reporting has been made optional unless an incident is associated with an adverse reaction. Case definition and immutability are now auto designated. Finally, we have encouraged the adoption of Clinical Documentation Architecture (CDA) for automatic upload of denominator data.

NHSN reporting for blood banks has been in place since 2014. 67 blood banks report monthly. Monthly reports are provided to regulatory colleagues. Numerous routine data reports and quality checks are performed. The TAG remains actively engaged.

NHSN data covers more than two million products transfused and has captured data over the last five years on nearly 3,000 adverse reactions. Statewide Annual Reports include cumulative trends and metrics, facility categorization, and key findings. The reports are posted on the MDPH website and shared with all blood banks. In addition, the group provides data cleaning reports twice a year and facility-specific reports.

She shared some example graphics of data reported out (e.g., volume of blood product transfused, changes in transfusion volume by product over time, volume of blood product discarded, summary data on adverse reactions, adverse reaction rates by product type or bed size group, and rates of adverse reactions summary tables).

Dr. Andrzejewski continued by discussing differing perspectives and needs along the continuum of data input from the bedside to the international level. Prior to NHSN, hospitals were compelled to have oversight and monitoring of adverse events of blood products. The mandate did not specify how to do this but that it should be done. This is important because there is still a difference to what is submitted to the CDC and what is maintained locally. The ability to cross check the two systems has been beneficial.

The TAG debated how to report data and adopted the box and whiskers format. He provided an example of data reported. The data includes volume transfused for 2018-2020 for a given facility, including product type and type transfused. Other tables explored volume discarded and transfusion reactions.

Ms. Cummings noted additional uses of the data, including one-page briefs and educational outreach. State level adoption of NHSN was possible, but a regulatory mandate was necessary for complete success. Collaboration between regulatory and epidemiology domains was critical. The TAG has been essential to ensure the system is moving forward in a robust way. We are detecting trends and signals that would have been missed otherwise. The blood banks and transfusion services benefit peer comparison.

Question & Answer/Discussion

Q: (Dr. Kuehnert) Is data entry burdensome. How big of a hill was this to climb?

A: (Dr. Uhl) Our institution was one of the early adopters for hemovigilance. Our way was paved because we worked closely with infection control folks. We started when it was still a request for filing incident reports and that was the heavy lift on our side. Once that requirement was discontinued that made the compliance person happy. Over time, the whole process has been streamlined and is much more straight forward for entering data.

Q: (Dr. Galel) How is the cost recovered? This is something to think about when we come up with recommendations.

C: (Dr. Basavaraju) There is no additional cost. It is part of the general roles and tasks of being in the government. We recognize that there is a need for more representativeness in the module to develop more generalizable national estimates. Based on the data we have collected, we have done our best to disseminate the data through conferences or journals. In the data we do collect, our estimates are aligned with those reported elsewhere but we recognize there is a bias in the sample of facilities that participate. We are also thinking about ways to enhance participation in this model, so it is more nationally representative (e.g., sentinel model). We are looking for way to incentivize facilities to report. We also hear that there is some reporting burden. We are looking for ways to make that easier or smoother. Is there a way to synch current electronic health record to the hemovigilance model? That would require discussions with manufacturers. We tried to do that but found little interest. There is no regulatory or financial incentive outside Massachusetts.

Q: (Dr. Kuehnert) Benchmarks might incentivize hospitals. Will hospitals get more out of the reporting? Should we form another AABB-like group?

C: (Dr. Basavaraju) There may be benefit if a blood collection organization formed a group of potential customer hospitals. The blood collector could observe trends in adverse reactions to identify potential differences in certain reactions that might be indicative for a need for an intervention (e.g., education, guidelines, etc.). We have published data from hemovigilance models so facilities can see how they are doing.

C: (Dr. Ness) One Blood once required incident issues but it was dropped because it was cumbersome.

C: (Dr. Uhl) Some of this data could contribute to a performance improvement initiative.

A: (Ms. Cumming) If there is a way to get at the data in an electronic way, it might be worth exploring. Incidents associated with a reaction are reported but are not as helpful as having them all reported.

Focus on Comparative Blood Utilization

David Levine, MD, FACEP, Group Senior Vice President, Advanced Analytics and Data Science, Vizient, Inc., provided a brief overview of Vizient Inc to strengthen members' delivery of high-value care by aligning cost, quality, and market performance.

Membership includes more than 50 percent of healthcare organizations, which includes 95 percent of academic medical centers and IDMs. The work crosses operations and quality, strategic growth, supply chain, and pharmacy. Vizient is the fourth largest healthcare consulting firm. It has 365 consultants, 450 member council partners, and 1,350 members in performance improvement offerings.

The data in the clinical database grew from academic medical centers, which share and benchmark administrative data. The Clinical Data Base includes 500 community hospitals and 97% of academic medical centers. The Clinical Practice Solutions center looks at physician productivity and reimbursement. Procedure Analytics marries supplies used and wasted and cost to clinical outcomes. The Operational Database pulls in comparative operational reporting around staffing, supplies, pharmaceuticals, and blood. Supply and pharmacy analytics identifies savings and standardization opportunities, benchmark pricing, and supply use.

Vizient partners with specialty societies and partners (e.g., CIBMTR and SRTR) to identify best practices operationally and clinically for research projects. Our members author 100 peer-reviewed papers a year that reference Vizient data.

The actionable tools, reports and services include a transparent database, robust networking, dashboards and reports, integrated insights, and data quality program. Vizient's Operational Data Base includes four laboratory-related departments, including clinical operations, blood bank, anatomic pathology, and administration. The Vizient Clinical Data Base allows clinical leaders to focus improvement efforts, realize improvements faster, and sustain improvements. Pairing the Clinical Data Base with the Operational Data Base leads to analysis of high-impact areas to reduce variation.

Saloni Kapur Jain, PharmD, MPA, Vice President, Advanced Analytics, and Informatics, Vizient, Inc., explained how tools are leveraged through an example of blood intensity to identify the CDB and procedures that are more blood intensive. Knowledge of the clinical picture informs the operational side of assessing a blood banks performance.

Comparative utilization in the data base is integrated within CDB reporting. We examine trends and patterns in utilization across eight clinical resource categories. The aim of the data was historically to reduce unnecessary variation and from comparative standpoint to look at protocol variation. This approach uses administrative billing data and focuses on blood, using specific individual resource codes (e.g., P9019, P9020, etc.).

The supply chain is evaluated for blood expense by tracking 'blood expense per BIS adjusted discharge.' We evaluate what contributes to this expense (e.g., cost per unit, amount used) to understand patterns of utilization. This can be drilled down further to specific products by clinical classification (e.g., 076 card valve/orth maj ct proc w/o card Cath) to understand how products are being used.

The data also allows one to evaluate how an institution's use of blood and clinical outcomes compared to other organizations (e.g., length of stay and albumin utilization). When you look at platelets-per-case you are reliant on billed unit, but it can be billed twice (e.g., storage and use). It is easier to evaluate within an organization rather than between organizations. Dr. Levine noted that they talk to their members regularly to understand how they bill to benchmark practices.

Dr. Jain continued. It is possible to examine blood utilization as it relates to patient acuity. We can compare RBC and platelets versus RBC alone to evaluate mortality, outcomes, etc. We can also evaluate when trauma cases receive platelets to evaluate outcomes to understand blood utilization and blood mitigation for different procedures, such as hip replacement surgery, to evaluate the best use of different technologies.

The data also allows us to evaluate blood mitigation in different case studies to evaluate where cases are being heard and how cases are being put into a cohort by intervention to evaluate the impact of cost and outcome (e.g., length of stay, complications, etc.). We can examine how different protocols and interventions affect patient length of stay, complications, and blood utilization. Each blood management protocol yielded similar outcomes with marginal differences.

Question & Answer/Discussion

Q: (Ms. Fredrick) The NHSN is tracking transfusion complications or adverse reactions. You can also track complications. One of the challenges is hospitals having to enter data in the NHSN. If your data matches the CDC system, could they enter that into your system and could it be passed over to NHSN or vice versa?

A: (Dr. Jain) The criteria for surveillance versus administrative coding data is different. I don't know enough about the complications being documented in the NHSN model. If it is more surveillance rather than administrative, it would not align. We would have to evaluate it.

A: (Dr. Levine) What we can most likely do is get NHSN to feed conferred rights to Vizient then you could upload the data and benchmark it. We will have to follow up with our NHSN contact.

C: (Dr. Free) I don't have as much experience with NHSN. I agree that surveillance might have different requirements for criteria.

A: (Dr. Jain) This also shows up in patient safety database, which is a hospital-reported adverse events.

A: (Dr. Levine) We are a patient safety organization. Some information will be protected by PSO rules.

Q: (Dr. Kuehnert) If you can form a group with NHSN, would you be able to compare the two datasets?

A: (Dr. Levine) Yes. My guess is that will be directionally aligned. We would be happy to publish with your group a white paper or research article.

Q: (Dr. Bryant) Can you pull lab charts for transfusion work-ups?

A: (Dr. Jain) We can capture the charge of the test but not the result.

Q: (chat) Do you look at overall blood use trends in clients through time?

A: (Dr. Jain) Part of operational metrics are tracked quarterly. We do not publish on it, but any organization can look at it. We have an advisory group that consults on blood utilization and are tracking trends in utilization, cost, impact of procedures, etc.

A: (Dr. Levine) We track trends in overall use by procedure and service line.

C: (Dr. Cohn) International Society for Blood Transfusion (ISBT) codes are attached to blood units. If there were ISBT codes for each NHSN category of transfusion reaction, then those could be attached to units after the fact and eventually have an automated pulling of the data. I don't know if that would be through your system or another system.

A: (Dr. Levine) If it was developed, we could pull it from our system as we get EHR direct feeds or flat files for fields that get populated.

Q:(Dr. Jain) Is that code linked by patient encounter?

A: (Dr. Cohn) We have to track a unit from receipt to transfusion but that lives in the laboratory information system.

C: (Dr. Jain) That is why we often source from the LIS. That would be another caveat as where the underlying data lives informs where it will show up in one of our tools. This could also play into doing long-term tracking as well. There are safety implications there also.

C: (Jed Gorlin) ISBT ran out of numbers.

Q: (Dr. Cohn) When you work with other organizations, like CIBMTR, could we fit the Vizient model into the national blood data collaborative? If hospitals already contracted with you, could they enter data into blood collaborative?

A: (Dr. Levine) My gut would be that members own their data. As long as the member is in Vizient, they can share their data, and the Vizient model be involved. Think this through the next few steps and then work with us to figure out how to set this up so you can garner the information you need.

Donor Data for Public Health

Brian Custer, PhD, MPH, Director, Epidemiology and Health Policy Science Vice President, Research and Scientific Programs, Vitalant Research Institute, Adjunct Professor, Laboratory Medicine, UCSF, began by explaining that the tools developed in Retrovirus Epidemiology Donor Study (REDS) has been used in subsequent programs, including Transfusion-Transmissible Infections Monitoring Systems (TTIMS) and Multistate Assessment of SARS CoV-2 Serology (MASS-BD) programs.

He began with the 2020 Report to Congress regarding TTIMS (e.g., funding and expansion of the program). One of the recommendations also suggests empowering a task force to evaluate the systems that have been built and coordination is important. He provided a history of the NHLBI REDS research programs, which began in 1989 to focus on retrovirus infections in blood donors for transfusion transmission safety in the United States. Today, REDS-IV-P has an expanded focus to donor-related topics and recipient-related topics.

REDS program has specifically focused on agents emerging infectious disease threats (e.g., ICL, vCJD, T Cruzi, PTLVs, WNV, Influenza, DENV, XMRV, CHIKV, PARV4, SFTSV, and ZIKV). The structure that exists allow us to deploy efforts to understand the size of the threat and best targeted studies to address the threat.

REDs-IV-P includes the ability to rapidly respond to new blood safety issues, particularly in donors. REDS-II ran a pilot to see if it was possible to monitor rates of infection across the United States (e.g., Transfusion-Transmitted Virus Infection (TTVI) marker rate study and Risk Factor Interview Case-Control Study). He shared data from this pilot study, which led to the development of the TTIMS program. Funding (e.g., FDA, OASH, NHLBI) for TTIMS has been renewed until 2025. It coordinates the Donation Database Center (DDCC) (e.g., prevalence and incidence and residual risk) and Laboratory and Risk Factor (LRCC) (e.g., biospecimen repository, genetic testing, risk factor analysis, and ancillary studies as needed to ensure blood safety). He shared LRDC and DDCC workflows to map out the system to make sure they are coordinated and functioning.

The population of states and number of donors represented from previous version of TTIMS program is represented at a rate per thousand data. This data is mapped to provide an impression for where coverage is high for overall number of donors. Where TTIMS participation is lower, the coverage and insight is lower and offers opportunities to focus efforts.

He showed data from donor population studies in HIV, Hep-B, and Hep-C from 2015 to 2019 to illustrate how TTIMS data can be analyzed. The data can be sorted into donor status, gender, etc. The work also provides opportunities for further insights (e.g., 2010-2018 HIV-seropositive donors for recently acquired infection in the U.S.). The data was stable over time. Every center implements verbal consent and captures demographic information.

TTIMS has expanded donations from ARC, NYBC Enterprises, OneBlood, and Vitalant. The next generation of TTIMS will expand the scope of data, inclusion of donor and donor data from additional participating centers, the scope of data, prevalence, and incidence with 3-month deferrals, demographic assessment, etc. The LRCC is expanding to include Hep-B (expanded definition), Syphilis, ARV and PrEP studies, etc.

The REDS-IV-P aims to 1) determine if SARS CoV-2 RNA is present in the contemporary blood donations in key U.S. outbreak regions; 2) perform donor antibody testing to understand infection dynamics; 3) track rates of potential COVID-19 post-donation information (PDI) (e.g., what can be learned by PDI); and 4) direct follow-up of SARS CoV-2 individuals into long-term longitudinal studies to understand pathogenic and vaccine research. He shared published results thus far.

Looking at questions like, "What can donors tell us about community infections?" we are looking at blood donations in 62 regions across the United States, consisting of monthly and demographic data. The regions are not comprehensive but include a larger number of blood collection agencies. He shared preliminary results thus far. The data can be compared by gender, age, and race/ethnicity.

Blood donor data is limited. It does not include people who are ill or younger than 16. The diversity of donors is limited. Not all infected people produce antibodies. Some blood centers advertised SARS CoV-2 antibody testing, which could bias results. The donor population provides a small-scale approach for a global immunological observatory for enhanced surveillance.

We are creating cohorts of repeat donors to identify waning immunity, breakthrough, and reinfections to correlate protections. REDS-IV-P (e.g., establish agents), MASS-BD (e.g., near nation-wide assessment of threats), and TTIMS (e.g., large-scale monitoring of PDIs) provides different insights at different points in time. Pathways to sustain these programs are what is necessary.

The TTIMS program has many directions it could go: survey data collection, donor health studies, manufacturing studies, donor recruitment and retention, emerging and re-emerging infectious diseases, and studies of known transfusion-transmitted infection.

Question & Answer/Discussion

Q: (Dr. Goodrich) My general sense has been that the time lag between identifying new agents that merge in human populations and the definition and data to show if there is a transfusion transmission risk has gone down dramatically. Is this due to these programs, or are there other factors involved?

A: (Dr. Custer) We have played a part, but there are many tools available now for identification/understanding of the agent, so the response time is reduced. The systems that have been built will continue to develop.

Q: (Dr. Goodrich) How do we make sure all of this education doesn't go for nothing? How does this information translate back into systems that provide policy or practice recommendations?

A: (Dr. Custer) At the simplest level, the data sets can be monitored for diversity in the donor base. Those type of tools can directly impact policy considerations. SARS CoV-2 has been an amazing opportunity to study. We need to make sure we communicate the results to help other organizations make decisive actions.

Q: (Dr. Levy) What behavioral data is collected for potential risk factors?

A: (Dr. Custer) We do have an existing risk factor questionnaire that is focused on HIV, Hep-B, and Hep-C risks as we understand them. If something is emerging, we do not have a system in place, but it is a way to focus on known and understood infections. A similar risk factor questionnaire is used in REDS-II that has been updated (e.g., pre-exposure prophylaxis for HIV). All questions are IRB and OMB approved.

Q: (chat) What do you believe is the optimal road forward to coordinate and integrate these three programs?

A: (Dr. Custer) What I was hoping to show by talking about each of them is that each is serving its own unique but important role. Each provides important parts of the information puzzle, and you need all of them. They are all built off of a common infrastructure. We could ask that question at the agency level to find out. How do we work together more effectively? The response to MASS-D program is providing data and is a beautiful model of how all three can work together.

Q: (Dr. Kuehnert) We have three programs funded by CDC, FDA, and NIH. Has there been any efforts to standardize data collection as far as data elements between these three programs?

A: (Dr. Custer) Not specifically. The tools that we use in TTIMS were originally built for the REDS program. It has been modified slightly but it built off of that. Likewise, some of the TTIMS data goes into MASS-BD. There is integration but it is not complete. When you get to the numerator side, that is where codebooks diverge a bit. They are more standardized rather than less.

Q: (chat) What would it take to expand TTIMS to all states?

A: (Dr. Custer) MASS-DB is exactly that. We are taking the structure to ask blood centers that do not normally participate in research endeavors now contribute data that can be processed in the same way. It is a huge step forward to ensure TTIMS or other future programs are as representative nationally as possible.

Q: (Ms. Fredrick) When we did the Congressional Report, the two regarding TTIMs went to Congress. If we were a university or a medical school, you would take the three different things and you would create a center. How would you word a recommendation to the ASH to explore the overarching structure that would ensure over time that the three survive and the support and funding is there for the long-term?

A: (Dr. Custer) Pull language from what is in the Report to Congress (e.g., Recommendation 5.3) by convening the government agencies and stakeholders to formally talk about this along with private-public partnerships underway. Now that we have a better appreciation of what can be achieved, how can we actively integrate that. I would propose something like that. A model has been shown that seems to have potential. How do we build off of that?

Q: (Dr. Kuehnert) We all agree the work is amazing, but the funding cycles are more challenging, and they are different. How do you make sure there is going to be funded in perpetuity?

A: (Dr. Custer) That is a big question. They are finite programs and need to go back for more funding. What I hope to demonstrate to the Committee is that there needs to be stable, core funding to continue them. MASS-BD was as successful as it was because it could draw on what was already achieved.

C: (Ms. Fredrick) I went back and looked at 5.3 in the Congressional Report. We could modify that to focus on strengthening the public health expertise by using the donor base.

C: (Dr. Custer) We are doing two things at the same time: 1) asking questions about transfusion safety; and 2) making sure a broader audience understands the importance of this contribution. Clearly, we are learning from SARS CoV-2.

Committee Discussion and Recommendation Formulation

Ms. Fredrick posed three core issues for the Advisory Committee: 1) data collection and infrastructure for inventory and supply; 2) recipient hemovigilance; and 3) donor data and public health. She suggested framing this as, "What is the mechanism such that a task force is created by the NIH, CDC, FDA, and private stakeholders to further analyze the strength we have and create a mechanism for long-term funding."

Dr. Kuehnert suggested bringing up the preamble for discussion.

Draft - Recommendations for Data Infrastructure - Preamble

Current monitoring of the blood supply, transfusion outcomes, and donor health in the United States is composed of a network of independent and federal organizations. In order to maintain a monitoring system that is responsive, efficient, and ensures safe and available blood for all patients, real-time integrated data infrastructure is essential. The Committee has examined possible models to establish, ~~and~~ implement and fund a comprehensive, sustainable, minimally burdensome infrastructure that monitors and makes available real-time data on 1) blood availability/utilization, 2) adverse events (i.e., hemovigilance) and patient outcomes, and 3) donor data to benefit public health. This is particularly important when considering the potential impact of public health emergencies on blood safety and availability. The role of blood and plasma donor centers in enhancing public health surveillance for emerging infections has been highlighted by blood donors' contributions to data and therapeutics during the COVID-19 pandemic.

The ACBTSA has previously proposed policies for a framework that would build upon current infrastructure and gap analysis. Specifically, a real-time blood inventory framework, plan for a more representative, national hemovigilance system, and coordination of research to monitor donor health— funded by a consistent and reliable mechanism— are needed. The recommendations of these three topics are outlined below.

Q: (Dr. Galel) Can you clarify 'systems to monitor donor health.' Is that referring to donor reactions or more what Dr. Custer was talking about?

A: (Dr. Kuehnert) It is the latter. The idea is to broaden it so it is not limited to infectious disease. The data is laboratory/epidemiological data.

Q: (Mr. MacPherson) What are we asking the Assistant Secretary to do? What is the gap we are trying to address?

A: (Dr. Kuehnert) Good point. This is the preamble. If we get into the actual recommendations, we will see it is a bigger lift for blood inventory and supply where we do not have a cohesive system. For recipient hemovigilance, it is about strengthening NHSN where it already exists and expand and ease hospital burden for data entry. For blood donor data for public health is about funding, interoperability of methods, and acknowledging that they are related to one another. All of them need further discussion. I don't think there will be any asks out of the box to the ASH without further consideration of a gap analysis and groups that will be able to identify more specifics of what the government can actually do.

A: (Ms. Fredrick) Remember we already made a recommendation to the ASH to establish, implement, and fund comprehensive, sustainable, minimally burdensome infrastructure that monitors and makes available real-time data on blood availability and utilization. This is what we would recommend comprehensively. Now that we have learned more, we could add to this and be more prescriptive, which is included in the draft recommendations. At this point, we are asking to literally form a task force to undertake the assessment of public and private models to assure reporting etc. We are asking the ASH to commit to forming a task force to evaluate this whether that is as workshops or such and to come back with a more specific plan on how to proceed.

Q: (Mr. MacPherson) Who are we tasking to do this?

A: (Ms. Fredrick) We are asking the ASH. As an Advisory Committee, we recognize we lack a valuable real-time inventory management system. Our previous recommendation was that this was critical and now we need to say we looked at this issue further and you need to convene a task force and fund the examination on how to proceed with the development of the system. We cannot solve this as an Advisory Committee. We can only make recommendations to the ASH. HHS needs to take the next step.

Q: (Dr. Galel) Is this one task force or separate task forces for the three bullet items here?

A: (Ms. Fredrick) These are three separate projects. There is infrastructure that is being worked on, in development, or exists. We need to identify the current infrastructure, identify gaps, and develop a plan. On the inventory side, we have very distributive infrastructure with blood centers and blood center groups. We would need to get these groups together to talk about what could be accomplished.

C: (Dr. Ness) We are talking about hemovigilance but what we are doing is so meager. Some of the sophistication that we are applying to donors could also be applied to recipients. That could produce high-yield information.

A: (Ms. Fredrick) I agree with you.

Q: (Dr. Cohn) Are you asking that we expand that part of the recommendations?

A: (Dr. Ness) I am suggesting that we expand hemovigilance to include passive and active reporting, perhaps developing recipient registries. It has been done for individual studies. We could also use some of the mechanisms that Dr. Custer talked about to go to recipient studies using similar technology.

C: (Dr. Cohn) If we are recommending three separate task forces, that would be the list that the task force would develop.

A: (Ms. Fredrick) To your point, I would look to asking for funding and support to have those workshops and then let the experts convene and identify the key attributes for them.

C: (Dr. Cohn) Yes. I cannot imagine in the next hour that we could put together appropriate language to address these needs.

Q: (Dr. Kuehnert) Is Jim Berger on? Can you help us understand how this happens?

A: (Mr. Berger) The Blood, Organ, Tissue Safety Executive Committee (BOTSEC) is comprised of the major HHS agencies involved with blood and tissue safety and availability (including plasma) and liaisons with the DOD and DVA. The recommendations go forward to the ASH. Dr. Levine calls BOTSEC together to decide the course of action, what to support, and how the support will be distributed among the agencies. Once the recommendations are agreed upon, they will move forward to the Secretary of HHS for his support.

Q: (Mr. MacPherson) We made these recommendations last year?

A: (Mr. Berger) Because of COVID and the change of administration, the recommendations did not receive the attention that it should have.

Q: (Mr. MacPherson) Do we make the recommendations again?

A: (Mr. Berger) If there were any recommendations that you think remain a priority, you should make them again.

Q: (Ms. Gustafson) Regarding BOTSEC, I find the public health issues and surveillance most interesting, are we within the scope of what we should be doing for safety and availability?

A: (Dr. Kuehnert) These programs are ultimately assessing blood safety. While they can have public health benefits they are primarily for the benefit of safety of recipients. Maybe we need to emphasize that more. The change in administration, change of ASH, and COVID has shown why a system for blood research is important. Some of this may not have been as visible the last time this was presented compared to now. I think it is worth a reframing and particularly regarding the donor data portion because it has been shown nicely in terms of COVID what can be done. That can strengthen the programs that exist on that side and for the inventory and recipient hemovigilance, it is emphasizing what we did before but in light of the pandemic people have more of a focus now.

C: (Ms. Gustafson) Once you have techniques in place and know products are safe, are we going beyond our mandate in terms of finding blood, plasma products, tissues, etc. With regard to funding for surveillance activities, who is paying for the activities, the staffing, sampling, track, etc.? There is a great expense of the public health benefits and having that fall on our industry seems somewhat unfair.

Q: (Dr. Goodrich) If our recommendation should be taken under consideration, the funding agency would be identified. Then the agency would put out an RFP for people to respond to the need to create a real-time data collection system or adverse event monitoring. How does this manifest itself?

A: (Mr. Berger) It is something the agency could do. A RFA or RFP would be sent out to ensure it addresses the needs of the community. It is a partnership. Whatever we do at HHS should address the needs of the community. We count on public feedback to address these needs.

Q: (Dr. Goodrich) We have to decide which points are raised to that level. Not to provide the solution but that it is a topic worth going through the process?

A: (Mr. Berger) He pointed to ASH's example of a national donor campaign. Congress identified this as a need. HHS identified the funds and moved it forward. It just depends on what Congress and HHS identify as priorities that need to be supported.

C: (Dr. Galel) We need to add the word funding in here, 'Establish, implement, and fund.' We should separate research that is not funded necessarily from hospitals having to absorb certain functions — data infrastructure — if we think reporting to a safety network is critical and there needs to be a funding mechanism for that. The funding mechanism is likely to be different than funding for research.

C: (Dr. Levi) The whole issue of patient safety requires recipient outcomes. It would be great to have a portal, similar to the solid organ system, for adverse events and infections, a similar national portal for blood transfusion reactions and infections.

A: (Ms. Fredrick) I look to UNOS and NNDP as excellent examples of how the government provided the funding and research component and data collection that is used real-time. I don't think that has ever existed for blood.

C: (Dr. Levi) I think this would be valuable going forward. With the integration taking place south of the border and now we are gathering individuals from the Middle East, we could potentially see pathogens that we do not normally test for. Having a hemovigilance system for safety in place and reporting nationally would be really important.

C: (Ms. Fredrick) Dr. Custer's last comment in the chat. None of these programs are assured after 2025, and this is an effective way to respond to future blood threats. Our recommendations should include continued and more sustainable funding.

C: (Dr. Goodrich) I would strongly second that.

C: (Dr. Kuehnert) Our job here is to figure out how to keep these programs going. This is working, and we need to expand and make sure they are funded in a reliable and sustainable way.

C: (Mr. MacPherson) For number 2, you can add patient outcomes.

A: (Ms. Fredrick) Agree. We need to also include the inventory system for blood is opportune. The blood system is not working right now. They do not intend to go back to the mobile model. If there is ever a time to get our arms around this, it is now. This is not a short-term problem, and I do not see it getting any better for the next six months. This is not being done in a vacuum. Organizations have been on the Hill working with people who received the Congressional Report to get Congressional support. Several have met with the Assistant Secretary of Health. She is hearing this message from multiple groups, and this works in our favor getting these recommendations to her.

Ms. Fredrick asked for other comments on how the Committee should proceed.

C: (Dr. Gorlin) There is a finite amount of money out there, and we need to focus our request on the most pressing needs.

Q: (Ms. Fredrick) How would you order the three issues?

A: (Dr. Gorlin) Blood product availability is only going to get worse. In part, present all three of them.

A: (Mr. Berger) I am also the DFO for the tickborne disease Working Group. We were able get $25 million for public-private partnership from the Cohen Foundation.

Q: (Ms. Fredrick) How was that done?

A: (Mr. Berger) The subject matter expert from the Cohen Foundation for HHS was a co-chair on the Work Group and worked with them to address the need for Lyme, testing, treatment, and diagnostics. They found it was something they would support through their organization.

C: (Ms. Fredrick) That sounds similar to how The American Society of Hematology received funding for sickle cell disease initiative.

Committee Recommendation Summary and Vote

Ms. Fredrick suggested that the Advisory Committee take the three focus areas for data infrastructure and have small teams work on the recommendations that are consistent and actionable for the Assistant Secretary. The data infrastructure and supply chain recommendations would be approved at a subsequent meeting.

She asked the Committee for their thoughts on this approach.

Ms. Gustafson approved.

Dr. Kuehnert noted that the groups will be working off draft recommendations for the three areas as well as for the supply chain recommendations.

Ms. Fredrick noted that it would be good to improve the structure and focus of the recommendations.

Dr. Cap agreed that is the only workable way to do this. He proposed a sign-up sheet.

Ms. Fredrick asked the Advisory Committee if the supply chain recommendations require additional review.

Dr. Cap suggested sending then out for comment may be useful.

Ms. Fredrick proposed sending out draft material and ask our members to identify the topic to work on. The Working Group Chairs will lead those discussions. Please send comments and edits for the supply chain recommendations to Ms. Caglioti and Mr. Perez. The recommendations will be cleaned and another meeting will be set in the near future to review and approve.

No one objected to this approach.

Closing Remarks and Adjournment

Dr. Kuehnert thanked the Advisory Committee members for their attention and participation during the meeting. He also thanked Ms. Fredrick for her leadership. Ms. Fredrick also thanked the Working Group Chairs, as well as the Committee staff for all of their assistance for the meeting.

Mr. Berger thanked all of the members for their participation and input during the discussion. We will send out a doodle poll for availability to ensure a quorum is met for the follow-on meeting in September. The meeting was adjourned at 6:30 p.m. Eastern.

ACBTSA SGE Members in Attendance (in alphabetical order)

Chair Jacquelyn (Jackie) Fredrick, MT (ASCP) SBB, MBA, Hon: DB/DPH
Sally Caglioti, MS, MT (ASCP)
Andrew Cap, MD, PhD
Claudia Cohn, MD, PhD
Raymond Goodrich, PhD
Elisa Gordon, PhD MPH
Jed B. Gorlin, MD, MBA
Jim MacPherson, MS, MPH
Paul M. Ness, MD
David Perez
Ron Waeckerlin, MD

ACBTSA Rep Members

Vice Chair Matthew J. Kuehnert, MD, FACP, FIDSA
Susan Galel, MD
Mary Gustafson, MS, MT (ASCP) SBB
Bennie H. Jeng, MD
Gary Marklin, MD
Lynne Uhl, MD

ACBTSA ex-officio Members

Sridhar V. Basavaraju, MD, FACEP, CDR, USPHS
Scott A. Brubaker
Barbara Bryant, MD
Rebecca Free, MD, MPH, LCDR, USPHS
Marilyn E. Levi, MD
Nicole Verdun, MD

Absent

Biree Andemariam, MD
Diane H. Corning, RN, JD
J. Chris Hrouda, MT (ASCP)
Daryl Kor, MD, MSc

OIDP Staff

James Berger, MT(ASCP) SBB, MS, ACBTSA DFO
Debbie Seem, MPH, Alternate ACBTSA DFO
Lauren Overman, MPH
Allison Petkoff

53rd Meeting August 17-18, 2021 - Meeting Summary

Tuesday, August 17, 2021 (Day 1)

Welcome, Roll Call, & Call to Order

Purpose of the Meeting

Questions for the Committee

Review of 2020 Recommendations

Public Comment

Common Definition of Supply Chain

Lessons Learned from the COVID-19 Pandemic

Inside A Pandemic: An Academic Medical Center's Response

BCA's COVID-19 Experience

The Canadian Experience

Question & Answer/Discussion

Identification and Prioritization of Key Risk Drivers for the Dutch Blood Supply

Identification and Prioritization of Key Risk Drivers for the Dutch Blood Supply

Question & Answer/Discussion

Panelist Discussion Risk Management: Impact of the COVID-19 Pandemic

Committee Discussion and Recommendation Formulation

Committee Discussion Summary and Vote

Supply Chain to Produce Blood Products

Closing Remarks and Adjournment

ACBTSA SGE Members in Attendance (in alphabetical order)

Wednesday, August 18, 2021 (Day 2)

Roll Call, & Call to Order

Introduction and Outline the Goal

Revision of the EU Blood Legislation - Lessons from COVID

Blood Donors as a Sentinel Population - Preparing for the Next Pandemic

Question & Answer/Discussion

AABB Interorganizational Task Force: U.S. Perspective on Blood Supply and Inventory Data

National Data Warehouse for Blood

Question & Answer/Discussion

Recipient Hemovigilance: How to Enable and/or Encourage Hospitals to Provide Data

Hemovigilance in Massachusetts

Question & Answer/Discussion

Focus on Comparative Blood Utilization

Question & Answer/Discussion

Donor Data for Public Health

Question & Answer/Discussion

Committee Discussion and Recommendation Formulation

Draft - Recommendations for Data Infrastructure - Preamble

Committee Recommendation Summary and Vote

Closing Remarks and Adjournment

ACBTSA SGE Members in Attendance (in alphabetical order)

Panelist Discussion
Risk Management: Impact of the COVID-19 Pandemic