Fifty-Eighth ACBTSA Meeting January 11, 2024 - Meeting Summary

Executive Summary

The Advisory Committee on Blood and Tissue Safety and Availability (ACBTSA) convened its 58th meeting to address four agenda items: a presentation on the Biomedical Advanced Research and Development Authority (BARDA)’s Skin Allograft Procurement and Vendor Managed Inventory (VMI), a presentation on Skin Allograft VMI at Solvita, a presentation on Circulate, LLC, Collaborative Blood Intelligence, and discussion and voting on recommendations proposed by the ACBTSA. Seven recommendations were passed by the ACBTSA. Working groups will be convened to revise the language of three further recommendations.

Action Items

Claudia Cohn and Diane Wilson will assemble working groups to revise the language of Recommendations II, III, and VI, and will redistribute the edited versions to the ACBTSA for revision and vote.

Meeting Summary

Welcome and Opening Remarks

Sarah Boateng, MHA, Principal Deputy Assistant Secretary for Health, provided brief welcoming remarks and led the swearing in of three new members joining the ACBTSA. James Berger, MS, MT (ASCP), SBB, conducted roll call to confirm a quorum.

Claudia Cohn, MD, PhD, welcomed ACBTSA members to the public meeting and provided an overview of the agenda. She highlighted that a meeting had occurred in December 2023 between representatives of the Office of the Assistant Secretary for Health (OASH), Office of Infectious Disease and HIV/AIDS Policy (OIDP), the Office of Pandemic Preparedness and Response Policy (OPPR), and the White House to discuss issues pertaining to blood, tissues, and organs. She added that interest from the White House pertaining to blood surge capacity is encouraging and that the presentations and recommendations shared during the ACBTSA meeting may continue to elucidate issues on surge capacity and its management.

BARDA’s Skin Allograft Procurement and VMI

Franco Aveau Administration for Strategic Preparedness and Response (ASPR)

Franco Aveau stated that the Administration for Strategic Preparedness and Response (ASPR) serves as the federal health agency primarily responsible for helping communities prepare for, respond to, and recover from disasters and emergencies that affect U.S. health care systems. ASPR accomplishes this mission by developing stockpiling and distributing response tools, dispatching clinical response teams to crisis areas, and providing education and support to health care and public health organizations. Within ASPR, BARDA is responsible for procuring Medical Countermeasures (MCMs) that act as critical infrastructure in the case of a national emergency. Franco explained that this presentation would describe BARDA’s skin allograft procurement and vendor managed inventory.

Background

ASPR established BARDA to catalyze innovation, advance research, as well as develop, manufacture, and procure MCMs to protect people during public health emergencies. BARDA leverages public-private partnerships to accelerate the development of MCMs from early research through the Food and Drug Administration (FDA) licensure and clinical application while also working alongside the Public Health Emergency Medical Countermeasure Enterprise (PHEMCE) to coordinate government approaches to MCM preparedness and emergency response.

Within BARDA is the Chemical, Biological, Radiological, and Nuclear (CBRN) division. CBRN supports advanced research & development (AR&D) to assist innovators in developing MCMs and obtaining FDA approval. CBRN also leverages Project BioShield (PBS) to procure approved or approvable MCMs. The goal of CBRN is to develop the capabilities required to rapidly mitigate threats while investing in the sustainable development, production, and administration of MCMs.

BARDA uses PBS to support the U.S. government’s preparedness for national emergencies. BARDA uses PBS to obtain and maintain skin allografts, the gold standard for treating burns. Skin allografts are widely used nationally and internationally, are affordable and available, and may be used to care for a variety of populations. Having sufficient supplies of skin allografts is crucial when preparing for and responding to national emergencies. As such, BARDA is required to maintain sufficient skin allografts to treat at least 5,000 people with burns covering approximately 40 percent of their total body surface area (TBSA). 

Skin Allograft Supply Chain

Procurement and maintenance of a large supply of skin allografts requires understanding the supply chain and risks associated with tissue donation, recovery, processing, storage, and use. Through market research, BARDA has identified risks and vulnerabilities throughout the supply chain and determined how they may result in tissue shortages. These risks and vulnerabilities include: the lack qualifying skin donors; difficulties faced by Organ Procurement Organizations (OPOs) in acquiring tissues within an appropriate timeframe; noncommunication between OPOs and tissue banks resulting in delays or inability to access tissues; complications when transferring tissues (e.g., maintaining temperatures, time in transit); limited shelf life of tissues; and loss of materials when transplant surgeries require tissue modification.

These factors led BARDA to form partnerships with Community Tissue Services and AlloSource HQ to build a preparedness inventory that mitigates risks associated with relying on a single supplier within the existing supply chain. Additionally, BARDA identified three key principles for operation: (1) minimize market disruptions; (2) perform within the capacity and capability of partnering tissue banks; and (3) use a first-in, first-out product rotation to limit waste. In line with these principles, BARDA purchases the same skin allografts that are available to any burn center or medical facility; BARDA’s purchases are sustainable and in-line with the annual surplus of partnering tissue banks; and purchases from multiple tissue suppliers provide market diversity and build security in the supply chain.

Product Procurement

BARDA procures products using (1) traditional procurement methods in partnership with the Strategic National Stockpile (SNS) and (2) a separate VMI. Using both methods allows BARDA to overcome limitations associated with SNS. SNS can only be applied to products with limited to no commercial use; is expensive to maintain; requires mass shipment and coordination with state and local authorities; and is not scalable. Using VMI allows BARDA to (1) acquire products with commercial uses; (2) rely on the vendor for disbursal and product management; (3) rely on the vendor for the education and training of end-users; and (4) scale up or down to accommodate BARDA’s needs.

In practice, the vendors manufacture products that they maintain and rotate as needed as products near their expiration date. Normal operations continue until a mass casualty occurs, in which case ASPR sends a directive to the vendor to prepare products for deployment. In response, the vendor packages and ships products directly to burn centers via SNS, vendor-managed deliveries, or third-party shipments.

Conclusions

Skin allografts represent one of the most widely used MCMs and are a critical component of national preparedness. However, BARDA identified that the supply chain for skin allografts was variable and prone to fluctuations due to donor availability, relationships between OPOs and treatment centers, inventory management, and other vulnerabilities.

To overcome these challenges, BARDA has partnered with two tissue banks to maintain a robust inventory of skin allografts. The vendors use both SNS and VMI methods to maximize effectiveness in procuring and distributing tissues while minimizing variability in the donor and processing supply chains, cost, and product loss. This strategy allows BARDA to maintain a stockpile of essential skin allografts while continuing to support the development and research of next generation burn products.

Discussion

Scott Brubaker asked if BARDA has engaged in discussions of using amniotic membranes or similar tissues to treat burns. Franco Aveau noted that BARDA had explored alternative types of tissues and skin substitutes while performing market research and determined that availability, costs, and familiarity with the products were important aspects of developing resource stockpiles. BARDA determined that skin allografts were the most appropriate resource.

Suchitra Pandey noted that BARDA’s partnering OPOs will incrementally increase their surplus to meet BARDA’s stockpiling requirements. She asked about the projected timeline for the partnering OPOs to meet BARDA’s stockpiling requirements. Franco Aveau clarified that the contract among BARDA’s OPOs established an initial baseline quantity of skin allografts to be procured and maintained by their vendors. This quantity will increase incrementally to allow for OPOs to scale their surplus supplies for a final requirement of treating 5,000 people with skin allografts. Within a year of contract implementation, the partnering OPOs met three-fourths of the initial baseline requirement. OPOs will increase their surplus and slowly taper off procurement and processing, which should result in sustainable practices with minimal product waste.

Stacy Sime asked how BARDA chose their final requirement of treating 5,000 people with skin allografts. Franco Aveau clarified that the requirement was determined by identifying the number of severe and moderate burn victims likely to result from a nuclear detonation scenario. BARDA’s analyses indicated that 5,000 is an approximate number of people determined from their modeling analyses.

Skin Allograft Vendor Management Inventory at Solvita

Sharon Smith, MBA, Solvita VMI Contract Lead

Sharon Smith described Solvita’s skin allograft tissue banks, including how they can procure and maintain an adequate supply of high-quality allografts to meet local, national, and international needs. She explained that Solvita has been processing skin allografts since 1988 and was awarded a contract with BARDA in September 2022. The focus of her presentation was Solvita’s Vendor Management Inventory and how Solvita meets the quality and quantity standards of BARDA.

Solvita’s Mission and Vision

Solvita, formerly known as Community Blood Center and Community Tissue Services, has been processing skin allografts since 1988 and now provides skin allografts locally, domestically, and internationally. Solvita is a 501(c)(3) not-for profit organization and is the top not-for-profit supplier of skin for burn victims. Solvita has received financial support from BARDA.

The mission at Solvita is to empower people to save and enhance the lives of others. Solvita seeks to provide high quality biologics and utilize their expertise and resources to create innovative solutions that honor their donors and improve patients’ lives. Solvita’s skin allograft activities contribute to BARDA’s overall goal of managing a stockpile of skin allograft materials and supply allograft materials to burn centers across the United States and internationally.

Tissue Procurement and Processing

Skin allografts are considered the gold standard for treating burns because they are inexpensive, surgeons are trained in their use, and their successful use has been proven over time.

Solvita receives donor materials from five Solvita branch locations and 25 OPOs. Donors are screened for relevant communicable diseases per FDA guidelines; microbiological cultures are obtained during two stages of the recovery process; and donor serology tests are performed. Medical charts are reviewed by Solvita’s doctors, and their medical director determines whether the donor materials may be released for use. Donor materials must be processed within 96 hours of recovery, but the review process may take anywhere from three months to over a year to complete to ensure recipient safety.

Donor materials are processed as full thickness or split thickness skin allografts in Solvita’s Dayton facility and are stored and distributed from their facility in Kettering. Donor materials are recovered by teams of skin technicians and clinical sterile technicians who operate in clean rooms and ISO-certified biosafety cabinets. They produce grafts ranging in size from 25 cm2 to 1,800 cm2, non-meshed graphs, and both 1:1 and 2:1 meshed grafts. Solvita seeks to provide a wide variety of options and sizes to meet diverse patient needs. They distribute over 21 million cm2 annually.

Solvita notes several considerations when procuring akin allografts. Donor materials must be processed within 96 hours of recovery. Donors are unique, and factors such as body size, skin integrity, and body modifications can affect the recovery of donor materials. Skin allografts are released, on average, three months post processing. Grafts must be stored at -40 °C to maintain viability. Finally, the skin graft discard rate is high. Combined, these considerations result in a delicate balance between producing grafts, meeting market demand, and managing inventory to account for daily demands, potential large orders, and emergencies.

Vendor Management

Solvita was granted a 10-year contract with BARDA in September 2022 and provided their first allotment of skin allografts in January of 2023. Solvita strives to maintain the delicate balance between meeting commercial demands, planning for future events, and maintaining sufficient skin allografts for BARDA’s stockpile.

Producing and maintaining the quantity and quality of skin allografts required by BARDA is both costly and requires intensive care. To ensure high-quality products are supplied to BARDA, Solvita (1) stores skin allografts in secure and confidential locations across the U.S., (2) provides BARDA with monthly reports, (3) uses highly specific product labels to increase transparency and maintain inventory awareness, (4) follows security protocols to assist with product storage and management should a national emergency occur, and (5) continually manages and rotates products to minimize waste from expiration, loss, and mishandling. Solvita performs regular audits of security procedures and products at every location. Solvita hosts monthly project coordination meetings, bi-weekly meetings with BARDA personnel, and engages in ongoing reporting and general communication with BARDA. 

Should a national emergency occur, Solvita has a contractual obligation to distribute skin allografts. Solvita has emergency response experience and can coordinate with foreign and domestic governments to ensure that skin allografts are distributed according to local laws and regulations. To prepare for national emergencies, Solvita maintains the BARDA inventory separately from the commercial inventory and is prepared to ship the inventory rapidly; shipping supplies are maintained at all storage locations. Solvita maintains core and on-call employees on standby and has teams experienced with managing requests for immediate responses.

Discussion

Jed Gorlin, MD, MBA requested additional details on how Solvita uses simulations to test their ability to rapidly mobilize in the event of a national emergency. Sharon explained that Solvita has their own standard operating procedures. Franco Aveau added that Solvita’s contract with BARDA stipulates that future activities will include simulation exercises to determine how BARDA and their contracted OPOs will coordinate their systems to respond to emergencies.

Glenn Ramsey, MD was interested in identifying the quantity of blood that would be required to treat 5,000 patients in the event of an emergency. Previous publications that had analyzed data from the September 11, 2001, national emergency indicated that ten patients required 18 units of red blood cells each. Scaled up, these data indicate that treating 5,000 similar patients would require 90,000 units of blood, not including blood products. Glenn requested input from the ACBTSA panel to clarify this concern. Sharon indicated that this topic may be revisited at a later date.

Scott Brubaker provided additional context for the question he had posed during the discussion period following Franco Aveau’s presentation. While skin allografts are considered the gold standard for burn treatment, amniotic membranes from births may be more available than donated skin because births occur daily. Sharon indicated that amniotic membranes are more expensive to obtain and maintain than skin allografts and do not provide additional benefits to patients. Claudia Cohn added that using freeze-dried products, such as amnions, would reduce the need for freezers and dry-ice availability. However, skin donations may yield three to four ft2 of skin while amnions require additional processing.

Circulate, LLC, Collaborative Blood Intelligence

Martin Grable, Executive Vice President, Chief Financial and Administrative Officer of OneBlood, and John Mass, Vice President of Biomedical Business Systems at the American Red Cross

Martin Grable of OneBlood and John Mass of the American Red Cross (ARC) described their efforts toward developing the Circulate, LLC, Collaborative Blood Intelligence. Circulate represents a private sector effort to develop and disseminate real-time data regarding blood collections. Circulate monitors approximately 60 percent of the national blood supply.

Establishment and Vision

Circulate was established in December, 2022, as a collaborative partnership between the ARC, Gulf Coast Regional Blood Center, OneBlood, and Vitalant, which represent a combined 60 percent of the U.S. blood supply. This small and highly collaborative group allowed for the rapid development of Circulate and allows for later scalability as additional organizations are added. Circulate is a Section 501(c)(3) not-for-profit-organization and is governed by a board of managers. Its governance allows for later extension and expansion of the organization.

The guiding principle of Circulate is to determine how they can best contribute to data-related issues that continually resurfaced in ACBTSA working group discussions and in the 2020 ACBTSA Report to Congress. These discussions, and the Report to Congress, identified key issues regarding disparate data collection and the need for a national view of real-time data that can be used to monitor the national blood supply. Circulate noted that current forms of data monitoring are manual, decentralized, and overall imprecise. The absence of real-time data made data-driven decision-making difficult. Circulate seeks to combat these issues by providing data-driven insights to promote the national blood supply. The data and insights available through Circulate may be used to inform and support both regulatory and legislative initiatives.

Circulate’s Capabilities and Insights

Circulate tracks the number of available units of blood and blood products daily. The platform can report the number of units collected, products that have been made, quantities of products available, number of days of products available, and number of units that have been dispersed. These data can be further broken down by blood grouping (e.g., ABO), ISBT information, and additional attributes of the products.

Circulate established methods of harmonizing data elements, definitions, and calculations among their participating organizations. These harmonization efforts ensure accuracy of their analyses across centers and improve overall reporting and messaging. Furthermore, these harmonization efforts contribute toward establishing consistency in the collection, manufacturing, distribution, and reporting of blood and blood components. The data can be used to provide valuable insight into periods of transition as new legislature or guidance are enacted and to visualize (1) the impact on standards of care, (2) utilization or adoption rates of new guidance, and (3) the introduction of new products. Circulate cites the evolving standards surrounding guidance for bacterial risk during transfusions as an example of when real-time data monitoring would allow for tracking changes in response to new guidance.

Circulate’s systems automatically download data daily, minimizing the time required to collect and compile data. The Circulate platform can perform a variety of analyses on collected data. Circulate allows users to recursively load data sets to improve the functional foundation of the data. Previously collected longitudinal discrete data sets can be extended and re-queried, and past datasets can be incorporated into the platform to increase the availability of data needed to answer questions, model inventory trends, and model demand over time. Further, data available in Circulate may be related to external datasets and features of interest such as geography, patient demographics, important dates, and events. Early in the COVID-19 pandemic, Johns Hopkins used the platform to monitor inpatient hospitalizations associated with COVID-19, providing proof of concept. The platform currently monitors the number of units available in the blood supply but could be expanded to integrate the number of units used by hospitals.

Circulate Dashboard

The overarching goal of Circulate is to use real-time data to estimate the national supply of blood and blood products. To this end, Circulate developed an integrated reporting platform that allows for continuous data monitoring. Through this platform, Circulate provides a data dashboard capable of reporting rich datasets that can be easily manipulated by its users, resulting in uniquely tailored and powerful data displays. Circulate designed its dashboard with an open architecture to allow for expansion, which will involve adding data from additional blood suppliers. Dashboard users can view the data at the macro-level (e.g., the number of days of blood products available). Days on hand is calculated as the inverse of daily inventory turnover and can be used to estimate current blood supplies should supplies be limited. Circulate can provide estimates of blood and blood product availability over periods of days to years. These estimates are valuable resources for identifying consistent trends in supply and demand and can assist in developing long-term plans for fluctuations in the blood supply. John Mass showed an example of the Circulate dashboard highlighting the relationship between the average estimate of red blood cells as days on hand and weekly average estimates. Numerous fluctuations in product availability can be observed across a single week, emphasizing the value of collecting data in real-time. Real-time data collection allows Circulate to track the quantity of products available on any given day, which would be extremely useful in the event of an emergency.

Dashboard users can also view the data at more nuanced levels (e.g., the number of blood products available from a specific grouping) to gain a detailed understanding of the current blood supply landscape. This is beneficial when considering the unique characteristics of various blood products. Platelets have a significantly shorter shelf life than that of whole blood. This can impact product availability over time and would be critical in an emergency scenario. The data gathered by Circulate indicates that there are approximately 6,000 units of platelets available on any given morning and that while daily quantities may vary, platelet supplies are relatively consistent over a period of months. These data may be used to determine the demand for platelets over time. Similar metrics can be shown for other blood products that can be labeled with an ISBT code.

Discussion

CDR Sridhar Basavaraju, MD, FACEP asked if the Circulate system could include all the U.S. blood collection centers and if it could be expanded to include hospitals. Sridhar continued to ask if the Circulate system could replace the National Blood Collection and Utilization Survey (NBCUS) in terms of its overall representativeness and quality of data. John Mass indicated that Circulate’s mission is to complement rather than replace NBCUS. John described NCBUS as a powerful tool that (unlike Circulate) acquires data from hospitals. Cassandra Josephson, MD requested clarification on whether Circulate accounts for hospitals that provide transfusion services and may retain blood inventory rather than return all inventory to blood collection centers. John Mass explained that hospitals do not typically maintain days of inventory; rather, they may maintain smaller allotments. However, this may be an area where the estimation is impacted by drawdown of inventory and discarded inventory.

Building on Cassandra’s previous question, Stacy Sime, MS asked whether Circulate assumes that once product moves to the hospital, it is considered out of inventory and is not returned to the blood collection center. She asked if Circulate accounts for the consignment model. John Mass indicated that products returned to blood collection centers are captured. Units not returned are not captured by Circulate and are assumed to be used.

Discussion on Recommendations

Claudia Cohn led the Committee in a review and live revision of proposed recommendations that were made available on the ACBTSA website. Several recommendations were previously discussed during the 57th ACBTSA meeting, and comments received during the public comment period were incorporated as revisions.

Stockpile Recommendations

Recommendations 1 through 4 discuss the expansion of a stockpile of blood, plasma, and collection supplies.

Recommendation 1

Recommendation: The Committee therefore recommends that during national and regional emergencies, government resources are made available to assist blood collection centers with the transport of blood samples and other key supplies that may be needed in affected areas of the country. The Emergency Support Function (ESF) #8 planning document should specifically incorporate this provision into their planning function. This may be done with an annex to the ESF.

This recommendation received support from the Association for the Advancement of Blood & Biotherapies (AABB), America’s Blood Centers (ABC), and the ARC.

Claudia motioned to vote on Recommendation 1 as written. Susan Galel, MD seconded the motion. The recommendation was opened to a group vote in which it received support from a majority of ACBTSA members.

Recommendation 2

Recommendation 2: The Committee further recommends an analysis of all required blood supply functions with cross-reference to the ESF #8 planning document to ensure that all functions are appropriately covered with an annex to the ESF.

This recommendation received support from the AABB, ABC, and the ARC.

Diane Wilson motioned to vote on Recommendation 2 as written. Raymond Goodrich, PhD seconded the motion. The recommendation was opened to a group vote in which it received support from a majority of ACBTSA members.

Recommendation 3

Original Recommendation 3: The Committee therefore recommends that the Zika payment model be used during long-term emergencies to support the collection and manufacture of blood components to allow for a minimum 10 percent increase over baseline usage during emergencies when surge capacity is required.

Public comments received from the AABB, ABC, and the ARC encouraged expanding the model to ensure that blood establishments are not collecting at-risk blood and are receiving necessary financial support through cost recovery function, similar to the collection and distribution of COVID-19 convalescent plasma (CCP). Comments noted that BARDA under ASPR provided cost recovery funds for the collection of CCP through contracts with ABC and ARC in 2020 and 2021. Provision of cost recovery directly to blood centers allowed for blood centers to invest in the collection of CCP when it would have been otherwise prohibitively expensive.

Comments encouraged establishing funding for local public awareness on the need for blood donors, which was cited as an essential aspect of the CCP model. The availability of donors is perceived as the greatest threat to long-term surge capacity, and it is critical that this message be tailored to local communities. During the COVID-19 pandemic, funding for local awareness was distributed through an Other Transaction Authority (OTA) with ABC and resulted in a sustained 244 percent increase in collections compared to previous baselines.

Revised Draft Recommendation 3: The Committee therefore recommends that BARDA (under ASPR) negotiate contracts directly with blood centers during long-term emergencies to support the collection and manufacture of blood components to allow for a minimum 10 percent increase over baseline usage during emergencies when surge capacity is required. The cost recovery shall be for collection (rather than transfusion) of blood that is deemed essential during the emergency period.

Joshua Penrod, JD, PhD requested clarification on whether there is a definition or understood usage for “long-term emergencies” and how it is distinct from other forms of emergencies. Claudia indicated that there is not a common definition or usage for “long-term emergencies.” The recommendations are intended to be broad and would be implemented appropriately by government entities. Joshua indicated that the term may be too broadly applicable. Sridhar Basavaraju proposed shifting the language to “public health emergencies” rather than “long-term emergencies.” Lynne Uhl, MD indicated her support for including these clarifications within the recommendation.

Susan Galel clarified that the term “cost recovery” is typically used for investigational protocol and was applied to the CCP model. Susan requested to clarify the intent of “cost recovery” for the collection of blood that is deemed essential during the emergency period. She proposed revising the sentence to include collection and manufacturing.

Cassandra Josephson indicated that additional clarification of the term “surge capacity” and the governing body determining when “surge capacity” is applicable would be beneficial. She stated that the blood community should determine what “surge capacity” means and where it needs to occur as blood and blood products can be shipped across the United States. She added that “surge capacity” may occur locally rather than nationally and should provoke targeted responses to best manage the needs of communities.

Claudia proposed inserting language to clarify that this recommendation will go into effect if normal collections and redistributions of the available blood supply are insufficient, resulting in the need for a 10 percent increase in collections to meet the current demand.

Jed Gorlin described surges in blood donations following national emergencies such as the Las Vegas shooting event and the COVID-19 pandemic. He indicated that real-time efforts of groups such as BARDA and Circulate would allow for implementation of the recommendation when there is a true need for an increase in donor materials. He described the economic forces that impact daily inventory and may negatively impact overall activity during disasters. He emphasized the need for mechanisms to ensure surge capacity because blood centers are unlikely to maintain extra staff or resources on hand. Jed proposed implementing preparedness planning, providing economic incentives for blood centers to collect more whole red cells, and empowering both BARDA and negotiating organizations to ask for what they need to respond to emergencies.

Raymond Goodrich requested clarification regarding the 10 percent increase described within the recommendation, which he interpreted as an increase in blood availability that might be required during surge capacity. Raymond indicated that the recommendation should consider the increased costs that are associated with increasing collection capacity at blood centers and that these considerations should be reflected within the proposed reimbursement. Anne Eder, MD, PhD expressed support for the comments made by Raymond.

The group revised the recommendation to further define when the recommendation would be activated, acting parties that may be included when considering responses to surge capacity, and the requirements and management of reimbursement. The final recommendation is as follows:

The Committee therefore recommends that BARDA (under ASPR) prepare to respond to situations that require a rapid increase in blood collections that cannot be met with current available capacity. BARDA would negotiate with blood collection agencies and suppliers prior to or during public health emergencies. These contracts would go into effect based on a federally declared emergency, and reimbursement shall be for the collection, manufacture, and distribution (rather than transfusion) of blood that is deemed essential during the emergency period.

Claudia Cohn motioned to vote on Recommendation 3 as revised. Raymond Goodrich seconded the motion. The recommendation was opened to a group vote in which it received support from a majority of ACBTSA members.

Recommendation 4

Original Recommendation 4: The Committee therefore recommends that Secretary Becerra fund additional public awareness campaigns including funding for data analytics to increase the donor pool and determine effectiveness.

Through public comments, the AABB, ABC, and ARC commended HHS for their support of the blood community during the COVID-19 pandemic and their efforts in carrying out the congressional requirement of a public awareness campaign for blood.

These organizations indicated that future federal funding to increase public awareness for blood donation is best directed locally. Comments cited that funding for local awareness distributed directly to blood centers as part of an OTS between the U.S. government and ABC during the COVID-19 pandemic resulted in a 244 percent increase in collections.

Revised Draft Recommendation 4: The Committee therefore recommends that Secretary Becerra fund additional public awareness campaigns. These funds should be distributed to blood centers for local campaigns. Funding should also support data analytics to increase the donor pool and determine effectiveness.

Paul Ness, MD requested to remove the specific name of the Secretary of HHS, Secretary Becerra, from the recommendation.

Raymond Goodrich requested clarification on whether the Secretary of HHS has a mechanism by which to award blood centers locally or if a mechanism needs to be created to allow for the distribution of local funds. James Berger explained that the Giving Equals Living campaign provides an example of how funds may be disbursed locally.

Glenn Ramsey proposed using the term “blood collection agencies” to increase cohesion with Recommendation 3.

The final recommendation is as follows:

The Committee therefore recommends that the Secretary of HHS funds additional public awareness campaigns. These funds should be distributed to blood collection agencies for local campaigns. Funding should also support data analytics to increase the donor pool and determine effectiveness.

Claudia Cohn motioned to vote on Recommendation 4 as revised. Cassandra Josephson seconded the motion. The recommendation was opened to a group vote in which it received support from a majority of ACBTSA members.

Blood Supply Recommendations

Recommendations I through VI discuss safeguarding and developing additional materials to stabilize the blood supply and meet surge capacity needs.

Recommendation I

Original Recommendation I: The Committee recommends that an agency within HHS be charged with safeguarding the availability of blood. (1) This agency should work closely with the FDA so that regulatory measures developed for blood safety are balanced by the need to maintain blood availability. (2) The Committee also recommends that companies providing critical supplies for blood manufacturing and storage shall work with HHS funding agencies to develop and enact contingency plans to stabilize the blood supply chain.

Through public comments, AABB, ABC, and ARC requested that ACBTSA revise the recommendation as follows:

Revised Draft Recommendation I: The Committee recommends that the HHS Office of Infectious Disease and HIV/AIDS Policy (OIDP) create a publicly available action plan that (1) includes specific activities to safeguard the availability of blood and (2) indicates how the agency intends to implement coordination and collaboration with other federal entities, including the FDA.

Claudia Cohn motioned to vote on Recommendation I as revised. Cassandra Josephson seconded the motion. The recommendation was opened to a group vote in which it received support from a majority of ACBTSA members.

Recommendation II

Original Recommendation II: The Committee recommends that companies providing critical supplies for blood manufacturing and storage shall work with HHS funding agencies to develop and enact contingency plans to stabilize the blood supply chain.

Through public comments, AABB, ABC, and ARC suggested revising the language to explicitly identify the HHS funding agencies with which the companies should collaborate to provide a more precise and actionable directive for the entities involved.

Revised Draft Recommendation II: The Committee recommends that HHS should provide companies that produce critical supplies for blood manufacturing and storage with specific pathways to speak with funding agencies to develop and enact contingency plans to stabilize the blood supply chain.

Anne Eder requested clarification regarding how this recommendation is distinct from the specific regulatory pathways used by companies. Claudia Cohn clarified that this recommendation is intended to function as a contingency plan. Anne further clarified that the actions proposed within Recommendation II should not function as a contingency plan but rather should be incorporated into everyday preparedness activities. Raymond Goodrich supported Anne’s proposal of incorporating the activities in Recommendation II as preparedness measures. Lou Barnes, BSEd, MBA, CTBS and Jed Gorlin indicated that companies lack incentives to incorporate these measures into daily operations. Provision of financial incentives would result in greater uptake of these measures. Lou Barnes noted that BARDA’s purchasing of safety stock from the current manufacturers may assist in addressing surge capacity.

Lou Barnes and Jed Gorlin provided further commentary regarding the proposed timeline. They indicated that a two-stage approach consisting of short-term interventions via BARDA and longer-term interventions addressing payer models would result in a more robust system.

Susan Galel stated that this recommendation is insufficient to resolve stockpiling issues. She elaborated that the recommendation is likely too broad and that the overall goal needs to be defined. Susan proposed further discussion of the issue as a working group and Raymond Goodrich agreed.

The Committee tabled editing and finalizing the language of Recommendation II. Members agreed that a separate working group would be convened at a later date to further refine Recommendation II.

Recommendation III

Original Recommendation III: The Committee recommends that OASH or other HHS funding organizations receive an enabling budget to be used for projects that stabilize the blood supply such as stockpile of key supplies and components.

Through public comments, AABB, ABC, and ARC requested that the ACBTSA also recommend that “the Assistant Secretary for Health recommend that ​ASPR (1) elucidate its role in stabilizing the blood supply chain and (2) revise its policies pertaining to MCMs to ensure the availability of essential items, including but not limited ​to, blood bags, saline, reagents, pipettes and other critical components necessary for maintaining a ​secure and adequate blood supply.

Revised Draft Recommendation III:​ The Committee recommends that OASH or other HHS funding organization receive an enabling ​budget to be used for projects that stabilize the blood supply such as stockpile of key supplies ​and components.  ​

1. ​The committee also recommends that the Assistant Secretary for Health recommend that ASPR ​elucidate its role in stabilizing the blood supply chain.​
2. The Assistant Secretary for Health revise its policies pertaining to Medical Countermeasures ​(MCMs) to ensure the availability of essential items, including but not limited to, blood bags, ​saline, reagents, pipettes and other critical components necessary for maintaining a secure and ​adequate blood supply.

Anne Eder proposed removing the example of a stockpile. Anne Eder, Stacy Sime, and Claudia Cohn discussed issues surrounding stockpiling, including the challenges of storing supplies due to space limitations and maintenance requirements as well as issues pertaining to reimbursements and payer models.

The Committee tabled editing and finalizing the language of Recommendation III. Members agreed that a separate working group would be convened at a later date to further refine Recommendation III.

Recommendation IV

Recommendation IV: The Committee recommends that an HHS funding organization offer grant or contract funding that enables the development of novel means for extending the outdate of perishable materials in the stockpile.

Public comments received from AABB, ABC, and ARC requested that ACBTSA revise the recommendation to request that HHS (1) ​identify the specific HHS funding organization entrusted with overseeing and implementing this ​endeavor, and (2) specify which agencies within HHS are responsible for advancing strategies to extend ​the shelf life of perishable materials. 

Revised Draft Recommendation IV:​ The Committee recommends that an HHS funding organization offer grant or contract funding that ​enables the development of novel means for extending the outdate of perishable materials in the ​stockpile. ​

1. The Assistant Secretary for Health should identify the specific HHS funding organization entrusted with overseeing and implementing this endeavor.​

2. The Assistant Secretary for Health should specify which agencies within HHS are responsible for ​advancing strategies to extend the shelf life of perishable materials. 

Anne Eder indicated that stability and shelf life can impact the safety and effectiveness of the materials used to test and collect blood. Therefore, she suggested that the recommendation should not raise issues that could compromise safety and effectiveness. Claudia Cohn clarified that this recommendation is intended to spur the development of research that could gain FDA approval. Raymond Goodrich agreed with Anne’s statement and indicated that the overall goal of Recommendation IV may be unclear.

Anne Eder and Raymond Goodrich commented that point (2) should be removed from Recommendation IV.

Lou Barnes stated that the requested funding may be better applied towards validation studies from current manufacturers rather than the development of novel materials.

Stacy Sime and Anne Eder indicated that the recommendation should be revised to describe perishable materials used to manufacture blood or blood components.

The final recommendation is as follows:

The Committee recommends that an HHS funding organization offer grant or contract funding that enables validation of existing products for extending the outdate of perishable materials used to manufacture blood or blood components.

1. The Assistant Secretary for Health should identify the specific HHS funding organization entrusted with overseeing and implementing this endeavor.

Diane Wilson motioned to vote on Recommendation IV as revised. Stacy Sime seconded the motion. The recommendation was opened to a group vote in which it received support from a majority of ACBTSA members.

Recommendation V

Recommendation V: The Committee recommends that the ACBTSA convene a working group dedicated​ to developing a risk-gap analysis with associated business costs for the mitigations and contingencies​ associated with these temporary regulatory measures. ​

1. The FDA should be engaged in this analysis to assess the risks. ​
2. This work should be completed by the end of calendar year 2024. 

Public comments received from AABB, ABC, and ARC recommended revising this recommendation to read, “The Committee recommends that HHS, ​including the FDA, work to convene a multiorganizational working group, including government agencies and national experts from leading blood associations and organizations, to identify potential opportunities to pre-establish ​additional regulatory flexibility that could be granted in case of short- or long-term surge capacity needs to extend the U.S. blood supply without impacting the safety, purity, or potency of blood donation. This analysis shall include an ​assessment of risks and burden associated with the different temporary options.” ​

Furthermore, AABB, ABC, and ARC requested that the ACBTSA clearly delineate the actionable goals and anticipated outcomes ​of this analysis to facilitate a targeted and productive assessment. 

Revised Draft Recommendation V Preamble:

Whereas,  ​

1. An emergency may place a short-term strain upon the blood supply that affects patient care​
2. Regulatory changes for blood component manufacturing could alleviate this short-term strain by temporary ​measures, such as: ​

1. Considering extension of storage duration ​
2. Considering triage of some lower risk infectious disease markers, such as syphilis ​
3. Decreasing bag volumes to allow for the manufacture of a greater number of blood components that are ​made with a limited supply of raw materials​
4. Triaging donor screening  ​
5. Considering other blood container types in the case of an extreme emergency​
6. Considering alternative plastics that could be used for blood bags for emergency situations​

1. The Committee therefore recommends that the ACBTSA convene a working group dedicated to developing a ​risk-gap analysis with associated business costs for the mitigations and contingencies associated with these temporary regulatory measures. ​

1. The FDA should be engaged in this analysis to assess the risks.​
2. This work should be completed by the end of calendar year 2024.

Revised Draft Recommendation V: The Committee recommends that HHS, including the FDA, work to convene a multiorganizational ​working group, including government agencies and national experts from leading blood associations ​and organizations, to identify potential opportunities to pre-establish additional regulatory flexibility ​that could be granted in case of short- or long-term surge capacity needs to extend the U.S. blood ​supply without impacting the safety, purity, or potency of blood donation. This analysis shall include ​an assessment of risks and burden associated with the different temporary options.

1. The actionable goals of this working group would be a list of suggested short-term changes to regulations that would be implemented only during emergencies when the necessary surge capacity could not be achieved in a timely manner without the implementation of some or all of these changes.

Jed Gorlin commented that the Minnesota Department of Health took actions at both the hospital and blood collection agency level. Their activities may provide a template for activities discussed in Recommendation V. Several ACBTSA members reviewed the document and agreed that it may provide a template for activities discussed in Recommendation V.

Susan Galel suggested adding suppliers or industry partners to the recommendation to provide additional avenues of support.

Paul Ness and Anne Eder indicated that the first paragraph of the recommendation is unclear and requires revision. Anne elaborated that blood centers can request alternative procedures provided they are supported by data. She added that she agrees with Paul that if something does not affect the safety, purity, or potency of donated blood, it would not be affected by FDA regulations. Ann indicated that this recommendation may not be required and the field should continue to engage in discussions regarding regulations. Anne continued to say that the group should define the circumstances in which regulatory flexibility is insufficient and determine how blood can be provided when none is available. Claudia indicated that the situation surrounding surge capacity can be considered catastrophic and regulatory flexibilities have been insufficient for obtaining and providing sufficient blood.

Glenn Ramsey stated that the FDA occasionally requests input on areas of concern. He suggested that the FDA could identify issues that they would be interested in hearing more about. This may stimulate additional discussions among interested parties. Anne Eder affirmed that the FDA occasionally requests information and may engage further with that mechanism.

ACBTSA members revised Recommendation V to reflect that the working group would balance the risks and benefits and suggest enacting the recommendation only when a crisis is ongoing and retract it immediately upon stabilization.

The final Recommendation V is as follows:

The Committee recommends that HHS, including the FDA, convene a multiorganizational ​working group, including suppliers, government agencies and national experts from leading blood associations ​and organizations, to identify potential opportunities to pre-establish additional regulatory flexibility ​that could be granted in case of short- or long-term surge capacity needs to extend the U.S. blood ​supply. This analysis shall include ​an assessment of risks and burden associated with the different temporary options.

1. The actionable goals of this working group would be a list of suggested short-term changes to regulations that would be implemented only during emergencies when the necessary surge capacity could not be achieved in a timely manner without the implementation of some or all of these changes.

Lynne Uhl motioned to vote on Recommendation IV as revised. Glenn Ramsey seconded the motion. The recommendation was opened to a group vote in which it received support from a majority of ACBTSA members.

Recommendation VI

Recommendation VI: The Committee recommends that a Memorandum of Understanding (MOU) be ​negotiated with Canada to allow their blood and blood products into the U.S. and utilization of their ​testing laboratories to relieve transient strains in the blood supply brought about by emergencies. ​​

1. The MOU would be bi-directional. ​
2. The FDA would participate in this work to assure the safety of the incoming blood from Canada ​or other countries. 

This recommendation received support from the AABB, ABC, and the ARC.

Sridhar Basavaraju noted that Canada has one-tenth of the population of the United States and the quantities of blood and blood products that Canada may supply might not be sufficient should the U.S. experience surge capacity.

Susan Galel underscored that Canada uses different testing procedures and products than the United States. She indicated that Canada does not require testing for diseases that the U.S. requires and noted that Canada does not require testing for Babesia. She continued to say that Canadian products may not be approved by the FDA. Claudia Cohn noted that Canada accepts blood and blood products from the U.S.

Stacy Sime commented that a working group may be able to evaluate the differences in blood collection and processing between Canada and the United States to develop guidance for using products obtained from Canada. She indicated that receiving support from Canada may serve as a stopgap and provide time for U.S. blood centers to increase their collection efforts.

Anne Eder agreed with the points raised by Sridhar, Susan, and Stacy and questions the practicality of the recommendation as written.

Glenn Ramsey described an event when the United States received substantial supplies of FDA-approved blood and blood products from Germany. Raymond Goodrich indicated seeing similar blood collections for U.S. import occurring in the Netherlands. Anne Eder clarified that importing blood and blood products via an FDA license requires blood collection centers to use FDA-approved products and testing procedures. Cassandra Johnson asked if tissues are imported into the U.S. for transplantation into American citizens. Diane Wilson indicated that Solvita does not typically import tissues; however, there may be cases of individual tissue banks receiving imported tissues.

Anne Eder stated that the United States provides 80 percent of global source plasma that is manufactured into plasma derivatives. International organizations and governments have developed procedures for accepting U.S. blood and blood products. She added that this recommendation may require additional effort from working groups to identify differences in blood collection and processing between the U.S. and Canada. An MOU does not adequately reflect the efforts that would be required to import blood and blood products from Canada.

The Committee tabled editing and finalizing the language of Recommendation VI. Members agreed that a separate working group would be convened at a later date to further refine Recommendation VI.

Recommendations 1, 2, 3, 4, I, IV, and V received sufficient support from ACBTSA members. Because members identified the need for further discussion and review of Recommendations II, III, and VI, the Committee decided to table editing and finalizing the language of recommendations III and VI. Claudia Cohn will develop two working groups to discuss how to address reimbursement issues to support the function of the blood industry and to determine the measures that can be taken during extreme circumstances to increase blood availability. The language of Recommendations III and VI will be revised in a way that addresses the concerns expressed during the discussion.

Future Work

Claudia Cohn and Diane Wilson described the future of ACBTSA activities. Claudia stated that two working groups will be convened. The first working group will address issues of reimbursement and the second will address measures that should be taken during extreme circumstances to support blood availability across the United States. These working groups should be collaborative efforts among health economists, industry representatives, and blood center representatives.

Claudia indicated that the ACBTSA had previously recommended supporting the development of a national alloantibody exchange. Work is ongoing to develop and implement a pilot exchange, including the establishment of common data elements. She indicated that the working group is developing a universal method of describing genotypes and phenotypes to increase understanding among blood centers and hospitals.

Diane Wilson described activities relating to tissue tracking working groups. Two cases of tuberculosis transmission resulting from tissue transplantation were observed in 2021 and 2023. Both cases were observed following the transplantation of live cells. The ACBTSA has responded by adjusting the criteria for donor selection and by convening working groups to discuss tissue tracking and traceability of individual grafts and donors as materials transition between surgical centers and hospitals, and are exported internationally.

Wrap-up and Adjournment

Claudia Cohn thanked ACBTSA committee members for their efforts and willingness to donate their time and expertise to improve the blood industry. She thanked members of HHS, OIDP, and RLA for their support during the ACBTSA meeting. James Berger officially adjourned the meeting at 3:54 PM ET.

List of Participants

Voting Members

Claudia Cohn (Co-Chair), University of Minnesota
Diane Wilson (Co-Chair), Community Blood Center Community Tissue Services (CBC/CTS)
Louis E. Barnes, American Association of Tissue Banks (AATB)
Susan Galel, Roche Diagnostics
Ray Goodrich, Colorado State University
Elisa Gordon, Vanderbilt University
Jed Gorlin, Innovative Blood Resources & University of Minnesota
Bennie Jeng, University of Pennsylvania
Cassandra D. Josephson, Johns Hopkins All Children’s Hospital
Michelle Kameka, Florida International University                                           
Paul Ness, Johns Hopkins University
Suchrita Pandey, Stanford University
Joshua Penrod, Plasma Protein Therapeutic Association (PPTA) 
Glenn Ramsey, Northwestern Medicine
Eric Santiago-Justiniano, Fresenius Kabi
Stacy Sime, LifeServe Blood Center
Lynne Uhl, Beth Israel Deaconess Medical Center and Harvard University

Ex-officio Members

Sridhar Basavaraju, Centers for Disease Control (CDC)
Scott Brubaker, Food and Drug Administration (FDA)
Marilyn Levi, Health Resources and Services Administration (HRSA)
David Stroncek, National Institutes of Health (NIH)
Anne Eder, Food and Drug Administration (FDA)

Presenters

Franco Aveau, Administration for Strategic Preparedness and Response (ASPR) 
Martin Grable, OneBlood
John Mass, American Red Cross (ARC)
Sharon Smith, Solvita VMI Contract Lead 

Additional Attendees

James Berger, Health and Human Services Office of the Assistant Secretary for Health (HHS OASH) Designated Federal Officer (DFO) for ACBTSA
Lauren Overman, Health and Human Services Office of the Assistant Secretary for Health (HHS OASH), Alternate Designated Federal Officer (DFO) for ACBTSA
Sara Parker, Health and Human Services Office of the Assistant Secretary for Health (HHS OASH)
Allison Petkoff, Health and Human Services Office of the Assistant Secretary for Health (HHS OASH)

Cecelia Garcia, (Science Writer), RLA
Cat Thomson, (Science Writer), RLA
Mike Kavounis (Meeting Host), RLA
Sandy Max, (Meeting Coordinator), RLA
Meghan Walsh (Project Manager), RLA