Fifty-Seventh ACBTSA Meeting: July 6-7, 2023

Federal Register Notice

Written Public Comments

Meeting Summary - Day 1

Meeting Summary - Day 2

Agenda

July 6, 2023

July 7, 2023

View the Meeting Recording

• Day 1 Part 1
• Day 1 Part 2
• Day 1 Part 3
• Day 2 Part 1
• Day 2 Part 2 

Recommendations Considered

Whereas,

1. Blood transfusions are an essential and irreplaceable lifesaving therapy.
2. The COVID-19 pandemic revealed or highlighted important weaknesses in the blood supply chain that must be addressed to ensure a safe and sufficient blood supply.
3. Surge capacity must be assured to meet transient, higher demand during emergencies
4. A stockpile of essential manufacturing and collection supplies must be maintained to safeguard the continued production of blood components during national and regional emergencies
5. While the CCP reimbursement model (payment for blood collection) provided assistance during the COVID-19 pandemic, the contemporary model for reimbursement of transfused components [payment for transfusion from the end-user (i.e., hospital)] has created financial instability for blood collection establishments, which will translate into blood shortages that could become catastrophic if not corrected.

Whereas,

1. Blood collection and manufacturing is a complex process with multiple time-dependent steps. The COVID-19 pandemic highlighted weaknesses within this process which must be addressed to ensure a steady production of blood components during crises.
2. Each blood sample must be tested for infectious disease markers to assure blood safety.
3. Air and other rapidly deployed networks must be available to transport these samples to testing laboratories.
4. The Committee therefore recommends that OASH actively provide blood collection centers priority status during national and regional emergencies so that government resources assist the transport of blood samples and other key supplies that may be needed in affected areas of the country.
   1. The Emergency Support Function (ESF) #8 planning document should specifically incorporate this provision into their planning function.
5. 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.

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

III. 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.

Whereas,

1. The 2020 Report to Congress notes that the current payment model for blood components led to dramatic loss of revenues, operating margins, and capital required to maintain and replace the current infrastructure. This in turn limits blood collection centers’ efforts to plan for emergencies where surge capacity is required.
2. The payment model used during the COVID-19 pandemic in which the Biomedical Advanced Research and Development Authority (BARDA) under the Administration for Strategic Preparedness and Response (ASPR) provided funds for collection of CCP was highly successful (see below for broader relevance). BARDA also established the contracts with the American Red Cross and Blood Centers of America (BCA) to collect and supply blood components to Puerto Rico during the Zika virus pandemic.

IV. The Committee therefore recommends that the CCP payment model be used during 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. To effectively operationalize this measure:

1. A working group would develop a strategy and business case for surge capacity.
   1. A stepwise plan for the business case would consider incremental surges from 5 - 25 percent, with a strategy and business case made for each surge level.
2. Pre-negotiated contract drafts would be developed and available for the rapid collection and deployment of blood components.

Whereas,

1. Experience indicates a stockpile of key manufacturing supplies must be compiled and maintained so that a two-month supply is available for regional and national emergencies.
2. The raw materials needed for blood component collection and manufacturing are not currently included in the Strategic National Stockpile.
3. BCA presented a report to ASPR that noted the lack of resiliency in the blood supply chain and indicated that a blood-related stockpile was not in the scope of ASPR’s focus.
   1. The BCA report to ASPR recommended that the private sector prepare an actionable plan to establish a national (with regional warehousing) blood center-specific stockpile.
4. Supplies that outdate must be circulated and replaced in a timely manner to avoid wastage.
5. The outdate of some supplies may be extended, but research is necessary to explore and validate processes that extend the outdate.

V. The Committee therefore recommends that a list of key materials, developed by BCA as part of an ASPR grant, be used to create regional stockpiles that are maintained by third party vendors.

1. The establishment of the stockpile would take into consideration the ongoing activities of BCA’s 3PL plan that will allow for consolidation of resources, which will be an important step toward the establishment of stockpiles.

VI. The Committee also 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.

VII. The Committee also 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.

VIII. The Committee further 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. Funding from OASH or other HHS funding organization would be used as start-up funding for the establishment of a stockpile.

Whereas,

1. The blood supply is vulnerable due to weaknesses with the blood manufacturing supply chain.
2. Over 90% of blood storage bags used in the U.S. are produced by a single company, while only two other companies provide the remainder (<10%).
   1. This near monopoly has created a highly vulnerable supply chain for blood components.
3. Manufacturing at a Fresenius-Kabi factory located in Puerto Rico was significantly limited by disruptions incurred from Hurricanes Maria, Irma and Fiona, and has not yet recovered to full manufacturing capacity.
4. Blood collection centers with single-source contracts with Fresenius-Kabi cannot obtain sufficient blood storage bags to meet current customer demand.
   1. However, under the FDA’s import license, they are manufacturing about 2 million bags annually out of the Fresenius-Kabi Czech Republic manufacturing site as an interim step while that plant has plans for US FDA approval.

IX. The Committee therefore recommends that OASH work with the FDA to build flexibilities to enable fast-track processes that will allow for the rapid availability of blood storage bags from alternate supply sites as a preparedness measure in the event of future public health emergencies. 

X. The Committee further 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.

Whereas,

1. Blood is an essential therapy that is treated as a commodity.
2. The costs of collecting, testing, and processing blood have continued to rise due to the increased number of mandated infectious disease tests and other associated costs. However, the increased cost for provisions has not been paralleled by appropriate increased reimbursement and has been significantly lower than expected, if adjusted by Consumer Price Index for Medical Care and Consumer Price Index Inflation.
3. Large hospital networks have used their bargaining power to drive down the price of blood. As blood centers gain or lose hospital contracts, their need for donors may also change.  These shifts in donor demand often lead to higher cost and confusion, among other implications.
4. The current model for reimbursement of blood products is based on transfusion and is not viable.
5. There is currently no consideration to build the cost of maintaining a reasonable amount of surge capacity into the model

XI. The Committee therefore recommends OASH contract a qualified organization to develop a risk-capability analysis with business case development informed by actuarial science. 

1. This agency would be administered by ASPR and OASH.
2. Representatives from blood centers, hospital transfusion services, blood system supply chain agents, and health economists would provide input.

Whereas,

1. The Giving=Living campaign was successful to both the blood and plasma community.
2. However, over the past 10 years, there has been a 47% decline in donors 30 and under. 
   1. This trend was further exacerbated by COVID during 2020/2021 when access to universities and schools was extremely limited.
3. Donor analytics shows that unless we make a concerted effort across the industry to recruit younger donors over the next 5 years, the sustainability of the blood supply is at risk. 
4. The increasing demand for antigen-negative blood will require greater diversity of the donor base.
5. These data are available from Blood Centers of America (BCA), which has invested extensively in an analytics program that provides extensive data for tracking trends and modeling future

XII. The Committee therefore recommends that this campaign be continued and expanded to encourage blood and plasma donations. 

XIII. The Committee further recommends that investments be made in data analytics to continue to have donor numbers across the industry that allows for further advocacy and tracking of marketing/collection-recruitment campaigns associated with recruitment of donors.  BCA has invested extensively in our analytics program.