ACBTSA Recommendations

The Advisory Committee will vote on the following recommendations during their next full committee meeting.  The meeting date has not yet been determined.  The public is welcome to comment on this draft language prior to the meeting.  Please send any comments to ACBTSA@hhs.gov, and include in the subject line ‘ACBTSA Public Comment.’

Since 2000, there have been significant changes in the requirements for blood components. The cost of provision has increased without a corresponding increase in reimbursement, which was significantly lower than expected if adjusted for inflation and considering the Consumer Price Index for Medical Care. Safety and quality measures mandated by the U.S. Food and Drug Administration (FDA) did not accompany reciprocal increases in the acquisition costs for blood users; in contrast, the costs of blood components have remained virtually unchanged since 2010. The current model, which is primarily based on the reimbursement for transfused components to the final user (such as hospitals and clinics), creates an incentive to negotiate the lowest price on delivery. This in turn shifts the costs of blood component safety and quality to blood centers with diminishing margins and the lack of investment in necessary improvements in infrastructure and research and development. The current financial status of blood centers is marginal to extremely poor.

In 2020, the Advisory Committee on Blood and Tissue Safety and Availability (ACBTSA) in conjunction with the Office of the Assistant Secretary for Health (OASH), issued a Report to Congress that warned the U.S. blood supply is reaching a point of instability. The free-market approach to blood collection, which has worked well in the past, has become strained due to several factors. Since the 1980s, the overall trend in costs for collecting, testing, and processing blood has continued to rise due to the increased number of mandated infectious disease tests, the need for more complex and integrated information systems, increased supply chain costs, wages, and other associated costs.  On the hospital side, the consolidation of medical systems has created a smaller number of larger hospital enterprises that have greater bargaining power. These large hospital networks take advantage of the competition between blood centers to drive down the price of blood, although the nationwide price of blood components has remained largely stable. As the cost to collect and process blood rises, and the price hospitals pay for blood continues to fall, the commoditization of blood components has resulted in financial uncertainty and economic instability. In fact, approximately 50 percent of U.S. blood centers reported dangerously narrow or negative margins, which threatens their ability to continue operations or to build and maintain surge capacity.

Lessons learned from the blood system’s response to issues arising during the COVID-19 pandemic add to our knowledge base. Specifically, transient blood shortages occurred but, more importantly, supply chain issues presented unexpected and extremely daunting challenges. Financial support for collecting and distributing COVID Convalescent Plasma (CCP) proved essential for sustaining the system.

These events present experienced-based data, demonstrating substantial threats to the U.S. health care system, in the event of a public health emergency requiring increased demands for life saving blood and blood component transfusions. The significance of an adequate and readily available blood supply cannot be overstated. Similarly, the unacceptable consequences of blood shortages should never be accepted.

Specific recommendations of the Committee follow.

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. 

Recommendation 1: 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.

Note: ESF #8 provides planning and coordination of federal public health, health care delivery and emergency response systems to minimize and/or prevent health emergencies from occurring, provide medical care and human services to those affected, and enhance community resiliency to respond to disasters.

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. 

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. An alternate payment model was used to provide blood to Puerto Rico during the Zika virus pandemic, when the Biomedical Advanced Research and Development Authority (BARDA) under the Administration for Strategic Preparedness and Response (ASPR) provided funds to collect and supply necessary blood components. This payment model was highly successful.
3. This model provided blood for long-term emergencies, but additional planning is needed to provide sufficient blood during short-term emergency surges.

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. 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. The working group would consider the measures necessary to fund the ability for a rapid, immediate response to surge requirements
2. The working group would recommend additional measures that would allow for smoother operations during emergency surges, such as pre-negotiated contract drafts that would be available for the rapid collection and deployment of blood components.
   1. These contract drafts would be between ASPR/BARDA and blood collection centers.

Whereas,

1. Blood donations increase following public awareness campaigns according to anecdotal and preliminary data analyses.
   1. The Giving=Living campaign was successful to both the blood and plasma community.
2. 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. Data analytics programs are needed for tracking trends and modeling future requirements.

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.

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 major blood suppliers [American Red Cross, Vitalant, and Blood Centers of America (BCA, representing smaller blood centers)] have agreements with vendors to maintain a two- to three-month supply of blood bags and other items required for the collection and manufacture of blood components.
3. Due to supply chain vulnerability, maintenance of a two- to three-month supply is not currently possible.
   1. Over 90% of blood storage bags used in the U.S. are produced by a single company (Fresenius-Kabi), while only two other companies provide the remainder (<10%).
   2. This near monopoly has created a highly vulnerable supply chain for blood components.
4. Manufacturing at a Fresenius-Kabi factory located in Maricao, Puerto Rico was significantly limited by disruptions incurred from Hurricanes Maria, Irma and Fiona, and has not yet recovered to full manufacturing capacity.
5. Fresenius-Kabi received a Warning Letter (September 14, 2023) from FDA concerning the Maricao facility’s significant deviations from current good manufacturing practice, which further highlights the vulnerability of the blood supply chain.
6. Blood collection centers with single-source contracts with Fresenius-Kabi cannot obtain sufficient blood storage bags to meet current customer demand.
7. Under the FDA’s import license, a Fresenius-Kabi site in the Czech Republic (Horatev) is manufacturing approximately 2 million bags annually as an interim step.
8. Additional blood bag manufacturers are needed in the US to strengthen the supply chain and maintain robust competition in the marketplace. 
9. The FDA is charged with the safety of the blood supply, but no US agency is charged with monitoring and safeguarding the availability of blood

1. The Committee recommends that an agency within HHS be charged with safeguarding the availability of blood
   1. This agency should work closely with FDA so that regulatory measures developed for blood safety are balanced by the need to maintain blood availability.
2. 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.

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. A blood-related stockpile is not in the scope of ASPR’s focus.
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.
6. Personal protective equipment (PPE) such as gloves, masks, etc.  are necessary for blood collection and transfusion, but may not be included in the two- to three-month supply of key items for blood collection and manufacture
7. Most PPE have extended outdate and are needed by all blood centers

3. 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.
4. 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.

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

5. 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.
6. 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.