The U.S. Department of Health and Human Services’ Advisory Committee on Blood Safety and Availability held an open public meeting Aug. 22-23 to discuss the elasticity of the blood supply and strategies and barriers to ensuring transfusion and transplantation safety during blood shortages.
Committee Recommendation
ACBSA concluded that it is unclear whether the blood supply is sufficiently elastic to address potential disasters, including possible radiological-nuclear attacks. While there are extensive blood center data, it is not comprehensively aggregated nor available to HHS. In addition, according to the committee, hospital blood supply data are limited. Among the resolutions the committee passed was a recommendation that HHS work with the blood community to define shortage scenarios that would require implementation of alternative strategies for blood collection, distribution and use.
Stakeholder Presentations
The committee heard a variety of presentations from stakeholders within the blood community on addressing blood shortages, supply status within the United States and disaster planning efforts. Theresa Wiegmann, JD, director of public policy at AABB, presented on behalf of the AABB Interorganizational Task Force on Domestic Disasters and Acts of Terrorism. Wiegmann explained that although there are periodic shortages in the blood supply, they are typically local, seasonal and corrected within a few days. In addition, in recent years blood centers and hospitals have become more efficient in blood management as evidenced by reduced outdates and unmet needs at hospitals. Shortages, however, do occur, and during these shortages as well as during disasters, the national blood organizations, including AABB’s National Blood Exchange, help move blood from region to region as necessary. During disasters, the few problems the task force has experienced in transporting blood to the affected areas have related to difficulties in obtaining needed fuel, communication and transportation assistance from states. The task force has been working with HHS to encourage blood centers and state governments to strengthen their relationships and establish plans for obtaining logistical support during the time of a disaster.
Because the community maintains an adequate blood supply, facilitating transport when necessary, the task force does not believe a national blood reserve, either real or virtual, is necessary at this time.
Wiegmann also discussed the availability of U.S. blood inventory data. Currently, America’s Blood Centers, American Red Cross and Blood Centers of America collect daily supply data. Recognizing the need to share this information with the public and the government, the blood organizations are working through the AABB task force to develop a mechanism to provide HHS with uniform, joint data, including days of supply of red blood cells as well as O positives and O negatives. Since current supply data already are being collected and sharing mechanisms are being developed, the blood community told ACBSA that it does not believe there is a need for the government to independently collect this information from blood centers. However, AABB, other presenters and the committee all noted that more data regarding hospital inventories are needed.
When discussing disaster planning, Ruth Sylvester, director of regulatory services at ABC, noted that in previous disasters within the U.S. only 200 to 300 units of RBCs have been used. On any given day within the U.S., there are approximately 40,000 units of blood collected and 200,000 units of RBCs on hospital shelves. Additionally, blood centers can increase processing by at least three-fold for a limited period of time, as seen during responses to the Sept. 11, 2001, terrorist attacks. Therefore, Sylvester stated that with logistical support from the federal and state governments the blood community is prepared to respond to any emergency or disaster.
In reviewing the effects of an influenza pandemic, Sylvester noted one of the greatest issues the blood community faces is a lack of supplies; therefore, ABC recommended that collection bags and materials be added to the Strategic National Stockpile. Blood centers would be urged to stock blood components in weeks preceding the pandemic, which would provide enough blood to carry the nation through the initial wave of the pandemic. It also was noted that triaging blood usage would be a key ethical issue during a pandemic.
In a presentation from ARC, the organization’s chief medical officer, Richard Benjamin, MD, PhD, summarized that the greatest shortage issue is the seasonality of donors. Blood supply levels typically drop during the summer months and winter holidays. In addition, Benjamin noted that the major challenges facing the blood community are donor base challenges — a shrinking and aging base and increased deferrals — optimal donor utilization, and optimal utilization of available supply.
ARC has seen its average donor age increase from 42.2 years in 2003 to 42.8 years in 2007, and it also has experienced a decrease in the number of donors in the 30- to 45-year-old age range. The increase in deferrals also has affected the donor pool, lowering the percentage of the population that is eligible to — and actually does — donate. Efforts to attract younger donors as well as more minority donors are current initiatives at ARC. Finally, as work patterns have transitioned, on-site blood drives have become less common. ARC is exploring ways to generate donations at hospitals and other locations within communities.
Optimal utilization also is another factor affecting the blood supply. Benjamin explained that the demand for universal O-type blood exceeds the natural supply, creating persistent inventory challenges. To address these challenges, ARC has begun setting collection goals by type and is utilizing technology to collect double red cells from type O donors. Finally, ARC maintained that the biggest area for improvement is blood utilization within the hospital. Currently, ARC is evaluating blood management programs designed to train staff on appropriate utilization of blood though system audits, gap analysis and best practices, implantation plans, education, and data tracking and analysis.
Government Agency Presentations
Jerry Holmberg, PhD, MT(ASCP)SBB, senior advisor for blood policy at HHS, provided the committee with a presentation on the blood and tissue-related medical countermeasures working group under the Biomedical Advanced Research and Development Authority. This working group was formed to determine blood and tissue needs as medical countermeasures during chemical, biological, radiological or nuclear threats. To understand potential needs, the working group reviewed previous national and international disasters such as the Madrid, Spain, train bombing. Holmberg noted that total blood usage during this disaster was 1,290 units of RBCs, 157 units of platelets and 455 units of fresh frozen plasma.
Using such information, the working group developed models to predict possible blood and tissue usage during a radiological-nuclear attack. The model is based off of a 10 KT RAD/NUC. According to Holmberg, initial requirements would possibly be 40,000 units of RBCs, 24,000 equivalent units of platelets and 68,000 units of FFP. Holmberg explained that, if available, irradiated products would be used in first response as well as supportive care. The committee was informed that a gap currently exists, as less than 10 percent of the blood supply is irradiated, and total collections throughout the country equal 40,000 units per day with current supply levels at less than three days. Holmberg suggested short-term solutions, including adding blood as a critical countermeasure, local planning and monitoring of the blood supply, and the creation of a national blood reserve. Holmberg has recommended that HHS support a reserve of 2,000 units to be located at a few blood centers strategically located across the country. Long-term solutions, such as efficacy studies of whole blood versus component therapy and hemoglobin based oxygen carriers, also are being explored, Holmberg said.
During the open discussion, the task force requested additional information on potential disasters that have not been seen in the past to give the organizations the ability to determine if current planning efforts are sufficient. The task force also asked to be involved in current and future modeling of blood needs to ensure the government and the blood community are prepared for a unified response in case of a disaster.
In a second presentation, Holmberg detailed the Blood Availability and Safety Information System run by HHS to monitor supply and demand. Holmberg emphasized that this system is not to interfere with day-to-day operations and decision making of blood centers, hospitals and community transfusion centers. BASIS tracks quantitative data on blood and platelet supply and demand as well as qualitative supply and demand chain events. It uses weighted values and is to be validated with the 2007 National Blood Collection and Utilization Survey. Holmberg noted that blood center participation is lower than anticipated, with only nine blood centers currently participating. The goal was 85 blood centers for statistical accuracy. Hospital participation is 65 percent, with 101 of the 156 needed hospitals participating. ACBSA discussed BASIS as a possible way to fill the gap in the hospital supply data.
The regulatory issues surrounding a blood shortage or disaster were discussed by the FDA’s Alan Williams, PhD, associate director for regulatory affairs at the Office of Blood Research and Review. The presentation outlined the agency’s outreach for disaster planning as a representative to the AABB Interorganizational Task Force on Domestic Disaster and Acts of Terrorism and the AABB Pandemic Influenza Task Force as well as collaborative efforts with U.S. Public Health Service agencies and HHS. Williams outlined ongoing discussions with the Pandemic Flu Task Force regarding regulatory flexibility. While FDA noted that flexibility runs counter to most of the current statutes, regulations, guidances and standards, specific proposed pandemic flexibilities included reduction of the 56-day RBC interdonation interval based upon pre-donation hemoglobin determination, reduction of weight requirements for double RBC apheresis by five pounds, relaxation of malaria and BSE-related travel deferrals, and relaxation of internal quality control frequency and FDA reporting timelines. These proposed flexibilities are a conceptual start, but they need more sophisticated assessment before FDA can fully respond, Williams stated.
Committee Resolutions
The following is the complete text of the resolution adopted unanimously by the committee:
Whereas the blood supply is a critical part of the Nation’s healthcare infrastructure, the HHS ACBSA believes that knowledge of real-time national blood and blood product inventory and its dynamics is essential for emergency preparedness and response. The committee finds that blood center data are extensive, but not comprehensively aggregated nor available to HHS; hospital data reporting is essential, but limited. Although the blood supply is elastic, it is unclear whether it is sufficiently elastic to address potential disasters.
The Committee recommends that:
1. HHS establish sufficient hospital and blood center participation in inventory reporting to allow accurate determination of national blood and blood product inventory as a trigger for efficient local, state, and federal responses.
2. HHS develop comprehensive models to address and respond to needs for blood and related critical materials in a variety of surge, donor depletion and other threat conditions to accurately cover blood needs.
3. HHS work with the blood community to define shortage scenarios that would require implementation of alternative strategies for blood collection, distribution, and use.
4. HHS support operations research to characterize and recruit potential donors who do not now routinely donate.
Erythropoietin-Stimulating Agent
Speaking on behalf of the Centers for Medicare and Medicaid Services, Louis B. Jacques, MD, presented a summary of recent events surrounding CMS’ national coverage determination for erythropoietin-stimulating agents. According to a final decision memo regarding coverage for ESAs published in the July 30 Federal Register, CMS would not cover specific off-label indications and would restrict the coverage of ESAs beyond specified duration and intensity.
The new policy does not restrict coverage for ESA treatment for Medicare beneficiaries with myelodysplasia. However, the decision includes several limitations for patients undergoing ESA treatment for anemia secondary to myelosuppressive anti-cancer chemotherapy in solid tumors, multiple myeloma, lymphoma and lymphocytic leukemia. For coverage of such indications, Medicare will now require that a patient’s hemoglobin be less than 10 grams per deciliter prior to initiation or maintenance of ESAs.
Due to the new coverage policies, there is a concern that the number of transfusions for patients previously prescribed ESAs will increase, possibly affecting the blood supply. ACBSA committee members asked Jacques if it was possible to forecast impact of the coverage policies on the blood supply, and he replied that the experts believe the blood supply is flexible and would not be greatly affected. ACBSA members raised the need for prospective analysis of the effect of the new policies on the blood supply.
Committee Resolutions
The following is the complete text of the ESA-related resolution adopted unanimously by the committee:
The Committee believes that there is inadequate information to accurately assess the impact of CMS’s National Coverage Determination (NCD) for Erythropoiesis Stimulating Agents (ESA) on the management of anemia in the general patient population and in cancer patients.
Whereas, the revised position on ESA coverage may increase blood demand, ACBSA recommends that
1. HHS perform an analysis of the impact of ESA NCD on blood demand in affected patient populations. The information needed should be derived from prospective data collection.
Whereas current demand for transfusion in various patient groups is not well characterized and varies with local practices, including adherence or non adherence with available transfusion guidelines, the ACBSA recommends that
2. HHS support studies to identify and characterize transfusion practices in relation to clinical outcomes in patient groups affected by the NCD, e.g., survival, quality of life (using validated instruments), adverse events, including cardiovascular events.
Other Topics
ACBSA also received updates from other HHS advisory committees and departments. Presentations included a summary of the FDA Blood Products Advisory Committee meeting, a review of the Human Tissue Task Force Report and an update on the formation of the HHS Advisory Council on Blood Stem Cell Transplantation. The HHS Office of the Assistant Secretary for Preparedness and Response also provided an overview of the office and current programs that involve transfusion and transplantation safety.