December 11, 2013
The Advisory Committee on Blood and Tissue Safety and Availability met on Dec. 4 and 5 to continue addressing the sustainability of the current blood center system in the era of health care reform. Following discussion of this topic during its last meeting in June, the committee adopted a number of recommendations relating to cost recovery, reimbursement and the need for innovation to address what it called an “emerging crisis for sustainability of the blood system.” The committee received updates on research studies relating to the deferral policy for men who have had sex with men (MSM) and recommended government support for a blood donor transfusion-transmissible viral infections monitoring system. In addition, the committee recommended various steps be taken to ensure blood and tissue availability in the event of a disaster.
Blood System Sustainability
The advisory committee heard a variety of presentations on the status of blood centers in the United States. Miriam Markowitz, CEO of AABB, presented on current cost-recovery difficulties facing blood centers. Speaking on behalf of a working group of blood center representatives focused on cost recovery, she recommended that the Secretary of the Department of Health and Human Services: 1) encourage the Food and Drug Administration (FDA) to review and update its blood-related regulations to ensure they are based on current scientific evidence; 2) support a study on the integration of blood system information technology and electronic health record systems (EHRs) and provide guidance on interoperability; 3) study and recommend approaches to link blood center cost-recovery options with provider reimbursement; and 4) support an analysis on the risk profile for single vendor reliance on blood product safety, availability and innovation.
Presenting on the capacity for blood product and service innovation, Ray Goodrich, PhD, vice president of Scientific and Clinical Affairs at Terumo BCT, highlighted the challenges in supporting research and development while facing economic constraints. As the blood market contracts, the tendency to reduce investments in innovation should be avoided. Rather, innovation is critical in these times, Goodrich noted. He recommended adoption of a value proposition-based research model with a focus on patient outcomes; continued investment through government and private industry; exploration of making blood products available to patients in the forms that benefit them most; and further implementation of patient blood management.
Other presenters echoed Goodrich’s support for the use of risk-based decision making (RBDM) in transfusion medicine. Judy Leach Bennett, director of the Centre for Innovation at the Canadian Blood Services, presented the RBDM framework being developed by the Alliance of Blood Operators. This project aims to “develop an integrated, internationally applicable framework, entrenched in donor safety and optimal patient outcomes, to guide major policy and operational change.” During the project’s first phase, which is expected to be completed in March 2014, an overall risk framework and tools are being developed. Phase two will involve testing and refinement of the framework as well as consultation with stakeholders. Bennett stated that the RBDM framework will contribute to a shift toward determination of acceptable risk based on society considerations, but the commitment and collaboration of all blood leaders is necessary.
In relation to the topic of blood center sustainability, the committee recommended that the HHS Secretary take steps to:
- Improve mechanisms of reimbursement to blood establishments to assure recovery of actual costs, including the costs of new safety measures required or recommended by the FDA.
- Promote innovations in the blood system by lowering the risks and costs of new technology development.
- Foster integration of blood establishment computer system databases with EHRs in hospitals.
- Encourage expanded use of RBDM for the blood system, including use of formal decisional tools (e.g., quantitative risk assessments), obtaining stakeholder input on acceptance of risks and consideration of economic impacts.
- Support research to establish the global value of transfusion therapies in the larger public health context.
MSM Deferral Policy and Related Research Initiatives
At its June 2010 meeting, the advisory committee voted against changing the current deferral policy for MSM. It instead recommended additional research to inform a revised policy. During the December 2013 meeting, updates on the following HHS-supported research and activities were presented:
- The Retrovirus Epidemiology Donor Study-II (REDS II) Transfusion-Transmissible Viral Infection Market Prevalence and Risk Factor Study funded by National Institutes of Health to analyze prevalence and incidence of major transfusion-transmissible infections and current risk factors reported by positive donors.
- An FDA-sponsored workshop on Quarantine Release Errors and subsequent QRE white paper prepared by an AABB interorganizational task force.
- A study of the Uniform Donor History Questionnaire (UDHQ) performed by the Centers for Disease Control and Prevention to assess blood donors’ understanding of the questionnaire.
- The Recipient Epidemiology and Donor Evaluation Study (REDS-III) Blood Donation Rules Opinion Study, designed to measure the attitudes and behaviors of MSM toward the donation screening process and the motivation of current MSM donors and those who would donate under revised donor eligibility criteria, was initiated with planned results reporting in mid-2014.
After hearing a presentation from Simone Glynn, MD, MSc, MPH, chief of the Transfusion Medicine and Cellular Therapies Branch at the National Heart Lung and Blood Institute’s Division of Blood Diseases and Resources, outlining the next steps in establishing a donor transfusion-transmissible infection monitoring system, the committee unanimously approved a recommendation that the HHS Secretary establish such a system prior to the implementation of any change in this deferral policy.
The committee also heard updates from subcommittees addressing blood and tissue availability in emergencies. Following a presentation from the subcommittee on blood-related disaster preparedness, chaired by committee member Aryeh Shander, MD, the committee noted that the AABB Interorganizational Task Force on Domestic Disasters and Acts of Terrorism “has served the country well in disaster situations since its inception in 2001.” Recognizing, however, that there continue to be concerns related to ensuring an adequate blood supply in large-scale disasters, the committee recommended that the Secretary:
- Establish regional targets for blood inventories sufficient to address potential disaster scenarios.
- Improve blood inventory reporting by hospitals to maintain a comprehensive knowledge of the source and availability of blood products, especially platelets.
- Establish stockpiles of devices and consumables needed to prepare blood components.
- Establish and maintain stockpiles of less perishable blood derivatives.
- Improve national-level coordination of the concurrent delivery of blood and tissues in disaster situations.
- Establish stable funding mechanisms to support and coordinate the availability of blood products in disasters.
- Enhance public communication to promote understanding of appropriate responses in disasters affecting blood availability.
- Improve delivery systems for blood products that would be able to operate in situations of disrupted infrastructures.
In addition, the advisory committee recommended a number of steps be taken to ensure availability of tissue in the event of a disaster. Significant concerns were raised during this meeting and a previous committee meeting regarding the possible need for significant supplies of skin and other tissues in a mass casualty event, including a nuclear attack.
A live webcast of the advisory committee meeting is available for viewing on