Cord Blood Establishing a National Hematopoietic Stem Cell Bank Program (2005) / Chapter Skim
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7 Recommended Structure of a National Program
7 Recommended Structure of a National Program
Pages 129-140
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From page 129... ...
It is clear to the committee that, at present, umbilical cord blood banks operate under various standards, that the outcomes of a significant proportion of cord blood transplants are not reported either to the bank from which the unit was obtained or to the transplant community in general, and that the economic status of cord blood banking is fragile. The structure that is ultimately identified should address all three of these issues.
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From page 130... ...
However, the NMDP, as currently configured, is not a simple solution for cord blood banking. While many aspects to be performed by the proposed National Cord Blood Stem Cell Bank Network have analogs in the NMDP (e.g., searching, outcomes tracking, patient support)
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From page 131... ...
However, the lack of a complete, coordinated network for assessing the national inventory and evaluating the outcome of transplants using units from various banks have made it difficult for the committee to accurately assess the status and quality of the available cord blood units and their current use in transplantation. Given all of these considerations, the committee sought to incorporate the following elements into the final structure of the network: · assured clinical access through substantial increases in the current inventory, · maximal efficiency of processes, · minimal redundancy of systems and investment, · guaranteed cord blood unit quality, · protected patient and donor confidentiality, · timely data collection and outcome reporting, · transparent policies and procedures, · the long-term financial viability of cord blood banks, · enhanced communication among all parties, · adherence to ethical standards.
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From page 132... ...
Unit The National Cord Blood Center should facilitate coordinated searches Selection while allowing transplant centers to customize reports according to local selection practices and to work directly with cord blood banks. Search support should provide guidance or information on the selection of adult donor versus cord blood graft sources.
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From page 133... ...
The National Board should ensure active interac tions among the various organizations involved in adult donor periph eral blood and bone marrow transplantation and umbilical cord blood transplantation. Relating directly to the earlier mentioned goal of transparent policies and procedures, this new National Board should be established by the Secretary of DHHS.
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From page 134... ...
. The Cord Blood Center would have day-to-day responsibility for car rying out the policies promulgated by the National Board, including: · managing a national network linking participating transplant cen ters with participating cord blood banks; · collecting data on the outcomes of subsequent cord blood trans plants; and · ensuring that data regarding banked cord blood units and the out comes of cord blood transplants are available to policy makers (includ ing the National Board)
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From page 135... ...
Source of Transplanted Material The National Board should set policy and the Cord Blood Center should perform its functions with full recognition that cord blood, peripheral blood, and bone marrow are complementary, alternative sources of HPCs. The source chosen must be driven by the patients' needs and anticipated outcomes on the basis of the best available evidence rather than on an a priori selection of the source.
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From page 136... ...
, and evaluation of the data therein, the National Cord Blood Policy Board should consider working toward the development of a mechanism by which all sources of HPCs can be concurrently searched. Outcomes Data Recommendation 7.3: The National Board should support the devel opment of an outcomes database that can guide decisions on inventory size and track cord blood bank quality and other policies as well as assist with the assessment of outcomes from all sources of hematopoi etic progenitor cells.
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From page 137... ...
As discussed in Chapter 6, the National Board should offer support to participating banks that are designing expansion plans for their inventories to include racially and ethnically diverse sources of cord blood, thus enhancing access to cord blood by individuals in racial and ethnic minority groups. Participating banks should be reimbursed for the units that they supply for transplantation through health care payment systems in a manner that allows them to become self-sufficient by the end of the period of federal funding.
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From page 138... ...
The ongoing program of accreditation of participating centers should be supported by the common method of participant fees. To ensure that the available cord blood units are used to the greatest advantage for patient care, federal funds should be provided for start-up and ongoing costs for the development of mechanisms for the sharing and publication of outcomes data; verification that the participating banks and transplant centers meet quality assurance standards; and encouragement of innovation and improvement in banking, matching, and related processes.
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From page 139... ...
The final decision on the body to be recognized by the national program should be made by an expert panel. Only those banks and transplant centers accredited by this body should be able to participate in the National Cord Blood Stem Cell Bank Program.
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