The HPC, Cord Blood DHQ materials were developed by an AABB interorganizational task force to provide establishments with a standardized tool to screen allogeneic as well as related cord blood (HPC, Cord Blood) donors for communicable disease risk factors in accordance with requirements of the Food and Drug Administration (FDA), AABB, Foundation for the Accreditation of Cellular Therapy (FACT), and the National Marrow Donor Program. Allogeneic donors are usually collected at public cord blood banks for use by the general public. Private cord blood banks generally collect related donors for either allogeneic use in a first or second degree relative, or for autologous use. Allogeneic and related cord blood donors are screened for the same risk factors; however, the regulations for using related units allow much more flexibility for distributing the cord blood units for transplantation.
FDA does not mandate the use of any particular screening tool to fulfill the requirements for screening donors for communicable disease risks and has determined that “official” recognition of the HPC, Cord Blood DHQ materials in a guidance document is not warranted. The task force believes the HPC, Cord Blood DHQ materials are harmonized with regulations and guidance documents and will optimize donor comprehension of the questions and provide facilities with the tools they need to evaluate donor responses and make appropriate donor eligibility determinations. Facilities should read the “User Instructions” carefully before adopting the materials for use.
The task force — which in addition to AABB representation includes an FDA liaison, an ethicist, and representatives from American Society for Blood and Marrow Transplantation, American Society for Apheresis, FACT, International Society for Cellular Therapy and National Marrow Donor Program — will periodically review the documents to ensure continued compliance with regulatory and accrediting agencies. New questions that are recommended by the task force or FDA but are between task force reviews should be added by the cord blood bank in the section at the end of the questionnaire designated for additional questions until the questionnaire can be updated to a new version by the task force. International members may find this area on the DHQ a useful place for any additional eligibility questions required by their national competent authority. Institutions will be notified of any changes as well as the timeline for implementation through existing publications and websites maintained by members of the task force. When a new version of the documents is posted the previous version will be maintained for a period of time to allow facilities to transition to the new version.
When a facility implements a new version of the HPC, Cord Blood DHQ materials, they should follow their established change control process for the incorporation of the new materials. The change control process should address validation of the use of the new version with other existing processes and appropriate staff training. To provide comments, feedback, or questions regarding the use of the HPC, Cord Blood DHQ Version 1.7 please send correspondence to regulatory@aabb.org.
Cord blood collection facilities should consider screening their cord blood donors for genetic disease risk. Adult cellular therapy donors would have the knowledge of a diagnosis of a genetic disease that can be transmitted, however in the case of cord blood donors the baby may not yet manifest disease characteristics and cannot be tested for the presence of every genetic disease. Therefore, the mother, father, baby’s siblings, baby’s grandparents, and baby’s mother’s or father’s siblings’ history must be obtained to evaluate for genetic disease risks. Some suggested disease categories to include when performing genetic screening are: Cancer or leukemia, Red Blood Cell Diseases, White Blood Cell Diseases, Immune Deficiencies, Platelet Diseases, Other Blood Diseases, Hemoglobin Problems, Metabolic/Storage Diseases, Acquired Immune System Disorders, or other serious or life – threatening diseases. Several sources, including the transplant center physicians, should be consulted in the process of creating a Family Medical and Genetic History Questionnaire.
The HPC, Cord Donor History Questionnaire materials have been updated to version 1.7. The changes update some FDA guidance document names, dates, and/or website links, located within the DHQ, to the current version. A complete summary of the updates incorporated in this new version is in the chart detailing the changes from version 1.6.
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