Proposed policies and procedures for the establishment of a cord blood bank.
To carry out cord blood transplants from allogeneic unrelated donors, cord blood stem cell banks must be established. This report proposed the policies and procedures that can be used to establish cord blood banks. The areas covered include donor consent and suitability criteria; infectious and genetic disease testing; collection, processing, and preservation of the cord blood; retention of specimens for special testing; confidentiality; documentation and record keeping; establishment of a quality control program; and related regulatory issues. There are no technologic impediments to establishing cord blood banks. Agreement on some standard policies and procedures would facilitate exchange of cord blood stem cells among transplant centers and should increase the number of transplants that can be done.
McCullough
J
J
Department of Laboratory Medicine and Pathology, University of Minnesota Medical School, Minneapolis, USA.
Clay
M E
ME
Fautsch
S
S
Noreen
H
H
Segall
M
M
Perry
E
E
Stroncek
D
D
D001769:Blood / Q000382:microbiology / Q000821:virology; D001771:Blood Banks / Q000331:legislation & jurisprudence / Q000458:organization & administration* / Q000592:standards; D001782:Blood Donors; D001793:Blood Preservation; D003140:Communicable Disease Control; D015925:Cryopreservation; D005312:Fetal Blood / Q000166:cytology; D005568:Forms and Records Control; D018380:Hematopoietic Stem Cell Transplantation; D006650:Histocompatibility Testing; D006801:Humans; D007231:Infant, Newborn; D007258:Informed Consent; D008499:Medical Records; D008910:Minnesota; D011296:Prenatal Diagnosis; D011785:Quality Assurance, Health Care / Q000458:organization & administration; D014481:United States; D014486:United States Food and Drug Administration