The global standard for the identification, labeling and information processing of human blood, tissue and organ products across international borders and disparate health care systems.
Solutions used for the replacement of acute extra-cellular fluid volume losses. The electrolyte (containing ions that are capable of conducting electricity) composition approaches that of the principal ions in plasma and is approximately isotonic (of the same tonicity) in relation to the extra-cellular fluid (therefore not lytic to cells). The pH is adjusted to 7.4. Two common commercially available solutions are Normosol®-R and Plasma-Lyte® A.
Critical for the correct performance of the procedure or processing. Used in reference to elements of a procedure, equipment used for the procedure, and supplies and reagents used in the procedure.
The process of proper physical identification of a hematopoietic stem cell product including: Assignment of a product alphanumeric identifier, cross reference of the identifier with laboratory records such that the donor and all processing steps are identifiable, the proper name of the product, the composition of the product and any product modifications, identity of the intended recipient, review and verification of the labeling accuracy and fixation of the label to the product in a secure fashion. The precise information required on a product label differs based on the processing step. Refer to the FACT standards, and to the CPL labeling procedure for exact specifications and examples.
The collection of leukocytes by apheresis.
Cancer of leukocytes. Most common types are:
Acute Lymphoblastic (Not abbreviated)
Acute Lymphocytic (ALL)
Acute Myelo/Monocytic (AMML)
Acute Non Lymphocytic (ANLL) or Acute Myelogenous (AML)
Chronic Lymphocytic (CLL)
Chronic Monocytic (Not abbreviated)
Chronic Myelogenous (CML)
Hairy Cell (HCL)
Juvenile Chronic Myelogenous (JCML)
White blood cell.
The ability of the method to elicit test results that are directly proportional to analyte concentration within a given range. Linearity is generally reported as the variance of the slope of the regression line.
The liquid form of Nitrogen. Used in the laboratory to maintain hematopoietic cells in the frozen state. The temperature in the liquid phase is -196oC, in the vapor phase temperature can be maintained at -130oC. Nitrogen levels must be controlled so as to maintain the correct temperature.
Lymphocyte Propagation Laboratory
A mononuclear leukocyte with deeply staining nucleus containing dense chromatin and a pale blue staining cytoplasm. Chiefly a product of lymphoid tissue that participates in humoral and cell-mediated immunity. Includes T cells, B cells, and NK cells.
An ex vivo procedure(s) that selectively removes, enriches, expands, or functionally alters hematopoietic progenitor cells.
Minimally Manipulated- Processing that does not alter the relevant biological characteristics of cells or tissues.
More than minimally manipulated- Processing that does alter the relevant biological characteristics of cells or tissues.
Unmanipulated hematopoietic progenitor cells- Hematopoietic progenitor cells as obtained at the time of collection and not subjected to any form of manipulation.
Includes, but is not limited to, any or all steps in the recovery, processing, storage, labeling, packaging, or distribution of any human cellular or tissue-based product, and the screening and testing of a cell or tissue donor.
A mixture of inorganic salts and other nutrients capable of sustaining cell survival in vitro.
Semisolid, organic chemical used to grow hematopoietic cell colonies in vitro.
Infectious agents including bacterial and fungal organisms.
A series of polymorphic self-antigens that are presented to the immune system in the context of MHC antigens. In cases of HLA identity, multiple mHA differences may result in clinical outcomes, GVHD or graft rejection, similar to that seen in transplants differing for MHC.
Mononuclear Cells
Antibody generated by a hybridoma obtained by fusion of mouse, rat or human myeloma cell line and specifically sensitized B-lymphocytes usually from the same species. The antibody obtained is of a single specificity that of the B cell fusion partner.
Blood and marrow cells excluding multi-nucleated granulocytes and erythrocytes. Within the peripheral blood this includes lymphocytes and monocytes and hematopoietic stem cells, within marrow those cell types as well as immature myeloid elements form a portion of the mononuclear cells.
















