The reciprocal testing of serum and red blood cells from the intended donor and recipient of a blood transfusion to detect the presence of antibody to blood group antigens.

Transfer of element(s) from one product, reagent, document or electronic record to another causing original, pure state to be compromised.

The preservation of material in a frozen state.  Human blood or bone marrow cryopreservation requires a cryoprotectant agent, usually dimethyl sulfoxide (DMSO), glycerol or a combination to prevent ice crystal formation and to maintain cell integrity during the freezing process.

Regulations as specified by the US FDA or other regulatory body that describes the methods, equipment and control procedures required for food processing, medical device manufacturing and related industries.  Such regulations are subject to change, thus the need to monitor such changes so as to be “current”.  Products covered under cGTP are considered as 351 products, under PHS 351 regulations.  Processing of such products will be under IND or IDE.  Covers most of the product processed in the MCW LPL.  See required reading folder for cGMP training presentation.

The methods used in, and the facilities and controls used for, the manufacture of HCT/P’s  including recordkeeping and the establishment of a quality program as required by the U.S. Food and Drug Administration for HCT/P establishments.  Products covered under cGTP are considered as 361 products, under PHS 361 regulations. Such products are not processed under IND or IDE.  Covers most of the products processed in the MCW CPL. See required reading folder for cGTP training presentation.

A soluble protein mediating signals between different or the same cell population (e.g., interleukin-1, interleukin-2).

Probably the most widespread of the Herpes virus group.  Infected cells enlarge and have a characteristic inclusion body (composed of virus particles) in the nucleus.  Causes disease only in utero (leading to abortion or stillbirth or to various congenital defects), although can be opportunistic in the immunocompromised host.

Deficiency in cellular elements of the blood.

Subset of T lymphocytes (mostly CD8) responsible for lysing target cells and for killing virus-infected cells (in the context of Class I histocompatibility antigens).  CD4+ T cells can also exhibit cytotoxic functions and kills in the context of Class II histocompatibility antigens.

A gradient formed by materials of different density either in a discontinuous or in a continuous fashion.

DNAase.  An endonuclease with preference for DNA.  Pancreatic DNAse I yields di- and oligo-nucleotide 5’ phosphates, pancreatic DNAse II yields 3’ phosphates.  In chromatin, the sensitivity of DNA to digestion by DNAse I depends on its state of organization, transcriptionally active genes being much more sensitive than inactive gene.

An individual who is given the authority to assume a specific responsibility based upon his or her experience or expertise to perform the task.

The relative proportion of white blood cell types composing the total white blood cell count.  Most often identified based on staining characteristics or cells size and granularity.  The major types of mature white blood cells in the circulation are Neutrophil, Eosinophils, Basophils (the first 3 collective called Granulocytes), Lymphocytes, and Monocytes.

The development of cells according to distinct lineages with different morphology and functions.

A cryoprotectant; chemical used together with electrolyte solutions to suspend cells as means of protection from cell membrane injury during the cryopreservation process.

For the purposes of the FACT Standards, there are five categories of Director:

Program Director- Physician responsible for all administrative and clinical operations of the clinical transplantation program, including compliance with FACT standards.  The Clinical Program Director shall be appropriately licensed to practice medicine in the jurisdiction in which the program is located and board certified (or non-U.S. equivalent) in one or more of the following specialties:  Hematology, Medical Oncology, Adult or Pediatric Immunology, or Pediatric Hematology/Oncology.  A non-board certified physician who completed medical training prior to 1985 may serve as Clinical Program Director if she/he has documented experience and published contributions in the field of hematopoietic cell transplantation extending over ten years.  The Clinical Program Director shall participate regularly in educational activities related to the field of hematopoietic stem cell transplantation.  The Program Director also has oversight of the care provided by the Clinical Program.

Collection Facility Director- An individual with a medical degree or doctoral degree in a relevant science, qualified by postgraduate training or experience for the scope of activities carried out in the Collection Facility.  The Collection Facility Director is responsible for all technical procedures, performance of the collection procedure, supervision of staff and administrative operations of the Collection Facility.  The Collection Facility Director shall participate regularly in educational activities related to the field of cell collection and/or transplantation.  The Collection Facility Director may also serve as the Medical Director if appropriately credentialed.

Collection Facility Medical Director- A licensed physician with postgraduate training in cell collection and/or transplantation.  This individual, or designee, is directly responsible for the medical care of patients undergoing apheresis or marrow harvest, including the pre-collection evaluation of the donor at the time of donation and care of any complications resulting from the collection procedure.  The Collection Facility Medical Director shall participate regularly in educational activities related to collection of cellular therapy products.  The Collection Facility Medical Director may also serve as the Collection Facility Director if appropriately credentialed.

Processing Facility Director- An individual with a medical degree or a doctoral degree in a relevant science, qualified by training or experience for the scope of activities carried out in the Processing Facility.  The Processing Facility Director is responsible for all procedures and administrative operations of the Processing Facility, including compliance with these Standards.  The Processing Facility Director shall participate regularly in educational activities related to the field of hematopoietic cell processing and/or transplantation.  The Processing Facility Director may also serve as the Processing Facility Medical Director if appropriately credentialed.

Processing Facility Medical Director- A licensed physician with postgraduate training and/or one year’s experience in the preparation and clinical use of cell therapy products.  The Processing Facility Medical Director or designee is directly responsible for all medical aspects related to the Processing Facility.  The Processing Facility Medical Director shall participate regularly in educational activities related to the field of cellular processing and/or administration.  The Medical Director may also serve as the Processing Facility Laboratory Director if appropriately credentialed.

Agent that kills all growing or vegetative forms of microorganisms, eliminating them from inanimate items.

A condition that begins with excessive clotting.  The excessive clotting is usually stimulated by a substance that enters the blood as part of a disease (such as an infection or certain cancers) as a complication of childbirth, retention of a dead fetus, surgery or as an adverse reaction to product infusion.