Definitions Applicable to 105 CMR 130.520 Through 130.580

The following definitions apply in 105 CMR 130.520 through 130.580 when used in regard to hematopoietic progenitor/stem cell transplantation services and programs. Cell Processing Facility. A clinical laboratory that processes and stores hematopoietic progenitor/stem cell components for clinical transplantation programs. Collection. Any procedure for harvesting hematopoietic progenitor/stem cells regardless of technique or source. Collection Facility or Service. A facility or service that collects or harvests hematopoietic progenitor/stem cells for clinical transplantation programs. FACT Standards. Department guidelines based upon the FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing and Administration Foundation for the Accreditation of Cell Therapy (FACT). The national accrediting body for hematopoietic progenitor/stem cell collection, processing and transplantation services. Hematopoietic Progenitor/Stem Cell Collection, Processing and Transplantation Services (HPCCPTS). A service performing blood and marrow transplantation in the treatment of human disease. The service includes all phases of the collection, processing and administration of hematopoietic progenitor/stem cells. This includes but is not limited to cells isolated from bone marrow, peripheral blood, or placental/umbilical cord blood, and any of a variety of manipulations including removal or enrichment of various cell populations, expansion of hematopoietic cell populations, cryopreservation, infusion, expansion or activation of mononuclear cell populations for immunological therapy, and genetic modification of lymphoid or hematopoietic cells, when the cells are intended to permanently or transiently engraft in the recipient, and/or be used in the treatment of disease. HPCCPTS does not include the collection, processing or administration of erythrocytes, mature granulocytes, platelets, plasma or plasma- derived components intended for transfusion support. Hematopoietic Progenitor/Stem Cell Transplantation Program or Clinical Transplantation Program. Consists of an integrated medical team housed in geographically contiguous or proximate space with a single Program Director, common staff, training programs, protocols and quality assessment systems licensed pursuant to 105 CMR 130.520 through 130.580. Hematopoietic Progenitor/Stem Cells. Primitive pluripotent hematopoietic cells capable of self- renewal as well as maturation into any of the hematopoietic lineages, including committed and lineage-restricted progenitor cells, unless otherwise specified in the (FACT) Standards, regardless of tissue source. Labeling. Steps taken to identify the original hematopoietic progenitor/stem cell collection, any components, and any component modifications; to complete the required reviews; and to attach the appropriate labels. Manipulation. An ex vivo procedure(s) that selectively removes, enriches, expands or functionally alters hematopoietic progenitor/stem cells. Processing. All aspects of manipulation, labeling, and infusion of harvested material, regardless of source. Stem Cell Transplant Program Director (Program Director). A physician who is board certified by a nationally recognized accrediting body in hematology or hematology/oncology and has expertise in bone and marrow transplantation for the treatment of disease and has operational oversight of the hematopoietic progenitor/stem cell transplantation program. Transplantation. The infusion of autologous, syngeneic or allogeneic hematopoietic progenitor/ stem cells with the intent of providing transient or permanent engraftment in support of therapy of disease.