Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 130.000 - Hospital Licensure › Subpart D - SUPPLEMENTARY STANDARDS: PARTICULAR SERVICES › Section 130.520 - Definitions Applicable to 105 CMR 130.520 Through 130.580

Current through Register 1525, July 5, 2024
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 selfrenewal 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.