scope:

This Standard addresses issues related to the safety of human allogeneic and autologous cells of lymphohematopoietic origin used for transplantation and includes quality system requirements. It includes aspects of safety for potential and actual donors and recipients, personnel, and others who might be exposed to or affected by the transplant of lymphohematopoietic cells. The requirements of this Standard apply to lymphohematopoietic cells intended for homologous use (i.e., the cells perform the same basic function after transplantation).

Note: In Canada, the use of lymphohematopoietic cells in non-homologous applications is subject to the Food and Drugs Act and applicable regulations.

This Standard applies to establishments performing transplantation of lymphohematopoietic cells, and establishments and individuals involved in the following activities related to lymphohematopoietic cells intended for transplantation:

(a) processing (including donor screening, testing and suitability assessment, and the collection of bone marrow, peripheral blood, or cord blood to be used for transplantation);

(b) evaluation of the safety of cells prior to transplantation;

(c) transplantation procedures;

(d) recordkeeping;

(e) error, accident, and adverse reaction investigation and reporting;

(f) distribution;

(g) importation or exportation; and

(h) complaints and recalls,