CAN CSA Z900.2.5:2017 pdf download.Lymphohematopoietic cells for transplantation
1.1 CAN CSA Z900.2.5 addresses issues related to the safety of human allogeneic and autologous cells of lymphohematopoietic origin used for transplantation and includes quality system requirements. This Standard 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).
Notes:
1) In Canada, the use of lymphohematopoietic cells in non-homologous applications is subject to the Food and Drugs Act and applicable regulations.
2) This Standard provides minimum requirements for lymphohematopoietic cells for transplantation; however,they are the result of national, expert consensus and therefore might offer the benefit of globally recognized good practices for collection, processing, and distribution of other products used for cell therapies and regenerative medicine. CAN/CSA-Z900.1 and this Standard can be applied to other cellular therapy products outside the scope of these Standards as guidance and used as a starting point for establishments developing quality programs for novel cellular therapies. Other regulations can apply.
4.2.2.2.1 Attending physicians shall have a minimum of one year of specific clinical training and experience in transplantation of lymphohematopoietic cells and the management of transplant patients in both in-patient and outpatient settings. Written confirmation of a physician's or attending physician's training or experience shall be provided by the training supervisor of the clinical program, department, or institution where that training or experience was obtained.
Notes:
1) Confirmation of training may be documented by a certificate or letter issued by the training supervisor.
2) For an example of training requirements for physicians, refer to FACT-JACIE International Standards for Cellular Therapy Product Collection, Processing, and Administration, Clause B3.400.
3) Attending physicians should participate regularly in educational activities related to the transplantation of lymphohematopoietic cells.
4.2.2.2.2 Clinical programs shall have a program for training nurses in the management of patients receiving transplants of lymphohematopoietic cells. Clinical programs treating pediatric patients shall have nurses formally trained and experienced in the management of pediatric patients.
Nurses shall participate regularly in educational activities related to the transplantation of lymphohematopoietic cells.
Note: For an example of training requirements for nurses, refer to the FACT-JACIE International Standards for Cellular Therapy Product Collection, Processing, and Administration, Clause B3.7.3.CAN CSA Z900.2.5 pdf download.