CAN/CSA-Z900.2.5:22

Preface This is the fourth edition of CAN/CSA-Z900.2.5, Lymphohematopoietic cells for transplantation. It supersedes the previous editions published in 2017, 2012, and 2003. This Standard is part of a series of management system StandardDetails related to the safety of cells, tissues, and organs for transplantation and assisted reproduction. This Standard was developed from work initiated by Health Canada’s Expert Working Group on Safety of Organs and Tissues for Transplantation. Major changes to this edition include the following: a) In Clause 7.1.2, the individuals from whom records are collected for unrelated allogeneic use have been revised. b) Guidance regarding how disclosed history of malignant disease with an established heritable component is addressed has been added in the new Clause 7.1.3. c) For allogeneic donors in Canada, the medical-social history requirements for unrelated cord blood donations and with respect to travel history has been revised in Clause 12.2.2.3.1. d) In clause 13.1.3.1, the exclusion criteria for allogenic donors in Canada have been updated. e) In clause 13.1.3.3, the contraindications for accepting a cord blood unit for unrelated allogeneic use have been revised. CSA Group acknowledges the International NetCord Foundation and the Foundation for the Accreditation of Cellular Therapy (FACT) for providing copyright permission to use the NetCord-FACT International StandardDetails for Cord Blood Collection, Banking and Release for Administration in developing this Standard. CSA Group acknowledges that the development of this Standard was made possible, in part, by the financial support of Health Canada. This Standard was prepared by the Subcommittee on Lymphohematopoietic Cells, under the jurisdiction of the Technical Committee on Safety of Cells, Tissues, and Organs for Transplantation and Assisted Reproduction and the Strategic Steering Committee on Health Care Technology and Systems, and has been formally approved by the Technical Committee. This Standard has been developed in compliance with StandardDetails Council of Canada requirements for National StandardDetails of Canada. It has been published as a National Standard of Canada by CSA Group. Scope 1.1 Purpose 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. 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 StandardDetails as guidance and used as a starting point for establishments developing quality programs for novel cellular therapies. Other regulations can apply. 1.2 Inclusions This Standard applies to establishments and individuals 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. Notes: 1) Examples of establishments include a) clinical transplant programs; b) collection facilities for lymphohematopoietic cells; and c) processing facilities for lymphohematopoietic cells. 2) The establishments listed in Items a) to c) of Note 1) can exist in the same geographical location or be physically separated and/or independently operated. This Standard is intended to serve as a benchmark and provide minimum requirements for the verification of safe practices in each of the activities listed in Items a) to h). 1.3 Limitations This Standard is not intended to replace detailed specifications and standard operating procedures, but is intended to be used in their preparation. 1.4 Exclusions This Standard does not address the collection, processing, or administration of erythrocytes, mature granulocytes, platelets, plasma, or plasma-derived products intended for transfusion support. 1.5 Priority This Standard contains particular requirements for lymphohematopoietic cells for transplantation and is intended to be used with CAN/CSA-Z900.1. Where differences exist, the requirements of this Standard apply. 1.6 Terminology In this Standard, "shall" is used to express a requirement, i.e., a provision that the user is obliged to satisfy in order to comply with the Standard; "should" is used to express a recommendation or that which is advised but not required; and "may" is used to express an option or that which is permissible within the limits of the Standard. Notes accompanying clauses do not include requirements or alternative requirements; the purpose of a note accompanying a clause is to separate from the text explanatory or informative material. Notes to tables and figures are considered part of the table or figure and may be written as requirements. Annexes are designated normative (mandatory) or (non-mandatory) to define their application.