CAN/CSA Z900.2.3:22 PDF

Preface 

This is the fourth edition of CAN/CSA-Z900.2.3, Perfusable organs for transplantation . It supersedes the previous editions published in 2017, 2012, and 2003. This Standard is part of a series of management system standards related to the safety of cells, tissues, and organs for transplantation and assisted reproduction. It 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) Guidance regarding how conscious and competent deceased donors are to be addressed with respect to organ donation has been added throughout the Standard. b) Requirements for HLA laboratories and guidelines for HLA typing have been added to Clauses 4.1.4and 14.3.1.2. c) Recovery surgeon qualifications have been added in Clause 4.2.4.7. d) Clause 7.3.2has been added to address informatics. e) The donor history requirements for travel and residence outside Canada and the United States have been updated in Clause 12.2.2.3. f) A requirement for full visualization of the external body has been added for deceased donors in Clause 13.2.5. g) Clarification has been provided in Clause 14.2.3that the results of cultures for deceased donors are permitted to be reported following organ distribution. h) The timeline for testing living donors has been added in Clause 14.2.6.6. i) The requirements for testing within 30 days before the donation instead of at the time of organ procurement have been revised in Clause 14.3.2.4.2. j) In Annex A, the deferral period for persons who report non-medical intravenous, intramuscular, or subcutaneous injection of drugs has been reduced from 5 years to 12 months. k) In Annex A, the deferral period for persons who have engaged in sex in exchange for money or drugs has been reduced from 5 years to 12 months. l) In Annex A, the deferral period for persons with a history of intranasal cocaine use has been expanded to include all drug use for non-medical reasons. 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 Perfusable Organs, 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 Standards Council of Canada requirements for National Standards 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 perfusable organs used for transplantation. It includes quality system requirements and aspects of safety for potential and actual donors and recipients, personnel, and others who might be exposed to, or affected by, the transplantation of perfusable organs. 

1.2 Areas of application This Standard applies to establishments (or facilities) and individuals involved in the following activities related to perfusable organs intended for transplantation: a) processing; b) evaluation of the safety of perfusable organs prior to transplantation; c) recordkeeping; d) error, accident, and adverse reaction reporting; e) distribution; f) importation or exportation; and g) recall of human organs intended for transplantation. 

1.3 Inclusions 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 g) in Clause 1.2. Note: Examples of establishments or individuals include the following: a) organ donation organizations (ODOs); b) transplant programs and facilities (hospitals and special clinics); and c) HLA laboratories. 

1.4 Limitations This Standard is not intended to replace detailed specifications and standard operating procedures but is intended to be used in their preparation. 

1.5 Priority This Standard contains particular requirements for perfusable organs 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 informative (non-mandatory) to define their application.