CAN/CSA-Z900.2.2:22

Description

Preface This is the fourth edition of CAN/CSA-Z900.2.2, Tissues 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. Major changes to this edition include the following: a) Additional guidance has been provided for the collection of travel history as part of the donor suitability assessment. b) In Clause 13.1.2, the donor screening contraindication or exclusion criteria list has been updated. c) In Clause 14.2.2.2, laboratory blood testing requirements for deceased and cadaveric donors have been updated. 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 Tissues, 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 tissues used for transplantation. It includes quality system requirements and aspects of safety for potential and actual donors and recipients, personnel, and others who could be exposed to, or affected by, the transplant of tissues. 1.2 Inclusions This Standard applies to establishments and individuals involved in the following activities related to tissues intended for transplantation: a) processing; b) evaluation of the safety of tissues prior to transplantation; c) recordkeeping; d) error, accident, and adverse reaction investigation; e) distribution; f) importation or exportation; and g) complaints and recalls. Notes: 1) Examples of establishments or individuals include the following: a) tissue banks; b) tissue processing facilities; c) transplant programs and facilities (hospital and clinic); d) tissue retrieval organizations; and e) other tissue-dispensing services. 2) For guidance on autologous tissues, see AORN “Guideline for Autologous Tissue Management” in Guidelines for Perioperative Practice. 1.3 Limitations This Standard is not intended to replace detailed specifications and SOPs but is intended to be used in their preparation. 1.4 Priority This Standard contains particular requirements for tissues for transplantation and is intended to be used with CAN/CSA-Z900.1. Where differences exist, the requirements of this Standard apply. 1.5 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.