CAN/CSA-Z900.2.2-17 Tissues for transplantation

CAN/CSA-Z900.2.2-17 Tissues for transplantation. 4 Establishment requirements 4.1 Establishment identity The requirements specified in Clause 4.1 of CAN/CSA-Z900.1 shall apply in this Standard. 4.2 Personnel 4.2.1 General In addition to the requirements specified in Clause 4.2 of CAN/CSA-Z900.1, the requirements specified in Clause 4.2.2 of this Standard shall apply. 4.2.2 Medical director In addition to the responsibilities of the medical director specified in Clause 4.2.3.5 of CAN/CSA-Z900.1, the medical director shall be ultimately responsible for determining the suitability of tissue for release for transplantation. Note: Clauses 4.2.3.7 and 4.2.3.8 of CAN/CS.4-Z900.1 address the topic of delegation of responsibility by the medical dfrector or scientific director, and the possible centralization of these roles in establishments that maintain multiple locations. 4.3 Quality management The requirements specified in Clause 4.3 of CAN/CSA-Z900.1 shall apply in this Standard. In addition, the tissue bank shall document and be able to demonstrate its protocol for the validation of its bioburden reduction processes. 5 Facilities The requirements specified in Clause 5 of CAN/CSA-Z900.1 shall apply in this Standard. 6 Standard operating procedures 6.1 General The requirements specified in Clause 6.1 of CAN/CSA-Z900.1 shall apply in this Standard. 6.2 Format The requirements specified in Clause 6.2 of CAN/CSA-Z900.1 shall apply in this Standard. 6.3 Content In addition to the requirements specified in Clause 6.3 of CAN/CSA-Z900.1, the requirements for the SOP manual shall include, where relevant, the following: a) retention times for different types of tissues (i.e., shelf life); b) procedures for tissue returns; c) procedures for records management, forms, and documentation; d) procedures for teaching and research; and e) procedures for identification and documentation of quality assurance (QA) activities. 6.4 Approvals and reviews The requirements specified in Clause 6.4 of CAN/CSA-Z900.1 shall apply in this Standard. 6.5 Extra copies The requirements specified in Clause 6.5 of CAN/CSA-Z900.1 shall apply in this Standard. 6.6 Archives The requirements specified in Clause 6.6 of CAN/CSA-Z900.1 shall apply in this Standard. 7 Records and tracking 7.1 General The requirements specified in Clause 7.1 of CAN/CSA-Z900.1 shall apply in this Standard. 7.2 Donor identification The requirements specified in Clause 7.2 of CAN/CSA-Z900.1 shall apply in this Standard. 7.3 Recordkeeping 7.3.1 In addition to the requirements specified in Clause 7.3 of CAN/CSA-Z900.1, the requirements specified in Clause 7.3.2 of this Standard shall apply. 7.3.2 The surgeon, physician, or dentist involved in the transplantation of a tissue shall be responsible for providing information regarding...