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 the disposition of that tissue to the providing establishment.
7.4 Tracking
7.4.1
In addition to the requirements specified in Clause 7.4 of CAN/CSA-Z900.1, the requirements specified in Clause 7.4.2 of this Standard shall apply.
CAN/CSA-Z900.2.2 pdf download.