CAN CSA Z900.2.1:2017 pdf download.Tissues for assisted reproduction
1.1 CAN CSA Z900.2.1 addresses issues related to the safety of donated tissues used for third-party assisted reproduction. It includes quality system requirements and aspects of safety for potential and actual donors and recipients, any children born as a result of an assisted reproduction procedure, personnel,and others who might be exposed to or affected by the use of reproductive tissues. This Standard is intended to serve as a benchmark and provide minimum requirements for the verification of safe practices in the processing, evaluation, recordkeeping, adverse event reporting, distribution,importation or exportation, and recall of tissues for assisted reproduction. Annex A is intended to provide guidance regarding reimbursements.
3.1 Definitions
The following definitions apply in this Standard:
Note: The Technical Committee is aware that some of the definitions in this Standard do not align completely with definitions as they appear in regulation. Where this occurs, it is often due to differences between the scope of this Standard and the scopes or jurisdictions of referencing bodies, i.e, the definition in this Standard would encompass more activities than the definition found in a specific regulation, which would be limited to the activities covered under that regulation.
Accident一an unexpected event, not attributable to a deviation from standard operating procedures or applicable laws, that could adversely affect the safety of a recipient of reproductive tissues or the safety, efficacy, or quality of reproductive tissues.
Adverse event一any event that potentially or actually affects the staff safety, patient safety, or the provision of treatment according to a patient's care plan or the expected outcome of their treatment.[Source: Mortimer and Mortimer, 2015]
4.1.5 The affiliations, governing board, and policy-making authority of the establishment shall be clearly
described and documented. Documentation should include the names and addresses of all affiliations of the establishment, the agreements and contracts defining activities to be performed, and the personnel responsible for compliance with this Standard and for performing audits or using other means to verify that these entities are in compliance with this Standard.
4.3.1.1 The establishment shall have a QA system to ensure that all policies, procedures, processes, products,and services of the establishment conform to the SOPs, this Standard, and applicable requirements. The QA system shall include QC functions and ongoing monitoring of all aspects of the operation.
Notes:
1) The QA system may be maintained either by the establishment or its parent organization.
2) Federal and provincial/territorial regulations can apply.CAN CSA Z900.2.1 pdf download.