CAN/CSA-Z900.2.5-17 Lymphohematopoietic cells for transplantation.
7 Records and tracking
In addition to the requirements specified in Clause 7.1 of CAN/CSA-Z900.1, the requirements specified in Clause 7.1.2 of this Standard shall apply.
If a cord blood donation is for unrelated allogeneic use, the records shall also include information gathered as part of the genetic history of the birth mother (or genetic mother, if a different person), including relevant genetic information for
a) parents (including egg, sperm, or embryo donor if applicable);
c) siblings as of the time of donation; and
d) parent’s siblings.
7.2 Donor identification
In addition to the requirements specified in Clause 7.2 of CAN/CSA-Z900.1, the requirement specified in Clause 7.2.2 in this Standard shall apply.
The system used for donor identification of a cord blood donation shall include provisions to allow the tracing of a cord blood unit to the infant donor data and the birth mother data for that donation, including delivery information, family history, test results, and all records describing the handling and final disposition of that cord blood unit.
In addition to the requirements specified in Clause 7.3 of CAN/CSA-Z900.1, the requirements specified in Clauses 7.3.2 to 7.3.4 of this Standard shall apply.
In the case of cord blood donation, documentation requirements specified in Clause 7.3.1 a), b), and f) of CAN/CSA-Z900.1 shall also apply for the birth mother.
Note: The referenced items include the donor identification code, documentation showing completion of the donor suitability assessment, and documentation of notification of test results and the interpretation of test results.
7.3.2 Clinical program
The clinical program shall keep complete and accurate patient records.
Data contained in the Transplant Essential Data Forms of the Centre for International Blood and Marrow and Transplant Research (CIBMTR) shall be collected for each patient.
7.3.3 Collection facility
If two or more facilities are involved in the collection, preparation, or transplantation of the same
lymphohematopoietic cells, the establishment’s description of its duties as outlined in its SOPs (see
Clause 6.3.1) shall be retained as part of its records.
The collection facility shall provide the following to the accepting facility (e.g., a cell bank or clinical program):
a) for related and unrelated donors, a copy of all records relating to the collection procedure and any other processing procedures performed as they affect the safety, purity, and potency of the Iymphohematopoietic cells; and
b) for unrelated donors, documentation showing completion of the donor suitability assessment.CAN/CSA-Z900.2.5 pdf download.