CAN/CSA-Z900.1-17 Cells, tissues, and organs for transplantation: General requirements.
7 Records and tracking
7.1 General
Records shall be confidential, accurate, complete, legible, and indelible.
Note: Federal and provincial/territorial regulations on privacy and confidentiality of information can apply.
Records may be maintained in paper or electronic form.
Note: See Clause 5.2 regarding the maintenance and security of records and record systems.
All entries shall be signed and dated by the person performing the activity documented in the records.
The establishment’s records shall contain copies of any agreements between the establishment and its affiliates.
The records shall contain documentation of personnel qualifications, training, and competency.
The records of a source establishment shall be able to provide a complete history of each donated cell, tissue, or organ and shall cover all activities from consent and donor suitability assessment to the final disposition of the cells, tissues, or organs.
The records shall be held in an area that is secure against the entry of unauthorized persons.
Designated personnel, as defined in the SOPs, shall be responsible for all activities pertaining to records and tracking described in this Standard.
7.2 Donor identification
A source establishment shall assign a unique donor identification code to each donor of a cell, tissue, or organ for which it has responsibility. This code shall be linked to all donor tests, records, archived samples, and QC specimens (if applicable).
Each establishment shall ensure that the donor identification code is a component of their traceability system, which will allow the tracking of all cells, tissues, and organs from donor to recipient and back to the donor again.
The unique donor identification code and type of cell, tissue, or organ shall be recorded in the recipient’s transplant/medical/dental record.
Prior to initiation of cell, tissue, or organ retrieval, staff shall verify the identity of the donor with the name stated on the consent or donation authorization form. This verification shall be documented in the donor record prior to retrieval.
7.3 Recordkeeping
The source establishment shall maintain records with respect to cells, tissues, and organs that it
processes that contain at least all of the following information:
a) the donor identification code;
b) documentation showing completion of the donor suitability assessment;
c) a description of the cells, tissues, and organs retrieved from the donor;
d) documentation of donor testing for infectious disease;
e) documentation of notification of referrals, processing, and distribution;
f) the test results and interpretation of the test results;
g) a complete history of the work performed to enable tracking of records to the particular cells, tissues, and organs involved,
h) the reagents that came into contact with the cells, tissues, or organs during preparation, the concentrations used, and the acceptable residual amount of reagent, where applicable;
i) for each phase of the process, the date and the name of personnel involved;
j) documentation of the destruction or other disposition of unsuitable or unused cells, tissues, or organs;
k) if applicable, the name of any source establishment from which it received a donor referral or to which it made a donor referral;
I) the name of the retrieval establishment;
m) documentation of all processing activities;
n) the notice of exceptional distribution, if any; and
o) documentation of any reported errors, accidents, and adverse reactions and their investigation, if any, in connection with cells, tissues, or organs retrieved from the donor that it banked or distributed and any corrective action taken.CAN/CSA-Z900.1 pdf download.