CAN/CSA-Z900.2.4-17 Ocular tissues for transplantation.
In addition to the requirements specified in Clause 7.4 of CAN/CSA-Z900.1, the requirements specified in Clauses 7.4.2 to 7.4.4 of this Standard shall apply.
Regarding corneal tissue, the eye bank shall seek follow up with a postoperative inquiry within a reasonable period of time (e.g., between three and six months) following distribution to assess the transplant. The follow-up record shall include the following:
a) the tissue identification number;
b) the recipient identification number;
c) the status of transplant; and
d) the occurrence of any adverse reaction or primary tissue failure.
The receiver of any ocular tissue shall be responsible for verifying and documenting the receipt of shipment in good order.
The receiver of any ocular tissue shall promptly provide to the issuing eye bank the recipient information described in Clause 7.5.1 and information on any complications or technical problems with the transportation and shipment of the ocular tissue(s).
7.5 Minimum information to be retained
7.5.1 Donor and recipient information
Note: See also Clause 16.
Forms for retaining donor and recipient information shall be established for permanent record and shall be readily accessible for inspection by the authority having jurisdiction. Eye bank records shall include, at a minimum, the following information:
a) the eye bank identifier;
b) the preservation type, media lot numbers, and expiry dates (see Clause 15.2.5);
c) the unique donor identification number;
d) the name of the donor (or, in the case of imported tissue, the name of the importing eye bank and its unique identifier);
e) the age of the donor;
f) the date, time, and cause of death;
g) the date and time of enucleation or in situ excision, as well as the name of the enucleator, evaluator, or technician;
h) the date and time of preparation of the tissue (e.g., pre-cutting for DSAEK, and pre-stripping for
DMEK), as well as the name of the processor or technician;
i) the date and time of preservation;
j) a slit-lamp report;
k) the results of specular microscopy (if done);
l) the name of the surgeon receiving the tissue;
m) the recipient identification number, readily traceable to each unique tissue identification number;
n) the date, time, and method of transportation;
o) the use of the tissue (i.e., surgical, research, or training);
p) the printed/electronic results of all required screening tests;
q) the microbiological screening results (if performed);
r) the microbiological reports of positive donor rim cultures from the receiving surgeon (if reported);
s) errors, accidents, and adverse reactions.
7.5.2 Recipient follow-up information
Each eye bank shall retain recipient information from each surgeon using tissue, for each tissue used.
This information shall be provided by the transplant surgeon and retained by the distributing eye bank.
The recipient information shall include the following:
a) two unique identifiers (e.g., patient’s name, patient’s date of birth, provincial health number, hospital identification number, passport number);
b) the patient’s diagnosis;
c) the name of the surgeon receiving the transplant tissue;
d) the date of the surgery;
e) the location of the surgery; and
f) tissue-related postoperative complications.CAN/CSA-Z900.2.4 pdf download.