CAN CSA Z900.2.4:2017 pdf download.Ocular tissues for transplantation
4.2.3.1 In addition to the requirements in Clause 4.2.3 of CAN/CSA-Z900.1, the requirements in Clauses 4.2.3.2 to 4.2.3.6 of this Standard shall apply.
4.2.3.2 The medical director of a stand-alone eye bank (i.e., one that is not part of a larger tissue bank) shall be an ophthalmologist who has completed a corneal fellowship or who has demonstrated an expertise in external eye disease, corneal surgery, or research or teaching in cornea and/or external eye disease.
4.2.3.3 An establishment that processes ocular tissues but is not a stand-alone eye bank (e.g., a tissue bank) may have a medical director who does not meet all of the qualifications specified in Clause 4.2.3.2;however, in this case, the establishment shall have a formal, documented consulting relationship with an ophthalmologist who meets the qualifications specified in Clause 4.2.3.2. The standard operating procedures (SOPs) shall include clear guidance on when such consultation is needed (e.g., a decision tree).
4.2.3.4 The medical director shall complete relevant continuing education at least once every three years.Documentation demonstrating fulillment of this requirement shall be filed in the medical director's personnel file.
4.2.3.5 The medical director shall oversee and provide advice on all medical aspects of the eye bank operations,including, but not limited to,
a) the formulation, approval, and implementation of medical policies and procedures;
b) participation in training and supervision of technical staff with regard to tissue retrieval, tissue preservation, and tssue evaluation; and
c) participation in the establishment and operation of a quality assurance program.
4.2.3.6 The eye bank shall replace the medical director within a reasonable period of time and shall notify the appropriate authorities within three months of the new appointment. Eye banks should have an alternate medical director.
Note: An example of a reasonable period of time is approximately three months.
12.1.2 Each eye bank shall have a consistent policy for examination and documentation of a prospective donor's available medical records and death investigation. Review of all available donor records shall be performed by an individual who is qualified by profession, education, or training to do so, and who is familiar with the intended use of the tissue.
13.3 West Nile virus
Persons who have had a medical diagnosis or suspicion of West Nile virus (WNV) infection (based on symptoms and/or laboratory results, or confirmed WNV viremia) should be deferred for 120 days following diagnosis or onset of ilness, whichever is later. A decision to use the ocular tissue in this situation shall be subject to the approval of the medical director.CAN CSA Z900.2.4 pdf download.