Changes being made to organ donation program
New Brunswick is voluntarily suspending its Organ Donation Program for up to two weeks while it makes interim changes to the program's operations.
Last Friday, a Health Canada inspection found elements of the program to be non-compliant with national guidelines. The Department of Health is suspending the program temporarily until it can put in place interim measures to operate on an exceptional distribution release basis. This means that organs referred from New Brunswick will be flagged to inform the transplant physician and recipient of the program's non-compliant status.
"We recognize that a thorough screening program is essential for patient safety, and we are taking steps to put the necessary quality assurance procedures in place so that the program can be compliant with the national guidelines as soon as possible," said Health Minister Madeleine Dubé (left).
Health Canada found several problems with the program's documentation, including one case in which a piece of necessary information was not obtained about a donor who had a tattoo. Donors with tattoos require additional screening before their organs can be referred for donation due to the potential health risks that may be involved in the tattoo procedure.
In this case, the donated organs were tested appropriately and found to be healthy. The transplant recipients did not experience any adverse health effects.
Health Canada generally inspects provincial organ donation programs every two years.
"New Brunswick's organ donation program is operated by compassionate staff dedicated to the cause of organ donation,” said Dubé. “They are responsible for creating awareness about the importance of organ donation among their peers and the public, meeting with grieving families to talk about organ donation and caring for the donor. However, quality assurance is very important, and steps are being taken within the department to improve our processes."
The department anticipates the quality assurance procedures necessary to satisfy Health Canada requirements will be in place by fall.
The Living Donor Program as well as the Tissue Program and Eye Bank, which are inspected and registered separately, will continue to function as usual.