N.B. organ donation program suspended
Health Canada inspection raised quality assurance concerns
CBC News
Posted: Jul 11, 2012 1:54 PM AT
Last Updated: Jul 11, 2012 4:02 PM AT
Health Minister Madeleine Dubé says the suspension will not affect New Brunswickers waiting for an organ donation. (CBC)The New Brunswick government is temporarily suspending the province's organ donation program after a Health Canada inspection raised some quality assurance concerns, Health Minister Madeleine Dubé announced Wednesday.
The inspection last Friday found parts of the program were non-compliant with national guidelines, including "several problems" with documentation, she said in a statement.
In one case, for example, "a piece of necessary information" was not obtained from a donor who had a tattoo, said Dubé.
Donors with tattoos are required to go through additional screening before their organs can be cleared for donation due to the potential health risks that may be involved in the tattoo procedure, she explained.
'We recognize that a thorough screening program is essential for patient safety.'—Health Minister Madeleine Dubé
The donated organs in that case were found to be healthy and the transplant recipients did not experience any adverse health effects, Dubé said.
But the government recognizes a "thorough screening program is essential for patient safety" and is voluntarily suspending the program for up to two weeks while it makes interim changes, she said.
"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."
When the program resumes, it will operate on an "exceptional distribution release basis," which mean organs referred from New Brunswick will be flagged to inform the transplant physician and the recipient of the program's non-compliant status, Dubé said.
The health minister says the temporary suspension won't affect New Brunswickers who are waiting for a transplant because the wait list is run nationally, so they could receive an organ donated from any part of the country.
She expects the program changes needed to satisfy Health Canada's quality assurance requirements will be in place by the fall.
The living donor program as well as the tissue program and eye bank, which are inspected and registered separately, will continue to operate, Dubé said.
Health Canada usually inspects provincial organ donation programs every two years.
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