July 16, 2012
New Brunswick's organ donation program is once again compliant with national regulations and is returning to its regular operations.
"On Thursday, July 12, around 5 p.m., Health Canada advised our department that it is now compliant, although we must improve our documentation practices," said Health Minister Madeleine Dubé. "Our department is committed to implementing a quality assurance program and will meet its objective of getting one in place by fall. We are especially relieved that we did not have to refuse a donation in the week that the system was suspended."
Last week, Health Canada inspectors found several problems with the way the program collects and manages its documentation, including one case in which a piece of necessary information was not obtained about a donor who had a tattoo. It was this case that resulted in the province's non-compliance rating and led to the province's decision to suspend the program
Health Canada conducted a national teleconference of its inspectors and scientific advisers during the afternoon of Thursday, July 12. During the call, the New Brunswick inspection report was reviewed in its entirety, and it was decided that the province was still acting within the regulations even if some of the information about the tattoo was not collected.
Health Canada also examined the work completed since Monday, July 9, to address the identified gaps and was reassured by New Brunswick's commitment to improve its documentation practices and to implement a quality assurance program by this fall.
Several questions are required to be asked about the history of a donor with a tattoo because of the potential health risks that may be involved in the tattoo procedure.
"A thorough screening program is essential for the safety of a transplant patient," Dubé said. "Recipients and their physicians have to have all the facts about a donor's background so they can be confident in their decisions about whether to accept organs available for donation. We are fortunate, that in this case, the donated organs were healthy and the transplant recipients did not experience any adverse health effects."
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