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<\/p>\nDocuments obtained by CBC News reveal inspections by Health Canada after the deaths of two Winnipeg plasma donors found multiple deficiencies at the Grifols locations.<\/p>\n
The shortcomings included issues with training, proper procedures not being followed and incomplete record-keeping.<\/p>\n
Health Canada inspected the Taylor Avenue location on Nov. 20 after 22-year-old Rodiyat Alabede died the previous month. The health regulator found deficiencies that required “immediate corrective actions,” the report, issued on Dec. 22, says.<\/p>\n
The redacted report, obtained by CBC News and first reported by the Globe and Mail, found:<\/p>\n
Multiple issues related to the training program.<\/p>\n
Standard operating procedures related to the collection process were incomplete and not followed.<\/p>\n
Records were not always legible or complete.<\/p>\n
Corrective and preventative actions ordered after earlier inspections were not implemented or not effective.<\/p>\n
Missing information in the interim report written by Grifols after Alabede’s death.<\/p>\n
The report also stated a serious donor reaction happened at the Taylor location on Aug. 3, 2023, and that the actions Grifols said it would take in response were not implemented.<\/p>\n
“The most … shocking thing, or a surprising thing \u2014 there was a history here of Grifols not being compliant with their procedures, and yet nothing happened,” said Conservative MP Dan Mazier, who is on the federal standing committee on health and is the party’s health critic.<\/p>\n
The compliance verification reports, along with the federal health regulator’s internal assessment, were released to the committee earlier this month after it ordered the documents to be handed over.<\/p>\n
They have not been made public.<\/p>\n
<\/p>\n
‘I think Canadians and the families deserve answers, and we’ll keep on pressing for answers,’ Conservative MP Dan Mazier, the party’s health critic, says. (The Canadian Press)<\/p>\n
“If it wasn’t for us pushing on the health committee and Conservatives asking for these documents, we would have never heard anything,” Mazier said. “I think Canadians and the families deserve answers, and we’ll keep on pressing for answers.”<\/p>\n
The report said 14 of the 20 staff members were new as of February 2025 and that training was not adequate to ensure staff were knowledgeable. They were allowed to fail and retake a quiz four times before followup actions were required, the report said.<\/p>\n
The health regulator found more deficiencies when a second person died earlier this year after donating at the Grifols location on Innovation Drive.<\/p>\n
The compliance verification documents show Health Canada was at that site between Feb. 12 and March 2 after the death.<\/p>\n
The report, dated March 4 and obtained by CBC, found:<\/p>\n
Critical equipment was not always maintained, and 20 of their 28 machines used to collect plasma had the incorrect date and time.<\/p>\n
Issues where staff were not able to explain to the regulator how they addressed alerts from the plasma collection machine when people donated.<\/p>\n
Staff not following procedures to document alerts from the plasma collection machine.<\/p>\n
Equipment being used after issues with the machine were identified.<\/p>\n
Health Canada did not respond to CBC’s request for comment before publication.<\/p>\n
Grifols is a Spain-based for-profit company that specializes in producing plasma medicines. It has more than a dozen plasma collection centres in Canada.<\/p>\n
The company said in an emailed statement that after these inspections, it submitted a detailed action plan to Health Canada and began implementation immediately.<\/p>\n
Both Grifols and Health Canada said a link has not been found between the deaths and the donation process.<\/p>\n
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<\/p>\n
The Health Canada inspections revealed a serious incident was reported at the Taylor Avenue location in 2023. (Justin Fraser\/CBC)<\/p>\n
Manitoba’s health minister said in a letter to the federal health minister earlier this month that the results of the investigation outlined several areas of concern.<\/p>\n
The investigations have “reinforced the need for strong and consistent regulator safeguards and enforcement to ensure the health and well-being of all donors,” Uzoma Asagwara wrote to Marjorie Michel.<\/p>\n
Asagwara said Wednesday those areas of concern must be addressed immediately.<\/p>\n
One recommendation Asagwara made was to start using electronic patient records at the Grifols sites. That way, clinicians can check whether there is anything in the person’s history they might not be aware of.<\/p>\n
“That could make the process safer for those that are donating,” Asagwara said.<\/p>\n
Donor’s cause of death revealed<\/p>\n
Alabede died in October of “fatal cardiac arrhythmia arising in the setting of dilated cardiomyopathy,” Manitoba’s chief medical examiner said.<\/p>\n
Younes said her death of cardiac arrest because of an enlarged heart was not linked to the donation process. However, there is no way an autopsy could determine if increasing blood volume or electrolyte levels played a contributing role, he said.<\/p>\n
Little is known about the second death, and the identity of the person has not been made public.<\/p>\n
Health Canada’s internal medical assessment of the person’s death in January, redacted and obtained by CBC, said the person made a donation at the Grifols location on Innovation Drive.<\/p>\n
Their last donation did not have any complications and they met all eligibility questions, the Feb. 4 assessment said.<\/p>\n
The person later experienced symptoms on Jan. 30 and was taken to hospital by ambulance. The assessment said a diagnosis was made, but the information is redacted. They later underwent an unnamed procedure and died the same day. It is not clear when the procedure was done.<\/p>\n
The assessment redacts a number of things in the report, including the cause of death, the person’s age, disclosed medical conditions and any medications. It also redacts a section in the assessment titled “Unknowns.”<\/p>\n
The information was provided to Health Canada by Grifols, and the assessment said the medical history and the list of medications from the pharmacy were not available.<\/p>\n
“Based on the provided information, it does not appear to be related to the plasma donation,” a Health Canada official wrote in their conclusion.<\/p>\n","protected":false},"excerpt":{"rendered":"Documents obtained by CBC News reveal inspections by Health Canada after the deaths of two Winnipeg plasma donors…\n","protected":false},"author":2,"featured_media":54579,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[12],"tags":[4499,1855,24221,24060,84],"class_list":["post-54578","post","type-post","status-publish","format-standard","has-post-thumbnail","category-winnipeg","tag-grifols","tag-health-canada","tag-inspections","tag-rodiyat-alabede","tag-winnipeg"],"_links":{"self":[{"href":"https:\/\/www.europesays.com\/canada\/wp-json\/wp\/v2\/posts\/54578","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.europesays.com\/canada\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.europesays.com\/canada\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/canada\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/canada\/wp-json\/wp\/v2\/comments?post=54578"}],"version-history":[{"count":0,"href":"https:\/\/www.europesays.com\/canada\/wp-json\/wp\/v2\/posts\/54578\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/canada\/wp-json\/wp\/v2\/media\/54579"}],"wp:attachment":[{"href":"https:\/\/www.europesays.com\/canada\/wp-json\/wp\/v2\/media?parent=54578"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.europesays.com\/canada\/wp-json\/wp\/v2\/categories?post=54578"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.europesays.com\/canada\/wp-json\/wp\/v2\/tags?post=54578"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}