It also cited deficiencies with complaint monitoring and management, insufficient staff training and evaluation, and problems with the calibration, cleaning or maintenance of critical equipment.

Records were not always accurate or complete, according to the inspection report, and some operating procedures were not always followed.

“The findings do raise some concern about not just the donor safety but the end products that could result from these collections as well,” said Dr. Bryan Tordon, a Calgary-based transfusion medicine specialist.

Based on the information available, his key concern is donor assessment.

“If there were errors or gaps at that time, then it can affect both donor safety and, again, the integrity of anything that is created from that donation,” said Tordon.

In an email, a Health Canada spokesperson said, “of the observations documented [at] the Grifols’ site in Calgary, none were deemed critical.”

“Based on the information that Health Canada has received and reviewed, the integrity of the blood components that were drawn by Grifols’ site in Calgary are not compromised, and the site is permitted to remain open.”

Health Canada ordered Grifols to take corrective actions after finding it did not comply with its Blood Regulations.

The company has three other paid plasma collection centres in Alberta, including two in Edmonton and one in Red Deer. 

‘Disturbing’ findings

Grifols’ Regina location was also rated as non-compliant in January. Its Saskatoon centre was found non-compliant in 2023, and the Saint John location received the same rating in a 2022 pre-licensing inspection.

“The facts that we have in front of us are unsettling and disturbing,” said Andrew Longhurst, a senior researcher with the Canadian Centre for Policy Alternatives.

He’s calling for greater scrutiny of the for-profit plasma industry. 

“It raises a lot of concerns about whether Health Canada’s regulatory approach is too hands-off. And I would argue we need a much more hands-on, robust enforcement and regulatory approach across the country,” he said.

In a statement, Health Canada said the country’s plasma system involves rigorous screening, testing and monitoring, and is recognized as one of the safest in the world.

Company working ‘swiftly’ to deal with problems

In a statement, Grifols said it is working to address the concerns documented in December.

“Donor safety and plasma quality remain our top priorities; and we are committed to ensuring the long-term integrity and reliability of our operations worldwide,” a spokesperson wrote in an email to CBC News.

According to Grifols, plasma donation centres face several layers of regulatory oversight as well as internal quality controls.

“A ‘non-compliant’ rating means that the identified operational processes require improvement; and we are working hard to address those swiftly,” the statement said in part.

Grifols said it has submitted detailed action plans to address the Calgary and Regina inspection findings and started implementing changes right away.

No Alberta deaths reported

Health Canada, which regulates both paid and unpaid plasma collection facilities, said it has not received any reports of deaths from plasma centres in Alberta since 2015. 

The federal agency confirmed it has received three reports of serious adverse reactions among donors dating back to 2023:  

• Feb. 14, 2023: Canadian Plasma Resources, Edmonton.
• March 21, 2023:  Canadian Plasma Resources,  Calgary.
• July 4, 2023: Canadian Plasma Resources, Calgary.

A fourth report from Grifols’ Calgary location in June 2024 was not confirmed.

Grifols announced plans to buy out Canadian Plasma Resources centres in June 2023.

“It is important to note these reports do not necessarily imply that a relationship between the adverse event and the plasma donation process has been established,” the Health Canada spokesperson said.

“However, they are an important information source for our ongoing safety monitoring.”

The agency said its Calgary inspection included verifying the centre’s incident investigations, examining records related to the incidents, as well as ensuring standard operating procedures were being followed and that sufficient qualified personnel are present.

It would not provide further specifics.

When a facility is deemed “non-compliant,” Health Canada will generally return for a re-inspection within a year, a spokesperson said.

The agency said it maintains strict oversight over plasma collection centres, and it “will not hesitate to take action to mitigate risks to Canadians.”

It is currently inspecting Grifols’ head office in Oakville, Ont.

No ban considered in Alberta

While plasma collection is regulated federally, provinces can decide whether or not to allow clinics to pay for plasma. 

British Columbia, Quebec and Ontario (with some exceptions) have legislation prohibiting them, and Manitoba’s health minister recently said a ban could be an option.

In response to questions following news of the Manitoba deaths, the Alberta government said a ban is not on the table.

“Canada faces a shortage of domestically produced blood plasma and imports the majority of the plasma it needs from paid donors in the United States. By allowing private plasma donation, including … in Alberta, Canada has increased its supply,” said Kyle Warner, press secretary for Alberta’s minister of hospital and surgical health services.

“There is no plan to reintroduce a ban.”

Plasma collected through Grifols is shipped away, often to the United States, for manufacturing before the products are used to treat Canadian patients, according to Tordon, who is also a clinical assistant professor in the department of pathology and laboratory medicine at the University of Calgary.

This involves extensive processing and safety testing, he said.

“There’s nothing that clearly implicates our blood supply as being unsafe or that there are extensive issues to the transfusion practices that we perform in Canada,” said Tordon.

While blood collection is generally safe, there are some inherent risks for donors, he noted, including bruising, blood pressure drops and seizures. Some cardiac conditions can put the donor at risk of serious problems or even death, he said.

Donor screening is key, according to Tordon.

He urges plasma donors to provide their full health and medication history, along with any previous donation problems, to ensure the process is as safe as possible.