No link found between deaths, plasma donations: Health Canada

Health Canada says it has found no linkage between the plasma donation process and the deaths of two Manitoba donors.

The federal regulator began its assessment following the deaths on Oct. 25 and Jan. 30 at two Grifols Plasma Donation Centres. The Spain-based company operates two for-profit paid plasma centres in Winnipeg on Taylor Avenue and Innovation Drive.

Health Canada spokesperson Mark Johnson says it visited the Winnipeg locations and identified areas of “non-compliance” in accordance with federal regulations. Grifols was required to provide a “corrective and preventative action plan” which Johnson says is currently under review.

Plasma centres in Calgary (December) and Regina (January), and Grifols’s head office in Oakville, Ont., (January) were also inspected.

“While the head office does not collect plasma, it oversees all 16 Canadian collection sites under its Blood Establishment Licence,” Johnson said in a follow-up email. “Inspectors conducted a virtual inspection and identified quality management issues, resulting in seven documented observations.”

Johnson said that Health Canada had prioritized an inspection of the Grifols head office to review its quality management system at a national level since the department had identified quality management system observations at multiple Grifols sites during routine inspections.

The three inspections resulted in non-compliance ratings. Johnson said the observations were not deemed “critical” and “there was no evidence that plasma safety or quality was affected.”

“Health Canada’s observations, as well as any corrective actions it requests from the head office inspection, are expected to be applied to all collection centres under the head office’s oversight,” Johnson said.

Health Canada has also added terms and conditions to Grifols’ licence for all 16 collection centres due to “recurring, systemic deficiencies across several sites.”

The new terms and conditions require Grifols to immediately reduce the number of appointments so staff can fully follow procedures, as well as strengthen quality checks to identify and address issues quickly.

Johnson said those terms and conditions will remain in place until Health Canada is satisfied with sustained compliance with blood regulations at their 16 sites.

“The inspection processes are ongoing and will only be considered complete when the inspectors have reviewed the establishments’ corrective action plans and require no further information,” he said. “In addition, Health Canada has the authority to conduct re-inspections or compliance checks to verify that corrective actions are carried out. Establishments that fail to comply may be subject to further enforcement.”

Although the inspection process is ongoing, Johnson says the investigation into the deaths is considered complete and directed further inquiries regarding the cause of deaths to the province’s chief medical examiner.

Paid plasma donation is banned in British Columbia, Ontario and Quebec, however Ontario has an exemption in place for Grifols through Canadian Blood Services.

scott.billeck@freepress.mb.ca