Grifols has sixteen locations across Canada, including this Whitby, Ont., site.Shay Conroy/The Globe and Mail
Private blood-plasma collector Grifols, which has for months faced intense scrutiny after the deaths of two of its donors, is temporarily pausing plasma collection at its donation centres across Canada.
The company, in a statement on Thursday, said it proactively and voluntarily made the decision to pause collection activities in light of what it called “unfounded attention” to its practices. Grifols is the only major commercial collector of plasma in Canada, with 17 sites in six provinces.
“The temporary pause will allow Grifols to work with Health Canada and Canadian Blood Services on the framework needed to support the continued development of a sustainable and robust plasma collection network in Canada,” Grifols said in its statement.
Plasma is a protein-rich fluid found in blood that is collected and processed into medicine. Grifols operates in partnership with Canadian Blood Services, but unlike at CBS’s own plasma donation centres, it pays donors.
The for-profit operator said it told Health Canada on Wednesday of its decision to pause operations. That same day, the federal agency issued Grifols a formal notice of non-compliance for its failure to abide by blood regulations, according to a senior official with close knowledge of the issue.
Health Canada did not consult inspectors’ work in review of plasma donor’s death
The Globe and Mail is not identifying the official because they were not authorized to speak publicly about the matter.
Health Canada inspections in the past year have identified recurring safety and operational deficiencies at multiple Grifols collection sites and its head office, including improper clearance of donors, staffing shortages and lack of oversight. In April, the agency imposed terms and conditions on Grifols’s licences because of “recurring, systemic deficiencies across several sites.”
Scrutiny increased after the death of Rodiyat Alabede, a 22-year-old university student in Winnipeg, who died last October after donating plasma at the Taylor Avenue location in the city. Another plasma donor who used a different Grifols clinic in Winnipeg on Innovation Drive died in January; the details of that incident have not been revealed. Both deaths were not made public until media reported on them in March.
In the following months, The Globe revealed more details of the concerns identified by Health Canada inspectors, such as Grifols staff not properly responding to alarms on donation machines or some donors being inappropriately found eligible to donate despite carrying disease risk.
A new Health Canada report, released publicly Thursday, detailed the findings of an unannounced June 23 inspection at the Taylor Avenue site, during which several operational problems were identified. Among the infractions were improper record keeping, insufficient maintenance of critical equipment and inaccurate assessment of donor suitability.
Grifols lifted plasma-donation ban despite disease concerns, Health Canada report shows
The report said some operating procedures were incomplete and “not always followed.” Additionally, Health Canada said Grifols did not thoroughly investigate some “errors and accidents,” nor did it “carry out sufficient correction and preventative actions when required.”
According to the senior official, Health Canada sent two letters to Grifols last month requesting that the company take immediate action to address regulatory deficiencies, including at its Taylor Avenue location, but it did not comply.
Emilie Gauduchon-Campbell, a spokesperson for Health Minister Marjorie Michel, confirmed in a statement on Thursday that Health Canada issued a formal warning to Grifols after identifying several compliance concerns.
“Canadians’ safety must always come first, and we welcome Grifols’ decision to temporarily close its plasma collection sites,” she said. “Health Canada will continue to work collaboratively with Grifols to ensure these concerns are addressed before any plasma collection sites can be reopened.”
Ms. Gauduchon-Campbell said there is no impact on the safety and security of Canada’s blood supply.
No plasma collected from donors flagged by Health Canada over disease concerns, Grifols says
Grifols maintains that donor safety and the quality of the plasma collected have “never been compromised.” The company said it is at the disposal of Health Canada and hopes to resume operations as soon as possible.
Kat Lanteigne, a patient advocate whom Ms. Alabede’s family have asked to speak on their behalf, said Grifols has proven itself “incapable” of following regulatory safety laws. She said the Spanish company should leave Canada permanently and that CBS should also take accountability.
Ms. Lanteigne said Grifols has “put donors and our blood system in harm’s way repeatedly.”
Questions remain about the investigation into Ms. Alabede’s death. A medical summary prepared by an unnamed Health Canada staff member this March said her death was “temporally coincident” with the plasma donation, but not caused by it. It also noted that staff training and emergency response at the site were compliant with applicable standard operating procedures.
But an earlier report written by Health Canada inspectors in December found deficiencies at the Winnipeg collection site, such as staff not terminating Ms. Alabede’s donation after the machine she was hooked up to displayed multiple alerts related to blood pressure and blood flow.
Canadian Blood Services CEO defends Grifols partnership after deaths of two donors
Health Canada previously said that it has records of 27 “serious adverse reactions” from plasma donation since 2018, which would include deaths, hospitalizations and significant disability. Two were from donors at Quebec’s non-profit collector, Héma-Québec, while 25 involved donors at commercial plasma collectors, all of which are now owned by Grifols.
This past spring, Health Canada ordered Grifols to conduct a yearly internal audit of its activities and to properly review its donor suitability records in order to maintain its licence. It must also reduce appointment numbers based on the number of plasma exchange machines in service, improve staff oversight and ensure appropriate staffing levels.
CBS signed a 15-year deal in 2022 with Grifols to expand plasma collection. The national organization said in a statement on Thursday that it is working with Grifols to address concerns raised by Health Canada.
“This pause will allow Grifols to complete staff retraining as part of its comprehensive action plan that’s been underway for some time. This plan will address the identified concerns and ensure its operations meet rigorous safety and quality standards,” CBS said.
The organization said a sufficient inventory of plasma-derived medicine exists to avoid any interruptions to patients.