Health Canada has imposed new terms and conditions on a company’s paid plasma centers following numerous unsuccessful inspections that revealed “recurring, systemic deficiencies.” This action comes after two individuals passed away in Winnipeg within a short span of less than four months after donating plasma at different Grifols sites in the city.
Furthermore, the company’s Canadian head office in Oakville, Ont., did not pass its January inspection. Although the head office does not collect plasma, Health Canada stated that it oversees all 16 Canadian collection sites.
A virtual inspection of the head office by Health Canada identified that Grifols was not accurately evaluating a donor’s suitability, inadequately investigating errors and accidents, and lacked sufficient properly trained staff. Additionally, it was observed that operating procedures were not consistently followed, and plasma donations were accepted even when data indicated potential risks to blood safety.
Grifols, a Spanish company specializing in plasma medicines production, operates over a dozen centers in Canada for plasma collection, which is crucial for treating various medical conditions such as bleeding disorders, liver diseases, and cancer.
Health Canada’s new conditions apply to all 16 Grifols collection centers in Canada and include reducing appointment numbers to ensure staff adherence to procedures, reassessing the required trained personnel, and enhancing quality assurance processes. These conditions will remain in effect until Grifols demonstrates sustained compliance with blood regulations at all licensed sites.
In response to the imposed conditions, a Grifols spokesperson emphasized that donor safety is their top priority. The Grifols site near the University of Manitoba in Winnipeg operates under a separate license with its quality management system.
Health Canada identified quality management issues during the head office inspection and has requested corrective actions from Grifols while closely monitoring their implementation progress. Dr. Ryan Zarychanski, a hematologist, commended Health Canada’s actions, stating that the system is functioning effectively in addressing identified deficiencies.
The Manitoba Health Coalition’s provincial director expressed that the new conditions should have been in place earlier and called for more investment in the voluntary public system managed by Canadian Blood Services. Health Canada is investigating the two deaths in Manitoba, emphasizing that no link has been established between the fatalities and plasma donation.
Recent inspections at Grifols centers in Calgary and Regina also yielded non-compliant ratings. Health Canada continues to monitor and enforce compliance across all licensed sites to ensure the safety and quality of plasma collection in Canada.