Health Canada inspection records show that an individual who reported having engaged in sexual activity with someone diagnosed with HIV was permitted to donate plasma twice at a for-profit donation facility in Regina. The CBC obtained an inspection exit report outlining several deficiencies that led to federal regulators deeming the Grifols paid plasma center in Regina non-compliant after an inspection starting on January 13 of this year.
Among the noted issues were instances where individuals with vein punctures and bruising were allowed to donate plasma without further assessment of their eligibility. Following a positive response to the HIV screening question, the donor should have been permanently ineligible to donate plasma. However, a Grifols physician substitute altered the response from “yes” to “no” without documented review by a qualified trainer.
The report did not clarify if the individual was truly HIV positive or why the response was changed. Additionally, the inspection report highlighted cases where donors were allowed to donate without completing the questionnaire and despite disclosing medications that should have rendered them ineligible.
Dr. Jacalyn Duffin, a hematologist and history of medicine professor, expressed disappointment at the report’s findings, emphasizing concerns about the donor selection process and overall operational oversight. The CBC also obtained a 2025 internal audit by Grifols, revealing significant findings necessitating increased regional supervision at the center.
The audit pointed out a case where plasma from an HIV-reactive donor was mishandled and not properly documented. It also highlighted lapses in notifying public health authorities about potential hepatitis B indicators in a donation. Major deficiencies such as improper biowaste storage and inadequate venipuncture site disinfection were also noted.
In response to inquiries regarding the Health Canada findings, a Grifols spokesperson emphasized their comprehensive safety measures beyond initial donor interviews to ensure plasma quality and donor safety. Dr. Graham Sher, CEO of Canadian Blood Services, acknowledged quality gaps at Grifols but emphasized the absence of critical defects impacting product safety.
Grifols has assumed full ownership of its Canadian operations, aiming to enhance operational oversight and adherence to regulatory standards. The temporary pause in plasma collection across Canada allows the company to implement its quality standards. Concerns raised by stakeholders, including the need for enhanced blood system protection, underscore ongoing scrutiny of plasma collection practices.
