Health Canada inspection records show an individual who disclosed having sexual contact with an HIV-positive person was permitted to donate plasma twice at a profit-making donation center in Regina. A report obtained by CBC outlines various deficiencies leading to the center being deemed non-compliant after an inspection that commenced on January 13 this year.
The report highlighted instances where individuals with vein punctures and bruising were allowed to donate plasma without further assessment of their eligibility. It noted that a donor who admitted to the HIV exposure question during screening should have been permanently banned from donating plasma. However, a Grifols physician in training modified the response from “yes” to “no,” as per the Health Canada report dated February 20.
Moreover, the report indicated gaps in documenting whether the assessment by the physician in training was reviewed by a qualified trainer. It remains unclear from the report whether the person was truly HIV positive or why the response was altered.
Additionally, the inspection report revealed cases where individuals donated without completing their questionnaire and others donated despite disclosing medications that rendered them ineligible. Dr. Jacalyn Duffin, a hematologist, expressed disappointment at the report’s revelations, emphasizing concerns over the selection process for donors.
An internal audit by Grifols in 2025 identified several significant findings at the Regina location, necessitating enhanced regional oversight. The audit highlighted instances where plasma from an HIV-reactive donor was not properly documented as discarded, emphasizing the need for improved training and adherence to procedures.
Grifols, a global health-care company that temporarily halted plasma collection in Canada, emphasized its commitment to a stringent donor screening process to ensure the safety of collected plasma. Despite acknowledged quality gaps, Dr. Graham Sher from Canadian Blood Services emphasized the absence of critical defects compromising donor safety or product quality.
Grifols recently assumed full ownership of its Canadian operations to bolster operational oversight and compliance standards. The pause in plasma collection in Canada aims to implement enhanced quality measures. Advocates are calling for stringent actions to safeguard the blood system following safety violations revealed in the reports. Health Canada, responsible for regulating plasma and blood collection in Canada, refrained from responding to inquiries by CBC’s deadline.