Grifols Regina plasma clinic permitted HIV-exposed donor to give plasma

Federal health regulators found a paid plasma collection facility in Canada operated by Grifols non-compliant after discovering that a donor who reported sexual contact with an HIV-positive individual was permitted to give plasma. The inspection documents, which shed new light on regulatory scrutiny surrounding for-profit plasma collection in the business sector, also revealed multiple instances of donors with visible arm punctures and bruising proceeding without proper medical clearance.

The regulatory findings stem from a federal inspection that began on January 13, 2025, at the commercial donation centre in Regina. According to the inspection exit report, the donor answered affirmatively to a screening question regarding sexual contact with someone who tested positive for HIV or AIDS. Standard protocol dictates an indefinite ban following such a disclosure, yet the response was altered to a negative by a Grifols physician substitute currently in training. The assessment lacked documentation indicating whether a qualified trainer reviewed the override.

Grifols stated in its response filed with regulators that the error surfaced on the donor's third visit. The company reported that it rejected the plasma collected during the prior two visits, applied an indefinite ban, and terminated the employment of the staff member involved. An internal audit conducted by Grifols further noted that plasma collected from an HIV-reactive donor was not documented properly as discarded, though a supervisor rejected the material before processing.

The investigation uncovered additional procedural lapses at the Regina facility. Inspectors found individuals permitted to donate despite possessing punctures and bruising near venipuncture sites without any documented secondary medical evaluation. In one instance, a donor presented with markings on both arms yet was cleared by staff rather than personnel acting under physician supervision. Grifols acknowledged to regulators that no established guidance existed at the time to differentiate normal donation wear from high-risk activities such as intravenous drug use.

Additional deficiencies included a person donating twice within forty-eight hours, an ineffective address verification system, and donors completing collections without finishing their questionnaires or disclosing disqualifying medications. Hematologist and professor emeritus Dr. Jacalyn Duffin characterized the findings as disappointing, telling reporters that the issues point toward insufficient controls and operational shortcuts within for-profit collection models.

The regulatory scrutiny in Regina follows broader public concern regarding Grifols operations across Canada. The company has faced intense questioning following the deaths of two individuals who collapsed after donating plasma at Winnipeg locations. While federal authorities reported no direct connection between those fatalities and the donation process, the cumulative inspection failures led Grifols to suspend paid plasma collection nationwide.

Dr. Graham Sher, chief executive officer of Canadian Blood Services, acknowledged systemic findings across multiple collection sites but defended the integrity of the national supply. He noted that rigorous testing protocols ensure no compromised material enters large-scale manufacturing or reaches patients who depend on plasma-derived medicines like immunoglobulin. Grifols similarly reported that positive infectious disease rates remain extremely low and fall well beneath established alert limits.

Advocates maintain a skeptical stance amid the ongoing suspension. Katherine Lanteigne, acting as a representative for the family of a deceased donor, called for a complete suspension of operating licences to allow for deeper investigative reviews. Meanwhile, corporate structural shifts are underway. Grifols acquired full ownership of its Canadian operations, removing previous governance limitations associated with its former partner, Canadian Plasma Resources.

Operations at Grifols collection centres remain suspended as the company implements staff retraining and updates its compliance standards alongside regulatory authorities. No formal reopening date has been announced.