Open this photo in gallery: Grifols has sixteen locations across Canada, including this Whitby, Ont., site. Shay Conroy/ Grifols, a private collector of blood plasma, is temporarily stopping plasma donations at its centres across Canada after facing heavy scrutiny following the deaths of two donors. In a statement released on Thursday, the company mentioned it decided to pause collection activities voluntarily due to what it referred to as “unfounded attention” toward its operations. Grifols stands as the sole major commercial plasma collector in Canada, operating 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 present in blood that is collected and turned into medicine. While Grifols collaborates with Canadian Blood Services, it compensates donors unlike CBS’s own donation centres. The for-profit entity informed Health Canada about its decision to halt operations on Wednesday. On the same day, the federal agency issued Grifols a formal notice regarding non-compliance for not adhering to blood regulations, as stated by an official familiar with the situation. Health Canada did not consult inspectors’ work in review of plasma donor’s death has chosen not to identify this official since they were not authorized to speak publicly about these matters. Over the past year, Health Canada’s inspections have revealed ongoing safety and operational issues at various Grifols collection sites and its head office. These include improper donor clearance processes, staffing shortages, and insufficient oversight. In April, conditions were imposed on Grifols’s licenses due to “recurring systemic deficiencies across several sites.” Concern heightened after Rodiyat Alabede, a 22-year-old university student from Winnipeg, died last October following her plasma donation at the Taylor Avenue site. Another donor passed away in January after visiting a different Grifols clinic located on Innovation Drive; details surrounding that incident remain undisclosed. Both deaths were only reported by media outlets in March. Following these incidents, The Globe uncovered more information regarding concerns raised by Health Canada inspectors. Issues included staff failing to respond correctly when alarms went off on donation machines or allowing some donors deemed eligible despite potential disease risks. A new report from Health Canada made public Thursday shared findings from an unannounced inspection conducted on June 23 at the Taylor Avenue site where multiple operational problems were noted. Infractions included inadequate record keeping, poor maintenance of critical equipment, and incorrect assessments of donor suitability. Grifols lifted plasma-donation ban despite disease concerns, Health Canada report shows The report indicated that some procedures weren’t complete or consistently followed. Additionally, Health Canada pointed out that Grifols failed to thoroughly investigate certain “errors and accidents,” nor did it take necessary corrective actions when needed. According to the senior official’s account, Health Canada sent two letters last month urging Grifols to act swiftly regarding regulatory shortcomings identified at their Taylor Avenue location; however they didn’t comply with these requests. Emilie Gauduchon-Campbell, spokesperson for Health Minister Marjorie Michel confirmed through a statement on Thursday that a formal warning was issued by Health Canada following several compliance issues found with Grifols’ practices. ” Canadians’ safety must always come first , and we welcome Gr if o ls ’ decision t o temporar ily close i ts p lasma c ol lection s ites , ” she said. “ H ealth C anada w i ll conti nue t o w ork col laborat ively w ith G r if o ls t o ens ure th ese conc erns are addressed before any p lasma c ol lection s ites can be reopened. ” Ms. G auduchon – Campbell said there i s no impact on th e safety an d security of C anada ’ s b lood supply. No plas ma coll ected f rom don ors flagged by H ealth C anada over d isease conc erns , G r if o ls says G rif o ls maintains tha t don or safety an d th e quality o f th e plas ma coll ected ha ve “ never been compromised. ” Th e company said it is ready t o assist H ealth C anada an d hopes t o resume operations as soon as possible. K at L ante ign e , a pat ient advocate whom Ms. A labede ’s fam ily has ask ed t o sp eak on their behalf , said G r ifo ls h as proven itself “ incap able ” of following regu latory saf ety laws. Sh e called for th e Spanish comp any t o leave C anada permanently while also asking CBS t o take responsibility. M s. L ante ign e stated that G ri fo ls h as “ put don ors an d our bl oo d system i n harm ’s way repeatedly.” Questions rem ain about th e investigatio n int o Ms. A labede ’s death. A medical summary prepared by an unnamed He alth Can ada st aff mem ber this March noted her death was “ temporally coincident ” with th e plas ma donation but wasn’t caused by it. It also mentioned staff training and emergency response measures complied with applicable standard operating procedures. However , earlier findings from He alth Can ada inspectors last December pointed out failures at th e Winnipeg collection site like staff neglecting to stop Ms. Alabede’s donation when alerts popped up related to blood pressure and flow issues involving her machine.
Canadian Blood Services CEO defends partnership with Gri fo ls af ter deaths of two donors
He alth Can ada previously stated they have records documenting 27 serious adverse reactions resulting from plas ma donations since 2018 which includes fatalities , hospitalizations , along with significant disabilities affecting patients wh ich occurred among donors; two incidents occurred within Quebec’s non-profit collector H éma-Q uébec while twenty-five were associated wit h commercial plasmacollectors now owned entirely b y G rifo ls.
This spring , He alth Can ada mandated that G ri fo ls perform yearly audits focusing on its operatio ns while reviewing donor eligibility records appropriately so they can keep their license active ; furthermore they needto limit appointment schedules accordingto availableplasm exchange machines during operation times ensuring enough staff supervision alongwith maintaining suitable staffing levels overall.
CBS signeda fifteen-year agreement backin2022 allowing G ri fo lstoincreaseplasmacollectionacross Canada. The national organization mentioned Thursdaythatitwasworkingtogetherwith Gri fo lstotackleconcernsraisedby Health Canada.”
The organization expressed howthis temporary halt allows Gri fo lstocompleteemployee retrainingas partofitsaction planalreadyin place. Additionally, itwill addressissueshighlightedensuringoperationsmeetstrictsafetyqualitystandards.” CBS concludedtheirstatement affirmingtheexistenceofadequateinventoryforplasmaderivedmedicinesallowingfor uninterrupted patientcare.”
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