The Food and Drugs Authority (FDA) has raised concerns over persistent regulatory non-compliance among blood banking facilities across Ghana, revealing that only 12 facilities have met the standards required for licensing despite years of inspections, audits and capacity-building efforts.
Speaking at a stakeholder engagement on blood regulation in Accra on Tuesday, held under the theme “Road to Compliance,” the FDA’s Director of Vaccine Vigilance and Clinical Trials, Dr Edwin Nkansah, said the findings highlight the need for greater commitment to quality and safety standards within the sector.
According to Dr Nkansah, approximately 350 health facilities have been licensed by the Health Facilities Regulatory Agency (HeFRA), with 112 blood banking facilities undergoing regulatory audits and 78 subjected to verification audits. However, only 12 facilities achieved the level of compliance required to secure licences.
He explained that since the FDA began regulating blood and blood products in 2014, the authority has implemented measures to ensure that all blood collected, processed, stored, distributed and transfused in Ghana meets internationally accepted safety and quality standards.
Dr Nkansah recalled key milestones in the regulatory process, including the development of inspection checklists and guidelines in 2015, as well as benchmarking exercises conducted with support from the World Health Organization (WHO) and the Blood Regulators Network in 2016.
He noted that the FDA has benefited from technical and financial assistance from WHO, the UK Blood Safety Programme and the 4Life Research Institute, which have supported annual refresher training programmes and institutional capacity-building initiatives. Nevertheless, logistical and financial challenges have recently affected the frequency and scope of regulatory audits.
The FDA identified several recurring compliance gaps across facilities, including the use of unregistered blood-related medical devices, inadequate donor care systems, poor documentation practices, insufficient staff training, lack of dedicated personnel, improper waste disposal methods and poor storage conditions.
Dr Nkansah also expressed concern that many facilities continue to rely exclusively on rapid diagnostic test kits without confirmatory testing, a practice that could compromise blood safety.
He further highlighted shortcomings in donor management, including inadequate privacy during donor screening and limited post-donation care, warning that such practices could discourage voluntary blood donation and undermine confidence in the system.
Despite these challenges, Dr Nkansah reported notable improvements among facilities that had undergone repeated inspections. He said non-compliance rates had declined in key areas, including haemovigilance, quality management and risk management systems.
He commended facilities for increasingly embracing haemovigilance frameworks, noting that verification audits had recorded fewer compliance breaches than initial inspections.
Data presented at the meeting showed that transfusion-related adverse reactions have fluctuated since 2016, with the Greater Accra Region recording the highest number of reported cases, followed by the Eastern Region. Whole blood transfusions accounted for approximately 87 per cent of all reported adverse reactions.
Dr Nkansah also noted an increase in the number of manufacturers and suppliers registering blood-related medical devices, including blood bags, transfusion sets, rapid test kits and screening reagents.
However, he expressed disappointment over the low number of licence renewal applications, revealing that some facilities that obtained licences in 2019 had failed to renew them.
He urged all blood banking facilities to prioritise regulatory compliance and licensing requirements to ensure the availability of safe and high-quality blood and blood products nationwide.
Dr Nkansah reaffirmed the FDA’s commitment to strengthening regulatory oversight and called for increased investment, improved logistics and stronger collaboration among stakeholders to expand regulatory coverage and enhance blood safety standards across the country.
