The Food and Drugs Authority (FDA) has expressed concern over persistent regulatory non-compliance in blood banking facilities, revealing that only 12 nationwide have met licensing standards despite years of audits and capacity-building.

Dr Edwin Nkansah, Director of Vaccine Vigilance and Clinical Trials at the FDA, disclosed this at a stakeholder meeting on blood regulation, held on the theme “Road to Compliance”, held in Accra on Tuesday.

He said out of about 350 health facilities licensed by the Health Facilities Regulatory Agency (HeFRA), 112 blood banking facilities had undergone audits, while 78 had verification audits.

But only 12 attained the compliance level required for licensing.

Dr Nkansah explained that since blood regulation activities began in 2014, the FDA had worked to ensure all blood and blood products collected, processed, stored, distributed and transfused met the highest safety and quality standards.

He recalled milestones including the development of regulatory guidelines and inspection checklists in 2015, and benchmarking exercises by the World Health Organization (WHO) and the Blood Regulators Network in 2016.

Dr Nkansah said the FDA had benefited from technical and financial support from WHO, the UK Blood Safety Programme and the 4Life Research Institute, which provided annual refresher training and capacity-building.

However, logistical and financial constraints had recently affected audits.

The FDA identified common non-compliance issues such as use of unregistered blood-related medical devices, inadequate donor care systems, poor documentation, lack of dedicated personnel, insufficient training, improper waste disposal and poor storage practices.

Dr Nkansah noted that many facilities relied solely on rapid diagnostic test kits without confirmatory testing, potentially compromising blood safety.

He highlighted challenges in donor management, including inadequate privacy during screening and insufficient post-donation care, warning that such practices could undermine voluntary blood donation.

Despite these challenges, Dr Nkansah reported improvements in compliance among facilities that had undergone multiple inspections, with reductions in non-compliance rates in areas such as haemovigilance, quality management and risk management.

He praised facilities for embracing haemovigilance frameworks, noting fewer cases of non-compliance after verification audits.

Data showed transfusion-related adverse reactions fluctuated since 2016, with Greater Accra recording the highest number of cases, followed by the Eastern Region.

Whole blood transfusions accounted for about 87 per cent of reported adverse reactions.

Dr Nkansah said more manufacturers and suppliers were registering blood-related medical devices, including screening reagents, rapid test kits, blood bags and transfusion sets.

He, however, expressed disappointment over the low number of licence applications, noting that some facilities licensed in 2019 had failed to renew their licences.

Dr Nkansah urged blood banking facilities to prioritise compliance and apply for licensing to ensure safe, quality blood and blood products nationwide.

He reaffirmed FDA’s commitment to strengthening oversight and called for increased investment, logistics and stakeholder collaboration to expand regulatory coverage and enhance blood safety standards.