The Food and Drugs Authority (FDA) has stated that only 12 blood banking facilities nationwide meet required licensing standards. This finding comes after years of regulatory work and audits by the authority. The situation highlights significant challenges in ensuring safe blood collection and transfusion services across Ghana.
These findings were presented by Dr Edwin Nkansah, Director of Vaccine Vigilance and Clinical Trials at the FDA. He spoke at a meeting in Accra focused on blood regulation. Out of approximately 350 health facilities licensed by the Health Facilities Regulatory Agency (HeFRA), 112 blood banking facilities were audited. A further 78 underwent verification audits. However, just 12 of these obtained the necessary compliance for licensing.
The FDA began its efforts to regulate blood and blood products in 2014. The goal was to ensure all collected, processed, stored, distributed, and transfused blood meets the highest safety and quality standards. Regulatory guidelines and inspection checklists were developed in 2015. The authority also engaged in benchmarking exercises with the World Health Organization (WHO) and the Blood Regulators Network. Support from the WHO, the UK Blood Safety Programme, and the 4Life Research Institute provided crucial technical and financial assistance, including annual refresher training. Despite these efforts, recent logistical and financial constraints have hindered audit processes.
Common issues leading to non-compliance include the use of unregistered medical devices. Facilities often lack adequate donor care systems. Poor documentation and a shortage of dedicated, well-trained personnel are also prevalent. Improper waste disposal and storage practices further compromise safety. Dr Nkansah noted that many facilities rely on rapid diagnostic test kits without confirmatory testing. This practice might compromise the safety of donated blood. Challenges in donor management, such as insufficient privacy during screening and inadequate post-donation care, can discourage voluntary donation. He observed that facilities undergoing multiple inspections show improvements. Compliance rates have fallen in areas like haemovigilance, quality management, and risk management for these facilities. Haemovigilance is the monitoring of the entire process of blood donation to transfusion. Data indicates that transfusion-related adverse reactions have fluctuated since 2016. The Greater Accra Region recorded the highest number of these reactions. The Eastern Region followed with the next highest count. Whole blood transfusions accounted for about 87 percent of all reported adverse reactions.
Dr Nkansah expressed disappointment over the low number of licence applications. He mentioned that some facilities licensed in 2019 have not renewed their licenses. The FDA urges blood banking facilities to prioritize compliance. They should apply for licensing to guarantee safe and quality blood products nationwide. The FDA remains committed to strengthening its oversight. Increased investment, better logistics, and enhanced stakeholder collaboration are needed. These steps will help expand regulatory coverage and improve blood safety standards across Ghana.