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Introduction
A functional blood transfusion service (BTS) is a critical component of a comprehensive healthcare system. Blood transfusion is an essential and lifesaving intervention which is key to patient treatment and management. BTS involves interrelated processes carried out by various cadres of medical and non-medical professionals. Errors may occur at any point, resulting in dire consequences for the blood donors, patients and the public at large.1,2
To ensure the high quality and safety of blood and blood components, a national BTS needs to have in place a comprehensive quality management system (QMS) covering the entire process from donor selection through blood donation to utilisation. This aligns with the World Health Organization’s strategy on universal access to safe blood transfusion, which promotes the safety and accessibility of blood and blood components, and the reduction of transfusion-associated risks.3 The strategy recommends implementation of effective quality systems for BTS, including quality management, development and implementation of quality standards, effective documentation systems, staff training and regular quality audits.3
The Kenya National Blood Transfusion Service (KNBTS), under the Ministry of Health, is mandated to provide safe and adequate blood and blood components in the country. KNBTS is managed through a national coordinating unit, six Regional Blood Transfusion Centres (RBTCs) and 11 satellites. The coordinating office also houses the KNBTS National Testing Laboratory (NTL), which mainly conducts confirmatory testing for transfusion transmissible infections for the RBTCs, quality assurance and reference checking. The NTL also serves as a backup testing facility for the RBTCs. The RBTC scope of service includes: (1) blood donor mobilisation, education, recruitment and retention; (2) blood collection and donor care, and laboratory testing of donated blood; (3) blood component preparation; (4) donor counselling and notification; (5) blood banking and distribution; and (6) haemovigilance. Kenya’s blood need is approximately 420 000 units per year based on the World Health Organization’s formula of 1% of the country’s total population, currently estimated at 42 million.4
In 2009, the World Health Organization’s Regional Office for Africa introduced the Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA) and Strengthening Laboratory Management Toward Accreditation (SLMTA) programmes. SLIPTA provides a benchmark framework that measures a laboratory’s compliance with ISO 15189 on a five-star scale using a comprehensive audit tool.5...