Experience of quality management system in a clinical laboratory in Nigeria

Abstract

IssuesQuality-management systems (QMS) are uncommon in clinical laboratories in Nigeria, and until recently, none of the nation’s 5 349 clinical laboratories have been able to attain the certifications necessary to begin the process of attaining international accreditation. Nigeria’s Human Virology Laboratory (HVL), however, began implementation of a QMS in 2006, and in 2008 it was determined that the laboratory conformed to the requirements of ISO 9001:2000 (now 2008), making it the first diagnostic laboratory to be certified in Nigeria. The HVL has now applied for the World Health Organization (WHO) accreditation preparedness scheme. The experience of the QMS implementation process and the lessons learned therein are shared here.DescriptionIn 2005, two personnel from the HVL spent time studying quality systems in a certified clinical laboratory in Dakar, Senegal. Following this peer-to-peer technical assistance, several training sessions were undertaken by HVL staff, a baseline assessment was conducted, and processes were established. The HVL has monitored its quality indicators and conducted internal and external audits; these analyses (from 2007 to 2009) are presented herein.Lessons learnedAlthough there was improvement in the pre-analytical and analytical indicators analysed and although data-entry errors decreased in the post-analytical process, the delay in returning laboratory test results increased significantly. There were several factors identified as causes for this delay and all of these have now been addressed except for an identified need for automation of some high-volume assays (currently being negotiated). Internal and external audits showed a trend of increasing non-conformities which could be the result of personnel simply becoming lax over time. Application for laboratory accreditation, however, could provide the renewed vigour needed to correct these non-conformities.RecommendationThis experience shows that sustainability of the QMS at present is a cause for concern. However, the tiered system of accreditation being developed by WHO–Afro may act as a driving force to preserve the spirit of continual improvement.

Strengthening national health laboratories in sub‐Saharan Africa: a decade of remarkable progress

“…; Audu et al . ). These improvements, partially stimulated by the WHO‐AFRO stepwise accreditation preparedness initiative, have been accompanied by an increase in the number of laboratories in the continent that are engaged in the accreditations process (Mothabeng et al .…”

“…This process has demonstrated that implementation of a stepwise accreditation preparedness approach can be user-friendly, attractive to all laboratory tiers and developmentally focused while providing a useful mechanism for identifying resource, training, system strengthening needs and target areas for specific interventions (Gershy-Damet et al 2010). Many African states are undertaking changes to strengthen their national laboratory systems (Zeh et al 2010;Audu et al 2012). These improvements, partially stimulated by the WHO-AFRO stepwise accreditation preparedness initiative, have been accompanied by an increase in the number of laboratories in the continent that are engaged in the accreditations process (Mothabeng et al 2012;Maruta et al 2012).…”

Active tracking of rejected dried blood samples in a large program in Nigeria

“…Active patient tracking systems that use social workers to track patients have been applied in Kenya to reduce LTFU among HIV, PMTCT and tuberculosis patients from 21% to 15% [43] . In other studies, peer-based strategies that engage expert and or mentor-mothers in educating and motivating HIV positive mothers to access PMTCT services using their own experience, have been instrumental in improving retention of mother-baby pair in care [58,59] . Interventions should therefore seek to educate mothers and guardians on the grave importance of early diagnosis in pediatric HIV.…”

Evaluation of Laboratory Performance with Quality Indicators in Infectious Disease Hospital, Kano, Nigeria

“…QMS are still uncommon in clinical laboratories in Nigeria [6] [7]. In January 2010, implementation of QMS toward WHO-AFRO laboratory accreditation [8] [9] commenced in Nigeria involving several laboratories including Infectious Disease Hospital (IDH), Kano [10], which is supported by FHI360.…”