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.
Introduction highly active antiretroviral therapy (HAART) has led to a decline in HIV-induced morbidity and mortality in recent years. However, it has been opined that this has led to elevated risks of cardiovascular diseases (CVDs). This study assessed the risks of CVDs among HAART experienced individuals living with HIV. Methods a cross sectional study involving 196 adults consisting of 118 HAART experienced and 78 HAART naïve was conducted. Anthropometric and blood pressure measurements were recorded for all participants. Blood samples obtained from the volunteers were used to determine glucose, creatinine, HIV viral load, CD4 count and lipid profile using standard methods. Lipid ratios, atherogenic indices and QRISK3 risk score were calculated. Results the median CD4 lymphocyte, mean body mass index (BMI) and HDL-c in HAART experienced participants were higher (P<0.05) than HAART naive individuals. The QRISK3 risk score and creatinine were higher (p<0.05) among HAART experienced group. In HAART experienced group, the risk of hypertension, increased low-density lipoprotein (LDL-c), atherogenic index of plasma (AIP) and QRISK3 were 3.7, 2.0, 2.38 and 3.85 times (p<0.05) higher respectively than in HAART naive. Atherogenic coefficient (AC) increase was more prevalent among male (p<0.05) participants. Risk of chronic renal disease (eGFR), hypertension and CVD (as measured by QRISK3) was higher (p<0.05) among the female and older participants respectively. Conclusion the risk of CVDs and renal disease appeared to be higher among HAART experienced volunteers and older (>45 years) volunteers. The risk of renal disease appeared higher in females.
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