Lessons from the Field

Experience of quality management system in a clinical laboratory in Nigeria

Rosemary A. Audu, Ugochukwu Sylvester-Ikondu, Chika K. Onwuamah, Olumuyiwa B. Salu, Fehintola A. Ige, Emily Meshack, Maureen Aniedobe, Olufemi S. Amoo, Azuka P. Okwuraiwe, Florence Okhiku, Chika L. Okoli, Emmanuel O. Fasela, Ebenezer O. Odewale, Roseline O. Aleshinloye, Micheal Olatunji, Emmanuel O. Idigbe
African Journal of Laboratory Medicine | Vol 1, No 1 | a18 | DOI: https://doi.org/10.4102/ajlm.v1i1.18 | © 2012 Rosemary A. Audu, Ugochukwu Sylvester-Ikondu, Chika K. Onwuamah, Olumuyiwa B. Salu, Fehintola A. Ige, Emily Meshack, Maureen Aniedobe, Olufemi S. Amoo, Azuka P. Okwuraiwe, Florence Okhiku, Chika L. Okoli, Emmanuel O. Fasela, Ebenezer O. Odewale, Roseline O. Aleshinloye, Micheal Olatunji, Emmanuel O. Idigbe | This work is licensed under CC Attribution 4.0
Submitted: 09 December 2011 | Published: 29 October 2012

About the author(s)

Rosemary A. Audu, Human Virology Laboratory, Nigerian Institute of Medical Research, Lagos, Nigeria
Ugochukwu Sylvester-Ikondu, Human Virology Laboratory, Nigerian Institute of Medical Research, Lagos, Nigeria
Chika K. Onwuamah, Human Virology Laboratory, Nigerian Institute of Medical Research, Lagos, Nigeria
Olumuyiwa B. Salu, Human Virology Laboratory, Nigerian Institute of Medical Research, Lagos, Nigeria
Fehintola A. Ige, Human Virology Laboratory, Nigerian Institute of Medical Research, Lagos, Nigeria
Emily Meshack, Human Virology Laboratory, Nigerian Institute of Medical Research, Lagos, Nigeria
Maureen Aniedobe, Human Virology Laboratory, Nigerian Institute of Medical Research, Lagos, Nigeria
Olufemi S. Amoo, Human Virology Laboratory, Nigerian Institute of Medical Research, Lagos, Nigeria
Azuka P. Okwuraiwe, Human Virology Laboratory, Nigerian Institute of Medical Research, Lagos, Nigeria
Florence Okhiku, Human Virology Laboratory, Nigerian Institute of Medical Research, Lagos, Nigeria
Chika L. Okoli, Human Virology Laboratory, Nigerian Institute of Medical Research, Lagos, Nigeria
Emmanuel O. Fasela, Human Virology Laboratory, Nigerian Institute of Medical Research, Lagos, Nigeria
Ebenezer O. Odewale, Human Virology Laboratory, Nigerian Institute of Medical Research, Lagos, Nigeria
Roseline O. Aleshinloye, Human Virology Laboratory, Nigerian Institute of Medical Research, Lagos, Nigeria
Micheal Olatunji, Human Virology Laboratory, Nigerian Institute of Medical Research, Lagos, Nigeria
Emmanuel O. Idigbe, Human Virology Laboratory, Nigerian Institute of Medical Research, Lagos, Nigeria

Abstract

Issues: Quality-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.

Description: In 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 learned: Although 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.

Recommendation: This 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.


Keywords

laboratory; certification; accreditation; indicators; quality management

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