Laboratory Quality Audit in 25 Anti-Retroviral Therapy Facilities in North West of Nigeria

Feyisayo Ebenezer Jegede, Henry Akwen Mbah^*, Timothy Nathaniel Yakubu, Oluwasanmi Adedokun, Olubunmi Ruth Negedu-Momoh, Kwasi Torpey

Family Health International (FHI360), Abuja, Nigeria.

DOI: 10.4236/ojcd.2014.44028                

Abstract

Introduction: A laboratory’s ability to consistently produce high-quality and reliable results hinges on adopting laboratory standards that guide daily practices to ensure steady quality improvement. Although assessment is an extremely rewarding exercise in health care quality improvement processes, it is always considered very time consuming and expensive in developing world settings. A quarterly internal audit was conducted in 25 FHI360 supported Antiretroviral Treatment laboratories in the North West of Nigeria which can surely provide reference for other countries. Methodology: A checklist adapted from the World Health Organization/African Regional Office laboratory accreditation checklist was used to quantitatively evaluate 7 quality essentials (QEs). A team composed of technical staff from FHI360, State Ministry of Health and facility laboratory heads, conducted the audits, developed and monitored intervention plans. Information obtained with the checklist was captured in excel, validated and imported into Grappa Prism software version 5.0 for analysis. Results: Most (92%) facilities were at secondary level with (8%) at tertiary level. The mean total score on all QEs across the facilities was 63.34 ± 9.77 in quarter (Q) 1, 68.8 ± 10.91 in Q2, 72.59 ± 8.02 in Q3 and 72.72 ± 9.16 in Q4 (p ≤ 0.0001). The most improved QE through Q1-Q4 was organization and personnel (32.2%), while signage/bench top reference had an 18.6% point decline. In ranking facilities based on differences of total scores between Q4 and Q1, Kachia General Hospital was the highest with 27 point increase. Considering the mean percentage score for all quarters per facility, 4 had ≥ 80%, 19 had between 60%-80% and 2 had ＜60%. The total non-conformities cited for QI-Q4 were 185, 100, 78 and 64 respectively with highest recorded in internal and external quality control and the least in facility and safety. Conclusion: We recorded some improvement in most QEs confirming the benefits of internal audits, reviews and follow-up. However, much more is needed in terms of technical assistance, capacity building, mentorship, and commitment at facility and state level to meet minimum acceptable laboratory quality standards.

Keywords

Laboratory, Internal Audits, Quality Essentials, Non-Conformities, Nigeria

Conflicts of Interest

The authors declare no conflicts of interest.

References

[1]	Carraro, P. and Plebani, M. (2007) Errors in a Stat Laboratory: Types and Frequencies 10 Years Later. Clinical Chemistry, 53, 1338-1342. http://dx.doi.org/10.1373/clinchem.2007.088344
[2]	Abimiku, A.G. (2009) Building Laboratory Infrastructure to Support Scale-Up of HIV/AIDS Treatment, Care, and Prevention: In-Country Experience. American Journal of Clinical Pathology, 131, 875-886. http://dx.doi.org/10.1309/AJCPELMG6GX6RQSM
[3]	Audu, R.A., et al. (2011) Experience of Quality Management System in a Clinical Laboratory in Nigeria. African Journal of Laboratory Medicine, 1, 1-5. http://dx.doi.org/10.4102/ajlm.v1i1.18
[4]	Guindo, M.A., et al. (2012) Promoting Good Clinical Laboratory Practices and Laboratory Accreditation to Support Clinical Trials in Sub-Saharan Africa. The American Journal of Tropical Medicine and Hygiene, 86, 573-579. http://dx.doi.org/10.4269/ajtmh.2012.11-0691
[5]	Zeh, C.E., Inzaule, S.C., Magero, V.O., Thomas, T.K., Laserson, K.F., Hart, C.E. and Nkengasong, J.N. (2010) Field Experience in Implementing ISO 15189 in Kisumu, Kenya. American Journal of Clinical Pathology, 134, 410-418. http://dx.doi.org/10.1309/AJCPZIRKDUS5LK2D
[6]	Erasmus, R.T. and Zemlin, A.E. (2009) Clinical Audit in the Laboratory. Journal of Clinical Pathology, 62, 593-597. http://dx.doi.org/10.1136/jcp.2008.056929
[7]	(2009) Comprehensive Accreditation Manual for Pathology and Laboratory Services. Joint Commission, Oakbrook.
[8]	Gershy-Damet, G.-M., et al. (2010) The World Health Organization African Region Laboratory Accreditation Process: Improving the Quality of Laboratory Systems in the African Region. American Journal of Clinical Pathology, 134, 393-400. http://dx.doi.org/10.1309/AJCPTUUC2V1WJQBM
[9]	Yao, K., McKinney, B., Murphy, A., Rotz, P., Wafula, W., Sendagire, H., Okui, S. and Nkengasong, J.N. (2010) Improving Quality Management Systems of Laboratories in Developing Countries: An Innovative Training Approach to Accelerate Laboratory Accreditation. American Journal of Clinical Pathology, 134, 401-409. http://dx.doi.org/10.1309/AJCPNBBL53FWUIQJ
[10]	International Organisation for Standardisation (2012) ISO 15189:2012: Medical Laboratories Requirements for Quality and Competence. International Organisation for Standardisation, Geneva. http://www.iso.org
[11]	Datema, T.A.M., Oskam, L. and Klatser, P.R. (2011) Review and Comparison of Quality Standards, Guidelines and Regulations for Laboratories. African Journal of Laboratory Medicine, 1, 1-7. http://dx.doi.org/10.4102/ajlm.v1i1.3
[12]	Wattanasri, N., Manoroma, W. and Viriyayudhagorn, S. (2010) Laboratory Accreditation in Thailand: A Systemic Approach. American Journal of Clinical Pathology, 134, 534-540. http://dx.doi.org/10.1309/AJCPZYY19WMKMAZT
[13]	Nordling, L. (2009) African Disease Labs to Get Health Check. Nature, Published Online. http://dx.doi.org/10.1038/news.2009.735
[14]	World Health Organization (2010) WHO Guide for the Stepwise Laboratory Improvement Process towards Accreditation in the African Region (Checklist). WHO, Geneva, 1-60.
[15]	Elbireer, A.M., Jackson, J.B., Sendagire, H., Opio, A., Bagenda, D. and Amukele, T.K. (2013) The Good, the Bad, and the Unknown: Quality of Clinical Laboratories in Kampala, Uganda. PLoS ONE, 8, e64661. http://dx.doi.org/10.1371/journal.pone.0064661
[16]	Schroeder, L.F. and Amukele, T. (2014) Medical Laboratories in Sub-Saharan Africa That Meet International Quality Standards. American Journal of Clinical Pathology, 141, 791-795. http://dx.doi.org/10.1309/AJCPQ5KTKAGSSCFN
[17]	Asamole-Osuocha, C., Mbah, H., Cartier, S., Ojo, E., Badru, T., Ibrahim, M., Oka, I., Egwa, E. and Chabikuli, O. (2014) External Quality Assessment?: On-Site Evaluation of HIV Testing and Counselling Sites in Nigeria. Journal of AIDS and HIV Research, 6, 97-103.
[18]	Mothabeng, D., Maruta, T., Lebina, M. and Lewis, K. (2012) Strengthening Laboratory Management towards Accreditation?: The Lesotho Experience. African Journal of Laboratory Medicine, 1, 1-2. http://dx.doi.org/10.4102/ajlm.v1i1.9
[19]	Ho, B. and Kong, H. (2012) The Most Common Nonconformities Encountered during the Assessments of Medical Laboratories in Hong Kong Using ISO 15189 as Accreditation Criteria. Biochemia Medica, 22, 247-257. http://dx.doi.org/10.11613/BM.2012.027
[20]	Chimzizi, R.B., Harries, A.D., Manda, E., Khonyongwa, A., Killam, W.P. and Salaniponi, F.M. (2005) The Use of a Monitoring Tool to Assess Counselling and HIV Testing in the Public Health Sector in Malawi. Tropical Doctor, 35, 72-75. http://dx.doi.org/10.1258/0049475054037020
[21]	Gough, L.A. and Reynolds, T.M. (2000) Is Clinical Pathology Accreditation Worth It? A Survey of CPA-Accredited Laboratories. Clinical Performance and Quality Healthcare, 8, 195-201. http://dx.doi.org/10.1108/14664100020361746
[22]	Alkhenizan, A. and Shaw, C. (2012) The Attitude of Health Care Professionals towards Accreditation: A Systematic Review of the Literature. Journal of Family and Community Medicine, 19, 74-80. http://dx.doi.org/10.4103/2230-8229.98281
[23]	Agyeman-Duah, J., Theurer, A., Munthali, C., Alide, N. and Neuhann, F. (2014) Understanding the Barriers to Setting up a Healthcare Quality Improvement Process in Resource-Limited Settings: A Situational Analysis at the Medical Department of Kamuzu Central Hospital in Lilongwe, Malawi. BMC Health Services Research, 14, 1. http://dx.doi.org/10.1186/1472-6963-14-1
[24]	Latham, T., Malomboza, O., Nyirenda, L., Ashford, P., Emmanuel, J., M’baya, B. and Bates, I. (2012) Quality in Practice: Implementation of Hospital Guidelines for Patient Identification in Malawi. International Journal for Quality in Health Care, 24, 626-633. http://dx.doi.org/10.1093/intqhc/mzs038
[25]	Mbah, H., Negedu-Momoh, O.R., Adedokun, O. and Anibbe, P. (2014) Implementing and Measuring the Level of Laboratory Service Integration in a Program Setting in Nigeria. PLoS ONE, 9, e107277. http://dx.doi.org/10.1371/journal.pone.0107277