Journal of Health and Medical Sciences
ISSN 2622-7258
Published: 04 January 2020
Quality Assurance in Medical Laboratories in Developing Countries: Assessment of Pre-Analytical Errors in a Chemical Pathology Laboratory in a Tertiary Hospital in Nigeria
Allison Frederick Igila, Ojule Aaron C.
University of Port-Harcourt, Nigeria
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10.31014/aior.1994.03.01.90
Pages: 1-11
Keywords: Pre-Analytical Phase, Quality Assurance, Quality Indicators (QIs), Total Testing Process, International Organization for Standardization (ISO), Defect Per Million (DPM)
Abstract
BACKGROUND: The total testing process is made up of the pre-analytical, analytical and post analytical phases. Most of the non-conformities to laid down laboratory procedures are known to be at the pre-analytical phase, amounting to about 70% of errors in the total testing phase. Most laboratories, in instituting total quality assurance, concentrate mainly on the analytical phase and the post analytical phase. The ISO, in a bid to correcting this oversight introduced a modifiable quality indicator system which monitors laid down processes and procedures of the laboratories. AIM- This study was therefore designed to assess the pre-analytical phase of the testing process in a Chemical Pathology laboratory of a teaching hospital in southern Nigeria. METHODS- The ISO quality indicators were modified to suit the standard operations of the Preanalytical phase of the said laboratory. With the help of a questionnaire, non-conformities to these laid- down procedures were assessed. Defects per million (DPM) of each indicator were calculated and a sigma value assigned as the performance level. A sigma value below 3 was seen as unacceptable performance and that between 3 and 4 was seen as acceptable performance. Lastly a sigma value above 4 indicated good performance. RESULT- A total of 17 quality indicators were used to assess the pre-analytical phase and 12 (70.6%) had unacceptable performance levels while 2 (11.8%) had acceptable performance levels. Only 3(17.6%) of these indicators had good performance levels. CONCLUSION- A holistic look at the performance of the quality indicators of the pre-analytical phase in this study showed that about 71% of the pre-analytical quality indicators assessed had unacceptable performance levels; 12% had acceptable performance level and only 18% had good performance level. This grossly indicates very poor quality pre-analytical sample acquisition and processing procedures. Steps therefore need to be taken to rectify these errors.
References
- Barth, J.H. (2011) ‘Clinical Quality Indicators in Laboratory Medicine: a survey of current practice in the UK’. Annals of Clinical Biochemistry, 48(3), 238-240.
- Da Rin, G.(2009), ‘Pre-analytical workstations: A tool for reducing laboratory errors’. Clinica Chimica Acta 404(1), 68-74.
- Eijsden, M.V., Van der wal, M.F., Hornstra, G. & Bonsel, G.J. (2005) ‘Can whole blood samples bestored over 24 hours without compromising stability of C-reactive protein, Retinol, Ferritin, Folic acid and Fatty acids in Epidemiologic Research?’ Clinical chemistry, 51(1), 230-232.
- Englezopoulou, A., Kechagia, M., Chatzikiriakou, R., Kanellopoulou, M., Valenti, M. & Masedu, F. (2016) ‘Pre Analytical Errors as Quality Indicators in Clinical Laboratory’. Austin Journal of Public Health Epidemiology, 3(5): 1048. ISSN: 2381-9014.
- Fraser, C.G. & Fogarty, Y.(1989) ‘Interpreting laboratory results’. British Medical Journal, 298(6689),1659-1660.
- Giménez-MarÃn, A., Rivas-Ruiz, F., Del Mar Pérez-Hidalgo, M.D.M.& Molina-Mendoza, P.(2014) ‘Pre-analytical errors management in the clinical laboratory: a five-year study’. Biochemia Medica, 24(2), 248-257.
- Kalra, J. & Kopargaonkar, A. (2016), ‘Quality Improvement in Clinical Laboratories: A Six Sigma Concept’. Pathology and Laboratory Medicine international, 1(1),11-20.
- Lima-Oliveira, G., Guidi, G.C., Guimaraes, A.V.P., Correa, J.A. & Lippi, G. (2017), ‘Preanalytical nonconformity management regarding primary tube mixing in Brazil’. Journal of Medical Biochemistry, 36(1), 39-43.
- Martins, J.M., Rateke, E.C.M.& Martinello, F.(2018), ‘Assessment of the pre-analytical phase of a clinical analyses laboratory’. Jornal Brasileiro de Patologia e Medicina Laboratorial, 54(4), 232-240
- Plebani, M., Chiozza, M.L. & Sciacovelli, L.(2013) ‘Towards harmonization of quality indicators in laboratory medicine’. Clinical Chemistry and Laboratory Medicine, 51(1), 187-195.
- Plebani, M., Sciacovelli, L., Aita, A. & Chiozza, M.L. (2014), ‘Harmonization of pre analytical quality indicators’. Biochemia Medica, 24(1), 105-113
- Salinas, M., López-Garrigós, M., Yago, M., Ortuño, M., Carratala, A. & Aguado, C. et al. (2011) ‘Quality assessment for pre-analytical phase in clinical laboratory: a multicentric study’. Revista de Calidad Asistencial, 26(4): 264-268.
- Simundic, A.M., Cornes. M., Grankvist. K., Lippi, G. & Nybo, M (2014) ‘Standardization of collection requirements for fasting samples: for the Working Group on Preanalytical Phase (WG-PA) of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM)’. Clinica Chimica Acta ,15(432),33-37.
- Singh H, Meyer AN, Thomas EJ. (2014), ‘The frequency of diagnostic errors in outpatient care: estimations from three large observational studies involving US adult populations’. BMJ Quality &Safty, 23 (9), 727-731.