Background: Turnaround Time (TAT) is an important Quality Indicator in the medical laboratory. The Rivers State University Teaching Hospital (RSUTH) Polymerase Chain Reaction (PCR) laboratory was enrolled in the process of World Health Organisation (WHO) - Regional Office for Africa (AFRO) accreditation by FHi360 in preparation for the ISO 15189 accreditation in 2016. One of the services rendered in the laboratory is Early Infant Diagnosis (EID)/Dried Blood Spots (DBS) in Human Immunodeficiency Virus (HIV) exposed infants. Clinicians depend on these results to determine the next step for the management of HIV exposed Infants. This study is aimed at assessing the rate of sample rejection (SR), determine the effect of specific intervention on this rate and the effect of SR on TAT.
Method: It involves the assessment of samples delivered to the RSUTH PCR Laboratory from January 2019 to March 2020. A baseline rate of sample rejection was established from January to July 2019. Interventional measures were put in place such as introducing the national algorithm for rejection and acceptance of samples, training was also done for EID sample collectors and a final assessment of changes in the rate of sample rejection was determined at the final period of January to March 2020.
Results: During the baseline period, sample rejection rate started at 5% in February and went back to 0% in March. In April however, the rate of rejection increased to 9%. There was a decline in rejection rate to 5% and 7% in May and June respectively. A sudden spike in rejection occurred in July at a rate of 19%. The major reasons for sample rejection were DBS cards with insufficient blood spots, DBS cards with clots present in spots, DBS cards that have serum rings and grossly haemolysed DBS. After baseline data was collected and interventions put in place. Sample rejection rate drastically reduced to 1%, 0% and 0% respectively from January to March which is way below the maximum threshold of 2% as advocated by WHO. At baseline EID, TAT was longer than a month, however; with SR, the TAT increased to about seven weeks. The final assessment in March from this study showed a significant reduction in sample rejection to 0%.
Conclusion and recommendations: This study has shown that quality improvement is achievable if interventional tools are utilized promptly. This will result in shorter TAT; fewer samples rejected and therefore prompt treatment of exposed infants thus reducing morbidity and mortality due to HIV.
G. J. Fermann and J. Suyama, “Point of care testing in the emergency department”. Journal of Emergency Medicine, vol. 22, pp. 393–404, 2002.
B. Bergman and B. Klefsjo, Quality: From customer needs to customer satisfaction. Maidenhead, England: McGraw-Hill, 1994.
N. B. Watts, “Reproducibility (precision) in alternate site testing. A clinician’s perspective.” Archives of Pathology & Laboratory Medicine, vol. 119, pp. 914–917, 1995.
C. R. Handorf, “College of American Pathologists Conference XXVIII on alternate site testing: Introduction.” Archives of Pathology & Laboratory Medicine, vol. 119, pp. 867–73, 1995.
P. J. Howanitz, and S. J. Steindel, “Intra-laboratory performance and laboratorians’ expectations for stat turnaround times. A College of American Pathologists Q-Probes study of four cerebrospinal fluid determinations”. Archives of Pathology & Laboratory Medicine, vol. 115, pp. 977–983, 1991.
P. A. Wayne, Application of a Quality Management System Model for Laboratory Services, Clinical and Laboratory Standards Institute. 3rd ed. CLSI; Document GP26-A3, pp. 1887-1898, 2004.
The Joint Commission, National patient safety goals: laboratory services program, 2009.
World Health Organization, Antiretroviral drugs for treating pregnant women and preventing HIV infection in infants-recommendations for a public health approach: 2010 version,” WHO, Geneva. Available: http://whqlibdoc.who.int/publications/2010/9789241599818_eng.pdf
J. A. Volmink, and B. J. Marais, HIV: Mother-to-Child Transmission,” Clinical Evidence (Online), 2008, Published Online 5 February. Available: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2907958/
M. L. H. Newell, M. Coovadia, N. Cortina-Borja, P. Rollins, S. Gaillard, and F. Dabis, “Ghent International AIDS Society (IAS) Working Group on HIV Infection in Women and Children, Mortality of Infected and Uninfected Infants Born to HIV-Infected Mothers in Africa: A Pooled Analysis.” Lancet, vol. 364, no. 9441, pp. 1236- 1243, 2004.
K. Mcintosh, J. Pitt, and D. Brambilla, “Blood culture in the first 6 months of life for the diagnosis of vertically transmitted human immunodeficiency virus infection: The women and infants transmission study group.” The Journal of Infectious Diseases, vol. 17, no. 4, pp. 996–1000, 1994.
G. G. Sherman, P. A. Cooper, A. H. Coovadia, A. J. Puren, S. A. Jones, and M. Mokhachane, “Polymerase chain reaction for diagnosis of human immunodeficiency virus infection in infancy in low resource settings.” Paediatric Infectious Disease Journal, vol. 24, no. 11, pp. 993-997, 2005.
T. L. Creek, G. G. Sherman, J. Lu, L. T. Finkbeiner, and M. G. Fowler, “Infant human immunodeficiency virus diagnosis in resource-limited settings: Issues, technologies, and country experiences.” American Journal of Obstetrics & Gynecology, vol. 197, no. 3, S64-S71, 2007.
W. Stevens, G. Sherman, R. L. Downing, M. C. Parsons, and Y. S. Crowley, “Role of the Laboratory in Ensuring Global Access to ARV Treatment for HIV-Infected Children: Consensus Statement on the Performance of Laboratory Assays for Early Infant Diagnosis.” Open Chemical Physics Journal, vol. 2, pp. 17-25, 2008.
J. S. Read, “Diagnosis of HIV-1 infection in children younger than 18 months in the United States”. Pediatrics, vol. 120, no. 6, e1547–e1562, 2007.
M. Tamhane, B. Gautney, and C. Shiu, “Analysis of the optimal cut-point for HIV-p24 antigen testing to diagnose HIV infection in HIV-exposed children from resource-constrained settings.” Journal of Clinical Virology, vol. 50, no. 4, pp. 338–341, 2011.
M. J. Wessman, Z. T. Heilgaard, and T. L. Katzenstein, “Determination of HIV status of infants born to HIV-infected mothers: A review of the diagnostic methods with special focus on the applicability of p24 antigen testing in developing countries.” Infectious Diseases, vol. 44, no. 3, pp. 209–215, 2012.
American Academy of Pediatrics Committee on Pediatric AIDS, “HIV testing and prophylaxis to prevent mother-to-child transmission in the United States.” Paediatrics, vol. 122, no. 5, pp. 1127–1134, 2010.
R. J. S. Kerr, G. S. Player, A. Fiscus and J. A. E. Nelson, “Qualitative human immunodeficiency virus RNA analysis of dried blood spots for diagnosis of infections in infants.” Journal of Clinical Microbiology, vol. 47, no. 1, pp. 220–222, 2009.
M. Hamufare, M. Owen, C. Addmore, “Early Infant Diagnosis Sample Management in Mashonaland West Province Zimbabwe.” Public Library of Science, vol. 9, no. 3, p. 61, 2017.
N. Grüner, O. Stambouli, R. S. Ross, “Dried blood spots - preparing and processing for use in immunoassays and in molecular techniques. Journal of Visualized Experiments,” in A Treatise on Electricity and Magnetism, C. Maxwell, ed. 3rd ed., vol. 2. Oxford: Clarendon, 1892, pp.68–73, 2015.