Original Research

Enhancing accreditation outcomes for medical laboratories on the Strengthening Laboratory Management Toward Accreditation programme in Kenya via a rapid results initiative

Ernest P. Makokha, Raphael O. Ondondo, Daniel K. Kimani, Thomas Gachuki, Frank Basiye, Mercy Njeru, Muthoni Junghae, Marie Downer, Mamo Umuro, Margaret Mburu, Jane Mwangi
African Journal of Laboratory Medicine | Vol 11, No 1 | a1614 | DOI: https://doi.org/10.4102/ajlm.v11i1.1614 | © 2022 Ernest P. Makokha, Raphael O. Ondondo, Daniel K. Kimani, Thomas Gachuki, Frank Basiye, Mercy Njeru, Muthoni Junghae, Marie Downer, Mamo Umuro, Margaret Mburu, Jane Mwangi | This work is licensed under CC Attribution 4.0
Submitted: 06 May 2021 | Published: 31 May 2022

About the author(s)

Ernest P. Makokha, Laboratory Services Branch, Division of Global HIV & TB, United States Centers for Disease Control and Prevention, Nairobi, Kenya
Raphael O. Ondondo, Laboratory Services Branch, Division of Global HIV & TB, United States Centers for Disease Control and Prevention, Nairobi, Kenya
Daniel K. Kimani, Laboratory Services Branch, Division of Global HIV & TB, United States Centers for Disease Control and Prevention, Nairobi, Kenya
Thomas Gachuki, National HIV Reference Laboratory, Division of Public Health Laboratories, Ministry of Health, Nairobi, Kenya
Frank Basiye, Laboratory Services Branch, Division of Global HIV & TB, United States Centers for Disease Control and Prevention, Nairobi, Kenya
Mercy Njeru, Laboratory Services Branch, Division of Global HIV & TB, United States Centers for Disease Control and Prevention, Nairobi, Kenya
Muthoni Junghae, Laboratory Services Branch, Division of Global HIV & TB, United States Centers for Disease Control and Prevention, Nairobi, Kenya
Marie Downer, Laboratory Services Branch, Division of Global HIV & TB, United States Centers for Disease Control and Prevention, Nairobi, Kenya
Mamo Umuro, National HIV Reference Laboratory, Division of Public Health Laboratories, Ministry of Health, Nairobi, Kenya
Margaret Mburu, Laboratory Services Branch, Division of Global HIV & TB, United States Centers for Disease Control and Prevention, Nairobi, Kenya
Jane Mwangi, Laboratory Services Branch, Division of Global HIV & TB, United States Centers for Disease Control and Prevention, Nairobi, Kenya


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Abstract

Background: Since 2010, Kenya has used SLIPTA to prepare and improve quality management systems in medical laboratories to achieve ISO 15189 accreditation. However, less than 10% of enrolled laboratories had done so in the initial seven years of SLMTA implementation.

Objective: We described Kenya’s experience in accelerating medical laboratories on SLMTA to attain ISO 15189 accreditation.

Methods: From March 2017 to July 2017, an aggressive top-down approach through high-level management stakeholder engagement for buy-in, needs-based expedited SLIPTA mentorship and on-site support as a rapid results initiative (RRI) was implemented in 39 laboratories whose quality improvement process had stagnated for 2–7 years. In July 2017, SLIPTA baseline and exit audit average scores on quality essential elements were compared to assess performance.

Results: After RRI, laboratories achieving greater than a 2-star SLMTA rating increased significantly from 15 (38%) at baseline to 33 (85%) (p < 0.001). Overall, 34/39 (87%) laboratories received ISO 15189 accreditation within two years of RRI, leading to a 330% increase in the number of accredited laboratories in Kenya. The most improved of the 12 quality system essentials were Equipment Management (mean increase 95% CI: 5.31 ± 1.89) and Facilities and Biosafety (mean increase [95% CI: 4.05 ± 1.78]) (both: p < 0.0001). Information Management and Corrective Action Management remained the most challenging to improve, despite RRI interventions.

Conclusion: High-level advocacy and targeted mentorship through RRI dramatically improved laboratory accreditation in Kenya. Similar approaches of strengthening SLIPTA implementation could improve SLMTA outcomes in other countries with similar challenges.


Keywords

rapid results initiative; accreditation; quality systems essentials; SLIPTA; SLMTA; e-SLIPTA checklist

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