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. 2022 May 31;11(1):1614.
doi: 10.4102/ajlm.v11i1.1614. eCollection 2022.

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

Ernest P Makokha  1 , Raphael O Ondondo  1 , Daniel K Kimani  1 , Thomas Gachuki  2 , Frank Basiye  1 , Mercy Njeru  1 , Muthoni Junghae  1 , Marie Downer  1 , Mamo Umuro  2 , Margaret Mburu  1 , Jane Mwangi  1
Affiliations

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

Ernest P Makokha et al. Afr J Lab Med. .

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

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Conflict of interest statement

The authors declare that they have no financial or personal relationships that may have inappropriately influenced them in writing this article.

Figures

FIGURE 1
FIGURE 1
Laboratory star rating before and after rapid results initiative implementation of Strengthening Laboratory Management Toward Accreditation in 39 laboratories in Kenya, 2017–2019.
FIGURE 2
FIGURE 2
Average percent score for quality system essentials performance before and after 100-day rapid results initiative for laboratories to fast-track Stepwise Laboratory Improvement Towards Accreditation in 39 laboratories in Kenya, 2017–2019. (a) All laboratories (n = 39); (b) laboratories with ≥ 2-step star increase (n = 13); (c) laboratories with < 2-step star increase (n = 26).
See this image and copyright information in PMC

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