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

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...

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Main Authors: 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
Format: Article
Language:English
Published: AOSIS 2022-05-01
Series:African Journal of Laboratory Medicine
Subjects:
Online Access:https://ajlmonline.org/index.php/ajlm/article/view/1614
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author 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
author_facet 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
author_sort Ernest P. Makokha
collection DOAJ
description 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.
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spelling doaj.art-705aef63d58d4aeb8b291d2949ddcff72022-12-22T02:37:13ZengAOSISAfrican Journal of Laboratory Medicine2225-20022225-20102022-05-01111e1e810.4102/ajlm.v11i1.1614367Enhancing accreditation outcomes for medical laboratories on the Strengthening Laboratory Management Toward Accreditation programme in Kenya via a rapid results initiativeErnest P. Makokha0Raphael O. Ondondo1Daniel K. Kimani2Thomas Gachuki3Frank Basiye4Mercy Njeru5Muthoni Junghae6Marie Downer7Mamo Umuro8Margaret Mburu9Jane Mwangi10Laboratory Services Branch, Division of Global HIV & TB, United States Centers for Disease Control and Prevention, NairobiLaboratory Services Branch, Division of Global HIV & TB, United States Centers for Disease Control and Prevention, NairobiLaboratory Services Branch, Division of Global HIV & TB, United States Centers for Disease Control and Prevention, NairobiNational HIV Reference Laboratory, Division of Public Health Laboratories, Ministry of Health, NairobiLaboratory Services Branch, Division of Global HIV & TB, United States Centers for Disease Control and Prevention, NairobiLaboratory Services Branch, Division of Global HIV & TB, United States Centers for Disease Control and Prevention, NairobiLaboratory Services Branch, Division of Global HIV & TB, United States Centers for Disease Control and Prevention, NairobiLaboratory Services Branch, Division of Global HIV & TB, United States Centers for Disease Control and Prevention, NairobiNational HIV Reference Laboratory, Division of Public Health Laboratories, Ministry of Health, NairobiLaboratory Services Branch, Division of Global HIV & TB, United States Centers for Disease Control and Prevention, NairobiLaboratory Services Branch, Division of Global HIV & TB, United States Centers for Disease Control and Prevention, NairobiBackground: 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.https://ajlmonline.org/index.php/ajlm/article/view/1614rapid results initiativeaccreditationquality systems essentialssliptaslmtae-slipta checklist
spellingShingle 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
Enhancing accreditation outcomes for medical laboratories on the Strengthening Laboratory Management Toward Accreditation programme in Kenya via a rapid results initiative
African Journal of Laboratory Medicine
rapid results initiative
accreditation
quality systems essentials
slipta
slmta
e-slipta checklist
title Enhancing accreditation outcomes for medical laboratories on the Strengthening Laboratory Management Toward Accreditation programme in Kenya via a rapid results initiative
title_full Enhancing accreditation outcomes for medical laboratories on the Strengthening Laboratory Management Toward Accreditation programme in Kenya via a rapid results initiative
title_fullStr Enhancing accreditation outcomes for medical laboratories on the Strengthening Laboratory Management Toward Accreditation programme in Kenya via a rapid results initiative
title_full_unstemmed Enhancing accreditation outcomes for medical laboratories on the Strengthening Laboratory Management Toward Accreditation programme in Kenya via a rapid results initiative
title_short Enhancing accreditation outcomes for medical laboratories on the Strengthening Laboratory Management Toward Accreditation programme in Kenya via a rapid results initiative
title_sort enhancing accreditation outcomes for medical laboratories on the strengthening laboratory management toward accreditation programme in kenya via a rapid results initiative
topic rapid results initiative
accreditation
quality systems essentials
slipta
slmta
e-slipta checklist
url https://ajlmonline.org/index.php/ajlm/article/view/1614
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