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ORIGINAL ARTICLE
Open Access

Hybrid Mentorship of Medical Laboratories to Achieve ISO 15189:2012 Accreditation in Malawi: The University of Maryland Malawi Experience

Hannaniah Moyo, Sophia Osawe, Charles Nyangulu, Philemon Ndhlovu, Visopo Harawa, Oscar Divala, Malango Msukwa, Talishiea Croxton, Natalia Blanco, Dyson Mwandama, Memory Mkandawire, Elizabeth Kampira, Muluken Kaba, Alice Maida, Andrew F. Auld, Lindsay Kim, Reuben Mwenda, Howard Kress, James Kandulu, Thresa Sumani, Joseph Bitilinyu, Thokozani Kalua and Alash’le Abimiku
Global Health: Science and Practice December 2024, 12(6):e2400254; https://doi.org/10.9745/GHSP-D-24-00254
Hannaniah Moyo
aCenter for International Health, Education, and Biosecurity, Lilongwe, Malawi.
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Sophia Osawe
bInstitute of Human Virology Nigeria, Abuja, Nigeria.
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  • For correspondence: sosawe{at}ihvnigeria.org
Charles Nyangulu
aCenter for International Health, Education, and Biosecurity, Lilongwe, Malawi.
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Philemon Ndhlovu
aCenter for International Health, Education, and Biosecurity, Lilongwe, Malawi.
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Visopo Harawa
aCenter for International Health, Education, and Biosecurity, Lilongwe, Malawi.
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Oscar Divala
aCenter for International Health, Education, and Biosecurity, Lilongwe, Malawi.
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Malango Msukwa
aCenter for International Health, Education, and Biosecurity, Lilongwe, Malawi.
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Talishiea Croxton
cCenter for International Health, Education, and Biosecurity, University of Maryland School Medicine, Baltimore, MD, USA.
dInstitute of Human Virology, University of Maryland School Medicine, Baltimore, MD, USA.
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Natalia Blanco
cCenter for International Health, Education, and Biosecurity, University of Maryland School Medicine, Baltimore, MD, USA.
dInstitute of Human Virology, University of Maryland School Medicine, Baltimore, MD, USA.
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Dyson Mwandama
eUniversity Research Co. Lilongwe, Malawi.
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Memory Mkandawire
eUniversity Research Co. Lilongwe, Malawi.
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Elizabeth Kampira
fDivision of Global HIV and TB, U.S. Centers for Disease Control and Prevention, Lilongwe, Malawi.
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Muluken Kaba
fDivision of Global HIV and TB, U.S. Centers for Disease Control and Prevention, Lilongwe, Malawi.
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Alice Maida
fDivision of Global HIV and TB, U.S. Centers for Disease Control and Prevention, Lilongwe, Malawi.
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Andrew F. Auld
fDivision of Global HIV and TB, U.S. Centers for Disease Control and Prevention, Lilongwe, Malawi.
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Lindsay Kim
fDivision of Global HIV and TB, U.S. Centers for Disease Control and Prevention, Lilongwe, Malawi.
gU.S. Public Health Service, Atlanta, GA, USA.
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Reuben Mwenda
fDivision of Global HIV and TB, U.S. Centers for Disease Control and Prevention, Lilongwe, Malawi.
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Howard Kress
fDivision of Global HIV and TB, U.S. Centers for Disease Control and Prevention, Lilongwe, Malawi.
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James Kandulu
hDiagnostic Department, Ministry of Health, Lilongwe, Malawi.
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Thresa Sumani
hDiagnostic Department, Ministry of Health, Lilongwe, Malawi.
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Joseph Bitilinyu
hDiagnostic Department, Ministry of Health, Lilongwe, Malawi.
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Thokozani Kalua
aCenter for International Health, Education, and Biosecurity, Lilongwe, Malawi.
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Alash’le Abimiku
bInstitute of Human Virology Nigeria, Abuja, Nigeria.
cCenter for International Health, Education, and Biosecurity, University of Maryland School Medicine, Baltimore, MD, USA.
iDepartment of Medicine, University of Maryland School Medicine, Baltimore, MD, USA.
jDivision of Global Health Sciences, Department of Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore, MD, USA.
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Figures & Tables

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  • FIGURE 1
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    FIGURE 1

    Mentorship and Accreditation Timelines for HIV Molecular Laboratories in Malawi

    Abbreviations: SADCAS, Southern African Development Community Accreditation Service; SLIPTA, Stepwise Laboratory Quality Improvement Process Towards Accreditation; SLMTA, Strengthening Laboratory Management Toward Accreditation; WHO, World Health Organization.

  • FIGURE 2
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    FIGURE 2

    Median Score of Pre- and Post-Tests for HIV Molecular Laboratory Trainings, Malawia

    a All post-test scores represent a statistically significant difference (P<.01).

Tables

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    TABLE 1.

    Characteristics of Malawi HIV Molecular Laboratories Selected for Mentorship to Achieve ISO 15189 Accreditation

    #Laboratory TypeSample TypeAccreditation ScopeTesting PlatformStaff, No.Distance From Lilongwe/ Central Lab, kmStar Recognition
    Cohort 1
    1Public/NGODBS/plasmaHIV viral loadAbbott m2000860 km3
    2Public/NGODBS/plasmaHIV viral loadAbbott m2000843 km3
    3ReferenceDBSHIV viral loadAbbott m2000140 km4
    4Private/publicDBS/plasmaHIV viral loadAbbott m20001220 km3
    5District hospitalaDBSHIV viral load, EID, TB, chemistry, serology, blood banking, and hematologyGeneXpert80 km3
    Cohort 2
    1Central hospitalDBSHIV viral loadAbbott m2000855 km4
    2Central hospitalDBSHIV viral loadAbbott m2000846 km1
    3Central hospitalDBS/plasmaHIV viral loadAbbott m200087 km4
    4Central hospitalDBS/plasmaHIV viral loadAbbott m2000810 km3
    5District hospitalaDBSHIV viral load, EID, TBGeneXpert80 km4
    • Abbreviations: DBS, dried blood sample; EID, early infant diagnosis; NGO, nongovernmental organization; ISO, International Organization for Standardization; SLIPTA, Stepwise Laboratory Quality Improvement Process Towards Accreditation.

    • a This laboratory was part of both cohort 1 and cohort 2, however, it reduced its scope for cohort 2.

    • View popup
    TABLE 2.

    Nonconformities Identified During Baseline Audit and SADCAS Assessments of Malawi HIV Molecular Laboratories

    Nonconformities, No.
    LaboratoryBaseline AuditSADCAS AssessmentChange
    MajorMinorTotalMajorMinorTotalMajorMinorTotalP Value
    Cohort 1
    130535741123124.06
    220929691514014
    3251035571220323
    4201030551015520
    52883630131-275
    Cohort 2
    1681078831160767.06
    2448521241632436
    3494531211337340
    445752561140141
    5a301311121319-118
    • Abbreviation: SADCAS, Southern African Development Community Accreditation Service.

    • ↵a Cohort 1 lab 5 transitioned to cohort 2 lab 5; therefore, its SADCAS assessment from cohort 1 was used as its baseline audit for cohort 2.

    • View popup
    TABLE 3.

    Accreditation Status for Malawi HIV Molecular Laboratories in Mentorship Program

    LaboratoryDate Mentorship BeganAccreditation Status/Date
    Cohort 1
    1January 2020October 27, 2020
    2January 2020October 16, 2020
    3January 2020October 22, 2020
    4January 2020October 29, 2020
    5aJanuary 2020Not successful
    Cohort 2
    1March 2021June 8, 2022
    2March 2021June 28, 2022
    3March 2021May 25, 2023
    4March 2021June 12, 2022
    5aMarch 2021July 27, 2022
    • a This laboratory was part of both cohort 1 and cohort 2, however, it reduced its scope for cohort 2.

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Global Health: Science and Practice: 12 (6)
Global Health: Science and Practice
Vol. 12, No. 6
December 20, 2024
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Hybrid Mentorship of Medical Laboratories to Achieve ISO 15189:2012 Accreditation in Malawi: The University of Maryland Malawi Experience
Hannaniah Moyo, Sophia Osawe, Charles Nyangulu, Philemon Ndhlovu, Visopo Harawa, Oscar Divala, Malango Msukwa, Talishiea Croxton, Natalia Blanco, Dyson Mwandama, Memory Mkandawire, Elizabeth Kampira, Muluken Kaba, Alice Maida, Andrew F. Auld, Lindsay Kim, Reuben Mwenda, Howard Kress, James Kandulu, Thresa Sumani, Joseph Bitilinyu, Thokozani Kalua, Alash’le Abimiku
Global Health: Science and Practice Dec 2024, 12 (6) e2400254; DOI: 10.9745/GHSP-D-24-00254

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Hybrid Mentorship of Medical Laboratories to Achieve ISO 15189:2012 Accreditation in Malawi: The University of Maryland Malawi Experience
Hannaniah Moyo, Sophia Osawe, Charles Nyangulu, Philemon Ndhlovu, Visopo Harawa, Oscar Divala, Malango Msukwa, Talishiea Croxton, Natalia Blanco, Dyson Mwandama, Memory Mkandawire, Elizabeth Kampira, Muluken Kaba, Alice Maida, Andrew F. Auld, Lindsay Kim, Reuben Mwenda, Howard Kress, James Kandulu, Thresa Sumani, Joseph Bitilinyu, Thokozani Kalua, Alash’le Abimiku
Global Health: Science and Practice Dec 2024, 12 (6) e2400254; DOI: 10.9745/GHSP-D-24-00254
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