South Africa - Reference laboratory establishment, SLIPTA AMR Scorecard Development and land of many meetings

Title: ASLM Fleming Fund Blueprint National Laboratory Quality Framework

Code: D20-11 and D22-04

Date: October 2020 - October 2022

Location: Ethiopia, The Netherlands, South Africa

Client: African Society for Laboratory Medicine

Type of services:

Develop the Africa CDC Guidance for Establishing a National Laboratory Quality Framework including a blueprint National Laboratory (Quality) Policy and Strategic Plan to advance quality management system implementation by laboratories in Africa.

Report(s):

[12 Nov 2021] Today, Tjeerd Datema gave a presentation introducing the guidance for establishment of a National Laboratory Quality Framework NLQF during a very well attended launch meeting. The NLQF guidance, endorsed by the African Society for Laboratory Medicine (ASLM), will be rolled-out in countries under the mandate of the Africa Centres for Disease Control and Prevention (Africa CDC) and regional stakeholders. It will definitely impact the advancement of LQMS in African Union Member states.

Source: DATOS LinkedIn Blog.

[31 May 2022] In May 2022 Tjeerd Datema and Linda Oskam were in South Africa for the launch of the NLQF guidance. DATOS assisted the African Society for Laboratory Medicine (ASLM) and Africa Centres for Disease Control and Prevention (Africa CDC) with development of this guidance, which helps policy makers to solidify LQMS efforts into national laboratory policy and planning. Tjeerd Datema presented the NLQF guidance to 14 country teams and we facilitated the development of country implementation plans. Moving into the next phase of advancing quality laboratory services in Africa!

Source: DATOS LinkedIn blog

[8 Jun 2022] DATOS contributed to the development of the NLQF guidance and were the lead facilitators of the workshop. We congratulate the 14 country teams assisted by six Directors of Laboratory Services, who have debated and reached consensus to assess their national QMS implementation strategies. The teams developed and presented roadmaps to strengthen their national laboratory quality policies and/or strategic plans using the NLQF guidance.

Source: DATOS LinkedIn blog

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Title: Support the establishment of the Laboratory Directors Forum

Code: D22-10

Date: September - December 2022

Location: Ethiopia, The Netherlands, South Africa

Client: African Society for Laboratory Medicine

Type of services:

• Support the establishment of the Laboratory Directors Forum
• Co-facilitate the first meeting of the Laboratory Directors Forum in South Africa
• Co-design the first Call to Action

Report(s):

[12 Oct 2022] Read the press release

[14 Oct 2022] The Laboratory Director's Forum met in Cape Town, where 30 national laboratory directors discussed the challenges their labs face, including supply chain management, waste management, silo funding, diagnostic network optimisation, human resources and more.

Source: DATOS LinkedIn blog

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Title: FIND Scorecard development to measure laboratory AMR and TB testing capacity

Code: D18-17, D20-05, D20-15

Date: September 2018 - December 2020

Location: Netherlands + South Africa

Client: Foundation for Innovative New Diagnostics (FIND), South Africa

Type of services:

• Development, review and revision of scorecards to measure AMR laboratory testing capacity and TB laboratory testing capacity.
• Digitalization of the scorecards into e-tools.
• Development of user guides for both scorecards.
• Review of TB-SLMTA curriculum and training materials.

Report(s):

[16 Jun 2021] We are happy to announce the launch of the Score-TB Package, a tool to help build quality-assured tuberculosis laboratory testing and management capacity utilizing the SLIPTA methodology. The Score-TB Package combines TB test-specific scorecards and the SLIPTA checklist in traditional and automated e-tool formats to facilitate user-friendly #quality assessment of modern TB laboratories.

The Score-TB Package is intended to inform Ministry of Health officials, health facility and laboratory managers, donors, implementing partners, quality assurance personnel, program managers and supervisory staff at national, regional and facility levels and it serves as a comprehensive, updated toolkit for #qualitymanagementsystem assessment in individual TB laboratories.

The development of the Score-TB Package was led by FIND, the global alliance for diagnostics. DATOS contributed to its development through review and revision of the scorecards and development of the e-tool. The work was funded by the African Society for Laboratory Medicine (ASLM) and Centers for Disease Control and Prevention through PEPFAR and endorsed by the Global Laboratory Initiative (GLI). Source: DATOS LinkedIn Blog.

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Title: FIND Scorecard development to measure veterinary laboratory AMR testing capacity

Code: D20-09

Date: December 2019 - December 2020

Location: Netherlands + South Africa

Client: Foundation for Innovative New Diagnostics (FIND), South Africa

Type of services:

• Development, review and revision of scorecards to measure AMR testing capacity in veterinary laboratories.
• Digitalization of the scorecards into e-tools.
• Development of a user-guide.

Report(s):

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Title: Webinar development for the Score-TB Package

Code: D20-07

Date: June - December 2019

Location: Netherlands + South Africa

Client: Foundation for Innovative New Diagnostics (FIND), South Africa

Type of services:

Development and provision of (a series of) webinars aimed at introducing the Score TB Package and training assessors on the use of the scorecards and etool.

Report(s):

[10 Dec 2020] Tuesday next week, the 15th of December, Linda Oskam and Tjeerd Datema will give two presentations in the African Society for Laboratory Medicine (ASLM) LabCoP Extended Echo Session to launch the Score-TB Package. 

The Score-TB package consists of an integrated set of assessment tools based on SLIPTA to support the implementation of a QMS in laboratories performing TB tests.

It will be launched by the Foundation for Innovative New Diagnostics (FIND), in collaboration with the Global Laboratory Initiative (GLI), the US Centers for Disease Control and Prevention (CDC) and the ASLM. We contributed to the development of the scorecards.

Source: DATOS LinkedIn Blog

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Title: TESA II Reference Laboratory establishment

Code: D19-08, D19-12

Date: May - August 2019

Location: Mozambique, Botswana, South Africa

Client: Trials of Excellence in Southern Africa, through the Amsterdam Institute for Global Health and Development

Type of services:

• Conducting assessments of capacity, structure, strengths and weaknesses to determine readiness to become reference laboratory for the Trials of Excellence in Southern Africa (TESA) network at:
  • The laboratory of the Centre em Investigação em Saúde de Manhiça (CISM), Mozambique, envisaged to become TESA malaria reference laboratory
  • The laboratory of the Botswana-Harvard Partnership, envisaged to become TESA HIV reference laboratory
  • The laboratory of the Stellenbosch University (SUN), envisaged to become TB reference laboratory
  • The laboratory of the University of Cape Town, to assess capacity to support SUN.
• Conducting interviews with TESA network members to determine needs in terms of reference laboratory testing and support.
• Providing assistance to CISM with resolving nonconformities identified in an ISO 15189:2012 audit conducted by the Portuguese National Accreditation Body.
• Facilitating a workshop to analyse interview and laboratory assessment findings, determine Terms of Reference for TESA reference laboratories, mapping progress of the TESA II project, and improving the TESA and institutional acquisition strategies.

Report(s):

[1 August 2019] In the months of June and July the focus of DATOS’ activities broadened to strengthening research laboratories by assisting the Trials of Excellence in Southern Africa network, shortly TESA network.

The TESA network was launched in 2009 during the European and Developing Countries Clinical Trials Partnership (EDCTP) phase 1. The objective of this network is to strengthen clinical research capacities in Southern Africa as well as increase North-South and South-South networks. Currently, TESA incorporates 13 institutions in eight Southern African and four European countries. The activities of the TESA network currently focus mostly on capacity building and strengthening less established institutions for the identification, treatment and prevention of poverty-related infectious diseases in the Southern Region of Africa.

DATOS was asked to assist with the establishment of reference laboratories within this network for HIV, malaria and tuberculosis. In June we visited:

• The laboratory of the Botswana Harvard Partnership (BHP) which is envisaged to become TESA HIV reference laboratory
• The laboratory of the Centro de Investigação em Saúde de Manhiça (CISM) which is envisaged to become the TESA malaria reference laboratory.

We conducted an assessment at both laboratories to investigate their structure, capacity, quality management system, and other strengths and weaknesses.

During a joint workshop directly following the laboratory visits, the teams of both institutes and the experts of DATOS formulated Terms of Reference (ToR) for the TESA reference laboratories and, based on that, developed an action plan for both laboratories to work towards implementing the ToR. Source: //blog.datos-advice.nl/?p=68

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Title: Laboratory AMR Quality Improvement Project

Code: D19-05

Date: February - March 2019

Location: Netherlands + South Africa

Client: Foundation for Innovative New Diagnostics (FIND), South Africa

Type of services:

Design of a laboratory AMR quality improvement project approach and repository of guidance materials.

Report(s):

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