1. Training and certification for POC sites and testers
ADVANCING THE LABORATORY PROFESSION AND NETWORKS IN AFRICA
Training and certification for POC sites and testers
Anafi Mataka
ASLM
IAS 2019 Satellite Session, Mexico City, 22 July 2019

2. Outline
Introduction
The Objectives
Implementation

3. Introduction to Rapid Testing Competency
Priority area in laboratory quality improvement efforts for goals
Major program component to effective screening, diagnosis, and viral load monitoring
The First 90 and Rapid Test Performance: False positives a problem?
Rapid testing laboratory competency continues to be a priority area in the laboratory quality improvement efforts and essential in meeting PEPFAR’s goals. It is a major program component to effective screening, diagnosis, and viral load monitoring. The pan-African consortium will emphasize continued support, training and technical assistance to countries already engaged in RTCQI efforts, including finalization of certification frameworks and implementation of selected training programs. In partnership with CDC and other implementing partners, the pan-African consortium will continue to support implementation of national certification frameworks for HIV testers and testing sites and RTCQI best practices and in the PEPFAR-supported countries of Uganda, Ghana, Zambia, Malawi, Cameroon, and Tanzania.

4. Personnel and site certification
ISO requirement – POCT Clause c: Only personnel who have completed the training and demonstrated competence shall carry out POCT. Records of training/attestation (or certification) and of retraining and re-attestation (or recertification) shall be retained.
Review the RT site records
Observe the RT site operations
practical
competence (100%) and written assessment (80%).
Ask open ended questions
Follow client specimen or result through the testing process

5. 20 Introduction to Rapid Testing Competency
ASLM and Pan African Consortium offering TA finalization of certification frameworks and implementation of selected training programs
RTCQI best practices in PEPFAR- supported countries: Uganda, Ghana, Zambia, Malawi, Cameroon, and Tanzania. 20
Rapid testing laboratory competency continues to be a priority area in the laboratory quality improvement efforts and essential in meeting PEPFAR’s goals. It is a major program component to effective screening, diagnosis, and viral load monitoring. The pan-African consortium will emphasize continued support, training and technical assistance to countries already engaged in RTCQI efforts, including finalization of certification frameworks and implementation of selected training programs. In partnership with CDC and other implementing partners, the pan-African consortium will continue to support implementation of national certification frameworks for HIV testers and testing sites and RTCQI best practices and in the PEPFAR-supported countries of Uganda, Ghana, Zambia, Malawi, Cameroon, and Tanzania.

6. The Objectives
To establish a national certification framework for HIV testers and testing sites
To improve the accuracy and reliability of HIV rapid testing through implementation of RTCQI best practices
To enhance the competency of HIV testers and testing sites towards national certification

7. Implementation

8. 1. National certification framework for HIV testers and testing sites
Drafted and finalized framework
Tanzania, Malawi, Cameroon, Uganda, Zambia
Regional sensitization meetings to promote implementation of the national certification framework
initiated in Tanzania, Malawi, Zambia; and is ongoing in other countries to ensure national coverage and expansion of RTCQI.
National certification bodies have been identified
Tanzania, Malawi, Uganda and Cameroon
National certification frameworks for HIV rapid testers and testing sites have been drafted and finalized in all countries – Tanzania, Malawi, Cameroon, Uganda, Zambia.
Official MOH endorsement and adoption of the national certification frameworks for HIV rapid testers and testing sites has been achieved in the countries of Tanzania, Malawi, Uganda.
National certification frameworks have been endorsed and printed for distribution in Tanzania, Uganda and Malawi; and efforts are on-going in Uganda. In Zambia and Cameroon, printing and distribution will commence following approval/endorsement of the certification framework by the MOH.
In Tanzania 900 copies printed/distributed to MOH and regional health facilities; while in Malawi 500 copies have been printed for regional distribution.
training to build in-country capacity and support for implementation of program activities are ongoing

9. 1. National certification framework contents – Example

10. 1. National certification framework – Example

12. Maintenance of site and tester certification. Monitoring and Evaluation

13. 2. Improving the accuracy and reliability of HIV rapid testing through implementation of RTCQI best practices
852 SITES enrolled
Refresher training sessions in preparation for national certification activities have been conducted in all countries - Tanzania, Malawi, Ghana, Cameroon, Zambia and Uganda..
Across all six countries a total of 852 sites have been enrolled in the RTCQI program – including Uganda (150), Tanzania (193), Cameroon (150), Zambia (93), Ghana (69), Malawi (197).

14. 3. Enhance the competency of HIV testers and testing sites towards national certification
Regional baseline assessments conducted to assess number of available testing facilities, testing points, testers, and establish targets for Year 1
Testing points
Testers Targeted
Tanzania
186
600
Uganda
150
518
Zambia 93
100
Regional baseline assessments planned in Tanzania, Zambia, Ghana, and Uganda to assess the number of testing points and testers within the targeted regions has been completed
Regional baseline assessments planned in Tanzania, Zambia, Ghana, and Uganda to assess the number of testing points and testers within the targeted regions has been completed.
In Tanzania, 186 testing points have been enrolled in RTCQI; a total of 600 testers are targeted.
In Uganda, 150 testing points have been enrolled in RTCQI; a total of 518 testers are targeted.
In Zambia, 93 testing points have been enrolled in RTCQI; a total of 100 testers are targeted.
actions

15. 3. Auditors and Competence Evaluators Trained
Trained site auditors and competency evaluators to support implementation of national certification activities

16. Coverage of audited sites over 90% in all the 6 countries
3. – Cont - Conducted audits of HIV testing sites towards national certification
Coverage of audited sites over 90% in all the 6 countries
Graph of country coverage / and Star Distribution

17. Ongoing and planned activities
Tester Certification has started
Tanzania (139/166 non-laboratory testers were evaluated, of which 93 certified)
Other countries - not yet fully implemented
Site assessment – ongoing
EQA
Ongoing
Performance of EQA in a few countries

18. Key take home messages
Rapid HIV testing has been essential in meeting goals
Competency – of testers is a requirement by international standards
Countries need to put in place systems and institutionalize continuous improvement of rapid testing and POC.
ASLM and the PAC has worked to develop national certification frameworks in 6 countries and hope to scale up to about 20 in the near future.

19. Thank You
Become and ASLM member!