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

Outline Introduction The Objectives Implementation

Introduction to Rapid Testing Competency Priority area in laboratory quality improvement efforts for 90-90-90 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 90-90-90 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.

Personnel and site certification ISO requirement – POCT - 22870 Clause 5.1.3 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

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 90-90-90 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.

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

Implementation

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

1. National certification framework contents – Example

1. National certification framework – Example

Maintenance of site and tester certification. Monitoring and Evaluation

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).

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

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

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

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

Key take home messages Rapid HIV testing has been essential in meeting 90-90-90 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.

Thank You Become and ASLM member!