Continuing Activity COP 11 funding = $400,000 - The Clinical and Laboratory Standards Institutes (CLSI) mandate is to develop best practices in clinical and laboratory testing and promote their use internationally. In Mozambique, the goal of the CLSI technical assistance program is to assist the Ministry of Health to implement internationally accepted laboratory standards towards quality improvement and WHO accreditation.

CLSI works strategically to provide accreditation preparedness and capacity building assistance aligned with USG goals as outlined in the Partnership Framework to strengthen laboratory support services for HIV diagnosis and management through improved quality diagnostics. In addition, CLSI supports broader country goals by developing mechanisms to strengthen individual laboratories and the national laboratory system as a whole. In FY12 training and mentorship support will also be given to the National Blood Service for the implementation of Quality Management Systems in the blood banks. CLSIs program strengthens the national system by developing master trainers amongst laboratory staff working in the clinical laboratories and cascading expertise through all laboratory tiers. Building capacity of local laboratory personnel ensures the continuation of accreditation preparedness activities. With local experts, coverage of programs can be expanded and sustainability ensured in the long run. Internal and external assessments to monitor and evaluate progress are built into the quality implementation and accreditation preparedness process to ensure continual improvement and adherence to best practices and set standards. In FY11 CLSIs funding was reduced due to a significant pipeline. The new MOASIS project is requesting 1 vehicle ($5,000) with FY12 funds,

Continuing Activity COP 12 funds = $250,000) The Clinical Laboratory Standards Institute (CLSI) will continue to support the strengthening of laboratory support services for HIV diagnosis and management, through the implementation of a standards based Quality Management System (QMS).

Mozambique has adopted the SLMTA program to set foundations for laboratory management and quality improvement. Whilst the program addresses the management tasks and processs critical to a quality laboratory it does not address some aspects that are pivotal to a fully established quality management system (QMS). With FY12 funding CLSI will provide support to labs enrolled in the SLMTA program to provide a comprehensive understanding of the fundamental aspects of a laboratory quality management system key to achieving accreditation. Achieving a level of laboratory accreditation will demonstrate: existence of processes, systems and procedures that ensure consistent, sustainable and quality lab performance; utilization of appropriate quality monitoring indicators and the essential engagement of the laboratory administration/management;

With FY12 funding CLSI will implement the following activities:

1) Develop master trainers, assessors, and laboratory operational and quality management personnel to ensure: the sustainability of the QMS and the achieved laboratory accreditation status; as well as expansion of the QMS and accreditation to all laboratory tiers. CLSI will support the development of Master Trainers and Quality/Management at the selected laboratories to ensure skills transfer to all levels of lab services throughout the country with minimal outside support in the long run.

2) With FY12 funding, CLSI will support training of laboratory quality managers. Pivotal to the success of the implementation of a QMS in any laboratory is an adequately equipped quality manager. Training quality managers will build key skills of a quality manager and will ensure that the responsibilities are clarified and skills provided on how to organize an effective quality program. CLSI will provide in-house mentorship post training workshop to guide and support the development of skills necessary to provide oversight of a quality Assurance program and Quality Management Systems.

3) CLSI will also provide training on how to conduct internal audits. This training will build personnel skills on how to plan for and conduct an internal audit as well as how utilize the findings from the audit, apply corrective action and improve processs.

In collaboration with the other laboratory coalition partners and the Federal University of Rio de Janeiro (FURJ) support will be provided to the eight laboratories currently enrolled in SLMTA as well as to three additional labs to be enrolled in FY12. In the implementation of these activities, CLSI will structure a scalable program to meet the needs of each specific lab, regardless of technical discipline or tier within the national lab structure. This will give each laboratory the ability to achieve the goal of laboratory accreditation regardless of its circumstances or unique challenges. Assessments will be carried out at baseline, after six months and post SLMTA implementation to assess improvements. Supervision will be conducted throughout the process and laboratories will receive feedback on corrective actions required.

This implementing mechanism seeks to support the National Blood Service in the implementation of Quality Management Systems in the blood banks. The activities will include training blood banks staff on QMS and provide direct mentorship to the National reference Blood Center. By supporting the establishement of QMS in the National Reference Blood Center this IM is expecting to reduce the risk of HIV transmission via blood transfusion in Mozambique.