The Clinical and Laboratory Standards Institute's (CLSI) mandate is to develop best practices in clinical and laboratory testing and promote their use throughout the world. To achieve this CLSI, works together with the CDC/GAP Laboratory coalition partners to build laboratory capacity and implement quality improvement strategies in resource-constrained settings through detailed assessments, training and education based on critical needs, and the implementation of laboratory "best practices." Driven by accepted clinical and laboratory standards and guidelines, CLSI is committed to facilitating the development of quality systems in the laboratory, and providing on-going advisement to sustain quality improvements.

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 strengthens the capacity of countries to collect and use surveillance data and manage national HIV, TB, and malaria programs by expanding surveillance programs and strengthening laboratory support for surveillance, diagnosis, treatment, disease-monitoring and HIV screening for blood safety. Additionally, CLSI supports broader country goals by developing mechanisms to strengthen individual laboratories, while supporting the enhancement of the national laboratory systems as a whole. Goals and objectives: CLSI's overall goal is to use a standardized approach to raise the operational quality of laboratories leading up to laboratory accreditation through implementation of CLSI and other internationally accepted best practices and standards. Their work is scalable to the level of the laboratory and acceptable to various accreditation agency models. 1) Implement Quality Management Systems (QMS) and internationally recognized laboratory standards in 8 provincial laboratories and 3 central level hospitals, ensuring the sustainable strengthening of national laboratory systems to achieve accreditation;

2) Develop master trainers, assessors, and laboratory operational and quality management personnel to ensure: a. sustainability of the QMS and the achieved laboratory accreditation status b. continued expansion of QMS and accreditation to all laboratory tiers

3) Assist with the implementation of the national strategic plan through this activity.

CLSI's standards-driven approach, together with the implementation of QMS bridges the gap between pre-service training and in-field application. This foundation prepares laboratory personnel to successfully implement and sustain the technical assistance of lab coalition partners across all lab disciplines.

The geographic coverage is national, through the development of master trainers from laboratory staff working in the clinical laboratories to cascade expertise through all laboratory tiers.

CLSI will contribute to health system strengthening by improving the quality of national, provincial and central laboratories with increased capacity to augment service quality at all laboratory levels. Apart from that they will build human resource capacity to train in quality implementation and improvement as well as to supervise and manage the implementation process.

CLSI's program strategy targets the training of master trainers and assessors and the development of Laboratory Operational and Quality Management staff on the application of QMS. Effective implementation of QMS is critical to continued accreditation preparedness and improved quality of service. Building capacity of local laboratory personnel ensures the continuation of accreditation preparedness activities allowing a timely exit of the technical assistance providers. With local experts coverage of programs can be increased as well as ensures sustainability in the long run.

CLSI uses a six phased approach to building lab capacity that can be scaled and adapted to specific

country needs, providing on-going monitoring, conducted remotely and in-country. Their curriculum is driven by standards and best practices. They work collaboratively in-country to customize training to meet local needs. In all cases, individuals and organizations will be mentored through on-going advisement and support to ensure the sustainability and effectiveness of all interventions. CLSI will work in close cooperation with the MOH, the USG, and USG supported implementing partners to ensure that determined goals are met successfully and in a timely manner in working toward the institution of Quality Management Systems and relevant standards and guidelines.

A key process in the monitoring and evaluation plan is the implementation of a QMS is internal and external audits or assessments. The program is 'self evaluating" as these assessments are built into the system to ensure continual improvement and adherence to best practices and set standards.

The Clinical Laboratory Standards Institute (CLSI) will commence support to Mozambique in FY 2010 to strengthen laboratory support services for HIV diagnosis and management, through the implementation of a standards based Quality Management System (QMS). The QMS aims to raise the operational quality of laboratories with the end goal of leading the laboratory to accreditation. This will be done through implementation of CLSI and other internationally accepted best practices. CLSI will implement the following activities:

1) Implement Quality Management Systems (QMS) and internationally recognized laboratory standards in 8 provincial laboratories and 3 central level hospitals in Maputo, Beira, and Nampula, ensuring sustainable strengthening of national laboratory systems to achieve accreditation. This will be done through assessments of the selected laboratories, training and education based on critical needs, followed by implementation of laboratory best practices. 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;

2) 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. Development of Master Trainers and Quality/Management at the selected laboratories should ensure the cascading of expertise to all levels of lab services throughout the country with minimal outside support.

In the implementation of these activities which support the National strategic plan, 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.