The main objective of the Lesotho Quality Assurance project is to assist the public health and clinical laboratories to attain readiness for accreditation through Stepwise laboratory improvement process toward accreditation (SLIPTA). NICD will ensure the standard 12 elements of a quality system will be used as a working framework. The key areas that will be reviewed include management requirements, (organization and management), current quality management system (QMS) in place, document control, technical records, external service including referral laboratory testing, internal audits, management review, environmental and accommodation, and safety. Support also included training, supportive supervision and mentoring,There are 21 laboratories nationwide and NICD support to for quality improvement and plans to accredit 5 laboratories and/or score 5 stars based on WHO SLIPTA by the end of 2014.NICD will implement the project in line with the national laboratory strategic plan. It will coordinate activities with partners to avoid duplication and to strengthen activities where NICD provides specific support that is not provided by partners e.g. External Quality Assurance/Proficiency Panel Testing (EQA/PT) for patient monitoring including CD4 and viral load testing. The activities that will that require close coordination with partners include QMS implementation and training. The NICD assumes responsibility for EQA/PT for patient monitoring tests and regular proficiency panels are distributed to all participating laboratories in lesotho. The NICD will therefore ensure that the laboratories are enrolled in the appropriate program and triangulate information from EQA/PT with ongoing QA implementation for continuous quality improvement.

Main objective is to assist laboratories to improve quality of diagnosis and patient monitoring and attain readiness for accreditation through mentoring and coaching of the laboratory staff. Major activities includeActivities:1) Quality Assurance implementation:Assist in mentoring the QA manager in terms of roles and responsibilities (on-site mentoring as well as formal training e.g. SANAS or ACILT). Assist in strengthening the Quality assurance Unit of MOHSW by active assistance and by providing opportunities for training such that the necessary knowledge and skills are obtained to assist the MOHSW reach its objectives.On-site mentoring will be provided that will strive to avoid disrupting the routine activities. Planned visits to laboratories for three months will be undertaken to ensure that there is sufficient time to cover test methods in terms of QA requirements. At the end of the period, processes will be assessed for completeness and milestones documented for processes that are not complete. Information will be collated to assess infrastructure by lab, range of staff employed, range of test procedures, qualifications, reporting structure, and other elements required for a functional QA system, i.e. a gap/needs analysis.Continue to enroll and monitor all Lesotho laboratories in relevant EQA/PT schemes for chemistry, microbiology, hematology and molecular tests.

2) Strengthening Molecular Diagnostics: Early Infant Diagnosis (EID) and viral load:NICD will provide technical assistance in technology transfer including additional training, assessment of readiness to perform routine PCR testing, equipment/reagent procurement, enrollment in PT schemes. It will support PCR and viral load and other tests and develop capacity of the central laboratory to perform these tests in the long term. NICD will assist with a re-testing program of 10% of EID samples tested in Lesotho and EQA/PT schemes.

NICD will continue supporting the referral testing services and transfer the technology and skills to in-country laboratory by the need of FY 2012 COPNICD will provide M & E in terms of the number of infants born to HIV positive women who received an HIV test within 12 months of birth, and establishing databasesNICD will provide necessary expertise in areas of Antiretroviral Drug resistance testing including technology transfer, equipment/reagent procurement, and enrollment in PT schemes activities3) Biosafety:Support the development of safety policies and guidance to improve safety and establishment of programs for occupational health and waste management.

4) Equipment maintenances and procurement:NICD will assist the MOHSH in support the equipment maintenance including development of guidelines on preventive and curative maintenance. It will also support the procurement of equipment accessories and supplies as a stop-gap measure5) Training:NICD will support and facilitate appropriate in-service training using the African Center for Integrated Laboratory Training (ACILT), for courses including EID, National Laboratory Strategic Planning and Biosafety. Training workshops on laboratory equipment preventive and curative maintenance