The National Institute of Communicable Diseases (NICD) quality assurance initiatives for Lesotho laboratories is a cooperative agreement awarded by HHS/CDC from 2009 to 2014, with a total potential value of $2,200,000. NICD supports quality improvement in HIV/TB/OI diagnosis and laboratory monitoring, accreditation of clinical laboratories, infrastructure and of human resource capacity development.

NICD in South Africa represents the country with respect to laboratory support and provides global public health services as a collaborating laboratory for a regional reference laboratory for World Health Organization (WHO). It has also established co-operative agreements with august institutions such as the Centers for Disease Control and Prevention (CDC) and NIH/NIAID of the USA and other internationally recognized institutions.

The NICD endeavors to establish itself as one of the major global role players in communicable diseases, providing the world health community with important communicable diseases information originating from a continent, which has traditionally been one of the most important sources of new emerging infectious diseases. For the African continent, the NICD provides a much needed laboratory and institutional resource. Diagnostic services, provision of reagents and biological materials and training facilities are made available to African countries to strengthen the existing African laboratory network for surveillance. The NICD supports regional countries including South African Development Community (SADC) countries in terms of Polio-AFP surveillance as well as an EQA/PT provider of HIV-1 testing and measles for SADC and other countries. Moreover, the NICD has been selected as a PEPFAR-supported site in the form of the African Centre for Integrated Laboratory Training (ACILT) that serves to train laboratory staff in various aspects to diagnostics, quality management and surveillance of communicable diseases with emphasis in HIV, TB and malaria. With the provision of PEPFAR funds the NICD aims to assist the Lesotho Government in laboratory capacity building.

The Lesotho Ministry of Health and Social Welfare (LMOHSW) has developed a Laboratory Services National Strategic plan. That serves a guide given that there is an increase in access (decentralization) and extension of services that these services meet international standards. The situational analysis performed has shown a number of strengths and weaknesses of the current Laboratory service. In this context the following strategic objectives were indentified including managing laboratory services, networking and coordination, lab quality assurance is strengthening, effective management of equipment and supplies, effective training at pre and in-service levels and to establishing a well-defined public health laboratory system.

In FY09/10, the NICD has provided assistance to Central Laboratory at Queen II in various activities including ensuring that staff has been trained on systems approaches to quality management, development of routine implementation of Quality Assurance (QA) activities ranging from temperature monitoring, to development of standard operating procedures and enrollment in external proficiency testing. The NICD has collaborated with various partners such as CHAI and ASCP in coordinating activities and developing and using a standardized monitoring tool to assess progress. The NICD has provided capacity to test for infant diagnosis of HIV using PCR. The NICD has tested more that 12,000 specimens.

Full implementation of all aspects of QA is required before accreditation is achieved. The NICD will use PEPFAR funds to provide assistance to MOHSW to increase laboratory capacity, assist in implementation and training of laboratory personnel in quality management system implementation in the following ways. The NICD will ensure that the there is a recognized structure to the QMS system that both management and laboratory staff are aware of and trained in. The standard 12 elements of a QA system will be used as a working framework. The key areas that will be reviewed include management requirements, (organization and management), current QMS system in place, document control, technical records, external service including referral laboratory testing, internal audits, management review, environmental and accommodation, and safety.

The principle objective is to implement laboratory quality system and the laboratories are accredited to provide quality services in support of treatment and care services. The major activities that NICD will support include:

1) Provide laboratory test support for PCR and viral load and other tests, where there is a need and assist in the development of the capacity of the lab to perform these tests in the long term.

2) Perform baseline assessments to determine the level of implementation of the quality managements systems

3) Implementation of QMS training/mentoring

4) Perform assessments/external audits at Lesotho laboratories to assess progress of QMS implementation and readiness for accreditation.

5) Continued enrollment in EQA/PT schemes and assess performance.

6) Provide support to inventory all available equipment in Lesotho laboratories to define needed equipment for procurement.

7) Provide and or facilitate appropriate in-service training using ACILT.

8) Assist in developing strategic information tools in the context of surveillance of ART drug resistance and Incidence/prevalence. In order to ensure that QA systems form part of the routine activities within the laboratory, NICD will review the activities to date in terms of systems in place and functionality and address the areas that require attention.

HIV DNA PCR and Viral load testing

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.

Quality Assurance (QA) program

NICD will perform baseline assessments to determine the level of implementation of the quality managements systems. Laboratory staff will be trained and mentored to implement the requirements of a QA system i.e. managerial and technical, understands the reasons for QA systems, the implementation of various Standard Operating Procedures (SOPs) and the Quality manual, and participation in EQA/PT programs.

All laboratories will be enrolled in the NHLS EQA/PT schemes for the different test procedures, including hematology, microbiology, serology, chemistry and TB. The NICD will provide guidance on additional tools and support equipment inventory and supply management of all available equipment in Lesotho laboratories to define needed equipment for procurement.

NICD will prepare the central and district laboratories for accreditation. The checklists developed by the WHO/CDC and Strengthening Laboratory Management toward Accreditation (SLMTA) will be applied in preparing the laboratories for accreditation. This will be implemented in coordination with the QA Unit of the Directorate of Laboratory Services, MOHSW and other partners.

NICD will develop/facilitate the required tools to monitor specific outcomes that will be linked to the ART program for adults and pediatric settings. This will include tools to monitor clinical outcomes with specific indicators including ART drug resistance monitoring. NICD will implement the program through employment of staff. Two full-time and technical advisors will oversight the support. The scientific advisor will be hired to coordinate this activity and liaising with the MOHSW with regard to program activities and alignment with goals, CDC, NICD and partners as well as provide required technical assistance.

As part of system strengthening, NICD will provide technical support to the MOHSW in management of laboratory services, referral networking, in-service training for laboratory professionals, and establishment of well-defined Public Health Laboratory systems.

In-service training: NICD will provide onsite training and/or facilitate appropriate in-service training using African Center for Integrated Laboratory training (ACILT) and South African Accreditation System (SANAS) based training as required. The training at ACILT will focus on laboratory management, biosafety and infrastructure development, and specific techniques in Early Infant Diagnosis (EID), TB culture and identification and HIV-related testing. In addition, National Health Laboratory Services (NHLS) continuing education program will also be used to strengthen training of staff in clinical chemistry, hematology, CD4 phenotyping, culture and susceptibility testing and basic laboratory.