The Malawi HIV/AIDS Laboratory Capacity Consortium is made up of four institutions with a long-standing history of work in Malawi: the College of Medicine, University of North Carolina (UNC) Project, Loma Linda University-Malawi Adventist Health Services, and Johns Hopkins University-College of Medicine Research Project. These are well established institutions experienced in capacity building in areas of laboratory services, with a long-standing history of collaboration with the Malawi Ministry of Health (MOH) and other partners. They have a large team of committed and experienced scientists with the ability to lead large laboratory initiatives.

Our overall goal is to empower and support the Ministry of Health in its efforts to implement a comprehensive plan to strengthen the national HIV care and treatment program in Malawi in the areas identified in the Partnership Framework and the National Strategic Laboratory Plan. Specifically, this entails supporting human resource development by training medical laboratory technology students and currently deployed laboratory professionals; supporting the Malawi Ministry of Health (MOH), Christian Hospital Association of Malawi (CHAM) and other partners to deliver high quality HIV diagnostic and disease monitoring services; improving the referral linkages from HIV testing to treatment and treatment monitoring sites; and assisting in collecting and using data to improve HIV prevention and treatment outcomes in Malawi.

To accomplish these goals training institutions at Malawi College of Health Sciences, Malamulo College of Health Sciences and College of Medicine will be supported in curriculum development and pre-service training. We will support upgrading of the current curriculum so that it is relevant to the needs of Malawi health care services. We will strengthen preservice training through staff support, and instructors will be sponsored for specialist training at internationally recognized institutions.

The National Reference and Diagnostics Laboratory at the Community Health Science Unit (CHSU) will be strengthened through infrastructure improvements. Support will be provided to CHSU to develop a national laboratory certification scheme and for CHSU to achieve accreditation from an internationally recognized laboratory accrediting body.

Four Mentoring Laboratories will be strengthened; QECH in the Southern Region, Malamulo Hospital in the Southern Region, KCH in the Central Region, and Mzuzu Central Hospital in the Northern Region to provide high quality laboratory services and act as training facilities for students. Support will be provided to the institutions to expand capacity and improve quality of CD4 counting, pediatric and adult HIV and OI diagnostics, TB fluorescence microscopy and TB culture, STI diagnosis, chemistry and hematology.

From the Mentoring Laboratories, District hospital and CHAM hospital laboratories will be supervised and mentored to achieve high quality diagnostic services and an expansion of HIV testing and CD4 count capacity, TB diagnostics, STI diagnosis, chemistry and hematology services. Staff in all Mentoring Laboratories and mentored district and CHAM hospitals will receive in-service training in Good Clinical Laboratory Practice and quality management systems. This programs targets urban and rural laboratories in all regions of Malawi, maximizing geographic impact and outreach to underserved populations.

Data collection and surveillance will provide feedback on program progress and inform national priorities. The current data collection and reporting system will be assessed and strengthened. Data sharing mechanisms with MOH and other stakeholders will be developed, so that routine lab, quality control and surveillance data can be collected at every laboratory in the entire national network. The Consortium will use its significant in-country experience and success with Laboratory Information Systems to support the MOH in its goal of implementing LIS technology.

In order to become cost efficient over time, we will centralize procurement of laboratory reagents and equipment, standardize equipment types across facilities, and strengthen preventative maintenance and

stock control mechanisms. Facilities which have already attained an acceptable standard of laboratory services will be supported and their services expanded with minimal expense.

This program will contribute significantly to the Partnership Framework goals of strengthening HIV treatment and support, providing systems strengthening in laboratory services, health information systems, and human resource development. It will be integrally involved in Partnership Framework goals of (1) scaling up quality assured CD4 testing, early infant diagnosis, TB microscopy, and cost effective methods for screening for virological treatment failure, (2) building MOH capacity to train, mentor, and supervise, laboratory staff, (3) improving referrals and linkages to strengthen the continuum of care, and (4) strengthening health information management systems. Close working relationships will be maintained with CDC, Howard University, CHAM, Malawi Defense Forces, and John Snow International to maximize our outreach and impact.

Budget Summary PFIP Year 1 Funding - $1,738,000 PFIP Year 2 Funding - $1,700,000

Budget Code - HVSI

Activity 1: Support to MOH and partners in collection of laboratory service delivery data collection and analysis. Monitoring and evaluation of laboratory services provides important feedback on program progress and inform national priorities. During FY10, the current data collection and reporting system will be assessed and strengthened under the direction of the MOH and in partnership with other USG partners including Baobab and CHAM. Standardized reporting forms and data sharing mechanisms with MOH, CDC, CHAM and other stakeholders will be developed. Discussions with stakeholders on development of a national laboratory information management system (LIMS) will take place. LIMS systems specifications will be developed and a funding mechanism identified. This contributes towards percentage of health facilities with record-keeping systems for monitoring HIV/AIDS care and support.

In FY11, strengthening the laboratory national data collection and reporting system will continue under the direction of the MOH and in collaboration with partners. Identification and procurement of a national laboratory information management system fitting the specifications developed in FY09 will take place. The system will be piloted and validated at KCH, Bwaila Hospital, and Dowa District Hospital. This contributes towards percentage of health facilities with record-keeping systems for monitoring HIV/AIDS care and support.

Budget Code - OHSS Activity 1: Support to pre-service training institutions In FY10, the laboratory pre-service training curriculum will be reviewed and revised. An advisory group for training incorporating members from relevant stakeholders will conduct a baseline assessment of the medical laboratory training curricula in Malawi, and update it where necessary to address technical and laboratory management skills development. Current district attachments for trainees are highly unstructured. The curriculum development process will specify activities and competencies that will be achieved in each training rotation and provide laboratory staff in the districts with training guidelines to more effectively mentor trainees, contributing to the number of new health care workers graduating from a pre-service training institution. In FY10, this standardized, comprehensive curriculum developed will be integrated into the degree, diploma and certificate programs at Malamulo College of Health Sciences, Malawi College of Health Sciences, and College of Medicine, contributing to the number of new health care workers graduating from a pre-service training institution.

In addition in FY10, full salary support will be provided for one expatriate at Malamulo College of Health

Sciences and one local clinical laboratory tutor at Malawi College of Health Sciences. These tutors will provide training and supervision of students, contributing to the number of new health care workers graduating from a pre-service training institution. This activity will continue in FY11.

In FY10, masters degree level specialty training in the US or South Africa will be provided to one qualified laboratory professional through the NIH Fogarty International Center (UNC AITRP), contributing to the number of new health care workers graduating from a pre-service training institution.

In both FY10 and FY11 we will be working in collaboration with HUTAP to support pre-service training in Malawi. Meetings are scheduled for mid-October 2009 to design with our HUTAP partners a complementary and comprehensive support program.

Activity 2: In service training support. Laboratory management and technical skills of currently deployed laboratory staff will be strengthened through in-service training in FY09. The advisory group for training will develop a 5 day intensive Good Clinical Laboratory Practice (GCLP) training tailored specifically to the types of assays and technical and management challenges met in clinical labs in Malawi. Training of Trainers will take place. The first round of GCLP in-service trainings involving 40 currently serving laboratory staff will take place, 10 from each Mentoring Laboratory catchment area, to provide national coverage. This will contribute to the number of health care workers who have successfully completed an in-service training program.

In FY11, this activity will continue, and in collaboration with other stakeholders, an advanced training curriculum in National Reference Laboratory and Disease Surveillance activities will be developed for Senior Technicians and Technologists selected to do training rotations at CHSU. The Good Clinical Laboratory Practice Training program developed in FY09 will be implemented in the Mentoring Laboratories, with each centre training 20 point of care lab staff in a series of small group trainings (a total of 80 technicians trained). This will contribute to the number of health care workers who have successfully completed an in-service training program.

In FY10, technician exchange & rotation programs will be implemented. Technicians in the Mentoring Laboratories will exchange benches for two weeks four times per year with technicians working at UNC Project and JHU/COM Research Project, giving MOH and CHAM lab staff the opportunity to experience first hand the quality culture and advanced diagnostic techniques offered at two of the country's premier clinical research labs while the JHU/COM and UNC Project exchange technicians share skills with their colleagues in the Mentoring Laboratories. Serving point of care lab technicians in District and CHAM laboratories will spend one week rotations in the Mentoring Laboratories to learn advanced diagnostic techniques and quality practices in those laboratories. This will contribute to the number of health care

workers who have successfully completed an in-service training program.

Budget Code - PMTCT ($350,000.00) In Malawi, HIV counseling and testing numbers are very high for the PMTCT program, but there is currently great concern about the quality of the testing itself, the counseling that is given, and the way that data are recorded. One example is that the prevalence from the program data was less than 60% of the prevalence from ANC surveillance at the same sites in 2007, seeming to indicate that about 40% of the HIV positive women who were tested were incorrectly told that they were negative. The availability of high quality ANC data will be useful in determining what the true ANC prevalence is in different areas and following the changes in ANC prevalence in first attendees over time as a proxy for incidence. Activity 1: Support to MOH to develop, implement, and monitor a comprehensive HIV rapid testing quality assurance program: The following steps will be taken in FY10: Our organization will support MOH through the National Reference Laboratory at CHSU to provide quality assurance for HTC occurring in the ANC settings and to improve HTC supervision at PMTCT sites nationally. Specifically, we will assist MOH to develop a PMTCT program assessment tool which will identify the current quality challenges in rapid testing and data collection and analysis, assist CHSU to strengthen its national HIV Rapid Testing Proficiency Testing Program, assist CHSU to strengthen and fully implement its national HIV Rapid Testing sample retesting program, and provide support for training for PMTCT program supervisors in enhanced documentation, reporting, and quality assurance measures at ANC level. We will also support HUTAP in monitoring the CHSU-based CD4 external quality assurance program.

Activity 2: Support to MOH for feasibility assessments for emerging POC technology Insufficient support for laboratory services means that only a small minority of HIV-positive pregnant women are able to access critical diagnostic tests including CD4 testing and HIV DNA PCR for early infant diagnosis. Use of point of care technology has the potential to increase access to the testing and to decrease costs to the national health system. Our organization will assist MOH to conduct a feasibility assessment and cost effectiveness analysis for use of point of care CD4 and EID testing and provide support for field testing of devices.

Budget Code - HLAB

Activity 1: Development and implementation of national laboratory quality assurance standards and national laboratory standard operating procedures

As part of the National Strategic Laboratory Plan, the MOH has developed strategic objectives addressing current needs in laboratory services delivery and quality management systems. In collaboration with CDC/Malawi, HUTAP and other partners, we will assist the MOH in developing and implementing a comprehensive quality service delivery program using internationally recognized Good Clinical Laboratory Practice standards. To achieve these goals the following steps will be taken in FY09: A quality service delivery advisory group incorporating members from relevant stakeholders will conduct a baseline needs assessment and develop a comprehensive plan for implementation of this activity.

The outputs of this group will be a National Quality Manual and national Laboratory Standard Operating Procedures which will include laboratory policies, laboratory safety, quality management program, specimen management, turn-around-time compliance, results reporting, reference ranges, and handling of abnormal values, equipment operation and testing procedures, equipment maintenance, and procurement/stock control systems. A national laboratory certification scheme will be developed to be used until a national laboratory accreditation scheme is in place. This will contribute to Health Systems Governance, Laboratory Accreditation.

Activity 2: Laboratory supervision and mentoring for quality service delivery: Four Mentoring Laboratories will be supported at high through-put hospitals, each of which will have 12 district and CHAM lab facilities under their supervision. Regional Coordinators and Outreach Supervisors will work hand-in-hand with MOH Laboratory Supervisors to perform baseline assessments of infrastructure and quality systems at their Mentoring Laboratory and the 2nd tier laboratories under their supervision using guidelines established in the national laboratory certification scheme. The Regional Coordinators and Outreach Supervisors in cooperation with their MOH counterparts will prepare a corrective action plan for each facility with a target timeline for implementation with the goal of achieving and maintaining certification.

Through this mentorship, quality standards, throughput, and maintenance and reagent stock-out down time will be improved and MOH Laboratory Supervisors will be trained and empowered. A vehicle for each of the four Mentoring Laboratories will be key to this activity, providing project and MOH staff with the mobility necessary to effectively mentor laboratories in underserved and remote areas. This activity will contribute to the number of testing facilities accredited according to national standards, and the percent of testing facilities with satisfactory performance on EQA for CD4, HIV Rapid testing, and TB

diagnostics, and the percent of designated laboratories with the capacity to monitor ART according to national and international guidelines.

Beginning in FY11 the Regional Outreach Supervisors and their MOH counterparts will visit each facility under their supervision (including the Mentoring Laboratory to which s/he is assigned) every month to monitor and mentor them in implementing the corrective action plans developed in FY10, guiding them toward certification. Monthly monitoring of professional competencies, operational performance measures, and stock control will be provided. The regional M&E Officer will perform data collection, analysis, and provide feedback to all facilities and to the National Coordinator to inform program management. This activity will contribute to the number of testing facilities accredited according to national standards, and the percent of testing facilities with satisfactory performance on External Quality Assurance (EQA) for CD4, HIV Rapid testing, and TB diagnostics, and the percent of designated laboratories with the capacity to monitor ART according to national and international guidelines.

Activity 3: Support to the National Reference Laboratory Development of national accreditation standards, accreditation of the National Reference Laboratory CHSU will be supported in FY10, beginning the process of developing national accreditation standards for laboratories. A suitable accreditation scheme will be identified/adapted. CHSU itself will be supported to achieve accreditation. In consultation with the selected accrediting agency, a plan will be developed for preparing CHSU for accreditation on selected testing systems by FY11. This will contribute to the number of testing facilities accredited according to national standards. This will contribute to Health Systems Governance, Laboratory Accreditation.

In FY11, we will continue to support CHSU in developing national accreditation standards for laboratories. CHSU's quality manual will be submitted to the external accreditation body selected in FY09 for evaluation. Action items from this evaluation will be addressed. The pre-accreditation inspection of CHSU by the external accreditation body will take place. This will contribute to the number of testing facilities accredited according to national standards. This will contribute to Health Systems Governance, Laboratory Accreditation.

Activity 4: Laboratory infrastructure development. Baseline infrastructure (laboratory equipment, furnishings, power, water and climate control systems) needs assessments will be conducted in FY09 for Mentoring Laboratories and the 2nd tier laboratories they support, with the target of a minimum service package of HIV adult and infant diagnostics, CD4 counting, viral load monitoring, AFB microscopy and culture, OI and STI diagnostics, chemistry and hematology services at the Mentoring Laboratories, and a minimum service package of HIV adult diagnostics and infant referral services, CD4 counting, AFB microscopy, syphilis testing, basic chemistry and hematology services at 2nd tier laboratories.

Service contract payments will be supplied for selected critical equipment. Laboratory equipment procurement will begin in FY10 for installation in FY11. This activity will contribute to the number of testing facilities accredited according to national standards, and the percent of testing facilities with satisfactory performance on EQA for CD4, HIV Rapid testing, and TB diagnostics, and the percent of designated laboratories with the capacity to monitor ART according to national and international guidelines. Infrastructure and selected instrumentation upgrades will be completed in the Mentoring Laboratories in FY10. Regional Coordinators in each Mentoring Laboratory will coordinate infrastructure upgrades to two District/CHAM laboratories (a total of 8 in FY10). Service contract support will be supplied for selected instrumentation. Fluorescence microscopy capacity will be revitalized in the Mentoring Laboratories and TB culture capability introduced. TB fluorescence microscopy capability will be revitalized in the district hospitals where it is currently available, and extended to strategic district and CHAM hospitals where it is not.

Given the synergistic relationship between STIs and HIV transmission and acquisition, correctly treating STIs is an essential component of a comprehensive HIV prevention program. All labs will be equipped and supported to perform syphilis serology testing. Discussions will be held with partners to identify an additional 5 institutions in strategic locations with space that has the potential to be converted to a laboratory with HIV rapid testing and CD4 count capacity to be brought on-line in subsequent grant years. Selected laboratory equipment for this activity was already costed in FY09. This activity will contribute to the number of testing facilities accredited according to national standards, and the percent of testing facilities with satisfactory performance on EQA for CD4, HIV Rapid testing, and TB diagnostics, and the percent of designated laboratories with the capacity to monitor ART according to national and international guidelines.

Activity 5: Strengthening of referral systems. MOH and partners are currently piloting several models for referral systems between laboratories providing HIV diagnosis and monitoring services and HIV treatment facilities. MOH will be supported to identify and develop an appropriate referral system addressing key issues of sample transport to testing laboratories and results turn around times to care providers. Training on and implementation of the referral system between laboratories providing HIV diagnosis and monitoring services defined in FY09 will take place in FY10. The regional M&E Officer will perform data collection, analysis, and provide feedback to all facilities and to the National Coordinator to inform program management. Improving turn-around-time for lab results will be prioritized so that by the end of FY10 80% of laboratory results in mentored facilities will be received by providers within the turn-around time specified by National SOPs.