The Uganda Virus Research Institute (UVRI) is a department of Government of Uganda (GOU), dedicated

to conduct research on viral diseases since 1936. UVRI has conducted research in isolation and

characterization of HIV strains, understanding better the epidemiology before and after the introduction of

ART, HIV vaccine and microbicide evaluation, PMTCT, HIV sero-behavioural survey, and provided the

Ministry of Health (MOH) with HIV surveillance data from ANC and STI clinics. UVRI is mandated by MOH

to provide Quality Assurance/Quality Control (QA/QC) to all HIV serological testing sites both public and

private.

This activity plays a vital role in the provision of accurate results that is essential for diagnosis, care and

treatment of the HIV infected. While the existing M&E plan will guide implementation of activities,

partnerships will be established with government structures at district level through the health facility

hierarchy i.e. from national to Health Center III level. This will entail combined training of their staff, support

supervision visits, provision of proficiency testing (PT) and providing QA/QC services.

In 2006, MOH developed an HIV prevention strategy which places special emphasis on HIV testing

especially for the epidemic drivers (fishermen, commercial sex workers discordant couples, those with

multiple sexual partners, transactional sexual relationships, etc). This calls for increased testing at health

facilities, home and through outreach/mobile clinics.

UVRI shall ensure quality HIV testing is offered to individuals through training, support supervision and

continuous assessment of laboratories for QA/QC in all laboratories testing for HIV, TB, STI and Malaria.

Through these means we shall support the TB, leprosy, and malaria strategic plans.

Training of counselors, phlebotomists, and the laboratory staff will be key in achieving the targets in the

Heath Sector Strategic Plan II and HIV/AIDS National Strategic Plan [2007-2012), with GOU aiming to test

millions of people and thus influence health seeking and safe behavior practices. The restructured GFATM

round three, phase one, plans to test about 2,200,000 people by the end of June 2008, and, an additional

58,000 started on ART.

While in-service training will be reinforced to ensure high standards are maintained, TOT conducted in 2007

will be further augmented in 2008 taking into account lessons learnt. We shall work with the District

Laboratory Focal Person [DFLP) to ensure that his activities are incorporated in the annual district plan, and

engage with the district leaders on the importance of high quality laboratory results in the prevention, care

and treatment of HIV/AIDS. By maintaining and developing strong linkages with key service providers and

trainers, we shall support integrated training especially in the diagnostics of HIV, malaria, syphilis and

tuberculosis thus maximizing benefits out of the available resources.

UVRI shall maintain and develop new partnerships in collaboration with CDC-Uganda and key PEPFAR

funded partners e.g. CPHL/MOH, AMREF, NUMAT, MJAP, JCRC, NMS, MUWRP, RHSP, RTI, and other

stakeholders in laboratory services and CT to ensure sustainability of internal and external quality

assurance at regional and district levels using Regional Laboratory Coordinators (RLC) and DFLP as

change agents. During supervision visits to the testing sites in collaboration with CPHL/MOH, Malaria

Control Program, National Tuberculosis and Leprosy Program and other stakeholders, we shall identify

needs in infrastructure, staffing, laboratory management, commodity availability, storage capacity, recording

keeping, availability and implementation of SOPs, M&E tools and customer service satisfaction. Supply

chain management of HIV commodities, will be addressed to avoid duplication. UVRI will draw up a

consumption plan of HCT commodities and work with NMS to ensure their availability. Buffer stock will be

budgeted for to avoid any disruption of services.

Due to the scarcity of trained laboratory staff and the need to get millions of people counseled and HIV

tested, MOH has decided to provide quality training to non-laboratory staff including PHAs to conduct HIV

rapid testing. This cadre of health workers will receive constant supervision to ensure they provide quality

results. In collaboration with RLC and DLFP we shall develop a strategy to achieve this. We shall liaise with

CPHL/ MOH to train non-laboratory staff performing HIV testing. We shall emphasize during training the

need for these groups providing complementary services to coordinate their activities.

The UVRI clinic shall continue providing apprenticeship to both counselors and laboratory trainees. Training

sessions for personnel at CT sites will emphasize the need for QA/QC in whatever service they render. The

SOP for counseling and testing will be integrated for the benefit of the counselors, phlebotomists, and

laboratory staff.

UVRI shall prepare and distribute PT panels to all testing sites and obtain the results immediately.

Concerted efforts will be made to ensure that specimens are received from the original sentinel sites

including ANC, STI, and PMTCT sites across the country but expand to cater for more private and public

sectors facilities. QC samples will be obtained, retested and return the results within six weeks These

outcomes will be used to measure the effect of pre-analytical and analytical QA/QC training on the quality of

results provided to clients.

Medical waste generated at UVRI will be disposed of using disinfectants, incineration and sharps containers

as appropriate. Hospitals will be requested to support other testing centers in their area of jurisdiction for

incineration of medical waste. These issues will be emphasized during training and support supervisory

visits.

UVRI shall work with MOH and Health Services Commission (HSC) to recruit project staff into Public

Service thus allowing long term sustainability of QA/QC for the country. The current salaries will be made

competitive supplemented by other forms of motivations for right caliber staff to be retained. The TOT

provided to support supervisors (RLC and DLFP), our supervisory visits, training RLC in preparation and

characterization of PT panels, their distribution and interpretation of the results will further contribute to

sustainability of the program. By opening direct channels of communication with RLC and DLFP we shall

learn more about activities in health facilities for us to influence HIV testing.

An annual report will be shared with MOH AIDS Control Program officials, covering our activities at HIV

testing sites in the country, needs assessment and work with them to ensure that CPHL/MOH as the

regulatory body accredits laboratories to ensure quality of HIV testing to the public.

The Uganda Virus Research Institute (UVRI) is a department of Government of Uganda (GOU), dedicated

to conduct research on viral diseases since 1936. UVRI has conducted research in isolation and

characterization of HIV strains, understanding better the epidemiology before and after the introduction of

ART, HIV vaccine and microbicide evaluation, PMTCT, HIV sero-behavioural survey, and provided the

Ministry of Health (MOH) with HIV surveillance data from ANC and STI clinics. UVRI is mandated by MOH

to provide Quality Assurance/Quality Control (QA/QC) to all HIV serological testing sites both public and

private.

This activity focuses on ensuring that the counselors and the staff that obtain samples for testing are

providing quality service to the client, provide quality samples, and follow biosafety guidelines. The well

trained laboratory staff in rapid HIV testing nationwide will provide high quality results to inform prevention,

care, and treatment of HIV/AIDS

While the existing M&E plan will guide implementation of activities, partnerships will be established with

government structures at district level through the health facility hierarchy i.e. from national to Health Center

III level. This will entail combined training of their staff, support supervision visits, provision of proficiency

testing (PT) and continuous assessment of laboratories for QA/QC services in laboratories testing for HIV,

TB, STI and malaria. Through these means we shall support the TB, leprosy, and malaria strategic plans.

Recently, MOH in collaboration with UAC has launched new preventive strategies to drive the HIV

seroprevalence below the current 6.4%. There is now an urgent need to have high-quality HIV serological

testing in all the laboratories across the country. As a result, in FY 2008, HIV serology testing QA/QC

project will expand services to all HIV testing sites in the country.

The importance MOH places on providing comprehensive, high-quality laboratory services throughout the

country is reflected in the newly-established position of Assistant Commissioner to oversee the activities of

the Central Public Health Laboratories (CPHL) and in particular, the implementation of a quality assurance

program according to the HIV Rapid Test Quality Assurance Manual, Uganda, 2006. Building on the

experience built over the past 5 years with USG funding, the HIV Reference and Quality Assurance

Laboratory at the Uganda Virus Research Institute has established a national laboratory quality assurance

(QA) program focused specifically on HIV-related testing. Working with existing programs within MOH,

particularly the Quality Assurance Unit, the HIV rapid test training coordination unit at CPHL and regional

and district-level laboratory supervisors, we shall continue to identify laboratories currently conducting HIV

serological testing and the tests/algorithms used, to include the HCT, ANC and PMTCT programs, as well

as clinical laboratories, in both the private and public sector. Based on the inventory of HIV-testing

laboratories, we shall develop a quality assurance plan that takes advantage of supervisory visits conducted

by CPHL and the NTLP to distribute proficiency testing (PT) panels, to collect quality control (QC) samples

for testing at UVRI and to meet reporting requirements. Laboratories failing to meet QA criteria will be

visited and remedial action taken. Testing algorithms for use in the field and for QC at UVRI will be

continuously monitored and new algorithms evaluated. The LIMS expanded and linked to databases at

CPHL and MOH in FY07 to facilitate reporting, logistics management and training needs will be maintained

and if funds. Special attention will be given to the development of both a laboratory management plan

including National and RRH for monitoring and evaluation. Activities will be in line with the Uganda National

Quality System Guidelines. This activity is currently the responsibility of UVRI and is coordinated by CPHL

Activities include the preparation and distribution of proficiency panels, quality control testing of specimens

from the field, and evaluation of new HIV testing kits and algorithms. Through coordination with other

national programs including those for TB and malaria, UVRI staff also contribute to national support

supervision. We shall work with the Ministry of Education and Sports in updating laboratory training

institutions. By doing so the standards of the institutions would be maintained and the clients served by well

trained people. We shall continue providing apprenticeship to both counselors and laboratory trainees at

the UVRI clinic.

The government laboratories relevant to our activity are at the national to Health Center III level. Our

partnership with these facilities will be strengthened through combined training of their staff, support

supervisory visits, provision of PT, obtaining QC samples, re- testing them, and returning results within six

weeks. While in-service training will be reinforced to ensure high standards are maintained, TOT conducted

in 2007 will be further augmented in 2008 taking into account lessons learnt. We shall work with the District

Laboratory Focal Person [DFLP) to ensure that his activities are incorporated in the annual district plan, and

engage with the district leaders on the importance of high quality laboratory results in the prevention, care

and treatment of HIV/AIDS. By maintaining and developing strong linkages with key service providers and

trainers, we shall support integrated training especially in the diagnostics of HIV, malaria, syphilis and

tuberculosis thus maximizing benefits out of the available resources.

Working with ACP and PMTCT programs, we shall expand the ANC sites both public and private, using

dried blood spots to obtain more samples for QC

Medical waste generated at UVRI will be disposed of using disinfectants, incineration and sharps containers

as appropriate. Hospitals will be requested to support other testing centers in their area of jurisdiction for

incineration of medical waste. These issues will be emphasized during training and support supervisory

visits.

UVRI shall work with MOH and Health Services Commission (HSC) to recruit project staff into Public

Service thus allowing long term sustainability of QA/QC for the country. The current salaries will be made

competitive supplemented by other forms of motivations for right caliber staff to be retained. The TOT

provided to support supervisors (RLC and DLFP), our supervisory visits, training RLC in preparation and

characterization of PT panels, their distribution and interpretation of the results will further contribute to

sustainability of the program. By opening direct channels of communication with RLC and DLFP we shall

learn more about activities in health facilities for us to influence HIV testing. An annual report will be shared

with MOH AIDS Control Program officials, covering our activities at HIV testing sites in the country, needs

assessment and work with them to ensure that CPHL/MOH as the regulatory body accredits laboratories to

ensure quality of HIV testing to the public.