SUMMARY:

Activities will be carried out to identify and address laboratory-specific unmet needs and national policy or

administrative issues that impede full implementation of laboratory programs. Activities will increase national

coverage of HIV and TB diagnostics and treatment monitoring capabilities; ensure uniform quality

assurance measures among laboratories; support activities to initiate new and strengthen existing External

Quality Assurance (EQA) programs; strengthen laboratory reporting systems and specimen transport needs

in support of rural clinics and laboratories; promote efforts to synchronize infection control activities in

collaboration with the National Institute of Occupation Health (NIOH); investigate, assess, and implement

new automated laboratory diagnostic equipment and high capacity instrumentation for high burden

diagnostics and service delivery needs; and to expand upon the regional support and collaboration with

other PEPFAR-funded countries through the established Regional Laboratory Training Center (RLTC).

BACKGROUND:

In 2001, South Africa restructured its public sector medical laboratory services and created the National

Health Laboratory System (NHLS), which is a parastatal. The NHLS is accountable to the National

Department of Health (NDOH) through its Executive Board and is responsible for public sector laboratory

service delivery. The NHLS also governs activities and provides funding to the National Institute of

Communicable Diseases (NICD) to provide surveillance, research and programmatic operations, as well as

funding to the NIOH for policy development activities related to occupational health. The service delivery

arm of NHLS is comprised of approximately 260 laboratories, which include all provincial diagnostic

pathology laboratories, tertiary level, secondary, and primary laboratories in all nine provinces and their

associated district hospital laboratories. Each district laboratory supports a network of local clinics where

primary care services are provided. These four regions encompass all laboratories throughout South Africa.

Consistent with the priorities identified by the NDOH, and implemented by the NICD and NHLS, PEPFAR

continues to provide funding to assure the accuracy and quality of testing services in support of rapid scale

up of HIV testing, antiretroviral treatment (ART) rollout and TB diagnostic capacity, and to build long-term

sustainability of quality laboratory systems in South Africa. Continued PEPFAR funding of NICD with

combined support to NHLS, efforts will focus to address existing gaps in laboratory testing outreach,

penetration, and quality of overall services.

ACTIVITIES AND EXPECTED RESULTS

ACTIVITY 1: EQA Programs

Activities will support measures to strengthen existing EQA and initiating new national proficiency testing

programs for ongoing review, measuring clinical performance, reporting indicators, and disseminating

performance reviews for action. Activities include decreasing the administrative burden of the existing EQA

programs through the development of a web-based system or possible utilization of fax/scan technologies

that will be used to monitoring performance of TB and HIV testing services. The current South Africa

PEPFAR laboratory indicators now include the reporting of EQA service reach and overall performance in

the areas of chemistry, hematology, CD4s, viral load, and infant PCR, TB smear, culture, and DST. By

automating the current EQA monitoring system, real time EQA performance can be measured to provide a

more robust and responsive EQA system. Currently, HIV rapid EQA services are limited to only one non-

governmental organization (NGO) in South Africa, a significant shortcoming relating to assurances of quality

testing services. To help detect shortcomings in performance and to improve assurances when reporting

HIV rapid test results, a robust EQA system is a necessity. The proposed national HIV rapid testing EQA

program will identify and provide a mechanism to quickly remedy deficiencies. This activity is currently an

integrated component of the national rollout plan for the HIV Rapid Testing Quality Assurance Program with

NICD, but to have an immediate impact, EQA services must be delivered in parallel with the training

package. By providing such an EQA program, an assessment of the quality of HIV rapid testing services

can be measured. Also as part of an effective TB EQA program, a TB National Rechecking program is also

proposed. In light of the human resource limitations in providing such a program, activities will target

vigorous investigations into the use of automated TB microscopy for diagnostic rechecking. Due to the

significant volumes of slides that would be necessary to effectively provide such a service, automation of

this particular task is a necessity.

ACTIVTY 2: Regional Laboratory Training Center (RLTC)

In most PEPFAR-funded countries, the quality and quantity of TB and HIV laboratory work is insufficient for

effective diagnosis and disease control. With the availability of significant technical and scientific resources

within South Africa, NICD and NHLS are well placed to continue to provide regional laboratory support

within Sub-Saharan Africa. NICD and NHLS will expand and strengthen existing regional support

mechanisms and enhance further collaboration with other PEPFAR-funded countries through the RLTC.

Regional support will include the expansion of laboratory services and training initiatives to other African

PEPFAR focus countries. Access to the RLTC will be available to all PEPFAR focus countries by allocating

funds within their respective country COPs. Expansion of services includes, but is not limited to extending

EQA programs, TB and HIV laboratory diagnostic technical support and services, regional HIV rapid testing

kit evaluations, integrated TB/HIV training programs, and other HIV and TB laboratory technical assistance.

ACTIVTY 3: Infection Control Policy

With the National Institute of Occupation Health (NIOH) residing within the NHLS organizational structure,

and with its mandate to develop policy for occupation health, activities will be leveraged to promote an

infection control network and to develop infection control policies and safety training programs in TB and

HIV laboratory safety. Collaboration with PEPFAR partners will assist in the development and will lead to

enhancement of existing infection control policies and implementation of national infection control standards

for all health care workers. Policies will provide the framework for training activities that will target improved

general knowledge of infection control practices.

ACTIVTY 4: Information Management

NHLS currently maintains a large data warehouse that is used to extract laboratory data from existing NHLS

Activity Narrative: laboratory information systems. This system requires strengthening and NHLS is actively working to

improve the capacity and utility associated with this system. Current laboratory reporting mechanisms, as

well as patient enrolment systems into antiretroviral and DOTs treatment programs need information

technology support and information bridges need to be created that currently do not exist. Activities will

continue to build upon the rollout of viable communication methods in rural areas for laboratory data and to

increase data turn-around-times. The currently proposed funds would be used, in partnership and through

co-funding with NHLS, for the development of modular logistical and information management support

systems as a means to address the current integration issues associated with the existing surveillance and

health information systems.

ACTIVITY 5: Further Automation

In light of the significant burden of HIV and TB diagnostics, and the immediate staffing needs, activities will

build upon COP 2007 efforts to include assessing existing, validating, and implementing new automated

laboratory diagnostic equipment and high capacity instrumentation for TB and HIV. Activities will be carried

out to increase laboratory through-put for infant PCR, viral load, and TB, to meet increased demand, as well

as strengthening NHLS ability to improve diagnostic, reporting and surveillance activities. FY 2008 funds will

be used, in partnership and through co-funding with NHLS, for the development and rollout of automated N-

acetyl-l-cysteine (NALC) decontamination instrumentation and technologies, high throughput infant PCR, as

well as other possible high throughput HIV automated technologies to meet current and future demands.