ACTIVITY HAS BEEN MODIFIED IN THE FOLLOWING WAYS:

This activity will no longer be implemented as the NDOH has decided to incorporate condom LMIS within

the NDOH pharmaceuticals. The IT component of the activity will be taken over by the NDOH IT Unit.

Therefore no FY 2009 funding is requested.

----------------------

SUMMARY:

John Snow Inc. (JSI), through the SCMS Project, will continue to support the STI, HIV and AIDS Prevention

Unit within the National Department of Health (NDOH) and provincial Departments of Health, by providing

logistics management technical assistance in the procurement, quality assurance, warehousing, distribution

and tracking of male and female condoms, targeting underserved, vulnerable and most at risk populations.

JSI has already begun an intensive capacity building phase and during FY 2007 period, the SCMS Project

will focus on human capacity development within the NDOH to make the condom distribution program

sustainable once funding comes to an end. Although it was anticipated that this process could be completed

in FY 2007, it is clear that given the NDOH's constraints in terms of hiring qualified staff, coupled with

substantial attrition of staff generally, that at least an additional year of USAID support will be required to

implement an effective transition that will ensure program sustainability. The need for continued support

beyond the original timeframe has been exacerbated from a programmatic perspective due to a recent

bribery and corruption scandal between the South African Bureau of Standards (SABS), where all public

sector condom batches are compliance-tested for quality assurance purposes, and a local manufacturer,

where some batches were passed for procurement and distribution by the SABS that actually failed quality

standards. After seven years of building public confidence and increasing condom distribution dramatically,

this scandal is likely to have a significant negative impact in terms of eroding this hard won public

confidence in the government's prevention program and the NDOH will need assistance in rebuilding public

perception. The emphasis area for this activity will be human capacity development through training, and

the target populations are youth, adults, family planning clients, the military and correctional services,

mobile populations (high transmission areas) and persons in sex work.

BACKGROUND:

In 2000 the NDOH requested USAID support in addressing two critical weaknesses in the South African

Government's (SAG) HIV prevention program relating to condom procurement and distribution: the poor

quality of condoms that were distributed in South Africa and the frequent and prolonged shortages and

stock-outs in the provinces - both problems which resulted in negative media towards, and an erosion of

public confidence in, the SAG HIV prevention program. JSI, co-located within the NDOH, and in close

collaboration with national and provincial counterparts, has successfully developed and implemented a

package of technical solutions to these two critical shortcomings. First, JSI-supported systems have

eliminated poor quality issues by ensuring compliance testing to World Health Organization specifications

and standards of all production batches regardless of local or overseas manufacture, thus guaranteeing that

only high quality public sector condoms are distributed in South Africa. Second, the JSI-developed Logistics

Management Information System (LMIS) has enabled the NDOH to eliminate shortages and stock-outs in

the provinces by establishing and servicing 172 primary distribution sites across all provinces. These two

achievements were crucial in empowering the SAG to sustain its HIV prevention focus in its response to

HIV and AIDS epidemic and maintain its long-term goal of ensuring that people, who are currently HIV-

negative, remain negative. PEPFAR funds will be concentrated on ensuring the NDOH's technical know-

how needed to efficiently operate the supply chain and sustain the focus on most at-risk populations.

ACTIVITIES AND EXPECTED RESULTS:

The funds originally destined for the USAID DELIVER Project will be reprogrammed under the SCMS

project. This decision was taken (effectively ending the USAID DELIVER Project presence in South Africa)

in order to reduce the Mission's financial burden of having two separate centrally-funded projects with

similar mandates and similar management structures. SCMS will continue to provide technical assistance in

the procurement, quality assurance, warehousing, distribution and tracking of approximately 30 million

condoms per month to sexually active youth, adults and family planning clients, with a particular focus on

non-traditional outlets for high risk, marginalized populations. SCMS will intensify efforts within the NDOH to

establish appropriate government posts for quality assurance and logistics management, and provide formal

and informal, on the job training. The expected result of this skills transfer is that the NDOH will be able to

fully operate and sustain the program once USG/LCS support ceases. It is recognized that it is critical from

the USG and SAG perspectives that this successful program is sustained into the future. SCMS will

contribute substantially towards the vision in the USG Strategic Plan for South Africa by building human

capacity within the NDOH in procurement, quality assurance, supplier contract management, warehousing

and distribution, while maintaining a zero stock-out rate for the primary distribution sites.

ACTIVITY 1: Supply chain strengthening at the Provincial level

This project will strengthen the condom distribution program at the provincial level, by engaging more

directly with provincial Departments of Health to further develop local organization capacity. In coordination

with the NDOH, SCMS will conduct an assessment of the supply chain at the Primary Distribution Sites that

the NDOH is responsible for servicing and at the secondary and community distribution sites. This will

include inventory control, good warehousing practices, reporting procedures, and distribution & tracking

systems. SCMS will synthesize practical recommendations in collaboration with provincial counterparts and

will provide TA as requested to implement supply chain best practices and standard operating procedures

(SOPs).

ACTIVITY 2: Provincial level LMIS development

Activity Narrative: During the re-development of the NDOH's LMIS in FY 2007, functionality will be added to allow provincial

access to the LMIS and information related to condom distribution nationally. Authorized users will be able

to report on condom distribution and inventory and will be allowed to generate management reports. In FY

2008 SCMS will facilitate the establishment of a provincial level LMIS that will enable more efficient

distribution and tracking of condoms to the secondary and community level outlets. This strategy will enable

the program to reach more people and promote improved reporting since the provincial DOH counterparts

will be given more responsibility for condom distribution management. This activity will include in-service

training in LMIS and logistics management.

New/Continuing Activity: Continuing Activity

Continuing Activity: 14260

Continued Associated Activity Information

Activity Activity ID USG Agency Prime Partner Mechanism Mechanism ID Mechanism Planned Funds

System ID System ID

14260 14260.08 U.S. Agency for Partnership for 6756 4132.08 $0

International Supply Chain

Development Management

Table 3.3.03:

ACTIVITY HAS BEEN MODIFIED IN THE FOLLOWING WAYS:

John Snow, Inc.'s (JSI) Supply Chain Management System (SCMS) project does not plan on continuing

with this activity, as it involves expertise with patient information systems development, which is not a core

mandate of the SCMS project. However, while SCMS does not currently have the technical expertise or

staff in country to lead and oversee this type of initiative, SCMS has stated that they could continue this

activity if requested by the U.S. Government. Therefore no FY 2009 funding is requested.

----------------------------------

SUMMARY:

John Snow, Inc. (JSI), through SCMS, is using PEPFAR funds to strengthen ARV patient information and

reporting capabilities utilizing a system based on biometric fingerprinting to ensure data verification and

smart cards as a mobile, patient-retained medical record. The prototype system that was successfully pilot

tested as a proof of concept was named STAT (Secure Technology Advancing Treatment). SCMS is further

developing the STAT system as a cost-effective system that is both scaleable and sustainable. The

emphasis areas are human capacity development, local organizational capacity building and strategic

information. The primary target populations are people living with HIV (PLHIV) and public and NGO

healthcare providers.

BACKGROUND:

The lack of verified program reporting data/performance indicators and use of cumbersome and often

incomplete paper-based patient medical records continue to present major challenges in scaling up

antiretroviral treatment (ART) programs. Under the DELIVER project, JSI developed a public-private

partnership with a local biometrics and smart card leader to design and field test a prototype patient

information and reporting system, named STAT, based on combination biometrics and smart card

technology. The system was successfully demonstrated in a static clinic environment and also in an offline,

remote, rural setting for both ART and care and support services. In order to address emerging issues

during the pilot phase around proprietary software, licensing fees, and data transmission costs, which made

large-scale implementation impractical, SCMS developed new partnerships in FY 2006 to continue the

development of the STAT system in an open source environment, eliminate licensing fees, and design a

data transmission mechanism that was both scaleable and sustainable. Specifically, SCMS partnered with

Right to Care (RTC), a leading PEPFAR-funded ART provider and their IT collaborator Therapy Edge, to

develop a smart card component in the context of a much needed down referral system where patients can

be down referred from specialist ART initiation sites to primary health care facilities. Of particular concern in

expanding ART services is the reality that large accredited ART sites are becoming overburdened with

patient follow-up and are struggling with the human capacity to add new patients. Under these

circumstances, the development of effective down referral systems where patients can receive follow-up

care and drug re-supply closer to their local communities is critical. The STAT system offers several crucial

components to a successful down referral model: from a clinical and quality of care perspective it enables

doctors who have stabilized ART patients to track patients over time, quickly assess them, and make

clinical treatment adjustments when patients are referred back to the initiating ART treatment site in case of

treatment failures; from a patient perspective it enables patients to easily access ARV services at multiple

service delivery sites; and from a program performance perspective, it enables program managers and

funding agencies to access verified (i.e. high quality) PEPFAR indicators at any time, providing virtually real

time reporting and strategic information capabilities. Using FY 2007, SCMS focuses on implementing the

solution at the RTC initiation site at Helen Joseph Hospital and several down referral sites that are currently

being identified. It is anticipated that this activity will result in a model demonstration system in which SCMS

will have developed an open source solution and a standard for smart card systems in health care. This

effort is important as the National Department of Health (NDOH) has included biometrics and smart cards in

its long-term strategic plan for developing an electronic patient medical record for South Africa. SCMS will

continue to build on their collaborative relationships with the SAG, and will also explore potential

deployment of the STAT system in private sector environments..

ACTIVITIES AND EXPECTED RESULTS FY 2008:

Specific activities will include STAT system training for ARV service providers, implementation and

maintenance of the STAT system at sites, and the development of sustainable financial support

mechanisms to ensure STAT remains after PEPFAR funding has been utilized to introduce the system and

provide the initial implementation. The focus of activities will include technical assistance and human

capacity development.

Activity 1: Technical Assistance

It is anticipated that once the demonstration system for down referral at RTC/Helen Joseph Hospital and its

down referral sites is fully operational and documented in FY 2007, that the Gauteng DOH will support

expansion of the down referral system across the province. This may involve the utilization of the Therapy

Edge/Smart Card as is from the demonstration site, or it may involve a full scale tendering process. Either

way SCMS will have made a significant contribution as even in the event of a tender, SCMS will be able to

provide the smart card standards that are required for successful systems development and integration. In

addition to Gauteng province, the Reproductive Health Research Unit (RHRU) and the Foundation for

Professional Development (FPD) have both expressed interest in the smart card concept to assist in down

referral systems development. SCMS will follow up on the feasibility of expanding the system to RHRU

and/or FPD sites once these PEPFAR partners and others have experienced and evaluated the

demonstration project

Activity 2: Human Capacity Development

Training on the patient information system for ARV service providers and data capturers will be conducted

Activity Narrative: for all those participating in the expansion program. Follow-up supervision and technical assistance will be

provided and evaluated. It is expected that overall quality of care will be improved by the system's ability to

track patient information including ARV initiation, drug regimen changes, and treatment outcomes. SCMS

will contribute significantly towards meeting the vision of the NDOH in developing an electronic patient-

retained record and will also contribute significantly towards meeting the vision of the USG PEPFAR Task

Force Five-Year Strategy for South Africa by providing a state-of-the-art system to facilitate the virtual real

time collection, analysis and reporting of the required PEPFAR M&E indicators for ART for thousands of

patients.

New/Continuing Activity: Continuing Activity

Continuing Activity: 14258

Continued Associated Activity Information

Activity Activity ID USG Agency Prime Partner Mechanism Mechanism ID Mechanism Planned Funds

System ID System ID

14258 8107.08 U.S. Agency for Partnership for 6756 4132.08 $0

International Supply Chain

Development Management

8107 8107.07 U.S. Agency for Partnership for 4480 4132.07 Supply Chain $3,000,000

International Supply Chain Management

Development Management

Table 3.3.09:

ACTIVITY HAS BEEN MODIFIED IN THE FOLLOWING WAYS:

BACKGROUND:

While a major activity for SCMS in most SCMS focus countries, procurement in South Africa is unique due

to the strict regulatory environment on parallel importing and registration of medicines. All medicines

procured need to be registered with the Medicinal Control Council (MCC) in South Africa besides the USG

FDA approval requirement. Procurement in South Africa takes place using local suppliers and at Single Exit

Price (SEP), a set price at which drugs must be sold. Thus the SCMS mechanisms to drive prices down

through use of generics and bulk buying directly from manufacturers do not apply to the South African

situation. This also means that this activity has been scaled back, and the activities below will be funded

using SCMS pipeline funds. Therefore no FY 2009 funding is requested.

ACTIVITIES AND EXPECTED RESULTS:

In South Africa, John Snow Inc. (JSI), through the JSI/SCMS Project will also work closely and

collaboratively with Management Sciences for Health's (MSH) Strengthening Pharmaceutical Systems

(SPS) in order to ensure there is no duplication of effort between JSI/SCMS and MSH/SPS technical

assistance or other activities, JJSI/SCMS will work closely with the USG and MSH/SPS in coordinating work

plan development and implementation.

ACTIVITY 1: Drugs and Related Commodity Procurement

Upon request, JSI/SCMS will procure drugs and related commodities for PEPFAR-supported care and

treatment partners in consonance with USG agreements with the Government of South Africa regarding

adherence to SEP and will make these commodities available via the South African domestic market.

JSI/SCMS will continue to focus procurement activities with SANDF. JSI/SCMS started procuring ARVs for

the South African National Defense Force (SANDF) at the beginning of this reporting period using a locally

developed procurement strategy specific to the South African regulatory environment. As of end of July

2008, JSI/SCMS has processed a total of seven orders for the SANDF and one for the Centre for AIDS

Program Research in South Africa (CAPRISA). A total of 37,359 units at a value of ZAR 3.608 million

(roughly $533,000) have been procured to date.

JSI/SCMS was looking forward to assisting the provincial Government of the Western Cape (PGWC) with

ARV procurement, but application to Treasury made by PGWC for additional funds required to expand the

ARV program in that province was unexpectedly granted thus allowing for the expansion of ART services

without JSI/SCMS assistance.

JSI/SCMS will only explore the feasibility of procuring for other partners with the USG's concurrence. A

small amount of commodity funds have been put aside to assist with future ad hoc or emergency requests

from IPs, if necessary. JSI/SCMS will continue to assist implementing partners (IPs) with strategic supply

chain information and link them to relevant resources as requested and appropriate.

ACTIVITY 2: Assistance to the Provinces

Technical assistance (TA) to the provinces will focus on the following areas: warehousing, quality

assurance, inventory management, and distribution logistics management information systems. JSI/SCMS

will collaborate closely with MSH/SPS project to avoid duplications and to fill-in the gaps. TA will be

provided by local staff and partners with possible support from international JSI/SCMS staff. TA will focus

initially on Mpumalanga province where the Department of Health and Social Services has requested

JSI/SCMS assistance in establishing their new Provincial Pharmaceutical Depot in Middleburg. JSI/SCMS

has also been requested by the Limpopo Provincial Government to conduct an assessment of their depot

and to make recommendations on system improvements. Other provinces such as Gauteng have also

expressed interest along similar lines.

JSI/SCMS offers expertise in a comprehensive range of technical areas relating to warehousing and

distribution including needs assessment, capacity planning, structural and systems improvement, human

resource skills assessment and development, security and risk evaluation, standard operating procedures

(SOP) development, and Good Manufacturing Practices (GMP) audit process design.

While official government letters expressing interest in JSI/SCMS's technical assistance have been

received, no commitments have been made for these activities to date. JSI/SCMS has shared this

information with USAID and further actions will be considered only if provincial MOUs are secured.

ACTIVITY 3: Human Capacity Development

JSI/SCMS offers a unique training opportunity in supply chain management in collaboration with its South

African partner, the Fuel Group, as it has established a state-of-the-art pharmaceuticals freight forwarding

and logistics service at its Regional Distribution Center (RDC) in Centurion. This facility is also utilized as an

on-the-job training site. The Fuel Group's Pharmaceuticals & Healthcare Distributors (PHD) division

operates the RDC and offers warehousing and distribution training through practical, hands-on work in the

RDC itself.

---------------------------------

SUMMARY:

The Supply Chain Management Systems (SCMS) Project is tasked with supporting PEPFAR by

strengthening secure, reliable, cost-effective, and sustainable supply chains that procure and deliver high-

quality antiretroviral drugs (ARVs) and related commodities to meet the care and treatment needs of people

living with HIV (PLHIV). The major emphasis areas are human capacity development and local organization

Activity Narrative: capacity building.

BACKGROUND:

In September 2005, SCMS was awarded an agreement by USAID to support PEPFAR in terms of

strengthening supply chains for ARVs and related commodities, with an initial focus on fourteen African

countries, including South Africa. In collaboration with in-country and international partners, the SCMS

mandate is to deploy innovative solutions to enhance supply chain capacity, ensure accurate supply chain

information is gathered, shared and used, and provide quality, best-value healthcare products. The SCMS

project team includes three organizations based in South Africa: the Fuel Group, where SCMS has

established a regional distribution center to service Southern Africa and beyond; North West University

which houses the only WHO-accredited quality assurance laboratory in sub-Saharan Africa; and Affordable

Medicines for Africa (AMFA) which has provided medicines to faith-based organizations throughout Africa

for many years.

ACTIVITIES AND EXPECTED RESULTS:

The SCMS Project will work closely and collaboratively with Management Sciences for Health's (MSH)

Strengthening Pharmaceutical Services (SPS) project in assisting PEPFAR treatment and palliative care

partners to improve the cost-effectiveness of their supply chains for the following: ARVs and related

commodities, including drugs for opportunistic infections and palliative care; drugs for sexually transmitted

infections (STIs); drugs and supplies for home-based care; drugs for TB; rapid HIV test kits; laboratory

equipment and supplies; and other medical supplies. In order to ensure there is no duplication of effort

between SCMS and SPS technical assistance or other activities, SCMS will work closely with the USG in

coordinating work plan development and implementation. SCMS activities will focus on technical assistance

and human and organizational capacity building in supply chain management and related areas and is

prepared to assist the National Department of Health (NDOH) and provincial health departments should it

be requested.

Activity 1: Drugs and Related Commodity Procurement

Upon request, SCMS will procure drugs and related commodities for PEPFAR-supported care and

treatment partners in consonance with USG agreements with the Government of South Africa regarding

adherence to Single Exit Pricing (SEP) and will make these commodities available via the South African-

based Regional Distribution Center on an ongoing basis. All procurement will follow SEP pricing unless and

until the PEPFAR Task Force is open to SCMS attempting to leverage lower pricing in South Africa that the

project is able to secure through direct negotiations with manufacturers on a global basis. SCMS will also

provide quality assurance for all commodities procured through the regional distribution center utilizing

SCMS partner North West University drug quality assurance laboratories where appropriate. SCMS will

focus procurement initially on Western Cape and the South Africa National Defense Force (SANDF) but will

explore the feasibility of procuring for other provinces and PEPFAR treatment NGOs.

Activity 2: Technical Assistance

Technical assistance (TA) will focus on the following areas: quantification and forecasting, procurement,

quality assurance, freight forwarding and inventory management, distribution (including pharmacy services

for individual patient treatment packs), logistics management information systems, and assistance to

manufacturers and suppliers. TA will be provided by local partners as well as international SCMS staff. TA

will focus initially on Mpumalanga Province where the Departments of Health and Social Services has

requested SCMS assistance in establishing a Provincial Pharmaceutical Depot in Middleburg. SCMS will

explore similar opportunities in other provinces.

Activity 3: Human and Organizational Capacity Development

SCMS will provide training as requested in technical areas of supply chain management for both PEPFAR

treatment partners and provincial and NDOH counterparts. SCMS will take advantage of the in-house

capacity of the Fuel Group's state-of-the-art Regional Distribution Center facilities and supply chain

expertise, and the North West University's quality assurance laboratories and expert training staff to provide

hands-on training and experience in freight forwarding and inventory management and quality assurance.

Training will also be provided by international SCMS staff.

Activity 4: Pain and Symptom Control

Anecdotal evidence suggests that PLHIV in PEPFAR-supported care and treatment programs experience

pain and symptoms related to HIV disease, opportunistic infections and/or side effects of ARV therapy

which are not adequately addressed by health providers. Increasingly, ART clients are switched to second-

line ARV treatment regimens due to medication side effects or other symptoms, raising questions as to

whether symptoms could be more effectively managed first, without resorting to sudden changes in

treatment regimens. In FY 2007 SCMS will assist the USG PEPFAR Task Force and its partners to review

the occurrence of common symptoms and pain experienced by PLHIV, current strategies to manage

symptoms and pain, including indications for switching PLHIV to second line treatment regimens.

Activity 5: Western Cape Support

In FY 2007 Plus Up Funds will enable PEPFAR to assist the Western Cape Department of Health with

procurement of ARV commodities. Western Cape requested assistance from the USG to expand ART

services to 13 new sites covering an anticipated 800 children and 7,000 adults. Specifically Western Cape

requested trained ART staff for the new sites, funding to pay for the required HIV testing, and ARVs - the

USG in turn requested SCMS to procure the ARVs. SCMS has a procurement plan in place for this

procurement and is ready to initiate the procurement once Western Cape has approval from the National

Activity Narrative: Treasury to accept this donation within the strict tendering and related regulatory environment which

governs the pharmaceutical marketplace in South Africa.

FY 2008 COP Activities:

ACTIVITY 1: Procurement

If the Western Cape procurement is successful, it is anticipated that additional provinces will request

procurement assistance. For example, Limpopo Province is unable to keep pace with the influx of new ART

patients, many of whom are entering South Africa from neighboring countries, especially Mozambique and

Zimbabwe. Indeed the demand for services continues to outstrip the ability to respond across South Africa.

Clearly, provision of adequate supplies of ARVs will be critical to expanding the national response.

ACTIVITY 2: Technical Assistance

SCMS will continue to provide technical assistance (TA) in warehousing and supply chain. Assuming the

successful establishment of the Provincial Pharmaceutical Depot in Mpumalanga Province in FY 2007 (TA

already requested from SCMS), it is anticipated that additional provinces will request TA in warehousing

design, equipment specification, as well as inventory control, commodity tracking, and management

systems. SCMS offers expertise in a comprehensive range of technical areas relating to warehousing and

distribution including needs assessment, capacity planning, structural and systems improvement, human

resource skills assessment and development, security and risk evaluation, standard operating procedures

(SOP) development, and Good Manufacturing (GMP) audit process design. SCMS will also provide TA in

quantification, forecasting, quality assurance, and logistics management systems. SCMS will work closely

with SPS colleagues and the USG in coordinating these TA activities to ensure there is no duplication of

effort.

ACTIVITY 3: Training

SCMS offers a unique training opportunity in supply chain management in collaboration with its South

African partner, the Fuel Group, as it has established a state-of-the-art pharmaceuticals freight forwarding

and logistics service at its Regional Distribution Center (RDC) in Centurion, and this facility is also utilized

as an on the job training site. The RDC is currently distributing PEPFAR-funded ARVs and related

commodities on behalf of SCMS to several sub-Saharan countries. The Fuel Group's Pharmaceuticals &

Healthcare Distributors (PHD) division operates the RDC and offers warehousing and distribution training

through practical, hands-on work in the RDC itself, where trainees learn about and experience best

practices in action and develop work plans for how their new skills and knowledge can be transferred to

practical systems improvements in their own workplaces in their home countries. Trainees to date have

generally been from national warehouses. In the South African context, where there is no national

warehouse, SCMS will offer the Warehousing and Distribution Excellence Course (one month) to interested

Provincial Depots, starting with Mpumalanga Province that has already requested technical assistance and

can benefit significantly from the RDC training. SCMS will contribute significantly towards meeting the

PEPFAR goals by assisting treatment and palliative care partners to establish and sustain secure, reliable,

and cost-effective supply chains of high quality products to meet the needs of HIV-infected care and support

and ARV treatment patients.

New/Continuing Activity: Continuing Activity

Continuing Activity: 14257

Continued Associated Activity Information

Activity Activity ID USG Agency Prime Partner Mechanism Mechanism ID Mechanism Planned Funds

System ID System ID

14257 7935.08 U.S. Agency for Partnership for 6756 4132.08 $4,849,952

International Supply Chain

Development Management

7935 7935.07 U.S. Agency for Partnership for 4480 4132.07 Supply Chain $6,700,000

International Supply Chain Management

Development Management

Table 3.3.15: