DRAFT_SOW_TO_PMI_Aug_15_2013.pdf

SECOND DRAFT PMI Task Order – 15 Aug 2013

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SECTION C – BACKGROUND/SPECIFICATIONS/STATEMENT OF WORK

C.1 BACKGROUND

The United States Agency for International Development (USAID) is the U.S.

Government’s (USG’s) principal implementing organization for international development assistance. This Task Order contract will be called upon to serve the needs of USAID, but also other USG agencies, as well as partner country governments, NGOs, and other entities. USAID is headquartered in Washington, D.C. and maintains USAID Missions in more than 75 countries across the globe. USAID/Washington is comprised of five geographic bureaus (Africa, Asia, Europe and Eurasia, Latin America and the Caribbean, and Middle East) and four functional bureaus, (1) Global Health, (2) Economic Growth, Education and Environment, (3) Democracy, Conflict, and Humanitarian Assistance, and (4) Bureau for Food Security, that conduct Agency programs globally. The Bureau for Global Health has the overarching goal of improving human health.

The purpose of this Task Order is to primarily serve the current and future requirements of the President’s Malaria Initiative (PMI), www.pmi.gov, and USAID’s malaria program. In addition the Task Order may be called upon to serve the needs of related maternal child health and other infectious disease programs when consistent with the primary goals of this Task Order as determined by USAID COR.

USAID has funded the provision of malaria commodities in a number of countries for several years in support of the PMI. PMI is on a path to meeting ambitious prevention and treatment targets by expanding access to, and ensuring appropriate use of, key malaria commodities.

This Task Order is intended to provide USAID Missions, Bureaus, and operating units with a worldwide mechanism to support PMI’s and USAID’s goal of reducing the burden of malaria and supporting related activities pursuant to USAID’s maternal and child health and other infectious disease goals. The Task Order will primarily support USAID’s implementation of malaria programs through the procurement, management and delivery of high quality, safe, and effective malaria commodities; the provision of on-the-ground logistics, supply chain, and related pharmaceutical management technical assistance and implementation capacity; and provide technical leadership to strengthen the global supply, demand, financing, and introduction of existing and future malaria commodities. Upon request from USAID, this Task Order may be called upon to serve the needs of related maternal child health other infectious disease programs when consistent with malaria programmatic activities.

The President’s Malaria Initiative Malaria is a global problem in over half the world’s countries but is a particularly severe public health problem in sub-Saharan Africa1. In 2010, there were an estimated 660,000

1 WHO, Roll Back Malaria, http://www.rbm.who.int/docs/rbm_brochure.pdf

2 | P a g e malaria deaths worldwide, of which 80% were in the African region.2 In addition, malaria contributes to premature delivery, low birth weight, and overall child mortality.3

Furthermore, economists estimate that malaria accounts for approximately 40 percent of public health expenditures in Africa and causes and annual loss of 1.3% of the continent’s gross domestic product.4

Malaria prevention and control is a major focus of US Government foreign assistance objectives. PMI launched by President Bush in 2005 and continued as a key objective of the Global Health Initiative by President Obama, is the US Government’s program to reduce the burden of malaria and mortality by accelerating delivery and scale up of proven prevention and treatment malaria interventions. PMI is an interagency initiative led by USAID and implemented together with CDC. It is overseen by the US Global Malaria Coordinator, who is advised by an Interagency Advisory Group, comprised of representatives of USAID, Centers for Disease Control and Prevention, Department of Health and Human Services, Department of State, Department of Defense, National Security Council and the Office of Management and Budget. Implementation of the Initiative is closely coordinated with the efforts of partner governments and national and international partners, including the non-governmental and private sectors.

The PMI strategy based on the goals and objectives mandated in the Lantos-Hyde United States Leadership against HIV/AIDS, Tuberculosis, and Malaria Act aims to halve the burden of malaria (morbidity and mortality) in 70 percent of the at-risk populations in Africa (approximately 450 million residents) over the six-year funding period (2009- 2014) of the USG Global Health Initiative. A key priority of the PMI in focus and non-focus countries and regional programs will be the provision and management of lifesaving commodities including insecticide-treated nets (ITNs), especially long-lasting insecticide treated nets (LLINs), effective treatment with artemisinin-based combination therapies (ACTs), and drugs for the treatment of uncomplicated and severe malaria, insecticides, equipment and supplies for indoor residual spraying (IRS), antimalarial drugs for the intermittent preventive treatment for pregnant women (IPTp), rapid diagnostic tests (RDTs) and laboratory supplies and equipment for malaria diagnosis. In addition to this established set of interventions, PMI will also focus on implementing new evidence-based policies, interventions and strategies as they emerge that could have a significant impact on the prevention and treatment of malaria.

Universal coverage5 of LLINs through campaign and routine, continuous distribution systems remains a key area of focus for malaria control. This task order will support this objective at the country level by ensuring cost effective procurement strategies and supporting distribution at the country level by using a variety of systems ranging from

2 WHO, World Malaria Report 2012, http://www.who.int/malaria/publications/world_malaria_report_2012/wmr2012_summary_and_keypoint.p df 3 WHO, World Malaria Report 2005, http://rbm.who.int/wmr2005/html/1-2.htm#box2 4 The President’s Malaria Initiative, Sustaining Momentum Against Malaria: Saving Lives in Africa, Fourth Annual Report, April 2010, http://www.fightingmalaria.gov/resources/reports/pmi_annual_report10.pdf 5 Universal Coverage of ITNs is often described as one net per sleeping space or one net per two persons.

3 | P a g e mass distribution campaigns to routine distribution to health facilities using partner country supply chain systems.

PMI will also continue to support coverage goals for Intermittent Preventive Treatment in Pregnancy (IPTp), diagnosis and case management through appropriate rational treatment. Community case management is strongly promoted through the PMI. This task order will support a range of procurement, logistics, and supply chain activities designed to support PMI and USAID’s goals of scaling up coverage and improved access to IPTp, malaria in pregnancy, case management of malaria and related febrile illnesses.

In 2010, the World Health Organization (WHO) issued updated guidelines that recommended that all people with suspected malaria undergo confirmatory testing for malaria parasites with microscopy, or rapid diagnostic tests in the event microscopy is not available, before treatment is administered. This change in guidance was based on concerns that overuse of ACTs might promote the spread of drug resistance and the need to promote correct diagnosis of non-malarial fevers. In addition, as efforts toward malaria control achieve success and the incidence of malaria falls, and fewer reported fevers will be attributable to malaria. The implementation of these new WHO recommendations regarding confirmatory testing represents a fundamental change in the management of febrile illnesses and suspected malaria, particularly in sub-Saharan Africa.

There are several new commodity based interventions and innovations that are expected to emerge and added to the intervention mix to achieve malaria control. These may include, but are not limited to: vaccines, new first-line malaria treatments (both artemisinin and non-artemisinin based), new medicines for use in IPTp, seasonal malaria chemoprevention, new vector control tools such as durable wall linings and new LLIN technology that combats insecticide resistance. This task order shall support the implementation of new interventions and related technologies by providing procurement, logistics, and delivery support through any means required to achieve PMI and USAID’s malaria health outcomes.

Related procurement and logistics contracts Several USAID Global Health mechanisms exist or will be developed in the future that either directly or indirectly support the implementation of PMI’s and USAID’s malaria program. The DELIVER Task Order 3 and Task Order 7 have supported PMI’s malaria commodity procurement and supply chain work to date http://deliver.jsi.com/dhome/health/malaria. The Indoor Residual Spray IQC http://www.pmi.gov/technical/irs/index.html is intended to provide implementation and technical leadership in the areas of indoor residual spraying and vector control. The NetWorks Project http://www.networksmalaria.org/ implements a comprehensive approach to improving LLIN distribution systems, by developing stronger, more efficient distribution programs to ensure broader coverage and correct use of this life-saving intervention. The System for Improving Access to Pharmaceuticals and Services (SIAPS) project http://siapsprogram.org/ continues to provide technical assistance in the areas of logistics, pharmaceutical management and ACT implementation. The United States Pharmacopeia Promoting the Quality of Medicines http://www.usp.org/global-health-

4 | P a g e impact-programs/promoting-quality-medicines-pqmusaid project will continue to provide technical assistance to country programs to help ensure the quality of antimalarial drugs, and develop and reinforce existing national drug laboratory systems to better enable drug quality monitoring. Other PMI cooperative agreements and contracts can be found on www.pmi.gov.

In addition, there are several mechanisms that USAID anticipates awarding under the new Supply Chain architecture and task orders under this IQC (refer IQC RFP). For this task order, USAID requires the contractor to coordinate and draw upon the resources available across the IQC including leveraging, coordinating and integrating with key functions under future task orders anticipated for award under the IQC to ensure best value for USAID.

In addition, the Contractor will be required to coordinate with the above USAID mechanisms plus others, Global Fund and other donors, National Malaria Control Programs, and Essential Drugs and National Food and Drug Administrations as necessary, Central/National Medical Stores, and others that are described further in section C.3 of this document to support worldwide commodities procurement and implementation goals of the PMI.

As summarized in the Global Health Supply Chain synopsis, which was posted on FBO.gov in August 2012, USAID is restructuring its existing portfolio of projects related to commodity security and supply chain management of essential health commodities. A diagram of the new portfolio of projects is illustrated in Figure 1 below. This RFTOP is for Task Order 1 within the single-award IQC for “Procurement and Supply Chain Assistance”. Note that the Global Health (GH) Supply Chain Group in Figure one below refers to the USAID management team responsible for oversight of each of the contracts identified in the figure. A Task Order Contracting Officer’s Representative (TOCOR) will be appointed after award for this Task Order.

Of critical importance to USAID in the transition from the existing DELIVER Task Order 7: Malaria to this new Task Order is to ensure an uninterrupted supply of commodities, a continuous provision of technical assistance, and a comprehensive knowledge transfer between the existing and new implementing partners. To this end, this Task Order contract will operate in parallel with the existing contracts for a sufficient period of time to ensure a successful transition. The transition period is expected to last 6-12 months. This transition will require all existing and new contracting parties to collaborate as directed by USAID in support of the overall mission of improving global public health.

C.2 TASK ORDER 1 OBJECTIVES

Given the scale and scope of this IQC and the requirements of this Task Order, it is imperative that the contractor actively collaborate, coordinate, and communicate with other partners to provide high quality services to USAID, actively seek opportunities to partner with entities with state of the art knowledge, experience, and expertise to

5 | P a g e accomplish the objectives of this Task Order. In executing this Task Order, the contractor shall implement a management structure that leverages the resources from other anticipated task orders under the overall IQC, consolidates select functions, while ensuring that the technical, customer service and operational requirements are met with high quality and responsiveness. The contractor shall be expected to maintain a high performing organizational structure that allows for flexible budget and staffing arrangements among subcontractors to maximize responsiveness to USAID demands.

USAID expects the contractor to recruit, hire and maintain staff with the appropriate mix of skills to either provide services directly, or to engage appropriate subcontractors to accomplish the objectives of this Task Order. In addition, USAID expect the contractor, whenever possible, to identify efficiencies through collaboration with other partners and awards under the architecture, as well as within the IQC, to achieve savings and best value for the USG.

The contractor shall maintain key performance indicators (KPIs) and have a program management plan (PMP) in order to evaluate its own processes and performance that can be independently verified for each objective area listed in the Task Order scope. The draft PMP shall be submitted within 45 days of award and will consist of agreed upon targets, benchmarks, and potential baseline data to measure performance against. The Contractor shall report periodic (quarterly or semiannually) performance against targets for all KPIs throughout the life of the contract.

USAID anticipates awarding a performance incentive fee component to this Task Order.

Contractor Delivery incentives under this IQC are intended to apply a reward structure to improve the performance and delivery schedule of the successful Contractor by encouraging on-time-delivery of essential health commodities. Additional details will be provided in the final RFTOP and will be negotiated with the prospective bidders during the contract negotiation process.

The three main objectives of this Task Order are to:

(1) Objective 1: Improve, implement and expand USAID’s provision of quality assured malaria and related commodities to programs worldwide and contribute to a reduction in malaria burden and a greater public health impact.

(2) Objective 2: Use and improve the performance and capacity of in-country supply systems to reliably deliver commodity- based malaria control interventions and support related maternal child health and infectious disease programs.

(3) Objective 3: Improve global supply and long-term availability of malaria commodities through strategic engagement, collaboration and analyses.

In pursuit of these objectives, the Contractor shall engage in the following types of activities, which are used only for illustrative purposes and are neither exhaustive nor intended to limit the breadth of activities the Contractor should engage in:

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1) Maintain, strengthen and improve cost-effective mechanisms for forecasting, procurement, logistics, delivery and management of malaria, and related maternal child health and other infectious disease commodities.

2) Provide USAID and host country institutions with technical expertise and implementation support in all aspects of malaria commodity forecasting, procurement, supply chain, and pharmaceutical management to particularly support the PMI and the USG Malaria Strategy’s long term vision and when appropriate, to develop and hone local technical expertise, generating country ownership and accountability.

3) Customize technical consultations and program support to meet evolving USAID requirements. Provide specialized supply chain technical assistance to malarious countries as needed.

4) Engage with international partners, other malaria donors, and technical experts as needed to ensure that country needs are met, collaboration is enhanced, and knowledge sharing is promoted.

5) Establish field offices and maintain country presence for the provision of direct technical assistance and implementation support, when requested by USAID. The Contactor shall furnish an appropriate skill mix of staff at the country level that is supported by Headquarters and responsive to the needs of the country and task order objectives.

6) Collaborate and support National Malaria Control Programs, Central Medical Stores, other Ministry of Health offices, and other in-country malaria stakeholders to support malaria control and related health objectives, build capacity, and ensure country ownership, C.3 TASK ORDER 1 SCOPE/STATEMENT OF WORK

(1) General The Contractor shall provide malaria and related commodities procurement and supply chain management services to USAID Missions, the USAID/Washington Global Health Bureau, and other USAID Bureaus and operating units. Through this contract, the Contractor shall provide, as requested by USAID, planning, organization, management, implementation, and reporting services related to commodity forecasting, procurement, and supply chain management; USAID Mission requested host-country technical assistance and capacity-building; long- and short-term technical assistance; and advisory and monitoring services to host country institutions (both governmental and non-governmental) to implement effective commodity forecasting, procurement and supply chain management programs.

The contractor will not receive a fee on the cost of commodities that it procures and distributes. The contractor may recover cost of the level of effort as a direct cost.

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The Contractor will develop their approach to procurement to be responsive to USAID’s current and future malaria objectives and programmatic approaches. However, there is the possibility that other governments, non-governmental organizations (NGOs), private sector, or public organizations may order, finance, obtain and report on commodities through this contract mechanism. If that need arises, and upon request from USAID, the Contractor will provide procurement services and/or related technical assistance for these other organizations.

This Task Order will primarily support the requirements of PMI and USAID’s larger malaria program. The Task Order may also be called upon to serve related maternal child health and other infectious disease programs to the extent the activities are aligned and technically integrated with malaria program goals. The Contractor will develop evidence-based strategies that identify and implement best practices for systems strengthening and integration, deploy innovative solutions to problems in supply chain management and long-term commodity availability, leverage global and local partnership efforts, build local capacities and increase country ownership, and produce measurable results. The Contractor should develop roles and responsibilities with and leverage the capacities of local (in-country) partners in the commercial, NGOs, and public sectors (as appropriate) for the execution of the Task Order’s work.

The Contractor is also encouraged to collaborate with private businesses, utilizing an approach both with local or regional nonprofit/private business when feasible and appropriate, as well as with US small or disadvantaged businesses.

(2) Contractor’s Roles The Contractor will provide technical resources which USAID missions, bureaus, and operating units may draw upon to meet commodities provision and management requirements of the Task Order Objectives as outlined below.

(3) Key Objectives The component objectives and illustrative activities to be performed under this RFTOP include the following:

Objective 1: Improve, implement and expand USAID’s provision of malaria and related commodities to programs worldwide and contribute to a reduction in malaria burden and greater public health impact. (Estimated LOE 50-60%)

Global malaria control over the past ten years has resulted in significant gains due to the scale up of effective prevention and treatment interventions—all of which are reliant on the provision of high-quality malaria commodities. Donors, host country governments and national malaria control programs will be required to sustain and increase access to proven effective malaria prevention and treatment measures, most of which rely on a steady and uninterrupted flow of commodities.

Factors adding to the complexity of malaria commodity management include introduction of rapid diagnostic tests (RDTs), fluctuations in ACT and LLIN supply and demand, 8 | P a g e growing concerns about insecticide and antimalarial drug resistance, changing epidemiology of malaria, changing guidance on what type of commodities to use, and need for replacing old and worn out nets. Challenges in the cultivation and extraction of artemisinins from Artemisia annua continue to impact prices and supply of ACTs.

Forecasting for RDTs and ACTs has grown more complex in recent years, requiring new quantification methods that incorporate evolving epidemiologic data, consumption patterns, and provider/patient behavior. Moreover, the introduction of new malaria interventions based on new medicines, diagnostics, and vector control commodities and technology are also expected during the life of this task order, all of which will directly impact forecasting activities. Together, these factors have contributed to an inherently complex global malaria commodities supply chain.

The Contractor shall manage all aspects of malaria commodity procurement including selection and administration of contracts with suppliers; insurance and delivery; and quality assurance. The procurement procedures must fully comply with the Federal Acquisition Regulations (FAR) and USAID regulations, and at the same time leverage volume purchasing to achieve prices comparable to the best prices obtained by USAID and/or, private sector buyers, and other donors. This Contractor’s capabilities must be flexible, efficient, fast, reliable, comprehensive and cost-effective. The Contractor shall be responsible for the timely, complete delivery of quality assured commodities as specified in the purchase order and for ensuring and enforcing contractual remedies, if conditions are not met.

The Contractor shall use firm fixed price subcontracts for procurement of commodities, unless there is a clear cost benefit and risk mitigation to using an alternative contracting arrangement for commodity procurement.

The Contractor shall be fully responsible for the timely procurement, delivery, and management of commodities, per agreed cost and shipment date as provided under the task order, including, without limitation, by purchase order, and/or OAA approval package, and/or COR agreement. The Contractor shall further be responsible for redressing any failures to meet terms and conditions of commodity delivery through, without limitation, adequate supervision and management of vendors and/or subcontractors, insurance claims, ensuring adequate contractual remedies, and enforcing contractual remedies on vendor subcontracts.

In particular, the Contractor shall demonstrate the capacity to deliver and distribute products to clinics, households, or local facilities (the ‘last mile) using public, not-for-profit, or private commercial channels. The Contractor shall be able to distribute LLINs, other malaria and related commodities and/or provide logistical support for both routine and campaign approaches. The Contractor should also support supply chain and logistics to provide pharmaceuticals and supplies to integrated malaria and maternal child health programs at the health facility and community level, on a case by case basis when approved by the USAID COR.

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The Contractor shall maintain inventory/stockpile for the most frequently requested ACTs in order to respond to emergencies and shorten lead times. Currently, the DELIVER Task Order 7 contract currently orders monthly deliveries, on average, of 500,000 to 750,000 treatments of artemether lumefantrine and artesunate amodiaquine for the stockpile inventory, which is subsequently allocated to different countries based on need. At present, the inventory is maintained in a UPS leased warehouse located in Amsterdam, Netherlands due to flight locations to Africa and proximity to key suppliers.

The Contractor should anticipate managing malaria and related commodity procurement volume in the range of $225-$300 million on an annual basis. The exact type and value of the commodities cannot be predicted at this time. However, the PMI annual reports available http://www.pmi.gov/resources/reports/index.html provide historic information on the number and types of commodities procured over time. The Contractor should have the capacity to provide procurement services as detailed below on a worldwide basis to any country designated by USAID.

1.1. Malaria Commodity Procurement—Ensure Strategic Sourcing of Quality- Assured Malaria, Related Maternal Child Health, and Other Infectious Disease Commodities

The Contractor shall develop and implement strategic sourcing strategies and procurement operations with demonstrated ability to obtain best value. The Contractor shall continuously review the marketplace for commodities and continuously review its supply contracts to ensure strategic alignment with USAID goals and to ensure that the USG is receiving the best value.

Tasks include, but are not limited, to:

a. Managing all aspects of malaria commodity procurement and vendor subcontract management: The Contractor shall provide and operate a malaria commodity procurement management system that is capable of efficient and accurate processing of all procurements and subcontracts under this task order. The Contractor shall be responsible for solicitation, evaluation, negotiation, award, management, administration and closeout of supply and commodity subcontracts, under USAID technical guidance and in compliance with USG/USAID contracting rules and policies. The Contractor shall analyze partnership and sourcing opportunities with different sources of supply including manufacturers, suppliers, or internationally-recognized wholesalers/procurement agents to determine the best procurement channels. The Contractor shall be responsible for the timely, quality, complete delivery of the commodity as specified in the purchase order and ensuring and enforcing contractual remedies, if conditions are not met.

Commodities to be procured under this task order will include, but are not limited to the following:

Insecticide-treated nets (ITNs) including long-lasting insecticide-treated nets (LLINs);

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Drugs including artemisinin-based combination therapies (ACTs), sulfadoxine-pyrimethamine, chloroquine, primaquine and artesunate drugs for use in the treatment of severe malaria including equipment for parenteral administration;

New malaria medicines, vector control technologies, vaccines, and commodities as needed;

Maternal child health and other infectious disease medicines and supplies when requested by USAID and consistent with the goals and objectives of this Task Order;

Rapid diagnostic tests (RDTs) and equipment for safe storage, disposal and transport;

Laboratory equipment and supplies including microscopes, stain and slides;

and

Other commodities as approved by USAID.

b. Defining criteria and developing preselected lists of commodities and appropriate supply sources/vendors for USAID procurement. The Contractor shall define and execute prequalification processes and criteria for malaria commodities working with domestic and international standards and partners as appropriate. The Contractor will identify and partner with international organizations, technical bodies, and other partners to develop prequalification criteria for USAID-procured commodities. Examples include other UN Agency prequalification; prequalification through internationally recognized wholesalers; technical bodies such as the U.S. Food and Drug Administration, the European Medicines Agency, the WHO Prequalification Project, and the WHO Pesticide Evaluation Scheme. Criteria will be based on technical input from USAID, other USG agencies, and other experts as designated with respect to dimensions such as quality, efficacy. This list of products, with characteristics such as pack size, cost, etc. and vendors will be assessed and modified as new products become available or newer, more stringent quality criteria are developed.

c. Providing commodity procurement management and commodity ordering support to all country programs supported under this Task Order. The Contractor shall undertake all steps necessary to support country programs to place and fulfill orders with high quality customer service. In-country personnel authorized by the USG will approve final commodity purchase request orders, in collaboration with national programs, as distinct from the formal subcontracting approval process. USAID may request the Contractor to assist malaria programs to identify the types and quantities of commodities to be procured, and timing of deliveries with funds other than PMI or USAID. The Contractor will also work closely with in-country PMI staff to develop commodity procurement/order plans for malaria commodity needs.

d. Identify, Plan and Mitigate Risks. – Controlling malaria and avoiding preventable malaria-related mortality, is dependent on the steady flow and availability of lifesaving commodities, particularly antimalarial medicines. The Contractor shall develop, continuously update, and maintain contingency plans and product risk profiles to mitigate the most likely risks affecting supply that could in turn result in a resurgence of malaria

11 | P a g e or loss of life. The contractor shall maintain a risk management strategy that will maximize the continuous flow of key, critical malaria commodities, particularly medicines. The contractor shall continuously monitor potential problems affecting supply, communicate such risks to USAID, and propose solutions to USAID that best address such issues.

e. Manage Commodity Subcontractor/Supplier Performance.– The Contractor shall track commodity subcontractor supplier performance by maintaining and circulating supplier performance scorecards to the USG. Evaluations shall be consistent over the life of the contract and across the variety of commodities and suppliers. These metrics are likely to include percentage of on-time supplier deliveries, supplier defect rate, supplier order cycle time, percentage of delivered orders as expected and documented, and others.

f. Coordinate Malaria Commodity Procurement. – The Contractor will seek to coordinate commodity procurements and deliveries with other international donors, particularly the Global Fund, and partner country counterparts. The contractor shall liaise with existing international donors and initiatives such as the Global Fund, UNICEF, UNITAID, the Roll Back Malaria Global Partnership, the World Health Organization, to effectively coordinate so as to avoid unnecessary shortages or overstocks of malaria-related commodities. In some cases, USAID may call upon the contractor to complete procurements on behalf of other international donors, in collaboration with USAID.

g. Implement Continuous Improvement. – As an integrated part of the program implementation, the contractor will establish a continuous improvement process to evaluate and improve its internal procurement processes and ensure data quality in all procurement transactions, reporting, and financial accounting. The contractor will conduct periodic internal and external reviews of procurement practices, management systems and results, and assess proposed alternatives. This process may include, but is not limited to, external audits of policies, procedures, and processes, and analysis of data quality, financial integrity, and performance history, as well as other activities.

1.2. Provide Efficient, High-Performing Logistics for Malaria Commodity Delivery at Any Level of the Health System

The Contractor shall be responsible for managing any and all logistics processes to deliver any malaria commodity to any point in a partner country. Logistics functions may include, but not be limited to: customer order fulfillment, freight forwarding, obtaining tariff exemptions, customs clearance, warehousing, transportation and inventory management. All functions and processes must be fully compliant with all applicable USG laws and regulations. Activities include but are not limited to:

a) Providing freight forwarding, insurance, security, interim warehousing, custom clearance, and consignment that shall ensure efficient and secure delivery of procured supplies. The Contractor shall seek to ensure best value of transportation costs through effective transport contracting, mode selection, and other means. The contractor will ensure timely, accurate, safe, and cost-effective freight-forwarding

12 | P a g e services for all commodities procured through this task order. The contractor shall be responsible for the secure storage and distribution of these commodities from the point commodities are released by the suppliers, to the point that ownership is transferred to in-country consignees, which may include a central medical store or “last mile” points such as the health facility and household when required by USAID.

The contractor shall also possess sufficient insurance to cover the value of the products in transit and/or storage and ensure secure chain of custody until the commodities are consigned. The Contractor shall manage all processes related to insurance claims and ensure that USAID is fully reimbursed, in a timely manner, for any commodity damage or loss incurred while in Contractor or subcontractor custody.

The contractor shall provide support to clearance, warehousing and transport of commodities not procured by the USG, as requested by USAID. Directly related to this, the contractor must maintain responsibility of the consignment and chain of custody directly within its own subcontractor control up to the point of consignment in country. The contractor shall maintain documentation regarding chain of custody on file for any needed reviews by USAID.

b) Providing malaria commodity warehousing and inventory management – The Contractor must establish implement and continuously maintain appropriate inventory strategies for key malaria commodities procured under this Task Order. The purpose of these strategies is to strike the right balance between cost (inventory, operating, transportation, etc.) with service (lead time, stockouts, etc.) as well as provide a mechanism for responding to epidemiologic needs, such as potential outbreaks, and programmatic bottlenecks, such as delays in other donor funding flows. These strategies should determine where best to locate inventory stores, what level to set inventory minimums, maximums, and reorder points by commodity, and should achieve best value of cost and service for USAID. The contractor must continuously review its inventory stock strategy and maintain the ability to adjust the number, size, and location of its warehousing facilities to ensure best value for the contractor’s logistics operation. The Contractor shall assume full responsibility for the management of malaria commodities held as central stock, including but not limited to maintaining processes, procedures and reporting to safeguard and account for stock inventory.

c) Providing in-country malaria commodity distribution and transportation. – To the greatest extent possible, the point at which commodities are consigned in-country should be appropriate to ensure the physical security and integrity of the commodities to their point of consumption. As necessary, USAID requires that the Contractor shall be capable of distributing products to the “last mile,” including beneficiary, as requested by USAID using multiple channels – public, private and community. For example, the Contractor shall support LLINs campaign logistics including distribution and temporary warehousing to the household level. In cases where the Contractor is managing in-country supply chain operations, the contractor must also have the capacity to collect related and appropriate data at all levels of engagement (e.g., commodity stock data, case management data, etc.) The Contractor shall also implement and augment direct supply chain logistics and capability to the facility or

13 | P a g e community level for malaria and related commodities. In addition to the capability for delivery to the “last mile”, the contractor must also have the capacity to provide related technical assistance on use (e.g., distribution of IEC/BCC materials on proper use of nets or how to hang nets) as well as have the capacity to collect logistics and related data at the “last mile.” Refer to the Malaria Operations Plans at www.pmi.gov for indicative LLIN distribution plans.

1.3 Ensure Quality Assurance of Commodities Financed Under this Task Order

At the task order level, the contractor will be responsible for ensuring that appropriate commodity quality assurance and quality control (QA/QC) processes are in place and maintained. Under Task Order 1, in collaboration with USAID or other designee such as the QA contractor, the global supply chain contractor will be responsible for acquiring and maintaining appropriate documentation supporting the quality certifications of essential health commodities that are procured under this mechanism. These QA/QC processes help ensure that the quality of the commodities meet the requirements of

USAID.

This activity includes, but is not limited to, the following elements:

a) Collaboration with Quality Assurance (QA) Contractor or USAID Designee

– It will be the responsibility of the contractor, in collaboration with USAID or USAID designee, such as the QA contractor, to ensure compliance with applicable USG and country requirements regarding quality.

b) Adherence to USAID’s Quality Assurance Requirements – Only quality assured commodities that have been approved by USAID may be purchased by the contractor. The contractor should ensure that its supply plans take into account the time necessary for adhering to these quality requirements and obtaining approval for purchases when necessary.

c) Managing Product Recalls – At the direction of USAID and with guidance from the QA contractor (or USAID designee) when appropriate, the contractor shall be responsible for implementing and tracking product recalls resulting from quality problems. The contractor shall track chain of custody to the original consignee and, if needed, assist host governments and in-country partners to further identify all recipients of defective products. As part of the recall process, the contractor may also be directed to collect recalled product, quarantine and/or destroy recalled product, obtain reimbursement from the vendor as required, and notify other stakeholders as directed by USAID.

d.) In-House QA Capability –The Contractor shall ensure compliance with applicable USG and country requirements regarding all aspects of quality and related specifications. The Contractor shall be responsible for acquiring and maintaining appropriate documentation supporting the quality certifications of pharmaceuticals, RDTs and vector control commodities. The Contractor must

14 | P a g e ensure that QA/QC processes are in place, maintained throughout the supply chain and reviewed/revisited periodically to ensure all standard operating procedures reflect the most up-to-date, internationally accepted practices. The Contractor must have the ability to independently sample and perform random testing of procured products and to support pre-acceptance quality testing in-country when necessary, and to continually update QA/QC processes to ensure compliance with evolving innovations and industry best practices. The Contractor shall possess the ability to subcontract with different laboratories that are certified and have demonstrated capabilities testing malaria pharmaceuticals, ITNs and RDTs and future malaria-related products (i.e., those under development and not yet approved).

The Contractor must demonstrate an understanding of and ability to implement domestic and international guidelines, policies, and regulations regarding the quality, safety, efficacy and use of malaria pharmaceutical products, LLINs and diagnostic supplies and equipment. The Contractor must demonstrate their understanding of the challenges of providing these products, addressing issues such as sub-standard commodities. The Contractor must also address the technical challenges in testing these commodities for quality. Additionally, the Contractor must recognize a dynamic and shifting procurement environment and respond accordingly, adapting QA/QC policies as necessary to be responsive to new products as they become available. The Contractor shall collaborate, communicate and share information, as mandated by USAID, on a timely basis with any designated USAID personnel or external partner.

Attention to QA/QC processes helps to mitigate risk of substandard essential health commodities from entering in to the supply chain and ensure essential health commodities meet contractual and product specifications in compliance with applicable USG and country requirements.

1.4 Data Visibility – Ensure visibility of procurement, logistics, and QA data.

As set forth in the IQC, the contractor shall have information systems that support all supply chain processes listed in this Task Order’s objectives. The contractor shall follow the protocol related to information systems listed below as further described in the IQC:

1. Pre‐Existing Information Systems

2. Documentation

3. Unexpendable IT Property Management

4. Risk Mitigation

5. Data

6. Updates to the Information Systems

7. System Maintenance

8. Data Ownership

9. Collaboration with Business Intelligence Contractor and Other Parties

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10. Data Transactions and Metrics

Objective 2: Use and improve the performance and capacity of in-country supply systems to reliably deliver commodity-based malaria control interventions and support related maternal child health and infectious disease programs. (Estimated

LOE 40%)

USAID is committed to using and strengthening the performance and capacity of in-country supply chain systems to improve malaria and related product availability. This Task Order defines in-country supply chain systems broadly and includes public, private, and non-profit sectors. The contractor must have the capacity to work in countries with supply chains of varying degrees of complexity and capacity. The contractor must address USAID’s commitment to building high performance and responsive supply chains through the provision of technical assistance (described below), performance-based incentives, and other evidence-based approaches, drawing from evidence-based best or most promising practices derived from the public and private sectors, academia, and elsewhere as appropriate. In-country, this may require the contractor to workwith a variety of country counterparts within the Ministry of Health and other private and NGO partners and stakeholders concerned with the regular and sustained availability of essential medical supplies and commodities.

Given that the supply chains in countries vary in their level of development, the contractor shall have the technical and operational capacity to use and/or address the complexities of supply chain systems of varying levels of sophistication.

The Contractor must provide in-country short- and long-term technical assistance and implementation support on all aspects of logistics, end-to-end supply chain management, pharmaceutical management, systems, appropriate use, share lessons learned, quality assurance and capacity development.

Building on the support already being provided by various groups (including UNICEF, Global Fund, USAID, and local Ministries of Health), the Contractor shall provide direct technical assistance and training to malaria endemic partner countries, as requested by USAID. The Contractor must provide support to ensure that short-term malaria control objectives are met with the ultimate long-term goal of establishing high performing, reliable country supply chain systems (public, private, non-profit) that are not dependent on the Contractor for operations.

The following table illustrates the countries and the level of technical assistance or implementation support that USAID expects the Contractor to provide based on current estimates of in-country need. Details for PMI focus countries can be found at http://www.pmi.gov/countries/mops/fy13/index.html. This list of countries and type of technical assistance is not intended to be exhaustive and is expected to change and potentially expand over the life of the Task Order. The Contractor shall have the capacity to respond to increasing or changing demand for technical assistance or direct implementation support, including “last mile” delivery. The Contractor should have the

16 | P a g e capacity to mobilize short term technical assistance and implementation support to any country that is receiving USAID/PMI financed commodities currently and in the future.

Tasks under this component objective will primarily be driven by Mission and partner country needs. The Contractor is required to devise flexible and creative solutions to meet the unique needs of each country and ensure that quality commodities reach the end user.

Tasks may include, but are not limited to, the following:

a) Engage in strategic planning: When requested by USAID, and in coordination with USAID Missions, USG partners, international partners, partner government officials and other partners, the Contractor shall develop multi-year strategic plans (3-5 years) that encompass its own activities with appropriate operating results frameworks. In many cases, country partners will have already undertaken extensive strategic planning exercises related to supply chain management overall and for the malaria control program. In these instances, USAID requires the contractor to plan its activities within strategic plans and frameworks that have been agreed upon by the country and its partners. In other cases, as requested by USAID and in collaboration with country partners, the contractor may be called upon to provide technical assistance to support the implementation of strategic planning related to supply chain management. In addition, USAID requires the Contractor to bring to bear the needs and considerations of malaria control issues within the context of overall country strategic plans for supply chain.

b) Coordinate all logistics functions throughout all levels of the supply chain, as requested. The Contractor shall provide any logistics support requested by the USAID Mission on behalf of the partner country required to support the delivery of commodities from port of entry to various points along country supply chains (public, private, non-profit), including to point of use. This shall include, but is not limited, to the on-time delivery of commodities through customs and through to specified points within the supply chain including facility, community, and household when required for subsequent proper distribution. This may also include functions such as customs clearance, warehousing and storage, in-country distribution, management of fees, minor physical improvements to warehouses, keeping accurate records, adequate stock status maintenance and inventory management, when appropriate and necessary.

c) Improve pharmaceutical management systems and supply chain performance. The Contractor shall improve supply chain performance by supporting a variety of activities such as, but not be limited to: helping host governments and/or programs develop related policies; selecting appropriate drugs and other commodities; assisting in-country programs in forecasting and quantification exercises and turning these forecasts into appropriate procurement information for NMCP and NGOs; ordering; reviewing equipment and storage requirements for the proper management of in-country supplies;

providing assistance to strengthen Central and Regional Medical Stores; managing inventory; transporting from one level to the next until the commodities and pharmaceuticals reach the clients, redistributing commodities at subnational levels to relieve stock overages and stockouts, and, managing data. Approaches may include performance incentives, contracting out specific supply chain functions, and use of

17 | P a g e metrics to measure performance.

d) Quantify, forecast and supply plan for malaria and related commodities – In collaboration with partner country counterparts, the contractor shall provide technical assistance to partner country counterparts to reliably quantify, forecast and support supply planning for all classes of malaria and related commodities.