DRAFT_SOW_TO_HIV_AIDS_Aug_15_2013.pdf

SECOND DRAFT HIV/AIDS Task Order – 15 August 2013

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HIV/AIDS DRAFT TASK ORDER

SECTION C – BACKGROUND/SPECIFICATIONS/STATEMENT OF WORK

C.1. BACKGROUND

The primary purpose of this Task Order is to serve the requirements of the President’s Emergency Plan for AIDS Relief (PEPFAR), www.pepfar.gov. In addition to HIV/AIDS related commodities, and as authorized in writing by the Contracting Officer’s Representative (COR), the Contractor may procure essential health commodities, hereinafter referred to as “essential health commodities”, needed to support USAID’s broader international health portfolio provided that such purchases are made using funds from the relevant appropriations account. Also, the Task Order may be called upon to serve the needs of other health programs from USG and host country partners, and/or respond to natural disasters in the field as authorized by USAID’s COR.

Since 2003, USAID has funded the provision of HIV/AIDS services and commodities in a number of countries in support of PEPFAR. This Task Order is intended to provide a mechanism to support the USG goal of an AIDS‐Free Generation and supporting related activities pursuant to health system strengthening goals.

The Contractor may be requested to operate global supply chains and provide related technical assistance on behalf of USAID Missions, Bureaus, operating units, other USG agencies, Public International Organizations, local and international non‐Governmental organizations, private sector entities, and/or Partner Countries, hereinafter referred to as “clients”. In these cases, the Contracting Officer Representative’s written approval is required. Non‐USG funded activities shall not be counted against the ceiling price of the

IQC.

The Task Order may also be called upon by USAID to respond to other international health activities (e.g. Haiti Cholera outbreak) and/or natural disasters (e.g. Haiti earthquake) should circumstances warrant it.

The Task Order will primarily support USAID’s and clients through the procurement, management, and delivery of high quality, safe, effective, and best value 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 essential health commodities.

PEPFAR

Since its inception, saving lives and improving broader health outcomes have been goals at the very core of PEPFAR. The release of the Obama Administration’s PEPFAR

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Blueprint for Creating an AIDS‐free Generation last November strongly reaffirmed the United States’ commitment to such goals http://www.pepfar.gov/documents/organization/201386.pdf. Over the past decade, PEPFAR has made strategic investments in collaborative networks that provide technical support, strengthen host country management, and build robust leadership and capacity in communities living with and affected by HIV/AIDS around the world.

Since PEPFAR started, the scale‐up of resources and efforts dedicated to the global HIV/AIDS pandemic has been unprecedented. In collaboration with partner country governments and implementing partners, PEPFAR is on track to support anti‐retroviral (ARV) treatment for six million people by the end of FY13. Behind the success of PEPFAR prevention, care, and treatment efforts has been the corresponding scale up in the HIV/AIDS commodity supply chain. During the life of this task order it is expected that this scale up will continue and demand will increase not only for antiretrovirals; for rapid test kits; laboratory diagnostics, equipment and supplies; but also for drugs to treat opportunistic infections and essential medicines. Responsiveness to the large and complex laboratory diagnostics, equipment and supplies needs has been particularly challenging during the past three years. As advances in the commodities associated with HIV care and treatment emerge, the Contractor is expected to procure these products (e.g. pharmaceutical and diagnostics) for PEPFAR programs in the field.

During the life of PEPFAR and other initiatives, countries have improved in the management of their supply chains. Challenges remain at each level of the supply chain (procurement, shipping, in‐country port clearance, warehousing, distribution and use at the service delivery site). Having personnel in place and systems that provide adequate information will enhance host country capacity to ensure that adequate products are available for successful project implementation. Many countries need to improve human resource capacity, information systems, and communications at each level of the supply chain.

Of particular concern is that part of the supply chain dealing with warehousing and distribution. In many countries, planning for the expansion of services in new areas is de‐linked with distribution and supply planning with key clients and stakeholders. Too often, new HIV services are planned or scaled‐up without any discussion of how the appropriate commodities will be shipped to the correct regional warehouses, zonal hospitals, or clinics.

In the context of scale‐up and expansion, the collaboration and coordination between clients, stakeholders and partners in the HIV/AIDS supply chain is essential at all levels.

Strong communication channels are integral parts of a successful supply chain, and information sharing must occur between all parties from international donors to drug manufacturers to ministries of health to implementing partners. Facilitating this information exchange and collaboration around supply chain issues represents an important part of the USG efforts addressed by this task order.

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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 PEPFAR’s and USAID’s HIV/AIDS program. The SCMS IQC has supported PEPFAR’s commodity procurement and supply chain work to date http://scms.pfscm.org.

In addition, there are several mechanisms that USAID anticipates awarding under the new Global Health Supply Chain architecture and task orders under the IQC. 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. The Contractor is required to coordinate with the other USAID mechanisms described in the scope of the IQC, Global Fund and other donors, National Malaria Control Programs, National Drug Regulatory Authorities, Central/National Medical Stores, and others to support worldwide essential health commodities’ procurement and implementation goals of this Task Order.

As summarized in the Global Health Supply Chain synopsis, which was posted on www.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 Task Order is within the single‐award IQC for “Procurement and Supply Chain Assistance”. Note that the Global Health (GH) Supply Chain Working 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.

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Of critical importance to USAID in the transition from the existing SCMS and Deliver Contracts 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 will operate in parallel with the existing SCMS Task Order 3 for an estimated period of 6‐9 months to ensure a successful transition. 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 accomplish the objectives of this Task Order. In executing this Task Order, the

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Contractor shall implement a management structure that leverages the resources from other anticipated task orders under the overall IQC, consolidates selected 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 and staffing arrangements 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 expects 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 draft a performance management plan in order to evaluate its own processes and performance that can be independently verified for each objective area listed in the Task Order scope. Within 45 days of award, the Contractor and USAID shall agree upon targets, benchmarks, and potential baseline data to measure performance against. The Contractor shall report periodic (quarterly) 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 HIV/AIDS and essential health commodities to programs worldwide, and a greater public health impact.

(2) Objective 2: Support and strengthen the performance and capacity of in‐country systems to reliably perform supply chain management functions.

(3) Objective 3: Improve coordination among global supply chain stakeholders through strategic engagement, collaboration and analyses in order to strengthen the collective response.

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 shall engage in:

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1) Maintain, strengthen and improve cost‐effective mechanisms for HIV/AIDS and essential health commodities including forecasting, procurement, logistics, delivery and management of commodities.

2) Provide USAID and appropriate country institutions with technical expertise and implementation support in all aspects of HIV/AIDS supply chain management in line with PEPFAR and the USG strategies; support should take into account the goals of country ownership, sustainability and accountability.

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

4) Engage with international partners, 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 with and support national HIV/AIDS plans, central medical stores, other Ministry of Health offices, and other in‐country stakeholders to support PEPFAR and related USAID health objectives, build capacity, and ensure country ownership.

7) Build upon existing frameworks to measure performance of country supply chains, determine ways to strategically invest technical support to achieve greatest impact, and institutionalize continuous performance improvement within country supply chain entities.

C.3. TASK ORDER STATEMENT OF WORK

1) General The Contractor shall provide HIV/AIDS and essential health commodities procurement and supply chain management services to clients. 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 country technical assistance and capacity‐building; long‐ and short‐term technical assistance; and advisory and monitoring services to country institutions (both governmental and non‐governmental) to implement effective commodity forecasting, procurement and supply chain

7 | P a g e management programs. The Contractor will develop their approach to procurement to be responsive to USAID’s and PEPFAR’s current and future programmatic approaches.

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.

The Contractor must develop or build upon existing 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 shall 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.

USAID also encourages the Contractor to work with host country government partners in efforts to collaborate with private businesses, utilizing an approach 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 clients 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 Task Order include the following:

Objective 1: To ensure the provision of quality essential health commodities to programs worldwide.

Global collaboration between international and host country partners during the past ten years has resulted in developing supply chains for anti‐retroviral drugs, test kits, and essential health related commodities that have enabled countries to scale up prevention and treatment programs. The rapidity of scale up, plus the changing dynamic of the products used to treat HIV/AIDS and other diseases with HIV infection have put pressures on supply chains. It is essential that the contractor have in‐depth knowledge of public health supply chains, can keep pace with the scientific changes that will impact the type and quantity of product needed for the epidemic, and can manage a complex supply chain enterprise in multiple countries simultaneously. Specific ongoing challenges include understanding the ARV and rapid test kit market, understanding the impact of API manufacturers to the finished formulation, and appreciate the new market for point of care (POC) diagnostics.

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The Contractor shall manage all aspects of essential health commodity procurement including selection and administration of subcontracts with suppliers; insurance and delivery; and quality assurance as required. The Contractor’s 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. The USG expects the Contractor’s approach to be flexible, efficient, reliable, comprehensive and cost‐effective. The Contractor shall be responsible for the timely delivery of quality assured commodities as specified in the purchase order and for ensuring and enforcing contractual remedies with suppliers (if the established contractual conditions regarding these elements are not met).

The Contractor shall use firm fixed price subcontracts for procurement of commodities, unless the Contractor can demonstrate and document for the file 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 this 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 be required to deliver and distribute products to district warehouses, health districts, and/or health facilities (the ‘last mile) using public, not‐for‐profit, or private commercial channels in the event the Contractor is so instructed by USAID.

The Contractor shall anticipate managing HIV/AIDS and essential health commodities’ procurement volume in the range of $350‐$500 million on an annual basis. The exact type and value of the commodities cannot be predicted at this time. However, an electronic catalog of commodities procured through the SCMS project can be found at www.scms.pfscm.org. The Contractor shall have the capacity to provide procurement services as detailed below on a worldwide basis to any country designated by USAID.

1.1 Commodity Procurement—Ensure Strategic Sourcing of Quality‐Assured HIV/AIDS, and Essential Health Commodities

The Contractor shall implement strategic sourcing plans and develop procurement operation systems that demonstrate to USAID their understanding of the concept of

9 | P a g e best value and abilities to procure appropriate products. It is the responsibility of the Contractor to keep abreast of product and industry specific changes in the market, and to ensure strategic alignment with USAID goals.

Tasks include, but are not limited, to:

a) Managing all aspects of commodity procurement and vendor subcontract management: The Contractor shall provide and operate a 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, and internationally‐recognized wholesalers/procurement agents to determine the best procurement channels. The Contractor shall be responsible for the timely, efficient, and delivery of the commodity as specified in the purchase order and ensuring and enforcing contractual remedies, if conditions are not met. It is the contractor’s responsibility to ensure that they are buying a product meeting USAID quality standards.

Examples of essential health commodities to be procured under this task order will include, but are not limited to, the following:

Pharmaceuticals o Antiretroviral medicines o Antimalarial medicines o Medicines to treat tuberculosis o Medicines to treat opportunistic infections o Other anti‐infective medicines o Hormonal Contraceptives o Essential medicines

Ready to Use Therapeutic/Supplementary Foods (RUTF/RUSF)

Laboratory diagnostics including rapid test kits and point of care diagnostics, equipment and supplies

Condoms and Intrauterine Devices

Kits for Voluntary Male Medical Circumcision (VMMC)

Medical supplies (gloves, gowns, etc.)

Medical Equipment (hospital beds, etc.)

Other products as requested

b) Defining criteria and developing preselected lists of commodities and appropriate supply sources/vendors for USAID procurement: The Quality Assurance Contractor shall ensure that products procured for this project meet USAID quality standards.

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In addition, it is their responsibility to ensure that manufacturers, wholesalers, and other vendors meet USAID standards. Examples of approved sources may include USAID approved international pharmaceutical wholesalers; manufacturers in countries with stringent regulatory authorities such as the U.S. Food and Drug Administration and the European Medicines Agency, and manufacturers prequalified by the World Health Organization’s (WHO) Prequalification of Medicines Programme. Criteria for approved sources will be guided by relevant USG and USAID policy. This list of approved sources shall be continually and routinely assessed, modified as new products and suppliers become available. In the event that the Quality Assurance Contract under the Global Health Supply Chain Architecture has not been awarded by the time of awarding of this task order, then the Contractor will need to present a contingency plan to execute the vendor prequalification process (see Section 1.3 below).

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. The contractor shall develop a system to continuously measure customer satisfaction with high quality customer service. USAID may request the Contractor to assist HIV/AIDS programs to identify the types and quantities of commodities to be procured, and timing of deliveries with funds other than PEPFAR or USAID. The Contractor will also work closely with in‐country HIV/AIDS staff to develop commodity procurement/order plans for commodity needs.

d) Identify, Plan and Mitigate Programmatic Risks: In order to ensure that there is not treatment interruptions, the Contractor shall develop, continuously update, and maintain contingency plans that can mitigate program and product risks that impact procurement, shipping, warehousing, and distribution and any other aspect of the supply chain.

e) Manage Supply Chain Aspects of Drug Recalls and essential health commodity recalls: The QA contractor, working in close collaboration with USAID will render any product recall decisions. The contractor however, will be required to manage the supply chain aspects of any recall action. This will include identification and retrieval of recalled products, temporary storage or quarantine of products, and arranging for appropriate disposition or destruction of recalled products.

f) Manage Commodity Subcontractor /Supplier Performance: The Contractor shall develop a commodity subcontractor supplier performance scorecard and alert USG to low performance according to agreed upon key performance indicators (KPIs).

Evaluations should be consistent and comparable over the life of the contract and across the variety of commodities and suppliers.

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g) Coordinate Commodity Procurement: When appropriate 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 World Health Organization, Bill and Melinda Gates Foundation (BMGF) and Clinton Health Access Initiative (CHAI) to effectively coordinate in order to avoid unnecessary shortages or overstocks of HIV/AIDS commodities and protect fragile market segments. In some cases, USAID may call upon the Contractor to complete procurements on behalf of other international donors.

h) Implement Continuous Improvement: The Contractor must have a demonstrated continuous improvement strategy, and after award submit a strategy to USAID for approval. This strategy must evaluate its internal procurement processes to promote increased accountability and efficiency and ensure data quality in all procurement transactions, reporting, and financial accounting. The Contractor shall conduct periodic internal and external reviews of procurement practices, management systems and results, and participate in the assessment of 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 and Delivery at Any Level of the Health

Care System for Essential Health Commodities

The Contractor shall be responsible for managing logistics processes to deliver any 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 commodities: The Contractor shall seek to ensure best value of transportation costs through effective transport contracting, mode selection, and other means. The Contractor shall ensure timely, accurate, and safe, effective freight‐forwarding services for all commodities procured through this task order.

Freighting should be done in a manner that meets country needs in the most cost efficient manner. 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 a health facility 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

12 | P a g e processes related to insurance claims and ensure that the program 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. 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 commodity warehousing and inventory management: The Contractor shall establish implement and continuously maintain appropriate inventory strategies for key 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 to prepare a strategy for responding to programs’ needs, such as changes in demand (whether increased or decreased), stock shortages, and implications of delays in other donor funding flows; the current program utilizes Regional Distribution Centers to warehouse ARVs, RTKs and VMMC. 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, price, 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 commodities held as central stock, if any, including but not limited to maintaining processes, procedures and reporting to safeguard and account for stock inventory.

c) Providing in‐country 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 be capable of distributing products directly to service delivery points. In cases where the Contractor is supporting or 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 and case management data). This data should be analyzed and presented to USAID in an appropriate format. In addition to the capability for delivery to the “last mile”, the Contractor must also have the capacity to provide related technical assistance as well as the capacity to collect logistics and related data at the “last mile” when so directed by USAID.

1.3 Assure Quality 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. In collaboration with the QA contractor, or USAID designee, the global

13 | P a g e supply chain contractor will be responsible for ensuring that that appropriate documentation supporting the quality of EHPs purchased under this mechanism is available. 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 and the QA contractor (or USAID designee), 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. For example, some EHP have been pre‐ approved by USAID (e.g. ARVs, RTKs for HIV) and can readily be purchased.

However, for those commodities that have not been pre‐approved by USAID, the contractor must seek approval from USAID prior to purchase.

c) Managing Product Recalls – At the direction of USAID and with guidance from the QA contractor (or USAID designee), 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 – Quality Assurance services for the Global Health Supply Chain Task Order 2 will be provided by the QA contractor. QA activities will be implemented by the Global Health Supply Chain contractor only at the specific request of USAID. The QA contractor will not be required to maintain in‐ house QA capability, however, at the task order level, the contractor must be prepared to propose and demonstrate the ability to independently establish and adhere to QA requirements if directed to do so by USAID. If the contractor is directed by USAID to implement QA services for the Global Health Supply Chain, the contractor will be required to implement all or selected elements of the QA contractor’s scope of work (see QA SOW in pre‐solicitation number SOL‐OAA‐ 13‐000999‐AC and its amendments) within 60 days.

If USAID directs the Global Health Supply Chain contractor to implement QA activities, 14 | P a g e the following are examples (not all inclusive) of activities that would be implemented:

a) The contractor shall assure appropriate collection and shipment of essential health commodities samples that require quality testing. Sample collection could occur at any point in the supply chain.

b) The Contractor shall arrange for appropriate quality testing of pharmaceuticals and essential health commodities at laboratories that are ISO 17025 certified, prequalified by the World Health Organization, or are otherwise certified to conduct quality testing on essential health commodities.

c) The Contractor shall be responsible for acquiring and maintaining appropriate documentation supporting the quality certifications of essential health products (i.e.

SRA certifications, GMP certificates) that are procured under this mechanism.

d) The contractor shall execute vendor prequalification activities as required (see QA SOW in pre‐solicitation number SOL‐OAA‐13‐000999‐AC and its amendments. This activity could include site visits to conduct good distribution practices (GDP) or good manufacturing practices (GMP) evaluations.

e) The contractor shall manage all aspects of a drug recall or any essential health commodity recall, in close collaboration with USAID.

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 Supply Chain System and Processes.

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

10. Data Transactions and Metrics

Objective 2: Support and strengthen the performance and capacity of in‐country systems to reliably perform supply chain management functions.

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USAID is committed to supporting and strengthening the performance and capacity of in‐country supply chain systems to improve the availability of essential health commodities, keeping in mind the PEPFAR and USAID commitments to country ownership, sustainability, and accountability. 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 shall address USAID’s commitment to strengthening country 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 work with a variety of country counterparts within the Ministry of Health and other clients 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 shall provide technical support and guidance to locally owned health supply chains and is not expected to fully operate or manage the local supply chain unless so directed by

USAID.

The Contractor shall 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, data management and use, quality assurance and human resource capacity development; Contractor shall identify ways to share lessons learned across countries, and through other appropriate global channels.

Building on country national strategies and 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 partner countries, as requested by USAID. The Contractor shall provide support to ensure that short‐term technical assistance needs 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 planning, implementation and operation.

The following table provides illustrative examples of countries and type of technical assistance or implementation support that USAID expects the Contractor to provide based on current estimates of in‐country need. 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. The Contractor should organize field office staffing in a way

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

Task Order Sample Activities

Country Types of Support Anticipated

Central America Regional

Field office for region. Assist government with implementation of good warehousing practices. Technical assistance on implementing and managing high‐functioning information systems.

Cote D'Ivoire Potentially managing warehouse‐in‐a‐box project, managing renovations to existing warehouses, support to PSP, and distribution support.

Ethiopia Technical assistance for establishing and maintaining local procurement of essential medicines ‐ QA visits to laboratory/wholesaler.

Support for development and implementation of an integrated LMIS providing high quality, timely data to drive supply chain processes.

Provide modeling for distribution optimization.

Haiti Possibly erecting a new warehouse in a box, warehouse management, waste management, direct logistics support for all commodities, training at site and central level for capacity building

Nigeria Field office based in Abuja. Collaborate with Government on warehousing renovations, procuring ARVs, RTKs, laboratory consumables and supplies, and managing donor run supply chains from central to facility levels.

South Africa Technical assistance to two provincial warehouses to strengthen internal processes and flow of HIV commodities to facilities.

Assistance provided through locally staffed field office.

Tanzania Technical assistance for warehousing, possibly standing up new 'warehouse in a box', data gathering, strategic planning around distribution, reporting, Enterprise Resource Planning (ERP) support and maintenance, electronic LMIS support and maintenance, prime vendor model support/maintenance, on‐going assistance to support new Logistics Management Unit.

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 that

17 | P a g e 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. 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 HIV/AIDS issues within the context of overall country strategic plans for supply chain. The contractor shall also develop and periodically update a comprehensive performance monitoring plan (including baseline measures) that track improvements in the supply chain based on the strategic plan.

b) Support all logistics functions throughout all levels of the supply chain, as requested by USAID. 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 health facility when required. This may also include functions such as customs clearance, warehousing and storage, in‐ country distribution, management of fees, accurate recordkeeping, adequate stock status maintenance and inventory management, when appropriate and necessary.

While the Contractor will generally be called upon to support and build capacity an in‐country partner to perform these functions, in some circumstances the Contractor may be directed to perform these functions directly.

c) Improve pharmaceutical management systems and supply chain performance. The

Contractor shall assist partner country organizations to improve their supply chain performance by supporting a variety of activities such as, but not limited to: helping host governments and/or programs develop related policies; selecting appropriate drugs and essential health commodities; assisting in‐country programs in forecasting and quantification exercises and turning these forecasts into appropriate procurement information; ordering; reviewing equipment and storage requirements for the proper management of in‐country supplies; providing assistance to strengthen Central and Regional Medical Stores; strengthening inventory practices;

advising on optimal transport from one level to the next until the commodities and pharmaceuticals reach the patients (depending on country’s need), and, improving the management of logistics data. Approaches may include performance incentives, contracting out specific supply chain functions, and shall include the use of appropriate supply chain metrics to measure performance.

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d) Quantify, forecast and supply plan for HIV/AIDS and essential health 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 types of HIV/AIDS and essential health commodities. To the greatest extent possible, the methodologies to quantify these commodities must include and incorporate aspects such as consumption, trends in treatment and diagnostic guidelines affecting commodity requirements, the contribution of other donors, and behavior. The Contractor must provide technical assistance to health care and service‐delivery programs in the timely submission of accurate forecasting data, procurement requests, and as necessary, detailed supply plans. The Contractor shall assist programs to ensure that procurement requests comply with national treatment guidelines, local drug product registration requirements, and other related regulations. When requested by USAID, the Contractor shall provide assistance to the partner country in new product introduction and quantification, forecasting, and procurement planning for future transitions to newer and more efficacious products or new interventions (treatment as prevention), voluntary male medical circumcision kits and new diagnostics. The Contractor shall provide technical assistance, routinely collaborate and convene with clients, and support the development of clearly understood, dependable systems, used by all service delivery programs dependent on USG‐funded supplies, for the estimation of re‐supply needs.

e) Support in‐country commodity, warehousing and inventory management. – In collaboration with partner country counterparts, the Contractor must provide technical assistance related to equipment and storage requirements for the proper management of supplies when requested by USAID. The Contractor shall evaluate critical equipment and storage needs to ensure compliance with Good Distribution Practices. . USAID may request the Contractor to advise and/or oversee warehouse/facility design and construction, racking, refurbishment, etc. In these instances, the Contractor must provide technical assistance in inventory management, which may include but is not limited to product slotting and positioning, setting of min/max levels, ABC analysis, SKU rationalization, technology selection, and other relevant activities.

f) Support commodity transportation and distribution. – When requested by USAID, the Contractor shall provide technical assistance and/or direct execution of commodity distribution and transportation on short term and long term basis. In these instances, the Contractor must be able to facilitate outsourcing of transportation for essential health commodity distribution. In some instances, USAID may request the Contractor to directly manage in‐country distribution and supply chain logistics, possibly down to the “last mile.”

g) Ensure quality commodity assurance and quality control within the supply chain.

USAID may request the Contractor to review and provide assistance in strengthening

19 | P a g e existing quality standards and practices and partner capacity to implement effective and appropriate quality assurance/quality control (QA/QC) measures within country‐ level supply chains. In these instances, the Contractor must have the capacity to make recommendations on improving QA/QC related measures in line with international standards and best practices within the industry. USAID may also at times request the Contractor to provide technical assistance with post‐market surveillance activities. The Contractor may also be requested to provide technical assistance and/or review the internal control systems of the supply chain handling USG or other donor product to minimize leakage or diversion of product.

h) Support supply chain performance to respond to new initiatives and modifications in treatment guidelines. The introduction and scale‐up of new initiatives, such as PMTCT Option B+ and Voluntary Medical Male Circumcision (VMMC), has resulted in accelerated roll out of diagnostics and new technologies, often reaching new patients. This has added new challenges to country supply chains as the demand for consistent supply of RTKs has increased, consumption of ARVs and essential health commodities has changed, and the VMMC program has targeted new populations in new settings. USAID expects further changes as country epidemiology changes, and new diagnostic tools and prevention and treatment regimens may be introduced.

USAID requires the Contractor to be prepared to support local supply chains to adapt to these new challenges and potential changes in epidemiology so that beneficiaries receive access to appropriate diagnosis and treatment.