Draft_SOW_for_Laboratory_Supplies_IQC.pdf

Draft Scope of Work for Small Business (SB) Set Aside Single Award IQC for a Procurement Service Agent for Laboratory Supplies

Section C – Scope of Work

Section C.1 – Introduction

This contract will be set aside for small businesses and will serve the requirements of the President’s Emergency Plan for AIDS Relief (PEPFAR), www.pepfar.gov. Its primary focus is the procurement and freight forwarding of HIV/AIDS Rapid Test Kits (RTKs).

As authorized in writing by the Contracting Officer’s Representative (COR), the Contractor may procure and deliver other diagnostic commodities, needed to support USAID’s broader international health portfolio provided that such purchases are made using funds from the relevant appropriations account. The COR will give the contractor advance written notice prior to ordering products other than RTKs.

Products to be purchase under this contract are hereinafter referred to as “Rapid Test Kits” or “RTKs”. Forecasting, quantification and specification requirements shall be provided by other Contractors under USAID’s new supply chain’s architecture as described in Synopsis No. OAA- GH-12-000128 dated 12 August 2012, and its modifications dated April 12 and April 18, 2013, as well as Synopsis No. OAA-SOL-13-000999-AC. This Contract is one of five procurement vehicles that serve the overall Global Health objectives. Prime contractors responsible for other procurement vehicles under the supply chain architecture are hereinafter referred to as “Contractors”.

The Contractor may be requested to serve the needs of USAID’s health programs 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”, as directed in writing by the Contracting Officer Representative. Non-USG funded procurement shall not be counted against the total estimated cost of this Contract.

Cost Recovery and Profit:

This Contract shall not include separate line items for effort, indirect costs, fee and/or profit.

USAID shall allow for a single procurement services agents’ charge that represents the Contractor’s total operational costs associated with the procurement and delivery of commodities. Procurement service charges shall be applied to the value of commodities, freight, insurance, and other costs as appropriate.

http://www.pepfar.gov/

Section C.2 – Background

The United States Agency for International Development (USAID)

USAID is the U.S. Government’s (USG’s) principal implementing organization for international development assistance. 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, (4) Bureau for Food Security, that conduct Agency programs globally. The Bureau for Global Health has the overarching goal of improving human health.

The President’s Emergency Plan for AIDS Relief (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 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 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 contractors, PEPFAR aims to support anti-retroviral (ARV) treatment for six million people by the end of FY13. In order to support prevention, care, and treatment efforts, there has been the corresponding scale up in the HIV/AIDS commodity supply chain. During the life of this Contract it is expected this scale up will continue and demand will increase for rapid test kits, laboratory diagnostics, equipment and supplies. Because of advances in the field and increased demand, responsiveness to procuring laboratory diagnostics, equipment and supplies needs has been 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.

In the context of scale-up and expansion, the collaboration and coordination between clients, and Contractors in the HIV/AIDS supply chain is essential at all levels. Strong communication channels are key, and information sharing must occur between all parties from international donors to drug manufacturers to ministries of health to Contractors. Facilitating this information exchange and collaboration around supply chain issues represents an important part of the USG efforts addressed by this Contract.

http://www.pepfar.gov/documents/organization/201386.pdf

USAID Bureau for Global Health

The Bureau’s portfolio includes programs and investments that represent the commitment and determination of the United States Government to prevent suffering, save lives, and create a brighter future for families across the globe. Successful implementation of USG health programs in partner countries is dependent, in part, on an uninterrupted supply of essential health commodities.

Procurement of essential health commodities has, therefore, been a focus of the USAID Bureau for Global Health for over 30 years. Since 2005, USAID has procured and delivered more than 4,300 different products valued at $2.4 billion and has provided more than $500 million in supply chain assistance to strengthen partner country systems to more than 50 countries.

These activities support USAID’s Global Health Bureau vision “a world where people lead healthy, productive lives and where mothers and children survive and thrive”.

The Bureau for Global Health includes three Offices that procure essential health commodities for USAID programs and Presidential initiatives globally: the Office of Health, Infectious Diseases, and Nutrition (HIDN); the Office of HIV/AIDS (OHA); and the Office of Population and Reproductive Health (PRH). These three offices plus the Office of Health Systems (OHS) provide in-country technical assistance related to supply chain management and commodity security.

These offices provide global leadership and technical support to USAID Missions, and undertake research and innovation to achieve the Global Health Bureau’s health objectives.

Office of Health, Infectious Diseases and Nutrition (HIDN) – HIDN manages a diverse portfolio. It is responsible for managing the Global Health Bureau’s activities in child survival health, maternal health, and infectious diseases, which include Tuberculosis, Malaria, Avian Influenza, and Neglected Tropical Diseases, and for providing technical leadership in each of these areas. The activities also include programs in nutrition/micronutrients, food security, health policy and health systems strengthening, child survival and health grants with NGO’s, monitoring, reporting, and performance management. USAID’s major malaria program is the President’s Malaria Initiative (PMI), and is implemented out of the HIDN office. PMI is a collaborative USG effort led by USAID and implemented together with the Department of Health and Human Services (U.S. Centers for Disease Control and Prevention), the Department of State, the Department of Defense, the White House, and others. HIDN is responsible for managing PMI’s central commodity procurement and supply chain assistance portfolio.

Office of HIV/AIDS (OHA) – OHA is the focus of HIV/AIDS technical leadership for the Agency and has primary responsibility for leading the Agency’s efforts within the U.S.

President’s Emergency Plan for AIDS Relief (PEPFAR). This responsibility entails ensuring the technical integrity of USAID/Washington and USAID Mission strategies; providing global technical leadership on the full range of issues related to HIV/AIDS prevention, care, and treatment; managing numerous research and USAID Mission support programs; managing PEPFAR’s central commodity procurement and supply chain http://www.pmi.gov/ http://www.pepfar.gov/ assistance portfolio; and monitoring and reporting on the impact of the Agency’s HIV/AIDS program.

Office of Population and Reproductive Health (PRH) – PRH provides strategic direction, technical leadership and support to USAID Mission programs in population, voluntary family planning, and reproductive health. It manages programs that advance and apply state-of-the-art technologies, expand access to quality services, promote biomedical and social science research, promote healthy behaviors, broaden contraceptive availability and choices, strengthen policies and systems to address family planning and reproductive health needs, and improve data collection and use. PRH is responsible for managing the Global Health Bureau’s central contraceptive procurement and supply chain assistance portfolio.

Office of Health Systems Strengthening (OHS) – The Office of Health Systems (OHS) leads the development of USAID’s agenda and strategy to promote effective, sustainable, country-owned health systems capable of advancing maternal, neonatal and child health and nutrition; combating infectious diseases including HIV/AIDS, malaria, tuberculosis and neglected tropical diseases; and addressing emerging public health priorities. OHS leads the Agency’s health systems research efforts including development of a research portfolio and of metrics and tools for measuring health systems improvements. OHS tracks and works to align USAID resources, funds and programs for health systems strengthening with this agenda. OHS also works to influence the priorities of others to support this agenda and strategy, including other US government agencies, partner country governments, donors, firms, and civil society.

The goal of OHS is to provide worldwide leadership and technical expertise in health systems strengthening.

The four offices described above currently work with various Contractors to procure and deliver essential health commodities and provide technical assistance to strengthen supply chain management and commodity security. The current supply chain and commodity security mechanisms are described in brief below.

USAID | DELIVER PROJECT – The USAID | DELIVER PROJECT is a single award IQC that is implemented by John Snow, Inc., in collaboration with 3i Infotech; Abt Associates; The Center for International Health and Development at Boston University School of Public Health; Crown Agents Consultancy, Inc.; FHI 360; Fuel Logistics Group (Pty) Ltd.; The Manoff Group, Inc.; MAP International; PATH; UPS Supply Chain Solutions; and U.S.

Pharmacopeia. The USAID | DELIVER PROJECT provides global procurement and delivery of essential health commodities for non-PEPFAR programs as well as technical assistance in many of the countries where these commodities are consumed. The project designs, develops, strengthens, and, on request, operates safe, reliable, and sustainable supply chains that provide a wide range of affordable essential health commodities, including drugs, diagnostics, and supplies to clients in country programs.

The project also provides technical support to strengthen global and country http://deliver.jsi.com/dhome http://deliver.jsi.com/dhome environments for commodity security, supporting policy development, financing, advocacy, etc. There are currently 4 active task orders in the USAID | DELIVER PROJECT.

Task order 4 relates to in-country technical assistance for USAID’s PRH office. Task order 5 relates to global procurement and logistics for PRH. Task order 6 relates to USAID’s response to emerging and pandemic threats. Task order 7 relates to global procurement and logistics as well as in-country technical assistance for USAID’s HIDN office. The project’s technical support strengthens all aspects of in-country supply chains including forecasting, procurement, distribution, management information systems, quality assurance, storage and infrastructure, and medical waste disposal. The USAID | DELIVER PROJECT supports, through supply chain strengthening and other technical assistance, a range of essential health commodities, including contraceptives and condoms, malaria treatment medicines, insecticide-treated bed nets, and rapid diagnostic tests for malaria, essential medicines, maternal and child health, infectious diseases, avian influenza(AI), and other emerging pandemic threats.

Supply Chain Management System (SCMS) – SCMS is a single award IQC that is implemented by the Partnership for Supply Chain Management, a non-profit consortium of 13 organizations led by John Snow Inc. (JSI) Research & Training Institute and Management Sciences for Health (MSH). Other partners include Booz Allen Hamilton, Crown Agents USA, Inc., The Manoff Group, MAP International, North-West University, Northrop Grumman, Imperial Health Sciences, UPS Supply Chain Solutions, Voxiva, and 3i Infotech. SCMS delivers essential lifesaving medicines and products to HIV/AIDS programs around the world as part of the US President’s Emergency Plan for AIDS Relief.

SCMS works to strengthen supply chains to enable the scale-up of HIV/AIDS care and treatment in partner countries. SCMS operates a safe, secure, and reliable supply chain to buy and distribute high-quality, low-cost essential medicines including antiretroviral (ARVs) drugs, HIV test kits, laboratory supplies, male circumcision supplies and other products. SCMS strengthens the capacity of national supply chains to ensure long-term sustainability. SCMS supports supply chain collaboration and information-sharing among global and local partners in the HIV/AIDS community.

System for Improved Access to Pharmaceuticals (SIAPS) – The SIAPS project is a cooperative agreement implemented by Management Sciences for Health (MSH) with four core partners, Accreditation Council for Pharmacy Education (ACPE), Harvard University, Logistics Management Institute (LMI) and University of Washington.

Specialized resource partners include Africa Medical and Research Foundation (AMREF), Ecumenical Pharmaceutical Network, Results for Development (R4D), RTT Group, VillageReach, and William Davidson Institute. The SIAPS project aims to ensure the availability of quality-assured pharmaceutical products and effective pharmaceutical services needed to achieve desired health outcomes by applying systems-strengthening approaches and principles of country ownership, integration of health programming, sustainability, and improved performance metrics. The SIAPS result areas address the intersections of five health systems components (governance, human resources, information, financing, and service delivery) as they relate to medicines policies, http://scms.pfscm.org/scms http://www.msh.org/global-presence/siaps.cfm management and use, including a focus on patient safety and therapeutic effectiveness.

Potential interventions are designed to ensure that they respond to health elements and cross-cutting concerns in support of health system strengthening.

Promoting the Quality of Medicines (PQM) – The Promoting the Quality of Medicines (PQM) program is a cooperative agreement that is implemented by the United States Pharmacopoeia (USP), works to strengthen quality assurance mechanisms at the country level by improving medicines quality control laboratories and systems for monitoring the quality of medicines in the marketplace, in addition to collaborating with worldwide efforts to combat counterfeit and substandard medicines. The latter includes support for regional initiatives to develop regulatory capacity, sharing of information on product quality, and developing improved tools and approaches to detect counterfeit and substandard medicines. PQM is working as well to expand the pool of WHO-prequalified manufacturers of second line TB medicines.

The table below provides a summary of USAID procurement through its existing essential health commodity procurement and supply chain assistance contracts.

Procurements by USAID Global Health Bureau, FY2009 to FY2012

Project Commodity

Value Suppliers Destinations

DELIVER TO1/5 $509M 12 consistent suppliers 43+ countries

DELIVER TO3/7 $705M

15 consistent suppliers, hundreds of ad hoc suppliers

26+ countries

SCMS $1,244M 200+ suppliers 42+ countries

Current Supply Chains for USAID Global Health Commodities

Below are figures related to scale and scope of the supply chains in calendar year 2012.

SCMS currently makes about 3,102 annual outbound shipments of 2,720 different SKUs, primarily composed of HIV/AIDS-related commodities. There are 36 countries that purchase commodities from SCMS in 2012 (over 50 countries for Life of Project). SCMS maintains inventory in 3 regional warehouses located in Africa. Approximately 1,347 monthly/16,164 annual pallet positions are maintained in Kenya, 651 monthly/7,812 annual pallet positions are maintained in Ghana, and 1,038 monthly/12,456 annual pallet positions are maintained in South Africa. Approximately 51% of commodity value is fulfilled from inventory with 49% being direct dropped from the manufacturer (For ARVs, these numbers are 83% and 17%, respectively.). Approximately 85% of commodity value is shipped inbound to the SCMS warehouses via ocean (69% of commodities if measured by weight) and 15% is shipped inbound to the warehouses via air (31% of commodities if measured by weight). Approximately 40% of http://www.usp.org/global-health-impact-programs/promoting-quality-medicines-pqmusaid commodity value is shipped outbound to customers via air with 60% of commodity value being shipped to customers via truck or rail. (Where trucking is available, this percentage is 82%. NB.

The Government of Nigeria does not currently allow pharmaceutical shipments via road/land.)

With the current supply chain structure, lead time expectations have been established by product by shipping mode by customer. SCMS’s performance is primarily measured as the percentage of customer orders delivered within +/- 14 days of the desired receipt date. SCMS is expected to maintain above 80% for this performance metric.

DELIVER TO5 currently makes about 260 annual outbound shipments of 55 different stock keeping units (SKUs), primarily composed of contraceptives and condoms. There are around 45 countries that purchase commodities from DELIVER TO5. DELIVER TO5 currently holds inventory of commodities for fulfillment of country orders as well as manages direct drop shipments from manufacturers for certain commodities and order sizes. Approximately 81% of commodity value is fulfilled from inventory with 19% being direct dropped from the manufacturer. Approximately 83% of commodity value is shipped to customers via ocean with 17% being shipped via air. Warehouses are currently positioned near DELIVER TO5’s supplier base with approximately 3,100 pallet positions of inventory held in the Netherlands and 3,300 pallet positions of inventory held in Singapore. With the current supply chain structure, lead time expectations have been established by product by shipping mode by customer. DELIVER TO5’s performance is primarily measured as the percentage of customer orders delivered within +/- 30 days of the desired receipt date. TO5 is expected to maintain above 95% for this performance metric.

DELIVER TO7 currently makes about 219 annual outbound shipments of 105 different SKUs, primarily composed of malaria commodities. There are around 25 countries that purchase commodities from DELIVER TO7. DELIVER TO7 holds emergency inventory in the Netherlands only to hedge against the risk of supply interruption, but fulfilled 93% of customer orders as direct drops from the manufacturer. Approximately 74% of commodity value is shipped to customers via air with 26% being shipped via ocean.

As summarized in the Global Health Supply Chain synopsis, which was posted in August 2012, and its modifications, 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 Contract labeled “Small Business IQC Laboratory Procurement” shall be responsible for procurement of diagnostic commodities. It is intended that this Contract will be awarded to a single Contractor, who may subcontract with other entities as necessary for the fulfillment of the Contract requirements.

Note that the GH Supply Chain Working Group in the figure below refers to the USAID management team responsible for oversight of the contracts.

https://www.fbo.gov/index?s=opportunity&mode=form&id=c167a3215b0bb901b47b64f775e41d04&tab=core&_cview=0

Of critical importance to USAID in the transition from the existing DELIVER and SCMS contracts to this new implementing architecture is ensuring an uninterrupted supply of commodities, a continuous provision of technical assistance, and a complete knowledge transfer between the existing Contractors and the new Contractors. To this end, this Contract is required to operate in parallel with the existing contracts for a sufficient period of time to ensure a successful transition. This transition period is expected to last for a period of six to nine months or until a full transition has been made. This transition will require all existing and new Contractors to collaborate as directed by USAID in support of the overall mission of improving global public health.

Section C.2 Statement of Work

The primary objective of this Contract is to ensure the availability of HIV/AIDS rapid test kits (RTKs) using a global procurement strategy. HIV rapid tests are defined as any assay that can detect HIV antibodies or antigen in the blood, saliva or urine in less than 30 minutes with 99% sensitivity and 98% specificity.

The list of HIV RTKs that are approved for procurement via this mechanism can be found at:

http://www.usaid.gov/sites/default/files/documents/1864/usaid_approved_test_kit_list.pdf.

The contractor will design, implement and maintain a program that has two elements:

procurement and freighting of RTKs. In support of this program, the contractor will maintain an information system that tracks and traces all elements of procurement and delivery, including

QA.

The Contractor is expected to recruit, hire and maintain staff with the appropriate mix of skills to provide these services directly, or to engage appropriate subcontractors to accomplish the objectives of this Contract. In addition, the Contractor is expected, whenever possible to identify efficiencies through collaboration with other Contractors under the architecture to achieve savings and best value for the USG.

The Contractor shall maintain key performance indicators (KPIs) to evaluate its own processes and performance. KPIs and first year targets will be established 45 days after award. The Contractor will receive baseline data from the incumbent and USAID, and will undergo periodic performance review against agreed upon targets for all KPIs throughout the life of the contract.

NOTE: Henceforth, all references to “commodities” or “supplies” refer to the RTK’s

Section C.3 – Goals and Objectives

To accomplish the overall goal, the Contractor shall address the objectives below:

Objective 1: Procurement and Delivery of Rapid Test Kits

Successful implementation of USAID’s health programs is dependent on an uninterrupted supply of rapid test kits, which play a critical role toward achieving the goals of Presidential Initiatives PEPFAR. Under PEPFAR, USAID’s efforts to ensure an adequate supply of quality medicines and diagnostic commodities for HIV programs has contributed significantly to the ability to provide care and treatment for 4.5 million persons living with HIV/AIDS. The availability of diagnostic commodities is critical to achieving President Obama’s goal of testing and treatment of six million people by the end of 2015.

This Contract will constitute one of USAID’s principle mechanisms for procuring RTKs during the period of performance of the contract. Throughout the period of performance, USAID requires the Contractor to demonstrate and maintain the technical capacity, as well as to implement a commodity procurement process that is competitive, fair and transparent across the range of

HIV RTK’s that are procured and delivered on behalf of the USAID Global Health Bureau. The

Contractor’s capability must be flexible, efficient, fast, reliable, comprehensive, cost effective, http://www.usaid.gov/sites/default/files/documents/1864/usaid_approved_test_kit_list.pdf and transparent. The Contractor must demonstrate the ability to provide support to USAID health programs in the current context and in changing environments.

The Contractor must develop a procurement approach that primarily supports USAID’s purposes and meets the needs of current and future health programs and USG health initiatives. In addition, it is likely that other governments, NGOs or public organizations will require the services of this Contract, and may order, finance, obtain and report on commodities through this mechanism. If the need arises, and upon written directions from COR, the Contractor must provide procurement services to these other organizations.

1.1 Commodity Procurement – Ensure strategic sourcing of quality-assured commodities to achieve best value.

Under USAID’s guidance, the Contractor shall be responsible for the timely delivery, quality, and complete procurement of HIV RTKs on behalf of the Global Health Bureau, USAID Missions, USG health initiatives and other clients. The Contractor shall be responsible for solicitation, evaluation, negotiation, award, management, administration and closeout of supply and commodity subcontracts.

The Contractor shall analyze partnership and sourcing opportunities with different suppliers, including manufacturers, internationally-recognized wholesalers, and procurement agents to determine the best procurement channels. The Contractor shall be responsible for the timely delivery of the commodity as specified in the purchase order, as well as enacting contractual remedies if conditions are not met. It is the Contractor’s responsibility to ensure that the commodities it supplies, pursuant to this contract, meet USAID quality standards.

The Contractor must develop and maintain procurement processes and procedures that are fully compliant with all applicable USG contracting laws and regulations, including the Federal Acquisition Regulation (FAR) and USAID’s Automated Directives System (ADS) policies and procedures, OMB circulars, CFR, and others.

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

a) Commodity Strategic Sourcing – The Contractor must develop and maintain overarching sourcing strategies that set the direction for its commodity procurement operations.

The Contractor must continuously review the marketplace for RTKs and continuously review its supply contracts to ensure strategic alignment with USAID goals and to ensure that the USG is receiving the best value.

b) Where possible, the Contractor should seek to source commodities from approved vendors local to the point-of-use of the procured commodity (e.g. Africa). The sourcing strategies must account for the emergence of new diagnostic tools and equipment used in addressing HIV/AIDS priorities.

http://www.acquisition.gov/far/ http://www.acquisition.gov/far/ http://www.usaid.gov/pubs/ads/

c) Commodity Cataloging – The Contractor must continuously maintain updated, pre-selected lists of RTKs and appropriate supply sources/vendors for USAID procurement with respect to requirements, such as quality and efficacy. The list of quality products and vendors will be continually assessed, modified as new products become available, or newer, more stringent quality criteria are developed.

Such cataloging should include all pertinent information for each item including but not limited to logistics information such as unit cost, weight, pack size, and carton dimensions. The Contractor must make the current version of this catalog available online to the USG and its clients, as well as ensure that it is continually updated to reflect current pricing and product information.

d) Communication Coordination– The Contractor will receive commodities orders from a central system operated by the Global Supply Chain Mechanism. The Contractor will be responsible for communication with USAID, or other Contractor(s) or clients to confirm order details, including specifications, timing, approvals and payment prior to placement of an order with the appropriate vendor. Forecasting, demand planning, quantification and countries’ testing protocols and algorithms shall be prepared by other Contractor(s) under the Global Health architecture and shall be provided to this Contractor when available.

e) Commodity Procurement and Subcontract Management – The Contractor will be responsible for tendering and administering commodity subcontracts through the solicitation, evaluation, negotiation, award, management, and administration of supply subcontracts, under USAID technical guidance and in compliance with USG contracting rules.

The Contractor will be responsible for securing bids through competitive international tenders or, where sole-source or limited source procurement is required, the Contractor must assist the USG in securing the appropriate waivers by preparing necessary documentation for the waiver requests, and shall be responsible for developing sole source justification documentation when the situation warrants a sole-source subcontract. The Contractor must provide and operate a procurement management system(s) that is/are capable of efficient processing of all procurements, including recurring procurements and short-term procurements.

For recurring procurement, the Contractor will likely seek to purchase commodities via long-term contracts. The Contractor shall also have the ability to manage multiple short-term contracts for certain items as directed by USAID. These items could be low volume commodities, equipment, non-recurring procurement, etc. Such procurements will likely be required on an ongoing basis for the life of the contract.

f) Commodity Procurement Risk Mitigation – The Contractor shall develop, continuously update, and maintain contingency plans and product risk profiles to mitigate the most likely risks affecting supply. These risk factors may include, but are not limited to production delays, disruption of raw material and component supplies, problems with manufacturing capacity, extreme changes in supply or demand of products, long lead times, theft, reduced accuracy of forecasting and planning, and other risks that may affect the timely availability of products. The Contractor shall maintain a supplier risk strategy that ensures continuous flow of key, critical commodities as designated by USAID. The Contractor shall continuously monitor potential problems affecting supply, communicate such risks to USAID, and propose solutions to USAID that best address such issues.

g) Best Value – The Contractor must identify supply sources and implement strategies that achieve best value for the USG. Best value in this context would represent the optimal balance between total landed cost and commodity quality and effectiveness, timeliness of delivery, supplier reliability, supplier diversification, supplier country of origin, relevant small business and local producer designations, and other relevant factors as determined by USAID.

h) Commodity Supplier Performance Management – The Contractor shall track supplier performance by maintaining and circulating supplier performance indicators to the USG.

Supplier performance metrics shall be consistent and comparable during the life of the contract, 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, and percentage of delivered orders as expected and documented.

i) Coordinated Commodity Procurement – The Contractor must seek to coordinate procurements and deliveries with other Contractors within the USAID Global Health Supply Chain Architecture, international donors and partner country counterparts. The Contractor should liaise with existing international donors to ensure a coordinated approach for the supply planning, purchasing, tracking and delivering of commodities.

The Contractor shall find means to effectively coordinate the global supply of diagnostics so as to promptly address potential emergency requests made by USAID or its clients. In some cases, the Contractor may be called upon to complete procurements on behalf of other international donors, in collaboration with USAID, as instructed in writing by the COR.

j) Continuous Improvement – Over the life of the project, the Contractor must establish a continuous improvement process to evaluate and improve its internal commodity procurement processes. The Contractor must conduct periodic reviews of procurement practices 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 and performance history, as well as other activities. The continuous improvement process also includes identifying special and reoccurring procurement delays and devising timely and cost-effective solutions for them.

1.2 Logistics – Ensure efficient and high-performing logistics services for commodity delivery and related services.

Under USAID guidance and over the entire period of performance of this Contract, the Contractor may be responsible for managing logistics processes to deliver any commodity to designated points in partner countries, including but not limited to customer order fulfillment, and freight forwarding. The Contractor will develop and maintain logistics processes and procedures that are fully compliant with all applicable USG contracting laws and regulations, including the Federal Acquisition Regulation (FAR) and USAID’s ADS policies and procedures.

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

a) Customer Order Fulfillment – The Contractor must provide customer service and order fulfillment to clients purchasing supplies via this Contract. The Contractor shall receive orders through the Global Supply Chain System and will be responsible for ensuring that all requirements are met for procurement. Clients will typically approve final commodity orders, in collaboration with other Contractors. The Contractor shall have the capability to provide automated order reminders to its clients to assist clients in maintaining appropriate stocks at client locations.

b) Insurance – The Contractor must possess sufficient insurance to cover the value of the products in transit and/or storage and shall ensure secure chain of custody until the commodities are consigned and handed over the intended recipient.

c) Freight Forwarding – The Contractor must provide freight forwarding, insurance and consignment that promote efficient and secure delivery of procured commodities. The Contractor must ensure timely, accurate, safe, and cost-effective freight-forwarding services for all commodities procured through this Contract. The Contractor shall be responsible for the secure storage and logistics of these commodities from the point commodities are released by the suppliers, until the point at which the Contractor delivers them to the in-country consignee(s). The Contractor, or its own subcontractor, if applicable, must maintain direct control of and responsibility for the consignment and chain of custody control up to the point of consignment in country. The Contractor must maintain documentation regarding chain of custody on file for any needed reviews by

USAID.

d) Continuous Improvement – For the life of the project, the Contractor must establish a continuous improvement process to evaluate and improve its internal processes. The Contractor must conduct periodic reviews of logistics practices 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 and performance history, as well as other activities. The continuous improvement process also includes identifying special and reoccurring delivery problems and devising timely and cost-effective solutions for them.

1.3 Commodity Quality Assurance – Ensure commodities are of high quality to help ensure patient safety.

The Contractor shall interface with Quality Assurance Contractor under the Global Health Supply Chain Architecture to ensure that procurements of RTKs for HIV are completed in adherence with applicable USG and USAID regulations regarding product quality and are in-line with the established Quality Assurance Program of the QA Contract.

The Contractor shall be responsible for ensuring that appropriate commodity quality assurance and quality control (QA/QC) approvals and processes are in place and maintained as long as the Contractor retains chain of custody of the commodities in question. The Contractor shall be responsible for acquiring and maintaining appropriate documentation supporting the quality certifications of RTKs that are procured under this mechanism. These QA/QC processes help ensure the quality and safety of the RTKs purchased under this contract.

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

Laboratory Procurement Contractor shall be responsible for procuring and delivering rapid test kits for HIV. USAID maintains a list of approved RTKs for HIV. The QA contractor must approve any purchase of RTK for HIV that is not included on the USAID approved list.

The Contractor will communicate and collaborate with the Quality Assurance Contractor on:

1. Daily, operational issues relating to specific procurements; and

2. Higher-level strategic issues that affect USAID’s RTKs portfolio and service to field programs. USAID expects that the majority of the RTK procured on behalf of USAID will be procured from the USAID pre–approved HIV RTK list. For those RTKs that have not been pre–approved by USAID, the QA Contractor shall communicate quality assurance approval to the Contractor prior to purchase.

As guided by the risk mitigation strategy outlined in the QA Contract, the Contractor shall work closely with the QA Contractor to collect and ship samples. In order to avoid stock– outs or delays, it will be critical that the QA Contractor conduct prompt reviews of orders, sampling, testing and render any required quality assurance decisions to the COR and the Contractor expeditiously.

Accordingly, the Contractor shall cooperate, collaborate, and communicate with the QA Contractor in order to:

1. Conduct any required quality assurance reviews promptly in order to avoid delays or stock-outs

2. Identify new sources for RTKs that meet USAID quality requirements

3. Provide technical guidance to USAID on product recalls

4. Plan and arrange for appropriate product sampling and testing of RTKs selected products

5. Work with the QA Contractor to ensure appropriate technical specifications for

RTKs

All procurement information generated by the Contractor will be made available to the QA Contractor by direct electronic data exchange between the Contractor and QA Contractor, or other means as may be necessary.

b) Managing Product Recalls – In the event of a recall, the Contractor shall immediately notify the COR and the QA Contractor who will investigate the initial quality problem scale and as soon as feasible develop an action plan for managing and quarantining commodities in question, to include a communication strategy that informs necessary parties and determines appropriate steps. Depending on the magnitude and classification of the recall, necessary parties may include, but are not limited to, USAID, USFDA, other USG agencies, WHO, GF, the applicable National Drug Regulatory Authority (NDRA), and others. This may involve a GMP/GDP audit of the facility, after the recall has been resolved.

In the event of a recall, the USAID CORs will coordinate and assign roles and responsibilities. These roles and responsibilities may include negotiation with the manufacturer for replacement or reimbursement for recalled commodities, operationalization of recall procedures and quarantine/destruction of RTKs in question.

Should a recall occur, the Contractor will provide product tracking data to identify all clients who have received recalled products.

1.4 Data Visibility – Ensure visibility of commodity procurement, logistics, and quality assurance data.

As the use of information is critical to effective management, USAID places emphasis on information accessibility, by USAID and Contractors, as well as on the capacity to generate reports and analyze relevant information for supply chain management. The Contractor must have, or be able to finance and procure, information systems that support all of its commodity procurement, logistics, and quality assurance processes listed in the objectives above. For these objectives, the Contractor should follow the protocol related to information systems described in summary below.

a) Information Systems – The systems used to accomplish the Contract’s objectives should: 1) already be established by the Contractor, prior to the award of the contract;

or 2) should be proposed to be procured by the Contractor, at the proposal submission stage. USAID shall not be expected to fund the procurement or the development of such systems. USAID may consider funding minor modifications required for the execution of this Contract, but the Contractor shall have demonstrated functionality and systems already in place prior to contract start. The information system should at a minimum perform the following functions:

Online catalog

Demand planning

Procurement

Customer Resource Management/online ordering

Inventory management

Order management and Fulfillment

Freight and logistics management, including detailed milestone tracking

Financial management

EDI/e-commerce

KPI/metric reporting

b) Risk Mitigation – As deemed appropriate by USAID, the Contractor must utilize data centers to enable the information system to be functional 24 hours a day, seven days a week (24/7) to meet the needs for world wide access to the system and to allow for fast system response time. The Contractor must utilize the latest technologies such as virtual machines to enable system recovery due to hardware/software failures or other reasons. The Contractor shall maintain an active backup or redundant system as well as implement and regularly practice disaster recovery plans that will allow for the IT system to be recovered quickly (in a new location as necessary) if (catastrophic) failure happens at the existing data center.

Also as part of the risk mitigation effort, the Contractor will create, practice and regularly update standard operating procedures (SOPs) to ensure all processes are repeatable and measurable. By having SOPs, the Contractor will mitigate organization risks associated with staff turnover (for example) as well as practice continuous process improvement.

c) Data – The specific data to be tracked must be specified in this Contract. The Contractor shall, at a minimum, maintain a data warehouse with data from predecessor projects (to be provided by USAID) plus other information required for the successful execution of requirements laid out in this Contract. The Contractor must have the ability to track funding, procurement, logistics, quality assurance, and batch traceability transactions by various filters. It is anticipated that this Contract will receive multiple sources of funding from clients. The Contractor shall track funding and report the following through its various financial systems:

The fund’s directive and account data;

The contributing Office or Mission location;

The program objective for each input of funds provided to the contract;

Pipelines, expenditures and accruals by country and further broken by technical assistance and type of commodity

The Contractor must maintain the data necessary for financial and contract management, including funds obligated and disbursed, funds transferred to the Contractor, vouchers submitted for payment and the related evidence of work completed, performance measures, supply planning, logistics management information systems data (as available) and other functions required to manage this Contract.

d) System Maintenance – In the event the information system needs to undergo a planned shutdown, the Contractor must provide USAID with at least 24 hours’ notice to all users of the system. For any planned shutdowns longer than 48 hours, the Contractor must provide prior justification and a corresponding contingency plan to the COR.

e) Data Ownership – As detailed in FAR clause 52.227-14, USAID claims primary rights to all data compiled by the Contractor to manage this Contract and all data collected and created in the fulfillment of this Contract. The Contractor shall, in all instances, proactively provide full access to this data to USAID.

Embedding of any proprietary information into a government deliverable, reports, or other material will constitute an implicit forfeiture of any proprietary rights by the Contractor over that information. In each instance where the Contractor believes data that was created or collected as a result of this Contract is proprietary and not to be shared with USAID, the Contractor shall in each instance follow the protocols designated by USAID for review of the circumstances of the situation by USAID legal department for evaluation for acceptance of proprietary exclusion. These protocols apply to data that might be proprietary to the Contractor or proprietary another entity (ex: partner country government).

f) Collaboration with Other Parties – In addition to management and execution of the Contractor’s internal processes, the Contractor shall provide an ongoing, continuous flow of information to USAID and to other contractors designated by USAID COR, in particular to the Business Intelligence contractor described in the synopsis referenced earlier in this document.

This information would be for use by other USAID contracting parties, USAID contract management, oversight, and for other purposes. The Contractor shall exchange all transactional data associated with procurement, logistics, and quality assurance to USAID and its designated contractors. The Contractor shall execute, at the request of USAID COR, a high-speed electronic link between the Business Intelligence contractor to furnish such information and data on a frequent, regular, and continuous basis, at a minimum two times per day.

g) Data Transactions and Metrics – The Contractor must track, timestamp, and communicate in real-time all process milestones, as agreed upon with USAID, throughout the full lifecycle of commodities flowing through the supply chain. These milestones might include order date, arrived into inventory date, shipment date, receipt date, and others. The milestones might also include status flags such as “pending QA approval”, “pending ship confirmation from customer”, and others.

At a minimum, the Contractor must maintain the ability to provide 24 hours a day, seven days a week (24/7) access to USAID and others as requested by USAID into procurement status, stock availability, stock on-order, transportation status, and other pertinent milestones. The Contractor must have the ability to link stock availability and on-order visibility to an online ordering system. In addition, for certain essential health commodities, the Contractor shall establish a clear and verifiable chain of custody and traceability for each commodity by lot and/or batch numbers.

Objective 2: Collaboration – Strategic engagement to improve long term global supply of RTKs.

In most partner countries, USAID is not the only source for the financing of the procurement and distribution of commodities. In order to strengthen USAID’s coordination and collaboration with key stakeholders in supply chain management and commodity provision, USAID expects that the Contractor will be in the position to coordinate and collaborate with key stakeholders.

These stakeholders include but are not limited to the following clients:

USG agencies working within partner countries: These include, but are not limited to:

the Department for Health and Human Services including the Centers for Disease Control and Prevention; the Department of Defense; the National Institutes of Health;

the Department of Agriculture; the Health Resources and Services Administration and others.

Partner country counterparts in procurement, finance, health, and education; partner country government counterparts and their country private sector counterparts in product technical services, manufacturing, procurement, freight forwarding, warehousing, and distribution and market development; and partner country regulatory agencies.

International donors and public international organizations working on supply chain issues. Private foundations active in health programs in partner countries.