J.14 NextGen Background.pdf

ATTACHMENT J.14

NEXTGEN BACKGROUND

1. Next Generation (NextGen) Supply Chain Program

The procurement and delivery of effective, quality-assured, essential, and life-saving health commodities is a foundation for providing health care to populations worldwide. In many low-and middle-income countries’ health supply chains, both the public and private sector, are challenged to meet the needs of their customers. The result is poor quality health products, stock-outs of life saving drugs, and waste and diversion of products, threatening the sustainability of the country's health system.

To support the USG’s global health priorities of preventing child and maternal deaths, controlling the HIV/AIDS epidemic, eradicating malaria, and combating infectious diseases, USAID requires high-performing and agile supply chains to ensure affordable, high-quality products reach those in need.

The NextGen for PEPFAR, the U.S. President’s Malaria Initiative (PMI) and GH builds on several guiding principles. These include, but are not limited to, responding to the unique requirements of each health program, identifying where to segment functions to maximize performance and respond to different program requirements and where to consolidate based on synergies and efficiencies, and developing a program that attracts best-in-class providers and increases accountability through key performance indicators and incentives. The NextGen program comprises multiple mechanisms, some segmented by health program area and some consolidated. The health program areas will tailor their use of mechanisms across the NextGen program to ensure that the supply chain is optimized to meet their individual health program goals, i.e. eradication of malaria and HIV epidemic control.

USAID adopted a new approach for the NextGen Supply Chain program. Under this new approach, USAID will issue a number of separate procurements to obtain high quality solutions for key activities, including but not limited to:

a. Procurement Service Agents (PSA), each under separate contracts, are responsible for procuring commodities based on specific health element requirements. PSAs arrange global logistic services for delivery of commodities to destinations within partner countries. Each PSA contract focuses on a single commodity type:

1. HIV commodities/logistics;

2. HIV laboratory, molecular, and diagnostic commodities/services;

3. Malaria commodities/logistics; and

4. Family planning and reproductive health, maternal and child health and nutrition, responding to infectious disease outbreaks, and ad hoc needs/logistics.

b. A quality assurance (QA) contractor will be responsible for ensuring that health commodities are safe, effective, and of acceptable quality for clients and patients;

c. An in-country logistics (ICL) contractor will be responsible, when required by USAID, for providing warehousing and transportation of procured health commodities within host countries;

d. Multiple technical assistance (TA) partners will be responsible for supporting operational excellence in the performance of country supply chains to meet the needs of today’s patients, while supporting countries in their efforts to build sustainable solutions to meet the needs of tomorrow’s patients and health programming beneficiaries;

e. Risk mitigation partners will be responsible for identifying and mitigating supply chain vulnerabilities and potential risks globally and locally, including fraud, abuse and/or misuse, counterfeit, and diversion of products and financial resources; and

f. A control tower contractor will be responsible for establishing and operating a central information hub that supports the operation and management oversight of NextGen.

2. NEXTGEN OBJECTIVE - Epidemic Control

In September 2017, the USG launched the PEPFAR Strategy for Accelerating HIV/AIDS Epidemic Control (2017–2020) for 13 high-burden countries with the greatest potential to achieve HIV/AIDS epidemic control by 2020. The Strategy reaffirmed PEPFAR’s continued support to more than 50 countries and to accessible HIV services, including for key populations (KPs) and other vulnerable groups. In September 2018, at the 73rd Session of the United Nations General Assembly, Secretary of State Michael R. Pompeo released the 2018 PEPFAR Strategy Progress Report, listing achievements and showing the 13 countries on pace to control HIV/AIDS epidemics by 2020.

Epidemic control is defined when the total number of new HIV infections falls below the total number of deaths from all causes among HIV-infected individuals.

See more on Epidemic Control on:

1. www.state.gov/pepfar/

2. PEPFAR 2019 Report to Congress

3. OPERATIONAL PLANNING AND SEQUENCING OF AWARDS DURING THE

TRANSITION PERIOD

The NextGen program comprises a number of interrelated acquisitions. Since these contracts will not be awarded simultaneously, if the COR determines that the completion of any deliverable specified in Section F is dependent upon the award of a separate NextGen contract, a due date will be set after such contract is awarded.

In addition, if the COR determines that the Contractor cannot complete any function as described in the contract because other involved NextGen awards are not yet operational, the Contractor will include in their Mobilization and Transition Plan an alternative means of accomplishing the function until the involved NextGen awards become operational.

4. RELATIONSHIP TO OTHER ACTIVITIES AND REDUNDANCIES

All NextGen Awards Coordination with other implementing partners responsible for the implementation of one or more of the components of NextGen is critical. Coordination might include, but is not limited to, meetings convened by USAID between contractors, coordination of work plan activities as directed by USAID, sharing of product catalogs and using data provided by other partners to drive operations and performance. Because the various NextGen activities are interdependent, it is required that NextGen contractors share operational data to ensure the smooth operation of the global health supply chain. For example, PSA contractors must receive quality inspection results from the QuTI contractor to be able to ship commodities. Similarly, PSA contractors need demand plans prepared by the TA partner and host country governments to be able to develop accurate procurement plans, and the ICL contractor needs order and shipment status information from the PSA contractors to manage in-country logistics support activities. The roles of the different NextGen implementing partners could include, but are not limited to the examples http://www.state.gov/pepfar/ https://www.state.gov/wp-content/uploads/2019/09/PEPFAR2019ARC.pdf highlighted below. More details of the roles and interrelationship between the different NextGen implementing partners is included in Section J.4 Collaboration slides

NextGen Control Tower Award Because the various NextGen activities are interdependent, it is critical that NextGen contractors share operational data to ensure the smooth operation of the global health supply chain. For example, PSA contractors must receive quality inspection results from the QuTI contractor to be able to ship commodities. Similarly, PSA contractors need demand plans prepared by the TA partner and host country governments to be able to develop accurate procurement plans, and the ICL contractor needs order and shipment status information from the PSA contractors to manage in-country logistics support activities.

To facilitate cost-efficient data sharing and provide centralized access to NextGen operational information, USAID will establish a supply chain control tower (the NextGen Control Tower), which is a technical platform serving as a single source of NextGen operational information.

The NextGen Control Tower will capture operational data from each NextGen activity to support decision-making by USAID and the NextGen contractors. The diagram below depicts the role the NextGen Control Tower will play in the data sharing/exchange and the centralized data access.

As a reference, J.5, the GHSC Operational Data Specification, describes the operational data collected from the current USAID GHSC program, representing the type and range of supply chain operational data that must be submitted to the NextGen Control Tower. The specification in J.5 is for informational purposes only, as the required data elements for NextGen may vary. In addition, Attachment J.6, Illustrative Data Exchange via the NextGen Control Tower, depicts the anticipated flow of certain significant data elements between the NextGen contractors via the NextGen Control Tower.

To support the NextGen design described above, USAID has incorporated a special solicitation requirement in Section H.X, Sharing of Operational Data with the NextGen Control Tower, which establishes USAID’s requirements for NextGen Control Tower data submission and data standards. The provision will also be incorporated into the resulting contracts.

Quality Assurance Award (Qualifying, Testing, Issuing (QuTI) The Contractor must cooperate with USAID and the NextGen quality assurance contractor (QuTI) to ensure compliance with applicable United States Government (USG) requirements for product quality. This may include, but is not limited to, adhering to the eligibility lists developed and maintained by the QuTI contractor; cooperative evaluations of the quality of prospective commodity suppliers; and/or evaluation and certification of storage and transport conditions. The QuTI contractor will develop the risk-based quality assurance strategy and identify the products that require sampling and testing. It will conduct required sampling and testing of orders.

In-Country Logistics (ICL) Award As appropriate, NextGen contractors will be expected to collaborate with the In-Country Logistics contractor (ICL) in countries where it operates. The ICL contractor will support customs clearance, storage and distribution of USAID-procured products. It will provide inventory data and proofs of delivery to the NextGen Control Tower. It will collaborate with PSA mechanisms while primarily relying on the NextGen Control Tower to obtain information regarding incoming shipments. It must collaborate with Technical Assistance contractors for planning and monitoring in-country distribution as required by USAID. Where relevant and required, the ICL contractor will facilitate activities such as product registration or liaising with host-country governments.

Comprehensive Technical Assistance (TA) and TA Marketplace Awards As appropriate, NextGen contractors must collaborate with the Technical Assistance contractors (TA) in the countries where they operate. The TA contractors will support forecasting and supply planning, order entry, customs clearance, distribution planning, and system strengthening. TA contractors will provide procurement-ready supply plans and orders to the NextGen Control Tower and will work with the PSAs on custom clearance. TA contractors may coordinate with the ICL contractor to plan and monitor in-country distribution. The TA contractors will provide other support to NextGen activities in areas such as participation in planning for phase-in and phase-out of medicines and health technologies, navigating product registration, liaising with host country governments, and strategic planning.

Procurement Service Agent (PSA) Awards The Contractor must coordinate with the other NextGen contractors. The PSAs will provide strategic sourcing, order management, supply management, and freight and logistics. For those health commodities that have not been pre-approved by USAID, the PSAs must seek approval from USAID or other USAID designee prior to purchase per ADS 312 requirements. The PSAs will receive demand data and orders from the NextGen Control Tower. They will maintain up-to-date catalogues and provide them to the NextGen Control Tower. The PSAs will provide order and shipment status to the NextGen Control Tower contractor as well as copies of shipping documents required for customs clearance by the TA and/or ICL contractors. Original shipping documents will be shared with the TA and/or ICL contractors when required.

PSAs may, in limited circumstances, and at the direction of USAID, be required to provide similar PSA services to other USAID GH elements such as HIV/AIDS, malaria, family planning, maternal and child health, etc. that are normally performed by a different PSA. The Contractor is not expected to retain staff to respond to such situations. USAID will provide ample time and resources for the Contractor to mobilize expertise and respond to such events.

Strategic Risk Management and Mitigation (SRM) Award The Contractor must collaborate with the Strategic Risk Management (SRM) contractor as directed by USAID.

5. DATA MANAGEMENT

5.1 Role of NextGen Control Tower

NextGen will be supported by a number of contractors under separate contracts, including three Procurement Service Agent (PSA) contractors providing procurement and global logistics services, a Qualifying Testing and Issuing (QuTI) contractor responsible for quality inspections of health commodities, an In-Country Logistics (ICL) contractor providing logistic services within host countries, and multiple Technical Assistance (TA) contractors supporting host country governments and USAID Missions in demand and supply planning and product ordering and tracking, among other activities. In addition, there will be one or more risk mitigation and management contractors focusing on identifying and mitigating risks associated with NextGen.

Because the various NextGen activities are interdependent, it is critical that NextGen contractors share operational data to ensure the smooth operation of the global health supply chain. For example, PSA contractors must receive quality inspection results from the QuTI contractor to be able to ship commodities. Similarly, PSA contractors need demand plans prepared by the TA partner and host country governments to be able to develop accurate procurement plans, and the ICL contractor needs order and shipment status information from the PSA contractors to manage in-country logistics support activities.

To facilitate cost-efficient data sharing and provide centralized access to NextGen operational information, USAID will establish a supply chain control tower (the NextGen Control Tower), which is a technical platform serving as a single source of truth for NextGen operational information. The NextGen Control Tower will capture operational data from each NextGen activity to support decision-making by USAID and the NextGen contractors. The diagram below depicts the role the NextGen Control Tower will play in the data sharing/exchange and the centralized data access.

As a reference, Section J.5, the GHSC Operational Data Specification, describes the operational data collected from the current USAID GHSC program, representing the type and range of supply chain operational data that must be submitted to the NextGen Control Tower. The specification in Section J.5 is for informational purposes only, as the required data elements for NextGen may vary. In addition, Attachment J.6 Illustrative Data Exchange via the NextGen Control Tower, depicts the anticipated flow of certain significant data elements between the NextGen contractors via the NextGen Control Tower.

To support the NextGen design described above, USAID has incorporated a special solicitation requirement in Section H.15, Sharing of GHSC Operational Data with the NextGen Control Tower, which establishes USAID’s requirements for NextGen Control Tower data submission and data standards. The provision will also be incorporated into the resulting contracts

5.2 Data Standards & Governance

5.2.1 Data Visibility

USAID’s Next Gen program requires greater data visibility across the supply chain mechanisms to effectively manage global supply chain activities. All of USAID’s systems will interact with the USAID GH’s Control Tower, which will capture and integrate a wide range of data based on the supply chain data information specification. The PSA HIV/AIDS Diagnostic Contractor must have the capability of exchanging and reporting data with the Control Tower.

https://drive.google.com/file/d/1bWKOhY0TEOSPEOtQSx_fWLbizJTFCZx-/view?usp=sharing https://docs.google.com/presentation/d/1b2jnfPHVvgylCt6fKV6iAmJzWbJKsscNHBWbAJjJ-TI/edit?usp=sharing https://docs.google.com/presentation/d/1b2jnfPHVvgylCt6fKV6iAmJzWbJKsscNHBWbAJjJ-TI/edit?usp=sharing

The ability to generate, collect, receive, share, analyze, and report on procurement data for tracking from commodity order through to procurement-defined destinations and to facilitate management and continuous improvement of the value chain of PaaS, on behalf of GH, is enabled through the adoption of technological innovation, implementation of information technology system (ITS) and ITS management. Utilization of automated systems facilitates faster turnaround times for any component of the procurement cycle, and from one component of the cycle to another. This allows Procurement teams to focus on more strategic relationship-based activities. Examples include: order fulfillment platforms, performance monitoring systems.

8.2.2 Data Sets and Documents

The PSA HIV/AIDS Diagnostic Contractor must capture and exchange with the Control Tower, essential data sets and documents. Information and documents generated by the Contractor will generally fall into three categories:

1. Quality Assurance Data – These data include, but not limited to, results of quality assurance testing for health commodities procured on behalf of USAID. Depending on the specific health commodities, testing results for each element of the testing process must be accessible by USAID Systems, for example, monograph testing for pharmaceuticals must include results for each required monograph element (identity, assay, dissolution, disintegration, etc.)

2. Quality Assurance Documents – These documents include, but not limited to, SOPs, minutes of quality assurance meetings, trip reports, consultant reports, summary reports on conferences attended, annual reports, etc.

3. Quality Assurance Business Documents – These documents include but not limited to budget information, financial management reports, cost information, etc.

8.2.3 Data Standards

The PSA HIV/AIDS Diagnostics Contractor must comply with data standards established by the USAID and the control tower (Illustrative examples: Attachment J.5, the GHSC Operational Data Specification, Section J.6 Illustrative Data Exchange via the NextGen Control Tower.)

To support the NextGen design, USAID has incorporated a special solicitation requirement in Section H.15, Sharing of GHSC Operational Data with the NextGen Control Tower, which establishes USAID’s requirements for NextGen Control Tower data submission and data standards. These data standards will enable all mechanisms within the described NextGen GHSC Program to communicate and exchange accurate and verified information. If the Contractor requires a change in the data standard or calculation of measurements, the Contractor must submit a change request to USAID in accordance with the change control process. \

5.2.4 Data Loss Prevention

The PSA HIV/AIDS Diagnostics Contractor must prevent data loss within its IT system(s). The Contractor must have a backup and disaster recovery plan to ensure the continuity of its operation. In the event the system needs to undergo a planned shutdown, the Contractor must provide USAID with a notice 24 hours in advance.

6. PROVIDE DATA VISIBILITY TO IMPROVE PROCUREMENT, DELIVERY,

AND PROMOTE AGILE AND ADAPTIVE SUPPLY CHAINS

Offerors must present their existing Information Technology System (ITS) in their proposal submission with End-To-End visibility and ability to generate, collect, receive, share, analyze, and report on procurement data for tracking from supply planning and commodity order creation through arrival at defined delivery destinations. ITS must be able to facilitate management and continuous improvement of the value chain of PaaS through the adoption and use of technological innovation (to include GS1 Healthcare standards and master data management) and two-way exchange with systems such as the NextGen Control Tower (to be determined at a later stage). Utilization of automated systems that maintain flexibility and data recovery capacities, facilitate faster turnaround times for any component of the procurement cycle, and from one component of the cycle to another. This allows Procurement teams to focus on more strategic relationship-based activities. The ITS must include a performance monitoring system and be able to create ad hoc visualizations and reports as needed by USAID.

Offeror must provide a draft approach for Management of Exchange of Operational Data - The Offeror must have an existing and operational information system, which is flexible, has a data recovery plan and is capable of performing the required functions in support of the contract objectives. The Offeror must submit a plan which demonstrates its understanding of the possible operational data exchange mapping specifications of USAID for the exchange of information between its ITS and those of other NextGen awards and details the requirements for the Offeror to incorporate the use of existing and new procurement-related platforms that will be both in and out of the Offeror’s direct management and will allow for USAID to continually have direct, and real-time (or very near) visibility into the status of commodity procurements, related logistics activities and overall operational performance. The Offeror’s plan for management of exchange of operational data between the Offeror’s ITS System and the NextGen Control Tower award, as well as other NextGen Awards will also detail how the Offeror’s ITS will provide the ability to visualize data, have standard dashboard reporting, the ability to run and export unique reports and fulfill the data production, analytics, data sharing and reporting, as well as other operational requirements of USAID such as the planning and conducting of system maintenance.

7. TRANSITION OF ACTIVITIES

The Contractor must work with USAID and its current GHSC-PSM implementing partners to achieve a seamless transition from the existing award to this contract. The Contractor must complete full transition within 9 months, including:

a. Supply Planning;

b. Final Deliveries, en route;

c. Final Deliveries;

d. Procurement, assignment of contracts;

e. Quality Assurance; and

f. Data migration.

The Contractor must work with future contractors to achieve a seamless transition to future contractors and host governments. The Contractors will assume responsibilities from existing USAID Global Health Supply Chain Program (GHSC) contracts that have worked for nearly a decade on improving health product availability. In addition, the Contractors must work with a new set of contractors under the Bureau for Global Health’s Next Generation Global Health Supply Chain Suite of Programs (NextGen).

Over several decades, USAID has managed significant transitions across the global health supply chains from one or more contractors which has enabled USAID to identify and refine guiding principles to help inform this transition. We encourage/believe these principles are critical for a successful transition and start-up. These key principles include, but are not limited to:

1. Providing for a respectful and congenial working relationship between the existing and in-coming contractors, which includes transparency and trust;

2. Adopting an action-oriented approach to the transition fueled by proactive information sharing with existing contractor and responsiveness to requests from USAID, Missions, and the existing contractor to ensure an informed and expedient transition; and

3. Operating with a flexible mindset towards the transition with the ability and foresight to adapt to existing program plans to be successful throughout the collaboration between the existing and in-coming contractors.

7.1 Timeline

The timing of the NextGen procurements was designed to provide overlap with the existing programs, to facilitate and ensure a smooth transition. Since each contract will start and end at different times, the Contractors should be inherently flexible and show adaptation to existing constraints, novel challenges, and future unknowns in both the HQ-based and country-level (if applicable) design and implementation of the transition. This new contract is expected to operate in parallel with the current GHSC-PSM contract as part of transitioning to the new award. The full transition is expected to take approximately 9 months, no longer than 12.

7.2 Transition-In

The In-coming contractors are responsible for taking a proactive and collaborative approach towards the transition of responsibilities from the incumbent contractors while ensuring an uninterrupted supply of commodities, a continuous provision of technical assistance, continuous product quality assurance, and a complete knowledge transfer between the existing implementing partners and the new implementing partners. All existing and new contracting parties will collaborate towards a successful transition under the guidance and recommendation of USAID.

A high-level, comprehensive transition approach and plan should be submitted to USAID for feedback with key milestones and timeframes outlined. The high-level transition plan along with supplementary documentation will be used to hold the Contractors accountable for progress towards a full and timely transition. In all plans, both the HQ-level and any existing field-office transitions should be considered, if applicable.

Within their proposal, in-coming contractors should:

a. Develop a transition risk mitigation and contingency plan to mitigate all real, potential and perceived risks that may inhibit the success of the transition.

b. Develop a change management plan, considering the breadth and scope of the project and the need to manage human resource capabilities and commitment.

c. Develop a stakeholder engagement plan to empower all relevant stakeholders impacted by the transition and enable opportunities for feedback and consultation; and updated as key actors are identified and will change. Stakeholder buy-in should be closely monitored through stakeholder analysis.

d. Establish a knowledge management plan to provide for transparency and a continual flow of information between the existing and new contractors, Control Tower when operational, and other stakeholders.

All plans should be updated continually to reflect changes to the operating environment and its stakeholders, including any barriers encountered to implementation. Adequate resources, including the assignment of a transition manager, should be devoted to the transition and all pertinent components of the mechanism’s design should be considered and assigned support.

Any lack of progress in the transition by any actors should and will be identified with the appropriate actor(s) being held accountable and monitored as needed.

6.3 Transition-Out

When the contract expires, the PSA contractor must provide the transition support to any new contractor(s) that will take over the support for the NextGen SC program, this may include information, plans and documentation and/or any other knowledge transfer. USAID expects the Contractor to operate with transparency and in the best interest of the program. USAID will provide guidance to the transition as needed. This will support a smooth transition to those activities and work with the incoming contractor(s).

8. QUALITY ASSURANCE

USAID views Quality Assurance (QA) as a continuous, comprehensive risk-management process involving rigorous preventive measures in assessing risk and selecting suppliers with continuous surveillance and detection, and rapid response when issues arise. The Contractor must work with USAID’s Qualifying, Testing, Issuing (QuTI) contractor to facilitate product recalls, quarantine products, and assist with root cause investigations for issues of product performance and complaints from end users or other sources. The Contractor must coordinate with QuTI to ensure laboratory products procured through this mechanism are eligible, safe, effective, and of acceptable quality for clients and patients. USAID’s strategic, risk-based approach to QA identifies and controls risks to product quality so that USAID’s programs have a reliable, uninterrupted supply of high quality health products at best value prices.

The Contractor must track risks to monitor trends, inform decision-making, and improve risk management. GHSC-QA builds the capacity of in-country partners through knowledge sharing on quality issues and development of global QA strategies and standards.

The contractor must procure only commodities determined as eligible under the following:

a. ADS 312 Eligibility of Commodities (https://www.usaid.gov/sites/default/files/documents/1876/312.pdf)

b. 22 CFR 228 Rules for Procurement of Commodities and Services Financed by USAID (https://www.ecfr.gov/cgi-bin/text-idx?node=pt22.1.228&rgn=div5)

c. Clauses incorporated elsewhere in this contract.

9. RISK MANAGEMENT

Supply chains and pharmaceutical management systems face a variety of risks across all levels of the health system, including theft and fraud, product quality issues, manufacturer/supplier issues, improper procurement processes, product loss through fire, damage or flooding, and others.

Some of those risks are particularly widespread in low and middle income countries (LMICs) and/or public sector systems. The Contractor will be expected to monitor and manage their own supply chain risks in collaboration with other NextGen contractors.

https://www.usaid.gov/sites/default/files/documents/1876/312.pdf https://www.ecfr.gov/cgi-bin/text-idx?node=pt22.1.228&rgn=div5