J.7. Industry Day NextGen GHSC Presentation.pptx

Wednesday, January 13, 2021 8am-1pm EST A virtual event Industry Day for USAID’s Next Generation Global Health Supply Chain Suite of Programs (NextGen)

DISCLAIMER

The following presentation is preliminary information only.

All information provided is subject to change Government is not currently soliciting proposals Both verbal and written answers are not binding: the circumstances of the proposed acquisition may change over time No part of Industry Day will be evaluated Your involvement in the Virtual Industry Day is strictly voluntary. No costs shall be charged to the Government Feedback is encouraged and greatly welcomed

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There shall be no video or audio recording by participants Virtual Industry Day Items:

Recording and transcript will be posted on beta.sam.gov as a special notice Attendees (company name and NAICS only) information will be shared Questions submitted will be answered after the presentations and posted online after the event

Rules of Engagement | Q&A

IF YOU WANT TO ASK A QUESTION:

Click the Q&A feature at the right side of your screen When asking a question, please state:

Your full name Organization Slide number reference Example: “Jane Doe, Company ABC: Question for General Counsel on slide 8: ….”

PLEASE DO NOT USE

The chat box for questions related to the solicitations The raise hand feature for questions

Please click the Q&A feature at the far right of your screen if you have a question It looks like this We will only review up to TWO questions per organization

Agenda 8:05am - 8:30am Moderated by: Dianna Edgil, Division Chief, Office of HIV/AIDS/Bureau for Global Health Welcome Remarks Bill Steiger, USAID Chief of Staff 8:30am - 8:35am USAID’s Supply Chain Vision Alma Golden, Assistant Administrator, Bureau for Global Health 8:35am - 8:50am The Role of USAID’s Acquisition and Assistance Ombudsman Crista Wise, USAID Ombudsman 8:50am - 9:00am Small Business Opportunities John Watson, Acting Director, Office of Small and Disadvantaged Business Utilization Jamala Peyton, Deputy Director, Office of Small and Disadvantaged Business Utilization 9:00am - 9:10am Resolving Potential Conflicts of Interest Samuel Jack, Office of General Counsel 9:10am - 9:15am Timelines Rita Habib, Office of Acquisition & Assistance

Alan Bornbusch, Global Health Bureau 10:35am - 11:35am NextGen: How It All Works Together Lisa Hare, Global Health Bureau Dianna Edgil, Global Health Bureau

Ken Staley, U.S. Global Malaria Coordinator, PMI, Global Health Bureau

This slide can be referenced between the speakers without PPT presentations (i.e. until the “NextGen Structure Overview”

Welcome Remarks Bill Steiger, USAID Chief of Staff

USAID’s Supply Chain Vision Alma Golden, Assistant Administrator, Bureau for Global Health

Crista Wise, USAID Ombudsman The Role of USAID’s Acquisition and Assistance Ombudsman

Role of the Ombudsman The primary purpose of the Acquisition and Assistance (A&A) Ombudsman is to ensure equitable treatment of all parties participating in USAID's contracts and grants (acquisitions and assistance) pre-award, post-award, and administration functions.

The Standards of Practice for the Ombudsman's Office

The A&A Ombudsman is:

A neutral, independent intermediary Responsible for maintaining anonymity of sources and confidentiality of matters

The principal goal of the A & A Ombudsman is to facilitate resolution of differences through an informal impartial administrative review of the action in question.

In addition, the A & A Ombudsman has a substantive role in A&A reform, A&A training, outreach, "customer-access" and "customer-services" matters.

Jurisdiction of the Ombudsman

On any aspects of the A&A process, the Ombudsman may:

Conduct inquiries;

Investigate, report findings, make recommendations;

Develop, evaluate, and discuss available options Facilitate, negotiate, and mediate;

Identify complaint patterns and trends; and Educate

Limitations of the Ombudsman

Cannot compel or direct Agency or CO action;

Does not substitute for USAID’s formal process;

Does not substitute for providing the Agency with formal notice;

Does not toll the time limitations for in the event of a protest, dispute, appeal, request for equitable adjustment, etc.

Cannot make binding decisions or determine rights.

Partner Inquiry Parameters

What is your complaint, issue, or concern?

What redress do you seek?

Who are the relevant parties?

Have you spoken to the AO/CO?

Do I have your permission to look into the matter?

Do you require confidentiality?

What are your time constraints?

Typical Partner Inquiries

Questions, concerns, complaints regarding any phase of the procurement process;

Good faith belief of unfair treatment in a procurement process;

Dispute or potential dispute that may be informally resolved;

Reporting misconduct by the CO/COR or USAID official regarding the procurement or administrative process that adversely affects ability to perform;

Any violation of procurement laws and/or regulations

For More Information

Please contact the USAID Acquisition and Assistance Ombudsman:

ombudsman@usaid.gov

8:05am - 8:30am Moderated by: Dianna Edgil, Division Chief, Office of HIV/AIDS, Bureau for Global Health

Welcome Remarks Bill Steiger, USAID Chief of Staff 8:30am - 8:35am USAID’s Supply Chain Vision Alma Golden, Assistant Administrator, Bureau for Global Health 8:35am - 8:50am The Role of USAID’s Acquisition and Assistance Ombudsman Crista Wise, USAID Ombudsman 8:50am - 9:00am Small Business Opportunities John Watson, Acting Director, Office of Small and Disadvantaged Business Utilization Jamala Peyton, Deputy Director, Office of Small and Disadvantaged Business Utilization 9:00am - 9:10am Resolving Potential Conflicts of Interest Samuel Jack, Office of General Counsel 9:10am - 9:15am Timelines Rita Habib, Office of Acquisition & Assistance

Alan Bornbusch, Global Health Bureau 10:35am - 11:35am NextGen: How It All Works Together Lisa Hare, Global Health Bureau Dianna Edgil, Global Health Bureau

This slide can be referenced between the speakers without PPT presentations (i.e. until the “NextGen Structure Overview”

Small Business Opportunities John Watson, Acting Director, Office of Small and Disadvantaged Business Utilization Jamala Peyton, Deputy Director, Office of Small and Disadvantaged Business Utilization

Resolving Potential Conflicts of Interest Samuel Jack USAID Office of the General Counsel

Resolving Potential Conflicts of Interest between NextGen Contracts

Given the nature of the work, there are situations where a contractor’s ability to render impartial advice to USAID could be undermined by holding multiple NextGen contracts.

This is of specific concern with two NextGen contracts: the Qualifying Testing Issuing (QuTI) contract and the Control Tower (CT) contract.

Resolution: the QuTI and CT prime contractors will be ineligible to receive certain other NextGen contracts (and vice versa).

CT: All other NextGen contracts QuTI: All procurement service agent (PSA) contracts

Resolving Potential Conflicts of Interest between NextGen Contracts, cont’d

Subcontracts: QuTI and CT subcontractors would also be precluded, although the contracting officer could exempt specific subcontractors from the restriction.

These preclusions are narrowly tailored to avoid the creation of unmitigatable organizational conflicts of interest (OCI).

USAID contracting officers will continue to avoid, neutralize, or mitigate all other OCIs consistent with the Federal Acquisition Regulation (FAR).

Procurement Timelines Rita Habib Office of Acquisition & Assistance

Break

Please return at 9:35am EST

8:05am - 8:30am Moderated by: Dianna Edgil, Division Chief, Office of HIV/AIDS/Bureau for Global Health

Welcome Remarks Bill Steiger, USAID Chief of Staff 8:30am - 8:35am USAID’s Supply Chain Vision Alma Golden, Assistant Administrator, Bureau for Global Health 8:35am - 8:50am The Role of USAID’s Acquisition and Assistance Ombudsman Crista Wise, USAID Ombudsman 8:50am - 9:00am Small Business Opportunities John Watson, Acting Director, Office of Small and Disadvantaged Business Utilization Jamala Peyton, Deputy Director, Office of Small and Disadvantaged Business Utilization 9:00am - 9:10am Resolving Potential Conflicts of Interest Samuel Jack, Office of General Counsel 9:10am - 9:15am Timelines Rita Habib, Office of Acquisition & Assistance

Alan Bornbusch, Global Health Bureau 10:35am - 11:35am NextGen: How It All Works Together Lisa Hare, Global Health Bureau Dianna Edgil, Global Health Bureau

This slide can be referenced between the speakers without PPT presentations (i.e. until the “NextGen Structure Overview”

Questions & Answers

Rules of Engagement | Q&A

IF YOU WANT TO ASK A QUESTION:

Click the Q&A feature at the right side of your screen When asking a question, please state:

Your full name Organization Slide number reference Example: “Jane Doe, Company ABC: Question for General Counsel on slide 8: ….”

PLEASE DO NOT USE

The chat box for questions related to the solicitations The raise hand feature for questions

Please click the Q&A feature at the far right of your screen if you have a question It looks like this We will only review up to TWO questions per organization

Key Websites beta.SAM.gov: where the Industry Day presentation, recording, Q&A will be posted ombudsman@usaid.gov: ombudsman contact https://sbmart.usaid.gov/: small business site

NextGen Program Overview Structure and vision of the global program

Alan Bornbusch, Division Chief, Commodity Security and Logistics Division, Office of Population and Reproductive Health, Global Health Bureau

Guiding Principles Maximize the availability, quality, and affordability of medicines and other health products and achieve better health outcomes for the clients served.

Advance the Journey to Self-Reliance and promote country-led procurement, supply chains, regulatory systems, pharmaceutical services, and other related functions.

globally-managed to locally-managed, partner-managed to supplier-managed, public-operated to private-operated.

Increase value for the U.S. taxpayer and beneficiaries and reduce the chances of waste, fraud, and diversion further.

Support Program Goals Control the HIV epidemic

Eliminate malaria

Increase and sustain access to safe, voluntary, high-quality family planning and reproductive health care

Prevent child and maternal deaths

Combat infectious diseases

Key Structural Features Segmentation by program/commodity Products used by programs differ (e..g, manufacturers, market dynamics) Attract best-in-class

Separation by function Different skills, expertise required for different services Mitigate potential conflicts of interest Attract best-in-class

Consolidation across programs Take advantage of synergies where appropriate Reduce duplication, misalignment of activities

Greater complexity brings rewards but risks must be managed Rewards Provides opportunities for specialization, greater competition, and prudent redundancy Managing Risks Shifts greater management burden to USAID Requires strong collaboration across the mechanisms Ensuring visibility along the entire supply chain Limiting complexity for the field

NextGen: How It All Works Together Interactions expected between Implementing Partners (IPs) for global supply chain operations

Lisa Hare, Chief, Supply Chain Branch, Office of Infectious Disease, Malaria Division, Bureau for Global Health

Dianna Edgil, Chief, Supply Chain for Health Division, Office of HIV and AIDS, Bureau for Global Health

This presentation is meant to help address some of the more specific questions we received from the RFIs around the various roles and responsibilities of the different awards within the suite of programs

PURPOSE OF THIS PRESENTATION

To provide information on how NextGen Implementing Partners (IPs) will work together to ensure quality products are available where they are needed and information is shared on a timely basis. This addresses many of the questions USAID received after releasing the Requests for Information (RFI).

Structure presented is subject to change.

Forecasting & Supply Planning Sourcing & Buying

Manufacturing

QA

QC

Global Transport In-Country Transport National Storage Level Global Stock Centers Sub-National Storage Level Last Mile Delivery Service Level Delivery

Customs Clearance

CHRONOLOGY:

* USAID provides guidance to all IPs and negotiates high level agreements with MOHs; communicates to TA

* PSA submits procurement data including unit price and lead times to CT MOH develops forecast and Supply Plans (SP) with TA (and ICL if applicable); TA responsible for ensuring high level agreements / updated procurement data are reflected in SP TA submits procurement-ready supply plan to CT (TA can conduct their own review) PSA accesses SP from CT and reviews for data quality for global forecast and SP; USAID reviews SP PSA (or for PMI, possibly TA) creates global forecast and SP and submits to CT

FORECASTING & SUPPLY PLANNING

ROLES WITHIN NEXTGEN:

ILLUSTRATIVE METRICS FOR SUCCESS:

On time supply plan submission (TA) Supply plan accuracy Global forecast accuracy Turnaround time for PSA & USAID feedback on SP Host Govt.

- Tracks/leads SP development

- Monitors execution

USAID

- Budget setting

- MOH coord.

- Feedback on SP - Monitors performance Control Tower

- Manage and house SP and procurement data -Basic logic check TA Partner

- Supports MOH to develop forecast and SP

- Ensures high level agreements, and updated procurement data are reflected in forecast/SP

- Conducts technical review of SP

- Submits procurement ready SP to CT

- Review USG & PSA feedback

PSA

- Product data shared with CT -Provides feedback SP data quality

- Aggregates into global SP Interdependency: Finalization of all supply plans

Manufacturing

QA

QC

Global Transport In-Country Transport National Storage Level Global Stock Centers Sub-National Storage Level

* Coordinated incident management system with collaborative process for quality events

* PSA runs supplier performance management system & relationship

* Partners to support market health, diversify supply base, and introduce new products

USAID policy approval & portfolio direction QA technical evaluations QuTI communicates via control tower Listing of eligible sources by product QC testing protocols by product/source Strategic sourcing & purchase execution within eligibility & protocols

PRODUCT SOURCING

USAID

- ADS 312 approvals

- Program product scope

Control Tower

- source of demand data -Interface for lists & testing protocols

QuTI

- Execute product technical evaluations

- Determine source eligibility & QC testing requirements

PSA

- Strategize & execute sourcing within eligible & program bounds

- Manages supplier communications & performance

ROLES WITHIN NEXTGEN:

ILLUSTRATIVE METRICS FOR SUCCESS:

QuTI -complete & accurate eligibility & testing protocols shared with PSAs PSA - cost savings delivered through strategic sourcing, on-time delivery, sourcing cycle time

Interdependency: Eligible sources & testing protocols

Manufacturing

QA

QC

Global Transport In-Country Transport National Storage Level Global Stock Centers Sub-National Storage Level

* Product Eligibility: QuTI and USAID determine product eligibility

* Orders for regional distribution centers can be initiated by the PSAs Order Entry: TA (or other in-country planners) engage with stakeholders to enter orders into Control Tower aligned to supply plan, monitor status, and answer questions from PSA into Control Tower. PSAs retrieve order information from Control Tower.* Order Clarification: PSA submits questions to partner entering the order via the Control Tower. Control Tower may have auto-validation function.

Order Processing & Approval: PSAs process orders. USAID provides final approval prior to PSA placing the order, provided through CT platform.

Order Placement: PSA places order with supplier.

Order Status Updates: PSAs to update order status throughout the procurement process in Control Tower. Information on status is available to relevant IPs and USAID staff through CT.

ORDERING PROCESS

-budget, initiate & approve order -Monitor performance

Control Tower -Order entry and catalog platform -Updated order status Interdependency: PSA must work closely with Control Tower.

TA Partner -Assist with developing order- ready supply plans -Assist USAID or MOH with order entry in CT

PSA

-Seek clarification on orders -Place orders with suppliers -Update order status in Control Tower -Updates catalog on CT Interdependency: Finalization of country supply plans, validation of product details, alignment of procurement expectations

ROLES WITHIN NEXTGEN:

ILLUSTRATIVE METRICS FOR SUCCESS:

QuTI -Provides framework for PSA -product eligibility Complete and timely submissions to Control Tower On-time order processing Cycle time (by segment), as presented in CT

Manufacturing

QA

QC

Global Transport In-Country Transport National Storage Level Global Stock Centers Sub-National Storage Level

Order Placement: PSA places order with supplier and updates the order status in the Control Tower.

Notification of orders for QA partner: QuTI receives notification of orders via the Control Tower.

Identification of Orders requiring QA: QuTI utilizes risk-based testing approach approved by USAID to identify orders requiring QA and updates via the Control Tower.

Order Ready for Testing: PSA updates order status in Control Tower indicating Goods Available (and ready for sampling).

Order Sampling & Testing: QuTI samples product and send for testing. QuTI updates status in Control Tower.

QA Completion: QuTI indicates when an order has passed QA in the Control Tower.

QUALITY ASSURANCE

ILLUSTRATIVE METRICS FOR SUCCESS:

USAID

-Monitor performance

Control Tower -Order entry platform -Updated order status QuTI -Monitor orders, determine which orders to be tested -Sample and test orders -Update status in CT

PSA

-Place orders with suppliers -Update order status in Control Tower -Ship product when clears QA (or proceed if concurrent testing) -Manage GSCs Interdependency: PSA places orders, QuTI determines risk-based sampling, updates on order status

Complete and timely submissions to Control Tower QA completion on time Cycle time (by segment), as presented in CT

3PL Transportation Metrics (full suite) Goods ready to pick-up time Pick-up to delivery time (need to define delivery destination) Freight lane cost

Manufacturing

QA

QC

Global Transport In-Country Transport National Storage Level Global Stock Centers Sub-National Storage Level

PSA:

Informs global freight provider of notice to pick up Informs country stakeholders delivery date & updates on transport milestones Manages and executes global freight Submits PODs upon delivery to agreed destination USAID / Mission/in-country POC/TA will inform PSA through CT platform if any delivery dates need to be adjusted (if possible). This may be informed by the TA or ICL partner. PSA informs same vice-versa.

PSA continuously develops global freight strategy which includes pricing mode and terms in addition to looking at expanding Vendor Managed Solutions. PSA maintains management strategy for any 3PL.

In country partners provide updated information on country context to CT

GLOBAL TRANSPORT

Interdependency: global forecasts for products within the Control Tower, submitted by TA partners, will inform the PSA’s global freight strategy

ILLUSTRATIVE METRICS FOR SUCCESS:

Host Govt

- Monitors and preps for arrival

TA

- Monitors & communicates arrival and changes

ICL

- Monitors and preps for arrival or changes

USAID

- Informs any delivery dates changes Control Tower

- Receives global forecasts and disseminates shipment status

PSA

- Manages all global freight, EXW, DDP or otherwise

Lead time reduction Losses/wastage (within GSC) disaggregated by expiry or damage

Manufacturing

QA

QC

Global Transport In-Country Transport National Storage Level Global Stock Centers Sub-National Storage Level

PSA, along with USAID, determines GSC strategy PSA determines and fulfills orders from GSC PSA manages inventory at GSC PSA delivers commodities to countries from GSC (follows same processes as “Global Transport”

GLOBAL STOCK CENTERS

ROLES WITHIN NEXTGEN:

ILLUSTRATIVE METRICS FOR SUCCESS:

USAID

- Helps inform decisions on stock in GSC Control Tower

- Receives global forecasts and disseminates shipment status

PSA

- Manages GSC -Decides what product is stored at and shipped from GSC QuTI -GDP certification of Global Stock Centers

Manufacturing

QA

QC

Global Transport In-Country Transport National Storage Level Global Stock Centers Sub-National Storage Level

* TA/ICL Supports USAID to Establish Country Specific Roles: to clarify within each country, roles for registration and tax waivers as well as any other importation documents. The USAID Mission provides input on turnaround time (TAT) expectations and approves the roles.

Complete documentation on:

Registration waivers organized by PSA because request often requires supplier dossiers or certifications, from the PSA’s supplier Tax waivers drafted by TA, ICL or other with USG support Other importation documents TA partner or ICL Clears customs and delivers goods to identified in country warehouse/storage, PSA clearing agent; Obtain proof of delivery (POD)

CUSTOMS CLEARANCE

USAID

- Importation support partner - Monitor performance

- Establish TAT for importation

CT

-Recording order status Interdependency: Updates of importation requirements. PSA has primary responsibility with input from others. Requirements shared on Control Tower.

ICL

- In-country importation support. May include dedicated staff

PSA

- Document & update importation requirements

- Share shipping docs and if necessary dossiers/certs Interdependency:

Shipment importation

ROLES WITHIN NEXTGEN:

ILLUSTRATIVE METRICS FOR SUCCESS:

Interdependency: Submitting updates to CT on shipment status Turnaround time for importation processes

TA

- Provides support for waivers, etc. May include dedicated staff

- May fill role of ICL in limited circumstances

- May conduct 3rd party performance monitoring

- Support to host govt/others (not ICL)

Manufacturing

QA

QC

Global Transport In-Country Transport National Storage Level Global Stock Centers Sub-National Storage Level

CHRONOLOGY/COMPONENTS:

* USAID identifies the need for ICL to warehouse

* For Vendor Managed (VNx) storage, PSA obtains PODs; stock levels are monitored by either host government, TA, or ICL

* ICL, host government, USAID and TA may conduct 3rd party performance monitoring

* SCSC conducts supply chain security assessment ICL (or TA, in limited circumstances, or host government) receives product at warehouse, manages inventory, and submits inventory reports. (For host government-operated supply chain, TA submits inventory reports). Reports are submitted to CT ICL (or TA, in limited circumstances, or host government) picks orders ICL (or TA, in limited circumstances) conducts waste management/reverse logistics activities

IN-COUNTRY WAREHOUSING

- Elects to use ICL to warehouse

- 3rd party performance monitoring

Control Tower

- Receives and houses inventory reports

ICL

- Receives product

- Manages Inventory

- Picks orders

- Conducts waste management/ reverse logistics functions

- Monitors stock levels for VMx

ROLES WITHIN NEXTGEN:

PSA

- For VMx storage, responsible for POD

ILLUSTRATIVE METRICS FOR SUCCESS:

Turnaround time for receipt, and order fulfillment Inventory accuracy Product loss due to theft, damage or avoidable expiration

Host Govt

- Coordinates with USAID and partners

Host government

- May establish distribution frequency

- May plan distribution/identify quantities to be distributed to sites

- May conduct 3rd party monitoring

ICL

- Execute distribution and obtain POD

- May plan distribution/ identify quantities to be distributed to sites

- May conduct 3rd party monitoring

TA

- May plan distribution/ identify quantities to be distributed to sites

- May conduct 3rd party performance monitoring

- May conduct route optimization

- May execute limited distribution Turnaround time for receipt, order fulfillment, delivery Inventory accuracy, delivery accuracy

Manufacturing

QA

QC

Global Transport In-Country Transport National Storage Level Global Stock Centers Sub-National Storage Level

CHRONOLOGY/COMPONENTS:

USAID or host government establish distribution frequency TA partner, ICL, or host government plan distribution/ identify quantities to be distributed to sites ICL executes distribution and obtains PODs

TA partner conducts route optimization For VMx distribution, PSA obtains PODs; 3rd party monitoring conducted by TA or ICL ICL, host government, USAID, or TA partner conduct 3rd party monitoring SCSC conducts post market surveillance to detect leakage of donated products

IN-COUNTRY DISTRIBUTION

USAID

- May establish distribution frequency

- May conduct 3rd party monitoring Control Tower

- Receives and houses reports

ROLES WITHIN NEXTGEN:

PSA

- For VMx storage, obtains PODs

Timely and quality data availability for USAID and partners Response time for data discrepancies Order platform functionality % of tickets resolved during the reporting period Data submitted on-time

KEY INTERDEPENDENCIES:

Signed Data Sharing Agreement by all NextGen Mechanisms (NGM): Define shared data, data standards, sharing frequency, technical mechanisms, exception handling, security, proprietary information Quality, timely, secure data provided to Control Tower (CT) by each NGM Successful electronic exchange of data between CT and NGM CT formats data for visibility and access by NGMs and USAID Communication between NGMs within CT and CT data utilized to address programmatic queries Data changes and discrepancies use CT ticket system. CT will initiate discussion between NGMs to reconcile data USAID reviews data and calculates KPIs within CT

CONTROL TOWER DATA EXCHANGE BASICS

PSA

Order Updates Catalogue Updates Control Tower

- Single source of truth for USAID data visibility -Ordering platform -Collaborative platform

TA

Orders (with Mission) Commodity plans Inventory status Registration status

USAID

Order Approvals

ROLES WITHIN NEXTGEN:

ILLUSTRATIVE METRICS FOR SUCCESS:

ICL

Country Dist. Plan QuTI Eligible Status/ QC Results CT Data:

Forecast & Demand Plan Requisition Orders Purchase Orders Distribution orders Order status Shipment status QA status Production status GSC inventory status Country inventory status ICL inventory status Country distribution plan

ASN

Product Catalog Registration status

RM

Manufacturing

QA

QC

Global Transport In-Country Transport National Storage Level Global Stock Centers Sub-National Storage Level

Manufacturing

QA

QC

Global Transport In-Country Transport National Storage Level Global Stock Centers Sub-National Storage Level

CONTROL TOWER - DATA EXCHANGE BY CONTRACT

Purchase Orders Distribution orders Order status GSC inventory status

ASN

Product Catalog Lead time tables Aggregated procurement plans Manufacturing capacity PSA Data to CT:

PSA from CT:

Forecast & Demand Plan (TA) Requisition Orders (TA/Mission) QA status (QuTI) Country inventory status (TA) ICL inventory status (ICL) Country distribution plan (ICL) Registration verification (TA)

Forecasts & Supply Plans (TA/ Mission) Country inventory status Registration status Requisition Orders TA Data to CT:

TA from CT:

Purchase Orders (PSA) Distribution Orders (PSA) Order Status (PSA) Manufacturing Capacity (PSA) GSC Inventory Status (PSA)

ASN (PSA)

Product Catalog (PSA) QA status (QuTI) ICL inventory status (ICL) Country distribution plan (ICL)

ICL inventory status Country distribution status ICL Data to CT:

ICL from CT :

Purchase Orders (PSA) Distribution Orders (PSA) Order Status (PSA) GSC Inventory Status (PSA)

ASN (PSA)

Lead Time Tables (PSA) Aggregated Procurement Plans (PSA) QA status (QuTI) Forecast & Demand Plans (TA) Registration Status (TA) Country Inventory Status (TA) Country/Program distribution plan

Eligibility Status Testing Protocols

QuTI Data to CT:

QuTI from CT:

Purchase Orders (PSA) Distribution Orders (PSA) Order Status (PSA) Shipment Status (PSA) Production Status (PSA) Manufacturing Capacity (PSA)

Manufacturing

QA

QC

Global Transport In-Country Transport National Storage Level Global Stock Centers Sub-National Storage Level

MEL Process:

Data submission: NextGen IPs submit transactional data to the Control Tower on a regular basis (defined by project) Data analysis: USAID MEL Team (incl. GHSC data analysts and scientists) and IPs will analyze submitted data.

Reporting: Each IP is responsible for preparing their own performance reports. USAID MEL Team and MEL IPs to prepare dashboard looking at shared metrics across NextGen projects using data submitted to the Control Tower.

Learning and CI: Identify and discuss key performance trends; validation and assessment/evaluative exercises.

MONITORING, EVALUATION & LEARNING

Other Partners -Routine DQAs, assessments, and learning activities.

USAID

-Reviews and analyzes submissions -Continuous improvement Interdependency: USAID and the USAID MEL IPs use data in the Control Tower for NextGen dashboard for project monitoring & reporting to USAID leadership NextGen IPs

- Provision transactional data

- Maintaining performance per contract

- Continuous improvement Control Tower

- Data platform and repository

- Generation of KPIs

- Aggregated reporting

Interdependency: All NextGen IPs submit data to Control Tower

ROLES WITHIN NEXTGEN:

ILLUSTRATIVE METRICS FOR SUCCESS:

Standard (Core) KPIs across the PSAs and across the TA partners Data submission on-time and in-full (Control Tower, DATIM, etc.)

IP coordination and collaboration Customer satisfaction

Manufacturing

QA

QC

Global Transport In-Country Transport National Storage Level Global Stock Centers Sub-National Storage Level

* USAID helps define the data standards that all NextGen IPs should use

* Control Tower hosts a product catalogue that is compliant with global standards TA award will identify data authorities in country and work with the entity to adopt standards within countries PSAs register with data standards authority and master data enterprise PSAs monitor supplier performance PSAs manage product Catalogue QuTI verifies physical attributes and product labels ICL or others receive shipments, manage inventory and provide delivery updates and PODs using GS1 data

IMPLEMENTING GLOBAL STANDARDS

-Recommend Global Standards -Monitor compliance across NextGen awards

Control Tower

- Host the global standard compliant product catalogue

QuTI

- Verify physical attributes and product labels

PSA

- Maintain catalog & procurements within program direction & QA eligibility

ROLES WITHIN NEXTGEN:

ILLUSTRATIVE METRICS FOR SUCCESS:

Proportion of suppliers with at least one in-scope item that demonstrate at least 95% compliance Percentage of in-scope products that are compliant w/global standards Percent of total order lines (DOs and POs) released for fulfillment in the past 12 months that are compliant w/global standards Number of NextGen awards accessing master data

TA to host govt Policy and architecture Governance and coordination

Host Govt.

- Tracks or leads SP development

- Monitors perf

•Number of RMPs submitted •Number of mitigation activities completed on time •Number of risks closed

CHRONOLOGY:

Prepare award specific risk management plan (RMP) Submit risk management plan Prepare consolidated NextGen risk profile and mitigation plan Risk management dashboard, monitored by USAID with follow up with specific IPs Disseminate risk alert

RISK MANAGEMENT

Manufacturing

QA

QC

Global Transport In-Country Transport National Storage Level Global Stock Centers Sub-National Storage Level

ICL

- RMP

USAID

- Oversight and Coordination Control Tower

- RMP

RMP alerts

TA

-RMP

QuTI

- RMP

PSA

- RMP

Risk Management

- RMP

RMP Dashboards RMP alerts

Interdependency: Risk management plan elements that are shared responsibilities between NextGen awards

PHASE I

Data Standards Set and Adopted by All IPs

PHASE II

Data Systems and Standards in Several Key Countries Adopted

PHASE II+

Expanded Country List with Data Standards/ Systems Adapted

Evolution of Data Standards Countries are expected to move along the cascade.

Phases are notional and will be agreed to post-award.

End State: Product visibility to sites increased and product tracing improved

Activities

Evolution of Distribution - Increased Vendor-managed Solutions (HIV Product Requirement: Affects HIV PSA, TA and ICL)

Traditional SC Activities

Only HIV laboratory products supplied via Vendor Managed Inventory (VMI)

All-Inclusive Service Pilots

Begin piloting service level agreements with suppliers to restock warehouses in critical countries

VMI Implementation under all inclusive contracts

Expand on supplier contracts to include high volume facilities

PHASE III

Contract Transition

Default for storage and distribution in several large countries is through suppliers

End State: Suppliers take greater role in supplying products to the final destination Countries are expected to move along the cascade

HIV Diagnostics PSA – Core Objectives

Traditional SC Activities

Support or provide direct traditional SC activities and diagnostic network optimizations that inform all inclusive procurement implementation

All-Inclusive Services

Provide data driven approaches to advance negotiations under all inclusive contracts and to move countries from traditional SC activities to all-inclusive procurements

VMI Implementation

Work with host governments and existing SC partners to include VMI strategies within all-inclusive contracts

PHASE III

Contract Transition

Development of contract management strategies and support for host governments to transition contracts Diagnostic PSA to lead efforts to advance Journey to Self Reliance

Provide leadership, oversight and in-country mission support to advance objectives

HIV Diagnostics PSA – as countries progress, focus and interactions shift

Control Tower

sample transport, Instrument connectivity VMI - Site level inventory instrument connectivity

Break

Please return at 11:10am EST

8:05am - 8:30am Moderated by: Dianna Edgil, Division Chief, Office of HIV/AIDS/Bureau for Global Health

Welcome Remarks Bill Steiger, USAID Chief of Staff 8:30am - 8:35am USAID’s Supply Chain Vision Alma Golden, Assistant Administrator, Bureau for Global Health 8:35am - 8:50am The Role of USAID’s Acquisition and Assistance Ombudsman Crista Wise, USAID Ombudsman 8:50am - 9:00am Small Business Opportunities John Watson, Acting Director, Office of Small and Disadvantaged Business Utilization Jamala Peyton, Deputy Director, Office of Small and Disadvantaged Business Utilization 9:00am - 9:10am Resolving Potential Conflicts of Interest Samuel Jack, Office of General Counsel 9:10am - 9:15am Timelines Rita Habib, Office of Acquisition & Assistance

Alan Bornbusch, Global Health Bureau 10:35am - 11:35am NextGen: How It All Works Together Lisa Hare, Global Health Bureau Dianna Edgil, Global Health Bureau

This slide can be referenced between the speakers without PPT presentations (i.e. until the “NextGen Structure Overview”

Questions & Answers

Final Reminders for Participants

Virtual Industry Day:

Recording and transcript will be posted on beta.sam.gov as a special notice Attendees (company name and NAICS only) information will be shared Questions submitted will be answered after the presentations and posted online after the event

CLOSING REMARKS

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