J.3 IEE - NextGen PSA Diagnostics.pdf

INITIAL ENVIRONMENTAL

EXAMINATION

PROJECT/ACTIVITY DATA

Project/Activity Name: Next Generation Global Health Supply Chain Suite of Programs (NextGen) Procurement Service Agent Lab, Diagnostics, and Molecular (NextGen PSA Diagnostics)

Geographic Location(s) (Country/Region): Global: Afghanistan, Angola, Bangladesh, Benin, Botswana, Burkina Faso, Burundi, Burma, Cambodia, Cameroon, Côte d'Ivoire, Dominican Republic, Colombia, D.R. Congo, Eswatini, Ethiopia, Ghana, Guatemala, Guinea, Guyana, Haiti, Honduras, India, Indonesia, Jamaica, Kenya, Lesotho, Liberia, Madagascar, Malawi, Mali, Mozambique, Namibia, Nepal, Nicaragua, Niger, Nigeria, Pakistan, Peru, Philippines, Rwanda, Senegal, Sierra Leone, South Africa, South Sudan, Tanzania, Thailand, Togo, T&T, Uganda, Ukraine, Venezuela, Vietnam, West Africa Region, Yemen, Zambia, Zimbabwe

Amendment (Yes/No), if Yes indicate # (1, 2...): No Implementation Start/End Date (FY or M/D/Y): 2021 – 2032

If Amended, specify New End Date:

Solicitation/Contract/Award Number(s): TBD Implementing Partner(s): TBD Bureau Tracking ID: GH-20-10383 Tracking ID of Related RCE/IEE (if any):

Tracking ID of Other, Related Analyses:

ORGANIZATIONAL/ADMINISTRATIVE DATA

Implementing Operating Unit(s):

(e.g. Mission or Bureau or Office)

GH/ID/MAL, MCH, OHA, OHS, PRH

Other Affected Operating Unit(s):

Lead BEO Bureau: Global Health (GH)

Funding Account(s) (if available):

Original Funding Amount: 2-2.49 billion USD

If Amended, specify funding amount:

If Amended, specify new funding total:

Prepared by: ECOS Date Prepared: April 2020

NEXTGEN PSA DIAGNOSTICS

[SBU PROCUREMENT SENSITIVE]

ii

ENVIRONMENTAL COMPLIANCE REVIEW DATA

Analysis Type: Environmental Examination Deferral Environmental Determination(s): Categorical Exclusion(s)

Negative Positive Deferred (per 22 CFR 216.3(a)(7)(iv)

IEE Expiration Date (if applicable): September 2026 - (with options for 5 year extension until 2032 with GH BEO approval)

Additional Analyses/Reporting Required: EMMP Climate Risks Identified (#): Low ___0___ Moderate ___6___ High ___4___ Climate Risks Addressed (#): Low ___0___ Moderate ___6___ High ___0___ iii

THRESHOLD DETERMINATION AND SUMMARY OF FINDINGS

PROJECT SUMMARY

The objective of the Next Generation Global Health Supply Chain Suite of Programs (NextGen) is to establish and operate high performing and agile supply chains that ensure the procurement and delivery of affordable, high-quality, essential, and life-saving health commodities. NextGen will support the U.S. Government’s (USG’s) global health priorities to prevent child and maternal deaths, control the HIV/AIDS epidemic, eradicate malaria, and combat infectious diseases through the procurement and delivery of health commodities. NextGen is committed to responding to unique requirements of each health program, identifying where to segment functions to maximize performance and respond to different program requirements, and developing a program that attracts reputable commodities providers and increases accountability. NextGen emphasizes strengthening supply chains in USAID-supported countries through investment in building country commitment and capacity of systems responsible for procurement, storage, distribution, dispensing and related supply chain services to ensure longevity and self-reliance in the absence of foreign assistance.

The NextGen planned awards are:

1. Procurement Service Agent HIV Pharma (NextGen PSA HIV Pharma)

This award will provide procurement and associated supply chain services for HIV/AIDS health commodities excluding HIV/AIDS diagnostic and lab commodities encompassing the required procurement functions of a supply chain (e.g., category management, strategic sourcing, supplier management, demand planning and procurement delivery). The PSA will negotiate incoterms with vendors for delivery of commodities into country, and, in exceptional cases, procure logistics services for commodities purchased under this award to ensure timely delivery.

The awardee must coordinate with other awardees under the program.

2. Procurement Service Agent Malaria (NextGen PSA Malaria)

This award will provide procurement and supply chain services for malaria health commodities.

It will encompass different services within the procurement as-a-service value chain (e.g., category management, strategic sourcing, supplier management, transactional procurement and demand planning). It will provide a robust information system to support operations and performance improvement. The PSA will negotiate incoterms with vendors for delivery of commodities to country, and as needed, provide freight and warehousing for commodities purchased under this award. The awardee must coordinate with other awardees under the program.

3. Procurement & Logistics Services - Family Planning and Reproductive Health (FP/RH), Maternal and Child Health and Nutrition (MCHN), Other Health Elements (Next Gen PLS) iv

This award will provide procurement and associated supply chain services (e.g., category management, strategic sourcing, supplier management, demand planning freight, warehousing, and delivery services) for family planning/reproductive health and other health commodities

4. Procurement Service Agent Lab, Diagnostics, and Molecular (NextGen PSA Diagnostics)

This award will provide procurement and associated supply chain services (e.g., category management, strategic sourcing, supplier management, demand planning freight, warehousing, and delivery services) for HIV/AIDS lab, diagnostic and molecular commodities.

5. In-country Logistics (NextGen ICL) One or more awards will provide for in-country logistics and delivery of NextGen commodities.

6. Control Tower for USAID Next Generation Global Health Supply Chain Suite of Programs (NextGen CT)

This award will provide a central hub to provide end-to-end visibility and specific and cross-program information for Missions, Bureaus, Agency leadership and program managers of commodities procured through NextGen.

7. Qualifying Testing Issuing (NextGen QuTI) This award will serve as the primary vehicle to help assure the quality of health commodities purchased under NexGen and other global health programs.

8. Risk Management and Mitigation (NextGen RMM) One or more awards will identify and mitigate supply chain vulnerabilities and potential risks both globally and locally, including fraud, abuse and/or misuse, counterfeit, and diversion of products and financial resources. It will also verify second- and third-tier suppliers and other vendors subcontracted under other NextGen awards to improve supply chain integrity and security.

9. Supply Chain Technical Assistance (NextGen SCTA) One or more awards will provide a comprehensive array of technical assistance (TA) services to improve operational excellence in country supply chains and improve the availability of health commodities to meet the needs of today’s populations and support countries on their journeys to self-reliance to meet the needs of tomorrow’s populations. TA investments could include supporting and strengthening warehousing, distribution, quantification, forecasting, procurement, transportation, and information systems with the mandate to achieve country-led and -managed supply chain systems. The award(s) will provide support to refocus the role of country governments from supply chain operators to stewards of product availability and security. This includes leveraging the broader landscape of country capacities, including increased use of private sector, to improve supply chain performance and client experience.

10. Public Private Partnerships (NextGen PPP) One or more awards will support public private partnerships focused on leveraging private sector expertise to strengthen health systems as it relates to procurement, logistic, supply chain, v data sharing, airtime, and strategic marketing expertise, in partnership with central and/or country programs.

ACTIVITY SUMMARY

The goal of the Procurement Service Agent Lab, Diagnostics, and Molecular (NextGen PSA Diagnostics) activity is to ensure the availability of quality-assured and affordable laboratory diagnostic services to people impacted by HIV/AIDS in partner countries to control the HIV/AIDS epidemic. NextGen PSA Diagnostics will work at a global level with USAID/Washington health portfolios and direct its efforts primarily to the U.S. President's Emergency Plan For AIDS Relief (PEPFAR). PEPFAR is the largest and most diverse HIV/AIDS prevention, care, and treatment initiative in the world and has saved more than 17 million lives through accountable, transparent, and cost-effective investments. As a key IP, USAID supports country-led efforts to combat the complex challenges of HIV/AIDS in over 50 countries. USAID’s work prevents and reduces new infections, provides cutting-edge care and treatment, addresses the needs of vulnerable populations, and revitalizes nations to take control of the epidemic – empowering them on their journeys to self-reliance.

USAID is looking for increased efficiencies and performance in testing capacity and promote growth in current and future in-country diagnostic networks. The NextGen PSA Diagnostics award will coordinate, purchase, and ensure the delivery of the appropriate types and quantities of HIV diagnostic commodities, to the locations where they are needed, in a timely manner; and to coordinate laboratory diagnostic services. Illustrative activities include:

1. Establishing a structured strategic sourcing process for procurement and delivery of diagnostic commodities and diagnostic laboratory services, to include:

(1) framework agreements with molecular, flowcytometry and other diagnostic manufacturers and suppliers of laboratory services and commodities, including private sector laboratories and in-country authorized distributors, wholesalers, and suppliers;

(2) comprehensive Vendor-Managed Inventory (VMI), including delivery at warehouses in partner countries, point-of-care facilities, and direct delivery of reagents to laboratories, via active stock management monitoring and oversight; and

(3) sample transport and result return services.

a. Strategy development (forecasting, sourcing, and supply planning)

b. Vetting of services, commodities

c. Spending analysis, marketplace surveys, and market forecasting

d. Pre-qualify vendors

e. Review and selection of products available from vendors

f. Negotiation and contracting for procurement of service delivery, including active negotiation of base prices

g. Vendor management (contract administration, sourcing allocation, purchase order creation, invoicing, receipt reconciliation)

2. Technical assistance, data collection, and oversight of vendors

a. Support to vendors to meet specifications and comply with contractual requirement, including technical assistance to address final product/service destination challenges.

vi

b. Auditing of vendors to ensure the terms of the agreements are met, including data collection, analysis and reporting on delivery of goods and vendor services.

3. Information sharing and coordination with other key stakeholders

a. Information sharing and coordination with stakeholders and IPs of the other activities under NextGen and host country authorities.

b. Consultations, meetings, workshops, and coordination with other partners, global donors, and host governments, including coordination of demand planning and market shaping strategies.

USAID is seeking to pay for a package of HIV testing services under all-inclusive pricing schemes, which means that supplies, reagents or test kits will not solely be procured through this award. However, for the vendors to provide comprehensive services, the vendors will need to purchase and manage the following types of commodities including their generated wastes according to best management practices. Commodities the activity may interact with include:

Laboratory supplies, reagents Rapid diagnostic tests (RDTs)

Lab supplies and equipment for diagnosis

The NextGen PSA Diagnostics activity will build on USAID’s more than 30 years of experience in procuring health commodities and use lessons learned during that period to increase efficiencies and performance results in testing capacity and to promote growth in in-country diagnostic networks.

ENVIRONMENTAL DETERMINATIONS

Upon approval of this document, the determinations become affirmed, per Agency regulations (22 Code of Federal Regulations [CFR] 216). For the purposes of environmental review in this IEE, the illustrative activities of the NextGen PSA Diagnostics awards are grouped into the following intervention categories.

TABLE 1: ASSIGNED INTERVENTION CATEGORIES AND ENVIRONMENTAL DETERMINATIONS

Intervention Categories/Sub-activities

Categorical Exclusion Citation

Negative Determination

Positive Determination1

Deferral2

Intervention Category 1: Establishing a Structured Strategic Sourcing Process for Procurement and Delivery of Diagnostic Commodities and Diagnostic Laboratory Services, to include:

1. framework agreements with molecular, flowcytometry and other diagnostic manufacturers and suppliers of laboratory services and commodities, including private sector laboratories and in-country authorized distributors, wholesalers, and suppliers;

2. comprehensive VMI, including delivery at warehouses in partner countries, point-of-care facilities, and direct delivery of reagents to laboratories, via active stock management monitoring and oversight;

3. sample transport and result return services.

Sub-activity 1.1: Strategy development (forecasting, §216.2(c)(2)(iii) Analyses, studies, 1 Positive Determinations require preparation of a Scoping Statement and Environmental Assessment.

2 Deferrals must be cleared through an Amendment to this IEE prior to implementation of any deferred activities.

vii sourcing, and supply planning) academic or research workshops and meetings workshops and meetings

Sub-activity 1.2: Vetting of services, commodities Sub-activity 1.3: Spending analysis, marketplace surveys, and market forecasting Sub-activity 1.4: Pre-qualify vendors Sub-activity 1.5: Review and selection of products available from vendors Sub-activity 1.6: Negotiation and contracting for procurement of service delivery, including active negotiation of base prices

§216.2(c)(2)(v) Document and information transfers

Sub-activity 1.7: Vendor management (contract administration, sourcing allocation, purchase order creation, invoicing, receipt reconciliation) Sub-activity 1.8: Private sector approaches to sample transport and result returns (electronic tracking, dashboards, interfaces, and new models, including unmanned aerial vehicles (UAVs) with specified conditions

Intervention Category 2: Technical Assistance, Data Collection, and Oversight of Vendors Sub-activity 2.1: Support to vendors to meet specifications and comply with contractual requirement, including technical assistance to address final product/service destination challenges, including: registration, shelf life, forecasting projected commodity needs, changes to Quality Assurance (QA) protocols, changes in supplier QA status, risks to continuous supply, managing product recalls and waste management, and managing phase-in and phase-out of commodities.

with specified conditions

Sub-activity 2.2: Auditing of vendors to ensure the terms of the agreements are met, including: validating the delivery of goods according to

§216.2(c)(2)(v) Document and information transfers viii the terms of the contract, validating vendor services for maintenance and other services under “all inclusive” laboratory contracts.

Intervention Category 3: Information Sharing and Coordination Sub-activity 3.1: Information sharing and coordination with stakeholders and IPs of the other activities under NextGen and host country authorities.

§216.2(c)(2)(i) Education, technical assistance, or training programs except to the extent such programs include activities directly affecting the environment (such as construction of facilities, etc.)

Sub-activity 3.2: Consultations, meetings, workshops, and coordination with other partners, global donors, and host governments, including coordination of demand planning and market shaping strategies.

§216.2(c)(2)(iii) Analyses, studies, academic or research workshops and meetings

CLIMATE RISK MANAGEMENT

This screening is required per the Mandatory Reference for ADS Chapter 201: Climate Risk Management (CRM) for USAID Projects and Activities.3 The project-level CRM for the entirety of the NextGen, including NextGen PSA Diagnostics, has been approved as of September 2019. While, the specific scopes of work for NextGen PSA Diagnostics have yet to be defined, but the project-level CRM noted “Moderate” or “High” climate risks of sub-activities for the NextGen PSA Diagnostics award. Refinements on the project-level CRM can be analyzed, built into activity design where risk mitigation is actionable, and documented as part of the EMMP of the activity. A summary of the project-level CRM Summary Table is attached in Annex 1.

IMPLEMENTATION

In accordance with 22 CFR 216 and Agency policy, the conditions and requirements of this document become mandatory upon approval. This includes the relevant limitations, conditions and requirements in this document as stated in Sections 4 and 5 of the IEE and any Bureau Environmental Officer (BEO) Specified Conditions of Approval.

3 Climate Risk Management for USAID Projects and Activities. https://www.usaid.gov/ads/policy/200/201mal ix

USAID APPROVAL OF INITIAL ENVIRONMENTAL EXAMINATION

PROJECT/ACTIVITY: NextGen PSA Diagnostics

Bureau Tracking ID: GH-20-10383

Approval: Email approval 11/2/20 Marita Eibl, Acting GH Deputy Assistant Administrator Date

Approval: Email approval 10/30/20 Charles Pope, GH Chief of Operations Date

Clearance: Clearance by Email 10/29/20 James Maloney, Deputy Director GH/OHA Date

Clearance:

Jennifer Slotnick, Acting Climate Integration Lead Date

Concurrence:

Jennifer Slotnick, Acting GH Bureau Environmental Officer Date

DISTRIBUTION:

Carol Chan Charles Pope James Maloney

Dennis Durbin Jan Miller Environmental Compliance

Jennifer Slotnick Digitally signed by Jennifer Slotnick Date: 2020.11.10 14:36:59 -05'00'

Jennifer Slotnick Digitally signed by Jennifer Slotnick Date: 2020.11.10 14:37:51 -05'00'

INITIAL ENVIRONMENTAL

EXAMINATION

CONTENTS

ACRONYMS

1.0 PROJECT/ACTIVITY DESCRIPTION

1.1 PURPOSE OF THE INITIAL ENVIRONMENTAL EXAMINATION (IEE) 4

1.2 PROJECT OVERVIEW 4

1.3 ACTIVITY DESCRIPTION 6

2.0 BASELINE ENVIRONMENTAL INFORMATION

2.1 LOCATIONS AFFECTED AND ENVIRONMENTAL CONTEXT (ENVIRONMENT,

PHYSICAL, CLIMATE, SOCIAL, THREATENED AND ENDANGERED SPECIES) 9

2.2 APPLICABLE AND APPROPRIATE PARTNER COUNTRY AND OTHER INTERNATIONAL

STANDARDS (E.G. WHO), ENVIRONMENTAL AND SOCIAL LAWS, POLICIES, AND

REGULATIONS 9

3.0 ANALYSIS OF POTENTIAL ENVIRONMENTAL RISK

4.0 ENVIRONMENTAL DETERMINATIONS

4.1 RECOMMENDED ENVIRONMENTAL DETERMINATIONS 13

4.2 CLIMATE RISK MANAGEMENT 15

5.0 CONDITIONS AND MITIGATION MEASURES

5.1 CONDITIONS FOR AGENCY IMPLEMENTATION 18

5.2 MITIGATION MEASURES 20

6.0 LIMITATIONS OF THIS INITIAL ENVIRONMENTAL EXAMINATION

7.0 REVISIONS

8.0 REFERENCES

ANNEXES:

ACRONYMS

22 CFR 216 Title 22, Code of Federal Regulations, Part 216 ADS Automated Directives System AM Activity Manager BEO Bureau Environmental Officer CFR Code of Federal Regulations CO Contracting Officer COR Contracting Officer’s Representative CRM Climate Risk Management EA Environmental Assessment EMMP Environmental Mitigation and Monitoring Plan EMMR Environmental Mitigation and Monitoring Report EPA Environmental Protection Agency ESF Environmental Screening Form FAA Foreign Assistance Act GH Global Health GHG Greenhouse Gas IEE Initial Environmental Examination IP Implementing Partner ISO International Organization for Standardization MEO Mission Environmental Officer NextGen Next Generation Global Health Supply Chain Suite of Programs NDRA National Drug Regulatory Authorities OECD Organization for Economic Cooperation and Development PEPFAR U.S. President's Emergency Plan For AIDS Relief PSA Procurement Service Agent PSA Diagnostics Procurement Service Agent Lab, Diagnostics, and Molecular QA Quality Assurance RDT Rapid Diagnostic Tests RTK Rapid Test Kits SOP Standard Operating Procedures UAV Unmanned Aerial Vehicles USAID United States Agency for International Development VMI Vendor-Managed Inventory WHO-PQ World Health Organization Prequalification Programme

WMP Waste Management Plan

1.0 PROJECT/ACTIVITY DESCRIPTION

1.1 PURPOSE OF THE INITIAL ENVIRONMENTAL EXAMINATION (IEE)

The purpose of this document, in accordance with Title 22, Code of Federal Regulations, Part 216 (22 CFR 216), is to provide a preliminary review of the reasonably foreseeable effects on the environment of the United States Agency for International Development (USAID) intervention described herein and recommend determinations and, as appropriate, conditions, for these activities. Upon approval, these determinations become affirmed, and specified conditions become mandatory obligations of implementation. This IEE also documents the results of the Climate Risk Management (CRM) process in accordance with USAID policy (specifically, Automated Directives System [ADS] 201mal).

This IEE is a critical element of USAID’s mandatory environmental review and compliance process meant to achieve environmentally sound design and implementation. Potential environmental impacts should be addressed through formal Environmental Mitigation and Monitoring Plans (EMMPs) and/or Environmental Assessments (EAs), if needed.

1.2 PROJECT OVERVIEW

The objective of the Next Generation Global Health Supply Chain Suite of Programs (NextGen) is to establish and operate high performing and agile supply chains that ensure the procurement and delivery of affordable, high-quality, essential, and life-saving health commodities. NextGen will support the U.S. Government’s (USG’s) global health priorities to prevent child and maternal deaths, control the HIV/AIDS epidemic, eradicate malaria, and combat infectious diseases through the procurement and delivery of health commodities. NextGen is committed to responding to unique requirements of each health program, identifying where to segment functions to maximize performance and respond to different program requirements, and developing a program that attracts reputable commodities providers and increases accountability.

NextGen emphasizes strengthening supply chains in USAID-supported countries through investment in building country commitment and capacity of systems responsible for procurement, storage, distribution, dispensing and related supply chain services to ensure longevity and self-reliance in the absence of foreign assistance.

The NextGen planned awards are:

1. Procurement Service Agent HIV Pharma (NextGen PSA HIV Pharma) This award will provide procurement and associated supply chain services for HIV/AIDS health commodities excluding HIV/AIDS diagnostic and lab commodities encompassing the required procurement functions of a supply chain (e.g., category management, strategic sourcing, supplier management, demand planning and procurement delivery). The PSA will negotiate incoterms with vendors for delivery of commodities into country, and, in exceptional cases, procure logistics services for commodities purchased under this award to ensure timely delivery. The awardee must coordinate with other awardees under the program.

2. Procurement Service Agent Malaria (NextGen PSA Malaria)

This award will provide procurement and supply chain services for malaria health commodities. It will encompass different services within the procurement as-a-service value chain (e.g., category management, strategic sourcing, supplier management, transactional procurement and demand planning). It will provide a robust information system to support operations and performance improvement. The PSA will negotiate incoterms with vendors for delivery of commodities to country, and as needed, provide freight and warehousing for commodities purchased under this award. The awardee must coordinate with other awardees under the program.

3. Procurement & Logistics Services - Family Planning and Reproductive Health (FP/RH), Maternal and Child Health and Nutrition (MCHN), Other Health Elements (Next Gen PLS)

This award This award will provide procurement and associated supply chain services (e.g., category management, strategic sourcing, supplier management, demand planning freight, warehousing, and delivery services) for family planning/reproductive health and other health commodities.

4. Procurement Service Agent Lab, Diagnostics, and Molecular (NextGen PSA Diagnostics)

This award will provide procurement and associated supply chain services (e.g., category management, strategic sourcing, supplier management, demand planning freight, warehousing, and delivery services) for HIV/AIDS lab, diagnostic and molecular commodities.

5. In-country Logistics (NextGen ICL) One or more awards will provide for in-country logistics and delivery of NextGen commodities.

6. Control Tower for USAID Next Generation Global Health Supply Chain Suite of Programs (NextGen CT)

This award will provide a central hub to provide end-to-end visibility and specific and cross-program information for Missions, Bureaus, Agency leadership and program managers of commodities procured through NextGen.

7. Qualifying Testing Issuing (NextGen QuTI) This award will serve as the primary vehicle to help assure the quality of health commodities purchased under NexGen and other global health programs.

8. Risk Management and Mitigation (NextGen RMM) One or more awards will identify and mitigate supply chain vulnerabilities and potential risks both globally and locally, including fraud, abuse and/or misuse, counterfeit, and diversion of products and financial resources. It will also verify second- and third-tier suppliers and other vendors subcontracted under other NextGen awards to improve supply chain integrity and security.

9. Supply Chain Technical Assistance (NextGen SCTA) One or more awards will provide a comprehensive array of technical assistance (TA) services to improve operational excellence in country supply chains and improve the availability of health commodities to meet the needs of today’s populations and support countries on their journeys to self-reliance to meet the needs of tomorrow’s populations. TA investments could include supporting and strengthening warehousing, distribution, quantification, forecasting, procurement, transportation, and information systems with the mandate to achieve country-led and -managed supply chain systems. The award(s) will provide support to refocus the role of country governments from supply chain operators to stewards of product availability and security. This includes leveraging the broader landscape of country capacities, including increased use of private sector, to improve supply chain performance and client experience.

10. Public Private Partnerships (NextGen PPP) One or more awards will support public private partnerships focused on leveraging private sector expertise to strengthen health systems as it relates to procurement, logistic, supply chain, data sharing, airtime, and strategic marketing expertise, in partnership with central and/or country programs.

1.3 ACTIVITY DESCRIPTION

The goal of the Procurement Service Agent (PSA) Diagnostics activity is to ensure the availability of quality-assured and affordable laboratory diagnostic services to people impacted by HIV/AIDS in partner countries to control the HIV/AIDS epidemic. NextGen PSA Diagnostics will work at a global level with USAID/Washington health portfolios and direct its efforts primarily to the U.S.

President's Emergency Plan For AIDS Relief (PEPFAR). PEPFAR is the largest and most diverse HIV/AIDS prevention, care, and treatment initiative in the world and has saved more than 17 million lives through accountable, transparent, and cost-effective investments. As a key IP, USAID supports country-led efforts to combat the complex challenges of HIV/AIDS in over 50 countries.

USAID’s work prevents and reduces new infections, provides cutting-edge care and treatment, addresses the needs of vulnerable populations, and revitalizes nations to take control of the epidemic – empowering them on their journeys to self-reliance.

USAID is looking for increased efficiencies and performance in testing capacity and promote growth in current and future in-country diagnostic networks. The NextGen PSA Diagnostics award will coordinate, purchase, and ensure the delivery of the appropriate types and quantities of HIV diagnostic commodities, to the locations where they are needed, in a timely manner; and to coordinate laboratory diagnostic services. Illustrative activities include:

1. Establishing a structured strategic sourcing process for procurement and delivery of diagnostic commodities and diagnostic laboratory services, to include:

(1) framework agreements with molecular, flowcytometry and other diagnostic manufacturers and suppliers of laboratory services and commodities, including private sector laboratories and in-country authorized distributors, wholesalers, and suppliers;

(2) comprehensive Vendor-Managed Inventory (VMI), including delivery at warehouses in partner countries, point-of-care facilities, and direct delivery of reagents to laboratories, via active stock management monitoring and oversight; and

(3) sample transport and result return services.

c. Strategy development (forecasting, sourcing, and supply planning)

d. Vetting of services, commodities

e. Spending analysis, marketplace surveys, and market forecasting

f. Pre-qualify vendors

g. Review and selection of products available from vendors

h. Negotiation and contracting for procurement of service delivery, including active negotiation of base prices

i. Vendor management (contract administration, sourcing allocation, purchase order creation, invoicing, receipt reconciliation)

2. Technical assistance, data collection, and oversight of vendors

j. Support to vendors to meet specifications and comply with contractual requirement, including technical assistance to address final product/service destination challenges.

k. Auditing of vendors to ensure the terms of the agreements are met, including data collection, analysis and reporting on delivery of goods and vendor services.

3. Information sharing and coordination with other key stakeholders

l. Information sharing and coordination with stakeholders and IPs of the other activities under NextGen and host country authorities.

m. Consultations, meetings, workshops, and coordination with other partners, global donors, and host governments, including coordination of demand planning and market shaping strategies.

USAID is seeking to pay for a package of HIV testing services under all-inclusive pricing schemes, which means that supplies, reagents or test kits will not solely be procured through this award. However, for the vendors to provide comprehensive services, the vendors will need to purchase and manage the following types of commodities including their generated wastes according to best management practices. Commodities the activity may interact with include:

Laboratory supplies, reagents Rapid diagnostic tests (RDTs)

Lab supplies and equipment for diagnosis

All vendors contracted through the NextGen PSA Diagnostics mechanism must comply with global quality standards, e.g. World Health Organization Prequalification Programme (WHO-PQ) listing, and local regulatory requirements (e.g., registration). Procurement must follow USAID’s commodity eligibility requirements specified in ADS 312 and source and nationality requirements policy as specified in ADS 310. Additionally, upon delivery, the commodities must be registered with the National Drug Regulatory Authorities (NDRA) of destination countries.

The NextGen PSA Diagnostics activity will build on USAID’s more than 30 years of experience in procuring health commodities and use lessons learned during that period to increase efficiencies and performance results in testing capacity and to promote growth in in-country diagnostic networks.

Will this project/activity involve construction4 as defined by ADS 201 and 303? Yes No

4 Construction, as defined by ADS 201 and 303, includes: construction, alteration, or repair (including dredging and excavation) of buildings, structures, or other real property and includes, without limitation, improvements, renovation, alteration and refurbishment. The term includes, without limitation, roads, power plants, buildings, bridges, water treatment facilities, and vertical structures. In the box below, describe any construction planned for this project/activity.

Refer to ADS 201maw for required Construction Risk Management procedures.

If yes, describe in the space below:

N/A

2.0 BASELINE ENVIRONMENTAL INFORMATION

2.1 LOCATIONS AFFECTED AND ENVIRONMENTAL CONTEXT (ENVIRONMENT, PHYSICAL,

CLIMATE, SOCIAL, THREATENED AND ENDANGERED SPECIES)

The geographic scope of this IEE is global—commodity procurement and delivery will be undertaken in any presence or non-presence country. Local conditions, capabilities, and infrastructure will strongly affect the commodities in demand; viable and appropriate treatment (incineration) and/or disposal (landfill) options for commodities that, for various reasons, must be treated and/or disposed of; and which commodities may be safely used and managed by local health facilities. Activities may occur in both rural and urban environments. The global nature of the IEE means that the IEE cannot characterize local conditions.

It is hereby verified that, due to the global aspect of this activity, no effect on an endangered or threatened species, or critical habitat, can be determined, in accordance with 22 CFR 216.5. If any activity would adversely impact threatened and endangered species or their critical habitats, additional environmental analysis would be required (e.g. an EA).

2.2 APPLICABLE AND APPROPRIATE PARTNER COUNTRY AND OTHER INTERNATIONAL STANDARDS

(E.G. WHO), ENVIRONMENTAL AND SOCIAL LAWS, POLICIES, AND REGULATIONS

While this IEE addresses global commodity distribution, the awards implementation will be subject to the environmental, health and safety laws of each host country, and particularly, national requirements regarding management and disposal of commodities and equipment. Where national requirements on waste management associated with commodity and equipment disposal do not exist, the selected vendors must comply with International Organization for Standardization (ISO) and WHO standards and best practices (e.g., WHO “Safe Management of Wastes from Healthcare Activities”) noted in their contract in order to receive orders.

Where NextGen PSA Diagnostics directs laboratories on waste handling, the following list of standards, guidelines, and useful references may apply:

INTERNATIONAL CONVENTIONS AND AGREEMENTS

Basel Convention on the Control of Transboundary Movements of Hazardous Wastes and their Disposal Organization for Economic Cooperation and Development (OECD) Council on the Decision on the control of Transboundary Movements of Wastes Stockholm Convention on Persistent Organic Pollutants Minamata Convention on Mercury

USAID RESOURCES AND REFERENCES

USAID. Sector Environmental Guidelines o Solid Waste o Healthcare Waste o Healthcare Facilities

USAID. Integrated Waste Management Plan

OTHER INTERNATIONAL REFERENCES AND STANDARDS

ISO 15190:2020 Medical Laboratories – Requirements for Safety ISO/IEC 17025:2005 General Requirements for the Competence of Testing and Calibration Laboratories ISO 14001 Environmental Management ISO 7765:2004 Safe Management of wastes from health-care activities (Note: Where national requirements on waste management associated with commodity disposal do not exist, WHO’s “Safe Management of Wastes from Healthcare Activities” handbook is the internationally-recognized standard used by the Bureau for Global Health) WHO List of Prequalified Quality Control Laboratories WHO Good Practices for Pharmaceutical Quality Control Laboratories WHO Good Practices for Pharmaceutical Microbiology Control Laboratories WHO Good Manufacturing Practices

3.0 ANALYSIS OF POTENTIAL ENVIRONMENTAL RISK

Each of the activities under the PSA portfolio were evaluated for the potential direct, indirect, and cumulative environmental and social (i.e. health and well-being) risks. The specific locations where the activities take place are yet to be determined; however, activities are generally associated with those taking place at warehouses and in offices rather than the natural environment as discussed below.

TABLE 2: ENVIRONMENTAL IMPACTS OF INTERVENTION CATEGORIES AND SUB-ACTIVITIES

Intervention Category 1: Establishing a Structured Strategic Sourcing Process for Procurement and Delivery of Diagnostic Commodities and Diagnostic Laboratory Services, to include:

1. framework agreements with molecular, flowcytometry and other diagnostic manufacturers and suppliers of laboratory services and commodities, including private sector laboratories and in-country authorized distributors, wholesalers, and suppliers;

2. comprehensive VMI, including delivery at warehouses in partner countries, point-of-care facilities, and direct delivery of reagents to laboratories, via active stock management monitoring and oversight;

3. sample transport and result return services.

Sub-activity 1.1: Strategy development (forecasting, sourcing, and supply planning)

These actions involve research, analyses, and contracting actions that have no direct physical impact on the environment with the exception of the potential for disposing of a very small amount of computer or IT equipment (e-wastes) (e.g., if an office computer is damaged).

NextGen PSA Diagnostics relies on economics and efficiencies of service through key indicators to mitigate waste and overordering in supply planning and forecasting as part of the strategy development and design (primary environmental impact potentially associated with this activity).

There are no negative social impacts associated with these actions.

Since laboratory services will be available at more local facilities through this award, the award may reduce greenhouse gas (GHG) emissions associated with the transport of samples, but will still make some contribution to total GHGs emissions.

Sub-activity 1.2: Vetting of services, commodities Sub-activity 1.3: Spending analysis, marketplace surveys, and market forecasting Sub-activity 1.4: Pre-qualify vendors Sub-activity 1.5: Review and selection of products available from vendors Sub-activity 1.6: Negotiation and contracting for procurement of service delivery, including active negotiation of base prices Sub-activity 1.7: Vendor management (contract administration, sourcing allocation, purchase order creation, invoicing, receipt reconciliation)

Sub-activity 1.8: Private sector approaches to sample transport and result returns (electronic tracking, dashboards, interfaces, and new models, including unmanned aerial vehicles (UAVs)

These actions primarily involve research, analyses, and information sharing actions that have no direct physical impact on the environment with the exception of the potential for disposing of computer or IT equipment (e-wastes). However, the private sector could propose new models of sample delivery which could include UAVs or other robotics.

UAVs potentially reduce the need for trucks or motorbikes to transport samples, thereby mitigating some GHG emissions. However, they still have the potential to collide with people, aircraft, or animals, posing a physical threat to safety. Disposal of drone batteries may also contaminate soils and waters if disposed of inappropriately.

Intervention Category 2: Technical Assistance, Data Collection, and Oversight of Vendors Sub-activity 2.1: Support to vendors to meet specifications and comply with contractual requirement, including technical assistance to address final product/service destination challenges, including: registration, shelf life, forecasting projected commodity needs, changes to Quality Assurance (QA) protocols, changes in supplier QA status, risks to continuous supply, managing product recalls and waste management, and managing phase-in and phase-out of commodities.

Most of the support and technical assistance that the PSA Diagnostic implementer may provide to contracted vendors will not have environmental risk, with one notable exception, described below.

The PSA Diagnostic mechanism seeks to minimize the need for treatment and/or disposal of commodities due to expiration and other supply and demand issues. However, the need for contracted vendors to deal with recalled, expired, or damaged commodities at their own facilities remains. At the local level, laboratories operated by other entities, such as CDC, will take over responsibility for environmental impacts for laboratory operation and maintenance.

Wastes handled by the vendor at their own facilities and indirectly at laboratories where the vendors are engaging, can lead to the need for incineration treatment or landfill disposal of commodities, which can contribute to GHG emission levels.

Sub-activity 2.2: Auditing of vendors to ensure the terms of the agreements are met, including: validating the delivery of goods according to the terms of the contract, validating vendor services for maintenance and other services under “all inclusive” laboratory contracts.

This action involves information sharing that has no physical impact on the environment.

There are no negative social impacts associated with this action.

Intervention Category 3: Commodities Inventory Management, Sourcing, and Procurement Sub-activity 3.1: Information sharing and coordination with stakeholders and IPs of the other activities under NextGen and host country authorities.

These actions involve information sharing, technical assistance, trainings, meetings, and workshops that have no physical impact on the environment except where meetings and event may create office and event related solid waste.

There are no negative social impacts associated with these actions.

Sub-activity 3.2: Consultations, meetings, workshops, and coordination with other partners, global donors, and host governments, including coordination of demand planning and market shaping strategies.

4.0 ENVIRONMENTAL DETERMINATIONS

4.1 RECOMMENDED ENVIRONMENTAL DETERMINATIONS

The following table summarizes the recommended determinations based on the environmental analysis conducted (Table 3). Upon approval, these determinations become affirmed, per 22 CFR

216. Specified conditions, detailed in Section 5, become mandatory obligations of implementation, per ADS 204.

CATEGORICAL EXCLUSIONS

Certain sub-activities within this IEE are eligible for a pre-determination categorical exclusion from further analysis as they do not have an effect on the natural or physical environment and belong to a class of activities described in 22 CFR 216.2(c)(2). Activities that include technical assistance, build capacity through training and education, offer analysis or academic studies and surveys, transfer information or data- do not have foreseeable impact on the environment or on social constructs. As a guard against inappropriate support actions that could adversely impact the environment or social constructs, efforts to improve overall sustainability of the activity is encouraged via such measures as green procurement, green initiatives,5 and proactive proper management of e-wastes and other materials.

Those sub-activities eligible for a pre-determination categorical exclusion are identified as such in Table 3, with a citation to the specific clause of 22 CFR 216.2(c)2 that allows their exclusion from further analysis. The following clauses of 22 CFR 216.2(c)2 are cited as justification:

i. Education, technical assistance, or training programs except to the extent such programs include activities directly affecting the environment (such as construction of facilities, etc.);

iii. Analyses, studies, academic or research workshops and meetings; and

v. Document and information transfers.

NEGATIVE DETERMINATIONS WITH CONDITIONS

Negative threshold determinations with associated conditions are those actions which, based on impacts analysis, have low or moderate potential for environmental impact. With mitigation measures in place, those impacts are expected to be minimal, and therefore, these actions are assigned a negative determination with conditions, as noted. Conditions are those requirements or specific mitigation measures applicable to the project planning, implementation, and operation.

Conditions are detailed for these activities in Section 5.1 and 5.2.

NextGen PSA Diagnostics vendors are only responsible for providing the equipment and supplies for carrying out diagnostic tests. They will not be responsible for handling of any waste, samples, equipment, or reagents at the laboratory facilities as those facilities are maintained and operated

5 The USAID Green Meeting Checklist provides a template for accounting for greening workshops and meetings. See Annex 2.

by host country authorities and/or the Centers for Disease Control and Prevention (CDC). If the local laboratory is in need of USAID assistance for any of these types of services, the assistance may be provided by the NextGen Qualifying Testing Issues (NextGen QuTI) or NextGen Supply Chain Technical Assistance (NextGen SCTA) awards.

TABLE 3: ENVIRONMENTAL DETERMINATIONS

Intervention Categories/Sub-activities

Categorical Exclusion Citation

Negative Determination

Positive Determination6

Deferral7

Intervention Category 1: Establishing a Structured Strategic Sourcing Process for Procurement and Delivery of Diagnostic Commodities and Diagnostic Laboratory Services, to include:

4. framework agreements with molecular, flowcytometry and other diagnostic manufacturers and suppliers of laboratory services and commodities, including private sector laboratories and in-country authorized distributors, wholesalers, and suppliers;

5. comprehensive VMI, including delivery at warehouses in partner countries, point-of-care facilities, and direct delivery of reagents to laboratories, via active stock management monitoring and oversight;

6. sample transport and result return services.

Sub-activity 1.1: Strategy development (forecasting, sourcing, and supply planning)

§216.2(c)(2)(iii) Analyses, studies, academic or research workshops and meetings workshops and meetings

Sub-activity 1.2: Vetting of services, commodities Sub-activity 1.3: Spending analysis, marketplace surveys, and market forecasting Sub-activity 1.4: Pre-qualify vendors Sub-activity 1.5: Review and selection of products available from vendors Sub-activity 1.6: Negotiation and contracting for procurement of service delivery, including active negotiation of base prices

§216.2(c)(2)(v) Document and information transfers

Sub-activity 1.7: Vendor management (contract administration, sourcing allocation, purchase order creation, invoicing, receipt reconciliation) Sub-activity 1.8: Private sector approaches to sample transport and result returns (electronic tracking, dashboards, interfaces, and new models, including unmanned aerial vehicles (UAVs) with specified conditions

6 Positive Determinations require preparation of a Scoping Statement and Environmental Assessment.

7 Deferrals must be cleared through an Amendment to this IEE prior to implementation of any deferred activities.

Intervention Category 2: Technical Assistance, Data Collection, and Oversight of Vendors Sub-activity 2.1: Support to vendors to meet specifications and comply with contractual requirement, including technical assistance to address final product/service destination challenges, including:

registration, shelf life, forecasting projected commodity needs, changes to Quality Assurance (QA) protocols, changes in supplier QA status, risks to continuous supply, managing product recalls and waste management, and managing phase-in and phase-out of commodities.

with specified conditions

Sub-activity 2.2: Auditing of vendors to ensure the terms of the agreements are met, including: validating the delivery of goods according to the terms of the contract, validating vendor services for maintenance and other services under “all inclusive” laboratory contracts.

§216.2(c)(2)(v) Document and information transfers

Intervention Category 3: Information Sharing and Coordination Sub-activity 3.1: Information sharing and coordination with stakeholders and IPs of the other activities under NextGen and host country authorities.

§216.2(c)(2)(i) Education, technical assistance, or training programs except to the extent such programs include activities directly affecting the environment (such as construction of facilities, etc.)

Sub-activity 3.2: Consultations, meetings, workshops, and coordination with other partners, global donors, and host governments, including coordination of demand planning and market shaping strategies.

§216.2(c)(2)(iii) Analyses, studies, academic or research workshops and meetings

4.2 CLIMATE RISK MANAGEMENT

The purpose of this CRM screening is to identify climate related risks to make the NextGen PSA Diagnostics more resilient to both future and current climate variability and change. This section summarizes the methodology used and findings of the CRM analysis (see Annex 1). The project level CRM was conducted for the entirety of NextGen, from which, this summary is taken for NextGen PSA Diagnostics. The project design team considered the potential effect of climate risks/stressors on the sustainability of the project (changing precipitation patterns, rising temperature, floods, droughts, fires, landslides, etc.) in addition to the impact of project activities on the climate (increased GHG emissions, land use changes, etc.).