JA No. 24-135 - MTaPS GH (2024).pdf

TAB 1 -

JUSTIFICATION AND APPROVAL FOR OTHER THAN FULL AND OPEN COMPETITION (J&A)

TO: Atul Gawande, Assistant Administrator, GH/AA

THRU: Imran Mahmud, Contracting Officer, M/OAA/GH Nidhi Bouri, Deputy Assistant Administrator, GH/DAA Jennifer Norling, Division Chief, M/OAA/E

FROM: Mai Hijazi, Office Director GH/OHS (cleared via email)

DATE: October 01, 2024

SUBJECT: Justification and Approval (J&A) for Other than Full and Open Competition for a no-cost extension of six months to the Medicines, Technologies, and Pharmaceutical Services (MTaPS) Contract (7200AA18C00074)

1. This document sets forth the facts and rationale justifying the use of other than full and open competition, under AIDAR 706.302-70(b)(3)(i), which provides an exception to competition for an award for which the Assistant Administrator responsible for the project or program makes a formal written determination, with supporting findings, that compliance with full and open competition procedures would impair foreign assistance objectives, and would be inconsistent with the fulfillment of the foreign assistance program. This document was prepared by the USAID/Bureau for Global Health/Office of Health Systems (GH/OHS), for the Medicines, Technologies, and Pharmaceutical Services (MTaPS) contract (7200AA18C00074).

2. The nature and/or description of the action being approved:

This is a request to approve a six month no-cost extension to the MTaPS contract period of performance, currently from September 20, 2018 to March 19, 2025, to be extended to September 19, 2025. Under this action, the contractor, Management Sciences for Health (MSH) will continue to implement critical activities supporting USAID’s Global Health Supply Chain (GHSC) programming that improve pharmaceutical systems and USAID’s Global Health Security efforts to combat antimicrobial resistance and improve infection prevention and control.

On June 9, 2023, MTaPS was extended through September 19, 2024, with a ceiling increase of $39,999,074 for a total estimated cost (TEC) of $209,705,563 via approved Action Memo.

MTaPS was later extended an additional six months to March 19, 2025 by exercising an option to extend services per FAR 52.217-8. The approved 12 month and subsequent six months extensions were to allow for additional time and funds to: 1) complete activities delayed due to COVID-19 disruptions 2) accommodate the considerable funds absorbed to address outbreak response and 3) allow for adequate overlap until the delayed Next Generation (NextGen) Comprehensive Technical Assistance for Health Supply Chain (Comprehensive TA) awards were fully operational.

The MTaPS activity decreases morbidity and mortality through ensuring access to safe and appropriate medicines and combating antimicrobial resistance (AMR). This activity is an essential piece of the current USAID Global Health supply chain awards program. Likewise, its planned follow-on mechanism will be a critical technical assistance provider under USAID’s NextGen Global Health Supply Chain suite of awards.

3. Description of the supplies or services required, including an estimated value:

The MTaPS project helps low- and middle-income countries strengthen their pharmaceutical systems to ensure sustainable access to and appropriate use of safe, effective, quality-assured, and affordable essential medical products and pharmaceutical services. MTaPS is one of USAID’s key mechanisms in the field of pharmaceutical management and AMR, and is uniquely qualified to advance USAID’s priorities through their capacity-building and response efforts.

The six month no-cost extension to the period of performance would allow MTaPS to continue critical support to USAID Missions and Bureaus and avoid a gap in services until a follow-on award(s) is in place and able to seamlessly provide the needed support.

A gap in services would mean that progress in maturing country supply chains and health systems is compromised, access to life saving medicines and products is hampered, country outbreak response efforts and preparatory measures are compromised, further emphasizing that the continuation of services under MTaPS is vital to reduce the burden of death and disease. Areas of critical support for the needed overlap include: ensuring that there is no disruption in access to quality, affordable medicines and other medical products; continuing to meet USG objectives around Global Health Security (GHS) through infection prevention and control (IPC) and other measures to combat AMR; and effectively responding to outbreaks such as ebola, mpox, and COVID-19.

MTaPS is a part of the current Global Health Supply Chain (GHSC) suite of awards; the new Next Generation Comprehensive Technical Assistance (NextGen Comprehensive TA) awards are the awards that need to be in place for a seamless transition of MTaPS services. NextGen Comprehensive TA Task Order(s) will provide the technical assistance for pharmaceutical services and GHS antimicrobial resistance (AMR) that MTaPS provides now, and so the NextGen Comprehensive TA Task Order(s) must be awarded and fully active before MTaPS closes, to ensure no interruption in services and/or a loss in years of financial investments and systems building with governments and counterparts. Maintaining consistency of technical support is critical to not compromise supply chain and pharmaceutical systems, patient safety and maintain continued progress in the US Government's Global Health Security efforts to combat

AMR.

During the extension period MTaPS would continue supporting countries' investments in USAID’s pharmaceutical strengthening support as a part of global health’s supply chain efforts thereby ensuring continued patient safety and access to quality medical products. Missions and GH-directed core-funded portfolios require MTaPS’ continued support in implementing pharmaceutical management activities, particularly to meet demands around medicines safety, vaccine availability and local manufacturing.

Services required from MTaPS under the extension period also include the key areas of technical assistance in combating antimicrobial resistance (AMR) and ensuring strong IPC programs under the Global Health Security (GHS) effort (all technical areas that will be supported by the NextGen Comprehensive TA award(s). A loss of momentum and progress would interrupt and undermine USAID Missions’ efforts to slow the emergence and spread of AMR and to reduce morbidity and mortality through improved infection prevention and control IPC. This would significantly negatively impact USAID’s, and in turn USG’s, ability to advance international collaboration and capacity building objectives regarding AMR, including under Goal 5 of the USG National Strategy to Combat Antibiotic-Resistant Bacteria (CARB) and the U.S. CARB National Action Plan. As a component of their IPC support MTaPS would also provide crucial support to outbreak response needs which have previously included ebola, mpox and

COVID-19.

It is critical to ensure a smooth transition from MTaPS and the start-up to the follow-on contract(s), the NextGen Comprehensive TA task order(s). An extension from March 2025 through September 2025 would allow up to six months time for start-up and transition to the new awards.

4. Statutory authority permitting other than full and open competition:

This action is requested under the authority of AIDAR 706.302-70 Impairment of foreign aid programs (a)(2) which states,“ Full and open competition need not be obtained when it would impair or otherwise have an adverse effect on programs conducted for the purposes of foreign aid, relief, and rehabilitation.” Under AIDAR 706.302-70(b)(3)(i), this authority may be used for “an award for which the Assistant Administrator responsible for the project or program makes a formal written Determination and Findings (D&F), that compliance with full and open competition procedures would impair foreign assistance objectives, and would be inconsistent with the fulfillment of the foreign assistance program.” No other authority provided under FAR

6.302 or AIDAR 706.302 is suitable.

5. A demonstration that the proposed contractor’s unique qualifications or the nature of the acquisition that requires use of the authority cited:

MSH is a uniquely qualified expert in the many technical disciplines involved in sustainably strengthening pharmaceutical systems, including systems that promote the appropriate use of medicines and combat the emergence and spread of antimicrobial resistance. The contractor's expertise in organizational capacity, country presence, and ongoing relationships is critical to the success of the remaining activities and in achieving expected results. Such support is provided within the current USAID GHSC suite of awards and MTaPS is the only provider of the technical AMR areas in up to 11 USAID GHS priority countries. MTaPS has established partnerships with Ministries of Health and other relevant government entities and in-country stakeholders to coordinate implementation of key activities critical to successful programming.

With a key MTaPS focus on IPC due to its GHS mandate, and supporting pharmaceutical and regulatory systems, it was poised to quickly address key needs highlighted by the pandemic. The activity has made significant contributions to key pandemic response technical areas, including IPC, AMR containment, regulatory, supply chain, vaccination and pharmacovigilance support through capacity building, training, and working closely with governments and country counterparts and continues these health systems efforts. As another disease outbreak could occur at any time, as evidenced by the escalation of the mpox outbreak, it is imperative to have MTaPS accessible to provide services until the NextGen Comprehensive TA task order(s) are operational in case countries need to quickly avail themselves of these services to respond to a new outbreak.

Through its implementation of the MTaPS program, the contractor has established strong working relationships with in-country counterparts and momentum in activity implementation that take time to establish and are intended to be handed over smoothly to the follow-on mechanism, thereby ensuring that the effectiveness of USAID’s programming is maintained.

Given these existing engagements across multiple countries, it would not be feasible to issue a new award to bridge the period between MTaPS’ current end date and the award of the planned follow-on NextGen mechanism. A bridge contract would further delay the competition and implementation of NextGen technical assistance.

Therefore the principal reason for the extension request is to avoid impairment of USAID’s global health foreign assistance objectives, under “Investing in People,” which requires that MTaPS’ ongoing work be properly transitioned to its follow-on program, NextGen Comprehensive TA, with sufficient overlap to ensure that decades of progressive support to USAID Missions and programs is not undermined. MTaPS activities will transition to the NextGen technical assistance awards, specifically the task order(s) (TOs) awarded under the Comprehensive Technical Assistance for Health Supply Chain and the Pharmaceutical Management (Comprehensive TA) indefinite delivery, indefinite quantity (IDIQ). Activities will begin to transition over immediately upon award. In order to not compromise the effectiveness of future awards, it is important to ensure current momentum is not lost and minimize any disruption of the TA areas covered by MTaPS that will transition to NextGen Comp TA. The NextGen Comprehensive TA IDIQ contracts were awarded on December 20, 2023 for use by Washington Bureaus and Operating Units and Missions, including task orders that will encompass implementation of this activity. The central task orders Request for Task Order

Proposal (RFTOPs) were released the week of August 11, 2024 and the TOs are currently anticipated to be awarded in December 2024. The proposed extension would allow for time required for transition and start up of the new TO(s). Any Comprehensive TA Task Order(s) will need to overlap with the MTAPs award for the necessary transition period to ensure seamless coverage, without which there would be an interruption in the Agency's provision of critical services.

One of the lessons learned from the previous transition of supply chain awards was that the period of overlap was insufficient, including transitioning over needed information and appropriate staff to the new award. The proposed extension would allow for proper overlap and start-up to smoothly transition to the new contract(s). A House Foreign Affairs Committee (HFAC) investigation into performance challenges early in the USAID Global Health Supply Chain

- Procurement and Supply Management (GHSC-PSM) project indicated that a longer overlap period would have helped manage the transition and recommended a sufficient period of overlap (potentially one year or longer) for future supply chain programs.1 The limited transition period between the previous pharmaceutical management award to MTaPS resulted in challenges that hampered maintaining pharmaceutical services support. It is imperative that the NextGen Comp TA contractor(s) have adequate time to assume responsibility for USAID’s pharmaceutical/supply chain support, AMR GHS, and other outbreak response support from the incumbent contractor.

A direct award to local contractors for the needed services was not considered to be feasible, given the planned transition to the NextGen TA award(s); the awards are designed to serve as the follow-on for the MTaPS scope of work, including all pharmaceutical systems strengthening, and other outbreak response, and AMR/IPC support for GHS services currently provided by MTaPS. Local contractors with the level of expertise required and capability to meet a USAID program of this magnitude are very limited and the time required to award contracts to local contractors in the 11 countries MTaPS supports would still lead to a gap in services.

6. Description of the efforts made to ensure that offers are solicited from as many potential sources as practicable, including whether a notice was publicized as required by Federal Acquisition Regulation (FAR) 5.2 [AIDAR 705.2].

The follow-on award(s) to this contract are in the process of being competed under the NextGen Comprehensive TA IDIQ. As a result, offers from other sources were not solicited.

Per AIDAR 705.202, justifications and approvals to restrict competition under the authority of AIDAR 706.302-70(b)(1)-(3) are exempt from pre-award synopsis posting.

1 Committee on Foreign Affairs U.S. House of Representatives. Oversight Investigation: USAID Global Health Supply Chain Contract. 2018 https://foreignaffairs.house.gov/wp-content/uploads/2018/10/Oversight-Investigation-USAID-Global-Health-Supply -Chain-Contract.pdf

7. A determination by the Contracting Officer that the anticipated cost to the Government will be fair and reasonable:

This action represents a continuation of work under the existing award under current award terms and rates that were considered reasonable at the time of the award via cost analysis, historical costs incurred, and Independent Government Cost Estimate (IGCE). All previously incurred costs were determined to be reasonable and the Contracting Officer has determined the costs covered by this J&A will be fair and reasonable.

8. Description of the market research conducted, and the results or a statement of the reasons market research was not conducted:

Market research was conducted prior to awarding the contract and again prior to the design and competition of the NextGen TA awards. Due to the scale and complexity of MTaPS, no other mechanisms and vendors were identified that could quickly mobilize these services at this magnitude for USAID. The MTaPS COR and Project Management Team did not identify other entities that are currently in a position to respond to the IPC, AMR, outbreak response, and key pharmaceutical systems strengthening needs as quickly and effectively as MTaPS. To date, USAID does not have another mechanism focused on these main services and new mechanism(s) that will have these capabilities are not yet available as the follow-on procurements are in progress.

9. Other facts supporting the use of other than full and open competition:

The process of continued support in these technical areas, unique quality of time needed to gain the confidence of host government counterparts and conversely the time needed for setting up the follow-on award for a smooth transition, as well as the use of seasoned AMR/IPC and pharmaceutical experts already engaged in the process would be severely compromised or halted as the ability to transition to new awardees is not yet available. Therefore, USAID’s best and most reasonable option is to pursue an extension of the current contract through September 2025 to allow time for the NextGen Comprehensive TA award(s) discussed above to be awarded and for activities to fully transition.

10. Sources, if any, that expressed an interest, in writing, in the acquisition:

None.

11. The actions the Agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the supplies or services required:

USAID is in the process of competing the NextGen technical assistance mechanism(s) using fair opportunity procedures in accordance with FAR 16.505.

12. Technical or requirement personnel certification:

In accordance with FAR 6.303-1(c), I hereby certify that the technical statements included above and which form a basis for the justification are complete and accurate.

cleared via email 10/01/2024 Alexis Leonard, Technical Office Representative Date

13. Contracting Officer Certification:

In accordance with FAR 6.303, I hereby certify that the justification is accurate and complete to the best of my knowledge and belief.

cleared via email ______________________________ 10/01/2024 Imran Mahmud, Contracting Officer Date