Statement of Work / Performance Work Statement

000HCWBB-2026-97958

Title: Abbott Molecular m2000 Viral Load Supplies

The period of performance of this contract consists of a single year, beginning 08/31/2026.

Period of performance of this contract is: 08/31/2026 to 08/30/2027.

SECTION 1 – BACKGROUND

The Abbott m2000 System from Abbott Molecular is the back-up reference method for HIV viral load testing in the International Laboratory Branch viral load and Early Infant Diagnosis (EID) Unit Laboratory. It is one of the current validated and accredited testing Systems under ISO 15189 and ISO 17025 in use at the requesting laboratory for HIV viral load. The Abbott m2000 System is internationally approved for HIV in vitro diagnostics for HIV viral load testing. This existing testing system located in the viral load and EID unit laboratory at the International Laboratory Branch is fully validated, FDA approved and meets the requirements needed for conducting HIV viral load testing at the International Laboratory Branch as part of of the Agency’s role in global HIV programs (i.e.,The President’s Emergency Plan for AIDS Relief

(PEPFAR)).

The viral RNA copies of HIV quantitated when conducting HIV viral load testing inform health care providers if a client’s prescribed antiretroviral therapy is working, if the client has a suppressed viral load, and if that client remains infectious and able to spread HIV to their partner and others. This test result impacts patient treatment decisions. The importance of quality HIV viral load test results is paramount as the wrong result can lead to unnecessary switch to an alternate treatment regimen, increased likelihood of developing HIV drug resistance, and potential HIV transmission from clients that may have received falsely suppressed results.

The requested items are required to continue performing quality laboratory testing services in accordance with the international accreditation requirements of International Organization for Standardization (ISO) which has accredited the International Laboratory Branch under ISO 15189 and ISO 17025 where the HIV viral load testing is conducted. These items are the same as those purchased over the past 10 years by the requesting laboratory and by international laboratories that the International Laboratory Branch supports across countries supported by the global HIV program (PEPFAR) and are required to maintain testing quality globally.

SUBSECTION A – DEFINITIONS

PEPFAR: The Presidents Emergency Plan for AIDS Relief is the United States governmental initiative to address the global HIV/AIDS epidemic and help save the lives of those suffering from the disease. PEPFAR was launched in 2003 by U.S. President George W. Bush. Through PEPFAR, the U.S. government has invested over $100 billion in the global HIV/AIDS response, the largest commitment by any nation to address a single disease in history, saving more than 25 million lives, preventing millions of HIV infections, and accelerating progress toward controlling the global HIV/AIDS pandemic in more than 55 countries.

Viral load: viral load is the measurement of the amount of HIV in a person’s blood.

SECTION 2 – PURPOSE/OBJECTIVE

The purpose of this project is for the contractor, Abbott Molecular Inc., to provide to the viral load and early infant diagnosis unit of the International Laboratory Branch, Division of Global HIV & TB, Global Health Center, CDC, all required service, maintenance, parts, repairs of the existing m20000 instrument and the requested reagents, consumables, and commodities required to operate the m2000 System and conduct HIV viral load testing shall also be provided and delivered to the laboratory. All supplies received from Abbott Molecular Inc. as the contractor must have a minimum of 12 months shelf life remaining upon receipt. The Abbott m2000 is a testing platform currently in use at the International Laboratory Branch and is required to maintain global testing standards for HIV viral load testing.

The requested items from the contractor, Abbott Molecular Inc., are required to conduct laboratory testing services in accordance with the accreditation requirements of International Organization for Standardization (ISO) which has accredited the International Laboratory Branch where the HIV viral load testing is conducted.

These items are the same as those purchased by the international laboratories that the International Laboratory Branch supports across countries supported by the global HIV program (PEPFAR and are required to fulfil the program needs and mission of the International Laboratory Branch and CDC’s global HIV program/PEPFAR.

The requested items are essential to generate high quality HIV viral load testing results at the International Laboratory Branch. The m2000 reagents and supplies shall be delivered to the International Laboratory Branch, by the contractor, Abbott Molecular Inc., by the terms set forth in the awarded contract, usually within 30 days or by the end of September 2027, whichever one comes first.

SECTION 3 – SCOPE OF WORK

Abbott Molecular Inc., as the contractor, shall provide all preventative maintenance, service, parts, labor, and repairs for the Abbott m2000 System.

Abbott Molecular Inc. shall provide all required technical service and support as requested on an as-needed basis. Abbott Molecular Inc. as the contractor shall provide both remote and on-site technical support as needed.

The existing m2000 System shall continue to be provided with all supplies required to operate the System including, but not limited to, functional uninterrupted power supply (UPS), laptop, and other ancillary supplies.

Abbott Molecular Inc. shall provide requested supplies within 30 days of the contract being awarded. All received supplies must have a minimum of 12 months shelf life remaining upon receipt by the International Laboratory Branch to minimize supply wastage and maximize cost efficiencies.

The contractor, Abbott Molecular Inc., has included in the cost of the reagents and consumables required to operate the m2000 system the continued provision of the m2000 System for the duration of the awarded contract. All preventative maintenance, service, parts, labor, and repairs for the m2000 System are covered by the contract. All service is to be provided by the contractor, Abbott Molecular Inc. under the period of the awarded contract.

This contract with Abbott Molecular Inc. is for a single year. All pricing and service to be provided under this contract is fixed.

SECTION 4 – TASKS TO BE PERFORMED

Task 1: Maintain functionality of the m2000 System

1. Conduct routine and periodic preventative maintenance

a. The contractor, Abbott Molecular Inc., shall provide service at the required intervals per the manufacturers’ guidelines.

b. The contractor, Abbott Molecular inc., shall provide all required parts to complete required preventative and scheduled maintenance per the manufacturers’ guidelines.

c. The contractor, Abbott Molecular Inc., shall provide a qualified service engineer to complete required preventative and scheduled maintenance per the manufacturers’ guidelines.

2. Conduct service and repairs to the m2000 System

a. The contractor, Abbott Molecular Inc., shall provide service and repairs if the m2000

System becomes inoperable or if errors occur.

b. The contractor, Abbott Molecular Inc., shall provide technical support, both remote, and on-site if the m2000 System becomes inoperable or if errors occur.

Task 2: Reagent Test Kits, consumables, and assay reagents

1. m2000 HIV quantitative viral load test kits

a. The contractor, Abbott Molecular Inc., shall provide the reagents for HIV viral load testing on the m2000 System with a minimum of 12-month shelf life remaining at time of receipt.

2. Consumables and ancillary reagents and supplies

a. The contractor, Abbott Molecular Inc., shall provide the consumables and additional reagents required to operate the m2000 System and perform quantitative HIV viral load testing on the m2000 System with a minimum of 12-month shelf life remaining at time of receipt.

SECTION 5 – GOVERNMENT FURNISHED PROPERTY

No government furnished property (GFP) is required to conduct the work outlined in this contract. The PC laptop and uninterruptable power supply (UPS) required to operate the m2000 System contains proprietary software and shall continue to be provided by the contractor, Abbott Molecular Inc.

SECTION 6 – PLACE OF PERFORMANCE AND CONTRACT SUPPORT HOURS

SUBSECTION A – PLACE OF PERFORMANCE

The contractor, Abbott Molecular Inc., shall provide remote technical support, as required. Abbott Molecular Inc., as the contractor shall provide on-site service, preventative maintenance per manufacturer requirements and accreditation standards, training, repairs, supply any required spare parts, for the existing m2000 System at the International Laboratory Branch. All on-site activities shall be performed at the CDC Roybal Campus, Atlanta, GA, USA. All supplies shall be delivered by the contractor, Abbott Molecular Inc., to building 15, Laboratory room 3101-E, 3rd floor of the CDC Roybal Campus. All associated costs for transport, travel and service engineers, shipping and handling are to be covered by the contractor, Abbott Molecular Inc.

SUBSECTION B – CONTRACT SUPPORT HOURS

All time required to provide technical support, to complete maintenance and conduct service and repairs per the manufacturers’ recommendations shall be provided by the contractor, Abbott Molecular Inc.

SECTION 7 – TRAVEL

No anticipated travel required.

Travel will be in accordance with / and not to exceed the Federal Travel Regulation rates. Travel costs need to be approved in advance by the COR. The contractor shall be required to provide their travel policy to the Government for review.

Travel does not include conferences. Conference Approval Management Systems (CAMS) approval is required in advance of any travel for conferences. If the need for conference travel occurs, the contract will be modified to separately add funding.

SECTION 8 – DELIVERABLES/REPORTING SCHEDULE

Abbott m2000 System testing consumables, and HIV reagents must be delivered with a minimum of 12 months shelf life remaining upon receipt.

Task Deliverable Quantity/Format Due Date Deliver To Service and repairs

Maintain functionality of the m2000 System

Contractor shall provide service, repair, parts, and labor at the required intervals per the manufacturers’ guidelines.

For duration of awarded contract

Katrina Sleeman International Laboratory Branch CDC Roybal Campus hhk6@cdc.gov 404 639 1886

Reagent Test Kits, consumables, and assay reagents

Availability of materials required to conduct viral load testing on the m2000 System

The contractor, Abbott Molecular, shall provide all requested reagents, supplies and consumables for HIV viral load on the m2000 System with a minimum of 12-month shelf life remaining at time of receipt.

Within 30 days of contract award

Katrina Sleeman International Laboratory Branch CDC Roybal Campus hhk6@cdc.gov 404 639 1886 https://easi.cdc.gov/Modules mailto:hhk6@cdc.gov mailto:hhk6@cdc.gov

SECTION 9 – REFERENCE MATERIALS

N/A.

SECTION 10 – MINIMUM VENDOR QUALIFICATIONS

No other vendors can be considered since Abbott Molecular Inc. is the manufacturer of the m2000 System. The m2000 system is currently validated and in use for HIV viral load testing in the viral load and EID Unit reference laboratory within the International Laboratory Branch. No other vendors were considered since the program needs and the nature of the work conducted by the viral load and EID Unit reference laboratory within the International Laboratory Branch requires the use of the m2000 System.

The use of the m2000 System at the International Laboratory Branch in Atlanta, GA, is required to maintain quality of test results, accreditation standards and to comply with the international test methodology for viral load testing. The data provided from the HIV viral load and EID testing conducted at the viral load and EID Unit reference laboratory within the International Laboratory Branch projects are important for the evaluation and approval by international regulatory bodies of new HIV molecular testing technologies, the integrity of the ISO 17043 accredited HIV viral load and early infant diagnosis proficiency testing program provided to more than 260 PEPFAR supported laboratories globally across 33 countries, the future planning of program funding including HIV treatment guidelines in PEPFAR-supported countries and therefore needs to be kept to the same standards.

SECTION 11 – ADDITIONAL REQUIREMENTS

Information Security and Privacy New Abbott contract for m2000, 000HCWBB-2026-97958

Human Subjects Protections in Research N/A

Paperwork Reduction Act (PRA) New Abbott contract for m2000, 000HCWBB-2026-97958

Section 508 Compliance Section 508 and Accessibility Requirements Part A – Provision Reference HHSAR 352.239-73[8] Electronic Information and [Communication] Technology Accessibility Notice.

[(Deviation)] [(a) Any offeror responding to this solicitation must comply with established HHS Information and Communication Technology (ICT) accessibility standards. Information about Section 508 is available at https://www.hhs.gov/web/section-508/index.html.

(b) The Section 508 accessibility standards applicable to this solicitation are stated in the clause at 352.239-79 Information and Communication Technology Accessibility. In order to facilitate the Government's determination whether proposed ICT supplies, products, platforms, information, and documentation meet applicable Section 508 accessibility standards, offerors must submit an appropriate HHS Section 508 Accessibility Conformance Checklist (see https://www.hhs.gov/web/section-508/accessibility-checklists/index.html) or an Accessibility Conformance Report (ACR) (based on the Voluntary Product Accessibility Template (VPAT) see https://www.itic.org/policy/accessibility/vpat), in accordance with the completion instructions.

The purpose of the checklists and conformance reports are to assist HHS acquisition and program officials in determining whether proposed ICT supplies, products, platforms, information, and documentation conform to applicable Section 508 accessibility standards. Checklists and ACRs evaluate—in detail—whether the ICT conforms to specific Section 508 accessibility standards and identifies remediation efforts needed to address conformance issues.

https://www.hhs.gov/web/section-508/index.html https://www.hhs.gov/web/section-508/accessibility-checklists/index.html https://www.itic.org/policy/accessibility/vpat

(c) If an offeror claims its supplies or services meet applicable Section 508 accessibility standards, and it is later determined by the Government, i.e., after award of a contract or order, that supplies, products, platforms, information, documentation, or services support delivered do not conform to the described accessibility standards, remediation of the supplies, products, platforms, information, documentation, or services support to the level of conformance specified in the contract will be the responsibility of the Contractor at its expense.

(d) In order to facilitate the Government's determination whether proposed ICT supplies meet applicable Section 508 accessibility standards, offerors must submit an Accessibility Conformance Report, in accordance with its completion instructions and tailored to the requirements in the solicitation. The purpose of the Report is to assist HHS acquisition and program officials in determining whether proposed ICT supplies conform to applicable Section 508 accessibility standards. The template allows offerors or developers to self-evaluate their supplies and document, in detail, whether they conform to a specific Section 508 accessibility standard, and any underway remediation efforts addressing conformance issues. Instructions for preparing the Template are available at https://www.section508.gov/.

(e) Additionally, offerors must provide enough information to assist the Government in determining that the ICT services conform to Section 508 accessibility standards, including any underway remediation efforts addressing conformance issues.

(f) Respondents to this solicitation must identify any inability to conform to Section 508 requirements. If an offeror claims its supplies or services meet applicable Section 508 accessibility standards, and it is later determined by the Government, i.e., after award of a contract or order, that supplies or services delivered do not conform to the described accessibility standards, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its expense.

(g) Items delivered as electronic content must be accessible to HHS acceptance criteria. Checklist for various formats are available at http://508.hhs.gov/. Materials, other than items incidental to contract management, that are final items for delivery should be accompanied by the appropriate checklist, except upon approval of the Contracting Officer or Contracting Officer's Representative.

(End of provision)]

Part B - Clause 352.239-74[9] Electronic, Information, and Communication Technology Accessibility.

[(Deviation)]

(a) Pursuant to Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998, all information and communication technology (ICT) supplies, products, platforms, information, documentation, and services, or support developed, acquired, maintained or delivered under this contract or order must comply with the Revised 508 Standards, which are located at 36 C.F.R. 1194.1 and Appendices A, B, and C, and are available at https://www.access-board.gov/ict/. Information about Section 508 is available at https://www.hhs.gov/web/section-508/index.html.

(b) Additional Section 508 accessibility standards applicable to this contract or order are identified as follows:

205 WCAG 2.0 Level A & AA Success Criteria 302 Functional Performance Criteria 502 Inoperability with Assistive Technology 504 Authoring Tools 602 Support Documentation 603 Support Services If it is determined by the Government that ICT supplies, products, platforms, information, documentation, and services support provided by the Contractor do not conform to the described accessibility standards in the contract, remediation of the supplies, products, platforms, information, documentation, or services support to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense.

https://www.section508.gov/ http://508.hhs.gov/ https://www.access-board.gov/ict/ https://www.hhs.gov/web/section-508/index.html

(c) In the event of a modification(s) to this contract or order, which adds new ICT supplies or services or revises the type of, or specifications for, supplies, products, platforms, information, documentation, or services support, the Contracting Officer shall require that the Contractor submit a completed HHS Section 508 Accessibility Conformance Checklist (see https://www.hhs.gov/web/section-508/accessibility-checklists/index.html) or an Accessibility Conformance Report (ACR) (based on the Voluntary Product Accessibility Template (VPAT) see https://www.itic.org/policy/accessibility/vpat), and any other additional information necessary to assist the Government in determining that the ICT supplies or services conform to Section 508 accessibility standards. If it is determined by the Government that ICT supplies, products, platforms, information, documentation, and services support provided by the Contractor do not conform to the described accessibility standards in the contract, remediation of the supplies, products, platforms, information, documentation, or services support to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense.

(d) If this is an Indefinite-Delivery type contract, a Blanket Purchase Agreement or a Basic Ordering Agreement, the task/delivery order requests that include ICT supplies, products, platforms, information, documentation, or services support will define the specifications and accessibility standards for the order. In those cases, the Contractor shall be required to provide a completed HHS Section 508 Accessibility Conformance Checklist (see https://www.hhs.gov/web/section- 508/accessibility-checklists/index.html) or an ACR (based on the VPAT see https://www.itic.org/policy/accessibility/vpat), and any other additional information necessary to assist the Government in determining that the ICT supplies, products, platforms, information, documentation, or services support conform to Section 508 accessibility standards. If it is determined by the Government that ICT supplies and services provided by the Contractor do not conform to the described accessibility standards in the provided documentation, remediation of the supplies, products, platforms, information, documentation, or services support to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense.

(e) The contractor shall identify to the Contracting Officer any perceived exception or exemption to Section 508 requirements for review by the agency Section 508 Program.

Part A – Provision

Reference HHSAR 352.239-73[8] Electronic Information and [Communication] Technology Accessibility Notice.

(Deviation)

(a) Any offeror responding to this solicitation must comply with established HHS Information and Communication Technology (ICT) accessibility standards. Information about Section 508 is available at https://www.hhs.gov/web/section-508/index.html.

(b) The Section 508 accessibility standards applicable to this solicitation are stated in the clause at 352.239- 79 Information and Communication Technology Accessibility. In order to facilitate the Government’s determination whether proposed ICT supplies, products, platforms, information, and documentation meet applicable Section 508 accessibility standards, offerors must submit an appropriate HHS Section 508 Accessibility Conformance Checklist (see https://www.hhs.gov/web/section-508/accessibility-checklists/index.html) or an Accessibility Conformance Report (ACR) (based on the Voluntary Product Accessibility Template (VPAT) see https://www.itic.org/policy/accessibility/vpat), in accordance with the completion instructions. The purpose of the checklists and conformance reports are to assist HHS acquisition and program officials in determining whether proposed ICT supplies, products, platforms, information, and documentation conform to applicable Section 508 accessibility standards. Checklists and ACRs evaluate—in detail—whether the ICT conforms to specific Section 508 accessibility standards and identifies remediation efforts needed to address conformance issues.

(c) If an offeror claims its supplies or services meet applicable Section 508 accessibility standards, and it is later determined by the Government, i.e., after award of a contract or order, that supplies, products, platforms, information, documentation, or services support delivered do not conform to the described https://www.hhs.gov/web/section-508/accessibility-checklists/index.html https://www.itic.org/policy/accessibility/vpat https://www.hhs.gov/web/section-508/accessibility-checklists/index.html https://www.hhs.gov/web/section-508/accessibility-checklists/index.html https://www.itic.org/policy/accessibility/vpat https://www.hhs.gov/web/section-508/index.html https://www.hhs.gov/web/section-508/accessibility-checklists/index.html accessibility standards, remediation of the supplies, products, platforms, information, documentation, or services support to the level of conformance specified in the contract will be the responsibility of the Contractor at its expense.

(d) In order to facilitate the Government's determination whether proposed ICT supplies meet applicable Section 508 accessibility standards, offerors must submit an Accessibility Conformance Report, in accordance with its completion instructions and tailored to the requirements in the solicitation. The purpose of the Report is to assist HHS acquisition and program officials in determining whether proposed ICT supplies conform to applicable Section 508 accessibility standards. The template allows offerors or developers to self-evaluate their supplies and document, in detail, whether they conform to a specific Section 508 accessibility standard, and any underway remediation efforts addressing conformance issues.

Instructions for preparing the Template are available at https://www.section508.gov/.

(e) Additionally, offerors must provide enough information to assist the Government in determining that the ICT services conform to Section 508 accessibility standards, including any underway remediation efforts addressing conformance issues.

(f) Respondents to this solicitation must identify any inability to conform to Section 508 requirements. If an offeror claims its supplies or services meet applicable Section 508 accessibility standards, and it is later determined by the Government, i.e., after award of a contract or order, that supplies or services delivered do not conform to the described accessibility standards, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its expense.

(g) Items delivered as electronic content must be accessible to HHS acceptance criteria. Checklist for various formats are available at http://508.hhs.gov/. Materials, other than items incidental to contract management, that are final items for delivery should be accompanied by the appropriate checklist, except upon approval of the Contracting Officer or Contracting Officer’s Representative.

Part B - Clause

HHSAR 352.239-74[9] Electronic, Information, and Communication Technology Accessibility.

(Deviation)

(a) Pursuant to Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998, all information and communication technology (ICT) supplies, products, platforms, information, documentation, and services, or support developed, acquired, maintained or delivered under this contract or order must comply with the Revised 508 Standards, which are located at 36 C.F.R. 1194.1 and Appendices A, B, and C, and are available at https://www.access-board.gov/ict/.

Information about Section 508 is available at https://www.hhs.gov/web/section-508/index.html.

(b) Additional Section 508 accessibility standards applicable to this contract or order are identified as follows:

205 WCAG 2.0 Level A & AA Success Criteria 302 Functional Performance Criteria 502 Inoperability with Assistive Technology 503 Applications 504 Authoring Tools 602 Support Documentation 603 Support Services

If it is determined by the Government that ICT supplies, products, platforms, information, documentation, and services support provided by the Contractor do not conform to the described accessibility standards in the contract, remediation of the supplies, products, platforms, information, documentation, or services support to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense.

(c) In the event of a modification(s) to this contract or order, which adds new ICT supplies or services or revises the type of, or specifications for, supplies, products, platforms, information, documentation, or services support, the Contracting Officer shall require that the Contractor submit a completed HHS Section 508 Accessibility Conformance Checklist (see https://www.hhs.gov/web/section-508/accessibility-https://www.section508.gov/ https://www.access-board.gov/ict/ https://www.hhs.gov/web/section-508/index.html checklists/index.html) or an Accessibility Conformance Report (ACR) (based on the Voluntary Product Accessibility Template (VPAT) see https://www.itic.org/policy/accessibility/vpat), and any other additional information necessary to assist the Government in determining that the ICT supplies or services conform to Section 508 accessibility standards. If it is determined by the Government that ICT supplies, products, platforms, information, documentation, and services support provided by the Contractor do not conform to the described accessibility standards in the contract, remediation of the supplies, products, platforms, information, documentation, or services support to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense.

(d) If this is an Indefinite-Delivery type contract, a Blanket Purchase Agreement or a Basic Ordering Agreement, the task/delivery order requests that include ICT supplies, products, platforms, information, documentation, or services support will define the specifications and accessibility standards for the order.

In those cases, the Contractor shall be required to provide a completed HHS Section 508 Accessibility Conformance Checklist (see https://www.hhs.gov/web/section-508/accessibility-checklists/index.html) or an ACR (based on the VPAT see https://www.itic.org/policy/accessibility/vpat), and any other additional information necessary to assist the Government in determining that the ICT supplies, products, platforms, information, documentation, or services support conform to Section 508 accessibility standards. If it is determined by the Government that ICT supplies and services provided by the Contractor do not conform to the described accessibility standards in the provided documentation, remediation of the supplies, products, platforms, information, documentation, or services support to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense.

(e) The contractor shall identify to the Contracting Officer any perceived exception or exemption to Section 508 requirements for review by the agency Section 508 Program.

Printing N/A

[ENTER TITLE OF OTHER CLEARANCE REQUIRED]

N/A

OTHER CONSIDERATIONS AND ADDITIONAL INFORMATION FOR OFFICE

OF ACQUISITION SERVICES