SOW_PDF.pdf

Statement of Work / Performance Work Statement

Title: Roche Diagnostics cobas® 4800 and cobas® 6800.

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 Roche cobas® 4800 and cobas® 6800 Systems from Roche Diagnostics are validated HIV molecular testing methods for method for HIV viral load and HIV early infant diagnosis (EID) testing in the

International Laboratory Branch viral load and Egarly infant diagnosis (EID) Unit Laboratory. These testing methodologies are the current validated testing Systems in use at the requesting laboratory for HIV viral load and early infant diagnosis testing. Bot the Roche cobas® 4800 and the Roche cobas® 6800 Systems are internationally approved for HIV in vitro diagnostics for HIV viral load testing using plasma and the cobas® plasma separation card (PSC), and for HIV EID testing using dried blood spots (DBS). These existing testing systems are in the viral load and EID unit laboratory at the International Laboratory Branch are fully validated, FDA approved and meet the requirements needed for conducting HIV viral load testing and HIV EID testing at the International Laboratory Branch as part of the program, agency, and mission of the Global HIV Program and The President’s Emergency Plan for AIDS Relief (PEPFAR).

The viral RNA copies of HIV quantitated when conducting HIV viral load testing informs 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. Early infant diagnosis testing is the definitive diagnostic test to determine if a baby or infant 18 months and younger of age is HIV positive. The importance of quality EID test results is paramount as the wrong diagnosis can lead to premature death or a lifetime of antiretroviral treatment and associated stigma that remains for those living with HIV.

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 where the HIV viral load and EID testing is conducted. These items are the same as those purchased over the past several years by the requesting laboratory and by international laboratories that the International Laboratory Branch supports across countries supported by the Global HIV Program and the Presidents Emergency Plan for AIDS Relief

(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 50 countries.

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

Early infant diagnosis (EID): EID is the definitive diagnostic test for HIV in an infant aged 18 months and younger.

SECTION 2 – PURPOSE/OBJECTIVE

The purpose of this project is for the contractor, Roche Diagnostics, 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 cobas 4800 and cobas 6800 instruments.

The requested reagents, consumables, and commodities required to operate the cobas® 6800 System and conduct HIV viral load and early infant diagnosis testing shall also be provided and delivered to the laboratory. All supplies received from Roche Diagnostics as the contractor must have a minimum of 12 months shelf life remaining upon receipt. The cobas® 4800 and cobas® 6800 Systems from Roche

Diagnostics are internationally recognized and approved reference methods for HIV viral load and early infant diagnosis (EID) testing. They are also the testing Systems that replaced the Roche COBAS

AmpliPrep/COBAS TaqMan which was sunset as of end of March 2024 by Roche Diagnostics globally. The

Roche cobas® 4800 and cobas® 6800 Systems are testing platforms currently in use at the International

Laboratory Branch and are required to maintain global testing standards for HIV viral load and early infant diagnosis testing.

The requested items from the contractor, Roche Diagnostics, 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 and EID 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 Presidents Emergency Plan for AIDS Relief

(PEPFAR) and are required to fulfil the program needs and mission of the International Laboratory Branch and PEPFAR.

The requested items are essential to generate high quality HIV viral load and EID testing results at the

International Laboratory Branch using the cobas® 4800 and the cobas® 6800 Systems. All requested supplies shall be delivered to the International Laboratory Branch, by the contractor, Roche Diagnostics, by the terms set forth in the awarded contract, usually within 30 days or by the 30 August 2027, whichever one comes first.

SECTION 3 – SCOPE OF WORK

Roche Diagnostics, as the contractor, shall provide all preventative maintenance, service, parts, labor, and repairs for the cobas® 4800 and cobas® 6800 Systems.

Roche Diagnostics shall provide all required technical service and support as requested on an as-needed basis. Roche diagnostics as the contractor shall provide both remote and on-site technical support as needed. The cobas® 4800 and the cobas® 6800 Systems 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.

Roche Diagnostics 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.

All service is to be provided by the contractor, Roche Diagnostics under the period of the awarded contract.

This contract with Roche Diagnostics is for a single year.

SECTION 4 – TASKS TO BE PERFORMED

All tasks shall be included in the award year. The cobas® 4800 and the cobas® 6800 Systems shall be provided by the contractor, Roche Diagnostics, for the duration of the contract.

Task 1: Maintain functionality of the cobas® 4800 System

1. Conduct routine and periodic preventative maintenance a. The contractor, Roche Diagnostics, shall provide service at the required intervals per the manufacturers’ guidelines.

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

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

2. Conduct service and repairs to the cobas® 4800 System a. The contractor, Roche Diagnostics, shall provide service and repairs if the cobas® 4800 System becomes inoperable or if errors occur.

b. The contractor, Roche Diagnostics, shall provide technical support, both remote, and on-site if the cobas®

4800 System becomes inoperable or if errors occur.

Task 2: Maintain functionality of the cobas® 6800 System

1. Conduct routine and periodic preventative maintenance a. The contractor, Roche Diagnostics, shall provide service at the required intervals per the manufacturers’ guidelines.

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

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

2. Conduct service and repairs to the cobas® 6800 System a. The contractor, Roche Diagnostics, shall provide service and repairs if the cobas® 6800 System becomes inoperable or if errors occur.

b. The contractor, Roche Diagnostics, shall provide technical support, both remote, and on-site if the cobas®

6800 System becomes inoperable or if errors occur.

Task 3: Reagent Test Kits, consumables, and assay reagents

1. cobas® 58/68/8800 HIV test kits a. The contractor, Roche Diagnostics, shall provide the reagents for HIV viral load testing on the cobas® 6800 System with a minimum of 12-month shelf life remaining at time of receipt.

2. cobas® 58/68/8800 HIV-1/HIV-2 QUAL test kits a. The contractor, Roche Diagnostics, shall provide the reagents for HIV EID qualitative testing on the cobas® 6800 System with a minimum of 12-month shelf life remaining at time of receipt.

3. Consumables and ancillary reagents and supplies a. The contractor, Roche Diagnostics, shall provide the consumables and additional reagents required to operate the cobas® 6800 System and perform quantitative

HIV viral load and EID qualitative testing on the cobas® 6800 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 required to operate the cobas® 6800 System, and the computer workstation required to operate the cobas® 4800 System contain proprietary software and shall be provided by the contractor, Roche

Diagnostics.

SECTION 6 – PLACE OF PERFORMANCE AND CONTRACT SUPPORT HOURS

SUBSECTION A – PLACE OF PERFORMANCE

The contractor, Roche Diagnostics, shall provide remote technical support, as required. Roche Diagnostics, as the contractor shall provide on-site service, preventative maintenance per manufacturer requirements and accreditation standards, repairs, supply any required spare parts, for the cobas® 4800 and cobas® 6800

Systems. All on-site activities shall be performed at the CDC Roybal Campus, Atlanta, GA, USA. The cobas® 4800 and cobas® 6800 System instruments, required operating materials including the PC to run the system and all testing supplies, including but not limited to consumables, and reagents, shall be delivered to building 15, laboratory room 3101, 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, Roche Diagnostics.

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, Roche Diagnostics. Adequate time for the maintenance and servicing of the cobas® 4800 and the cobas® 6800 Systems shall be provided by

Roche Diagnostics as the awarded contractor.

SECTION 7 – TRAVEL

Any travel costs shall be incurred and covered by the contractor, Roche Diagnostics. No CDC staff members shall be required to travel.

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

All deliverables shall be due in full by the end of the award year. The cobas® 4800 and the cobas® 6800

Systems shall be provided by the contractor, Roche Diagnostics, for the duration of the contract.

• Task: Maintain functionality of the cobas® 4800 System o Conduct routine and periodic preventative maintenance a. The contractor, Roche

Diagnostics, shall provide service at the required intervals per the manufacturers’ guidelines.

▪ Format: The contractor, Roche Diagnostics, shall provide service at the required intervals per the manufacturers’ guidelines, minimum of annual preventative maintenance service. Roche shall provide a qualified service engineer to complete required preventative and scheduled maintenance per the manufacturers’ guidelines. All parts shall be covered under this award.

▪ Due date: Annual preventative maintenance service due within 12 months of last annual service and by the end of the award date. Semi-annual service to be provided per manufacturers guidelines.

▪ Deliver to: Katrina Sleeman (hhk6@cdc.gov) and Clement Zeh (cbz2@cdc.gov)

• Task: Conduct service and repairs to the cobas® 4800 System o Conduct service repairs, virtual technical support to maintain testing workflow on the cobas® 4800 System.

▪ Format: shall provide service and repairs if the cobas® 4800 System becomes inoperable or if errors occur. Roche Diagnostics, shall provide technical support, both remote, and on-site if the cobas® 4800 System becomes inoperable or if errors occur.

▪ Due date: Initial technical support within 5 business days of reporting issue.

▪ Deliver to: Katrina Sleeman (hhk6@cdc.gov) and Clement Zeh (cbz2@cdc.gov)

• Task: Maintain functionality of the cobas® 6800 System o Conduct routine and periodic preventative maintenance a. The contractor, Roche

Diagnostics, shall provide service at the required intervals per the manufacturers’ guidelines.

▪ Format: The contractor, Roche Diagnostics, shall provide service at the required intervals per the manufacturers’ guidelines, minimum of annual preventative maintenance service. Roche shall provide a qualified service engineer to complete required preventative and scheduled maintenance per the manufacturers’ guidelines. All parts shall be covered under this award.

▪ Due date: Annual preventative maintenance service due within 12 months of last annual service and by the end of the award date. Semi-annual service to be provided per manufacturers guidelines.

▪ Deliver to: Katrina Sleeman (hhk6@cdc.gov) and Clement Zeh (cbz2@cdc.gov)

• Task: Conduct service and repairs to the cobas® 6800 System o Continuous functionality of the cobas® 6800 System

▪ Format: shall provide service and repairs if the cobas® 6800 System becomes inoperable or if errors occur. Roche Diagnostics, shall provide technical support, both remote, and on-site if the cobas® 6800 System becomes inoperable or if errors occur.

▪ Due date: Initial technical support within 5 business days of reporting issue.

▪ Deliver to: Katrina Sleeman (hhk6@cdc.gov) and Clement Zeh (cbz2@cdc.gov)

• Task: Reagent Test Kits, consumables, and assay reagents https://easi.cdc.gov/Modules mailto:hhk6@cdc.gov mailto:cbz2@cdc.gov mailto:hhk6@cdc.gov mailto:cbz2@cdc.gov mailto:hhk6@cdc.gov mailto:cbz2@cdc.gov mailto:hhk6@cdc.gov mailto:cbz2@cdc.gov o Maintaining testing reagent kit supply for HIV molecular testing on the cobas® 6800

System

▪ Format: The contractor, Roche Diagnostics, shall provide the reagents for HIV viral load testing on the cobas® 6800 System with a minimum of 12-month shelf life remaining at time of receipt. cobas® 58/68/8800 HIV-1/HIV-2 QUAL test kits.

The contractor, Roche Diagnostics, shall provide the reagents for HIV EID qualitative testing on the cobas® 6800 System with a minimum of 12-month shelf life remaining at time of receipt.

▪ Due date: To be delivered in full by the end of the award period.

▪ Deliver to: Katrina Sleeman (hhk6@cdc.gov) and Clement Zeh (cbz2@cdc.gov)

• Task: Consumables and ancillary reagents and supplies o Maintaining testing consumables supply for correct operation of the c6800 System

▪ Format: The contractor, Roche Diagnostics, shall provide the consumables and additional reagents required to operate the cobas® 6800 System and perform quantitative HIV viral load and EID qualitative testing on the cobas® 6800 System with a minimum of 12-month shelf life remaining at time of receipt..

▪ Due date: To be delivered in full by the end of the award period.

▪ Deliver to: Katrina Sleeman (hhk6@cdc.gov) and Clement Zeh (cbz2@cdc.gov)

SUBSECTION A – PERFORMANCE MATRIX

PERFORMANCE

OBJECTIVE

STANDARD PERFORMANCE

THRESHOLD

ACCEPTABLE

QUALITY LEVELS

(AQLs)

METHOD OF

SURVEILLANCE

Task No. 1 - Maintain functionality of the cobas®

4800 System

Receipt of technical support and service by qualified Roche engineers.

Provision of service reports and documentation

Zero Deviation from

Standard.

100% inspection

Task No. 2 - Conduct service and repairs to the cobas® 4800 System

Conduct service repairs, virtual technical support to maintain testing workflow on the cobas® 4800

System by qualified Roche engineers. Provision of service reports and documentation.

Zero Deviation from

Standard.

100% inspection

Task No. 3 - Maintain functionality of the cobas®

6800 System

Receipt of technical support and service by qualified Roche engineers.

Provision of service reports and documentation

Zero Deviation from

Standard.

100% inspection

Task No. 4 - Conduct service and repairs to the cobas® 6800 System

Conduct service repairs, virtual technical support to maintain testing workflow on the cobas® 6800

System by qualified Roche engineers. Provision of service reports and

Zero Deviation from

Standard.

100% inspection mailto:hhk6@cdc.gov mailto:cbz2@cdc.gov mailto:hhk6@cdc.gov mailto:cbz2@cdc.gov

PERFORMANCE

OBJECTIVE

STANDARD PERFORMANCE

THRESHOLD

ACCEPTABLE

QUALITY LEVELS

(AQLs)

METHOD OF

SURVEILLANCE

documentation.

SECTION 9 – REFERENCE MATERIALS

N/A.

SECTION 10 – MINIMUM VENDOR QUALIFICATIONS

No other vendors can be considered since Roche Diagnostics is the manufacturer of the cobas® 4800 and the cobas® 6800 Systems. The cobas® 4800 and the cobas® 6800 Systems are the newer models for HIV viral load and EID testing from Roche Diagnostics and replace the sunset Roche COBAS AmpliPrep/COBAS

TaqMan System which was in use in the viral load and EID Unit reference laboratory within the International

Laboratory Branch until September 2024. 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 one of the current internationally recognized pre-qualification reference test methods for viral load and EID testing which are conducted using the cobas® 6800 System.

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 ISO17043 accredited HIV viral load and early infant diagnosis proficiency testing program provided to more than 200

Global HIV Program and PEPFAR supported laboratories globally, the future planning of program funding including HIV treatment guidelines in Global HIV Program and PEPFAR-supported countries and therefore needs to be kept to the same standards.

SECTION 11 – ADDITIONAL REQUIREMENTS

N/A

Information Security and Privacy

Information Security and Privacy clearance has been attached to this procurement.

Human Subjects Protections in Research

N/A

Paperwork Reduction Act (PRA)

N/A

Section 508 Compliance

Part A

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.

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 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.

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.section508.gov/ http://508.hhs.gov/

(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 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.

https://www.hhs.gov/web/section-508/index.html 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.section508.gov/

Part B

(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

402 Closed Functionality

403 Biometrics

404 Preservation of Information Provided for Accessibility

405 Privacy

406 Standard Connections

407 Operable Parts

408 Display Screens

409 Status Indicators

410 Color Coding

411 Audible Signals

502 Inoperability with Assistive Technology

503 Applications

504 Authoring Tools

602 Support Documentation

603 Support Services https://www.access-board.gov/ict/

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-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.

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 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.itic.org/policy/accessibility/vpat https://www.access-board.gov/ict/

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-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 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/accessibility-checklists/index.html https://www.itic.org/policy/accessibility/vpat