A19 75D301-24-q-78358 Attachment 1 - SOW.pdf

Statement of Work (SOW) for the Acquisi�on of a Second Interface Tes�ng System (ITS)

Title: Acquisi�on of a Second Interface Tes�ng System for Interlaboratory Tes�ng and Valida�on

SECTION 1 – BACKGROUND

Healthcare personnel (HCP) wear personal protec�ve equipment (PPE) to protect themselves against contamina�on from poten�ally infec�ous blood and body fluids. This protec�ve barrier may be breached during healthcare tasks and HCP’s interac�ons with pa�ents. Although significant improvements have been made in materials and manufacturing techniques, litle aten�on has been paid to the interfaces between different garments and the interoperability of PPE components.

Among the various PPE elements such as gowns, gloves, respirators, hoods, and boot covers, gowns and gloves are iden�fied as the most frequently used in healthcare se�ngs. Despite the high level of protec�on, they are designed to offer, HCP can experience blood or body fluid exposure due to breaches at the interface between the protec�ve clothing (e.g., gown, coverall) and gloves. This interface has been recognized as one of the weakest points of the protec�ve ensemble, yet no standard test method exists to quan�fy fluid leakage through this interface while simula�ng the movements of HCP’s upper extremi�es and typical healthcare body fluid exposures.

The exis�ng test method, ASTM F1359, which was mostly developed for chemical protec�ve clothing, involves using a sta�onary manikin subjected to gallons of shower-sprayed fluids. This method fails to mimic the ar�cula�ons of arms and hands typical of healthcare se�ngs and thus won’t be appropriate to assess the integrity of healthcare PPE at cri�cal interfaces. As a result, there is a pressing need for a new test method that evaluates these interfaces to determine the level of protec�on provided by healthcare PPE against body fluid exposures.

The World Health Organiza�on (WHO) has also iden�fied the juncture areas where two PPE elements meet, especially the glove-protec�ve clothing interface, as an area of concern due to the risk of exposure (WHO, 2018). While some manufacturers have begun marke�ng products with design features aimed at elimina�ng leakage at this interface, such as gowns with thumb loops designed to secure the sleeve within the glove, there remains no test method available to assess the magnitude of performance improvement these features offer. Exis�ng standards also fail to provide guidance on the level of protec�on that should be provided at the interface region between the gloves and the protec�ve clothing.

In the absence of effec�ve, standardized solu�ons, end users o�en employ makeshi� methods such as using adhesive tapes or rubber bands to reduce or eliminate exposure to poten�ally harmful blood or body fluids through the glove and protec�ve clothing interface. However, these solu�ons are not only temporary but may also introduce other types of risks, par�cularly during the doffing process, where improper removal of PPE can lead to contamina�on.

Our project team recently developed a new tes�ng methodology to evaluate the leakage through the glove-protec�ve clothing interface using a sophis�cated, but prac�cal upper-extremity prosthesis, responding to the urgent need for an interface leakage test method for healthcare PPE. The modular prosthe�c limb, developed by Johns Hopkins University (JHU) to improve upper-extremity prosthe�cs, effec�vely simulates the arm movements of HCP and was incorporated into a test system designed by NIOSH to simulate fluid exposures. Recent publica�ons from NIOSH (Kilinc-Balci et al. 2018, Kahveci et al.

2019) demonstrated that this system could precisely measure the fluid leakage through the glove-protec�ve clothing interface. The method has been used to quan�fy and compare the fluid leakage among four surgical glove models, two examina�on glove models, ten gown models, and five coverall models.

Furthermore, the system can evaluate the barrier performance improvements with temporary solu�ons developed by end-users, such as taping over the interface and double gloving. Over 900 experiments have thus far shown that the system can significantly iden�fy product performance differences.

The tes�ng methodology developed by NIOSH and u�lizing a loaned robo�c arm, validated the feasibility and effec�veness of the approach. Building on this success, we contracted a company to develop a complete automated interface tes�ng system (ITS). This first unit has been successfully developed.

However, to validate the reliability and reproducibility of our tes�ng methodology through interlaboratory tes�ng, a second unit of this system is essen�al. Interlaboratory tes�ng is crucial as it helps ensure that the test results are consistent and repeatable across different se�ngs, which is fundamental for the acceptance and standardiza�on of new tes�ng methods. Such tes�ng is par�cularly important in the context of healthcare PPE, where consistent performance across mul�ple manufacturers and laboratories can be cri�cal to ensuring the safety and effec�veness of protec�ve equipment used by healthcare professionals worldwide.

Given the success of the ini�al tes�ng system and the first ITS unit, along with the recognized vulnerabili�es at the interface where no standard test method currently exists, there is a clear need within the PPE community for standardized tes�ng of the protec�ve clothing and glove interface. To facilitate the development of a new standard for tes�ng these interfaces, interlaboratory tes�ng is essen�al. This requires the produc�on of a second, iden�cal unit. This secondary unit for interlaboratory tes�ng shall be an exact replica or may have minor design advancements which NIOSH agrees on (e.g., updated so�ware or material use) of the ini�al system. The awardee of this contract shall receive the know-how from the first development contract, including schema�cs, so�ware source code, design documents, and other relevant informa�on. However, certain custom components or so�ware elements of this system may contain proprietary informa�on and licensing rights that are not accessible to the government and may be subject to restricted access. In such instances, it will be the responsibility of the awardee to manage and procure the necessary licensing agreements.

The ITS system will feature an average human-size mannequin with a robo�c arm capable of simula�ng the complex movements of HCP upper extremi�es, housed within a chamber equipped with a mechanism to simulate fluid exposures such as spraying and soaking. The robo�c arm will meet stringent specifica�ons, including an anthropomorphic form factor and appearance, human-like strength and dexterity, high-resolu�on tac�le and posi�on sensing, and a user-friendly interface control system. These features will ensure that the system can accurately mimic human movements and interac�ons with protec�ve garments under various condi�ons.

The proposed system will enable interlaboratory tes�ng valida�on to determine the barrier effec�veness of various PPE types—including gloves, gowns, and coveralls—across different models. This new tes�ng procedure has been published extensively (Kilinc-Balci et al. 2018, Kahveci et al. 2019, Kahveci et al. 2021) and presented at several na�onal/interna�onal conferences, and standard development organiza�ons' mee�ngs, and has garnered extensive support from na�onal and interna�onal stakeholders, including HCP, professional organiza�ons (AORN, APIC, AST), and prominent manufacturers, as well as standard development organiza�ons like the ASTM F23.50 PPE Conformity Assessment, Interoperability, and Compa�bility Subcommitee. This commitee has agreed to develop a new standard test method based on the NIOSH technique and has ini�ated a new work item to address this urgent need. The implementa�on of this methodology will provide a crucial framework for interlaboratory tes�ng, offering manufacturers a unique opportunity to compare the barrier effec�veness of different products on the market and to develop new products designed to reduce or eliminate fluid leakage.

SECTION 2 – PURPOSE

The acquisi�on of a second interface tes�ng system, iden�cal to the developed first ITS unit or may have minor design advancements which NIOSH agrees on (e.g., updated so�ware or material use), aims to be used interlaboratory tes�ng, a cri�cal step toward the establishment of a new standard. This endeavor will:

• Ensure Reproducibility: Confirm that the test results are consistent across different laboratories, a requirement for the acceptance of a new standard by regulatory and standardiza�on bodies.

• Validate Reliability: Demonstrate that the tes�ng methodology can reliably predict the performance of PPE in preven�ng fluid leakage at the glove-gown interface, thus ensuring the safety of HCP.

• Support Standard Development: Provide the necessary data to support the adop�on of this methodology as a standard by organiza�ons such as ASTM, poten�ally leading to improved PPE design and manufacturing prac�ces.

SECTION 3 – SCOPE OF WORK

The contractor selected for this project will be tasked with manufacturing a second, iden�cal unit of the ITS or may have minor design advancements which NIOSH agrees on (e.g., updated so�ware or material use), u�lizing the comprehensive knowledge compiled during development of the first unit. This includes access to detailed design schema�cs, the original so�ware source code, a precise list of materials with specific part numbers, and all data generated during the development process of the first unit. This extensive sharing of informa�on ensures that the second unit will replicate the first not only in construc�on but also in func�onality and performance, maintaining consistency and reliability essen�al for accurate interlaboratory tes�ng. All the developmental documenta�on will be accessible to the contractor. However, certain custom components or so�ware elements of this system may contain proprietary informa�on and licensing rights that are not accessible to the government and may be subject to restricted access. In such instances, it will be the responsibility of the awardee to manage and procure the necessary licensing agreements.

Below is an overall general specifica�on for the robo�c arm and the test chamber:

The robo�c arm will possess the following features:

1. The robo�c arm must have an anthropomorphic form factor and appearance with a natural shoulder-size atachment, ensuring no abnormal extension from the mannequin.

2. The size of the robo�c arm should align with the average dimensions of a U.S. healthcare worker and be consistent with the dimensions of the mannequin.

3. The arm must be water-resistant or include means to protect it from water exposure.

4. It should demonstrate human-like strength and dexterity, capable of suppor�ng the weight of the robo�c arm, an addi�onal 15 pounds of external load, and facilitate movement.

5. The robo�c arm shall operate using a 120V power supply.

6. It shall be able to simulate shoulder, elbow, and wrist movements with high precision, including:

(a) Shoulder: Extension/Flexion (-20° – 0°- 180°), abduc�on/adduc�on (0° – 135°), humeral rota�on (-45° – 0° – 45°)

(b) Elbow: Flexion (0°-135°)

(c) Wrist: Prona�on/Supina�on (0°–90°), Extension/Flexion (-45° – 70°), Ulnar devia�on/Radial devia�on (-15° – 45°)

(d) All driver motors must complete each movement within 2-8 seconds.

7. The driver motors are designed to operate for prolonged tes�ng hours (~8 hours daily with a 1-hour break every 4 hours) without overhea�ng.

8. Controls for the robo�c arm will include:

(a) An embedded control system that allows the operator to program the speed, degree of movement, and number of repe��ons of movement cycles.

(b) An embedded computer system that manages all low-level details of joint control such as motor commuta�on, mo�on control, and fault monitoring, using a ROS interface for GUI control.

(c) Programming for the embedded systems controls shall be done using Python or C, depending on the final hardware chosen.

(d) The arm shall be a standalone device that performs motor skills similar to a human arm and will NOT require network use or so�ware installa�on for connec�vity. The arm will NOT move data across any medium for transfer external to itself.

(e) The controls shall ensure smooth arm movements and include an easily accessible emergency stop buton.

(f) The controls shall be configured to operate the robo�c arm only when the chamber door is closed.

The Chamber, Mannequin, Fluid Exposure System, and User Interface will have the following features:

1. General Chamber Informa�on:

(a) The chamber will accommodate at least an average-sized mannequin, with minimum dimensions of 50” x 50” x 72”, constructed from sturdy framing that can be easily disassembled.

(b) It will not require gas-�ght gaskets, but the botom must be waterproof.

(c) The chamber will be designed to minimize shaking, vibra�on, or jarring from the mechanical mo�on of the robo�c arm.

2. Walls: All side walls and ceiling will be made from transparent and thick sturdy shee�ng, such as polycarbonate. Alterna�ve thicknesses may be considered if necessary for the chamber design.

3. Door: The chamber will have two hinged doors at the front, full height and a minimum width of

25” each.

4. Floor:

(a) The floor shall be made of sturdy materials and supports to allow a person to walk on it.

(b) The chamber shall sit directly on the laboratory floor.

(c) A drainage system shall be included to collect fluid in a container.

5. Mannequin:

(a) A mannequin shall be supplied to support the weight of the robo�c arm and arm movements, sized similarly to an average U.S. healthcare worker (e.g., chest size 42R inches, Large).

(b) There shall be a natural shoulder size atachment to robo�c arm (no abnormal extension from the mannequin)

(c) A mechanism such as a harnessing system shall be supplied for securing the mannequin to the floor pla�orm.

(d) The mannequin shall include a head, torso, and a dummy half-length right arm, complemented by legs atached to a raised, sturdy pla�orm to simulate realis�c human height.

6. Fluid Exposure System for Spraying Type of Exposure:

(a) Automated spray nozzles will introduce spray type exposure to the designated area.

(b) The spray nozzles shall be controlled by the same computer system as the robo�c arm, ensuring synchronized opera�on.

(c) The sprayed fluid shall target the protec�ve clothing and glove interface area (wrist) and have 360-degree coverage.

(d) The spray system shall include a manually controlled pump opera�ng on a 120V electric supply, made from sturdy and water-resistant materials (aluminum or steel) to resist corrosion.

(e) The pump and nozzles shall be operated with 120V electric supply and electrical systems shall be protected from water.

(f) The nozzles should be developed from a sturdy and strong water-resistant material (aluminum or steel) to resist corrosion.

7. Elevator and Fluid Container for Soaking Type of Exposure:

(a) An automated elevator shall be used to rise the fluid container to soak the robo�c arm for a certain amount of �me.

(b) The elevator shall be controlled by the same computer system as robo�c arm within the same movement protocol.

(c) The elevator shall be operated with 120V electric supply and electrical systems shall be protected from water.

(d) The elevator should be developed from sturdy and strong water-resistant material

(aluminum or steel) and shall be able to bare minimum of 50 pounds of weight.

(e) A fluid container shall be used to soak the robo�c arm in and should be water resistant.

(f) The fluid container should be placed on top of the elevator. It could be atached to the elevator (a drainage valve needed in that case) or could be placed on the elevator pla�orm in a secure fashion without ge�ng affected from the elevator movement.

8. User Interface: The embedded user interface shall allow the operator to program the speed, degree of movement, and number of repe��ons of movement cycles.

9. Electrical Outlets: The chamber shall need 120V electrical receptacles mounted inside to power the robo�c arm and elevator.

10. Delivery/Assembly/Set-Up/Installa�on:

(a) The contractor shall deliver, assemble, set-up, and install the system at the specified loca�on, providing opera�ng, troubleshoo�ng, and maintenance manuals for training and demonstra�on.

(b) Materials wider than 33” may require on-site assembly due to door size restric�ons.

11. Warranty: A one-year warranty on the complete interface tes�ng system, including parts and labor is required.

SECTION 4 –TASKS TO BE PERFORMED

The ini�al proposal shall s�ll include a review and verifica�on of the design, engineering, and electrical schema�cs of the tes�ng system to ensure no devia�ons from the approved specifica�ons.

Task 1-4: Manufacture the interface tes�ng system, which includes the robo�c arm, mannequin, chamber, fluid exposure system, and user interface based on the exis�ng specifica�ons and documents provided or may have minor design advancements which NIOSH agrees on (e.g., updated so�ware or material use).

Task 5: Handle the shipment, assembly, and installa�on of the equipment to designated laboratory, including a comprehensive demonstra�on and training session to ensure that personnel are fully equipped to operate and maintain the system.

Task 6: Provide technical support and assistance for 12 months following delivery. This should include �mely responses to any opera�onal issues or ques�ons regarding the system.

Task 7: The final report shall have the following:

• The documenta�on confirming adherence to the original design, so�ware code, mechanical drawings, engineering, and electrical schema�cs. Confirm parts lists (including model/manufacturer), assembly instruc�ons, and all other aspects are consistent with the first unit.

• Calibra�on procedures that have been applied to validate the performance of the system.

• Updated opera�ng, maintenance, and troubleshoo�ng manuals that reflect any nuances or updates in the second unit.

REPORTING TASKS TO BE PERFORMED FOR THE CONTRACT

Task: Kick-off Meeting: Conduct within two (2) weeks of contract award to ensure all par�es have a clear understanding of the project requirements and �melines.

Task: Quarterly Reports: Submit quarterly reports outlining the progress of the system’s manufacture and any issues encountered. These reports should include:

• Detailed accounts of work started and completed during the repor�ng period.

• An indica�on of any current problems which may impede performance along with proposed correc�ve ac�ons.

• A forecast of work planned for the next quarter.

• Any changes or delays an�cipated to previously established schedules.

• These reports should be delivered one (1) week a�er the end of each quarter.

Task: Final Report: Prepare a final report for the project, as applicable.

Prepare a comprehensive final report documen�ng all aspects of the work accomplished under this contract. This report should mirror the format and content of the original final report to maintain consistency between both units. It should also include any specific challenges or learning points encountered during the replica�on of the unit. This final report must be submited to the Government at least within three (3) months a�er the delivery of the system.

SECTION 5 – GOVERNMENT FURNISHED MATERIALS

None. The contractor is expected to u�lize their resources and materials to fulfill the objec�ves of this project.

SECTION 6 – PERIOD OF PERFORMANCE

The period of performance for this contract shall extend 24 months from the date of award. This �meframe includes all phases of manufacturing, interlaboratory setup, training, final repor�ng, and 12 months warranty period.

SECTION 7 – PLACE OF PERFORMANCE

Primary development and manufacturing ac�vi�es shall occur at the contractor's facility. Deployment for interlaboratory tes�ng, including setup and training, shall take place at designated laboratories agreed upon by NIOSH/NPPTL and the contractor.

SECTION 8 – DELIVERABLES/REPORTING SCHEDULE

The contractor shall provide the following deliverables to the Project Officer by the Due Dates given below.

All electronic files should be delivered in MS Office format and provided via e-mail.

Task Means of Delivery

Due Date

Kick-off Mee�ng Teleconference Within two (2) weeks of date of contract award Task 1: Document crea�on

(Project plan, proposal) Email Within three (3) months of contract award

Task 2: Manufacture robo�c arm

Email (the picture of the system) Within nine (9) months of contract award

Task 3: Manufacture chamber, and robo�c arm integra�on

Email (the picture of the system) Within nine (9) months of contract award

Task 4: Develop user interface

Email Within twelve (12) months of contract award

Quarterly Reports Email Within one (1) week a�er the end of each quarter Shipment, Installa�on and

Training Delivery Within twelve (12) months of contract award

Final Report Email Within three (3) months a�er the delivery of the system Technical support and assistance during the warranty period

In person, conference or email Twelve (12) months a�er delivery

Project Officer:

Selcen Kilinc-Balci

CDC/NIOSH/NPPTL

Jcq8@cdc.gov mailto:Jcq8@cdc.gov

Phone: 412-386-4086

Report Approvals:

1. Quarterly Reports Approval: The Government shall be allowed fourteen (14) days to review the quarterly reports and no�fy the Contractor in wri�ng of approval or of recommended changes to be made in the final copy. If the Government does not approve or recommend changes within fourteen (14) days of receipt of the dra�, the report shall be deemed approved. Within fourteen

(14) days of receipt of a no�ce of approval from the Government of any contract related document, the Contractor shall furnish the Government with 508 compliant Portable Document Format (PDF) file versions of the reports and addi�onally a reproducible master hard copy of the instructor’s guides in final form.

2. Final Report Approval: The Government shall be allowed fourteen (14) days to review the dra� final report and no�fy the Contractor in wri�ng of approval or of recommended changes to be made in the final version. If the Government does not approve or recommend changes within fourteen (14) days of receipt of the dra� final report, the report shall be deemed approved. Within fourteen (14) days of receipt of a no�ce of approval from the Government of any contract related document, the Contractor shall furnish the Government with 508 compliant Portable Document Format (PDF) file versions of the report and addi�onally a reproducible master hard copy of the instructor’s guides in final form.

SECTION 9 – TRAVEL

Travel to instalment loca�on is an�cipated for up to five in-person mee�ngs, system delivery, installa�on, and training sessions.

SECTION 10 – SPECIAL REQUIREMENTS

The contractor must demonstrate a successful track record in developing complex electro-mechanical and robo�c systems. Evidence of previous work, including references and case studies, may be requested to validate the contractor's exper�se and capability to execute the project successfully.

SECTION 11 - CDC CAPITAL PLANNING AND INVESTMENT CONTROL REQUIREMENTS

Capital Planning and Investment Control (CPIC) is an integral part of CDC strategic planning ini�a�ve. In accordance with FITARA, Clinger-Cohen Act, HHS and CDC CPIC Polices, the contractor shall follow the HHS EPLC framework, a product and project management methodology, and shall provide complete, reliable, consistent, and �mely life-cycle informa�on, to include development and cost informa�on, and systema�c measurement of performance.

a. The Contractor shall report monthly to the NIOSH PMO the actual expenditures to produce the Informa�on Technology (IT) products and services in accordance with CDC EPLC cost and schedule repor�ng requirements.

b. The Contractor shall furnish appropriate project documenta�on as required by HHS EPLC.

c. The Contractor shall furnish documenta�on that describes the final IT product or service and their respec�ve informa�on flows at a sufficient level of detail.

SECTION 12 – REFERENCE MATERIALS

• World Health Organiza�on (WHO). (2018). Infection prevention and control of epidemic- and pandemic-prone acute respiratory infections in health care.

• Kilinc-Balci, F. Selcen, Zafer Kahveci, and Patrick L. Yorio. "Novel Test Method for the Evalua�on of Fluid Leakage at the Glove-Gown Interface and Inves�ga�on of Test Parameters." Journal of the American College of Surgeons 227.6 (2018): 573-586.

• Kahveci, Zafer, F. Selcen Kilinc-Balci, and Patrick L. Yorio. "Cri�cal inves�ga�on of glove–gown interface barrier performance in simulated surgical se�ngs." Journal of Occupational and Environmental Hygiene 16.7 (2019): 498-506.

• Kahveci, Zafer, F. Selcen Kilinc-Balci, and Patrick L. Yorio. "A simula�on study to assess fluid leakage through the glove-gown interface in isola�on se�ngs." American Journal of Infection Control

49.12 (2021): 1481-1487.

SECTION 13 – TRAVEL AND SPECIAL CONSIDERATIONS

Special considera�ons include compliance with all applicable federal and state safety and environmental regula�ons during the development, tes�ng, and deployment phases of the project. The contractor must ensure that all personnel involved in the project are adequately trained and equipped to work safely, par�cularly when handling poten�ally infec�ous materials or opera�ng complex machinery.

SECTION 14 – INTELLECTUAL PROPERTY AND DATA RIGHTS

The awardee of this contract shall receive the know-how from the first development contract, including schema�cs, so�ware source code, design documents, and other relevant informa�on. However, certain custom components or so�ware elements of this system may contain proprietary informa�on and licensing rights that are not accessible to the government and may be subject to restricted access. In such instances, it will be the responsibility of the awardee to manage and procure the necessary licensing agreements.

CDC shall have the intellectual property rights as defined herein to the design, development, and fabrica�on of the interface tes�ng system. Technical data package shall include final report, so�ware code, mechanical drawings, electrical schema�cs, parts lists (including the model/manufacturer), assembly instruc�ons, computer aided design model, user interface and programming, test data, and all other necessary informa�on to duplicate, reproduce, manufacture, disseminate, further research, or improve for any other purpose the government deems appropriate.

The awardee of this contract shall receive the know-how from the first development contract, including schema�cs, so�ware source code, design documents, and other relevant informa�on. However, certain custom components or so�ware elements of this system may contain proprietary informa�on and licensing rights that are not accessible to the government and may be subject to restricted access. In such instances, it will be the responsibility of the awardee to manage and procure the necessary licensing agreements.

Pursuant to FAR clauses 52.227-11 and 52.227-13 defining intellectual property rights retained by the Contractor and the Government for intellectual property developed under a contract, the Contractor shall provide the Government with a non-exclusive, irrevocable, nontransferable, royalty-free, worldwide license to use all deliverables outlined in this Statement of Work for federal purposes. The contractor shall provide the delivered deliverable to the government under unlimited rights as specified in clause FAR 52.227-14 Rights in Data--General (May 2014) and as modified by NFS 1852.227-14, Rights in Data-General (April 2015). Unlimited rights mean the rights for the Government to use, modify, disclose, reproduce, prepare deriva�ve works, distribute copies to the public, and perform publicly and display publicly on the web or elsewhere, in any and all formats or manner and for any purpose, and to have or permit others to do so. It is the responsibility of the Contractor to ensure that deliverables are delivered as such, and ensure that if partnering or subcontrac�ng, that the subcontractor(s) agree to such terms. In addi�on, the Contractor shall ensure it is the owner of or has the right to use, any copyrightable works that the deliverables comprise, that the works are wholly original or is an improved version of an exis�ng work that the Contractor has sufficient rights to use and improve, that the deliverable does not infringe any copyright or any other rights of any third party of which the Contractor is aware, and warrants that the deliverable is free of security threats and/or malware.

Special Considera�ons

Electronic and Information Technology Accessibility Notice

(a) Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998 and the Architectural and Transportation Barriers Compliance Board Electronic and Information (EIT) Accessibility Standards (36 CFR part 1194), require that when Federal agencies develop, procure, maintain, or use electronic and information technology, Federal employees with disabilities have access to and use of information and data that is comparable to the access and use by Federal employees who are not individuals with disabilities, unless an undue burden would be imposed on the agency. Section 508 also requires that individuals with disabilities, who are members of the public seeking information or services from a Federal agency, have access to and use of information and data that is comparable to that provided to the public who are not individuals with disabilities, unless an undue burden would be imposed on the agency.

(b) Accordingly, any offeror responding to this solicitation must comply with established HHS EIT accessibility standards. Information about Section 508 is available at http://www.hhs.gov/web/508. The complete text of the Section 508 Final Provisions can be accessed at http://www.access-board.gov/sec508/standards.htm.

(c) The Section 508 accessibility standards applicable to this contract are: 1194.

205 WCAG 2.0 Level A & AA Success Criteria http://www.hhs.gov/web/508 http://www.access-board.gov/sec508/standards.htm http://www.access-board.gov/sec508/standards.htm

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

In order to facilitate the Government's determination whether proposed EIT supplies meet applicable Section 508 accessibility standards, offerors must submit an HHS Section 508 Product Assessment Template, in accordance with its completion instructions. The purpose of the template is to assist HHS acquisition and program officials in determining whether proposed EIT supplies conform to applicable Section 508 accessibility standards. The template allows offerors or developers to self-evaluate their supplies and documentation detail - whether they conform to a specific Section 508 accessibility standard, and any underway remediation efforts addressing conformance issues. Instructions for preparing the HHS Section 508 Evaluation Template are available under Section 508 policy on the HHS Web site http://hhs.gov/web/508.

http://hhs.gov/web/508

In order to facilitate the Government's determination whether proposed EIT services meet applicable Section 508 accessibility standards, offerors must provide enough information to assist the Government in determining that the EIT services conform to Section 508 accessibility standards, including any underway remediation efforts addressing conformance issues.

(d) Respondents to this solicitation must identify any exception to Section 508 requirements. If a 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 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.

(e) Electronic content must be accessible to HHS acceptance criteria. Checklist for various formats are available at http://508.hhs.gov/, or from the Section 508 Coordinator listed at https://www.hhs.gov/web/section-508/additional-resources/section-508-contacts/index.html.

Materials that are final items for delivery should be accompanied by the appropriate checklist, except upon approval of the Contracting Officer or Representative.

http://508.hhs.gov/ https://www.hhs.gov/web/section-508/additional-resources/section-508-contacts/index.html