A19 Attachement 1 Statement of Work.pdf

February 2026

Statement of Work

Title: Maintenance Agreement - Automated Equipment Monitoring – Division of High Consequence Pathogens & Pathology

Period of Performance: 12 months from date of award

SECTION 1 – BACKGROUND

The Centers for Disease Control and Prevention (CDC) works 24/7 to protect America from health, safety and security threats, both foreign and in the U.S.

Whether diseases start at home or abroad, are chronic or acute, curable or preventable, human error or deliberate attack, CDC fights diseases and supports communities and citizens to do the same. CDC’s Division of High Consequence Pathogens & Pathology (DHCPP) aims to prevent disease, disability, and death caused by a wide range of high-consequence pathogens.

In order for DHCPP to achieve their mission, state-of-the-art laboratory equipment must be in working order and compliant with either the Clinical Laboratory Improvement Amendments (CLIA) regulations or with the International Standards Organization (ISO) requirements or meet Quality Manual for Microbiological Laboratories (QMML) requirements. These regulations and standards require monitoring of temperature and humidity in all laboratory areas where quality assurance materials, specimens, and reagents, are manufactured, stored, and/or tested. Accurate recordings are essential to ensure the quality of the materials being used and stored in the laboratory. Typically, monitoring and recording temperature, humidity, and CO2, and asset management was done manually with over half of our equipment inventory requiring at least daily monitoring. This process is inaccurate, impractical and cost prohibitive. The lack of automated notifications when levels are out of range could lead to severe damage to our collection full of invaluable, well-characterized specimens from around the world. DHCPP laboratories have an urgent need for a robust automated temperature, humidity, and CO2 monitoring and notification system across all five branches.

A contract was awarded in FY21 for a comprehensive monitoring system for each branch in the Division under an umbrella contract to the Office of the Director under 75D30121P12026. This system included a network of temperature, CO2 and humidity transmitters, laboratory receivers, and software to collect, compile and save data (centralized via on-premises server) and generate graphs and reports; remote access and notification capabilities;

and door sensors to indicate when equipment is opened, closed, or left ajar.

System included user and management features to allow for role-based access for users from different branches and tracking of equipment. Tracking included tracking CDC barcodes, barcode locations, maintenance, whether replaced equipment has been properly re-equipped for monitoring and whether temporary or permanent. This contract was critical to maintain environmental monitoring to meet Quality Manual for Microbiological Laboratories (QMML) requirements and electronic Quality Management System (eQMS) standards.

SUBSECTION A – DEFINITIONS

CLIA: Clinical Laboratory Improvement Amendments BSPB: Bacterial Special Pathogens Branch CVDB: Chronic Viral Diseases Branch DHCPP: Division of High Consequence Pathogens & Pathology eQMS: electronic Quality Management System IDPB: Infectious Diseases Pathology Branch ISO: International Standards Organization PRB: Pox & Rabies Virus Branch QMML: Quality Manual for Microbiological Laboratories VSPB: Viral Special Pathogens Branch

SECTION 2 – PURPOSE

This requirement is to obtain a service agreement for an automated monitoring and notification system that electronically records and transmits environmental data (i.e.: temperature, humidity, and CO2 levels) obtained from IntelliSense hardware probes installed in equipment and rooms in DHCPP laboratories and automatically notify laboratory staff when measurements are out of established range.

SECTION 3 – SCOPE OF WORK

Mapping environmental conditions of the areas where laboratories store products ensure the products are kept in the correct condition which is essential for safety and compliance. The Government currently operates an installed IntelliSense environmental monitoring environment. Any hardware, software, maintenance, repair, calibration, or replacement components provided under this requirement shall be fully compatible and interoperable with the Government's existing environment without degradation of existing system functionality. It also will include annual options to purchase additional Intellisense hardware, warrantied for one (1) year, with installation, software set up and monitoring.

1) The vendor shall be ISO 17025 certified vendor to perform required NIST traceable calibration/recalibration services; perform installation qualification (IQ) and operational qualification (OQ) following laboratory protocol; and provide documentation on all service and calibration activities and installations.

2) Equipment must be monitored to meet the following Specifications

a) NIST traceable sensors (Temperature range -200 to 300C)

b) Minimum of 0.1C resolution out of specification reporting with the ability to electronically review and/or approve reports

c) Door status sensor and 2 analog sensor inputs on each transmitter

d) LCD temp/humidity/CO2 display on transmitter modules

e) Ability to monitor liquid nitrogen levels

f) Text and email alerts

g) Audible and visual alarms

h) Single-server 21 CFR part 11/CLIA/ISO compliant system

i) Server and SQL instance that supports virtualization using VMWare

ESC Hypervisor

j) Active Directory or LDAP Domain Authentication

k) 900Mhz Zigbee IEEE 802.15.4 Wireless Transmitters

l) Transmitter battery-life of at least 12 months, based on minimum two readings per hour

m) Minimum 14 days data buffering when power or connection to server fails

n) Replacing batteries does not erase logged data

o) 900Mhz Zigbee IEEE 802.15.4 Wireless Receivers with Gigabit

Ethernet network ports

p) Self-healing, redundant MESH network topology that auto-recovers from receiver failures

q) User-friendly web-based client GUI (no client application required)

r) Ability to create user groups and at least 3 permission levels including admin

s) Ability to track assets by user group and log maintenance and relevant notes

t) Graphs of monitored readings

u) Secure and auditable logs of all system activity, recording user and action with date/time

v) Ability to document corrections/corrective action with electronic signature

w) Table, List and Map views of monitored resources with ability to export to .csv or .xlsx

x) Travel may be required for installation of environmental monitoring equipment and training of laboratory staff. Contractor shall be responsible for all associated travel costs.

SECTION 4 – TASKS TO BE PERFORMED

1. CLIN 0001 – Service to BSPB

a. One (1) year service agreement

b. Perform annual qualification (IQ) and operational qualification

(OQ)

c. Unlimited phone, fax, e-mail and website operational support for up to ten DHCPP points-of-contact.

d. Remote support must be available 24 hours per day, 7 days per week.

e. Onsite support must be available 8 hours per day, 5 days per week, excluding federal holidays.

f. Remote 24/7 tech support (for support during emergency response activities)

g. Users’ phone calls must be returned within four (4) business hours if not handled immediately.

h. Provide support for all equipment in ATTACHMENT 2:

Equipment list.

i. Provide NIST traceable calibration services by an ISO 17025 certified vendor.

j. Provide application server software /firmware updates in a timely manner and without additional cost.

k. Provide a HHS Product Accessibility Template (HHS PAT) for every software release or upgrade (for Section 508 compliance).

l. Provide one annual training to identified laboratory staff (up to 5 staff will be included) on how to access and use temperature monitoring equipment and software effectively as well as what to do in the case of an issue with the monitoring system. Staff shall be trained on how to remove and replace probes for equipment in these labs (with assistance via phone or email) from the monitoring company

2. CLIN 0002 – Service to CVDB

a. One (1) year service agreement

b. Perform annual qualification (IQ) and operational qualification

(OQ)

c. Unlimited phone, fax, e-mail and website operational support for up to ten DHCPP points-of-contact.

d. Remote support must be available 24 hours per day, 7 days per week.

e. Onsite support must be available 8 hours per day, 5 days per week, excluding federal holidays.

f. Remote 24/7 tech support (for support during emergency response activities)

g. Users’ phone calls must be returned within four (4) business hours if not handled immediately.

h. Provide support for all equipment in ATTACHMENT 2:

Equipment list.

i. Provide NIST traceable calibration services by an ISO 17025 certified vendor.

j. Provide application server software /firmware updates in a timely manner and without additional cost.

k. Provide a HHS Product Accessibility Template (HHS PAT) for every software release or upgrade (for Section 508 compliance).

l. Provide one annual training to identified laboratory staff (up to 5 staff will be included) on how to access and use temperature monitoring equipment and software effectively as well as what to do in the case of an issue with the monitoring system. Staff shall be trained on how to remove and replace probes for equipment in

3. CLIN 0003 – Service to IDPB

b. Perform annual qualification (IQ) and operational qualification

(OQ)

c. Unlimited phone, fax, e-mail and website operational support for up to ten DHCPP points-of-contact.

d. Remote support must be available 24 hours per day, 7 days per week.

e. Onsite support must be available 8 hours per day, 5 days per week, excluding federal holidays.

f. Remote 24/7 tech support (for support during emergency response activities)

g. Users’ phone calls must be returned within four (4) business hours if not handled immediately;

h. Provide support for all equipment in ATTACHMENT 2:

Equipment list.

i. Provide NIST traceable calibration services by an ISO 17025 certified vendor.

j. Provide application server software /firmware updates in a timely manner and without additional cost.

k. Provide a HHS Product Accessibility Template (HHS PAT) for every software release or upgrade (for Section 508 compliance).

l. Provide one annual training to identified laboratory staff (up to 5 staff will be included) on how to access and use temperature monitoring equipment and software effectively as well as what to do in the case of an issue with the monitoring system. Staff shall be trained on how to remove and replace probes for equipment in

4. CLIN 0004 – Service to PRB

b. Perform annual qualification (IQ) and operational qualification

(OQ)

c. Unlimited phone, fax, e-mail and website operational support for up to ten DHCPP points-of-contact.

d. Remote support must be available 24 hours per day, 7 days per week.

e. Onsite support must be available 8 hours per day, 5 days per week, excluding federal holidays.

f. Remote 24/7 tech support (for support during emergency response activities)

g. Users’ phone calls must be returned within four (4) business hours if not handled immediately.

h. Provide support for all equipment in ATTACHMENT 2:

Equipment list.

i. Provide NIST traceable calibration services by an ISO 17025 certified vendor.

j. Provide application server software /firmware updates in a timely manner and without additional cost.

k. Provide a HHS Product Accessibility Template (HHS PAT) for every software release or upgrade (for Section 508 compliance).

l. Provide one annual training to identified laboratory staff (up to 5 staff will be included) on how to access and use temperature monitoring equipment and software effectively as well as what to do in the case of an issue with the monitoring system. Additional training for staff who will be responsible for equipment in High Containment Labs or other laboratories that cannot be taken down for entry. Staff shall be trained on how to remove and replace probes for equipment in these labs (with assistance via phone or email) from the monitoring company

5. CLIN 0005 – Service to VSPB

b. Perform annual qualification (IQ) and operational qualification

(OQ)

c. Unlimited phone, fax, e-mail and website operational support for up to ten DHCPP points-of-contact.

d. Remote support must be available 24 hours per day, 7 days per week.

e. Onsite support must be available 8 hours per day, 5 days per week, excluding federal holidays.

f. Remote 24/7 tech support (for support during emergency response activities)

g. Users’ phone calls must be returned within four (4) business hours if not handled immediately.

h. Provide support for all equipment in ATTACHMENT 2:

Equipment list.

i. Provide NIST traceable calibration services by an ISO 17025 certified vendor.

j. Provide application server software /firmware updates in a timely manner and without additional cost.

k. Provide a HHS Product Accessibility Template (HHS PAT) for every software release or upgrade (for Section 508 compliance).

l. Provide one annual training to identified laboratory staff (up to 5 staff will be included) on how to access and use temperature monitoring equipment and software effectively as well as what to do in the case of an issue with the monitoring system. Additional training for staff who will be responsible for equipment in High Containment Labs or other laboratories that cannot be taken down for entry. Staff shall be trained on how to remove and replace probes for equipment in these labs (with assistance via phone or email) from the monitoring company

6. CLIN 0006 – Optional Scale Up (Up to 30 Additions)

a. The Government may require up to thirty (30) additions to the existing automated environmental monitoring system during the period of performance as laboratory monitoring requirements evolve. An “addition” consists of the hardware/system component(s), installation, configuration, setup, qualification, and other associated services necessary to incorporate one additional monitoring capability or monitoring point into the Government's existing system.

The Contractor shall provide an all-inclusive unit price per addition. The Government is not obligated to order any minimum quantity under this optional CLIN. The Government may exercise quantities under this CLIN as requirements arise during the period of performance.

SECTION 5 – GOVERNMENT FURNISHED MATERIALS

CDC will not furnish any property. The server is hosted in a consolidated virtual environment provided by CDC. The vendor shall ensure that all IT equipment (e.g., laptops, desktops, servers, routers, mobile devices, peripheral devices, etc.) used to process information on behalf of CDC are deployed and operated in accordance with approved security configurations and meet the following minimum requirements:

A. Encrypt equipment and sensitive information stored and/or processed by such equipment in accordance with HHS and FIPS 140-2 encryption standards.

B. Configure laptops and desktops in accordance with the latest applicable United States Government Configuration Baseline (USGCB), and HHS Minimum Security Configuration Standards;

C. Maintain the latest operating system patch release and anti-virus software definitions;

D. Validate the configuration settings after hardware and software installation, operation, maintenance, update, and patching and ensure changes in hardware and software do not alter the approved configuration settings;

E. Automate configuration settings and configuration management in accordance with HHS security policies, including but not limited to:

a. Configuring its systems to allow for periodic HHS vulnerability and security configuration assessment scanning; and

b. Using Security Content Automation Protocol (SCAP)-validated tools with USGCB Scanner capabilities to scan its systems at least on a monthly basis and report the results of these scans to the CO and/or COR, Project Officer, and any other applicable designated POC

SECTION 6 – PLACE OF PERFORMANCE AND CONTRACT

SUPPORT HOURS

SUBSECTION A – PLACE OF PERFORMANCE

The work will be performed on the customer’s site within labs in DHCPP.

1600 Clifton Road NE, Atlanta, GA 30329

SUBSECTION B – CONTRACT SUPPORT HOURS

Contract support hours shall be as specified under Section 4. Routine onsite maintenance and service shall be scheduled in advance between the Contractor and the COR or designated laboratory representative.

SECTION 7 – TRAVEL

All travel necessary to perform the requirements of this SOW shall be included in the Contractor's quoted prices. Travel will not be separately reimbursed by the Government.

SECTION 8 – DELIVERABLES/REPORTING SCHEDULE

1. The delivery schedule for equipment service must be annually as identified in Attachment 2 for each laboratory: BSPB, CVDB, IDPB, PRB and VSPB.

2. New Equipment must be under warranty for a period of twelve (12) months minimum beginning the day after installation and qualifications are completed.

3. The system may be expanded and/or additional systems /components may be acquired in the future. Expansion will be determined as needed and funded through issuance of a contract modification.

4. The CDC COR and/or designee will monitor the contractor's performance and shall be responsible for documenting acceptance or rejection of contractor services with five (5) business days of services being rendered. The COR or authorized designee will inspect the Contractor's deliverables and document acceptance or rejection within five (5) business days following receipt. Rejected deliverables shall be corrected and resubmitted at no additional cost to the Government.

Items

Description

Quantity or No.

of Copies

Delivery Date

Deliver To

Maintenance Report per Branch

Laboratory Maintenance Report; vendor can submit Invoice monthly after installation

1 copy Within 10 business days after annual maintenance

COR: Niyai Johnson (fbn4@cdc.gov) Project Officer:

Gitika Panicker (dhv1@cdc.gov)

Scale Up Report Report on new installation or applicable Lab Maintenance Report of installed equipment

1 copy

Within 10 business days of installation

COR: Niyai Johnson (fbn4@cdc.gov) Project Officer:

Gitika Panicker (dhv2@cdc.gov)

Training Training to identify laboratory staff (up for HCL Labs) to 5 staff per branch on how to access and use temperature monitoring equipment and software

1 per branch plus additional training for High Containment Labs (HCL)

Annual (additional training for staff who will be responsible for equipment in HCL or other laboratories that cannot be taken down for entry)

COR: Niyai Johnson (fbn4@cdc.gov) Project Officer:

Gitika Panicker (dhv2@cdc.gov) mailto:fbn4@cdc.gov mailto:hv1@cdc.gov mailto:@cdc.gov mailto:dhv2@cdc.gov mailto:@cdc.gov mailto:dhv2@cdc.gov

Job-Aids Concise user-friendly document that provides step by step instructions on specific topics to assist staff perform tasks related to the system

Depends upon changes made to the system

Within 10 days after changes in the system and/or lack of sufficient detail in the user manual

COR: Niyai Johnson (fbn4@cdc.gov) Project Officer:

Gitika Panicker (dhv2@cdc.gov)

Quarterly Review Meetings

Meeting between vendor and users to discuss current issues, quick training and/or system updates and shall provide meeting minutes to COR 2 days after meeting

4 Quarterly COR: Niyai

Johnson (fbn4@cdc.gov) Project Officer:

Gitika Panicker (dhv2@cdc.gov)

SECTION 9 – REFERENCE MATERIALS

a. Safety (as applicable for each laboratory): As required by the Occupational Safety and Health Administration’s (OSHA) Bloodborne Pathogens Program (BBP), Standard 29 CFR 1910.1030, CDC’s Exposure Control Plan (ECP) is in place to inform employees about appropriate control measures necessary to eliminate or minimize exposure to human blood and other potentially infectious materials.

1. CDC requires contractors that may be exposed to these hazards comply with the requirements listed in the BBP ECP.

2. All mechanical or electrical systems that must be deactivated prior to service shall be deactivated by whatever disconnect or shut-off means are provided. Each deactivated system shall be properly "tagged-out" to prevent accidental reactivation. The CDC Environmental, Safety and Health Compliance (ESHCO) will furnish "tag-out" procedures and tags. The government shall be responsible for performing surface decontamination of equipment; removing the contents of equipment and ensuring the equipment is biologically safe before making it available to the contractor service representative for service or repair.

b. Security: Information Security Continuous Monitoring - Upon the government issuance of an Authority to Operate (ATO), the vendor owned/operated systems that input, store, process, output, and/or transmit government information, shall meet or exceed the information security continuous monitoring (ISCM) requirements in accordance with FISMA and NIST SP 800-137, Information Security Continuous Monitoring (ISCM) for Federal Information Systems and Organizations, and HHS IS2P. The following are the minimum requirements for ISCM:

1. Annual Assessment/Pen Test - Assess the system security and privacy controls (or ensure an assessment is conducted) at least annually to determine the implemented security and privacy controls are operating as intended and producing the desired results (may involve penetration testing conducted by the agency or independent third-party.) Review relevant SA&A documentation (SSP, POA&M, Contingency Plan, etc.).

2. Asset Management - Using any available Security Content Automation Protocol (SCAP)-compliant automated tools for active/passive scans, provide an inventory of all information technology (IT) assets for hardware and software, (computers, servers, routers, databases, operating systems, etc.) that are processing HHS-owned information/data. It is anticipated that this inventory information will be required to be produced at least annually or to comply with CDC/ATSDR change management requirements. IT asset inventory information shall include IP address, machine name, operating system level, security patch level, and SCAP- compliant format information.

The contractor shall maintain a capability to provide an inventory of 100% of its IT assets using SCAP-compliant automated tools.

3. Configuration Management - Use available SCAP-compliant automated tools, per NIST IR 7511, for authenticated scans to provide visibility into the security configuration compliance status of all IT assets, (computers, servers, routers, databases, operating systems, application, etc.) that store and process government information.

Compliance will be measured using IT assets and standard HHS and government configuration baselines. The contractor shall maintain a capability to provide security configuration compliance information for 100% of its IT assets using SCAP-compliant automated tools.

4. Vulnerability Management - Use SCAP-compliant automated tools for authenticated scans to scan information system(s) and detect any security vulnerabilities in all assets (computers, servers, routers, Web applications, databases, operating systems, etc.) that store and process government information. Contractors shall actively manage system vulnerabilities using automated tools and technologies where practicable and in accordance with HHS policy. Automated tools shall be compliant with NIST-specified SCAP standards for vulnerability identification and management. The contractor shall maintain a capability to provide security vulnerability scanning information for 100% of IT assets using SCAP-compliant automated tools and report to the agency at least monthly.

5. Patching and Vulnerability Remediation - Install vendor released security patches and remediate critical and high vulnerabilities in systems processing government information in an expedited manner, within vendor and agency specified timeframes.

6. Secure Coding - Follow secure coding best practice requirements, as directed by United States Computer Emergency Readiness Team (US- CERT) specified standards and the Open Web Application Security Project (OWASP), that will limit system software vulnerability exploits.

7. Boundary Protection - The contractor shall ensure that government information, other than unrestricted information, being transmitted from federal government entities to external entities, is routed through a Trusted Internet Connection (TIC).

8. End of Life Compliance. The Contractor (and/or any subcontractor) must use Commercial off the Shelf (COTS) software or other software that is supported by the manufacturer. In addition, the COTS/other software needs to be within one major version of the current version;

deviation from this requirement will only be allowed via the HHS waiver process (approved by HHS CISO). The contractor shall retire and/or upgrade all software/systems that have reached end-of-life in accordance with HHS End-of-Life Operating Systems, Software, and Applications Policy.

SECTION 10 – MINIMUM VENDOR QUALIFICATIONS AND

LEVEL OF EFFORT

1. One (1) year equipment warranty on new installs.

2. The vendor shall employ a formal tracking system to identify and track equipment or software issues reported to them by the customer. The tracking system shall include a critical evaluation of the reported issues, proposed resolutions for each issue, an estimated timeline for release of updates to correct each issue, and documentation of product quality assurance activities related to validation of software fixes and enhancements. The vendor must maintain a timeline of planned future product releases to include estimated timelines and specific issues addressed as part of the expected product release and make such timelines available on request.

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.

(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 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

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

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

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

(end clause)

SECTION 11 – INFORMATION SECURITY and PRIVACY

COMPLIANCE

Standard-1: Procurements Requiring Information Security and/or Physical Access Security

1. Baseline Security Requirements a. Applicability. The requirements herein apply whether the entire contract or modification (hereafter "contract"), or portion thereof, includes either or all of the followings. No contractor will be permitted to access or operate CDC infrastructure or systems overseas unless prior approval is received from CDC CISO. i. Access (Physical or Logical) to Government Information: A Contractor (and/or any subcontractor) will have or will be given the ability to have, routine physical (entry) or logical (electronic) access to government information.

ii. Operate a Federal System Containing Information: A Contractor

(and/or any subcontractor) will operate a federal system and information technology containing data that supports the CDC mission. In addition to the Federal Acquisition Regulation (FAR) Subpart 2.1 definition of "information technology" (IT), the term as used in this section includes computers, ancillary equipment (including imaging peripherals, input, output, and storage devices necessary for security and surveillance), peripheral equipment designed to be controlled by the central processing unit of a computer, software, firmware and similar procedures, services (including support services), and related resources.

b. Safeguarding Information and Information Systems. All government information and information systems must be protected in accordance with HHS/CDC policies and level of risk. At a minimum, the Contractor (and/or any subcontractor) must:

i. Protect the: Confidentiality, which means preserving authorized restrictions on access and disclosure, based on the security terms found in this contract, including means for protecting personal privacy and proprietary information;

Integrity, which means guarding against improper information modification or destruction, and ensuring information non-repudiation and authenticity; and Availability, which means ensuring timely and reliable access to and use of information.

ii. Categorize all information owned and/or collected/managed on behalf of CDC and information systems that store, process, and/or transmit HHS information in accordance with FIPS 199 and National Institute of Standards and Technology (NIST) Special Publication (SP) 800-60, Volume II:

Appendices to Guide for Mapping Types of Information and Information Systems to Security Categories. Based on information provided by the ISSO, CISO, CDC CPO, or other representative, the impact level for each Security Objective (Confidentiality, Integrity, and Availability) and the Overall Impact Level, which is the highest watermark of the three factors of the information or information system are the following: Confidentiality: [ ] Low [ x ] Moderate [ ] High Integrity: [ ] Low [ x ] Moderate [ ] High Availability: [ ] Low [ x ] Moderate [ ] High Overall Impact Level: [ ] Low [ x ] Moderate [ ] High

iii. Based on the agreed-upon level of impact, implement the necessary safeguards to protect all information systems and information collected and/or managed on behalf of CDC regardless of location or purpose.

iv. Report any discovered or unanticipated threats or hazards by either the agency or contractor, or if existing safeguards have ceased to function immediately after discovery, within one (1) hour or less, to the government representative(s).

v. Adopt and implement all applicable policies, procedures, controls, and standards required by the CDC Information Security Program to ensure the confidentiality, integrity, and availability of government information and government information systems for which the Contractor is responsible under this contract or to which the Contractor may otherwise have access under this contract. Obtain all applicable security and privacy policies by contacting the CO/COR or CDC security and/or privacy officials.

c. Privacy Act. Comply with the Privacy Act requirements (when applicable), and tailor FAR and HHSAR clauses as needed.

d. Privacy Compliance. Comply with the E-Government Act of 2002, NIST SP 800-53, and applicable CDC privacy policies, and complete all the requirements below: i. Per the Office of Management and Budget (OMB) Circular A-130, Personally Identifiable Information (PII), is "information that can be used to distinguish or trace an individual's identity, either alone or when combined with other information that is linked or linkable to a specific individual." Examples of PII include, but are not limited to the following:

Social Security number, date and place of birth, mother's maiden name, biometric records, etc.

ii. To ensure that the public's personal information is protected in a manner commensurate with the privacy risks, CDC uses a privacy analysis process to assess the risks associated with CDC's collection and maintenance of PII and to ensure information is handled in accordance with applicable legal, regulatory, and policy requirements. PTAs analyze how information is handled in IT systems and electronic information collections and determines if the IT system or electronic information collection collects, disseminates, maintains, or disposes of PII. PIAs are used to assess the privacy risks of IT systems and electronic information collections that collect, disseminate, maintain, or dispose of PII about members of the public. PIAs also provide transparency into how CDC collects, disseminates, maintains, or disposes of the public's PII.

iii. The Contractor must support the agency with conducting a Privacy Threshold Analysis (PTA) for the information system and/or information handled under this contract to determine whether or not PII is collected, disseminated, maintained, or disposed as part of the contract. The PTA will determine if a full Privacy Impact Assessment (PIA) needs to be completed.

If the results of the PTA show that a full PIA is needed, the Contractor must support the agency with completing a PIA for the system or information within 60 days after completion of the PTA and in accordance with CDC policy and OMB M-03-22, Guidance for Implementing the Privacy Provisions of the E-Government Act of 2002.

The Contractor must support the agency in reviewing the PIA at least every three years throughout the system development lifecycle (SDLC)/information lifecycle, or when determined by the agency that a review is required based on a major change to the system, or when new types of PII are collected that introduces new or increased privacy risks, whichever comes first.

e. Controlled Unclassified Information (CUI). Executive Order 13556 defines CUI as "information that laws, regulations, or Government-wide policies require to have safeguarding or dissemination controls, excluding classified information." The Contractor (and/or any subcontractor) must comply with Executive Order 13556, Controlled Unclassified Information, (implemented at 3 CFR, part 2002) when handling CUI. 32 C.F.R.

2002.4(aa) As implemented the term "handling" refers to "…any use of CUI, including but not limited to marking, safeguarding, transporting, disseminating, re-using, and disposing of the information." 81 Fed. Reg.

63323. The requirements below apply only to nonfederal systems that process, store, or transmit CUI, or that provide security protection for such components. All sensitive information that has been identified as CUI by a regulation or statute, handled by this solicitation/contract, must be: i. Marked appropriately;

ii. Disclosed to authorized personnel on a Need-To-Know basis;

iii. Protected in accordance with NIST SP 800-53, Security and Privacy Controls for Information Systems and Organizations applicable baseline if handled by a Contractor system operated on behalf of the agency, or NIST SP 800-171, Protecting Controlled Unclassified Information in Nonfederal Information Systems and Organizations if handled by internal Contractor system; and

iv. Returned to HHS/CDC control, destroyed when no longer needed, or held until otherwise directed. Information and/or data must be disposed of in accordance with NIST SP 800-88, Guidelines for Media Sanitization.

f. Protection of Sensitive Information. For security purposes, information is or may be sensitive because it requires security to protect its confidentiality, integrity, and/or availability. The Contractor (and/or any subcontractor) must protect all government information that is or may be sensitive by securing it with a solution that is validated with current FIPS 140 validation certificate from the NIST CMVP.

g. Confidentiality and Nondisclosure of Information. Any information provided to the contractor (and/or any subcontractor) by CDC or collected by the contractor on behalf of CDC must be used only for the purpose of carrying out the provisions of this contract and must not be disclosed or made known in any manner to any persons except as may be necessary in the performance of the contract. The Contractor assumes responsibility for protection of the confidentiality of Government records and must ensure that all work performed by its employees and subcontractors must be under the supervision of the Contractor. Each Contractor employee or any of its subcontractors to whom any CDC records may be made available or disclosed must be notified in writing by the Contractor that information disclosed to such employee or subcontractor can be used only for that purpose and to the extent authorized herein.

The confidentiality, integrity, and availability of such information must be protected in accordance with HHS/CDC policies. Unauthorized disclosure of information will be subject to the HHS/CDC sanction policies and/or governed by the following laws and regulations:

i. 18 U.S.C. 641 (Criminal Code: Public Money, Property or Records);

ii. 18 U.S.C. 1905 (Criminal Code: Disclosure of Confidential Information);

and

iii. 44 U.S.C. Chapter 35, Subchapter I (Paperwork Reduction Act). h.

Internet Protocol Version 6 (IPv6). All procurements using Internet Protocol must comply with OMB Memorandum M-05-22, Transition Planning for Internet Protocol Version 6 (IPv6).

i. Information and Communications Technology (ICT). ICT products and services from prohibited entities/sources must not be used/acquired in compliance with Public Law 115-232, Section 889 Parts A and B, FAR 4.21, FAR 52.204.23, FAR 52.204.24, and FAR 52.204.25. The contractor (and/or any subcontractor) must notify the government if they identify prohibited ICT products and/or services are used during the contract performance.

j. Government Websites. All new and existing public-facing government websites must be securely configured with Hypertext Transfer Protocol Secure (HTTPS) using the most recent version of Transport Layer Security (TLS). In addition, HTTPS must enable HTTP Strict Transport Security (HSTS) to instruct compliant browsers to always assume HTTPS to reduce the number of insecure redirects and protect against attacks that attempt to downgrade connections to plain HTTP. For internal-facing websites, HTTPS is not required, but it is highly recommended. Consult HHS/CDC Policy for Internet and Email Security for additional information.

k. Contract Documentation. The Contractor must use provided templates, policies, forms and other agency documents specify which documents/forms will be provided to contractor] to comply with contract deliverables as appropriate.

l. Standard for Encryption. The Contractor (and/or any subcontractor) must: i. Comply with the HHS Standard for Encryption of Computing Devices and Information to prevent unauthorized access to government information.

ii. Encrypt all sensitive federal data and information (i.e., PII, protected health information [PHI], proprietary information, etc.) in transit (i.e., email, network connections, etc.) and at rest (i.e., servers, storage devices, mobile devices, backup media, etc.) with encryption solution that is validated with current FIPS 140 validation certificate from the NIST CMVP.

iii. Secure all devices (i.e.: desktops, laptops, mobile devices, etc.) that store and process government information and ensure devices meet and CDC Component-specific encryption standard requirements. Maintain a complete and current inventory of all laptop computers, desktop computers, and other mobile devices and portable media that store or process sensitive government information (including PII).

iv. Verify that the encryption solutions in use have been validated under the Cryptographic Module Validation Program to confirm compliance with current FIPS 140 validation certificate from the NIST CMVP. The

Contractor must provide a written copy of the validation documentation to the COR.

v. Use the Key Management system on the CDC personal identification verification (PIV) card or establish and use a key recovery mechanism to ensure the ability for authorized personnel to encrypt/decrypt information and recover encryption keys http://csrc.nist.gov/publications/. Encryption keys must be provided to CSPO.

m. Contractor Non-Disclosure Agreement (NDA). Each Contractor (and/or any subcontractor) employee having access to non-public government information under this contract must complete the CDC non-disclosure agreement, as applicable. Contractors (and/or subcontractors) must submit a copy of each signed and witnessed NDA to the Contracting Officer (CO) and/or CO Representative (COR) prior to performing any work under this acquisition.

2. Training Requirements a. Mandatory Training for All Contractor Staff.

All Contractor (and/or any subcontractor) employees assigned to work on this contract must complete the applicable CDC Contractor Information Security Awareness, Privacy, and Records Management training (provided upon contract award) before performing any work under this contract.

Thereafter, the employees must complete CDC Security Awareness, Privacy, and Records Management training at least annually, during the life of this contract. All provided training must be compliant with CDC training policies.

b. Role-based Training. All Contractor (and/or any subcontractor) employees with significant security responsibilities (as determined by the program manager) must complete role-based training annually commensurate with their role and responsibilities in accordance with HHS/CDC policy and the CDC Role-Based Training (RBT) of Personnel with Significant Security Responsibilities.

c. Training Records. The Contractor (and/or any subcontractor) must maintain training records for all its employees working under this contract in accordance with CDC policy. A copy of the training records must be provided to the CO and/or COR within 30 days after contract award and annually thereafter or upon request.

3. Rules of Behavior a. The Contractor (and/or any subcontractor) must ensure that all employees performing on the contract comply with CDC Implementation of the HHS Rules of Behavior for Use of HHS Information Technology Resources.

b. All Contractor employees performing on the contract must read and adhere to the Rules of Behavior before accessing agency data or other information, systems, and/or networks that store/process government information, initially at the beginning of the contract and at least annually thereafter, which may be done as part of annual CDC Information Security Awareness Training.