Performance of Work Statement.pdf

Performance Work Statement

Title: Service and Maintenance of AB Sciex Laboratory Equipment

Period of performance of this contract is: 05/01/2026 to 04/30/2031

Base Period: 05/01/2026 to 04/30/2027

Option Period One: 05/01/2027 to 04/30/2028

Option Period Two: 05/01/2028 to 04/30/2029

Option Period Three: 05/01/2029 to 04/30/2030

Option Period Four: 05/01/2030 to 04/30/2031

SECTION 1 – BACKGROUND

The Centers for Disease Control and Prevention (CDC) in Atlanta, GA, utilizes AB Sciex laboratory instrumentation to perform critical chemical analyses in support of its public health mission. Most of this equipment is housed within the Division of Laboratory Sciences (DLS) of the National Center for

Environmental Health (NCEH). These instruments play a vital role in analyses related to chemical terrorism; emergency response, biomonitoring, and research and development aimed at creating new analytical methods for a diverse range of sample types across critical projects.

The government requires ongoing preventative maintenance and repair services for all instrumentation listed in the attached equipment list. This contract pertains to the maintenance of AB Sciex instrumentation within the DLS. The DLS/NCEH/CDC is recognized by Congress’ Federal Response Plan for Terrorism as the primary facility for measuring chemical warfare agents and their metabolites in humans. Additionally, the Division is tasked with assessing environmental toxicants in humans, a process referred to as biomonitoring.

Due to the complexity of these instruments, their maintenance and repair require a high level of technical expertise and specialized training. To ensure preparedness for potential chemical or biological terrorist events, as well as environmental emergencies, it is critical that these instruments remain operational at least 95% of the time.

SECTION 2 – PURPOSE/OBJECTIVE

The purpose of this procurement is to obtain a service agreement for AB Sciex mass spectrometers and liquid chromatographs, which are no longer covered by warranties, along with the third-party gas generators and vacuum pumps essential for their operation. The Government expects this acquisition to ensure optimal performance of all instruments, thereby minimizing costly repairs and downtime, ultimately enhancing the efficiency of public health analyses.

The primary objective is to maintain the functionality and reliability of the Sciex mass spectrometers and liquid chromatographs to support critical public health missions. Required performance objectives include maintaining an operational uptime of at least 95% for all instruments, ensuring timely repairs, and preventing equipment failures that could disrupt laboratory operations.

SECTION 3 – SCOPE OF WORK

This contract covers maintenance and repair services for hundreds of instruments and instrument components, as detailed in the attached equipment list. The primary purpose of this project is to ensure the functionality and reliability of AB Sciex mass spectrometers, liquid chromatographs, and associated equipment, thereby supporting the CDC's critical public health mission.

The objectives include maintaining optimal performance, minimizing downtime, and reducing the risk of costly repairs due to equipment failures. The project requires comprehensive maintenance services, with the understanding that instruments may be added or removed from the list as they reach the end of their operational life.

Contractor responsibilities include performing scheduled maintenance and repairs, providing qualified personnel, and maintaining accurate records of all activities. The Government will ensure access to the instrument and meet deadlines to avoid delays.

Overall, this contract aims to keep analytical systems operational and effective in supporting public health initiatives while allowing for flexibility in managing the instrument inventory throughout the contract's duration.

SECTION 4 – TASKS TO BE PERFORMED

All activities are ongoing and should continue as outlined in the base year. Upon award of the contract, the contractor shall provide maintenance, both remedial and preventative, for equipment included on the attached equipment list. The contractor will perform the following tasks:

Task 1: General Service Requirements

1. Upon completing work at each service location, the contractor must restore the work site to its original condition or better. This includes disposing of discarded parts, containers, packing materials, and debris, as well as cleaning any chemical spills. The contractor must ensure no safety or fire hazards exist at the site. Government-owned dumpsters may be used for waste disposal, except for metal parts, which must be removed by the contractor. The area around serviced equipment should be left clean and orderly. The contractor is responsible for all labor, parts, and travel costs for both repair and preventative maintenance services. Warranty instruments will receive the same entitlements and response times as the covered instruments, excluding preventative maintenance until the warranty expires.

Task 2: Repair Services

1. Repair services include troubleshooting, replacement or restoration of parts, and all contractor services required to return installed CDC laboratory equipment to the operational levels prior to need for repair and design specifications in accordance with OEM recommendations and requirements or exceeding them.

2. Initial confirmation of request shall be within 4 hours of formal service call placement.

3. The contractor shall respond within 24 hours to service call requests for instruments covered in the contract. Response will be in one of the following forms, depending on the nature of the problem and as requested by CDC personnel:

a. a telephone call or email troubleshooting the problem and resulting in repair of the equipment by CDC personnel;

b. dispatch of part(s) for problem resolution with instructions for replacement or repair by

CDC personnel;

c. an on-site visit by service representative;

d. other method that will resolve the issue and is acceptable to the CDC end user.

4. If the contractor service representative is unable to complete the required service and return equipment to good working conditions during the initial service call and within 5 working days, the contractor shall provide a written timeline for repair agreed upon by both the end user, service technician and senior service representative by no later than 48 hours thereafter.

5. During situations where the CDC laboratory is responding to a national emergency directly involving the DLS laboratories, the Contractor will provide repair services required as needed 24 hours per day, 7 days per week at no additional cost to the Government. The Contractor will provide a point of contact, available 24 hours, to receive service requests for the duration of the national emergency. The Contractor shall respond within four (4) hours to notification of problems or equipment failure and shall perform repairs as necessary to put the system back into service.

6. Contractor workmanship shall be at or above industry quality standards; and any government notice of non-acceptability shall be rectified by the contractor within 48 hours of notice, at no additional cost to the government.

7. Necessary replacement parts shall be “new” not “used” or “reconditioned” (unless mutually agreed to by the CDC program in advance and replacement parts are Sciex Factory Reconditioned).

8. The cost of labor, travel, replacement materials, parts or supplies required to complete routine repair of CDC laboratory equipment and restore to OEM operational specifications shall be the sole responsibility of the contractor; and shall be provided at no additional cost to the government.

9. In the event that covered equipment is to be relocated to an alternate site, the Contractor shall provide appropriate service to ensure the safe transport, installation, and ensure the full operational condition of the equipment in the new location at no additional cost to the government.

10. For equipment where it is determined the quickest fix is to ship the equipment for repairs, the contractor shall provide a suitable loaner agreed upon by the end user. The Contractor shall pay for all shipping charges for return, repair, loaner or replacement of equipment.

11. The contractor shall ensure hardware and software installation, operation, maintenance, update, and patching will not alter the configuration settings or requirements specified above.

12. The contractor shall guarantee that the service performed, and the products and parts supplied to repair or replace the equipment, conform to standards of workmanship prevailing in the trade.

13. If service is required for instruments not currently under contract, repair costs and/or preventative maintenance visits may be covered by government purchase card.

Task 3: Preventative Maintenance

1. The contractor shall perform up to two annual electrical and mechanical preventive maintenance services on CDC laboratory equipment in accordance with original equipment manufacturer

(OEM) recommendations and requirements or exceeding them.

2. Preventive maintenance services include up to two annual periodic inspections and on-site service of installed equipment, in accordance with OEM recommendations or exceeding them; including, but not limited to cleaning, calibration, adjustments, replacement or restoration of parts, as necessary, and all services required to ensure equipment operates at peak capacity for the laboratory use and meets OEM operational and design specifications.

3. PM shall include Q1 and Q3 cleaning and detector replacement if needed by the instrument or reported as needed by the end user.

4. Preventive maintenance services shall be performed in accordance with a proposed contractor schedule, which shall be coordinated with CDC scientists.

5. The contractor shall provide a copy of the preventative maintenance schedule to the COR within 2 months of contract award or new option year.

6. Preventative maintenance services shall be coordinated with scientists to maximize system efficiency and minimize system downtime.

7. The contractor shall provide all consumables and reagents used for troubleshooting and performance verification testing both for preventative maintenance visits and repairs.

8. If during the course of preventative maintenance, the engineer detects any parts or components that are not performing properly, the contractor shall take necessary steps to make repairs at that time or schedule repairs and notify CDC program that additional repairs are necessary. If potential issues are noticed by the contractor that fall outside the scope of the preventative maintenance being performed, the CDC program shall be notified.

9. If preventative maintenance is not completed by the scheduled date, the contractor shall notify the

COR and develop a plan for completing the PM within two weeks of the PM scheduled date.

Task 4: Service Engineers

1. Service engineers are considered visitors and must have proper approved access into CDC laboratories. Service engineers must follow all CDC policies and procedures and abide by all DLS laboratory safety requirements.

2. At CDC, all non-U.S. citizen service engineers are required to register 10 days prior to a visit through the Non-U.S. Citizens Access Management System (NCAMS). Due to the time sensitivity of instrument repairs and maintenance, it is required that field service engineers be a U.S. citizen or plan accordingly to ensure no delay to service.

3. On-site Contractor operations are subject to compliance with all applicable OSHA rules and regulations. All incidents and injuries to Contractor employees shall be promptly investigated by the

Contractor. A copy of the incident report shall be furnished to the COR and the Contracting Officer.

4. The service engineers shall provide CDC with Sciex training records and certifications requisite for

DLS instrumentation in order to maintain records necessary for CDC equipment Clinical Laboratory

Improvement Amendments (CLIA) certification.

5. On-site engineers shall abide by all CDC laboratory safety guidelines.

6. Service engineers shall follow CDC standards of conduct and ethics.

7. CDC badges may be given to on-site service engineers and service engineers who visit CDC/DLS regularly and are considered essential by the Contracting Officer Representative.

a. Service Engineers must complete any CDC or laboratory safety required training in order to receive a badge.

b. CDC Badges may be revoked at any time.

Task 5: Service Records and Point of Contact

1. The Contractor shall provide a service invoice (field service report) to the instrument user and the

COR/technical monitor detailing the work that was completed following remedial and preventative maintenance. This includes:

a. Providing the user with a printout and electronic copy of calibration verification performed during preventative maintenance to include in instrument logs.

b. At a minimum, service tickets shall contain the following information: Contract Order #, Manufacturer, Model Number, Serial Number, CDC Property Number (if applicable), Program Contact, Location, Type of Service (preventive maintenance, routine repair, etc.), Ticket open date/time, Date of Service and a Description of Service that was performed

(i.e. calibration, parts replaced, etc.) for each instrument, ticket closed date/time.

2. The Contractor shall designate a point of contact to coordinate all activities including, but not limited to, contract administration, billing, ordering and shipping, and serve as the primary Point of

Contact (POC) between the Contractor and CDC Contracting Officer or designated CDC

Contracting Officer’s Representative (COR).

Task 6: Reporting Schedule

The contactor shall, at a minimum, provide the following:

1. Monthly Report: by the 15th day of each month, the contractor shall provide the Contracting

Officer’s Representative a Monthly Report of services provided during the preceding calendar month. From, format and content of the report may be revised, but as a minimum shall provide the following information:

a. A summary of the number of preventive service calls originally scheduled and completed to date.

b. A summary of the number and types of government requests for service, dates received, and dates completed; individual turn-around time for each service; and average turn-around times for each type of service.

c. A brief description of any outstanding problems and/or issues for each type of service, with options and recommendations for resolution.

d. An updated list of badged Field Service Engineers currently working in DLS labs.

e. An updated list of newly installed equipment with date and serial number.

2. Quarterly Conference Call: A quarterly conference call with CDC COR/Technical Monitor must be held in the last two weeks of each quarter, initiated and led by the contractor. The purpose of this call is to be an ongoing review of contract performance. The discussion from the conference call must be documented in the following monthly report. Any required performance improvements must be documented/reported in the monthly reports.

3. Annual Meeting: An annual meeting initiated and led by the contractor. The meeting shall be focused on equipment service issues and continuous improvement for instrument end users. The meeting may also include hands-on training provided by the contractor, designed to train end users in basic to intermediate instrument cleaning, maintenance, troubleshooting, or simple repairs.

SECTION 5 – GOVERNMENT FURNISHED PROPERTY

No Government Furnished Property is specified. The contractor shall be responsible for providing all labor, parts, and materials.

SECTION 6 – PLACE OF PERFORMANCE AND CONTRACT SUPPORT HOURS

SUBSECTION A – PLACE OF PERFORMANCE

Centers for Disease Control and Prevention in Atlanta, GA

SUBSECTION B – CONTRACT SUPPORT HOURS

Normal hours of operation follow the CDC standard operating hours. During situations where the CDC laboratory is responding to a national emergency, the Contractor shall provide repair services required as needed 24 hours per day, 7 days per week at additional costs to the government. The Contractor shall provide a point of contact available to receive service requests in after-hour times. The Contractor shall respond within four (4) hours to notification of problems or equipment failure and shall perform repairs as necessary to put the system back into service.

SECTION 7 – TRAVEL

None.

SECTION 8 – DELIVERABLES/REPORTING SCHEDULE

The following deliverables shall be carried out and completed by the contractor:

Task Deliverable Quantity Delivery Date Deliver To

2 Confirmation of repair request 1 per service call

Within 4 hours of service request placement

End users

2 Software and firmware patches and support

As needed Throughout the award period based on need

End users

3 Preventive maintenance visits Up to 2 annually per instrument

Throughout the award period based on individual instrument service record

End users

3 Preventative maintenance instrument schedule

1 per year Within 2 months of the initial contract award or option year exercise

COR

4 Sciex certificate of trainings for service engineers

1 per FSE Within 2 months of the initial contract award or option year exercise

COR

5 Service invoice/records (field service reports) for all remedial and preventative maintenance visits

1 per service request/PM

Throughout the award period due upon completion of PM or remedial service

End users

6 Monthly report 1 per month By the 15th of each month COR

6 Quarterly conference call 1 per quarter During the last two weeks of each quarter

COR

6 Annual meeting 1 Due within 12 months after the award or option period expiration

COR

SUBSECTION A – PERFORMANCE MATRIX

PERFORMANCE

OBJECTIVE

STANDARD PERFORMANCE

THRESHOLD

ACCEPTABLE

QUALITY LEVELS

(AQLs)

METHOD OF

SURVEILLANCE

Prompt confirmation of service call requests

Contractor shall provide written confirmation of request for repair within four hours of formal service call placement

90% compliance Review of field service reports

Prompt and effective resolution of service call requests

The contractor shall provide 24-hour response by service engineer and fully, successfully repair equipment within 5 working days.

If the repair requires additional time, a written plan must be agreed upon within 48 hours.

90% compliance Review of field service reports

Timely and effective preventive

The contractor shall provide preventive maintenance services

90% compliance Review of field service reports

PERFORMANCE

OBJECTIVE

STANDARD PERFORMANCE

THRESHOLD

ACCEPTABLE

QUALITY LEVELS

(AQLs)

METHOD OF

SURVEILLANCE

maintenance of instruments in accordance with a contractor proposed schedule that shall be coordinated with CDC scientists, and the PM visits shall meet or exceed OEM PM guidelines

Thorough and accurate field service reports

Contractor shall provide a field service report following remedial or preventative maintenance within one week of service

95% compliance Review of field service reports

Timely, fully complete, and accurate monthly reports

Contractor shall provide a monthly report by the 15th of every month

95% compliance 100% inspection

Timely quarterly conference calls

Contractor shall lead a quarterly conference call within the last two weeks of each quarter

95% compliance 100% inspection

Annual onsite meeting The contractor shall provide an annual onsite meeting focused on equipment service issues and continuous improvement for end users.

95% compliance 100% inspection

SECTION 9 – REFERENCE MATERIALS

OCISO Standard for Portable Media and Mobile Device Security

SECTION 10 – MINIMUM VENDOR QUALIFICATIONS

Certified OEM Sciex trained service engineers; ability to provide service records and training certificates.

SECTION 11 – ADDITIONAL REQUIREMENTS

Information Security and Privacy

1. Baseline Security Requirements:

a. Applicability. The requirements herein apply whether the entire contract or modification (hereafter "contract"), or portion thereof, includes either or both of the following:

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:

c. 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/[CDC Component] and information systems that store, process, and/or transmit CDC 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 System Security and

Privacy Officer (previously referred to as 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 [ ] Moderate [ ] High

▪ Integrity: [ ] Low [ ] Moderate [ ] High

▪ Availability: [ ] Low [ ] Moderate [ ] High

▪ Overall Impact Level: [ ] Low [ ] 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/[CDC Component] 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/[CDC

Component] 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 http://csrc.nist.gov/publications/nistpubs/800-60-rev1/SP800-60_Vol2-Rev1.pdf http://csrc.nist.gov/publications/nistpubs/800-60-rev1/SP800-60_Vol2-Rev1.pdf http://csrc.nist.gov/publications/nistpubs/800-60-rev1/SP800-60_Vol2-Rev1.pdf http://csrc.nist.gov/publications/nistpubs/800-60-rev1/SP800-60_Vol2-Rev1.pdf 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/[CDC

Component] security and/or privacy officials.

d. Privacy Act. Comply with the Privacy Act requirements

(when applicable), and tailor FAR and HHSAR clauses as needed.

e. Privacy Compliance. Comply with the E-Government Act of 2002, NIST SP 800-53, and applicable CDC Component 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 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 [CDC to insert contract-specific timeline] 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.

f. 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.

g. 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.

h. 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).

i. 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).

j. 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.

k. 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. According to the CDC Web policy, all CDC web content must reside on a CDC.gov domain and must be hosted on CDC or CDC-authorized information systems .

l. Contract Documentation. The Contractor must use provided templates, policies, forms, and other agency documents [CDC

Component] specify which documents/forms will be provided to contractor] to comply with contract deliverables as appropriate.

m. 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 CDC 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 [CDC Component- provided delivery date].

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.

n. 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. [inserted information/link should be cited here], 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 Component-specified]

Information 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 http://csrc.nist.gov/publications/ 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 the CDC

Implementation of the HHS Rules of Behavior for Use of HHS

Information Technology Resources, and [insert any CDC

Component-specific rules, as applicable].

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. If the training is provided by the Contractor, the signed

ROB must be provided as a separate deliverable to the CO and/or

COR per defined timelines above.

4. Incident Response:

a. The Contractor (and/or any subcontractor) must respond to all alerts/Indicators of Compromise (IOCs) provided by CDC

Computer Security Incident Response Center (CSIRC) IRT teams within 24 hours, whether the response is positive or negative. In accordance with FISMA and OMB M-17-12, Preparing for and Responding to a Breach of Personally

Identifiable Information (PII)29, an incident is "an occurrence that

(1) actually or imminently jeopardizes, without lawful authority, the integrity, confidentiality, or availability of information or an information system; or (2) constitutes a violation or imminent threat of violation of law, security policies, security procedures, or acceptable use policies" and a privacy breach is "the loss of control, compromise, unauthorized disclosure, unauthorized acquisition, or any similar occurrence where (1) a person other than an authorized user accesses or potentially accesses personally identifiable information or (2) an authorized user accesses or potentially accesses personally identifiable information for an other than authorized purpose." For additional information on the CDC breach response process, please see the CDC Standard for Responding to

Breaches of Personally Identifiable Information (PII).30"

b. Contracts with entities that collect, maintain, use, or operate Federal information or information systems on behalf of CDC must include in the following requirements:

i. The Contractor shall cooperate with and exchange information with CDC officials, as deemed necessary by the CDC Breach Response Team, to report and manage of a suspected or confirmed breach.

ii. All contractors and subcontractors shall properly encrypt

PII in accordance with OMB Circular A-130 and other applicable policies, including CDC-specific policies, and comply with HHS-specific policies for protecting PII. To this end, all contractors and subcontractors shall protect all sensitive information, including any PII created, stored, or transmitted in the performance of this contract, with encryption solution that is validated with the current

FIPS 140 validation certificate from the NIST CMVP.

iii. All contractors and subcontractors shall participate in regular training on how to identify and report a breach

iv. NOT notify affected individuals unless so instructed by the Contracting Officer or designated representative. If instructed by the Contracting Officer or representative, the Contractor must send [CDC Component] approved notifications to affected individuals [insert CDC

Component Specific timeline, process, and format].

v. Report all suspected and confirmed information security and privacy incidents and breaches to the CSPO Incident

Response Team (IRT) [contact information should be cited here], COR, CO, CDC CPO (or his or her designee), and other stakeholders, including breaches involving PII, in any medium or form, including paper, oral, or electronic, as soon as possible and without unreasonable delay, no later than one

(1) hour, and consistent with the applicable CDC Component and

CDC policy and procedures, NIST standards and guidelines, as well as US-CERT notification guidelines. The types of information required in an incident report must include at a minimum: company and point of contact information, impact classifications/threat vector, and the type of information compromised. In addition, the Contractor must:

▪ Cooperate and exchange any information, as determined by the

Agency, necessary to effectively manage or mitigate a suspected or confirmed breach;

▪ Not include any sensitive information in the subject or body of any reporting e-mail; and

▪ Encrypt sensitive information in attachments to email, media, etc.

vi. Comply with OMB M-17-12, Preparing for and

Responding to a Breach of Personally Identifiable

Information, and CDC Component and CSPO privacy breach response policies when handling PII breaches.

vii. Provide full access and cooperate on all activities as determined by the Government to ensure an effective incident response, including providing all requested images, log files, and event information to facilitate rapid resolution of sensitive information incidents. This may involve disconnecting the system processing, storing, or transmitting the sensitive information from the Internet or other networks or applying additional security controls. This may also involve physical access to contractor facilities during a breach/incident investigation [CDC Component insert timeline if required].

viii. All contractors and subcontractors shall be able to determine what Federal information was or could have been accessed and by whom, construct a timeline of user activity, determine methods and techniques used to access Federal information, and identify the initial attack vector.

ix. Cloud service providers shall use guidance provided in the FedRAMP Incident Communications

Procedures when deciding when to report directly to

US-CERT first or notify CDC first.

x. Acknowledge that CDC will not interpret report of a breach, by itself, as conclusive evidence that the

Contractor or its subcontractor failed to provide adequate safeguards for PII.

5. Position Sensitivity Designations:

All Contractor (and/or any subcontractor) employees must obtain a background investigation commensurate with their position sensitivity designation that complies with Parts 1400 and 731 of Title 5, Code of Federal Regulations (CFR). The following position sensitivity designation levels apply to this solicitation/contract.

6. Homeland Security Presidential Directive (HSPD)-12:

The Contractor (and/or any subcontractor) and its employees must comply with Homeland Security Presidential Directive (HSPD)-12, Policy for a Common Identification Standard for Federal Employees and

Contractors; OMB M-05-24; OMB M-19-17; FIPS 201, Personal

Identity Verification (PIV) of Federal Employees and Contractors;

HHS/CDC HSPD-12 policy; and Executive Order 13467, Part 1 §1.2.

7. Roster:

The Contractor (and/or any subcontractor) must submit a roster by name, position, e-mail address, phone number and responsibility, of all staff working under this acquisition where the Contractor will develop, have the ability to access, or host and/or maintain a government information system(s). The roster must be submitted to the COR and/or CO by [CDC Component Specific timeline] of the effective date of this contract. Any revisions to the roster as a result of staffing changes must be submitted immediately upon [CDC Component Specific timeline] change. The COR will notify the Contractor of the appropriate level of investigation required for each staff member.]

If the employee is filling a new position, the Contractor must provide a position description, and the Government will determine the appropriate suitability level.

8. Contract Initiation and Expiration:

a. General Security Requirements. The Contractor (and/or any subcontractor) must comply with information security and privacy requirements, Enterprise Performance Life Cycle

(EPLC) processes, CDC Enterprise Architecture requirements to ensure information is appropriately protected from initiation to expiration of the contract. All information systems development or enhancement tasks supported by the Contractor must follow the CDC EPLC framework and methodology or

[insert CDC Component-specific requirement] and in accordance with the CDC Office of Financial Resources (OFR)

Contract Closeout Guide and HHS Closeout Guide: Contracts and Orders.

b. System Documentation. Contractors (and/or any subcontractors) must follow and adhere to CDC System

Development Life Cycle requirements, at a minimum, for system development and provide system documentation at designated intervals (specifically, at the expiration of the contract) within the EPLC that require artifact review and approval.

c. Sanitization of Government Files and Information. As part of contract closeout and at expiration of the contract, the Contractor

(and/or any subcontractor) must provide all required documentation to the CO and/or COR to certify that, at the government's direction, all electronic and paper records are appropriately disposed of and all devices and media are sanitized in accordance with NIST SP 800-88, Guidelines for Media

Sanitization.

d. Notification. The Contractor (and/or any subcontractor) must notify the CO and/or COR and System Security and Privacy

Officer (previously referred to as ISSO) within [CDC

Component-specific timeline] before an employee stops working under this contract.

e. Contractor Responsibilities upon Physical Completion of the

Contract. The Contractor (and/or any subcontractors) must return all government information and IT resources (i.e., government information in non-government-owned systems, media, and backup systems) acquired during the term of this contract to the CO and/or COR. Additionally, the Contractor must provide a certification that all government information has been properly sanitized and purged from Contractor-owned systems, including backup systems and media used during contract performance, in accordance with HHS and/or CDC policies.

f. The Contractor (and/or any subcontractor) must perform and document the actions identified in the [CDC Component]

Contractor Employee Separation Checklist [insert links to CDC

Component form] when an employee terminates work under this contract within [insert CDC Component-specific timeline] days of the employee's exit from the contract. All documentation must be available to the CO and/or COR upon request.

9. Records Management and Retention:

a. The Contractor (and/or any subcontractor) must maintain all information in accordance with Executive Order 13556 --

Controlled Unclassified Information, National Archives and

Records Administration (NARA) records retention policies and schedules and CDC Policy for Records Management and [CDC

Component] policies and must not dispose of any records unless authorized by CDC/ [CDC Component].

b. If a Contractor (and/or any subcontractor) accidentally disposes of or destroys a record without proper authorization, he/she must document and report the incident in accordance with CDC/ [CDC Component] policies.

10. High Value Asset (HVA):

If a system is identified as HVA, the Contractor must comply with the HHS

Policy for the High Value Asset (HVA) Program and the Department of

Homeland Security (DHS) HVA Control Overlay in addition to the above requirements.

Installation and Servicing of Equipment Contractor shall scan all media (CDs, DVDs, portable hard drives, thumb drives, etc.) used for upgrading and installing the vendor’s software/firmware with antivirus software that has the latest virus signatures. The scans shall occur before using the media in a CDC computer/device and when moving the media between CDC computers/devices.

If in the performance of this contract, the contractor must replace an information storage device (hard drive, non-volatile flash memory module, etc.) or service equipment offsite, the contractor must remove the information storage device(s) from the equipment and provide it to CDC to be either destroyed or erased. The contractor shall not bring off-site any part of the equipment they are servicing that contains CDC data.

Human Subjects Protections in Research

N/A

Paperwork Reduction Act (PRA)

N/A

Section 508 Compliance

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

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.