75D301-24-Q-78290_Attachment_CDC_Agilent Bravo Silver Maintenance 2024-2029_PWS_Clauses and Provisions.pdf

75D301-24-Q-78290_Attachment_CDC_ Agilent Bravo Silver Maintenance 2024-2029_PWS, Clauses and Provisions

Title: Simple Acquisition Procurement of Maintenance Service Agreement for Agilent Bravo NGS System (Platform

S/N:SG1931B006 and Tip Head S/N:1929N003)

SECTION 1 – BACKGROUND

The Chronic Viral Diseases Branch (CVDB) within the National Center for Emerging and Zoonotic Infectious

Diseases (NCEZID) at the Centers for Disease Control and Prevention (CDC) uses the Agilent Bravo NGS liquid handling system to conduct laboratory research that helps support the mission to improve public health with focused biomedical research in Human Papillomavirus (HPV).

CVDB uses the Bravo to help save time and achieve consistent data across samples. Molecular Epidemiology team uses Bravo mainly for library preparation for HPV whole genome sequencing method(eWGS). Through these methods the program was able to identify novel HPV types and is currently investigating the consequences of these findings.

The program has a current contract with Agilent Technologies, purchased as a simplified acquisition procurement and the final exercised option year ends on August 31st, 2024. The Bravo system has had a maintenance plan since the instrument purchase in 2019. To avoid gap in coverage, Chronic Viral Diseases Branch requests to establish a new agreement starting on September 1st, 2024. Agilent Technologies has maintained CVDB Bravo system according to manufacturer specifications with no issues with the provider to report.

SUBSECTION A – DEFINITIONS

CVDB: Chronic Viral Diseases Branch

HPV: Human Papillomavirus

NGS: Next Generation Sequencing eWGS: Whole Genome Sequencing

QC: Quality Control

QMS: Quality Management System

Nucleic Acid: DNA (Deoxyribonucleic Acid) and RNA (Ribonucleic Acid) are molecular structures that codes for genetic instructions for living and reproduction of all known organisms and many viruses.

SECTION 2 – PURPOSE

The purpose of this acquisition is to establish an annual maintenance service contract to provide any maintenance services and any repair to the Agilent Bravo NGS system, serial number (SG1931B006), from the manufacturer, Agilent Technologies. The instrument shall be maintained to the level of manufacturer’s specifications and function to meet CVDB’s laboratory needs in specimen processing. The Bravo liquid handling platform with gripper

(S/N:SG1931B006) and 96 channel disposable tip head (S/N:G5055A) will be covered under the annual maintenance service contract. The manufacturer will provide exceptional customer service and send expert-level engineers for maintenance and repairs. Technical support will be provided by those who are certified to perform work on the Agilent Bravo NGS system including software updates when necessary. Preventative maintenance shall be provided annually by the manufacturer and document all repair or maintenance work in service reports. Agilent

Technologies will not replace any parts of the instrument with refurbished materials, but only with parts by original equipment manufacturer.

SECTION 3 – SCOPE OF WORK

1. The contractor shall perform one (1) annual preventive maintenance service on the equipment following original equipment manufacturer (OEM) recommendations and requirements.

2. Preventive maintenance services shall be performed, under the proposed schedule listed in the contract, which shall be coordinated with CDC scientists at the beginning of each contract year, to minimize disruption to planned laboratory experiments.

3. The contractor shall provide unscheduled repair services as requested by the CDC Project Officer or designee. It is expected that a response to these requests will happen within 2-4 business days.

4. The contractor will supply detailed reports of all tasks performed at every service visit.

SECTION 4 – TASKS TO BE PERFORMED

Task 1: General Services

a) The contractor shall perform necessary, appropriate, and complete mechanical and electrical

“preventative maintenance” or “repair” services for the Agilent Bravo NGS system, serial number

(SG1931B006)

b) The contractor shall service the 96 channel disposable tip head (S/N: G5055A) at their service center and must provide a return form, guidance and/or materials to the end user to ensure proper delivery to service site.

c) The contractor shall perform the maintenance on the Bravo liquid handling platform with gripper

(S/N:SG1931B006) onsite following CDC’s guidance on visitation and laboratory safety.

d) A schedule of equipment maintenance services shall be proposed by the contractor at the beginning of the contract.

e) Contractor shall coordinate with program scientists for any services scheduled and approved by the

Project Officer.

f) Contractor shall communicate any deviations of services to the program and approved by the Project

Officer. Any significant changes shall be reported in a modification of contract by the Program Office.

g) Contractor Service Representatives scheduled to service equipment at CDC need to adhere to CDC visitor guidelines.

i. Designated program contacts will escort Contractor Service Engineers to the location of equipment to be serviced; and shall be present at that location until service work is completed.

ii. During all times that the Contractor Service Engineer is on-site at CDC, he or she shall be escorted by an appropriate program contact – no exceptions.

h) At the completion of work at each service location, the Contractor Service Engineer shall restore the work site to its original condition.

i. Work site clean-up shall include disposal of any discarded parts, empty containers, packing materials, trash, and debris.

ii. All chemical spills on equipment and/or surrounding floor shall be removed using proper procedures stated in CDC Laboratory Safety guidelines; and these areas shall be cleaned to return to their original condition.

iii. The contractor shall comply with all applicable hazardous waste disposal requirements.

iv. The contractor shall not create or permit any safety or fire hazard to exist at the equipment site.

v. Government-owned dumpsters may be used for disposal of waste materials except for metal parts and components, which shall be removed by the vendor.

vi. The general area of serviced equipment shall be left in a clean and orderly condition free of any trash or debris resulting from preventive maintenance and/or service activities.

i) If equipment must be removed from the CDC Roybal Campus to complete required service, the vendor must first obtain written approval of the CDC Project Officer or designee. Any contractor limitations or restrictions on the use of replacement equipment shall be provided in writing to the CDC Project Officer or designee and conspicuously posted at the site of the equipment.

i. The contractor shall be solely responsible for purchase, replacement, installation and disposal of materials, parts, travel, labor, and supplies required to return CDC laboratory equipment to OEM operational and design specifications.

ii. The contractor shall be responsible for safeguarding any equipment that must be removed from

CDC campuses to complete service.

iii. 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.

iv. The government shall be responsible for performing surface decontamination of equipment;

removing the contents of equipment; and, ensuring that the equipment is biologically safe before making it available to the contractor service representative for service or repair.

j) On-Site Record of Service: At the completion of each service call, including preventive maintenance calls, contractor service representatives shall present the CDC program contact with a service ticket, which both the contractor service representative and the CDC program contact shall sign.

i. The vendor service representative shall affix a service sticker to each piece of equipment each time service is performed on that piece of equipment. The sticker shall reflect the vendor

(manufacturer) name, contract number, equipment model and serial number, vendor service representative (name and phone number), date of service and provide a detailed description of the services performed.

ii. One (1) copy of the signed service ticket or report shall be left with the CDC program contact;

one (1) copy of the signed service ticket shall be provided to the Project Officer. As a minimum, service tickets shall contain the following information: Contract #, Manufacturer, Model

Number, Serial Number, CDC Property Number (if applicable), Program Contact, Location, Type of Service (preventive maintenance, routine repair, etc.), Date of Service and a Description of Service that was performed (i.e., calibration, parts replaced, etc.) for each instrument.

iii. Service invoices shall be sent to CDC Office of Acquisition Services (OAS) according to payment terms listed in the award contract.

Task 2: Preventive Maintenance Services

a) Preventive maintenance services include periodic inspections and on-site service of installed equipment, in accordance with OEM recommendations; including, but not limited to cleaning, calibration, adjustments, replacement or restoration of parts, as necessary, and all services required to return equipment to OEM operational and design specifications.

b) Necessary replacement parts shall be “new”; not “used” or “reconditioned”. The cost of replacement materials, parts or supplies required to complete preventive maintenance service and restore CDC’s laboratory equipment to OEM operational and design specifications shall be the sole responsibility of the contractor; and shall be provided at no additional cost to the government.

c) The contractor shall provide necessary, appropriate, and complete preventive maintenance services to

CDC’s laboratory equipment, as specified by subsequent task orders against awarded contract.

d) The contractor shall provide update installations at the time of scheduled preventive maintenance visits, as released for use on the instrument per manufacturer’s recommendations to maintain instrument reliability, usability, and safety; third party software upgrades are only included in the coverage if explicitly listed in the quotation as essential hardware, firmware, or software updates.

e) Preventive maintenance services shall be performed in accordance with a schedule to be proposed by the contractor at the beginning of each contract year, coordinated with program scientists and approved by the

CDC Project Officer or designee.

f) Only certified and technically qualified service representatives shall be assigned to perform preventive maintenance services and/or to work on CDC laboratory equipment. In addition, supervisory technical personnel shall always be available to assist contractor service representatives, as necessary to resolve problem issues.

Task 3: Repair Service

a) Routine repair services include replacement or restoration of parts and all contractor services required to return installed CDC laboratory equipment to OEM operational and design specifications.

b) Necessary replacement parts shall be “new”; not “used” or “reconditioned”. The cost of 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 vendor; and shall be provided at no additional cost to the government.

c) Only certified and technically qualified service representatives shall be assigned to respond to government requests for repair services and/or to work on CDC laboratory equipment. In addition, supervisory technical personnel shall always be available to assist vendor service representatives, as necessary to resolve problem issues.

d) Requests for routine repair service may be made by the Project Officer, or designee. Requests may be made via phone or e-mail.

e) Requests for repair services are expected to be addressed within two (2) to four (4) business days.

f) In the event CDC’s equipment must be removed from government facilities to complete necessary repairs, the Project Officer shall be notified before any such action is taken; and current CDC procedures for removal of government-owned equipment shall be followed. Written procedures and appropriate forms will be provided by the CDC program contact.

g) Contractor shall perform necessary, appropriate, and complete repair services of the Agilent Bravo system within CVDB Laboratory as requested by the CDC Project Officer or designee throughout the period of performance specified by the contract.

h) Contractor responses to requests for repair services shall be performed within two (2) to four (4) business days and shall be considered “complete” when the equipment has been returned to good operating condition and is performing in accordance with OEM operational and design specifications.

Task 4: Government Responsibilities

a) CDC program contacts shall meet contractor service representatives at visitor location, when needed.

CDC program staff shall always escort vendor service representatives to and from equipment locations and while the vendor service representative is on CDC property. At completion of the service call, the

CDC program contact shall escort the contractor service representative back to the visitor center.

b) The CDC Project Officer and/or designee will monitor the service performance; and shall be responsible for documenting acceptance or rejection of vendor services with five (5) calendar days of services being rendered. If inspection and written (e-mail) notice of rejection has not been provided to the vendor within ten (10) days of service, such services will be determined acceptable.

SECTION 5 – GOVERNMENT FURNISHED MATERIALS

None

SECTION 6 – PERIOD OF PERFORMANCE

The period of performance of this contract consists of a base year and four option years, beginning on September

1st, 2024.

Base Period: September 1st, 2024, to August 31st, 2025

Option Period One: September 1st, 2025, to August 31st, 2026

Option Period Two: September 1st, 2026, to August 31st, 2027

Option Period Three: September 1st, 2027, to August 31st, 2028

Option Period Four: September 1st, 2028, to August 31st, 2029

SUBSECTION A – PLACE OF PERFORMANCE AND CONTRACT SUPPORT HOURS

1. One year from date of award

2. Optional task – within the original period of performance

3. Severability Statement: This task order is severable.

SUBSECTION B – PLACE OF PERFORMANCE

Onsite maintenance work shall be performed at the CDC facility (CDC Roybal Campus, Building 23, Room 4-430). For the 96 channel tip head, the maintenance will be done at the Agilent Technologies service center in Santa Clara.

SUBSECTION C – CONTRACT SUPPORT HOURS

The service is provided between 08:00 am and 05:00 pm Eastern Time on working days Monday to

Friday, excluding statutory holidays.

SUBSECTION D – TRAVEL

Travel costs for any maintenance service or repair visits shall be covered by the contractor. The contractor shall be required to provide their travel policy to the Government for review.

SECTION 7 – DELIVERABLES/REPORTING SCHEDULE

Task Deliverable Quantity/Format Due Date Deliver To

1 Draft preventive maintenance schedule; See Section 4, Task 1 of the SOW.

One schedule annually/as MS Word or PDF format and delivered by email.

Within two weeks of contract award;

and annually thereafter.

➢ CDC Project

Officer

➢ CDC Contracting

Officer

2 Government comments on contractor’s Draft Preventive

Maintenance Schedule*; See

Section 4, Task 1 of the SOW.

All response shall be delivered to

Contractor by email.

Within one week of receiving contractor’s proposed (draft) schedule. *

Contractor

3 Final Preventive Maintenance

Schedule; See Section 4, Task

1 of the SOW.

One schedule annually/as MS Word or PDF format and delivered by email.

Within one week of receiving CDC

Project Officer comments

CDC Project Officer and CDC Contracting

Officer

4 On-Site Record of Service; See

Section 4, Task 1 of the SOW.

Report shall be provided in PDF format and delivered by email.

Affixed to equipment at completion of each service call

One copy to be affixed to equipment being serviced at completion of service and One copy to CDC

Project Officer

5 Service Invoicing; See Section

4, Task 1 and 4 of the SOW.

Payment terms will be determined by

CDC Office of

Acquisition Services

(OAS) and listed on the award document

Designated by

CDC

One copy to CDC

Project Officer; and one copy to the CDC

Contracting Officer

*Note: The reports may be subject to revisions and will be accepted as final after all queries have been responded to.

SECTION 8 – REFERENCE MATERIALS\

Not applicable

SECTION 9 – POINT OF CONTACT INFORMATION

The Point of Contact (POC) for this procurement is:

Nathan R. Amador, Contracting Officer, CDC/OCOO/OFR/OAS

E-mail Address: wlv7@cdc.gov

Preferred method of communication: email mailto:wlv7@cdc.gov

SECTION 10 – PAYMENT TERMS

Payment terms will be determined by CDC Office of Acquisition Services (OAS) and listed on the award document.

Invoice in arrears is required. Payment is made after invoice is received. Invoicing no more frequently than monthly is required. Quarterly invoicing is preferred.

SECTION 11 – MINIMUM VENDOR QUALIFICATIONS AND LEVEL OF EFFORT

Only certified and technically qualified service representatives shall be assigned to perform preventive maintenance services and/or to work on CDC laboratory equipment. In addition, supervisory technical personnel shall always be available to assist contractor service representatives, as necessary to resolve problem issues.

SECTION 12 - Information Security 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 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 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: [ x ] Low [ ] Moderate [ ] High

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

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

▪ Overall Impact Level: [ x ] 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 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.

http://csrc.nist.gov/publications/

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. 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)1, 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).2"

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.

1 Memorandum is available at: https://www.whitehouse.gov/wp-content/uploads/legacy_drupal_files/omb/memoranda/2017/m-17-12_0.pdf 2 Standard is available at: https://cdc.sharepoint.com/teams/OCIO-CSPO- PUBDOCS/Standards/CSPO%20Responding%20to%20Breaches%20of%20Personally%20Identifiable%20I nformation.pdf

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) [CDC Component inserted 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; 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 30 days prior to the effective date of this contract. Any revisions to the roster as a result of staffing changes must be submitted immediately upon the 30 days 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 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

ISSO within 15 days 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 CDC policies.

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

CDC Out-Processing Checklist

(http://intranet.cdc.gov/od/hcrmo/pdfs/hr/Out_Processing_Checklist.pdf) when an employee terminates work under this contract within 15 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 HHS policies and must not dispose of any records unless authorized by CDC Program.

http://intranet.cdc.gov/od/hcrmo/pdfs/hr/Out_Processing_Checklist.pdf

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 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[22] in addition to the above requirements.

11. Deliverables

Deliverable Title/Deliverable

Type

Description Due Date

Roster Roster Within 30 days of the effective date of this contract

Contractor Employee Non-

Disclosure Agreement (NDA)

Contractor Employee Non-

Disclosure Agreement (NDA)

Prior to performing any work on behalf of HHS

Privacy Threshold Analysis

(PTA)/ Privacy Impact

Assessment (PIA)

Assist in the completion of a

PTA/PIA form

Within 60-90 days after contract award

Training Records Copy of training records for all mandatory training

In conjunction with contract award and annually thereafter or upon request

Rules of Behavior Signed ROB for all employees Initiation of contract and at least annually thereafter

Incident Response Incident Report (as incidents or breaches occur)

As soon as possible and without reasonable delay and no later than

1 hour of discovery

Personnel Security

Responsibilities

List of Personnel with defined roles and responsibilities

Within 7 days; that is before an employee begins working on this contract.

Personnel Security

Responsibilities

Off-boarding documentation, equipment and badge when leaving contract

Within 5 days or less after the

Government’s final acceptance of the work under this contract, or in the event of a termination of the contract.

Background Investigation Onboarding documentation when beginning contract.

Prior to performing any work on behalf of HHS

Certification of Sanitization of Government and

Government Activity-

Related Files, Information, and Devices.

Form or deliverables required by

CDC

At contract expiration.

Contract Initiation and

Expiration

If the procurement involves a system or cloud service, additional documentation will be

At contract expiration.

https://login.max.gov/cas/login?service=https%3A%2F%2Fcommunity.max.gov%2Flogin.action%3Fos_destination%3D%252Fpages%252Fviewpage.action%253FspaceKey%253DHHS%2526title%253DHHS%252BCyberSecurity%252BPolicy%252BCollaboration%252BPage required, such as

Disposition/Decommission Plan

Standard-2 Requirements for Procurements Involving Privacy

Appropriate security controls and Rules of Behavior should be incorporated to protect the confidentiality of information, proprietary, sensitive, and Personally Identifiable Information (PII) the Contractor may come in contact with during the performance of this contract.

Standard-5. Other IT Procurements

1. Hardware Procurements

a. Card Readers. The Contractor (and/or any subcontractor) must include Federal Information

Processing Standard (FIPS) 201-compliant smart card readers (referred to as LACS Transparent

Readers) with the purchase of servers, printers, desktops, and laptops.

b. Mobile Devices. The contractor must follow NIST 800-124, Rev. 1, Guidelines for Managing the

Security of Mobile Devices in the Enterprise and comply with Public Law 115-232 § 889, when purchasing mobile devices that process or store CDC data.

2. Non-Commercial and Open-Source Computer Software Procurements

The Contractor (and/or any subcontractor) must follow secure coding best practice requirements, as directed by the 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. The contractor will be liable for malicious or defective code or failure to reduce risk.

3. Information Technology Application Design, Development, or Support

a. The Contractor (and/or any subcontractor) must ensure IT applications designed and developed for end users (including mobile applications and software licenses) run in the standard user context without requiring elevated administrative privileges.

b. The contractor must consult the guidelines from NIST SP 800-160 volume 1, Systems Security

Engineering: Considerations for a Multidisciplinary Approach in the Engineering of Trustworthy

Secure Systems, NIST SP 800-160 volume 2, Systems Security Engineering: Considerations for a

Multidisciplinary Approach in the Engineering of Trustworthy Secure Systems, and NIST SP 800-53 to implement security during the development of all applications and throughout the life cycle stages of software development.

c. The Contractor (and/or any subcontractor) must follow secure coding best practice requirements, as directed by United States Computer Emergency Readiness Team (US-CERT) specified standards, the

Open Web Application Security Project (OWASP), System Admin, Audit, Network and Security

(SANS), HHS Policy for Software Development Secure Coding Practices and CDC Secure Software

Development Standard that will limit system software vulnerability exploits.

d. The Contractor (and/or any subcontractor) must ensure that computer software developed on behalf of

CDC or tailored from an open-source product, is fully functional and operates correctly on systems configured in accordance with government policy and federal configuration standards. The contractor must test applicable products and versions with all relevant and current updates and patches updated prior to installing in the CDC environment. No sensitive data must be used during software testing.

e. The contractor must, at a minimum, segregate physically or logically, all test and development systems from production systems as applicable in accordance with the HHS Standard for Segregation of

Dev/Test Environments from Production.

https://www.idmanagement.gov/approved-products-list-pacs-products/ https://www.idmanagement.gov/approved-products-list-pacs-products/

f. The Contractor (and/or any subcontractor) must protect information that is deemed sensitive from unauthorized disclosure to persons, organizations or subcontractors who do not have a need to know the information. Information which, either alone or when compared with other reasonably-available information, is deemed sensitive or proprietary by CDC must be protected as instructed in accordance with the magnitude of the loss or harm that could result from inadvertent or deliberate disclosure, alteration, or destruction of the data. This language also applies to all subcontractors that are performing under this contract.

4. Physical…