A1b DRAFT SOW.pdf

Statement of Work

Project Title: CDC-Wide Consolidated Laboratory Equipment Maintenance Agreement

1.0 Introduction/Background.

The Centers for Disease Control and Prevention (CDC), is an agency of the Department of Health and Human Services (DHHS). As the world’s leading public health agency, CDC has the responsibility for promoting health and quality of life by preventing and controlling disease, injury and disability. CDC works with States, local public health agencies and partners throughout the Nation and the world to accomplish this mission. CDC serves as the national focus for developing and applying disease prevention and control methodologies, environmental health strategies, and health promotion and education activities designed to improve the health of the people of the United States and throughout the world.

2.0 Contract Scope

The overall objective of this contract is to ensure that CDC’s laboratory equipment is properly calibrated, serviced and maintained in accordance with the Original Equipment Manufacturer (OEM) recommendations or is exceeding it. To ensure that CDC’s equipment is on-site and available for its intended use in accordance with OEM operational and design specifications.

The services shall meet the original equipment manufacturer (OEM) recommendations and requirements. The geographic scope of this contract is to include all CDC locations in the United States, including Hawaii, Alaska and other US territories.

This contract will further decrease costs, reduce paperwork, and save time by eliminating the need for repetitive, individual purchases for similar services, while reducing the administrative burden on the program to generate multiple contracts for the same activity. The end result is to create a purchasing mechanism that works better and costs less. The CDC has a need for preventive maintenance, repair, and quality management (documentation) of CDC’s laboratory equipment.

The offeror selected for this contract shall be registered in SAM. The offeror shall fully comply with all specifications, clauses and terms and conditions in this contract’s Statement of Work.

The contractor shall provide technically qualified service personnel, management, materials, transportation, tools, supplies and equipment necessary to successfully meet the overall objectives and on-site performance requirements of this contract, as set forth herein.

3.0 Requirements:

The contractor shall provide laboratory equipment maintenance for Life Technologies equipment located at CDC labs domestic and international locations. Solutions must be timely, comprehensive, reliable, and cost-effective. Laboratory equipment shall be properly calibrated, serviced and maintained in accordance with or to exceed the Original Equipment Manufacturer (OEM) recommendations. The contractor shall be able to demonstrate the capacity to ensure that repairs and preventive maintenance are done in a timely fashion with service that is equivalent or exceeds manufacturing specifications. Guarantee original equipment of manufactured parts for all repairs. The contractor shall have capacity to provide a loaner equipment, if the repair takes longer than three days or must be performed offsite.

Contractor’s service representatives shall be technically qualified and fully trained, with experience in repair, maintenance and safe relocation of all equipment that they will be assigned to service under this Contract.

3.1 Preventive Maintenance

The contractor shall perform electrical and mechanical preventive maintenance services on CDC laboratory equipment as specified by order in accordance with original equipment manufacturer (OEM) recommendations and requirements or exceeding them.

1. Preventive maintenance services include periodic inspections and on-site service of installed equipment, in accordance with OEM recommendations or exceeding them;

including, but not limited to cleaning, calibration (pure dye), adjustments, replacement or restoration of parts, as necessary, and all services required to return equipment to OEM operational and design specifications.Provide a PM checklist that highlights user recommended & required maintenance while performing the preventive maintenance.

2. Preventive maintenance services shall be performed, in accordance with a contractor proposed schedule; which shall be coordinated with CDC scientists and, reviewed/approved by the COR at the time of the Task Order award, to minimize disruption to planned laboratory experiments.

3. To the maximum extent possible individual equipment preventative maintenance services shall be coordinated to maximize efficience and reduce preventative maintenance costs.

3.2 Repair Service (24-48 hour response by service engineer; 5 workdays timeframe to repair equipment) Routine repair services includes replacement or restoration of parts and all contractor services required to return installed CDC laboratory equipment to the operational and design specifications in accordance with OEM recommendations and requirements or exceeding them.

1. Requests for routine repair service may be made by the CDC COR or program designee.

Requests may be made via phone or e-mail. Laboratory equipment covered by this agreement shall be specified in the contract award and all calls for service will be done by either CDC COR or program designee against specific instrumentation.

2. The contractor shall provide “repair services”, as requested by the CDC COR or program designee.

3. Necessary replacement parts shall be “new”; not “used” or “reconditioned” (unless mutually agreed to by the CDC program, in advance). 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 contractor;

and, shall be provided at no additional cost to the government.

3.3 Service Reports/Records

The contractor service representative shall affix a service sticker to each piece of equipment each and every time service is performed on that piece of equipment. The sticker shall reflect the contractor’s name, purchase order number, manufacturer’s name, equipment model and serial number, contractor service representative (name and phone number), date of service and brief description of service. (The service ticket will be signed by the contractor service representative and CDC program contact at the completion of the service call.) The contractor shall provide an instrument management system where electronic service records and a list of past, current laboratory equipment is accessible to CDC scientists and program offices.

1. One (1) copy of the signed service ticket will be left with the CDC program contact, the day of service; and, one (1) copy of the signed service ticket will be submitted with the contractor’s quarterly billing submission.

2. The service report will be entered in an electronic instrument management system within three days of service completion.

3. As a minimum, service reports 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.), Date of Service and a Description of Service that was performed (i.e. calibration, parts replaced, etc.) for each instrument. The report shall define “if needed” or “if recommended”. The service report shall include a summary of maintenance tasks along with the standard report for records.

4. After each service call, including preventive maintenance calls, contractor shall prepare a record to document services performed on CDC equipment in accordance with CDC laboratory quality management standards.

3.4 General Service Requirements

If the contractor service representative is unable to complete required service and return equipment to good working condition during the initial service call, the contractor shall provide a senior service representative on-site, to resolve any remaining problems by no later than 48 hours thereafter. 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.

At the completion of work at each service location, the contractor service representative shall restore the work site to its original condition. Contractor site clean-up shall include disposal of any discarded parts, empty containers, packing materials, trash and debris. All chemical spills on equipment and/or surrounding floor shall be removed; and, these areas shall be cleaned to return to their original condition. The contractor shall not create or permit any safety or fire hazard to exist at the equipment site. Government-owned dumpsters may be used for disposal of waste materials except for metal parts and components, which shall be removed by the contractor. 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.

If equipment must be removed from any CDC locations to complete required service, the contractor must first obtain written approval of the CDC COR or program designee. Any contractor limitations or restrictions on the use of replacement equipment shall be provided in writing to the CDC COR or program designee and conspicuously posted at the site of the equipment. The contractor shall be responsible for safeguarding any equipment that must be removed from CDC campuses to complete service.

3.5 Safety Precautions

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

3.6 Government Responsibilities

CDC program contacts shall meet contractor service representatives at visitor location, when needed. CDC program contacts shall escort contractor service representatives to and from equipment locations and at all times while the contractor 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.

3.7 Inspection and Acceptance Criteria

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

4.0 Terms and Conditions:

The Government anticipates a fixed price contract. The contract will specify a list of equipment to be covered by the contract. The equipment list will be evaluated at least quarterly to determine if new equipment needs to be added or taken off the list. Changes to the equipment list will be done by modification to the contract. The Government does not guarantee any quantity for any of the services.

4.1 Point of Contact

At a minimum the Offeror shall designate someone as the project manager 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 offeror and CDC Contracting Officer or designated CDC Contracting Officer’s Representatives (COR's).

4.3 Period of Performance

This contract is effective for a base period and four option years for a total of five (5) years beginning July 1st, 2024. Based on CDC's current projected date of contract award, the Term of the contract will be as follows:

Base period: 07/01/2024 – 06/30/2025 Option year 1: 07/01/2025 – 06/30/2026 Option year 2: 07/01/2026 – 06/30/2027 Option year 3: 07/01/2027 – 06/30/2028 Option year 4: 07/01/2028 – 06/30/2029

5.0 Reporting Schedule

By the 10th day of each month, the contractor shall provide the Contracting Officer’s Representative and the Contracting Officer with a Monthly Report of services provided during the preceding calendar month. Form, format and content of the report may be revised from time to time, but as a minimum shall provide the following information:

1. A summary of the number of preventive service calls originally scheduled vs. actually made during the month of the report. And new next month dates will be provided for performance of preventive maintenance that was missed altogether.

2. 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.

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

6.0 Special Considerations

Contractor service representatives who may require access to the Building 18 High Containment Laboratory (HCL) while the lab is hot must have a current smallpox vaccination (minimum inoculation: once every three years). This vaccination can be obtained at the CDC, at no cost to the contractor.

Work inside Biosafety Level 3+ containment areas while the laboratory is hot requires the use of a Chemical, Biological, Radiological, and Nuclear (CBRN) Full Facepiece Powered Air Purifying Respirator (PAPR). Any contractor representative who may require access to BSL3+ containment areas while the lab is hot must be properly trained and certified to use this equipment. Equipment will be available on-site at the CDC, at no cost to the contractor

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

Contractor personnel scheduled to service equipment at CDC need to adhere to CDC visitor guidelines. Designated program contacts will escort contractor service personnel to the location of equipment to be serviced; and, shall be present at that location until service work is completed. During all times that the contractor service representative is on-site at CDC, he or she shall be escorted by an appropriate program contact – no exceptions.

Electronic and Information Technology Accessibility Notice

(a) Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998 and the Architectural and Transportation Barriers Compliance Board Electronic and Information (EIT)

Accessibility Standards (36 CFR part 1194), require that when Federal agencies develop, procure, maintain, or use electronic and information technology, Federal employees with disabilities have access to and use of information and data that is comparable to the access and use by Federal employees who are not individuals with disabilities, unless an undue burden would be imposed on the agency. Section 508 also requires that individuals with disabilities, who are members of the public seeking information or services from a Federal agency, have access to and use of information and data that is comparable to that provided to the public who are not individuals with disabilities, unless an undue burden would be imposed on the agency.

(b) Accordingly, any offeror responding to this solicitation must comply with established HHS EIT accessibility standards. Information about Section 508 is available at http://www.hhs.gov/web/508. The complete text of the

Section 508 Final Provisions can be accessed at http://www.access-board.gov/sec508/standards.htm.

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

205 WCAG 2.0 Level A & AA Success Criteria

302 Functional Performance Criteria

402 Closed Functionality

403 Biometrics

404 Preservation of Information Provided for Accessibility

405 Privacy

406 Standard Connections

407 Operable Parts

408 Display Screens

409 Status Indicators

410 Color Coding

411 Audible Signals

502 Inoperability with Assistive Technology

503 Applications

504 Authoring Tools

602 Support Documentation

603 Support Services

In order to facilitate the Government's determination whether proposed EIT supplies meet applicable Section

508 accessibility standards, offerors must submit an HHS Section 508 Product Assessment Template, in accordance with its completion instructions. The purpose of the template is to assist HHS acquisition and program officials in determining whether proposed EIT supplies conform to applicable Section 508 accessibility standards. The template allows offerors or developers to self-evaluate their supplies and documentation detail -whether they conform to a specific Section 508 accessibility standard, and any underway remediation efforts addressing conformance issues. Instructions for preparing the

HHS Section 508 Evaluation Template are available under Section 508 policy on the HHS Web site http://hhs.gov/web/508.

In order to facilitate the Government's determination whether proposed EIT services meet applicable Section

508 accessibility standards, offerors must provide enough information to assist the Government in determining that the EIT services conform to Section 508 accessibility standards, including any underway remediation efforts addressing conformance issues.

(d) Respondents to this solicitation must identify any exception to Section 508 requirements. If a offeror claims its supplies or services meet applicable Section 508 accessibility standards, and it is later determined by the

Government, i.e., after award of a contract or order, that supplies or services delivered do not conform to the accessibility standards, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its expense.

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

508/additional-resources/section-508-contacts/index.html. Materials that are final items for delivery should be accompanied by the appropriate checklist, except upon approval of the Contracting Officer or Representative.

7.0 Delivery Schedule:

Item/Description Delivery Date Deliver To 1-a. Draft preventive maintenance schedule;

Within two weeks of award; and, annually thereafter

CDC COR; and CDC Contracting Officer.

1-b. Government comments on contractor’s Draft Preventive Maintenance Schedule; see Section

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

Contractor

1-c. Final Preventive Maintenance Schedule

Within one week of receiving CDC COR comments

CDC COR; and, CDC Contracting Officer

2. On-Site Record of Service

Affixed to equipment at completion of each service call

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

3. Service tickets Within 5 days of completing each service call

One copy to CDC program on-site contact; and, one copy to the CDC COR.

4. Monthly Contractor Reports

By the 10th of each calendar month.

One copy to CDC COR;

and, one copy to the CDC Contracting Officer.

8.0 Security Requirments:

Security and Privacy Compliance

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

1. Baseline Security Requirements

a. Applicability. The requirements herein apply whether the entire contract or modification (hereafter "contract"), or portion thereof, includes either or all of the followings. No contractor will be permitted to access or operate CDC infrastructure or systems overseas unless prior approval is received from CDC CISO.

i. Access (Physical or Logical) to Government Information: A Contractor (and/or any subcontractor) will have or will be given the ability to have, routine physical (entry) or logical (electronic) access to government information.

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

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

i. Protect the:

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

Integrity, which means guarding against improper information modification or destruction, and ensuring information non-repudiation and authenticity; and

Availability, which means ensuring timely and reliable access to and use of information.

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

Based on information provided by the ISSO, CISO, CDC CPO, or other representative, the impact level for each Security Objective (Confidentiality, Integrity, and Availability) and the Overall Impact Level, which is the highest watermark of the three factors of the information or information system are the following:

Confidentiality: [ 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.

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.

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

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%20Informati on.pdf

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.

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 required, such as Disposition/Decommission Plan

At contract expiration.

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…