A5-SOW.pdf

Statement of Work / Performance Work Statement

Title: eSlide Manager Service Agreement (IDPB) SN#5330

SECTION 1 – BACKGROUND

IDPB's ePathology platform is available for expedited and remote consultations with IDPB pathologists on cases with suspected infectious diseases. This platform is also used for training and information sharing. Users can electronically submit photographs (including electron microphotographs) or scanned digital whole-slide images for consultation. IDPB receives formal teleconsultation requests that allow for the pathologist to provide preliminary insights into a cause of death and can provide early warnings on outbreaks of infectious disease etiology.

Definitive diagnosis of infectious etiologies does require submission of FFPE tissue for laboratory testing by IDPB's lab.

SUBSECTION A – DEFINITIONS

ePathology-digital pathology eSlide-digital slide FFPE-formalin fixed paraffin embedded IDPB-Infectious Diseases Pathology Branch

SECTION 2 – PURPOSE/OBJECTIVE

The purpose of this contract is to provide a service agreement that maintains the functionality of the eSlide manager software that is required for the Leico Aperio CS eSlide Manager Production Application and separate Test Application to support ePathology.

SECTION 3 – SCOPE OF WORK

Service Maintenance on eSlide Manager Device for one year with four option years to provide updates to ensure that the equipment remains current with the latest technology and functionality to meet server expectations.

SECTION 4 – TASKS TO BE PERFORMED

Task 1: Provide software updates, as released to ensure that the software remains current with the latest technology

1. Installation of all updates

2. Unlimited phone and email support

Task 2: Provide upgrades as released to ensure that the latest functionality on the licensed software is available and working

1. Verify Customer Server meets Server specifications

2. Installation of all updates

3. Unlimited phone and email support

SECTION 5 – GOVERNMENT FURNISHED PROPERTY

N/A

SECTION 6 – PLACE OF PERFORMANCE AND CONTRACT SUPPORT HOURS

SUBSECTION A – PLACE OF PERFORMANCE

Contract will be performed entirely at the government facility

SUBSECTION B – CONTRACT SUPPORT HOURS

Onsite Service calls will be Monday through Friday between 8:00AM and 5:50PM. There is unlimited phone and email support.

SUBSECTION C- Observance of Legal Holidays and Administrative Leave

Holidays-Government personnel observe the following listed days as holidays:

Washington’s Birthday

Memorial Day

Juneteenth

Independence Day

Labor Day

Veteran’s Day

Thanksgiving

Christmas Day

New Year’s Day

Columbus Day

Martin Luther King Day

Any other day designated by Federal Statue

Any other day designated by Executive Order

Any other day designated by Presidential proclamation

SECTION 7 – TRAVEL

N/A

SECTION 8 – DELIVERABLES/REPORTING SCHEDULE

Task Deliverable Quantity/Format Due Date Deliver To Service Report Word or PDF Annually Contracting Officer’s

Representative Update Identifying the report work Program Office performed and any noted details or findings

SECTION 9 – REFERENCE MATERIALS

SECTION 10 – MINIMUM VENDOR QUALIFICATIONS

Leica Microsystems is the manufacturer and is the only vendor qualified to provide the service agreement for the eSlide Manager platform as the equipment is no longer being manufactured, and the software is only being maintained by Leica.

SECTION 11 – ADDITIONAL REQUIREMENTS

Information Security and Privacy 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 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 http://csrc.nist.gov/publications/ 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 Contracting Officer 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:

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%20Identifiab le%20Information.pdf https://www.whitehouse.gov/wp-https://www.whitehouse.gov/wp-https://cdc.sharepoint.com/teams/OCIO-CSPO-

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

ii. All contractors and subcontractors shall properly encrypt PII in accordance with OMB Circular A-130 and other applicable policies, including CDC-specific policies, and comply with HHS-specific policies for protecting PII. To this end, all contractors and subcontractors shall protect all sensitive information, including any PII created, stored, or transmitted in the performance of this contract, with encryption solution that is validated with the current FIPS 140 validation certificate from the NIST

CMVP.

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

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

v. Report all suspected and confirmed information security and privacy incidents and breaches to the CSPO Incident Response Team (IRT) [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 http://intranet.cdc.gov/od/hcrmo/pdfs/hr/Out_Processing_Checklist.pdf) 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

At contract expiration.

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.

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 Access to Government Controlled Facilities

(NOTE: For procurements involving physical access to government facilities, selected language from Appendix B: Standards may apply. This includes, but not limited to security awareness, incident response, and HSPD-12. Consult with the CDC Component Information Systems Security Officer (ISSO), CDC CPO, and other relevant stakeholders to select applicable language.)

Additionally, due to the COVID-19 Epidemic of 2020 (Effective as of March 30, 2020), The below contract language must be included in all COVID-19 contract actions until such time the CDC Director makes a determination to issue rated contracts related to items used for allowing CDC employees/contractors to physically use and/or operate in CDC facilities and spaces.

"CDC reserves the right to exercise priorities and allocations authority with respect to this contract, to include rating this order in accordance with 45 CFR Part 101, Subpart A— Health Resources Priorities and Allocations System."

5. Deliverables Deliverable Title Description Due Date

Other IT Procurements (Non- Commercial and Open-Source Computer Software Procurements)

Computer software, including the source code.

Prior to performing any work on behalf of HHS

Standard-6: Installation and Servicing of Equipment

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

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

Human Subjects Protections in Research

DOES NOT INCLUDE activities or tasks that meet the definition of research and DOES NOT INVOLVE Live Vertebrate Animal

Paperwork Reduction Act (PRA)

PRA does not apply. Qualifies for a regulatory exclusion: No Information being collected. No new public data collection is proposed. OMB review and approval are not required.

Section 508 Compliance

Section 508 and Accessibility Requirements

Part A – Provision

352.239-73 Information System Design and Development. (Deviation) As prescribed in 339.106-70(b), insert the following clause:

INFORMATION SYSTEM DESIGN AND DEVELOPMENT (FEB 2024) (DEVIATION)

(a) Design or development at non-HHS facilities. Information systems that are designed or developed for or on behalf of HHS at non-HHS facilities shall comply with all HHS directives developed in accordance with the Federal Information Security Modernization Act of 2014, Health Insurance Portability and Accountability Act (HIPAA) regulations, National Institute of Standards and Technology (NIST), and related HHS security and privacy control requirements for Federal information systems. This includes standards for the protection of electronic protected health information (PHI), outlined in 45 CFR Part 164, Subpart C, information and system security categorization level designations in accordance with Federal Information Processing Standards (FIPS) 199 and FIPS 200 with implementation of all baseline security controls commensurate with the FIPS 199 system security categorization and the Trusted Internet Connections Reference Architecture.

(b) Privacy Impact Assessment. During the development cycle a Privacy Impact Assessment must be completed by the contractor, provided to the Contracting Officer Representative, and approved by the appropriate HHS and Operating Division security and privacy officials;

government, contractor, or independent third party.

(c) Security of procured or developed systems and technologies. The Contractor shall ensure the security of all procured or developed systems and technologies, including their subcomponents (hereinafter referred to as "Systems"), throughout the life of the contract and any extension, warranty, or maintenance periods. This includes, but is not limited to, workarounds, patches, hotfixes, upgrades, and any physical components (hereafter referred to as Security Fixes) which may be necessary to fix all security vulnerabilities published or known to the Contractor anywhere in the Systems, including Operating Systems and firmware.

The Contractor shall ensure that security fixes shall not negatively impact the Systems.

(d) Subcontract flow down requirements. The Contractor shall incorporate and flow down the substance of this clause to all subcontracts where services to perform information system design and development are required.

Part B - Clause

352.239-74 Information System Hosting, Operation, Maintenance, or Use. (Deviation)

As prescribed in 339.106-70(c), insert the following clause:

INFORMATION SYSTEM HOSTING, OPERATION, MAINTENANCE, OR USE (FEB 2024)

(DEVIATION)

(a) Definitions. As used in this clause—

Assessment and Authorization (A&A) means the process used to ensure information systems including Major Applications and General Support Systems have effective security safeguards which have been implemented, planned for, and documented in an Information Technology Security Plan. The A&A process per applicable HHS policies and procedures is the mechanism by which HHS provides an Authorization to Operate (ATO), the official management decision given by the HHS to authorize operation of an information system.

Information system security plan means a formal document that provides an overview of the security requirements for an information system or an information security program and describes the security controls in place or planned for meeting those requirements.

(b) Hosting, operation, maintenance, or use at non-HHS facilities. For information systems that are hosted, operated, maintained, or used on behalf of HHS at non-HHS facilities, Contractors/subcontractors are fully responsible and accountable for ensuring compliance with all applicable Health Insurance Portability and Accountability (HIPAA) Act of 1996 (HIPAA) regulations, the Privacy Act and other required HHS confidentiality statutes included in HHS mandatory yearly training and privacy policy, Federal Information Security Modernization Act (FISMA), National Institutes of Standards and Technology (NIST), Federal Information Processing Standards (FIPS), and HHS security and privacy policy. This includes conducting compliant risk assessments, routine vulnerability scanning, system patching and change management procedures, and the completion of an acceptable contingency plan for each system.

The Contractor's security and privacy control procedures must be equivalent to or exceed, those procedures used to secure HHS systems. A Privacy Impact Assessment (PIA) (if the system includes Personally Identifiable Information (PII)) or a Privacy Threshold Analysis (to determine if the system includes PII) must also be provided to the Contracting Officer Representative (COR) and approved by HHS Senior Agency Official for Privacy (SAOP) or designee prior to ATO. All external Internet connections to HHS network involving HHS information must be in accordance with the Trusted Internet Connections (TIC) Reference Architecture and reviewed and approved by HHS prior to implementation. For Cloud Services hosting, the Contractor shall also ensure compliance with the Federal Risk and Authorization Management Program (FedRAMP).

(c) Collecting, processing, transmitting, and storing of PII. Adequate security and privacy controls for collecting, processing, transmitting, and storing of PII, as determined by the HHS SAOP or designee, must be in place, tested, and approved by HHS prior to hosting, operation, maintenance, or use of the information system, or systems by or on behalf of HHS. These security and privacy controls are to be assessed and stated within the PIA, Information System Security Plan, Information System Privacy Plan, Security Control Assessment Report, and/or Privacy Control Assessment Report, as agreed upon by the Contractor, COR, and the Operating Division Senior Official for Privacy. If these controls are determined not to be in place, or inadequate, a Plan of Action and Milestones (POA&M) must be submitted and approved prior to the collection of PII.

(d) Annual FISMA security controls assessment. The Contractor/subcontractor's system must adhere to all FISMA, FIPS, and NIST standards related to the annual FISMA security controls assessment and review and update the PIA. Any deficiencies noted during this assessment must be provided to the Contracting Officer for entry into HHS Plan of Action & Milestones (POA&M) management process. The Contractor/subcontractor must use HHS POA&M process to document planned remedial actions to address any deficiencies in information security policies, procedures, and practices, and the completion of those activities. Security deficiencies must be corrected within the timeframes specified by the HHS in the performance work statement or statement of work, or in the approved remediation plan through the HHS POA&M process. Contractor/subcontractor procedures are subject to periodic, unannounced assessments by HHS officials, including the HHS Office of Inspector General. The physical security aspects associated with Contractor/subcontractor activities must also be subject to such assessments. The results of an annual review or a major change in the cybersecurity posture at any time may indicate the need for reassessment and reauthorization of the system. If major changes to the system occur that may affect the privacy or security of the data or the system, the A&A of the system may need to be reviewed, retested and re-authorized per HHS Rules of Behavior for the Use of HHS Information and IT Resources Policy. Major changes introducing new privacy risks require an updated and reapproved PIA.

(e) Annual self-assessment. The Contractor/subcontractor must conduct an annual self�assessment on all systems and outsourced services as required. Both hard copy and electronic copies of the assessment must be provided to the COR. HHS reserves the right to conduct such an assessment using government personnel or another Contractor/subcontractor. The Contractor/subcontractor must take appropriate and timely action, as may be specifically addressed in the contract, to correct or mitigate any weaknesses discovered during such testing, at no additional cost to the Government to correct Contractor/subcontractor systems and outsourced services.

(f) Prohibition of installation and use of personally-owned or Contractor-owned equipment or software on HHS networks. HHS prohibits the installation and use of personally-owned or Contractor/subcontractor-owned equipment or software on HHS networks. If non-HHS owned equipment must be used to fulfill the requirements of a contract, it must be stated in the service agreement, performance work statement, statement of work, or contract. All of the security controls required for government furnished equipment must also be utilized in approved other equipment (OE) at the Contractor’s expense. All remote systems must be equipped with, and use, an HHS-approved antivirus software and a personal (host-based or enclave based) firewall that is configured with an HHS-approved configuration. Software must be kept current, including all critical updates and patches. Owners of approved OE are responsible for providing and maintaining the anti-viral software and the firewall on the non-HHS owned OE.

(g) Disposal or return of electronic storage media on non-HHS leased or non-HHS owned IT equipment. All electronic storage media used on non-HHS leased or non-HHS owned IT equipment that is used to store, process, or access HHS information must be handled in adherence with disposition instructions upon—

(1) Completion or termination of the contract; or

(2) Disposal or return of the IT equipment by the Contractor/subcontractor or any person acting on behalf of the Contractor/subcontractor, whichever is earlier. Media (e.g., hard drives, optical disks, CDs, back-up tapes) used by the Contractors/ subcontractors that contain HHS information must be returned to the HHS for sanitization or destruction or the Contractor/subcontractor must self-certify that the media has been disposed of per disposition instructions. This must be completed within 30 days of termination of the contract.

(h) Bio-Medical devices and other equipment or systems. Bio-Medical devices and other equipment or systems containing media (e.g., hard drives, optical disks) with HHS sensitive information will not be returned to the Contractor at the end of lease, for trade-in, or other purposes. For purposes of these devices and protection of HHS sensitive information the devices may be provided back to the Contractor under one of three scenarios—

(1) The Contractor must accept the system without the drive;

(2) A spare drive must be installed in place of the original drive at time of turn-in if HHS initial medical device purchase included a spare drive; or

(3) The Contractor may request reimbursement for the drive at a reasonable open market replacement cost to be separately negotiated by the Contracting Officer and the Contractor at time of contract closeout.

SECTION 1 – PROPOSED CONTRACT TYPE

Firm Fixed Price

SECTION 2 – OPTIONAL SPECIAL CONSIDERATIONS

SUBSECTION A – PAYMENT CLAUSES

Quartely payments

SUBSECTION B – DATA RIGHTS CLAUSES

SUBSECTION C- Observance of Legal Holidays and Administrative Leave (Government Facilities Performance)

(a) Holidays - Government personnel observe the following listed days as holidays:

Washington's Birthday Memorial Day Juneteenth Independence Day Labor Day Veterans' Day Thanksgiving Day Christmas Day New Year's Day Columbus Day Martin Luther King Day Any other day designated by Federal Statute Any other day designated by Executive Order

Any other day designated by Presidential proclamation

SECTION 3 – EVALUATION FACTORS

Sole Source to Manufacturer

SUBSECTION A – TECHNICAL

Sole Source to Manufacturer

Technical Evaluation Criteria:

This solicitation will be awarded to the Offeror whose proposal is considered to be the most advantageous to the Government, price and other factors identified below considered.

Leica Microsystems

• Equipment manufacturer

• Aperio CS is no longer being produced

• Only Leica is providing/developing software updates

OTHER CONSIDERATIONS AND…