Combined Synopsis Solicitation_75D30125Q78592.pdf

Combined Synopsis/Solicitation for InterOperability Bidco Rhapsody Software Subscription

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Requirements (FAR) Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested, and a written solicitation will not be issued.

The Centers for Disease Control and Prevention intends to award a sole source, fixed price purchase order for Rhapsody Annual Software Subscription and Maintenance Support to InterOperability Bidco. This action is necessary because only InterOperability Bidco, the original developer and exclusive provider of Rhapsody support services, has the proprietary knowledge and legal rights required to perform these services. No other vendor can legally or technically modify, maintain, or upgrade this software to support the CDC Infectious Diseases Enterprise Laboratories.

The solicitation number for this requirement is 75D30125Q78592 and is hereby issued as a Request for Quote (RFQ) using FAR Subpart 13.1 Simplified Acquisition Procedures.

The Centers for Disease Control and Prevention intends to award a firm-fixed-price contract for the following requirement, please either fill in the dollar amounts or provide quote containing the same information including a list of line-item number(s) and items, quantities, units of measure, and options, if applicable.

Supplies/Services and Prices/Costs:

Base Period Period of Performance: February 1, 2025 – January 31, 2026

ITEM SUPPLIES / SERVICES QTY / UNIT UNIT PRICE EXTENDED PRICE

0001 Annual Software Subscription and

Maintenance Support - Rhapsody software

1 / Each

Option Period 1 Period of Performance: February 1, 2026 – January 31, 2027

ITEM SUPPLIES / SERVICES QTY / UNIT UNIT PRICE EXTENDED PRICE

1001 Annual Software Subscription and

Maintenance Support - Rhapsody

Option Period 2 Period of Performance: February 1, 2027 – January 31, 2028

ITEM SUPPLIES / SERVICES QTY / UNIT UNIT PRICE EXTENDED PRICE

2001 Annual Software Subscription and

Maintenance Support - Rhapsody

Option Period 3 Period of Performance: February 1, 2028 – January 31, 2029

ITEM SUPPLIES / SERVICES QTY / UNIT UNIT PRICE EXTENDED PRICE

3001 Annual Software Subscription and

Maintenance Support - Rhapsody

Option Period 4 Period of Performance: February 1, 2029 – January 31, 2030

ITEM SUPPLIES / SERVICES QTY / UNIT UNIT PRICE EXTENDED PRICE

4001 Annual Software Subscription and

Maintenance Support - Rhapsody software

1 / Each

It is the offeror's responsibility to be familiar with the applicable clauses and provisions. Clauses and provisions may be accessed via the Internet at www.acquisition.gov.

This solicitation document and incorporated provisions and clauses are those in effect through the Federal Acquisition Circular (FAC) 2025-03 (January 17, 2025).

This acquisition is under North American Industry Classification System (NAICS) code 513210 - Software Publishers. A firm-fixed-price purchase order will be issued in writing to the successful offeror. To be eligible to receive an award resulting from this solicitation, the contractor must be registered in the System for Award Management (SAM).

The following solicitation provisions apply to this acquisition:

The provision at FAR 52.212-1, Instructions to Offerors-Commercial Products and Commercial Services, applies to this acquisition.

The provision at FAR 52.212-2, Evaluation-Commercial Items, applies to this acquisition and indicates the evaluation procedures to be used.

Offeror shall include FAR 52.212-3, Offeror Representations and Certifications with Offer or indicate if it is available online at SAM.gov.

The following contract clauses apply to this acquisition:

The clause at FAR 52.212-4, Contract Terms and Conditions-Commercial Products and Commercial Services, applies to this acquisition.

The clause at FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Products and Commercial Services, applies to this acquisition.

All responses to this combined synopsis/solicitation must be submitted to James Brown III at xvn8@cdc.gov no later than 12:00 P.M. EST on Tuesday, January 28, 2025.

STATEMENT OF WORK

Title: Rhapsody Software Licensing and Maintenance Supporting the ELIMS Project

SECTION 1 – BACKGROUND

The Enterprise Laboratory Information Management System (ELIMS) Interoperability project is designed to standardize electronic laboratory result messaging and ensure the secure transfer of sensitive data between the Centers for Disease Control and Prevention’s (CDC) Infectious Disease (ID) laboratories and various Public Health Agencies (PHAs). This project is critical for enabling timely analysis and decision-making by PHAs at the state, tribal, local, and territorial (STLT) levels. Laboratory results are processed in two key locations, CDC ELIMS Atlanta and Fort Collins, Colorado using the Health Level Seven (HL7) 2.5.1 messaging standard. These results are then packaged as Electronic Lab Reports (ELRs). The ELRs are vital for public health activities, as they allow for efficient communication of laboratory findings, which are used in routine diagnostics, outbreak detection, epidemiological studies, and public health surveillance. To securely transmit these lab reports to PHAs, the CDC has implemented the use of InterOperability Bidco Rhapsody software, a specialized integration engine designed for the healthcare industry. This software facilitates secure data exchange by converting lab results into the HL7 format and transporting the messages over encrypted channels to the relevant health agencies. These agencies rely on this data to inform public health decisions, track infectious disease trends, and respond to potential outbreaks in a timely manner. In support of this interoperability effort, the CDC has previously procured a license for the Rhapsody 6.2 software. This version of Rhapsody is central to the continued operation of the secure messaging infrastructure that underpins electronic laboratory reporting. Rhapsody, as the Original Equipment Manufacturer (OEM), is responsible for the software’s development, as well as ongoing maintenance, updates, and technical support. The CDC’s decision to procure Rhapsody stems from its reliability, scalability, and compliance with healthcare data standards like HL7 and Fast Healthcare Interoperability Resources (FHIR, ensuring that the system meets current and future needs for secure and efficient public health data exchange. By maintaining this software, the CDC ensures continuity in the exchange of critical health data, enabling PHAs to receive standardized laboratory reports in near real-time. This supports public health objectives by reducing delays in reporting, enhancing data quality, and enabling quicker responses to public health threats.

The Rhapsody software plays a pivotal role in CDC’s mission to protect public health through efficient and secure data interoperability with its partners.

SECTION 2 – PURPOSE/OBJECTIVE

The purpose of this procurement is to extend the existing software maintenance agreement for the InterOperability Bidco Rhapsody software, which is essential for the continued secure transmission of ELRs from CDC ELIMS to PHAs. This extension will ensure that the CDC can maintain uninterrupted use of the Rhapsody software, which is critical for standardized messaging and secure data transfer between the CDC and its STLT partners.

Additionally, the procurement includes provisions for software upgrades, allowing the CDC to stay current with the latest Rhapsody versions and enhancements. These upgrades are necessary to ensure the software continues to meet evolving healthcare data standards (such as HL7 and FHIR), improve system security, and enhance performance. The extended maintenance agreement will also provide access to ongoing technical support, ensuring any operational issues are promptly addressed and minimizing potential disruptions to public health data exchange.

By extending the maintenance agreement and including software upgrades, the CDC ensures the long-term reliability, security, and efficiency of its data exchange systems, which are vital for public health reporting, outbreak response, and surveillance activities.

SECTION 3 – SCOPE OF WORK

1. Software Maintenance Extension

Provide ongoing maintenance services for the InterOperability Bidco Rhapsody software, including updates, patches, and security fixes. This will ensure the CDC’s ELIMS system continues to function reliably and securely, facilitating the standardized transmission of ELRs to PHAs. Maintenance services must cover all deployed instances of Rhapsody software within CDC’s infrastructure to support the LIMS systems based in ELIMS Atlanta and Fort Collins

2. Software Upgrades

Deliver version upgrades of the Rhapsody software as they become available, ensuring that the CDC remains compliant with the latest healthcare data standards, such as HL7 2.5.1, HL7 FHIR, Logical Observation Identifier Names and Codes (LOINC), and Systematized Nomenclature of Medicine (SNOMED). These upgrades must enhance performance, improve system security, and introduce any new features required to support evolving public health data needs.

The vendor must provide CDC with detailed release notes and technical guidance for each upgrade, ensuring smooth transitions with minimal system downtime.

3. Technical Support

Provide comprehensive technical support to troubleshoot and resolve any issues with the Rhapsody software.

Support should include a service-level agreement (SLA) that guarantees timely responses based on the criticality of the issue. The vendor will offer 24/7 support for critical incidents to ensure uninterrupted data flow between CDC laboratories and PHAs, as any disruptions could impact public health decision-making and outbreak response.

4. Compliance with Security Standards

Ensure that the Rhapsody software adheres to all relevant federal information security requirements, including encryption protocols, to maintain the secure transfer of sensitive laboratory data. The vendor will conduct regular security audits and provide updates to maintain compliance with the CDC’s security standards and protect public health data.

5. Training and Documentation

Provide virtual training for CDC technical staff on new features or significant changes introduced through software upgrades. This virtual training should ensure that CDC personnel can manage and troubleshoot the system effectively. Supply detailed documentation for all upgrades, maintenance procedures, and troubleshooting processes to support CDC's internal IT teams.

6. License Management

Ensure that CDC’s Rhapsody software licenses remain active and compliant throughout the contract period. The vendor must track and report on the status of licenses, ensuring timely renewals to avoid any lapse in functionality.

SECTION 4 – TASKS TO BE PERFORMED

1. Software Maintenance and Support

Ongoing Maintenance: Deliver regular updates, patches, and security fixes to maintain the reliability and security of the Rhapsody software. This includes ensuring compatibility with current healthcare messaging standards (e.g., HL7, FHIR) and optimizing software performance. The vendor should specify response times if they differ from the stated CDC ELIMS standards and provide clear escalation procedures for both regular and emergency situations to ensure seamless support and minimal operational disruption.

Issue Resolution: Diagnose and resolve any technical issues or software bugs that arise. Support should include 24/7 coverage for critical incidents and a structured ticketing system for less urgent issues.

Upon receipt by the contractor of notice from client of an error, defect, malfunction or nonconformity in the software, the contractor shall respond as provided below:

Severity 1 (Urgent): Produces an emergency situation in which the CDC ID LIMS software is inoperable, produces incorrect results, or fails catastrophically. Failure of essential applications or components in the production environment where there is no workaround available. The contractor shall notify the Contracting Officer’s Representative that the contractor cannot conduct core business because one or more of the following:

a. System is unavailable

b. Data is lost, corrupted

c. Security is compromised

d. Business/financial operations cannot be completed

e. Good laboratory practice operations cannot be completed; legal/regulatory implications

RESPONSE: The contractor shall provide a response by a qualified member of its staff to begin to diagnose and correct a Severity 1 problem (ticket) as soon as reasonably possible, but in any event a response will be provided within four (4) business hours. The contractor shall continue to provide best efforts to resolve Severity 1 problems (tickets) in less than two (2) business days. The resolution will be delivered to CDC as a work-around or as an emergency software fix. If the contractor delivers an acceptable work-around, the severity classification will drop to a Severity 2 (High) Ticket.

Severity 2: Produces a detrimental situation in which performance (throughput or response) of the software degrades substantially such that there is a severe impact on use; the software is usable, but materially incomplete; one or more mainline functions or commands is inoperable; or the use is otherwise significantly impacted.

RESPONSE: The contractor shall provide a response by a qualified member of its staff to begin to diagnose and to correct a Severity 2 problem (ticket) as soon as reasonable possible, but in any event a response will be provided within two (2) business days. The contractor shall exercise best efforts to resolve Severity 2 problems (tickets) within three (3) business days. The resolution will be delivered to CDC in the same format as Severity 1 problems. If the contractor delivers an acceptable work-around for a Severity 2 problem, the severity classification will drop to a Severity 3.

Severity 3 (Normal): Failure of applications or components in any environment (production, development, or test) that are not essential to the daily operations. A potential workaround or degraded mode of operation shall be made available.

RESPONSE: The contractor shall provide a response by a qualified member of its staff to begin to diagnose and to correct a Severity 3 problem (ticket) and advise the Contracting Officer’s Representative of the timeframe in which it will take to resolve the problem (ticket) within four (4) business days. The contractor shall exercise the best efforts to resolve Severity 3 problems (tickets) within five (5) business days.

Severity 4 (Low): A minor defect that does not impact the government’s ability to carry out business components in any environment (production, development, or test). The Severity 4 problems (tickets) may include defects in user interface, grammatical errors, or other minor cosmetic or usability issues.

RESPONSE: The contractor shall provide a response by a qualified member of its staff to begin to diagnose and to correct a Severity 4 problem (ticket) an advice the Contracting Officer’s Representative of the timeframe in which it will take to resolve the problem (ticket) within ten (10) business days. The contractor shall exercise best efforts to resolve Severity 4 problems (tickets) within ten (10) business days.

2. Software Upgrades

Version Upgrades: Provide CDC with access to the latest versions of Rhapsody software as they are released quarterly for the contract period of performance. This includes any new features, performance improvements, and enhanced security measures.

Testing and Implementation: Perform testing and validation of each software upgrade in a non-production environment to minimize disruption to ongoing operations during the upgrade process.

Provide post-upgrade support to address any issues that may arise from new versions, ensuring a seamless transition to updated software.

3. Technical Assistance and Training

Technical Support: Offer support for resolving critical software issues. The vendor must ensure rapid response times for urgent matters, especially those affecting data transmission to Public Health Agencies.

Training Sessions: Provide training for CDC staff on new software features, functionality, and any system management changes introduced in upgrades. This includes training for IT personnel responsible for managing the system.

Documentation: Deliver comprehensive and up-to-date documentation for software upgrades, troubleshooting procedures, and system configuration guidelines.

4. License and Asset Management

License Renewals: The vendor is responsible for managing and renewing Rhapsody software licenses to ensure uninterrupted usage. Annual updates on license status must be provided to CDC, along with assurance of compliance with all licensing agreements.

Asset Tracking: The vendor must maintain a current inventory of all licensed software assets and deliver detailed reports to CDC upon request.

SECTION 6 – PLACE OF PERFORMANCE AND CONTRACT SUPPORT HOURS

SUBSECTION A – PLACE OF PERFORMANCE

Performance will be at vendor’s facility.

SUBSECTION B – CONTRACT SUPPORT HOURS

The vendor to provide help desk services during our regular business hours, ensuring consistent support throughout the workday. Regular business hours are defined as 8:30 AM to 5:00 PM EST, Monday through Friday. Additionally, we anticipate the vendor being available for after-hours support to address critical emergencies that cannot wait until the next business day. The vendor should clearly outline their response times and escalation procedures for both regular hours and emergency situations to ensure seamless support and minimal disruption to operations.

SECTION 7 – DELIVERABLES/REPORTING SCHEDULE

The vendor must deliver comprehensive and up-to-date documentation for all software upgrades, maintenance procedures, and troubleshooting processes to support CDC's internal IT teams. This includes detailed release notes, technical guidance for each upgrade, and system configuration guidelines to ensure smooth transitions with minimal system downtime. All documentation must be provided at least two weeks prior to scheduled upgrades or maintenance. These materials should be submitted to CDC's IT Manager. Upon receipt, the documentation will undergo a thorough review process by the CDC IT team to verify accuracy, completeness, and alignment with operational needs.

SECTION 8 – Information Security Compliance Standard-1: Procurements Requiring Information Security and/or Physical Access Security

1. Baseline Security Requirements

a. Applicability. The requirements herein apply whether the entire contract or modification

(hereafter "contract"), or portion thereof, includes either or all of the followings. No contractor will be permitted to access or operate CDC infrastructure or systems overseas unless prior approval is received from CDC CISO.

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

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

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

i. Protect the:

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

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

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

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

Table 1: Information Types and Risk Ratings

Information Type Title Confidentiality Impact Level

Integrity Impact Level

Availability Impact Level

C.3.5.4 IT Infrastructure Maintenance Low Low Low

Table 2: Information/System Categorization and Overall Risk

Information Type Title Confidentiality (Low, Moderate, High)

Integrity (Low, Moderate, High)

Availability (Low, Moderate, High)

Security Objectives Impact Level: (NIST SP 800-60) Low Low Low Security Objectives Impact Level: (If System / Information Owner need to downgraded / upgraded risk)

Moderate Moderate Moderate

Overall Impact Level: (Low, Moderate, High)

Moderate Moderate Moderate

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.

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:

Investigation Position Requirement NAC National Agency Check Tier 1 Low-Risk Non-Sensitive, including HSPD-12 Credentialing

Tier 2 Moderate-Risk Public Trust (MRPT) Tier 3 Non-Critical Sensitive, National Security, including Secret and “L” access eligibility Tier 4 High-Risk Public Trust

Tier 5 Critical Sensitive and Special Sensitive, National Security, including Top Secret, SCI, and “Q” access eligibility

Not Applicable No Requirement

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.

Standard-3: Procurements Involving Government Information Processed on GOCO or COCO Systems

a. Security Requirements for GOCO and COCO Resources: Federal Policies. The Contractor (and/or any subcontractor) must comply with applicable federal laws, directives and CDC policies that include, but are not limited to, HHS Information Security and Privacy Policy (IS2P), the CDC IT Security Program Implementation Standards, Federal Information Security Modernization Act (FISMA) of 2014, (44 U.S.C. 101); National Institute of Standards and Technology (NIST) Special Publication (SP) 800-53, latest revision, Security and Privacy Controls for Information Systems and Organizations; Office of Management and Budget (OMB) Circular A-130, Managing Information as a Strategic Resource; and other applicable federal laws, regulations, NIST guidance, and agency policies.

b. Security Assessment and Authorization (SA&A). A valid authority to operate (ATO) certifies that the Contractor's information system meets the contract's requirements to protect the agency data. If the system under this contract does not have a valid ATO, the Contractor (and/or any subcontractor) must work with the agency and supply the deliverables required to complete the ATO prior to any use of the system in a production capacity, i.e., its intended users able to collect, store, process or transmit data to fulfill the system’s function. The Contractor must conduct the SA&A requirements in accordance with HHS IS2P/CDC IT Security Program implementation standard and Appendix K: CDC Organizationally Defined Minimum Numbers and Time Periods Derived from NIST SP 800-53 Revision 5 , NIST SP 800-37, Guide for Applying the Risk Management Framework to Information Systems: A Security Life Cycle Approach (latest revision), NIST SP 800- 53B, Control Baselines for Information Systems and Organizations, and the NIST SP 800- 53A (latest revision).

CDC acceptance of the ATO does not alleviate the Contractor's responsibility to ensure the system security and privacy controls are implemented and operating effectively.

i. SA&A Package Deliverables - The Contractor (and/or any subcontractor) must provide an

SA&A package timeline, process, and formats prescribed for a Full system authorization in the CDC Security Assessment and Authorization Standard Operating Procedure (CDC SA&A SOP). The following SA&A deliverables are required to complete the SA&A package:

Baseline System Information (BSI) – The Contractor will document a system overview, in accordance with the timeline, process and formats described in the CDC SA&A SOP. The BSI will include information concerning: system identification and ownership; system data, information types, impact levels and system categorization; system functional description / general purpose; system authorization boundary and environment; system user descriptions;

and system interconnections and dependencies. The Contractor shall update the BSI at least annually thereafter.

Privacy Threshold Analysis / Privacy Impact Analysis – The Contractor (and/or any subcontractor) shall provide a PTA/PIA (as appropriate), in accordance with the timeline, process and formats described in the CDC SA&A SOP, if applicable. Also see the sections of this contract concerning “Privacy Threshold Analysis (PTA)/Privacy Impact Assessment (PIA)” and “Requirements for Procurements Involving Privacy Act Records.” NOTE: If social security numbers (SSN) are expected to be handled by the system, the program and Contractor must include an SSN Elimination or Usage Approval Request along with the PTA/PIA. That request will be processed in accordance with the CSPO Standard for Limiting the Use of Social Security Numbers in CDC Information Systems.

System Security Plan (SSP) – due in accordance with the timeline prescribed in the CDC A&A SOP. The SSP must comply with the NIST SP 800- 18, Guide for Developing Security Plans for Federal Information Systems, the Federal Information Processing Standard (FIPS) 200, Recommended Security Controls for Information Systems, and NIST SP 800-53, Security and Privacy Controls for Federal Information Systems and Organizations applicable baseline requirements, and other applicable NIST guidance as well as CDC policies and other guidance.

The SSP must be consistent with and detail the approach to IT security contained in the Contractor's bid or proposal that resulted in the award of this contract. The SSP must provide an overview of the system environment and security requirements to protect the information system as well as describe all applicable security controls in place or planned for meeting those requirements. It should provide a structured process for planning adequate, cost-effective security protection for a system.