Statement of Work - Final.pdf

Statement of Work / Performance Work Statement

Title: EMS Data Project for Injury Surveillance in States Throughout the United States

Period of performance of this contract is: April 11, 2024 to April 10, 2027 Base Period: April 11, 2024 to April 10, 2025 Option Period One: April 11, 2025 to April 10, 2026 Option Period Two: April 11, 2026 to April 10, 2027

SECTION 1 – BACKGROUND

The Centers for Disease Control and Prevention (CDC) National Center for Injury Prevention and Control (NCIPC) is engaging in efforts to better understand drug overdose trends in the United States by using timely and comprehensive data from emergency departments, death certificates, and medical examiner/coroner reports including toxicological results. In order to complement surveillance data currently being collected by several of CDC’s programs [e.g., Overdose Data to Action (OD2A), Firearm Injury Surveillance Through Emergency Rooms (FASTER), Advancing Violence Epidemiology in Real Time (AVERT), Emergency Department Surveillance of Nonfatal Suicide-Related Outcomes (ED-SNSRO)], NCIPC is interested in gaining access to near real-time emergency medical services (EMS) data and a analytic platform that allows querying state and county-level EMS records for trends in various health syndromes within states.

Previously, NCIPC entered into a contract with Biospatial (75D30120P09781) to provide access to near real-time state-level EMS data and provide an analytic platform that enables querying these EMS records for trends in various health syndromes. Biospatial has established unique data use agreements with states to access electronic patient care reports from thousands of EMS providers in over 40 US states. The Biospatial platform leverages analytics and proprietary artificial intelligence to normalize and make sense of complex structured and unstructured data, link complementary data assets, and provide web-based tools, automated reporting, and alerting. A range of information is included in the platform including reason for EMS transport, diagnosis information, patient demographics and other symptoms and side effects, treatments provided, and other risk and protective factors for injury and health outcomes.

SECTION 2 – PURPOSE/OBJECTIVE

The objective is to acquire, at a minimum, five (5) Single Seat User Licenses to access the Biospatial platform to access near real-time state-level Emergency Medical Services (EMS) trend data to enable timely monitoring of injury and violence epidemiologic trends for widespread dissemination.

SECTION 3 – SCOPE OF WORK

Independently and not as an agent of the Government the contractor shall furnish the necessary personnel and services, except as provided in the schedule, and otherwise do all things necessary for the performance of the work as described below:

3.1 Allow infrastructure access for a minimum of five (5) individual NCIPC staff workstations.

3.2 Provide technical, analytical and scientific support, including software documentation, as agreed upon in writing.

3.3 Provide annually (1) one (1)-hour online training sessions, to NCIPC program personnel on data access/query within the infrastructure. These training sessions will be held yearly via webcast, skype (or other CDC approved) with the expectation that the session will be recorded for internal NCIPC use only.

SECTION 4 – TECHNCIAL REQUIREMENTS (Base + Option Years, if exercised)

• Contractor shall provide access to an EMS platform that includes the following specifications:

o Includes near real-time EMS data that should be able to be queried in a web browser.

o Data on syndrome trends should be downloadable as count data by county by day; a suitable baseline or denominator should also be available such as count of all EMS encounters by day for each geographic entity.

o The Biospatial dashboard should have the ability for users to apply data quality filters and specify data exclusion/inclusion thresholds (i.e., Underlying Event Coverage and Data Submission Completeness).

o Direct access to complete individual or identifiable patient records is not needed by CDC (see exception below about request for truncated records for piloting and validating syndrome definitions); however, the platform should allow for querying and reporting on trends derived from complete individual records. This includes the ability to directly query the Patient Care Report Narrative using inclusion/exclusion keywords.

o Data product should allow for identification of health syndromes including but not limited to overdose, violence, and suicide, using both medical/billing codes and natural language processing/text analysis of records to enable more direct comparability with CDC’s existing emergency department based syndromic surveillance efforts. CDC should be able to generate new syndromic surveillance definitions with Contractor assistance.

o Include wide-ranging geographic coverage and an ability of CDC, immediately upon contract execution, to query and disseminate data from at least 35 states.

• Contract shall allow CDC Scientist to query retrieve, download and export syndrome and denominator count data by day at the level of county, state, and national via an Application Programming Interface (API). Include API functionality that allows users to apply data quality filters and specify thresholds within their query (i.e., Underlying Event Coverage and Data Submission Completeness).

• Provide licensing to access to the Biospatial platform for a minimum of five (5) NCIPC workstation.

• Provide technical, analytical and scientific support and discussion on best practices for querying the data and using the biospatial platform.

• Provide assistance to NCIPC staff on conducting ad hoc data pulls or validating data pulls from the API as needed.

• Provide standard API code with annotations about where it can be modified to change the data pull (e.g., change the syndrome definition, time period, binning, data quality thresholds, etc.). This should include guidance on how to query data by national NEMSIS data elements (i.e., not solely those available on the biospatial dashboard). Add up to 15 additional national NEMSIS data elements to the API for querying (e.g., eResponse variables, eMedication variables, and eOutcome variables). All variables currently in the biospatial API will continue to be available for querying by NCIPC staff.

• Meet one of the two following requirements, with the preference being for Option 1:

o Option 1 (preference): Provide access to a limited number of deidentified line level records (i.e., all demographic variables removed such as state/county, age, sex, etc.) to NCIPC staff for piloting and validating syndrome definitions; at a minimum, the following variables should be available: Patient Care Report Narrative (eNarrative.01), Patient Complaint

(eSituation.04), Primary/Other Associated Symptoms (eSituation.09/eSituation.10), Provider Primary/Secondar Impression (eSituation.11/eSituation.12), Medication Given (eMedications.03), and Response to Medication (eMedications.07). Data should be available from a minimum of 5 states for at least a one-year period (e.g., January–December 2022).

o Option 2: Provide a bulk data export (e.g., via Excel or other agreed upon format) of line level records meeting all of the Option 1 requirements using an agreed upon sampling strategy (e.g., all records meeting the opioid overdose definition for a one year period) except the sharing of the Patient Care Report Narrative (eNarrative.01); in lieu of the narrative, biospatial will share the “biospatial symptoms” variable and a corresponding description of how the symptom variable was generated for the syndrome being assessed (e.g., for opioid overdoses).

• Provide one (1), one (1) hour online training sessions yearly via webcast, skype (or other CDC approved) with the expectation that the session will be recorded for internal NCIPC use only.

SECTION 5 – GOVERNMENT FURNISHED PROPERTY

The Government shall not provide furnished materials, property, or office space for the Contractor.

SECTION 6 – PLACE OF PERFORMANCE AND CONTRACT SUPPORT HOURS

It is estimated that approximately 0% the contract will be performed on-site at CDC facilities and 100% will be performed off-site at the contractor’s facilities. Contractor shall not be required to travel domestically or internationally on this contract.

SUBSECTION A – PLACE OF PERFORMANCE

It is estimated that approximately 0% the contract will be performed on-site at CDC facilities and 100% will be performed off-site at the contractor’s facilities. Contractor shall not be required to travel domestically or internationally on this contract.

SUBSECTION B – CONTRACT SUPPORT HOURS

Contractor shall provide support for (1) hour for Task 8 with start and end time to be determined in the time zone specified by the contracting officer’s representative

SECTION 7 – TRAVEL

The Government does not anticipate any travel on this contract.

SECTION 8 – DELIVERABLES/REPORTING SCHEDULE

The following deliverables shall be provided to the Contracting Officer’s Representative and relevant CDC staff no later than the dates specified in the tables.

Item # Deliverable Description Date of Delivery [Time after the Contract Award]

1 Within one week following the award:

Kickoff Meeting planned by Contractor shall meet via teleconference, utilizing teams, zoom for virtual meeting with Contracting Officer Representative (COR) and other key personnel to

Within one week following award discuss the administration and performance of the contract.

2 Provide usernames and passwords to access the platform

Within one week following award

3 Allow infrastructure access from a minimum of five (5) individual NCIPC workstations

Within one week following award

4 Provide annual one (1), one (1) hour online trainings to NCIPC program personnel using the Biospatial platform

First training to begin within 1 month of award and following NCIPC staff access to registry

5 Provide access to a limited number of deidentified line level records from a minimum of 5 states for at least a one-year period.

OR

Option 2: Provide a bulk data export of a limited number of deidenfitied line level records from a minimum of 5 states using an agreed upon sampling strategy, not including the patient care report narrative.

Within six months following award

Option 2: On an as requested basis within one week following award

6 Add up to 15 additional national NEMSIS data elements to the biospatial API for querying.

Within six months following award

All contract deliverables intended for communication to the public must comply with Public Law 111–274, the Plain Writing Act of 2010. For Plain Language information and the Federal Plain Language Guidelines see www.plainlanguage.gov.

Deliverables – Applicable to the base period and all option years, if exercised

All materials will be submitted electronically in MS compatible format that meets CDC standards and is readily available at CDC (e.g. MS Office (Word, Excel, PowerPoint) or Adobe Acrobat. All reporting requirements and written deliverables as part of this contract will be supplied to the project Contracting Officer Representative (COR). Acceptance of any written deliverables is pending CDC COR review and correction to any resulting comments, to be confirmed in writing and documented in the closest following monthly report. Any schedule of interim deliverables may be revised according to CDC acceptance of an updated written work plan by the COR during the project with the restriction that these changes must not impact the overall period of performance, scope, or specifications of the award, or otherwise impinge on the authority of the contracting officer. It is the responsibility of the contractor to fully understand what changes require contracting officer approval.

SECTION 9 – REFERENCE MATERIALS

No reference materials included

SECTION 10 – ADDITIONAL REQUIREMENTS

Information Security and Privacy

1. Baseline Security Requirements:

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

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

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

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

i. Protect the:

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/NCIPC and information systems that store, process, and/or transmit CDC information in accordance with FIPS 199 and National Institute of Standards and Technology (NIST) Special Publication (SP) 800-60, Volume II: Appendices to Guide for Mapping Types of Information and Information Systems to Security

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

Confidentiality: [X] Low [ ] Moderate [ ] High Integrity: [ ] Low [X] Moderate [ ] High Availability: [X ] Low [ ] Moderate [ ] High Overall Impact Level: [ ] Low [X ] 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/NCIPC 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/NCIPC 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/NCIPC 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 Component privacy policies and complete all the requirements below:

i. Per the Office of Management and Budget (OMB) Circular A-130, Personally Identifiable Information (PII), is "information that can be used to distinguish or trace an individual's identity, either alone or when combined with other information that is linked or linkable to a specific individual." Examples of PII include, but are not limited to the following: Social Security number, date and place of birth, mother's maiden name, biometric records, etc.

ii. To ensure that the public's personal information is protected in a manner commensurate with the privacy risks, CDC uses a privacy analysis process to assess the risks associated with CDC's collection and maintenance of PII and to ensure information is handled in accordance with applicable legal, regulatory, and policy requirements. PTAs analyze how information is handled in IT systems and electronic information collections and determines if the IT system or electronic information collection collects, disseminates, maintains, or disposes of PII. PIAs are used to assess the privacy risks of IT systems and electronic information collections that collect, disseminate, maintain, or dispose of PII about members of the public. PIAs also provide transparency into how CDC collects, disseminates, maintains, or disposes of the public's PII.

iii. The Contractor must support the agency with conducting a Privacy Threshold Analysis (PTA) for the information system and/or information handled under this contract to determine whether PII is collected, disseminated, maintained, or disposed as part of the contract. The PTA will determine if a full Privacy Impact Assessment (PIA) needs to be completed.

If the results of the PTA show that a full PIA is needed, the Contractor must support the agency with completing a PIA for the system or information 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. According to the CDC Web policy, all CDC web content must reside on a CDC.gov domain and must be hosted on CDC or CDC-authorized information systems .

k. Contract Documentation. The Contractor must use provided templates, policies, forms, and other agency documents NCIPC 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 CDC and CDC Component-specific encryption standard requirements. Maintain a complete and current inventory of all laptop computers, desktop computers, and other mobile devices and portable media that store or process sensitive government information (including PII).

iv. Verify that the encryption solutions in use have been validated under the Cryptographic Module Validation Program to confirm compliance with current FIPS 140 validation certificate from the NIST CMVP. The Contractor must provide a written copy of the validation documentation to the COR [CDC Component- provided delivery date].

v. Use the Key Management system on the CDC personal identification verification (PIV) card or establish and use a key recovery mechanism to ensure the ability for authorized personnel to encrypt/decrypt information and recover encryption keys http://csrc.nist.gov/publications/. Encryption keys must be provided to CSPO.

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, https://intranet.cdc.gov/ofr/documents/contracts/Non-Disclosure- Agreement-Con.docx, 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 Information Security Awareness, Privacy, and Records Management training at least annually, during the life of this contract. All provided training must be compliant with CDC training policies.

b. Role-based Training. All Contractor (and/or any subcontractor) employees with significant security responsibilities (as determined by the program manager) must complete role- based training annually commensurate with their role and responsibilities in accordance with HHS/CDC policy and the CDC Role-Based Training (RBT) of Personnel with Significant Security Responsibilities.

c. Training Records. The Contractor (and/or any subcontractor) must maintain training records for all its employees working under this contract in accordance with CDC policy. A copy of the training records must be provided to the CO and/or COR within 30 days after contract award and annually thereafter or upon request.

3. Rules of Behavior:

a. The Contractor (and/or any subcontractor) must ensure that all employees performing on the contract comply with the CDC Implementation of the HHS Rules of Behavior for Use of HHS Information Technology Resources.

b. All Contractor employees performing on the contract must read and adhere to the Rules of Behavior before accessing agency data or other information, systems, and/or networks that store/process government information, initially at the beginning of the contract and at least annually thereafter, which may be done as part of annual CDC Information Security Awareness Training. If the training is provided by the Contractor, the signed ROB must be provided as a separate deliverable to the CO and/or COR per defined timelines above.

4. Incident Response:

a. The Contractor (and/or any subcontractor) must respond to all alerts/Indicators of Compromise (IOCs) provided by CDC Computer Security Incident Response Center (CSIRC) IRT teams within 24 hours, whether the response is positive or negative. In accordance with FISMA and OMB M-17-12, Preparing for and Responding to a Breach of Personally Identifiable Information (PII)29, an incident is "an occurrence that

(1) actually or imminently jeopardizes, without lawful authority, the integrity, confidentiality, or availability of information or an information system; or (2) constitutes a violation or imminent threat of violation of law, security policies, security procedures, or acceptable use policies" and a privacy breach is "the loss of control, compromise, unauthorized disclosure, unauthorized acquisition, or any similar occurrence where (1) a person other than an authorized user accesses or potentially accesses personally identifiable information or (2) an authorized user accesses or potentially accesses personally identifiable information for an other than authorized purpose." For additional information on the CDC breach response process, please see the CDC Standard for Responding to Breaches of Personally Identifiable Information (PII).30"

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

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

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

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

iv. NOT notify affected individuals unless so instructed by the

Contracting Officer or designated representative. If instructed by the Contracting Officer or representative, the Contractor must send NCIPC approved notifications to affected individuals within 60 days.

v. Report all suspected and confirmed information security and privacy incidents and breaches to the CSPO Incident Response Team (IRT) at csirt@cdc.gov or 866-655-2245, 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.

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.

29 Memorandum is available at: https://www.whitehouse.gov/wp-content/uploads/legacy_drupal_files/omb/memoranda/2017/m-17-12_0.pdf 30 Standard is available at: https://cdc.sharepoint.com/teams/OCIO-CSPO- PUBDOCS/Standards/CSPO%20Responding%20to%20Breaches%20of%20Personally%20I dentifiable%20Information.pdf

x. Acknowledge that CDC will not interpret report of a breach, by itself, as conclusive evidence that the Contractor or its subcontractor failed to provide adequate safeguards for PII.

5. Position Sensitivity Designations:

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

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

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

OMB M-05-24; OMB M-19-17; FIPS 201, Personal Identity Verification (PIV) of Federal Employees and Contractors; HHS/CDC HSPD-12 policy;

and Executive Order 13467, Part 1 §1.2.

7. Roster:

The Contractor (and/or any subcontractor) must submit a roster by name, position, e-mail address, phone number and responsibility, of all staff working under this acquisition where the Contractor will develop, have the ability to access, or host and/or maintain a government information system(s). The roster must be submitted to the COR and/or CO by the effective date of this contract. Any revisions to the roster as a result of staffing changes must be submitted immediately upon 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 in accordance with the CDC Office of Financial Resources (OFR) Contract Closeout Guide and HHS Closeout Guide: Contracts and Orders.

b. System Documentation. Contractors (and/or any subcontractors) must follow and adhere to CDC System Development Life Cycle requirements, at a minimum, for system development and provide system documentation at designated intervals (specifically, at the expiration of the contract) within the EPLC that require artifact review and approval.

c. Sanitization of Government Files and Information. As part of contract closeout and at expiration of the contract, the Contractor (and/or any subcontractor) must provide all required documentation to the CO and/or COR to certify that, at the government's direction, all electronic and paper records are appropriately disposed of and all devices and media are sanitized in accordance with NIST SP 800-88, Guidelines for Media Sanitization.

d. Notification. The Contractor (and/or any subcontractor) must notify the CO and/or COR and System Security and Privacy Officer (previously referred to as ISSO) within [CDC Component-specific timeline] before an employee stops working under this contract.

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

f. The Contractor (and/or any subcontractor) must perform and document the actions identified in the NCIPC Contractor Employee Separation Checklist when an employee terminates work under this contract within [insert CDC Component-specific timeline] days of the employee's exit from the contract.

All documentation must be available to the CO and/or COR upon request.

9. Records Management and Retention:

a. The Contractor (and/or any subcontractor) must maintain all information in accordance with Executive Order 13556 -- Controlled Unclassified Information, National Archives and Records Administration (NARA) records retention policies and schedules and CDC Policy for Records Management and NCIPC policies and must not dispose of any records unless authorized by CDC/ NCIPC.

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/ NCIPC policies.

10. High Value Asset (HVA):

If a system is identified as HVA,31 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.

31 For definition of HVA, see the Glossary section at the end of this document.

Human Subjects Protections in Research Does not include activities or tasks that meet the definition of research- Does not involve: Live vetebrate animal (see Funding Determination_Eclearance)

Paperwork Reduction Act (PRA) PRA doies not apply. Qualifies for a regulatory exclusion: No information being collected Justification: Service Contract (see Funding Determination_Eclearance)

Section 508 Compliance- Special Considerations

508 Acquisition Clearance: Please add the 508 language in the SOW under a section called “Special Considerations.” This is cleared with this change. If the IGCE is $250k or above, your ISSO may determine that FITARA applies, and will be cleared a second time for 508 during that process.

The 508 language must be in the SOW in order to be cleared in ICE.

(Start of verbiage) Electronic and Information Technology Accessibility Notice

(a) Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998 and the Architectural and Transportation Barriers Compliance Board Electronic and Information (EIT) Accessibility Standards (36 CFR part 1194), require that when Federal agencies develop, procure, maintain, or use electronic and information technology, Federal employees with disabilities have access to and use of information and data that is comparable to the access and use by Federal employees who are not individuals with disabilities, unless an undue burden would be imposed on the agency. Section 508 also requires that individuals with disabilities, who are members of the public seeking information or services from a Federal agency, have access to and use of information and data that is comparable to that provided to the public who are not individuals with disabilities, unless an undue burden would be imposed on the agency.

(b) Accordingly, any offeror responding to this solicitation must comply with established HHS EIT accessibility standards. Information about Section 508 is available at http://www.hhs.gov/web/508. The complete text of the Section 508 Final Provisions can be accessed at Revised 508 Standards and 255 Guidelines (access-board.gov)

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

205 WCAG 2.0 Level A & AA Success Criteria 302 Functional Performance Criteria 502 Inoperability with Assistive Technology 503 Applications 504 Authoring Tools 602 Support Documentation 603 Support Services

In order to facilitate the Government’s determination whether proposed EIT supplies meet applicable Section 508 accessibility standards, offerors must submit an HHS Section 508 Product Assessment Template, in accordance with its completion instructions. The purpose of the template is to assist HHS acquisition and program officials in determining whether proposed EIT supplies conform to applicable Section 508 accessibility standards. The template allows offerors or developers to self-evaluate their supplies and document—in detail—whether they conform to a specific Section 508 accessibility standard, and any underway remediation efforts addressing conformance issues. Instructions for preparing the HHS Section 508 Evaluation Template are available under Section 508 policy on the HHS website https://www.hhs.gov/web/508. Offerors may alternatively provide a Section 508 Accessibility conformance report (ACR) as described at www.section508.gov.

In order to facilitate the Government’s determination whether proposed EIT services meet applicable Section 508 accessibility standards, offerors must provide enough information to assist the Government in determining that the EIT services conform to Section 508 accessibility standards, including any underway remediation efforts addressing conformance issues.

(d) Respondents to this solicitation must identify any exception to Section 508 requirements. If a offeror claims its supplies or services meet applicable Section 508 accessibility standards, and it is later determined by the Government, i.e., after award of a contract or order, that supplies or services delivered do not conform to the described accessibility standards, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its expense.

(e) Electronic content must be accessible to HHS acceptance criteria. Checklist for various formats is available at http://508.hhs.gov/, or from the Section 508 Coordinator listed at Accessibility Resources | HHS.gov. Materials that are final items for delivery should be accompanied by the appropriate checklist, except upon approval of the Contracting Officer or Representative.

(end of language)

Printing

No printing clearance required

Additional Special Considerations

The contractor shall as an independent organization and not as part of the Government, furnish all necessary services, facilities, equipment, qualified personnel, and material (except for those, if any, to be furnished by the Centers for Disease Control and Prevention (CDC) as specified to perform the services required by the Performance Work Statement. Contractor performance and resulting deliverables must adhere to all federal, HHS, and CDC IT security and privacy policies, standards and procedures

A. The contractor is prohibited from publishing, presenting, or disseminating results or information without the prior written approval of the COR and the SME.

1. All data collected and products developed under this contract shall become and remain the property of the Government.

2. Travel to the funded sites is not anticipated.

3. The contractor must notify CDC in writing within 30 days if the contractor’s

Project Manager, Project Lead, or any proposed staffing changes.

B. Data Rights: 52.227-14 Rights in Data-General, Alternate IV (Dec 2007). As prescribed in 27.409(b) (5), substitute the following paragraph (c) (1) for paragraph

(c) (1) of the basic clause: (c) Copyright—(1) Data first produced in the performance of the contract. Except as otherwise specifically provided in this contract, the Contractor may assert copyright in any data first produced in the performance of this contract. When asserting copyright, the Contractor shall affix the applicable copyright notice of 17 U.S.C. 401 or 402, and an acknowledgment of Government sponsorship (including contract number), to the data when such data are delivered to the Government, as well as when the data are published or deposited for registration as a published work in the

C. U.S. Copyright Office. For data other than computer software, the Contractor grants to the Government, and others acting on its behalf, a paid-up, nonexclusive, irrevocable, worldwide license for all such data to reproduce, prepare derivative works, distribute copies to the public, and perform publicly and display publicly, by or on behalf of the Government. For computer software, the Contractor grants to the Government and others acting on its behalf, a paid-up, nonexclusive, irrevocable, worldwide license for all such computer software to reproduce, prepare derivative works, and perform publicly and display publicly (but not to distribute copies to the public), by or on behalf of the Government.

D. The contractor shall provide CDC de-identified data set(s) at the end of the project that can be shared with the public through restricted-use data agreements.

Documentation should be included, and a final Data Management Plan should be drafted (See CDC Plan for Increasing Access to Scientific Publications and Digital Scientific Data Generated with CDC Funding. Available at:

https://www.cdc.gov/od/science/docs/final-cdc-public-access-plan-jan-2015_508-compliant.pdf for guidance.

SECTION 1 – PROPOSED CONTRACT TYPE

Sole Source, Small Business (SB) Biospatial POC: Jon Woodworth, jon.woodworth@biospatial.io

PH: (919) 946.1787

SUBSECTION A – PROCUREMENT POINT OF CONTACT (POC) INFORMATION

Charla L. Jackson, MHSA Public Health Advisor, FAC-COR II Epidemiology Surveillance Branch Division of Overdose Prevention National Center for Injury Prevention and Control Tel: 770-488-1563 | ckj5@cdc.gov

APPENDIX A: TECHNICAL EVALUATION CRITERIA

Offeror shall demonstrate that the offeror’s plan to accomplish the effort is feasible, efficient, and effective, including recognition of potential performance difficulties/risks and appropriateness and soundness of proposed solutions. The Government will perform a qualitative technical review of proposals. The technical evaluation will be performed in accordance with the following:

1. Technical Approach The Offeror shall provide a discussion of their technical approach for providing the services required for this solicitation. The Offeror shall provide their understanding of the task requirements, solicitation objectives, and the operating environment. The Government will evaluate the quality and feasibility of the methodology and performance techniques describing how the Offeror proposes to perform each task.

The Offeror shall provide a Project Plan describing the process and approach they propose to use in successfully completing this project. The Project Plan should correlate to the Offeror’s price/cost proposal. The Offeror shall specifically address aspects such as technical understanding, methodology and approach, along with the sub-factors listed below:

a. Provide a detailed and comprehensive statement of the problem, scope, and purpose of the project to demonstrate complete understanding of the intent and requirements of the contract.

b. Describe the proposed technical approach to comply with each of the requirements specified in this solicitation. The proposal must be consistent with the stated goals and objectives. The proposed approach must ensure the achievement of timely and acceptable performance and will include a milestone and/or phasing charts to illustrate a logical sequence of proposed events.

c. Discuss the plan and solutions for overcoming difficulties involved with performing the work requirements.

2. Management Approach

The Offeror shall provide a management plan that describes their approach for managing the work, identifying the roles and responsibilities of pertinent players, and subcontracting management plans, if applicable. The Offeror shall demonstrate an overall understanding of the project and adequacy and feasibility of plans to address all items in the solicitation.

This includes the detailed description of specific tasks to be performed, methods and resources to be

OTHER CONSIDERATIONS AND ADDITIONAL INFORMATION FOR OFFICE

OF ACQUISITION SERVICES

used and a discussion of problems likely to occur and plans for addressing them.

a. The Offeror shall describe their organizational structure and how they propose to manage this task, including a discussion of timelines and issues. Document the decision-making authority of the project director as related to other elements of the organization, including subcontractors if applicable.

b. The Offeror shall provide rationale for their management approach.

c. The Offeror shall clearly indicate how the metrics in the PWS will be monitored and corrective action taken if appropriate. The Offeror shall specify its approach for maintaining control of all contract change management issues.

d. The Offeror shall identify anticipated management barriers and risks. The Offeror shall provide a description of their approach to risk management during the solicitation from a management perspective and the planned actions to mitigate or eliminate risks.

e. Offeror shall identify (if any) assumptions or conditions relating to their Management Plan and Other Qualification Information. The Government reserves the right to reject any proposal that includes any assumption or condition that adversely impacts or affects the Government’s requirement.

3. Similar Experience The Government will evaluate the offeror’s narrative description of two (2) relevant contracts similar in scope, size, and…