75D30123R72688 Synopsis Solicitation Inpatient Outpatient Data.pdf

RFP# 75D301-23-R-72688

SECTION A – SYNOPSIS AND DESCRIPTION OF REQUIREMENT

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in

Subpart 12.6. This announcement constitutes the only solicitation. Proposals are being requested, and a written solicitation will not be issued. The solicitation number is 75D301-23-R-72688, and is being issued as a request for proposals (RFP). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular FAC 2023-02. The associated North American Industrial Classification System (NAICS) code for this procurement is 513210 Software Publishers.

THIS RFP IS BEING SOLICITED FOR FULL AND OPEN COMPETITION

Offerors must be registered in the System for Award Management (SAM) at http://www.sam.gov, in order to be considered for award.

This combined synopsis solicitation notice is a request for competitive proposals. This requirement is for de-identified healthcare data extracts and is expected to result in the award of one Firm Fixed Price contract. The term of the resulting contract shall be thirty-six (36) months comprised of a base period of twelve (12) months followed by two (2) twelve (12) month option periods. A Government review of performance will be performed annually through the Contractor Performance Assessment Reporting System (CPARS), which provides timely and relevant information on Contractor performance for use in source selection. The anticipated Period of Performance for this requirement and any resultant contract, inclusive of all option periods, is 09/01/2023 – 08/31/2026.

All questions/inquiries must be submitted to the contracting officer via electronic mail (e-mail) no later than 12:00 PM EDT on Friday, 06/02/2023. Inquiries via telephone will be re-directed to an e-mail submission. Submit offers and/or any questions to the attention of Michael Crow at wyv2@cdc.gov. Questions will not be answered on an individual basis, and all responses will be posted to www.sam.gov.

Proposals are due via email to wyv2@cdc.gov no later than 5:00 PM EDT on Tuesday, 06/20/2023.

Offerors who fail to complete and submit a proposal in accordance with the requirements of this combined synopsis/solicitation may be considered non-responsive at the discretion of the Contracting Officer and will not be considered for award. Only proposals received prior to the RFP closing date and time will be considered by the CDC. Late proposals will not be accepted.

https://acquisition.gov/far/current/html/Subpart%2012_6.html#wp1088488 http://www.sam.gov/ mailto:wyv2@cdc.gov.

http://www.sam.gov/ mailto:wyv2@cdc.gov

TABLE OF CONTENTS

Issued 05/26/2023

Section Document/Clause/Provision Page No.

A Synopsis and Description of Requirement 1 B Supplies or Services and Prices/Costs 3 C Statement of Work 6 D Contract Clauses 20 E Contract Documents, Exhibits or Attachments 34 F Solicitation Provisions 35 G Additional Instructions 38

SECTION B – SUPPLIES OR SERVICES AND PRICES/COSTS

Base Year Items:

ITEM SUPPLIES / SERVICES QTY / UNIT UNIT PRICE EXTENDED PRICE

0001 Comprehensive Data Extract:

Task 1

This is a Severable Firm Fixed Price Line Item.

Period of Performance: 09/01/2023 – 08/31/2024

12 Each

0002 Social Determinants of Health Data Extract:

Task 2

This is a Severable Firm Fixed Price Line Item.

Period of Performance: 09/01/2023 – 08/31/2024

12 Each

0003 Training and Technical Support:

Task 3

This is a Severable Firm Fixed Price Line Item.

Period of Performance: 09/01/2023 – 08/31/2024

1 Job

Option Year 1 Items:

1001 Comprehensive Data Extract:

Period of Performance: 09/01/2024 – 08/31/2025

12 Each

1002 Social Determinants of Health Data Extract:

Task 2

This is a Severable Firm Fixed Price Line Item.

Period of Performance: 09/01/2024 – 08/31/2025

12 Each

1003 Training and Technical Support:

Task 3

This is a Severable Firm Fixed Price Line Item.

Period of Performance: 09/01/2024 – 08/31/2025

Option Year 2 Items:

2001 Comprehensive Data Extract:

Period of Performance: 09/01/2025 – 08/31/2026

12 Each

2002 Social Determinants of Health Data Extract:

Task 2

This is a Severable Firm Fixed Price Line Item.

Period of Performance: 09/01/2025 – 08/31/2026

12 Each

2003 Training and Technical Support:

Task 3

This is a Severable Firm Fixed Price Line Item.

Period of Performance: 09/01/2025 – 08/31/2026

Summary of Pricing Base Period Option Period 1 Option Period 2 Total:

B.1 Points of Contact:

Contractor: TBD Telephone:

Email:

CDC/PHIC: TBD

Telephone:

Email:

CDC/OAS: Michael Crow Telephone: (770) 488-3208 Email: wyv2@cdc.gov mailto:wyv2@cdc.gov

SECTION C – STATEMENT OF WORK

Title: Comprehensive and Longitudinal Inpatient and Hospital-based Outpatient Data for the U.S. Government for COVID-19 Response, Post COVID-19 Response, and Other Public Health Priority Activities

C.1 BACKGROUND AND NEED:

Data to understand spread and impact of the COVID-19 outbreak pandemic, as well as other public health threats, are critical. The U.S. Centers for Disease Control and Prevention (CDC) intends to continue to obtain and use electronic healthcare data for public health purposes to inform situational awareness, predictive modeling, and strategic, tactical, and policy decision making; to help track the spread and intensity of COVID-19 infection, as well as the impact of post-COVID-19 conditions and other public health threats, and identify areas that have been highly impacted; to determine where federal resources (e.g., technical, financial, or in-kind assistance) should be routed to jurisdictions in need; to understand spectrum of illness, disease burden, risk factors for severe disease, and outcomes; and to understand the impact on healthcare systems and communities.

CDC intends to undertake these activities in coordination with United States Department of Health and Human Services (HHS) and the United States Government to ensure appropriate access to covered data elements by authorized users. To facilitate that access, CDC has developed a system called CDC Data Hub in the CDC Office of the Chief Information Officer’s Microsoft Azure cloud environment. This system is designed to receive, manage, and analyze data from electronic health record (EHR) vendors, non-profit organizations, academia, and health care data providers. The CDC Data Hub system consists of services for enforcing security and governance, scalable service for data exchange, data platform for managing received data, analytics tooling for querying and visualizing data (exploratory analysis) and services for data processing and preparation.

C.2 PURPOSE:

The purpose of this requirement is for CDC to obtain healthcare data extracts from a comprehensive database of individual-level inpatient and hospital-based outpatient data that allows the CDC to monitor trends over time and conduct epidemiologic analyses related to the COVID-19 pandemic and other public health priorities. To support execution of a holistic government response to fight the COVID-19 pandemic and potential future public health emergencies, CDC may share data products with Authorized Users in: HHS; other federal agencies supporting the United States Government (USG) response; and state, local, tribal, and territorial governments.

C.3 SCOPE OF WORK:

The Contractor shall provide the necessary license(s), technical support, and training necessary for complete access to data for use by CDC and CDC designees. The data extracts sent to CDC shall include records for 2019 through the most recent files available to the Contractor.

C.4 TECHNICAL REQUIREMENTS:

The Contractor shall provide the following: Standard hospital discharge files, including the patient’s demographic and disease state, information on the billed services, medications, laboratory tests performed, diagnostics and therapeutic services in de-identified patient daily service records. The documentation shall also include all procedures and diagnoses captured for each patient, as well as all drugs and devices received. Drug utilization information shall be categorized by the day of stay, and the quantity, strength used, charge, and hospital reported costs. Admission and discharge dates (mm/dd/yyyy) shall be provided in a manner that protects personally identifiable information, and information on length of stay will be available. Discharge status and discharge disposition, including in-hospital death, shall be provided. Facility location shall be provided at the three-digit zip code level.

All data provided to CDC shall have personally identifiable information (PII) removed in accordance with the Health Insurance Portability and Accountability (HIPAA). Other protections shall be put in place to limit the ability to use protected health information (PHI) to potentially re-identify patients, understanding that public health practice often requires the acquisition, use, and exchange of PHI to support public health activities, including surveillance efforts during public health emergencies. Such information enables public health authorities to implement mandated activities (e.g., identifying, monitoring, and responding to death, disease, and disability among populations) and accomplish public health objectives.

C.5 TASKS TO BE PERFORMED:

C.5.1 Task 1 – Comprehensive Data Extract:

The Contractor shall provide CDC with a comprehensive data extract encompassing at least 1,000 U.S. hospitals using a secure method in accordance with all applicable CDC and HHS data security and privacy regulations. The data extract shall include the discharge-level data variables from sequenced patient files and provider files Metadata listed below.

The contractor shall provide available data provenance support with each data delivery to support confidence in and validation of the data. Healthcare data extracts shall be transmitted electronically in a format that is easily ingested into CDC’s Enterprise Data Catalogue. The contractor shall provide a table of re-admission information as applicable.

Patient Data:

1. De-identified Discharge ID (use this field to link a patient’s hospital visit across data files);

2. De-identified Unique Patient ID (use this field to track a patient across multiple visits within the same hospital system, including inpatient and outpatient visits);

3. Patient Validation Indicator;

4. Discharge month and year;

5. Admission month and year;

6. Provider ID (de-identified);

7. Inpatient versus Outpatient visit indicator;

8. Patient type;

9. Medicare Severity Diagnosis related groups (MS-DRG);

10. MS-DRG major diagnostic category (MDC);

11. Admission source;

12. Admission type;

13. Discharge status and disposition;

14. Age at time of admission (if age is greater than 89, age is adjusted to 89);

15. Sex;

16. Race (Reported as White, Black, Asian, Other, Unknown);

17. Ethnicity (Reported as Hispanic, Non-Hispanic, Other/Unknown);

18. Admitting physician specialty;

19. Admitting physician de-identified linking identifier;

20. Attending physician specialty;

21. Attending physician de-identified linking identifier;

22. Primary payer;

23. Length of stay

24. Total charges;

25. Total cost;

26. Total fixed cost;

27. Total variable cost;

28. National inpatient projection;

29. Discharge month sequence (used with discharge month to order multiple discharges for a unique patient within a particular month).

Hospital Data:

1. De-identified Provider ID;

2. Urban versus rural designation;

3. Teaching status;

4. Bed size;

5. U.S. Census region;

6. U.S. Census division;

7. U.S. State;

8. First three digits of ZIP code (zip3).

International Classification of Diseases, Tenth Revision (ICD-10) Diagnosis and Procedure Data:

1. De-identified Discharge ID (use this field to link a patient’s hospital visit across data files);

2. ICD-10 Diagnosis related information – ICD-10-Clinical Modification (ICD-10-CM):

a. Primary ICD-10-CM diagnosis code and description;

b. All secondary ICD-10-CM diagnosis codes and descriptions reported by the hospital;

c. Admitting ICD-10-CM diagnosis code (if provided by the hospital);

d. Major category code and description;

3. ICD-10 Procedure related information – ICD-10 Procedure coding system (ICD-10 PCS):

a. Primary ICD-10 PCS procedure code and description;

b. All secondary ICD-10 PCS procedure codes and descriptions reported by the hospital;

c. Procedure day;

d. Procedure physician specialty;

e. Procedure physician de-identified linking identifier;

Current Procedural Terminology (CPT) Data:

1. De-identified Discharge ID (use this field to link a patient’s hospital visit across data files);

2. All CPT4 codes and descriptions reported by the hospital.

Billing Data:

1. De-identified Discharge ID (use this field to link a patient’s hospital visit across data files);

2. Hospital specific charge master id and description;

3. Standard Charge Master code and description;

4. Clinical Detail code and description;

5. Date of Service;

6. Standard Quantity (to be used with the Standard charge master description);

7. Clinical Detail Quantity (to be used with the Clinical detail description);

8. Billing charges;

9. Billing cost;

10. Billing fixed cost;

11. Billing variable cost;

12. Standard Department Code and description;

13. Pharmacy, Central Supply, Laboratory, Diagnostic Imaging, Surgery, etc.;

14. Pharmacy billing information, including:

a. Drug name (generic);

b. Drug strength (from Standard Charge Master Description);

c. Drug therapeutic class;

d. Route of administration (oral, parenteral, topical).

General Laboratory File from a subset of facilities with available data:

1. Specimen source SNOMED Code;

2. Specimen source SNOMED Description;

3. Collection Day Number;

4. Collection Time of Day;

5. Lab Test LOINC code;

6. Lab Test LOINC description;

7. Lab Test Result;

8. Result Unit;

9. Flags;

10. Result Day Number;

11. Result Time of Day;

12. Reference Interval;

13. Numeric Value;

14. Numeric Value Operator.

Microbiology Laboratory File from a subset of facilities with available data:

1. Specimen ID;

2. Test day and time of collection;

3. Test name;

4. Observation (test result);

5. Sensitivity data for positive test results;

6. Organism;

7. Drug tested;

8. Interpretation;

9. Minimal inhibitory concentration (MIC).

Vitals Data from a subset of facilities with available data:

1. Facility Test Name;

2. Systolic Blood Pressure;

3. Pulse;

4. Temperature;

5. Diastolic Blood Pressure;

6. Oxygen Saturation Level;

7. Respiration Rate;

8. Height;

9. Weight;

10. LOINC Code Description;

11. LOINC Code;

12. Observation Day and Time;

13. Observation Result.

C.5.2 Task 2 – Social Determinates of Health Data Extract:

The Contractor shall provide CDC with a data table that contains indicators of social determinants of health (SDOH) described below. The SDOH table shall be linkable to the patient-level data provided to CDC pursuant to Task 1 using the de-identified unique discharge or patient ID. The SDOH variables shall be linked to the patients’ place of residence (not at the facility location) at the lowest (or smallest) level of geography available (i.e., census tract, ZIP Code Tabulation Areas (ZCTAs), ZIP code, or county). The SDOH variables shall be provided to CDC at the highest level of resolution allowable (i.e., exact value rounded to whole number). If exact values are not permitted to be shared, the Contractor shall provide the SDOH variable categorized into deciles (or ten equally sized groups). The Contractor shall use the most recent SDOH variables available to them and shall link the SDOH indicators temporally to the patients’ visit (i.e., 2020 SDOH indicators linked to 2020 visits). For more recent visits in which the corresponding year of SDOH indicators are not available, the Contractor shall use the most recent year available (e.g., 2020 SDOH indicators linked to 2021 or 2022 visits).

The Contractor shall deliver the data extracts using a secure method in accordance with all applicable CDC and HHS data security and privacy regulations. The data extract(s) shall include, at a minimum, (a) an electronic data dictionary and contents listing and (b) de-identified unique patient ID in addition to the following patient-level data variables:

SDOH information will be provided as stated below:

American Community Survey data by ZCTA:

1. Value (absolute or decile) of average household size;

2. Value (absolute or decile) of Gini index of income inequality;

3. Value (absolute or decile) of median household income;

4. Value (absolute or decile) of weighted average of highest level of education achieved (less than high school, high school, associate degree, bachelor’s degree, and graduate degree).

CDC Social Vulnerability Index variables by Census tract:

1. Percentile (absolute or decile) ranking: Theme 1, socioeconomic;

2. Percentile (absolute or decile) ranking: Theme 2, household composition;

3. Percentile (absolute or decile) ranking: Theme 3, minority status/language theme;

4. Percentile (absolute or decile) ranking: Theme 4, housing/transportation;

5. Percentile (absolute or decile) ranking for overall SVI.

2013 Urban-Rural Classification Schema for Counties:

1. Large central metro;

2. Large fringe metro;

3. Medium metro;

4. Small metro;

5. Micropolitan;

6. Non-core.

C.5.3 Task 3 – Training Services:

Contractor shall provide four (4) hours of virtual, web-based training in the Base Year period of performance and four (4) hours of virtual, web-based training in Option Years 1 and 2 if option years are exercised. The initial training will be scheduled within three (3) weeks of initial data delivery at a mutually agreed upon date and the four (4) hours of virtual, web-based training for Option Years 1 and 2, if exercised, will also be scheduled at a mutually agreed upon date within (3) weeks of initial data delivery for that year.

C.6 DELIVERABLES AND REPORTING REQUIREMENTS:

C.6.1 Monthly Progress Report:

The contractor shall provide a monthly progress report that includes a listing of all data extracts delivered, the date data extracts were delivered, and a summary of any technical issues impeding data delivery.

C.6.2 Table of Deliverables:

Contract Task Associated Deliverable Required Frequency Delivery Method

Task 1

Comprehensive Data Extract

Monthly, by the last Monday of each month.

Microsoft Azure Cloud.

Notification to the Contracting Officer’s Representative (COR) via email.

Task 2

Social Determinants of Health Data Extract

Monthly, by the last Monday of each month.

Microsoft Azure Cloud.

Notification to the Contracting Officer’s Representative (COR) via email.

Contract Task Associated Deliverable Required Frequency Delivery Method

Task 3

Virtual Training Once during the base year, within 3 weeks following the initial data extract delivery, and once for each exercised option year, within 3 weeks following the first data extract delivery for that option year.

Virtual via Microsoft Teams or similar platform.

Tasks 1, 2, and 3

Monthly Progress Report

Monthly, by the 5th working day of each month.

Via email to the Contracting Officer’s Representative (COR).

C.7 QUALITY ASSURANCE SURVEILLANCE PLAN:

C.8 IT SECURITY REQUIREMENTS:

A. Baseline Security Requirements

1. Applicability. The requirements herein apply whether the entire contract or order (hereafter “contract”), or portion thereof, includes either or both of the following:

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

a. Operate a Federal System Containing Information: A Contractor (and/or any subcontractor) employee will operate a federal system and information technology containing data that supports the HHS 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.

2. Safeguarding Information and Information Systems. In accordance with the Federal Information

Processing Standards Publication (FIPS) 199, Standards for Security Categorization of Federal Information and Information Systems, the Contractor (and/or any subcontractor) shall:

a. Protect government information and information systems in order to ensure:

Work Requirement / Performance Standard

Acceptable Quality Level Surveillance Method

Incentive for Meeting Performance Standard

Perform of all tasks listed in the deliverables schedule

Deliverables provided in accordance with contract requirements, at an acceptable quality. 90% compliance within each contract period.

Surveillance by Assigned CDC Contracting Officer’s Representative

(COR)

- Negative or positive CPARS Evaluations

- Invoice reduction or non-payment for deliverables that do not meet contract requirements.

1. 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;

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

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

a. Provide security for any Contractor systems, and information contained therein, connected to an HHS network or operated by the Contractor on behalf of HHS regardless of location. In addition, if new or unanticipated threats or hazards are discovered by either the agency or contractor, or if existing safeguards have ceased to function, the discoverer shall immediately, within one (1) hour or less, bring the situation to the attention of the other party, as well as be notified to the system security steward for potential escalation to ISSO and CSIRT

b. Adopt and implement the policies, procedures, controls, and standards required by the HHS 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 the HHS Information Security Program security requirements, outlined in the HHS Information Security and Privacy Policy (IS2P), by contacting the CO/COR or emailing fisma@hhs.gov.

c. Comply with the Privacy Act requirements and tailor FAR clauses as needed.

3) Information Security Categorization. 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, Appendix C, and based on information provided by the ISSO, CISO, or other security representative, the risk level for each Security Objective and the Overall Risk Level, which is the highest watermark of the three factors (Confidentiality, Integrity, and Availability) of the information or information system are the following:

Based on information provided by the ISSO, Privacy Office, system/data owner, or other security or privacy representative, it has been determined that this solicitation/contract involves:

[ ] No PII [X] Yes PII

1. Personally Identifiable Information (PII). Per the Office of Management and Budget (OMB) Circular A- 130, “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.

PII Confidentiality Impact Level has been determined to be: [X ] Low [] Moderate [] High mailto:fisma@hhs.gov

2. Controlled Unclassified Information (CUI). CUI is defined 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 32 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.

All sensitive information that has been identified as CUI by a regulation or statute, handled by this solicitation/contract, shall be:

a. marked appropriately;

b. disclosed to authorized personnel on a Need-To-Know basis;

c. protected in accordance with NIST SP 800-53, Security and Privacy Controls for Federal 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

d. returned to HHS control, destroyed when no longer needed, or held until otherwise directed.

1. 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) shall protect all government information that is or may be sensitive in accordance with OMB Memorandum M-06-16, Protection of Sensitive Agency Information by securing it with a FIPS 140-2 validated solution.

2. Confidentiality and Nondisclosure of Information. Any information provided to the contractor (and/or any subcontractor) by HHS or collected by the contractor on behalf of HHS shall be used only for the purpose of carrying out the provisions of this contract and shall 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 shall ensure that all work performed by its employees and subcontractors shall be under the supervision of the Contractor. Each Contractor employee or any of its subcontractors to whom any HHS records may be made available or disclosed shall 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 shall be protected in accordance with HHS and [CDC] policies. Unauthorized disclosure of information will be subject to the HHS/[CDC] sanction policies and/or governed by the following laws and regulations:

a. 18 U.S.C. 641 (Criminal Code: Public Money, Property or Records);

b. 18 U.S.C. 1905 (Criminal Code: Disclosure of Confidential Information); and

c. 44 U.S.C. Chapter 35, Subchapter I (Paperwork Reduction Act).

1. Internet Protocol Version 6 (IPv6). All procurements using Internet Protocol shall comply with OMB Memorandum M-05-22, Transition Planning for Internet Protocol Version 6 (IPv6). .

2. 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 shall enable HTTP Strict Transport Security (HSTS) to instruct compliant browsers to assume HTTPS at all times to reduce the number of insecure redirects and protect against attacks that attempt to downgrade connections to plain HTTP. For internal-facing websites, the HTTPS is not required, but it is highly recommended.

3. Contract Documentation. The Contractor shall use provided templates, policies, forms and other agency documents to comply with contract deliverables as appropriate. See Section 7 for full list of contract deliverables

4. Standard for Encryption. The Contractor (and/or any subcontractor) shall:

a. Comply with the HHS Standard for Encryption of Computing Devices and Information to prevent unauthorized access to government information.

b. 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 FIPS 140-2 validated encryption solution.

c. Secure all devices (i.e.: desktops, laptops, mobile devices, etc.) that store and process government information and ensure devices meet HHS and CDC- 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).

d. Verify that the encryption solutions in use have been validated under the Cryptographic Module

Validation Program to confirm compliance with FIPS 140-

2. The Contractor shall provide a written copy of the validation documentation to the COR.

e. Use the Key Management system on the HHS 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. Encryption keys shall be provided to CDC Office of Chief Information Security Officer (OCISO).

12) Contractor Non-Disclosure Agreement (NDA). Each Contractor (and/or any subcontractor) employee having access to non-public government information under this contract shall complete the CDC non-disclosure agreement, as applicable. A copy of each signed and witnessed NDA shall be submitted to the Contracting Officer (CO) and/or CO Representative (COR) prior to performing any work under this acquisition.

13. Privacy Threshold Analysis (PTA)/Privacy Impact Assessment (PIA) – The Contractor shall assist the CDC Senior Official for Privacy (SOP) or designee with conducting a PTA for the information system and/or information handled under this contract in accordance with HHS policy and OMB M-03-22, Guidance for Implementing the Privacy Provisions of the E-Government Act of 2002.

a. The Contractor shall assist the CDC SOP or designee in reviewing the PIA at least every three years throughout the system development lifecycle (SDLC)/information lifecycle, or when determined by the CDC SOP that a review is required based on a major change to the system (e.g., new uses of information collected, changes to the way information is shared or disclosed and for what purpose, or when new types of PII are collected that could introduce new or increased privacy risks), whichever comes first.

B. Training

a. Mandatory Training for All Contractor Staff. All Contractor (and/or any subcontractor) employees assigned to work on this contract shall complete the applicable HHS/CDC Contractor Information Security Awareness, Privacy, and Records Management training (provided upon contract award) before performing any work under this contract. Thereafter, the employees shall complete CDC Security Awareness Training (SAT), Privacy, and Records Management training at least annually, during the life of this contract. All provided training shall be compliant with HHS 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 (RBT) within 60 days of assuming their new responsibilities. Thereafter, they shall complete RBT at least annually in accordance with HHS policy and the HHS Role-Based Training (RBT) of Personnel with Significant Security Responsibilities Memorandum.

All HHS employees and contractors with SSR who have not completed the required training within the mandated timeframes shall have their user accounts disabled until they have met their RBT requirement.

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

C. Rules of Behavior

a. The Contractor (and/or any subcontractor) shall ensure that all employees performing on the contract comply with the HHS Information Technology General Rules of Behavior.

b. All Contractor employees performing on the contract must read and adhere to the Rules of

Behavior before accessing Department 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 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.

D. Incident Response The Federal Information Security Modernization Act (FISMA) defines an incident as “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. The HHS Policy for IT Security and Privacy Incident Reporting and Response further defines incidents as events involving cybersecurity and privacy threats, such as viruses, malicious user activity, loss of, unauthorized disclosure or destruction of data, and so on.

A privacy breach is a type of incident and is defined by FISMA as 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.

OMB Memorandum M-17-12, “Preparing for and Responding to a Breach of Personally Identifiable Information” (03 January 2017) states:

Definition of an Incident:

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.

Definition of a Breach:

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.

It further adds:

A breach is not limited to an occurrence where a person other than an authorized user potentially accesses PII by means of a network intrusion, a targeted attack that exploits website vulnerabilities, or an attack executed through an email message or attachment. A breach may also include the loss or theft of physical documents that include PII and portable electronic storage media that store PII, the inadvertent disclosure of PII on a public website, or an oral disclosure of PII to a person who is not authorized to receive that information. It may also include an authorized user accessing PII for any other than authorized purpose.

The HHS Policy for IT Security and Privacy Incident Reporting and Response further defines a breach as “a suspected or confirmed incident involving PII.”

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

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

2. 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 so as to avoid a secondary sensitive information incident with FIPS 140-2 validated encryption.

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

4. All contractors and subcontractors shall report a suspected or confirmed breach in any medium as soon as possible and no later than 1 hour of discovery, consistent with applicable CDC IT acquisitions guidance, HHS/CDC and incident management policy, and United States Computer Emergency Readiness Team (US-CERT) notification guidelines. To this end, the Contractor (and/or any subcontractor) shall respond to all alerts/Indicators of Compromise (IOCs) provided by HHS Computer Security Incident Response Center (CSIRC) or CDC Computer Incident Response Team (CSIRT) within 24 hours via email at csirt@cdc.gov or telephone at 866-655-2245, whether the response is positive or negative.

5. 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.

6. All contractors and subcontractors shall allow for an inspection, investigation, forensic analysis, and any other action necessary to ensure compliance with HHS/CDC Policy and the HHS/CDC Breach Response Plan and to assist with responding to a breach.

7. 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.

8. Identify roles and responsibilities, in accordance with HHS/CDC Breach Response Policy and the HHS/CDC Breach Response Plan. To this end, the Contractor shall NOT notify affected individuals unless and until so instructed by the Contracting Officer or designated representative. If so instructed by the Contracting Officer or representative, all notifications must be pre-approved by the appropriate CDC officials, consistent with HHS/CDC Breach Response Plan, and the Contractor shall then send CDC-approved notifications to affected individuals.; and,

9. 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.

E. 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).

mailto:csirt@cdc.gov

F. Homeland Security Presidential Directive (HSPD)-12 The Contractor (and/or any subcontractor) and its employees shall comply with Homeland Security Presidential Directive (HSPD)-12, Policy for a Common Identification Standard for Federal Employees and Contractors; OMB M-05-24; FIPS 201, Personal Identity Verification (PIV) of Federal Employees and Contractors; HHS HSPD-12 policy; and Executive Order 13467, Part 1 §1.2.

For additional information, see HSPD-12 policy at: https://www.dhs.gov/homeland-security- presidential-directive- 12)

Roster. The Contractor (and/or any subcontractor) shall 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 shall 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 shall 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 shall provide a position description and the Government will determine the appropriate suitability level.

G. Contract Initiation and Expiration

1. General Security Requirements. The Contractor (and/or any subcontractor) shall comply with information security and privacy requirements, Enterprise Performance Life Cycle (EPLC) processes, HHS 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 shall follow the HHS EPLC framework and methodology and in accordance with the HHS Contract Closeout Guide (2012).

2. System Documentation. Contractors (and/or any subcontractors) must follow and adhere to NIST

SP 800-64, Security Considerations in the System Development Life Cycle, 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.

3. Sanitization of Government Files and Information. As part of contract closeout and at expiration of the contract, the Contractor (and/or any subcontractor) shall 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.

1. Notification. The Contractor (and/or any subcontractor) shall notify the CO and/or COR and system ISSO before an employee stops working under this contract.

https://www.dhs.gov/homeland-security-presidential-directive-12 https://www.dhs.gov/homeland-security-presidential-directive-12 https://www.dhs.gov/homeland-security-presidential-directive-12

2. Contractor Responsibilities Upon Physical Completion of the Contract. The contractor (and/or any subcontractors) shall 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 shall 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.

3. The Contractor (and/or any subcontractor) shall 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. All documentation shall be made available to the CO and/or COR upon request.

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

In the event that a contractor (and/or any subcontractor) accidentally disposes of or destroys a record without proper authorization, it shall be documented and reported as an incident in accordance with HHS policies.

C.9 ELECTRONIC AND INFORMATION TECHNOLOGY ACCESSIBILITY NOTICE:

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

(b) Accordingly, any offeror responding to this solicitation must comply with established HHS EIT accessibility standards. Information about Section 508 is available at http://www.hhs.gov/web/508. The complete text of the Section 508 Final Provisions can be accessed at http://www.access-board.gov/sec508/standards.htm.

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

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

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

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

http://intranet.cdc.gov/od/hcrmo/pdfs/hr/Out_Processing_Checklist.pdf) http://www.hhs.gov/web/508 http://www.access-board.gov/sec508/standards.htm http://hhs.gov/web/508

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

(e) Electronic content must be accessible to HHS acceptance criteria. Checklist for various formats is available at http://508.hhs.gov/, or from the Section 508 Coordinator listed at https://www.hhs.gov/web/section-508/additional-resources/section-508-contacts/index.html. Materials that are final items for delivery should be accompanied by the appropriate checklist, except upon approval of the Contracting Officer or Representative.

http://508.hhs.gov/ https://www.hhs.gov/web/section-508/additional-resources/section-508-contacts/index.html https://www.hhs.gov/web/section-508/additional-resources/section-508-contacts/index.html

SECTION D - CONTRACT CLAUSES

Section D-1 - Clauses Incorporated By Reference

D-1.1 52.252-2 Clauses Incorporated by Reference (Feb 1998) This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available.

Also, the full text of a clause may be accessed electronically at this/these address(es):

https://www.acquisition.gov/browse/index/far https://www.ecfr.gov/current/title-48

(End of Clause)

FAR SOURCE TITLE DATE

52.212-4 Contract Terms and Conditions—Commercial Products and Commercial Services

Dec 2022

52.227-14 Rights in Data-General May 2014

HHSAR SOURCE TITLE DATE

352.203-70 Anti-Lobbying Dec 2015

352.208-70 Printing and Duplication Dec 2015

352.222-70 Contractor Cooperation in Equal Employment Opportunity Investigations

Dec 2015

Section D-2 - Clauses Incorporated In Full Text

D-2.1 FAR 52.212-5 Contract Terms and Conditions Required To Implement Statutes or Executive Orders— Commercial Products and Commercial Services (Mar 2023)

(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial products and commercial services:

(1) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (JAN 2017) (section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).

(2) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities (NOV 2021) (Section 1634 of Pub. L. 115-91).

(3) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment. (NOV 2021) (Section 889(a)(1)(A) of Pub. L. 115-232).

https://www.acquisition.gov/browse/index/far https://www.ecfr.gov/current/title-48 https://www.acquisition.gov/far/52.203-19#FAR_52_203_19 https://www.acquisition.gov/far/52.204-23#FAR_52_204_23 https://www.acquisition.gov/far/52.204-25#FAR_52_204_25

(4) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (NOV 2015).

(5) 52.