PO 75D30121P10944 ABFM.pdf

ORDER FOR SUPPLIES OR SERVICES

PAGE OF PAGES

1 38 IMPORTANT: Mark all packages and papers with contract and/or order numbers.

1. DATE OF ORDER 2. CONTRACT NO. (If any) 6. SHIP TO:

08/24/2021 75D30121P10944 a. NAME OF CONSIGNEE

3. ORDER NO. 4. REQUISITION/REFERENCE NO.

00HCPNED-2021-55473 b. STREET ADDRESS

5. ISSUING OFFICE (Address correspondence to) Centers for Disease Control and Prevention (CDC) Office of Acquisition Services (OAS) 2900 Woodcock Blvd, MS TCU-4 Atlanta, GA 30341-4004

c. CITY

d. STATE

e. ZIP CODE

f. SHIP VIA

a. NAME OF CONTRACTOR

AMERICAN BOARD OF FAMILY MEDICINE, INC.

DUNS NUMBER: 079659108 8. TYPE OF ORDER

b. COMPANY NAME X a. PURCHASE b. DELIVERY

REFERENCE YOUR:

c. STREET ADDRESS

1648 MCGRATHIANA PKWY STE 550

d. CITY

LEXINGTON

e. STATE

KY

f. ZIP CODE

40511-1342

9. ACCOUNTING AND APPROPRIATION DATA

9390EX5 2512 2021 75-2024-0943 C323111101

10. REQUISITIONING OFFICE

HCPNED

11. BUSINESS CLASSIFICATION (Check appropriate box(es))

a. SMALL X b. OTHER THAN SMALL c. DISADVANTAGED d. WOMEN-OWNED

12. F.O.B. POINT

Destination

13. PLACE OF

a. INSPECTION b. ACCEPTANCE

14. GOVERNMENT B/L NO.

15. DELIVER TO F.O.B. POINT

ON OR BEFORE (Date)

08/23/2022

16. DISCOUNT TERMS

Net 30 Days

17. SCHEDULE (See reverse for Rejections)

ITEM NO.

(a)

SUPPLIES OR SERVICES

(b)

QUANTITY

ORDERED

(c)

UNI

T

(d)

UNIT

PRICE

(e)

AMOUNT

(f)

QUANTITY

ACCEPTED

(g) To ensure payment invoice must reference

Purchase Order# 75D30121P10944 and DUNS Number and Tax ID, Invoice/ Payment information: 404-718-8100. Send invoices to FAX: 404-638-5324 or Email:

cpbapinv@cdc.gov

Vendor: Robert L. Phillips, Jr. MD Email: bphillips@theabfm.org

CDC: Mark Hansey Tele: (404) 498-0399 Email: cvf7@cdc.gov

Contract Specialist: Michael Crow Tele:(770) 488-3208 Email: wyv2@cdc.gov

18. SHIPPING POINT

19. GROSS SHIPPING WEIGHT

20. INVOICE NO.

21. MAIL INVOICE TO: $1,473,888.00

a. NAME

Centers for Disease Control and Prevention (FMO)

b. STREET ADDRESS (or P.O. Box)

PO Box 15580 404-718-8100

c. CITY

Atlanta

d. STATE

GA

e. ZIP CODE

303330080 $1,473,888.00

22. UNITED STATES

OF AMERICA (Signature)

23. NAME (Typed)

Michael Crow

TITLE: CONTRACTING/ORDERING OFFICER

NSN 7540-01-152-8083

PREVIOUS EDITION NOT USABLE OPTIONAL FORM 347 (REV. 6/95)

Prescribed by GSA/FAR 48 CFR 53.213(e)

Except for billing instructions on the reverse, this delivery order is subject to instructions contained on this side only of this form and is issued subject to the terms and conditions of the above-numbered contract.

Please furnish the following on the terms and conditions specified on both sides of this order and on the attached sheet, if any, including delivery as indicated.

17(h) TOT.

(Cont.

pages) SEE BILLING

INSTRUCTIONS

ON

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17(i)

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7. TO:

mailto:cpbapinv@cdc.gov mailto:bphillips@theabfm.org mailto:cvf7@cdc.gov mailto:wyv2@cdc.gov

75D30121P10944

Contractor Confirmation and Acceptance:

Contractor agrees to furnish and deliver all items or perform all the services set forth or otherwise identified herein.

The rights and obligations of the parties to this Purchase Order shall be subject to and governed by the following documents: (a) this purchase order, (b) the solicitation, if any, and (c) such provisions, representations, certifications, and specifications, as are attached or incorporated by reference herein.

NAME AND TITLE OF SIGNATORY for American Board of Family Medicine, Inc.

BY ___________________________________

(Signature of person authorized to sign) DATE SIGNED

Roger M. Bean, Chief Financial Officer

August 24, 2021

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

ITEM SUPPLIES / SERVICES QTY / UNIT UNIT PRICE EXTENDED PRICE

0001 American Family Cohort Data:

This is a Severable Fixed Price Line Item.

Period of Performance: 08/24/2021 - 08/23/2022

12 Months $122,824.00 $1,473,888.00

Line(s) Of Accounting:

9390EX5 2512 2021 75-2024-0943 C323111101

$1,473,888.00

Priorities and Allocations Authority (HHS ACQUISITION ALERT 2020-10)

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

Section C – Statement of Work

Title: Outpatient Electronic Health Record Data from Primary Care and Family Medicine Practices to Support CDC’s COVID-19 Emergency Response (American Board of Family Medicine)

C.1 Background:

Access to timely and comprehensive data on the spread and impact COVID-19 remain critical to understanding and combatting the COVID-19 pandemic. The U.S. Centers for Disease Control and Prevention (CDC) is using 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 and identify areas that are highly impacted by COVID-19; to understand spectrum of illness, disease burden, risk factors for severe disease, and outcomes; and to understand the impact of COVID-19 on healthcare systems and communities. CDC intends to work collaboratively with electronic health record (EHR) vendors to agree on and construct a set of queries which can then be used on the surveillance data summary sets. The intent is to achieve as much standardization and harmonization, as possible across the various data sets generated and shared voluntarily by the different EHR system developers.

The majority of COVID-19 patients have been treated in outpatient settings and most care for Post COVID Conditions (also referred to as post-acute COVID-19 sequelae (PASC)) will occur in the outpatient setting. Thus, it is important that CDC have regular and ongoing access to comprehensive, outpatient EHR data and analytics for a large and diverse sample of primary care and family medicine practices from across the United States.

Comprehensive outpatient EHR data are needed to monitor the impact of COVID-19 on the U.S. population and address key clinical and epidemiological questions. There have been an increasing number of reports of patients who experience persistent symptoms and/or organ dysfunction after acute COVID-19. At this time, there is limited information on the prevalence, duration, underlying causes, and effective management strategies for these lingering signs and symptoms. The incidence, natural history, and etiology of these symptoms are currently unknown.

Currently, there is no case definition for PACS, and no specific time frame has been established to define late sequelae of COVID-19.

Through a no-cost Data Use and Sharing Agreement (signed in May 2020), the American Board of Family Medicine (ABFM) provided CDC with EHR data from the American Family Cohort.

The American Family Cohort. The American Family Cohort (AFC) is a research dataset derived the American Board of Family Medicine (ABFM) PRIME Registry electronic health record (EHR) data. In 2018, the ABFM partnered with Stanford University to convert the ABFM PRIME Registry data into a resource suitable for research, public health and science in the public interest. ABFM PRIME is an outpatient Qualified Clinical Data Registry certified by CMS in 2016 to report clinical quality measures for federal and other reporting requirements. The ABFM PRIME data are curated and prepared for research by Stanford University. This process involves harmonization, cleaning and removal, recoding, enhancement of some variables and removal, recoding or aggregation of certain sensitive variables. AFC includes EHR data from over 6.6 million unique patients throughout the US and representation from populations which are underserved and often missing from other data sources including rural, low income and racial and ethnic minorities. The data to be delivered to CDC shall consist of the dataset(s) derived from the PRIME Registry data in the AFC, as defined in Table 1, Section 1, below (“AFC Data”), and covers >800 primary care practices across 47 states with 40% of AFC patients residing in rural areas, for all patient encounters that occurred from January 2018 through the end of the project period. AFC Data include visit notes (free text), lab values, medications, procedures (CPT), diagnoses (ICD) notes, insurance type, vital signs (including temperature), and social history. AFC Data includes a wide payer mix with patients on private insurance plans, Medicaid and Medicare, increasing the representation of vulnerable populations, and the generalizability of the sample to the overall US population.

The CDC evaluated the AFC Data for their completeness and usability and determined that the data fill a gap in the agency’s current healthcare data portfolio for the COVID-19 Response. Regular access to these data is greatly needed as CDC continues to provide public health prevention and mitigation guidance for the COVID-19 response efforts.

CDC intends to use the AFC Data to conduct complex analysis on disease patterns, progression, and health outcomes; evaluate clinical guidelines uptake, treatments, and interventions; and conduct public health surveillance for COVID-19 and related conditions. The AFC Data can also be used to monitor indirect effects of the COVID-19 pandemic on clinical preventive services, chronic disease control, and mental/behavioral health, as well as other chronic and infectious disease agency priorities.

C.2 Purpose

The purpose of this acquisition is for the CDC to acquire comprehensive outpatient EHR data and analytics from the AFC Data. CDC seeks to obtain de-identified, longitudinal, line-level data from 2018 onward, including updated data files delivered to CDC every other month for a period of one year. In addition, CDC seeks to obtain the analytic products and deliverables derived from the AFC Data to expedite use and dissemination of the data to inform the COVID-19 emergency public health response.

The AFC Data will be used by CDC personnel (defined as CDC employees, fellows, and contractors) to address COVID-19 and other agency priorities that require access to outpatient EHR data and/or data from patients residing in rural areas. These data will allow CDC personnel to conduct complex analysis on COVID-19 disease patterns, progression, and outcomes, including PASC; assess clinical guidelines uptake, treatments, and interventions; and monitor patterns in COVID-19 prevalence and outcomes related to health disparities.

The AFC Data will be used to support a holistic government response to fight the COVID-19 pandemic and other public health threats. CDC will share findings and reports generated using the AFC Data with other federal, state, local, territorial, and tribal governmental partners, non-governmental organizations, and the general public as needed to disseminate key information to stakeholders and the scientific community.

C.3 Scope of Work:

American Board of Family Medicine (ABFM), not as an agent of the Government, shall provide the necessary license, documentation, training, and technical assistance to support agency-wide access to the AFC Data for use by CDC personnel as described below in Table 1. The AFC Data provided by ABFM shall include a limited data set for the years 2018 to current and, upon completion, a de-identified dataset which retains variables needed by the CDC (e.g., five digit zip code and dates of service). Trainings, data curation and analytic support shall be provided through a research collaboration between ABFM and its subcontractor(s). ABFM shall send AFC Data dated from January 1, 2018 through the most recent files available during the project period. ABFM shall provide an updated data extract to CDC every other month for a period of one (1) year from the date of award (total of 6 data deliveries). The term of this agreement shall be one (1) year from the date signed by the parties. CDC shall retain license to use the data extracts received for an additional 12 months after the period of performance ends. CDC shall dispose of the AFC Data in accordance with applicable federal records management policies.

ABFM shall also provide analytic and summary products derived from analysis of the AFC Data. These include sample weights and summary data on health disparities, symptoms and morbidity of patients experiencing late sequelae, and ABFM-initiated assessments of family medicine physicians regarding management and best practices for patients.

C.4 Tasks:

Task 1: Provide AFC Data and Documentation

a) ABFM shall provide CDC with comprehensive, longitudinal, line-listed EHR-based AFC Data as described in

Table 1, Section 1, below. ABFM shall provide AFC Data from January 1, 2018 through the most recent files available to ABFM. ABFM shall deliver updated AFC Data to CDC bimonthly for a period of one year (total of six (6) data deliveries). The AFC Data shall be comprehensive and include line listed (record listed) information on patient demographics, insurance, social history, family history, lab orders, immunizations, medications, prescriptions, problem, procedure, observations, diagnoses, and visit type (in person vs.

telemedicine). The AFC Data shall include a unique patient ID that can be used to link patients across data files and longitudinally. ABFM shall deliver the AFC Data to CDC using a secure method that is in accordance with CDC data security and privacy policy. ABFM shall ensure that all CDC data security and privacy regulations are followed.

b) The AFC Data shall comprise a “Limited Data Set” as defined under the Health Insurance Portability and

Accountability Act (HIPAA). ABFM shall ensure that data are prepared and de-identified in accordance with the HIPAA Privacy Rule. De-identification approach shall be agreed upon with CDC. ABFM shall evaluate and notify CDC of all data elements known or suspected to contain individually identifiable health information (i.e., protected health information (PHI)). ABFM shall develop and implement a systematic method for data review and cleaning to mask or remove PHI not included or approved as part of the limited dataset prior to delivering AFC Data to CDC.

c) ABFM shall clean key data elements and provide standardized code sets. ABFM shall clean and provide clinical and demographic data in standard, coded formats.

d) ABFM shall provide coded variables for COVID-19 diagnoses, COVID-19-like-illness (CLI), influenza diagnoses, and influenza-like illness (ILI) using agreed upon definitions.

e) ABFM shall provide comprehensive documentation of unit of analysis for each table, linkage schema and variables to create patient-level and visit-level files, and data dictionaries for each of the tables.

Task 2: Summary Report:

ABFM shall provide a report summarizing data in the AFC Data in tandem with the frequency of data deliveries.

Contents of the report to be finalized in partnership with ABFM. Possible topics include, but are not limited to:

a) weekly trends in COVID-19 diagnoses, CLI, positive SARS-CoV-2 and antibody laboratory results, influenza diagnoses, ILI, positive influenza rapid test results

b) demographic characteristics of COVID-19 patients, including distribution of race/ethnicity, social deprivation or vulnerability, and other relevant indicators for monitoring health disparities

c) clinical characteristics of COVID-19 patients, including frequency of follow-up visits and post-acute diagnoses among COVID-19 patients

d) number of reporting facilities, status of facilities (e.g., remained open, closed and re-opened with associated dates, remain closed), and weekly trends in number of patients seen in the facilities

e) any available information on SARS-CoV-2 variants, vaccination (including vaccine type and data of administration), and patient outcomes such as mortality.

Task 3: Sample Weight:

ABFM shall create sample weights so that findings from the AFC Data are more generalizable to the U.S.

population. This shall be at the individual and census tract levels and shall be standardized to distributions of the U.S. population. ABFM shall construct variance stabilized inverse-probability weights using individual-level data on age, race and ethnicity, and census block, along with quintiles of the census tract-level social deprivation index. Preliminary descriptive analysis suggests that distributions of the population of PRIME and the U.S.

population are similar enough across these variables that valid weights can be constructed.

Task 4: Health and Health Disparities:

ABFM shall assess health and social inequities, using available information (e.g., residential urban-rural status, social deprivation, race/ethnicity, and other relevant variables) as predictors of COVID-19 prevalence and outcomes (those available in EHR) over space and time. Social vulnerability and other socio demographic characteristics can be appended to line-level records for analysis using granular patient residential location information (e.g., census block). At the direction of and with input from CDC, ABFM shall:

a) Develop a data analysis plan to examine health disparities among COVID-19 patients

b) Conduct analysis described in 4a, including assessment of data completeness

c) Develop a report describing findings of health and social inequities analyses

d) Support or prepare manuscripts for peer review publications (in accordance with CDC publication and clearance policies) to disseminate results for public health and clinical use.

Task 5: Post-acute Sequelae of SARS-COV-2 Infection (PASC):

ABFM shall provide summary data and analytic products to monitor PASC including clinical characterization, duration of symptoms, associated conditions, and morbidity and mortality that occur at least 4 weeks after evidence of initial COVID illness or SARS-CoV-2 infection. At the direction of and with input from CDC, ABFM shall:

a) Develop a suspect PASC case definition using EMR data to include a clinical characterization of newly presenting or incident diagnosis of conditions, and including fatigue, difficulty thinking or concentrating (sometimes referred to as “brain fog”), difficulty breathing (with and without abnormal imaging and pulmonary function testing), cough, painful joints or muscles, chest pain, depression or anxiety, headache, fever, palpitations, loss of smell or taste, or dizziness on standing

b) Conduct descriptive analyses showing geographic, demographic, clinical characteristics, spectrum of management, duration of symptoms, and associated morbidity and mortality

c) Calculate associations between PASC and demographic and clinical characteristics

d) Conduct a comparative analysis of patients reporting similar PASC symptoms after influenza or influenza like illness

e) Conduct up to three assessments of ABFM providers regarding diagnosis, management, and best practices for making EMR data more available for public health and share summary findings with CDC.

f) Summarize findings of analyses (Tasks 5b-5d) in a report to CDC

g) Support or prepare manuscripts for peer review publications (in accordance with CDC publication and clearance policies) to disseminate results for public health and clinical use.

Task 6: COVID-19 Vaccination:

ABFM shall provide summary data and analytic products to monitor SARS-CoV-2 vaccination geographic spread and gaps. The data elements may include vaccine name/manufacturer date of administration, location of vaccination, and demographic and clinical characteristics. ABFM shall:

a) Provide a data dictionary and summary of how vaccination information is captured or recorded in EMRs within the practices in the AFC Data.

b) Develop a report describing vaccine impact by geography, urbanicity, health disparities, social vulnerability, demographic, and clinical factors.

c) At the direction of and with input from CDC support the dissemination and findings in the form of a scientific publication

Task 7: Regular Meetings:

a) ABFM shall participate in a project kickoff meeting with CDC and provide a meeting agenda.

b) ABFM shall participate in monthly check-in meetings with CDC to assess status of deliverables and address outstanding questions or concerns.

Table 1. Deliverables / Schedule

Number Task Number Description Quantity Delivery Date 1 1a,1b,1c, 1d, and 1e AFC Research Data and Documentation.

Data Delivery, Historic (01/1/2018– 06/30/2021. Every two months thereafter.)

a. Longitudinal patient level EHR-based data. Includes patient demographics, insurance, social history, family history, lab orders, immunizations, medications, prescriptions, problem, procedure, observations, diagnoses, visit type. Unique patient and provider IDs.

b. Limited dataset retaining granular time and geographic variables (e.g., 5 digit zip and dates of service) as agreed upon with CDC team.

c. Data de-identification approach and parameters to be agreed upon in collaboration with CDC research team to preserve needed variables.

d. Cleaned clinical and demographic data delivered in standard coded formats.

e. Provide coded variables for COVID-19 diagnoses, COVID-19-like-illness (CLI), influenza diagnoses, and influenza-like illness (ILI) using agreed upon definitions.

f. Availability of fully de-identified data set via API.

6 Within 30 days of award for first data delivery.

Updates provided every other month from initial data delivery.

Delivered within 12 months of award.

2 1b ABFM shall provide CDC with a statistically de-identified AFC dataset which retains granular geographic and date information. Approach to be agreed upon collaboratively with CDC team.

2 Meeting to discuss de-identification strategy within 30 days of award.

Tabular data statistically de-identified available to CDC within 6 months.

De-identified notes available to CDC within 10 months.

3 1e Comprehensive documentation of unit of analysis for each table, linkage schema and variables to create patient-level and visit-level files, and data dictionaries for each of the tables.

6 First draft to be provided within 90 days of award.

Updates to be delivered with each subsequent data delivery.

4 2a, 2b, 2c, 2d Summary Report. AFC or monitoring health disparities and weekly trends in COVID-19, ILI and other information as agreed upon with CDC.

6 First report to be delivered with second data delivery (90 days) of award.

Updates shall be delivered with each subsequent data delivery

5 2e Exploration of data options and acquisitions necessary to explore SARS-CoV-2 risk factors, disparities, variants, vaccination (including vaccine type and data of administration) and outcomes such as mortality.

4 First meeting with CDC scheduled within 30 days of award Meetings held a minimum of quarterly thereafter.

6 3 ABFM shall deliver sample weights.

Weights shall be at the census tract level to enable findings from the AFC data to be more generalizable to the U.S. population and aid in disparities research.

1 First iteration to be delivered within 120 days of award with final iterations due at the end of the award period.

7 4a, 4b, 4c ABFM shall provide estimates (in collaboration with CDC) to assess social risk and race/ethnicity as predictors of COVID prevalence and outcomes as available in the

EHR.

3 Initial estimates due 120 days of award.

Subsequent estimates at 270 days.

8 6a, 6b, 6c, 6d COVID-19 Vaccination. Provide summary data and analytic products to monitor SARS- CoV-2 vaccination geographic spread and gaps.

Provide a data dictionary and summary of how vaccination information is captured or recorded in EMRs within the PRIME Registry practices spread and gap tracking.

a) Develop a report describing vaccine impact by geography, urbanicity, health disparities, social vulnerability, demographic, and clinical factors.

b) Meet regularly with CDC to cover which data sources necessary to answer this question.

3 Meeting to discuss vaccine tracking shall be scheduled within 30 days of award.

Initial report on vaccines in AFC data shall be delivered to CDC within 6 months of award.

Draft report on vaccines including ancillary AFC-linked data shall be delivered to CDC

c) Develop a report describing information contained in the AFC data on vaccine impact by geography, urbanicity, health disparities, social vulnerability, demographic, and clinical factors.

d) Develop a draft manuscript describing vaccine impact by geography, urbanicity, health disparities, social vulnerability, demographic, and clinical factors for linked datasets as available.

within 1 year of award.

9 5a, 5b, 5c, 5d, 5e, 5f

Post-acute Sequelae of SARS-COV-2 Infection (PASC). Provide summary data and analytic products to monitor PASC. End product shall be an academic publication.

a) Develop a suspect PASC case definition using EMR data

b) Conduct descriptive analyses

c) Calculate associations between

PASC and demographic and clinical characteristics with an emphasis on disparities in incidence, prevalence and outcomes.

d) Conduct a comparative analysis of patients reporting similar PASC symptoms after influenza or influenza like illness

1 Meeting to discuss PASC definition shall be scheduled within 30 days of award.

Definition of PASC to be finalized within 4 months of award.

Report on preliminary findings re PASC including demographic and clinical characteristics within AFC data shall be delivered within 6 months of award.

Draft publication on findings re PASC including demographic and clinical characteristics within AFC data and ancillary datasets as agreed on with CDC shall be delivered within 12 months of

10 4d, 5g, 6c ABFM, in collaboration with CDC, shall produce at least three draft manuscripts for submission to scientific journals within 12 months of the award. Aims to be selected in consultation with CDC.

3 ABFM shall produce at least three draft manuscripts within 12 months of the

11 7 Kickoff Meeting: ABFM shall participate in a project kickoff meeting with CDC and provide a meeting agenda.

1 Within 10 days of award

12 7 ABFM shall participate in monthly check-in meetings with CDC to assess status of deliverables and address outstanding questions or concerns.

11 By the 30th day of each month

13 4d, 5g, 6c, 7 Participate in regular specific manuscript meetings with CDC to assess status of deliverables and address outstanding questions or concerns.

12 or as needed By the 30th day of each month

C.5 IT Security and Privacy Considerations:

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.

b. 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:

• 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.

b. 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 after it is determined that a threat or hazard exists, bring the situation to the attention of the other party.

c. 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.

d. 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

4) 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: [ ] Low [X] Moderate [ ] High

5) 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. Destruction of information and/or data shall be accomplished in accordance with NIST SP 800-88, Guidelines for Media Sanitization.

6) 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.

7) 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).

8) 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).

9) 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.

10) Contract Documentation. The Contractor shall use provided templates, policies, forms and other agency documents to comply with contract deliverables as appropriate.

11) 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

1) 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.

2) 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.

3) 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

1) 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.

2) 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

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 Federal Information Security Modernization Act (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 an 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 confirmed breach in any medium as soon as possible and no later than 1 hour after it is determined that a breach occurred, 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

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.

4) 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.

5) 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.

6) 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,…