Attachment 5 Domain 5 sample RFTOP.pdf

ATTACHMENT 5 SAMPLE TASK ORDER DOMAIN 5

DOMAIN 5- Sample RFTOP

RFTOP Title: Assessing Reporting Specifications that Call for Use of Healthcare Data in Electronic Form and Healthcare Information Technology for Purposes of National Healthcare Safety Network (NHSN) Surveillance

Multiple task orders may be awarded subject to availability of funds and that contractors should prepare technical proposals that are priced no higher than $300,000 in order to be considered for award.

PROPOSED PERIOD OF PERFORMANCE: Work shall begin from date of award of the task order and shall continue for a period of 24 months. This project is a non-severable and will be funded fully at the time of award.

Multiple task orders may be awarded under this RFTOP.

PROPOSAL PREPARATION AND SUBMISSION

1. General Instructions: Offeror(s) shall submit proposals consisting of the following volumes:

Technical Proposal – Volume I Business Proposal – Volume II

a. Technical Proposal-Volume I

Technical Proposal Preparation Instructions – Page limit is (10) single-spaced pages of text for the technical proposal; (the page limit does not include appendices or resumes). Each volume in the proposal shall include a copy of the cover letter (letter of transmittal), title page and table of contents. The table of contents shall list sections, subsections and page numbers.

The technical proposal should be in as much detail as you consider necessary to reflect a clear understanding of the nature of the work being undertaken.

The technical proposal must NOT contain reference to cost; however, resource information, such as data concerning labor hours and categories, material, subcontracts, etc., must be contained in the technical proposal so that your understanding of the statement of work can be evaluated.

b. Business Proposal-Volume II

Pricing Narrative: The Offeror shall provide an explanation and/or detailed information on how the fully loaded labor rates were derived. The business proposal shall be an Excel spreadsheet, with an itemized price breakout per task for each period (e.g. Base Year, Option Years), including itemized prices for any subcontracted work. Proposed labor hours, labor costs, travel and other direct costs for this task order request shall be organized around the tasks and related deliverables described herein.

Pricing Worksheet: Utilizing the format in Attachment 11 of RFP, provide all applicable labor categories, descriptions, and rates, travel for the Prime Contractor/Subcontractor for each period (e.g. Base Year, Option Years). Please return Section B (CLIN and payment milestone) with Business Proposal.

ATTACHMENT 5 SAMPLE TASK ORDER DOMAIN 5

SECTION B SUPPLIES OR SERVICES AND PRICES/COSTS

BASE PERIOD

ITEM SUPPLIES / SERVICES QTY / UNIT UNIT

PRICE

EXTENDED

PRICES

0001 Safety and Healthcare Epidemiology Prevention Research Development (SHEPheRD) Program 2021 Domain 5 Assessing Reporting Specifications that Call for Use of Healthcare Data in Electronic Form and Healthcare Information Technology for Purposes of National Healthcare Safety Network (NHSN) Surveillance POP: 18 months from award This is a Firm-Fixed Price and Non-Severable Line Item

1 Job $________ $ ___________

**The offeror requires to identify the zip code of the work site so the appropriate wage determination can be identified and included with an awarded task order.

B.1 PAYMENT TERMS

Payment will be made subject to receipt of deliverables in accordance with the payment schedule established herein and in accordance with FAR 52.232-25. Prompt Payment, which states that the due date for making invoice payments shall be the 30th day after the designated billing office (see block 21 of the order) has received a proper invoice from the vendor or the 30th day after Government acceptance of the services provided by the vendor, whichever is later.

B.2 Schedule of Milestones for Performance-Based Payments In accordance with FAR 52.232-32, PERFORMANCE BASED PAYMENTS (April 2012), upon successful completion of an event, the contractor may request performance based payments. The determination of eligibility for receipt of payment will be made by the Contracting Officer upon written certification from the Contracting Officer’s Representative (COR) that the performance milestone has been met. It is anticipated that each milestone payment will approximate the estimated timeline listed below but variation is anticipated and eligibility for payment could occur sooner or later depending upon the time of completion of the designated milestone.

Milestone payments are subject to the terms of FAR 52.232-32 incorporated in this contract. The COR receiving and acceptance of monthly performance based payments is based on verification that work on the contract was satisfactorily performed during the month and that, at a minimum, the following activities were satisfactorily performed.

Milestone Payment Schedule

CONTRACTOR PROPOSED

MILESTONE EVENT PAYMENT %* DOLLAR AMOUNT

TOTAL 100 % $

*Milestone event payments may be allocated on a periodic basis as long as a completed event is associated with that payment.

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PERFORMANCE-BASED WORK STATEMENT

OVERVIEW

The National Healthcare Safety Network (NHSN) is a web-based system developed and maintained by CDC and used by CDC and its partners in healthcare and public health to track healthcare-associated infections (HAIs), antimicrobial use (AU) and antimicrobial resistance (AR), and adherence to prevention practices and antimicrobial stewardship. Data are reported to the system via manual data entry at a web interface or by means of electronic messages produced by electronic health record systems (EHRs) or infection surveillance systems and transmitted to NHSN. NHSN is the main HAI reporting system in the United States, and over 18,000 healthcare facilities participate in the system, including over 5,000 hospitals, as of 2015.

The NHSN Patient Safety Component is the most widely used part of the system; it enables hospitals to report central line-associated bloodstream infections (CLABSIs), catheter-associated urinary tract infections (CAUTIs), surgical site infections (SSIs), and other HAIs. Antibiotic susceptibility data are included in the HAI records submitted to NHSN, enabling CDC to estimate antibiotic resistance prevalence and trends nationally among these HAIs. Antimicrobial Use (AU) and Antimicrobial Resistance (AR) also can be reported to the NHSN Patient Safety Component, specifically the NHSN AUR Module. AU and AR data are reported to the AUR Module via electronic messages; there is no manual entry of AU and AR data into the AUR Module. All supporting documentation along with startup guides, FAQs and pointers to Implementation Guides for AU and AR reporting may be found at the

NHSN CDA Submission Support Portal (http://www.cdc.gov/nhsn/cdaportal/index.html). NHSN’s emergence as a widely used platform for surveillance of healthcare outcomes, e.g. HAIs, and care processes, e.g., AU, provides precedence and opportunities to extend use of NHSN for new purposes, including surveillance of (1) new HAI events, such as late onset neonatal sepsis and meningitis, (2) sepsis among pediatric and/or adult patients, regardless of whether an HAI led to the sepsis, (3) new HAI event indicators or proxies, i.e., markers for infection that may be useful for surveillance but may not be specific enough to correspond to a specific disease condition; (4) non-HAI adverse events, such as adverse drug events (e.g., hypoglycemia following administration of drugs used for glycemic control) or new and emerging blood safety events; (5) use or insertion of devices intraoperatively, tracked by means of the device’s Unique Device Identifier (UDI).

PROJECT GOALS

The goal of this task order is to fund activities that will assess the technical feasibility of introducing new surveillance reporting specifications to NHSN that will extend the scope of NHSN’s surveillance coverage to additional healthcare outcomes or processes, not currently in scope, that call for detection and reporting using healthcare data in electronic form and healthcare information technology.

CDC is requesting proposals in which the Contractor:

• Identifies a healthcare process or outcome that will be brought under surveillance using NHSN that is either a new HAI event, such as late onset neonatal sepsis or meningitis; sepsis among all patient age groups or a specific patient age group regardless of whether the sepsis is caused by an HAI; new HAI event indicator, such as a proxy or marker for an infection; a non-HAI adverse event, such as an adverse drug event or blood safety incident; or use or insertion of an intraoperative device.

• Specifies the data requirements for the healthcare outcome or process that would be brought under surveillance using NHSN and develops a plan for systematically evaluating the technical feasibility of http://www.cdc.gov/nhsn/cdaportal/index.html

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implementing those requirements by using healthcare data in electronic form and healthcare information technology to automate surveillance processes.

Scope of Work

The contractor should describe a health care process or outcome, not currently reported to NHSN, that would be brought under surveillance using NHSN and systematically assess the technical feasibility of using existing healthcare data in electronic form and healthcare information systems to implement the surveillance requirements for the specified process or outcome.

a. Candidate process or outcome events for assessment include but are not limited to (1) new healthcare-associated infection (HAI) events, such as late onset neonatal sepsis and meningitis, (2) new HAI event indicators or proxies, i.e., markers for infection that may be useful for surveillance but may not be specific enough to correspond to a specific disease condition; (3), sepsis, regardless of whether an HAI led to sepsis, (4) new HAI event indicator, non-HAI adverse events, such as adverse drug events (e.g., hypoglycemia following administration of drugs used for glycemic control) or new and emerging blood safety events; (5) insertion of devices intraoperatively, tracked by means of the device’s Unique Device Identifier (UDI).

b. Candidate healthcare data sources and systems include but are not limited to electronic health record systems (EHRs), EHRs components or modules, laboratory information systems, medication administration systems, and infection control surveillance systems.

c. The Contractor shall systematically evaluate the technical feasibility of using systems for surveillance purposes that are already in operational use in healthcare and that can provide data for electronic detection and reporting of a specified process or outcome.

Each assessment shall evaluate the extent to which healthcare data are available in standardized and structured electronic form for a new surveillance purpose; the technical implementation opportunities and challenges of using healthcare information technology for that surveillance purpose, including the opportunities or challenges of automating surveillance processes; and the clinical or record keeping implications—if any—at the healthcare facility level of implementing the new set of NHSN surveillance reporting requirements.

Task A: Communication

Task A1: Start Up Meeting

• The Contractor shall arrange and conduct an initial meeting (by teleconference) with the CDC Contracting Officer Representative, (COR), and other relevant staff within two weeks of the effective date of the task order. The purpose of the meeting will be to confirm critical contract performance milestones and roles and responsibilities that will be taken on by the Contractor, and to establish communication protocols (such as a regular call schedule). Each task and deliverable will be reviewed.

• The Contractor shall submit an agenda for the above meeting within one week of the effective date of the task order.

Task A2: Maintain Communication with CDC Staff

• The Contractor shall organize a second meeting (via webinar) to review and discuss with CDC staff the technical approach and systems they will use to assess reporting specifications that call for use of healthcare data in electronic form and healthcare information technology to extend use of NHSN for surveillance purposes.

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a. The Contractor shall review the new surveillance use of NHSN will be assessed, i.e., either a new HAI event, sepsis regardless of etiology, a new HAI event indicator, a non-HAI adverse event, or intraoperative device uses and insertions.

b. The Contractor shall discuss the data requirements for the new surveillance use of NHSN, and the plan that will be used for systematically evaluating the technical feasibility of those requirements.

• The Contractor shall coordinate with the Contracting Officer Representative, (COR)/Science Officer a monthly teleconference. The Contractor shall maintain regular communications with the Contracting Officer Representative (COR)/Science Officer staff involved with the project.

o The chief means of communication will be via conference calls that will be scheduled every month throughout the project period required to complete the project.

o Additional calls will be scheduled as needed.

o The Contractor shall provide an agenda and meeting minutes for each call. All conference calls shall be scheduled and administered by the Contractor.

o The Contractor shall respond to all emails and telephone communications from the Contracting

Officer Representative, (COR)/Science Officer, within three business days.

o In the event of multiple awards, the Contractor shall participate on multi-contractor calls coordinated by the CDC COR/Science Officer on validation with other contractors working on similar initiative with different hospitals and overall coordination of purpose and direction of this task order.

Task B: Contractor shall complete an assessment project

• The contractor shall specify a health care process or outcome, not currently reported to NHSN, and assess the technical feasibility of using existing healthcare data in electronic form and healthcare information systems to implement the surveillance requirements for the specified process or outcome.

• Candidate process or outcome events for assessment include but are not limited to (1) new healthcare-associated infection (HAI) events, such as late onset neonatal sepsis and meningitis, (2) new HAI event indicator or proxy, i.e., a marker for infection that may be useful for surveillance purposes but may not be specific enough to correspond to a specific disease condition ; (3) sepsis regardless of whether an HAI led to sepsis, (4) non-HAI adverse events, such as adverse drug events (e.g., hypoglycemia following administration of drugs used for glycemic control) or new and emerging blood safety events; (5) insertion of devices intraoperatively, tracked by means of the device’s Unique Device Identifier (UDI).

• Candidate healthcare data sources and systems include but are not limited to electronic health record systems (EHRs), EHRs components or modules, laboratory information systems, medication administration systems, and infection control surveillance systems.

• The contractor shall systematically evaluate the technical feasibility of using systems for surveillance purposes that are already in operational use in healthcare and that can provide data for electronic detection and reporting of a specified process or outcome.

Task C: Reporting

Task C1: Quarterly Progress Reports

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On the 10th day following the three months being reported, the Contractor shall prepare and submit a quarterly progress report containing the current status of work. The report shall contain, at a minimum, the current progress on each of the requirements set forth below, the problems encountered during the month, solutions implemented, planned activity for the upcoming month, and any other information mutually agreed upon between the contractor and the CDC Contracting Officer Representative (COR).

Task C2: Final Report The contractor will provide CDC with quarterly and a final report. Metrics for all reports shall include, but not limited to, a description of all tasks and deliverables completed during the funding period. The final report shall include feedback and recommendations to healthcare facilities and partners

Deliverables Summary Table The following deliverables shall be provided to the Contracting Officer Representative, (COR) and Science Officer no later than the dates specified below:

Task Task Description Deliverable Quantity/ Frequency Due Date

A1 Start-up meeting with appropriate CDC COR/Science Officer

Agenda for initial planning meeting

1 teleconference meeting

• Agenda within 1 week of task order award

• Meeting within 2 weeks of task order award

A2 Maintain communication with CDC COR/Science Officer

Agenda for webinar meeting with the purpose of reviewing and discussing with CDC staff with technical approach and existing platforms related to the Contractor’s hospital network

1 webinar meeting Meeting within 2 months of task order award

A2 Maintain communication with CDC COR/Science Officer

Agendas and meeting minutes for monthly conference calls; timely responses to emails and telephone communications from CDC staff

Monthly • Agenda at least 1 day prior to conference call

• Meeting minutes within 1 week of conference call

• Responses to emails and telephone communications within 3 days

A2 Maintain communication with CDC COR/Science Officer

Participation in multi-vendor conference calls

Monthly Monthly

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Task Task Description Deliverable Quantity/ Frequency Due Date

B1 Define a new HAI event, new HAI event indicator, non-HAI adverse event, or use or implant of intraoperative devices that would be brought under surveillance using NHSN and describe methods for systematically evaluating the technical feasibility of using existing healthcare data in electronic form and healthcare information technology to implement the surveillance requirements

Fully specified data requirements for extending use of NHSN for a new surveillance purpose and a detailed description of the analytic methods and measurements for systematically evaluating the associated data requirements in terms of their technical feasibility

1-2 months after award

B1 A project plan with milestones for evaluating the technical feasibility of a new surveillance use of

NHSN

Project Plan 1 project plan 4 months after award

B1 Draft report on evaluating technical feasibility of a new surveillance use of

NHSN

Draft Report

1 draft report

9 months after award

C1 Quarterly progress reports

Electronic report per quarter with current status of work, and invoice report

1 every 3 months Due on the 10th day of the month following the 3 months being reported

C2 Final Report Electronic report that includes summaries, recommendations, and all prior reports

1 final report 24 months after award

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1. General Information

A. Place of Performance: The work to be performed under this contract will be performed at the

Contractor’s facility and associated academic, healthcare or research facilities as required.

B. Type of Contract: The government will award a Firm-fixed price contract.

C. Contractor Travel: The cost associate with completing the work/task, should be part of the task cost (i.e CLIN 0001).

D. Government Furnished Property, Equipment, and Services: Not Applicable

Special Clearances:

Check all that apply: Comments

OMB

Human Subjects Privacy Act Appropriate security controls and Rules of Behavior should be incorporated to protect the confidentiality of information, proprietary, sensitive, and Personally Identifiable Information (PII) the Contractor may come in contact with during the performance of this contract.

IT Security IT Contractor performance and resulting deliverables must adhere to all federal, HHS, and/or CDC IT security policies and procedures. Based upon the scope of this contract, the SOW must include the appropriate language to address the following IT security topics:

Standard for Security Configurations; Standard for Encryption Language; and Security requirements for Federal Information technology Resources.

A. Confidentiality of Information: Work on this project may require that personnel have access to Privacy

Information. Personnel shall adhere to the Privacy Act, Title 5 of the U.S. Code, Section 552a and applicable agency rules and regulations. The user agency will identify and provide direction and guidance for safeguarding all information subject to the Privacy Act. Reports and case files containing individual personal information are confidential. The CDC is not authorized to release individual case reports, and access to individual case data is strictly controlled. The contractor personnel are required to work with case records as well as databases. It is a requirement that the data remain in a controlled access environment.

B. Section 508 Compliance

By agreeing to the terms of the Safe Healthcare, Epidemiology, and Prevention Research Development (SHEPheRD) Program IDIQ Contract, the offeror must comply with Section 508 standards for all deliverables in this task order. The offeror must complete an HHS/CDC checklist(s) as needed for each deliverable specified.

The applicable Section 508 standards to this task order are 1194.

205 WCAG 2.0 Level A & AA Success Criteria 302 Functional Performance Criteria

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502 Inoperability with Assistive Technology 503 Applications 504 Authoring Tools 602 Support Documentation 603 Support Services

IT Security and Privacy Requirements

The below information complies with CDC Security and Privacy compliance requirements for E- Government Act of 2002 (FISMA 2002) and Federal Information Security Modernization Act of 2014

(FISMA 2014)

Security Compliance If the contractor will host or create an information system on behalf of the CDC, provide IT services to the CDC, or provide IT products to the CDC, then the contractor shall comply with the applicable IT security references below (Standards 1 - 4).

Standard-1: Procurements Requiring Information Security and/or Physical Access Security 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, 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

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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:

Confidentiality: [ ] Low [ x ] Moderate [ ] High Integrity: [ ] Low [ x ] Moderate [ ] High Availability: [ ] Low [ x ] Moderate [ ] High Overall Risk Level: [ ] Low [ x ] Moderate [ ] High

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

Complete this section using the information obtained from the Security and Privacy Checklist in Appendix A, parts A and B.

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.

http://csrc.nist.gov/publications/nistpubs/800-60-rev1/SP800-60_Vol2-Rev1.pdf http://csrc.nist.gov/publications/nistpubs/800-60-rev1/SP800-60_Vol2-Rev1.pdf

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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.

See Appendix D for baseline deliverables.

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 http://csrc.nist.gov/publications/fips/fips140-2/fips1402.pdf

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acquisition.

See Appendix C for the Contractor Non-Disclosure Agreement.

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.

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

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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 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

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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).

The requiring activity representative, in conjunction with Personnel Security, shall use the OPM Position Sensitivity Designation automated tool (https://www.opm.gov/investigations/) to determine the sensitivity designation for background investigations. After making those determinations, include all applicable 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

HHS EA requirements may be located here:

https://www.hhs.gov/ocio/ea/documents/proplans.html CDC EPC Requirements: https://www2a.CDC.gov/CDCup/library/other/eplc.htm https://www.opm.gov/investigations/ https://www.dhs.gov/homeland-security-presidential-directive-12 https://www.dhs.gov/homeland-security-presidential-directive-12 https://www.hhs.gov/ocio/ea/documents/proplans.html https://www2a.cdc.gov/CDCup/library/other/eplc.htm

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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, it shall be documented and reported as an incident in accordance with HHS policies.

Standard-2: Requirements for Procurements Involving Privacy Act Records A. Privacy Act

Appropriate security controls and Rules of Behavior should be incorporated to protect the confidentiality of information, proprietary, sensitive, and Personally Identifiable Information (PII) the Contractor may come in contact with during the performance of this contract.

Standard-3: Procurements Involving Government Information Processed on GOCO or COCO Systems A. Security Requirements for GOCO and COCO Resources

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

2) Security Assessment and Authorization (SA&A). A valid authority to operate (ATO) certifies that the Contractor’s information system meets the contract’s requirements to protect the agency data. If the system under this contract does not have a valid ATO, the Contractor (and/or any subcontractor) shall work with the agency and supply the deliverables required to complete the ATO prior to any use of the system in a production capacity, i.e., its intended users able to collect, store, process or transmit data to fulfill the system’s function.