Attachment 1 - DRAFT Performance Work Statement.pdf

Performance Work Statement

Title: NCHS/Division of Vital Statistics Coding of the Vital Statistics Data

Period of performance of this contract is: 01/01/2027 to 12/31/2031 Base Period: 01/01/2027 to 12/31/2027 Option Period One: 01/01/2028 to 12/31/2028 Option Period Two: 01/01/2029 to 12/31/2029 Option Period Three: 01/01/2030 to 12/31/2030 Option Period Four: 01/01/2031 to 12/31/2031

SECTION 1 – BACKGROUND

Over the last several years, the NVSS has benefited greatly from an accelerated program of technology upgrades.

NCHS has invested heavily in automating manual coding procedures to provide better approaches to statistical quality control and data file development. These new approaches, coupled with more traditional ones, are designed to produce highly complete national vital statistics files with improved quality.

Historically, 2.8 million death records have been received annually. With COVID-19 and the excess deaths in 2020, the annual volume has exceeded 3.3 million deaths. NCHS coded about 68% of these records electronically, leaving more than 1 million records to be coded manually using both Federal and contractor resources. Over the next two years, it is anticipated that the auto-coding rate could increase by 10-15% due to system improvements.

In addition, if mortality volume reduces due to COVID-19 public health measures, the need for manual coding could be reduced further. Because of these uncertainties, the need for manual contractual coding could range from 75,00 – 3,850,000.

In addition, the government has ad hoc needs to review the quality of records coded by the system for system improvements or before closing the national mortality file. This may require review and recoding of records previously coded.

SECTION 2 – PURPOSE/OBJECTIVE

The purpose of this Contract is to provide information management services to support the manual coding of the causes of death on mortality and fetal death records for the National Vital Statistics System (NVSS). Specifically, the Contractor shall:

Provide coding of the causes of death for those mortality or fetal death records unable to be coded electronically, or for the purposes of quality control and system validation, through the National Vital Statistics System using procedures established at NCHS’s Research Triangle Park facility.

SECTION 3 – SCOPE OF WORK

The objective of this work is to provide cause-of-death coding services to the DVS, Data Acquisition, Classification and Evaluation Branch (DACEB) for those records rejected through the DVS automated coding system or for the purposes of quality control. This work will be electronically assigned randomly or by priority for completion.

This work benefits DVS data divisions that analyze the data, and ultimately researchers and policy makers in the state, national, and international public health community, and the general public.

SECTION 4 – TASKS TO BE PERFORMED

Task 1: Coding of Causes of Death on Mortality and Fetal Death Records

1. The Contractor staff shall code the volume of purchased records on an ongoing basis, starting no later than one week after contract award and provide continual service. The minimum number of records coded per month is determined by the total number purchased divided by the number of months. The Contractor must ensure an error rate of less than 4 percent. The DACEB staff, who must ensure that all data is of the highest quality possible in accordance with approved specifications and procedures, will verify a sample of these coded records to assess the error rate per each Contractor staff and provide that information to the Contracting Officer’s Representative (COR), who will provide such information to the Contractor. The Contractor shall take such steps as necessary to ensure that the coding requirements are timely and completely met.

2. The Contractor staff work part time from multiple locations and coding is dependent on the government furnished computers and access to the CDC network. If an employee’s production is interrupted for more than one hour per week due to failure of the CDC equipment or CDC systems, the contractor may invoice for up to 37 records per hour for the time when no coding could occur. The employees are not permitted to use personal devices or non-CDC information resources/devices to complete work under this contract.

3. Annual refresher training is required for all coders, and this training is done via webcast and usually lasts four hours. The contractor may invoice for 37 records per hour for this annual refresher training.

4. On occasion, there may be a need for coding by Contractor staff for the purpose of quality control activities. In these cases, the records to be coded would be assigned by batch and have the same interface as used for production coding. For validation of the automated coding system, a similar coding or adjudication screen will be provided. The contractor may invoice for 37 records per hour for any time spent orienting Contractor staff to new coding interfaces. These activities must be performed by nosologists with an average quality control error rate <2%.

5. Increased need for manual coding and record review is variable by year but may happen during the course of this Contract; therefore, additional coding may be purchased throughout the year, not to exceed the maximum.

Task 2 – Transition-In and Continuity of Performance

The Contractor shall submit a written Transition-In Plan to the Contracting Officer no later than five calendar days after contract award. The plan shall demonstrate how the Contractor will assume responsibility for the services without disruption and shall address staffing, personnel onboarding, required NCHS training, PIV and Government-furnished equipment requirements, MedCoder access, work assignment procedures, payroll administration, quality control, and achievement of the required production and accuracy standards. The plan shall include a schedule identifying the activities and milestones necessary to begin performance within 30 calendar days after contract award.

The Contractor shall provide sufficient qualified personnel to begin performance no later than 30 calendar days after contract award and shall maintain adequate staffing throughout performance. The Contractor is solely responsible for recruiting, hiring, supervising, scheduling, training, compensating, and replacing its employees.

The Government may provide the Contractor with information regarding existing procedures, training, work assignments, and incumbent personnel, subject to applicable privacy and security requirements. The Contractor may offer employment to incumbent personnel at its discretion; however, the Government does not require the Contractor to hire or retain any particular incumbent employee.

The Contractor shall maintain continuity of services during personnel turnover, workload fluctuations, system changes, and transition activities. Any replacement personnel shall possess qualifications sufficient to perform the assigned duties and shall complete all required Government-provided training before performing work requiring such training.

The Contractor shall comply with FAR 52.237-3, Continuity of Services, including any required phase-in or phase-out training and cooperation with a successor contractor.

SECTION 5 – GOVERNMENT FURNISHED PROPERTY

Government furnished property (GFP) will be issued to select contractor staff who are determined to require CDC network access, such to facilitate administrative tasks using CDC’s Office 365 Services or compliance activities using CDC security programs. GFP will include CDC government laptops and CDC Smart Cards (also known as PIV cards).

SECTION 6 – PLACE OF PERFORMANCE AND CONTRACT SUPPORT HOURS

SUBSECTION A – PLACE OF PERFORMANCE

Contractor employees may work on-site at NCHS, but it is anticipated the contractor employees will work remotely via telework.

SUBSECTION B – CONTRACT SUPPORT HOURS

Provide support for eight (8) consecutive hours Monday through Friday.

SECTION 7 – TRAVEL

N/A

SECTION 8 – DELIVERABLES/REPORTING SCHEDULE

Task Deliverable Quantity/Format Due Date Deliver To Coding of Causes of Death

Monthly coding at minimum rate of total records purchased divided by number of months and with a per coder error rate < 4%

25,000 – 45,000 per month are expected.

Monthly Program POC

Quality Review and correction of coded records code assigned records

As requested, code assigned batches within two weeks of assignment

Program POC

Task Deliverable Quantity/Format Due Date Deliver To Coding of mortality records for validation testing of automated coding system.

code assigned records

As requested, code assigned records within 1 week of assignment

Program POC

2 Transition-In Plan

Word (no more than 10 pages) No later than five

(5) days after contract award.

CO and COR

SUBSECTION A – PERFORMANCE MATRIX

PERFORMANCE

OBJECTIVE

STANDARD PERFORMANCE

THRESHOLD

ACCEPTABLE

QUALITY LEVELS

(AQLs)

METHOD OF

SURVEILLANCE

Coding of mortality and fetal death records

Minimum of 16,500 records coded per month in the base year or the minimum monthly rate based on total purchased divided by 12. Coding must have less than 4% error rate per coder

Achieve this performance level 98% of the time

Monthly government reports;

Quality review of coded records

Once quality review batch is assigned, the batch must be completed within 2 weeks, only by contractor staff with an average error rate < 2%

Achieve this performance level 98% of the time

Monthly review of a sample of coded records of each contract employee

Coding of mortality records for validation testing of automated coding system

Once records are assigned, they are completed within 1 week, only by contractor staff with an average error rate < 2%

Achieve this performance level 98% of the time

Monthly government reports

SECTION 9 – REFERENCE MATERIALS

SECTION 10 – MINIMUM VENDOR QUALIFICATIONS

SECTION 11 – ADDITIONAL REQUIREMENTS

Information Security and Privacy

1.1 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/or 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.

1.1 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 Information Security Program security requirements, outlined in the HHS Information Security and Privacy Policy (IS2P), by contacting the CO/COR.

(d) Comply with the Privacy Act requirements and tailor FAR clauses as needed.

1.2 Information Security Categorization

The Contractor and any sub-Contractors shall handle/protect all information in accordance with FIPS 199 and National Institute of Standards and Technology (NIST) Special Publication (SP) 800-60, Volume II: Appendices to Guide for Mapping Types of Information and Information Systems to Security Categories, Appendix C, and based on information provided by the System Security and Privacy Officer (SSPO), Chief Information Security Officer (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: [ X] Low [ ] Moderate [ ] High Integrity: [x ] Low [ ] Moderate [ ] High Availability: [ X ] Low [ ] Moderate [ ] High Overall Risk Level: [x ] Low [ ] Moderate [ ] High

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

[x ] No PII [ ] Yes PII

PII Confidentiality Impact Level has been determined to be: [ x ] Low [ ] Moderate [ ] High

1.3 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.

1.4 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) as determined by CDC, 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.

1.5 Protection of Sensitive Information

Protection of Sensitive Information. For security purposes, information is or may be sensitive because it requires security to protect its confidentiality, integrity, and/or availability. The Contractor (and/or any subcontractor) must protect all government information that is or may be sensitive by securing it with a solution that is validated with current FIPS 140 validation certificate from the NIST CMVP.

1.6 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, CDC, and NCHS policies. Unauthorized disclosure of information will be subject to the applicable HHS, CDC, and NCHS sanction policies and/or governed by the following laws and regulations:

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

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

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

1.7 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).

1.8 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. As per CDC Policy, CDC-IR-2008-01, the use of non-CDC.GOV domain names is prohibited.

1.10 Software Assurance

The Contractor (and/or any subcontractor) shall ensure IT applications designed and developed for end users (including mobile applications and software licenses) run in the standard user context without requiring elevated administrative privileges.

(a) The Contractor (and/or any subcontractor) shall follow secure coding best practice requirements, as directed by the United States Computer Emergency Readiness Team (US-CERT) specified standards and the Open Web Application Security Project (OWASP) that will limit system software vulnerability exploits.

(b) The Contractor (and/or any subcontractor) shall ensure IT applications designed and developed for end users (including mobile applications and software licenses) run in the standard user context without requiring elevated administrative privileges.

(c) The Contractor (and/or any subcontractor) shall follow secure coding best practice requirements, as directed by United States Computer Emergency Readiness Team (US-CERT) specified standards and the Open Web Application Security Project (OWASP), that will limit system software vulnerability exploits.

(d) The Contractor (and/or any subcontractor) shall ensure that computer software developed on behalf of HHS or tailored from an open-source product, is fully functional and operates correctly on systems configured in accordance with government policy and federal configuration standards. The Contractor shall test applicable products and versions with all relevant and current updates and patches updated prior to installing in the HHS environment. No sensitive data shall be used during software testing.

(e) The Contractor (and/or any subcontractor) shall protect information that is deemed sensitive from unauthorized disclosure to persons, organizations or subcontractors who do not have a need to know the information. Information which, either alone or when compared with other reasonably-available information, is deemed sensitive or proprietary by HHS shall be protected as instructed in accordance with the magnitude of the loss or harm that could result from inadvertent or deliberate disclosure, alteration, or destruction of the data. This language also applies to all subcontractors that are performing under this contract.

(f) The Contractor (and/or any subcontractor) shall remediate all risks or vulnerabilities immediately after the risks or vulnerabilities have been identified in the software.

1.11 Contract Documentation

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

1.12 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],

(c) 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.

(d) 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).

(e) 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.

(f) 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 Officer (OCIO).

1.13 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 Contractor Non-Disclosure Agreement form (Attachment A), 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.

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.

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.

1.14 Training

1.15.1 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.

1.15.2 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.

1.15.3 Training Record

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.

1.15 Rules of Behavior

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

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

1.17 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 another 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 another 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 another use rather than the 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:

(a) 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.

(b) 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.

(c) All Contractors and subcontractors shall participate in regular training on how to identify and report a breach.

(d) 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.

(e) 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.

(f) 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.

(g) 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.

(h) 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,

(i) 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.

1.18 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). As such, the following position sensitivity designations apply unless otherwise adjusted by the COR with a risk-based decision accepted by the NCHS Information Systems Security Officer and the Contract Officer.

Sensitive / High Risk Positions – Public Trust Level 6 or Higher is required for all Contractor (and/or any subcontractor) employees with elevated privileges (e.g. logical/physical systems access privileges that exceed ordinary/routine access or use), such as:

system administrators;

database administrators;

system developers;

staff with duties that involve physical/logical control and/or protection of information technology systems that process high, moderate, or low US Government information; and or similar as determined by the COR, SSPO, and CO.

Sensitive / Moderate Risk Positions – Public Trust Level 5 or Higher is required for all Contractor (and/or any subcontractor) employees who, as part of their duties, are exposed to or handle sensitive US Government information (e.g. PII, Procurement Information, information subject to NDA, Controlled Unclassified Information (CUI)…) in any format (e.g. Audio, Electronic, Printed…)

An HSPD-12/PIV card is required for all Contractor (and/or any subcontractor) employees who require unescorted, regular physical access to CDC facilities, and/or require access to the CDC enterprise network / PIV-enabled IT systems to carry out their job duties.

A favorable National Agency Check is the minimum investigation required for this contract for all Contractor (and/or any subcontractor) employees whose positions are not considered Sensitive / High Risk, Sensitive / Moderate Risk or require HSPD-12/PIV cards.

1.19 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).

1.20 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.

1.21 Contract Initiation and Expiration

(a) 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).

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

(b) 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.

(c) 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.

(d) Notification

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

(e) 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.

(f) 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.

1.22 Security Requirements for Contractor-Operated Federal Information Systems & Resources

It is possible that the Contractor-Operated components and associated artifacts will fall under a larger/multiple Security Authorization Boundary(s) for the purposes of federal information security oversight and security authorization.

(a) 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.

(b) Security Assessment and Authorization (SA&A):

1) SA&A Package Deliverables. The Contractor (and/or any subcontractor) shall provide an SA&A package to the C/I/O Information System Security Officer (SSPO) in accordance with the timeline, process and formats proscribed for a Full system authorization in the CDC Security Assessment and Authorization Standard Operating Procedure (CDC SA&A SOP). The following SA&A deliverables are required to complete the SA&A package:

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

(b) Privacy Threshold Analysis / Privacy Impact Analysis – The Contractor (and/or any subcontractor) shall provide a PTA/PIA (as appropriate), in accordance with the timeline, process and formats described in the CDC SA&A SOP, if applicable. Also see the sections of this contract concerning “Privacy Threshold Analysis (PTA)/Privacy Impact Assessment (PIA)” and “Requirements for Procurements Involving Privacy Act Records.”

NOTE: If social security numbers (SSN) are expected to be handled by the system, the program and Contractor must include a SSN Elimination or Usage Approval Request along with the PTA/PIA. That request will be processed in accordance with the OCIO Standard for Limiting the Use of Social Security Numbers in CDC Information Systems.

(c) System Security Plan (SSP) – The SSP must be provided in a digital format supporting copy or export of all content into the HHS/CDC automated SA&A tool. The SSP shall comply with the NIST SP 800-18, Guide for Developing Security Plans for Federal Information Systems, the Federal Information Processing Standard (FIPS) 200, Recommended Security Controls for Federal Information Systems, and NIST SP 800- 53, Security and Privacy Controls for Federal Information Systems and Organizations applicable baseline requirements, and other applicable NIST guidance as well as HHS and CDC policies and other guidance.

The SSP shall be consistent with and detail the approach to IT security contained in the Contractor’s bid or proposal that resulted in the award of this contract. The SSP shall provide an overview of the system environment (including an inventory of all devices and software contained within the system boundary) and security requirements to protect the information system as well as describe all applicable security controls in place or planned for meeting those requirements. It should provide a structured process for planning adequate, cost-effective security protection for a system. The Contractor shall update the SSP at least annually thereafter.

(d) Risk Assessment Report (RAR) – The initial security assessment shall be conducted by the Contractor in conjunction with the program’s Information System Security Officer, consistent with NIST SP 800-53A, NIST SP 800-30, and HHS and CDC policies. The assessor will document and submit the assessment results in the RAR, in accordance with the process and formats described in the CDC SA&A SOP. The Contractor shall address all “High” deficiencies before submitting the package to the Government for acceptance. All remaining deficiencies must be documented in a system Plan of Actions and Milestones (POA&M) for CDC OCIO approval in accordance with the CDC SA&A SOP. Thereafter, the Contractor, in coordination with CDC shall conduct an assessment of the security controls and update the RAR within 365 days.

(e) POA&M – The POA&M shall be documented consistent with the HHS Standard for Plan of Action and Milestones and CDC policies. Identified risks stemming from deficiencies related to the security control baseline implementation, assessment, continuous monitoring, vulnerability scanning, and other security reviews and sources, as documented in the Security Assessment Report (SAR), shall be documented and tracked by the Contractor for mitigation in the POA&M document. Depending on the severity of the risks, CDC may require designated POAM weaknesses to be remediated before an ATO is issued. Thereafter, the POA&M shall be updated at least quarterly.

(f) Contingency Plan and Contingency Plan Test –The Contingency Plan must be developed in accordance with NIST SP 800-34, Contingency Planning Guide for Federal Information Systems, and be consistent with HHS and CDC policies. Upon acceptance by the System Owner, the Contractor, in coordination with the System Owner, shall test the Contingency Plan and prepare a Contingency Plan Test Report that includes the test results, lessons learned and any action items that need to be addressed. Thereafter, the Contractor shall update and test the Contingency Plan at least annually.

(g) E-Authentication Assessment – The Contractor (and/or any subcontractor) shall collaborate with government personnel to ensure that an E-Authentication Threshold Analysis (E-auth TA) is completed to determine if a full E-Authentication Risk Assessment (E-auth RA) is necessary. System documentation developed for a system using E-auth TA/E-auth RA methods shall follow OMB 04-04; NIST SP 800-63, Digital Identity Guidelines; the OCIO Standard for Electronic Authentication (E-Authentication); and the

CDC SA&A SOP.

Based on the level of assurance determined by the E-Auth, the Contractor (and/or subcontractor) must ensure appropriate authentication to the system, including remote authentication, is in-place in accordance with the assurance level determined by the E-Auth (when required) in accordance with HHS policies.

Information Security Continuous Monitoring. Upon the government issuance of an Authority to Operate (ATO), the Contractor (and/or subcontractor)-owned/operated systems that input, store, process, output, and/or transmit government information, shall meet or exceed the information security continuous monitoring (ISCM) requirements in accordance with FISMA and NIST SP 800-137, Information Security Continuous Monitoring (ISCM) for Federal Information Systems and Organizations, and HHS IS2P. The following are the minimum requirements for ISCM:

1. Annual Assessment/Pen Test - Assess the system security and privacy controls (or ensure an assessment of the controls is conducted) at least annually to determine the implemented security and privacy controls are operating as intended and producing the desired results (this may involve penetration testing conducted by the agency or independent third-party). In addition, review all relevant SA&A documentation (SSP, POA&M, Contingency Plan, etc.) and provide updates by specified due date.

2. Asset Management - Using any available Security Content Automation Protocol (SCAP)-compliant automated tools for active/passive scans, provide an inventory of all information technology (IT) assets for hardware and software, (computers, servers, routers, databases, operating systems, etc.) that are processing HHS-owned information/data. It is anticipated that this inventory information will be required to be produced at least annually. IT asset inventory information shall include IP address, machine name, operating system level, security patch level, and SCAP-compliant format information. The Contractor shall maintain a capability to provide an inventory of 100% of its IT assets using SCAP-compliant automated tools.

3. Configuration Management - Use available SCAP-compliant automated tools, per NIST IR 7511, for authenticated scans to provide visibility into the security configuration compliance status of all IT assets, (computers, servers, routers, databases, operating systems, application, etc.) that store and process government information. Compliance will be measured using IT assets and standard HHS and government configuration baselines at least annually. The Contractor shall maintain a capability to provide security configuration compliance information for 100% of its IT assets using SCAP-compliant automated tools.

4. Vulnerability Management - Use SCAP-compliant automated tools for authenticated scans to scan information system(s) and detect any security vulnerabilities in all assets (computers, servers, routers, Web applications, databases, operating systems, etc.) that store and process government information. Contractors shall actively manage system vulnerabilities using automated tools and technologies where practicable and in accordance with HHS policy. Automated tools shall be compliant with NIST-specified SCAP standards for vulnerability identification and management.

The Contractor shall maintain a capability to provide security vulnerability scanning information for 100% of IT assets using SCAP-compliant automated tools and report to the agency at least annually.

5. Patching and Vulnerability Remediation - Install vendor released security patches and remediate critical and high vulnerabilities in systems processing government information in an expedited manner, within vendor and agency specified timeline per OCIO Vulnerability Remediation Framework Standard.

6. Secure Coding - Follow secure coding best practice requirements, as directed by United States Computer Emergency Readiness Team (US-CERT) specified standards and the Open Web Application Security Project (OWASP), that will limit system software vulnerability exploits.

7. Boundary Protection - The Contractor shall ensure that government information, other than unrestricted information, being transmitted from federal government entities to external entities is routed through a Trusted Internet Connection (TIC).

2) Government Access for Security Assessment. In addition to the Inspection Clause in the contract, the Contractor (and/or any subcontractor) shall afford the Government access to the Contractor’s facilities, installations, operations, documentation, information systems, and personnel used in performance of this contract to the extent required to carry out a program of security assessment (to include vulnerability testing), investigation, and audit to safeguard against threats and hazards to the confidentiality, integrity, and availability of federal data or to the protection of information systems operated on behalf of HHS, including but are not limited to:

a) At any tier handling or accessing information, consent to and allow the Government, or an independent third party working at the Government’s…