B Reader Classifications Services for Chest Radiographs

The Centers for Disease Control and Prevention (CDC) and the National Institute of Occupational Safety and Health (NIOSH), Respiratory Health Division, Surveillance Branch, Coal Workers' Health Surveillance Program, Morgantown, WV intends to award a sole source firm fixed price purchase order for the base year and three option years if funds are available to the nine vendors below:
Colella Consulting, LLC, 219 Royal Daulton Ct, Gibsonia, PA 15044
Daniel Henry Consulting, 14441 Leafield Drive, Midlothian, VA 23113
Diagnostic Imaging Associates, 935 Virginia Ave, NW, Norton, VA 24273
Dr. Charles Greer, 2808 Atlantic Ave, Sullivan's Island, SC 29482
Dr. Elon Gale, 190 Parker Road, Meedham, MA 02494
Dr. James Smith, 1420 Connell Road, Charleston WV 25314
Dr. Myung Sup Kim, 12614 Nicklaus Ct, Cumberland, MD 21502
Respiratory Consultants of Houston, PA, 6550 Fannin Street, Suite 2403, Houston, TX 77030
Dr. Stephen Schabel, Sr., 905 High Nest Lane, Charleston, SC 29412
for B-Reader classifications services for the chest radiographs taken for all components of the Coal Workers' Health Surveillance Program (CWHSP) includes Enhanced, Expanded and Special Studies.
This contract action is for a services for which the government intends to solicit and negotiate with only one source under the authority of FAR 13.106-1(b) (SAP) and 41 U.S.C 3304(a) (1). Interested persons may identify their interest and capability to respond to the requirement or submit proposals.
The notice of intent is not a request for competitive quotations; however, all quotations/responses received within (15) days of the issuance of this notice will be considered by the Government. A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement. Any quotation/response should be e-mailed to purchasing agent Rebecca Mullenax at rmullenax@cdc.gov by COB on December 28, 2018.
Statement of Work
Title: Coal Workers' Health Surveillance Program
Period of Performance: Fiscal Year 2019
SECTION 1 - BACKGROUND
The Coal Workers' Health Surveillance Program (CWHSP) was initially established in 1970 by the Federal Coal Mine Health and Safety Act of 1969. In accordance with the Mine Safety and Health Administration's recently published rule on respirable coal mine dust exposure, the CWHSP provides U.S. coal miners with the opportunity to undergo health screening for respiratory disease with respiratory symptom questionnaires, chest radiography, and spirometry (a type of lung function test) at first entry into coal mining and at intervals thereafter throughout their coal mining careers. Medical facilities must be approved by NIOSH for participation in CWHSP before they can provide services to coal miners under the program.

SECTION 2 - PURPOSE
The primary objective of the CWHSP is to screen miners for coal workers' pneumoconiosis (CWP). The vendor will perform required classifications of chest radiographs taken for all components of the CWHSP (includes Enhanced, Expanded, and Special Studies). These chest radiographs must be interpreted by physicians/radiologists who are certified by NIOSH as being proficient in the use of the International Labor Office (ILO) system for classifying radiographs of the pneumoconiosis (B Readers). Analog radiographs will be shipped to the vendor in groups with a return shipment form. Digital radiographs will be loaded in the Picture Archiving Communications System (PACS) for the vendor to retrieve, classify, and return - all electronically.
SECTION 3 - SCOPE OF WORK
Vendor agrees to classify all radiographs (both analog and digital) sent to them not to exceed 2,000 radiographs for the period of performance. A two-week turnaround time is required.
SECTION 4 - TASKS TO BE PERFORMED
This contract includes a bi-lateral no-cost agreement of Government Furnished Property as identified below in accordance with FAR 45.102.
SECTION 5 - GOVERNMENT FURNISHED MATERIALS
The Government Furnished Property on this contract is valued at dollar amount _____ and includes:
• Desktop computer
• Diagnostic 5MP Grayscale Monitor
• Diagnostic 5MP Grayscale Monitor
• Standard display, cables, keyboard, and mouse which are not barcoded

SECTION 6 - PERIOD OF PERFORMANCE
Fiscal Year 2019
SECTION 7 - DELIVERABLES/REPORTING SCHEDULE
Deliverables for will be based on short term daily tasks and assignments.
Items Description Delivery Date
Classification of Radiographs Provide analog and digital readings - not to exceed 2,000 radiographs for the period of performance As needed - with a two week turnaround
Roster Roster Within7 days of the effective date of this contract
Contractor Employee Non-Disclosure Agreement (NDA) Contractor Employee Non-Disclosure Agreement (NDA) Prior to performing any work on behalf of HHS
Training Records Copy of training records for all mandatory training In conjunction with contract award and annually thereafter or upon request
Rules of Behavior Signed ROB for all employees Initiation of contract and at least annually thereafter
Incident Response Incident Report (as incidents or breaches occur) As soon as possible and without reasonable delay and no later than 1 hour of discovery
Personnel Security Responsibilities List of Personnel with defined roles and responsibilities Within 7 days that is before an employee begins working on this contract
Personnel Security Responsibilities Off-boarding documentation, equipment and badge when leaving contract Within 7days after the Government's final acceptance of the work under this contract, or in the event of a termination of the contract
Background Investigation Onboarding documentation when beginning contract. Prior to performing any work on behalf of HHS

Severability:
This is a severable service contract.

SECTION 8 - Proposed Costs

Vendor agrees to classify all radiographs (both analog and digital) sent to them not to exceed 2,000 radiographs. A two-week turnaround time is required.
Payments will be in 4 quarterly installments. Invoices will be submitted from the vendor on a quarterly schedule.
The incumbent of this position will be a passenger in both government vehicles and government rental cars while on travel status (they will NOT be a driver for either type of government vehicle).

SECTION 9 - SPECIAL REQUIREMENTS
N/A
SECTION 10 - REFERENCE MATERIALS
N/A
SECTION 11 - Security

Procurements Requiring Information Security and/or Physical Access

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) 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 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

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.

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 3 CFR, part 2002) when handling CUI. 32 C.F.R. 2002.4(aa) As implemented the term "handling" refers to "...any use of CUI, including but not limited to marking, safeguarding, transporting, disseminating, re-using, and disposing of the information." 81 Fed. Reg. 63323. 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.

5) 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.

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 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).

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). .

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.

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

10) 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 prior to performing any work on behalf of HHS.

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 the COR upon request and at the conclusion of the contract.

11) 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. 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.

12) Privacy Impact Assessment (PIA) - The Contractor shall assist the CDC Senior Official for Privacy (SOP) or designee with conducting a PIA for the information system and/or information handled under this contract.

a. The Contractor shall assist the CDC SOP or designee with completing a PIA for the system or information within prior to performing any work on behalf of HHS in accordance with HHS policy and OMB M-03-22, Guidance for Implementing the Privacy Provisions of the E-Government Act of 2002.

b. The Contractor shall assist the CDC SOP or designee in reviewing the PIA at least every year throughout the system development lifecycle (SDLC)/information lifecycle, or when determined by the agency that a review is required based on a major change to the system, or when new types of PII are collected that introduces new or increased privacy risks, whichever comes first.

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 Information Security Awareness, 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 annually commensurate with their role and responsibilities in accordance with HHS policy and the HHS Role-Based Training (RBT) of Personnel with Significant Security Responsibilities Memorandum.

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

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

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 HHS/CDC Information Security Awareness Training. If the training is provided by the contractor, the signed ROB must be provided as a separate deliverable to the CO and/or COR per defined timelines above.

D. Incident Response
The Contractor (and/or any subcontractor) shall respond to all alerts/Indicators of Compromise (IOCs) provided by CDC Computer Security Incident Response Team (CSIRT) within 24 hours, whether the response is positive or negative.

FISMA defines an incident as "an occurrence that (1) actually or imminently jeopardizes, without lawful authority, the integrity, confidentiality, or availability of information or an information system; or (2) constitutes a violation or imminent threat of violation of law, security policies, security procedures, or acceptable use policies. The HHS Policy for IT Security and Privacy Incident Reporting and Response further defines incidents as events involving cybersecurity and privacy threats, such as viruses, malicious user activity, loss of, unauthorized disclosure or destruction of data, and so on.

A privacy breach is a type of incident and is defined by Federal Information Security Modernization Act (FISMA) as the loss of control, compromise, unauthorized disclosure, unauthorized acquisition, or any similar occurrence where (1) a person other than an authorized user accesses or potentially accesses personally identifiable information or (2) an authorized user accesses or potentially accesses personally identifiable information for an other than authorized purpose. The HHS Policy for IT Security and Privacy Incident Reporting and Response further defines a breach as "a suspected or confirmed incident involving PII".

In the event of a suspected or confirmed incident or breach, the Contractor (and/or any subcontractor) shall:

1) 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.

2) NOT notify affected individuals unless so instructed by the Contracting Officer or designated representative. If so instructed by the Contracting Officer or representative, the Contractor shall send CDC approved notifications to affected individuals within 30 days.

3) Report all suspected and confirmed information security and privacy incidents and breaches to the CDC Computer Security Incident Response Team (CSIRT) at 866-655-2245 and CSIRT@cdc.gov, COR, CO, CDC SOP (or his or her designee), and other stakeholders, including incidents involving PII, in any medium or form, including paper, oral, or electronic, as soon as possible and without unreasonable delay, no later than one (1) hour, and consistent with the applicable CDC and HHS policy and procedures, NIST standards and guidelines, as well as US-CERT notification guidelines. The types of information required in an incident report must include at a minimum: company and point of contact information, contact information, impact classifications/threat vector, and the type of information compromised. In addition, the Contractor shall:

a. cooperate and exchange any information, as determined by the Agency, necessary to effectively manage or mitigate a suspected or confirmed breach;

b. not include any sensitive information in the subject or body of any reporting e-mail; and

c. encrypt sensitive information in attachments to email, media, etc.

4) Comply with OMB M-17-12, Preparing for and Responding to a Breach of Personally Identifiable Information, HHS and CDC incident response policies when handling PII breaches.

5) Provide full access and cooperate on all activities as determined by the Government to ensure an effective incident response, including providing all requested images, log files, and event information to facilitate rapid resolution of sensitive information incidents. This may involve disconnecting the system processing, storing, or transmitting the sensitive information from the Internet or other networks or applying additional security controls. This may also involve physical access to contractor facilities during a breach/incident investigation.

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 following position sensitivity designation levels apply to this solicitation/contract:

Level 5C: Sensitive - Moderate Risk

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.

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 within 14 of the effective date of this contract. Any revisions to the roster as a result of staffing changes shall be submitted within 14 of the change. The COR will notify the Contractor of the appropriate level of investigation required for each staff member.

If the employee is filling a new position, the Contractor shall provide a position description and the Government will determine the appropriate suitability level.

G. Contract Initiation and Expiration
1) General Security Requirements. The Contractor (and/or any subcontractor) shall comply with information security and privacy requirements, Enterprise Performance Life Cycle (EPLC) processes, HHS Enterprise Architecture requirements to ensure information is appropriately protected from initiation to expiration of the contract. All information systems development or enhancement tasks supported by the contractor shall follow the HHS EPLC framework and methodology and in accordance with the HHS Contract Closeout Guide (2012).

2) System Documentation. Contractors (and/or any subcontractors) must follow and adhere to NIST SP 800-64, Security Considerations in the System Development Life Cycle, at a minimum, for system development and provide system documentation at designated intervals (specifically, at the expiration of the contract) within the EPLC that require artifact review and approval.

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

4) Notification. The Contractor (and/or any subcontractor) shall notify the CO and/or COR and system ISSO within 14 days 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 Contractor Employee Separation Checklist when an employee terminates work under this contract within 1 days of the employee's exit from the 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/CDC policies and shall not dispose of any records unless authorized by HHS/CDC.

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/CDC policies.

.