9 - Amendment 0001.docx

N6264520Q0001

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

SECTION SF 1449 - CONTINUATION SHEET

The following have been modified:

PERFORMANCE WORK STATEMENT

SRRB UID Number: 68546173636

Navy Asbestos Medical Surveillance Program Roentgenographic Interpretation for Pneumoconiosis (NAMSRI)

SECTION 1 – GENERAL

1.1 General: This is a non-personal services contract to provide roentgenographic interpretation services. The roentgenographic interpretation services (also referred to as B Reading services) are performed by a physician which is also known as a B Reader. The Government will not exercise any supervision or control over the contract service provider’s performance of the services herein. Such contract services providers shall be accountable solely to the Contractor who, in turn is responsible to the Government.

1.2 Description of Services: Navy and Marine Corps Public Health Center (NMCPHC), Portsmouth, VA requires interpretation and reports on chest radiographs in accordance with current International Labour Organizations (ILO) Classification of Pneumoconiosis Radiograph System Standards for multi-service, enterprise-wide Military Treatment Facilities (MTFs). ILO is a system of classifying radiographs (chest X-rays) for persons with pneumoconiosis. This system gives the contractor the means for describing and recording systematically the radiographic abnormalities in the chest provoked by the inhalation of dust. A B Reader is a physician certified by the National Institute for Occupational Safety and Health (NIOSH) as demonstrating proficiency in classifying radiographs of the pneumoconiosis. B Readers participate in medical surveillance programs that utilize chest radiographs for the early detection of pneumoconiosis in dust exposed workers. For further information regarding the NIOSH Approved B Reader Program please go to the following web link: (http://www.cdc.gov/niosh/topics/chestradiography/breader.html). The Asbestos Medical Surveillance Program (AMSP) maintains a record of service members and civilian employees with a history of occupational exposure to asbestos.

1.3 Scope: This contract requires B Reading services in support of the NAMSRI and AMSP programs in coordination with NMCPHC. NMCPHC supports the AMSP across an enterprise-wide medical community to include medical facilities in the Defense Health Agency (DHA) and United States Navy, Army, and Air Force. Medical facilities within this enterprise-wide community fall within the scope of this contract. Quantities provided under this contract are based on historical data and includes a margin for growth. However, NMLC reserves the right to increase the quantity up to 25% if necessary to account for any unforeseen spikes in growth due to the unknown growth potential through the upcoming DHA transition. It is expected that a yearly average of 4,000 radiographs will require B Reading, but no minimum quantity is guaranteed.

1.4 Place of Performance: The contractor shall provide off-site roentgenographic interpretations of chest X-Rays and report results remotely in support of the Medical Treatment Facility performing the X-ray and of NMCPHC, Portsmouth, VA. The location of the Contractor’s facility shall be within the Continental United States (CONUS).

SECTION 2 - DUTIES

2.1 Contractor shall provide interpretation and a complete report on Digital Chest Radiographs received electronically accordance with the current International Labour Organization (ILO) Classification of Pneumoconiosis Radiographs System Standard and 29 Code of Federal Regulation (C.F.R.) 1926.1101 - Asbestos and 29 C.F.R. 1910.1001 – Asbestos which governs and regulates the exposure to asbestos in work environments.

2.2 Contractor shall utilize reference images for the ILO Standard Digital Images (ILO 2011-D) in Digital Imaging and Communications in Medicine (DICOM). These images are the digitized versions of the 2000 ILO standard radiographs that were adapted to allow pneumoconiosis classification of digital (digitally acquired) radiographs using diagnostic monitors. These referenced images will not be provided by the government and are the responsibility of the contractor to obtain.

2.3 Contractor shall have access to a computer and computer monitor meeting current American College of Radiology and NIOSH specifications for displaying digital radiograph images that will allow the B Reader to read digital x-rays.

2.4 Contractor shall have access to the Internet for transmission of communications. The Contractor must have the capability to incorporate changes in process as technology from NMCPHC and NIOSH requires. This includes the ability to access and process online NAVMED 6260/7 forms (See Attachment 1). NAVMED 6260/7 form will be transmitted electronically only. No paper transmissions will be exchanged. The offeror shall have the capability to view digital radiographs over the internet. The contractor shall submit the completed NAVMED 6260/7 form to NMCPHC.

2.5 Navy Medicine’s tele-radiology system uses a Business-to-Business (B2B) gateway connection. Each medical facility uses its own primary means of image transmissions (e.g., a Virtual Private Network (VPN) portal Picture Archiving and Communication System (PACS), NAVMISSA/DISA-approved B2B/Juniper VPN using Common Access Card/Public Key Infrastructure (CAC/PKI) authentication, via HTTPS in DICOM standard format, via DHA approved secure electronic methods) The contractor shall coordinate with the Contracting Officer Representative (COR) at NMCPHC to obtain information regarding the process at each location. The contractor shall provide the technical information required for the Government to send images from the B2B gateway connection to the contractor’s facility, including Server IP address, DICOM Application Entity (AE) titles, and Secure Shell requirements.

2.6 The B Read process will be initiated electronically by the medical treatment facility (MTF) by notifying NMCPHC for the need of B Read services. NMCPHC will then electronically notify the B Reader via a memo initiating the request for a B Read service. The contractor shall work with the COR at NMCPHC to develop a notification and workflow process.

2.7 NAVMED 6260/7 form shall be completed and returned electronically by the contractor to NMCPHC, no later than 10 business days after received. Returns shall be completed virtually in a manner that ensures the protection of personal health and privacy data as described in the Health Insurance Portability and Accountability Act (HIPAA) and allows for traceable means that shows the date delivered and the email address delivered to.

2.8 The contractor shall notify the COR immediately upon recognition that technical difficulties prevent the contractor from receiving, reading, or submitting images.

2.9 The contractor shall submit a monthly invoice, accompanied by a detailed listing of radiographs evaluated provided to the COR specified in each task order. The invoice should include the name of the patient(s) who received B Read services.

SECTION 3 - QUALITY ASSURANCE SURVEILLANCE PLAN (QASP) MATRIX

3.1 The Quality Assurance Surveillance Plan (QASP) is the document that will be used to assess the contractor’s performance. Refer to Attachment 2.

SECTION 4 - PERSONNEL QUALIFICATIONS

4.1 Be a U.S. Citizen per Attachment 3.

4.2 The contractor shall provide personnel who hold a NIOSH B Reader Certification throughout the life of this contract according to http://www.cdc.gov/niosh/topics/chestradiography/breader.html . B Reader approval is granted to physicians with a valid U.S. State medical license who demonstrate proficiency in the classification of chest radiographs for pneumoconioses using the ILO Classification System. A copy of the NIOSH certification letter is required for determination of contractor acceptability/qualification.

4.2.1 The certification(s)/ re-certification(s) must be maintained to participate under this contract. Once NIOSH certified, a B Reader is not eligible for re-certification until they have been certified for four years. If any B Reader is removed from the current NIOSH certification list, participation under this contract shall not be permitted. B Readers who are re-certified during the term of this agreement must provide a copy of the NIOSH re-certification letter to the COR.

SECTION 5 - AUTOMATED INFORMATION SYSTEMS

5.1 Unless otherwise specified in the requirements statement of the specific MTF locations, the Government will provide access to the electronic information systems required for the performance of services and will maintain all Government information systems. Contractor access to sensitive data will be granted at the level determined by the Government to be appropriate to the performance of services under this contract.

5.2 The Government will provide all technical information required for the contractor’s successful reception of radiographic interpretations to the respective MTF Radiology Department.

5.3 The Government will provide a Common Access Card (CAC) to all eligible contract employees that successfully complete the access and security requirements. The contract employees shall comply with the MTF policies and instructions associated with processing a CAC.

5.4 Personnel background investigations must be initiated within seven (7) days after contract award. Advanced fingerprint and (NACLC) results must be received by the MTF prior to a CAC being issued to the contract employees.

5.5 Contractor personnel shall comply with DoD, Department of the Navy (DON), and Navy Medicine directed security requirements to include Computer Task Orders (CTO’s), Information Operations Condition (INFOCON) changes, Information Assurance Vulnerability Management (IAVM) directives, and other Information Assurance (IA) related requirements.

SECTION 6 - CONTRACTOR FURNISHED ITEMS

6.1 The contractor’s facility where the work is performed shall be located within the continental United States.

6.2 The contractor shall provide a static IP address for a server where image studies shall be sent. The contractor shall ensure that all required HIPAA guidelines are followed in accordance with the sending facilities request. The contractor shall provide a Secure Shell to their server for image receiving. All images are to be read on monitors that meet the requirements set forth in the ACR STANDARD FOR DIGITAL IMAGE DATA MANAGEMENT. The contractor’s information system shall be in compliance with DoDI 8582.01 Security of Unclassifed DoD Information on Non-DoD Information Systems (See Attachment 4).

6.3 The contractor shall furnish all supplies, equipment, and personnel necessary to perform the services described in this contract.

6.4 Contractor personnel shall ensure all computers have the latest Microsoft Windows updates, anti-virus signatures and other software vendor security updates (examples include Adobe Acrobat (Reader or Professional), etc.). Non-compliance with the latest security patches/signatures will result in denied access to the network.

SECTION 7 – QUALITY CONTROL

7.1 A designated official from the contractor shall be responsible for providing assistance to the contract employees performing radiological imaging interpretations and ensure services are performed in accordance with the Quality Control Plan.

7.2 This is a non-personal services contract that supports the Navy Medicine mission to oversee and coordinate the delivery of economical and effective health care services. The B Reading services required by the contract supports the provision of patient care and ensures proper services are available to beneficiaries.

7.3 The contractor shall comply with applicable provisions of the law, rules, and regulations of all Governmental authorities, including the regulations and standards of the MTF. The contractor shall adhere to and comply with all DON, Bureau of Medicine and Surgery (BUMED) and MTF Instructions and notices which may be in effect during the term of the contract. The contractor shall adhere to and comply with Government chain of command hierarchy of authority for all communication.

7.4 To achieve the Navy Medicine mission, the contractor shall establish, submit for Government approval immediately after contract award, and implement a Quality Control (QC) Plan. Contract employees shall read, be familiar with, and implement the Performance Work Statement and the contractor’s QC Plan to include any revisions.

SECTION 8 - STANDARDS

8.1 All financial, statistical, personnel, and technical data which are furnished, produced, or otherwise available to the contractor during the performance of this contract are considered confidential business information and shall not be used for purposes other than performance of work under this contract. Such data shall not be released by the contractor without prior written consent of the COR. Any presentation of any statistical or analytical materials, or any reports based on information obtained from studies covered by this contract, will be subject to review and approval by the COR before publication or dissemination. All inquiries from the media shall be forwarded to the Command Public Affairs Officer via the COR.

8.2 All records produced in the performance of this contract and all evaluations of patients are the property of, and subject to the exclusive control of, the Government. The contractor may retain a copy of all such records or evaluations, but may not provide further copies or disclose the information from such records or evaluations to third parties. All requests from other treatment facilities or other individuals for patient records shall be handled in accordance with procedures specified by applicable MTF instructions.

8.3 The contractor and all contract employees shall comply with the government checkout processes at the facility that issued an identification badge.

SECTION 9 - CONFLICT OF INTEREST

9.1 The contractor shall not, while performing services under this contract, advise, recommend, or suggest to persons eligible to receive medical care at the Government’s expense that such persons should receive care from the contractor at any place other than a Government facility.

SECTION 10 - INDEPENDENT CONTRACTOR

10.1 The services provided by the contractor are provided in the capacity of an independent contractor. The Government will evaluate the quality of services for purposes of contract inspection and acceptance. The contractor shall be solely responsible for any and all liability caused by the acts or omissions of its agents or employees. The contractor shall not in any manner represent or infer that it is an instrumentality or agent of the US Government. The contractor shall recognize that the Commanding Officer maintains administrative and operational responsibility for all activities within the Command and may take such actions as necessary to preserve and maintain the integrity of the Command, subject to the limitations prescribed by law and U.S. Navy Regulations.

SECTION 11 – MODIFICATIONS

11.1 The Contracting Officer will designate and authorize an individual to act as the COR. Any such representative appointed will be specifically designated by letter from the Contracting Officer. The COR exclusively represents the Contracting Officer in all technical phases of the work, but is not authorized to issue Change Orders, Supplemental Agreements, or direct any contract performance requiring contractual modification or adjustment. Changes in the scope of work can only be made by modification properly executed by the Contracting Officer. All observations made by persons other than the Contracting Officer or the COR are strictly advisory and shall not influence the contractor's operations except for administrative requirements and responsibilities specified herein.

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