36C24623Q1089_1.docx

36C24623Q1089

PAGE 1 OF

1. REQUISITION NO.

2. CONTRACT NO.

3. AWARD/EFFECTIVE DATE

4. ORDER NO.

5. SOLICITATION NUMBER

6. SOLICITATION ISSUE DATE

a. NAME

b. TELEPHONE NO. (No Collect Calls)

8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY

CODE

10. THIS ACQUISITION IS

UNRESTRICTED OR

SET ASIDE:

% FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ

IFB

RFP

15. DELIVER TO

CODE

16. ADMINISTERED BY

CODE

17a. CONTRACTOR/OFFEROR

CODE

FACILITY CODE

18a. PAYMENT WILL BE MADE BY

CODE

TELEPHONE NO.

UEI:

EFT:

PHONE:

FAX:

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER 18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKED

SEE ADDENDUM

19.

20.

21.

22.

23.

24.

ITEM NO.

SCHEDULE OF SUPPLIES/SERVICES

QUANTITY

UNIT

UNIT PRICE

AMOUNT

(Use Reverse and/or Attach Additional Sheets as Necessary)

25. ACCOUNTING AND APPROPRIATION DATA

26. TOTAL AWARD AMOUNT (For Govt. Use Only) 27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA

ARE

ARE NOT ATTACHED.

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA

ARE

ARE NOT ATTACHED

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________

29. AWARD OF CONTRACT: REF. ___________________________________ OFFER

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND

DATED ________________________________. YOUR OFFER ON SOLICITATION

DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY

(BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED

SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER) 30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION

(REV. NOV 2021)

PREVIOUS EDITION IS NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

659-23-3-063-0056 36C24623Q1089 07-20-2023

AMY BALICAT

757-315-3072 07-26-2023 08:00

EDT

Department of Veterans Affairs Network Contracting Office 6 100 Emancipation Drive Hampton VA 23667 X 513210 $47 Million

NET 30

N/A X

SEE DELIVERY SCHEDULE

Department of Veterans Affairs Network Contracting Office 6 100 Emancipation Drive Hampton VA 23667

Department of Veterans Affairs Financial Services Center

PO BOX 149971

Austin TX 78714-9971 512-460-5049 512-460-5221 X See CONTINUATION Page This is a solicitation for VISN 6 Imaging Exam Digital Transmission System for the Salisbury VAMC in Salisbury, NC Submit quotes no later than 07/26/2023 at 0800 EST Delivery from 09/01/2023 – 08/30/2024 See CONTINUATION Page 659-3630160-063-822200-2632 010022243 X X

AMY BALICAT

Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

1. Contract Administration: All contract administration matters will be handled by the following individuals:

a. CONTRACTOR:

b. GOVERNMENT: Contracting Officer 36C246

Department of Veterans Affairs Network Contracting Office 6 100 Emancipation Drive Hampton VA 23667

2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with:

3. INVOICES: Invoices shall be submitted in arrears:

4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests.

ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

Statement of Work Purpose of Acquisition/Procurement This requirement is for a system which enables electronic, bi-directional exchange of radiology imaging exams and reports with commercial healthcare facilities providing services to VA patients to remove bottlenecks and delays in the continuity of Veteran care and archiving patient images; end examinations that are repeated when CDs are not requested, get misplaced, or are not “readable” due to software incompatibility; prevent harm to the Veteran via previous examinations that are not available, causing delayed diagnosis of cancer, aggressive and needless workups, and increased radiation exposure; enable retrieval of requested images and diagnostic reports from private sector facilities electronically, thereby saving VISN 6 healthcare systems the time and cost of using courier services to transport CD-ROMs and faxing requests to and from the Radiology File Room and Care in the Community (CITC) Office; automate processes for importing images and reports reduce the burden imposed on VA personnel across the Imaging Services Lines in VISN 6.

List of the equipment and/or supplies needed

Detailed product description (to include features/functions):

· (ESSENTIAL FEATURE) Allows the VA to search, locate, and access prior clinical information held across various IT systems and private sector providers.

· (ESSENTIAL FEATURE) Data sent from the private sector to the VA is sent through a secure conduit via a FIPS 140-2 validated connection with the VA TIC, providing a secure method of exchanging health data while ensuring that no VHA data is held in a cloud or hosted environment for storage, viewing, or processing. Requires access to a VA system or VA sensitive information.

· (ESSENTIAL FEATURE) platform operates as a vendor-agnostic patient record locator service that can locate prior medical images and reports residing in the private sector, allowing clinicians to locate patient information without calling and waiting for private sector facilities to send patient data to VA.

· (ESSENTIAL FEATURE) Utilizes a patient matching process to update DICOM images and reports as they arrive from the private sector with capability to automatically add the information to the patient’s chart in CPRS and image file in commercial PACS, with capability to have the outside data can be held for manual review by staff in Medicom’s Checkpoint worklist if a distinct match is not found.

· (ESSENTIAL FEATURE) When outside images are received, the system can automatically generate an ‘outside’ order in VistA so data is associated properly between the DICOM archives and VistA/CPRS through a Class 2 Interface.

· (ESSENTIAL FEATURE) Automated searches based on an upcoming appointment/procedure using an HL7 order (ORM) or scheduling (SIU) message from VistA, enabling searching private sector facilities on a peer-to-peer network for the patient, retrieve clinically relevant prior images and reports, reconcile the prior information, and store the prior information in VistA Imaging and Commercial PACS once a patient event is received.

· (ESSENTIAL FEATURE) Automated internal prefetch capability to locate and move a patient’s clinically relevant prior images within an organization to a specified location (normally a reading workstation or a radiation therapy planning system) based on an upcoming appointment/procedure using an HL7 order (ORM) or scheduling (SIU) message.

· (ESSENTIAL FEATURE) Electronic Requests: End-users can search for and request patient information from private sector.

· (ESSENTIAL FEATURE) Enables the United States Department of Veterans Affairs Hospitals (VISN 6) to bidirectionally exchange medical images and diagnostic reports with the following community and Federal health care system’s Picture Archiving and Communication System (PACS), with the vendor providing seamless/uninterrupted continuity of service from the end of the the current contract to the following established sites:

21st Century Oncology / GenesisCare

Advanced Cardiac Care Clinic (Mission)

Asheville Cardiology Associates (Mission)

Asheville Heart (Mission)

Asheville Orthopedic Associates (Mission)

Atrium Health

Augusta Health Care Inc

Beckley VAMC -- VISN 5

Blue Ridge Cancer Care ( All imaging done at Carilion or LewisGale

Carilion Clinic

Carolina Center for Surgery

Carolina Neurology and Spine Associates (Atrium)

Carolina Neurosurgery & Spine Associates of Greensboro ( Canopy PACS Archive)

Carolina Vascular (Mission)

CaroMont Health

Catawba Valley Medical Center

Centra Bedford Memorial Hospital

Centra Health

Centra Lynchburg General Hospital

Centra Southside Community Hospital

Centra Virginia Baptist Hospital

Central Carolina Hospital (LPNT)

Charlotte Radiology (Atrium)

Chesapeake Regional Imaging Centers

Cleveland VA - VISN 10

Columbus Regional Healthcare System

Cone Health ( Canopy PACS / Rad Partners )

Danville Medical Center / Sovah Health (LPNT)

Delaney Radiologists PA

DRI Health Group ( Canopy PACS / Rad Partners )

Eastern Radiologists Inc.

Emerge Ortho - Blue Ridge Division

Emerge Ortho - Foothills Division

EmergeOrtho - Triad Division

EmergeOrtho - Triangle Division

EmergeOrtho - Wilmington Division

FRYE REGIONAL MEDICAL CENTER

Greensboro Radiology / Canopy PACS

Hampton Roads Orthopaedic Spine & Sports Medicine

Haywood Regional Medical Group

Las Vegas VA

LEVINE CANCER INSTITUTE (Atrium)

LewisGale Medical Center (HCA Capital Div)

Maria Parham Health (LPNT)

MCV Associated Physicians ( VCU )

Milwaukee VA Medical Center - VISN 12

Mission Cancer Specialists

Mission Health System

Mountain Kidney & Hypertension Associates (Mission)

MOUNTAIN SPINE CARE- MILLER, WILLIAM (Haywood Affiliate)

Nelson & Nelson Chiropractic

Northern Regional Hospital

Onslow Radiology Center

Orthopaedic & Spine Center

Physicians For Women of Greensboro ( Canopy PACS / Rad Partners )

Pinehurst Radiology

Pinehurst Surgical Clinic

Radiology Associates of Richmond

Radiology Consults Lynchburg / Central Virginia Imaging (CENTRA)

Raleigh Radiology Associates

Randolph Health ( Canopy PACS / Rad Partners )

Rutherford Regional Health System

Salem Chest Specialists

San Antonio VA

Scotland Health Care System ( Atrium )

Sovah Danville Imaging Center (LPNT)

Tampa VA - VISN 8

Tucson VA

Twin County Regional Healthcare (LPNT)

Unifour Pain Management (Frye Regional)

VA Tampa Health System - VISN 8

Valley Radiology - Angier

Valley Radiology - IR Clinic

Valley Radiology - VRI

VCU Health / Virginia CommonWealth University

VISN 19 - MT, WY, UT, CO, & OK

VISN 2 - New York / New Jersey VA HCS

VISN 23 (Des Moines, Grand Island, Iowa City, Lincoln, Omaha)

VISN 23 (Fargo, Black Hills, Minneapolis, Sioux Falls, St. Cloud))

VISN 4 -- PA & DE

VISN 8 - Tampa VAMC

VISN 9 (TN & KY)

Wake Forest Baptist Health

Wake Radiology

Wayne Radiologists - Goldsboro ( affiliated with UNC Health )

Wilson Medical Center (LPNT)

· (ESSENTIAL FEATURE) The software is currently approved for use/interface with VA IT systems, providing exchanges of medical images and reports through encrypted, peer-to-peer conduits between providers on a federated health information network by way of the FIPS 140-2 validated Site-to-Site connection.

· Compatible with the McKesson PACS system incorporated in VISN 6.

· The vendor is able to provide VISN to VISN PACS image exchanges upon approval by participating VISNs.

· Utilizes an upcoming appointment, procedure, or community consult to automatically pre-fetch relevant images and reports from commercial or private sector imaging providers relevant to the upcoming care event.

· Conducts patient matching to automatically match inbound data to an existing patient and generate an order to obtain a VA accession number.

· Handles electronic requests that allow community care providers to request information electronically instead of sending a fax to the VA.

· Gives the VA the ability to request and conduct a broadcast query of the private sector providers to locate prior images and reports conducted through a care in the community program.

· Facilitates order generation and retrieval of results from community care providers, opposed to calling community care providers to track down patient results and wait on a fax.

· Supports advanced integrations with DICOM, FHIR, API, and HL7 standards.

· Is capable of simultaneous usage by all seven VISN 6 Health Care Systems and their relevant satellite clinics:

· Charles George VA Medical System (Asheville, NC)

· Durham VA Medical Center (Durham, NC)

· Fayetteville VA Medical Center (Fayetteville, NC)

· Hampton VA Medical Center (Hampton, VA)

· Hunter Holmes McGuire VA Medical Center (Richmond, VA)

· Salem VA Medical Center (Salem, VA)

· Salisbury - W.G. (Bill) Hefner VA Medical Center (Salisbury, NC)

· The awarded vendor must provide the relevant labor, equipment, certification supervision, and materials necessary to perform all operations in connections with this contract. On-site training, implementation services and ongoing support/upgrades must be provided.

· The required services must integrate with VistA Imaging Importer, McKesson PACS, VistA Imaging, Computerized Patient Record System (“CPRS”), Laurel Bridges’ Compass DICOM router or any other DICOM router provisioned by the VA, and Cerner which will be implemented in the future.

· The Radiology departments currently use software to import images from CD-ROMs received by the VA. The current importing process, which uses VistA Importers allows the user to select either a CD-ROM or directory on the workstation containing DICOM images and import them to VistA Imaging and McKesson PACS. The acquired network services must ensure the VA can continue to save these images to McKesson PACS and to VistA Imaging. The acquired services must authenticate and validate bi-directional, electronic exchange of DICOM images, Radiology reports, and Radiology orders using a FIPS 140-2 validated cryptographic methodology.

· The service must allow the Radiology department to search the commercial imaging providers located within the service area of each of the VISN Healthcare Systems, locate prior medical images and reports, and retrieve them to the VA where they can be incorporated to VA systems using a quality assurance step.

· The system must automatically match patient IDs to update the patient’s MRN # with the VA’s MRN #, when possible. Further, the system must generate a non-VA order through VistA Imaging in CPRS and update the inbound studies with the VA accession number for reconciliation in McKesson PACS. In some cases, these studies may be stored through Compass DICOM Router.

· The acquired services will directly increase the workflow for importing Radiology exams into VistA Imaging and McKesson PACS. In all the listed cases, there is no cost to the private sector or commercial facilities and there is no limit on workflow. Furthermore, information can be exchanged bi-directionally with no limitation on volume. The process must support the following:

· A one-time setup is initiated, and a trust with various permission sets is formed with outside facilities through the system. The system can have an unlimited number of trusted connections to the private sector through this single acquisition and through a single MoU/ISA with the service provider.

· A query or request will be initiated by the VA through the acquired system can be end-user initiated or initiated automatically by the acquired system based on an upcoming appointment, a care in the community consult, an upcoming Radiology procedure, or an admittance to the hospital. The query is broadcast to the entire community of providers participating in the health information network.

· The prior medical images and reports are located at outside facilities are retrieved from the outside facility using DICOM, FHIR, proprietary APIs, HL7, and other methods which are available in a web-portal.

· The images and reports are sent through a one-time-use conduit negotiated through the internet and terminating through a Site-to-Site VPN with the TIC, with the images downloaded to the local system at the VISN.

· The local system attempts to match the correct patient demographics, update the patient ID, generate an order, and import the studies and reports with the VA MRN and a VA Accession number. In cases where this automated reconciliation process fails, the system provides a mechanism for modifying this information before importing it.

· When sending information to the private sector, the following capabilities are required:

· A one-time setup is initiated, and a trust with various permission sets is formed with outside facilities through the acquired system. The system can have an unlimited number of trusted connections to the private sector through this single acquisition and through a single MoU/ISA with the service provider.

· The private sector facility can place a request through a portal.

· The file room at the various VISN 6 sites included in this project will be notified of the request.

· The VA employee can initiate a query of the VA systems to identify whether any studies exist which meet the specifications of the request. o If no studies exist, the request can be rejected.

· Once the internal query is complete, the staff can select studies and reports which meet the specifications and initiate sharing with the outside facility.

· The system will package and send the images and reports through the direct conduit through the internet to the outside provider by way of the Site-to-Site VPN.

· The commercial provider will receive the images and the acquired system can automatically import the images to private sector facility’s PACS and EMR.

· The vendor is able to provide seamless/uninterrupted continuity of service from the end of the the current contract to the following established sites:

Notional /preferred products (to include the vendor, product number, etc):

Medicom’s Imagex

Total quantity of each:

1 VISN-wide software system

Any other unique requirements

Need date: 09/01/2023

Limitations on equipment or facilities that might preclude a certain product: Must be capable of working with the PACS systems for all currently community and federal established users listed earlier in the document.

Need for training: If a new vendor is selected, training will be needed per the conditions noted within the salient characteristics Installation/setup: The awarded vendor must provide the relevant labor, equipment, certification supervision, and materials necessary to perform all operations in connections with this contract. On-site training, implementation services and ongoing support/upgrades must be provided.

Preventative or Full-Service Maintenance: The awarded vendor must provide the relevant labor, equipment, certification supervision, and materials necessary to perform all operations in connections with this contract. On-site training, implementation services and ongoing support/upgrades must be provided.

Any other known needs in addition to the equipment and/or supply: n/a

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

IMAGEX with Assistant Edition.

Support Services, Maintenance, and Training Agreement.

B.3 DELIVERY SCHEDULE

B.4 IT CONTRACT SECURITY

VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY

1. GENERAL

Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security.

2. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

a. A contractor/subcontractor shall request logical (technical) or physical access to VA information and VA information systems for their employees, subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order.

b. All contractors, subcontractors, and third-party servicers and associates working with VA information are subject to the same investigative requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for contractors must be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office for Operations, Security, and Preparedness is responsible for these policies and procedures.

c. Contract personnel who require access to national security programs must have a valid security clearance. National Industrial Security Program (NISP) was established by Executive Order 12829 to ensure that cleared U.S. defense industry contract personnel safeguard the classified information in their possession while performing work on contracts, programs, bids, or research and development efforts. The Department of Veterans Affairs does not have a Memorandum of Agreement with Defense Security Service (DSS). Verification of a Security Clearance must be processed through the Special Security Officer located in the Planning and National Security Service within the Office of Operations, Security, and Preparedness.

d. Custom software development and outsourced operations must be located in the U.S. to the maximum extent practical. If such services are proposed to be performed abroad and are not disallowed by other VA policy or mandates, the contractor/subcontractor must state where all non-U.S. services are provided and detail a security plan, deemed to be acceptable by VA, specifically to address mitigation of the resulting problems of communication, control, data protection, and so forth. Location within the U.S. may be an evaluation factor.

e. The contractor or subcontractor must notify the Contracting Officer immediately when an employee working on a VA system or with access to VA information is reassigned or leaves the contractor or subcontractor's employ. The Contracting Officer must also be notified immediately by the contractor or subcontractor prior to an unfriendly termination.

3. VA INFORMATION CUSTODIAL LANGUAGE

a. Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights in Data - General, FAR 52.227-14(d) (1).

b. VA information should not be co-mingled, if possible, with any other data on the contractors/subcontractor's information systems or media storage systems in order to ensure VA requirements related to data protection and media sanitization can be met. If co-mingling must be allowed to meet the requirements of the business need, the contractor must ensure that VA's information is returned to the VA or destroyed in accordance with VA's sanitization requirements. VA reserves the right to conduct on site inspections of contractor and subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are in compliance with VA directive requirements.

c. Prior to termination or completion of this contract, contractor/ subcontractor must not destroy information received from VA, or gathered/ created by the contractor in the course of performing this contract without prior written approval by the VA. Any data destruction done on behalf of VA by a contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination of the contract.

d. The contractor/subcontractor must receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with the terms of the contract and applicable Federal and VA information confidentiality and security laws, regulations and policies. If Federal or VA information confidentiality and security laws, regulations and policies become applicable to the VA information or information systems after execution of the contract, or if NIST issues or updates applicable FIPS or Special Publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations and policies in this contract.

e. The contractor/subcontractor shall not make copies of VA information except as authorized and necessary to perform the terms of the agreement or to preserve electronic information stored on contractor/subcontractor electronic storage media for restoration in case any electronic equipment or data used by the contractor/subcontractor needs to be restored to an operating state. If copies are made for restoration purposes, after the restoration is complete, the copies must be appropriately destroyed.

f. If VA determines that the contractor has violated any of the information confidentiality, privacy, and security provisions of the contract, it shall be sufficient grounds for VA to withhold payment to the contractor or third party or terminate the contract for default or terminate for cause under Federal Acquisition Regulation (FAR) part 12.

g. If a VHA contract is terminated for cause, the associated BAA must also be terminated and appropriate actions taken in accordance with VHA Handbook 1600.01, Business Associate Agreements. Absent an agreement to use or disclose protected health information, there is no business associate relationship.

h. The contractor/subcontractor must store, transport, or transmit VA sensitive information in an encrypted form, using VA-approved encryption tools that are, at a minimum, FIPS 140-2 validated.

i. The contractor/subcontractor's firewall and Web services security controls, if applicable, shall meet or exceed VA's minimum requirements. VA Configuration Guidelines are available upon request.

j. Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the contractor/subcontractor may use and disclose VA information only in two other situations: (i) in response to a qualifying order of a court of competent jurisdiction, or (ii) with VA's prior written approval. The contractor/subcontractor must refer all requests for, demands for production of, or inquiries about, VA information and information systems to the VA contracting officer for response.

k. Notwithstanding the provision above, the contractor/subcontractor shall not release VA records protected by Title 38 U.S.C. 5705, confidentiality of medical quality assurance records and/or Title 38 U.S.C. 7332, confidentiality of certain health records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse, or infection with human immunodeficiency virus. If the contractor/subcontractor is in receipt of a court order or other requests for the above mentioned information, that contractor/subcontractor shall immediately refer such court orders or other requests to the VA contracting officer for response.

l. For service that involves the storage, generating, transmitting, or exchanging of VA sensitive information but does not require C&A or an MOU-ISA for system interconnection, the contractor/subcontractor must complete a Contractor Security Control Assessment (CSCA) on a yearly basis and provide it to the COR.

4. INFORMATION SYSTEM DESIGN AND DEVELOPMENT

a. Information systems that are designed or developed for or on behalf of VA at non-VA facilities shall comply with all VA directives developed in accordance with FISMA, HIPAA, NIST, and related VA security and privacy control requirements for Federal information systems. This includes standards for the protection of electronic PHI, outlined in 45 C.F.R. Part 164, Subpart C, information and system security categorization level designations in accordance with FIPS 199 and FIPS 200 with implementation of all baseline security controls commensurate with the FIPS 199 system security categorization (reference Appendix D of VA Handbook 6500, VA Information Security Program). During the development cycle a Privacy Impact Assessment (PIA) must be completed, provided to the COR, and approved by the VA Privacy Service in accordance with Directive 6507, VA Privacy Impact Assessment.

b. The contractor/subcontractor shall certify to the COR that applications are fully functional and operate correctly as intended on systems using the VA Federal Desktop Core Configuration (FDCC), and the common security configuration guidelines provided by NIST or the VA. This includes Internet Explorer 7 configured to operate on Windows XP and Vista (in Protected Mode on Vista) and future versions, as required.

c. The standard installation, operation, maintenance, updating, and patching of software shall not alter the configuration settings from the VA approved and FDCC configuration. Information technology staff must also use the Windows Installer Service for installation to the default "program files" directory and silently install and uninstall.

d. Applications designed for normal end users shall run in the standard user context without elevated system administration privileges.

e. The security controls must be designed, developed, approved by VA, and implemented in accordance with the provisions of VA security system development life cycle as outlined in NIST Special Publication 800-37, Guide for Applying the Risk Management Framework to Federal Information Systems, VA Handbook 6500, Information Security Program and VA Handbook 6500.5, Incorporating Security and Privacy in System Development Lifecycle.

f. The contractor/subcontractor is required to design, develop, or operate a System of Records Notice (SOR) on individuals to accomplish an agency function subject to the Privacy Act of 1974, (as amended), Public Law 93-579, December 31, 1974 (5 U.S.C. 552a) and applicable agency regulations. Violation of the Privacy Act may involve the imposition of criminal and civil penalties.

g. The contractor/subcontractor agrees to:

(1) Comply with the Privacy Act of 1974 (the Act) and the agency rules and regulations issued under the Act in the design, development, or operation of any system of records on individuals to accomplish an agency function when the contract specifically identifies:

(a) The Systems of Records (SOR); and

(b) The design, development, or operation work that the contractor/ subcontractor is to perform;

(1) Include the Privacy Act notification contained in this contract in every solicitation and resulting subcontract and in every subcontract awarded without a solicitation, when the work statement in the proposed subcontract requires the redesign, development, or operation of a SOR on individuals that is subject to the Privacy Act; and

(2) Include this Privacy Act clause, including this subparagraph (3), in all subcontracts awarded under this contract which requires the design, development, or operation of such a SOR.

h. In the event of violations of the Act, a civil action may be brought against the agency involved when the violation concerns the design, development, or operation of a SOR on individuals to accomplish an agency function, and criminal penalties may be imposed upon the officers or employees of the agency when the violation concerns the operation of a SOR on individuals to accomplish an agency function. For purposes of the Act, when the contract is for the operation of a SOR on individuals to accomplish an agency function, the contractor/subcontractor is considered to be an employee of the agency.

(1) "Operation of a System of Records" means performance of any of the activities associated with maintaining the SOR, including the collection, use, maintenance, and dissemination of records.

(2) "Record" means any item, collection, or grouping of information about an individual that is maintained by an agency, including, but not limited to, education, financial transactions, medical history, and criminal or employment history and contains the person's name, or identifying number, symbol, or any other identifying particular assigned to the individual, such as a fingerprint or voiceprint, or a photograph.

(3) "System of Records" means a group of any records under the control of any agency from which information is retrieved by the name of the individual or by some identifying number, symbol, or other identifying particular assigned to the individual.

i. The vendor shall ensure the security of all procured or developed systems and technologies, including their subcomponents (hereinafter referred to as "Systems"), throughout the life of this contract and any extension, warranty, or maintenance periods. This includes, but is not limited to workarounds, patches, hotfixes, upgrades, and any physical components (hereafter referred to as Security Fixes) which may be necessary to fix all security vulnerabilities published or known to the vendor anywhere in the Systems, including Operating Systems and firmware. The vendor shall ensure that Security Fixes shall not negatively impact the Systems.

j. The vendor shall notify VA within 24 hours of the discovery or disclosure of successful exploits of the vulnerability which can compromise the security of the Systems (including the confidentiality or integrity of its data and operations, or the availability of the system). Such issues shall be remediated as quickly as is practical, but in no event longer than days.

k. When the Security Fixes involve installing third party patches (such as Microsoft OS patches or Adobe Acrobat), the vendor will provide written notice to the VA that the patch has been validated as not affecting the Systems within 10 working days. When the vendor is responsible for operations or maintenance of the Systems, they shall apply the Security Fixes within days.

l. All other vulnerabilities shall be remediated as specified in this paragraph in a timely manner based on risk, but within 60 days of discovery or disclosure. Exceptions to this paragraph (e.g. for the convenience of VA) shall only be granted with approval of the contracting officer and the VA Assistant Secretary for Office of Information and Technology.

5. INFORMATION SYSTEM HOSTING, OPERATION, MAINTENANCE, OR USE

a. For information systems that are hosted, operated, maintained, or used on behalf of VA at non-VA facilities, contractors/subcontractors are fully responsible and accountable for ensuring compliance with all HIPAA, Privacy Act, FISMA, NIST, FIPS, and VA security and privacy directives and handbooks. This includes conducting compliant risk assessments, routine vulnerablity scanning, system patching and change management procedures, and the completion of an acceptable contingency plan for each system. The contractor's security control procedures must be equivalent, to those procedures used to secure VA systems. A Privacy Impact Assessment (PIA) must also be provided to the COR and approved by VA Privacy Service prior to operational approval. All external Internet connections to VA's network involving VA information must be reviewed and approved by VA prior to implementation.

b. Adequate security controls for collecting, processing, transmitting, and storing of Personally Identifiable Information (PII), as determined by the VA Privacy Service, must be in place, tested, and approved by VA prior to hosting, operation, maintenance, or use of the information system, or systems by or on behalf of VA. These security controls are to be assessed and stated within the PIA and if these controls are determined not to be in place, or inadequate, a Plan of Action and Milestones (POA&M) must be submitted and approved prior to the collection of PII.

c. Outsourcing (contractor facility, contractor equipment or contractor staff) of systems or network operations, telecommunications services, or other managed services requires certification and accreditation (authorization) (C&A) of the contractor's systems in accordance with VA Handbook 6500.3, Certification and Accreditation and/or the VA OCS Certification Program Office. Government- owned (government facility or government equipment) contractor-operated systems, third party or business partner networks require memorandums of understanding and interconnection agreements (MOU-ISA) which detail what data types are shared, who has access, and the appropriate level of security controls for all systems connected to VA networks.

d. The contractor/subcontractor's system must adhere to all FISMA, FIPS, and NIST standards related to the annual FISMA security controls assessment and review and update the PIA. Any deficiencies noted during this assessment must be provided to the VA contracting officer and the ISO for entry into VA's POA&M management process. The contractor/subcontractor must use VA's POA&M process to document planned remedial actions to address any deficiencies in information security policies, procedures, and practices, and the completion of those activities. Security deficiencies must be corrected within the timeframes approved by the government. Contractor/subcontractor procedures are subject to periodic, unannounced assessments by VA officials, including the VA Office of Inspector General. The physical security aspects associated with contractor/ subcontractor activities must also be subject to such assessments. If major changes to the system occur that may affect the privacy or security of the data or the system, the C&A of the system may need to be reviewed, retested and re- authorized per VA Handbook 6500.3. This may require reviewing and updating all of the documentation (PIA, System Security Plan, Contingency Plan). The Certification Program Office can provide guidance on whether a new C&A would be necessary.

e. The contractor/subcontractor must conduct an annual self assessment on all systems and outsourced services as required. Both hard copy and electronic copies of the assessment must be provided to the COR. The government reserves the right to conduct such an assessment using government personnel or another contractor/subcontractor. The contractor/subcontractor must take appropriate and timely action (this can be specified in the contract) to correct or mitigate any weaknesses discovered during such testing, generally at no additional cost.

f. VA prohibits the installation and use of personally-owned or contractor/ subcontractor-owned equipment or software on VA's network. If non-VA owned equipment must be used to fulfill the requirements of a contract, it must be stated in the service agreement, SOW or contract. All of the security controls required for government furnished equipment (GFE) must be utilized in approved other equipment (OE) and must be funded by the owner of the equipment. All remote systems must be equipped with, and use, a VA-approved antivirus (AV) software and a personal (host-based or enclave based) firewall that is configured with a VA-approved configuration. Software must be kept current, including all critical updates and patches. Owners of approved OE are responsible for providing and maintaining the anti-viral software and the firewall on the non-VA owned OE.

g. All electronic storage media used on non-VA leased or non-VA owned IT equipment that is used to store, process, or access VA information must be handled in adherence with VA Handbook 6500.1, Electronic Media Sanitization upon: (i) completion or termination of the contract or (ii) disposal or return of the IT equipment by the contractor/subcontractor or any person acting on behalf of the contractor/subcontractor, whichever is earlier. Media (hard drives, optical disks, CDs, back-up tapes, etc.) used by the contractors/ subcontractors that contain VA information must be returned to the VA for sanitization or destruction or the contractor/subcontractor must self-certify that the media has been disposed of per 6500.1 requirements. This must be completed within 30 days of termination of the contract.

h. Bio-Medical devices and other equipment or systems containing media (hard drives, optical disks, etc.) with VA sensitive information must not be returned to the vendor at the end of lease, for trade-in, or other purposes. The options are:

(1) Vendor must accept the system without the drive;

(2) VA's initial medical device purchase includes a spare drive which must be installed in place of the original drive at time of turn-in; or

(3) VA must reimburse the company for media at a reasonable open market replacement cost at time of purchase.

(4) Due to the highly specialized and sometimes proprietary hardware and software associated with medical equipment/systems, if it is not possible for the VA to retain the hard drive, then;

(a) The equipment vendor must have an existing BAA if the device being traded in has sensitive information stored on it and hard drive(s) from the system are being returned physically intact; and

(b) Any fixed hard drive on the device must be non-destructively sanitized to the greatest extent possible without negatively impacting system operation. Selective clearing down to patient data folder level is recommended using VA approved and validated overwriting technologies/methods/tools. Applicable media sanitization specifications need to be pre-approved and described in the purchase order or contract.

(c) A statement needs to be signed by the Director (System Owner) that states that the drive could not be removed and that (a) and (b) controls above are in place and completed. The ISO needs to maintain the documentation.

6. SECURITY INCIDENT INVESTIGATION

a. The term "security incident" means an event that has, or could have, resulted in unauthorized access to, loss or damage to VA assets, or sensitive information, or an action that breaches VA security procedures. The contractor/ subcontractor shall immediately notify the COR and simultaneously, the designated ISO and Privacy Officer for the contract of any known or suspected security/privacy incidents, or any unauthorized disclosure of sensitive information, including that contained in system(s) to which the contractor/ subcontractor has access.

b. To the extent known by the contractor/subcontractor, the contractor/ subcontractor's notice to VA shall identify the information involved, the circumstances surrounding the incident (including to whom, how, when, and where the VA information or assets were placed at risk or compromised), and any other information that the contractor/subcontractor considers relevant.

c. With respect to unsecured protected health information, the business associate is deemed to have discovered a data breach when the business associate knew or should have known of a breach of such information. Upon discovery, the business associate must notify the covered entity of the breach. Notifications need to be made in accordance with the executed business associate agreement.

d. In instances of theft or break-in or other criminal activity, the contractor/subcontractor must concurrently report the incident to the appropriate law enforcement entity (or entities) of jurisdiction, including the VA OIG and Security and Law Enforcement. The contractor, its employees, and its subcontractors and their employees shall cooperate with VA and any law enforcement authority responsible for the investigation and prosecution of any possible criminal law violation(s) associated with any incident. The contractor/subcontractor shall cooperate with VA in any civil litigation to recover VA information, obtain monetary or other compensation from a third party for damages arising from any incident, or obtain injunctive relief against any third party arising from, or related to, the incident.

7. LIQUIDATED DAMAGES FOR DATA BREACH

a. Consistent with the requirements of 38 U.S.C. 5725, a contract may require access to sensitive personal information. If so, the contractor is liable to VA for liquidated damages in the event of a data breach or privacy incident involving any SPI the contractor/subcontractor processes or maintains under this contract.

b. The contractor/subcontractor shall provide notice to VA of a "security incident" as set forth in the Security Incident Investigation section above. Upon such notification, VA must secure from a non-Department entity or the VA Office of Inspector General an independent risk analysis of the data breach to determine the level of risk associated with the data breach for the potential misuse of any sensitive personal information involved in the data breach. The term 'data breach' means the loss, theft, or other unauthorized access, or any access other than that incidental to the scope of employment, to data containing sensitive personal information, in electronic or printed form, that results in the potential compromise of the confidentiality or integrity of the data. Contractor shall fully cooperate with the entity performing the risk analysis. Failure to cooperate may be deemed a material breach and grounds for contract termination.

c. Each risk analysis shall address all relevant information concerning the data breach, including the following:

(1) Nature of the event (loss, theft, unauthorized access);

(2) Description of the event, including:

(a) date of occurrence;

(b) data elements involved, including any PII, such as full name, social security number, date of birth, home address, account number, disability code;

(3) Number of individuals affected or potentially affected;

(4) Names of individuals or groups affected or potentially affected;

(5) Ease of logical data access to the lost, stolen or improperly accessed data in light of the degree of protection for the data, e.g., unencrypted, plain text;

(6) Amount of time the data has been out of VA control;

(7) The likelihood that the sensitive personal information will or has been compromised (made accessible to and usable by unauthorized persons);

(8) Known misuses of data containing sensitive personal information, if any;

(9) Assessment of the potential harm to the affected individuals;

(10) Data breach analysis as outlined in 6500.2 Handbook, Management of Security and Privacy Incidents, as appropriate; and

(11) Whether credit protection services may assist record subjects in avoiding or mitigating the results of identity theft based on the sensitive personal information that may have been compromised.

d. Based on the determinations of the independent risk analysis, the contractor shall be responsible for paying to the VA liquidated damages in the amount of per affected individual to cover the cost of providing credit protection services to affected individuals consisting of the following:

(1) Notification;

(2) One year of credit monitoring services consisting of automatic daily monitoring of at least 3 relevant credit bureau reports;

(3) Data breach analysis;

(4) Fraud resolution services, including writing dispute letters, initiating fraud alerts and credit freezes, to assist affected individuals to bring matters to resolution;

(5) One year of identity theft insurance with $20,000.00 coverage at $0 deductible; and

(6) Necessary legal expenses the subjects may incur to repair falsified or damaged credit records, histories, or financial affairs.

8. SECURITY CONTROLS COMPLIANCE TESTING

On a periodic basis, VA, including the Office of Inspector General, reserves the right to evaluate any or all of the security controls and privacy practices implemented by the contractor under the clauses contained within the contract. With 10 working-day's notice, at the request of the government, the contractor must fully cooperate and assist in a government-sponsored security controls assessment at each location wherein VA information is processed or stored, or information systems are developed, operated,…