36C26123Q0871.docx

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6525--VISN 21 Medicom ImageX Network Access Federal contract opportunity
Solicitation number
36C26123Q0871
Issued by
Department of Veterans Affairs Veterans Health Administration Veterans Integrated Service Network 21

About this file

This is a solicitation for a network access solution from Medicom ImageX to enable electronic exchange of radiology imaging exams and reports between Department of Veterans Affairs hospitals and commercial healthcare facilities. The solution must integrate with various VA systems including VistA Imaging, Philips IntelliSpace PACS, and Cerner. It must authenticate and validate bi-directional DICOM and HL7 exchange with commercial providers, and allow the VA to search for and retrieve prior exams to induct into VA systems. Pricing is included for individual VA facilities. Responses are due by July 5, 2023.

The solicitation requires the solution to pre-fetch relevant prior exams for upcoming VA appointments based on information from commercial providers on the network. It must automatically match patient IDs and generate VA orders to archive studies. The solution provides unlimited, bi-directional workflow between the VA and commercial partners via an encrypted, peer-to-peer network connecting to the VA via VPN. The contractor must support, maintain, and train on the solution. Information security and privacy requirements are also specified.

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36C26123Q0871

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. SIGNAT

URE 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

612-23-3-476-0087

36C261-23-AP-4158

36C26123Q0871 06-29-2023

LEAH SMITH

702-791-9000 15065 07-05-2023 11:00

PDT

36C261 Department of Veterans Affairs Network Contracting Office 21 VA Southern Nevada Healthcare System 6900 N. Pecos Road, Building 6 North Las Vegas NV 89086 513210 $41.5 Million N/A X See Delivery Schedule

36C261 Department of Veterans Affairs Network Contracting Office 21 Southern Nevada Healthcare System 6900 N. Pecos Road, Building 6 North Las Vegas NV 89086

Department of Veterans Affairs Financial Services Center P.O. Box 149971 Austin TX 78714-9971 See CONTINUATION Page

MEDICOM IMAGEX NETWORK ACCESS

SEE PRICE/COST SCHEDULE

THIS IS A SOLE SOURCE SOLICITATION TO OEM MEDICOM

TECHNOLOGIES, INC.

RESPONSE IS DUE VIA EMAIL ONLY TO LEAH SMITH AT

LEAH.SMITH@VA.GOV NO LATER THAN THE

DUE DATE/TIME IN BOX 8.

See CONTINUATION Page X Angela M. Oppenheimer

CONTRACTING OFFICER

Table of Contents

SECTION A1
A.1 SF 1449 SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES1
SECTION B - CONTINUATION OF SF 1449 BLOCKS3
B.1 CONTRACT ADMINISTRATION DATA3
B.3 PRICE/COST SCHEDULE17
ITEM INFORMATION17
B.4 DELIVERY SCHEDULE19
B.5 IT CONTRACT SECURITY20
SECTION C - CONTRACT CLAUSES31
C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (DEC 2022)31
C.2 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)37
C.3 VAAR 852.203-70 COMMERCIAL ADVERTISING (MAY 2018)37
C.4 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV 2018)37
C.5 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020)38
C.6 VAAR 852.247-73 PACKING FOR DOMESTIC SHIPMENT (OCT 2018)38
C.7 VAAR 852.246-71 REJECTED GOODS (OCT 2018)39
C.8 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (MAR 2023)39
SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS48
SECTION E - SOLICITATION PROVISIONS49
E.1 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (MAR 2023)49
E.2 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB 1998)53
E.3 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)54
E.4 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (NOV 2021)56
E.5 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (DEC 2022)57

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 36C261 ANGELA M. OPPENHEIMER Department of Veterans Affairs Network Contracting Office 21 VA Southern Nevada Healthcare System 6900 N. Pecos Road, Building 6 North Las Vegas NV 89086

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

[X]
52.232-33, Payment by Electronic Funds Transfer—System For Award Management, or
[]
52.232-36, Payment by Third Party

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly[]
b. Semi-Annually[]
c. Other[X] UPON DELIVERY AND ACCEPTANCE BY THE GOVERNMENT.

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:

AMENDMENT NO
DATE

B.2 STATEMENT OF WORK

MEDICOM IMAGEX VISN21

INTRODUCTION:

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.

BACKGROUND:

The Mission Act has made it possible for Veterans to seek diagnostic imaging services outside of the VA. As a result, diagnostic results, which are in the form of DICOM images and textual reports, need to be couriered back to the VA for further patient care. As it exists currently, CD-ROMs and DVD-ROMs are hand-carried or mailed to and from the VA at the completion of a diagnostic test; this causes bottlenecks and delays in the continuity of Veteran care. There has also been a delay in archiving the images, delivered to the ordering provider by the patient who diligently obtains the requested images from the outside provider on a CD-ROM. The VA relies on CDs to share imaging examinations with community care providers, but examinations are often repeated when CDs are not requested, get misplaced, or are not “readable” due to software incompatibility. CDs and repeat imaging cost the VA an estimated $163-181 million per year, nationally. But more importantly, the Veteran can be harmed when previous examinations are not available: delayed diagnosis of cancer, aggressive and needless workups, and increased radiation exposure.

SCOPE:

Medicom’s Imagex deploys a proprietary peer-to-peer network that would give the United States Department of Veterans Affairs Hospitals the ability to electronically exchange data with the community. In so doing, Medicom’s Imagex would minimize delays in the delivery of care and reduce the operational costs associated with seeing a Veteran imaged outside of VA under the Mission Act. By using the unique peer-to-peer secure network technology provided by Medicom, the VA VISN21 Healthcare System would be able to, in effect, retrieve the requested images from our community providers electronically, saving the time and cost of using courier services to transport the CD-ROMs to the Radiology File Room.

GENERAL REQUIREMENTS:

The required services must integrate with VistA Imaging Importer, Philips IntelliSpace 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 department currently uses 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 Philips IntelliSpace PACS.

The acquired network services must ensure the VA can continue to save these images to Philips IntelliSpace 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 VA VISN21 Healthcare System service area, locate prior medical images and reports, and retrieve them to the VA where they can be inducted to VA systems using a quality assurance step.

In addition, 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 Philips IntelliSpace 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 Philips IntelliSpace PACS – the process will occur as follows:

· Receiving Information at the VA

· 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:

· This query 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 broadcasted to the entire community of providers participating in the health information network.

· The prior medical images and reports are located at outside facilities.

· The images and reports 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.

· The images are 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.

· Sending information to the private sector:

· 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 a VISN21 Healthcare System 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.

· 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.

In all the above 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.

MARKET RESEARCH

The acquired system facilitates the exchange 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. The system provides enhanced automation which:

· 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.

VHA DIRECTIVES: MEDICAL CENTER MEMORANDUM IT-13-04

No ESMD’s will be removed from VA property by a vendor or any other individual without following the instructions contained in this policy. Facilities Management Services/Biomedical Engineering will be responsible for sanitizing any Electronic Storage and Memory Devices (ESMD) attached to medical equipment which requires replacement, upgrade, repair, or turn-in. Information Technology Service (ITS) is responsible for sanitizing all IT-related ESMD’s. Sanitizing processes outlined in VHA Handbook 6500 will be used. All devices containing an ESMD will be prominently flagged with a bright red sticker containing the proper instructions to follow if the ESMD needs servicing in any way.

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.

ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

· 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.

· 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.

· 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.

· 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.

VA INFORMATION CUSTODIAL LANGUAGE

· 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).

· 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 within 30 days to the VA or destroyed in accordance with VA’s sanitization requirements as noted below. VA reserves the right to conduct onsite 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.

· 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.

· 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.

· 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.

· 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.

· 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.

· 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.

· 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.

· 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, or Release of Information (ROI) Unit for response. 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 or ROI for response.

· 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.

INFORMATION SYSTEM HOSTING, OPERATION, MAINTENANCE, OR USE

· 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.

· 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.

· 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.

· 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.

SECURITY INCIDENT INVESTIGATION

· 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.

· 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.

· 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.

· 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.

LIQUIDATED DAMAGES FOR DATA BREACH

· 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.

· 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.

· 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.

Based on the determinations of the independent risk analysis, the contractor shall be responsible for paying to the VA liquidated damages 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.

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-days’ 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, maintained, or used on behalf of VA, including those initiated by the Office of Inspector General. The government may conduct a security control assessment on shorter notice (to include unannounced assessments) as determined by VA in the event of a security incident or at any other time.

TRAINING

· All contractor employees and subcontractor employees requiring access to VA information and VA information systems shall complete the following before being granted access to VA information and its systems:

· (1) Sign and acknowledge (either manually or electronically) understanding of and responsibilities for compliance with the Contractor Rules of Behavior, Appendix E relating to access to VA information and information systems;

· (2) Successfully complete the VA Privacy and Information Security Awareness and Rules of Behavior training and annually complete required security training;

· (3) Successfully complete the appropriate VHA HIPAA privacy training and annually complete required privacy training; and

· (4) Successfully complete any additional cyber security or privacy training, as required for VA personnel with equivalent information system access.

· The contractor shall conduct training using the Talent Management System (TMS) for each applicable employee within 1 week of the initiation of the contract and annually thereafter, as required.

· Failure to complete the mandatory annual training and sign the Rules of Behavior annually, within the timeframe required, is grounds for suspension or termination of all physical or electronic access privileges and removal from work on the contract until such time as the training and documents are complete.

RECORDS MANAGEMENT OBLIGATIONS

A. Applicability This clause applies to all Contractors whose employees create, work with, or otherwise handle Federal records, as defined in Section B, regardless of the medium in which the record exists.

B. Definitions “Federal record” as defined in 44 U.S.C. § 3301, includes all recorded information, regardless of form or characteristics, made or received by a Federal agency under Federal law or in connection with the transaction of public business and preserved or appropriate for preservation by that agency or its legitimate successor as evidence of the organization, functions, policies, decisions, procedures, operations, or other activities of the United States Government or because of the informational value of data in them.

The term Federal record:

1. includes VHA records.

2. does not include personal materials.

3. applies to records created, received, or maintained by Contractors pursuant to their VHA contract.

4. may include deliverables and documentation associated with deliverables.

C. Requirements

1. Contractor shall comply with all applicable records management laws and regulations, as well as National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. chs. 21, 29, 31, 33), NARA regulations at 36 CFR Chapter XII Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a). These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion.

2. In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of 44 U.S.C. chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), as amended, and the Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation.

3. In accordance with 36 CFR 1222.32, the Contractor shall maintain all records created for Government use or created in the course of performing the contract and/or delivered to, or under the legal control of the Government and must be managed in accordance with Federal law. Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data.

4. VHA and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Records may not be removed from the legal custody of VHA or destroyed except in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting Activity. Willful and unlawful destruction, damage, or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, the Contractor must report to VHA. The agency must report promptly to NARA in accordance with 36 CFR 1230.

5. The Contractor shall immediately notify the appropriate Contracting Officer upon discovery of any inadvertent or unauthorized disclosures of information, data, documentary materials, records, or equipment. Disclosure of non-public information is limited to authorized personnel with a need-to-know as described in the contract. The Contractor shall ensure that the appropriate personnel, administrative, technical, and physical safeguards are established to ensure the security and confidentiality of this information, data, documentary material, records, and/or equipment is properly protected. The Contractor shall not remove material from Government facilities or systems, or facilities or systems operated or maintained on the Government’s behalf, without the express written permission of the Head of the Contracting Activity. When information, data, documentary material, records, and/or equipment is no longer required, it shall be returned to VHA control or the Contractor must hold it until otherwise directed. Items returned to the Government shall be hand-carried, mailed, emailed, or securely electronically transmitted to the Contracting Officer or address prescribed in the contract. Destruction of records is EXPRESSLY PROHIBITED unless in accordance with Paragraph (4).

6. The Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material, and/or records generated under, or relating to, contracts. The Contractor (and any sub-contractor) is required to abide by Government and VHA guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information.

7. The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with VHA policy.

8. The Contractor shall not create or maintain any records containing any non-public VHA information that is not specifically tied to or authorized by the contract.

9. The Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected from public disclosure by an exemption to the Freedom of Information Act.

10. The VHA owns the rights to all data and records produced as part of this contract. All deliverables under the contract are the property of the U.S. Government for which VHA shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Any Contractor rights in the data or deliverables must be identified as required by FAR 52.227-11 through FAR 52.227-20.

11. Training. All Contractor employees assigned to this contract who create, work with or otherwise handle records are required to take VHA-provided records management training. The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training.

D. Flow down of requirements to subcontractors

1. The Contractor shall incorporate the substance of this clause, its terms, and requirements including this paragraph, in all subcontracts under this contract, and require written subcontractor acknowledgment of same.

2. Violation by a subcontractor of any provision set forth in this clause will be attributed to the Contractor.

User, Technical, Delivery, Administrative Point of Contact:

POC:Steven Hughes - VISN 21 HTM
Steven.Hughes3@va.gov

VISN 21 Site POCs:

Central California HCS (2615 E. Clinton Avenue Fresno, CA 93703), Attention Uriel Gomez Northern California HCS (10535 Hospital Way Mather, CA 95655), Attention Victor Wei Pacific Islands HCS (459 Patterson Rd, Honolulu, HI 96819), Attention Kylie Matsumoto Palo Alto HCS (3801 Miranda Avenue Palo Alto, CA 94304-1290), Attention Morten Green San Francisco HCS (4150 Clement Street San Francisco, CA 94121), Attention Gabriella Orteza Sierra Nevada HCS (1000 Locust Street Reno, NV 89502), Attention Kylynn Nelson

B.3 PRICE/COST SCHEDULE

ITEM INFORMATION

ITEM NUMBER
DESCRIPTION OF SUPPLIES/SERVICES
QUANTITY
UNIT
UNIT PRICE
AMOUNT
1.00
YR
__________________
__________________

VISN 21 VA Northern California Healthcare System MEDICOM IMAGEX WITH ASSISTANT - INCLUDES SUPPORT, SERVICES, MAINTENANCE, AND TRAINING SEE SOW FOR FULL DETAILS.

PRINCIPAL NAICS CODE: 513210 - Software Publishers PRODUCT/SERVICE CODE: 6525 - Imaging Equipment and Supplies: Medical, Dental, Veterinary

MANUFACTURER PART NUMBER (MPN): N/A

1.00
YR
__________________
__________________

VISN 21 San Francisco VA Health Care System MEDICOM IMAGEX WITH ASSISTANT - INCLUDES SUPPORT, SERVICES, MAINTENANCE, AND TRAINING SEE SOW FOR FULL DETAILS.

1.00
YR
__________________
__________________

VISN 21 VA Palo Alto Healthcare System MEDICOM IMAGEX WITH ASSISTANT - INCLUDES SUPPORT, SERVICES, MAINTENANCE, AND TRAINING SEE SOW FOR FULL DETAILS.

1.00
YR
__________________
__________________

VISN 21 VA Sierra Nevada Health Care System MEDICOM IMAGEX WITH ASSISTANT - INCLUDES SUPPORT, SERVICES, MAINTENANCE, AND TRAINING SEE SOW FOR FULL DETAILS.

1.00
YR
__________________
__________________

VISN 21 VA Pacific Islands Health Care System MEDICOM IMAGEX WITH ASSISTANT - INCLUDES SUPPORT, SERVICES, MAINTENANCE, AND TRAINING SEE SOW FOR FULL DETAILS.

1.00
YR
__________________
__________________

VISN 21 VA Central California Health Care System MEDICOM IMAGEX WITH ASSISTANT - INCLUDES SUPPORT, SERVICES, MAINTENANCE, AND TRAINING SEE SOW FOR FULL DETAILS.

GRAND TOTAL
__________________

B.4 DELIVERY SCHEDULE

ITEM NUMBER
QUANTITY
DELIVERY DATE
0001
SHIP TO:
VA Northern California Healthcare System

10535 Hospital Way

MATHER, CA 95655

USA

1.00
365 DAYS ARO
MARK FOR:
Steven Hughes

916.281.4133 Steven.Hughes3@va.gov

0002
SHIP TO:
San Francisco VA Health Care System

4150 Clement Street

SAN FRANCISCO, CA 94121 1563

USA

1.00
365 DAYS ARO
MARK FOR:
Steven Hughes
0003
SHIP TO:
VA Palo Alto Healthcare System

3801 Miranda Avenue

PALO ALTO, CA 94304 1207

USA

1.00
365 DAYS ARO
MARK FOR:
Steven Hughes
0004
SHIP TO:
VA Sierra Nevada Health Care System

975 Kirman Ave

RENO, NV 89502

USA

1.00
365 DAYS ARO
MARK FOR:
Steven Hughes
0005
SHIP TO:
VA Pacific Islands Health Care System

459 Patterson Rd

HONOLOLU, HI 96819 1522

USA

1.00
365 DAYS ARO
MARK FOR:
Steven Hughes
0006
SHIP TO:
VA Central California Health Care System

2615 E. Clinton Avenue

FRESNO, CA 93703 2223

USA

1.00
365 DAYS ARO
MARK FOR:
Steven Hughes

B.5 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…

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