36C26021Q0198.docx

36C26021Q0198

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.

DUNS:

DUNS+4:

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. 2/2012)

PREVIOUS EDITION IS NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

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

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

101-21-1-5209-0025

36C26021Q0198

Melita Bernardo 253-888-4902 01-15-2021 16:00

PST

36C260 Department of Veterans Affairs Network Contracting Office 20

5115 NE 82nd Ave, Suite 103 Vancouver WA 98662

X

541512 $30 Million

N/A

36C101 Department of Veterans Affairs VISN 20 Sites See SOW for locations

Same as block 9

Department of Veterans Affairs

FMS-VA-2(101)

Financial Services Center PO Box 149971 Austin TX 78714-9971

See CONTINUATION Page The Department of Veterans Affairs, VISN 20 NW Healthcare Network intends to establish a single award contract to Patient Radiation Dose Management System for the VISN locations identified in the statement of work.

The anticipated period of performance is one year from date of award.

Offerors shall review the quote preparation instructions located at the Addendum to FAR 52.212-1 Instructions to Offerors - Commercial Items.

This is a total SDVOSB set-aside. As such any offerors must be verified in VIP in order to be eligible for award.

Questions regarding this solicitation must be submitted in writing no later than 0800 Tuesday, 12 January 2021 to Melita.Bernardo@va.gov.

See CONTINUATION Page

Michael J. Allred

VA-VHA-2020-66C4F642

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: To be determined

b. GOVERNMENT: Contracting Officer 36C260 Department of Veterans Affairs Network Contracting Office 20 5115 NE 82nd Ave, Suite 103 Vancouver WA 98662

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.

Department of Veterans Affairs

FMS-VA-2(101)

Financial Services Center PO Box 149971 Austin TX 78714-9971

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

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

IR105d-Interfaces Upgrades V20 REQ0123- PACS Dose Monitoring-Radimetrics

0001A

ME - EXP-4 - CT/IR PROCEDURES

(Study Volume: 275,000 CT + 75,000 IR Exams. No audit on license for the first 5-years of use)

0001B

ME - EXP-TST-2 - TEST SERVER FOR CT/IR VOLUME >100K

(Provides 1-Test Server as a VM)

0001C

ME -EXP-ADT - ADT FEED

)Provides Inbound ADT Interface:

Note - there will initially be inbound ADTs from 8-VISTA instances. All VISTA instances will be converted to a common Cerner instance by the end of 2020. 1-License will be used w-multiple installation events)

0001D

ME - EXP-SR-2 - OUTBOUND SR INTERFACE, VOLUME >100K

(Provides 1-Outbound to an Enterprise Speech Reporting Tool)

0001E

ME -EXP-RDSD-2 Outbound RDSR Interface - vol >= 100K (Provides 1-Outbound to Cerner)

0001F

ME -EXP-ACR - ACR DIR INTERFACE

0001G

ME-EXP-PS Professional Services

0001H

ME-EXP-PRI Process Prior Studies - Up to 1 year back

0001I

ME-85141775 Radimetrics Pre-Processor Server Instance

0001J

ME- EXP-PS MRN Conversion - Crosswalks (Provides Professional Services to analyze and format Crosswalk Tables from the 8-VISTA EMR Instances for the VISTA to Cerner MRN Conversion)

0001K

ME- EXP-PS MRN Conversion – Test Servers (Provides Professional Services to prep a Test server with Radimetircs production data, to develop and apply scripting for the MRN conversion, and to validate conversion results for the MRN Conversion Project. These services will be provided for the 8-VISTA EMR Instances for the VISTA to Cerner MRN Conversion)

0001L

ME- EXP-PS MRN Conversion - Pre-Processors (Provides Professional Services to apply scripting to 7-Pre-Processor servers and to validate conversion results for the MRN Conversion Project.)

0001M

ME-EXP-PSMRN Conversion – Production Server (Provides Professional Services to apply scripting to the Production server and to validate conversion results for the MRN Conversion Project. These services will be provided for the 8-VISTA EMR Instances for the VISTA to Cerner MRN Conversion)

0001N

ME-EXP-PS MRN Conversion – Project Management (Provides Project Management for the MRN Conversion Project)

0001O

ME-EXP-TRAVEL

Travel Fee 2-day onsite Super User Class |(CT/IR > 50,000 Procedures (Flat fee for travel expenses associated with 16-on-site visits).

0001P

ME-EXP-TRN-1

1-Day On-Site Training Session (Provides 8 x 1-Day Follow Up Sessions for IR Training)

0001Q

ME-EXP-TRN-2

1-Day On-Site Training Session (Provides 7 x 2-Day Session of CT Introductory Training (in addition to the 1-2-day session the that is included with Standard Implementation)

GRAND TOTAL

B.3 STATEMENT OF WORK

STATEMENT OF WORK

1. Contract Title: VISN 20, Patient Radiation Dose Management System, Cerner Project

2. Background. The VA Northwest Health Network, Veterans Integrated Service Network (VISN) 20, is responsible for providing health care to Veterans in the states of Alaska, Washington, Oregon, most of the state of Idaho, and one county each in Montana and California.

Radiation dose management systems document patient radiation dose for CT, “C”-arm, cardiology, interventional radiology and other types of relatively high dose x-ray exams. This system helps to automate the collection and reporting of radiation dose per study, and per patient over time. It can set dose reference levels, send alerts when reference levels are exceeded, and report cumulative dose. It is used to meet current regulatory and American College of Radiology (ACR) guidelines in an automated manner to fit, and improve, the radiology technologists and radiologists workflow. It can also improve efficiency by reducing repetitive manual and dictation documentation, monitoring equipment and staff utilization, quantifying productivity and reducing repeat exams. It allows imaging management to set up Key Performance Indicators (KPIs) to monitor both internal performance improvement efforts and make comparisons to external recommendations (e.g. ACR and American Association of Physicists in Medicine (AAPM) guidelines).

3. Applicable Documents. In performance of the tasks associated with this Performance Work Statement, the Contractor shall comply with the following:

3.1. 44 U.S.C. § 3541, “Federal Information Security Management Act (FISMA) of 2002”

3.2. FIPS Pub 201, “Personal Identity Verification of Federal Employees and Contractors,” March 2006

3.3. 5 U.S.C. § 552a, as amended, “The Privacy Act of 1974”

3.4. 42 U.S.C. § 2000d “Title VI of the Civil Rights Act of 1964”

3.5. VA Directive 0710, “Personnel Suitability and Security Program,” September 10, 2004

3.6. VA Directive 6102, “Internet/Intranet Services,” July 15, 2008

3.7. 36 C.F.R. Part 1194 “Electronic and Information Technology Accessibility Standards,” July 1, 2003

3.8. Office of Management & Budget (OMB) Circular A-130, “Management of Federal Information Resources,” November 28, 2000

3.9. 32 C.F.R. Part 199, “Civilian Health and Medical Program of the Uniformed Services (CHAMPUS)”

3.10. An Introductory Resource Guide for Implementing the Health Insurance Portability and Accountability Act (HIPAA) Security Rule, October 2008

3.11. Sections 504 and 508 of the Rehabilitation Act (29 U.S.C. § 794d), as amended by the Workforce Investment Act of 1998 (P.L. 105-220), August 7, 1998

3.12. Homeland Security Presidential Directive (12) (HSPD-12)

3.13. VA Directive 6500, “Information Security Program,” August 4, 2006

3.14. VA Handbook 6500.6, “Contract Security,” March 12, 2010

3.15. Program Management Accountability System (PMAS) portal (reference PWS References – Technical Library at https://www.voa.va.gov/)

4. Scope.

4.1. The vendor shall provide software, software licenses, installation services and maintenance and support services to provide Digital Imaging and Communications in Medicine (DICOM) -based radiation dose management per study and per patient over time (see Table 1: VISN 20 Sites below). Vendor shall provide implementation services remotely to assist with the implementation of the Licensed Software installation. Onsite applications training at each of the VISN 20 sites shall also be provided. Vendor will assist VISN 20 sites with the following tasks:

4.1.1. Project Initiation and coordination of installation resources

4.1.2. Configuration and installation of the Licensed Software

4.1.3. Connectivity with local hospital instances of the Licensed Software to central server

4.1.4. Data validation

4.1.5. Configuration and testing of applicable systems interfaces (e.g. VistA, , Cerner Electronic Health Record, Picture Archiving Communication System (PACS))

4.1.6. Clinical application configuration and training

4.1.7. Go-live support

4.2. Deliverables:

4.2.1. Vendor Project Management: Vendor’s project manager will manage and coordinate the implementation project using standard project methodology from initiation through completion, including software testing, interface testing and training. The Vendor’s project manager will also set up weekly or bi-weekly project status report meetings to be conducted via conference call during the implementation cycle.

4.2.2. Project Kickoff Meeting: Once award and acceptance has occurred, there will be a mutually agreed upon date between vendor and VISN 20 staff to start the implementation project. Initiation typically consists of a kickoff meeting/call and introduction between key resources from both organizations. These individuals will review the SOW deliverables to ensure that nothing has changed. More specific implementation details will be addressed in this meeting. The goal of the meeting will be to review implementation requirements and determine an agreed upon installation date(s).

4.2.3. Kickoff follow up: Upon completion of the project kickoff, the Vendor’s project manager assigned to the implementation will document any action items pertaining to the installation and application training. Required action items will be highlighted. An installation timeline and task schedule will be provided by the Vendor’s project manager to the VA.

4.2.4. Installation: The vendor will assist VISN 20 technical resources with the installation of the Licensed Software remotely. Licensed Software is to be installed in a virtualized environment within the VA virtualized environment. A vendor POC will provide the patient radiation dose software installation package to VISN 20 technical resources via an Open Virtualization Format (OVF) appliance which contains the application and underlying operating system. Upon completion of the installation, vendor and VISN 20 staff will jointly to conduct an acceptance test as outlined below. Vendor will provide prompt notice to VISN 20 staff if it determines at any time that there will be any delay in completing the installation.

4.2.5. Acceptance Testing: Upon completion of installation of the dose management software, Vendor shall demonstrate (the “Acceptance Test”) that the software is capturing and calculating dose data (the “Acceptance Criteria”).

4.2.6. DICOM Connectivity: The vendor will configure and validate connectivity for the Licensed Software from all applicable DICOM connections to the Licensed Software. The vendor will also work with VISN 20 staff to configure and test all systems integrations included in the award. For the Test Instance License, initial DICOM connectivity and testing and initial systems integration testing will be performed in the Test environment as needed before validation is performed in the production environment.

4.2.7. Clinical Configuration & Application Setup: A Vendor Clinical Informatics Specialist will work with VISN 20 staff resources to configure and organize the following data in the production Licensed Software instance to include:

4.2.7.1. Institutions/sites

4.2.7.2. Devices/modalities

4.2.7.3. Protocols

4.2.7.4. Application Users

4.3. Specifications for radiation dose management software must have the minimum capabilities:

4.3.1. Radiation dose monitoring for all CT and Fluoro exams

4.3.2. Capture dose for CR/DR

4.3.3. Utilization data for all modalities sent to Licensed Software

4.3.4. Ability to estimate effective dose based on International Commission on Radiological Protection (ICRP) 103 or ICRP 60 definitions.

4.3.5. Automated calculation of SSDE (size specific dose estimate)

4.3.6. Protocol management system, upon completion of the implementation services.

4.3.7. Automated scan length analysis

4.3.8. Customizable alerts based on CTDIvol, DLP, effective dose, organ dose, fluoro time, DAP or Air Kerma at the patient, exam, or acquisition level (i.e. which alerts will be included during customization).

4.3.9. Intelligent reporting with customizable dashboards (i.e. which customizations occur as part of implementation and customization services).

4.4. Clinical & Workflow Education Services: A Vendor Clinical Informatics Specialist will provide start up services to assist in the initial clinical configuration and use of the radiation dose management system. This could include remote and on-site sessions focused on:

4.4.1. Introducing the Vendor Clinical team and Process (Clinical Kickoff)

4.4.2. Outcome/Workflow and Level of Effort Scoping

4.4.3. Clinical customization/configuration working sessions

4.4.4. Standard implementations include two onsite Super user training and two onsite clinical training visits per site with a duration based on the project scope. Travel expenses associated with the on site training shall be included in the proposal and will not be reimbursed individually.

4.4.5. Vendor also provides additional "Clinical Adoption Services" as a part of the standard maintenance and support agreement to assist customers over time as they leverage the dose management system to achieve their outcome goals.

Table 1: VISN 20 Sites

Anchorage, AK 99504

Boise, ID 83702

Portland, OR 97239-2999

Roseburg, OR 97470

Seattle, WA 98108-1597

Tacoma, WA 98493

Spokane, WA 99205

Walla Walla, WA 99362

8495 Crater Lake Highway

White City, OR 97503

Figure 1: Dose Management System Example (Radimetrics):

Enterprise Platform Architecture for Cerner Interoperability

5. Performance Period. Work on the first site (Spokane) shall start immediately upon contract issuance and VISN 20 readiness. Vendor and VISN 20 staff shall develop a site-by-site schedule for the remaining sites. It is estimated that all sites will be completed within one year.

6. Place of Performance. Contract performance shall take place at the contractor’s location(s) and at the locations in Table 1.

7. Travel for Installation, Implementation and Training. The Government anticipates Contractor travel under this contract. All travel shall be incorporated into the price schedule for the contract. No travel costs will be reimbursed by VA

7.1. Travel is anticipated for on-site installation, configuration, implementation, and end-to-end testing. The Government acknowledges the possible use of remote access for installation and implementation purposes, within the constraints of all applicable VA Information Security Requirements

8. Government Furnished Equipment/Information. The Contractor shall be allowed access to Government equipment including servers and network infrastructure. Information on Government equipment and systems shall be provided as necessary. No Government-owned property will be transferred into the Contractor’s control. Additional software products may be provided by the Government as identified to facilitate Contractor access, e.g. Microsoft Terminal Services.

9. Security Requirements. All contractor employees are subject to the same level of investigation as VA employees who have access to VA sensitive information or access to VA facilities. The background investigation includes the following requirements: 1) Completed documentation 2) Fingerprints 3) Completion of OPM’s e-QIP Questionnaire. The Contractor is required to fulfill all of the security requirements. The Contractor, upon completion of fingerprinting, and an initial suitability determination, may be authorized tentative access to start the performance period of the contract, but only on condition of completion of all security requirements. This requirement is applicable to all subcontractor personnel requiring the same access.

10. Hours of Coverage & Federal Holidays. Maintenance Service will be provided during regular coverage hours of 8:30am to 5:30pm, Monday through Friday, excluding federal holidays. The contractor shall contact the POC or his/her designee prior to commencing any work on the premises.

Federal Holidays are:

Christmas Day

B.4 VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY LANGUAGE FOR INCLUSION INTO CONTRACTS, AS APPROPRIATE

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 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.

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 POC.

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 POC, and approved by the VA Privacy Service in accordance with Directive 6507, VA Privacy Impact Assessment.

b. The contractor/subcontractor shall certify to the POC 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;

(2) 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

(3) 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 ___5_ 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 ___5_ 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 vulnerability 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 POC 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 POC. 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 POC 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…