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J065--INTENT TO SOLE TO OMINCELL INC. VISN WIDE OMINICELL
Solicitation number
36C24525Q0662
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This Special Notice is a sole source intent to award a contract to Omnicell Inc. for full-service support of Medication Dispensing Systems across the VA Capitol Health Care Network (VISN 05). The contract covers seven VA medical centers and their associated Community Based Outpatient Clinics (CBOCs) located in Maryland and West Virginia, with a base year from 10-01-2025 to 09-30-2026 and four additional one-year option periods through 09-30-2030.

The contract includes comprehensive services such as unscheduled and preventative maintenance, 24/7 telephone consultation, diagnosis and issue resolution, software and drug database updates, and ongoing interface maintenance for a wide range of Omnicell equipment. Covered equipment includes medication dispensing systems, carousels, label printers, barcode scanners, workstations, controlled substance dispensers, and various software licenses and services. The solicitation number is 36C24525Q0662, with a response date of 07-21-2025 at 10:00 Eastern Time, and the contracting office is located in Baltimore, MD.

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Special Notice Special Notice

SUBJECT*
INTENT TO SOLE TO OMINCELL INC. VISN WIDE OMINICELL

GENERAL INFORMATION

CONTRACTING OFFICE’S ZIP CODE*
21902
SOLICITATION NUMBER*
36C24525Q0662
RESPONSE DATE/TIME/ZONE
07-21-2025 10:00 EASTERN TIME, NEW YORK, USA
ARCHIVE
60 DAYS AFTER THE RESPONSE DATE
RECOVERY ACT FUNDS
N
PRODUCT SERVICE CODE*
J065
NAICS CODE*
811210
CONTRACTING OFFICE ADDRESS
Department of Veterans Affairs

VISN 5 NCO 5

VISN 5 Contracting Satellite office 361 Boiler House Rd BLDG 101 Baltimore MD 21201

POINT OF CONTACT*

CONTRACTING OFFICER

Bill Pratt Billie.Pratt@va.gov 410-642-2411

ADDITIONAL INFORMATION

AGENCY’S URL
https://www.va.gov
URL DESCRIPTION
VA

AGENCY CONTACT’S EMAIL ADDRESS

EMAIL DESCRIPTION

DESCRIPTION

See attached document: SOLE SOURCE LETTER OMNICELL INC.

Statement of Work

The purpose for this BPA is to provide an efficient procurement vehicle for full-service support of the Omnicell Medication Dispensing Systems located throughout the VA Capitol Health Care Network (VISN 05). Stations include Baltimore VAMC, Perry Point VAMC, Beckley VAMC, Louis A. Johnson Clarksburg VAMC, Huntington VAMC, Martinsburg VAMC and the Washington DC VAMC and their respective Community Based Outpatient Clinics (CBOCs).

LOCATIONS:

1. Station 512

a. Baltimore VAMC, 10 North Greene Street, Baltimore, MD 21201

b. Perry Point VAMC, 361 Boiler House Road, Building 361, Perry Point, MD 21902

c. Loch Raven VAMC, 3901 The Alameda, Baltimore, MD 21218

i. Baltimore VA Clinic, 209 West Fayette Street, Baltimore, MD 21201

ii. Cambridge VA Clinic, 830 Chesapeake Drive, Cambridge, MD 21613-9408

iii. Eastern Baltimore County VA Clinic, 5235 King Avenue Franklin Square Professional Center Suite 200, Rosedale, MD 21237-4068

iv. Fort Meade VA Clinic, 2479 5th Street, Fort Meade, MD 20755-0000

v. Glen Burnie VA Clinic, 808 Landmark Drive, Suite 128, Glen Burnie, MD 21061-4983

vi. Pocomoke City VA Clinic, 1701 Market Place, Suite 211, Pocomoke City, MD 21851-1738

2. Station 517

a. Beckley VAMC, 200 Veterans Ave, Beckley, WV 25801

i. Greenbrier County VA Clinic, 228 Shamrock Lane, Ronceverte, WV 24970-8380

ii. Princeton VA Clinic, 150 Courthouse Road, Princeton, WV 24740-2419

3. Station 540

a. Louis A. Johnson VAMC, 1 Medical Center Dr., Clarksburg, WV 26301

i. Braxton County VA Clinic, 40 Reston Place, Gassaway, WV 26624-7899

ii. Monongalia County VA Clinic, 40 Commerce Drive, Suite 101, Westover WV 26501-3952

iii. Tucker County VA Clinic, 260 Spruce St., Parsons, WV 26287-1015

iv. Wood County VA Clinic, 2311 Ohio Avenue, Suite A, Parkersburg, WV 26101-2559

4. Station 613

a. Martinsburg VAMC, 510 Butler Ave, Martinsburg WV 25405

i. Cumberland VA Clinic, 200 Glen Street, Cumberland, MD 21502-2573

ii. Fort Detrick VA Clinic, 1433 Porter Street Building 1433, Frederick MD 21702-9211

iii. Franklin VA Clinic, 91 Pine Street, Franklin, WV 26807-0000

iv. Hagerstown VA Clinic, 1101 Opal Court, Suite 202, Hagerstown, MD 21740-5941

v. Harrisonburg VA Clinic, 1755 South High Street, Harrisonburg, VA 22801-1553

vi. Petersburg VA Clinic, 15 Grant Street, Petersburg, WV 26847-1613

vii. Winchester VA Clinic, 100 Dawson Drive Winchester, VA 22602-5307

5. Station 581

a. Hershel "Woody" Williams VAMC, 1540 Spring Valley Drive, Huntington WV 25704

i. Charleston VA Clinic, 700 Technology Drive, South Charleston, WV 25309-8571

ii. Gallipolis VA Clinic, 323A Upper River Road, Gallipolis, OH 45631-1840

iii. Lenore VA Clinic, 2867 Route 65, 15 Lenore Business Mall, Williamson, WV 25661-9199

iv. Prestonsburg VA Clinic, 5230 KY Route 321, Suite 8, Prestonsburg, KY 41653-9169

6. Station 688

a. Washington DC VAMC, 50 Irving Street, NW, Washington DC 20422

i. Charlotte Hall VA Clinic, 29640 Three Notch Road, Charlotte Hall, MD 20622-3244

ii. Fort Belvoir VA Clinic, 9300 Dewitt Loop, Fort Belvoir, VA 22060-5285

iii. Franklin Street VA Clinic, 1500 Franklin Street Northeast, Community Resource & Referral Center (CRRC) Washington, DC 20018-2000

iv. Lexington Park VA Clinic, 45870 East Run Drive, East Run Center, Suite 300 Lexington Park, MD 20653-2383

v. Southeast Washington VA Clinic, 820 Chesapeake Street, SE, Washington, DC 20032

vi. Southern Prince George’s County VA Clinic, 5801 Allentown Rd, Suites 104/106, Camp Springs, MD 20746-4563

vii. Montgomery County VA Clinic, 15810 Gaither Drive, Gaithersburg, MD 20877

Period of Performance for this contract:

Base Year: 10-01-2025 to 09-30-2026 Option Year 1: 10-01-2026 to 09-30-2027 Option Year 2: 10-01-2027 to 09-30-2028 Option Year 3: 10-01-2028 to 09-30-2029 Option Year 4: 10-01-2029 to 9-30-2030

Covered Equipment and Systems

The following equipment and system types are to be covered under this service contract and will be specified on each individual task order for each station.

Part #
Description
ANT-SCN-009-SV
2D ITEM SCAN,AWS-XT
ANT-FRM-006-SV
SV-XT AWS
ANT-PNT-005-SV
SV,SYRINGE LABEL PRINTER - EPSON & SHELF
CPA-AIO-001-SV
SERVICE-CENTRAL PHARMACY AIO PC
CPA-CAR-058-SV
SV-CAROUSEL MEG-RS350.1.3050.4.419.9,CRX
CPA-LIC-001-SV
SRV-CENTRAL PHARMACY CLIENT LIC 1ST COPY
CPA-LIC-002-SV
SERVICE-CENTRAL PHARMACY SATELLITE LIC
CPA-PKG-008-SV
SV-PACKAGER 260 W CASSETTES, NARROW PKG
CPA-PKG-009-SV
SV-PACKAGER 336 W CASSETTES, NARROW PKG
CPA-PNT-001-SV
SERVICE-CENTRAL PHARMACY LABEL PRINTER
CPA-SCN-001-SV
SERVICE-2D BARCODE SCANNER,CPA
CPA-SCN-002-SV
SERVICE,BIO-ID READER,DESKTOP,USB
CRX-SRV-004-SV
SERVICE-BASE+ WIN2016 CRX,PHYSICAL SRV
CRX-WKS-002-SV
SERVICE-XR2 PHARMACY WORKSTATION
CSM-AIO-011-SV
SERVICE-CSM SOFTWARE AND WORKSTATION
CSM-AIO-018-SV
SV-CSM G4 TO XT CONVERSION
CSM-FRM-001-SV
SERVICE-1-CELL CSM AUX
CSM-FRM-002-SV
SERVICE-2-CELL CSM AUX
CSM-FRM-102-SV
SV-CSM AIO AUX-XT 2-CELL
CSM-FRM-103-SV
SV-CSM AIO AUX-XT 3-CELL
CSM-FRM-107-SV
SV-CSM AUX-XT 1-CELL
CSM-FRM-108-SV
SV-CSM AUX-XT 2-CELL
CSM-PNT-003-SV
SERVICE-CSM SATO LABEL PRINTER
CSM-SCN-001-SV
SERVICE-2D BARCODE SCANNER, CSM
CSM-SCN-002-SV
SERVICE,BIO-ID READER,DESKTOP,USB
IVS-HDW-001-SV
SV- IVX WORKFLOW
IVS-PNT-001-SV
SV- I.V.SOLUTIONS COLOR PRINTER
IVS-SUB-001
IVX CLOUD LICENSE SUBSCRIPTION
IVS-SUB-005
IVX NICELABEL SUBSCRIPTION
MED-AUX-101-SV
SERVICE-MED AUX-XT 1-CELL
MED-AUX-102-SV
SERVICE-MED AUX-XT 2-CELL
MED-AUX-103-SV
SERVICE-MED AUX-XT 3-CELL
MED-CSD-001-SV
SV-XT CONTROLLED SUBSTANCE DISPENSER
MED-FRM-101-SV
SERVICE-MED-XT 1-CELL
MED-FRM-102-SV
SERVICE-MED-XT 2-CELL
MED-FRM-103-SV
SERVICE-MED-XT 3-CELL
MED-FRM-104-SV
SERVICE-MED-XT 1/2-HEIGHT
MED-FRM-106-SV
SERVICE-MED-XT 1/4-HEIGHT
MSA-OPT-014-SV
SV-FLEXLOCK W TEMPCHECK 50 INSTL,2.0
MSA-OPT-016-SV
SV-FLEXLOCK W/ TEMPCHECK (50'),2.0
MSA-OPT-015-SV
SV- FLEXLOCK WITH TEMPCHECK (12FT) INSTL,2.0
MSA-OPT-017-SV
SV-FLEXLOCK W/ TEMPCHECK (12'),2.0
OCRA1-SV
SERVICE OMNICENTER REMOTE ACCESS(SINGLE
OMC-LIC-019-SV
SERVICE-OC REMOTE ACCESS WIN2016 (SINGLE
OMC-LIC-020-SV
SV-OC REMOTE ACCESS WIN2016 UPG (SINGLE)
OMC-LIC-032-SV
SV-OC REMOTE ACCESS WIN2019,UPG(SINGLE)
OMC-SRV-082-SV
SERVICE-OMNICENTER BASE SERVER
OMC-SRV-083-SV
SERVICE-VIRTUAL TEST SERVER VMWARE
OMC-SRV-091-SV
SV-OC SERVER WIN2019 21-175 DEVICES
OMC-SRV-092-SV
SV-OC SERVER WIN2019 176-600 DEVICES
OMC-SRV-094-SV
SV-OC VIRTUAL WIN2019 TEST SERVER
SRD-LIC-001-SV
SERVICE-OMNIEXPLORER PER CT CABINET
SRD-LIC-002-SV
SERVICE-WEB BROWSER
SRD-OPT-011-SV
SV-XT FLEXLOCK,WIRELESS,ALACARTE
SRD-OPT-012-SV
SV-FLEX LOCK 3.0 WITH 50 FT CABLE,INSTL
SRD-OTH-002-SV
SERVICE-AGED EQUIPMENT SURCHARGE
SRD-SCN-005-SV
SV-SCANNER,WIRELESS 1-2 AND 1-4 HEIGHT
WRX-CR-002-SV
MAIN CAROUSEL SERVICE
WRX-LP-001-SV
SERVICE-LABEL PRINTER KIT
WRX-PKG-008-SV
SERVICE-PACKAGER II WITH 336 CASSETTES
WRX-SCN-001-SV
SERVICE-2D WIRELESS BARCODE SCANNER
WRX-SP-003-SV
Service Workstation Kit
XR2-CTM-002-SV
SERVICE-CART MODULE
XR2-OPT-003-SV
SERVICE- RESTOCK CART
XR2-RBT-004-SV
SERVICE- XR2 4-BAY SYSTEM
XR2-STM-002-SV
SERVICE- STORAGE MODULE
OMC-SUB-011
OC ANALYTS,DIVERSION,1YR PVIA,1-50 BEDS Monthly Fee
OMC-SUB-012
OC ANALYTS,DIVERSION,1YR PVIA,51-150 BED Monthly Fee
OMC-SUB-013
OC ANALYTS,DIVERSION,1YR PVIA,151+ BEDS Monthly Fee
OMC-SUB-014
OC ANALYTS,DIVERSION,5YR PVIA,1-50 BEDS
OMC-SUB-015
OC ANALYTS,DIVERSION,5YR PVIA,51-150 BED
OMC-SUB-016
OC ANALYTS,DIVERSION,5YR PVIA,151+ BEDS
MSA-LIC-001
SERVICE- ANYWHERERN
OMC-PNT-001
SAFETYSTOCK
SRD-LIC-002
WEB ENABLED
MED-LIC-006
SW LICENSE- SINGLEPOINTE
XR2-BDS-001-SV
XR2 AUTOBAGGER

DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

1. SERVICES:

Contractor shall furnish the following:

· Unscheduled Service, including remote and onsite service, is provided. Unscheduled Service parts, time, travel, and labor are provided. Customer replaceable parts are not included. For remote services, contractor shall have established MOU-ISA with VA.

· Preventative Maintenance, including remote and onsite service, is provided. Preventative Maintenance parts, time, travel, and labor are provided. Customer replaceable parts are not included. For remote services, contractor shall have established MOU-ISA with VA.

· Telephone Consultation and Support is provided 24 hours a day, 7 days a week, 365 days a year by the Contractor at no additional customer cost.

· Diagnosis and Issue Resolution Services are provided and include:

· Diagnosis/root cause problem analysis.

· Defined resolution approach - workaround or fix.

· Instructions to authorized customer representatives regarding actions to be taken to correct, or assists in correcting, the problem.

· Adjustment of software configuration.

· Correction of errors or defects in software programs including sourcing, testing, and implementation of patches and service packs provided by third party software providers.

· Correction of interfaces and reports.

· Documentation of problems, corrections, tests, and resolutions.

· Quality/training initiatives to increase operator knowledge and decrease the number of reportable incidents.

· Dispatch of a technician should the repair, servicing, or troubleshooting not be able to be performed remotely. The Technician will arrive during the pharmacy’s standard hours of operation. The minimum standard response time for dispatch will be no later than the following workday after it is determined a technician is needed. Field Service Technicians work in and around the pharmacy workflow to be as non-intrusive as possible, and they work efficiently to bring the products back into normal service.

· Software Updates and Drug Database Updates are provided.

· Ongoing Interface Maintenance is provided.

· Equipment Verification will be provided by the Contractor at no additional customer cost.

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

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

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

d. Custom software development and outsourced operations must be located in the U.S.

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

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

3. VA INFORMATION CUSTODIAL LANGUAGE

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

- General, FAR 52.227-14(d) (1).

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

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

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

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

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

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

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

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

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

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

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

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

b. The contractor/subcontractor shall certify to the COTR 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 ____ days.

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

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

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

a. For information systems that are hosted, operated, maintained, or used on behalf of VA at non-VA facilities, contractors/subcontractors are fully responsible and accountable for ensuring compliance with all HIPAA, Privacy Act, FISMA, NIST, FIPS, and VA security and privacy directives and handbooks. This includes conducting compliant risk assessments, routine vulnerablity scanning, system patching and change management procedures, and the completion of an acceptable contingency plan for each system. The contractor’s security control procedures must be equivalent, to those procedures used to secure VA systems. A Privacy Impact Assessment (PIA) must also be provided to the COTR 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 COTR. 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/subcontractorowned 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 VAapproved 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 preapproved 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 COTR and simultaneously, the designated ISO and Privacy Officer for the contract of any known or suspected security/privacy incidents, or any unauthorized disclosure of sensitive information, including that contained in system(s) to which the contractor/subcontractor has access.

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

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

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

7. LIQUIDATED DAMAGES FOR DATA BREACH

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

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

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

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

(2) Description of the event, including:

(a) date of occurrence;

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

(3) Number of individuals affected or potentially affected;

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

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

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

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

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

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

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

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

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

(1) Notification;

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

(3) Data breach analysis;

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

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

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

8. SECURITY CONTROLS COMPLIANCE TESTING

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

9. TRAINING

a. 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 Cyber Security Awareness and Rules of Behavior training and annually complete required security training;

(3) Successfully complete the appropriate VA 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 [to be defined by the VA program official and provided to the contracting officer for inclusion in the solicitation document – e.g., any role-based information security training required in accordance with NIST Special Publication 800-16, Information Technology Security Training Requirements.]

b. The contractor shall provide to the contracting officer and/or the COTR a copy of the training certificates and certification of signing the Contractor Rules of Behavior for each applicable employee within 1 week of the initiation of the contract and annually thereafter, as required.

c. 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.

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