RFQ 36C26124Q1042 AVVIGO.docx

36C26124Q1042

PAGE 1 OF

1. REQUISITION NO.

2. CONTRACT NO.

3. AWARD/EFFECTIVE DATE

4. ORDER NO.

5. SOLICITATION NUMBER

6. SOLICITATION ISSUE DATE

a. NAME

b. TELEPHONE NO. (No Collect Calls)

8. OFFER DUE

DATE/LOCAL

TIME

9. ISSUED BY

CODE

10. THIS ACQUISITION IS

UNRESTRICTED OR

SET ASIDE:

% FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ

IFB

RFP

15. DELIVER TO

CODE

16. ADMINISTERED BY

CODE

17a. CONTRACTOR/OFFEROR

CODE

FACILITY CODE

18a.

PAYMENT WILL BE MADE BY

CODE

TELEPHONE NO.

UEI:

EFT:

PHONE:

FAX:

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

SEE

ADDENDUM

19.

20.

21.

22.

23.

24.

ITEM NO.

SCHEDULE OF SUPPLIES/SERVICES

QUANTITY

UNIT

UNIT PRICE

AMOUNT

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

25. ACCOUNTING AND APPROPRIATION DATA

26.

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

ARE

ARE NOT ATTACHED.

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

ARE

ARE NOT ATTACHED

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

29. AWARD OF CONTRACT: REF. ___________________________________ OFFER

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND

DATED ________________________________. YOUR OFFER ON SOLICITATION

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

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

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED

SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

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

AUTHORIZED FOR LOCAL REPRODUCTION

(REV. NOV 2021)

PREVIOUS EDITION IS NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES

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

36C261-24-AP-4665

640-24-3-163-0124 36C26124Q1042 09-03-2024 Carlos M. Exconde 702-340-6822 09-11-2024 15:00

PDT

00261 Department of Veterans Affairs Network Contracting Office 21 VA Palo Alto Health Care System (90/NCA) 3801 Miranda Ave Palo Alto CA 94304-1207 X 334510 1250 Employees N/A X See Delivery Schedule

00261 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 ****AVVIGO Multi-Modality Guidance System*** This will be a Full and Open Competition Firm Fixed Price Brand Name Only Solicitation for AVVIGO System.

All offerors must provide Authorized Distributor Documentation if not the manufacturer and shipping lead time for the quoted items.

VA POC: Carlos M. Exconde Please send information to: carlos.exconde@va.gov See CONTINUATION Page X Carlos M. Exconde Contracting Officer Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

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

a. CONTRACTOR:

b. GOVERNMENT: Contracting Officer 36C261 Department of Veterans Affairs Network Contracting Office 21 VA Palo Alto Health Care System (90/NCA) 3801 Miranda Ave Palo Alto CA 94304-1207

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

3. INVOICES: Invoices shall be submitted in arrears:

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

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

36C26124Q1042

Page 1 of Page 1 of

Statement of Work (SOW)

VA Palo Alto Health Care System 3801 Miranda Ave Palo Alto, CA 94304

Transaction Number: 640-24-3-163-0124

STATEMENT OF WORK

1.0 GENERAL SCOPE

The VA Palo Alto Healthcare System is upgrading the current equipment in cardiology department to provide for a New Hybrid Operating Room/Upgrade Cath Lab. This solicitation pertains to AVVIGO+ system, and associated accessories. Any reference to "the vendor for this package" will pertain to the manufacturer or offeror for the AVVIGO+ system, and associated accessories provided, along with necessary associated tools, labor, and materials for installation.

Contractor will manufacture, deliver, and install AVVIGO+ system, and associated accessories and its components to be installed in cardiology department at VA Palo Alto in building # 100, 3801 Miranda Avenue Palo Alto, CA

2.1. The vendor for this package shall provide all labor, materials, tools, and supervision to provide as well as to install the AVVIGO+ system, accessories, and associated parts. The AVVIGO+ system, and associated accessories requirements are described in detail in this equipment’s salient characteristics.

All finished items/ parts shall be free of scratches, marks, dents, or blemishes, other defects, and deficiencies, and withstand staining, and to exhibit no flaking, cracking, or loss or adhesion.

System’s Installation/Services provided:

a. Supervise all parts/ items to be set in place after they arrive in loading dock at project site as required per contract documents.

b. Refer to Terms and Conditions from the manufacturer for additional information pertaining to equipment’s accessories and installation.

c. Assembly of the equipment and its associated parts and accessories.

d. Pre-install/ site walk.

e. Provide protections for floor, wall, elevator, etc., along all areas/ rooms where all items/ parts will be traveled from loading dock to project site.

f. Equipment’s shipping and delivery.

4.0 PERFORMANCE REQUIREMENTS

Associated design/drafting, structural engineering, project management, assembly and installation services shall be provided by the awarded Contractor.

4.1 AVVIGO+ system, and associated accessories.

The contractor shall procure and deliver the AVVIGO+ system, and associated accessories for VA Palo Alto Healthcare System.

INCLUDES TOUCH SCREEN MEDICAL GRADE TABLET WITH

BATTERY, DESKTOP DOCKING STATION, POWER SUPPLY

AND INSTALLATION GUIDE. INCLUDES UP TO 5 FFR

LINKs (UPN H7495551000), 1-YEAR STANDARD

MANUFACTURER WARRANTY.

5.0 SPECIFICATIONS AND SUBMITTALS

8.1 Deliver, assemble, and install AVVIGO+ system, and associated accessories. Install all the parts/ items listed on the IGCE, and deliver them to project site.

Installation Requirements.

a. Contractor shall be familiar with VA Palo Alto’s forthcoming Cath Lab Renovation project, regulations, security requirements, loading dock locations, and hours of operations.

b. Any contractor personnel, including permanent and temporary staff installers, shall be cleared prior to installation start date through VA Palo Alto Police Department. Personnel shall always wear contractor provided identification and VA visitor’s badge while on VA property.

c. Contractor shall provide Proof of Insurance upon request by the VA.

d. Contractor Storage Facility shall meet all current building code requirement including but not limited to sprinkler, secure, safe, environmental controls – not to void AVVIGO+’s warranties.

e. Contractor shall have trained personnel in various stages of AVVIGO+’s installation.

f. Contractor shall provide Project Manager/Lead Supervisor, Client Representative, Installers, and Service Technicians as needed when providing service to the VA.

g. Contractor shall provide all necessary materials, labor, supervisor, and Manager to:

i. Coordinate delivery.

ii. Load and unload.

iii. Place/install in designated room/location.

iv. Assemble items as required.

v. Secure all parts in a secured storage space designated by the VA.

vi. Properly dispose of all associated packing/crating materials off-site of VA premises.

h. Contractor shall track manufacturing schedule and notify VA Point of Contact (POC) with updates of estimated completion date by email.

i. Contractor shall coordinate installation date with VA Point of Contact (POC) to occur at the convenience of the Government or no later than 30 days after notification of receipt of AVVIGO+.

j. Contractor shall obtain VA CO, COR or POC approval for any changes or corrections to the original approved contract. CO must approve any monetary changes in scope.

k. Contractor shall coordinate delivery and installation date with VA POC to occur at the convenience of the Government.

l. Contractor shall deliver excess supplies, parts, and pieces to offsite storage location at VAPAHCS Warehouse. Address to be provided by POC to awarded contractor upon request.

m. Contractor shall be responsible for the removal and disposal of all trash / debris connected with uncrating and assembling the cart and other items installed under this contract. Final acceptance from the VA will not occur until all debris connected with the installation is removed from the VA site.

n. Recyclable products shall be disposed of in accordance with applicable statutes, at respective off-site locations.

o. Packing materials shall not be stored in the building for any period exceeding 24 hours.

p. Contractor shall remove all personal trash (food wrappers, drink containers, etc.,) from the work site daily.

q. Conduct of Contractor installation crew shall always be courteous and respectful. Be particularly mindful of our Veteran’s and their needs.

13.1 Assembly, Installation, and Removal

a. Contractor shall uncrate all items received and perform all required assembly in accordance with the manufacturers’ instructions.

b. Contractor shall place items in building(s) and in room as identified in the contract that is in accordance to project’s equipment list and/or design drawings submitted by the POC.

c. Contractor shall complete installation of the Cart in the time specified (07:30 am - 4:30 pm.). If an additional unforeseen scheduling is required, Contractor shall coordinate revised scheduled with the VA, to be approved by CO.

d. Contractor shall inspect components to ensure that they are clean, dust free, free of defects and that installation is complete and all items are ready for use. Floors shall be swept/vacuumed upon completion.

e. Contractor shall adhere to manufacturer’s specifications and not use other manufacturer’s product to interlock with new or existing product potentially invalidating warranties.

f. Contractor shall do a final walkthrough with VA POC and provide a punch list before releasing crew.

g. Contractor Service Technician shall be available for possible service call backs for 30 days following installation.

h. Contractor is responsible for removal of damaged or replaced products in accordance with Quality Control section listed below.

i. VA POC shall coordinate with the contractor to give access to other rooms as necessary for the contractor to complete installation of the cart and make it fully operational.

j. After installation is complete, conduct inspections and certifications (if required) by a contractor prior to operating AVVIGO+.

k. Awarded contractor shall appoint a Project Manager who becomes the main POC to represent the Contractor.

l. Contractor shall complete a pre-installation meeting with VA POC, at a minimum of (10) business days, prior to installation.

m. Contractor PM shall be available and on site to coordinate and oversee the delivery of product to project site.

n. Contractor shall complete a final walkthrough with VA POC, confirming completion of all previously identified punch list items prior to final VA acceptance of project completion.

14.0 PROTECTION OF PROPERTY

14.1 Contractor shall protect all items from damage.

a. Contractor shall take precaution against damage to the building, ground, and adjacent furnishings/furniture/fixtures. Contractor shall repair or replace any items related to building or ground damaged accidentally, or on purpose due to actions by the Contractor, utilizing materials of the same quality, size, grade and color, to match existing work.

b. Contractor shall perform an inspection of the building and ground with the VA POC prior to commencing work so VA POC can report them to the general contractor. Then, they shall be able to repair or replace any damaged items, components, building, or ground due to negligence and/or actions taken by the General Contractor. Repairs shall utilize materials of the same quality, size, texture, grade, and color to match adjacent existing work.

c. Contractor shall be responsible for security of the areas in which the work is being performed prior to completion.

d. Contractor shall provide floor, door, and elevator wall protections while working in all VA facilities. All material carrying the equipment shall have rubber wheels. Public elevators shall have temporary padded wall protection when freight elevator is unavailable.

15.0 DELIVERY

a. Contractor shall contact VA POC, when complete order has been received, to schedule installation.

b. Contractor shall confirm the scheduled installation date of no less than 15 working days prior to start of installation to ensure that all parts have been received and in good condition. VA POC will confirm that the space will be made available at appointed installation start date. Installation shall not be scheduled until Contractor has confirmed the receipt of full order.

c. In the event there is a delay in delivery, Contractor shall notify the VA POC immediately.

d. Contractor shall notify VA POC a minimum of 120 hours in advance notice of the scheduled date and time of delivery.

e. Contractor shall ensure that the driver of the delivery vehicle has copies of the delivery order at time of delivery.

f. Contractor shall not attempt to deliver any items before the scheduled delivery date.

16.0 RECEIVE AND UNLOAD

a. The Contractor shall verify and inspect all items both at time of receipt and at off-site storage warehouse (if applicable) and upon arrival to the VA site. Any and all deficiencies (damage/overage/shortage) shall be brought to the attention of the VA POC.

b. If the Contractor is unable to complete the assembly and placement of all unloaded items before the end of the workday, the Contractor shall be responsible for moving these items to a secure location, until the next scheduled workday. Contractor shall be responsible for moving the items back from the overnight storage site to its designated site in the building.

c. Contractor shall store damaged items in the location designated by the VA POC. Contractor shall maintain a complete file of all documents relating to each discrepancy and copies of all Discrepancy Reports shall be forwarded to the VA POC daily.

d. Contractor shall repair or coordinate for replacement of damaged, defective, or missing items.

20.0 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 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.

21.0 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 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 follow 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 while 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.

22.0 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 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/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 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 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.

23.0 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.

24.0 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. However, it is the policy of the VA to forgo collection of liquidated damages in the event the contractor provides payment of actual damages in the amount determined to be adequate by the agency.

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 $37.50 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.

25.0 SECURITY CONTROLS COMPLIANCE TESTING

On a periodic basis, VA, including the Office of Inspector General, reserves the right to evaluate any or all 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.

26.0 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.

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

AVVIGO MOBILE GUIDANCE SYSTEM

INCLUDES: TOUCH SCREEN MEDICAL GRADE TABLET WITH BATTERY, MOBILE MOUNTING SYSTEM, POWER SUPPLY AND INSTALLATION GUIDE.