S02-36C26222Q1678 MRI Trailer 2.pdf

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

664-22-3-405-0684

36C26222Q1678 09-02-2022

Kim, Peter 09-08-2022

10:00 PDT

36C262

Department of Veterans Affairs

Network Contracting Office 22

4811 Airport Plaza Drive

Suite 600

Long Beach CA 90815

X 100

X

334510

1250 Employees

N/A

36C262

Department of Veterans Affairs

VA San Diego Healthcare System

3350 La Jolla Village Drive

San Diego CA 92161

Network Contracting Office 22

4811 Airport Plaza Drive

Suite 600

Long Beach CA 90815

Financial Services Center

Submit invoices electronically through https://portal.tungsten-network.com

(877) 353-9791

See CONTINUATION Page

This solicitation is issued to obtain leased MRI trailer for the VA San Diego Healthcare System.

This solicitation is 100% set aside for SDVOSB vendors.

Period of performance is 12 months from notice to proceed.

Delivery location will be one of two locations specified in the SOW.

Submit offers via email to peter.kim33@va.gov no later than

10AM PT Thursday September 8, 2022.

See CONTINUATION Page

PETER KIM

VA-VHA-SAOW-2019-BF97501D

36C26222Q1212

Table of Contents

SECTION A

A.1 SF 1449 SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS

AND COMMERCIAL SERVICES

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

B.2 STATEMENT OF WORK

B.3 PRICE/COST SCHEDULE

ITEM INFORMATION

B.4 IT CONTRACT SECURITY

SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS

AND COMMERCIAL SERVICES (NOV 2021)

C.2 52.217-6 OPTION FOR INCREASED QUANTITY (MAR 1989)

C.3 VAAR 852.211-72 TECHNICAL INDUSTRY STANDARDS (NOV 2018)

C.4 VAAR 852.212-70 PROVISIONS AND CLAUSES APPLICABLE TO VA

ACQUISITION OF COMMERCIAL ITEMS (APR 2020)

C.5 VAAR 852.219-74 LIMITATIONS ON SUBCONTRACTING—MONITORING AND

COMPLIANCE (JUL 2018)

C.6 VAAR 852.219-78 VA NOTICE OF LIMITATIONS ON SUBCONTRACTING—

CERTIFICATE OF COMPLIANCE FOR SUPPLIES AND PRODUCTS (SEP 2021)

(DEVIATION)

C.7 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020)

C.8 VAAR 852.247-73 PACKING FOR DOMESTIC SHIPMENT (OCT 2018)

C.9 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.10 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (MAY 2022) (JUL 2020) (DEVIATION)

SECTION E - SOLICITATION PROVISIONS

E.1 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (NOV 2021)

E.2 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS

AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)

E.3 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT 2018)

E.4 52.216-1 TYPE OF CONTRACT (APR 1984)

E.5 52.233-2 SERVICE OF PROTEST (SEP 2006)

E.6 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB

1998)

E.7 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND COMMERCIAL

SERVICES (NOV 2021)

E.8 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—

COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (MAY 2022) (JUL 2020)

(DEVIATION)

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 36C262

Network Contracting Office 22

4811 Airport Plaza Drive

Suite 600

Long Beach CA 90815

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

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

[] 52.232-36, Payment by Third Party

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly []

b. Semi-Annually []

c. Other [X] Monthly

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.

Submit invoices electronically through https://portal.tungsten-network.com

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

AMENDMENT NO DATE

B.2 STATEMENT OF WORK

1. Contract Title. Lease of mobile MRI unit.

2. Background. MRI is a very important function and essential for a hospital. The existing MRI unit in Building 14 at the facility is old and in need of replacement. To prevent failure, a new unit will be installed to replace the existing. Additionally, the back log of scans is still growing due to the COVID-19 pandemic. Meanwhile, a mobile MRI unit will be temporarily installed to fulfill the requirements of the hospital.

3. Scope. This solicitation is for the lease of a Mobile GE Voyager 1.5 Tesla Magnetic Resonance Imaging System (MRI) or equivalent GE Mobile self-contained Trailer. This unit shall be located at either the Oceanside Community Based Outpatient Clinic (CBOC) located at 1300 Rancho Del Oro Dr., Oceanside, CA 92056 or at the Kearny Mesa Community Based Outpatient Clinic (CBOC) located at 8875 Aero Dr., San Diego, CA 92123. Both sites have a pad that includes power and data.

4. Specific Tasks.

Task 1: Contractor Responsibilities: Contractor shall provide a GE Voyager 1.5 Tesla MRI unit mounted in a mobile specialty vehicle in compliance with all applicable safety codes and regulations. Contractor shall provide a site planning guide for installation and operation of mobile scanner. In addition to the other requirements contained herein or in other areas of the solicitation and/or resulting contract, the contractor shall be responsible for the following:

a. The resulting contract will provide equipment, delivery/set-up of equipment and pick-up/transport of the equipment from the VA site to the contractor home site at the termination of the contract. No staffing is required.

b. MRI Trailer size shall be at least 10’ wide x 48’ long. A 12’ x 50’ trailer is acceptable.

c. Trailer shall contain an Americans with Disabilities Act (ADA) compliant Patient Dressing Area (minimum size of 5’ x 5’) that contains storage for exam gowns and lockable storage for patient personal items.

d. All maintenance and service of the MRI Trailer and Equipment to include all preventative maintenance, service calls, transportation, parts, and labor at no additional cost to the VA.

e. All Preventative Maintenance, licensures, inspection, adjustments, calibrations, shall be current at all times with no lapses or pending discrepancies. Note: The VA reserves the right to request copies of all documentation relating to the equipment.

Evidence of performance of recommended maintenance shall be provided by the contractor upon request from the VA.

f. All contracted equipment will undergo mandatory manufacturer upgrades and scheduled preventative maintenance at the vendor suggested time and or when needed, allowing a 30-day notice to the facility prior to commencing to ensure proper notification to reschedule.

g. All responsibilities will be scheduled and coordinated to be performed after business hours with the COR.

h. System scan protocols shall be verified and validated by VA reading radiologists.

i. Mobile MRI Trailer and Equipment may need to be moved during the duration of the contract. The offered price should include initial delivery, installation/implementation, set-up, disconnect and removal. Additional moves will be addressed through a contract a modification. The distance of the move if required would be approximately 34 miles one way.

j. MRI Trailer shall maintain proper temperature to ensure maximum operation, calibration, and care of equipment and to ensure patient comfort.

k. Effective noise abatement system capable of delivering over 35dB of gradient noise abatement.

l. HVAC System to maintain MRI Trailer environmental systems.

m. 24-Hour per Day, 7 Days per Week, telephone technical support (telephone technical support shall be provided within 1-hour of phone call being made). Contractor shall provide the names of technical/service support representatives (if known) and their 24/7 phone numbers to the COR or designee. These services shall be provided at no additional cost to the VA.

n. On-site emergency repair service within 2 hours of notification during normal business operations (Monday through Friday, 8am – 5pm (Pacific Time). If the request is made on a weekend or holiday, the contractor shall begin repair services no later than the next work (duty) day (i.e. be onsite NLT 8am to start the repairs). The contractor’s repair personnel shall maintain constant communication with the COR or designee concerning the status of the repairs so that the COR or designee can notify other medical personnel of potential downtime affecting patient care. These services (to include all travel, labor, per diem, parts, and equipment) shall be provided at no additional cost to the VA.

o. No routine maintenance will be scheduled or performed such that it conflicts with the imaging schedules of the mobile MRI. No maintenance will be scheduled or performed during scheduled scanning hours except to address emergency failures of the mobile units. Service response time to emergency failures should be within two hours.

p. On-site non-emergency service within 24 hours of notification during normal business operations (Monday through Friday, 8am – 5pm Pacific Time). The contractor’s repair personnel shall maintain constant communication with the COR or designee concerning the status of the repairs so that the COR or designee can notify other medical personnel of potential downtime affecting patient care. All repairs shall be conducted during normal business hours (8am to 5pm Pacific Time) unless otherwise coordinated with the COR or designee. These services (to include all travel, labor, per diem, parts, and equipment) shall be provided at no additional cost to the VA.

q. The contractor will be responsible for providing all necessary cryogen.

r. Mobile MRI unit shall have MRI safe/compatible portable oxygen and suction equipment.

s. Mobile MRI unit will have an emergency contrast reaction medication kit.

t. MRI Trailer and Equipment shall be capable to supporting patients weighing up to 500 lbs. (i.e. have a 500 lb. load table limit).

u. MRI Trailer and Equipment Uptime (in-service) Rate of 100% during normal business hours of operations (which are Monday through Friday, 8am – 5pm Pacific Time). The VA will not incur any costs for any down-time of equipment.

v. Contractor will provide an orientation to the operation of the components of the mobile specialty vehicle including safety features, operation of the wheelchair lift, location of emergency off switch and any other features required for employee safety.

Task 2: MRI Trailer and Systems Capabilities/Requirements: The MRI Trailer and

Equipment shall provide a full range of scan parameters to meet all routine clinical demands, including 70 cm Bore Size, 160 cm long system, and shall have the following:

a. Shall have the same capabilities of the standard configuration for a GE Voyager 1.5 Tesla MRI unit. VASD needs a unit that will accommodate its patients and provide comparable imaging to what is currently in operation, which is a GE Artist, 70 cm bore scanner.

b. Wheelchair lift - Provide a wheelchair lift for patient access to the mobile MRI with all required safety tie downs and guards.

c. Support - The unit shall be self-supporting and have a rear stabilizer stand and adjustable jack legs in front to accommodate leveling on a site that is flat but on a slight sloped grade.

d. Mobile MRI unit will have an MRI contrast power injector.

e. Unit shall operate on 480 Volts, 3 Phase, 150 Amps using a 5-wire system. Mobile MRI shall have a minimum length of 50-foot cable with a male connector. If a generator is provided on the unit, it must be permitted with the Air Pollution Control District in accordance with all local and state requirements.

f. Gradients and Slew Rate –36/150

g. System shall have a minimum 16-channel head coil.

h. System shall be able to connect multiple coil elements which can be seamlessly integrated into one examination.

i. Gradient noise level of 99db or below without reducing performance.

j. Telephone and Data interface - Mobile MRI unit will have 2 telephone and 2 data hookups to interface with facility’s telephone and IT and PACS systems.

k. System/equipment shall be fully capable and able to transfer image and data to multiple modalities including PACS, VISTA Imaging, printers, and Hospital RIS System (full DICOM Communication). Each location shall have different IP addresses, subnet masks, and VPNs. Communication between MRI and Radiology Services PACS: The Contractor shall ensure that a convenient and robust means of DICOM transfer of MRI studies to the Radiology Service PACS is operational. The Contractor shall obtain and provide to the VA any technology necessary to ensure that MRI studies can be conveniently read on the existing PACS display technology.

l. Magnet shall be superconducting with a magnetic strength of 1.5T.

m. Magnet shall be self-shielded.

MRI Scan Protocols: The following MRI Protocols (including but not limited to) shall be able to be supported by the Mobile MRI Trailer and Equipment: Routine Brain, Brain with Gadolinium, MRA Brain, Brain-MS, MRV Brain, Brain-Seizures, Brain-IACs, Brain-Orbits, Brain-Pituitary, Brain-Complex Seizures, Face/Neck, Tongue/Salivary Glands, Brain- Bell’s Palsy, Cervical Spine, Thoracic Spine, Lumbar Spine, C/T/L Spine Cord Compression, Spine- Infection, Spine-Syrinx, Routine Knee, Routine Shoulder, Shoulder- Post Arthrogram, Hips- AVN, Hips-Occult Fracture, Routine Wrist, Routine Ankle, Ankle-Achilles Tendon, Ankle- Plantar Fasciitis, Routine Elbow, Thigh/Lower Leg, TMJ, Infection-Osteo, Routine Abdomen, Kidneys, MRCP, Eovist Liver, Pelvis-Female, Pelvis-Prostate, Brachial Plexus, Carotids, Renal MRA, and Arterial Run-Off, Cardiac, Breast, Enterography, Thoracic Aorta, MRA/MRV Abdomen, Perfusion, Spectroscopy.

MRI Scan Sequences: The following MRI sequences (including but not limited to) shall be able to be supported by the mobile MRI trailer and equipment: Turbo Lava, Turbo Lava Flex and DISCO.

Task 2: Deliverables: Operations and Technical Support Manuals

Task 3: Patient Digital Video and Audio Entertainment System: The Mobile MRI Trailer shall contain the following minimum Patient Digital Video and Audio Entertainment System features/functions to help mitigate the claustrophobic effects of the MRI Bore:

a. Entertainment Video.

b. Digital Video Goggles to view DVD or Broadcast TV during MRI scan.

c. High fidelity digital audio headset for patient to listen to audio channels to include DVD, TV (if provided by VA), Internet Radio (if provided by VA) or other external audio sources.

d. Camera at MRI Technologist station so when talking to the patient, the patient sees and hears the MRI Technologist with positive 2-way communication. The patient’s voice response is transmitted from the microphone to the MRI Technologists’ station speaker.

e. Capability to play and offer the patient FM Radio, Internet Radio (if provided by VA), MP3, DVD, or Digital Broadcast TV (if provided by VA), Connections for CD, iPad, iPod, or other audio sources.

f. S-Video and RCA (White, Red, Yellow) audio/video in-ports.

5. Performance Monitoring

The contractor shall comply with the following:

a. Provide Service Reports to the Contracting Officer Representative upon request.

b. The VA reserves the right to request copies of all documentation relating to the equipment.

c. Evidence of performance of recommended maintenance shall be provided by the contractor upon request from the VA.

d. VA shall conduct MRI physicist inspections as needed.

e. Equipment shall be subject to the same quality assurance standards in meeting or exceeding current recognized National Standards as established by the Joint Commission for Accreditation of Healthcare Organization (JCAHO). Copies of the quality assurance standards are on file in the medical facility and will be available to the Contractor. The Contractor shall perform services in accordance with the ethical, professional, and technical standards of the healthcare industry as consistent with VA policy, regulations, and procedures.

6. Security Requirements:

a. System scan protocols shall be verified and validated by VA radiologists.

b. When removing the Mobile MRI Trailer and Equipment from the VA premises at the end of the contract period, the contractor shall remove the hard drives containing Patient Privacy Information (PII) in the presence of the COR or designee and permanently surrender the hard drive(s) to the COR or designee for sanitization and destruction per VA guideline, policies, directives, etc. prior to removing the trailer.

c. Mandatory HIPPA privacy training and any other required training shall be completed by all contractor employees directly associated with the contract before any work begins under the contract. Any new contractor employee(s) associated with this contract hired after the contract becomes effective shall complete the mandatory HIPPA provided privacy training and any other VA required training prior to starting work.

d. Protection of computer equipment, confidentiality of patient information, and the integrity of computer software/data at the VA San Diego Healthcare System are essential.

Software installed on each personal computer is copyrighted and copy of software for use elsewhere is prohibited. In the event of a possible security violation, the VA San Diego Healthcare System Automated Data Protection (ADP) Security Committee will investigate and recommend corrective action to the appropriate agency.

e. Contractor understands and implements the IT security requirements for system interconnection documents required per the VA.

f. Contractor understands their participation in IT security requirements for C&A of the VA system to which they connect.

g. Enforce contractor performance (timely submission of deliverables and termination activity as appropriate).

7. Government-Furnished Equipment (GFE)/Government-Furnished Information (GFI).

The Government will be responsible for providing the appropriate facilities and property site necessary for delivery and set-up of the equipment. Contractor shall use Government furnished items in conjunction with and exclusively for, performance under this contract.

Use thereof for any other purpose will not be allowed.

8. Other Pertinent Information or Special Considerations. None

9. Risk Control

a. MRI Trailer and Equipment shall meet all Federal, State, and Local Fire and Safety requirements.

b. Safety and Warning Systems with Visual and Audible Alarms.

c. MRI Safe Smoke Detectors and MRI Safe Fire Extinguishers.

d. Emergency Lighting.

b. On-board generator to power HVAC in the event of a power interruption.

c. Trailer shall contain an Americans with Disabilities Act (ADA) compliant patient dressing area (minimum size of 5’ x 5’) that contains storage for exam gowns and lockable storage for patient personal items.

d. Shall provide sufficient external lighting for personnel and equipment safety.

e. Effective noise abatement system capable of delivering over 35dB of gradient noise abatement.

f. Shall provide a wheelchair lift for patient access to the mobile MRI with all required safety tie downs and guards.

g. All provided supplies and equipment shall be MRI safe and compatible.

10. Place of Performance. The mobile MRI Trailer shall be located at either the Oceanside Community Based Outpatient Clinic (CBOC) located at 1300 Rancho Del Oro Dr., Oceanside, CA 92056 or at the Kearny Mesa Community Based Outpatient Clinic (CBOC) located at 8875 Aero Dr., San Diego, CA 92123.

11. Period of Performance. 12 months

12. Delivery Schedule.

The contractor will deliver the equipment to the VA San Diego Healthcare system (location to be determined) on an agreed upon date after the contract is awarded.

SOW

Task

Deliverable Title Format Number

Calendar Days After CO Start

1 Monthly Status Contractor-Determined 2 Copies to COR; Monthly, on

Report Format Letter Only to CO 5th Workday

Commissioning Report

Contractor-Determined Format

SOW Task # 2 30 days

Continue as needed to document all deliverables

* Standard Distribution: 1 copy of the transmittal letter without the deliverables shall be emailed to the Contracting Officer.

B.3 PRICE/COST SCHEDULE

ITEM INFORMATION

ITEM

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

12.00 MO ________________ ________________

Lease of Mobile GE 1.5T Voyager Mobile MRI Scanner.

1.00 EA ________________ __________________

Implementation, set up, disconnect, removal.

GRAND TOTAL __________________

B.4 IT CONTRACT SECURITY

VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY

1. GENERAL

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

2. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

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

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

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

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

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

3. VA INFORMATION CUSTODIAL LANGUAGE

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

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

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

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

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

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

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

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

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

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

k. Notwithstanding the provision above, the contractor/subcontractor shall not release VA records protected by Title 38 U.S.C. 5705, confidentiality of medical quality assurance records and/or Title 38 U.S.C. 7332, confidentiality of certain health records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse, or infection with human immunodeficiency virus.

If the contractor/subcontractor is in receipt of a court order or other requests for the above mentioned information, that contractor/subcontractor shall immediately refer such court orders or other requests to the VA contracting officer for response.

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

4. INFORMATION SYSTEM DESIGN AND DEVELOPMENT

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

(PIA) must be completed, provided to the COR, and approved by the VA Privacy Service in accordance with Directive 6507, VA Privacy Impact Assessment.

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

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

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

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

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

g. The contractor/subcontractor agrees to:

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

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

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

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

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

SOR.

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

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

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

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

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

j. The vendor shall notify VA within 24 hours of the discovery or disclosure of successful exploits of the vulnerability which can compromise the security of the Systems (including the confidentiality or integrity of its data and operations, or the availability of the system). Such issues shall be remediated as quickly as is practical, but in no event longer than 3 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 vulnerablity scanning, system patching and change management procedures, and the completion of an acceptable contingency plan for each system. The contractor's security control procedures must be equivalent, to those procedures used to secure VA systems. A Privacy Impact Assessment (PIA) must also be provided to the COR and approved by VA Privacy Service prior to operational approval. All external Internet connections to VA's network involving VA information must be reviewed and approved by VA prior to implementation.

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

c. Outsourcing (contractor facility, contractor equipment or contractor staff) of systems or network operations, telecommunications services, or other managed services requires certification and accreditation (authorization) (C&A) of the contractor's systems in accordance with VA Handbook 6500.3, Certification and Accreditation and/or the VA OCS Certification

Program Office. Government- owned (government facility or government equipment) contractor-operated systems, third party or business partner networks require memorandums of understanding and interconnection agreements (MOU-ISA) which detail what data types are shared, who has access, and the appropriate level of security controls for all systems connected to VA networks.

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

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

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

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

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

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

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

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

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

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

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

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

6. SECURITY INCIDENT INVESTIGATION

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

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

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

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

7. LIQUIDATED DAMAGES FOR DATA BREACH

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

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

Failure to cooperate may be deemed a material breach and grounds for contract termination.

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

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

(2) Description of the event, including:

(a) date of occurrence;

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

(3) Number of individuals affected or potentially affected;

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

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

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

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

(8)…