S02. 36C24827Q0044.docx

36C24827Q0044

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

10-06-2026

VICTOR J MERCADO

352-214-6492 10-16-2026

12:00PM

EDT

36C248 Department of Veterans Affairs Network Contracting Office 8 (NCO 8)

1601 S.W. Archer Road Gainesville FL 32608-1197

X

621511 $41.5 Million

N/A

Department of Veterans Affairs Network Contracting Office 8 1601 S.W. Archer Road

Gainesville FL 32608-1197 36C248 Department of Veterans Affairs Network Contracting Office 8 (NCO 8)

1601 S.W. Archer Road Gainesville FL 32608-1197

Financial Services Center

P.O. Box 149971 Austin TX 78714-9971

See CONTINUATION Page

See CONTINUATION Page

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 36C248

Network Contracting Office 8 (NCO 8) 1601 S.W. Archer Road Gainesville FL 32608-1197

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:

Page 1 of Page 1 of Statement of Work Mobile PET/CT Services North/South Georgia VA Health System (NF/SGVHS)

1. 0 INTRODUCTION:

The Government has a requirement for a firm fixed-price contract for an onsite full service mobile Positron Emission Tomography/Computerized Tomography (PET/CT) unit for the North/South Georgia VA Health System (NF/SGVHS) for a base period of twelve (12) months and the option to renew. This is a high priority of requirement because it impacts access to care for patients.

Cost shall be inclusive to include mobile PET/CT unit, transportation, mobilization, training, full-service maintenance and repairs, replacement parts, and technical support 24 hours-a-day, 7 days-a-week in accordance with the specifications incorporated herein.

The contractor shall provide a Mobile PET/CT, that is a Siemens Biograph 64 TruePoint Mobile PET/CT, with ability to complete scanning as per facility protocols.

The protocols will be provided by the NF/SGVHS Diagnostic Imaging Service, in the form of existing protocols, and uploaded by contractor onto the Mobile PET/CT Unit.

Any unit providing service must provide the minimum specifications as outlined in the Statement of Work. The facility will schedule a site visit showing potential contractors where the PET/CT will be placed and to help best determine more exact system specifications.

2.0 SCOPE OF WORK:

1. Contractor shall provide a Siemens Biograph 64 TruePoint Mobile PET/CT unit and all services in accordance with the specifications incorporated herein. The Contractor shall be responsible for the set up and transportation of the Mobile PET/CT unit to and from the VA Hospital.

2. Furnish all labor, material, and transportation for the verification of site suitability of proposed location.

3. The unit must be able to perform all procedures typically performed at the medical center.

3.0 SERVICES:

During the term of the service contract, the Contractor shall be required to provide the following services as specified below:

· Dedicated use of the PET/CT system 24 hours a day to include Saturday and Sunday as required by NF/SGVHS.

· Full service and maintenance on the complete PET/CT unit in accordance with manufacturing recommendation and as required by NF/SGVHS.

· System capable of transferring images and data to multiple modalities including the VAMC PACs, VISTA Imaging, and printers. Each location shall have different IP addresses, subnet masks, VPN’s etc. OEM Engineer shall establish network and printer connectivity at each site in coordination with local IT staff.

Note: Verification of connectivity shall be made by Contractors prior to the start of patient procedures immediately following the award of this solicitation.

3.1 EQUIPMENT CONFIGURATIONS/FUNCTIONS:

The PET/CT system shall be required to meet or exceed the minimum requirements, specifications and/or functions as stated below:

A. Equipment Features and Configurations:

· Siemens Biograph 64 TruePoint Mobile PET/CT system.

· Radiation shielding within the trailer.

· 3-Ring PET/ 64-slice CT

· 60 cm. diameters bore or larger.

· Weight limit of 400 lbs. or more.

· Neuro Suite, Angio Suite, Cardiac Suite, Body Suite, Onco Suite and Ortho Suite will be included.

· PET imaging- PET HiRez, PET Dynamic Replay, PET Gated Replay, PET applications, Respiratory Retro, Respiratory Pro

· Cardiac- CardioPro, Bolus Tracking, Cardiac Speed 037

· CT Imaging-Sensation 64, Extended FOV, High Speed, Power Tube

· Advanced Visualization (CAP3D Suite)- CAP3D Main, CAP3D Filter SSD, CAP3D Filter MIP, CAP3D Filter VRT, CAP3D VOI Mode, CAP3D Editor, CAP3D Rotating MIP, CAP3D, FusionLM, CAP3D Fusion Auto, CAP3D FusionLayout, CAP3D, FusionClipView.

· Dose Management- CARE Dose.

· Workflow and Connectivity- syngo General License, DICOM SR Viewer, Get Worklist, MPPS. Support, Volume Workflow, MR Support i, NMG CD Viewer.

TRAILER REQUIREMENTS:

The 48-60 foot long, 10-12 foot wide, mobile PET/CT unit trailer shall be equipped as specified below:

· Large entry door, removable entry stairs, and a patient platform powered lift for easy access to trailer. The patient lift capacity shall be 2,000 pounds, gated with safety guardrails and 75 to 90 inches wide.

· Patient dressing curtain, multiple area adjustable lighting, and storage cabinets.

· Five-gauss exclusion zone in magnet room.

· On board generator, heating, air conditioning and humidity control systems. Generator unit must be equipped with Air Pollution Control District in accordance with all local and state requirements.

· Telephone and data interface to connect with VA Medical Center telephone and IT/PACS Systems.

· Electrical Power source shall be 480V, 3-phase at 150 amps, 60Hz, WYE along with a 50 foot cable with a male connector. FOOTPRINT: (Max Dimensions of Trailer are 12 foot wide x 60 foot long).

· Contractor will coordinate with the owner of the building to deliver, set-up, connect, and test unit on cement pad provided by the NFSGVAMC located at 1601 SW Archer Rd. Gainesville, FL 32608. Adequate length electrical & data cables must be provided to reach VA connections on the outside of the building and will be compatible with VA current power/data/phone connectors.

LOCATION OF EQUIPMENT:

Contractor shall park the trailer equipped with the PET/CT system at the designated parking area at the Malcom Randall VAMC located at 1601 SW Archer Rd. Gainesville, FL 32608. Contractor shall contact the NF/SGVHS COR and building owner/representative for parking assignment information prior to parking the mobile PET/CT trailer.

COR consulted FMS and walked the site. A location behind the building that was a prior site for another trailer was suggested. Appropriate shore power is already in place. Site visit with vendor recommended to finalize logistics., When completion of PET/CT renovation at the Malcom Randall VA Medical Center, the mobile PET/CT will be returned to vendor.

DELIVERY SCHEDULE:

Delivery and set up of the mobile PET/CT unit at the clinic shall be completed by 8:00 a.m. thirty (30) calendar days from contract award to include all computers and network interfacing in full working order. Delivery and set up schedules shall be coordinated with the Contracting Officer’s Representative (COR). The Contractor shall be responsible for the set up and transportation of the mobile PET/CT unit to and from NF/SGVHS. The mobile PET/CT unit shall always remain on NF/SGVHS premises during the contract period unless a request is made in writing to the Contractor to relocate and/or move the mobile PET/CT unit.

8.0 INSTALLATION STANDARDS:

Contractor shall be required to set up and install the mobile PET/CT unit including the system equipment and all wiring in a safe and reliable manner to meet manufacturers’ specifications for operation and conformance with local, state and federal regulations.

8.1 SAFETY AND FIRE PREVENTION:

Contractor shall take such safety precautions as necessary to protect the lives and health of the occupants of the Outpatient Clinic. The Contractor shall comply with all applicable Federal, State, and local safety and fire regulations and codes, which are in effect during the performance period of the contract. Contractor personnel shall follow applicable facility policies concerning fire/disaster programs.

When conducting any installation, maintenance or repairs, the Contractor shall display appropriate warning devices in all areas where operations may cause traffic obstruction and/or personnel hazard. Fire and safety deficiencies which result by the Contractor’s equipment or personnel shall be immediately corrected.

9.0 TRAINING:

Pre-launch performance shall be conducted on-site with the opportunity for the VA Medical Center staff to confirm scanning processes and procedures and confirm connectivity. The vendor shall provide appropriate clinical training to ensure all technologists have experience with appropriate operation of system with facility protocols.

9.1 INSTRUCTIONAL/OPERATORAL MANUALS:

Contractor shall provide two (2) copies of the instructional/operator manuals and two (2) copies of the service manuals to the Government at no additional cost.

9.2 ACCESS TO EQUIPMENT:

The Government shall permit Contractor representatives to enter the VA Medical facility to install, inspect, repair or prepare for the removal of equipment. All preventive maintenance and/or repairs shall be conducted during normal business hours unless otherwise coordinated with the Contracting Officer.

10. MAINTENANCE AND REPAIR:

Contractor should provide a telephone number for technical and service support to include service calls, technical assistance, maintenance and repairs. These services shall be provided at no additional cost to the Government and shall be available 24 hours-a-day, Monday through Saturday, by telephone. The Contractor shall be required to begin on-site emergency service repairs within 8 hours and non-emergency service within a 24-hour window after receiving such notification from the Government. If the request is made on a Saturday, Contractors shall be required to begin service repairs no later than Monday morning. The Contractor shall notify the Contracting Officer or the designated COR, when an emergency request for service or repair shall not be completed or resolved to Government satisfaction within 24 hours of receiving such request or notice. Requests for telephone support, if due to technical problems, require a response time of two (2) hours from receipt of initial call. All parts and labor necessary to repair or replace any unsafe, worn, malfunction or defective equipment shall be furnished by the Contractor at no additional cost to the Government. Travel expenses incurred for maintenance and/or repairs shall not be reimbursed since the price quoted on the schedule shall be all inclusive.

The Contractor shall provide, in the space below, the name, location and telephone number of the office where service calls are to be placed:

Name:

Address:

Telephone No. Fax Number:

At least one (1) fluent English-speaking Contractor representative shall be required to come on site, if the VA staff requires any assistance with the Contractor equipment that cannot be handled by phone.

10.1 CONTRACTOR POINT OF CONTACT:

Contractor shall designate one (1) employee as the Point of Contact (POC) responsible for administrative matters in the performance of services under this contract. The POC shall have full authority to act for Contractor on all matters relating to the daily performance of this contract. The POC may be contract personnel performing under this contract. An alternate may be designated, but the Contractor shall notify the Contracting Officer in writing those times when the alternate shall act as the POC.

The Contractor shall provide the name and telephone number of the person designated as Point of Contact and Alternate upon contract award.

Point of Contact, Name:

Telephone Number:

Alternate Point of Contact, Name:

Telephone Number:

The POC shall be available by telephone Monday through Friday, between 8:00 a.m. to 4:30 p.m. excluding national holidays.

The parties agree that the contractor’s personnel including POC and subcontractors performing under this contract shall not be considered VA employees for any purpose. They all shall be considered employees of the contractor.

10.2 DEFICIENCIES:

The Contractor shall be expected to comply with all service and repair guidelines as specified herein. Any malfunction or failure of the PET/CT system over a 24-hour period excluding Sundays may result in a per diem abatement of the monthly payment which will be based on a daily rate of 3.33% of the contracted monthly price. Continuous failures could result in the contractor being terminated for cause in accordance with the clauses of the resulting contract.

10.3 COMPLAINTS:

The Contractor shall promptly and courteously respond to complaints, including complaints brought to the contractor’s attention by the Contracting Officer acting as the common agent, the Quality Assurance Evaluator (QAE) or COR.

10.4 MONITORING PROCEDURES:

The Contracting Officer shall be responsible for monitoring the Contractor's performance. Performance deficiencies or poor performance identified during the term of the contract shall be reported to the Contractor. Upon notification of deficiencies or poor performance, the Contractor shall be given a reasonable time to take corrective action. If determined appropriate, the Contracting Officer shall meet with representatives of the Contractor to review performance and resolve issues. All deficiencies or poor performance shall be documented and MUST be corrected within the timeframe specified in the cure notice. The Contractor shall notify the Contracting Officer when correction(s) have been made. If the appropriate correction is not made within the timeframe specified in the cure notice, the Government shall have the right to terminate the contract in its entirety.

11.0 QUALITY ASSURANCE:

The Contractor shall be responsible for complying with all appropriate regulations and guidelines of the Joint Commission (JC), OSHA, and/or any other pertinent federal, state, and local policies relating to the herein mentioned work or service.

The equipment shall be maintained in optimum operating condition to meet manufacturer’s specifications for operation and performance. The Contractor shall replace worn or defective parts as required to maintain all equipment in optimum operating condition.

All tasks accomplished by the Contractor personnel shall be performed to preclude damage or defacement of government-owned furnishings, fixtures, equipment and facilities. The Contractor shall report any damage observed or caused by the Contractor personnel to the COR. If determined to be at fault, the Contractor shall be responsible for repairs or replacement of government-owned items or facilities to previous condition.

12.0 GENERAL INFORMATION

12.1 NORMAL WORKING HOURS:

Normal working hours are defined as 7:00 a.m. to 5:30 pm local Eastern Standard Time, Monday through Friday, including National Holidays.

12.2 NATIONAL HOLIDAYS:

Listed below are the ten national holidays:

12.3 PARKING POLICY:

Parking information is available from the VA Police. It is the responsibility of Contractor personnel to park only in designated parking areas. The VA shall not invalidate or make reimbursement for parking violations of the Contractor's personnel under any circumstances.

12.4 BADGES:

All Contractor personnel are required to wear VA identification (I.D.) badges during the entire time they are on the VA grounds. Temporary VA I.D. badges shall be obtained from the SPD located on the ground floor. VA I.D. badges shall be returned at the end of the day or on completion of the service.

12.5 SMOKING POLICY:

Smoking is not permitted within or around VA Medical facilities, except in designated areas.

12.6 HIPPA/SECURITY

Employee Identification Badges: Contractor personnel shall wear VA provided identification badges at all times while on VA property and shall return the identification badges to the service, or his/her designee, at the end of each service period.

13. ADMINISTRATION

13.1 INVOICE REQUIREMENT:

The invoice shall be itemized to include the information listed below. Incomplete and incorrect invoices shall be returned for correction.

(1) Invoice Number and Date

(2) Contract Number

(3) Purchase Order/Obligation Number

(4) Line item from Schedule of Service associated with each charge

(5) Net Payment Due Contractor shall submit original invoice with pre-printed company name. For the Government invoice/billing address information, reference Contract Administration Data section.

13.2 POST-AWARD PERFORMANCE CONFERENCE:

The Contracting Officer shall schedule a post-award performance conference with the Contractor, if deemed necessary, for contract orientation purposes.

The contract shall be subject to the regulations issued by the Department of Health and Human Services, as mandated by the Health Insurance Portability and Accountability Act (HIPAA) of 1996 and the Privacy Act of 1974. The contractor shall comply with all VA security policies and applicable confidentiality statutes, including 38 USC 5701, 38 USC 5705, 38 USC 7332, 5 USC 552a (Privacy Act), as well as 45 CFR Parts 160,162 and 164 (Health Insurance Portability and Accountability Act). Federal Acquisition Regulations 52.224-1 Privacy Act Notification and 52.224-2 Privacy Act are provided in full text in the Addendum to FAR clause 52.212-4. The Contractor is not authorized to release any medical record information. The VA is the sole entity authorized to release this information upon written request from the patient.

All hard drives that contain protected information will become the property of VA at the conclusion of the contract.

13.3 CONTRACTOR SUBMITTALS/INSURANCE REQUIREMENTS:

Contractor shall be required to provide copies of the following:

a. The Contractor shall be required to comply with Federal and State Workers Compensation and liability insurance. Reference FAR clause 52.228-5- Insurance and Subpart 28.307-2-Liability.

b. Prior to contract award, the Contractor shall furnish to the Contracting Officer certification from the insurance company indicating that the coverage has been obtained and that it shall not be changed or cancelled without guaranteed thirty (30) day notice to the Contracting Officer. New certifications shall be furnished at least 30 days prior to the expiration date of the current insurance policy.

c. In accordance with “FAR 28.307-2(c) the Contractor shall maintain automobile liability insurance for bodily injury and property damage on all vehicles used in the performance of this contract. Policies covering automobiles operated in the United States shall provide coverage of at least $200,000 per person and$500,000 per occurrence for bodily injury and $20,000 per occurrence for property damage.

14. Privacy Agreement:

14.1 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.

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.

14.2 VA INFORMATION CUSTODIAL LANGUAGE

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

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

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

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

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

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

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

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

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

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

l. For service that involves 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.

14.3 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 one (1) day.

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.

14.4 INFORMATION SYSTEM HOSTING, OPERATION, MAINTENANCE, OR USE

a. For information systems that are hosted, operated, maintained, or used on behalf of VA at non-VA facilities, contractors/subcontractors are fully responsible and accountable for ensuring compliance with all HIPAA, Privacy Act, FISMA, NIST, FIPS, and VA security and privacy directives and handbooks. This includes conducting compliant risk assessments, routine vulnerability scanning, system patching and change management procedures, and the completion of an acceptable contingency plan for each system. The contractor’s security control procedures must be equivalent, to those procedures used to secure VA systems. A Privacy Impact Assessment (PIA) must also be provided to the 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 require 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.

c. 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.

d. The contractor/subcontractor must conduct an annual self-assessment on all Systems and outsourced services as required. Both hard copies 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.

e. 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.

f. 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.

g. 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.

14.5 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.

14.6 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.