36C24521Q0378_1.docx

36C24521Q0378 Contract Opportunity Combined Synopsis/Solicitation Notice

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ADDRESS

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ADDITIONAL INFORMATION

GENERAL INFORMATION

PLACE OF PERFORMANCE

* = Required Field Contract Opportunity Combined Synopsis/Solicitation Notice MRI Rental Mobile Trailer 21902 36C24521Q0378 05-07-2021 4pm

EASTERN TIME, NEW YORK, USA

N

SBA

334510 Department of Veterans Affairs VA Maryland Health Care System Contracting Officer (90C) P.O. Box 1000, Bldg. 101B, Room 13 Perry Point MD 21902 Contract Specialist Theresa Thomas theresa.thomas7@va.gov 410-642-2411 x25261 Hershel "Woody" Williams VA Med Cntr 1540 Spring Valley Drive Huntington, WV. 25704

25704

USA

https://beta.sam.gov/content/contract-data https://beta.sam.gov/content/contract-data theresa.thomas7@va.gov See attached RFQ 36C24521Q0378 for SDVOSB

This is a SDVOSB set aside.

All questions regarding this email solicitation shall only be submitted in writing only via e-mail to the Contract Specialist, Theresa Thomas, Theresa.Thomas7@va.gov. .

Questions are due no later than May 5, 2021 at 10:00 a.m. EST.

Responses are due by 5/7/2021 at 4PM EST.

Please email responses to Theresa.thomas7@va.gov

PAGE 1 OF

1. REQUISITION NO.

2. CONTRACT NO.

3. AWARD/EFFECTIVE DATE

4. ORDER NO.

5. SOLICITATION NUMBER

6. SOLICITATION ISSUE DATE

a. NAME

b. TELEPHONE NO. (No Collect Calls)

8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY

CODE

10. THIS ACQUISITION IS

UNRESTRICTED OR

SET ASIDE:

% FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ

IFB

RFP

15. DELIVER TO

CODE

16. ADMINISTERED BY

CODE

17a. CONTRACTOR/OFFEROR

CODE

FACILITY CODE

18a. PAYMENT WILL BE MADE BY

CODE

TELEPHONE NO.

DUNS:

DUNS+4:

PHONE:

FAX:

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

SEE ADDENDUM

19.

20.

21.

22.

23.

24.

ITEM NO.

SCHEDULE OF SUPPLIES/SERVICES

QUANTITY

UNIT

UNIT PRICE

AMOUNT

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

25. ACCOUNTING AND APPROPRIATION DATA

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

ARE

ARE NOT ATTACHED.

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

ARE

ARE NOT ATTACHED

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

29. AWARD OF CONTRACT: REF. ___________________________________ OFFER

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND

DATED ________________________________. YOUR OFFER ON SOLICITATION

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

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

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED

SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

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

AUTHORIZED FOR LOCAL REPRODUCTION

(REV. 2/2012)

PREVIOUS EDITION IS NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

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

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

36C24521Q0378 Theresa Thomas Please email only 05-7-2021 4pm

EDT

36C245 Department of Veterans Affairs VA Maryland Health Care System Theresa Thomas Contract Specialist (90C) Theresa.thomas7@va.gov X X 334510 1250 Employees N/A X Department of Veterans Affairs Hershel "Woody" Williams VA Medical Ctr 1540 Spring Valley Drive Huntington WV 25704 36C245 Department of Veterans Affairs VA Maryland Health Care System Theresa Thomas Contract Specialist (90C) Theresa.thomas7@va.gov

PAYMENT WILL BE MADE BY

FSC e-Invoice Payment Invoice must be submitted electronically http://www.fsc.va.gov/einvoice.asp Invoice Setup Information 1-877-489-6135 See CONTINUATION Page Parked Rental Mobile MRI Trailer, including delivery, setup and removal.

Rental of 4 months with option to extend weekly.

Urgent – Must be operational June 1, 2021 See page 3-for detailed information.

See CONTINUATION Page X X X Contracting Officer Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

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

b. GOVERNMENT: Department of Veterans Affairs VA Maryland Health Care System Theresa Thomas Contract Specialist (90C) theresa.thomas7@va.gov

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.

PAYMENT WILL BE MADE BY

FSC e-Invoice Payment Invoice must be submitted electronically http://www.fsc.va.gov/einvoice.asp Invoice Setup Information 1-877-489-6135

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

STATEMENT OF WORK FOR THE HERSHEL “WOODY” WILLIAMS VAMC

Mobile MRI Trailer Rental

1. SERVICES: Contractor shall provide all tools, equipment, maintenance and repair of all Contractor furnished equipment (including a mobile trailer/unit), in accordance with terms and conditions listed herein for Hershel “Woody” Williams VAMC, Huntington, WV. Contractor shall be responsible to maintain all Contractor equipment in good working order at all times. Every effort should be made to keep equipment down time to a minimum of 24 hours or less. This will be a limited time contract for the duration of the de-install of current MRI system, construction and installation of a new MRI system. The expected time frame for mobile MRI needs will be 120 days. We would like to reserve the right to extend this contract on a weekly basis as may be dictated by delays in construction or installation.

2. CONTRACTOR’S FURNISHED EQUIPMENT: Equipment shall include but not be limited to a Contractor furnished fully equipped Mobile MRI Trailer where studies will be performed on a MRI Magnet manufactured after January 2004. All equipment to be used shall be Food and Drug Administration (FDA) approved imaging equipment placed at a location designated by the Contracting Officer Representative (COR) on VISN 5 sites. The entire offering of a MRI Mobile Trailer service shall meet all local, state, federal, industry, THE JOINT COMMISSION or equivalent standard, National Electrical Code (NEC), National Fire Protection Association (NFPA), Veterans Administration (VA), Occupational Safety and Health Administration (OSHA), and other regulatory standards internal or external for which the VISN 5 is currently accountable and will be kept current with all future Federal and State regulations. While on Federal property, the contractor’s personnel shall abide by all policies of the site of service to include but not limited to: smoking, radiation and patient safety policies.

3. SYSTEM CAPABILITY REQUIREMENTS: The Contractor shall provide an on-site Mobile MRI system that is a GE 1.5T system with software version 15 or higher with at least 8-channel capability in accordance with the terms and conditions of this requirement. The unit shall have the requested Coils onboard the trailer as noted below:

HD High Resolution Brain Array Coil HD CTL Array Coil HD NV Array Coil HD Body Array Coil HD Knee Array Coil T/R Quad Extremity Coil HD Shoulder Array Coil

4. MOBILE UNIT CAPABILITIES:

Contractor shall provide the following:

a. Hardware and software necessary to permit interpretation of MRI Images at the site where images are obtained.

b. Ability to create, store and export Digital Imaging and Communications in Medicine (DICOM), Joint Photographic Experts Group (JPEG) and Moving Picture Experts Group (MPEG) file formats.

c. The mobile unit shall be equipped with Compact Disk-Recordable CD-R/DVD-R burning capabilities as a backup to network transfer of data.

d. The mobile unit shall be equipped with an Image Analysis Station for image registration quality assurance.

1. Scan delay

1. Multiphase option

1. Protocol storing

1. Pause hold functionality

g. Data/Image Transfer: Digital Imaging and Communications in Medicine (DICOM) 3.0 system shall be used to export images from Contractor mobile unit to the facilities PACS system. VA will provide an Access Control List (ACL) for a secure port for imaging connection.

Minimum security requirements:

1. Up-to-date Microsoft (MS) patches and anti-virus software at the vendor mobile unit

1. Any workstation configuration must be compatible with VA supplied anti-virus (currently McAfee Enterprise)

1. Medical Device Isolation Architecture (MDIA) security to be provided by VA

1. No patient identifiers such as name and Social Security Number shall reside on the mobile unit and images shall have an identifier which does not disclose Personally Identifiable Information (PII).

5. MOBILE UNIT ACCESSORIES: Accessory equipment that shall be provided by the Contractor:

a. Handicap/Gurney/Hospital Bed accessibility.

b. Intercom system between the control room and scanning room.

6. MOBILE UNIT EQUIPMENT SPECIFICATIONS: The following minimum performance characteristics of the equipment are required:

THE HERSHEL “WOODY” WILLIAMS SHALL PROVIDE THE FOLLOWING UTILITIES/SERVICES UP TO THE DOCKING PAD (IF NECESSARY) FOR OPERATION OF THE MRI MOBILE UNIT.

· Pad (12’ X 52’X 8” thick concrete (3000psi) with air entrainment, broom finish, reinforcing steel to be ASI-615 Grade 60, #4 bars @ 8” each way, top of steel to be 2” from the top of the concrete surface.)

1. Electricity (150 amp panel breaker, 3 phase, 480v), (200 amp receptacle, 5 wire, Russelstoll #DF 2504 Frabo)*

1. Telephone Line(s) **

1. Data Port ***

1. Restroom Facilities

7. EQUIPMENT MAINTENANCE: Equipment provided shall be in good working order at all times in order to provide high quality scans required under this requirement and any resulting contract. Contractor shall be completely responsible for the preventive maintenance, emergency and general repairs, safety, cleaning, and upkeep of all equipment furnished by the Contractor. Preventative maintenance/repairs on the Mobile MRI unit and all associated equipment shall be performed in accordance with the Conformance Standards and manufacturer’s recommendations.

8. SITE PREPARATION: The Hershel “Woody” Williams VAMC site participating in this contract will provide a docking site for the contractors MRI mobile unit. The Contractor or designee shall perform a site visit at each the Hershel “Woody” Williams VAMC location after notification of contract award and prior to commencement of work to coordinate with the COR in order to confirm site conditions for trailer/mobile unit docking.

9. CONTRACTOR’S STAFF: MRI Mobile Unit Driver shall be licensed as applicable to operate and drive the mobile vehicle in which the unit is housed

10. CONTRACTOR’S RESPONSIBILITIES:

1. Contractor shall be responsible for the timely delivery and pick up of the MRI trailer.

1. DATA/IMAGE TRANSFER SUPPORT: Contractor shall provide IT Technical Support while the MRI mobile unit is located on-site. Technical Support personnel must have complete knowledge of all Transmission Control Protocols/Internet Protocols (TCP/IP) modification required to interface with the VA network and the Contractor shall provide IT Technical Support to facilitate data transfer to the VA network.

The Contractor will be provided an IP address for Source Data, Default Gateway, and Subnet Mask from the VI OI&T personnel. The Contractor shall be responsible for implementation of data transfer to the VA network with the assistance of VA OI&T personnel. The mobile truck’s IP address (es) cannot be part of the VA network. The IP range for the workstation/equipment must be in a range supplied by the Government. It should allow for the IP address to be changed locally. The VA will create an Access Control List (ACL) to address security controls. The Contractor shall ensure all IT devices located in the MRI mobile unit be cleansed of all Virus and Malware prior to connecting to the VA network.

1. CONTRACTOR FURNISHED FACILITIES, SERVICES, SUPPLIES AND EQUIPMENT:

1. The Contractor’s Vehicle shall be parked and leveled no more than 12” from docking pad ramp. Contractor shall be responsible for leveling of the vehicle at location designed by the Hershel “Woody” Williams VAMC.

1. Contractor shall contact the COR to make the necessary arrangements for a site visit where the actual location of the mobile trailer shall be located so that precise measurements etc. can be taken by the Contractor who shall be responsible to confirm compatibility of the docking pad and connections as noted herein. Any additional costs as a result of the Contractor’s failure to confirm the above shall be the responsibility of the successful Contractor.

1. Contractor shall be held responsible for any damages, which may be done to the Hershel “Woody” Williams VAMC property during delivery, hookup and/or removal of equipment at the site. Any damages caused by the Contractor shall be repaired at the Contractor’s expense to the satisfaction of the facility Chief of Engineering.

1. Proper installation/staging of the Contractor’s furnished equipment including the mobile trailer must be completed in accordance with industry standards, all OSHA regulations and applicable manufacturer’s recommendations. The above must be completed prior to commencement of services. Dates and time for completion of the above shall be mutually agreed upon between the Hershel “Woody” Williams VAMC and the Contractor.

1. NON-CONFORMING PRODUCTS OR SERVICES:

Nonconforming products or services will be rejected. Unless otherwise agreed by the parties, deficiencies shall be corrected within seven (7) days of the rejection notice. If the deficiencies cannot be corrected within seven (7) days, the Contractor shall immediately notify the COR and the Contracting Officer of the reason for the delay and provide a proposed corrective action plan within seven (7) working days.

1. EMERGENCY REPAIRS:

Emergency service: Contractor shall provide, at no cost to the Hershel “Woody” Williams VAMC, all emergency service to include all required personnel, parts and labor, and preventive maintenance/repairs of MRI mobile structure and equipment to maintain a safe environment as recommended by the original equipment manufacturer (OEM) recommendations/specifications in accordance with the agreed upon schedule with the COR.

Response Time: In the event of an equipment failure during normal working hours while in the performance of the Contractor’s services, the Contractor shall notify the COR or designee immediately after discovery of equipment failure while on site. Every effort should be made to keep equipment down time to a minimum of 24 hours or less. If repair services are required to be performed on site after the normal working hours, the Contractor must notify the COR and the VA Police that services will be performed on-site. All emergency repairs are the responsibility of the contractor and only qualified service engineers shall perform emergency repairs.

Replacement Unit: In the event that the equipment fails and the failed equipment is un-repairable, the Contractor must obtain an alternate unit which shall be available on the next scheduled day and which meets all of the requirements of the resulting contract to ensure that schedule services shall be performed as agreed upon under this agreement.

1. DOCUMENTATION/REPORTS:

1. The Contractor shall provide equipment and maintenance reports to the COR if requested during the duration of the contact. The Contractor shall also provide system pre-check and associated documentation at the time the unit is set up at the site where services are to be performed. This is to ensure safety of equipment utilized by the Hershel “Woody” Williams VAMC personnel/beneficiaries.

1. The Contractor shall permit onsite inspection by personnel selected by the Hershel “Woody” Williams VAMC without prior notice to ensure the Contractor’s equipment is operated in accordance with appropriate safety guidelines and/or regulations as applicable.

1. Additional Reports/Documentation required by the successful Contractor prior to commencement of services of Preventive Maintenance (PM) / Repair services, unless otherwise stated. This VISN may require specialized documentation to satisfy the requirements of local state and federal government agencies, and independent consultants such as THE JOINT COMMISSION, as well as for “services rendered” verification for payment of monthly statement. At a minimum, the following information shall be maintained by the Contractor and be available for inspection by a duly authorized VA representative:

1. Certificate of Insurance not limited to but, includes liability and property insurance of Contractor’s furnished equipment which shall be submitted to the Contracting Officer within ten (10) calendar days of receipt of notification of award. It is agreed upon and understood that the Hershel “Woody” Williams VAMC or VISN 5 shall not be held responsible for any damage or vandalism, which may be caused to the Contractor’s equipment while on Hershel “Woody” Williams VAMC premises.

1. Required Federal, State and local licenses.

1. DELIVERY/ SETUP AND REMOVAL OF CONTRACTOR’S EQUIPMENT: Contractor shall be responsible for the timely removal of the MRI trailer from the Hershel “Woody” Williams VAMC premises as agreed upon with the COR not to exceed a 2 week period after completion contract.

11. GOVERNMENT FURNISHED FACILITIES, SERVICES, SUPPLIES AND EQUIPMENT:

a. The VA facility shall provide all patient services and MRI Technologists.

1. Retain full medical responsibility for its patients and shall be responsible for patient upon pickup at the Hershel “Woody” Williams VAMC designated waiting area, while on the Mobile unit and during the entire scanning procedure until patient is returned to the designated waiting area.

1. The facility will be responsible for transporting patients to and from the Contractor furnished Mobile Trailer.

1. The VA facility shall ensure each patient arriving for the MRI scans has a written physician order to receive services and such other forms or information as required.

1. The VA facility will designate in writing one or more qualified physicians who will review orders for appropriateness, interpret MRI reports and take such other steps as may be medically necessary.

b. The Hershel “Woody” Williams VAMC facilities will provide the following services, supplies and facilities:

0. All medical supplies, facilities, personnel and physicians required to provide patients with such emergency medical care as may be required, including oxygen, aspirator and defibrillator when deemed necessary.

0. The successful Contactor shall provide during the Post Award Orientation a reasonable list of incidental supplies which may be necessary. (Excluding those which are defined as the Contractor’s responsibility).

12. COMMENCEMENT OF SERVICES:

Commencement of service date is to be coordinated with the COR. Unit must be ready for patient services no later than June 1, 2021 after contract award unless otherwise agreed to in writing with the Contracting Officer.

13. PLACE OF INSPECTION AND ACCEPTANCE:

Delivery location of MRI Mobile Trailer site shall be coordinated with the COR.

14. SCOPE OF INSPECTION:

a. Compliance with Statement of Work will be inspected for content, completeness, and accuracy and conformance to contract requirements by the COR or his/her designee. Inspection will include validation of information or software through the use of automated tools and/or testing of the deliverables, as specified in the contract order. The scope and nature of this testing must be negotiated prior to the contract award and will be sufficiently comprehensive to ensure the completeness, quality and adequacy of all deliverables.

b. In the event that rework of a Scan is required due to no fault of the Veteran Administration or the Veteran beneficiary, the contractor agrees to remake or replace the scan at no cost to the Veteran Administration or to the Veteran beneficiary.

c. Reports, documents and narrative type deliverables shall only be accepted when all discrepancies, errors or other deficiencies identified in writing by the government have been corrected.

d. Maintenance logs shall be available upon request.

e. Payment Reconciliation will be accomplished by the Government monthly. The COR or Designated Ordering Office or Officer will validate invoices by reconciliation. If issues occur the COR or Designated Ordering Officer will contact the contractor for clarification and/or correction.

15. VA HANDBOOK 6500.6: Appendix B Security Clause

852.273-75 - SECURITY REQUIREMENTS FOR UNCLASSIFIED INFORMATION

TECHNOLOGY RESOURCES (INTERIM- OCTOBER 2008)

As prescribed in 839.201, insert the following clause:

The contractor, their personnel, and their subcontractors shall be subject to the Federal laws, regulations, standards, and VA Directives and Handbooks regarding information and information system security as delineated in this contract.

(END OF CLAUSE)

16. VA HANDBOOK 6500.6: 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 onsite inspections of contractor and subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are in compliance with VA directive requirements.

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

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

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

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

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

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

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

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

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

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

4. INFORMATION SYSTEM DESIGN AND DEVELOPMENT

a. Information systems that are designed or developed for or on behalf of VA at non-VA facilities shall comply with all VA directives developed in accordance with FISMA, HIPAA, NIST, and related VA security and privacy control requirements for Federal information systems. This includes standards for the protection of electronic PHI, outlined in 45 C.F.R. Part 164, Subpart C, information and system security categorization level designations in accordance with FIPS 199 and FIPS 200 with implementation of all baseline security controls commensurate with the FIPS 199 system security categorization (reference Appendix D of VA Handbook 6500, VA Information Security Program). During the development cycle a Privacy Impact Assessment (PIA) must be completed, provided to the COTR, and approved by the VA Privacy Service in accordance with Directive 6507, VA Privacy Impact Assessment.

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

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

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

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

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

g. The contractor/subcontractor agrees to:

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

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

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

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

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

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

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

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

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

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

j. The vendor shall notify VA within 24 hours of the discovery or disclosure of successful exploits of the vulnerability which can compromise the security of the Systems (including the confidentiality or integrity of its data and operations, or the availability of the system). Such issues shall be remediated as quickly as is practical, but in no event longer than ____ days.

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

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

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

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

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

c. Outsourcing (contractor facility, contractor equipment or contractor staff) of systems or network operations, telecommunications services, or other managed services requires certification and accreditation (authorization) (C&A) of the contractor’s systems in accordance with VA Handbook 6500.3, Certification and Accreditation and/or the VA OCS Certification Program Office. Government-owned (government facility or government equipment) contractor-operated systems, third party or business partner networks require memorandums of understanding and interconnection agreements (MOU-ISA) which detail what data types are shared, who has access, and the appropriate level of security controls for all systems connected to VA networks.

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

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

f. VA prohibits the installation and use of personally-owned or contractor/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 preapproved and described in the purchase order or contract.

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

6. SECURITY INCIDENT INVESTIGATION

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

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

c. With respect to unsecured protected health information, the business associate is deemed to have discovered a data breach when the business associate knew or should have known of a breach of such information. Upon discovery, the business associate must notify the covered entity of the breach.