36C24120Q0539_1.docx

36C24120Q0539

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

689-20-4-7935-0701 36C24120Q0539 08-28-2020 Leah Bennett leah.bennett2@va.gov 207-623-8411 x2290 09-04-2020

11:00AM

Department of Veterans Affairs Network Contracting Office 1 1 VA Center Augusta

ME

04330 X X 621512 $16.5 Million N/A X Department of Veterans Affairs West Haven VAMC 950 Campbell Ave West Haven

CT

06516 Department of Veterans Affairs

NCO1

1 VA Center Augusta

ME

04330 www.fsc.va.gov/einvoice.asp Invoices to be submitted electronically in accordance with VAAR 852.232-72

See CONTINUATION Page This is a request for quote for the lease of a mobile Multiple Detector Computed Tomography Imaging (MDCT) unit.

The period of performance shall be for 12 months from date of award plus additional option year. (base + 1 option year) See CONTINUATION Page 689-3600160-7935-822200-2560 0100B00T6 X X X William Prenzler Contracting Officer Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

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

a. CONTRACTOR:

b. GOVERNMENT: Contracting Officer 36C241 Bill Prenzler Department of Veterans Affairs Network Contracting Office 1

1 VA Center Augusta ME 04330

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.

www.fsc.va.gov/einvoice.asp Invoices to be submitted electronically in accordance with VAAR 852.232-72

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

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

Mobile CT service 6 days per week, monday-saturday- exclusive of holidays

- inclusive of staff to operate the scanner, 7am-5pm Base Year: Date of Award - 12 months

Mobile CT service 6 days per week, Monday-Saturday- exclusive of holidays

- inclusive of staff to operate the scanner, 7am-5pm Option Year 1

Page 1 of Page 1 of

B.3 STATEMENT OF WORK

1.0 OVERVIEW SERVICES:

VA Connecticut Healthcare System requires the lease of mobile Multiple Detector Computed Tomography Imaging (MDCT) unit for use to address the backlog of CT scans created by the limiting of routine services during the Coronavirus Pandemic. Contractor shall provide all expertise, trained personnel, equipment and supplies as necessary to deliver, install, and operate this mobile unit at the West Haven campus of the VA Connecticut Healthcare System (VACTHS).

Contractor shall provide an Aquilian Prime SP, with Adaptive Iterative Dose Reduction 3D Enhanced CT system and associated equipment (hereinafter referred to as a mobile unit). Above shall include a system scalable to 160 Slice Multiple Detector CT mobile scanner, which shall be delivered F.O.B. Destination to the West Haven campus, VACTHS – 950 Campbell Ave West Haven, CT 06095. Contractor shall be provided a minimum of 30 days’ notice when the mobile unit is no longer required after meeting a minimum lease period of 12 months. If the return of the unit is anticipated to be in the middle of month, the Contractor price will be prorated, and price will be decreased accordingly. This agreement shall include all labor, material, tools, maintenance/repairs, equipment, hookup, delivery, and the complete removal of the mobile unit upon conclusion of the contract period. Mobile unit shall be delivered and removed on a date and time mutually agreed upon between the COR and the Contractor.

It is also agreed upon and understood that only qualified/trained technologists supplied by the contractor or VA trained technologist will be allowed to perform scans on the Contractor furnished equipment. The contractor is always required to staff the mobile CT unit with one qualified / certified CT Technologist and one Technologist Aide. The hours of normal operation are 7am-5pm Monday - Saturday, exclusive of federal holidays. VA may need to perform CT scans at any time; therefore, the Mobile unit will be available, and the VA will have access on site 24 hours a day, 7 days a week (24/7) for the agreed upon period. Contractor shall be responsible to maintain all the equipment in good working order and shall reimburse the VA for any reasonable costs which may be associated with any defective workmanship or equipment failure as further defined herein. All required software updates/maintenance performed by the vendor must take place after 7PM on weekdays and weekends.

1.1 TERM OF CONTRACT: The contract is effective after award from the date specified for a 12-month period with an option to renew for additional 12- month period. The option period is subject to the availability of VA funds. No service shall be performed by the Contractor after dates indicated, unless authorized by the Contracting Officer in writing.

1.2 TRAINING: Government or government contract personnel shall provide all patient services. Contractor is required to provide all necessary training for full operation of the Mobile CT unit, if necessary. Contractor shall make the necessary arrangements with the Contracting Officer’s Representative (COR) to schedule training sessions. Training sessions shall not be performed on weekends and federal holidays.

1.3 USE OF EQUIPMENT: It is agreed upon and understood that a qualified CT technologist(s) (who has completed and received the proper training on the use of the equipment) will be authorized to use the Contractor’s furnished equipment 24/7 to perform a variety of CT exams. This includes VA Connecticut employees and contract staff.

1.4 AUTHORITY: This procurement can be conducted under Federal Acquisition Regulation (FAR) Part 8, Required Sources of Supplies and Services under GSA Schedule or FAR Part 13, Open Market. The resultant contract is non-exclusive and shall not prohibit VA or Contractor from entering into agreement(s) with other health care providers or purchasers of health care services.

1.5 PURPOSE: The intent of this procurement is to provide interim mobile CT lease to increase patient access to CT services post Coronavirus Pandemic. Contractor’s equipment shall be state-of-the art in order to achieve high quality scans utilizing low radiation dosing techniques for VA patient diagnosis.

1.6 CONTRACTOR’S FURNISHED EQUIPMENT: Equipment shall be limited to a fully equipped Aquilian Prime SP, with Adaptive Iterative Dose Reduction 3D Enhanced CT scanner where studies will be performed on the contractor’s furnished equipment. Contractor shall submit an equipment specification list of all equipment, including the CT Mobile Unit with his/her signed quotes as further detailed in Paragraph 1.7. Include name of manufacturer, model number, manufacturer’s brochures, cut sheets, equipment specifications, and all pertinent data. All equipment to be used will be FDA approved imaging equipment placed at a location designated by the COR on site at the West Haven campus. The entire offering of a CT Mobile lease shall meet all local, state, federal, industry, JC, NEC, NFPA, VA, OSHA, and other regulatory standards, internal or external, that the VACTHS is currently accountable for.

In addition, the CT Mobile unit shall meet the following specifications:

· Max width of mobile: 16 feet

· Max length of mobile: 50 feet

· Mobile unit shall be compatible with the following main electrical power specifications: 480V, 150A 3 phase, 125KVA, fused at 150, 4 pole 5 wire service in place with a Russelstoll outlet consisting of 4 #3/0 & 1 #6g, Maximum allowable line voltage variation is +/- 10 percent. Phase balance + 2% maximum, as per the OEM Site Guide.

· (Power needed is: 380, 400, 420, 440, 460 or 480 VAC, 50/60 Hz, 3-phase)

1.7 SYSTEM CAPABILITY REQUIREMENTS: The Contractor shall provide a Computed Tomography Imaging scanner which shall allow the contract personnel/staff to perform a wide range of exams as listed below:

1. Diagnostic CT imaging, but not limited to, all Body, MSK, Neuro.

1.8 SYSTEM NETWORKING INTERFACES: to be provided at no additional cost to VACTHS.

Scanner and all associated equipment - Both hardware and software, which shall have ability to send Digital Imaging and Communications in Medicine (DICOM) images to VACTHS PACS:

· System shall be able to send to multiple DICOM destinations

· System shall operate on Windows 10 operating system

· Shall act as a Service Class Provider (SCP) for third party workstations to pull DICOM

· The mobile unit shall be equipped with a DVD disk archival system however VA will be responsible for DVD Discs. The patient data and optical disk shall the property of the VACTHS and remain with VACTHS at the end of the contract term.

· The mobile unit shall be equipped with DVD-R burning capabilities as a backup, these backups shall be in DICOM format.

· Shall be compatible with DICOM Modality Worklist C-Find (MWL) to query exams

1.9 ACCESSORY EQUIPMENT: Accessory equipment that shall be provided by the Contractor:

· Handicap accessibility - via ramp or lift

· Intercom system between the control room and scanning room

· Medical gas outlets (1 outlet each of air oxygen and suction) in the CT room close to the head of the table

· Supply tanks/compressor for the source of the gases/suction shall be supplied with the mobile unit

· Changing area for patients within mobile unit (if available)

· CT Medrad Stellant Dual Injector which is compatible to the CT system provided

1.10 EQUIPMENT SPECIFICATIONS: The following minimum performance characteristics of the equipment are required: Brand name Toshiba is required in order to avoid the need to train staff that is already familiar with the use of this brand CT, currently in use at the VACTHCS.

Aquilian Prime SP CT is also required for this mobile space in order to ensure ease of use and to prevent additional training for the clinical users. A Medrad Stellant Dual Injector brand is required in order to maintain consistent use of current stock of injector syringes that logistics currently has on contract with the vendor. Additionally, all sponges and table attachments shall be included. In this instance, the supplies to be included are:

· Head holder attachment

· Head stability sponges

· Footboard attachment

· Patient safety Velcro table straps

· Cardiac Monitor for Cardiac CTA

· EKG Leads for Cardiac Monitor

· Postprocessing workstation that is compatible with Vital Vitrea Imaging Workstation Additionally, the unit shall include, but not be limited to, the following specifications:

· The Gantry

· Gantry tilts ±30 degrees

· Large aperture: 78 cm

· Two scan fields of view

· Wide range of scan times provides greater flexibility for optimal image quality

· Control touch panel – many functions can be controlled in-room for quick setup and improved workflow

· Noise, % at 25 mGy (2.5 rads) <0.5%

· Output, kw 72

· Kvp range 80, 100, 120, 135 X-RAY TUBE

· Heat storage, MHU (X-RAY TUBE) 7.5

· Heat dissipation rate, kHU/min (X-RAY TUBE) 1,386 maximum

· Tube cooling (X-ray tube anode) Oil/air

· Tube focal spots, mm (X-RAY TUBE) 1.6 x 1.4, 0.9 x 0.8 (IEC standard)

· Gantry angle deg (GANTRY) +/-22

· Dicom 3-d image export

· Standard Rotation times, sec, 0.35, 0.375, 0.4, 0.45, 0.5, 0.6, 0.75, 1, 1.5

· Table Weight: >440 lbs

· Other features include:

· Easy 3D

· Bone removal

· Maximum intensity projection (MIP)

· Minimum intensity projection

· Intensity volume rendering

· Quantitative Analysis

· Profile display of CT numbers along a selected line in the axial plane

· Distance measurement and display

· CT number display

· Histogram display

Connectivity to PACS is required as well as all capabilities in Section 1.8 in the above document.

Equipment provided shall also include the following:

· DICOM [connectivity / functionality between VABHS CareStream PACS]

· DVD disk archival system

Contractor shall be required to make whatever adaptations are necessary so that the Contractor’s equipment is compatible with the VA furnished services defined herein.

· The Mobile CT shall provide images with consistently high technical diagnostic quality which meet the standard of care.

· The Mobile CT unit shall be ready for use regardless of outside environmental conditions.

· The Mobile CT unit shall maintain a temperature as to assure proper operation of the scanner without frequent calibration and provide for patient comfort.

· Meet all federal, state and local fire and safety requirements.

· Telecommunications: The mobile unit shall be equipped with an outlet connection capable of transmitting data and voice through a Government provided network cable. The Government will provide the connection required for the transmission of images, data and voice. (PACS interface contact person shall be provided to the Contractor during the post-award orientation).

1.11 ADDITIONAL REQUIREMENTS/MOBILE CT UNIT: Contractor shall provide a Mobile CT Unit that meets the following physical requirements:

· Has been approved by the FDA and meets or exceeds minimal standards for the type of equipment being provided as defined herein.

· The Contractor’s Mobile CT shall provide the space enough for the monitoring of sedated patients and conducting CPR and code if needed.

1.12 VA PROVIDED UTILITIES/SERVICES: VACTHS SHALL PROVIDE THE FOLLOWING UTILITIES/SERVICES (IF NECESSARY) FOR OPERATION OF THE CT MOBILE UNIT:

· Maintenance of the site which meets the requirements for the system.

· Housekeeping – during use of the mobile unit.

· Provision of electricity utilities, telephone service and network (HVAC, water and steam will NOT be provided).

· Provision of a Radiologist to oversee procedures, to protocol studies.

· VA Staff to respond medical emergencies.

· VA will be responsible for scheduling of patients to maximize patient throughput and will provide clerical support for scheduling, patient registration and other administrative responsibilities related to the CT Schedule.

· Provision of medical staff, when required, for procedures.

· Transportation of patients to/from their medical ward to the waiting area assigned to the CT service.

· Provision of medical supplies necessary to perform the procedure.

· Provision of standard protocols for CT technical staff and availability of radiologist to confer with regarding protocols.

· VA physicians will obtain any written consent that may be required in accordance with VA regulations.

· Canopy, walkway and covering for the safe transportation of patients to and from the hospital to the mobile unit

1.13 EQUIPMENT MAINTENANCE/REPAIRS: Equipment provided shall always be in good working order in order to provide high quality scans required under this solicitation and any resulting contract. Contractor shall be completely responsible for the preventive maintenance, emergency and general repairs, replacement of any defective parts/components, safety, cleaning, and upkeep of all equipment furnished by the Contractor. Preventative maintenance/repairs on the CT mobile unit and all associated equipment shall be performed in accordance with the Conformance Standards and manufacturer’s recommendations.

If the equipment should fail during normal working hours, emergency repairs shall be performed on-site by the Contractor’s qualified service engineers within a four-hour response time in order to reduce equipment downtime. Contract price shall be reduced by pro-rated amount in the event that the contractor is unable to meet the response times stated herein or as mutually agreed upon with the COR based upon patient scheduling. Notwithstanding, if it is determined that the equipment cannot be repaired on site within an agreed upon period of time, the contractor agrees to replace the Mobile Unit within forty-eight (48) hours of equipment failure. Contract price will be adjusted for any days in which the equipment cannot be used.

All required software updates/maintenance (non-emergent) performed by the vendor must take place after 7PM on weekdays and weekends as to not interrupt patient access.

VA shall be responsible for the overall housekeeping of the unit including but not limited to removal and proper disposal of all debris daily or as often as necessary to maintain a sanitized and neat environment in accordance with the Conformance Standards.

1.14 PARTS: The Contractor shall furnish and replace parts to meet times specified in this agreement. The Contractor shall maintain ready access to all parts, including unique and/or high mortality replacement parts. All parts supplied shall be compatible with existing equipment. The contractor shall include all parts required. The Contractor shall use new or rebuilt parts. All parts shall be of current manufacture and have complete versatility with the presently installed equipment. All parts shall perform identically to the original equipment specifications. Rebuilt parts, used parts or those removed from another piece of equipment shall not be installed without specific approval by the CO or the COR.

Contractor’s equipment shall be compatible with the VA existing equipment and/or systems in order to provide an interface between the Mobile CT Unit and the Contractor’s equipment and the VA firewall. VA personnel will be assigned to the successful Contractor during the post award orientation to establish network connectivity from the trailer through the VACTHS firewall. The Contractor and OIT official will discuss firewall security and patient data purging procedures from the Contractor’s computer hard drives on the trailer unit. The Contractor shall comply with firewall security and patient data purging procedures determined to be applicable by the VA OIT official.

All hard drives and removal media that store sensitive patient information will be turned into the VA at the conclusion of the contract period.

CT Mobile Unit Driver shall be licensed as applicable to operate and drive the mobile vehicle in which the unit is housed. Contractor shall be responsible for delivery and set up of unit on site.

1.15 RECORDS AND CONFIDENTIALITY

Records created by the Contractor in the course of treating VA patients under this agreement are the property of the VA and shall not be accessed, released, transferred or destroyed except in accordance with applicable federal laws and regulations. Whenever possible, records and reports will be made available in digital form.

The contractor shall provide VACTHS with the hard-drive system at the conclusion of the contract period. This shall be signed off by a VA Connecticut’s Information Security Officer (ISO) and Clinical Engineering (CE) services.

The treatment and administrative records created by, or provided to the Contractor under this award, shall be covered by the VA system of records entitled “Patient Medical Records- VA (24VA136). In responding to VA Patient requests that copies of their patient records be released to a third party, the Contractor shall refer the VA patient/family to the Release of Information Act (ROI), located within the VA Business office for response.

1.16 TORT CLAIMS

The Federal Tort Claims Act does not cover the Contractor and/or its employees. When the group or its employees has been identified as a provider in a tort claim, the Group or Group Employee is responsible for notifying their own legal counsel and/or insurance carrier. Any subsequent settlement or judgment arising from a group or Group employee’s act or omission under this agreement is the responsibility of the Group, Group employee and/or insurance carrier unless such act or omission was at the direction of the VA clinical staff member or other VA employee.

1.17 QUALITY CONTROL

All studies shall conform to VA protocol established by VA Radiologists prior to any examination being performed. Studies will be performed according to VA BHS protocols. VA estimates 35 CT exams to be completed daily.

B.3 IT CONTRACT SECURITY

VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY

1. GENERAL

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

2. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

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

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

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

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

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

3. VA INFORMATION CUSTODIAL LANGUAGE

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

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

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

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

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

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

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

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

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

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

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

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

4. INFORMATION SYSTEM DESIGN AND DEVELOPMENT

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

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

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

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

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

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

g. The contractor/subcontractor agrees to:

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

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

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

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

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

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

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

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

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

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

j. The vendor shall notify VA within 24 hours of the discovery or disclosure of successful exploits of the vulnerability which can compromise the security of the Systems (including the confidentiality or integrity of its data and operations, or the availability of the system). Such issues shall be remediated as quickly as is practical, but in no event longer than 10 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 10 days.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

6. SECURITY INCIDENT INVESTIGATION

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

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

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

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

7. LIQUIDATED DAMAGES FOR DATA BREACH

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

b. The contractor/subcontractor shall provide notice to VA of a "security incident" as set forth in the Security Incident Investigation section above. Upon such notification, VA must secure from a non-Department entity or the VA Office of Inspector General an independent risk analysis of the data breach to determine the level of risk associated with the data breach for the potential misuse of any sensitive personal information involved in the data breach.