36C25819Q0368-001.docx

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PVAHCS Mobile MRI Lease to Purchase Federal contract opportunity
Solicitation number
36C25819Q0368
Issued by
Department of Veterans Affairs Veterans Health Administration Veterans Integrated Service Network 22

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36C25819Q0368

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

36C25819Q0368 08- -2019 Nonya Montano (nonya.montano@va.gov) 520-838-3600 09-09-2019 11:00am EST Department of Veterans Affairs NCO22-Gilbert Network Contracting 3601 S. 6th Avenue Bldg. 45 Tucson AZ 85723 X X 621512 $15 Million N/A X Department of Veterans Affairs Phoenix VA Healthcare System 650 E Indian School Rd Phoenix AZ 85012 Department of Veterans Affairs NCO22-Gilbert Network Contracting 3601 S. 6th Avenue Bldg. 45 Tucson AZ 85723

This is accomplished through the Tungsten Network located at:

http://www.fsc.va.gov/einvoice.asp This is mandatory and the sole method for submitting invoices.

See CONTINUATION Page Mobile MRI Unit - Lease to Purchase per the Statement of Work (SOW) X X X Nonya Montano Contracting Officer Table of Contents

SECTION A1
A.1 SF 1449 SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS1
SECTION B - CONTINUATION OF SF 1449 BLOCKS4
B.1 CONTRACT ADMINISTRATION DATA4
B.2 PRICE/COST SCHEDULE5
ITEM INFORMATION5
B.3 DELIVERY SCHEDULE6
B.4 STATEMENT OF WORK7
SECTION C - CONTRACT CLAUSES25
C.1 52.207-5 OPTION TO PURCHASE EQUIPMENT (FEB 1995)25
C.2 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)25
C.3 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000)26
C.4 SUPPLEMENTAL INSURANCE REQUIREMENTS26
C.5 VAAR 852.215-71 EVALUATION FACTOR COMMITMENTS (DEC 2009)26
C.6 VAAR 852.219-10 VA NOTICE OF TOTAL SERVICE-DISABLED VETERAN-OWNED SMALL BUSINESS SET-ASIDE (JUL 2016)(DEVIATION)27
C.7 VAAR 852.219-74 LIMITATIONS ON SUBCONTRACTING—MONITORING AND COMPLIANCE (JUL 2018)28
C.8 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV 2018)28
C.9 VAAR 852.237-70 CONTRACTOR RESPONSIBILITIES (APR 1984)29
C.10 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)30
C.11 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS—COMMERCIAL ITEMS (MAY 2019)30
SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS38
D.1 BUSINESS ASSOCIATE AGREEMENT38
SECTION E - SOLICITATION PROVISIONS43
E.1 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL ITEMS (OCT 2018)43
E.2 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT 2018)48
E.3 52.216-1 TYPE OF CONTRACT (APR 1984)49
E.4 52.233-2 SERVICE OF PROTEST (SEP 2006)49
E.5 VAAR 852.211-72 TECHNICAL INDUSTRY STANDARDS (NOV 2018)49
E.6 VAAR 852.215-70 SERVICE-DISABLED VETERAN-OWNED AND VETERAN-OWNED SMALL BUSINESS EVALUATION FACTORS (JUL 2016)(DEVIATION)50
E.7 VAAR 852.233-70 PROTEST CONTENT/ALTERNATIVE DISPUTE RESOLUTION (OCT 2018)50
E.8 VAAR 852.233-71 ALTERNATE PROTEST PROCEDURE (OCT 2018)51
E.9 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB 1998)51
E.10 52.212-2 EVALUATION—COMMERCIAL ITEMS (OCT 2014)52
E.11 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—COMMERCIAL ITEMS (OCT 2018)53

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 36C258

Department of Veterans Affairs NCO22-Gilbert Network Contracting 3601 S. 6th Avenue Bldg. 45 Tucson AZ 85723

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

[X]
52.232-33, Payment by Electronic Funds Transfer—System For Award Management, or
[]
52.232-36, Payment by Third Party

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly[]
b. Semi-Annually[]
c. Other[X] Monthly

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

This is accomplished through the Tungsten Network located at:

http://www.fsc.va.gov/einvoice.asp This is mandatory and the sole method for submitting invoices.

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

AMENDMENT NO
DATE

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

ITEM NUMBER
DESCRIPTION OF SUPPLIES/SERVICES
QUANTITY
UNIT
UNIT PRICE
AMOUNT
3.00
MO
____________
________________

Mobile MRI (3-month lease) - 1 Siemens Mobile Advanto MRI Unit per the Statement of Work.

Contract Period: Base POP Begin: 12-01-2019 POP End: 02-29-2020

3.00
MO
____________
________________

Mobile MRI (3-month lease) - 1 New Siemens Mobile Aera MRI Unit per the Statement of Work.

Contract Period: Base POP Begin: 03-01-2020 POP End: 05-31-2020

1.00
EA
____________
________________

Mobile MRI (lease to purchase) - Siemens Mobile Aera MRI Unit per the Statement of Work.

Contract Period: Option 1 POP Begin: 06-01-2020 POP End: 06-01-2020

GRAND TOTAL
________________

B.3 DELIVERY SCHEDULE

ITEM NUMBER
QUANTITY
DELIVERY DATE
0001
SHIP TO:
650 E Indian School Rd.

Phoenix, AZ 85012

USA

3.00
12/1/2019
MARK FOR:
Steave Kantarowski

602-277-5551 Ext. 6341 steave.kantarowski@va.gov

0002
SHIP TO:
650 E Indian School Rd.

Phoenix, AZ 85012

USA

3.00
3/1/2020
MARK FOR:
Steave Kantarowski
1001
SHIP TO:
650 E Indian School Rd.

Phoenix, AZ 85012

USA

1.00
6/1/2020
MARK FOR:
Steave Kantarowski

Page 1 of Page 1 of

B.4 STATEMENT OF WORK

Statement of Work Mobile MRI – Lease to Purchase

1. GENERAL:

1.1. Unit Provided: The Contractor shall provide one (1) Mobile MRI Advanto Unit followed by one (1) Mobile MRI Aera Unit to the Department of Veterans Affairs (VA) Phoenix VA Health Care System (PVAHCS).

1.2. Delivery Location - Contractor delivery the unit to Phoenix VA Health Care System (PVAHCS) at 650 E. Indian School Rd. Phoenix, AZ 85012. (Amethyst area)

1.3. Period of Performance: December 1, 2019 to February 29, 2020 for the Advanto Unit; March 1, 2020 to May 31, 2020 for the Aera Unit and an option to purchase the Aera Unit in accordance with FAR 52.207-5.

1.4. Scope: The Magnetom AREA is the world’s leading edge 1.5T MR system for MR exploration that offers a platform for the most demanding clinical and research challenges of today and the future. Its breakthrough design delivers maximum performance under prolonged high-strain conditions and provides the power to perform the most ambitious MR experiments/studies. From brain functionality, to body physiology, organ morphometry, tissue metabolism, and quantitative MRI, MAGNETOM Prisma delivers the answers. The Magnetom AERA provides MRI exams for the whole body in clinical studies and will be used to perform the most demanding 1.5T exams of the facility. This system will be in place of the 1.5 T MRI Avanto while under construction. The facility continues to see growth in the demand for MRI exams, with an average of 80 orders daily or about 1500 orders monthly. The Mobile MRI will be parked on an existing pad on the east side of the hospital. Contractor shall provide all equipment, service and maintenance while the units are leased. The contractor shall install the mobile MRI so that patient access is through existing patient ramp and Zone II screening building.

Included:

-Transportation, Delivery and Set-up of Unit -Complete System and Trailer Service during rental months.

-MRI unit must be installed in a double wide trailer.

-Demobilization of Advanto Unit -Each mobile unit must be installed with a fire alarm subpanel, EST 3 System.

1.5. Policy/Handbooks - the contractor shall be subject to the following policies, including any subsequent updates during the period of performance:

1.5.1. - VA Directive 1663: Health Care Resources Contracting - Buying http://www1.va.gov/vapubs/viewPublication.asp?Pub_ID=347

1.5.2. VHA Handbook 1907.01 Health Information Management and Health Records: http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=2791

1.5.3. - Privacy Act of 1974 (5 U.S.C. 552a) as amended http://www.justice.gov/oip/foia_updates/Vol_XVII_4/page2.htm

1.5.4. – VHA Directive 1129 Radiation Protection for Machine Sources of Ionizing Radiation http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=3081

1.5.5. VHA Directive 1105.05 Magnetic Resonance Safety https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=6430

1.5.6. – VHA Handbook 1105.05 Magnetic Resonance Imaging Safety https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=6430

2. REQUIREMENTS:

a. Contractor shall provide MRI equipment that is able to pass American College of Radiology (ACR) certification. Contractor shall provide equipment that meets the following requirements:

i) System manufacturer of the MRI must meet or exceed the specifications of a Siemens 1.5T Avanto SQ B19 and Aera Unit. See paragraph 2.1 and 2.2 for full Mobile MRI specifications.

ii) MRI and Accessories that meet or exceed industry standards for the service provided and the American College of Radiology (ACR). Contractor shall ensure all licensures, inspection, adjustments, calibrations, and certifications are current at all times with no lapses or pending discrepancies.

iii) The VA reserves the right to request copies of all documentation relating to the equipment. The contractor upon request shall provide evidence of performance of recommended maintenance for the VA.

iv) The mobile MRI will require installation to current Zone II screen building and ramp.

b. MRI Trailer - Contractor shall provide the lease of a relocatable MRI unit meeting the following requirements:

1) Trailer Size not to exceed 12’ wide x 50’ long to accommodate full access inside trailer and around MRI scanner. Trailer Size must not exceed 50’ to meet limitations of site and future planning.

2) Trailer must contain an ABA (Architectural Barriers Act) compliant Patient Dressing Area: minimum size of 5’ x 5’.

3) Hand washing sink.

4) Fire Alarm, code alarm, and intercom connection to VA systems; alarm and intercom shall be available in MRI trailer within close reach to MRI technologist stations.

5) HVAC system; MRI Trailer shall maintain proper temperature to ensure maximum operation, calibration, and care of equipment and to ensure patient comfort.

6) Smoke Detectors and MRI Safe Fire Extinguishers

7) MRI Trailer and Equipment shall meet all Federal, State, and Local Fire and Safety requirements

8) Emergency Generator to operate Cryogens during planned or emergency power outage.

9) Quality Control (QC) Program which meets or exceeds The Joint Commission (TJC) Standards.

10) All permits, insurance and transportation and set-up costs of mobile unit.

11) Delivery and Set-up of Contractor Equipment: The Contractor shall be responsible for proper installation/set-up of the Contractor's furnished equipment including the trailer that houses the MRI unit. Installation/ setup shall be accomplished in accordance with industry standards, all OSHA regulations and applicable manufacturer's recommendations.

12) Provide connecting power cable compatible to existing receptacle manufactured by Russel Stoll.

13) Contractor shall connect power, data, phone and alarm systems to the Mobile MRI trailer.

c. Guarantee

1) The contractor guarantees the equipment against defective material, workmanship and performance for a period of one year from purchase date. The contractor agrees to furnish, without cost to the Government, replacement of all parts and material that are found to be defective during the guarantee period. Replacement of material and parts will be furnished to the Government at the point of installation. Cost of installation of replacement material and parts shall be borne by the contractor.

2.1. Mobile MRI Advanto Unit Specifications

2.2.1 Contractor shall provide MRI system that’s meets or exceeds the capabilities of a Siemens 1.5T Avanto system with TIM technology SQ Gradients level B19 software including DIXON, to include:

a. 32 Channel 76 Elements

b. Minimum Gradient Strength - 45 T/m per @ 200 T/m/s slew rate

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

d. Neuro Suite

e. Angio Suite

f. Cardiac Suite

g. Body Suite

h. Breast Suite

i. Ortho Suite

j. Pediatric

k. SPACE

l. TWIST

m. BLADE

n. Diffusion

o. SWI

p. Argus Flow Quantification

q. DTI

r. DIXON

s. Matrix Head Coil

t. Matrix Neck Coil

u. Matrix Body Coil

v. Matrix Spine Coil

w. Peripheral Angio Coil

x. 4 channel shoulder array, small and large coils

y. Large and Small CP Flex coils

z. 8 channel foot/ankle/knee coil

aa. 8 channel wrist coil

bb. Connection to VA VPN to enable OEM remote MRI troubleshooting and system analysis.

cc. Minimum of 500 lb. load table limit

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

ee. Equipment capable of sending images to a minimum of 3 destinations (printer, PAC’s, Hospital RIS System)

2.2.2 Patient Digital Video and Audio Entertainment System: Contractor shall provide Mobile MRI trailer that contains the following minimum Patient Digital Video and Audio Entertainment System features/functions to help mitigate the claustrophobic effects of the MRI. The Patient Digital Video and Audio Entertainment System shall include:

a. Entertainment DVD Video capability.

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

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

d. Patient microphone to enable communication with VA MRI Technologist.

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

f. Emergency call button for the patient to alert the MRI Technologist of any problems or to speak to the MRI Technologists.

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

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

2.2. Mobile MRI Aera Unit Specifications

2.2.1. MAGNATOM Aera – System 1.5T with Tim(r) and Dot(r) technology – -Short and Open appearance 145 cm system length and 70 cm Open Bore -Whole-body superconductive Zero Helium Boil-Off magnet -Actively Shielded water-cooled Siemens gradient system for maximum performance -True Form Magnet and Gradient Design

2.2.2. Tim 4G (Total imaging matric in the 4th generation)–

-Siemens unique Direct RF™ technology enabling the all-digital-in/digital-out design -Dual-Density Signal Transfer Technology -Head/Neck 16 Direct Connect Coil -Spine 24 Direct Connect Coil -Body 6 Coil -Flex Large 4 Coil -Flex Small 4 Coil -Flex Coil interface -Tim Co -Shoulder 16 Coil & Kit -Tx/Rx Knee 15 Channel -CP Extremity Coil

2.2.3. Dot (Day optimization throughput) for higher consistency, flexibility and efficiency– -Dot Display -Dot Control Centers -Brain Dot Engine

2.2.4. Tim Application Suite allowing excellent head-to-toe imaging:

-Nuero Suite -Angio Suite -Cardiac Suite -Body Suite -Onco Suite -Breast Suite -Ortho Suite -Pediactric Suite -Scientific Suite

2.2.5. Further Included:

-High performance host computer measurement and reconstruction system -Siemens unique TimCT FastView localizer and CAIPIRINHA

-1D/2D PACE

-BLADE-iPAT2 -Phoenix -Inline Diffusion

-WARP

-MDDW (Multiple Direction Diffusion Weighting)

-CISS

-DESS

2.2.6. Tim [204x24] XJ Gradients Performance:

-33 mT/m peak amplitude with a slew rate of 125T/m/s

2.2.7. Time Table:

2.2.8. SW syngo MR E11C Software:

2.2.9. Quite Suite:

2.2.10. Spine Dot Engine:

-syngo MR software including interface

2.2.11 HVAC Blower Curtain:
- install HVAC blower curtain above main entrance door

4.0 CONTRACTOR RESPONSIBILITIES:

1.

2.

3.

4.

4.1. MRI MAINTENANCE REQUIREMENTS:

4.1.1 Contractor shall be responsible for all maintenance of the relocatable MRI unit including all Preventive Maintenance (PMs) as required by the manufacturer’s literature. The Contractor shall bear all costs for labor and parts and shall make all arrangements for service upon notification of failure. Service response time for equipment failures shall be within 24 hours.

4.1.2 Contractor shall maintain a 24/7/365 call in Hot Line for the VA Technologist to call for technical service on the MRI, accessories and trailer.

4.1.3 Contractor shall ensure that anyone performing maintenance on the MRI unit shall be factory trained by the manufacturer. Contractor shall address any FDA alerts or recalls associated with this equipment in a timely manner.

4.1.4 All PMs shall be done after normal operating hours, Monday – Friday.

4.1.5 Contractor shall ensure a 95% or better up-time based upon the normal operation hours, Monday – Friday 7:00 a.m. – 5:00 p.m.

4.2. CONFORMANCE STANDARDS/REGULATORY ADHERENCE

a. Contractor shall perform the required services in accordance with the following:

1) The standards of the Joint Commission for the Accreditation of Healthcare Organizations (JCAHO) to include Patient Safety Standards (a copy of these standards may be obtained from the Joint Commission on Accreditation of Healthcare Organizations, One Renaissance Blvd., Oakbrook Terrace, IL 60181)

2) Occupational Safety and Health Act (OSHA)

3) Veterans Health Administration (VHA)

4) United States Department of Transportation (US DOT) Health Information Portability and Accountability Act (HIPAA)

5) VHA Automated Information Security (AIS)

6) Privacy Act of 1974

b. Contractor shall ensure that the equipment/system functions in conformance with the current edition at time of award or option period of OSHA and the manufacturer's specifications.

4.3. APPLICATIONS TRAINING

Contractor shall provide all travel and expenses for on-site OEM trained system applications specialist to train VA technologists in MRI operation and to build and confirm MRI protocols as described by VA reading radiologists.

4.4. MRI DATA OWNERSHIP

VA shall maintain sole ownership of all data of studies performed on the MRI under this contract. The Contractor may not use any portion of imaging data obtained from patient studies under the contract. The Contractor may not use any portion of imaging data obtained from patient studies for quality control or educational purposes without written consent of VA.

4.5. TELECOMMUNICATIONS

The mobile unit shall be equipped with an outlet connection capable of transmitting data and voice through a Government provided network interface jack (RJ11 Analog Voice and RJ45 IEEE 803.x). The Government shall provide the necessary network services required for the transmission of images, data and voice. The Contractor's mobile unit shall be able to connect to VISTA Imaging Network and to transmit all images to VISTA Imaging to include being compatible to DICOM 3.0 imaging standards.

4.6. MEDICAL RECORDS

4.6.1. Authorities: Contractor’s unit shall provide services to VA patients shall be considered as part of the Department Healthcare Activity and shall comply with the U.S.C.551a (Privacy Act), 38 U.S.C. 5701 (Confidentiality of claimants records), 5 U.S.C. 552 (FOIA), 38 U.S.C. 5705 (Confidentiality of Medical Quality Assurance Records) 38 U.S.C. 7332 (Confidentiality of certain medical records), Title 5 U.S.C. § 522a (Records Maintained on Individuals) as well as 45 C.F.R. Parts 160, 162, and 164 (HIPAA).

4.6.2. HIPAA: The contractor must adhere to the provisions of Public Law 104-191, Health Insurance Portability and Accountability Act (HIPAA) of 1996 and the National Standards to Protect the Privacy and Security of Protected Health Information (PHI). As required by HIPAA, the Department of Health and Human Services (HHS) has promulgated rules governing the security and use and disclosure of protected health information by covered entities, including the Department of Veterans Affairs (VA). In accordance with HIPAA, the Contractor may be required to enter into a Business Associate Agreement (BAA) with VA.

4.6.3. Access: Any and all Protected Health Information (PHI) stored in the equipment will be transferred to either VistA Imaging or a dedicated server for long-term retention and incorporation into patient records. During equipment install, warranty repair, or maintenance, the contractor may have physical or administrative access to the equipment included in this contract that captures, stores, and processes e-Protected Health Information (e-PHI). If warranty repair is done on or off-site, all hard drives or other data storage devices will be removed or purged of data, prior to release to contractor. The contractor shall not remove from VA facilities, any hardware or external devices that contain memory or agency electronic information. All hardware and devices will be purged of data upon de-commission or uninstall from the agency network. The Contractor shall treat all deliverables under the contract as property of the U.S. Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. The Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government IT equipment and/or Government records. The Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected by the Freedom of Information Act. The Contractor shall not create or maintain any records containing any government Agency records that are not specifically tied to or authorized by the contract. The Government Agency owns the rights to all data/records produced as part of this contract. The Government Agency owns the rights to all electronic information and all supporting documentation created as part of this contract. The Contractor must deliver sufficient technical documentation with all data deliverables to permit the Agency to use the data. The Contractor agrees to comply with Federal and Agency records management policies, including those policies associated with the safeguarding of records covered by the Privacy Act of 1974. These policies include the preservation of all records created or received regardless of format, mode of transmission, or state of completion.

5.0 VA RESPONSIBILITIES

a. VA will perform preparation and maintenance of the site for unit.

b. VA will provide electrical power (on Emergency Generator Backup), (2) Two 480-volt AC 3 phase 125 KVA fused at 150 amps Maximum voltage variation is +- 5% from nominal steady state, Voltage surges must not exceed +5%, 5 wire Russell Stoll receptacle DF 2504 FRAB, waterproof.

c. VA will provide 3 data lines and 2 telephone lines and connections to the VA Police/Fire Alarm system and the Code Alarm system.

d. VA will provide network access for MRI remote diagnosis connection between trailer and service organization.

e. VA will provide the services of MRI technicians to perform all scans.

f. VA will provide the services of a Radiologist(s) who will provide guidance for protocols and assume responsibility for medical care of patients. Radiologist(s) will also review studies for appropriateness according to ACR protocols.

g. A VA physician will be on-site and will obtain any written consent that may be required in accordance with VA regulations.

h. VA will provide medical staff for procedures, when required.

i. 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 MRI Schedule.

j. VA will provide staff and equipment for emergency care of patients.

k. VA will provide medical supplies necessary to perform the procedures including gadolinium, injector kits, laundry and other necessary medical supplies and consumable supplies.

l. VA will provide film media (film, CD’s) where required.

m. VA will provide transportation of inpatients to/from their medical ward.

n. VA will provide plumbing for sink in trailer.

6.0 Registration with Contractor Performance Assessment Reporting System (CPARS)

6.1. As prescribed in Federal Acquisition Regulation (FAR) Part 42.15, the Department of Veterans Affairs (VA) evaluates Contractor past performance on all contracts that exceed $250,000 and shares those evaluations with other Federal Government contract specialists and procurement officials. The FAR requires that the Contractor be provided an opportunity to comment on past performance evaluations prior to each report closing. To fulfill this requirement VA uses an online database, CPARS, which is maintained by the Naval Seal Logistics Center in Portsmouth, New Hampshire. CPARS has connectivity with the Past Performance Information Retrieval System (PPIRS) database, which is available to all Federal agencies. PPIRS is the system used to collect and retrieve performance assessment reports used in source selection determinations and completed CPARS report cards transferred to PPIRS. CPARS also includes access to the federal awardee performance and integrity information system (FAPIIS). FAPIIS is a web-enabled application accessed via CPARS for Contractor responsibility determination information.

6.2 Each Contractor whose contract award is estimated to exceed $250,000 requires a CPARS evaluation. A government Focal Point will register your contract within thirty days after contract award and, at that time, you will receive an email message with a User ID (to be used when reviewing evaluations). Additional information regarding the evaluation process can be found at www.cpars.gov or if you have any questions, you may contact the Customer Support Desk @ DSN: 684-1690 or COMM: 207-438-1690.

6.3 For contracts with a period of one year or less, the contracting officer will perform a single evaluation when the contract is complete. For contracts exceeding one year, the contracting officer will evaluate the Contractor’s performance annually. Interim reports will be filed each year until the last year of the contract, when the final report will be completed. The report shall be assigned in CPARS to the Contractor’s designated representative for comment. The Contractor representative will have sixty (60) days to submit any comments and re-assign the report to the CO.

6.4 Failure for the Contractor’s representative to respond to the evaluation within those sixty (60) days, will result in the Government’s evaluation being placed on file in the database with a statement that the Contractor failed to respond; the Contractor’s representative will be “locked out” of the evaluation and may no longer send comments.

7.0 VA Information and Information System Security/Privacy Language

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;

(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 60 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 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 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.

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