36C26326Q0835 0002.pdf

5. PROJECT NUMBER (if applicable)

CODE7. ADMINISTERED BY

2. AMENDMENT/MODIFICATION NUMBER

CODE

6. ISSUED BY

8. NAME AND ADDRESS OF CONTRACTOR

4. REQUISITION/PURCHASE REQ. NUMBER3. EFFECTIVE DATE

9A. AMENDMENT OF SOLICITATION NUMBER

9B. DATED

PAGE OF PAGES

10A. MODIFICATION OF CONTRACT/ORDER NUMBER

10B. DATED

BPA NO. 1. CONTRACT ID CODE

FACILITY CODECODE

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers

E. IMPORTANT:

is extended,

(a) By completing Items 8 and 15, and returning __________ copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY is not extended.

12. ACCOUNTING AND APPROPRIATION DATA

(REV. 11/2016)

is required to sign this document and return ___________ copies to the issuing office.is not, A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A.

15C. DATE SIGNED

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER

Contractor

16C. DATE SIGNED

14. DESCRIPTION OF AMENDMENT/MODIFICATION

16B. UNITED STATES OF AMERICA

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER 16A. NAME AND TITLE OF CONTRACTING OFFICER

15B. CONTRACTOR/OFFEROR

STANDARD FORM 30 PREVIOUS EDITION NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.243

(Type or print) (Type or print)

(Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

(Number, street, county, State and ZIP Code)

(If other than Item 6)

(Specify type of modification and authority)

(such as changes in paying office, appropriation date, etc.)

(If required)

(SEE ITEM 11)

(SEE ITEM 13)

(X)

CHECK

ONE

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS,

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

(Signature of person authorized to sign) (Signature of Contracting Officer)

1 24

0002 07-28-2026

36C618

DEPARTMENT OF VETERANS AFFAIRS

Minneapolis HCS

1 Veterans Dr.

Minneapolis MN 55417

36C263

DEPARTMENT OF VETERANS AFFAIRS

NETWORK CONTRACTING OFFICE 23

316 ROBERT STREET N, SUITE 506

SAINT PAUL MN 55101

To all Offerors/Bidders

36C26326Q0835

X

X X

** HOUR & DATE for Receipt of Offers is EXTENDED to: 07-31-2026 12:00pm CDT

See CONTINUATION Page

X 1

The purpose of this modification is to answer vendor questions and extend the due date of bids from offerors.

See below for questions and answers from interested vendors. Attached are pictures to provide additional information relating to vendor questions.

Below the Price/Cost Schedule has been adjusted to correspond to the new period of performance starting on 08/15/2026.

See below to changes to the SOW with changes in red.

The bid due date was 12:00pm Central time on 07/30/2026 and has now been changed to 12:00pm on 07/31/2026.

Cameron Rick Contracting Officer

CONTINUATION PAGE

Offeror Questions and Answers

1. For purposes of measuring compliance with the limitation on subcontracting, will the Government treat the cost of the leased MRI scanner/trailer paid by the prime to the equipment's owner/lessor as an excludable other direct cost under 13 CFR 125.6 and VAAR 852.219-75(a)(1)(i) — such that the 50% limitation is measured against the service portion of the contract (e.g., preventive maintenance, on-call repair, cryogens, walkway construction, site planning, delivery/removal, applications training, and system integration)?

A: The cost of the leased MRI trailer is not excludable when assessing compliance with the Limitations on Subcontracting.

2. Will the equipment lease cost be counted as an amount paid to a non-similarly-situated subcontractor that is subject to the 50% limitation?

A: Yes, the equipment lease will be counted as an amount paid to a non-similarly situated subcontractor.

3. Based on the photos provided in Appendix A, can the Government confirm that the proposed Siemens Aera mobile trailer’s Zone 3 and Zone 4 configuration is acceptable, including the patient preparation area, staff workspace, storage, and access to the MRI scan room? If not, please identify any specific layout requirement the proposed trailer does not meet.

A: The Government can confirm that the layout provided in Appendix A is acceptable.

Two staff need to be present during all examinations. There is sufficient space for two personnel in this layout (see Workstation Photo).

4. The proposed Siemens Aera includes the dockable patient table shown in Appendix A.

Can the Government confirm that this table satisfies the detachable/dockable MRI gantry table requirement?

A: The Government can confirm that the table shown in Appendix A is acceptable.

5. Will a multipurpose coil that covers multiple anatomies, such as a flex or body-array coil, satisfy the knee, foot/ankle, and hand/wrist coil requirements in SOW Item 8, or is a dedicated coil required for each anatomy?

A: No, a multipurpose coil is not acceptable. Offerors are to provide a full set of coils as outlined in the solicitation as they provide the best imaging quality.

6. Can the Government provide the manufacturer and part number of the existing cannon-plug receptacle and confirm the available voltage, phase, frequency, and continuous amperage available to the mobile MRI trailer (referenced as a cannon plug served from the 250 Amp breaker in prior Q&A #40)?

A: See attached photos for the electrical connection. Please note that the mobile MRI is served from a 200 Amp breaker as opposed to a 250 Amp as previously stated (see attached picture 1772). This plug has been used for pervious MRI trailers at this location for the past five years without issue. There is no part number on the receptacle. The receptacle is 277/480v 4 pole.

7. Can the Government confirm that contractor performance will not be considered delayed when the trailer is otherwise ready for operation but final go-live is awaiting VA-controlled network, cybersecurity, PACS, EHR, electrical, or other Government-furnished configuration?

A: We can confirm that the contractor’s performance will not be considered delayed if go-live is delayed due to VA controlled responsibilities. However, it is incumbent on the contractor to notify the VA of the configuration that will be provided in order for the VA to review and adjust as necessary.

8. Is August 5, 2026, the required date for the MRI trailer to be fully installed, connected, tested, and operational for patient scanning, or is it the beginning of the contract mobilization period?

A: This is the beginning of the contract; the contractor is not expected to have everything completed by this time. However, plans for the walkway should be submitted within the first two weeks of the contract as well as the MRI should be operational (go-live) within the first week of the contract. The period of performance start date has been moved to 15 August 2026 to allow time for this solicitation, evaluation, award, and preparation for the contract to begin.

9. What is the anticipated contract award date?

A: Anticipated award date is 7-11 August 2026.

10. May the MRI trailer be delivered, positioned, blocked, electrically connected, and tested before the temporary enclosure is completed?

A: Yes, the MRI should be operational within the first week of the contract. The walkway is estimated to be installed within the first 4 weeks of the contract (2 weeks for plans to be submitted, 1 week for the VA to review the plans, 1 week for construction).

11. If the proposed trailer cable or connector is not directly compatible with the existing cannon-plug receptacle, will the VA perform and fund the necessary electrical modification, or must the contractor include that work in its quote?

A: If the trailer is not able to connect to the existing cannon-plug the offeror should include the modification work in its quote. The VA will not perform or separately fund the electrical modifications, if necessary.

12. Are there any additional VA-specific construction requirements that should be included in the enclosure contractor’s price and schedule, such as infection-control procedures, badging, escorts, staging restrictions, utility shutdown coordination, or other site-access requirements?

A: Personnel needing access to the main Minneapolis VA facility will need to be escorted while on campus and adhere to VA access control procedures. Details for these requirements will be provided to the winning offeror when necessary.

13. Is emergency or standby power available for the mobile MRI trailer, or is the contractor expected to provide backup-power capability?

A: The electrical connection is fed by emergency backup generators. The contractor is not expected to provide backup power.

14. If the MRI scanner has capabilities for equipment required but not currently on hand, is it acceptable to guarantee that equipment will be provided if we win the bid?

A: The offeror is expected to provide the equipment required within the solicitation when the trailer is delivered to the location. Delays due to supply chain issues will not be accepted. It is of no concern to the Government if the offeror does not currently have the equipment on hand at time of bid. However, information provided in an offeror’s bid must match what is provided when delivered unless prior coordination and approval has been received.

15. Does the Government require a separate ceiling below the roof of the enclosure?

A: No, a separate ceiling is not required below the roof.

16. Is Functional MRI (FMRI) used or needed?

A: No, a FMRI is not needed.

17. Can the outside sidewalk be penetrated for construction purposes?

A: Yes, the sidewalk can be penetrated for construction.

18. Does the Government require a dock-able table?

A: Per the solicitation the Government can confirm. The dock-able table is required for Code Blue and fire response.

19. Is it acceptable to erase the computer hard drive and keep it, or does the vendor have to remove the hard drive and turn it over to the Government at the end of contract?

A: Per VA regulations the hard drive must be turned in at the conclusion or termination of the contract or disposal or return of the IT equipment by the contractor/subcontractor or any person acting on behalf of the contractor/subcontractor. The following is taken from VA Handbook 6500.6: VA Information and Information System Security/Privacy Language:

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 Business Associate Agreement (BAA) if the device being traded in has sensitive information stored on it and hard drive(s) from the system are being returned physically intact; and

(b) Any fixed hard drive on the device must be non-destructively sanitized to the greatest extent possible without negatively impacting system operation.

Selective clearing down to patient data folder level is recommended using VA approved and validated overwriting technologies/methods/tools. Applicable media sanitization specifications need to be preapproved and described in the purchase order or contract.

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

20. Request for Quote only includes the building of the enclosure, not the tear down?

A: Per the Statement of Work: Upon contract completion, the portion of the walkway connected to the trailer will be removed by the contractor. The walkway will remain on site with the possibility of enclosing the space. Any additional costs for this process will be discussed at a future date and executed through a modification to the contract.

21. Construction of the Enclosure - If adjustments in construction are needed due to unforeseen issues, would the cost be absorbed by the contractor?

A: Costs as a result of negligence and/or not adhering to building codes will be the responsibility of the contractor. Any other additional costs must first be communicated to the CO and COR prior to execution of additional work. A bilateral modification agreement to the contract may be required to authorize additional funding for walkway construction. Any additional costs not prior approved may be denied and the responsibility of the contractor.

22. Is the request for the newest technology and software more related to software or actual manufacture date of the equipment? Such as, the date attached to the serial number, or is it just updated software and equipment?

A: Preference is given to equipment with the newest date of manufacture as it will also have the newest software installed on the equipment. It also stands to reason that equipment with the newest manufacture date will have the best operational capabilities and less likely to become inoperable due to mechanical or technological reasons.

23. If a newer system is available at a higher price, is there any preference to price over age of equipment?

A: Preference will be given to operational capabilities of the system. If two systems have the same operational capability, the preference will be for the newer system. A price analysis will be executed to ensure that prices are fair and reasonable based on competition and comparison with other contracts in which prices were previously found fair and reasonable.

24. The proposed MEDRAD Spectris Solaris MR injector uses the Bayer dual-syringe kit, part number SSQK 65/115VS. Can the Government confirm that this kit meets the facility’s inventory and operational requirements?

A: The Minneapolis VA can confirm that the above part meets the requirements. The offeror must still provide information concerning this equipment with their bid documents in accordance with the solicitation.

25. The proposed Siemens MAGNETOM Aera operates on the OEM’s syngo MR VE11C software platform using an HP Z440 host workstation. Can the Government confirm that this platform satisfies the console workstation requirement when connected through the facility’s medical-device network architecture?

A: A MRI Trailer which housed a Siemens Aera was previously used at the Minneapolis HCS and connected at the same location as this procurement. It is not anticipated that there would be issues connecting this type of MRI and supporting software to the VA network. However, the VA cannot definitely confirm that this platform will be able to connect without issue. Per the solicitation, the Minneapolis VA requires “The Contractor’s mobile scanner system must be able to connect to the VA commercial PACS system and Electronic Health Record network and must be able to transmit all images to both systems with HL7 and DICOM imaging standard compatibility.”

26. Can you please specify what would be assessed as a technical risk for offering low prices?

A: A comparison against the other offers will be executed during evaluation. If it is found that the lowest offer’s total price is significantly less than the next lowest offer it will be assessed technical risk due to the pricing alone. After further review of this low offer there are other technical or past performance concerns, the offer may not be selected due to these and pricing concerns. However, if after additional evaluation the lowest offeror meets the technical and past performance evaluation standards the offeror may be referred to the Small Business Administration for them to conduct a Certificate of Competency evaluation on the offeror. See FAR 19.204.

27. Can you please specify how the government may determine an offer is unacceptable if the option prices are significantly unbalanced?

A: See FAR 15.404-6. Price analysis will be utilized to assess offeror pricing and if prices are unbalanced with no apparent reason why (initial start up costs, additional work to be completed in base versus option years, etc.), the offer may be assessed additional risk.

28. What benefits beyond the minimum requirements would the Government value most?

A: The Minneapolis HCS values a technologically advanced, newly manufactured MRI with a robust service program to ensure the greatest capabilities are available and that the MRI becomes operational with minimal downtime in the event of a system failure.

29. Does the government find value in an extra large patient lift platform to accommodate the detectable table that is requested in the solicitation?

A: The standard patient lift platform is sufficient for the VA’s needs.

30. The solicitation States that there must be a “Minimum room size 323 sq. ft. in Zone 4 where the MRI is located.” This would indicate that a minimum trailer size to obtain that much square footage would have to be 12 feet wide. Is that correct? Trailers smaller that 12 foot wide could not meet this Salient requirement.

A: Single or double wide trailers are acceptable for this solicitation. The SOW has been adjusted to remove this requirement. However, the Minneapolis VA finds value in a double wide trailer configuration in order to allow greater space for imaging operations.

31. The solicitation states that the Salient configuration for RF channels, and Gradient strength to be as stated:

a. “RF Tim [204x48] or [204x64]”: Does the government find more technical value or just value in the 64 RF channels over the 48 RF channels since the 64 channels gives more imaging capabilities, and speed to the end user for better patient outcomes?

A: The Minneapolis VA has a preference for the 64 RF channels .

b. Gradient strength “XJ Gradients (33 mT/m @ 125 T/m/s)” or “XQ Gradients (45mT/m @ 200 T/m/s)”: Does the government find more technical value or just value with the much faster XQ gradients since the XQ gradients gives more imaging capabilities, and speed to the end user for better patient outcomes?

A: The Minneapolis VA has a preference for the XQ Gradients

32. Would the government find more value with high channel count coils than the ones listed in the solicitation?

A: The channel counts found within the solicitation are minimums that must be adhered to in any MRI provided. Anything above this count is acceptable but not necessary.

33. ADA compliant dressing room specifies "hard walls and locking door", are those two a requirement?

A: See previous answer in “Previous Solicitation Questions from Contractors and Answers” attachment to the solicitation.

34. Media sanitization at the end of term. The SOW Security Statement requires that non-volatile memory not leave the facility until the ISO certifies data destruction, specifying degaussing for magnetic media and "other forms of cleansing" for non-magnetic media.

For solid-state / non-magnetic storage, will the Government accept a certified sanitization (e.g., NIST SP 800-88 / VA Handbook 6500.1) in lieu of degaussing?

Degaussing the hard drives effectively destroys the hard drives and therefore they would need to be replaced. Essentially, we just need confirmation on whether or not the hard drives will need to be replaced (handed over to biomed at the end of the lease).

A: See above question for turn in/replacement of hard drives.

35. Basis for the re-solicitation. To ensure our quotation fully aligns with the Government's current requirements and avoids any issues identified in the prior procurement, is it possible to share the basis for re-soliciting this requirement? Specifically, are there any corrective actions, revised requirements, or compliance determinations from the prior action that offerors should take into account when QCing their response to this solicitation?

A: This procurement was resolicited due to an error in the previous solicitation regarding the Limitations on Subcontracting clause that was selected. The previous solicitation included VAAR Clause 852.219-76 VA Notice of Limitations on Subcontracting— Certificate of Compliance for Supplies and Products. Since this procurement is categorized as a service the Limitations on Subcontracting clause has been changed to VAAR 852.219-75 VA Notice of Limitations on Subcontracting—Certificate of Compliance for Services and Construction. Offerors must be able to adhere to the Limitations on Subcontracting for services in order to be eligible for this solicitation.

36. The SOW states plans are due within two weeks and construction within one week of plan approval. Please confirm the start point for these periods (contract award versus Government notice-to-proceed / confirmed site access) and confirm that CLIN 0002 covers only the connecting walkway enclosure described, not the potential future full enclosure referenced previously.

A: See above answers for timelines on walkway construction. The period of performance start date is the beginning of the contract. It is the winning contractor’s prerogative if they would like to begin earlier than the date on the contract to ensure timelines are met. Site access will be granted to the winning contractor prior to the period of performance start date if requested. As outline in the Statement of Work, construction cost are only to contain the construction of the walkway. Any costs associated with any enclosure of the walkway at the conclusion of the contract will be discussed at a later date and executed through a modification to the contract.

37. The solicitation references a base-year start of 08/05/2026. Which is a week and a half from solicitation due date. Is that a firm and qualifying/disqualifying delivery date?

A: See above question for adjustments to the period of performance start date. The contractor is expected to adhere to the timelines outlined in the solicitation and the answers provided to offeror questions.

38. If we are offering a brand-new (newly manufactured) trailer and MRI system rather than an existing refurbished unit, would the Government consider flexibility on the delivery/installation date? If not, would the Government accept an interim system until the brand new is complete/delivered at no additional cost to the government? If so, please advise the latest acceptable delivery date or if its flexible based on offering, and confirm whether the base-year period of performance would begin upon acceptance/go-live or remain fixed at 08/05/2026.

A: Offerors are expected to provide an MRI in accordance with the timeline outlined above. The MRI provided should remain on site for the duration of the contract excepting any mechanical/technological failures that would necessitate the exchange of the trailer.

39. Can you provide pictures of the previous walkway that was constructed?

A: Yes, see attached pictures.

A.1 PRICE/COST SCHEDULE

ITEM INFORMATION

ITEM

NUMBE

R

DESCRIPTION OF

SUPPLIES/SERVIC

ES

QUANTIT

Y

UNI

T UNIT PRICE AMOUNT

0001 1.00 EA ________________

Mobile MRI Rental Contract Period: Base POP Begin: 08-15-2026 POP End: 08-14-2027 PRINCIPAL NAICS CODE: 532490 - Other Commercial and Industrial Machinery and Equipment Rental and Leasing PRODUCT/SERVICE CODE: W065 - Lease or Rental of Equipment - Medical, Dental, and Veterinary Equipment and Supplies

0002 1.00 JB ________________

Walkway Shelter Installation Contract Period: Base POP Begin: 08-15-2026 POP End: 08-14-2027 PRINCIPAL NAICS CODE: 532490 - Other Commercial and Industrial Machinery and Equipment Rental and Leasing PRODUCT/SERVICE CODE: W065 - Lease or Rental of Equipment - Medical, Dental, and Veterinary Equipment and Supplies

1001 1.00 YR ________________

Mobile MRI Rental

Contract Period: Option 1 POP Begin: 08-15-2027 POP End: 08-14-2028 PRINCIPAL NAICS CODE: 532490 - Other Commercial and Industrial Machinery and Equipment Rental and Leasing PRODUCT/SERVICE CODE: W065 - Lease or Rental of Equipment - Medical, Dental, and Veterinary Equipment and Supplies

2001 1.00 YR ________________

Mobile MRI Rental Contract Period: Option 2 POP Begin: 08-15-2028 POP End: 08-14-2029 PRINCIPAL NAICS CODE: 532490 - Other Commercial and Industrial Machinery and Equipment Rental and Leasing PRODUCT/SERVICE CODE: W065 - Lease or Rental of Equipment - Medical, Dental, and Veterinary Equipment and Supplies

3001 1.00 YR ________________

Mobile MRI Rental Contract Period: Option 3 POP Begin: 08-15-2029 POP End: 08-14-2030 PRINCIPAL NAICS CODE: 532490 - Other Commercial and Industrial Machinery and Equipment Rental and Leasing PRODUCT/SERVICE CODE: W065 - Lease or Rental of Equipment - Medical, Dental, and Veterinary Equipment and Supplies

4001 1.00 YR ________________

Mobile MRI Rental Contract Period: Option 4 POP Begin: 08-15-2030 POP End: 08-14-2031 PRINCIPAL NAICS CODE: 532490 - Other Commercial and Industrial Machinery and Equipment Rental and Leasing PRODUCT/SERVICE CODE: W065 - Lease or Rental of Equipment - Medical, Dental, and Veterinary Equipment and Supplies

GRAND TOTAL ________________

MRI Mobile System Lease

Statement of Work

Overview Mobile MRI Scanner Lease General: This document highlights the technical specifications and services being requested by the Minneapolis VA Health Care System for consideration towards the lease of a 1.5 Tesla MRI Mobile unit with a high-quality scanner and full range of operational MRI coils.

Performance Period Contractor shall complete the work required under this SOW during base year of 12 months, and all renewed option years of 12 months lengths. Contractor shall work with Mpls. VA HCS Contracting Officer’s Representative (COR) or appointed point of contact (POC) to schedule work.

Contractor will provide a Point of Contact (POC) phone number to contact for all corrective repairs and return all support/ trouble shooting calls within 30 minutes. Contractor shall plan a minimum of 2 scheduled preventative maintenance visits per (12) month term. Scheduled preventative maintenance will be coordinated with Mpls. VA MRI POC and done outside of scanning hours whenever possible to avoid disruption of patient care.

NOTE: Hardware/software update/upgrade installations will be scheduled and performed at a mutually agreed upon time at no additional charge to the Government (unless it would be detrimental to equipment up-time; to be determined by the COR or Mpls. VA MRI POC.

Travel, labor, and replacement parts All Contractor transportation, lodging, and incidental expenses incurred by the Contractor shall be incorporated into the Contractor’s fees and are the sole responsibility of the Contractor.

Contractor is responsible for costs related to travel, labor, and replacement parts for corrective maintenance and repair services. There shall be no additional charge for time spent at the site during or after the normal hours of coverage awaiting the arrival of repair parts.

Training Provided / Training Materials: On-site train-the-trainer clinical applications training (up to 4 days depending on the system provided) for technologists during go-live. Vendor to provide all appropriate training materials and equipment manuals for proper end user training and reference Service Requirements. Contractor responsible for assisting with building imaging exam protocols during training / initial MRI start-up.

Place of Performance Tasks under this SOW shall be performed at the following location:

Minneapolis VA Health Care System 1 Veterans Drive Minneapolis, MN 55417

Changes to Statement of Work Any changes to this SOW shall be authorized and approved only through written correspondence from the CO. A copy of each change will be kept in a project folder along with all other products of the project. Costs incurred by the Contractor through the actions of parties other than the CO shall be borne by the Contractor.

Scope of Work The Contractor shall provide One (1) 1.5 Tesla MRI scanner and software with the newest technology available at time of contract award, offering a full range of clinical applications housed in a mobile trailer. Under this proposal, the Contractor shall provide all software, hardware, accessories, and coils for the MRI scanner to include, but not limited to:

Requirements for the Mobile MRI Unit:

1) 1.5 Tesla MRI scanner (Siemens Aera or equal) and software with the newest technology available at time of contract award offering a full range of clinical applications housed in a mobile trailer.

2) The Contractor will build an enclosed shelter (approximately 10w’ x 20l’x15h’) to connect the MRI coach to the existing Mpls. VA MRI walkway. This structure is to be completed in a week after plans have been approved by the Mpls. VA Engineering department.

Plans for the structure will be submitted within the first two weeks after contract award, prior to construction to show compliance with state building codes and undergo review by the Mpls. VA Engineering department. Plans for the structure are to be prepared and stamped by a certified Architect licensed in the state of Minnesota. The design should be constructed using low-maintenance materials and connect the existing walkway and MRI coach seamlessly. The structure shall be weatherproof, constructed using fire retardant lumber framing with aluminum siding, insulated walls and roofing, and designed to withstand snow loads and wind speeds. Upon contract completion, the portion of the walkway connected to the trailer will be removed by the contractor. The walkway will remain on site with the possibility of enclosing the space. Any additional costs for this process will be discussed at a future date and executed through a modification to the contract. The walkway will be constructed in accordance with the International Building Code (IBC) Chapter 31 for Temporary Structures and the State of Minnesota codes.

3) The Contractor will perform all site planning and provide delivery and removal of MRI mobile coach.

4) Vendor will provide cryogens, service, and preventive maintenance of the MRI equipment.

5) MRI Magnet Specifications:

Field strength 1.5 Tesla Short Bore Design with a bore size of 70 cm Minimum room size 323 sq. ft. in Zone 4 where the MRI is located.

RF Tim [204x48] or [204x64] Gradient strength XJ Gradients (33 mT/m @ 125 T/m/s) or XQ Gradients (45 mT/m @ 200 T/m/s)

6) The mobile coach must be climate controlled and fitted with a safety lift gate which can accommodate patients in wheelchairs and gurneys.

7) In Zone 3, inside the mobile coach:

a) Two MRI staff workstations with seating

b) An ADA compliant dressing Room

c) Lockable storage area for the patient’s personal property

8) The Contractor shall provide all software, hardware, accessories, and a full set of functioning MRI coils, to include at a minimum:

a) 16 channel or greater RF head coil

b) 8 or 16 channel knee coil

c) 8 or 16 channel Neuro Vas coil

d) 16 channel spine coil

e) 8 or 16 channel shoulder coil (small and large)

f) 8 or 16 channel foot / ankle coil

g) 8 or 16 channel hand / wrist coil

h) 8 channel small body array coil or equivalent

i) 16 channel large/XL body array coil or equivalent

9) Tim 4G Application Suite or equivalent with compatible coil interface for multi-channel arrays that minimize cables and maintain high-resolution imaging.

a) Neuro Suite

b) Angio Suite

c) Body Suite

d) Onco Suite

e) Ortho Suite

Applications Software Included or manufacturer’s equivalent.

1. 1D/2D Pace

2. BLADE

3. iPAT2

4. Phoenix

5. WARP

6. MDDW

7. CISS

8. DESST

9. GSE

10. SWI #Tim

10) Detachable MRI Gantry table – safer access to patients in code situations – crucial for patient care of non-ambulatory patients that must be slid from hospital bed to MRI gantry table.

11) Wireless synchronization for physiology and fMRI signals to minimize artifacts.

12) The Contractor shall provide Medrad Spectris Solaris programmable MR injector system with pressure monitor, or equal, having the following capabilities: scan delay, Multiphase option, protocol storing, and pause hold functionality. *To include a single injector kit. (In order for the same kit to be ordered via inventory)

13) The Contractor shall provide an MRI compatible Pulse Oximeter with easy-to-read digital display.

14) The Contractor must maintain MRI equipment at an “up-time” of 90% or better

15) The Contractor will provide a plan for repairs of the MRI trailer to include:

a) A point of contact for reporting system issues, on-site response time for service call back within 30 minutes of notification.

b) If the event requires a Field Engineer (FE) the vendor will have the FE onsite within 24hrs after the vendor is notified and it is determined an FE is required.

c) Resolution for the event will be no greater than 72 hours from the issue being reported. Repairs taking longer than 72 hours may result in negative performance evaluation, equitable price reduction, and possible termination of the contract.

d) Once the repairs are completed a report needs to be generated to reflect what repairs were completed. This report needs to be presented to the VA POC or COR to keep for our records.

16) The mobile scanner system shall be equipped with an outlet connection capable of transmitting data and voice through a Government provided category (CAT 5 or 6a) cable to communicate with the VA’s system.

17) The Contractor’s mobile scanner system must be able to connect to the VA commercial PACS system and Electronic Health Record network and must be able to transmit all images to both systems with HL7 and DICOM imaging standard compatibility.

18) The Contractor’s MRI mobile scanner system Image Quality should be free of system artifacts, meet industry standards, and be of diagnostic quality comparable to MRI images performed in the Minneapolis VA hospital facility using a similar scanner/software combination.

Minneapolis VA Health Care System will be responsible for providing electrical and network connections, network connection software, and hardware connections :

The Government will provide the connection required for the transmission of images, data and voice.

MVAHCS will provide cabling for three (3) voice and three (3) data connections to mobile MRI trailer with weatherproof RJ-45 connectors

All services performed shall be in accordance with the original equipment manufacturer (OEM) specifications. Product delivery will be the responsibility of the vendor working with the VA MRI Biomed POC.

The vendor will be responsible for delivery and installation of the equipment. Summary of Service & Equipment Specifications: Equipment, Software, Hardware, Labor, Travel, Delivery & Installation of a Windows 10 compatible MRI console workstation will be provided by vendor.

VPN/Remote Access: The vendor shall provide any and all equipment service programs, such as remote diagnostics, during the lease period. The system shall provide vendor remote diagnostics via VPN. The vendor shall either utilize the VA national site-to-site VPN or work with the Office of Cyber and Information Security and the VAMC Information Systems Security Officer to establish a client-based VPN. Service and Operator Manuals The vendor shall provide the following documentation for the proposed systems: Two (2) copies of operator instruction manuals (one (1) electronic and one (1) physical copy) Two (2) copies of a service manuals (one (1) electronic and one (1) physical copy)

Minimum Warranty: The system and accessories shall be covered under the manufacturer’s warranty and shall include all parts and labor for the period of this lease This warranty must include PMs as required by the manufacturer. The manufacturer’s factory-trained field service representatives shall perform installation and maintenance during the lease period.

Conformance Standards: Contractor shall provide service and ensure that the equipment functions in accordance with the equipment manufacturer’s technical performance specifications. Contractor shall conform to all regulations to include but not be limited to federal, state, and local governing any chemicals, equipment or work which may be used or performed in the work under this contract.

Preventative Maintenance: Perform system scheduled maintenance inspections as outlined in the user’s manual developed by the manufacturer for the main devices and any peripheral devices of the system. Parts & Software Exchange: All parts and software required for the installation of the system (excludes instruments and accessories) are covered. Part Protection:

Preferred pricing on repairs or replacement due to accidental damage.

Maintenance and repairs to be performed by Certified Trained Technicians: Technicians shall include fully qualified Facility Service Engineers (FSE) and a fully qualified FSE who will serve as the backup and show proof of competency, as shown by training conducted on said system.

"Fully Qualified" is based upon training and on experience in the field. For training, the FSE(s) has successfully completed a formalized training program, for the equipment identified in this statement of work. For field experience, the FSE(s) has a minimum of two years of experience (except for equipment newly on the market) with respect to scheduled and unscheduled preventive and remedial maintenance. Proof of training shall be provided upon demand and be immediately sent via fax, upon demand to the COR. All FSE s and technicians shall be authorized by the Contractor to perform the maintenance services. All work shall be performed by "Fully Qualified" competent FSE's. The COR and/or designated representative specifically reserve the right to reject any of the Contractor's personnel and refuse them permission to work on the VAMC equipment. It is anticipated that any hospital regulatory inspections (TJC, etc.) will have the vendor providing proof that they meet industry standards of quality, and traceable standards, as used to calibrate this device- system, at the time of the maintenance event.

Service Manuals/Tools/Equipment: All required service manuals, tools, and equipment are to be provided by the vendor.

FSE Check in Requirements: The Contractor’s Field Service Engineer must report to the Biomedical Engineering Department to obtain a badge and sign in with the Biomedical Engineering Service before work begins. Submit any mobile media devices that would be used on the system to a virus scan. Upon completion of work, the Field Service Engineer must report to the Biomedical Engineering Service to sign out and brief Biomedical Staff or Supervisor if Biomedical Staff is unavailable concerning completion of service. At the end of briefing Field Service Engineer will return the badge and sign out in the Biomedical Engineering Department.

Documentation: Contractor shall furnish a detailed field service report upon completion of work to Biomedical Staff in the Biomed Department. Payment will not be processed until a properly completed service report is received. The service report shall contain, at a minimum, the following information:

Identification of equipment to be serviced:

VA EE Number Vendor Inventory ID number Manufacturer Name, Device Name, Model Number, Serial Number / System ID Name of contractor and contract number Name of FSE who performed services Contractor service ESR number/log number Date, time (starting and ending), equipment downtime and hours on-site for service call VA purchase order number(s) covering the call if outside normal working hours Total time spent performing maintenance.

Detailed narrative and itemized description of the services required and performed including: Labor and travel Parts (with part numbers) Materials Location, Corrective Action, Copies of all test reports, Complete list of parts replaced (when applicable) Date and time the repair/support was completed Total Cost to be billed (if applicable i.e., part(s) not covered, or service rendered after normal hours of coverage).

Signatures: FSE performing services described Authorized VA employee who witnessed service described

NOTE: - Any additional charges claimed must be approved by the COR or designated representative before service is completed!

The service report shall itemize every item in the specification. Each item shall state the "as found" condition or values, the "calibrated to" or "adjusted to" values, the factory design tolerances, and a complete description of all work performed concerning the items. Included will be a list of new parts used and recommended future repairs.

FSE Reporting Requirements: When the service is completed, the FSE shall document services rendered on a legible ESR(s). The FSE shall be required to log out with Biomedical Engineering and submit the ESR(s) to the COR or designated representative. ALL ESRs shall be submitted to the equipment user for an "acceptance signature" and to the COR or designated representative for an "authorization signature". If COR or designated representative is unavailable, a signed, authorized copy of the ESR will be left with the MRI POC.

Contracting Officer Representatives: Prior to contract award, the Contracting Officer shall designate a VA Health Care System employee as the COR. The Contractor shall be provided a copy of the letter of delegation authorizing the COR at the commencement of the term of the contract. No other person shall be authorized to act in such capacity unless appointed in writing by the Contracting Officer.

Information Technology Security Requirements: The contractor, their personnel, and their subcontractors shall be subject to the Federal laws, regulations, standards, and VA Directives and Handbooks regarding information and information system security as delineated in this contract. The contractor shall comply with all Federal laws and regulations the VA has developed when VA sensitive information is accessed, used, stored, generated, transmitted, or exchanged by and between VA and a contractor. The information made available to the contractor by VA for the performance of this contract will be used only for the purposes of performance under this contract. The certification and accreditation requirements do not apply to this requirement and a security accreditation package is not required.

Security Statement: Sensitive VA information is contained within the systems covered by this contract. Biomedical Engineering shall perform virus scans on all removable media prior to use on VA medical equipment. This includes all types of removable media, including media (e.g., USB devices, CDs, dongles, etc.) that has been issued by VA, media not issued by VA, and media brought in by vendors or independent service organizations. Within accordance of VA Directive 6500, Information Security Program, September 2007 the Vendor will not transfer any VA information to a location outside the VA and only to VA locations determined by the VA System Administrator. The information in these systems may be covered by the Privacy Act 1974 which contains criminal penalties of abuse of information. During onsite service, the Vendor shall be chaperoned by VA Personnel. However, the vendor shall not be issued a User ID/Password. Non-volatile memory devices, working or non-working, shall NOT be removed from the Mpls. VA HCS until the ISO has certified that the data has been destroyed. For magnetic devices and media, the data destruction will be by degaussing. Other forms of cleansing will be used for non-magnetic media. The vendor will not have remote access to complete the repair(s) and preventive maintenance. 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.

Terms of Agreement

1. Replacement Parts and Additional Charges. Contractor shall supply necessary parts, provided replacement of the parts is required because of normal wear and tear or otherwise deemed necessary by Contractor and Mpls. VA HCS All parts will be new, standard parts, or used, reworked or refurbished parts that comply with applicable performance and reliability specifications.

2. Inspection. An initial inspection will be conducted to ensure the equipment is in working order prior to any work being performed. Any deficiencies discovered, or conditions listed in the specified exclusions will not be covered under the Service Warranty Policy.

3. Access to Equipment. Contractor’s authorized representatives shall coordinate with the VA POC or COR to schedule any routine service or maintenance. The Contractor’s Service Representative may charge for time waiting for equipment availability after a sixty (60) minute wait beyond the scheduled time.

General Requirements

1. The Contractor shall provide the COR with a list of contractor employees expected to enter building. While on VA premises, all contractor personnel shall comply with the rules, regulations, and procedures governing the conduct of personnel and the operation of the facility.

2. An access badge will be given to the contractor’s employee upon entrance into VA buildings. The contractor employee must safeguard the access badge and immediately report any lost, stolen, or destroyed badges to the COR. All contract personnel must properly display their access badges. Access badges must always be worn at or above the waist (facing forward) in the facility. The contractor’s employees must return the access badge(s) to the COR or designee when the work is complete.

3. It is the responsibility of the contractor’s personnel to park in the appropriate designated parking areas. Parking information shall be coordinated with each facility COR.

4. Mpls. VA HCS does not validate or make reimbursement for parking violations of the contractor’s personnel under any circumstance.

GOVERNMENT RESPONSIBILITIES:

The Government shall be responsible for making the equipment available to the Contractor during normal business hours. If there is a need for work to be done after hours, the Government will make arrangements for the Contractor to have access to the equipment.

CONTRACTOR PERSONNEL SECURITY REQUIREMENTS:

The contractor shall be required to comply with all security policies/requirements. All security policies/requirements must be met, and employees cleared prior to the contractor performing work under this contract. Employees that cannot meet the security and clearance requirements shall not be allowed to perform work under this contract.

INTERFERENCE TO NORMAL FUNCTION:

Contractor may be required to interrupt their work at any time so as not to interfere with the normal functioning of the facility, including utility services, fire protection systems, and passage of facility patients, personnel, equipment, and carts.

1. In the event of an emergency, contractor services may be stopped and rescheduled at no additional cost to the government.

2. Contractor personnel shall inform the COR or the designee of the need to gain access to secured areas. If access is required to secure areas, prearranged scheduling will be made with COR or designee.

Contracting Requirements

REMOTE ACCESS:

If required, Contractor must comply with all VA Office of Information and Technology security requirements. Contractor must contact Mpls. VA HCS before accessing the system remotely.

REPORTING:

For repairs or services that will be performed during normal working hours, the Contractor’s repairman must report to the Biomedical Engineering Section by telephone at 612-467-2012, and while on station an identification badge shall always be worn. During the repair process, once the problem is identified, the Contractor shall notify VA Biomedical Engineering before replacement parts are installed. After all work is completed, the Contractor’s repairman must again report to the Biomedical Engineering Section and provide a complete report of services or repairs performed for each item of equipment and must also include a listing of replacement parts, when applicable.

NOTE: Payment of invoices may be delayed if the appropriate reports are not properly completed and submitted to the Biomedical Engineering Section as required above.

HOURS OF WORK:

If it is deemed necessary that work be done outside of normal business hours due to clinic schedule, the contract will be flexible and decide – with Mpls. VA HCS staff – on a time that does not impact patient care.

ADDITIONAL SERVICES:

The Contractor guarantees all equipment covered in this contract shall be in optimum working condition at the contract expiration date, provided the Contractor is notified of deficiencies at least one (1) day before the contract expiration date.