S02 - RFQ - 36C25725Q0043 - Mobile MRI.pdf

PAGE 1 OF 1. REQUISITION NO.

2. CONTRACT NO. 3. AWARD/EFFECTIVE DATE 4. ORDER NO. 5. SOLICITATION NUMBER 6. SOLICITATION ISSUE DATE

a. NAME b. TELEPHONE NO. (No Collect Calls) 8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY CODE 10. THIS ACQUISITION IS UNRESTRICTED OR SET ASIDE: % FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ IFB RFP

15. DELIVER TO CODE 16. ADMINISTERED BY CODE

17a. CONTRACTOR/OFFEROR CODE FACILITY CODE 18a. PAYMENT WILL BE MADE BY CODE

TELEPHONE NO. UEI: EFT:

PHONE: FAX:

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER

18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKED

SEE ADDENDUM

19. 20. 21. 22. 23. 24.

ITEM NO. SCHEDULE OF SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

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

25. ACCOUNTING AND APPROPRIATION DATA 26. TOTAL AWARD AMOUNT (For Govt. Use Only)

27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA ARE ARE NOT ATTACHED.

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA ARE ARE NOT ATTACHED

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________ 29. AWARD OF CONTRACT: REF. ___________________________________ OFFER COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND DATED ________________________________. YOUR OFFER ON SOLICITATION DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY (BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER)

30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION (REV. NOV 2021)

PREVIOUS EDITION IS NOT USABLE Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

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

674-25-2-137-0001

36C25725Q0043 11-26-2024

Myrtis F. Clemons 210-818-1575 12-16-2024

13:00 EST

36C257 Department Of Veterans Affairs Network Contracting Office 17 Plaza Lacea 5441 Babcock Road Ste. 302 San Antonio TX 78240

X 100

X

621512

$19 Million

NET 30

N/A

X

36C674

Department of Veterans Affairs Austin Outpatient Clinic Attn: Imaging Service 7901 Metropolis Drive Austin TX 78744

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.

(877) 353-9791 (512) 460-5540

See CONTINUATION Page

Mobile MRI Service including Technologists

See CONTINUATION Page

X X

36C25725Q0043

Table of Contents

SECTION A

A.1 SF 1449 SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

B.3 DELIVERY SCHEDULE

B.4 STATEMENT OF WORK

SECTION C - CONTRACT CLAUSES

C.1 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.2 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

C.3 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000)

C.4 VAAR 852.219-73 VA NOTICE OF TOTAL SET-ASIDE FOR CERTIFIED SERVICE-

DISABLED VETERAN-OWNED SMALL BUSINESSES (JAN 2023) (DEVIATION)

C.5 VAAR 852.219-75 VA NOTICE OF LIMITATIONS ON SUBCONTRACTING—

CERTIFICATE OF COMPLIANCE FOR SERVICES AND CONSTRUCTION (JAN 2023)

(DEVIATION)

C.6 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV

2018)

C.7 VAAR 852.237-75 KEY PERSONNEL (OCT 2019)

C.8 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020)

C.9 VAAR 852.247-71 DELIVERY LOCATION (OCT 2018)

C.10 VAAR 852.247-73 PACKING FOR DOMESTIC SHIPMENT (OCT 2018)

C.11 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (MAY 2024)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

SECTION E - SOLICITATION PROVISIONS

E.1 52.201-1 ACQUISITION 360: VOLUNTARY SURVEY (SEP 2023)

E.2 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB

1998)

E.3 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS

AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)

E.4 52.204-29 FEDERAL ACQUISITION SUPPLY CHAIN SECURITY ACT ORDERS—

REPRESENTATION AND DISCLOSURES (DEC 2023)

E.5 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT 2018)

E.6 52.216-1 TYPE OF CONTRACT (APR 1984)

E.7 52.233-2 SERVICE OF PROTEST (SEP 2006)

E.8 VAAR 852.233-71 ALTERNATE PROTEST PROCEDURE (OCT 2018)

E.9 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND COMMERCIAL

SERVICES (NOV 2021)

E.10 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES (MAY 2024)

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 36C671 Department Of Veterans Affairs Network Contracting Office 17 Plaza Lacea 5441 Babcock Road Ste. 302 San Antonio TX 78240

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] UPON RECEIPT OF INVOICE

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

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

AMENDMENT NO DATE

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

ITEM

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

12.00 EA __________________ __________________

Mobile MRI and technologist for MRI services at the Austin OPC.

Contract Period: Base POP Begin: 01-01-2025 POP End: 12-31-2025 PRINCIPAL NAICS CODE: 621512 - Diagnostic Imaging Centers PRODUCT/SERVICE CODE: Q522 - Medical - Radiology

Option Year 1 for Mobile MRI and technologist services.

Contract Period: Option 1 POP Begin: 01-01-2026 POP End: 12-31-2026

Option Year 2 for Mobile MRI and technologist services.

Contract Period: Option 2 POP Begin: 01-01-2027 POP End: 12-31-2027

Option Year 3 for Mobile MRI and technologist services.

Contract Period: Option 3 POP Begin: 01-01-2028 POP End: 12-31-2028

Option Year 4 for Mobile MRI and technologist services.

Contract Period: Option 4 POP Begin: 01-01-2029 POP End: 12-31-2029

GRAND TOTAL __________________

B.3 DELIVERY SCHEDULE

ITEM

NUMBER SHIPPING INFORMATION QUANTITY

DELIVERY

DATE

0001-

SHIP TO: Department of Veterans Affairs Austin Outpatient Clinic

(AOPC)

7901 Metropolis Drive Austin, TX 78744

USA

12.00

MARK FOR: David Dzenowski david.dzenowski@va.gov

B.4 STATEMENT OF WORK

The Department of Veterans Affairs Austin Outpatient Clinic located at 7901 Metropolis Drive, Austin, TX 78744 has a request for a Mobile MRI Trailer including Technologist Services. The services are to include all the necessary personnel, supervision, equipment, transportation, materials, supplies, and training to perform the services as specified herein. The contract will be for a 12-month base period with four (4) one-year optional renewal periods.

1. GENERAL REQUIREMENTS: The Contractor shall provide a mobile 1.5T MRI Coach and

Technologist Services for CTVHCS, Austin, TX, in accordance with the SOW.

a. Schedule: Services shall be required five (5) days per week.

b. Hours of Service: Contractor's mobile unit and personnel shall be on site to perform exams eight (8) hours per day, Monday - Friday, between the hours of 7:30 am and 4:30 pm. The first MRI will begin at 7:30 am with the last patient being seen such that the exam is completed no later than 4:30pm.

c. Pro-rated Monthly Rental Fee: The Contractor shall prorate the monthly rental fee when

MRI coach is not functioning in accordance with prescribed guidelines. The monthly fee shall be prorated based on the number of hours the coach is out of service during regularly scheduled clinic hours M-F, 7:30am – 4:30pm. The Contractor shall include the hourly rate in the space provided below:

2. CONTRACTOR RESPONSIBILITIES:

a. Contractor shall be solely responsible for all driver and technologist staffing issues related to the operation of the mobile system.

b. Contractor shall provide a mobile 1.5T MRI unit (5 years old or newer) (including scanner, acquisition and processing station, and physician viewing stations) with a high-performance gradient system for use at CTVHCS. Specific equipment requirements include:

(1) Operating system must be Windows 10 or newer

a. MRI system minimum requirements:

i. 1.5T

ii. 45 mT/m gradient strength “minimum prerequisites”

iii. 200 T/m/s Slew rate [T/m/s} “minimum prerequisites”

iv. 70 cm Bore dimensions.

v. 550 lbs. or greater scanner table weight limit

vi. Minimum number of receiver channels – 45

vii. Motorized table with integrated coil design and ports

viii. Patient positioning and support aids

ix. MRI compatible dual head injector pedestal or ceiling mounted.

x. Zero boil-off cryogen technology

1. Vendors are expected to provide and install all cryogens.

xi. Chiller must meet or exceed MRI and location needs.

1. Central Texas temperature can exceed 100 deg F

xii. All phantoms that are required for calibration and performance verification.

1. Vendor must provide ACR compliant phantom for system QA.

b. Software minimum requirements:

i. Motion correction technology

ii. Magnetic Artifact Reduction

iii. Noise reduction

iv. ECG (VCG), respiratory, and peripheral pulse gating/triggering

v. Real-time MIP, MPR, and 3D surface rendering

vi. Advanced non-contrast MRA imaging technology

vii. Bolus tracking capabilities

viii. Integrated music system to include:

1. Direct communication and audio for patients

2. MRI safe headphones

ix. Video camera system for patient monitoring

c. Advanced Applications requirements:

i. 3D processing for all modality datasets

ii. Neuro package

iii. Ortho package

iv. Body package with respiratory navigator

v. Musculoskeletal software package

vi. Oncology package

vii. Vascular package

viii. MRA package

ix. Cardiac MRI package

x. Elastography package

xi. MRI spectroscopy package that includes single voxel, 2D/3D chemical shift imaging

xii. FAT analysis calculation including iron analysis

xiii. Phase contrast MRI and flow analysis

xiv. Parametric prostate imaging package

xv. Diffusion Brain, whole body, computed, microview, and FSE

xvi. Diffusion B value capabilities from 0-35000

xvii. Diffusion computed B-values 0-2500

xviii. Diffusion Tensor Imaging

xix. Water/Fat shift Imaging

xx. Blood oxygen level dependent imaging

xxi. Whole heart coronary, QF, cardiac tagging and mapping

d. Processing Workstation minimum requirements:

i. Stitching

ii. Dynamic evaluation

iii. Brain perfusion

iv. MRS (SVS, CSI)

v. Advanced neuro (DTI, tractography, BOLD)

vi. MAPs

vii. Fusion

viii. Breast evaluation

ix. Vessel analysis

x. Cardiac function and flow quantification

xi. Workstation computer with 23-inch LCD Monitor

e. Mobile Trailer minimum requirements:

i. 12’ x 60’

ii. 40” minimum width RF scan room door

iii. Patient Changing Room with locking storage for valuables

iv. Patient Hydraulic Lift

v. Patient stairs & Landing

vi. Code blue button

vii. Nurse call button

viii. Handwashing facilities

(2) The RF coils supplied with the system will include at a minimum:

a) Multi-Channel Phased Array NV/head/neck Coil

b) Multi-Channel Phased Array for spine Coil – table integrated assembly

c) Multi-Channel Phased Array Shoulder Coil

d) Multi-Channel Phased Array Body Coil

e) Multi-Channel Phased Array Knee Coil

f) Multi-Channel Phased Array Ankle/Foot Coil

g) Multi-Channel Phased Array Shoulder Coil

h) Multi-Channel Phased Array Wrist/Hand Coil

i) Multi-Channel Phased Array Blanket style Super flex Body Coil

j) Multi-Channel Phased Array Super Flex small Coil

k) Multi-Channel Phased Array Run-off compatible Coil

l) Multi-Channel Prostate imaging compatible Coil

m) Multi-Channel Elbow imaging compatible Coil

(3) A power injector for intravenous contrast administration must be included

(4) The scanner must be able to scan:

a) Cervical, thoracic, and lumbar spines continuously without requiring patient movement

b) Liver Elastography

c) Prostate Imaging

d) Rectal Imaging

(5) The system must be capable of performing 2D,3D TOF & PCA and total Body contrast enhanced MRA (intracranial and body) studies

(6) The scanner must include some form of effective noise abatement system for the patients

(7) The scanner must offer a patient entertainment system that enables the patient to experience digital media during the MRI scan procedures

c. Contractor shall be responsible for the transportation of the Mobile MRI coach to and from CTVHCS. Cost of transportation shall be included in the monthly rate. Austin facility is gated and locked after-hours. The facility is open from 6:30 am through 6 pm Monday through Friday for removal of trailer for other assignments.

d. 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 mobile trailer. Installation/setup shall be accomplished in accordance with industry standards, all OSHA regulations and applicable manufacturer's recommendations.

e. Contractor's Equipment: The Contractor shall be responsible for the following daily functions:

(1) Transmit completed electronic data after each exam. Ensure that all of the day’s exam data is completely transferred to the CTVHCS computer systems.

(2) Any patient data archived to magnetic optical disk (MOD), or DVD is handed to a designated VA staff member for storage on site at CTVHCS. The MOD and/or DVD shall be the property of CTVHCS. All patient information required for Contractor's records shall be secured in accordance with HIPAA guidelines.

(3) All connections from the trailer to CTVHCS property are properly disconnected from trailer when moved from CTVHCS’ site.

(4) Any temporary site preparations are removed upon completion of services.

(5) Contractor shall ensure mobile MRI is maintained in optimum working condition to ensure the highest level of patient safety at all times. Maintenance documents shall be made available to CTVHCS upon request

f. Contractor shall ensure each patient arriving for mobile MRI exam has a written or electronic medical record physician order to receive services and a completed MRI Screening Checklist.

g. Contractor shall use appropriate screening devices to ensure patient has no ferro-magnetic materials on or in his/her body.

h. Contractor shall be responsible for adhering to all Federal regulations regarding patient care, patient safety, medical practice and operation of mobile MRI.

i. Contractor shall provide a copy of a current, comprehensive MRI Safety Program policy to which each technologist is expected to comply. MRI Technologist is required to complete CTVHCS MRI Safety Training yearly.

j. Contractor shall be responsible for patient after pick up at the designated area, while on the mobile unit and during the entire scanning procedure up to the patient's release.

k. In the event a patient is injured while in Contractor's care, Contractor shall immediately notify the assigned nurse or a designated VA physician and complete a written report.

l. Contractor shall be responsible for providing a qualified MRI Technologist(s) to perform services defined herein. The MRI Technologist shall be required to provide scanning services as well as training on the full operation of the Mobile MRI unit. Training shall be provided to the assigned CTVHCS technical personnel at no additional cost to the Government. If the MRI Technologist is unable to come in to work as per the schedule, an alternate MRI Technologist is available to cover the shift to avoid having to reschedule patients. All MRI Technologists must complete the credentialing requirements established by CTVHCS.

m. Environment of Care Rounds shall be conducted quarterly by the COR and CTVHCS

Austin Administrator. All identified deficiencies shall be corrected by the Contractor prior to the next scheduled day of service.

3. MAINTENANCE REQUIREMENTS:

a. Contractor shall be responsible for all maintenance of the unit including all PMs as required by the manufacturer’s literature. The Contractor shall assume all cost for labor and parts including glassware and will make all arrangements for service upon notification of failure. Contractor shall communicate these occurrences and progress in a timely manner with Imaging Service staff and Biomedical Staff. Anyone performing maintenance on the unit shall be factory trained by the manufacturer on this specific unit. Any FDA alerts or recalls associated with this equipment will be ameliorated in a timely manner.

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

c. Contractor shall ensure a 95% or better up-time based upon the normal operation hours, Monday – Friday, 7:30 a.m. – 4:30 p.m.

d. If the system breaks down, the MRI Technologist is responsible for informing Imaging

Service representative and Bio Medical of the issue immediately upon determining there is a problem. The MRI Technologist will contact the vendor immediately if an on-site service technician is needed. It is expected that the on-site service technician will respond within 2 hours to determine what the problem is and a proposed timeframe of how long the machine is expected to be down. Repairs and delays that will be beyond two working days will require a replacement trailer to be brought in.

4. CTVHCS RESPONSIBILITIES:

a. CTVHCS shall provide a covered walkway, utility connections, and an appropriate computer line(s) for use by the Contractor.

b. CTVHCS shall be responsible for scheduling exams for the mobile MRI unit.

c. CTVHCS shall transport patients to the VA furnished waiting area.

d. CTVHCS shall identify patients and provide and administer prescribed sedation which patients may require prior to the scans provided by the Contractor. Sedated patients shall be identified and given special care by the Contractor during the performance of procedures. A CTVHCS registered nurse shall monitor sedated patients in the Contractor's trailer.

Conscious sedation/moderate sedation will not be used for these exams.

5. CONTRACTOR PERSONNEL QUALIFICATIONS/POLICIES:

a. The Contractor's Technologist shall possess a current Radiologic Technologist (RT) license, through the ARRT. A copy of all applicable operators’ license(s) shall be provided with the proposal along with a copy of the updated license immediately upon renewal. The Contractor shall ensure that a copy of the technologist’s current license is provided to the COR for inclusion in CTVHCS’ 6-part folder at all times.

b. The Contractor shall be responsible to ensure that Contractor employees providing work on this contract are fully trained and completely competent to perform the required work.

Evidence of the Contractor’s Technologist’s competency review shall be provided with the proposal. Competency checklists must contain evidence of supervisory review at least annually and must contain the written signature of the supervisory official performing the review. A current copy of the employee’s competency checklist shall be maintained in CTVHCS’ 6-part folder at all times. Competency checklists shall be resubmitted to CTVHCS each time the checklist is updated, no more than 12 months beyond the original date of review.

c. The Contractor shall be required to maintain documentation and provide copies, with their proposal, of the following for each employee working under the contract:

(1) credentials and qualifications for the job

(2) a current competency assessment checklist (an assessment of knowledge, skills, abilities, and behaviors required to perform a job correctly and skillfully; includes age-specific knowledge and skills required to provide care for certain patient populations, as appropriate.)

(3) a listing of relevant continuing education for the last two years.

(4) health examination records of all individuals performing work under this contract to ` include:

(a) Annual TB Skin Test and recent (within the last year) chest X-ray if there is a history of positive TB skin test

(b) Evidence of Hepatitis B immunity (hepatitis immune titer, if provider has had the series of shots; if no immunity, evidence that provider has started the Hepatitis B vaccination series.)

(c) Varicella titer if provider has not had chicken pox and has direct patient contact.

This is a non-personal health care service contract under which the Contractor is an independent Contractor. Contractor employees shall not be considered VA employees for any purpose.

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

a. Contractor shall make whatever adaptations are necessary so that the Contractor's equipment is compatible with the CTVHCS data network as specified in Paragraph 12, Telecommunications.

b. MRI images shall be of a high-resolution diagnostic image quality.

c. The Mobile MRI unit shall be ready for use regardless of outside environmental conditions.

d. The Mobile MRI unit shall maintain a temperature to assure proper operation of the scanner and provide for patient comfort.

e. The Mobile MRI unit shall include a private dressing area with secured cabinets for patient use.

f. Contractor shall provide an MRI-compatible Automatic External Defibrillator (AED). The system must contain the minimum characteristics:

(1) AED Unit with LCS Screen showing voice prompt messages, device advisory messages, elapsed time, shock count and chest compression graph, Operator's Guide and Carrying Case;

(2) Two (2) Sets of CPR-D Pads, one piece defibrillation and CPR system with compression, depth and rate sensors, supplies with gloves, barrier mask, scissors, razor, wet wipes and dry wipes;

(3) Two (2) Sets of Type 123 Lithium Batteries with storage sleeve.

7. 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 (JC) 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) the established principles and ethics of the medical profession established by the AMA and ACEP and is responsible for the quality of care rendered to all patients.

(3) all relevant Federal and State regulations regarding patient care, medical practice, operation of MRI equipment; to include but not be limited to

Occupational Safety and Health Act (OSHA) The Joint Commission (JC) Veterans’ Health Administration (VHA) United States Department of Transportation (US DOT) Health Information Portability and Accountability Act (HIPAA) VHA Automated Information Security (AIS) Privacy Act CTVHCS Medical Staff Bylaws

Contractor shall ensure that the equipment/system functions in conformance with the latest published edition of OSHA and the manufacturer's specifications.

Contractor shall 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 Veterans Health Administration (VA).

8. MRI STUDY INTERPRETATION: A CTVHCS radiologist shall read/interpret all MRI studies and dictate all required study reports.

9. MRI DATA OWNERSHIP: CTVHCS shall maintain sole ownership of all data of studies performed on the mobile 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 CTVHCS.

10. EMERGENCIES ON MOBILE MRI UNIT: Emergency 911 shall handle all medical emergencies occurring on the mobile coach. The Contractor shall provide, with their proposal, a written emergency plan addressing emergencies such as patient codes, personal injury, fire, and disruptive behavior.

11. MRI POINT OF CONTACT: The Contracting Officer may designate an individual as the

Contracting Officer's Technical Representative (COR) who shall be the primary point of contact at CTVHCS for communication between CTVHCS and the Contractor with regards technical aspects of imaging protocols and medical aspects of MRI studies. The Contractor shall communicate to the COR any possible and actual disruptions of MRI service. Upon becoming aware of possible or actual disruption of MRI service, the Contractor shall communicate such service-disruption information to the COR in a timely manner so that patient and service schedules can be appropriately modified with as little inconvenience as possible to patients and services. The Contractor shall provide contact information with their solicitation proposal and provide an update to CTVHCS immediately upon any change in the designation(s).

12. TELECOMMUNICATIONS:

a. 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. (PACS interface contact person shall be provided to the Contractor during the post-award orientation).

b. The Contractor shall be responsible for all expenses incurred to interface the MRI

Scanner OEM using the DICOM 3.0 network with the existing VISTA RAD (soon to be McKesson PACs system). System must be compatible with HL7 – V2.3 soon to be V2.4.

14. CONFIDENTIALITY OF PATIENT RECORDS:

a. The Contractor, as a VA provider, shall assist in the provision of health care to patients seeking such care from or through VA. As such, the Contractor is considered as being part of the Department health care activity. Contractor is considered to be a VA provider for purposes of the Privacy Act, Title 5 U.S.C. 552a. Further, for the purpose of VA records access and patient confidentiality, Contractor is considered to be a VA provider for the following provisions: Title 38 U.S.C. 5701, 5705, and 7362. Therefore, Contractor may have access, as would other appropriate components of VA, to patient medical records including patient treatment records pertaining to drug and alcohol abuse, HIV, and sickle cell anemia, to the extent necessary to perform its contractual responsibilities. However, like other components of the Department, and not withstanding any other provisions of the contract, the Contractor is restricted from making disclosures of VA records, or information contained in such records, to which it may have access, except to the extent that explicit disclosure authority from VA has been received. The Contractor is subject to the same penalties and liabilities for unauthorized disclosures of such records as VA.

b. The records referred to above shall be and remain the property of VA and shall not be removed or transferred from VA except in accordance with U.S.C.551 a (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) and Federal laws, rules and regulations. Subject to applicable Federal confidentiality or privacy laws, the Contractor, or their designated representatives, and designated representatives of Federal regulatory agencies having jurisdiction over Contractor, may have access to VA's records, at VA's place of business on request during normal business hours, to inspect and review as needed in order to perform the examination contracted for but in no case will copies of records be made and/or removed from the VA’s place of business.

15. HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT OF 1996

(HIPAA):

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.

16. CONTRACT INFORMATION SECURITY REQUIREMENTS:

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.

CONTRACTOR PERSONNEL SECURITY REQUIREMENTS: LOW RISK

(1) All Contractor employees having or requiring access to the Department of Veterans Affairs’ computer systems or to sensitive data (to include patient or beneficiary records), shall be the subject of a background investigation and must receive a favorable adjudication from the VA Security Investigation Center prior to contract performance. This requirement is applicable to all subcontractor personnel requiring the same access.

(2) The Contracting Officer will provide the appropriate Background Investigation information to the Contractor for completion. Required background investigation initiation documentation must be completed and returned to the Contracting Office within five (5) calendar days after receipt.

(3) Contractor staff shall not begin performance until notification is received from the Contracting Officer that the Security Package has been received and is considered a complete package. It is not necessary that the full investigation be complete prior to commencement of work. However, if the investigation is not completed prior to the start date of the contract, the Contractor shall be responsible for the actions of those individuals they provide to perform work for VA.

(4) Position Sensitivity - The position sensitivity has been designated as Low Risk.

(5) Background Investigation - The level of background investigation commensurate with the required level of access is a National Agency Check with Written Inquiries (NACI).

(6) Contractor Responsibilities:

a. The Contractor shall bear the expense of obtaining background investigations. The VA shall be responsible for payment to the Security Investigations Center; however, upon final payment, the VA shall submit a Bill of Collections to the Contractor. The Contractor shall be responsible for reimbursement to the VA within thirty (30) calendar days. The current cost for a low-risk background investigation is $230 per case.

b. For Low-Risk Sensitivity Designation, each Contractor/Subcontractor employee must complete the following forms.

i. Standard Form 85, Questionnaire for Non-Sensitive Positions

ii. (ii)Optional Form 306, Declaration for Federal Employment

c. The Contractor, when notified of an unfavorable determination by the Government, shall withdraw the employee from consideration from working under the contract.

d. Failure to comply with the Contractor personnel security requirements may result in termination of the contract for default.

(7) Fingerprinting Requirements – Contractor/subcontractor employees will be required to have fingerprints taken as part of the background investigation process. The preferred method of obtaining fingerprints is to have them taken electronically at the Human Resources Service at a VA facility. If fingerprints cannot be obtained at a VA facility the Contracting Officer will provide the Contractor with a Form FD258 fingerprint chart, which can be taken to any local police station for fingerprints. However, local entities may assess a fee for this service. The fingerprint chart must accompany the OF 306 when returned by the contractor.

ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS:

(1) A contractor/subcontractor shall be granted 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.

(2) All contractor/subcontractors 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.

(3) 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.

INFORMATION SYSTEM HOSTING, OPERATION, MAINTENANCE, OR USE.

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

(2) 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:

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

(b) 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

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

(d) 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;

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

(4) 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.

(5) 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.

TRAINING:

(1) All contractor employees and subcontractor employees requiring access to VA information and VA information systems shall complete the following before being granted access to VA information and its systems:

(a) Sign and acknowledge (either manually or electronically) understanding of and responsibility for compliance with the Contractor Rules of Behavior, attached, relating to access to VA information and information systems.

(b) Successfully complete the VA Cyber Security Awareness and Rules of Behavior training and annually complete required security training;

(c) Successfully complete the appropriate VA privacy training and annually completed required privacy training; and

(d) Successfully complete any additional cyber security or privacy training, as required for VA personnel with equivalent information system access as deemed necessary.

(2) The contractor shall provide the contracting officer and/or the COR a copy of the training certificates and certification of signing the Contractor Rules of Behavior for each applicable employee within one week of the initiation of the contract and annually thereafter, as required.

(3) Failure to complete the mandatory annual training and sign the Rules of Behavior annually, within the timeframe required, is grounds for suspension or termination of all physical or electronic access privileges and removal from work on the contract until such time as the training documents are complete.

17. CONTRACTOR REMOTE ACCESS REQUIREMENTS: The Contractor shall be allowed remote access to VA computer systems or network in the performance of the contract.

VA has stringent policies and procedures covering remote access, therefore the following responsibilities are outlined below:

a. All remote connections to the VA network shall be through the Office of Cyber and

Information Security (OCS) authorized configurations and access points. Contractor's remote access sessions through the Internet or other networks shall be conducted using VA's remote access Virtual Private Network (VPN) Service.

b. The VA shall provide secure and reliable remote access to systems, applications, and information on the VA network to the Contractor.

c. All Contractor personnel requesting remote access shall be required to sign a One-VA VPN

Rules of Behavior. The Contractor shall be responsible to ensure Contractor personnel follow the terms of the agreement.

d. VA shall provide VPN software; host based personal firewall, and anti-virus software to the

Contractor.

e. The Contractor shall install VA provided VPN software, host-based personnel firewall, and anti-virus protection software on all Contractor computer systems that will connect to the VA network or computer systems.

f. The Contractor shall adhere to the remote access requirements, and ensure that systems are properly configured, and appropriately security mechanism and monitoring devices are up to date with best practices and technical standards.

18. PATIENT REFERRAL: The Contractor is not authorized to refer any VA patients for additional medical treatment.

19. LIABILITY AND INSURANCE COVERAGE: The Contractor shall provide insurance coverage in accordance with Federal Acquisition Regulation (FAR) Clause 52.228-5, "Insurance

- Work On A Government Installation (Jan 1997)" and VA Acquisition Regulation (VAAR) Clause 852.237-7, "Indemnification And Medical Liability Insurance (Oct 1996) incorporated herein under the Clause Section. The Contractor shall furnish a proof of insurance certificate prior to commencement of services under the awarded contract.

20. POST AWARD REQUIREMENTS: The Contractor shall be responsible to contact the COR upon receipt of Notice of Award to schedule a post-award orientation. This orientation shall be held on a mutually agreed upon date and time to discuss commencement of services, completion of site renovations required to accept the equipment, scheduling of patients and additional services defined in the specifications.

21. ID BADGES/PARKING/SMOKING POLICY:

a. BADGES: All Contractor personnel are required to wear identification (ID) badges during the entire time they are on the VA grounds.

b. PARKING: It is the responsibility of Contractor personnel to park only in designated parking areas. Parking information is available from the VA Security Service. The VA will not invalidate or make reimbursement for parking violations of the Contractor’s personnel under any circumstances.

c. SMOKING: Smoking is not permitted within or around the VA Healthcare System facilities, except in designated areas.

(END OF SOW)

SECTION C - CONTRACT CLAUSES

ADDENDUM to FAR 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES

Clauses that are incorporated by reference (by Citation Number, Title, and Date), have the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available.

The following clauses are incorporated into 52.212-4 as an addendum to this contract:

C.1 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):

https://www.acquisition.gov/browse/index/far https://www.va.gov/oal/library/vaar/

(End of Clause)

FAR

Number

Title Date

52.203-17 CONTRACTOR EMPLOYEE WHISTLEBLOWER RIGHTS NOV 2023

52.204-13 SYSTEM FOR AWARD MANAGEMENT MAINTENANCE OCT 2018

52.204-18 COMMERCIAL AND GOVERNMENT ENTITY CODE

MAINTENANCE

AUG 2020

52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES

NOV 2023

852.203-70 COMMERCIAL ADVERTISING MAY 2018

852.246-71 REJECTED GOODS

OCT 2018

C.2 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor within 10 DAYS.

C.3 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR

2000)

(a) The Government may extend the term of this contract by written notice to the Contractor within 10 DAYS; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 20 days before the contract expires. The preliminary notice does not commit the Government to an extension.

(b) If the Government exercises this option, the extended contract shall be considered to include this option clause.

(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed five (5) years.

C.4 VAAR 852.219-73 VA NOTICE OF TOTAL SET-ASIDE FOR CERTIFIED

SERVICE-DISABLED VETERAN-OWNED SMALL BUSINESSES (JAN 2023)

(DEVIATION)

(a) Definition. for the Department of Veterans Affairs, ‘‘Service-disabled Veteran-owned small business concern or SDVOSB’’:

(1) Means a small business concern—

(i) Not less than 51 percent of which is owned by one or more service-disabled Veterans or, in the case of any publicly owned business, not less than 51 percent of the stock of which is owned by one or more service-disabled Veterans or eligible surviving spouses (see VAAR 802.201, Surviving Spouse definition);

(ii) The management and daily business operations of which are controlled by one or more service-disabled Veterans (or eligible surviving spouses) or, in the case of a service-disabled Veteran with permanent and severe disability, the spouse or permanent caregiver of such Veteran;

(iii) The business meets Federal small business size standards for the applicable North American Industry Classification System (NAICS) code identified in the solicitation document;

(iv) The business has been certified for ownership and control pursuant to 38 U.S.C. 8127, 13 CFR 128, and is listed as certified in the SBA certification database at https://veterans.certify.sba.gov/; and

(v) The business agrees to comply with VAAR subpart 819.70 and Small Business Administration (SBA) regulations regarding small business size, government contracting, and the Veteran Small Business Certification Program at 13 CFR parts 121, 125, and 128.

(2) The term ‘‘Service-disabled Veteran’’ means a Veteran, as defined in 38 U.S.C. 101(2), with a disability that is service-connected, as defined in 38 U.S.C. 101(16).

(3) The term ‘‘small business concern’’ has the meaning given that term under section 3 of the Small Business Act (15 U.S.C. 632).

(4) The term ‘‘small business concern owned and controlled by Veterans with service-connected disabilities’’ has the meaning given the term ‘‘small business concern owned and controlled by service-disabled veterans’’ under section 3(q)(2) of the Small Business Act (15 U.S.C. 632(q)(2)).

(5) The term “SDVOSB participant” or certified SDVOSB means a small business that has been certified in the SBA Veteran Small Business Certification Program and listed in the SBA certification database (see 13 CFR 128.102).

(b) General. In order for a concern to submit an offer and be eligible for the award of an SDVOSB set-aside or sole source contract, the concern must qualify as a small business concern under the size standard corresponding to the NAICS code assigned to the contract and be listed as an SDVOSB participant in the SBA certification database as set forth in 13 CFR 128.

(1) Offers received from entities that are not certified SDVOSBs and listed in the SBA certification database at the time of offer shall not be considered.

(2) Any award resulting from this solicitation shall be made to a certified SDVOSB listed in the SBA certification database who is eligible at the time of submission of offer(s) and at the time of award.

(3) The requirements in this clause apply to any contract, order or subcontract where the firm receives a benefit or preference from its designation as an SDVOSB, including set-asides, sole source awards, and evaluation preferences.

(c) Representation. Pursuant to 38 U.S.C. 8127(e), only certified SDVOSBs listed in the SBA certification database are considered eligible to receive award of a resulting contract. By submitting an offer, the prospective contractor represents that it is an eligible and certified SDVOSB as defined in this clause, 13 CFR 121, 125, and 128, and VAAR subpart 819.70.

(d) Agreement/LOS certification. When awarded a contract action, including orders under multiple award contracts, an SDVOSB agrees that in the performance of the contract, the SDVOSB shall comply with requirements in VAAR subpart 819.70 and SBA regulations on small business size, and government contracting programs at 13 CFR part 121 and part 125, including the non-manufacturer rule and limitations on subcontracting (LOS) requirements in 13 CFR 121.406(b) and 13 CFR 125.6. For the purpose of limitations on subcontracting, only certified SDVOSBs listed in the SBA certification database

(including independent contractors) shall be considered eligible and/or ‘‘similarly situated’’ (i.e., a firm that has the same small business program status as the prime contractor). An otherwise eligible firm further agrees to comply with the required LOS certification requirements in this solicitation (see 852.219–75 or 852.219–76 as applicable). These requirements are summarized as follows:

(1) Services. In the case of a contract for services (except construction), the SDVOSB prime contractor will not pay more than 50% of the amount paid by the government to the prime for contract performance to firms that are not certified SDVOSBs listed in the SBA certification database (excluding direct costs to the extent they are not the principal purpose of the acquisition and the SDVOSB/ VOSB does not provide the service, such as airline travel, cloud computing services, or mass media purchases). When a contract includes both services and supplies, the 50 percent limitation shall apply only to the service portion of the contract.

(2) Supplies/products.

(i) In the case of a contract for supplies or products (other than from a non-manufacturer of such supplies), the SDVOSB prime contractor will not pay more than 50% of the amount paid by the government to the prime for contract performance, excluding the cost of materials, to firms that are not certified SDVOSBs listed in the SBA certification database. When a contract includes both supply and services, the 50 percent limitation shall apply only to the supply portion of the contract.

(ii) In the case of a contract for supplies from a non-manufacturer, the SDVOSB prime contractor will supply the product of a domestic small business manufacturer or processor, unless a waiver as described in 13 CFR 121.406(b)(5) has been granted. Refer to 13 CFR 125.6(a)(2)(ii) for guidance pertaining to multiple item procurements.

(3) General construction. In the case of a contract for general construction, the SDVOSB prime contractor will not pay more than 85% of the amount paid by the government to the prime for contract…