36C24725Q0875 0001_2 RFQ Amendment.pdf

5. PROJECT NUMBER (if applicable)

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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

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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

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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.)

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(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 31

0001 09-15-2025 557-26-1-2115-0001 None

Department of Veterans Affairs VISN 7 Network Contracting Activity 501 Greene Street Hatcher Building - Suite 2 Augusta GA 30901

Department of Veterans Affairs VISN 7 Network Contracting Activity 501 Greene Street Hatcher Building - Suite 2 Augusta GA 30901

To all Offerors/Bidders 36C24725Q0875

09-10-2025 X

X X

See CONTINUATION Page

The purpose of this amendment is to add and update corrections to the Statement of Work (SOW) and to address questions received.

RFQ due date is hereby extended to 9/19/2025 12PM EST.

Changes made to the period of performance are as follows:

Base year 11/22/2025-11/21/2026 Option Year 1 – 11/22/2026-11/21/2027 Option Year 2- 11/22/2027-11/21/2028 Option Year 3- 11/22/2028-11/21/2029 Option Year 4- 11/22/2029-11/21/2030

1. Confirm if the unit's maintenance schedule and servicing are to be included by the contractor?

A. Please see amended language in section 3.5 of the Statement of work that will address the maintenance and servicing schedule.

2. Is the unit ACR-accredited a requirement?

A. No

3. How far in advance can schedules be changed or adjusted?

A. Patient schedules are always booked outward of 1 (one) month. MRI staffing- staff are required each day (with notification of backup if needed). MRI maintenance schedules-notification ASAP is required.

4. What is the protocol for urgent or stat scans?

A. Stat- process within one hour but only for spinal cord compression; Urgent within 48 hours. Both are extremely rare occurrences.

5. Please confirm whether staffing is to be included with the mobile MRI unit or billed separately?

A. MRI staffing is included in billing. Please see Section B.2 for updated line items.

6. Are utilities (power, internet, HVAC) included or separate?

A. HVAC is not included; all other utilities are included.

7. What space or site requirements are needed to park and operate the unit?

A. Concrete pad area will accommodate a Mobile MRI unit of 12’x60’. Area measurements of 14 ft. (W) x 68 ft. (L) x 16 ft. (H).

8. Does the facility assist with permitting, site prep, or pad construction?

A. The unit will rest on a concreate pad that is already in place.

9. How is the unit secured after hours?

A. MRI staff will secure the doors and confirm the unit is locked.

10. Please provide pictures of the setup area, connections, or may a site visit be granted?

A. Pictures attached below.

11. What size/type of truck will fit to deliver the unit, and what height clearance is required?

A. Concrete pad area will accommodate a Mobile MRI unit of 12’x60’. Area measurements of 14 ft. (W) x 68 ft. (L) x 16 ft. (H).

12. Will the facility assist the contractor with EMR integration or PACS connectivity? Please confirm which computer operating system/version and connections will be used.

A. Yes, facility will assist the vendor with set up and EMR integration. Systems must be

Windows 11 compliant/compatible, Philips BUE PACS system, VistA/CPRS system for patient records/information. See updated Statement of Work Section 3.2 C.

13. Could you provide me with any information regarding if the Dublin VA has any preference to GE or Siemens MRI equipment?

A. Please see the minimum machine requirements in the above statement of work, section

3.1.

14. We would like to know if this is a brand-new contract OR if there is (was) an incumbent performing these services.

A. This is a recurring requirement.

15. If not brand new, could you please provide the current / previous contract number?

A. 36C24720P1148

STATEMENT OF WORK

Mobile MRI Services

1. General Information

1.1 Overview: This is a non-personal services requirement to provide Mobile MRI Scanner Services for the Department of Veterans Affairs, Carl Vinson VA Medical Center (CVVAMC), Radiology Service. The Government will not exercise any supervision or authority over the Contractor personnel providing these services. Contractor personnel rendering services under this requirement are not subject, either by the contract terms or by the manner of its administration, to the supervision and control usually prevailing in relationships between the Government and its employees. Such contract services providers shall be accountable solely to the Contractor who, in turn, is responsible for providing services to the Government as stated herein.

1.2 Contract Type: Firm Fixed Price

1.3 Place of Performance: Carl Vinson VA Medical Center, Radiology Service 1826 Veterans Blvd. Dublin, GA 31021

1.4 Period of Performance: The services shall be provided for one (1) 12-month base period, and four (4) 12-month option periods.

Base Year 11/22/2025-11/21/2026 Option Year 1 11/22/2026-11/21/2027 Option Year 2 11/22/2027-11/21/2028 Option Year 3 11/22/2028-11/21/2029 Option Year 4 11/22/2029- 11/21/2030

1.5 Hours of Operation: The contractor shall provide the service during the hours of operation Monday-Friday 8:00 AM – 4:30 PM eastern standard time (EST) and is subject to change depending on the Governments need. Weekends may be added through contract modification if funds permit. The Government observes the following holidays:

New Year’s Day January 1

Martin Luther King Birthday Third Monday in January

President’s Day Third Monday in February

Memorial Day Last Monday in May

Juneteenth Independence Day June 19th

Independence Day July 4

Labor Day First Monday in September

Columbus Day Second Monday in October

Veterans Day November 11

Thanksgiving Day Fourth Thursday in November

Christmas Day December 25

Other Federal Holidays Any other day specifically declared to be a national holiday (per Federal Statute, Executive Order, or by the President’s Proclamation).

2. Scope: The Contractor shall provide all personnel, equipment, materials, supplies, services, and supervision necessary to provide mobile MRI scanner services and qualified MRI technologists as detailed in the schedule of Supplies/Services and Price/Cost, all in accordance with the Statement of Work (SOW), terms and conditions described herein. to perform imaging procedures at the Carl Vinson VAMC, Dublin, GA as stated herein.

3. Performance Requirements: Mobile MRI scanner shall be outfitted with changing area and locker for patient use and a ramp of lifting device for non-walking patients.

3.1 Specifications (Mobile MRI): The contractor shall provide a mobile magnetic resonance scanner (mobile MRI) to perform the following examinations:

A. Head (including brain, posterior fossa, temporomandibular Joint (TMJ), pituitary gland, and acoustic nerve, MRA and MRV capabilities.

B. Cervical spine (including spinal cord)

C. Thoracic spine (including spinal cord)

D. Lumbar spine (including spinal cord)

E. Spine

F. Extremities (multipurpose- flexible-lightweight coils)

G. Abdomen (single flexible- lightweight coil)

H. Pelvis (prostate) Array Coil

3.2 Mobile Equipment:

A. Minimum Requirements: The contractor shall deliver and remain on station, a clean well-maintained state-of-the-art mobile MRI unit with a minimum of a 1.5 tesla magnet system with a 70cm wide short bore, with a minimum of 8 3/4-foot wide by 48-foot long and a maximum of 12-foot wide by 60-foot- long trailer, containing a detachable table or an MRI safe stretcher for patient transfer (per safety protocol), designed to perform body, abdominal, neurological, vascular, and extremity and joint imaging. Mobile MRI scanner shall be outfitted with changing area and locker for patient use and a ramp or lifting device for non-walking patients. The contractor will have available, at contractor expense, surface coils for performance or all imaging studies. The Contractor shall be responsible for maintenance of all connectivity cables from the unit to the fixed connectivity ports. The Dublin VAMC will provide well maintained fixed connectivity ports. The contractor shall be responsible for connecting and disconnecting power, phone, and network connections during each visit. The MRI acquisition environment will have a means of redundant backup of all patient data.

B. Communication with MRI workstation technology and Radiology service medical printers. The Dublin VAMC Radiology Service presently has Lexmark printers. The Contractor shall ensure that all software and licenses necessary to have full Digital Imaging Communications in Medicine (DICOM) communication between the MRI workstation technology and Dublin VAMC Radiology service medical printers are acquired and installed.

C. Communication between MRI systems and Radiology service Picture Archiving and Communication System (PACS). Systems must be Windows 11 compliant/compatible. Philips BUE PACS system and VistA/CPRS system will be utilized for patient records/information.

Contractor shall ensure that a convenient and robust means of DICOM transfer of MRI studies to the VAMC Radiology Service PACS is operational. The Contractor shall obtain and provide to VAMC any technology necessary to ensure that MRI studies can be conveniently read on the existing VAMC PACS display technology. Any peripherals and the VAMC does not have but that are needed to ensure convenient and timely display of MRI studies in the Dublin VAMC Radiology service will be obtained by the contractor, be installed, and maintained by the Contractor, and become the property of the VAMC. Such technology will be retained by the VAMC so that at future dates the archived studies can be reviewed. Each MRI study will be transferred to the VAMC PACS immediately following acquisition of the study so that it can, if necessary, be reviewed before the patient leaves the mobile MRI.

3.3 The equipment shall have the capabilities necessary to perform the following:

A. Dedicated imaging protocols for head and spine applications. optimum water or fat selective excitation imaging, in multi-slice or 3D volume technique.

B. Pre-pulses that achieve suppression of blood signal for optimum lumen visualization in vascular imaging.

C. Dedicated imaging protocols for orthopedic applications with metal suppression software.

D. High quality imaging for assessment of lesions in all anatomical areas.

E. Complete clinical studies that are selectable at a single touch.

F. Performance of automatic planning method based on flexibility to chose three anatomical landmarks.

G. Copying of all examination parameters from any previous scan to a new acquisition.

H. Selection of image matrix sizes freely up to 1024 X 1024.

I. Dynamic studies with all imaging methods allowing entire scans to be repeated multiple times.

J. Manual start controlled from the gantry or operator’s console.

K. Various motion and artifact reduction techniques.

L. Spin Echo

M. Fast field echo

N. Turbo spin echo

O. Echo planar imaging

P. Inversion recovery time of flight imaging

Q. Phase contrast imaging

R. Quantitative flow studies

S. Imaging using 3D k-space shutter

T. Pre-pulses (pre-saturation, magnetization transfer contrast, fat saturation)

U. Movie for sequential display of up to 24 slices of dynamics/phases

V. Rapid T2 Weighted MR imaging

W. The MRI shall be capable of performing 1mm thick scan images.

3.4 Pre-operation Tests of Mobile Unit: The Contractor and Dublin VAMC personnel will conduct tests of the mobile units when they are first located. The tests will be performed to ensure the units are working properly, to ensure proper connectivity and functioning before the contract begins.

3.5 Maintenance Requirements: Contractor shall be responsible for all maintenance of the unit including all Preventive Maintenances (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 Healthcare Technology Management 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. All PMs shall be done after normal operating hours, Monday – Friday. If the system breaks down, the MRI Technologist is responsible for informing Imaging Service representative and the COR or designated representative 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.

3.6 Supplies: A. The Contractor shall be responsible for providing all necessary cryogen.

B. The Contractor shall provide a clean mobile MRI and dispose of trash in a responsible manner.

3.7 Contractor Personnel A. Mobile Unit Staffing: The Contractor shall be solely responsible for hiring, training, and compensation the MRI technologists and assistants needed to perform MRI examinations. It is required that staffing levels be such that the mobile units operate competently, professionally, and efficiently. All technologists shall have all credentials necessary to work as such within the VA system. All technologists must have current certifications in basic life support procedures. All technologists must maintain all immunizations required of practicing medical professionals. All technologists must adhere to all relevant radiation safety practices and relevant magnetic safety practices. All technologists must always work in a professional manner. The unit will be staffed by one MRI technologist and one assistant at all times of operation.

B. Qualifications for MRI Technologist

(1) Must be registered under the American Registry of Radiologic Technologists (ARRT).

(2) Must be Basic Life Support (BLS) certified

(3) Must be Cardiopulmonary Resuscitation (CPR) certified

(4) Preferably at least three (3) years’ experience.

(5) All training and certifications must be up to date and maintained throughout the life of the contract.

4. Tasks:

A. Contractor shall provide mobile MRI Services utilizing equipment meeting the minimum specifications listed under Paragraph 3.

B. Contractor shall be available and provide patient exams five (5) days per week, excluding Federal Holidays as listed above in section 1.5.

C. Contractor shall perform arrival and departure such that the fixed mobile MRI unit operates full days (8AM-4:30PM EST).

D. Contractor shall verify that equipment is used for federal government contract work only.

E. Contractor shall be solely responsible for all driver-staffing issues related to the mobile MRI.

F. Contractor shall perform arrival, set-up, take-down, and departure of mobile MRI in a manner that results in limited or no disruption to normal operations of the Dublin VAMC.

G. Contractor shall perform an estimated sixteen to twenty (16-20) MRI studies per day.

H. Contractor shall provide an accurate screening form for each patient.

I. Contractor shall provide an “Average” patient scan time of thirty (30) minutes.

J. Contractor shall provide a system that is compatible with Vista Imaging.

K. Contractor shall transfer images to Vista Imaging immediately on completion of each scan via network connection.

L. Contractor shall abide by all VA hospital rules and regulations, to include all VA Information and Security guidelines.

M. Contactor shall maintain all training, licenses, and certifications to perform this service and provide technologist that meet the qualifications in paragraph 3.

N. Contractor shall be solely responsible for all technologist and other staffing issues related to operation of the mobile MRI.

O. Contractor shall provide each day a clean mobile MRI and dispose of trash in a responsible manner.

P. Contractor shall adhere to all Health Insurance Portability and Accountability Act (HIPPA) and Occupational Safety and Health Administration (OSHA) requirements and regulations.

Q. Contractor shall communicate effectively with radiologist and physicians.

R. Contractor shall provide excellent customer service to all patients and staff.

S. Contractor shall provide back-up MRI technologists when needed to limit and downtime.

5. Government Responsibilities:

5.1 Utilities and Government Furnished Materials:

A. Fiber reinforced concreate pad

B. Power outlet located approximately 25 feet from the pad. (The contractor must provide the needed power requirements. An example of power requirements would be 480 volts, 3 phase, 150 amps, 112kVA).

C. Water for MRI unit, if needed

D. One (1) telephone line located near the power outlet.

E. One computer terminal with Dublin VAMC Radiology PACS network access.

F. Telephone instruments as needed for the mobile unit(s)

G. Restroom facilities within a reasonable walking distance

H. Provide all supplies, including basic consumables and linens required to perform the MRI examinations.

5.2 Site Maintenance: The Dublin VAMC will be responsible for the maintenance of a concrete pad appropriate for the support and location of the mobile units. The Dublin VAMC will be responsible for maintenance of connectivity ports appropriate for linking the mobile units to power, computer network, and local-access phone/modem/fax as needed. The telephone technology will include one line dedicated for direct access to the code emergency response line in the Dublin VAMC. The emergency phone line must be a dedicated sole sure line. The Dublin VAMC will be responsible for connectivity from within the Dublin VAMC to connectivity ports located outside the Dublin VAMC facility at the site of the pad. The Contractor shall be responsible for connectivity from within the mobile units to the connectivity ports of the Dublin

VAMC.

6. Other Requirements:

6.1 Study Quality: The Contractor shall provide the Dublin VAMC a study-quality standard (a binder and/or CD of data and studies) that reflects the quality of the studies the contractor is prepared to ensure will be maintained throughout the duration of the contract. Examples of most, if not all, study types to be performed will be included in the study-quality standard.

6.2 Quality Control: The contractor will have a documented quality assurance program and provide Dublin VAMC copies of quality assurance documents. The program will comply with all relevant to The Joint Commission (TJC) and HIPPA standards. The Contractor will have readily available several phantoms that can be used to determine MRI parameters. Phantom studies will be conducted as needed to test and ensure study quality.

6.3 Medical Records: Clinical and/or other medical records, including images in DICOM form, of VA beneficiaries treated by the Contractor must be forwarded to Dublin VAMC and shall remain the property of the US Government. The Dublin VAMC will own solely the data/images of the examinations and studies performed on the mobile unit.

6.4 Insurance: The Contractor shall provide proof of liability and workers’ compensation, a certificate of insurance providing evidence of liability coverage including the name of the insurance carrier, limits of liability and type of coverage (Ref: VAAR 852.237-70), Indemnification and Medical Liability Insurance). Standard requirement, $200,000.00 per person and $500,000.00 per occurrence for bodily injury and $20,000.00 per occurrence for property damage as well.

6.5 Medical Emergencies: The Contractor shall provide to the Dublin VAMC written emergency plans addressing emergencies such as patient codes, personal injury, fire, and disruptive behavior. A crash cart will be appropriately located within the Dublin VAMC. All emergencies will be handled by Dublin VAMC code Team. The mobile Contractor shall provide to the Dublin VAMC written emergency pans addressing emergencies such as patient codes, personal injury, fire and disruptive behavior.

6.6 Regulatory Adherence: The Contractor shall adhere to all relevant regulations regarding patient care, medical practice, use of contract agents, use of radiopharmaceuticals, operation of PET technology, CT technology, and MRI technology. Examples of relevant regulations of those of National Health Physics Program (NHPP), Occupational Safety and Health Administration (OSHA), TJC, National Research Council (NRC), VHA, and various other federal agencies.

6.7 Conflict of Interest: The Contractor shall not employ any person who is an employee of the Untired States Government if the employment of that person would create a conflict of interest.

The contractor shall not employ any person who is an employee of the Department of Veterans Affairs, nor shall the Contractor employ any person who is a member of the immediate family of a VA employee, if the employment of that family member would create a conflict of interest, or the appearance of a conflict of interest, particularly with regard to influencing the contract negotiations, terms of the contract or the work carried out under the contract. In any such case, VA must review the matter and give its approval in accordance with agency ethics rules.

7. Quality and Contract Monitoring: The Contractor will be monitored though a variety of mechanisms appropriate to VA regulations and policies. Upon award, the Contracting Officer

(CO) will appoint a Contracting Officer Representative (COR) that will be responsible for monitoring the quality of services provided under this contract.

7.1 The Contractor is responsible for performance management and quality control actions to ensure performance complies with ALL requirements, including terms and conditions stated in the contract. The Contractor shall develop a quality control plan (QCP) to ensure services are performed in accordance with this SOW and provide a copy of the QCP to the Contracting Officer Representative (COR).

7.2 Quality Assurance: The performance standards outlined in the Government’s Quality Assurance Surveillance Plan (QASP) define desired services and will be used to determine the level of contractor performance in the elements defined. The Performance Requirement Summary (PRS) Matrix (para 7.3) lists performance standards and Acceptable Quality Levels (AQL) to determine if the contractor exceeds, meets, or does not meet the standards.

7.3 Performance Requirements Summary Matrix

Measures PWS Referenc e

Performance Requirement

Standard Accept able

Quality Level

Surveill ance

Method

Incentiv e

Met

AQL/DI

D NOT

MEET

AQL-

Timeliness Provide personnel in the work area and available for work at appointed times; Prompt delivery of images and completion of scheduled work exams daily

1.5, 3.4, 3.7(A),4(B ,C,K) 6.1, 6.2, 6.3

Verification of images received, technologist workflow complete, and ready for radiologist to read.

100% of care provided within clinical standards of care

100% Compli ance

Periodic Inspecti on or Random Samplin g of docume nts

CPARS

Rating to reflect level of perform ance.

Perform ance used to determin e whether to

Availability and timeliness of services at designated location.

1.1, 1.5, 2.0, 4, 5.2, 7.5 (C&E)

8.0 IT

Contract Secruity

Services will be provided as scheduled with vehicle and staff present to provide services on-time.

100% of care provided within clinical standards of care

Zero toleranc e for non-availabi lity, 99% on-time

Periodic Inspecti on or Random Samplin g of docume nts exercise an option.

Terminat ion for cause under

FAR

52.212- 4(m).

Patient privacy/confid entiality.

4 (P), 6.2, 6.3, 8.1 (A), 8.3 (F), 8.4 (A, E, F, G), 8.5 (A,B,D),

8.0 IT

Security

Maintains patient privacy/confid entiality.

Zero breaches of privacy.

100% Compli ance

Weekly review of submitte d timeshe ets

Licensing, Registration and Certification

3.2 (B),

3.7 (A, B), 4(M), 6.6, 8,0 IT

Maintains appropriate Federal, state licensure/ certification requirements and utilizing qualified professionals.

immediately (within 24 hours.)

Mandator y prior to performan ce of duties within 24 hours of incident.

Zero toleranc e for violatio ns.

Periodic Inspecti on or Random Samplin g

Adhere to

HIPPA /OSHA

standards and requirements

4(P), Sect. 6,

8.0 IT

Contract Security

Adhere to all Health Insurance Portability and Accountability Act (HIPPA) and Occupational Safety and Health Administration

(OSHA)

requirements and regulations.

Zero toleranc e for violatio ns.

Inspecti on by

COR

and Radiolog y manage ment

Clinical Standards/ Performance/ Regulation

2, 3.3, 3.4, 3.5, 4(L,M,N, P),6.2, 7.1, 7.2,

8.0 IT

Maintains high quality exam standards and follows VA exam protocols

Noncompl iance after first redirectio n is not tolerated.

Any deviation s from exam protocol due to patient inability to perform must be document ed in technolog ist notes in Vista.

99% Periodic Inspecti on or Random Samplin g

Mandatory Training

3.7 (A, B), 4(M)

8.0 IT

Contract Security

Contractor’s technician(s) shall complete all required training per VAMC policy

Noncompl iance will result in removal of personnel from contract.

(Final

99.99%

Periodic Inspecti on or Random Samplin g decision will be by the VISN Chief Medical Officer or designee)

8. 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.

8.1 Access to VA Information and Information Systems

A. A contractor/subcontractor shall request logical (technical) or physical access to VA information and VA information systems for their employees and subcontractors only to the extent necessary to perform the services specified in the solicitation or contract. This includes indirect entities, both affiliate of contractor/subcontractor and agent of contractor/subcontractor.

B. Contractors and subcontractors shall sign the VA Information Security Rule of Behavior (ROB) before access is provided to VA information and information systems (see Section 4, Training, below). The ROB contains the minimum user compliance requirements and does not supersede any policies of VA facilities or other agency components which provide higher levels of protection to VA’s information or information systems. Users who require privileged access shall complete the VA elevated privilege access request processes before privileged access is granted.

C. All contractors and subcontractors working with VA information are subject to the same security investigative and clearance 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 shall be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office of Human Resources and Administration/Operations, Security and Preparedness (HRA/OSP) is responsible for these policies and procedures. Contract personnel who require access to classified information or information systems shall have an appropriate security clearance. Verification of a Security Clearance shall be processed through the Special Security Officer located in HRA/OSP.

Contractors shall conform to all requirements stated in the National Industrial Security Program Operating Manual (NISPOM).

D. All contractors and subcontractors shall comply with conditions specified in VAAR 852.204- 71(d); Contractor operations required to be in United States. All contractors and subcontractors working with VA information must be permanently located within a jurisdiction subject to the law of the United States or its Territories to the maximum extent feasible. If services are proposed to be performed abroad the contractor must state where all non-U.S. services are provided. The contractor shall deliver to VA a detailed plan specifically addressing communications, personnel control, data protection and potential legal issues. The plan shall be approved by the COR/CO in writing prior to access being granted.

E. The contractor shall notify the COR/CO in writing immediately (no later than 24 hours) after personnel separation or occurrence of other causes. Causes may include the following: (1) Contractor/subcontractor personnel no longer has a need for access to

VA information or VA information systems. VA Handbook 6500.6 April 22, 2024 APPENDIX C C-5 (2) Contractor/subcontractor personnel are terminated, suspended, or otherwise has their work on a VA project discontinued for any reason. (3) Contractor believes their own personnel or subcontractor personnel may pose a threat to their company’s working environment or to any company owned property. This includes contractor-owned assets, buildings, confidential data, customers, employees, networks, systems, trade secrets and/or VA data. (4) Any previously undisclosed changes to contractor/subcontractor background history are brought to light, including but not limited to changes to background investigation or employee record. (5) Contractor/subcontractor personnel have their authorization to work in the United States revoked. (6) Agreement by which contractor provides products and services to VA has either been fulfilled or terminated, such that VA can cut off electronic and/or physical access for contractor personnel.

C. VA information will not be co-mingled with any other data on the contractor’s information systems or media storage systems. The contractor shall ensure compliance with Federal and VA requirements related to data protection, data encryption, physical data segregation, logical data segregation, classification requirements and media sanitization.

D. VA reserves the right to conduct scheduled or unscheduled audits, assessments, or investigations of contractor Information Technology (IT) resources to ensure information security is compliant with Federal and VA requirements. The contractor shall provide all necessary access to records (including electronic and documentary materials related to the contracts and subcontracts) and support (including access to contractor and subcontractor staff associated with the contract) to VA, VA's Office Inspector General (OIG), and/or Government Accountability Office (GAO) staff during periodic control assessments, audits, or investigations.

E. The contractor may only use VA information within the terms of the contract and applicable Federal law, regulations, and VA policies. If new Federal information security laws, regulations or VA policies become applicable after execution of the contract, the parties agree to negotiate contract modification and adjustment necessary to implement the new laws, regulations, and/or policies.

F. The contractor shall not make copies of VA information except as specifically authorized and necessary to perform the terms of the contract. If copies are made for restoration purposes, after the restoration is complete, the copies shall be destroyed in accordance with VA Directive 6500, VA Cybersecurity Program and VA Information Security Knowledge Service.

G. If a Veterans Health Administration (VHA) contract is terminated for default or cause with a business associate, the related local Business Associate Agreement (BAA) shall also be terminated and actions taken in accordance with VHA Directive 1605.05, Business Associate Agreements. If there is an executed national BAA associated with the contract, VA will determine what actions are appropriate and notify the contactor.

H. The contractor shall store and transmit VA sensitive information in an encrypted form, using VA-approved encryption tools which are, at a minimum, Federal Information Processing Standards (FIPS) 140-2, Security Requirements for Cryptographic Modules (or its successor) validated and in conformance with VA Information Security Knowledge Service requirements.

The contractor shall transmit VA sensitive information using VA approved Transport Layer Security (TLS) configured with FIPS based cipher suites in conformance with National Institute of Standards and Technology (NIST) 800-52, Guidelines for the Selection, Configuration and Use of Transport Layer Security (TLS) Implementations.

I. The contractor’s firewall and web services security controls, as applicable, shall meet or exceed VA’s minimum requirements.

J. Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the contractor may use and disclose VA information only in two situations: (i) in response to a qualifying order of a court of competent jurisdiction after notification to VA CO (ii) with written approval from the VA CO. The contractor shall refer all requests for, demands for production of or inquiries about, VA information and information systems to the VA CO for response.

K. Notwithstanding the provision above, the contractor shall not release VA records protected by Title 38 U.S.C. § 5705, Confidentiality of medical quality medical records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse or infection

F. In such cases of contract fulfillment, termination, or other causes; the contractor shall take the necessary measures to immediately revoke access to VA network, property, information, and information systems (logical and physical) by contractor/subcontractor personnel. These measures include (but are not limited to): removing and then securing Personal Identity Verification (PIV) badges and PIV – Interoperable (PIV-I) access badges, VA-issued photo badges, credentials for VA facilities and devices, VA-issued laptops, and authentication tokens.

Contractors shall notify the appropriate VA COR/CO immediately to initiate access removal.

G. Contractors/subcontractors who no longer require VA accesses will return VAissued property to VA. This property includes (but is not limited to): documents, electronic equipment, keys, and parking passes. PIV and PIV-I access badges shall be returned to the nearest VA PIV Badge Issuance Office. Once they have had access to VA information, information systems, networks and VA property in their possessions removed, contractors shall notify the appropriate VA

COR/CO.

8.2 VA Information Custodial Language:

A. The Government shall receive unlimited rights to data/intellectual property first produced and delivered in the performance of this contract or order (hereinafter “contract”) unless expressly stated otherwise in this contract. This includes all rights to source code and all documentation created in support thereof. The primary clause used to define Government and Contractor data rights is FAR 52.227-14 Rights in Data – General. The primary clause used to define computer software license (not data/intellectual property first produced under this contractor or order) is FAR 52.227-19, Commercial Computer Software License.

B. Information made available to the contractor by VA for the performance or administration of this contract will be used only for the purposes specified in the service agreement, SOW, PWS, PD, and/or contract. The contractor shall not use VA information in any other manner without prior written approval from a VA Contracting Officer (CO). The primary clause used to define Government and Contractor data rights is FAR 52.227-14 Rights in Data – General.

with Human Immunodeficiency Virus (HIV). If the contractor is in receipt of a court order or other requests for the abovementioned information, the contractor shall immediately refer such court order or other requests to the VA CO for response.

L. Information made available to the contractor by VA for the performance or administration of this contract or information developed by the contractor in performance or administration of the contract will be protected and secured in accordance with VA Directive 6500 and Identity and Access Management (IAM) Security processes specified in the VA Information Security Knowledge Service.

M. Any data destruction done on behalf of VA by a contractor shall be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management, VA Handbook 6300.1, Records Management Procedures, and applicable VA Records Control Schedules.

N. The contractor shall provide its plan for destruction of all VA data in its possession according to VA Directive 6500 and NIST 800-88, Guidelines for Media Sanitization prior to termination or completion of this contract. If directed by the COR/CO, the contractor shall return all Federal Records to VA for disposition.

O. Any media, such as paper, magnetic tape, magnetic disks, solid state devices or optical discs that is used to store, process, or access VA information that cannot be destroyed shall be returned to VA.The contractor shall hold the appropriate material until otherwise directed by the Contracting Officer’s Representative (COR) or CO. Items shall be returned securely via VA-approved methods. VA sensitive information must be transmitted utilizing VA-approved encryption tools which are validated under FIPS 140-2 (or its successor) and NIST 800-52. If mailed, the contractor shall send via a trackable method (USPS, UPS, FedEx, etc.) and immediately provide the COR/CO with the tracking information. Self-certification by the contractor that the data destruction requirements above have been met shall be sent to the COR/CO within 30 business days of termination of the contract.

P. All electronic storage media (hard drives, optical disks, CDs, back-up tapes, etc.) used to store, process or access VA information will not be returned to the contractor at the end of lease, loan, or trade-in. Exceptions to this paragraph will only be granted with the written approval of the VA CO.

8.3 Information System Design and Development

A. Information systems designed or developed on behalf of VA at non-VA facilities shall comply with all applicable Federal law, regulations, and VA policies. This includes standards for the protection of electronic Protected Health Information (PHI), outlined in 45 C.F.R. Part 164, Subpart C and information and system security categorization level designations in accordance with FIPS 199, Standards for Security Categorization of Federal Information and Information

Systems and FIPS 200, Minimum Security Requirements for Federal Information Systems.

Baseline security controls shall be implemented commensurate with the FIPS 199 system security categorization (reference VA Handbook 6500 and VA Trusted Internet Connections (TIC) Architecture).

B. Contracted new developments require creation, testing, evaluation, and authorization in compliance with VA Assessment and Authorization (A&A) processes in VA Handbook 6500 and VA Information Security Knowledge Service to obtain an Authority to Operate (ATO). VA Directive 6517, Risk Management Framework for Cloud Computing Services, provides the security and privacy requirements for cloud environments.

C. VA IT contractors, subcontractors and third-party service providers shall address and/or integrate applicable VA Handbook 6500, VA Handbook 6517, Risk Management Framework for Cloud Computing Services and Information Security Knowledge Service specifications in delivered IT systems/solutions, products and/or services. If systems/solutions, products and/or services do not directly match VA security requirements, the contractor shall work though the COR/CO to identify the VA organization responsible for governance or resolution. Contractors shall comply with FAR 39.1, specifically the prohibitions referenced.

D. The contractor (including producers and resellers) shall comply with Office of Management and Budget (OMB) M-22-18 and M-23-16 when using third-party software on VA information systems or otherwise affecting the VA information. This includes new software purchases and software renewals for software developed or modified by major version change after the issuance date of M22-18 (September 14, 2022). The term “software” includes firmware, operating systems, applications and application services (e.g., cloud-based software), as well as products containing software. The contractor shall provide a self-attestation that secure software development practices are utilized as outlined by Executive Order (EO)14028 and NIST Guidance. A third-party assessment provided by either a certified Federal Risk and Authorization Management Program (FedRAMP) Third Party Assessor Organization (3PAO) or one approved by the agency will be acceptable in lieu of a software producer's self-attestation.

E. The contractor shall ensure all delivered applications, systems and information systems are compliant with Homeland Security Presidential Directive (HSPD) 12 and VA Identity and Access management (IAM) enterprise identity management requirements as set forth in OMB M-19-17, M-05-24, FIPS 201-3, Personal Identity Verification (PIV) of Federal Employees and Contractors (or its successor), M-21-31 and supporting NIST guidance. This applies to Commercial Off-The- Shelf (COTS) product(s) that the contractor did not develop, all software configurations and all customizations.

F. The contractor shall ensure all contractor delivered applications and systems provide user authentication services compliant with VA Handbook 6500, VA Information Security Knowledge Service, IAM enterprise requirements and NIST 800-63, Digital Identity Guidelines, for direct, assertion-based authentication and/or trust-based authentication, as determined by the design and integration patterns. Direct authentication at a minimum must include Public Key Infrastructure (PKI) based authentication supportive of PIV and/or Common Access Card (CAC), as determined by the business need and compliance with VA Information Security Knowledge Service specifications.

G. The contractor shall use VA authorized technical security baseline configurations and certify to the COR that applications are fully functional and operate correctly as intended on systems in compliance with VA baselines prior to acceptance or connection into an authorized VA computing environment. If the Defense Information Systems Agency (DISA) has created a Security Technical Implementation Guide (STIG) for the technology, the contractor may configure to comply with that STIG. If VA determines a new or updated VA configuration baseline needs to be created, the contractor shall provide required technical support to develop the configuration settings. FAR 39.1 requires the population of operating systems and applications includes all listed on the NIST National Checklist Program Checklist Repository.

H. The standard installation, operation, maintenance, updating and patching of software shall not alter the configuration settings from VA approved baseline configuration. Software developed for VA must be compatible with VA enterprise installer services and install to the default “program files” directory with silently install and uninstall. The contractor shall perform testing of all updates and patching prior to implementation on VA systems.

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

J. The contractor-delivered solutions shall reside on VA approved operating systems.

Exceptions to this will only be granted with the written approval of the COR/CO.

K. The contractor shall design, develop, and implement security and privacy controls in accordance with the provisions of VA security system development life cycle outlined in NIST 800-37, Risk Management Framework for Information Systems and Organizations: A System Life Cycle Approach for Security and Privacy, VA Directive and Handbook 6500, and VA Handbook 6517.

L. The Contractor shall comply with the Privacy Act of1974 (the Act), FAR 52.224- 2 Privacy Act, and VA rules and regulations issued under the Act in the design, development, or operation of any system of records on individuals to accomplish a VA function.

M. The contractor shall ensure the security of all procured or developed information systems, systems, major applications, minor applications, enclaves and platform information technologies, including their subcomponents (hereinafter referred to as “Information Systems”) throughout the life of this contract and any extension, warranty, or maintenance periods. This includes security configurations, workarounds, patches, hotfixes, upgrades, replacements and any physical components which may be necessary to remediate all security vulnerabilities published or known to the contractor anywhere in the information systems (including systems, operating systems, products, hardware, software, applications and firmware). The contractor shall ensure security fixes do not negatively impact the Information Systems.

N. When the contractor is responsible for operations or maintenance of the systems, the contractor shall apply the security fixes within the timeframe specified by the associated controls on the VA Information Security Knowledge Service. When security fixes involve installing third party patches (such as Microsoft OS patches or Adobe Acrobat), the contractor shall provide written notice to the VA COR/CO that the patch has been validated as to not affecting the Systems within 10 business days.

8.4 Information System Hosting, Operation, Maintenance, or Use

A. The contractor shall comply with all Federal laws, regulations, and VA policies for Information systems (cloud and non-cloud) that are hosted, operated, maintained, or used on behalf of VA at non-VA facilities. Security controls for collecting, processing, transmitting, and storing of VA sensitive information, must be in place. The controls will be tested by VA or a VA sanctioned 3PAO and approved by VA prior to hosting, operation, maintenance or use of the information system or systems by or on behalf of VA. This includes conducting compliance risk assessments, security architecture analysis, routine vulnerability scanning, system patching, change management procedures and the completion of an acceptable contingency plan for each system. The contractor’s security control procedures shall be the same as procedures used to secure VA-operated information systems.

B. Outsourcing (contractor facility, equipment, or staff) of systems or network operations, telecommunications services or other managed services require Assessment and Authorization (A&A) of the contractor’s systems in accordance with VA Handbook 6500 as specified in VA Information Security Knowledge Service. Major changes to the A&A package may require reviewing and updating all the documentation associated with the change. The contractor’s cloud computing systems shall comply with FedRAMP and VA Directive 6517 requirements.

C. The contractor shall return all electronic storage media (hard drives, optical disks, CDs, back-up tapes, etc.) on non-VA leased or non-VA owned IT equipment used to store, process or access VA information to VA in accordance with A&A package requirements. This applies when the contract is terminated or completed and prior to disposal of media.