36C24123Q1109.docx

36C24123Q1109

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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. SIGNAT

URE 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

36C24123Q1109 09-14-2023 Divianna Mathurin 914-325-3258 09-22-2023

12PM

EDT

Department of Veterans Affairs Network Contracting Office 1 950 Campbell Avenue West Haven CT 06516 X X 621512 $19 Million N/A X Department of Veteran Affairs Northampton VA Medical Center 421 N. Main Street Leeds MA 01053 Department of Veterans Affairs Network Contracting Office 1 950 Campbell Avenue West Haven CT 06516

Department of Veterans Affairs Financial Services Center Invoices to be Submitted Electronically in accordance with VAAR 852.232-72 https://www.fsc.va.gov/einvoice.asp 1-877-353-9791 See CONTINUATION Page The purpose of this solicitation is to award a firm-fixed contract including (4) option years to one contractor to provide Northampton VA Medical Center with (1) Siemens MAGNETOM Aera 1.5T MRI Scanner in a fully self-contained MRI Trailer with insulated walls including one Registered MRI Technologist and one MRI Assistant as described in the

SOW.

Period of Performance: (1) Base Year + (4) Option Years.

Wage Determinations will apply, see Section D .

Please follow the statement of work to meet the necessary criteria to provide this requirement.

See CONTINUATION Page X X

CONTRACTING OFFICER

Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

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

a. CONTRACTOR:

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

950 Campbell Avenue West Haven CT 06516

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

3. INVOICES: Invoices shall be submitted in arrears:

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

https://www.fsc.va.gov/einvoice.asp ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

This is a new, brand name requirement. Northampton VA Medical Center is requesting a contractor to provide (1) Siemens MAGNETOM Aera 1.5T MRI Scanner Mobile Unit, one Registered MRI technologist and one MRI assistant. This procurement is for a Base + (4) Option Years contract to address the MRI needs at Northampton VA Medical Center. The Mobile MRI system will be housed in an OEM approved and verified mobile trailer along with full preventative maintenance and repair service coverage.

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B.2 STATEMENT OF WORK

Northampton VA Medical Center Siemens Mobile MRI Unit

The Northampton VA Medical Center is requesting a contractor to provide mobile Magnetic Resonance Imaging (MRI), one Registered MRI technologist and one MRI assistant.

Brand Name Only:

The contractor must utilize Siemens Aera equipment or newer model while providing these services.

Period of Performance: Base Plus (4) Option Years

· Base Year: 09/29/2023 – 09/28/2024

· Option 1: 09/29/2024 – 09/28/2025

· Option 2: 09/29/2025 – 09/28/2026

· Option 3: 09/29/2026 – 09/28/2027

· Option 4: 09/29/2027 – 09/28/2028

MRI Staff Transportation Set up Total All CLIN items

MO

EA

(1 year of performance outlined in the SOW) MRI Staff Total All CLIN

MO

(1 year of performance outlined in the SOW) MRI Staff

MO

(1 year of performance outlined in the SOW) MRI Staff Total All CLIN

MO

(1 year of performance outlined in the SOW) MRI Staff Hard Drive replacement

MO

Total Contract Pricing

BASICS

B1. Requirements:

The contractor will provide a mobile, handicap-accessible 1.5T Siemens Aera magnetic resonance scanner, one Registered MRI technologist and one MRI assistant that have been vetpro’d and oriented to VA operations. The Contractor will attend site walk throughs before the delivery of the unit to ensure the mobile MRI pad is the correct depth to support the MRI, the correct power and data is at the site for the equipment. The Contractor will be responsible for all servicing of the unit including but not limited to repairs, preventative maintenance, and security patches.

B2. Authority:

This procurement is executed under:

1.1 The Enhanced Sharing Authority, Public Law 104-262, Title 38 U.S.C. 8153 [The Government, under this authority reserves the right to sell excess capacity.];

1.2 The procedures described in FAR Subpart 12.6 and Part 13, as updated through FAC and as supplemented with information included in this solicitation;

1.3 VHA Handbook 1105.05, Magnetic Resonance Imaging Safety;

1.4 Title 38 United States Code 7301 (b); and

1.5 Title 38 Code of Federal Regulations 17.38.

1. Specifications:

1.1 General Requirements:

a. The MRI unit will be available for patient exams five (5) days per week, excluding Federal Holidays, i.e. New Year’s Day, Martin Luther King, Jr’s. Birthday, Presidents’ Day, Memorial Day, Juneteeth, Independence Day, Labor Day, Columbus Day, Veterans Day, Thanksgiving, Christmas and any other days specifically declared by the President of the United States to be national holidays.

b. The equipment is to be used for federal government contract work only.

c. Contractor will be solely responsible for all driver-staffing issues related to the mobile MRI. Contracted staff must comply with all VA staffing rules and requirements.

d. Contractor will perform arrival, set-up, take-down, and departure of mobile MRI at contract end.

e. Contractor will provide a mobile MRI that operates full days (7:30 AM-4:30 PM M-F).

f. Contractor will be solely responsible for all technologist and other staffing related to operation of the mobile MRI. Minimum staff is a MRI technologist and a Safety Trained and qualified MRI Assistant at all times.

g. Contractor will supply all cleaning products and services to the trailer.

1.2 MRI Trailer:

a. Contractor will provide a fully self-contained MRI Trailer with insulated walls. The walls of the trailer should be completely RF shielded including the large RF door with window and the punch out panel. The MRI trailer must also have a fully contained 5 gauss field within the trailer.

b. Contractor will provide a trailer with an onboard chilled water system and humidification unit for the MRI.

c. Contractor will provide a trailer with an extra-large RF Window for patient viewing, a patient viewing camera, dimmable LED lights and smoke/ heat detectors throughout the trailer.

d. Contractor will provide a trailer with four network connections for technician workstations and phones.

e. Contractor will provide the ability to connect the fire alarm system on the mobile to the facility alarm system

f. Contractor will provide a trailer with doors that are ADA complaint and allow for patient accessibility in stretchers or wheelchairs.

g. Contractor to provide a trailer with hot water and a hand washing sink. The facility will supply the water to the trailer.

h. The trailer should have a separate locking door for the operators with stairs and rails.

i. Contractor shall provide the appropriate number of qualified personnel for the required tasking at all times. (i.e The Contractor shall provide a qualified technologist and tech aide to perform the required services.) The Contractor shall provide backup staff in the event of a planned or unplanned absence in order to provide uninterrupted services due to staffing.

1.3 MRI Specifications:

a. Contractor will provide a 1.5T Siemens Magnetom Aera or newer System. The MRI must have a minimum of a 48 channel system, run VE11C-SP01 software and have a 4GDOT engine with a 99.99% uptime based on hours of service. The MRI must include the following software packages:

· Flow Quantification, Argus Flow, Soft Tissue Motion Correction TIM, Fusion, Inline Composing Syngo, MR Workplace Table, Interactive Realtime, TIM Planning Suite, Inline Perfusion, Composing Spine, Arterial Spin Labeling 2D, MR Workplace, SWI, TWIST Syngo, ASI, GRACE, Argus 4D, AutoAlign Spine, Abdomen DOT Engine, NATIVE Syngo, , Tissue 4D Syngo, TIM Whole Body Suite, Knee DOT Engine, Neuro Perfusion Evaluation, Design Pure White, Cardiac DOT Engine, Peripheral Angio, and TIM CT Onco DOT Engine.

b. The mobile MRI must meet all OIT guidelines including having a supported Windows10 Operating System and patching/ remediating any vulnerabilities. The Contractor will remove and surrender to the VA the MRI system hard drive(s) at the end of the contract date before the MRI leaves VA Property.

c. The mobile MRI shall provide images with consistently high technical diagnostic quality which meet the standard of care.

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

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

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

g. The mobile MRI unit shall be ready for use regardless of outside environmental conditions.

h. The Contractor shall be responsible for all maintenance, upgrades, updates, and servicing of Contractor owned equipment during the contract period. Any of these services shall be scheduled and coordinated with the COR to be performed after business hours.

1.4 Coil Specifications:

a. Contractor shall provide the following coils:

· Spine -24ch,

· Body -18ch

· Flex 4ch Small, Flex 4ch Large

· ShoulderSmall-16ch, ShoulderLarge-16ch

· Head Neck 20ch

· Hand Wrist 16ch

· Foot Ankle 16ch

· Tx Rx 15ch Knee.

1.5 Additional Equipment Specifications:

a. Contractor shall provide two workstations for radiology technicians with PACS compatibility. There should be DICOM connectivity to VACWM HS Carestream (Philips) PACS and an optical disk archival system.

b. Contractor will provide a Medrad Stellant dual head power injector to maintain use of the current stock of injector syringes that logistics has on contract with the vendor.

c. All sponges and table attachments shall be included.

d. The Contractor shall be responsible for all maintenance, upgrades, updates, and servicing of Contractor owned equipment during the contract period. Any of these services shall be scheduled and coordinated with the COR to be performed after business hours.

1.4 Utilities and Government Furnished Materials provided by the VA:

a. Fiber reinforced concrete pad

b. Power outlet located approximately 25 feet from the pad. Power requirements 480 volts, 3 phase, 150 amps, 112 kVA Russel Stohl connector

c. Water for MRI unit.

d. Two (2) telephone line terminals located near the 480v power outlet

e. One computer terminal with VA Radiology PACS network access

f. Telephone instruments for the mobile unit

g. Restroom facilities within a reasonable walking distance

h. All supplies, including basic consumables and linens, required to perform the MRI examinations, contrast material and supplies.

Emergency crash cart with special oxygen tanks and regulators One MRI safe stretcher One MRI safe wheelchair will be provided by the VA All cleaning supplies All PPE required by COVID 19- Masks, hand sanitizer, Digital Temperature gauge.

1.5 Supplies:

a. The Contractor will be responsible for providing all necessary cryogen.

2. Special Requirements:

2.1 Resources:

a. The resources specified in this contract may be changed only by written modification by the assigned VISN 1 VA Contracting Officer.

b. The MRI services to be performed by the Contractor will be under the direction of the Chief of Staff and their dsignee.

2.2 Term of Contract:

a. The contract is effective for one (1) year base period and four (4) 12-month option period with an expected award date no later then September 30th 2023.

b. Funds for option period will be subject to the availability of funds. Service will not be performed by the Contractor after the ending date of this contract, until the Contracting Officer authorizes such services in writing.

2.3 Site Prep Support

The Contractor will be responsible for assessing the site before the delivery of the mobile MRI. This includes but is not limited to: ensuring the MRI pad will support the MRI and trailer and the correct power and data at the location is sufficient for the equipment delivered.

2.4 Study Quality:

The Contractor will provide the VA a study-quality standard that reflects the quality of the studies the provider is prepared to insure 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 and maintained on the MRI hard drive system. All protocols will be entered and tested. Reading radiologists will confirm protocols, and request modifications as necessary.

2.5 Quality Control:

The Contractor will have a documented quality assurance program and provide a copy of quality assurance documents with the proposal. The program will comply with all relevant 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.

2.6 Site Maintenance:

The VA will be responsible for maintenance of a concrete pad appropriate for support and location of the mobile unit. The VA will be responsible for maintenance of connectivity ports appropriate for linking the mobile unit 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 VA Clinic. The emergency phone line must be a dedicated sole use line. The VA will be responsible for connectivity from within the VA Clinic to connectivity ports located outside the VA Clinic facility at the site of the pad. The Contractor will be responsible for connectivity from within the mobile unit to the connectivity ports of the VA Clinic.

One phone line will have access to long distance for reporting concerns issues to the contractor 24/7/365 service line.

2.7 Pre-operation Contractor/ Tests of Mobile Unit:

The Contractor and VA personnel will conduct tests of the mobile unit when they are first located. The tests will be performed to ensure the unit are working properly, to insure all needed/desired connectivity’s are functioning properly, and to ensure functionality is such that the conditions of this contract are met prior to the date of award. All MRI protocols will be entered and tested with images sent to reading radiologists for confirmation.

2.8 Networking Requirements:

The Contractor will be responsible for providing a 1.5T MRI with a Windows10 operating system. Any unsupported operating system will not be allowed on the VA hospital network. The Contractor will be responsible for patching the devices for any vulnerabilities the VA discovers to be complaint with VA cybersecurity practices. The contractor must scan any removable media (including laptops) before connecting to the VA network or equipment.

2.9 Service Contracts:

The Contractor will be responsible, throughout the period of the contract, for acquiring service personnel and parts with for the mobile unit during maintenance and repairs. This will include service on the MRI, and on any peripherals required to insure connectivity to the VA Radiology Service PACS. No routine maintenance will be scheduled or performed such that it conflicts with the imaging schedules of the mobile MRI. No maintenance will be scheduled or performed during scheduled scanning hours except to address emergency failures of the mobile unit. Service response time to emergency failures should be within two hours.

2.10 Medical Records:

Clinical and/or other medical records, including images in DICOM form, of VA beneficiaries treated by the Contractor will be forwarded to the VA and shall remain the property of the US Government. The VA will own solely the data/images of the examinations and studies performed on the mobile unit. MRI staff are responsible to complete all VA privacy trainings and adhere to all VA privacy policies.

2.11 Insurance:

The Contractor will 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 852.237-7, Indemnification and Medical Liability Insurance).Standard requirement for $200,000 per person and $500,000 per occurrence for bodily injury and $20,000 per occurrence for property damage as well.

2.12 Medical Emergencies:

The VA will provide the Contractor with written emergency plans addressing emergencies such as patient codes, personal injury, fire, and disruptive behavior. All emergency response teams at the VA will be trained in MRI safety. The MR Safety Officer will conduct the training, to emphasize the critical safety issues with the MRI Magnet.

2.13 Regulatory Adherence:

The Contractor is responsible for adhering to all relevant regulations regarding patient care, medical practice, use of contract agents, use of radiopharmaceuticals, MRI technology. Examples of relevant regulations are those of NHPP, OSHA, TJC, NRC, VHA, and various other federal agencies.

2.14 Quality and Contract Monitoring:

a. The Contractor will be monitored through a variety of mechanisms appropriate to VA regulations and policies.

b. The Contracting Officers Representative (COR) () will be responsible for monitoring the quality of services provided under this contract.

2.14 Past Performance:

a. The Contractor must provide past performance information to establish their established ability to provide this service.

3. Payment:

3.1 The VA agrees to reimburse the Contractor on a unit basis for resources furnished at the price listed in the schedule of this contract.

3.2 The Contractor will coordinate with the VA for Mobile MRI delivery upon site prep completion. The Contractor will be paid monthly, in arrears, upon receipt of a properly prepared invoice and upon VA approval that the mobile MRIis deemed safe for patient use. The invoice shall include at a minimum: invoice number, invoice amount, Contract’s name and address, contract number, purchase order number and period of performance. The Contractor will provide backup document to COR for verification of amount invoiced. Backup document shall include invoice number, Contractor’s name and address, the contract number, purchase order number, date of exam, Veteran Patient ID, type of exam, invoice amount and any additional cases. Invoices will be reconciled with VA record prior to disbursement of payments.

3.3 The Contractor shall submit all invoices to the following address:

FSC VA (667)

PO BOX 149971

Austin, TX 78714-8971

4. Administration of Contract:

The Contractor shall contact the Contracting Officer on all matters pertaining to the administration of this contract. Only the Contracting Officer is authorized to make changes that will affect the price, quantity, quality, or delivery terms of this contract.

5. Conflict of Interest:

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

6. Contract Monitoring Procedures:

6.1 At the time of contract award, the Contracting Officer will appoint a Contracting Officer Representative (COR) to assist with the contract monitoring requirements. The COR will monitor such items as quality of service, timeliness of performance, customer service, cost control business relations. In accordance with FAR 1.601 (a) “Contracts may be entered into and signed on behalf of the Government only by contracting officers.” A COR is not authorized to modify the stated terms of the contract, including extending the length of the contract period. Quality of service will be monitored through a continuous review of requested studies vs. performed studies, the appropriateness of images produced and morbidity and mortality figures. These factors will be rated by a consensus of radiologists interpreting the MRI studies and through a radiologist.

6.2 Timeliness of performance will be measured through daily workload counts compared to daily number of studies ordered. Customer service will be monitored through periodic unannounced visits to the MRI unit and through patient satisfaction surveys completed by MRI patients. Cost control will be monitored through a comparison of hours worked and the type and number of studies completed per day. Appropriate regulatory and accrediting standards will apply, and all adverse events will be reported in accordance with medical center and other applicable guidelines.

6.3 The delegated COR will notify the Contracting Officer of any non-compliance immediately upon his/her gaining knowledge of any such situation or incident. Initial communication of such may be communicated by telephone. After such communication, the COR will provide a written statement to the Contracting Officer along with any supporting documentation regarding the performance failure noticed.

6.4 Upon receipt of a proper invoice, the COR shall certify that the services identified have been performed within 48 hours. Once certification has been made, the invoice will be forward through the proper billing channels and payment shall be made to the Contractor.

6.5 Both parties shall jointly conduct a review of Contractor’s performance to evaluate if services being provided are in accordance with the contract terms and if payments and billings are being properly handled. This review shall include but is not limited to analysis of all billings, payments, costs, administrative issues, patient satisfaction, quality of care and other related documentation that identifies that services have been received. Any concerns need to be brought to the Contractor/COR’s attention at the time noted rather than an agreement reached prior to the expiration of services provided and consideration being received are satisfactory.

6.6 Upon conclusion of the initial contract period and all option periods, and in coordination with the Contracting Officer, the using service shall provide a statement to the Contracting Officer providing a summary of Contractor’s actions and a statement that all requirements of the contract were fulfilled as agreed. This information shall be forwarded by the COR to the Contracting Officer at least 90 days prior to the end of base period and each option period if option periods are included. A CPAR will be completed for each annual period of performance.

7. Locations and Period of Performance:

7.1 The VA Central Western MA, including the Radiology Service is located at:

421 North Main St.

Leeds, MA 01053

7.2 The mobile MRI is to be sited at:

421 North Main St, Leeds, MA 01053

7.

7.1.

7.2.

7.3. Period of Performance (POP):

Base Year: 09/29/2023 – 09/28/2024 Option 1: 09/29/2024 – 09/28/2025 Option 2: 09/29/2025 – 09/28/2026 Option 3: 09/29/2026 – 09/28/2027 Option 4: 09/29/2027 – 09/28/2028

7.4. Hours of Operation:

The contractor will provide the service during the hours of operation Monday – Friday, 7:30 AM – 4:30 PM and is subject to change depending on the Governments need. Weekends may be added through contract modification if funds permit. Unless otherwise specified the Government observes the following holidays:

Any other date specifically declared by the President of The United States to be a national holiday will also be observed.

INFORMATION SECURITY:

a. IT access: All Contractor personnel accessing Veterans Health Information and Technology architecture (VISTA, etc.) system will be required to sign and abide by all VA security policies and applicable confidentiality statues and the privacy act.

b. Patient confidentiality: Contractor to maintain the confidentiality of patient records in accordance with the Privacy Act. HIPAA and all VHA Privacy regulations.

c. Security requirements: Contractor shall insure the confidentiality of all patient and employee information and are subject to the completion of all mandatory training specified by the VHA.

d. Employee Background Checks: Contractor(s) are required to have background investigations initiated; to include fingerprints, PRIOR to start of contract. Contractor(s) will have completed VA Information Security and Privacy along with Rules of Behavior from the following link https://www.ees-learning.net/librix/loginhtml.asp?v=librix prior to start of contract and will compete on an annual basis, before the expiration of previous training. The contractor, when notified of an unfavorable determination by the Government, shall withdraw the employee from consideration from working under the contract.

ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS:

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

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

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

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

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

g. The contractor shall provide to 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 1 week of the initiation of the contract and annually thereafter, as required.

h. 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 the training and documents are complete.

i. Due to the threat of data breach, compromise or loss of information that resides on either VA-owned or contractor-owned systems, and to comply with Federal laws and regulations, VA has developed an Information and Information Technology Security clause to be used when VA sensitive information is accessed, used, stored, generated, transmitted, or exchanged by and between VA and a contractor, subcontractor or a third party in any format (e.g., paper, microfiche, electronic or magnetic portable media).

i. The contractor and their personnel shall be subject to the same Federal laws, regulations, standards and VA policies as VA personnel, regarding information and information system security. These include but are not limited to Federal Information Security Management Act (FISMA), Appendix III of OMB Circular A-130, and guidance and standards, available from the Department of Commerce’s National Institute of Standards and Technology (NIST). This also includes the use of common security configurations available from NIST’s Web site at: http://checklists.nist.gov/. To ensure appropriate security controls are in place, contractors must follow the procedures set forth in “VA Information and Information System Security/Privacy Requirements for IT Contracts” located at the following Web site: http://www.iprm.oit.va.gov/ (852.273-75, Security Requirements for Unclassified Information Technology Resources).

j. The contractor, their personnel, and their subcontractors shall be subject to the Federal laws, regulations, standards, and VA Directives and Handbooks regarding information and information system security as delineated in this contract.

VA INFORMATIONAL CUSTODIAL TERMS:

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

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

c. Prior to termination or completion of this contract, contractor/subcontractor must not destroy information gathered/created by the contractor in the course of performing this contract without prior written approval by the VA. Any data destruction done on behalf of VA by a contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and accordance to VA policy. Self-certification by the contractor that the data destruction requirements above have been met must be sent to the VA contracting officer within 30 days of termination of the contract.

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

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

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

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

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

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

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

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

INFORMATION SYSTEM HOSTING, OPERATION, MAINTENANCE, OR USE:

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

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

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

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

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

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

g. All electronic storage media used on non-VA leased or non-VA owned IT equipment that is used to store, process, or access VA information must be handled in adherence with VA policy 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 VA policy. This must be completed within 30 days of termination of the contract.

SECURITY INCIDENT INVESTIGATION:

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

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

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

d. In instances of theft or break-in or other criminal activity, the contractor/subcontractor must concurrently report the incident to the appropriate law enforcement entity (or entities) of jurisdiction, including the VA Office of Inspector General and VA Security and Law Enforcement.