Mobile MRI TRAILER Services

2
Mobile Magnetic Resonance Imaging (MRI)
Statement of Work
SCOPE OF WORK: Contractor shall provide all equipment, tools, and initial labor to provide mobile Magnetic Resonance Imaging (MRI) services for VA referred beneficiaries of the Veterans Affairs Illiana Health Care System, 1900 East Main St, Danville, Illinois 61832 (hereinafter referred to as VAIHCS). MRI studies shall be performed as deemed medically appropriate and requested by VAIHCS. The Contractor shall be responsible for all Contractor personnel, Subcontractors, agents, and anyone acting for or on behalf of the Contractor.
TERM OF CONTRACT AND PRICING: This contract is to be effective for one (1) year from date of award, with four (4) one (1) year renewal options to be exercised at the discretion of the Government.
PERIOD OF PERFORMANCE: Initial Year March 1, 2019 February 28, 2020, plus Four (4) Option years. Offerors are requested to provide pricing in accordance with Attachment A.
The contract is subject to the availability of VA funds. The Contractor shall perform no services after January 30 of any year until the Contracting Officer authorizes such services in writing.
1. Schedule of Supplies/Services and Price/Cost
MRI Work Hours: The MRI trailer shall be used to perform studies Monday through Friday: 8:00 a.m. to 5:00 p.m. Extended hours and weekends may be utilized at the discretion of the facility. The facility will be closed on National Holidays.
National Holidays: Federal Government Holidays: New Years Day, Martin Luther King's Birthday, President's Day, Memorial Day, Independence Day, Labor Day, Columbus Day, Veterans Day, Thanksgiving Day, and Christmas Day and any other day specifically declared by the President of the United States to be a national holiday.
A firm fixed price single award contract shall be made based on the best value to the Government.
Evaluation Factors:
Price, Discounts and Best Value to Government
Capabilities and Specifications of MRI
Demonstrated Past Performance
Business Size and Veteran or Service Disabled Veteran Owned Status
Contractor is authorized and encouraged to use the VA Vendor Information Service (VIS) to electronically submit invoices monthly. No copies need to be sent to the addresses below in that event. If VIS is not used then submit monthly Invoices to both:
IMAGING SECTION SUPERVISOR (115) AUSTIN FINANCIAL SERVICE CENTER
VA ILLIANA HEALTH CARE SYSTEM P O BOX 149971
1900 EAST MAIN STREET AUSTIN, TX 78714
DANVILLE IL 61832
2. Contractor Responsibilities:
2.1 Contractor will be responsible for all transportation, delivery, set-up, connection to VA provided 450v power, data and phone lines. Contractor will supply a 1.5 magnet and will have Cryogens-liquid Nitrogen capability. Contractor must provide the type of magnet and software version/coils proposed channels, and a personnel training schedule. Contractor will ensure the trailer size (8.5 feet wide by 52 feet in length or 12 feet wide by 50 feet wide in length) will be able to connect to the existing corridor attached to B-58 and provide functioning service. Contractor will be responsible for the construction and removal of extension of the covered corridor from the VAIHCS to the Mobile unit that creates a weather-tight connection to the Mobile unit. The hydraulic lift will not be used. The contractor must note the site has a nearby electrical transformer and they must confirm there will not be any electrical interference.
2.2 The Veterans Administration will be solely responsible for all technologist-staffing to operate the mobile MRI and all accessories.
2.3 Contractor shall provide OEM recommended Preventative Maintenance on MRI, trailer and and accessories at no additional charge to the Government.
Contractor shall be responsible for the proper maintenance of each mobile unit and will provide evidence of required preventative maintenance and calibration of equipment as required by the manufacturer of the MRI unit. The Contracting Officers Representative (COR) shall require access to proof of preventative maintenance and calibration during the performance of the contract.
In the event of equipment failure or unavailability of the mobile MRI unit trailer and/or or equipment, the contractor shall make a sound effort to get the unit fully operational within 12 hours. As a result of normal duty time lost during the downtime, the contractor may be required to work outside regular business hours and/or weekends at no additional costs to the Government to reduce patient backlog. VA personnel shall be notified immediately of any equipment malfunctions that would hinder the completion of studies. In the event of a system failure, Contractor and the Imaging Supervisor shall work cooperatively to remedy the situation as quickly as possible.
Contractor shall provide a system that maintains a minimum of 95% up time performance rate, based on the Normal MRI duty days and hours. Failure to provide this shall result in a deduction on the contract price by 1/30th for full MRI duty day down.
No routine maintenance will be scheduled or performed such that it conflicts with the required schedules of the MRI unit, except to address emergency failures of the unit. Service response time to emergency failures shall be within two hours. Provide 365/24/7 telephone service response line to be answered immediately or within 30 minutes.
2.4 The VA personnel are responsible for the cleaning of the mobile unit and for disposal of trash in VA provided location.
The contractor will not be responsible for providing MRI personnel services under this contract.
Contractor is also required to maintaining applicable insurance policies commensurate with normal business practices and as required by Federal/State/Local laws, and to provide copies of those certificates to the VAIHCS.
INSURANCE - EVIDENCE OF COVERAGE: Before commencing work under this contract, the Contractor shall furnish certification to the Contracting Officer that the coverage required has been obtained and such Policy shall state "THIS POLICY MAY NOT BE CHANGED OR CANCELED WITHOUT WRITTEN NOTICE TO THE VA." Said policy must bear an appropriate "loss payable clause" to the United States as its interest may appear. Such evidence of insurance will not be waived.
Contractor personnel shall not be considered VA employees for any purpose.
To ensure that individuals providing services under the contract have not engaged in fraud or abuse regarding Section 1128/A of the Social Security Act regarding federal health care programs, the contractor is required to check the Health and Human Services-Office of Inspector General (HHS/OIG), list of Excluded Individuals/Entities on the OIG website: www.hhs.gov/oig for each person providing services under this contract.
Contractor is to certify that persons listed in contractor s proposal have been compared against the OIG list and are not listed. During the performance of this contract the contractor is prohibited from using any individual or business listed on the list of excluded Individuals/Entities.
Contractor is to maintain the confidentiality of patient records in accordance with the Privacy Act, Title 5, U.S.C. 552a, Title 38 U.S.C. 5701, 5705, and 7362.
Release of Medical Information: Contractor personnel shall only release medical information obtained during the course of this contract to those VAIHCS staff members involved in the necessary care and treatment of that individual patient. Patient lists and names of patients are considered privileged information and shall not be disclosed or revealed in any way for use outside the VAIHCS without prior written permission from the Chief of Staff or her/his designee.
VA personnel shall be responsible for the preparation of each patient for the scan, i.e., safety screening, gowning, scanning for metals, etc. If sedation is needed for a particular patient, it will be on a conscious sedation level only. The Government will be responsible for providing the sedation orders and dosage, instructions for pre and post sedation and recovery and the sedation drug. The VA is responsible for the safety of each beneficiary while in their care, throughout the exam.
Special Contractor Responsibilities: Contractor shall perform the required work in accordance with Joint Commission, VHA and other regulatory standards. Joint Commission standards may be obtained from the Joint Commission, One Renaissance Blvd, Oakbrook Terrace, IL 60181.
The contractor shall prescreen all personnel requiring access to the computer systems to ensure they maintain a U.S. citizenship and are able to read, write, and speak and understand the English language.
Contractor shall maintain a Drug-free Work Place in accordance with Federal regulations. Contractor shall comply with the VAICHS maintain a drug-free workplace program. The administration of this program will be the responsibility of the contractor, as well as, the establishment of disciplinary actions.
All costs associated with obtaining clearances for Contractor(s) provided personnel shall be the responsibility of the Contractor(s). Further, the Contractor(s) shall be responsible for the actions of those individuals they provide to perform work for the VA under this contract. In the event that damages arise from work performed by Contractor(s) provided personnel, under the auspices of this contract, the Contractor(s) shall be responsible for all resources necessary to remedy the incident.
All Contractors are required to wear identification (I.D.) badges during the entire time they are on VA properties. I.D badges must have an identification picture, name of the individual and the represented company.
Government Responsibilities. After receiving a list of names and addresses of the contractor employees, the VA shall provide electronic notice to the contractor with directions on obtaining, completing, and submitting the necessary background investigation forms.
The Office of Security and Law Enforcement shall notify the Contracting Officer and Contractor after adjudicating the results of the background investigations received from OPM / Contracting Officer.
The Contracting Officer shall ensure that the Contractor provides evidence that investigations have been completed or are in the process of being requested.
2B. VA Information and Information System Security/Privacy
2b.1 Please see Attachment C (VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY LANGUAGE FOR INCLUSION INTO CONTRACTS, AS APPROPRIATE)
3. VAIHCS Responsibilities:
3.1 VAIHCS will be responsible for providing all consumables such as contrast, gloves, syringes, needles etc..
3.2 VAIHCS will provide a Parking site with all required power and utility hook ups.
Dimensions and Specifications:
The parking site in place has the following dimensions: 20 x 60 in size and is asphalt
The site is arranged so that the trailer is parked to match the corridor and the patient access door. The contractor will verify that the size of the trailer (8.5 feet wide by 52 feet in length or 12 foot wide by 50 foot wide in length) will be able to connect to the existing corridor attached to B-58 and provide functioning service.
Electrical service: Single power receptacle (Russell-Stoll DF2504FRAB) connected to a 200 amp 3 pole 480 volt disconnect switch.
Two (2) telephone connections and two (2) data connections. Data connections have RJ45 jacks. Cable to telephone and data connections is category 5e.
No water connection is provided.
Site visit is recommended.
3.3 VAIHCS will be responsible for providing clean linen and for the laundering of the dirty linen.
3.4 A contract award can be terminated by the VAIHCS if a Contractor does not meet adequately the requirements of this Statement of Work. A 30-day notice detailing one or several inadequacies will precede termination. Termination will occur if inadequacies are not rectified within 60 days of notification or VA determines that corrections are not sufficient for resolution.
3.5 MRI Technologists provided by VAIHCS.
4. MRI Scan Interpretation provided by VAICHS
5. MRI Equipment
5.1 MRI system is contained within a parked mobile unit
The Contractor will provide a clean well-maintained state-of-the-art mobile MRI unit with a minimum or a 1.5 tesla magnet system designed to perform body, abdominal, neurological, vascular, and extremity/ joint imaging, with minimum capabilities as described in Attachment B, including appropriate coils for all imaging studies performed at VAIHCS.
5.2 Communication with VAIHCS PACS MRI workstation technology & Radiology service medical printers. The Contractor will insure that all software and licenses necessary to have full DICOM communication between the MRI workstation technology and VAIHCS PACS and Radiology service work stations and medical printers. Each MRI study will be transferred to the VAIHCS PACS immediately following acquisition of the study so that it can, if necessary, be reviewed before the patient leaves the mobile MRI.
5.3 Emergencies on Mobile MRI Unit:
A crash cart will be appropriately located within the VAIHCS Imaging Department. All emergencies will be handled by the VAIHCS code Team. VAIHCS will provide written emergency plans addressing emergencies such as patient coded, personal injury, fire, and disruptive behavior. MRI technologists will also review MRI safety guidelines with Emergency Responders from VAIHCS. All code patients will be removed from MRI scan room and MRI technologist will ensure code responders or ferrous equipment is not allowed in MRI scan room.
6. MRI Point of Contact:
The VAIHCS Radiology Service COR (Contracting Officers Representative) will be the primary point of contact at the VAIHCS for communication between the VA and the MRI mobile Contractor as regards technical aspects of imaging protocols and medical aspects of patient studies. The MRI mobile Contractor will communicate to the COR any possible and actual disruptions of MRI service. Upon becoming aware of possible or actual disruption of MRI service, the Contractor will communicate such service-disruption information to the COR as soon as possible (ASAP) so the patient and service schedule can be appropriately modified with as little inconvenience as possible to patients and services.
7. Acronyms
ARRT
American Registry of Radiologic Technologists
HIPAA
Health Insurance Portability and Accountability Act
OSHA
Occupation Safety and Health Administration
PACS
Picture Archiving Communication System
VA
Department of Veterans Affairs
VAMC
VA Medical Center
VistA
Veterans Health Information System and Technology Architecture
8. CONTRACT PERFORMANCE MONITORING: The contractor will be monitored through a variety of mechanisms, including but not limited to:
Cancellations due to equipment failure
Maintenance Schedules
QA/QC Measures (Physicist Reports)
AQL
Any new or revised quality/performance criteria or standards will be provided to the contractor before their implementation date and renegotiated into the contract as necessary. If renegotiation is not possible, contract may be terminated and resolicited. Unsatisfactory performance may be re-performed as required at no additional cost to the Government.
Acceptable Quality Levels (AQL)
TASKS
Performance Measures
Acceptable Quality Levels (AQL)
Deductions/
Resolution
if below AQL
Adhere to HIPPA requirements
Within acceptable standards
100%
Subject to contract termination.
Provide maintenance personnel in the work area available for work at the appointed times
Daily
>98%
Monitored by COR, contract subject to termination
MRI scan evaluation and completion
Daily
>95%
Complete and provide.
Provide proper equipment in working order.
Within acceptable medical standards
100%
Properly clean equipment as directed. Repair equipment.
9. SPECIAL CONTRACT REQUIREMENTS
9.1 SERVICES: MRI system is contained within a parked mobile unit
The Contractor will provide a clean well-maintained state-of-the-art mobile MRI unit with a minimum or a 1.5 tesla magnet system designed to perform body, abdominal, neurological, vascular, and extremity/ joint imaging, with minimum capabilities as described in Attachment B, including appropriate coils for all imaging studies performed at VAIHCS.
The Contracting Officer (CO) is the only person authorized to approve changes or modify requirements. Contractor shall communicate with CO on all matters pertaining to contract administration. Only the CO is authorized to make commitments or issue changes, which will affect price, quantity, or qualify of performance of this contract. Services specified may be changed by written modification to this contract. Modification will be prepared by the VA CO.
9.2 Designation of Contracting Officer s Representative (COR):
A representative of the CO will be designated to represent the CO in furnishing technical guidance and advice regarding the work performed under this contract. The foregoing is not to be construed as authorization to interpret or furnish advice and information to the Contractor relative to financial or legal aspects of the contract, but the technical matter experts reside in the serviced departments and as such they are authorized to give technical assistance and guidance.
The services to be performed by the contractor will be under the direction of the Chief of Staff, and the Chief, Radiology services.
ATTACHMENT A PRICING
CLIN 1001 Base Year March 1, 2019 February 28, 2020
MRI lease Monthly Price Qty Annual
$ 12 Mos $
CLIN 2001 Option Year One March 1, 2020 February 28, 2021
MRI lease Monthly Price Qty Annual
$ 12 Mos $
CLIN 3001 Option Year Two March 1, 2021 February 28, 2022
MRI lease Monthly Price Qty Annual
$ 12 Mos $
CLIN 4001 Option Year Three March 1, 2022 February 28, 2023
MRI lease Monthly Price Qty Annual
$ 12 Mos $
CLIN 5001 Option Year Four March 1, 2023 February 28, 2024
MRI lease Monthly Price Qty Annual
$ 12 $
TOTAL COST BASE YEAR PLUS 4 OPTION YEARS $_________________________________
Monthly Price Discount offered if any: __________________
ATTACHMENT B
MINIMUM TECHNICAL SPECIFICATIONS FOR THE PROPOSED MRI
Equipment
Contractor will provide a state of the art 1.5T with a minimum 70 cm bore, that includes the following:
MRI Protocols (including, but not limited to)
Brain (MRI and MRA), Orbit/Face/Neck, Spine (Cervical, Thoracic, & Lumbar), Routine MSK, Abdomen/Pelvis, Pelvis-Male and Female, Brachial Plexus, Carotid and Renal MRA.
MRI software packages should include the following, but not limited to:
2D/3D Imaging
ADC Mapping
Neuro
Angio
Body
Ortho
EPI/DWI
T2 Dark fluid 3D TSE
Fast Imaging (i.e. Blade or Propeller, but not limited to)
Care Bolus
2D/3D Phase Contrast
Post-processing
Non-contrast MRA and CE MRA
Parallel Imaging
Single Shot EPI
DICOM Worklist
DICOM SCU
Coils:
Appropriate coils will be included to accommodate and accurately examine all MRI procedures and protocols listed above.
System should also include:
Contrast Power Injector
Minimum of 400 lb load table limit
Ability to plug in multiple coils which can be used simultaneously
HVAC system for environmental control
On board Generator to maintain HVAC in event of shore power failure
Equipment will be capable of sending images to destinations including (printer, PAC s, Hospital RIS System, etc)
Accessories
Best Bore size to accommodate over weight MRI patients and claustrophobia
Optional Accessories to enhance VA Patient experience and comfort such as Digital video goggles and audio headset.
Enhanced communication between patient and MRI technologist.
Positioning Sponges and Straps
MRI Safe Transfer Table
Metal Detector
Hand Held Metal Detector
MRI Safe Wheel chair
MRI Safe Fire Extinguisher
Options to upgrade MRI system configuration and capabilities during life of contract
ATTACHMENT C
VA HANDBOOK 6500.6; APPENDIX C
VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY LANGUAGE FOR INCLUSION INTO CONTRACTS, AS APPROPRIATE
1. GENERAL
Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be
subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security.
2. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS
a. A contractor/subcontrator shall request logical (technical) or physical access to VA
information and VA information systems for their employees, subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order.
b. All contractors, subcontractors, and third-party servicers and associates working with
VA information are subject to the same investigative requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for contractors must be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office for Operations, Security, and Preparedness is responsible for these policies and procedures.
c. Contract personnel who require access to national security programs must have a valid security clearance. National Industrial Security Program (NISP) was established by Executive Order 12829 to ensure that cleared U.S. defense industry contract personnel safeguard the classified information in their possession while performing work on contracts, programs, bids, or research and development efforts. The Department of Veterans Affairs does not have a Memorandum of Agreement with Defense Security Service (DSS). Verification of a Security Clearance must be processed through the Special Security Officer located in the Planning and National Security Service within the Office of Operations, Security, and Preparedness.
d. Custom software development and outsourced operations must be located in the U.S. to the maximum extent practical. If such services are proposed to be performed abroad and are not disallowed by other VA policy or mandates, the contractor/subcontractor must state where all non-U.S. services are provided and detail a security plan, deemed to be acceptable by VA, specifically to address mitigation of the resulting problems of communication, control, data protection, and so forth. Location within the U.S. may be an evaluation factor.
e. The contractor or subcontractor must notify the Contracting Officer immediately when
an employee working on a VA system or with access to VA information is reassigned or leaves the contractor or subcontractor s employ. The Contracting Officer must also be notified immediately by the contractor or subcontractor prior to an unfriendly termination.
3. VA INFORMATION CUSTODIAL LANGUAGE
a. Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights in Data - General, FAR 52.227-14(d) (1).
b. VA information should not be co-mingled, if possible, with any other data on the
contractors/subcontractor s information systems or media storage systems in order to ensure VA requirements related to data protection and media sanitization can be met. If co-mingling must be allowed to meet the requirements of the business need, the contractor must ensure that VA s information is returned to the VA or destroyed in accordance with VA s sanitization requirements. VA reserves the right to conduct on site inspections of contractor and subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are in compliance with VA directive requirements.
c. Prior to termination or completion of this contract, contractor/subcontractor must not
destroy information received from VA, or gathered/created by the contractor in the course of performing this contract without prior written approval by the VA. Any data destruction done on behalf of VA by a contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination of the contract.
d. The contractor/subcontractor must receive, gather, store, back up, maintain, use,
disclose and dispose of VA information only in compliance with the terms of the contract and applicable Federal and VA information confidentiality and security laws, regulations and policies. If Federal or VA information confidentiality and security laws, regulations and policies become applicable to the VA information or information systems after execution of the contract, or if NIST issues or updates applicable FIPS or Special Publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations and policies in this contract.
e. The contractor/subcontractor shall not make copies of VA information except as
authorized and necessary to perform the terms of the agreement or to preserve electronic information stored on contractor/subcontractor electronic storage media for restoration in case any electronic equipment or data used by the contractor/subcontractor needs to be restored to an operating state. If copies are made for restoration purposes, after the restoration is complete, the copies must be appropriately destroyed.
f. If VA determines that the contractor has violated any of the information confidentiality,
privacy, and security provisions of the contract, it shall be sufficient grounds for VA to withhold payment to the contractor or third party or terminate the contract for default or terminate for cause under Federal Acquisition Regulation (FAR) part 12.
g. If a VHA contract is terminated for cause, the associated BAA must also be terminated and appropriate actions taken in accordance with VHA Handbook 1600.01, Business Associate Agreements. Absent an agreement to use or disclose protected health information, there is no business associate relationship.
h. The contractor/subcontractor must store, transport, or transmit VA sensitive information in an encrypted form, using VA-approved encryption tools that are, at a minimum, FIPS 140-2 validated.
i. The contractor/subcontractor s firewall and Web services security controls, if applicable, shall meet or exceed VA s minimum requirements. VA Configuration Guidelines are available upon request.
j. Except for uses and disclosures of VA information authorized by this contract for
performance of the contract, the contractor/subcontractor may use and disclose VA information only in two other situations: (i) in response to a qualifying order of a court of competent jurisdiction, or (ii) with VA s prior written approval. The contractor/subcontractor must refer all requests for, demands for production of, or inquiries about, VA information and information systems to the VA contracting officer for response.
k. Notwithstanding the provision above, the contractor/subcontractor shall not release VA records protected by Title 38 U.S.C. 5705, confidentiality of medical quality assurance records and/or Title 38 U.S.C. 7332, confidentiality of certain health records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse, or infection with human immunodeficiency virus. If the contractor/subcontractor is in receipt of a court order or other requests for the above mentioned information, that contractor/subcontractor shall immediately refer such court orders or other requests to the VA contracting officer for response.
l. For service that involves the storage, generating, transmitting, or exchanging of VA
sensitive information but does not require C & A or an MOU-ISA for system interconnection, the contractor/subcontractor must complete a Contractor Security Control Assessment (CSCA) on a yearly basis and provide it to the COTR.
5. INFORMATION SYSTEM HOSTING, OPERATION, MAINTENANCE, OR USE
a. For information systems that are hosted, operated, maintained, or used on behalf of VA at non-VA facilities, contractors/subcontractors are fully responsible and accountable for ensuring compliance with all HIPAA, Privacy Act, FISMA, NIST, FIPS, and VA security and privacy directives and handbooks. This includes conducting compliant risk assessments, routine vulnerablity 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 COTR 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 COTR. 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/subcontractorowned equipment or software on VA s network. If non-VA owned equipment must be used to fulfill the requirements of a contract, it must be stated in the service agreement, SOW or contract. All of the security controls required for government furnished equipment (GFE) must be utilized in approved other equipment (OE) and must be funded by the owner of the equipment. All remote systems must be equipped with, and use, a VA-approved antivirus (AV) software and a personal (host-based or enclave based) firewall that is configured with a VAapproved
configuration. Software must be kept current, including all critical updates and patches. Owners of approved OE are responsible for providing and maintaining the anti-viral
software and the firewall on the non-VA owned OE.
g. All electronic storage media used on non-VA leased or non-VA owned IT equipment
that is used to store, process, or access VA information must be handled in adherence with VA Handbook 6500.1, Electronic Media Sanitization upon: (i) completion or termination of the contract or (ii) disposal or return of the IT equipment by the contractor/subcontractor or any person acting on behalf of the contractor/subcontractor, whichever is earlier. Media (hard drives, optical disks, CDs, back-up tapes, etc.) used by the contractors/subcontractors that contain VA information must be returned to the VA for sanitization or destruction or the contractor/subcontractor must self-certify that the media has been disposed of per 6500.1 requirements. This must be completed within 30 days of termination of the contract.
h. Bio-Medical devices and other equipment or systems containing media (hard drives,
optical disks, etc.) with VA sensitive information must not be returned to the vendor at the end of lease, for trade-in, or other purposes. The options are:
Vendor must accept the system without the drive;
VA s initial medical device purchase includes a spare drive which must be installed in place of the original drive at time of turn-in; or
VA must reimburse the company for media at a reasonable open market replacement cost at time of purchase.
Due to the highly specialized and sometimes proprietary hardware and software
associated with medical equipment/systems, if it is not possible for the VA to retain the hard drive, then;
(a) The equipment vendor must have an existing BAA if the device being traded in has
sensitive information stored on it and hard drive(s) from the system are being returned
physically intact; and
(b) Any fixed hard drive on the device must be non-destructively sanitized to the greatest extent possible without negatively impacting system operation. Selective clearing down to patient data folder level is recommended using VA approved and validated overwriting technologies/methods/tools. Applicable media sanitization specifications need to be preapproved and described in the purchase order or contract.
(c) A statement needs to be signed by the Director (System Owner) that states that the
drive could not be removed and that (a) and (b) controls above are in place and completed. The ISO needs to maintain the documentation.
6. 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 COTR 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 OIG and Security and Law Enforcement. The contractor, its employees, and its subcontractors and their employees shall cooperate with VA and any law enforcement authority responsible for the investigation and prosecution of any possible criminal law violation(s) associated with any incident. The contractor/subcontractor shall cooperate with VA in any civil litigation to recover VA information, obtain monetary or other compensation from a third party for damages arising from any incident, or obtain injunctive
relief against any third party arising from, or related to, the incident.
7. LIQUIDATED DAMAGES FOR DATA BREACH
a. Consistent with the requirements of 38 U.S.C. §5725, a contract may require access to sensitive personal information. If so, the contractor is liable to VA for liquidated damages in the event of a data breach or privacy incident involving any SPI the contractor/subcontractor processes or maintains under this contract.
b. The contractor/subcontractor shall provide notice to VA of a security incident as set
forth in the Security Incident Investigation section above. Upon such notification, VA must secure from a non-Department entity or the VA Office of Inspector General an independent risk analysis of the data breach to determine the level of risk associated with the data breach for the potential misuse of any sensitive personal information involved in the data breach. The term 'data breach' means the loss, theft, or other unauthorized access, or any access other than that incidental to the scope of employment, to data containing sensitive personal information, in electronic or printed form, that results in the potential compromise of the confidentiality or integrity of the data. Contractor shall fully cooperate with the entity performing the risk analysis. Failure to cooperate may be deemed a material breach and grounds for contract termination.
c. Each risk analysis shall address all relevant information concerning the data breach,
including the following:
Nature of the event (loss, theft, unauthorized access);
Description of the event, including:
date of occurrence;
data elements involved, including any PII, such as full name, social security number,date of birth, home address, account number, disability code;
Number of individuals affected or potentially affected;
Names of individuals or groups affected or potentially affected;
Ease of logical data access to the lost, stolen or improperly accessed data in light of the degree of protection for the data, e.g., unencrypted, plain text;
Amount of time the data has been out of VA control;
The likelihood that the sensitive personal information will or has been compromised made accessible to and usable by unauthorized persons);
Known misuses of data containing sensitive personal information, if any;
Assessment of the potential harm to the affected individuals;
Data breach analysis as outlined in 6500.2 Handbook, Management of Security and Privacy Incidents, as appropriate; and
Whether credit protection services may assist record subjects in avoiding or mitigating the results of identity theft based on the sensitive personal information that may have been compromised.
Based on the determinations of the independent risk analysis, the contractor shall be responsible for paying to the VA liquidated damages in the amount of $______ per affected individual to cover the cost of providing credit protection services to affected individuals consisting of the following:
Notification;
One year of credit monitoring services consisting of automatic daily monitoring of at least 3 relevant credit bureau reports;
Data breach analysis;
Fraud resolution services, including writing dispute letters, initiating fraud alerts and credit freezes, to assist affected individuals to bring matters to resolution;
One year of identity theft insurance with $20,000.00 coverage at $0 deductible; and
Necessary legal expenses the subjects may incur to repair falsified or damaged credit records, histories, or financial affairs.
8. SECURITY CONTROLS COMPLIANCE TESTING
On a periodic basis, VA, including the Office of Inspector General, reserves the right to
evaluate any or all of the security controls and privacy practices implemented by the contractor under the clauses contained within the contract. With 10 working-day s notice, at the request of the government, the contractor must fully cooperate and assist in a government-sponsored security controls assessment at each location wherein VA information is processed or stored, or information systems are developed, operated, maintained, or used on behalf of VA, including those initiated by the Office of Inspector General. The government may conduct a security control assessment on shorter notice (to include unannounced assessments) as determined by VA in the event of a security incident or at any other time.
9. TRAINING
a. All contractor employees and subcontractor employees requiring access to VA
information and VA information systems shall complete the following before being granted access to VA information and its systems:
(1) Sign and acknowledge (either manually or electronically) understanding of and
responsibilities for compliance with the Contractor Rules of Behavior, Appendix E relating to access to VA information and information systems;
(2) Successfully complete the VA Cyber Security Awareness and Rules of Behavior
training and annually complete required security training;
(3) Successfully complete the appropriate VA privacy training and annually complete
required privacy training; and
(4) Successfully complete any additional cyber security or privacy training, as required for VA personnel with equivalent information system access [to be defined by the VA program official and provided to the contracting officer for inclusion in the solicitation document e.g., any role-based information security training required in accordance with NIST Special Publication 800-16, Information Technology Security Training Requirements.]
b. The contractor shall provide to the contracting officer and/or the COTR 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.
c. Failure to complete the mandatory annual training and sign the Rules of Behavior
annually, within the timeframe required, is grounds for suspension or termination of all physical or electronic access privileges and removal from work on the contract until such time as the training and documents are complete..