Attachment B PERFORMANCE WORK STATEMENT 36C25725Q0439.pdf

PERFORMANCE WORK STATEMENT

1. Scope: The intent of this Request for Proposal is to enter into a contract to provide Mobile MRI and Technologist Services to include all the necessary personnel, supervision, equipment, transportation, materials, supplies and training to perform the services as specified herein. Service shall be performed at any West Texas VA Healthcare Facility, including both owned and/or leased facilities, main and/or community-based outpatient clinics where indicated.

2. Summary of Requirement: The West Texas Healthcare System is seeking a 12-month

Base, plus 4 (four) 12-month Option Periods, contract for a mobile MRI and associated service agreement and Technologist staffing. The mobile MRI will be placed on an as-needed basis for delivery or move within 10 days, to remain in a single location no less than 6 months.

3. Delivery and Set-up of Contractor Equipment: The Contractor shall be responsible for proper installation/set-up of the Contractor's furnished equipment including the mobile coach. Installation/set-up shall be accomplished in accordance with industry standards, all OSHA regulations and applicable manufacturer's recommendations.

a. The Contractor shall provide a mobile 1.5T MRI coach and MRI Technologists Services at station 519 (West Texas Healthcare System), in accordance with the SOW (Statement of Work).

b. Schedule: Services shall be required five (5) days per week, except on federal holidays.

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

d. Pro-rated Monthly Rental Fee: The Contractor shall prorate the monthly rental fee when MRI coach is not functioning in accordance with prescribed guidelines.

The monthly fee shall be prorated based on the number of hours the coach is out of service during regularly scheduled clinic hours M-F, 7:30am – 4:30pm. The Contractor shall include the hourly rate in the space provided below:

4. Contractor's Responsibilities: The Contractor shall be responsible for the following daily functions:

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

b. Delivery and Set-up of Contractor Equipment: The Contractor shall be responsible for proper installation/set-up of the Contractor's furnished equipment including the mobile trailer.

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

c. Transmit completed electronic data after each exam. Ensure that all of the day’s exam data is completely transferred to the West Texas VA Healthcare System computer systems.

d. All patient information required for Contractor's records shall be secured in accordance with HIPAA guidelines.

e. All connections from the trailer to West Texas VA Healthcare System site/property are properly disconnected from trailer when moved from the site.

f. Any temporary site preparations are removed upon completion of services.

g. Contractor shall ensure mobile MRI is maintained in optimum working condition to ensure the highest level of patient safety at all times. Fire extinguisher to be supplied by the vendor. Vendor shall provide MRI compatible wheelchair, stretcher and O2 tank.

h. Maintenance documents shall be made available to the West Texas VA

Healthcare System upon request.

i. Contractor shall ensure each patient arriving for mobile MRI exam has a signed MRI order for services.

j. MRI tech must complete the final MRI Screening Assessment which is incorporated in the patient’s electronic medical record.

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

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

m. Contractor shall provide a copy of a current, comprehensive MRI Safety Program policy to which each technologist is expected to comply. MRI Technologist is required to complete West Texas VA Healthcare System or analogous MRI Safety Training yearly.

n. Contractor shall be responsible for patient while on the mobile unit and during the entire scanning procedure up to the patient's release.

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

p. Environment of Care Rounds shall be conducted quarterly by the local site COR and West Texas VA Healthcare System Administrator. All identified deficiencies shall be corrected by the Contractor prior to the next scheduled day of service.

q. Contractor shall be responsible for providing 2 qualified MRI Technologists to perform services defined herein. The MRI Technologists shall be required to provide scanning services as well as training on the full operation of the Mobile MRI unit. Training shall be provided to the assigned West Texas VA Healthcare System technical personnel at no additional cost to the Government. If the MRI Technologist is unable to come in to work as per the schedule, an alternate MRI Technologist is available to cover the shift to avoid having to reschedule patients.

All MRI Technologists must complete the credentialing requirements established by West Texas VA Healthcare System.

r. MRI Technologist shall attend the quarterly MRI Safety Committee meeting.

s. Comply with VHA Directive 1105.05 Magnetic Resonance (MR) Safety, WTVAHCS MRI Policy and Procedures and MRI scanning protocols.

t. A one-time cleaning once delivered is required. The entire mobile unit shall be cleaned inside to be ready for use.

5. Delivery Locations:

See below for location of West Texas VA Healthcare System sites of care. The delivery locations include but are not limited to these locations. If new VA locations within the geographic boundaries of West Texas VA Healthcare System (such as a new clinic in Abilene) are added during the duration of the contract, those will presume to be included as potential deployment locations for a mobile MRI as well, provided that they are affiliated with station 519.

George H. O'Brien, Jr., Department of Veterans Affairs Medical Center 300 Veterans Boulevard Big Spring, TX 79720-5566

Abilene VA Clinic 3850 Ridgemont Drive Abilene, TX 79606-2728

Colonel Charles and JoAnne Powell VA Clinic 4240 Southwest Boulevard San Angelo, TX 76904-5634

Fort Stockton VA Clinic 1205 North Sycamore Street Fort Stockton, TX 79735-4122

Hobbs VA Clinic 1301 North Turner Street

Hobbs, NM 88240-8446

Wilson and Young Medal of Honor VA Clinic 8050 East Highway 191 Odessa, TX 79765-8615

6. Physical Access and Security:

a. Contractor will ensure all doors (access) going directly into the mobile unit (Zone

4) and has physical security locking mechanism to control access while continuing to allow MRI personnel and patients access.

b. Direct lift access must include lockable gate.

c. Secure the area around the mobile unit including access to the underside and sides. Facility to review vendor-provided fringe field map showing the 5-gauss line and ensure access is restricted. Fencing would be ideal to ensure MR safety compliance and security (Access to the underside, top and sides of the mobile unit must also be restricted to avoid public exposure.)

7. Invoices and Payment: Payment to be made monthly, in arrears, following satisfactory performance by Contractor’s personnel and upon receipt of a properly prepared invoice.

Contractor shall be required to invoice through the Tungsten System at http://www.tungsten-network.com/us/en/veterans-affairs/.

Additional information regarding Tungsten shall be provided upon award.

The contract shall have current registration in the System for Award Management (SAM) for this solicitation; URL: www.sam.gov The invoice MUST be itemized to include the following information. Any information listed below, and not provided on an invoice, will render that invoice incomplete and the invoice will be returned for immediate correction.

Time period being invoiced for.

Description of services performed.

Unit Cost billed.

Extended amount due.

Invoice number, date Contract and obligation numbers.

8. Magnetic Resonance Imaging (MRI) Mobile Device Salient Characteristics:

Contractor shall make whatever adaptations are necessary so that the Contractor's equipment is compatible with the West Texas Healthcare System data network as specified in Paragraph 16, Telecommunications.

Salient characteristics Details Magnet strength 1.5 Tesla Minimum Bore width (cm) 70cm Minimum bore depth (cm) 130cm Minimum slew rate (T/m/s) 125 Minimum number of channels 48

Maximum patient table load capacity for vertical and horizontal table movement (lbs)

Maximum system weigh (lbs) 10,000 Helium consumption Zero Helium boil-off technology Min patient comfort requirement Short and wide bore for greater patient comfort and easier access for various patient sixes Gradient system XJ Gradients with high performance capable of handling advanced imaging techniques RF Technology TIM 4G 9Toal Imaging Matrix) technology, allowing flexible coil combinations and faster imaging Coil Technology Up to 204 coil elements, allowing for whole body imaging without patient repositioning Imaging speed Up to 48 channels supported with Tim 4G, enabling faster scans and higher throughput Image quality High spatial and temporal resolution, with advanced features, post processing and workflow optimization tools Patient handling Comfortable positioning for long exams, with respiratory and cardiac gating options Application range Neurology, musculoskeletal, cardiovascular, Ortho, Oncology, MRA, Elastography, Spectroscopy, Phase contrast MRI and flow analysis, parametric prostate imaging, high intensity focused ultrasound with the flexibility to expand due to different facility provider requirements

Advanced Imaging Techniques Diffusion weighted imaging (DWI), functional MRI (fMRI), cardiac imaging, MR spectroscopy, etc.

Environment Energy efficiency and reduced operating costs Installation space Mobile trailer installation capable; Semi-trailer truck equipped with stabilizing shocks to prevent disruption of the machine, compact design with low space requirements ideal for a mobile trailer

Operator workflow Intuitive user interface, customizable protocols, and easy data management

Connectivity DICOM compliant integrated with hospital information system (HIS) and Picture Archiving (PACS)

Upgradeable Must be upgradeable to newer software and hardware innovations

Safety features Advanced patient monitoring, acoustic noise reduction, and patient emergency systems. Safety system for magnet quenching and emergency shutdown, to include the following:

• Alarms for low cryogen levels, temperature limits, scans in progress

• Indicators for cryogen levels

• Heat sensor shut offs for room temperature problems.

• Oxygen monitor in gantry room.

Table requirement • Motorized

• Detachable

• Adjustable height

• Stepping capable

UPS requirement Maintains full functionality of the system for a minimum of 30 minutes during a power outage

Coil requirement Imaging of the Torso, knee, shoulder, head/spine/array, neuro vascular, run-off, foot/ankle, wrist, elbow, cardiac, breast, prostate imaging, functional MRI head, carotid, endorectal, periphery vascular, extremity, flexible, transmit/receive, adjustable neurovascular head, whole body imaging

Security/Connectivity requirements

• OEM supported operating system.

• Latest DICOM print, store, commit, structured report (SR) and modality worklist.

• Wireless connectivity to VA network –

Compatible with 802.11b/g/n and FIPS 140-2 or FIPS 140-3 compliant

• Encrypted hard drive.

• PACS compatibility – Change Healthcare

• Integration to Advanced Visualization Systems

Chiller requirement Chiller meeting or exceeding MRI needs Cryogen requirement Cryogens (Vendor expected to provide and install all cryogens.)

Phantom requirements All phantoms required for proper calibration and performance verification (Vendors are expected to provide phantoms for all system requirements and options identified in this document that require phantoms.)

Patient comfort/entertainment package

Integrated music system, to include the following:

• Control room controls

• Speech communication for patient direction

• Speakers in both the exam room and control room

• Headphone jack on patient table

• MRI-safe headphones

Shielding requirement Active Shielding Workstation requirement • Min acquisition workstation monitor size of 19in

• Minimum acquisition workstation hard drive space 200 [GB]

• Minimum number of processing/reading workstations: 2

• Minimum processing/reading workstation monitor size 19 [in]

• Minimum processing/reading workstation hard drive space 200 [GB]

Additional technology specifications

• Compressed sense technology

• Motion correction technology

• Helium save technology.

• Noise reduction technology

• Power conditioning

• Vector ECG(VCG), respiratory and peripheral pulse gating/triggering

• Advanced Exam planning technology

• Geometry linking (multi station exams)

• Real time MIP, MPR, AND 3D surface rendering

• Advanced MR viewing environment, processing, and image generation.

• Patient specific shimming

• Dixon type technology for body, neuro, and musculoskeletal imaging

• Advanced non-contrast MRA imaging technology

• 3D FSE based sequence for isotropic resolution in all contrasts.

• Bolus tracking system

• Heavy duty wide patient restraints

• Patient positioning and support aids

• Video camera system for monitoring inside the exam room from the control room

• MRI-compatible contrast injector

• Operating system must be Windows 10 or newer

• The scanner must be able to scan the cervical, thoracic, and lumbar spines continuously without requiring patient movement.

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

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

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

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

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

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

Trailer space requirement (based on max system dimensions) Location Requirement Width

(cm) Depth (cm)

Height (cm)

Weight (cm)

Examination Room

Magnet and Helium 210 150 220 3200

Magnet, gradient coils body coil, table and covers

250 450 225 5000

Min room height clearance 245 Control Room Workplace table and monitor 130 90 120 Equipment room

Cabinets with system controls, RF system, gradient power system image processor

170 70 200 1500

9. MRI Technologist Staffing Salient Characteristics:

a. The Contractor's Technologists shall possess a current American Registry of Radiologic Technologists (ARRT) license, certified in MRI through ARRT and Basic Life Support (BLS) certified. A copy of all applicable operators’ license/certifications shall be provided with the proposal along with a copy of the updated license immediately upon renewal. The Contractor shall ensure that a copy of the technologist’s current license is provided to the local COR for inclusion in the West Texas VA Healthcare System 6-part folder at all times.

b. The Contractor shall be responsible to ensure that Contractor employees providing work on this contract are fully trained and completely competent to perform the required work. Evidence of the Contractor’s Technologist’s competency review shall be provided with the proposal. Competency checklists must contain evidence of supervisory review at least annually and must contain the written signature of the supervisory official performing the review. A current copy of the employee’s competency checklist shall be maintained in West Texas VA Healthcare System 6-part folder at all times. Competency checklists shall be resubmitted to West Texas VA Healthcare System each time the checklist is updated, no more than 12 months beyond the original date of review.

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

(1) credentials and qualifications for the job

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

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

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

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

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

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

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

10. HOUSEKEEPING REQIREMENTS: The contractor is responsible for all housekeeping requirements. Environment of Care Rounds shall be conducted and deficiencies shall be corrected by the Contractor prior to the next scheduled day of service.

11. MAINTENANCE REQUIREMENTS:

a. 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.

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

c. Contractor shall ensure a 98% or better up-time based upon the normal operation hours, Monday – Friday, 7:30 a.m. – 4:30 p.m.

d. If the system breaks down, the MRI Technologist is responsible for informing Imaging Service representative and Healthcare Technology Management 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.

12. THE WEST TEXAS HEALTHCARE SYSTEM RESPONSIBILITIES:

a. The West Texas VA Healthcare System shall provide a covered walkway (per VA design guidelines where applicable), utility connections, and an appropriate computer line(s) for use by the Contractor.

b. The West Texas VA Healthcare System shall be responsible for scheduling exams for the mobile MRI unit.

c. Providing Mobile MRI Pad:

d. Mobile Pad (MRI criteria most stringent)

1. Size: 55’ X 11’

2. 12” thick, no steel reinforcing under scanner section (may use carbon fiber, polyester, stainless steel)

3. Assess for vibration (road, adjacent machinery)

4. Assess for RF interference (adjacent electrical equipment, etc.)

e. Connectivity:

1. 480V 3 phase power, Russell Stoll connector

2. Data , telephone, water

13. CONFORMANCE STANDARDS/REGULATORY ADHERENCE:

a. Contractor shall perform the required services in accordance with the following:

(1) the standards of the Joint Commission for the Accreditation of Healthcare Organizations (JC) to include Patient Safety Standards (a copy of these standards may be obtained from the Joint Commission on Accreditation of Healthcare Organizations, One Renaissance Blvd., Oakbrook Terrace, IL 60181)

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

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

Occupational Safety and Health Act (OSHA)

The Joint Commission (JC)

Veterans Health Administration (VHA)

United States Department of Transportation (US DOT)

Health Information Portability and Accountability Act (HIPAA)

VHA Automated Information Security (AIS)

Privacy Act

THE VISN 17 FACILITY Medical Staff Bylaws

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

c. Contractor shall adhere to the provisions of Public Law 104-191, Health Insurance

Portability and Accountability Act (HIPAA) of 1996 and the National Standards to Protect the

Privacy and Security of Protected Health Information (PHI). As required by HIPAA, the

Department of Health and Human Services (HHS) has promulgated rules governing the security and use and disclosure of protected health information by covered entities, including the Department of Veterans Affairs Veterans Health Administration (VA).

14. MRI STUDY INTERPRETATION: A VA-identified radiologist shall read/interpret all MRI studies and dictate all required study reports.

15. MRI DATA OWNERSHIP: The West Texas Healthcare System shall maintain sole ownership of all data of studies performed on the mobile MRI under this contract. The Contractor may not use any portion of imaging data obtained from patient studies under the contract. The Contractor may not use any portion of imaging data obtained from patient studies for quality control or educational purposes without written consent of the West Texas Healthcare System.

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

17. MRI POINT OF CONTACT: The Contracting Officer shall designate an individual as the

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

18. TELECOMMUNICATIONS:

a. The mobile unit shall be equipped with an outlet connection capable of transmitting data and voice through a Government provided network interface jack (RJ11 Analog Voice and RJ45 IEEE 803.x). The Government shall provide the necessary network services required for the transmission of images, data and voice. The Contractor's mobile unit shall be able to connect to VISTA Imaging Network and to transmit all images to VISTA Imaging to include being compatible to DICOM imaging standards in use at the West Texas Healthcare System. (PACS interface contact person shall be provided to the Contractor during the post-award orientation).

b. The Contractor shall be responsible for all expenses incurred to interface the MRI Scanner OEM using the DICOM network with the existing in use West Texas Healthcare System Picture Archiving and Communications System.

19. QUALITY ASSURANCE MONITOR:

a. The Contractor shall have a Quality Assurance Program in place at the time of contract award. The Contractor shall provide, with their proposal, a copy of their Quality Assurance Program Plan.

b. The Contractor's Quality Assurance Program Plan shall be in accordance with all JC and HIPAA standards.

c. The Contractor shall maintain equipment service records to document performance reports.

d. Quality Improvement: The Government may evaluate the quality of professional and administrative services provided but retain no control over the medical, professional aspects of services rendered (e.g., professional judgments, diagnosis for specific medical treatment), in accordance with FAR 37.401.b. unless otherwise stated herein.

e. The results of all Quality Improvement activities performed by the Contractor involving the West Texas Healthcare System patients shall be provided to the COR. This shall include, but not be limited to, quality improvement plans, minutes of staff meetings where quality improvement has been discussed and which include practitioner-specific findings, conclusions, recommendations, written plans for actions taken in response to such conclusions and recommendations, and evaluation of those actions taken. It will also include the annual evaluation required by JCAHO. The monitors should reflect, at a minimum, issues related to quality of care and appropriateness of referral. The Contractor shall submit Quality reports by the 10th workday of the first month of each Government fiscal quarter (i.e. October, January, April, July).

f. At the end of each scheduled day of scanning, the Contractor shall provide a log of patients who were scanned on that date and all diagnostic information regarding each patient scanned that day.

g. See attachment A, Quality Assurance Surveillance.

20. CONFIDENTIALITY OF PATIENT RECORDS:

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

b. The records referred to above shall be and remain the property of VA and shall not be removed or transferred from VA except in accordance with U.S.C.551 a (Privacy Act), 38 U.S.C. 5701 (Confidentiality of claimants records), 5 U.S.C. 552 (FOIA), 38 U.S.C. 5705 (Confidentiality of Medical Quality Assurance Records) 38 U.S.C. 7332 (Confidentiality of certain medical records) and Federal laws, rules and regulations. Subject to applicable Federal confidentiality or privacy laws, the Contractor, or their designated representatives, and designated representatives of Federal regulatory agencies having jurisdiction over Contractor, may have access to VA's records, at VA's place of business on request during normal business hours, to inspect and review as needed in order to perform the examination contracted for but in no case will copies of records be made and/or removed from the VA’s place of business.

21. HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT OF 1996

(HIPAA): Contractor must adhere to the provisions of Public Law 104-191, Health Insurance Portability and Accountability Act (HIPAA) of 1996 and the National Standards to Protect the Privacy and Security of Protected Health Information (PHI). As required by HIPAA, the Department of Health and Human Services (HHS) has promulgated rules governing the security and use and disclosure of protected health information by covered entities, including the Department of Veterans Affairs (VA). In accordance with HIPAA, the Contractor may be required to enter into a Business Associate Agreement (BAA) with VA.

22. CONTRACT INFORMATION SECURITY REQUIREMENTS:

a. 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.

b. CONTRACTOR PERSONNEL SECURITY REQUIREMENTS: LOW RISK

(1) All Contractor employees having or requiring access to the Department of Veterans

Affairs’ computer systems or to sensitive data (to include patient or beneficiary records), shall be the subject of a background investigation and must receive a favorable adjudication from the VA Security Investigation Center prior to contract performance.

This requirement is applicable to all subcontractor personnel requiring the same access.

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

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

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

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

(6) Contractor Responsibilities:

(a) The Contractor shall bear the expense of obtaining background investigations.

The VA shall be responsible for payment to the Security Investigations Center;

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

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

(i) Standard Form 85, Questionnaire for Non-Sensitive Positions

(ii)Optional Form 306, Declaration for Federal Employment

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

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

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

c. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS:

(1) A contractor/subcontractor shall be granted access to VA information and VA information systems for their employees, subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order.

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

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

d. VA INFORMATION CUSTODIAL LANGUAGE:

(1) Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information development 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).

(2) 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 onsite 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.

(3) 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 or completion of the contract.

(4) 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 into this contract.

(5) 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.

(6) If VA determines that the contractor has violated any of the information confidentiality, privacy, and security provision 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.

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

(8) 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.

(9) 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.

(10) 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.

f. INFORMATION SYSTEM HOSTING, OPERATION, MAINTENANCE, OR USE.

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

(2) Bio-Medical devices and other equipment or systems containing media (hard drives, optical disks, etc.) with VA sensitive information must not be returned to the vendor at the end of lease, for trade-in, or other purposes. The options are:

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

(b) VA’s initial medical device purchase includes a spare drive which must be installed in place of the original drive at time of turn-in; or

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

(d) Due to the highly specialized and sometimes proprietary hardware and software associated with medical equipment/systems, if it is not possible for the VA to retain the hard drive, then;

1) 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

2) 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.

3) 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.

g. LIQUIDATED DAMAGES FOR DATA BREACH

(1) 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.

(2) 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.

(3) Each risk analysis shall address all relevant information concerning the data breach, including the following:

(a) Nature of the event (loss, theft, unauthorized access);

(b) Description of the event, including:

1) date of occurrence;

2) data elements involved, including any PII, such as full name, social security number, date of birth, home address, account number, disability code;

(c) Number of individuals affected or potentially affected;

(d) Names of individuals or groups affected or potentially affected;

(e) 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;

(f) Amount of time the data has been out of VA control;

(g) The likelihood that the sensitive personal information will or has been compromised (made accessible to and usable by unauthorized persons);

(h) Known misuses of data containing sensitive personal information, if any;

(i) Assessment of the potential harm to the affected individuals;

(j) Data breach analysis as outlined in 6500.2 Handbook, Management of Security and

Privacy Incidents, as appropriate; and

(k) 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.

(4) 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 $37.50 per affected individual to cover the cost of providing credit protection services to affected individuals consisting of the following:

(a) Notification;

(b) One year of credit monitoring services consisting of automatic daily monitoring of at least 3 relevant credit bureau reports;

(c) Data breach analysis;

(d) Fraud resolution services, including writing dispute letters, initiating fraud alerts and credit freezes, to assist affected individuals to bring matters to resolution;

(e) One year of identity theft insurance with $20,000.00 coverage at $0 deductible; and

(f) Necessary legal expenses the subjects may incur to repair falsified or damaged credit records, histories, or financial affairs.

21. SECURITY INCIDENT INVESTIGATION:

(1) 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 procedure. 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.

(2) 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.

(3) With respect to unsecured protected health information, the contractor/subcontractor is deemed to have discovered a data breach when the contractor/subcontractor knew or should have known of a breach of such information. Upon discovery, the contractor/subcontractor must simultaneously notify the COR, ISO and Privacy Officer.

(4) 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 the 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.

f. SECURITY CONTOLS 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-days’ 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.

g. TRAINING:

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

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

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

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

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

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

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

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

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

a. All remote connections to the VA network shall be through the Office of Cyber and Information Security (OCS) authorized configurations and access points.