36C24720Q0166-000.docx

Contract Opportunity Combined Synopsis/Solicitation Notice

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* = Required Field Contract Opportunity Combined Synopsis/Solicitation Notice Q522 Mobile MRI Service and PET/CT Atlanta VA Medical Center 30901 36C24720Q0166 05-21-2020 N

SDVOSBC

339112 Department of Veterans Affairs VISN 7 Network Contracting Activity 501 Greene Street Hatcher Building - Suite 2 Augusta GA 30901 Chaz Bowling, Contract Specialist Office: (706) 733-0188 Ext. 1125 Cell: (615) 440-3018 Email: Chaz.Bowling@va.gov Department of Veterans Affairs Atlanta VA Medical Center 1670 Clairmont Road Decatur, GA 30033

USA

chaz.bowling@va.gov chaz.bowling@va.gov

COMBINED SYNOPSIS/SOLICITATION

GENERAL INFORMATION

Contracting Office Address

NCO 7

ATTN: Chaz D. Bowling Department of Veterans Affairs 501 Greene Street Hatcher Building – Suite 2 Augusta, GA 30901

Description This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, “Streamlined Procedures for Evaluation and Solicitation for Commercial Items,” as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotations are being requested, and a written solicitation document will not be issued.

This solicitation is a request for quotations (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2020-05 / 03-30-2020.

The associated North American Industrial Classification System (NAICS) code for this procurement is 339112, with a small business size standard of 1000 employees.

The Network Contracting Office 7 is seeking to mobile imaging services for the Atlanta VA Medical Center.

All questions regarding this RFQ must be in writing and may be sent by e‐mail to Chaz.Bowling@va.gov. Questions must be received no later than May, 13 2020 at 9:30 AM EST. No further questions will be accepted after that date and time.

You are reminded that representatives from your company SHALL NOT contact any VA Medical Center employees to discuss this RFQ during this RFQ process. All questions and concerns regarding this RFQ shall be directed to the Contracting Officer.

All interested companies shall provide quotation(s) for the following:

(1 year of performance outlined in the SOW)

Brand Name Only:

Please note that this is a brand name only requirement in accordance with Federal Acquisition Regulations (FAR) 6.302-1. The contractor must utilize Siemens equipment while providing these services. See attachment one for brand name justification.

STATEMENT OF WORK STATEMENT—Radiology Services

The Atlanta Veterans Affairs Health Care System, 1670 Clairmont Road, Decatur, GA 30033, herein called ATL VAHCS is requesting a contractor to provide mobile Magnetic Resonance Imaging (MRI) equipment / operations to provide exams for the ATL VAHCS Veterans.

BASICS

B1. Requirements:

The contractor will provide a mobile, handicap-accessible, magnetic resonance imager (mobile MRI) for comprehensive services.

The requirements of services include MRI Imaging for our Veterans for a specific period of performance (POP) to ensure quality patient care if offered. Most vendors can provide one modality for the duration of the contract, and we require services that are comprehensive to the need of the facility without duplicating or utilizing more than one acquisition contract. We are requesting a 48-hour turn-around time / or change-out for additional mobile services that may or may not include CT, PET/CT, Cardiac PET/CT, and Mammography, in lieu of MRI service. This is to include all specialty modality staffing. In addition, when providing PET/CT services, we require an existing source and RAM license for FDG, and radiopharmaceuticals is readily available. Back-up Registered Technologist staffing are available when needed so that there is no delay in care. Any new additional staffing availability is preferred within 4-5 days of request. All required Technologist staffing be current in licenses, credentialing and service training. Vendor is to attend all quarterly reviews with Atlanta VAHCS staff at the main facility for quality review and evaluation of imaging. Local operational support proximity is 30 miles or less to the main facility / Arcadia Clinic, with response time of less than 30 to 45 minutes. All contracted equipment will undergo manufacturer upgrades and scheduled preventative maintenance at the vendor suggested time and or when needed, allowing a 7 to 10-day notice to the facility prior to commencing to ensure proper notification to reschedule.

B2. Authority:

This procurement is executed under:

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

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

1.3 VHA Handbook 1105.02, Nuclear Medicine Service and Radiation Safety;

1.4 VHA Handbook 1105.05, Magnetic Resonance Imaging Safety;

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

1.6 Title 38 Code of Federal Regulations 17.38.

1. Specifications (mobile MRI):

1.1 The Contractor shall provide a mobile magnetic resonance imager (mobile MRI) to perform the following examinations:

a. Head (including brain, posterior fossa, temporomandibular Joint (TMJ), pituitary gland, and acoustic nerve)

b. Cervical spine (including spinal cord)

c. Thoracic spine (including spinal cord)

d. Lumbar spine (including spinal cord)

e. Spine

f. Extremities (single coil)

g. Abdomen (single coil)

h. Pelvis

1.2 General Requirements (mobile MRI):

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

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

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

d. Contractor will perform arrival, set-up, take-down, and departure of mobile MRI in a manner that results in limited or no disruption to normal operations of the ATL VA Clinic.

e. Contractor will perform arrival and departure such that the mobile MRI operates full days (7AM-5PM).

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

g. The Contractor will provide each day a clean mobile MRI and dispose of trash in a responsible manner

1.3 Mobile Equipment:

a. A state-of-the-art self-shielded big-bore magnet (60cm or larger) shall be provided. Its strength shall be 1.5 Tesla or greater. The Contractor shall provide a detachable table that is rated for scanning patients with weight up to 450lbs or greater. The technology shall be Digital Imaging and Communication (DICOM) compatible and be such that it can and will be integrated with the ATL VAHCS Radiology Service PACS and Vista Rad PACS. The unit shall be such that it has not exceeded the five (5) years manufacturer’s original life cycle. The last two (2) years of Preventative Maintenance records of the contracted unit(s) and all corrective action records relevant to operation and repair within the last 2 years shall be provided. All corrective action records relevant to repairs of the unit(s) during the contracted period of performance will be made available to ATL VAHCS Radiology and ATL VAHCS Biomedical Engineering personnel upon request.

b. The equipment shall have the capabilities necessary to perform the following:

1) Dedicated imaging protocols for head and spine applications

2) Optimum water or fat selective excitation imaging, in multi-slice or 3D volume technique

3) Pre-pulses that achieve suppression of blood signal for optimum myocardial and lumen visualization in cardiac and vascular imaging

4) Dedicated imaging protocols for orthopedic applications

5) High quality imaging for assessment of lesions in all anatomical areas

6) Complete clinical studies that are selectable at a single touch

7) Performance of automatic planning method based on flexibility to choose three anatomical landmarks

8) Copying of all examination parameters from any previous scan to a new acquisition

9) Selection of image matrix sizes freely up to 1024 X 1024

10) Dynamic studies with all imaging methods allowing entire scans to be repeated multiple times

11) Manual start controlled from the gantry or operator’s console

12) Various motion and artifact reduction techniques

13) Spin echo

14) Fast field echo

15) Turbo field echo

16) Turbo spin echo

17) Echo planar imaging

18) Inversion recovery

19) Time of flight imaging

20) Phase contrast imaging

21) Quantitative flow studies

22) Imaging using 3D k-space shutter

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

24) Movie for sequential display of up to 24 slices or dynamics/phases

25) Rapid T2 Weighted MR Imaging

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

d. The unit(s) will be in compliance with all federal safety and shielding regulations.

e. Except for electricity and telephone, the unit shall have its own utilities to function independently of the ATL VA Clinic.

f. Telephone wiring: See attached page 1 of 2

g. The Contractor shall be responsible for all maintenance, upgrades, updates, and servicing of Contractor owned equipment during the contract period.

h. All responsibilities in line g will be scheduled and coordinated to be performed after business hours with the COR.

i. The unit(s) will be equipped with a hydraulic lift to accommodate a wheelchair or to accommodate a stretcher and the person transporting the patient.

j. Emergency crash cart with special oxygen tanks and regulators, if needed

k. One MRI safe stretcher and one MRI safe wheelchair

1.4 Utilities and Government Furnished Materials:

a. Fiber reinforced concrete pad

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

c. Water for MRI unit, if needed

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

e. One computer terminal with ATL VAHCS Radiology PACS network access

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

g. Restroom facilities within a reasonable walking distance

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

1.5 Supplies:

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

b. The Contractor will provide a clean mobile MRI and dispose of trash in a responsible manner.

2. Special Requirements:

The Contractor will provide all services listed in BASICS B1. Requirements above, to the Atlanta VAHCS, 1670 Clairmont Road, Decatur, GA 30033; at the ATL VA Clinic, in strict accordance with the terms and conditions of this contract.

2.1 Resources:

a. The resources specified in this contract may be charged only by written modification by the assigned VISN 7 VA Contracting Officer.

b. The MRI services to be performed by the Contractor will be under the direction of the Chief, Radiology Service, ATL VAHCS. The resulting contract is a non-personnel services contract under which the personnel rendering services are not subject, either by the contract terms or by the manner of its administration, to the supervision and control usually prevailing in relationships between the Government and its employees.

2.2 Term of Contract:

a. The contract is effective for one (1) year base period and four (4) 12-month option period with an expected award date that is to be TBD.

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

2.3 Mobile Unit Staffing:

The Contractor will be solely responsible for hiring, training, and compensating the MRI technologists and assistants needed to perform MRI examinations. It is required that staffing levels be such that the mobile units operate competently, professionally, and efficiently. All technologists will have all credentials necessary to work as such within the VA system. All technologists will have current certifications in basic life support procedures. All technologists will maintain all immunizations required of practicing medical professionals. All technologists will adhere to all relevant radiation safety practices and relevant magnetic safety practices. All technologists will always work in a professional manner.

2.4 Study Quality:

The Contractor will provide the ATL VAHCS a study-quality standard (a binder and/or CD of data and studies) that reflects the quality of the studies the provider is prepared to insure will be maintained throughout the duration of the contract. Examples of most, if not all, study types to be performed will be included in the study-quality standard.

2.5 Quality Control:

The Contractor will have a documented quality assurance program and provide the ATL VA HCS copies of quality assurance documents. The program will comply with all relevant TJC and HIPPA standards. The Contractor will have readily available several phantoms that can be used to determine MRI parameters. Phantom studies will be conducted as needed to test and ensure study quality.

2.6 Site Maintenance:

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

2.7 Pre-operation Contractor/ATL VA HCS Tests of Mobile Units:

The Contractor and ATL VA HCS personnel will conduct tests of the mobile units when they are first located. The tests will be performed to ensure the units are working properly, to insure all needed/desired connectivity’s are functioning properly, and to ensure functionality is such that the conditions of this contract are met prior to the date of award.

2.8 Service Contracts:

The Contractor will have, throughout the period of the contract, a service contract with the vendors of the mobile units. These service contracts will include service on the MRI, and on any peripherals required to insure connectivity to the ATL VAHCS Radiology Service PACS. No routine maintenance will be scheduled or performed such that it conflicts with the imaging schedules of the mobile MRI. No maintenance will be scheduled or performed during scheduled scanning hours except to address emergency failures of the mobile units. Service response time to emergency failures should be within two hours.

2.9 Medical Records:

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

2.10 Insurance:

The Contractor will provide proof of liability and workers’ compensation, a certificate of insurance providing evidence of liability coverage including the name of the insurance carrier, limits of liability and type of coverage (Ref: VAAR 852.237-7, Indemnification and Medical Liability Insurance).Standard requirement for $200,000 per person and $500,000 per occurrence for bodily injury and $20,000 per occurrence for property damage as well.

2.11 Medical Emergencies:

The Contractor will provide to the ATL VAHCS written emergency plans addressing emergencies such as patient codes, personal injury, fire, and disruptive behavior.

2.12 Regulatory Adherence:

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

2.13 Quality and Contract Monitoring:

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

b. The Contracting Officers Technical Representative (COR) (114) will be responsible for monitoring the quality of services provided under this contract.

3. Payment:

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

3.2 The Contractor will be paid monthly, in arrears, upon receipt of a properly prepared invoice. The invoice shall include at a minimum: invoice number, invoice amount, Contract’s name and address, contract number, purchase order number and period of performance. The Contractor will provide backup document to COR for verification of amount invoiced. Backup document shall include invoice number, Contractor’s name and address, the contract number, purchase order number, date of exam, type of exam, referring physician’s name, invoice amount and any additional cases. Invoices will be reconciled with VA record prior to disbursement of payments.

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

FSC VA (667)

PO BOX 149971

Austin, TX 78714-8971

4. Administration of Contract:

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

5. Conflict of Interest:

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

6. Contract Monitoring Procedures:

6.1 At the time of contract award, the Contracting Officer will appoint a Contracting Officer Technical Representative (COR) to assist with the contract monitoring requirements. The COR will monitor such items as quality of service, timeliness of performance, customer service, cost control business relations. In accordance with FAR 1.601 (a) “Contracts may be entered into and signed on behalf of the Government only by contracting officers.” A COR is not authorized to modify the stated terms of the contract, including extending the length of the contract period. Quality of service will be monitored through a continuous review of requested studies vs. performed studies, the appropriateness of images produced and morbidity and mortality figures. These factors will be rated by a consensus of radiologists interpreting the MRI studies and through a radiologist or resident in the MRI unit setting protocols for scan and observing patients and procedures through the study process. Timeliness of performance will be measured through daily workload counts compared to daily number of studies ordered. Customer service will be monitored through periodic unannounced visits to the MRI unit and through patient satisfaction surveys completed by MRI patients. Cost control will be monitored through a comparison of overtime hours worked and the type and number of studies completed per day. Appropriate regulatory and accrediting standards will apply, and all adverse events will be reported in accordance with medical center and other applicable guidelines.

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

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

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

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

7. Locations and Period of Performance:

7.1 The ATL VAHCS, including the Radiology Service is located at:

Atlanta Veterans Affairs Medical Center 1670 Clairmont Road Decatur, GA 30033

7.2 The mobile MRI are to be sited at:

Atlanta Veterans Affairs Clinic 250 N Arcadia Ave Decatur, GA 30030

7.

7.1.

7.2.

7.3. Period of Performance (POP):

7.4. Hour of Operation:

The contractor will provide the service during the hours of operation Monday – Friday, 7:00 AM – 5:00 PM and is subject to change depending on the Governments need. Weekends may be added through contract modification if funds permit. Unless otherwise specified the Government observes the following holidays:

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

8. Specifications (mobile PET/CT):

The ATL VA HCS Nuclear Medicine Service will be the primary point of contact at the ATL VA Clinic for communication between the ATL VA Clinic and Contractor as regards to technical aspects of imaging protocols and medical aspects of PET-CT patient studies. The Contractor will communicate to the Nuclear Medicine Service any possible and actual disruptions of PET-CT service. Upon becoming aware of possible or actual disruption of PET-CT service, the Contractor will communicate such service-disruption information to the Nuclear Medicine Service as soon as possible. The Contractor will inform the ATL VAHCS in a timely manner so that patient and Nuclear Medicine Service schedules can be appropriately modified with as little inconvenience as possible to patients and the Nuclear Medicine Service. In addition, all required Technologist staffing be current in licenses, credentialing and service training. When providing PET/CT services, we require an existing source and RAM license for FDG and radiopharmaceuticals readily available.

The Contractor will provide a mobile PET-CT to perform studies for the following:

a. head-and-neck cancer

b. thyroid cancer

c. lung cancer

d. breast cancer

e. esophageal cancer

f. liver cancer

g. pancreatic cancer

h. renal cancer

i. colon cancer

j. melanoma

k. cardiac viability

l. brain perfusion

m. fever of unknown origin

8.1 Study Protocols:

The ATL VAHCS will provide the Contractor protocols for the indications in 1.1 above. Copies of protocols for each of the indications above will be provided as needed to the Contractor. The Contractor should note ATL VA HCS NM Service protocols are often more extensive than those routinely used at many medical centers. Changes to the PET-CT protocols for specific patients may be made by an ATL VA HCS nuclear medicine physician if patient management dictates that such be done. Such changes require authorization of an ATL VA HCS nuclear medicine physician. Parameters that may be changed include, but are not limited to, injected dose, time from injection to start of acquisition (length of radiopharmaceutical uptake phase), duration of emission scans, nature and duration of transmission (CT) scans, number of bed positions, and reconstruction algorithms and parameters.

8.2 General Requirements (mobile PET-CT):

a. The PET-CT unit shall be available for patient exams five (5) days per week, excluding Federal Holidays.

b. The Equipment is to be used for Government contract work only.

c. Contractor shall be solely responsible for all driver-staffing issues related to the mobile PET-CT unit.

d. Contractor shall perform arrival, set-up, take-down, and departure of mobile PET-CT in a manner that results in limited or no disruption to normal operations of the ATL VA Clinic.

e. Contractor shall perform arrival and departure such that the mobile PET-CT operates full days (7AM-5PM).

f. Contractor will be solely responsible for all technologist and other staffing issues related to operation of the mobile PET-CT.

g. The Contractor will provide each day a clean mobile PET-CT and dispose of trash in a responsible manner, ensuring all radioactive waste is properly handled.

8.3 Equipment (mobile PET-CT):

a. The Contractor will provide on each scan day a clean well-maintained state-of-the-art PET-CT. The imaging table of the unit shall be rated for scanning patients with a weight up to 500lbs or greater. The technology will be Digital Imaging and Communication (DICOM) compatible and be such that the unit can and will be integrated with a Siemens MMWP workstation in the ATL VAHCS Nuclear Medicine Service and with the ATL VAHCS Radiology Service PACS. The last two (2) years of Preventative Maintenance records of the unit and any corrective action records within the last 2 years will be provided. All corrective action records during the contracted period of performance will be made available to ATL VAHCS Nuclear Medicine and Biomedical Engineering personnel upon request. The Contractor will be responsible for maintenance of all connectivity cables used to connect the mobile PET-CT to the fixed connectivity ports and will be responsible for connecting and disconnecting power, phone, and network connections during each visit.

b. The PET component of the PET-CT will be a state-of-the-art full-ring multi-crystal PET system.

c. The CT component of the PET-CT will be a state-of-the art 6-, 8-, 16-, or more slices CT.

d. The PET-CT acquisition environment will have a means of backup of all patient data. The raw PET data (the PET sinogram) and the reconstructed PET, CT, and PET-CT registered data/images will be stored such that the reconstructed data can be displayed and such that the PET raw data can be re-reconstructed with different parameters at later dates. In addition, the reconstructed PET and CT data/images and the registered PET-CT DICOM data/images will for each patient be written to a CD or DVD as a secondary means of archiving and backup.

e. The hardware and software environment will be such that all PET, CT, and PET-CT data/images, can be transferred conveniently and rapidly to the PACS in the ATL VAHCS Radiology Service.

8.4 Radiopharmaceuticals:

The Contractor will be fully responsible for the ordering of, acquisition of, quality control of, and payment for doses of FDG (fluorodeoxyglucose). The cost of FDG will be included in the standard charge for the mobile service. The Contractor will follow all federal and best-practice requirements for the safe use of radioactive materials. No interruption in service should occur due to non-delivery of FDG.

8.5 Radioactive Waste:

The Contractor will be responsible for disposal of radioactive waste. No radioactive waste will be disposed of in any conventional waste receptacle. Radioactive waste will be labeled and disposed of in a manner consistent with all regulations relevant to the safe disposal of radioactive materials.

8.6 Study Performance:

The PET-CT technologists hired by the Contractor will be required to complete accurately, for each patient, a study parameter form so that study acquisition and processing details are documented for each study performed. This form will be developed by the VAMC in conjunction with the Contractor.

8.7 Study Interpretation:

Physicians of the ATL VA HCS NM Service will read/interpret all PET-CT studies and dictate all required study reports. The provider of the mobile PET-CT is not responsible for the reading of PET-CT or for the dictation of PET-CT study reports.

8.8 Utilities and Government Furnished Materials:

a. Fiber reinforced concrete pad

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

c. One (1) telephone line located near the power outlet [Telephone access for local, toll free, and long-distance calls will be provided.]

d. One computer terminal with ATL VAHCS network access

e. Telephone instruments as needed for the mobile units

f. Emergency crash cart

g. Restroom facilities within a reasonable walking distance

h. One stretcher and one wheelchair

i. Provide all supplies, including basic consumables and linens, required to perform PET-CT studies with and without oral contrast.

8.9 Supplies:

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

INFORMATION SECURITY:

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

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

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

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

ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS:

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

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

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

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

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

g. The contractor shall provide to the Contracting Officer and/or the COR a copy of the training certificates and certification of signing the Contractor Rules of Behavior for each applicable employee within 1 week of the initiation of the contract and annually thereafter, as required.

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

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

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

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

VA INFORMATIONAL CUSTODIAL TERMS:

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

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

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

INFORMATION SYSTEM HOSTING, OPERATION, MAINTENANCE, OR USE:

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

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

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

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

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

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

g. All electronic storage media used on non-VA leased or non-VA owned IT equipment that is used to store, process, or access VA information must be handled in adherence with VA 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.