36C24618R0818-001.docx

36C24618R0818 (PET/CT Scan Services for Hampton VAMC and Salem VAMC)

1. REQUISITION NO.

2. CONTRACT NO.

3. AWARD/EFFECTIVE DATE

4. ORDER NO.

5. SOLICITATION NUMBER

6. SOLICITATION ISSUE DATE

a. NAME

b. TELEPHONE NO. (No Collect Calls)

8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY

CODE

10. THIS ACQUISITION IS

UNRESTRICTED OR

SET ASIDE:

% FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ

IFB

RFP

15. DELIVER TO

CODE

16. ADMINISTERED BY

CODE

17a. CONTRACTOR/OFFEROR

CODE

FACILITY CODE

18a. PAYMENT WILL BE MADE BY

CODE

TELEPHONE NO.

DUNS:

DUNS+4:

PHONE:

FAX:

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER 18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKED

SEE ADDENDUM

19.

20.

21.

22.

23.

24.

ITEM NO.

SCHEDULE OF SUPPLIES/SERVICES

QUANTITY

UNIT

UNIT PRICE

AMOUNT

(Use Reverse and/or Attach Additional Sheets as Necessary)

25. ACCOUNTING AND APPROPRIATION DATA

26. TOTAL AWARD AMOUNT (For Govt. Use Only) 27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA

ARE

ARE NOT ATTACHED.

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA

ARE

ARE NOT ATTACHED

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________

29. AWARD OF CONTRACT: REF. ___________________________________ OFFER

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND

DATED ________________________________. YOUR OFFER ON SOLICITATION

DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY

(BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED

SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER) 30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION

(REV. 2/2012)

PREVIOUS EDITION IS NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

36C24618R0818 07-0 -2018 Larry Lapp 757-315-3988 07-31-2018 2:00 pm EDT Department of Veterans Affairs Network Contracting Office 6 100 Emancipation Drive Hampton VA 23667 X X 621512 $15 Million X N/A X Department of Veterans Affairs Network Contracting Office 6 100 Emancipation Drive Hampton VA 23667 Department of Veterans Affairs Network Contracting Office 6 100 Emancipation Drive Hampton VA 23667

Department of Veterans Affairs Financial Services Center

PO BOX 149971

Austin TX 78714-9971 See CONTINUATION Page Contractor shall provide all labor, material, tools, equipment, maintenance and repair of all Contractor furnished equipment (including a mobile trailer/unit), specialized staff, training, required supplies, and medications/drugs necessary to perform Positron Emission Tomography/Computerized Tomography (PET/CT) Services for Hampton VAMC and Salem VAMC within the VA Mid Atlantic Health Care Network, VISN 6.

See CONTINUATION Page X X Marchelle Peyton Contracting Officer Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

(continuation from Standard Form 1449, block 18A.)

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

a. CONTRACTOR:

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

3. INVOICES: Invoices shall be submitted in arrears:

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

Department of Veterans Affairs Financial Services Center

PO BOX 149971

Austin TX 78714-9971

ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

B.2 LIMITATIONS ON SUBCONTRACTING-- MONITORING AND COMPLIANCE (JUN 2011)

Accordingly, any contract resulting from this solicitation will include this clause. The contractor is advised in performing contract administration functions, the CO may use the services of a support contractor(s) retained by VA to assist in assessing the contractor's compliance with the limitations on subcontracting or percentage of work performance requirements specified in the clause. To that end, the support contractor(s) may require access to contractor's offices where the contractor's business records or other proprietary data are retained and to review such business records regarding the contractor's compliance with this requirement. All support contractors conducting this review on behalf of VA will be required to sign an “Information Protection and Non-Disclosure and Disclosure of Conflicts of Interest Agreement” to ensure the contractor's business records or other proprietary data reviewed or obtained in the course of assisting the CO in assessing the contractor for compliance are protected to ensure information or data is not improperly disclosed or other impropriety occurs. Furthermore, if VA determines any services the support contractor(s) will perform in assessing compliance are advisory and assistance services as defined in FAR 2.101, Definitions, the support contractor(s) must also enter into an agreement with the contractor to protect proprietary information as required by FAR 9.505-4, obtaining access to proprietary information, paragraph (b). The contractor is required to cooperate fully and make available any records as may be required to enable the CO to assess the contractor's compliance with the limitations on subcontracting or percentage of work performance requirement.

B.3 SCHEDULE OF SUPPLIES/SERVICES

Table 1 below “Medicare Per-Procedure Reimbursement Rates” for the HCPSC/CPT service code specified are established as the baseline for calculating Actual Unit Costs within the Schedule of Supplies/Services and includes F-18 FDG contrast charge.

Table 1 - Medicare Per-Procedure Reimbursement Rates (Base Year 1 April 2019 through 31 March 2020)

Hampton, VA VAMC 78814 – Tumor image PET/CT, limited 78815 – Tumor image PET/CT, skull-thigh 78816 – Tumor image PET/CT, full body

$1,358.03 $1,358.03 $1,358.03

Salem, VA – VAMC 78814 – Tumor image PET/CT, limited 78815 – Tumor image PET/CT, skull-thigh 78816 – Tumor image PET/CT, full body

$1,358.03 $1,358.03 $1,358.03

BASE PERIOD (1 Apr 2019 – 31 Mar 2020)

QTY

Cost Actual Total Cost

A

B

C

D Hampton, VA – VAMC 78814 – Tumor image PET/CT, limited

78815 – Tumor image PET/CT, skull-thigh

78816 – Tumor image PET/CT, full body

No Show

TOTAL

N/A

EA

EA

EA

EA

A

B

C

D

Salem, VA – VAMC 78814 – Tumor image PET/CT, limited

78815 – Tumor image PET/CT, skull-thigh

78816 – Tumor image PET/CT, full body

No Show

TOTAL

N/A

EA

EA

EA

EA

TOTAL AMOUNT CLINs 0001 – 0002 Base Period………………….

Base Year NTE Total = $ ____________ OPTION PERIOD 1 (1 Apr 2020 – 31 Mar 2021)

QTY

Cost Actual Total Cost

A

B

C

D Hampton, VA – VAMC 78814 – Tumor image PET/CT, limited

78815 – Tumor image PET/CT, skull-thigh

78816 – Tumor image PET/CT, full body

NA

EA

EA

EA

EA

A

B

C

D

Salem, VA – VAMC 78814 – Tumor image PET/CT, limited

78815 – Tumor image PET/CT, skull-thigh

78816 – Tumor image PET/CT, full body

N/A

EA

EA

EA

EA

TOTAL AMOUNT CLINs 1001-1002 Option Period 1………………….

Option Year 1 NTE Total = $_____________

OPTION PERIOD 2 (1 Apr 2021 – 31 Mar 2022)

QTY

Cost Actual Total Cost

A

B

C

D Hampton, VA – VAMC 78814 – Tumor image PET/CT, limited

78815 – Tumor image PET/CT, skull-thigh

78816 – Tumor image PET/CT, full body

N/A

EA

EA

EA

EA

A

B

C

D

Salem, VA – VAMC 78814 – Tumor image PET/CT, limited

78815 – Tumor image PET/CT, skull-thigh

78816 – Tumor image PET/CT, full body

N/A

EA

EA

EA

TOTAL AMOUNT CLINs 2001-2002 Option Period 2………………….

Option Year 2 NTE Total = $_____________

OPTION PERIOD 3 (1 Apr 2022 – 31 Mar 2023)

QTY

Cost Actual Total Cost

A

B

C

D Hampton, VA – VAMC 78814 – Tumor image PET/CT, limited

78815 – Tumor image PET/CT, skull-thigh

78816 – Tumor image PET/CT, full body

N/A

EA

EA

EA

EA

A

B

C

D

Salem, VA – VAMC 78814 – Tumor image PET/CT, limited

78815 – Tumor image PET/CT, skull-thigh

78816 – Tumor image PET/CT, full body

N/A

EA

EA

EA

EA

TOTAL AMOUNT CLINs 3001-3002 Option Period 3………………….

Option Year 3 NTE Total = $_____________

OPTION PERIOD 4 (1 Apr 2023 – 31 Mar 2024)

QTY

Cost Actual Total Cost

A

B

C

D Hampton, VA – VAMC 78814 – Tumor image PET/CT, limited

78815 – Tumor image PET/CT, skull-thigh

78816 – Tumor image PET/CT, full body

No Show

TOTAL

N/A

EA

EA

EA

A

B

C

D

Salem, VA – VAMC 78814 – Tumor image PET/CT, limited

78815 – Tumor image PET/CT, skull-thigh

78816 – Tumor image PET/CT, full body

No Show

TOTAL

N/A

EA

EA

EA

EA

TOTAL AMOUNT CLINs 4001-4002 Option Period 4………………….

Option Year 4 NTE Total = $_____________

36C24618R0818 (Mobile PET/CT Scan Services for Hampton VAMC and Salem VAMC)

Page 1 of

B.4 PERFORMANCE WORK STATEMENT

Mobile Positron Emission Tomography/Computerized Tomography (PET/CT) Services for Hampton VAMC and Salem VAMC

1. SERVICES: Contractor shall provide all labor, material, tools, equipment, maintenance and repair of all Contractor furnished equipment (including a mobile trailer/unit), specialized staff, training, required supplies, and medications/drugs necessary to perform Mobile Positron Emission Tomography / Computerized Tomography (PET/CT) Services in accordance with terms and conditions listed herein for Hampton VA Medical Center and Salem VA Medical Center within Veterans Administration (VA) Mid Atlantic Health Care Network VISN 6. Contractor shall be responsible to maintain all Contractor equipment in good working order always. Every effort should be made to keep equipment down time to a minimum of 72 hours or less. Scheduled service shall be furnished to both Hampton VAMC and Salem VAMC as needed by the facility. Coordination with the COR for exact scheduled dates is required. Estimated coverage is as follows:

· Hampton VAMC requires services twice per month with the option to add days if needed.

· Salem VAMC requires services one day each weekly with an additional day every other week with the option to add days if needed.

2. SUPPLIES: Contractor shall be solely responsible for the procurement, receipt, dispensing, administration, and safekeeping, of all supplies and medications/drugs required in the performance of the services defined herein and authorized by the COR/ACOR. These supplies include but are not limited to radioisotopes to be handled in accordance with Contractor’s licensing, State and Nuclear Regulatory Commission (NRC) regulations. Contractor shall also be responsible for the waste management, removal and proper disposal of all radioactive waste materials off the Hampton VAMC and Salem VAMC property. The cost for proper disposal of radioactive waste materials and other materials furnished under this contract shall be part of any line item pricing listed in the Schedule of Supplies/Services and should not be separately priced for this requirement.

3. CONTRACTOR’S FURNISHED EQUIPMENT: Equipment shall include but not be limited to a Contractor furnished fully equipped PET/CT Mobile Trailer where studies will be performed on a PET/CT scanner manufactured after January 2004 and a PET/CT review station and fusion software to be placed within each medical center obtaining service under this contract. All equipment to be used shall be Food and Drug Administration (FDA) approved imaging equipment placed at a location designated by the Contracting Officer Representative (COR) on VISN 6 sites. The entire offering of a PET/CT Mobile Trailer service shall meet all local, state, federal, industry, The Joint Commission or equivalent standard, National Electrical Code (NEC), National Fire Protection Association (NFPA), Veterans Administration (VA), Occupational Safety and Health Administration (OSHA), and other regulatory standards internal or external for which the VISN 6 is currently accountable and will be kept current with all future Federal and State regulations. While on Federal property, the contractor’s personnel shall abide by all policies of the site of service to include but not limited to: smoking, HIPAA, information security, radiation and patient safety policies.

4. SYSTEM CAPABILITY REQUIREMENTS: The Contractor shall provide an on-site Mobile PET/CT system that is a full body PET/CT scanner system in accordance with the terms and conditions of this requirement. The unit shall have the ability to perform a wide range of exams as listed below:

The types of exams expected to be performed with the PET/CT:

1. Oncology related PET/CT exams.

1. Imaging of cardiac metabolism with F-18 Fludeoxyglucose (FDG).

1. Brain imaging with F-18 FDG.

5. MOBILE UNIT CAPABILITIES:

Contractor shall provide the following:

a. Hardware and software necessary to permit interpretation of PET/CT Images at the site where images are obtained.

b. The mobile unit shall be equipped with a hot lab to receive and store the radioisotope and radioactive waste.

c. Ability to create, store and export Digital Imaging and Communications in Medicine (DICOM), Joint Photographic Experts Group (JPEG) and Moving Picture Experts Group (MPEG) file formats.

d. The mobile unit shall be equipped with Compact Disk-Recordable CD-R/DVD-R burning capabilities as a backup to network transfer of data.

e. The mobile unit shall be equipped with an Image Analysis Station for image registration quality assurance.

f. The mobile unit shall be equipped with an Intravenous (IV) contrast injector and warmer.

g. The mobile unit shall be equipped with a programmable injector with pressure monitor having the following capabilities (example unit would be the Medrad Stellant Single Syringe Injector):

1. Scan delay

1. Multiphase option

1. Protocol storing

1. Pause hold functionality

h. The Contractor’s PET/CT trailer shall provide the space sufficient and designed for a ‘Quiet Room’ where the radiopharmaceutical is administered and the patient rests comfortably with no physical activity and minimum possible external stimuli such as noise and light during the uptake period of the radiopharmaceutical.

i. The Contractor’s PET/CT trailer shall provide the space sufficient and appropriate equipment for the monitoring of sedated patients and conducting cardiopulmonary resuscitation if necessary.

j. The couch for the PET/CT scanner shall be provided with a flatbed insert approximating the table top of a linear accelerator for the purposes of radiation therapy treatment planning purposes.

k. Data/Image Transfer: Digital Imaging and Communications in Medicine (DICOM) 3.0 system shall be used to export images from Contractor mobile unit to Contractor supplied fusion workstation within the medical center. VA will provide an Access Control List (ACL) for a secure port for imaging connection. The Vendor furnished Microsoft Windows 7 x64 workstation shall be placed on the VA Network and be a domain member. The Vendor Workstation shall reside in a Medical Virtual Local Area Network (VLAN) and will have access to the VA Network. The Vendor’s equipment shall use a VA supplied IP address. The Vendor must have technical support available to address technical issues within two hours of notification.

Minimum security requirements:

1. Up-to-date Microsoft (MS) patches and anti-virus software at the vendor mobile unit

1. Up-to-date MS patches and anti-virus software at the vendor workstation

1. Any workstation configuration must be compatible with VA supplied anti-virus (currently McAfee Enterprise)

1. Medical Device Isolation Architecture (MDIA) security to be provided by VA

1. No patient identifiers such as name and Social Security Number shall reside on the mobile unit and images shall have an identifier which does not disclose Personally Identifiable Information (PII).

6. MOBILE UNIT ACCESSORIES: Accessory equipment that shall be provided by the Contractor:

a. Handicap accessibility.

b. Intercom system between the control room and scanning room.

7. MOBILE UNIT EQUIPMENT SPECIFICATIONS: The following minimum performance characteristics of the equipment are required:

a. The PET/CT shall provide images with consistently high technical quality to be approved by VA employed experts. Poor image quality will be considered non-performance under this contract and must be remedied within 30 days of notification or incurred default.

b. The PET must have the capability to acquire images in multiple modes including but not limited to static emission scans and whole-body scans.

c. The PET/CT shall have a PET detector crystal specifically made for PET imaging.

d. The PET/CT should have the capability to acquire 2-dimensional and/or 3-dimensional PET images or true 3-dimensional images.

e. The CT component of the PET/CT Unit shall have a minimum of a 6-slice detector and can acquire the transmission images within one breath hold.

f. The CT component of the PET/CT shall have the capability to acquire data for anatomic localization and attenuation correction.

g. The PET/CT system shall have attenuation correction algorithm(s) that are designed to use non-contrast enhanced CT data.

h. The PET/CT system shall have attenuation correction algorithm(s) that are designed to use CT data with intravenous contrast enhancement.

i. The PET/CT system shall have attenuation correction algorithm(s) that are designed to use CT data with oral contrast enhancement with positive contrast (iodinated contrast).

j. The PET/CT system shall have attenuation correction algorithm(s) that are designed to use CT data with oral contrast enhancement with negative contrast (water).

k. The contractor shall provide two PET/CT review stations with fusion software compatible with the brand of PET/CT system provided, to be installed within each of the participating VISN 6 hospitals and connected to the mobile system via VA provided network infrastructure over Virtual Local Area Network (V-LAN). The review stations shall have the capacity to handle the computational load of 3-dimensional datasets and sufficient storage to keep images for a minimum of 12 months. The PET/CT review station shall be provided with hardware, software and licenses capable of producing DICOM PET and CT image data on vendor supplied CDR/DVD-R disks for import into the VA Picture Archiving and Communication System (PACS). The vendor shall provide hardware and software maintenance and support during the term of this contract.

l. The review stations shall each have two (2) 19” or larger color monitors of diagnostic quality for the type of images being reviewed. High resolution and high-lumen monitors shall not be accepted in place of diagnostic quality.

m. The review stations shall have computers with high processing performance and large memory capacity to achieve real-time interactive navigation without compromising the native resolution of CT images (spatial resolution and dynamic range) or the scale of PET data to match the CT resolution.

n. The review stations shall each have image fusion capability as well as whole body display.

o. The review stations shall each have software tools that allow interpreting physicians to easily and efficiently navigate between the two (2) modalities and through multidimensional PET/CT datasets.

p. The review stations shall each have software tools that have the capability to provide three (3) orthogonal planes of the CT images alone, the PET images alone and the superimposed PET/CT images and an additional set of non-corrected PET images.

q. The Mobile PET/CT unit shall be ready for use regardless of outside environmental conditions.

r. The Mobile PET/CT unit shall maintain a temperature to assure proper operation of the scanner without frequent calibration and provide for patient comfort.

s. The PET/CT unit shall meet all federal, state and local fire and safety requirements.

t. Telecommunications: The mobile unit shall be equipped with outlet jack’s connections capable of transmitting data and voice through Government provided category five (5) cable and dual pair phone cable. The Government will provide the connection required for the transmission of images, data and voice.

u. The mobile unit shall support DICOM Modality Work list (DMWL), for future use.

v. The mobile unit shall be able to export DICOM images to at least one destination.

w. System shall have been approved by the Federal Drug Agency (FDA) and meets or exceeds minimal standards for the type of equipment being provided as defined herein.

x. The PET/CT scanner shall have an accessory top duplicating the flat table top of a linear accelerator and laser localization system to facilitate radiation therapy treatment planning set-ups. Requirements responses shall include a description of the localization system to be provided with the PET/CT system.

VISN 6 SITES SHALL PROVIDE THE FOLLOWING UTILITIES/SERVICES UP TO THE DOCKING PAD (IF NECESSARY) FOR OPERATION OF THE PET/CT MOBILE UNIT.

· Pad (12’ X 52’X 8” thick concrete (3000psi) with air entrainment, broom finish, reinforcing steel to be ASI-615 Grade 60, #4 bars @ 8” each way, top of steel to be 2” from the top of the concrete surface.)

1. Electricity (150-amp panel breaker, 3-phase, 480v), (200-amp receptacle, 5-wire, Russel Stoll #DF 2504 Frabo)*

1. Telephone Line(s) **

1. Data Port ***

1. Housekeeping ****

1. Restroom Facilities

* In accordance to the Original Equipment Manufacturers (OEM) electrical specifications.

** Two (2) telephone lines. Use of telephone extension while mobile unit is on site shall be to permit personnel of the unit to make and receive telephone calls, and to facilitate the movement of patients to and from the unit. Telephone calls placed and received by the personnel of the unit on the extension shall be restricted to the appropriate free dialing areas. Long distance calls shall be made with calling cards, reverse charges or to toll free numbers provided by and paid for by the vendor.

*** Two (2) data lines. Data Port requirements are for the support of Data/Image transfer support (See Para. 11 of the Statement of Work).

**** Hampton VAMC and Salem VAMC shall be held responsible for areas within the hospital facility prior to entrance of the Mobile Trailer. Contractor shall be responsible for all housekeeping duties and responsibilities within the Mobile Unit and within the general vicinity around the outside of the Mobile Unit.

8. EQUIPMENT MAINTENANCE: Equipment provided shall be in good working order always to provide high quality scans required under this requirement and any resulting contract. Contractor shall be completely responsible for the preventive maintenance, emergency and general repairs, safety, cleaning, and upkeep of all equipment furnished by the Contractor. Preventative maintenance/repairs on the Mobile PET/CT unit and all associated equipment shall be performed in accordance with the Conformance Standards and manufacturer’s recommendations.

Contractor shall be responsible for the overall housekeeping of the unit including but not limited to removal and proper disposal of all debris daily or as often as necessary to maintain a sanitized and neat environment in accordance with the Conformance Standards.

Contractor shall be responsible for all equipment while on Hampton VAMC and/or Salem VAMC property. Contractor’s personnel must be present during working hours while the equipment is located on the Hampton VAMC and/or Salem VAMC property. Hampton VAMC and/or Salem VAMC will not be held responsible for any loss or damage to the Contractor’s property, which may be vandalized or damaged, including the mobile trailer while on site. Contractor shall maintain property insurance on all equipment throughout the duration of the contract and the successful Contractor shall provide proof of insurance as required herein.

9. SITE PREPARATION: Hampton VAMC and Salem VAMC will provide a docking site for the contractors PET/CT Scan mobile unit. The Contractor or designee shall perform a site visit at Hampton VAMC and Salem VAMC after notification of contract award and prior to commencement of work to coordinate with the COR to confirm site conditions for trailer/mobile unit docking.

10. CONTRACTOR’S QUALIFICATIONS: The contractor must be regularly established in the business called for, financially responsible and have the necessary equipment and personnel to furnish service in the volume required for all items under this requirement. The successful Contractor shall meet all Federal, State and Local codes and requirements for the operation of this service and equipment provided. Employees authorized by the Contractor to perform services under this specification and any resulting contract, (including all PET/CT Scanning Technologists) shall be licensed and/or registered in a State, Territory or Commonwealth of the United States or the District of Columbia and meet the Nuclear Medicine Technologist professional qualification criteria of Virginia. In addition, the PET/CT scanning technologists shall be certified Nuclear Medicine Technologists American Registry of Radiologic Technologists (ARRT) and/or Nuclear Medicine Technology Certification Board (NMTCB) as defined herein.

If additional technologists are required to increase services under this contract, the Contractor shall be requested to provide a written description of those personnel to the Contracting Officer for approval and security clearance (background investigation) prior to the commencement of any additional services.

The Contractor is required to develop and maintain the following documents for each Contractor employee working on the contract: credentials and qualifications for the job; a current competence assessment checklist (an assessment of knowledge, skills, abilities and behaviors required to perform a job correctly and skillfully; including knowledge and skills required to provide care for certain patient populations, as appropriate.); a current performance evaluation supporting ability of the Contractor employee to successfully perform the work required in this requirement; and listing of relevant continuing education for the last two (2) years. The Contractor shall provide current copies of these records at the time of contract award and annually on the anniversary date of contract award to the Hampton VAMC and Salem VAMC COR or Radiology management designee; or upon request, for each Contractor employee working on the contract.

Personnel assigned by the Contractor to perform the services covered by this contract shall be proficient in written and spoken English (38 USC 7402). Contractor’s technologists shall be required to type patient information into the PET/CT computer ensuring that all images are identified with the correct patient information to include: full name, social security number, date/accession number and modality type.

Contractor’s assigned personnel must be computer literate in the type of software and/or hardware associated with their duties.

11. CONTRACTOR’S STAFF: Contractor shall provide all required specialized medical PET/CT Technologist(s) and any qualified support staff (as patient volume requires) necessary to provide services for Hampton VAMC and Salem VAMC patients.

PET/CT Mobile Unit Driver shall be licensed as applicable to operate and drive the mobile vehicle in which the unit is housed. Contractor technical employees shall have valid, in date Basic Life Support (BLS) certification and be authorized to initiate this life-saving act if necessary.

DAILY ACCESS TO VISN 6 FACILITIES: The contractor shall be responsible for contacting the VA Police at the site of service at the time of arrival, in which the contractor will need access to both the building and data port connections for that day’s operation. The contractor shall also be responsible for contacting the site VA Police at the closing of each workday to ensure that both the building and the data port connections are secured. The location and contact numbers will be provided by the COR to the contractor at the post award orientation meeting.

12. CONTRACTOR’S RESPONSIBILITIES:

1. Contractor shall be responsible for providing the qualified PET/CT Scanning Technologist(s) to perform services defined herein.

1. Contractor shall be responsible for training Hampton VAMC and Salem VAMC physicians on the use of the Contractor provided workstation and image analysis software as directed by the COR.

1. Contractor shall be responsible for the timely delivery of the PET/CT trailer such that the Contractor may facilitate the following start up functions:

1. Prior to the commencement of daily services, the Contractor shall perform whatever tests are necessary so that the mobile trailer and all associated equipment is fully operational, safe and ready for services so that the schedule of patients is maintained always.

1. Prior to the commencement of services, the Contractor shall ensure that the mobile trailer is properly positioned and docked. Contractor shall also ensure that the normal temperature within the mobile trailer is set and maintained prior to services.

1. Prior to the commencement of daily services, the Contractor shall ensure that the mobile trailer is level and safe for all Hampton VAMC and Salem VAMC patients and that appropriate utilities are connected for proper warm up of all on board systems.

1. Contractor shall allow sufficient time for contacting the VA Police when gaining access to Hampton VAMC or Salem VAMC.

1. Communications systems shall be operational before commencement of services.

1. The contractor shall develop, provide and maintain Management, Staffing and Quality Control Plans which include the substitution of personnel for sicknesses, vacations, accidents and emergency conditions. Replacement personnel shall be from a pool of personnel that are available and fully cleared and approved to work on the contract. See B.4, paragraph 4 “Personnel and Temporary Substitutions”.

1. Contractor should be professional and courteous to patients always.

1. Daily Quality Control time must not interfere with the regular scheduling of patients for exams. This start up functions must be completed prior to 8:00 am on each day when trailer is scheduled to be on site in time for the first patient’s injection.

1. Contractor shall be responsible for ensuring quality diagnostic images are provide always. Hampton VAMC and Salem VAMC reserves the right to require corrective action if image quality or other service problems are brought to the attention of the Contractor.

1. Contractor shall be responsible for monitoring the number of PET/CT scans performed, and that the billing is in accordance with the correct pricing.

1. DATA/IMAGE TRANSFER SUPPORT: Contractor shall provide IT Technical Support while the PET/CT mobile unit is located on-site. Technical Support personnel must have complete knowledge of all Transmission Control Protocols/Internet Protocols (TCP/IP) modification required to interface with the VA network and the Contractor shall provide IT Technical Support to facilitate data transfer to the VA network.

The Contractor will be provided an IP address for Source Data, Default Gateway, and Subnet Mask from the VI OI&T personnel. The Contractor shall be responsible for implementation of data transfer to the VA network with the assistance of VA OI&T personnel. The mobile truck’s IP addresses cannot be part of the VA network. The IP range for the workstation/equipment must be in a range supplied by the Government. It should allow for the IP address to be changed locally. The VA will create an Access Control List (ACL) to address security controls. The Contractor shall ensure all IT devices located in the PET/CT mobile unit be cleansed of all Virus and Malware prior to connecting to the VA network.

1. SCHEDULING OF PATIENTS/SERVICES: The contractor shall coordinate with the Designated Ordering Office or Officer from the participating VISN 6 sites and schedule services at their discretion. Each VISN 6 site will designate an ordering office or officer upon award of a contract. Scheduling conflicts, which cannot be resolved, shall be decided by the Contracting Officer. The decision of the Contracting Officer shall be final in accordance with the disputes provisions of this contract. (VA will consider alternative schedules if advantageous to the Government).

The Contractor shall be required to confirm the scheduled examinations, including additional visits, by contacting the Contracting Officer’s Representative (COR) or designee two (2) working days prior to the date of services. Failure to verify scheduled services shall not obligate Hampton VAMC or Salem VAMC for payment if services were not required. The Contractor shall establish a firm cut off time for next day add-on exams that shall guarantee delivery of the 18-FDG doses if required. Procedures will be established and shall be mutually agreed upon between the COR, CO and the successful Contractor during the post-award orientation.

The Contractor, based on the knowledge of their PET/CT system and of PET/CT technology shall determine a maximum number of patients that may be imaged within a day where the first patient is injected at 8:00 a.m. and the last patient is completed by 6:30 pm, or until the last scheduled patient with a usable dose, exam is completed. In accordance with the above, the Contractor shall submit with his/her signed proposal, a proposed schedule based upon the level of expertise of the Contractor’s personnel. Contractor shall take into consideration all components necessary to maximize on the quantity of scans anticipated to be performed in the at least eight (8) hour period per day.

1. CANCELLATIONS/NO CHARGE SERVICES: The Contractor shall not charge Hampton VAMC or Salem VAMC for exams or supplies (including unused 18-FDG doses) or other radioactive agents when:

1. Exam is cancelled 24 hours in advance of scheduled procedure. If the above should occur, the Contractor shall not include the cost of the cancelled scan(s) in its monthly invoice.

1. The quality of the exam is unacceptable as determined by the Hampton VAMC or Salem VAMC physician interpreting the exam. Factors include but are not limited to poor positioning, inadequate or inappropriate tracer uptake and motion during scan acquisitions which prevents fusion. Contractor shall be notified by the COR if the above should occur and monthly billing shall be adjusted accordingly.

The Contractor shall not charge Hampton VAMC or Salem VAMC for a complete exam when:

1. On the day of the exam, new contraindications for the exam are discovered resulting in cancellation of the exam for the patient’s safety

1. On the day of the exam, the patient is found to be claustrophobic or is otherwise unable to complete the examination.

1. CONTRACTOR FURNISHED FACILITIES, SERVICES, SUPPLIES AND EQUIPMENT:

1. The Contractor’s vehicle shall be parked and leveled no more than 12” from docking pad ramp. Contractor shall be responsible for leveling of the vehicle at location designed by Hampton VAMC or Salem VAMC.

1. Contractor shall contact the COR to make the necessary arrangements for a site visit where the actual location of the mobile trailer shall be located so that precise measurements etc. can be taken by the Contractor who shall be responsible to confirm compatibility of the docking pad and connections as noted herein. Any additional costs because of the Contractor’s failure to confirm the above shall be the responsibility of the successful Contractor.

1. Contractor shall be held responsible for any damages, which may be done to the Hampton VAMC or Salem VAMC property during delivery, hookup and/or removal of equipment at the site. Any damages caused by the Contractor shall be repaired at the Contractor’s expense to the satisfaction of the facility Chief of Engineering.

1. Proper installation/staging of the Contractor’s furnished equipment including the mobile trailer must be completed in accordance with industry standards, all OSHA regulations and applicable manufacturer’s recommendations. The above must be completed prior to commencement of services. Dates and time for completion of the above shall be mutually agreed upon between the Hampton VAMC and/or Salem VAMC and the Contractor.

1. NON-CONFORMING PRODUCTS OR SERVICES:

Nonconforming products or services will be rejected. Unless otherwise agreed by the parties, deficiencies shall be corrected within seven (7) days of the rejection notice. If the deficiencies cannot be corrected within seven (7) days, the Contractor shall immediately notify the COR and the Contracting Officer of the reason for the delay and provide a proposed corrective action plan within seven (7) working days.

1. EMERGENCY REPAIRS:

Emergency service: Contractor shall provide, at no cost to Hampton VAMC and Salem VAMC, all emergency service to include all required personnel, parts and labor, and preventive maintenance/repairs of positron emission tomography (PET/CT) structure and equipment to maintain a safe environment as recommended by the original equipment manufacturer (OEM) recommendations/specifications in accordance with the agreed upon schedule with the COR.

Response Time: In the event of an equipment failure during normal working hours while in the performance of the Contractor’s services, the Contractor shall notify the COR or designee immediately after discovery of equipment failure while on site. Every effort should be made to keep equipment down time to a minimum of 72 hours or less. If repair services are required to be performed on site after the normal working hours, the Contractor must notify the COR and the VA Police that services will be performed on-site. All emergency repairs are the responsibility of the contractor and only qualified service engineers shall perform emergency repairs.

Replacement Unit: If the equipment fails and the failed equipment is un-repairable, the Contractor must obtain an alternate unit which shall be available on the next scheduled day and which meets all the requirements of the resulting contract to ensure that schedule services shall be performed as agreed upon under this agreement.

Appointment Rescheduling: The COR shall determine if appointments previously scheduled should be cancelled and rescheduled because of the equipment failure. If directed by the COR the Contractor shall promptly reschedule all appointments postponed because of equipment, staffing and/or radiopharmaceutical failure. Every effort shall be made to insure rescheduled emergency services are performed by the contractor at the original imaging site within 2 days of the initial appointment during the normal operating hours of the PET clinic services. Routine exams canceled or postponed due to failure of services provided by the contractor must be rescheduled and performed by the contractor at the original imaging site within 7 days of the initial appointment during the normal operating hours of the PET clinic services.

1. DOCUMENTATION/REPORTS:

1. The Contractor shall provide equipment and maintenance reports to the COR if requested during the duration of the contact. The Contractor shall also provide system pre-check and associated documentation at the time the unit is set up at the site where services are to be performed. This is to ensure safety of equipment utilized by Hampton VAMC and Salem VAMC personnel/beneficiaries.

1. The Contractor shall permit onsite inspection by personnel selected by Hampton VAMC or Salem VAMC without prior notice to insure the Contractor’s equipment is operated in accordance with appropriate safety guidelines and/or regulations as applicable.

1. The contractor shall develop, provide and maintain Management, Staffing and Quality Control Plans which include the substitution of personnel for sicknesses, vacations, accidents and emergency conditions. The contractor shall notify the COR when replacing personnel and start the security clearance/approval process for the replacement person a minimum of 30 calendar days in advance. See B.4, paragraph 4 “Personnel Replacements and Temporary Substitutions”.

1. Additional Reports/Documentation required by the successful Contractor prior to commencement of services of both PET/CT Technologist and Preventive Maintenance (PM) / Repair services, unless otherwise stated. Hampton VAMC and/or Salem VAMC may require specialized documentation to satisfy the requirements of local state and federal government agencies, and independent consultants such as The Joint Commission, as well as for “services rendered” verification for payment of monthly statement. At a minimum, the following information shall be maintained by the Contractor and be available for inspection by a duly authorized VA representative:

1. Certificate of Insurance not limited to but, includes: Professional Liability, Worker’s Compensation, liability and property insurance of Contractor’s furnished equipment shall be submitted to the Contracting Officer within ten (10) calendar days of receipt of notification of award. It is agreed upon and understood that the Hampton VAMC or Salem VAMC shall not be held responsible for any damage or vandalism, which may be caused to the Contractor’s equipment while on Hampton VAMC or Salem VAMC premises.

1. Required Federal, State and local licenses.

1. Employees Certifications/Registrations, Competency Check List and Training Certificates.

1. Technologists Health examination records of Annual TB Skin Test and recent chest X-ray if there is a history of positive TB skin test. Copies of records shall be submitted to the Contracting Officer prior to commencement of services.

1. RADIOACTIVE MATERIALS HANDLING REQUIREMENTS:

1. The Contractor shall procure all radioactive materials (including but not limited to 18F-FDG) under their NRC (Nuclear Regulatory Commission) agreement/state license and shall be ordered directly by the Contractor from a source approved by the FDA under CGMP 21 CFR 212. Copy of the Contractor’s NRC license or Reciprocity.

1. Contractor shall be solely responsible for the receipt, administration, safekeeping, waste management and proper disposal of all radioactive materials required in the performance of the services by the Contractor. Contractor shall be responsible to ensure compliance with all regulations on the handling of the above as may be required under this agreement.

1. The Contractor agrees that if any additional medications/drugs approved by the FDA are required during the performance of services, that Hampton VAMC and Salem VAMC would have the right to purchase such drugs (either from the Contractor or from another source) and have these medications delivered directly to the Contractor’s trailer during the duration of this contract. The Contractor shall accept the drugs in behalf of Hampton VAMC or Salem VAMC under the Contractor’s current NRC license at no additional cost to the government. If the above should occur, the contract shall be modified accordingly and an acceptance procedure will be established between Hampton VAMC and/or Salem VAMC and the successful Contractor regarding delivery, acceptance and payment. Regardless of the source of purchase, if radioactive, the material shall be received at the Contractor’s property, which is the PET/CT trailer, by qualified and authorized Contractor personnel.

1. Radioactive waste management shall be provided on the Contractor’s property, which is the PET/CT trailer, by Contractor personnel. VA facilities shall not be used for disposal of any materials from the trailer.

1. Unless otherwise defined herein, radioactive administration to patients shall be provided on the Contractor’s property, which is the PET/CT trailer.

1. Radioactive decontamination of the Contractor’s property due to any cause shall be provided by Contractor personnel. Storage of such contaminated items shall be provided by the Contractor.

1. All record keeping requirements regarding the receipt, use, storage and disposition of radioactive material is the responsibility of the Contractor under their appropriate license. An audit of the PET service will be accomplished at least quarterly by the site Radiation Safety Officer. This audit will be scheduled with the vendor at least two weeks in advance and will take no more than 60 minutes per period.

1. The Contractor agrees to ensure compliance/acceptance testing of the PET/CT equipment is performed on at least an annual basis or if major components of the machine is serviced or replaced. The compliance/acceptance tests shall be done in accordance with nationally recognized standards National Council on Radiation Protection (NCRP), American Association of Physicists in Medicine (AAPM) and The Joint Commission requirements.

1. The Contractor is responsible for ensuring the compliance testing of the PET/CT machine shall be performed by a qualified medical physicist. A qualified medical physicist as defined is an individual who is certified by the American Board of Radiology, American Board of Health Physics, or American Board of Medical Physics in the appropriate disciplines of radiologic physics and maintain state certification as a Health Physicist in the state of Virginia.

1. The Contractor is responsible for maintaining all appropriate records and documentation relevant to compliance and performance of the equipment.

1. REMOVAL OF CONTRACTOR’S EQUIPMENT: Contractor shall be responsible for the timely removal of the PET/CT trailer from Hampton VAMC and Salem VAMC premises as agreed upon with the COR not to exceed a 24-hour period after completion of the last procedure is performed and shall also be responsible for the following daily exit functions:

1. Ensure that the day’s entire exam data is completely transferred to the vendor provided advanced analysis workstations inside the medical center.

1. All patient exams (raw and fused data) are burned to CD-R/DVD-R in DICOM format and labeled for archive. The CD-R/DVD-R(s) shall be handed to a designated VISN 6 staff member for storage on site at the VISN 6.