36C24121Q0385_1.docx

36C24121Q0385

PAGE 1 OF

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

405-21-3-7934-0010 36C24121Q0385 04-29-2021 Clark Crandall 774-826-4845 05-06-2021

4PM

EDT

Department of Veterans Affairs VA Boston Healthcare System Contracting Officer (90C) 940 Belmont Street Brockton MA 02301 X X 532490 $35 Million N/A X Department of Veterans Affairs White River Junction VAMC 215 North Main Street Attn: Radiology White River Junction VT 05001 Department of Veterans Affairs VA Boston Healthcare System Contracting Officer (90C) 940 Belmont Street Brockton MA 02301

Department of Veterans Affairs Financial Services Center PO Box 149971 Austin TX 78714-9971 See CONTINUATION Page Contractor shall provide all labor, materials, equipment, maintenance and repair of all Contractor furnished equipment (including the mobile trailer unit), specialized staff, training, required supplies, and medications/drugs to perform Positron Emission Tomography/Computerized Tomography (PET/CT) for the Department of Veteran Affairs in White River Junction, VT 05009.

The period of performance will be May 6, 2021 to May 5, 2022 with four (4) one-year options to extend.

The government intends to issue a contract to the vendor who presents the best value to the government.

Contact Specialist: Clark Crandall Email: clark.crandall@va.gov $0.00 See CONTINUATION Page 405-3610160-7934-822900-2631 0100B00H6 X X Rotondo, Karla Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

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

a. CONTRACTOR:

b. GOVERNMENT: Contracting Officer 36C241 Department of Veterans Affairs VA Boston Healthcare System Contracting Officer (90C) 940 Belmont Street Brockton MA 02301

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 PRICE/COST SCHEDULE

ITEM INFORMATION

Coach Rental

Base Year - May 6, 2021 to May 5, 2022 PRINCIPAL NAICS CODE: 621512 - Diagnostic Imaging Centers PRODUCT/SERVICE CODE: 6515 - Medical and Surgical Instruments, Equipment, and Supplies

FDG-18 doses

Axumin doses 24 doses

Coach Rental

Option Year 1 - May 6, 2022 to May 5, 2023

FDG-18 doses

Option Year 1 - May 6. 2022 to May 5, 2023

Axumin doses 24 doses

Option Year 1 - May 6. 2022 to May 5, 2023

Coach Rental

Option Year 2 - May 6, 2023 to May 5, 2024

FDG-18 doses

Option Year 2 - May 6. 2023 to May 5, 2024

Axumin doses 24 doses

Option Year 2 - May 6. 2023 to May 5, 2024

Coach Rental

Option Year 3 - May 6, 2024 to May 5, 2025

FDG-18 doses

Option Year 3 - May 6. 2024 to May 5, 2025

Axumin doses 24 doses

Option Year 3 - May 6. 2024 to May 5, 2025

Coach Rental

Option Year 4 - May 6, 2025 to May 5, 2026

FDG-18 doses

Option Year 4 - May 6. 2025 to May 5, 2026

Axumin doses 24 doses

Option Year 4 - May 6. 2025 to May 5, 2026

B.3 DELIVERY SCHEDULE

Attn: Radiology 215 North Main Street White River Junction, VT 05001 3833

USA

12.00

Attn: Radiology 215 North Main Street White River Junction, VT 05001 3833

12.00

Attn: Radiology 215 North Main Street White River Junction, VT 05001 3833

24.00

Attn: Radiology 215 North Main Street White River Junction, VT 05001 3833

12.00

Attn: Radiology 215 North Main Street White River Junction, VT 05001 3833

12.00

Attn: Radiology 215 North Main Street White River Junction, VT 05001 3833

24.00

Attn: Radiology 215 North Main Street White River Junction, VT 05001 3833

12.00

Attn: Radiology 215 North Main Street White River Junction, VT 05001 3833

12.00

Attn: Radiology 215 North Main Street White River Junction, VT 05001 3833

24.00

Attn: Radiology 215 North Main Street White River Junction, VT 05001 3833

12.00

Attn: Radiology 215 North Main Street White River Junction, VT 05001 3833

12.00

Attn: Radiology 215 North Main Street White River Junction, VT 05001 3833

24.00

Attn: Radiology 215 North Main Street White River Junction, VT 05001 3833

12.00

Attn: Radiology 215 North Main Street White River Junction, VT 05001 3833

12.00

Attn: Radiology 215 North Main Street White River Junction, VT 05001 3833

24.00

B.4 Statement of work

White River Junction, VA Medical Center Radiology Service Statement of Work Mobile PET/CT Scanner

Provide the following service in accordance with the requirements of the contract: Health Care Resources in accordance with Public law 104-262 and 38 USC 8153 to be furnished by the contractor at the Department of Veterans Affairs, White River Junction VA Medical Center, 215 N. Main St., White River Junction, VT, 05009. A purchase order will be issued to the responsive, responsible contractor offering the best value for the total time frame of the contract.

1. Services: Contractor shall provide all labor, materials, equipment, maintenance and repair of all Contractor furnished equipment (including the mobile trailer unit), specialized staff, training, required supplies, and medications/drugs to perform Positron Emission Tomography / Computerized Tomography (PET/CT) for the Department of Veterans Affairs, White River Junction VA Medical Center, 215 N. Main St., White River Junction, VT, 05009. Contractor shall always be responsible to maintain all the equipment in good working order and shall reimburse the site for lost time, which may result from defective workmanship or equipment failure. Services shall be performed as listed in the Schedule- supplies and Service/Price /Cost.

2. Supplies: Contractor shall solely be responsible for the procurement, receipt, dispensing, administration and safekeeping of all supplies and medications/drugs required in the performance of the services defined herein. These supplies include but are not limited to radioisotopes to be handled in accordance with contractor's licensing, state, and NRC regulations. Contractor shall also be responsible for the waste management and proper disposal of all radioactive waste materials off the White River Junction VA Medical Center premises. The cost for the disposal and materials furnished under this contract must be included in the contract.

3. Authority: This procurement is being conducted under Federal Acquisition Regulation (FAR), acquisition of commercial items and contracting by Negotiation for procurement of enhanced Health Care resources in accordance with Public law 104-262 and 38 USC 8153. The resultant contract is non-exclusive and shall not prohibit White River Junction VAMC or contractor from entering into agreement(s) with other health care providers or purchase of health care services.

4. Term of Contract: This solicitation and any resulting contract shall be effective for a period of one year from date of award plus four (4) one-year options to renew. This contract is subject to the availability of White River Junction VA Medical Center funds. No option year services shall be performed unless the contracting officer exercises the next option year.

5. Purpose: The intent of contracting a mobile PET/CT scanner for the White River Junction VA Medical Center is to provide a cost-effective solution that allows greater control over image quality, improve availability and convenience to our patients.

6. 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 Philips 16 slice or better PET/CT scanner, manufactured after 2010, and a review station and fusion software to be placed in the White River Junction Medical Center Nuclear Medicine Department or other appropriate site. Contractor shall submit detailed specifications on the equipment. Scanner specifications will include year, manufacturer, model number, and make of all pertinent information. All equipment used will be FDA approved imaging equipment. The entire offering of a PET/CT mobile Trailer service shall meet all local, state, federal, industry, JCAHO, NEC, NFPA, VA, OSHA and other regulatory standards, internal and external, for which the White River Junction VAMC is currently accountable and will be kept current with all federal and state regulations. The contractor's personnel will abide by all policies of the site of service to include but not limited to: radiation and patient safety policies. All exams will be reviewed for appropriateness and protocoled by a VA staff radiologist prior to the start of scanning.

7. System Capability Requirements: 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 contract. The unit shall have the ability to perform a wide range of exams as listed below.

a. Oncology related PET/CT exams

b. Imaging of cardiac metabolism with F- 18 FDG

c. Brain imaging with F- 18 FDG

8. Mobile Unit Capabilities: To be provided at no additional cost to White River Junction VAMC:

a. Hardware and software to permit interpretation and transmission of images

b. A hot lab to receive and store radioisotopes and radioactive waste.

c. Ability to create, store and export DICOM, JPEG and MPEG file formats.

d. DICOM 3.0 network capability for export of images to Contractor supplied fusion workstation within White River Junction VAMC and or another VISN 1 VA Medical Center. Transport of images will be over VA supplied network infrastructure.

e. The mobile shall be equipped with a CD-R/DVD burner for a backup to transfer data.

f. The mobile shall be equipped with an image analysis station for image registration and quality assurance

g. The mobile unit shall be equipped with a MedRad IV contrast injector which is programmable for pressure injections. The injector should have the following capabilities

5. Weight based contrast dosing

h. The mobile PET/CT unit shall interface to an access ramp which will provide a barrier to outside weather conditions. As part of the bid submission process, the vendor will supply drawings and specifications unique to the trailer which is to provide services under this contract. This is to evaluate existing mobile pad suitability.

i. The contractor's trailer shall provide the space sufficient and designed for injections, an area for a quiet room with minimum possible external stimuli such as noise and light during the period of the radiopharmaceutical uptake.

k. The contractor's trailer shall provide the space sufficient and the appropriate equipment for monitoring of sedated patients and performing CPR if necessary.

9. Mobile Unit Accessories: Accessory equipment that shall be provided by the contractor:

a. Handicap accessibility.

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

10. Mobile Unit Equipment Specifications: The following minimum performance characteristics of the equipment are required:

a. Contractor shall provide coach specific requirements for access, docking pad and covered enclosure with the solicitation. Contractor or designee will be required to perform a site visit in advance of contract award to consult with VA supplied engineer to verify improvements required to allow trailer docking.

b. The PET/CT shall provide images with consistently high technical quality to be assessed by VA employed experts. Poor image quality will be considered non-performance under this contract and must be remedied within 10 days of notification or incur default.

c. The PET must be capable of acquiring images in multiple modes including but not limited to limited body part scans and whole-body scans.

d. The PET/CT will have a PET detector crystal specifically made for PET imaging LSO or LYSO or digital detector is required.

e. Time of flight imaging capabilities will be considered a plus

f. The CT scanner unit shall have at minimum:

1) A minimum of a 16 slice detector and be capable of acquiring the transmission image within one breath.

2) Capable of acquiring data for anatomic localization and attenuation correction.

3) Attenuation correction algorithm designed to use non contrast CT data.

4) Attenuation correction algorithm designed to use CT data with intravenous contrast enhancement.

5) Attenuation correction algorithm designed to use CT data with oral contrast enhancement with positive contrast (iodinated contrast).

6) Attenuation correction algorithm designed to use CT data with oral contrast enhancement with negative contrast (water).

7) CT will be optimized for low dose procedures to include such features as: automated dose modulation, iterative reconstruction, and DICOM Structured Dose Reporting.

g. Provision of one PET/CT review station to include:

1) Fusion software compatible with the Philips PET/CT system provided and connected to the mobile system via VA provided network infrastructure over V-LAN. The review station shall have the capacity to handle the computational load of 3 –dimensional datasets and sufficient storage to keep images for a minimum of one year or at the contract conclusion.

2) The vendor will provide hardware and software maintenance during the term of this contract. The review station will be provided with software and hardware license, capable of producing PET and CT image data for input into VA PACS.

3) The review station shall have two large color monitors of diagnostic quality.

4) The review station 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.

5) The review station shall have image fusion capability as well as whole body display.

6) The review station shall have software tools that allow interpreting physicians to navigate between the two modalities easily and efficiently.

7) The review station shall have software tools that are capable of providing 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 and generating suv and Hounsfield measurements, size volume and angle measurements

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

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

2) The mobile PET/CT unit will meet all federal, state, fire, and safety requirements.

i. Telecommunications: The mobile unit shall be equipped with outlet jacks’ connections capable of transmitting data and voice through Government provided category five (5) and dual power phone cable. The Government will provide connections required for the transmission of images, data, and voice.

j. The mobile unit shall support DICOM Modality Worklist (DMWL), for future use and shall be able to export DICOM images to multiple destinations.

k. The system must be approved by the FDA and meets or exceeds minimal standards for the type of equipment provided as defined herein.

l. White River Junction VAMC will provide:

1) Electricity

2) Telephone lines

3) Data port

4) Housekeeping--- White River Junction VAMC will be responsible for the area within the facility prior to the entrance of the mobile trailer.

5) Emergency support equipment (Crash cart)

6) Expendable medical supplies as related to the standard provision of PET/CT services

11. EQUIPMENT MAINTENANCE/REPAIRS: Equipment provided shall always be in good working order to provide high quality scans required under this solicitation 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 PET/CT mobile unit and all associated equipment shall be performed in accordance with the Conformance Standards and manufacturer’s recommendations. If the equipment should fail during normal working hours, qualified service engineers will perform emergency repairs on-site to reduce equipment downtime.

Quality Control and monitoring will be performed by the contractor provided staff daily or at the regular intervals as specified by the manufacturer and in accordance with standard practices established by all governing agencies. Any and all discrepancies will be reported to the VA prior to the start of any patient procedure/exam. Documentation will be provided to the VA and kept in the Nuclear Medicine Department. The VA maintains the right to monitor compliance with all required QC/M as well as compliance with all appropriate rules and regulations as applicable.

Contractor agrees to reimburse White River Junction VAMC for costs over and above the contracted cost associated with obtaining PET/CT exams though other sources which are necessary for appointments cancelled or postponed as a result of equipment, staffing and/or radiopharmaceutical failure. 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/CT clinic services. If it is not possible to reschedule the patient within 7 days and White River Junction VAMC must make alternate arrangement to have the patient sent to another local facility for the tests, the Contractor shall bear the costs associated with such re-procurement over the contracted examination price. White River Junction will provide the Contractor with an itemized list of costs because of any service failure and cost will be deducted from the Contractor’s invoice for the period involved.

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 White River Junction premises. At least one of Contractor’s personnel must be present during working hours while the equipment is located on the White River Junction campus. White River Junction 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.

12. SITE PREPARATION: White River Junction VAMC in this contract will provide a mobile docking pad meeting the specifications specified by the Contractor. Site specifications including dimensions, weight restrictions and utility connections must be specified by the contractor when presenting pricing information. Pre-award site visits will be provided by potential Contractor to advise each medical center on changes required to make their site acceptable for mobile services.

13. CONTRACTOR’S QUALIFICATIONS: A proposal will be considered only from offerors who are regularly established in the business called for, who are financially responsible and have the necessary equipment and personnel to furnish service in the volume required for all items under this solicitation. 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 White River Junction VAMC. Contractor shall provide with his or her signed proposal, a description of all personnel, who will be providing services under this RFP. These personnel shall include, but not be limited to the technologists, support and driver staff who may visit a medical center as part of their duties under this contract or have access to confidential personal patient information. In addition, the PET/CT scanning technologists shall be certified Nuclear Medicine Technologists (ARRT and/or NMTCB) as defined herein. In addition, if performing diagnostic CT exams, the technologist will have the appropriate competencies and certifications. The Contractor shall provide documentation of training and competency of all proposed technologists in all of the following areas:

1) PET imaging.

2) Operation of a PET/CT scanner. CT certification

3) Intravenous administration of radioisotopes.

4) Administration of both I.V. and oral contrast.

In the event that 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 solicitation; and listing of relevant continuing education for the last two (2) years. The Contractor will provide current copies of these records at the time of contract award and annually on the anniversary date of contract award to the White River Junction COR, 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 will 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 associate with their duties.

14. 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 the White River Junction VAMC patients. It is anticipated that equipment and staff will be required up to a ten (10) hour day, one (1) day per week. The personnel will perform a function that requires them to access VA system or VA sensitive information.

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 be CPR BLS certified and are authorized to initiate this life-saving act if necessary.

15. CERTIFICATIONS/LICENSING DOCUMENTS: PET/CT SCANNING TECHNOLOGIST

The vendor should submit with their offer the following documents (as applicable):

· Copy of all of personnel’s current licenses (Certification / Registration)

· A list of the experience of the proposed contract employees

· PET/CT competency Check List(s)

· CPR BLS certificate Any other requested reports/documentation as defined in the Statement of Work (SOW) and Specifications.

A. GENERAL REQUIREMENTS:

1. SCHEDULE: The successful Contractor will perform services up to ten hours per day on a weekday to be established independently with the medical center. Initially, the medical center will require services one day per week. Government reserves the right to increase the number of days as noted herein. Contractor will be given at least sixty (60) calendar days’ notice of a site’s intention of increasing the number of days per month for which the Contractor will perform services on site. Any additional days added, will be agreed upon between the Contracting Officer (CO), COR and the successful Contractor.

2. NORMAL HOURS OF OPERATION: Contractor personnel shall be available on site to perform exams on patients for up to ten (10) hours per day on a weekday identified by the schedule, excluding Federal holidays. The first radiopharmaceutical injection will start at 8:00 am and the last patient being injected such that the exam is completed by no later than 6:00 pm. Trailer delivery, setup and daily quality control procedures shall not delay the start of examinations. Contractor and COR shall mutually agree upon a schedule establishing dates and time for the mobile unit with technicians to be present on station. Hours of operation less than ten must be approved in advance by the site COR.

a) National Holidays: The ten (10) holidays observed by the Federal Government, are New Year's Day, Martin Luther King's Birthday, Presidents Day, Memorial Day, Independence Day, Labor Day, Columbus Day, Veterans Day, Thanksgiving, and Christmas or any other day specifically declared by the President of the United States to be a national holiday.

b) Off-Duty Hours: Days and hours other than stated above.

3. DAILY ACCESS TO White River Junction VAMC: The contractor will 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 will 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.

B. CONTRACTOR’S RESPONSIBILITIES:

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

2. Contractor will be responsible for the training of at least one (1) White River Junction Nuclear Medicine Physician on site on the use of the Contractor provided workstation and image analysis software.

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

· 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 at all times.

· 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.

· Prior to the commencement of daily services the Contractor shall ensure that the mobile trailer is level and set for the safety of patients and the appropriate utilities connected for proper warm up of all on board systems.

· Contractor shall allow sufficient time for contacting the VA Police when gaining access to White River Junction VAMC site

· Communications systems will be operational before commencement of services.

4. Daily Quality Control time must not interfere with the regular scheduling of patients for exams. These 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.

5. Contractor will be responsible for providing quality review in order to ensure quality diagnostic images at all sites. White River Junction VAMC reserves the right to require corrective action if image quality or other service problems are brought to the attention of the Contractor.

6. Contractor will be responsible for monitoring the number of PET/CT scans performed, by maintaining a daily log.

7. Contractor shall be Joint Commission Accreditation of Healthcare Organizations (JCAHO) certified or shall follow established JCAHO guidelines as they pertain to mobile PET/CT operations, injection control, patient safety and shall follow the guidelines of the Department of Veteran’s Affairs (VA) and Occupational Safety Health Administration (OSHA). JCAHO accredited Quality assurance survey reports shall be provided to the Contracting Officer’s Technical Representative (COR) consistent with Joint Commission recommendations

8. SCHEDULING OF PATIENTS/SERVICES: Services shall be scheduled for one day weekly up to ten (10) hours per day. Scheduling conflicts, which cannot be resolved, will be decided by the Contracting Officer. The decision of the Contracting Officer will 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, by contacting the Contracting Officer’s Technical Representative (COR) or designee two (2) working days prior to the date of services. Contractor shall establish a firm cut off time for next days add on exams that will guarantee delivery of the 18-FDG doses if required. Procedures will be established and will 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 6:00 p.m. 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 in order to maximize on the quantity of scans anticipated to be performed in the ten (10) hour period per day.

9. CANCELLATIONS/NO CHARGE SERVICES:

The Contractor will not charge White River Junction for services or supplies (including unused 18-FDG doses) or other radioactive agents when the PET/CT scanner is inoperable due to equipment malfunction or staff shortage occurs.

10. RADIOACTIVE MATERIALS HANDLING REQUIREMENTS:

· The Contractor will 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. Copy of the Contractor’s NRC license or Reciprocity Agreement shall be provided with the signed proposal as further defined in 52.212-2.

· 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.

· The Contractor agrees that if any additional medications/drugs approved by the FDA are required during the performance of services, that White River Junction 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 will accept the drugs in behalf White River Junction under the Contractor’s current NRC license at no additional cost to the government. Regardless of the source of purchase, if radioactive, the material will be received at the Contractor’s property, which is the PET/CT trailer, by qualified and authorized Contractor personnel.

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

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

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

· 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.

· The Contractor agrees to ensure that compliance/acceptance testing of the PET/CT equipment is performed on at least an annual basis or if major components of the machine are serviced or replaced. The compliance/acceptance tests will be done in accordance with nationally recognized standards (NCRP, AAPM) and JCAHO requirements.

· The Contractor is responsible for ensuring the compliance testing of the PET/CT machine will 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.

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

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

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

· All patient exam data is purged from Contractor’s computer systems once it is verified that exams are viewable on the vendor provided advanced analysis workstation.

· At the termination of the contract, the VA site will be allowed 30 days to overwrite the hard drive of the workstation removing all information of any kind including software and operating system before the workstation is removed by the vendor.

· VA information retained by the PET/CT scanner itself and other Contractor equipment will be returned to the VA at the end of the contract and when no longer required for regulatory purposes. The security of information retained by the PET/CT scanner and other Contractor equipment both during the contract period and post contract period will be the responsibility of the vendor.

· All connections from the trailer to property are properly disconnected.

· Any temporary site preparations are removed upon completion of services on a daily basis.

C. CONTRACTOR STAFF QUALIFICATIONS/RESPONSIBILITIES

1. Contractor will provide the services of an experienced PET/CT Scanning Technologist(s) to operate the mobile trailer. The PET/CT technologist(s) shall be fully trained / qualified according to the qualification standards that have been previously defined in this document. The technologist must also be basic life support CPR- certified. The qualifications of such personnel shall also be subject to review and approval by the facility Chief of Staff and Chief of Radiology. The technologist shall be trained and qualified to perform venipuncture, assess IV patency, and administer the radioisotope, according to procedures and protocols.

2. The PET/CT scanning technologist shall be trained and qualified to screen patients using a facility questionnaire for potential contraindications to PET/CT imaging, based on facility imaging procedure/protocols.

3. PET/CT Scanning Technologist shall maintain a log of all VA patients receiving PET/CT scans. Such logs shall be available for inspection by duly authorized representatives of the facility upon reasonable notice to the mobile unit’s personnel. Inspection shall be during normal working hours of the mobile unit while at the facility.

4. PET/CT Scanning Technologist shall ensure that, when applicable, patient informed consent (according to applicable VHA policies/procedures) is obtained and presented prior to performing examinations. PET/CT Scanning Technologist shall be responsible to screen patients prior to performing PET/CT exams to verify the patient’s identification, pregnancy status, breast-feeding status, and confirm the procedure to be performed prior to commencement of any services. Disqualification of a patient from the exam must be documented and provided to facility Nuclear Medicine staff before the patient leaves the PET/CT Trailer during each visit.

5. Any side effects that may develop from injection of the radiopharmaceutical and/or iodinated contrast agent or from patient preparation must be reported to the designated nuclear medicine physician as quickly as possible considering the clinical situation while the patient is in the trailer.

6. The PET/CT technologist is responsible for the initial assessment and identification of medical emergencies and initiating the emergency response procedure for patients in their care. The training for this will be a part of initial facility orientation

7. PET/CT Scanning Technologist shall ensure that all PET/CT exams shall be acquired and processed per procedures and protocols provided by the facility Nuclear Medicine physicians. Raw and processed data remain the property of the government.

8. PET/CT Scanning Technologist shall present (electronically transmit and notify) each completed PET/CT examination to the designated facility Nuclear Medicine physician to review for diagnostic quality before the patient is discharged back to the medical center, this will be determined by the Nuclear medicine physician. VA Nuclear Medicine physicians will perform interpretations of the examination(s). Unsatisfactory/non-diagnostic PET/CT examinations shall be re-performed at the discretion of designated Nuclear Medicine Physician.

9. The PET images shall be reconstructed by the PET/CT technologist with and without attenuation correction and be available at the time of interpretation.

10. Additional requirements for Contractor personnel and Contractor operation:

(a) Contractor shall provide White River Junction VAMC seven (7) day per week telephone access to the mobile PET/CT company used in performance of this contract.

Name: _____________________________, Telephone No. _______________________________,

(b) Services provided by the Contractor shall be performed within the policies, procedures and regulations of White River Junction.

(c) Contractor shall meet the safety requirements of posting Radiation hazardous signs around the mobile unit and make certain the electrical power cable is under a metal cover, if it crosses the sidewalk.

11. Neither the Contractor nor the contract personnel shall in any way undertake the practice of medicine, render medical opinions or services other than those services required to support the well-being of the patient, or in any way with the patient other than to provide all ancillary and technical services required for the operation of the unit.

D. 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 White River Junction VAMC.

2. Contractor shall contact the COR to make the necessary arrangements for a site visit where the actual location where the mobile trailer will 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 as a result of the Contractor’s failure to confirm the above shall be the responsibility of the successful Contractor.

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

4. 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 White River Junction VAMC and the Contractor.

E. GOVERNMENT FURNISHED FACILITIES, SERVICES, SUPPLIES AND EQUIPMENT:

1. The VA facility shall provide all patient services, with exception of the services provided by the Contractor’s PET/CT Scan Technologist including the following:

2. White River Junction VAMC will provide the following services, supplies and facilities:

(a) All medical supplies, facilities, personnel and physicians required to provide patients with such emergency medical care as may be required,…