Solicitation PET CT 20AUG2024 final.pdf

36C24524Q0796

50 Irving St. NW Washington D.C. 20422

PAYMENT WILL BE MADE BY

FSC e-Invoice Payment Invoice must be submitted electronically http://www.fsc.va.gov/einvoice.asp Invoice Setup Information 1-877-489-6135

See CONTINUATION Page

Mobile Positron Tomography/Computed Tomography (PET/CT) Onsite Services for the Huntington VA Medical Center.

Performance Work Statement is on page 10.

Contractor shall be responsible for correct wages, titles, and compliance with applicable wages and hour laws.

PAGE 1 OF

1. REQUISITION NO.

2. CONTRACT NO.

3. AWARD/EFFECTIVE DATE

4. ORDER NO.

5. SOLICITATION NUMBER

See CONTINUATION Page

6. SOLICITATION ISSUE DATE

a. NAME

b. TELEPHONE NO. (No Collect Calls)

X

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. UEI: EFT:

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. NOV 2021)

PREVIOUS EDITION IS NOT USABLE Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

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

581-25-1-178-0002

36C24524Q0796 20AUG2024

Christopher E. Polk| christopher.polk@va.gov (202-745-8000 x53367 30AUG2024 07:00am ET

Department of Veterans Affairs VA Health Care System George Sherrin, Contracting Officer Christopher E. Polk, Contracting i li50 Irving St NW Washington D.C. 20422

X 100

621512

$19 Million

N/A

Department of Veterans Affairs VA Maryland Health Care System Contracting Officer (90C) 1540 Spring Valley Dr.

Huntington, WV, 25704

Department of Veterans Affairs VAMC VA Maryland Health Care System Christopher E. Polk, Contracting Specialist one (1)

George Sherrin, Contracting Officer

36C24524Q0273

Crime Control Act - Requirement for Background Checks

Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

B.2 PRICE/COST SCHEDULE

B.3 PERFORMANCE WORK STATEMENT (PWS)

B.4 IT CONTRACT SECURITY

SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS

AND COMMERCIAL SERVICES (NOV 2023)

C.2 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

C.3 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000)

C.4 52.237-3 CONTINUITY OF SERVICES (JAN 1991)

C.5 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.6 852.211-76 LIQUIDATED DAMAGES—REIMBURSEMENT FOR DATA BREACH

COSTS (FEB 2023)

C.7 852.219-75 VA NOTICE OF LIMITATIONS ON SUBCONTRACTING—

CERTIFICATE OF COMPLIANCE FOR SERVICES AND CONSTRUCTION (NOV 2022)

C.8 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV 2018)

C.9 852.237-70 INDEMNIFICATION AND MEDICAL LIABILITY INSURANCE (OCT

2019)

C.10 852.237-72 CRIME CONTROL ACT – REPORTING OF CHILD ABUSE (OCT

2019)

C.11 852.237-74 NON-DISCRIMINATION IN SERVICE DELIVERY (OCT 2019)

C.12 852.237-75 KEY PERSONNEL (OCT 2019)

C.13 852.239-76 INFORMATION AND COMMUNICATION TECHNOLOGY

ACCESSIBILITY (FEB 2023)

C.14 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020)

C.15 SUPPLEMENTAL INSURANCE REQUIREMENTS

C.16 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (MAY 2024)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

D.1 QUALITY ASSURANCE SURVEILLANCE PLAN (QASP)

D.2 CONTRACTOR RULES OF BEHAVIOR

D.3 CONTRACTOR CERTIFICATION: IMMIGRATION AND NATIONALITY ACT OF

1952, AS AMENDED

D.4 DEPARTMENT OF LABOR WAGE DETERMINATION

SECTION E - SOLICITATION PROVISIONS

E.1 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (SEP 2023)

E.2 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT 2018)

36C24524Q0273

E.3 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND COMMERCIAL

SERVICES (NOV 2021)

E.4 52.229-11 TAX ON CERTAIN FOREIGN PROCUREMENTS—NOTICE AND

REPRESENTATION (JUN 2020)

E.5 52.233-2 SERVICE OF PROTEST (SEP 2006)

E.6 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB

1998)

E.7 852.201-70 CONTRACTING OFFICER’S REPRESENTATIVE (DEC 2020)

E.8 852.233-71 ALTERNATE PROTEST PROCEDURE (OCT 2018)

E.9 852.273-74 AWARD WITHOUT EXCHANGES (NOV 2021)

E.10 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—

COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (NOV 2023)

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:

BUSINESS NAME

ADDRESS

CITY/STATE/ZIP CODE

UEI

POINT OF CONTACT

EMAIL ADDRESS

TELEPHONE NUMBER

b. Government:

George Sherrin, Contracting Officer 36C245 Department of Veterans Affairs

VA Maryland Health Care System NCO 5 Contracting Office (90C)

PO Box 1000, Bldg. 101, Room 26 Perry Point, MD 21902

George.Sherrin@va.gov (304)-871-0873

Christopher E. Polk, Administrative Contracting Officer

Department of Veteran Affairs VA Maryland Health Care System NCO 5 Contracting Office (90C)

50 Irving St. NW Washington, D.C. 20422 Christopher.Polk@va.gov

(202)-745-8000 Ext. 53367

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

[X] 52.232-33, Payment by Electronic Funds Transfer—System For Award Management, or

[] 52.232-36, Payment by Third Party

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly []

b. Semi-Annually []

c. Other [X] Monthly

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.

PAYMENT WILL BE MADE BY

FSC e-Invoice Payment Invoice must be submitted electronically http://www.fsc.va.gov/einvoice.asp Invoice Setup Information 1-877-489-6135

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

AMENDMENT NO DATE

5. CONTRACT MODIFICATIONS: The Contractor is advised that only the Contracting Officer, acting within the scope of the contract and his/her duties and responsibilities and after advice and consultation with the Contracting Officer’s Representative (COR), has the authority to make changes that will affect contract prices, quantity, quality, delivery terms and conditions, or the term of the contract. In no event shall any understanding or agreement, modification, change order, or other matters in deviation from the terms of this contract between Contractor and a person other than the Contracting Officer be effective or binding upon the Government. All such actions must be formalized by the proper contractual document executed by the Contracting Officer.

6. CONTRACTING OFFICER REPRESENTATIVE: The Contractor shall be provided a copy of the letter of delegation authorizing the Contracting Officer Representative (COR) at the commencement of the term of this contract. No other person shall be authorized to act in such capacity unless appointed in writing by the Contracting Officer.

7. CONTRACT PERFORMANCE: Contractor shall be required to begin providing Mobile PET/CT services under the contract awarded as a result of this solicitation beginning on the first date of the base period listed in the Schedule of Services. Failure to understand the contract requirements shall not relieve the Contractor from performing in accordance with the strict meaning and intent of the specifications. The Government will not reimburse any costs not incorporated into the Contractor’s price.

8. SOLICITATION/CONTRACT: This solicitation and resulting contract adheres to the format defined in Federal Acquisition Regulation (FAR) Parts 12 and 13. An official copy of the FAR can be obtained at https://www.acquisition.gov/far/ .

9. POST AWARD ORIENTATION: The Contracting Officer may schedule a post-award orientation for contract orientation purposes as required by VA regulations.

10. STATUS AS INDEPENDENT ENTITIES: None of the provisions of this contract are intended to create or shall be deemed or construed to create any relationship between VA and the Contractor other than that of independent entities contracting with each other solely for the purpose of effecting the provisions of this contract. Neither VA nor the Contractor, nor any of their respective agents, employees or representatives, shall be construed to be the agent employee or representative of the other.

11. NON-SOLICITATION: Neither the Contractor nor any employee, agent or subcontractor of the Contractor shall solicit or attempt to convince or otherwise persuade any veteran not to participate or to discontinue participation in the services provided under this contract.

12. SECURE FAX: All faxes should contain the following language: “This fax is intended only for the use of the person or office to which it is addressed and may contain information that is privileged, confidential, or protected by law. All others are hereby notified that the receipt of this fax does not waive any applicable privilege or exemption for disclosure and that any dissemination, distribution, or copying of this communication is prohibited. If you have received this fax in error, please notify this office immediately at the telephone number listed above.”

13. PRIVACY AND CONFIDENTIALITY: Contractors to the Department of Veterans Affairs may be exposed to sensitive information. Information may be overheard, seen on documents or electronic devices, or observed that could potentially violate the privacy and confidentiality of our Veterans, employees, volunteers and their families. Regulations such as, but not limited to the Health Insurance Portability and Accountability Act of 1996 (HIPAA), Freedom of Information

(FOIA) and Privacy Act of 1974 have been enacted to protect sensitive information from being improperly disclosed. Information should not be divulged or released to anyone unless specifically authorized by this contract or its attached documents accordance with the contracted services. Failure to comply with applicable statutes and regulation can result in the termination of this contract and civil and criminal penalties, including fines and imprisonment. All suspected or actual breeches of privacy and confidentiality should be reported immediately to the Contracting Officer, Contracting Officer Representative (COR) or the Facility Privacy Officer.

B.2 PRICE/COST SCHEDULE

The Huntington VA Medical Center is seeking to procure Mobile Positron Emission Tomography/ Computerized Tomography (PET/CT) services. A contractor providing such services shall meet the guidelines described in the Performance Work Statement (PWS).

Place of Performance: Services shall be provided at the Huntington VA Medical Center, 1540 Spring Valley Dr, Huntington, WV 25704.

Estimated coverage is as follows:

Huntington VAMC requires services twice per month and may request additional days or service locations within VISN 5.

Period of Performance: Five (5) years, base plus four (4) option years.

Base Year: October 01, 2024 – September 30, 2025

Option Year 1: October 01, 2025 – September 30, 2026

Option Year 2: October 01, 2026 – September 30, 2027

Option Year 3: October 01, 2027 – September 30, 2028

Option Year 4: October 01, 2028 – September 30, 2029

Pricing Instructions:

Offerors must fill out the cells in the following columns in the Price Schedule for each Contract Line-Item Number (CLIN).

ITEM INFORMATION

NAICS Code: 621512; Product Service Code (PSC): Q522

Base Year: October 01, 2024 – September 30, 2025

CLIN # Description Qty Unit Unit Cost Total Cost

0001 78814 - Tumor image PET/CT, limited 10.00 EA

0002 78815 - Tumor image PET/CT, skull-thigh 290.00 EA

0003 78816 - Tumor image PET/CT, full body 50.00 EA

0004 F18 – FDG 320.00 EA

0005 Ga68 30.00 EA

BASE YEAR

TOTAL

Option Year 1: October 01, 2025 – September 30, 2026

CLIN # Description Qty Unit Unit Cost Total Cost

0001 78814 - Tumor image PET/CT, limited 10.00

EA

0002 78815 - Tumor image PET/CT, skull-thigh 290.00 EA

0003 78816 - Tumor image PET/CT, full body 50.00 EA

0004 F18 – FDG

320.00

EA

0005 Ga68 30.00

EA

Option Year 1

Option Year 2: October 01, 2026 – September 30, 2027

CLIN

Description Qty Un it

Unit Cost Total Cost

2001 78814 - Tumor image PET/CT, limited 10.00 EA

2002 78815 - Tumor image PET/CT, skull-thigh 290.00 EA

2003 78816 - Tumor image PET/CT, full body 50.00 EA

2004 F18 –FDG 320.00 EA

2005 Ga68 30.00 EA

Option Year 2

Option Year 3: October 01, 2027 – September 30, 2028

3001 78814 - Tumor image PET/CT, limited 10.00 EA

3002 78815 - Tumor image PET/CT, skull-thigh 290.00 EA

3003 78816 - Tumor image PET/CT, full body 50.00 EA

3004 F18 –FDG 320.00 EA

3005 Ga68 30.00 EA

Option Year 3

Option Year 4: October 01, 2028 – September 30, 2029

4001 78814 - Tumor image PET/CT, limited

10.00 EA

4002 78815 - Tumor image PET/CT, skull-thigh

290.00 EA

4003 78816 - Tumor image PET/CT, full body

50.00 EA

4004 F18 –FDG 320.00 EA

4005 Ga68 30.00 EA

Option Year 4

Total price if all options are exercised: ________________________

Note: Evaluation of 52.217-8 will be in accordance with 52.212-2(b), below.

B.3 PERFORMANCE WORK STATEMENT (PWS)

Mobile Positron Emission Tomography/Computerized Tomography (PET/CT) Services

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 Hershel “Woody” Williams VAMC, Huntington, WV.

Contractor shall be responsible to maintain all Contractor equipment in good working order at all times. Every effort should be made to keep equipment down time to a minimum of 72 hours or less.

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 Hershel “Woody” Williams VAMC premises. 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 2019 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).

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 5 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, 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:

Oncology related PET/CT exams.

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

Brain imaging with F-18 FDG.

Prostate-Specific Membrane Antigen - PSMA with 68GA-PSMA11.

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):

Scan delay Multiphase option Protocol storing 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 tabletop 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 10 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:

Up-to-date Microsoft (MS) patches and anti-virus software at the vendor mobile unit Up-to-date MS patches and anti-virus software at the vendor workstation Any workstation configuration must be compatible with VA supplied anti-virus. Medical Device Isolation Architecture (MDIA) security to be provided by VA 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 be capable of acquiring 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 be capable of acquiring 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 16-slice or greater with recon of 32 slices and be capable of acquiring the transmission images within one breath hold.

The system shall have Time of Flight and or equivalent.

f. The CT component of the PET/CT shall be capable of acquiring 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 one PET/CT review station with fusion software compatible with the brand of PET/CT system provided, to be installed within the Hershel “Woody” Williams VAMC and each of the participating VISN 5 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 station shall 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 have image fusion capability as well as whole body display.

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

p. The review stations 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.

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 jacks connection 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 tabletop 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.

THE HERSHEL “WOODY” WILLIAMS 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.)

Electricity (150-amp panel breaker, 3 phase, 480v), (200-amp receptacle, 5 wire, Russelstoll #DF 2504 Frabo) * Telephone Line(s) ** Data Port *** Housekeeping **** Restroom Facilities

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

** Three (3) telephone lines. Use of telephone extension while mobile unit is on site shall be in order 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.

*** Three (3) data lines. Data Port requirements are for the support of Data/Image transfer support (See Para. 11 of the Statement of Work).

**** The Hershel “Woody” Williams and VISN 5 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 at all times in order 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 on a daily basis 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 the Hershel “Woody” Williams VAMC (HWWVAMC) premises. At least one of Contractor’s personnel must be present during working hours while the equipment is located on the Hershel “Woody” Williams VAMC premises. The HWWVAMC facility 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: The Hershel “Woody” Williams VAMC will provide a docking site for the contractors PET/CT scan mobile unit. The Contractor or designee shall perform a site visit at the Hershel “Woody” Williams VAMC location after notification of contract award and prior to commencement of work to coordinate with the COR in order 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 VISN 5. 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.

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 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 Hershel “Woody” Williams VAMC and the 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 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 associate 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 the Hershel “Woody” Williams 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 be Cardiopulmonary Resuscitation (CPR) and Basic Life Support ( BLS) certified and are authorized to initiate this life-saving act if necessary.

DAILY ACCESS TO 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:

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

Contractor shall be responsible for training the Hershel “Woody” Williams VAMC and VISN 5 physicians on the use of the Contractor provided workstation and image analysis software as directed by the COR.

Contractor shall 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 all Hershel “Woody” Williams VAMC 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 Hershel “Woody” Williams VAMC

Communications systems shall be operational before commencement of services.

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”.

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

This start up functions must be completed prior to 7:30 am on each day when trailer is scheduled to be on site in time for the first patient’s injection.

Contractor shall be responsible for ensuring quality diagnostic images at all sites. HWWVAMC reserves the right to require corrective action if image quality or other service problems are brought to the attention of the Contractor.

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

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 address (es) 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.

SCHEDULING OF PATIENTS/SERVICES: The contractor shall coordinate with the Designated Ordering Office or Officer from the Hershel “Woody” Williams VAMC and schedule services one day per week. The Hershel “Woody Williams VAMC require services to be scheduled on a Monday, Tuesday or Wednesday, if the scheduled day is a Holiday, then services will be scheduled on an additional day for that week. The Hershel “Woody” Williams VAMC 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 dispute’s 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 the Hershel “Woody” Williams 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 or 68Ga-PSMA11 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 Hershel “Woody” Williams VAMC requires service one day per week with an anticipated patient load of seven to ten patients scheduled for each day of service with a maximum of 15 scheduled patients. The first patient is to be injected at 7.30 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 meet up to 15 scheduled appointments per day of service.

CANCELLATIONS/NO CHARGE SERVICES:

The Contractor shall not charge the VISN 6 for exams or supplies (including unused 18-FDG or 68GA-PSMA11 doses) or other radioactive agents when:

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

The quality of the exam is unacceptable as determined by the Hershel “Woody” Williams 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 the Hershel “Woody” Williams VAMC for a complete exam when:

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

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

CONTRACTOR FURNISHED FACILITIES, SERVICES, SUPPLIES AND EQUIPMENT:

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 the Hershel “Woody” Williams VAMC.

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 as a result of the Contractor’s failure to confirm the above shall be the responsibility of the successful Contractor.

Contractor shall be held responsible for any damages, which may be done to the Hershel “Woody” Williams 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.

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 Hershel “Woody” Williams VAMC and the Contractor.

NON-CONFORMING PRODUCTS OR SERVICES:

Non-conforming 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.

EMERGENCY REPAIRS:

Emergency service: Contractor shall provide, at no cost to the Hershel “Woody” Williams 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: In the event that 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 of 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 as a result of the equipment failure. If directed by the COR the Contractor shall promptly reschedule all appointments postponed as a result of equipment, staffing and/or radiopharmaceutical failure. Every effort shall be made to ensure 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.

DOCUMENTATION/REPORTS:

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 the Hershel “Woody” Williams VAMC personnel/beneficiaries.

The Contractor shall permit onsite inspection by personnel selected by the Hershel “Woody” Williams VAMC or VISN 5 without prior notice to ensure the Contractor’s equipment is operated in accordance with appropriate safety guidelines and/or regulations as applicable.

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”.

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. This VISN 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:

Certificate of Insurance not limited to but, includes Professional Liability, Worker’s Compensation, liability and property insurance of Contractor’s furnished equipment which 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 Hershel “Woody” Williams VAMC or VISN 5 shall not be held responsible for any damage or vandalism, which may be caused to the Contractor’s equipment while on Hershel “Woody” Williams VAMC premises.

Required Federal, State and local licenses.

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

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.

RADIOACTIVE MATERIALS HANDLING REQUIREMENTS:

The Contractor shall procure all radioactive materials (including but not limited to 18F-FDG 68Ga-PSMA11) 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.

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 the Hershel “Woody” Williams 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 on behalf of the Hershel “Woody” Williams 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 the Hershel “Woody” Williams 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.

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.

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

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.

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 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.