36C25222Q0199 Issued 3-10-22.pdf

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. 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

36C25222Q0199 3/10/2022

Sandra McAnany 414-844-4800 x 43233 3/31/2022

1:00 pm CST

36C252

Department of Veterans Affairs

Great Lakes Acquisition Center (GLAC)

115 S 84th Street, Suite 101

Milwaukee WI 53214-1476

X

621512

$16.5 Million

N/A

36C607

Department of Veterans Affairs

William S Middleton Veterans Hospital

2500 Overlook Terrace

Madison WI 53705-2259

36C252

Department of Veterans Affairs

Great Lakes Acquisition Center (GLAC)

115 S 84th Street, Suite 101

Milwaukee WI 53214-1476

Department of Veterans Affairs

Financial Services Center

PO Box 149971

Austin TX 78714-9971

877-353-9791 512-460-5540

Contractor to provide Mobile Position Emission Tomography and Computerized Tomography (PET/CT) Services at the

William S. Middleton Veterans Memorial Hospital (Madison VA) in accordance with the specifications, terms, and conditions herein.

See Pages 7 and 8 for Price Schedule.

X ONE

Sandra McAnany

Contracting Officer

36C25222Q0199

Table of Contents

A.1 SF 1449 SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION

B.2 SCHEDULE OF SERVICES

B.3 PERFORMANCE WORK STATEMENT

B.4 SPECIAL CONTRACT REQUIREMENTS

B.5 CONTRACT SECURITY REQUIREMENTS

SECTION C - CONTRACT CLAUSES

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

COMMERCIAL SERVICES (NOV 2021)

C.2 52.204-21 BASIC SAFEGUARDING OF COVERED CONTRACTOR INFORMATION SYSTEMS

(NOV 2021)

C.3 52.216-18 ORDERING (AUG 2020)

C.4 52.216-19 ORDER LIMITATIONS (OCT 1995)

C.5 52.216-22 INDEFINITE QUANTITY (OCT 1995)

C.6 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

C.7 52.228-5 INSURANCE—WORK ON A GOVERNMENT INSTALLATION (JAN 1997)

C.8 SUPPLEMENTAL INSURANCE REQUIREMENTS

C.9 52.232-19 AVAILABILITY OF FUNDS FOR THE NEXT FISCAL YEAR (APR 1984)

C.10 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.11 VAAR 852.204-70 PERSONAL IDENTITY VERIFICATION OF CONTRACTOR PERSONNEL (MAY

2020)

C.12 VAAR 852.212-70 PROVISIONS AND CLAUSES APPLICABLE TO VA ACQUISITION OF

COMMERCIAL ITEMS (APR 2020)

C.13 VAAR 852.219-71 VA MENTOR-PROTÉGÉ PROGRAM (DEC 2009)

C.14 VAAR 852.219-75 SUBCONTRACTING COMMITMENTS MONITORING AND COMPLIANCE

(JUL 2018)

C.15 VAAR 852.219-76 SUBCONTRACTING PLANS MONITORING AND COMPLIANCE (JUL 2018)

C.16 VAAR 852.237-75 KEY PERSONNEL (OCT 2019)

C.17 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020)

C.18 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR

EXECUTIVE ORDERS—COMMERCIAL ITEMS (JAN 2021) (JUL 2020) (DEVIATION)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

SECTION E - SOLICITATION PROVISIONS

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

SERVICES (NOV 2021)

E.2 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS AND VIDEO

SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)

E.3 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT 2018)

E.4 52.216-1 TYPE OF CONTRACT (APR 1984)

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

E.6 VAAR 852.219-72 EVALUATION FACTOR FOR PARTICIPATION IN THE VA MENTOR-PROTÉGÉ

PROGRAM (DEC 2009)

E.7 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB 1998)

E.8 VAAR 852.215-72 NOTICE OF INTENT TO RE-SOLICIT (OCT 2019)

E.9 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (NOV

2021)

E.10 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—COMMERCIAL ITEMS (FEB

2021) (JUL 2020) (DEVIATION)

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

1. CONTRACTOR ADMINISTRATION MATTERS WILL BE HANDLED BY:

a. Contractor’s Name/Address/City-State-Zip (please print or type):

Point of Contact/Title:

Telephone Number:

Fax Number:

Email:

Dun & Bradstreet Number:

Federal Taxpayer Identification Number:

b. Contractor’s CPARS Point of Contact:

Name & Title:

Telephone Number:

Email:

c. Government:

Contracting Officer Sandra McAnany Telephone: (414) 844-4800 #43233 Sandra.McAnany@va.gov

Department of Veterans Affairs Great Lakes Acquisition Center 115 South 84th Street, Suite 101 Milwaukee, WI 53214-1476

2. CONTRACTOR REMITTANCE ADDRESS:

All payments by the Government to the Contractor will be made in accordance with Federal Acquisition

Regulation (FAR) Clause 52.232-33, Payment by Electronic Funds Transfer-- System for Award

Management (31 U.S.C. 3332).

3. INVOICES:

In order to comply with the Improper Payment Elimination and Recovery Act of 2010 (IPERA), the VA has mandated electronic invoice submission to the Veterans Affairs Financial Services Center (VAFSC). VAFSC has partnered with Tungsten Corporation e-Invoicing network, for submissions of all electronic invoices to VA. Tungsten Network electronic invoicing is free to all VA vendors. In order to submit electronic invoices, all VA vendors must register with Tungsten Network by submitting an email to Tungsten Network

VA.Registration@tungsten-network.com or calling 1-877-752-0900 option 2 for Enrollment.

mailto:Sandra.McAnany@va.gov mailto:VA.Registration@tungsten-network.com

Contractor shall submit an electronic invoice by the tenth (10th) of the following month services were performed to the Veterans Affairs Financial Services Center (VAFSC) e-Invoice through the website at

Tungsten https://authentication.tungsten-network.com/login. For questions regarding the submission of

VA electronic invoices, Tungsten Network customer service may be contacted at 1-877-489-6135.

The invoice sent to Tungsten Network shall reference the vendor’s name and address, customer name, contract number, appropriate obligation/funding order number, description of services provided & CPT code, price per scan, quantity of scans, the extended price, and the total invoice cost. Invoices shall also include any payment discount terms. A separate invoice, including the patient’s last name and ascension

# of scan, date of service, CPT code, and quantity, shall be sent securely to the Contractor Officer’s

Representative (COR) in order to validate invoices.

For questions regarding invoice receipt or payment, please call VAFSC directly at 1-877-353-9791.

Payments shall be made monthly in arrears upon receipt of a properly prepared invoice.

4. ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the

Solicitation numbered and dated as follows:

AMENDMENT NO DATE

5. POST AWARD ORIENTATION: The Contracting Officer will schedule a post award orientation for contract orientation purposes.

6. SUBCONTRACTING GOALS (applies to large business prime contractors):

All specifications, terms, conditions, clauses, and provisions contained in this solicitation will apply to any other entity, performing contract services on behalf of the prime contractor. It is the responsibility of the prime contractor to ensure all subcontractors/partners comply with the requirements herein and perform services in accordance with industry standards. A subcontracting plan is required in accordance with Federal

Acquisition Regulation 19. The VA’s current departmental goals are:

Service -

Disabled

Veteran -

Owned Small

Business

Veteran - Owned

Small Business

Small

Disadvantaged

Business

Women-Owned

Small Business

Certified HUB-

Zone Small

Business

Small

Business

3.00% 5.00% 5.00% 5.00% 3.00% 17.50% https://authentication.tungsten-network.com/login

B.2 SCHEDULE OF SERVICES

1. AUTHORITY:

This procurement is being conducted under the authority of authority of 38 U.S. Code §513 and will follow procedures in accordance with FAR 13.5 - Simplified Procedures for Certain Commercial Items. As such, the Government will utilize simplified procedures for soliciting competition, evaluation, award documentation, and notification. Contractor shall provide services in accordance with the terms, conditions, and prices contained herein.

2. PURPOSE:

Contractor shall provide all management, labor, equipment, tools, and supplies necessary to perform Mobile Positron Emission Tomography & Computerized Tomography (PET/CT) Services at the William S.

Middleton Veterans Memorial Hospital (Madison VA) located at 2500 Overlook Terrace. Madison, WI 53705. Services shall also include maintenance and repair of all Contractor furnished equipment (including the mobile trailer/scanner) and the provision of radiopharmaceuticals. The resultant contract will be an Indefinite Delivery/Indefinite Quantity contract. The anticipated period of performance is May 1, 2022 through April 30, 2027.

3. GOVERNMENT’S MINIMUM & CEILING:

The VA attempts to be as accurate as possible when providing estimated quantities; however, actual quantities may vary from quantities listed in the Price Schedule. The Government’s guaranteed minimum to be ordered during the fiscal year in which the contract is awarded is $50,000.00. The Government’s ceiling amount of this contract is $5,000,000.00.

4. ORDERING:

Personnel from the Madison VA Imaging Department and Nuclear Medicine Department are the only individuals authorized to schedule PET/CT scans. The Madison VA will submit weekly schedules to the contractor via facsimile. An order under this contract for PET/CT scans is considered placed when the scan is completed. The contractor will be paid the unit price for each complete scan performed including doses provided.

Ordering Officers (OOs) may be authorized to place orders against this contract. If used, the Contracting Officer (CO) will furnish the Contractor with the names of individuals authorized as OOs, by separate memorandum. When OOs are added after award, the CO will furnish the Contractor with the names of individuals authorized as OOs, by memorandum upon OO appointment. OOs are responsible for issuing and administering orders placed under this contract. OOs have no authority to modify any term of this basic contract. Any deviation from the terms of the basic contract must be approved in writing by the CO responsible for this contract. The Contractor shall accept orders against this contract only from the CO and/or authorized OOs. Fulfilling orders from persons other than the CO or OO may result in loss or delay in payment for supplies/services provided under such orders.

5. PRICE SCHEDULE:

Contractor shall complete the Price Schedule with an all-inclusive unit price per scan and dose.

ITEM

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

250.00 EA __________________ __________________

Mobile PET/CT Services

Contract Period: Ordering Period One POP Begin: 05-01-2022 POP End: 04-30-2023

160.00 EA __________________ __________________

18F-FDG radiopharmaceutical

Contract Period: Ordering Period One

90.00 EA __________________ __________________

Pylarify radiopharmaceutical

Contract Period: Ordering Period One

Contract Period: Ordering Period Two POP Begin: 05-01-2023 POP End: 04-30-2024

Contract Period: Ordering Period Two

Contract Period: Ordering Period Two

Contract Period: Ordering Period Three POP Begin: 05-01-2024 POP End: 04-30-2025

Contract Period: Ordering Period Three

Contract Period: Ordering Period Three

Contract Period: Ordering Period Four POP Begin: 05-01-2025 POP End: 04-30-2026

Contract Period: Ordering Period Four

Contract Period: Ordering Period Four

Contract Period: Ordering Period Five POP Begin: 05-01-2026 POP End: 04-30-2027

Contract Period: Ordering Period Five

Contract Period: Ordering Period Five

GRAND TOTAL

B.3 PERFORMANCE WORK STATEMENT

1. OVERVIEW

Contractor shall provide all management, labor, equipment, supplies, radiopharmaceuticals, and tools necessary to perform mobile Positron Emission & Computerized Tomography (PET/CT) at the William S.

Middleton Memorial Hospital (Madison VAH). Services shall also include maintenance and repair of all Contractor furnished equipment (including the mobile trailer/scanner).

Mobile PET/CT services will be performed during Madison VAH Radiation Oncology clinic hours 8:00 a.m.

– 4:30 p.m. Services shall be performed a minimum of five (5) hours, with the first patient arrival at 7:30 a.m. Trailer delivery, setup and daily quality control procedures shall not delay the start of examinations.

2. SUPPLIES/PHARMACEUTICALS

Contractor shall procure, receive, dispense, administer, store, and safeguard all supplies, radioactive material, and pharmaceuticals required in the performance of the PET/CT services. These supplies include but are not limited to syringes, needles, tourniquets, sterile IV starter kits, band-aids, etc. The radiopharmaceuticals required include the 18F-FDG (12-15 mCi), and Pylarify. The Madison VAH will provide the required linens for patients and any required contrast.

3. CONTRACTOR FURNISHED EQUIPMENT

A. General: All equipment to be used during the performance of the contract must be FDA approved imaging equipment and placed at a location designated by the on-site COR at the Madison VAH.

Contractor will be required to make whatever adaptions are necessary to ensure that the contractor’s equipment is compatible with the VA physical space and information systems. Madison VAH has a designated mobile pad and dock (with data lines nearby) that connects to the facility.

B. PET/CT Mobile Trailer: Contractor shall furnish a handicapped accessible PET/CT Mobile Trailer where studies will be performed on equipment furnished by the Contractor. The entire offering of a PET/CT Mobile Trailer service shall meet all local, state, federal, industry, FDA, Joint Commission, NRC, NFFPA, VA, OSHA, and other applicable regulatory standards internal or external to the Madison VAH. The PET/CT Mobile Trailer shall provide the space sufficient for conducting CPR and emergency code procedures, if needed. The PET/CT Mobile Trailer shall have an intercom system between the control room and scanning room, CD-R burning capabilities as a backup to network transfer of data, and Optical Disk archival system.

The patient data and optical disk is the property of the Madison VAH. The PET/CT Trailer shall maintain a temperature to assure proper operation of the scanner without frequent calibration and patient comfort.

The Mobile PET/CT unit shall possess sufficient space and design to ensure a ‘Quiet Room’ where the radiopharmaceutical can be administered, and patients can rest comfortable with no physical activity and minimum possible external stimuli such as noise and light during the uptake period of the radiopharmaceutical.

C. PET/CT Scanner System: Contractor shall furnish a fully equipped open bore PET/CT system designed to perform oncology related PET/CT exams, brain imaging with 18F-FDG static emission scans, prostate imaging (with appropriate radiopharmaceuticals and whole-body scans. Open bore must be a minimum of 60cm however the Madison VA highly prefers 70cm bore for patient comfort. The PET/CT shall possess a PET detector crystal with a high light output and short decay constant such as Lutetium Oxyortho-Silicate (LSO) in order to shorten the PET data acquisition time to the minimum possible. The PET/CT must be capable of acquiring 2-dimensional and/or 3-dimensional PET images or true 3-dimensional images. The

CT Component of the PET/CT must contain a multi-slice detector and capable of acquiring the transmission images within one breath hold. The CT component must also be capable of acquiring data for anatomic localization and attenuation correction. The PET/CT system must include attenuation correction algorithm(s) that are designed to use non-contrast enhanced, intravenous contrast enhancement, oral contrast enhancement with positive contrast (iodinated contrast) and oral contrast enhancement with negative contrast (water) data. Images shall be of diagnostic quality; there should be no more than five returned studies per quarter.

D. Accessory Equipment: Contractor shall provide new hardware and software, and upgrade when new hardware/software becomes available (as long as performance is not adversely impacted), to ensure ability to read PET/CT images and create and export JPEG and MPEG files. The mobile unit will be equipped with a hot lab to receive and store the radiopharmaceuticals and radioactive waste. Additionally, the contractor must furnish an independent workstation with the Mobile PET/CT for post processing and manipulation of the acquired PET/CT images. This workstation should contain a full system of these elements: CPU, monitor(s), keyboard, mouse, all software, and applicable licenses that the interpreting radiologist will need to successfully dictate the exam. Software must be capable of image fusion, providing three orthogonal planes of the CT images alone, the PET images alone and the superimposed PET/CT images and an additional set of noncorrected PET images, multimodality display capability, including magnetic resonance imaging, computerized tomography, radiography, ultrasonography etc. Ideally the workstation would be placed within the Imaging Department at Madison VAH, next to a PACS dictation system for comparison and post processing by the interpreting radiologist, or within the Cancer Center.

E. Telecommunications: The mobile scanner shall be equipped with an outlet connection capable of transmitting data and voice through a Government provided network cable. The Government will provide the connection required for the transmission of images, data, and voice. The Contractor’s mobile scanner system must also be compatible with DICOM 3 imaging PACS standards (PACS interface contact person will be provided to the Contractor, if necessary).

F. Maintenance: Contractor shall be responsible for the proper maintenance of the mobile unit and PET/CT scanner so that it stays in good working order. Contractor will provide evidence of the required preventative maintenance and calibration of equipment as required by the manufacturer. The COR shall be allowed access to proof of maintenance during the performance of this contract.

Contractor shall provide a PET/CT system that maintains a minimum of 95% up-time performance rate, which is based on the normal PET/CT duty days and hours. No routine maintenance will be scheduled or performed such that it conflicts with the required schedules of the PET/CT unit, except to address emergency failures of the unit. Contractor shall provide an emergency telephone service line to be answered upon initial call, or if a message is left, the return call to the Madison VAH will be within 30 minutes of notification. Service response times to emergency failures shall be within two hours of notification.

In the event of equipment failure or unavailability of the PET/CT Mobile Trailer and/or equipment, the contractor shall make a sound effort to get the unit fully operational within 12 hours. Additionally, contractor shall make alternate accommodations for the VA for lost time resulting from defective workmanship or equipment failure. As a result of normal duty time lost during the downtime, the contractor may be required to work outside regular business hours and/or weekends, at no additional costs to the Government, to reduce patient backlog. VA personnel, including the COR, shall be notified immediately of any equipment malfunctions that would hinder the completion of the scans. In the event of a system failure, the contractor and Madison VAH Imaging Supervisor shall work cooperatively to remedy the situation as quickly as possible.

5. GOVERNMENT FURNISHED EQUIPMENT, FACILITIES, UTILITIES

Contractor shall be held responsible for any damages, which may be done to the VA property during hookup and/or removal of equipment at the site.

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. Installing and staging must be completed prior to commencement of services. The mobile unit may remain on-site and connected to power at all times; however, the Madison VAH is not responsible for issues that may arise as a result.

The Government will provide the following utilities/services to the Contractor if required for the operation of the mobile PET/CT unit.

a. Water

b. Electricity*

c. Steam

d. Sewage

e. Natural Gas

f. Telephone Line(s) **

g. Data Port

h. Housekeeping ***

* In accordance with the Original Equipment Manufacturers’ (OEM) electrical specifications. The Madison VAH has 480-volt and 200-amp power hook ups available.

** Use of a telephone extension while mobile unit is on-site to make and receive telephone calls and to facilitate the movement of patients to and from the unit is permissible. Telephone calls placed and received shall be restricted to the appropriate free dialing areas and long distance without charge to the

VA.

*** The VA shall be held responsible for areas within the hospital facility prior to entrance of the PET/CT Mobile Trailer. The Contractor shall be responsible for all housekeeping duties and responsibilities within the trailer itself to include hazardous/radioactive waste removal and disposal.

6. Contractor’s Staff:

A. Contractor shall provide a minimum of 2 (two) Certified Nuclear Medicine Technologist(s) specialized in PET/CT for each day services are performed, and any qualified support staff (as patient volume requires) necessary to provide services for the VA patients. Technologists must have VA computer access to retrieve PET/CT orders and enter notes into the Electronic Health Record (EHR), currently known as the Computerized Patient Record System (CPRS). Technologists must verify studies in the PACS system, daily.

Contractor shall also provide a PET/CT Mobile Unit Driver who is appropriately licensed to operate and drive the mobile vehicle in which the scanner is housed.

B. Mobile PET/CT Technologists are responsible for performing the duties and tasks listed below.

• Ensure applicable patient informed consent is obtained and presented prior to performing examinations.

• Review the PET/CT paperwork to ensure accuracy of the exam protocol, time allotted, required labs, allergies, etc. If questions arise, PET/CT technologist shall consult with the VA Radiologist or Madison VAH Imaging Supervisor.

• Screen patients for potential contradictions to PET/CT imaging based on Madison VAH

Imaging procedures and guidelines.

• Verify patient’s identification and confirm procedure to be performed prior to commencement of any services.

• Document and provide disqualifications of a patient from the exam to designated VA

Imaging staff before the patient leaves the PET/CT Trailer during each visit.

• Report immediately any examination that is unsafe to perform to the patient’s physician and the VA designated Imaging staff member before the patient leaves the

PET/CT site.

• Perform venipuncture, assess IV patency, and administer the radiopharmaceutical/contrast consistent with accepted procedures and protocols approved by Madison VAH.

• Operate the PET/CT scanner and perform PET and CT imaging.

• Report immediately while the patient is on the trailer any side effects that may develop from injection of the radiopharmaceutical and/or iodinated contrast agent or from patient preparation to the designated staff physician.

• Perform initial assessment and identification of medical emergencies. If required, initiate the Madison VAH Rapid Response/Code 4 procedure for patients on the mobile truck unit or for patients otherwise in their care.

• Ensure that all PET/CT exams are acquired and processed per procedures and protocols provided and/or approved by the Madison VAH Medical Imaging staff physicians.

• Ensure EHR documentation is complete and CPRS note includes injection site, type of contrasts, radiopharmaceuticals used, lot number of radiopharmaceuticals, reactions, complications, and any information pertinent to the patients record.

• Re-perform unsatisfactory/un-diagnosable PET/CT examinations at the discretion of designated Madison VAH Medical Imaging staff at no additional charge.

• Ensure EHR documentation is complete and includes injection site, type of contrasts and radiopharmaceuticals used along with LOT numbers, reactions, and complications, and any other information pertinent to the patient’s record.

C. Contractor shall identify its contact person(s), who shall serve as liaison between the Contractor and the Madison VAH, and who shall ensure that the Contractor performs services in accordance with contract specifications. The Contractor’s liaison shall contact the COR and the Madison VAH Imaging Supervisor for all delays and cancellations by the contractor immediately. The Contractor’s contact person(s) shall be available 30 minutes prior to first scheduled scan and 30 minutes after last scheduled scan.

7. Radioactive Materials Handling Requirements

The Contractor will procure all radioactive materials directly under its NRC (Nuclear Regulatory Commission) license or Reciprocity with the NRC. A copy of the Contractor’s NRC license shall be provided with the signed quote.

Contractor shall be solely responsible for the receipt, dispensing, administration, storage, surveys, decontamination, waste management, proper disposal and record keeping in accordance with Contractor’s Radioactive Materials License for all radioactive materials required in the performance of the services by the Contractor.

Contractor’s Radioactive Materials License must include the list of VA Madison Authorized Users.

Administration of radioactive material by the Contractor’s technologist will be in accordance with VA Madison Authorized User instructions.

Contractor shall be liable for the cost of any unused dosages of 18F-FDG due to VA cancellations and no shows, as well as for any required supplies or pharmaceuticals associated with the VA having to reschedule the services. The VA will be responsible for the covering the cost of unused doses of Pylarify due to cancellation and no shows.

[End of Performance Work Statement]

B.4 SPECIAL CONTRACT REQUIREMENTS

1. SERVICES

A. The services specified herein may be changed by written modification to this contract. The Contracting

Officer will prepare the modification (reference FAR clause 52.212-4(c), Changes) and, prior to becoming effective, shall be signed by both parties. Only the Contracting Officer is authorized to make commitments or issue changes that affect price, quantity, or quality of performance of this contract. In the event the

Contractor effects any such change at the direction of any person other than the Contracting Officer, the change shall be considered unauthorized, and no adjustment will be made in the contract price to cover any increase in costs incurred as a result thereof.

B. This is a non-personal services contract as defined in FAR 37.101. There is no employer-employee relationship between the Government and the contractor or the contractor’s employee(s). Contractor personnel are not subject to the supervision and control of a Government officer or employee. Rather contractor personnel perform their duties in accordance with the Statement of Work. Supervisory functions such as hiring, firing, directing, and counseling of contractor personnel are not performed by the Government. The healthcare provider(s) who furnish services under this contract is/are subject to

Government technical oversight of the services. The Government retains the right to reject services for contractual non-performance.

C. The Government may evaluate the quality of professional and administrative services provided, but retains no control over the medical, professional aspects of services rendered.

D. Contractor is required to maintain medical liability insurance for the duration of this contract. Medical liability insurance must cover the provider(s) for services in all states where services are rendered by the provider.

E. The services to be performed by the contractor will be performed in accordance with VA policies, procedures, regulations, and the medical staff bylaws of the VA facility (copies and/or links will be provided upon request). In all cases, dignity of the patient shall be given the highest regard and the precepts of the American Hospital Association’s “Bill of Rights for Patients” shall be observed.

F. Contractor shall, in writing, keep the Contracting Officer informed of any unusual circumstances in conjunction with the contract.

2. TERM OF CONTRACT

This contract is effective for the period May 1, 2022 through April 30, 2027. There are five one-year ordering periods. The contractor shall perform no services after April 30, of any year until the Contracting

Officer authorizes such services in writing.

3. FEDERAL HOLIDAYS

The 11 holidays observed by the Federal Government are: New Year’s Day (January 1st), Martin Luther

King’s Birthday (3rd Monday in January), Presidents’ Day (3rd Monday in February), Memorial Day (last

Monday in May), Independence Day (July 4th), Juneteenth Day (June 19th), Labor Day (1st Monday in

September), Columbus Day (2nd Monday in October), Veterans Day (November 11), Thanksgiving Day (4th

Thursday in November), Christmas Day (December 25th). Services on federal holidays are not required;

however, when a federal holiday falls on a Monday, the Milwaukee VAMC would like the contractor to provide services that Wednesday instead.

When one of the above designated legal holidays falls on a Sunday, the following Monday will be observed as a legal holiday. When a legal holiday falls on a Saturday, the preceding Friday is observed as a holiday by U.S. Government agencies.

4. QUALIFICATIONS OF PERSONNEL

A. Nuclear Medicine PET/CT Technologists assigned by the contractor to perform the services covered by this contract shall have a full and unrestricted license and/or registered in a State, Territory, or

Commonwealth of the United States or the District of Columbia. Technologists must be in good standing with the Nuclear Medicine Technology Certification Board (NMTCB) or the American Registry of Radiologic

Technology (ARRT-N). PET/CT Technologists shall be able to insert IV needles for administration of contrast material when necessary. The Contractor must perform the required work in accordance with

National Regulatory Commission (NRC), the Joint Commission standards and Department of Nuclear

Safety (DNS).

B. PET/CT Technologists shall also be BLS certified. Certifications must be obtained or issued by the

American Heart Association (AHA), an organization recognized by the AHA, or Military Training Network

(MTN). There may be reactions the patient has that require immediate attention so that harm does not come to the patient. PET/CT Technologists are authorized to perform this life-saving act, if necessary.

Certification also in Advanced Cardiac Life Support (ACLS) is preferred.

C. Personnel assigned by the contractor to perform the services covered by this contract shall be proficient in written and spoken English (38 USC 7402).

D. Personnel assigned by the contractor to perform the services covered by this contract must be computer literate as patient documentation is directly input in the patient’s electronic medical record.

Proficiency in the use of the Veterans Health Information Systems and Technology Architecture (VISTA) system and the Computerized Patient Record System (CPRS) is preferred.

E. Contractor must possess all licenses, permits, accreditation and certificates as required by law. The

Contractor must perform the required work in accordance with National Regulatory Commission (NRC) and Department of Nuclear Safety (DNS). All personnel must be competent and proficient to introduce contrast and or radiopharmaceuticals.

F. Any new requirements for mandatory education and/or competency reassessment, which occur during the contract period, must be completed by the individual contractor employee(s) within established timeframes.

G. The contracted individual(s) will be required to show two proofs of identification on their first day of work. Acceptable proofs of identification are shown in the table below.

Acceptable PICTURE IDs:

• State-issued Driver’s License

• State DMV-Issued ID Card

• US Passport

• Military ID/Dependents Card

• Foreign Passport

• Permanent Resident Card/Alien Registration Card w/Photo

Acceptable NON-PICTURE IDs:

• Social Security Card

• Certified Birth Certificate

• State Voter Registration Card

• Native American Tribal Document

• Certificate of US Citizenship

• Certificate of Birth Abroad Issued by Dept of State

H. Physical Requirements: The contractor must provide documentation that demonstrates that all contractor employees have a satisfactory health status including a current physical, which includes the following:

1) TUBERCULOSIS TESTING: Contractor shall provide proof of a negative TB Blood Test (also called interferon-gamma release assays (IGRA)) for all Contractor employees as a baseline. Two TB blood tests are approved by the FDA: the QuantiFERON – TB Gold In-

Tube test (QFT-GIT) and the T-SPOT TB test (T-Spot). Subsequent testing is not required unless the contractor employee has been exposed to someone with TB.

2) MEASLES, MUMPS, & RUBELLA TESTING: Contractors shall provide proof of immunity for all Contractor employees, i.e., at least 2 doses of vaccine are required or serologic evidence of immunity.

3) VARICELLA: Contractors shall provide proof of immunity for all Contractor employees, i.e., at least 2 doses of vaccine are required or serologic evidence of immunity.

4) TDAP (TETNUS/DIPTHERIA/PERTUSSIS): Contractors shall provide proof of 1 dose of Tdap vaccination for all Contractor employees. Boosters are required every 10 years.

5) INFLUENZA: Contractors shall provide proof that all Contractor employees have received the annual Influenza vaccine unless it is contraindicated. If the Contractor employees has a medical contraindication to the vaccine, they shall be required to wear a mask during the Influenza season.

6) HEPATITIS B: Contractor shall provide evidence of completing and passing generic self-study blood-borne pathogen training for all Contractor employees; provide their own

Hepatitis B vaccination series (3 doses required) plus a serologic titer (1-2 months after final dose) to document immunity following the hepatitis B vaccination series; maintain an exposure determination and control plan; maintain required records; and ensure that proper follow-up evaluation is provided following an exposure incident.

5. CREDENTIALING

An application package will be provided by the Madison VAH Credentialing Coordinator and shall be completed by the provider(s) working under this contract and returned within two weeks of receiving the application package This includes: facility-specific paperwork, curriculum vitae (CV)/resume, current references, signed release of information from provider(s), copies of licenses or certifications, CPR/BLS/ACLS, competencies, statement that provider does not have any physical or mental health condition that would adversely affect his/her ability to carry out assigned duties, and any additional credentialing and privileging forms.

Provider(s) will also be required to complete an application through the VetPro Internet process within two weeks of being enrolled in VetPro. Provider(s) will need to be enrolled in VetPro by VA personnel. The website address is: https://fcp.vetpro.org. Facility ID number is as follows: 607.

6. APPROVAL OF CONTRACTOR PERSONNEL

The VA reserves the right to refuse acceptance of any contractor employee or subcontractor employee under this contract when that individual does not qualify under the requirements of VHA Handbook

1100.19 http://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=2910 and/or the specific VA

Hospital/Medical Center Policy on Credentialing and Privileging or fails to perform at the proficiency level expected by the VA Facility Director. In addition, VA reserves the right to restrict the services or require dismissal of any contractor employee or subcontractor employee under this contract, if personal or professional conduct jeopardizes patient care. Breaches of conduct include intoxication or debilitation resulting from drug use, theft, patient abuse, dereliction, or negligence in performing directed tasks, physical or verbal abuse, or other conduct resulting in formal complaints by the patient(s). Standards of conduct shall mirror those prescribed by current federal personnel regulations. The Contracting Officer and the Contracting Officer’s Representative shall deal with issues raised concerning contract personnel’s conduct. The final decision maker on questions of acceptability is the Contracting Officer.

A Clinical Panel consisting of the Chief of Staff and Chief of Imaging Service will address any issues relating to egregious actions (patients harmed during treatment or other events that trigger patient incident reports or sentinel events). The panel will make recommendations of appropriate action to the

Contracting Officer (i.e., substitution of provider).

VA reserves the right to approve the assignment of any and all personnel furnished by the Contractor to perform the functions specified in this contract. The Contractor shall notify the Contracting Officer prior to any changes in personnel.

7. KEY PERSONNEL & PERSONNEL SUBSTITUTIONS

A. It is essential that continuity of services be maintained to the maximum extent possible. Changes in contractor’s key personnel shall be kept to a minimum necessary to continue required performance and to provide adequate back-up personnel. The Contractor shall assign to this contract the following key personnel, PET/CT Scan Technologists:

NAME NAME

https://fcp.vetpro.org/ http://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=2910

B. During the first ninety (90) days of performance, the Contractor shall make NO substitutions of key personnel unless the substitution is necessitated by illness, death, or termination of employment or if mutually agreed upon by the Contracting Officer and the contractor. The Contractor shall notify the

Contracting Officer, in writing, within 5 calendar days after the occurrence of any of these events and provide the information required by paragraph (b) below. After the initial 90-day period of the contract, the Contractor shall submit the information required by paragraph (b) to the Contracting Officer at least

15 days prior to making any permanent substitutions.

C. The Contractor shall provide a detailed explanation of the circumstances necessitating the proposed substitutions, complete resumes for the proposed substitutes, and any additional information requested by the Contracting Officer. Proposed substitutes shall have comparable qualifications to those of the persons being replaced. The Contracting Officer will notify the Contractor within 15 calendar days after receipt of all required information of the decision on the proposed substitutes. The contract will be modified to reflect any approved changes of key personnel.

D. Prior to rendering services, substitutes must be credentialed and privileged by the medical facility and obtain a medical staff appointment, in accordance with VA Bylaws, Rules and Regulations.

8. HHS/OIG

To ensure that the individuals providing services under the contract have not engaged in fraud or abuse regarding Sections 1128 and 1128A of the Social Security Act regarding federal health care programs, the contractor is required to check the Health and Human Services - Office of Inspector General (HHS/OIG), List of Excluded Individuals/Entities on the OIG Website (https://exclusions.oig.hhs.gov/) for each person providing services under this contract. The listed parties and entities may not receive Federal Health Care program payments due to fraud and/or abuse of the Medicare and Medicaid programs. During the performance of this contract the contractor is prohibited from using any individual or business listed on the List of Excluded Individuals/Entities. Any healthcare provider or entity that employ or enter into contracts with excluded individuals or entities may have a Civil Monetary Penalty (CMP) imposed against them. By signing this offer, the Contractor certifies that all persons or entities listed in the contractor’s proposal have been compared against the OIG list and are NOT listed as of the date the quote was signed.

9. JOINT COMMISSION STANDARDS

A. Joint Commission accreditation is not required, it is preferred. The contractor shall perform the required work in compliance with Joint Commission Standards. A copy of these standards may be obtained from Joint Commission, One Renaissance Blvd., Oakbrook Terrace, IL 60181.

B. The contractor will be responsible to ensure the contractor employees or subcontractors providing work on this contract are fully trained and completely competent to perform the required work.

Contractor will gather all credentialing documents requested by the VA as well as any other documentation that the carrying out of this contract may require. However, the contractor is not able to nor is the contractor required to make clinical competence determinations on behalf of the VA.

https://exclusions.oig.hhs.gov/

10. PERSONNEL POLICY

A. The contractor shall be responsible for protecting the personnel furnishing services under this contract.

To carry out this responsibility, the contractor shall provide the following for these personnel:

1) Workers’ compensation

2) Professional liability insurance

3) Health examinations/immunization

4) Income tax withholding, and

5) Social security payments.

B. The parties agree that the contractor, its employees, agents, and subcontractors shall not be considered

VA employees for any purpose.

C. The VA shall notify the Contractor of any significant communicable disease exposure as appropriate. The

Contractor shall adhere to current CDC/HICPAC Guideline for Infection Control in health care personnel (AIJC

1998: 26:2890354) for disease control. The Contractor shall provide follow up documentation of clearance to return to the workplace prior to contractor’s or subcontractor’s employee(s) return.

11. RECORD KEEPING – CONTRACTOR

Contractor must establish a record keeping system of the number of scans performed for the VA. These records must be available to the Contracting Officer (CO) or the Contracting Officer Representative (COR) upon request within five (5) business days.

12. MEDICAL RECORDS

Clinical or other medical records of VA veteran patients treated by Contractor under this contract are VA records. Clinical or other medical records of VA beneficiaries that are released to the Contractor shall be returned to the VA after review. The VA will provide the Contractor with access to the patient’s medical records when necessary. The Contractor shall be responsible for the safekeeping of both the electronic and paper medical records (whichever is applicable). Patient Privacy Provisions and HIPAA regulations are applicable to the release of patient Information.

If a subpoena or court order is received for the production of a medical record, the contractor shall refer the subpoena or court order to the Contracting Officer.

13. CONFIDENTIALITY OF PATIENT RECORDS

A. The Contractor is a VA contractor and will assist in the provision of health care to patients seeking such care from or through VA. As such, the Contractor is considered as being part of the Department health care activity. Contractor is considered to be a VA contractor for purposes of the Privacy Act, Title 5

U.S.C. 552a. Further, for the purpose of VA records access and patient confidentiality, Contractor is considered to be a VA contractor for the following provisions: Title 38 U.S.C. 5701, 5705, and 7332.

Therefore, Contractor may have access, as would other appropriate components of VA, to patient medical records including patient treatment records pertaining to drug and alcohol abuse, HIV, and sickle cell anemia, to the extent necessary to perform its contractual responsibilities. However, like other components of the Department, and not withstanding any other provisions of the sharing agreement, the

Contractor is restricted from making disclosures of VA records, or information contained in such records, to which it may have access, except to the extent that explicit disclosure authority from VA has been received. The Contractor is subject to the same penalties and liabilities for unauthorized disclosures of such records as VA.

B. The records referred to above shall be and remain the property of VA and shall not be removed or transferred from VA except in accordance with U.S.C.552a (Privacy Act), 38 U.S.C. 5701 (Confidentiality of claimant’s records), 5 U.S.C. 552 (FOIA), 38 U.S.C. 5705 (Confidentiality of Medical Quality Assurance

Records) 38 U.S.C. 7332 (Confidentiality of certain medical records) and federal laws, rules, and regulations. Subject to applicable federal confidentiality or privacy laws, the Contractor, or their designated representatives, and designated representatives of federal regulatory agencies having jurisdiction over Contractor, may have access to VA’s records, at VA’s place of business on request during normal business hours, to inspect and review and make copies of such records.

14. HIPAA COMPLIANCE

Contractor must adhere to the provisions of Public Law 104-191, Health Insurance Portability and

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

Protected Health Information (PHI). As required by HIPAA, the Department of Health and Human Services

(HHS) has promulgated rules governing the security and use and disclosure of protected health information by covered entities, including the Department of Veterans Affairs (VA). In accordance with

HIPAA, the Contractor is conducting health care, Mobile PET/CT services, on VA’s behalf – therefore, the contractor is not required to enter into a Business Associate Agreement (BAA) with VA.

15. DESIGNATION OF CONTRACT OFFICER REPRESENTATIVE (COR)

A Contracting Officer’s Representative or Representatives (COR(s)) will be assigned to this contract. The

COR will furnish technical guidance and advice regarding the work being performed under this contract.

The foregoing is not to be construed as authorization to interpret or furnish advice and information to the contractor relative to the financial or legal aspects of the contract. Enforcement of these segments is vested in and is the responsibility of the Contracting Officer. The extent and limitations of this designation will be provided in the COR Delegation Memo.

16. CONTRACT PERFORMANCE MONITORING

A. Upon arrival at the Madison VAH, the contractor's employee(s) shall report to the Cancer Center

Radiation Oncology front desk, Building 1 Ground Floor.

B. Monitoring of contractor’s performance shall be demonstrated through clinical and administrative record reviews. COR will be responsible for verifying contract compliance. The COR will designate appropriate VA personnel to monitor services through one or a combination of the following mechanisms:

1) Departments being served will monitor Contractor performance to ensure that services called for in the contract have been received by VA in a timely manner. Any incidents of Contractor noncompliance as evidenced by the monitoring procedures will be forwarded immediately to the Contracting Officer.

2) Documentation of services performed will be reviewed prior to certifying payment. The COR or service Administrative Officer will perform periodic spot checks and document with the using service to ensure records monitoring. VA will pay only for services provided, and in strict accordance with the Price Schedule. Contract monitoring and recordkeeping procedures will be sufficient to ensure proper payment and allow audit verification that services were provided.

3) The using service, through the COR, will provide a written statement annually to the

Contracting Officer to include a summary of Contractor actions and a statement that all…