36C25221Q1141_3.docx

36C25221Q1141

PAGE 1 OF

1. REQUISITION NO.

2. CONTRACT NO.

3. AWARD/EFFECTIVE DATE

4. ORDER NO.

5. SOLICITATION NUMBER

6. SOLICITATION ISSUE DATE

a. NAME

b. TELEPHONE NO. (No Collect Calls)

8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY

CODE

10. THIS ACQUISITION IS

UNRESTRICTED OR

SET ASIDE:

% FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ

IFB

RFP

15. DELIVER TO

CODE

16. ADMINISTERED BY

CODE

17a. CONTRACTOR/OFFEROR

CODE

FACILITY CODE

18a. PAYMENT WILL BE MADE BY

CODE

TELEPHONE NO.

DUNS:

DUNS+4:

PHONE:

FAX:

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

SEE ADDENDUM

19.

20.

21.

22.

23.

24.

ITEM NO.

SCHEDULE OF SUPPLIES/SERVICES

QUANTITY

UNIT

UNIT PRICE

AMOUNT

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

25. ACCOUNTING AND APPROPRIATION DATA

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

ARE

ARE NOT ATTACHED.

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

ARE

ARE NOT ATTACHED

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

29. AWARD OF CONTRACT: REF. ___________________________________ OFFER

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND

DATED ________________________________. YOUR OFFER ON SOLICITATION

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

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

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED

SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

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

AUTHORIZED FOR LOCAL REPRODUCTION

(REV. 2/2012)

PREVIOUS EDITION IS NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

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

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

36C25221Q1141 09-29-2021 Becky Cincotta 414-844-4822 10-14-2021 13:00

CDT

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 X 36C695 Department of Veterans Affairs Clement J. Zablocki Veterans Affairs Medical Center 5000 W. National Avenue Milwaukee WI 53295-0000 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 Positron Emission Tomography and Computerized Tomography (PET/CT) Services at the Clement J. Zablocki Veterans Affairs Medical Center (Milwaukee VAMC) in accordance with the specifications, terms, and conditions herein.

See pages 4 through 6 for Price Schedule...

X X

BECKY CINCOTTA

Contracting Officer

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

1. CONTRACT 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: _________________________________________________ DUNS Number: __________________________________________ Federal Taxpayer Identification Number: _________________________________________ Contractor Performance Assessment Rating System (CPARS) Past Performance Point of Contact:

Name & Title: _________________________ Email Address: ___________________________

B. GOVERNMENT:

Email: becky.cincotta@va.gov Fax: (414) 844-4891

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.

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 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. POST AWARD ORIENTATION: The Contracting Officer will schedule a post award conference call for contract orientation purposes. Contractor is required to participate.

5. 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:

[End of Contract Administration Data]

B.2 SCHEDULE OF SUPPLIES/SERVICES AND PRICE

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 Clement J. Zablocki VA Medical Center (Milwaukee VAMC) located at 5000 West National Ave. Milwaukee, WI 53295. 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 November 1, 2021 through October 31, 2026.

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 $3,750,000.00.

4. ORDERING:

Personnel from the Milwaukee VAMC Imaging Department and Nuclear Medicine Department are the only individuals authorized to schedule PET/CT scans. The Milwaukee VAMC 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.

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.

November 1, 2021 through October 31, 2022

Total Year 1

November 1, 2022 through October 31, 2023

Total Year 2

November 1, 2023 through October 31, 2024

Total Year 3

November 1, 2024 through October 31, 2025

Total Year 4

November 1, 2025 through October 31, 2026

Total Year 5

Total Estimated Contract Value $_____________________________ [End of Schedule of Supplies/Services and Price]

B.3 PERFORMANCE WORK STATEMENT

1. OVERVIEW

Contractor shall provide all management, labor, equipment, supplies, and tools necessary to perform Mobile PET/CT Services at the Milwaukee VAMC. Services shall also include maintenance and repair of all Contractor furnished equipment (including the mobile trailer/scanner) and the provision of radiopharmaceuticals.

Mobile PET/CT services will be performed during Milwaukee VAMC Medical Imaging clinic hours (7:00 a.m. – 3:30 p.m.) on Mondays and Tuesdays. Services shall be performed a minimum of five (5) hours a day, with the first patient arrival at 7:00 a.m. Trailer delivery, setup and daily quality control procedures shall not delay the start of examinations.

2. SUPPLIES/RADIOPHARMACEUTICALS

Contractor shall procure, receive, dispense, administer, store, and safeguard all supplies and radiopharmaceuticals 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), Axumin, Pylarify or equivalent prostate radiopharmaceutical. The Milwaukee VAMC 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 Imaging Supervisor at the Milwaukee VAMC. 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. Milwaukee VAMC has a designated mobile pad/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, VHA, OSHA, and other applicable regulatory standards internal or external to the Milwaukee VAMC. 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 Milwaukee VAMC. The PET/CT Trailer shall maintain a temperature that provides patient comfort and ensures proper operation of the scanner without frequent calibration. The Mobile PET/CT unit shall possess sufficient space and design to contain a ‘Quiet Room’ where the radiopharmaceuticals can be administered, and where patients can rest comfortably 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 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. Bore must be a minimum of 60cm; however, the Milwaukee VAMC 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.

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 radioisotope and radioactive waste. Additionally, the contractor must furnish two independent workstations with the Mobile PET/CT for post processing and manipulation of the acquired PET/CT images. These workstations 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, and ultrasonography. The workstations would be placed within the Imaging Department at Milwaukee VAMC, next to a PACS dictation system for comparison and post processing by the interpreting radiologist, as well as in the Nuclear Medicine Department at the Milwaukee VAMC.

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 Imaging Supervisor and 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 Milwaukee VAMC shall 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 Imaging Supervisor, 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 Milwaukee VAMC 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 trailer can be left on-site and hooked up to electricity during non-operational hours starting the night before services are required through Wednesday at 5:00 p.m. local, unless other arrangements are prearranged and approved by VA.

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 Milwaukee VAMC 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 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 two Certified Nuclear Medicine Technologists; registered in PET/CT preferred, 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 technologists shall consult with the VA Radiologist or Milwaukee VAMC Imaging Supervisor.

· Screen patients for potential contradictions to PET/CT imaging based on Milwaukee VAMC 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 trailer.

· Perform venipuncture, assess IV patency, and administer the radiopharmaceutical/contrast consistent with accepted procedures and protocols approved by Milwaukee VAMC.

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

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

· Perform initial assessment and identification of medical emergencies. If required, initiate the Milwaukee VAMC Rapid Response/Code 4 procedure for patients on the mobile trailer 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 Milwaukee VAMC Medical Imaging staff physicians. There should be no more than five returned studies per quarter for image quality.

· Re-perform unsatisfactory/un-diagnosable PET/CT examinations at the discretion of designated Milwaukee VAMC 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 Milwaukee VAMC, and who shall ensure that the Contractor performs services in accordance with contract specifications. The Contractor’s liaison shall contact the COR and the Milwaukee VAMC 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) Radioactive Materials (RAM) License, agreement state radioactive materials license or Reciprocity with the NRC. A copy of the Contractor’s RAM license shall be provided with the vendor’s quote and upon renewal. The contractor’s Radioactive Materials License must include the list of Milwaukee VAMC Authorized Users.

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. Administration of radioactive material by the Contractor’s technologists will be in accordance with Milwaukee VAMC Nuclear Medicine physician’s prescription and be provided on the Contractor’s property, which is the PET/CT trailer.

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

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 Performance Work Statement. Supervisory functions such as hiring, firing, directing, and counseling of contractor personnel are not performed by the Government. The healthcare providers who furnish services under this contract 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 providers 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 November 1, 2021 through October 31, 2026, and any options that are exercised at the discretion of the Government. The contractor shall perform no services after October 31st, 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. If the President declares any other day a federal holiday, the Milwaukee VAMC will determine if services are still required.

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 competent and proficient to insert IV needles for administration of radiopharmaceuticals and contrast material and when necessary. The Contractor must perform the required work in accordance with National Regulatory Commission (NRC) regulations, The Joint Commission standards and Milwaukee VAMC policies.

B. PET/CT Technologists shall also be BLS certified. Certifications must be obtained or issued by the American Heart Association (AHA) or an organization recognized by the AHA. 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 to perform Mobile PET/CT Services. The Contractor must perform the required work in accordance with the NRC regulations and Milwaukee VAMC policies.

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

G. Personnel assigned by the contractor 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.

SPECIAL NOTICE: COVID-19 & MASKING REQUIREMENTS

Due to the current pandemic, Contractor employees who enter VHA facilities shall comply with published CDC guidance for masking and physical distancing, and other guidance per the facility. Contractor employees may be screened for COVID-19, and if results are positive for COVID-19, they shall not be allowed to enter VHA facilities.

Contractor must ensure that all of its contract employees who work under this contract are fully vaccinated for COVID-19 by the first day of the period of performance, unless the employee is legally entitled to an accommodation.

Contractors must designate a person or persons to coordinate the implementation of and compliance with these workplace safety protocols to covered contractor workplace.

Designated person/persons: _________________________________________

5. CREDENTIALING

An application package will be provided by the Milwaukee VAMC Credentialing Coordinator and shall be completed by the providers working under this contract and returned within five business days 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, BLS and ACLS, competencies, statement that provider does not have any physical or mental health conditions that would adversely affect his/her ability to carry out assigned duties, and any additional credentialing and privileging forms.

Providers will also be required to complete an application through the VetPro Internet process within two weeks of being enrolled in VetPro. Providers will need to be enrolled in VetPro by VA personnel. The website address is: https://fcp.vetpro.org. Facility ID number is as follows: 695.

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, as key personnel on this contract, the PET/CT Technologists identified below.

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. Although 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.

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/immunizations/vaccinations

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) within five (5) business days of a request.

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 claimants 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 (COR) 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. PET/CT Technologists shall report to the Nuclear Medicine Department upon arrival at the VA Medical Center (Building 111), Room 10501.

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 will perform periodic spot checks and document with the using service to ensure records monitoring. VA will pay only for services actually 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 requirements of the contract have been fulfilled as agreed. This summary evaluation will be submitted 30 days prior to expiration of contract (and/or prior to election of option year renewals, if applicable).

C. Contractor's employee(s) may not certify bills for payment.

17. QUALITY ASSURANCE MONITORING

A. Contractor shall have in place and maintain a Quality Control Program related to the PET/CT services covered under this contract. The results of all Quality Improvement activities performed by the Contractor involving VA patients will be shared with VA facility staff and COR. This will include, but not be limited to, quality improvement plans, minutes of staff meetings where quality improvement has been discussed and which include practitioner-specific findings, conclusions, recommendations, written plans for actions taken in response to such conclusions and recommendations, and evaluation of those actions taken. Monitors should reflect at a minimum, issues related to quality care and appropriateness of referral.

B. Contractor shall perform services in accordance with the ethical, professional and technical standards of the…