Attachment 2- STATEMENT OF WORK.pdf

STATEMENT OF WORK

RADIOPHARMACEUTICAL (ISOTOPES) SUPPLIES & SERVICES

I. STATEMENT OF OBJECTIVES

The Contractor will be required to provide radiopharmaceutical supplies and services to the

Tennessee Valley Health Care System (TVHS) on a daily basis, Monday through Friday, and on weekends and national holidays as needed for emergency procedures. Services will include, but are not limited to the following:

1. DELIVERY:

1.1 Authorized employees of TVHS will place orders on an as needed basis.

Individual radiopharmaceuticals will be provided in unit dose form and will be delivered at the request of TVHS.

1.2 Contractor will supply two (2) free daily deliveries during routine business hours defined as Monday-Friday 0800-04:00 pm (excluding holidays).

1.3 Contractor will supply two (2) phone numbers for ordering after working hours.

1.4 Orders shall be placed the afternoon before the required delivery date for exact quantities of each unit dose or quantity for bulk (vial) orders.

1.5 Emergency orders can be placed at any time with expected delivery within one

(1) hour of the order.

1.6 Deliveries during normal business hours will be to: Nuclear Medicine, Room A-

25, VA Tennessee Valley Healthcare System, 1310 24th Avenue South, Nashville, TN 37212, and 3400 Lebanon Pike, Murfreesboro, TN 37129. Delivery personnel will be bonded by the contractor.

1.7 Contractor will provide TVHS a copy of their current radioactive material permit or license for the authorized service of a radiopharmacy. The contractor will provide updated copies when permit or license has expired.

1.8 The contractor will provide, prepare and quality control (QC) Myoview or

Sestamibi kits for Myocardial Perfusion Imaging. Technetium will be provided by the contractor.

1.9 The contractor will ensue compliance with U.S. Nuclear Regulatory Commission

(US NRC) and U.S. Department of Transportation (DOT) regulations and requirements for the delivery and return of products to the designated Nuclear

Medicine Department.

1.9.a Radiopharmaceuticals and sealed sources will be delivered in

Department of Transportation (DOT) approved shipping containers.

1.9.b Contractor shall provide evidence of DOT training for individuals making deliveries.

1.10 As needed, the contractor will provide unit dose radiopharmaceuticals on weekends and holidays for emergency procedures. Radioactive shipments prepared in advance to anticipate emergency or routine studies are not acceptable. Deliveries outside of normal business hours will be to:

Nuclear Medicine, Room A-25, VA Tennessee Valley Healthcare System, 1310 24th

Avenue South, Nashville, TN 37212, and 3400 Lebanon Pike, Murfreesboro, TN 37129.

Federal Holidays:

• New Year’s Day

• Martin Luther King’s Birthday

• President’s Day

• Memorial Day

• Juneteenth Day

• Independence Day

• Labor Day

• Columbus Day

• Veterans Day

• Thanksgiving Day

• Christmas Day

2. QUALITY:

2.1 Contractor shall guarantee the quality of the radiopharmaceutical. Quality Control shall include pH testing, percent tag, alumina and 99Mo breakthrough as appropriate. Quality Control shall be performed on each agent dispensed. Complete documentation of QC results will be provided upon request. All radiopharmaceuticals shall be calibrated and labeled with concentration, time, total volume, and total activity. Consultation service regarding radiopharmaceutical applications, problems, controls, etc. shall be provided twenty-four hours per day, seven days per week, upon request and at no charge.

2.2 The contractor must be licensed and in good standing with the state board of pharmacy to operate a radio-pharmacy and possess a radioactive material permit/license issued by the US NRC or an agreement state for the receipt, preparation, and distribution of radiopharmaceuticals and sealed sources. Any notice of violation (NOV) issued against the contractor by licensing and/or regulatory agencies (state of Tennessee, US Nuclear Regulatory Commission (NRC), Department of Transportation (DOT), FDA, and all other agencies state or federal will be provided to the Tennessee Valley Healthcare System VAMC within 10 business days of the contractor’s receipt of the NOV.

2.3 Individual radiopharmaceuticals and unsealed materials used for Quality Control

(QC) and performing confirmatory shielding surveys will be provided in unit dose form. Delivered unit doses will be placed in the appropriate calibration device designed to reduce exposure from gamma emitting or beta emitting depending on primary ionizing radiation emitters of radiopharmaceutical.

3. WASTE REMOVAL:

3.1 Each workday, the contractor shall remove all radioactive waste generated by contractor (to include all syringes and vials) without cost. Safe transport of the waste is the responsibility of the contractor.

3.2 The Contractor shall provide evidence of special driver’s licenses (competency) due to transporting hazardous materials.

3.3 Contractor must adhere to OSHA guidelines regarding blood borne pathogens, DOT regulations, Board of Pharmacy regulations pertinent to radiopharmaceuticals, and

Nuclear Regulatory Commission (NRC) requirements regarding radioactive materials.

4. INVOICES:

4.1 The Nuclear Medicine Department shall be provided with copies of the invoices.

Invoices shall be paid to the contractor monthly, in arrears, upon submission of a properly prepared invoice for services/ supplies during the period. All invoices will include name of company name and address, point of contact, contract number, dates of services, purchase order number, invoice number, and an itemized listing of charges.

Invoices shall be sent to Austin, Texas for on-line certification.

5. COMPUTER SYSTEM:

5.1 The Contractor shall provide computer hardware and software for the management and disposal of inventory, patient dose records that is current and able to be backed up for record keeping and support. The Contractor will provide updates on computer systems as needed.

6. HARDWARE:

The Contractor will provide equipment as needed and deliver the equipment to the Nuclear

Medicine, Room A-25, VA Tennessee Valley Healthcare System, 1310 24th Avenue South, Nashville, TN 37212, and 3400 Lebanon Pike, Murfreesboro, TN 37129.

The VA Tennessee Valley Healthcare System VAMC will prepare the area to which the equipment is to be delivered.

Training on the equipment shall include a minimum of two (2) personnel.

The VA Tennessee Valley Healthcare System VAMC will use the equipment in a careful and proper manner and shall comply with the laws, ordinances, and regulations relating to the possession, use, or maintenance of the equipment. The equipment is intended to be used with the software package described in this section. The equipment shall be kept at the VA

Tennessee valley Healthcare System VAMC and will not be removed without contractor’s prior written consent. Upon receipt, the equipment will be inspected by the VA Tennessee valley

Healthcare System VAMC’s Engineering Service prior to use to assure it is in good working condition. The VA Tennessee valley Healthcare System VAMC shall not make any alterations, additions, or improvements to the equipment without prior written consent of Contractor. All additions or improvements of any kind made to the equipment shall belong to and become the property of the Contractor upon the expiration or earlier termination of the lease.

The contractor shall keep the equipment in good working order, and shall furnish all parts, mechanisms, and devices to keep the equipment in good mechanical working order. Should the equipment fail to operate at no fault to the VAMC, the contractor will repair and/or replace by close of business the next business day. In the event VA Tennessee Valley Healthcare System act or negligence causes damage to the equipment, the costs of repairing such damage will be the responsibility of the VA Tennessee Valley Healthcare System. The VA Tennessee Valley

Healthcare System assumes the risk of loss, theft, or destruction of, and damage to the equipment. Should one or more units of the equipment be totally and permanently lost, stolen, or damaged beyond repair as to preclude continued use for the purpose intended, VA

Tennessee valley Healthcare System shall replace the same.

Upon termination, for any reason, VA Tennessee Valley Healthcare System shall promptly return the software together with all its copies, modifications, and merged portions in any form to the contractor. The VA Tennessee Valley Healthcare System may not copy, reproduce, sublicense, assign or transfer this license or the software or remove any copyright or other proprietary notices form the licensed software. Any attempt to sublicense, assign, or transfer any of the rights, duties or obligations hereunder is expressly prohibited. The licensed software and all its intellectual property rights, including without limitation, patent, trademark, copyright and trade secret rights in the licensed software are and shall be the property solely of the contractor. The contractor does not warrant that the functions contained in the software will meet VA Tennessee valley Healthcare System requirements or that the operation of the software will be uninterrupted or error free. The contractor warrants the disk on which the software is furnished, to be free from defects in materials and workmanship under normal use for the period of ninety days from date of delivery to the VA Tennessee valley Healthcare System as evidenced by a copy of the receipt. The contractor makes no other warranties with regard to the software. The contractor expressly and specifically disclaims any warranty of merchantability or fitness for a particular purpose. The contractor entire liability and VA Tennessee valley Healthcare

Systems exclusive remedy shall be: (a) the replacement of any disk not meeting the contractor’s

“limited warranty” and which is returned to the contractor within 90 days of the date of delivery;

or (b) if the contractor is unable to deliver a replacement disk which is free of defects in materials or workmanship. The VA Tennessee valley Healthcare System may terminate this agreement by returning the software to the contractor. In no event will the contractor be liable to the VA Tennessee Valley Healthcare System for any damages including and lost profits, lost savings, or other incidental or consequential damages arising out of the use, or inability to use such software or for any claim by any other party.

7. TERM OF CONTRACT

This contract is effective for the period October 1, 2025, thru September 30, 2030, with five (5) one-year (1) ordering periods for review. The option to extend for additional periods (if required) will be at the discretion of the Government. This contract is subject to the availability of VA funds.

II. DEFINITIONS

Terms used in this contract shall be interpreted as follows unless the context expressly requires a different construction and/or interpretation. In case of a conflict in language between the definitions and other sections of this contract, the language in this section shall govern.

A. Contracting Officer (CO) - The person executing this contract on behalf of the

Government with the authority to enter into and administer contracts and make related determinations and findings.

B. Contracting Officer’s Representative (COR) - A person appointed by the CO to take necessary action to ensure the contractor performs in accordance with and adheres to the specifications contained in the contract and to protect the interest of the Government. The COR shall report to the CO promptly any indication of non-compliance in order that appropriate action can be taken.

C. Veterans Health Administration (VHA) - The central office for administration of the VA medical centers throughout the United States. The VHA is located in Washington, DC.

D. Veterans Integrated Services Network (VISN) - The regional oversight for the VA Medical

Centers in Memphis, TN, Tennessee Valley Healthcare System (Murfreesboro and Nashville), Louisville, KY, Lexington, KY, Huntington, West Virginia and Mt. Home, TN. The VISN office is located at 1801 West End Avenue, Suite 1100, Nashville, TN 37203.

III. QUALITY REQUIREMENTS

Contractor shall guarantee the quality of the radiopharmaceutical. Quality Control (QC) shall include pH testing, percent tag, alumina and 99Mo breakthrough as appropriate. Quality Control shall be performed on each agent dispensed. Complete documentation of QC results will be provided upon request. All radiopharmaceuticals shall be calibrated and labeled with concentration, time, total volume, and total activity. Consultation service regarding radiopharmaceutical applications, problems, controls, etc. shall be provided upon request at no charge.

On an annual basis, the Contractor will provide documentation demonstrating compliance with state and regulatory requirements for a radiopharmacy to the Radiation Safety Officer.

IV. CREDENTIAL REVIEWS/PRIVILEGING

Not Applicable

V. KEY PERSONNEL

A. The Contractor will designate one person who can be contacted for any problems or issues that arise in the performance of this contract to the VA Tennessee Valley

Healthcare System with a phone number. The VA Tennessee Valley Healthcare System will also designate a contact person.

B. The contractor must identify key personnel proposed to provide the required services and their qualifications upon award of contract and on an annual basis thereafter. The contractor cannot change key personnel without VAMC approval.

VI. PATIENT RIGHTS AND SAFETY

A. The VA Tennessee Valley Healthcare System is not responsible or liable for any unsafe condition caused by the Contractor or Veteran.

B. The Contractor will have evidence of implementation of the Joint Commission

National Patient Safety Goals as applicable.

VII. CONTINUUM OF CARE

Individual radiopharmaceuticals will be provided in unit dose form and will be delivered at the request of the VA Tennessee Valley Healthcare System

VIII. ENVIRONMENT OF CARE

Each workday, the contractor shall remove all radioactive waste generated by contractor (to include all syringes and vials). Safe transport of the waste is the responsibility of the contractor.

Contractor must adhere to OSHA guidelines regarding blood borne pathogens, DOT regulations, Board of Pharmacy regulations pertinent to radiopharmaceuticals, and NRC requirements regarding radioactive materials.