P09-SOW VISN 9 Pluvicto.pdf

Statement of Work - PLUVICTO (lutetium Lu 177)

1.1. Scope

1.1.1. The VISN 9 VA Medical Center requires a Blanket Purchase Agreement (BPA) 5 ordering periods agreement for the manufacture and delivery of PLUVICTO (lutetium Lu 177 vipivotide tetraxetan) a radioactive therapy treatment agent indicated for prostate cancer treatment. This project will provide all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision, and other items necessary to perform the manufacture and delivery of PLUVICTO (lutetium Lu 177 vipivotide tetraxetan) as stated in this Statement of Work and specifications on a daily and/or as needed basis. The contractor shall perform as to meet or exceed NPS Standards and TIL Specifications in this agreement. Facility sites are listed below:

Robley Rex Veterans Affairs Medical Center Robley Rex Veterans Affairs Medical Center Nuclear Medicine Dept HOT LAB Nuclear Medicine Dept HOT LAB 800 Zorn Avenue 4906 Brownsboro Road Louisville, Kentucky 40206-1499 Louisville, KY 40222

James J. Quillen Veterans Affairs Medical Center Nuclear Medicine Dept Lamont Street & Veterans Way Johnson City, TN 37684

Tennessee Valley Healthcare System Nuclear Medicine Dept 1310 24th Avenue South Nashville, TN 3721

Alvin C. York Veterans Affairs Medical Center 3400 Lebanon Pike Murfreesboro, TN 37129

Troy Bowling Veterans Affairs Medical Center Nuclear Medicine Dept 1101 Veterans Drive Lexington, KY 40502

Lt. Col Luke Weathers Veterans Affairs Medical Center Nuclear Medicine Dept 1030 Jefferson Avenue Memphis, TN 38104

1.2. Estimated Workload

1.2.1. Delivery of PLUVICTO necessary for treatment of prostate Contractor/licensee shall have available an adequate supply of contracted products to meet the requirements of the VAMC facilities with proof of contingency supply chain to prevent disruption of clinical care. Doses will be ordered/scheduled with at least 72 hours advance notice to the vendor. Should the vendor’s ability to supply product from the applicable pharmacy be limited for any reason the vendor shall notify the Customer of any limitations on the delivery times and dates that may affect its ability to supply Product when requested.

VISN 9 VA Medical Center intends to purchase Pluvicto in quantities listed below:

NDC# Description Estimated quantities

UI

Ordering Period 1 69488-0010-61

PLUVICTO :: LUTETIUM LU 177

VIPIVOTIDE TETRA 27mCi/ML

261 EA

Ordering Period 2 69488-0010-61

PLUVICTO :: LUTETIUM LU 177

VIPIVOTIDE TETRA 27mCi/ML

279 EA

Ordering Period 3 69488-0010-61

PLUVICTO :: LUTETIUM LU 177

VIPIVOTIDE TETRA 27mCi/ML

298 EA

Ordering Period 4 69488-0010-61

PLUVICTO :: LUTETIUM LU 177

VIPIVOTIDE TETRA 27mCi/ML

317 EA

Ordering Period 5 69488-0010-61

PLUVICTO :: LUTETIUM LU 177

VIPIVOTIDE TETRA 27mCi/ML

331 EA

1.3. Requested Services

1.3.1. Deliveries. Routine daily deliveries and documentation shall be provided by the Contractor. The Contractor shall contact the Contracting Officer Representative (COR) or appropriate nuclear medicine representative with any order/delivery concerns.

1.3.2. Lead Shielding. Deliveries will incorporate sufficient lead or other high-density metal shielding to comply with all applicable federal and/or state standards and regulations relating to shipment of radioactive materials. Shipping containers must comply with all federal and state regulations. This will include Department of Transportation (DOT), Department of Energy (DOE), and Nuclear Regulatory Commission (NRC), and/or agreement state licensure. The level of non-fixed contamination on the external surfaces of each package must be in accordance with 49 CFR 173.443 and may not exceed the limits set forth in Table 9 of that standard.

1.3.3. Radioactive Waste. All used radioactive waste syringes and/or vials of acceptable radiotherapy will be retrieved by the Contractor within 72 hours. The contractor shall supply the “secure system” for the prevention of biohazard and radioactive contamination of reusable lead container.

1.3.4. Safety Data Sheets. The Contractor must provide current material safety data sheets (SDS) in a binder and updates as necessary on all delivered products.

1.3.5. Radiotherapy. Contractor/licensee will deliver Pluvicto therapy doses in an amount greater than or equal to the activity ordered with calibration for the specified appointment time so that patient administered quantity is within regulatory limits of the prescribed dose. All routine radiopharmaceutical dose deliveries must occur >30 minutes prior to the calibration time. If Nuclear Medicine Service is unable to perform a patient scan due to a PLUVICTO dose arriving in an unusable form (e.g., too low activity and below the recommended range for therapeutic treatments of prostate cancer).

1.3.5.1. Calibration time for each requested radiopharmaceutical will be specified with each order or will be spelled out in the requirements provided by the facilities Nuclear Medicine service.

1.3.5.2. All packages containing radioactive material must be labeled (Including with the international symbol for radiation hazard posted on opposing sides of each package) and shipped IAW Title 49, Code of Federal Regulations Part 172 and 173

1.3.5.3. All labels must include the international radiation symbol and the words "CAUTION, RADIOACTIVE MATERIAL" or "DANGER, RADIOACTIVE MATERIAL" and an identifier that ensures that the syringe, vial, or other container can be correlated with the information on the transport radiation shield label. Contractor/licensee shall label all unit doses of delivered radiopharmaceutical with the following details:

Amount of radiotherapy dose at calibration/preparation date and time radiotherapy dose expiration date and time radiotherapy dose volume Label must be affixed to each unit dose.

1.3.6. Contractor/supplier shall abide by Title 10, Code of Federal Regulation, which states: A Licensee may use for medical purposes only:

By-product material, Advanced Accelerator or cyclotron produced materials manufactured, labeled, packaged, and distributed in accordance with a license issued pursuant to the regulations in Title 10, Code of Federal Regulations, Part 35 and/or the equivalent regulations of an Agreement State.

1.3.7. Software. The Contractor must provide a barcode label that has been tested and found to be compatible with BIODOSE software to allow for scanning by a Barcode reader that transmits the exact dose into the electronic dose tracking software system used at the VAMC facilities. A letter confirming the contractor’s ability to consistently comply with this requirement must be submitted with the quote. If the Contractor's/licensee’s system varies or is incompatible with the VAMC system, the Contractor shall provide with their quote a detailed written explanation of their proposed means for electronic record compatibility and/or an alternative system with any needed data migration, technical support, and training for staff on its use at no additional cost to the Government. Any additional tracking system(s) provided must comply with all VA and associated IT, as well as information security, requirements [see above].

Any Contractor-provided system must be capable of adequately and securely linking the Contractor’s records of Nuclear Medicine Service operations with those used at the VISN 9 Facilities with 100% accuracy.

1.3.8. Instrument Calibrations. The Contractor must provide instrument calibration/testing for dose calibrators, wipe counters, and probe/well. Testing must document: Accuracy, Geometry, Linearity, and annual or as needed calibrations. Contractor shall submit with its proposal a sample of its calibration compliance documentation SOP with testing record.

1.3.9. Contractor will utilize only FDA approved products and sources for those products, unless otherwise mutually agreed upon in the context of compassionate care or IRB approved research. Pricing will be based upon a unit dose price per quantity of doses ordered with no other fees or surcharges.

1.4 Quality Control (QC)

1.4.1. The objective of QC is to ensure that the medication or radiopharmaceutical has passed all required testing to ensure that it is of the highest quality and has been determined to be safe for administration to patients before it is packaged and sent to the VAMC. The Contractor shall perform all QC’s IAW the manufacturer/governing body specifications, the approved QC instructions, and schedule.

1.4.2. QC Instructions. Using applicable manufacturer’s specifications, standard industry practices and this Scope of Work (SOW), the Contractor must test all products for Quality Control and only those products that pass quality control may be sent to the VAMC facilities. This testing shall be performed at no cost to the VA. The contractor shall provide a detailed description of their quality control and testing procedures, including all SOPs, demonstrating how every dose shall be tested and determined safe for patient administration with their proposal. The Record of dosage testing and results shall be included with each dose shipped to VAMC facilities.

1.4.2.1. In the event that a quality control or material defect is suspected and/or detected by the VISN 9 Facilities staff Nuclear Medicine Technologist or staff Nuclear Medicine Physician, or qualified personnel from the VISN 9 Facilities Radiation Safety Office, the Contracting Officer Representative (COR) for this contract will notify the Contractor and request the Contractor provide immediate consultation and all documentation necessary to address any product concern and/or product defect by taking the following actions:

Provide technical expertise in calibration.

Provide records of dosage testing and results.

Provide professional examination of the product; submit results and recommendations to the

Contracting Officer.

Make expedient replacement of any product suspected of being defective.

1.4.2.2 Deliveries for The VISN 9 Facilities shall be delivered in a lead or other high-density metal-shielded container that fully complies with all applicable international, federal and/or state standards and regulations relating to the safe shipment of radioactive materials. Shipping containers must comply with all federal and state regulations. This will include IAEA, Department of Transportation (DOT), Department of Energy (DOE), and Nuclear Regulatory Commission (NRC), and/or agreement state licensure. The level of non-fixed contamination on the external surfaces of each package must be in accordance with 49 CFR 173.443 and may not exceed the limits set forth in Table 9 of that standard.

1.5. Radiopharmacy Licensing

1.5.1. The Contractor shall hold a current unrevoked US Nuclear Regulatory Commission (NRC) and/or agreement state Radioactive Material License (RAM) and applicable Food and Drug Administration (FDA) license to produce and distribute radiotherapy for human administration, and applicable RAM license to receive, and dispose of radioactive waste. The Contractor shall ensure that the VAMC has a current (non-expired) copy of said license(s) and that said license is replaced with subsequent copies as licenses are renewed.

1.5.2. Contractor shall immediately notify the Contracting Officer and the Nuclear Medicine Service at the VAMC facilities, upon any action by the NRC and/or FDA to suspend or modify contractor’s license.

1.6. Radiopharmaceutical/Medication Evaluations

1.6.1. Pricing will be based upon a unit dose price per quantity of doses ordered with no other fees or surcharges, including delivery fees. In addition, the Contractor shall accept returns, issuing full credit toward future orders under the following conditions:

Product(s) ordered or shipped in error.

Product(s) damaged in shipment.

Concealed shipping damages Recalled product(s) Outdated products in unopened, original containers.

1.6.2. The Contractor shall provide a complete copy of each “Safety Audit of Federal Compliance” report (issued by the contractor’s Radiation Safety Officer (RSO)) to the VISN 9 Facilities Radiation Safety Officer on a Quarterly basis.

1.7. Authorizations for Access

1.7.1. The Contractor will provide updated lists of delivery personnel who will sign in/sign out or barcode in/barcode out with the VISN 9 Facilities Nuclear Medicine Service staff upon each delivery of radiotracer and follow all relevant policies and procedures in place at the VISN 9 Facilities Nuclear Medicine Service. Compliance with all applicable regulatory bodies, including FDA, NRC and US DOT is required.

1.7.2. Delivery personnel will deliver as needed to the designated Nuclear Medicine Dept HOT LAB within the VAMC facility ‘Controlled areas’/Nuclear Medicine Service, as per Joint Commission and NRC/regulatory requirements.

1.8. Deliverables and Acceptance Criteria

1.8.1. The Contractor shall provide competent service and capable staff, and otherwise do all things necessary for or incidental to the performance of all work under this contract, as set forth below:

1.8.1.2. All radiotherapy/treatment doses shall be delivered directly to the following address:

Robley Rex Veterans Affairs Medical Center Robley Rex Veterans Affairs Medical Center Nuclear Medicine Dept HOT LAB Nuclear Medicine Dept HOT LAB 800 Zorn Avenue 4906 Brownsboro Road Louisville, Kentucky 40206-1499 Louisville, KY 40222

James J. Quillen Veterans Affairs Medical Center Nuclear Medicine Dept Lamont Street & Veterans Way Johnson City, TN 37684

Tennessee Valley Healthcare System Nuclear Medicine Dept 1310 24th Avenue South Nashville, TN 37212

Alvin C. York Veterans Affairs Medical Center 3400 Lebanon Pike Murfreesboro, TN 37129

Troy Bowling Veterans Affairs Medical Center Nuclear Medicine Dept 1101 Veterans Drive Lexington, KY 40502

Lt. Col Luke Weathers Veterans Affairs Medical Center Nuclear Medicine Dept 116 N. Pauline Street Memphis, TN 38105

A Nuclear Medicine Technologist or appropriate VAMC badged member of its staff will be at the location to receive and sign for the materials which were ordered.

1.8.1.3. All orders shall be placed by authorized VA personnel during VA normal business hours throughout the workday. The Contractor will be furnished in writing the name(s) of VA personnel that are authorized to place orders against the Contract and shall likewise provide appropriate personnel and contact information for the Contractor staff who shall be receiving orders, staff able to offer technical or administrative support, as well as staff involved in radiopharmaceutical delivery, in accordance with VA Radiation Safety Office requirements. Orders shall only be placed by authorized VISN 9 Facilities Nuclear Medicine Service personnel via telephone, fax, e-mail, or via an approved, secure, online ordering system. For electronic ordering systems, a closed-loop communication process with confirmation e-mails is required.

1.8.1.4. VISN 9 Medical Center/Facility patient care requirements, the Contractor may be required to provide routine delivery, depending on specific treatment dose ordered for a date and time of treatment therapy.

For purposes of this contract, a “DAY” is defined as occurring between Monday through Friday, from 0630 hours to 1630 hours. These dates and hours exclude Federal Holidays, facility closures due to inclement weather and Federal Furlough Closure Days if applicable.

Delivery orders, or the Electronic Ordering System, shall include the following (without which an order cannot be considered valid):

Item(s) ordered with exact quantity.

Date and time(s) of requested and agreed-upon delivery.

VA unique purchase order (PO) number In the event of invalid order, the Contractor shall immediately contact the VAMC to provide notification of receipt of invalid order.

1.8.1.5 The Contractor shall ensure that all shipments have a Packing Slip enclosed which contains the required information about the product and its identification:

The current contract numbers.

The VISN 9 Facilities Purchase Order (PO) Number. (Incorrect P.O. numbers may cause a substantial delay in payments.)

The date and time of the order.

The Contractor’s invoice number.

A designated space for both parties to record and sign off on the date and time of delivery.

1.8.1.6. The Contractor must understand the limitations of the Nuclear Medicine Service (NMS) at the VISN 9 Facilities due to Radiation Safety. Deliveries must only contain unit dose orders placed by authorized VA personnel.

1.8.1.7. The Contractor/licensee shall have available an adequate supply of products to meet the requirements of the VISN 9 Facilities and provide proof of a viable deep contingency supply chain to prevent disruption of clinical care. It is mutually understood that the pharmaceuticals ordered by the VAMC are used in the treatment of patients with life threatening medical conditions. It is for this reason that the Contractor is expected to - without fail - fulfill every order as ordered at the agreed delivery date and time. Should the vendor’s ability to supply a product as ordered be limited for any reason the vendor shall notify the VAMC Point of Contact identified herein of said limitation as soon as the delay is known to the Contractor and prior to the lapse. The Contractor is expected to have exhausted all possible sources to procure the needed pharmaceutical. In the event of failure to fulfill any order the contractor shall provide to the VAMC detailed documentation as to all actions taken to procure the pharmaceuticals for which it accepted order via contingent supply chain and the result.

**It is mutually understood that by acceptance of this contract, the Contractor assumes responsibility to identify alternative sources IN ADVANCE an event in which local radiopharmacies are unable to provide routine delivery PLUVICTO radiotherapy dose. The Contractor shall provide The VISN 9 Facilities NMS its written PLUVICTO Procurement Contingency Plan which identifies other source locations (with points of contact and all company information) which can deliver doses with the least impact to patient care within 5 days of contract award and update this plan quarterly thereafter, or more frequently should something has contained in the plan change. **

1.9. Hours of Operation

1.9.1. Normal operating days and hours for this requirement are Monday through Friday, from 0630 hours to 1630 hours. These dates and hours exclude Federal Holidays, facility closures due to inclement weather and Furlough Days, as applicable.

GOVERNMENT HOLIDAYS:

New Year’s Day………………………………………… January 1 Martin Luther King’s Birthday…………………………. 3rd Monday in January President’s Day…………………………………………. 3rd Monday in February Memorial Day……………………………………………Last Monday in May Juneteenth………………………………………………...Jun 19th Independence Day………………………………………..July 4th Labor Day……………………………………………… 1st Monday in September Columbus Day……………………………………………2nd Monday in October Veteran’s Day……………………………………………November 11 Thanksgiving Day………………………………………. Last Thursday in November Christmas Day………………………………………........December 25

Any other day designated by the President as a national holiday. When one of the holidays falls on a Sunday, the following Monday will be observed as a legal holiday. When holiday falls on a Saturday, the preceding Friday is observed as a legal holiday by US Government agencies.

1.9.2 Although infrequent, emergency orders for this requirement include all hours and days outside of normal operating hours.

1.10. Contractor Personnel

1.10.1. The Contractor shall provide the name of its Contract Manager (CM) and all alternate(s) who shall act for the Contractor when the Contract Manager is absent. These individuals shall be designated in writing to the VAMC CO and COR within five (5) business days after contract award. The Contractor shall provide telephone numbers, and email addresses as well as mobile phone numbers of the CM and alternate(s) where these persons may be contacted at any time. The CM and any designated alternates shall have authority to provide necessary assets (i.e., information, personnel, or equipment, etc.) in order to respond to emergencies and contingencies. The CM or alternate shall have full authority to act for the Contractor on all matters relating to operation of this contract at the VAMC facilities. The CM or alternate shall be available to meet on the VISN 9 Facilities installation with VA personnel designated by the CO upon request within 5 business days to discuss and address this contract, performance and any concerns or problem areas. The Contractor shall provide a CM who can read, write, speak, and understand English fluently.

1.10.2. The Contractor and Contractor personnel shall be required to identify themselves as Contractor personnel by introducing themselves or being introduced as Contractor personnel and by visibly displaying a Contractor-issued badge with their name and title clearly displayed for all meetings with the VISN 9 Facilities personnel. For all scheduled meetings with the VAMC, the Contractor is required to have present a leader who is well familiar with this contract and its operations and who can commit the Contractor to mutually agreed upon actions to be taken pursuant to agreements reached during each meeting. The Contractor and Contractor personnel shall identify themselves as Contractor employees in telephone conversations and in formal and informal written and electronic correspondence with the

VAMC.

1.11. Listing of Contractor Employees

1.11.1. The Contractor shall provide an initial listing of all Contractor Employees’ who shall perform any work under this contract to include, name, position title and all contact information to the COR within five (5) business days of contract award. The Contractor shall also provide an updated listing of personnel cleared to perform work under this contract to the COR quarterly, at minimum, or more frequently when employees involved in the work of this contract are newly assigned, their status or position changes within five (5) business days of such change.

1.11.2. The Contractor shall not employ persons on this contract if the employee is identified to the Contractor as a potential threat to the health, safety, security and/or general well-being of the installation and its population. The Contractor shall be prohibited from employing off-duty government-employed contract department staff or CORs who are providing surveillance on any federal contract, subcontract or awarded to the Contractor. All contract personnel, depending on the condition, occasion or place or job assignment shall be required to present themselves in suitably professional attire. All Contractor personnel shall conduct themselves in a professional, courteous manner. The Contractor shall employ and maintain a technically trained and experienced work force capable of performing all services and functions under this contract, including accessing alternative sources in the event of shortage.

1.12. Environmental Protection & Safety

1.12.1. The Contractor shall be knowledgeable of and comply with all applicable federal, state and local laws, regulations, instructions and requirements regarding radiation safety, exposure or hazard response and abatement, environmental protection and occupational safety and health. The Contractor shall comply with all laws, regulatory requirements, directives, instructions, or regulatory changes during the term of this contract.

1.12.2. Radioactive Waste. The Contractor shall dispose of acceptable radioactive waste syringes and/or vials. The Contractor shall notify the RSO of any such radioactivity deemed ‘unacceptable for return’ within five (5) business days after the contract is awarded.

1.13. Privately Owned Motor Vehicles (POV)

1.13.1. Contractor personnel shall be notified of their duty to comply with the directives pertaining to the operation of POVs at all times while on the VISN 9 Facilities campus. The Contractor (in its entirety) shall comply with all regulations at the VISN 9 Facilities pertaining to the safe and legal operation of POVs while on the VISN 9 Facilities campus (NOTE: Requirements may differ from those on State roads and shall be posted). Vehicles on the property must be currently registered and display a license plate.

Insurance requirements are as per state law. The drivers must be authorized to operator that vehicle and are always personally responsible for its safe operation while on Federal property.

1.14. Health and Safety on Government Installations

1.14.1. While performing work under this contract while on the VISN 9 Facilities installation, the Contractor shall comply with federal, state and Installation regulations and the express instructions/directives of VISN 9 Facilities Occupational Safety officers. The Contractor shall notify the CO of damage to Government property or equipment during the execution of the contract. The Contractors employees shall only be allowed access to the installation for the performance of their duties under the contract and must immediately exit the installation upon completion of assigned duties. In the interest of security and safety, in the event of non-compliance with rules and safe operating requirements, the VAMC reserves the right to deny future access to the installation by any driver or passenger for any reason.

1.15. Emergency Procedures

1.1.1. The Contractor personnel shall follow the direction of the VISN 9 Facilities personnel regarding emergency procedures, i.e., fire, tornado, active shooter, bomb threats, etc. It is the responsibility of the Contractor to provide guidance and establish procedures for responding to an emergency for their employees. It is the Contractor’s responsibility to account for their employees in the event of emergency and following an emergency evacuation.

1.16. Contractor Billing/Invoicing

1.16.1. The Contractor shall follow all CO directives and guidelines for billing/invoicing through Tungsten and must include the current dates of order, delivery, and the PO for every itemized order.

Backup documentation of signed receipt of each individual delivery shall be maintained and submitted when required. The contractor shall provide billing/invoicing monthly, from the 1st of the month through the last day of the month. All billing/invoice statements must also include an itemized listing of all items delivered each day by calendar date. Invoices submitted after the last billing day (weekday) of the month without CO approval shall not be paid.

1.16.2. All billing/invoices must also be sent to the COR for approval on or before the last billing day (weekday) of the month.

1.17. Term of Contract

1.17.1. The period of performance will be:

Ordering Period 1:12/01/24 through 11/30/25 Ordering Period 2: 12/01/25 through 11/30/26 Ordering Period 3: 12/01/26 through 11/30/27 Ordering Period 4: 12/01/27 through 11/30/28 Ordering Period 5: 12/01/28 through 11/30/29

Contractor agrees to provide all needed PLUVICTO as identified, to the VAMC facilities, Nuclear Medicine department, on a daily and/or as needed basis per this SOW.

It is anticipated that a Buyer Purchase Agreement, multi award contract shall be made based on the best value to the Government. The VA intends to award a contract to a single contractor.