Attachment B- Scope of Work.pdf

Scope of Work

Section I – Description

1.1. Scope

1.1.1. VA North Texas Health Care System (VANTHCS) requires the manufacturing and delivery of Gallium (Ga68) DOTATATE for the diagnosis and treatment of patients with gatroenteropancreatic neuroendocrine tumors that are positive for the hormone receptor somatostatin.

1.2. Estimated Workload

1.2.1. Delivery of Gallium (Ga68) DOTATATE is necessary for the diagnostic PET/CT imaging of neurodendocrine positive lesions in patients with gastroenteropancreatic cancer. Contractor/licensee shall have available an adequate supply of contracted products to meet the requirements of the VANTHCS with proof of contingency supply chain to prevent disruption of clinical care. Routine dose requests will be ordered/scheduled with at least 48 hours advance notice to the vendor. Upon receiving Urgent requests, VANTHCS will call the vendor first to confirm dose availability < 48 hours prior to ordering. 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.

1.3. Delivery and Handling of Products

1.3.1. Deliveries. Routine and potentially add-on 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 for VANTHCS 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 radiopharmaceuticals will be transferred back to the Contractor. All such radioactive waste shall be returned (picked-up) by the next working day when feasible.

1.3.4. Material Safety Data Sheets. The Contractor must provide current material safety data sheets (MSDS) in a binder and updates as necessary on all delivered products or the contractor must provide their website link where MSDS and package inserts for all radiopharmaceuticals can be read and printed.

1.3.5. Radiopharmaceuticals. Contractor/licensee will deliver radioisotope 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 >10 minutes prior to the calibration time. In the event that Nuclear Medicine Service is unable to perform a patient scan due to a NETSPOT dose arriving in an unusable form (e.g. too low activity and below the recommended range for diagnostic imaging radiopharmaceuticals, typically 10% to 20%), the vendor will not invoice for the dose.

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 VANTHCS Nuclear Medicine service.

1.3.5.2 All packages containing radioactive material must be labeled and shipped IAW Title 49, Code of Federal Regulations Part 172 and 173.

1.3.5.3 The label must include the 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 radiopharmaceutical at calibration/preparation date and time

• Radiopharmaceutical expiration date and time

• Radiopharmaceutical 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:

(a) By-product material 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.

(b) Reagent kit that has been manufactured, labeled, packed and distributed in accordance with approval by the Commission pursuant to Title 10 CFR 32.72 or an Agreement State under equivalent regulations for the preparation of radiopharmaceuticals for medical use.

1.3.7. Software. The Contractor must provide compatible software to allow for scanning by a Barcode reader using existing “Nuclear Management Information System” software at VANTHCS. A letter confirming this requirement must be submitted with the quote. If the Contractor's/licensee’s system varies or is incompatible from the VANTHCS facility NMIS, the Contractor shall provide means for compatibility 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 provided system must adequately, and securely, link different sites of Nuclear Medicine Service operations.

1.3.8. Instrument Calibrations. The Contractor must provide instrument calibration/testing for dose calibrators, wipe counters, and probe/well. Testing must include Accuracy, Geometry, Linearity, and annual or as needed calibrations.

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. A tiered pricing structure with lower cost per increased quantity used is preferred.

1.4. Quality Control (QC)

1.4.1. The objective of QC is to ensure that the medication or radiopharmaceutical passes all required testing to ensure that it is a quality product and safe for patient use.

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 PWS, the Contractor must test all products for Quality Control and only those products that pass quality control may be sent to the VANTHCS.

This testing shall be performed at no cost to the VA. The contractor will provide a detailed description of the test upon request.

1.4.2.1. In the event that a quality control or material defect is suspected and/or detected by any VANTHCS staff Nuclear Medicine Technologist or staff Nuclear Medicine Physician, or qualified personnel from the VANTHCS Radiation Safety Office, the Contracting Officer Representative (COR) for this contract will notify the Contractor and request the Contractor to provide any consultation necessary to alleviate any said suspicion and/or defect by the following:

• Provide technical expertise in calibration.

• Provide professional examination of product; submit results and recommendations to the Contacting Officer.

• Make expedient replacement of any product suspected of being deficient.

1.4.2.2 Deliveries for VANTHCS- Dallas/ Fort Worth 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.

1.5. 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 radiopharmaceuticals for human administration, and applicable RAM license to receive, and dispose of radioactive waste.

1.5.2. Contractor shall immediately notify the Contracting Officer and the Nuclear Medicine Service at VANTHCS- Dallas/ Fort Worth, upon any action by the NRC and/or FDA to suspend or modify contractor.

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 for 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 container.

1.6.2. Upon request by VANTHCS/Radiation Safety Officer, the Contractor shall provide a copy/reports of contractor’s Radiation Safety Officer (RSO) Safety Audits of Federal Compliance.

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 VANTHCS- Dallas/ Fort Worth Nuclear Medicine Service staff upon each delivery of radiotracer and follow all relevant policies and procedures in place at VANTHCS facilities/Nuclear Medicine Service. Compliance with all applicable regulatory bodies, including FDA and TX/US DOT is required.

1.7.2. Delivery personnel must be escorted at all times within 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 services and staff, and otherwise do all things necessary for or incidental to the performance of work, as set forth below:

1.8.1.2. All PET isotopes will be delivered directly to the following address:

VA North Texas HCS (Dallas)

Nuclear Medicine Service (115) PET Imaging Center Building 2J, 3rd Floor, Room 3B-672E 4500 S. Lancaster Road Dallas, TX 75216

A Nuclear Medicine Technologist or appropriate staff will be at each location to receive the materials requested.

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 the name(s) of VA personnel that are authorized to place orders against the Contract and will provide appropriate personnel and contact information for staff receiving orders, 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 VANTHCS 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 such as confirmation e-mails is preferred.

1.8.1.4. Deliveries: Depending upon changing Medical Center/Facility patient care requirements, the Contractor may be required to provide routine delivery and pick-up, multiple times throughout the day Delivery orders, or the electronic ordering system, shall include the following:

• Contract item(s) and quantity

• Time(s) of delivery

• Applicable VA purchase order number must always be identified for current contract.

Note that the VANTCHS facility in Dallas provides both inpatient and outpatient care and is the tertiary VA Medical Center for the North Texas area. Additional radiopharmaceutical delivery may be required based upon clinical schedule and pending vendor dose availability, including emergency/STAT deliveries, at no additional cost.

1.8.1.5 The Contractor will ensure that all shipments will have a Packing Slip enclosed, giving information about the product and its identification, plus (for billing purposes) the VANTHCS Purchase Order Number issued for the current contract, and possibly the Contractor’s invoice number. (Incorrect P.O. numbers may cause a substantial delay in payments.)

1.8.1.6. The Contractor must understand the limitations of the Nuclear Medicine Service at VANTHCS due to Radiation Safety with regards to storage and making radioactive kits for multiple use: Deliveries must only contain unit dose orders placed by authorized VA personnel.

1.8.1.7. Contractor/licensee shall have available an adequate supply of contracted products to meet the requirements of the VA North Texas Healthcare System with proof of contingency supply chain to prevent disruption of clinical care. 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.

**In the event local radiopharmacies are unable to provide routine delivery of Ga68 DOTATATE (NETSPOT) radiopharmaceuticals, Contractor shall provide NMS a contingency plan for other locations to deliver doses with the least impact to patient care**

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.

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

1.10. Contractor Personnel

1.10.1. The Contractor shall provide the name of the Contract Manager (CM) and any alternate(s) who shall act for the Contractor when the manager is absent and they shall be designated in writing to the CO and COR within five (5) business days after contract award. The Contractor shall provide telephone numbers and email addresses 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 VANTHCS. The CM or alternate shall be available to meet on the VANTHCS installation with VA personnel designated by the CO to discuss 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 displaying distinguishing badges or other visible identification for meetings with VANTHCS personnel. The Contractor and Contractor personnel shall identify themselves as Contractor employees in telephone conversations and in formal and informal written correspondence.

1.11. Listing of Contractor Employees

1.11.1. The Contractor shall provide an initial listing of Contractor employees’ names and position titles to the COR within five (5) business days after contract award. The Contractor shall also provide an updated listing of personnel to the COR when employees affecting the work of this contract, status changes or position changes within five (5) business days.

1.11.2. The Contractor shall not employ persons on this contract if such 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 CORs who are providing surveillance on any contracts/subcontracts awarded to the Contractor. All contract personnel depending on particular condition, occasion or place or job assignment shall require professional, suitable 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.

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, environmental protection and occupational safety and health. The Contractor shall comply with any laws, instructions or regulation 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 COR 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 comply with the directives pertaining to operation of POVs on VANTHCS Motor Vehicle Traffic. The Contractor shall comply with VANTHCS (in its entirety) for the operation of POVs within VANTHCS.

1.14. Health and Safety on Government Installations

1.14.1. While performing work under this contract on VANTHCS installation, the Contractor shall comply with federal, state and local regulations and VANTHCS Occupational Safety Instructions. The Contractor shall notify the CO of damage to Government property or equipment during the execution of the contract.

1.15. Emergency Procedures

1.1.1. The Contractor personnel shall follow the direction of the VANTHCS personnel in regard to 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 following an emergency evacuation.

1.16. Contractor Billing/Invoicing

1.16.1. The Contractor shall follow all CO guidelines for billing/invoicing through Tungsten and must include current PO on all invoices. 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 per day.

1.16.2. All billing/invoices must also be sent to the COR for approval.

2. Schedule of Supply and Services** Contractor agrees to provide all needed Ga68 DOTATATE (NETSPOT) as identified, to the North Texas Veterans Health Care System (VANTHCS – Dallas/ Fort Worth), Nuclear Medicine department, on a daily and/or as needed basis per this PWS.

It is anticipated that a Firm-Fixed Price, single award contract shall be made based on the best value to the Government. The VA intends to award a contract to a single contractor.

Item # Vendor/Description/Part Number

12 month estimated

Qty

Ga68 DOTATATE (NETSPOT)

2 Delivery 150

3. Quality Assurance Surveillance Plan (QASP)

The Contractor shall be aware that in the absence of any contract requirement from the Service Summary (SS) does not detract from its enforceability nor limit the rights or remedies of the Government under any other provision of the contract. The Contractor shall ensure the following SS requirements are accomplished:

SS PERFORMANCE OBJECTIVE PWS

PARA.

PERFORMANCE

THRESHOLD

SS

Deliveries. Routine and add-on daily deliveries and documentation shall be provided by the Contractor. The Contractor shall contact the Contracting Officer Representative (COR) or nuclear medicine representative order/delivery concerns. The Contractor must provide and guarantee delivery times (with the exception for uncontrollable circumstances such as a natural disaster) for routine orders, same day routine orders, and same day add-ons before contract award and maintain those times throughout the entirety of the contract. Delivery times shall be > 30 minutes prior to radiopharmaceutical calibration.

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.

In the event local radiopharmacies are unable to provide routine delivery of F18 PYLARIFY radiopharmaceuticals, Contractor shall provide NMS a contingency plan for other locations to deliver doses with the least impact to patient care

1.2.1 1.3.1.

1.3.5 1.8.17

100% Compliance

SS

Lead Shielding. Deliveries for VANTHCS- Dallas/ Fort Worth 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.

1.3.2.

100% Compliance

SS

Radioactive Waste. All used radioactive waste syringes and/or vials of acceptable radiopharmaceuticals will be transferred back to the Contractor. All such radioactive waste shall be returned (picked-up) the next working day.

The contractor shall supply the “secure system” for the prevention of biohazard and radioactive contamination of reusable lead container.

1.3.3. 100% Compliance

SS

Material Safety Data Sheets. The Contractor must provide current material safety data sheets (MSDS) in a binder and updates as necessary on all delivered products or the contractor must provide their website link where MSDS and package inserts for all radiopharmaceuticals can be read and printed.

1.3.4.

100%

SS

Radiopharmaceuticals. The Contractor must deliver radioisotope 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. In the event that Nuclear Medicine Service is unable to perform a patient scan due to a PYLARIFY dose arriving in an unusable form (e.g. too low activity and below the recommended range for diagnostic imaging radiopharmaceuticals, typically 10% to 20%), the vendor will not invoice for the dose will not deviate more than +10% or -5% at the time of calibration, from the quantities specified.

Calibration time for each requested radiopharmaceutical will be specified with each order or will be spelled out in the requirements provided by the VANTHCS Nuclear Medicine service. The calibration date and time, expiration date and time, and amount of radiopharmaceutical at calibration time shall be indicated and affixed to each product

1.3.5 1.3.5.1 1.3.5.2 1.3.5.3

100% Compliance

SS

Software. The Contractor must provide compatible software to allow for scanning by a Barcode reader using existing “Nuclear Management Information System” software at

VANTHCS.

1.3.7. 100%

SS

Instrument Calibrations. The Contractor must provide instrument calibration/testing for dose calibrators, wipe counters, and probe/well.

Testing must include Accuracy, Geometry, Linearity, and annual or as needed calibrations.

1.3.8. 100% Compliance

SS

QC Instructions. Using applicable manufacturer’s specifications, standard industry practices and this PWS, the Contractor must test all products for Quality Control and only those products that pass quality control may be sent to the VANTHCS. This testing shall be performed at no cost to the VA. The contractor will provide a detailed description of the test upon request.

The Contractor must provide a copy of their laboratory’s current quality control manual and must be willing to discuss any discrepancies in lab results, which do not fit the clinical picture.

In the event that a quality control or material defect is suspected and/or detected by any VANTHCS staff Nuclear Medicine Technologist or staff Nuclear Medicine Physician, or qualified personnel from the VANTHCS Radiation Safety Office, the Contracting Officer Representative (COR) for this contract will notify the Contractor and request the Contractor to provide any consultation necessary to alleviate any said suspicion and/or defect by the following:

Provide technical expertise in calibration.

Provide professional examination of product;

submit results and recommendations to the Contacting Officer.

Make expedient replacement of any product suspected of being deficient.

1.4.1.

1.4.2.1.

1.4.2.2.

100% Compliance

SS

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 radiopharmaceuticals for human administration, and applicable RAM license to receive, and dispose of radioactive waste.

1.5.1. 100%