SOW Prostate Brachytherapy seeds.docx

STATEMENT OF WORK

Prostate Brachytherapy utilizing permanently implanted radioactive seeds Brand Name Or Equal, Small Business Solicitation

Background

The VANJHCS East Orange NJ Radiation Oncology Service requires a vendor to supply radioactive seeds used in permanent implant prostate brachytherapy for the treatment of prostate cancer. Prostate low dose rate permanent seed brachytherapy is a procedure in which “sealed radioactive sources” are implanted directly into the prostate.

There are currently several acceptable implant techniques, but our process involves preloaded needles although we require loose seeds for assays.

VANJHCS Radiation Oncology currently orders approximately 50 to 110 seeds for each patient receiving treatment. The number of seeds needed for each patient varies depending on the size of the prostate being treated. While not routine, some patient orders may include an additional 10 seeds for quality assurance. Additional supplies include but are not limited to needles, seed spacers, and templates: all sterile. The radioactive seeds may be constructed with Iodine-125 or Palladium-103.

The VANJCHS Radiation Oncology Department performs approximately 4 Brachytherapy procedures per month and has been performing this procedure for nearly 3 years. As the program grows, it is expected the need will grow to 5 procedures per month.

Inherently, the seeds are only temporarily radioactive, therefore the seed activity will decay over time, making delivery time important. The selected vendor needs a minimum of 7 to 10 days lead time to process, manufacture, and deliver an order of radioactive seeds to our facility. Strict State and Federal rules apply to each phase; the ordering, confirmation of assay, delivery by United Parcel Service (UPS) (currently), acceptance testing, storage and disposal of radioactive isotope material. These rules and regulations are monitored and audited by the National Health Physics Program (NHPP) in accordance with the Nuclear Regulatory Commission (NRC) regulations.

A physician’s experience with and the dependability of the vendor supplying the sources is important in ensuring appropriate treatment for each patient. Vendors may advertise they can supply isotopes identified as Iodine-125 or Palladium-103, but each vendor may have variations in the construction of the “outer capsule” and how the “seeds” are stranded, often with material of differing composition. These factors may influence the ability of the physician to place seeds into a location dictated on the pre-plan, and the seeds ability to stay in that location resisting migration.

Vendors must provide their own assay of the radiation material as well as “3rd party assay”, custom services when requested, such as calibration of well chambers, return shipping containers and prepaid return shipping labels with instructions for material that is being returned. Customer service representatives must be knowledgeable and available during usual business hours at least 5 days per week with emergency phone access if needed. A personal representative salesman must be available to discuss individual needs of our facility.

In the event a brachytherapy procedure is cancelled (for medical reasons), the vendor must accept a return shipment of the ordered seeds and waive charges for that order.

Following a successful brachytherapy procedure, any unused isotope may be shipped back to the vendor for decay at their facility and final disposal at the appropriate time.

Objectives

Authorized User Radiation Oncologists require a vendor who can provide:

1) radiation material within a 7-day period from order to implant day

2) isotopes consistently provided in the format requested

3) isotopes packaged in an easy to understand manner

4) isotopes packaged to ensure the radiation safety of staff involved

5) isotopes guaranteed to be the activity that was ordered

6) the vendor seed must be listed on the NJ VA NHPP Permit to prevent delays in treatment

Period of Performance

July 1, 2020 – June 30, 2021 with 4 option years to follow

Place of Performance / Place of Delivery

VA Medical Center, 385 Tremont Ave, East Orange, NJ 07018

Scope or Tasks (for services) / Product Specifications (for supplies)

I 125 loose in a vial-price per seed I 125 preloaded needle with seeds and spacers sterile - price per seed I 125 preloaded needle Stranded seeds sterile - price per seed

Pd 103 Loose in a vial - price for seed Pd 103 preloaded needle with seeds and spacers sterile - price per seed Pd 103 preloaded needle Stranded seeds sterile - price per seed

Third party assay costs

Additional supplies

18 gauge sterile templates - price per unit Brachy balloon- price per unit Sterile Fixation needles-price per unit Return kit for unused seeds - price per unit : shipping containers : prepaid return shipping labels Calibration services for well chambers - price per service Shipping costs Credit for returns of unused seeds in cancelled patients For additional supplies we request the price for standalone orders and the price when ordered with seeds.

Technical requirements; Please provide this detailed information:

1) Price-details regarding what is included in price such as applicators; shipping costs; whether vendors will refund cost of seeds when patient cancels etc.

2) Past Performance: - other users within the VA, if applicable; turnaround time from order to delivery; processing invoices with Austin if applicable.

3) Technical Capability: -reliability of product.

4) Quality Assurance: -accuracy of seed strength; quality of catheters, applicators, strands.

5) Compliance with NHPP/NRC rules and regulations regarding ordering and delivery.