36C24219Q1201-017.pdf

STATEMENT OF WORK

Prostate Brachytherapy utilizing permanently implanted radioactive seeds

Brand Name Or Equal, Small Business Solicitation

This solicitation is for ALL SMALL BUSINESSES

The VANJHCS East Orange NJ Radiation Oncology Service requires a vendor to supply radioactive seeds used in permanent low dose rate (LDR) 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 sterile preloaded needles.

VANJHCS Radiation Oncology currently orders approximately 30 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. Each patient order includes an additional 10 seeds in individual needles (1 seed per needle; 10 needles per order) for use as needed. Additional sterile supplies include but are not limited to needles, seed spacers, and templates. The radioactive seeds may be constructed with Iodine-125 or Palladium-103.

The VANJCHS Radiation Oncology Department performs approximately 20 prostate LDR brachytherapy procedures per year.

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; ordering, confirmation of assay, delivery by 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.

Authorized User Radiation Oncologists prefer a vendor who can provide:

1) radiation material within a 7-day period of time 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 consistently guaranteed to be the activity that was ordered

An ideal vendor will 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, 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.

Period of Performance:

The contract is planned for a base year, and four option years.

Item Descriptions:

Please quote prices for supplies/services, for each year, base and the four option years:

Base Year

Item Quantity Unit, Price

• I-125 Seeds Stranded Loaded in Needles per

Treatment Plan 1350 seeds each seed, $________

• Single I-125 seeds and spacers loaded in individual needles 150 seeds each seed, $________

• Pd-103 Seeds Stranded Loaded in Needles per

Treatment Plan, 240 seeds each seed, $________

• Single Pd-103 Seeds and spacers loaded in individual needles 30 seeds each seed, $________

TOTAL, BASE YEAR $______________

100% credit on all medical cancellations Standoff balloon, 2 stabilization needles and disposable template included with each case

Option Year 1

Item Quantity Unit, Price

• I-125 Seeds Stranded Loaded in Needles per

Treatment Plan 1350 seeds each seed, $________

• Single I-125 seeds and spacers loaded in individual needles 150 seeds each seed, $________

• Pd-103 Seeds Stranded Loaded in Needles per

Treatment Plan, 240 seeds each seed, $________

TOTAL, OPTION YEAR 1 $______________

Option Year 2

• I-125 Seeds Stranded Loaded in Needles per Treatment Plan 1350 seeds each seed, $________

• Single I-125 seeds and spacers loaded in individual needles 150 seeds each seed, $________

• Pd-103 Seeds Stranded Loaded in Needles per Treatment Plan, 240 seeds each seed, $________

TOTAL, OPTION YEAR 2 $______________

Option Year 3

• I-125 Seeds Stranded Loaded in Needles per Treatment Plan 1350 seeds each seed, $________

• Single I-125 seeds and spacers loaded in individual needles 150 seeds each seed, $________

• Pd-103 Seeds Stranded Loaded in Needles per Treatment Plan, 240 seeds each seed, $________

TOTAL, OPTION YEAR 3 $______________

Option Year 4

• I-125 Seeds Stranded Loaded in Needles per Treatment Plan 1350 seeds each seed, $________

• Single I-125 seeds and spacers loaded in individual needles 150 seeds each seed, $________

• Pd-103 Seeds Stranded Loaded in Needles per Treatment Plan, 240 seeds each seed, $________

TOTAL, OPTION YEAR 4 $______________

Technical requirements; Please provide this detailed information:

1) Price -Unit cost with 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, 3rd party assay and verification of needle loading.

5) Compliance with NHPP/NRC rules and regulations for ordering, 3rd party assay and delivery.

Award will be determined by meeting or exceeding technical requirements, and then by lowest price.