SPECIAL NOTICE
65 -- Progenics Pylarify PSMA F18 Radiopharmaceutical, Base 4 Option Years
- Notice Date
- 8/6/2024 8:56:02 AM
- Notice Type
- Special Notice
- NAICS
- 334510
— Electromedical and Electrotherapeutic Apparatus Manufacturing
- Contracting Office
- 249-NETWORK CONTRACT OFFICE 9 (36C249) MURFREESBORO TN 37129 USA
- ZIP Code
- 37129
- Solicitation Number
- 36C24925Q0009
- Response Due
- 8/9/2024 8:00:00 AM
- Archive Date
- 10/08/2024
- Point of Contact
- Delaney Dickey, Contracting Specialist, Phone: 615-002-8150
- E-Mail Address
-
delaney.dickey@va.gov
(delaney.dickey@va.gov)
- Awardee
- null
- Description
- The Department of Veterans Affairs, Louisville VA Medical Center (VAMC) and Network Contracting Office (NCO) 09 intends to issue and award a Sole Source Base + 4 Option Year single award Firm-Fixed Price type contract to LANTHEUS INC. LATHENUS INC. is the OEM for the requested PYLARIFY (piflufolastat F 18) Injections and has the requested product on FSS Contract #36F79719D0170. This VAMC is located at 800 Zorn Avenue, Louisville, KY 40206. It has been determined that through initial Market Research that LANTHEUS INC. can provide the supplies required at the level of quality required because the supplies are unique or highly specialized; (FAR 8.405-6(a)(1)(i)(B)). The NAICS code is 334510 and has a size standard of 1,300 employees for this procurement. Model / Part Number Item /Description of Supplies/Equipment Qty 71258-022-01 F18 Pifluflostat (PYLARIFY), a radioactive diagnostic agent indicated for Positron Emission Tomography (PET) 115 EA Period of Performance: BASE: 10/01/2024 to 09/30/2025 OPTION YEAR 1: 10/01/2025 to 09/30/2026 OPTION YEAR 2: 10/01/2026 to 09/30/2027 OPTION YEAR 3: 10/01/2027 to 09/30/2028 OPTION YEAR 4: 10/01/2028 to 09/30/2029 Statement of Work: 1.1. Scope 1.1.1. The Robley Rex VAMC requires the manufacture and delivery of F18 Pifluflostat (PYLARIFY), a radioactive diagnostic agent indicated for Positron Emission Tomography (PET) imaging of prostate-specific membrane antigen (PSMA) positive lesions in male patients with prostate cancer. PYLARIFY is indicated for patients with suspected metastasis who are candidates for initial therapy and patients with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level. Contractor agrees to provide all needed F18 Pifluflostat (PYLARIFY) as identified, to the Robley Rex VAMC, Nuclear Medicine department, on a daily and/or as needed basis per this Statement of Work (SOW). 1.2. Estimated Workload 1.2.1. Delivery of F18 Pifluflostat (PYLARIFY), necessary for the diagnostic PET/CT imaging of prostate-specific membrane antigen (PSMA) positive lesions in male patients with prostate cancer. Contractor/licensee shall have available an adequate supply of contracted products to meet the requirements of the Robley Rex VAMC with proof of contingency supply chain to prevent disruption of clinical care. Contractor shall supply written contingency plan with points of contract on an annual basis. Doses will be ordered/scheduled with at least 24 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. 1.3. Requested Services 1.3.1. Deliveries. Routine and on demand 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 Robley Rex VAMC 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 after acceptable decay. All such radioactive waste shall be returned (picked-up) after decayed. 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. 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 >60 minutes prior to the calibration time. In the event that Nuclear Medicine Service (NMS) 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. If it is found outside of the acceptable limits the contractor shall be notified and shall not bill. 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 Robley Rex VAMC 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 hazard 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 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 Robley Rex VAMC. 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 Robley Rex VAMC 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 SOW, the Contractor must test all products for Quality Control and only those products that pass quality control may be sent to the Robley Rex VAMC. 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 Robley Rex VAMC. 1.4.2.1. In the event that a quality control or material defect is suspected and/or detected by the Robley Rex VAMC staff Nuclear Medicine Technologist or staff Nuclear Medicine Physician, or qualified personnel from the Robley Rex VAMC 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 product; submit results and recommendations to the Contacting Officer. Make expedient replacement of any product suspected of being defective. 1.4.2.2 Deliveries for The Robley Rex VAMC 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 radiopharmaceuticals 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 Robley Rex VAMC, upon any action by the NRC and/or FDA to suspend or modify contractor s license. THIS IS NOT A REQUEST FOR COMPETITIVE QUOTES/PROPOSALS AND NO SOLICIATION IS AVAILABLE. Telephone requests will not be honored. No award will be made based on quotes or offers received in response to this notice. All responsible sources may identify their interest to meet this requirement to Delaney Dickey by 10:00 am (CST), Wednesday, August 9, 2024. Additionally, any response to this notice must show clear, compelling, and convincing evidence that competition will be advantageous to the government by providing the following: 1.Business Size and Socio-Economic Status: (a) Indicate whether your business is large or small (b) If small, indicate if your firm qualifies as a small, emerging business, or small disadvantaged business (c) If disadvantaged, specify under which disadvantaged group and if your firm is certified under Section 8(a) of the Small Business Act (d) Indicate if your firm is a certified Hub zone firm (e) Indicate if your firm is a woman-owned or operated business (f) Indicate if your firm is a VIP verified Service-Disabled Veteran Owned Small Business (SDVOSB) or Veteran Owned Small Business (VOSB) (g) Include the DUNS number of your firm. (h) State whether your firm is registered with the System for Award Management (SAM) at www.sam.gov and/or the VetBiz Registry at www.vetbiz.gov. If not, please NOTE: any future solicitation could only be awarded to a contractor who is registered in SAM. To receive award based on VOSB or SDVOSB status you must be registered in the VetBiz Registry. 2. Authorization to Perform: Prospective non-OEM contractors MUST provide an authorization letter from LANTHEUS INC. identifying they are authorized to provide the required Original Equipment Manufacturer (OEM) parts/equipment. The intent of this notice is for informational purposes only. Interested parties may submit information for consideration by the government to: delaney.dickey@va.gov no later than the response due date/time identified above.
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- SN07157768-F 20240808/240806230116 (samdaily.us)
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