DOCUMENT
65 -- Ytttrium-90 Theraspheres - Attachment
- Notice Date
- 3/8/2016
- Notice Type
- Attachment
- NAICS
- 325412
— Pharmaceutical Preparation Manufacturing
- Contracting Office
- Department of Veterans Affairs;Ralph H. Johnson VA Medical Center;109 Bee Street;Charleston SC 29403-5799
- ZIP Code
- 29403-5799
- Solicitation Number
- VA24716N0398
- Response Due
- 3/16/2016
- Archive Date
- 6/23/2016
- Point of Contact
- Michael Giffon
- E-Mail Address
-
9-6682<br
- Small Business Set-Aside
- N/A
- Description
- This is a sources sought to determine the availability of potential sources having the capabilities to provide the SPECIFIED REQUIREMENT. All interested vendors are invited to provide information to contribute to this market survey/sources sought including commercial market information. THIS IS NOT A SOLICITATION ANNOUNCEMENT. This is a sources sought synopsis only. Questions should be submitted by email to michael.giffon@va.gov. Provide only the requested information below. The purpose of this synopsis is to gain knowledge of potential qualified sources and their size classifications (Service Disabled/Veteran Owned Small Business (SDVOSB/VOSB), Hub zone, 8(a), small, small disadvantaged, woman owned small business, FSS/GSA contract schedule holders or large business) relative to NAICS 325412, Pharmaceutical preparation manufacturing. Responses to this synopsis will be used by the Government to make appropriate acquisition decisions. After review of the responses to this sources sought synopsis, a solicitation announcement may be published on the FBO website. Responses to this sources sought synopsis are not considered adequate responses to the solicitation announcement. All interested offerors will have to respond to the solicitation announcement in addition to responding to this sources sought announcement. SPECIFIED REQUIREMENT: Network Contracting Office 7, Charleston, SC is seeking sources for a potential contractor to supply the following item: ITEM NO. DESCRIPTION QUANTITY UNIT 1.Y90 (THERASPHERES) See Statement Of work for full description 12Mo STATEMENT OF WORK From:Radiology (114) Subj:Yttrium-90 Theraspheres - Statement of Work To:Contract Specialist (NCO 7) Part I: General Information A. Introduction The Ralph H. Johnson VA Medical Center (RHJVAMC) located 109 Bee Street, Charleston, SC 29401-5799 has a requirement for radiopharmaceuticals, specifically Yttrium-90 microspheres, for the Interventional Radiology Department's treatment of primary liver cancer. B. Background Yttrium 90 microsphere (Y-90) treatment of primary hepatocellular carcinoma (HCC) is now the standard of care for select patients with HCC. However, for many patients with HCC the best and only hope for survival rests with Yttrium-90 microspheres, known as Theraspheres. Each dose is calibrated to be patient specific and is intended to prolong the patient's life while awaiting liver transplant. RHJVAMC wishes to establish an indefinite delivery, indefinite quantity (IDIQ) type contract in order to achieve ordering efficiencies and pre-established pricing. C. Scope Contractor shall provide all single unit doses of Yttrium-90 microspheres for the treatment of HCC used by the Interventional Radiology Clinic, RHJVAMC in Charleston, SC. This request is for an IDIQ contract with a base year plus four option years. D. Applicable Documents 10 Code of Federal Regulations Part 35: United States Nuclear Regulatory Commission- Medical Use of Byproduct Material 49 Code of Federal Regulations Part 173 Subpart I: Class 7 (Radioactive) Materials Department of Veteran Affairs Materials Permit: Reference # 030-01212 Amendment # 61 Part II: Requirements E. Ordering Requirements 1. The Contractor shall provide personnel for orders for Yttrium-90 microspheres to be placed by VAMC employees during standard hours of care Monday through Friday from 0730 (7:30 AM EST) until 1600 hours (4:00 PM EST), not including Federal holidays. Upon the order being placed, the Contractor is to send confirmation to the ordering VAMC official and the Contracting Officer's Representative (COR) via email. Information to be included in the confirmation email must include, at a minimum, the following information: - Order date & time - Name of Staff Radiology Technologist who placed order - Dosage information - Delivery date - Planned treatment date 2. The Contractor shall receive orders for Yttrium-90 microspheres from Staff Radiology or Nuclear Medicine Staff at the RHJVAMC. The Contractor shall ensure the name and contact information for the person placing the order are included with the Contractor's internal order processing system so that the Contractor can immediately verify who placed the order at the VA's request. 3. The Contractor shall calibrate all Radiopharmaceutical doses to ensure proper activity ranges of +/- 10 percent of the specified ordered dose per specific requirements provided by the Interventional Radiology Clinic based on guidelines outlined in 10 CFR Part 35. 4. The Contractor shall notify the RHJVAMC Interventional Radiology Clinic and Nuclear Medicine Department immediately should the inability arise to provide radiopharmaceutical (Yttrium-90) doses by the required date and time. Notification shall be made within two (2) hours of the Contractor becoming aware of the inability to provide the required doses. F. Delivery Requirements 1. The Contractor shall deliver ordered radiopharmaceutical doses to: Department of Veterans Affairs Ralph H. Johnson VA Medical Center Nuclear Medicine Department 109 Bee Street Charleston, SC 29401-5799 2. The Contractor shall ensure all orders are to be delivered prior to the administration date specified on the order form. 3. The Contractor shall provide a packing slip accompanying all Radiopharmaceutical shipments to the Interventional Radiology Clinic for all orders placed. The packing slip should include, at a minimum, the following information: - Order date & time - Name of Staff Radiology Technologist who placed order - Dosage information - Planned treatment date 4. The Contractor shall ensure that all radiopharmaceutical doses provided are compounded and calibrated by or under the supervision of a certified Nuclear Pharmacist Contractor who will calibrate doses based on a Sunday, noon EST baseline. 5. The Contractor shall provide courier service licensed to transport radioactive material in accordance with Department of Transportation, Nuclear Regulatory Commission and other applicable regulating authorities enabling the delivery of all Yttrium-90 microspheres. G. Additional Requirements 1. The Contractor shall provide any training or education required to meet commercial standards related to use of the radiopharmaceutical (Yttrium-90) to qualified Interventional Radiology and Nuclear Medicine staff stationed at the Ralph H. Johnson VAMC. 2. The Contractor shall obtain, maintain, and provide evidence of at the request of the Government, U.S. Food & Drug Administration (FDA) approval of the Yttrium-90 microspheres prior to shipment. 3. The Contractor agrees to credit the Ralph H. Johnson VAMC within 30 business days for any Y-90 dose not administered for medical reasons. 4. The Contractor stipulates that multiple dose administrations to a single patient on a single day constitute (for pricing) a single dose administration. H. Government Responsibilities 1.The Government shall ensure all orders for Yttrium-90 microsphere doses be placed by the RHJVAMC to the Contractor in accordance with currently accepted Contractor guidelines: a.Standard dose vial sizes (3, 5, 7, 15 and 20 GBq) can be ordered from inventory for next-day shipping b.Customer dose vial sizes will be placed by the end of business on Tuesday prior to Sunday calibration. 2.The Government shall notify Contractor in writing within 30 days in any event where an ordered dose of radiopharmaceutical was not administered for medical reasons. Part III: Supporting Information I. Place of Performance: The place of performance will be the Ralph H. Johnson VA Medical Center located at109 Bee Street, Charleston, SC 29401 J. Period of Performance: Period of performance is from May 1, 2016 through April 30, 2017, with four (4) one year option periods to be exercised at the discretion of the Government in accordance with FAR 52.217-9. K. Hours of Work: Normal business hours for the Interventional Radiology Department at the Ralph H. Johnson VAMC are 7:30 a.m. to 4:00 p.m., Monday through Friday. L. Supplies or Services and Prices/Cost: Contractor shall provide unit dose Yttrium-90 microspheres used by the Interventional Radiology Service. Base Year: 1 April 2016 through 31 March 2017 Est.Est. UnitEstimated Unit Dose ProductsQuantityUnitPriceTotal Price 1YTTRIUM-90 THERASPHERES 3 GBq-20GBq36EA Option Year 1: 1 April 2017 through 31 March 2018 Est.Est. UnitEstimated Unit Dose ProductsQuantityUnitPriceTotal Price 1YTTRIUM-90 THERASPHERES 3 GBq-20GBq36EA Option Year 2: 1 April 2018 through 31 March 2019 Est.Est. UnitEstimated Unit Dose ProductsQuantityUnitPriceTotal Price 1YTTRIUM-90 THERASPHERES 3 GBq-20GBq36EA Option Year 3: 1 April 2019 through 31 March 2020 Est.Est. UnitEstimated Unit Dose ProductsQuantityUnitPriceTotal Price 1YTTRIUM-90 THERASPHERES 3 GBq-20GBq36EA Option Year 4: 1 April 2020 through 31 March 2021 Est.Est. UnitEstimated Unit Dose ProductsQuantityUnitPriceTotal Price 1YTTRIUM-90 THERASPHERES 3 GBq-20GBq36EA Total Base and Option Years 1-4: Contracting Office Address: Department of Veterans Affairs;Ralph H. Johnson VA Medical Center;109 Bee Street;Charleston SC 29403-5799 Point of Contact(s): Michael Giffon michael.giffon@va.gov 843-789-6682 Michael.Giffon@va.gov REQUESTED INFORMATION: (1) STATEMENT OF CABABILITY: Submit a brief description that demonstrates how your company has the ability to provide the afore mentioned item. Include past experience in providing this items to the VA, other Government (Federal or State) agency, or for a private facility. (2) 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 certified 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 https://www.sam.gov/portal/public/SAM/ and/or the VetBiz Registry at http://vip.vetbiz.gov/. If not, please (i) NOTE that any future solicitation could only be awarded to a contractor who is registered in SAM and to receive award based on VOSB or SDVOSB status you must be registered in the VetBiz Registry. Responses must be emailed to michael.giffon@va.gov no later than 3:00pm EST, Wednesday, March 16, 2016. Your response should include both the STATEMENT OF CABABILITY and BUSINESS SIZE AND SOCIO-ECONOMIC STATUS information as explained above. Please place "Attention: Y-90 Theraspheres" in the subject line of your email. This notice is to assist the VA in determining sources only. A SOLICITATION IS NOT CURRENTLY AVAILABLE. If a solicitation is issued it will be announced at a later date, and all interested parties must respond to that solicitation announcement separately from the responses to this announcement.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/VA/ChaVAMC/VAMCCO80220/VA24716N0398/listing.html)
- Document(s)
- Attachment
- File Name: VA247-16-N-0398 VA247-16-N-0398.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=2604544&FileName=VA247-16-N-0398-000.docx)
- Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=2604544&FileName=VA247-16-N-0398-000.docx
- Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
- File Name: VA247-16-N-0398 VA247-16-N-0398.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=2604544&FileName=VA247-16-N-0398-000.docx)
- Record
- SN04042987-W 20160310/160308234903-133763fdf6c4f0e80f6c8f6fcc1523ea (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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