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FBO DAILY - FEDBIZOPPS ISSUE OF FEBRUARY 10, 2017 FBO #5558
DOCUMENT

65 -- 549-17-1-068-0005 Annual Radiopharmaceutical Contract - Attachment

Notice Date

2/8/2017
 

Notice Type

Attachment
 

NAICS

325412 — Pharmaceutical Preparation Manufacturing
 

Contracting Office

Department of Veterans Affairs;VISN17 Network Contracting Activity;7400 Merton Minter Blvd. (10N17/90C);San Antonio TX 78229
 

ZIP Code

78229
 

Solicitation Number

VA25717N0406
 

Response Due

2/15/2017
 

Archive Date

3/17/2017
 

Point of Contact

Susan A. Flores
 

Small Business Set-Aside

N/A
 

Description

This is a Request for Information (RFI) to conduct market research to determine the availability of vendors capable of providing the requirement listed below for the Department of Veterans Affairs (VA). This RFI does not guarantee the issuance of an RFQ. However, if an RFQ is issued, VA will follow the Contracting Order of Priority in accordance with Veterans Affairs Acquisition Regulation (VAAR) Part 819.7004. Based on responses to this RFI, if multiple SDVOSBs, VOSBs, HubZones, or other small businesses are determined to be capable of providing the full requirement, VA will issue a RFQ as a set-aside to the applicable socioeconomic category. If interested in responding to a future RFQ for this requirement, please provide a brief capabilities statement or unofficial pricing information. Requirement 1. Contractor must be licensed by the US Nuclear Regulatory Commission (USNRC), or a State with a formal Agreement with the USNRC that allows the State to regulate radioactive materials (Licensee), and be regularly established in the business of providing radiopharmaceuticals at the scale and frequency necessary to meet this requirement. A contractor may subcontract with a Licensee to provide Radiopharmaceuticals to the VA North Texas Health Care System (VANTHCS). The Radiopharmaceuticals must be shipped from the Licensee directly to VANTHCS. Please note that the Offeror must provide copies of all relevant licenses, certifications, and/or partnering agreement(s), along with their proposal to the Contracting Officer. 2. Contractor/licensee shall meet all applicable Nuclear Regulatory Commission, VA/National Health Physics Program (NHPP), Department of Transportation, FDA, Joint Commission, OSHA, State, and Federal requirements, rules, and/or regulations related to the supply of Radiopharmaceuticals. 3. Contractor/licensee must be able to provide general & therapeutic Nuclear Medicine radiopharmaceuticals to VANTHCS facilities: a) VA North Texas HCS (Dallas VA Medical Center) b) VA North Texas HCS (FW Outpatient Clinic) 4. In accordance with Presidential/White House request for preferential procurement made to the Veterans Health Administration (VHA), >90% of Technetium-99m unit doses will be derived from Non-High Enriched Uranium-235 (Non-HEU) sources, also known as Low Enriched Uranium-235 (LEU) sources. Pricing should include cost for both LEU and non-LEU derived Technetium-99m to account for those instances were product availability becomes limited. 5. Contractor/licensee shall label all unit doses of delivered radiopharmaceutical with the amount, preparation time, expiration time, date, etc. Contractor must supply each VANTHCS facility with a bar code reader or comparable VA approved device that is compatible with the VANTHCS Nuclear Medicine Information System (NMIS). 6. If the Contractor's/licensee s system varies 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 price to the Government. Any additional tracking system(s) provided must comply with all VA and associated IT, as well as information security, requirements. 7. An additional label shall be affixed to each syringe, vial, or other container used to hold a radioactive drug to be transferred for commercial distribution. 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. 8. All packages containing radioactive material must be labeled and shipped in accordance with Title 49, Code of Federal Regulations Part 172 and 173. 9. Contractor/licensee shall perform all quality control procedures as required by Federal, and when applicable, State regulatory agencies. Quality Control results will be furnished to VANTHCS upon request. 10. 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. 11. 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. 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. 12. 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 >30 minutes prior to the calibration time. 13. Contractor/licensee shall provide at least three (3) scheduled deliveries of radiopharmaceutical per day. Note that the VANTHCS 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, including emergency/STAT deliveries. STAT delivery times during routine business hours should not exceed 60 minutes from time the order is placed, and 90 minutes afterhours and holidays. All other add-on deliveries, including radiolabeled blood products, should not exceed 120 minutes. 14. Radiopharmaceutical Returns for Credit: The Contractor shall accept returns for full credit toward future orders under the following conditions: a. Product(s) ordered or shipped in error. b. Product(s) damaged in shipment c. Concealed shipping damages d. Recalled product(s) e. Outdated products in unopened, original container. Note: VANTHCS facilities are each allowed a minimum 10% radioisotope returns due to patient cancellation, no show, and/or rescheduling at no cost to the facility. Contractor shall invoice at least once per month showing period covered, billing date, name of preparation, quantity and amount, as well as the correct purchase order number. If volume-based tiered pricing is quoted, thresholds may be set at monthly or quarterly increments. 15. Normal/ Routine Ordering: Routine orders shall be placed by authorized VA personnel during normal business hours throughout the workday, and first delivery shall be received no later than 07:00 am the following workday via direct delivery to the VANTHCS Nuclear Medicine Service Radiopharmacy. After award, the Contractor/licensee will be furnished the name(s) of VA personnel that are authorized to place orders against the Contract. Orders shall only be placed by authorized VANTHCS NMS personnel via telephone, fax, e-mail, or via an approved, secure, online ordering system. 16. Normal/ Routine Deliveries: Depending upon changing Medical Center/Facility patient care requirements, the Contractor/licensee may be required to provide routine delivery and pick-up, multiple times throughout the day. Delivery orders shall include the following information: Contract item(s) and quantity, Time(s) of delivery, Applicable VA purchase order number. As noted above, Contractor/licensee agrees to accept unused radiopharmaceutical and provide reimbursement per unit dose applicable towards future orders. Contractor is responsible for on time delivery of radiopharmaceutical and will have back-up facilities/production options available to maintain greater than 99% on time delivery (per invoice cycle) or risk penalty that includes no charge doses that, at a minimum, equal the amount of missed doses and 10% discount for that invoice. 17. Contractor will provide VANTHCS NMS personnel access to relevant online and/or live Continuing Education opportunities at no cost to VANTHCS to ensure staff remain current in safe receipt and handling of radioactive materials/radiopharmaceuticals, as well as related regulatory requirements. 18. Same-Day Delivery/STAT Orders: Contractor/licensee will be available for and provide Emergency/STAT radiopharmaceuticals, 24/7/365, in accordance with the schedule of supplies, and with no associated delivery or STAT fees. STAT deliveries during normal business hours will occur within 60 minutes from time the order is placed, and 90 minutes afterhours and holidays. Same-Day Add-on Delivery of routine non-Emergent radiopharmaceutical can be received at VANTHCS facilities up to 90 minutes after the order is placed during normal business hours if approved by VANTHCS authorized personnel. Nuclear Medicine Service normal business hours are considered Monday through Friday: 7:00 am 4:30 pm, except Federal Holidays, and Saturdays from 7:00 am 11:00 am. The following are Federal Holidays: New Year s Day Birthday of Martin Luther King, Jr. (day of observance) Washington s Birthday Memorial Day Independence Day Labor Day Columbus Day Veteran s Day Thanksgiving Day Christmas Day (Any other day designated as a National Holiday by the President of the United States.) 19. Ordering Contact Information: Contractor/licensee shall provide contact information for the placement of orders for items listed in the Schedule of Supplies and Services Section. POC Name: Address: City/State/Zip Code: Ordering Phone Number: Ordering Fax Number: Ordering E-Mail Address: 20. DELIVERY COMMITMENT: Time of delivery specified or mutually agreed to at the time of receipt of telephone orders shall become mandatory upon the Contractor's/licensee s acceptance to commitment. Delivery of supplies by the scheduled time will be complete except as otherwise authorized by the Ordering Personnel. Failure to perform in accordance with the delivery commitment may be grounds for termination of contract in accordance with the provisions for default. The Government may terminate this contract in whole or in part if the contractor fails to meet the required delivery schedule. The contractor/licensee shall not be charged with damages when the delay in delivery arises out of causes beyond their control and without the fault or negligence of the contractor/licensee. DELIVERY LOCATION: Deliveries will be made to: VA North Texas HCS (Dallas) Attn: Nuclear Medicine Service (115) 3rd Floor, Room 3B-672E 4500 S. Lancaster Road Dallas, TX 75216 or VA North Texas HCS (Fort Worth) Attn: Nuclear Medicine Service (115) Ground Floor, Room 1N-234 2201 South East Loop 820 Fort Worth, TX 76119 Delivery location will be defined for each shipment by VANTHCS authorized personnel. Access to a VANTHCS radiopharmacy, during non-business hours, shall be obtained by contacting designated on-call personnel, or the VA Police Service. Delivery personnel must be escorted at all times within facility Controlled areas /Nuclear Medicine Service, as per TJC and NRC/regulatory requirements. Contractor/licensee will provide updated lists of delivery personnel who will sign in/sign out with VANTHCS/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 requisite. Upon request by VANTHCS/Radiation Safety Officer, the Contractor shall provide a copy/reports of contractor s/licensee s RSO Safety Audits of Federal Compliance. SCHEDULE OF SUPPLIES AND SERVICES The Department of Veterans Affairs North Texas Health Care System, Nuclear Medicine Service requires the contractor/licensee to provide radiopharmaceuticals, and any needed check/QC/etc. sources to be used with Radioassay, Radiopharmacy, Gamma Camera/SPECT & SPECT/CT imaging systems within VANTHCS. Items will be unit dose or bulk delivery, daily, and on an as needed basis, in accordance with patient requirements for the period of one Base Year with four Option Years that may be exercised at the Agency s discretion. Note: All annual quantities are estimates, contractor will only be paid for items and quantities actually ordered and delivered. Item # Vendor/Description/Part Number 12 Month Qty Est 1 Ga-67 Gallium Citrate UD 1-10 mCi/102279 20 2 I-123 Iobenguane Sulfate 1-30 mCi/102330 5 3 I-123 USP NaI 100 uCi Cap/102337 80 4 I-123 USP NaI 200 uCi Cap/102338 80 5 I-131 USP NaI Dx Cap mCi 1-30 mCi/102366 20 6 I-131 USP NaI Tx Cap 1-6 mCi/102372 15 7 I-131 USP NaI Tx Cap Each add l mCi/102372 1500 8 In-111 Autologous WBC Suspension/102410 60 9 In-111 Capromab Pendetide UD/102376 1 10 In-111 Pentetate SDV/Vial/102396 10 11 In-111 Pentetreotide UD/102400 20 12 Pentetate Vial/102653 20 13 Sincalide Solution (UD)/102765 20 14 99mTc Exametazime(Ceretec) UD/102940 5 15 99mTc Exametazime(Ceretec) WBC/103012 10 16 99mTc Filtered Sulfur Colloid (Melanoma Lympho) UD/10294 5 17 Tc-99m Macro Aggregated Albumin UD/102970 25 18 Tc-99m Mebrofenin UD/102974 5 19 Tc-99m Medronate UD/102977 10 20 Tc-99m Meriatide UD/102980 15 21 Tc-99m NaTc04 MD (Per mCi)/102983 50 22 Tc-99m NaTc04 UD mCi (Up to 30 mCi)/102984 20 23 Tc-99m Oxidronate UD/102986 30 24 Tc-99m Penetate UD /102990 15 25 Tc-99m Pyrophosphate UD/102991 25 26 Tc-99m Penetate (UD) (Aerosol)/102990 175 27 Tc-99m Sestamibi UD/102994 750 28 Tc-99m Sulfur Colloid UD/103003 10 29 Tc-99m Tetrofosmin UD/103006 5 30 Tl-201 Thallous Chloride/103039 20 31 Ultra Tag Kits (GI Bleed, MUGA, Liver Hemangioma) /103080 50 32 Tc-99m Non-HEU Exametazine UD/103648 3 33 Tc-99m Non-HEU Exametazime(Ceretec) WBC/103720 125 34 Tc-99m Non-HEU Filtered Sulfur Colloid/103651 30 35 Tc-99m Non-HEU MAA UD/103682 175 36 Tc-99m Non-HEU Mebrofenin UD/103685 75 37 Tc-99m Non-HEU Medronate UD/103685 35 38 Tc-99m Non-HEU Meriatide UD/103688 80 39 Tc-99m Non-HEU NaTc04 MD (Per mCi)/103691 500 40 Tc-99m Non-HEU Tc-99m NaTc04 UD mCi (Up to 30 mCi)/103692 100 41 Tc-99m Non-HEU Oxidronate UD/103694 375 42 Tc-99m Non-HEU Penetate/103698 125 43 Tc-99m Non-HEU Sestamibi/103701 3500 44 Tc-99m Non-HEU Sulfur Colloid UD/103711 100 45 I-131 USP NaI Dx UD Sol uCi/102371 3 46 In-111 WBC Blood Kit (Heparin)/102409 65 47 Tc-99m WBC Blood Kit (Heparin)/103011 135 48 Tc-99m Non-HEU NaTc04 UD uCi/103692 5 49 Sm-153 Lexidronam UD/102768 2 50 Tc-99m NaTc04 UD uCi/102982 35 51 In-111 Chloride Point Source/102379 2 52 After-Hours Call Out Charge 20 53 Sr-89 SrCl 1 54 Tc99m Succimer 1-6 mCi 1 55 Lymphoseek Tc-99m Tilmanocept 12 Please respond in the affirmative if you are able to provide the full requirement. This RFI is issued solely for information and planning purposes - it does not constitute a RFQ or a promise to issue a RFQ in the future. This request does not commit the Government to contract for any supply or service whatsoever. The VA is not, at this time, seeking quotes and will not accept unsolicited proposals. Responders are advised that the U.S. Government will not pay for any information or administrative costs incurred in response to this RFI; all costs associated with responding to this RFI will be solely at the interested vendor's expense. Not responding to this RFI does not preclude participation in any future RFQ, if any is issued. Any information submitted by respondents to this RFI is strictly voluntary. All submissions become Government property and will not be returned.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/VA/VASTHCS/VASTHCS/VA25717N0406/listing.html)
 

Document(s)

Attachment
 

File Name: VA257-17-N-0406 VA257-17-N-0406.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=3262724&FileName=VA257-17-N-0406-000.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=3262724&FileName=VA257-17-N-0406-000.docx

 

Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
 

Record

SN04395778-W 20170210/170208234600-288a0574bb6809541a57baf0a832f6cf (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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