6505--Radiopharmaceuticals - Nuclear Medicine

36C25226Q0243 Effective Date: 03/15/2023 Revision: 01 This is a combined synopsis/solicitation for commercial products or commercial services prepared in accordance with FAR Part 12. This announcement constitutes the only solicitation. Offers are being requested, and a separate written solicitation will not be issued. Solicitation number 36C25226Q0243 is issued as a request for quotation (RFQ) for the provision of unit dose radiopharmaceuticals for nuclear medicine procedures to support diagnostic imaging for veteran patient care. This acquisition is unrestricted. This solicitation incorporates provisions and clauses by reference. The full text of provisions and clauses may be accessed electronically at www.acquisition.gov. The associated North American Industrial Classification System (NAICS) code for this procurement is 325412 Pharmaceutical Preparation Manufacturing. Small Business Administration (SBA) small business size standard of 1,300 employees. The FSC/PSC is 6505 Drugs and Biologicals. The Department of Veterans Affairs, Network Contracting Office 12 (NCO 12), Veterans Integrated Services Network 12 (VISN 12), Clement J. Zablocki VA Medical Center, Imaging Service, Nuclear Medicine Section, located at 5000 W. National Avenue, Milwaukee, WI 53295-1000, requires the provision of unit dose radiopharmaceuticals for nuclear medicine procedures to support diagnostic imaging for veteran patient care. The Department of Veterans Affairs (VA) intends to award a firm-fixed-price contract with a base 12-month period of performance and four 12-month option years. The contractor shall provide routine weekday delivery and pickup of radiopharmaceuticals, ensure compliance with all applicable federal and state regulations (including USP 797 and Nuclear Regulatory Commission requirements), perform quality control testing at no cost to the Government, maintain all required licenses, and provide internet-based ordering capabilities. Additional requirements include proper disposal of radiopharmaceuticals using OSHA-compliant containers, replacement of expired or incorrect items at no charge, and same-day delivery of critical items such as I-131 capsules. The contractor must also provide specialized services for labeled white blood cells, including inventory management of In111 Oxine, compliant transport containers, and spare blood draw kits. Interested contractors are invited to provide quotations for the following: Performance Work Statement (PWS) Background The Imaging Service, Nuclear Medicine Section at the Clement J. Zablocki VA Medical Center (herein referred to as VA) provides diagnostic imaging services to veteran patients. Nuclear medicine procedures require the use of unit dose radiopharmaceuticals to ensure accurate and timely diagnostic imaging. These radiopharmaceuticals must be prepared, labeled, and delivered in compliance with strict federal and state regulations to maintain patient safety and procedural integrity. Reliable delivery and support services are essential to meet clinical schedules and provide high-quality care to veterans. Scope The contractor shall provide unit dose radiopharmaceuticals and related services to support nuclear medicine procedures for diagnostic imaging of veteran patients. Services include delivery, labeling, quality control, disposal, and compliance with all applicable federal and state regulations. Period of Performance The VA intends to award a firm-fixed-price contract with a base 12-month period of performance and four 12-month option years. Requirements Contractor must provide up to five daily routine deliveries and/or pick-ups at no charge to the VA. a. Routine daytime (Monday Friday, not including holidays) deliveries: 5:30 a.m. 4:00 p.m. i. The contractor will deliver to Bldg. 111, Room 10528. ii. The contractor s radio pharmacist must be available on-site at the contractor s facility to take orders up to 4:00 p.m., unless otherwise agreed to by the VA. iii. For doses and non-radioactive items ordered prior to the day of calibration, delivery should be a minimum of one hour prior to calibration time or stated time of use. iv. The VA may request delivery as soon as possible. If this results in delivery of less than one hour from the time of the order, this does not imply a request for stat delivery and will not result in stat charges by the contractor. Contractor must replace any items delivered in error at no cost to the VA. Contractor must label all products delivered as to the unit and activity of radiopharmaceutical, time of preparation, expiration time and date, and name of person(s) drawing the unit dose. Contractor must comply with USP 797 guidelines. Contractor must meet all Nuclear Regulatory Commission (NRC), Department of Transportation (DOT), Food and Drug Administration (FDA), and all other Federal and State agency rules and regulations. Contractor must perform all quality control procedures as required by Federal and State regulatory agencies. Items must be adequately packaged to prevent damage during handling and storage. All packaging and labeling must meet all federal and state regulations. Contractor must provide the VA, when requested, all specification testing on each package. Before contract award, contractor must provide a copy of their laboratory s current quality control manual to the VA. Contractor must test all products for quality control. This testing must be performed at no cost to the VA. The contractor must provide a detailed description of the test upon request. Contractor must assign an individual sales representative to aid in facilitating smooth coordination between the VA and the contractor s laboratory pharmacy. Contractor must pick up radiopharmaceuticals for proper disposal at no cost to the VA. The contractor must provide an Occupational Safety and Health Administration (OSHA)-compliant, puncture-resistant, leak-proof disposal container to safely transport used and unused doses back to the radiopharmacy for disposal. Contractor must replace, after written notice from the VA, any expired cold kits 10 days prior to their expiration date at no charge to the VA. Contractor must provide current material safety data sheets and updates on all delivered products upon request by the VA. Contractor must provide patient orientation education video presentations and other appropriate material at no cost to the VA. Any cost to replace damaged or incorrect products will be at the expense of the contractor. Replacements must be received as soon as possible after notification by the VA. Contractor must be licensed by the State of Wisconsin. Additionally, the contractor must be licensed by the NRC and be regularly established in the business of providing radionuclides. Offeror must provide copies of these licenses and certifications as part of the proposal. Contractor must provide the option to order, review, and revise unit doses via the internet. Contractor must provide certain critical radiopharmaceuticals with the following lead times for routine weekday delivery: I-131 capsules for therapy: Same-day delivery. The VA will alert the contractor of estimated quantity as soon as the procedure is known but will not order the dose until the exact dose has been determined, generally the day of the procedure. Requirements specific to labeled white blood cells (WBC): a. Contractor must provide labeling services for WBC doses for dates requested. This includes doses requested for near-future dates and for same day. b. Contractor must maintain sufficient inventory of In-111 Oxine to allow for same-day labeling requests. c. Contractor must provide process and transport container for the transport of VA-provided In-111 Oxine from the VA to the contractor s radiopharmacy. The transport container must meet or exceed all criteria for the shipment of limited quantities of radioactive materials as defined by the NRC. d. Contractor must provide spare blood draw kits to be maintained on-site at the VA to accommodate cases where the patient s blood needs to be drawn urgently to initiate the exam. In the absence of spare blood draw kits, the contractor must develop a process where the VA collects the blood sample and then transfers it to the contractor s blood transport system at the time of blood sample pick-up. Item Description Item # Description/Part Number* Estimated Qty 1 Tc99m DTPA for multiple indications (1 - 20 mCi) 4 2 Tc99m DTPA for multiple indications (20 - 40 mCi) 75 3 Tc99m ECD (aka Neurolite) (30 mCi) 1 4 Tc99m HMPAO (aka Ceretec) (30 mCi) 1 5 Tc99m MAA Standard Particles (5 mCi) 60 6 Tc99m MAA Reduced Particles (5 mCi) 10 7 Tc99m MAG3 (10 mCi) 25 8 Tc99m MDP (25 mCi) 250 9 Tc99m Mebrofenin or similar (5 mCi) 35 10 Tc99m PYP for Cardiac (25 mCi) 25 11 12 Tc99m Sestamibi for Cardiac (8 - 12 mCi rest; 24 - 35 mCi stress) 2 13 Tc99m Sestamibi for Parathyroid (30 mCi) 15 14 Tc99m NaTcO4 (1 - 30 mCi) 15 15 Tc99m NaTcO4 (30 mCi or more) (per mCi) 1000 16 Tc99m Sulfur Colloid for Gastric empty (2 mCi) 50 17 Tc99m Sulfur Colloid for Liver (6 mCi) 2 18 Tc99m Sulfur Colloid Ultra filtered for Lymphoscintigraphy (200 uCi to 1 mCi) 4 19 Tc99m Tetrofosmin for Cardiac (8 - 12 mCi rest; 24 - 35 mCi stress) 3050 20 21 I-123 Capsules (100 uCi) 75 22 I-123 Capsules (200 uCI) 1 23 I-123 Capsules (2 - 10 mCi) (per mCi) 1 24 I-131 Capsules (Thereputic ) (Part of therapeutic dose) (1 - 6 mCi) 6 25 I-131 Capsules (Therapeutic) (Part of therapeutic dose) (7 or more mCi) 300 26 I-131 Capsules (Diagnostic) (1 - 6 mCi) 10 27 In-111 DTPA 1 28 29 Xe-133 gas (20 mCi) 2 30 Tc99m Ceretec labeled leukocytes, including Ceretec (4 - 6 mCi) 1 32 In-111 labeled leukocyte (VA does not provide In-111 Oxine) (500 uCi) 55 33 DTPA Vial 1 34 MAA Vial 1 35 MDP Vial 1 36 Mebrofenin or similar Vial 1 37 Pyrophosphate Vial 1 38 Ultra Tag Kit 10 39 Deliveries during normal business hours 5 40 Emergency After-Hours Delivery 15 41 Pharmacist After-Hour Emergency Call-Back 15 42 Weekend White Blood Cell Labeling charge 1 43 Ioflupane I 123 25 (End Performance Work Statement) This solicitation incorporates one or more solicitation provisions by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identified and provide the appropriate information with its quotation or offer. The full text of FAR and VAAR provisions or clauses may be accessed electronically at: https://www.acquisition.gov/far-overhaul https://www.acquisition.gov/vaar The following solicitation provisions apply to this acquisition: FAR 52.212-1, Instructions to Offerors-Commercial Products and Commercial Services (SEP 2023) (DEVIATION OCT 2025) FAR 52.252-1, Solicitation Provisions Incorporated by Reference (FEB 1998) FAR 52.212-2, Evaluation-Commercial Products and Commercial Services (NOV 2021) (DEVIATION OCT 2025) FAR 52.203-11, Certification and Disclosure Regarding Payments to Influence Certain Federal Transactions (SEP 2024) FAR 52.203-18, Prohibition on Contracting with Entities that Require Certain Internal Confidentiality Agreements or Statements-Representation (JAN 2017) FAR 52.204-7, System for Award Management (NOV 2024)(DEVIATION NOV 2025) FAR 52.209-7, Information Regarding Responsibility Matters (OCT 2018) (DEVIATION NOV 2025) FAR 52.217-3, Evaluation Exclusive of Options (APR 1984) FAR 52.219-1, Small Business Program Representations (FEB 2024) (DEVIATION NOV 2025) FAR 52.225-6, Trade Agreements Certificate (FEB 2021) FAR 52.225-18, Place of Manufacture (AUG 2018) FAR 52.233-2, Service of Protest (SEP 2006) (DEVIATION NOV 2025) FAR 52.252-5, Authorized Deviations in Provisions (NOV 2020) VAAR 852.233-70, Protest Content/Alternative Dispute Resolution (OCT 2018) VAAR 852.233-71, Alternate Protest Procedure (OCT 2018) VAAR 852.252-70, Solicitation Provisions or Clauses Incorporated by Reference (JAN 2008) The Offeror shall have an active Federal Government contracts registration in the System for Award Management (SAM) when submitting an offer or quotation in response to this solicitation and at the time of award. To register in SAM, go to https://www.sam.gov. Allow for processing time when registering in SAM. If the Offeror is not registered in SAM, it should register immediately after receiving this solicitation. The following contract clauses apply to this acquisition: FAR 52.212-4, Contract Terms and Conditions-Commercial Products and Commercial Services (NOV 2023)(DEVIATION OCT 2025) FAR 52.252-2, Clauses Incorporated by Reference (FEB 1998) FAR 52.203-6, Restrictions on Subcontractor Sales to the Government ALT 1(NOV 2021) FAR 52.203-17, Contractor Employee Whistleblower Rights (Nov 2023) FAR 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (JAN 2017) FAR 52.204-13, System for Award Management Maintenance (OCT 2018)(DEVIATION NOV 2025) FAR 52.204-18, Commercial and Government Entity Code Maintenance (AUG 2020) FAR 52.209-6, Protecting the Government's Interest When Subcontracting with Contractors Debarred, Suspended, Proposed for Debarment, or Voluntarily Excluded (JAN 2025) (DEVIATION NOV 2025) FAR 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (OCT 2018) (DEVIATION NOV 2025) FAR 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (NOV 2015) (DEVIATION NOV 2025) FAR 52.217-7, Option for Increased Quantity-Separately Priced Line Item (MAR 1989) FAR 52.217-9, Option to Extend the Term of the Contract (MAR 2000) FAR 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (OCT 2022) (DEVIATION NOV 2025) FAR 52.219-8, Utilization of Small Business Concerns (JAN 2025) (DEVIATION NOV 2025) FAR 52.222-3, Convict Labor (JUN 2003) (DEVIATION NOV 2025) FAR 52.222-19, Child Labor-Cooperation with Authorities and Remedies (JAN 2025) (DEVIATION NOV 2025) FAR 52.222-35, Equal Opportunity for Veterans (JUN 2020) (DEVIATION NOV 2025) FAR 52.222-36, Equal Opportunity for Workers with Disabilities (JUN 2020) (DEVIATION NOV 2025) FAR 52.222-37, Employment Reports on Veterans (JUN 2020) (DEVIATION NOV 2025) FAR 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (DEC 2010)(DEVIATION NOV 2025) FAR 52.222-50, Combating Trafficking in Persons (NOV 2021) (DEVIATION NOV 2025) FAR 52.223-23, Sustainable Products (MAY 2024) (DEVIATION NOV 2025) FAR 52.224-1, Privacy Act Notification (APR 1984) FAR52.224-2, Privacy Act (APR 1984) FAR 52.225-5, Trade Agreements (NOV 2023) FAR 52.226-8, Encouraging Contractor Policies to Ban Text Messaging While Driving (May 2024) FAR 52.229-3, Federal, State, and Local Taxes (FEB 2013) (DEVIATION SEP 2025) FAR 52.232-33, Payment by Electronic Funds Transfer - System for Award Management (OCT 2018) FAR 52.232-40, Providing Accelerated Payments to Small Business Subcontractors (Mar 2023) FAR 52.233-3, Protest After Award (AUG 1996) (DEVIATION NOV 2025) FAR 52.233-4, Applicable Law for Breach of Contract Claim (OCT 2004) (DEVIATION NOV 2025) FAR 52.240-91, Security Prohibitions and Exclusions (DEVIATION NOV 2025) FAR 52.244-6, Subcontracts for Commercial Products and Commercial Services (JAN 2025)(DEVIATION OCT 2025) FAR 52.252-6, Authorized Deviations in Clauses (NOV 2020) VAAR 852.203-70, Commercial Advertising (MAY 2018) VAAR 852.208-70, Service-Disabled Veteran-Owned and Veteran-Owned Small Business Evaluation Factors Orders or BPAs (JAN 2023) (DEVIATION) VAAR 852.208-71, Service-Disabled Veteran-Owned and Veteran-Owned Small Business Evaluation Factor Commitments Orders and BPAs (JAN 2023) (DEVIATION) VAAR 852.211-72, Technical Industry Standards (NOV 2018) VAAR 852.222-71, Compliance with Executive Order 13899 (DEVIATION)(APR 2025) VAAR 852.223-71, Safety and Health (SEP 2019) VAAR 852.232-72, Electronic Submission of Payment Requests (NOV 2018) VAAR 852.237-74, Nondiscrimination in Service Delivery (OCT 2019) VAAR 852.242-71, Administrative Contracting Officer (OCT 2020) VAAR 852.246-71, Rejected Goods (OCT 2018) VAAR 852.247-71, Delivery Location (OCT 2018) VAAR 852.247-72, Marking Deliverables (OCT 2018) (End of clause) Option for Increased Quantity-Separately Priced Line Item The Government reserves the right to request delivery of any line item identified in the Schedule as an option item, in the quantity and at the price stated in the Schedule. The Contracting Officer may exercise this option by providing written notice to the Contractor at least thirty (30) calendar days prior to the expiration of the current contract period. Delivery of additional items shall continue at the same rate as similar items under the contract, unless otherwise agreed upon by both parties. Option to Extend the Term of the Contract The Government reserves the right to extend the term of this contract by providing written notice to the Contractor. A preliminary written notice of intent to extend will be issued at least 30 calendar days prior to the expiration of the current contract period; however, such notice does not obligate the Government to exercise the option. The total contract duration, including all exercised option periods, shall not exceed five (5) years. Protests Protests, as defined in section 33.101 of the Federal Acquisition Regulation, that are filed directly with an agency, and copies of any protests that are filed with the Government Accountability Office (GAO), shall be served on the Contracting Officer (addressed as follows) by obtaining written and dated acknowledgment of receipt from the Contracting Officer, Stacy Massey at [email protected]. The copy of any protest shall be received in the office designated above within one day of filing a protest with the GAO. Invoicing The Contractor will submit each invoice online, including all back-up data, to VA s Electronic Invoice Presentment and Payment System. The Financial Services Center (FSC) uses a third-party contractor, Tungsten, to transition vendors from paper to electronic invoice submission. Please go to this website: http://www.tungsten-network.com/US/en/veterans-affairs/ to begin submitting electronic invoices, free of charge. Additional information can be found at http://www.fsc.va.gov/einvoice.asp. When preparing offers/quotes in response to this solicitation, offerors shall refer to FAR 52.212-1 (Instructions to Offerors-Commercial Products and Commercial Services), and FAR 52.212-2 (Evaluation-Commercial Products and Commercial Services). These sections contain specific instructions, guidance, format, and exact requirements for what constitutes a complete and responsive offer/quote. As specified in these sections an incomplete and/or non-responsive offer/quote shall not be considered for a contract award by the contracting officer. The following provision is incorporated into 52.212-1 as an addendum to this solicitation: 52.212-1 Instructions to Offerors Commercial Products and Commercial Services (SEP 2023) (DEVIATION OCT 2025) (a) Submission of offers. Submit signed and dated offers to the office specified in this solicitation at or before the exact time specified in this solicitation. As a minimum, offers shall include (NOTE: The Contracting Officer is not responsible for locating or obtaining any information not identified in the offer.) The solicitation number; The name, address, and telephone number of the Offeror; The Offeror s Unique Entity Identifier (UEI) and, if applicable, Electronic Funds Transfer (EFT) indicator; The offeror must demonstrate compliance with all mandatory requirements in the PWS. The offeror must demonstrate the ability to meet delivery requirements Relevant experience with similar contracts Completed Attachment 1: Price Cost Schedule Template and any discount terms; Completed Trade Agreements Certificate "Remit to" address, if different than mailing address; Authorized distributor/reseller letter signed by the manufacturer, if applicable; A statement specifying the extent of agreement with all terms, conditions, and provisions included in the solicitation and any solicitation amendments. (b) Period for acceptance of Quotes. The Offeror agrees to hold the prices in its offer firm for 60 calendar days from the date specified for receipt of offers, unless another time period is specified in an addendum to the solicitation. (c) Late submissions, modifications, revisions, and withdrawals of offers. (1) Offerors are responsible for submitting offers and any modifications or revisions to the Government office designated in the solicitation by the time specified in the solicitation. (2) Any offer, modification, or revision received after the time specified for receipt of offers is late and will not be considered unless it is received before award is made and the Contracting Officer determines that accepting the late offer would not unduly delay the acquisition. However, a late modification of an otherwise successful offer that makes its terms more favorable to the Government will be considered at any time it is received and may be accepted. (3) If an emergency or unanticipated event interrupts normal Government processes so that offers cannot be received at the Government office designated for receipt of offers by the exact time specified in the solicitation, and urgent Government requirements preclude amendment of the solicitation or other notice of an extension of the closing date, the time specified for receipt of offers will be deemed to be extended to the same time of day specified in the solicitation on the first work day on which normal Government processes resume. (4) Offerors may withdraw their offers by written notice to the Government received at any time before award. (d) Contract award (not applicable to Invitation for Bids). The Government intends to evaluate offers and award a contract without discussions with Offerors. Therefore, the Offeror s initial offer should contain the Offeror s best terms. However, the Government reserves the right to conduct discussions, if necessary. The Government may reject any or all offers if such action is in the public interest, accept other than the lowest offer, and waive informalities and minor irregularities in offers received. (e) Debriefings. If a postaward debriefing is given to requesting Offerors, the Government will disclose the following information, if applicable: (1) The agency s evaluation of the significant weak or deficient factors in the debriefed Offeror s offer. (2) The overall evaluated cost or price and technical rating of the successful Offeror and the debriefed Offeror and past performance information on the debriefed Offeror. (3) For acquisitions of commercial products, the make and model of the product to be delivered by the successful Offeror. (End of provision) Evaluation The award will be based upon a comparative evaluation of quotes in accordance with the evaluation process of FAR 12.201-1. Comparative evaluation is the side by side pairwise comparison of quotes based on price and other factors resulting in a Contracting Officer s decision for the quote that is most favorable to the Government. The award will be made to the contractor whose response is most advantageous to the Government. Responses should contain your best terms and conditions. The government reserves the right to select a response that provides benefit to the government that exceeds the minimum. The government is not required to select a response that exceeds the minimum. Responses may exceed requirements. Each response must at a minimum meet the solicitation requirement. While price is important, the Government reserves the right to award to a higher-priced offeror if the technical solution and delivery reliability provide greater value and lower risk to patient care. The following provision is incorporated into 52.212-2 as an addendum to this solicitation: 52.212-2 Evaluation Commercial Products and Commercial Services (NOV 2021) (DEVIATION OCT 2025) Evaluation factors. The Government will award a contract resulting from this solicitation to the responsible Offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors will be used to evaluate offers: The following factors will be used to evaluate quotations: Technical Capability: Demonstrated ability to meet all requirements outlined in the Performance Work Statement (PWS), including: Routine weekday delivery and pickup of radiopharmaceuticals. Compliance with USP 797, NRC, DOT, FDA, and state regulations. Proper labeling, packaging, and quality control testing at no cost. Internet-based ordering and dose management capabilities. Disposal services using OSHA-compliant containers. Same-day delivery for critical items (e.g., I-131 capsules). Specialized services for labeled white blood cells. Past Performance: Relevant experience providing similar radiopharmaceutical services to healthcare facilities. Price: Reasonableness and competitiveness of pricing for the base year and option years. Delivery and Support: Ability to meet delivery timelines (including same-day requirements). Availability of dedicated sales representative for coordination. Provision of patient education materials and MSDS upon request. (b) Options (if applicable). The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. The evaluation of options does not obligate the Government to exercise the option(s). (c) Notice of award. A written notice of award or acceptance of an offer furnished to the successful Offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer s specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award. (End of Provision) Submission of your response shall be received not later than 5:00pm on February 19, 2025. Responses should be sent to the Contracting Officer, Stacy Massey at [email protected]. Any questions or concerns regarding this solicitation should be forwarded in writing via e-mail to the Point of Contact listed below. Point of Contact Stacy Massey Contracting Officer Network Contracting Office 12 [email protected]