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36C25225Q0403 Effective Date: 03/15/2023 Revision: 01 Combined Synopsis-Solicitation for Commercial Products and Commercial Services Description This is a combined synopsis/solicitation for commercial... 36C25225Q0403 Effective Date: 03/15/2023 Revision: 01 Combined Synopsis-Solicitation for Commercial Products and Commercial Services Description This is a combined synopsis/solicitation for commercial products and commercial services prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, Streamlined Procedures for Evaluation and Solicitation for Commercial Products and Commercial Services, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested, and a written solicitation document will not be issued. This solicitation is issued as an RFQ. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular Deviations FEB 2025 CAAC Letters 2025-01/02 (eff.02/18/2025). This solicitation is unrestricted. The associated North American Industrial Classification System (NAICS) code for this procurement is 325412, Pharmaceutical Preparation Manufacturing. The small business size standard of 1,300 employees. The FSC/PSCs 6505, Biological Drugs. The Department of Veterans Affairs, Network Contracting Office 12 (NCO 12), Veterans Integrated Services Network 12 (VISN 12), Clement J. Zablocki VA Medical Center located at 5000 W. National Avenue, Milwaukee, WI 53295-0001 has a requirement for the provision of Fludeoxyglucose F 18 (18F-FDG) unit dose PET/CT radiopharmaceuticals for diagnostic patient care as identified in the Pricing Schedule. This supply must be contracted due to the local production requirements of the radioisotope being provided. PET/CT pharmaceuticals have a short shelf life (<6 hours), necessitating requirements for local production and delivery. Production and delivery of the 18F-FDG) unit doses are estimated to be needed for a base period of one (1) year and four (4) 12-month option periods. The government is seeking a Contractor to provide unit dose (5-15 mCi) of Fludeoxyglucose F 18 (18F-FDG) PET/CT radiopharmaceuticals, as needed to the Milwaukee VAMC for PET/CT nuclear medicine examinations, based on caseload and patient schedule. Deliveries may need to be performed 5 days a week (Monday through Fridays) during Milwaukee VAMC Medical Imaging clinic hours (7:00 a.m. 3:30 p.m.). This is a non-personal services requirement. The contractor will be responsible for all management, oversight, supervision, labor, transportation, tools, materials, parts, other items, and the support necessary to perform work, execute services, and to successfully complete all deliverables as contained within this Statement of Work. All interested contractors should provide quotations for the following: Price/Cost Schedule & Item Information Base Period 05/01/2025 04/30/2026 Line Item Description Qty Unit of Measure Unit Price Total 0001 18F-FDG Dose 600 EA Option Year One 05/01/2026 04/30/2027 Line Item Description Qty Unit of Measure Unit Price Total 1001 18F-FDG Dose 625 EA Option Year Two 05/01/2027 04/30/2028 Line Item Description Qty Unit of Measure Unit Price Total 2001 18F-FDG Dose 650 EA Option Year Three 05/01/2028 04/30/2029 Line Item Description Qty Unit of Measure Unit Price Total 3001 18F-FDG Dose 675 EA Option Year Four 05/01/2029 04/30/2030 Line Item Description Qty Unit of Measure Unit Price Total 4001 18F-FDG Dose 700 EA Pricing Overview Total Cost for each Period of Performance Base Period $ Option Year One $ Option Year Two $ Option Year Three $ Option Year Four $ Total $ Statement of Work/Description/Specifications OVERVIEW Contractor shall provide all equipment and tools necessary to perform for the production and delivery of Fludeoxyglucose F 18 (18F-FDG) unit dose PET/CT radiopharmaceuticals for diagnostic patient care to the Clement J. Zablocki VA Medical Center (herein referred to as the Milwaukee VAMC). PET/CT pharmaceuticals have a short shelf life (<6 hours), necessitating requirements for local production and delivery. Deliveries may be performed 5 days a week (Monday through Friday) during Milwaukee VAMC Medical Imaging clinic hours (7:00 a.m. 3:30 p.m.). This is a non-personal services requirement. The contractor shall provide all management, oversight, supervision, labor, transportation, tools, materials, parts, other items, and the support necessary to perform work, execute services, and to successfully complete all deliverables as contained within this Statement of Work. The Government will not exercise any supervision and/or control over contractor personal (which includes contractor service providers, contractor representatives, and subcontractors employed with and/or being utilized by the prime contractor) during all active performance periods of the final contract. All contractor personal shall be accountable solely to the Contractor, who in turn is responsible to the Government. SCOPE The government is seeking a Contractor shall provide unit dose (5-15 mCi) of Fludeoxyglucose F 18 (18F-FDG) PET/CT radiopharmaceuticals, as needed, to the Milwaukee VAMC for PET/CT nuclear medicine examinations, based on caseload and patient schedule. Contract to start May 1, 2025, and continue for 1-year with four (4) 12-month ordering periods. PLACE OF PERFORMANCE Work will be performed at the Contractors site and deliverables will be completed at the Clement J. Zablocki VAMC located at 5000 W. National Avenue, Milwaukee, WI, 53295-0001. PERIOD OF PERFORMANCE The expected period of performance for this acquisition is the following: Base Period: 05/01/2025 thru 04/30/2026 Option Period One: 05/01/2026 thru 04/30/2027 Option Period Two: 05/01/2027 thru 04/30/2028 Option Period Three: 05/01/2028 thru 04/30/2029 Option Period Four: 05/01/2029 thru 04/30/2030 Option years may or may not be exercised based on the needs of (and at the discretion of) the Government. The contract is subject to the availability of VA funds. The Contractor shall perform no services after September 30 of any year until the Contracting Officer authorizes such services in writing. FEDERAL HOLIDAYS The 11 holidays observed by the Federal Government are: New Year s Day (January 1st), Martin Luther King s Birthday (3rd Monday in January), Presidents Day (3rd Monday in February), Memorial Day (last Monday in May), Juneteenth (June 19th), Independence Day (July 4th), Labor Day (1st Monday in September), Columbus Day (2nd Monday in October), Veterans Day (November 11), Thanksgiving Day (4th Thursday in November), Christmas Day (December 25th) and any other day specifically declared by the President of the United States to be a national holiday. When one of the above designated legal holidays falls on a Sunday, the following Monday will be observed as a legal holiday. When a legal holiday falls on a Saturday, the preceding Friday is observed as a holiday by U.S. Government agencies. SPECIFIC TASKS Contractor will provide multiple daily routine deliveries of 18F-FDG PET/CT Radiopharmaceutical doses. Routine delivery times will be based on patient schedule and caseload. PET/CT scans will be routinely performed on Mondays and Tuesdays, except for federal holidays. However, additional days may be requested. Vendor shall be located in close proximity (preferably within 30 miles) to Milwaukee VAMC in order to modify schedule of FDG delivery in the event of scheduling change and/or urgent exams. Vendor shall provide data regarding their Delivery Reliability ( Uptime ), including refunds or credits applied in the event of inability to deliver. This request is to ensure a reliable source of radiopharmaceuticals. Contractor shall label all products delivered as to the calibrated activity of each PET/CT radiopharmaceutical, expiration time and date. Items must be adequately packaged to prevent damage during handling and storage. All packaging and labeling must meet all federal and state regulations. All packaging of radioactive material MUST BE clearly labeled RADIOACTIVE on the outside of the carton in which it is shipped. Contractor shall provide current Safety Data Sheets (SDS) and updates on all delivered products if requested. Contractor shall meet all Nuclear Regulatory Commission, Department of Transportation and FDA regulations and USP 825 guidelines. (Federal and State as applicable). Contractor shall be licensed by the State of Wisconsin (Department of Health Services) and be regularly established in the business of providing radiopharmaceutical. Contractor shall provide copies of these licenses and certifications to the Contracting Officer prior to award. Contractor shall test products periodically for Quality Control as required by USP 825, Federal and State regulatory agencies. This testing shall be performed at no cost to the VA. The contractor shall provide a detailed description of the test upon request. Contractor shall assign an individual sales representative to aide in facilitation in the smooth coordination between the hospital and Contractor s laboratory pharmacy. Any cost to replace damaged or incorrect products will be at the cost of the Contractor. PERFORMANCE MONITORING Every package is inspected by the department. Testing is performed on the packaging to make sure it meets requirements and is not contaminated. Associated invoices are compared to the packing slips. COR or designated POC notifies vendor if delivery times fall out of required time or if invoicing does not match delivery/orders. GOVERNMENT FURNISHED EQUIPMENT, FACILITIES, UTILITIES None RADIOACTIVE MATERIALS HANDLING REQUIREMENTS The contract deals with radioactive materials which are regulated by the Nuclear Regulatory commission (NRC), Wisconsin Department of Health Services, Department of Transportation (DOT) and VA National Health Physics Program (NHPP). The vendor is responsible for safely transporting and delivering the materials from the centralized nuclear pharmacy to the facility. The Milwaukee VAMC shall be solely responsible for the receipt, dispensing, administration, storage, surveys, decontamination, waste management, proper disposal and record keeping. CONTRACTOR KEY PERSONAL The Contractor shall identify its contact person(s), who shall serve as liaison between the Contractor and the Milwaukee VAMC, and who shall ensure the Contractor performs services in accordance with contract specifications. The Contractor s liaison must contact the COR and the Milwaukee VAMC Imaging Supervisor for all delays and cancellations by the contractor immediately. The Contractor s contact person(s) shall be available 30 minutes prior to first scheduled scan and 30 minutes after last scheduled scan. PERSONAL PERFORMING WORK/SERVICES - REQUIRED CORE COMPETENCIES Personal performing work, executing services, and completing deliverables during the active performance periods of the contract must possess the knowledge, skills, and abilities required to successfully complete the requirement. No unqualified individual shall be allowed to perform work, execute services, and to complete deliverables at any time under the final contract. Contractor personal shall not be considered VA employees for any purpose. DELIVERABLES Required Deliverables DELIVERABLE #1: Unit doses (5-15 mCi) of Fludeoxyglucose F 18 (18F-FDG) PET/CT radiopharmaceuticals, as needed, to the Milwaukee VAMC Nuclear Medicine Section 5 days a week (Monday through Friday) during Milwaukee VAMC Medical Imaging clinic hours (7:00 a.m. 3:30 p.m.). VA INFORMATION & INFORMATION SYSTEM SECURITY & PRIVACY LANGUAGE Refer to ATTACHED: VA INFORMATION & INFORMATION SYSTEM SECURITY & PRIVACY LANGUAGE SPECIAL CONTRACT REQUIREMENTS Contract Administration: The Contracting Officer (CO) is the only person authorized to approve changes or modify requirements. Contractor shall communicate with CO on all matters pertaining to contract administration. Only the CO is authorized to make commitments or issue changes, which will affect price, quantity, or qualify of performance of this contract. Services specified may be changed by written modification to this contract. Modification will be prepared by the VA CO. Designation of Contracting Officer s Representative (COR): A representative of the CO will be designated to represent the CO in furnishing technical guidance and advice regarding the work performed under this contract. The foregoing is not to be construed as authorization to interpret or furnish advice and information to the Contractor relative to financial or legal aspects of the contract, but the technical matter experts reside in the serviced departments and as such they are authorized to give technical assistance and guidance. The services to be performed by the contractor will be under the direction of the Chief of Staff, and the Chief, Radiology services. The Imaging Service, Nuclear Medicine Section COR or appointed Point of Contact will be the primary point of contact at the Milwaukee VA for communication between the VA and the Contractor regarding any delivery interruptions. The Contractor will communicate to the COR any possible and actual disruptions of service. Upon becoming aware of possible or actual disruption of service, the Contractor will communicate such service-disruption information to the COR as soon as possible (ASAP) so the patient and service schedule can be appropriately modified with as little inconvenience as possible to patients and services. Contract Termination: A contract award can be terminated by the Milwaukee VA if a Contractor does not adequately meet the requirements of this Statement of Work. A 30-day notice detailing one or several inadequacies will precede termination. Termination will occur if inadequacies are not rectified within 60 days of notification, or the Milwaukee VA determines corrections are not sufficient for resolution. Identification and Badges: Any individual performing work under this contract shall wear a badge or other identification while on site that is clearly displayed at all times. Badges must have an identification picture, name of the individual and the represented company. While on site, any person performing work directly or indirectly must be in a position to specify their authorized purpose for their presence at the facility in the event that such information is requested by VA facility personal. Parking: It is the responsibility of the contractor to park in the appropriate designated parking areas, to avoid ticketing or towing (if/when on site at the facility). Information on parking is available from the facility if requested by the contractor. Invoicing and Payment: Contractor is authorized prompt payment IAW applicable regulation following the successful performance of work, execution of services, and completion of required deliverables. Contractor invoices shall be submitted IAW VAAR Clause 852.232-72 Electronic Submission of Payment Requests. Invoices submitted for payment must be detailed to the extent necessary to reflect the work done and the services performed during the time periods when completed so an accurate assessment can be made by the facility for certification of these invoices for payment. Advance payments are not authorized, and contractor is not authorized payment for planned or anticipated work not performed and/or for work that has not been successfully completed. Supplemental Insurance Requirements: In accordance with FAR 28.307-2 and FAR 52.228-5, the following minimum coverage shall apply to this contract: (a) Workers' compensation and employers liability: Contractors are required to comply with applicable Federal and State workers' compensation and occupational disease statutes. If occupational diseases are not compensable under those statutes, they shall be covered under the employer's liability section of the insurance policy, except when contract operations are so commingled with a Contractor's commercial operations that it would not be practical to require this coverage. Employer's liability coverage of at least $100,000 is required, except in States with exclusive or monopolistic funds that do not permit workers' compensation to be written by private carriers. (b) General Liability: $500,000 per occurrences. (c) Automobile liability: $200,000 per person; $500,000 per occurrence and $20,000 property damage. (d) The successful bidder must present to the Contracting Officer, prior to award, evidence of general liability insurance without any exclusionary clauses for asbestos that would void the general liability coverage. Option to Extend Services: The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor within 10 days of the expiration of the current performance period. Option to Extend the Term of the Contract: The Government may extend the term of this contract by written notice to the Contractor; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 10 days before the contract expires. The preliminary notice does not commit the Government to an extension. The total duration of this contract, including the exercise of any options under this clause, shall not exceed 5 years. (end Statement of Work) Period of Performance Base Period: 05/01/2025 thru 04/30/2026 Option Period One: 05/01/2026 thru 04/30/2027 Option Period Two: 05/01/2027 thru 04/30/2028 Option Period Three: 05/01/2028 thru 04/30/2029 Option Period Four: 05/01/2029 thru 04/30/2030 Place of Performance/Place of Delivery Address: Clement J. Zablocki VA Medical Center 5000 W. National Avenue Milwaukee, WI Postal Code: 53295-0001 Country: UNITED STATES The full text of FAR provisions or clauses may be accessed electronically at http://acquisition.gov/comp/far/index.html. The following solicitation provisions apply to this acquisition: FAR 52.201-1, Acquisition 360: Voluntary Survey (SEPT 2023) FAR 52.212-1, Instructions to Offerors-Commercial Products and Commercial Services (SEP 2023) Refer to Attachment 2 ADDENDUM to FAR 52.212-1 INSTRUCTIONS TO OFFERORS--COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES FAR 52.252-1, Solicitation Provisions Incorporated by Reference (FEB 1998) FAR 52.204-7, System for Award Management (NOV 2024) FAR 52.204-16, Commercial and Government Entity Code Reporting (AUG 2020) FAR 52.204-20, Predecessor of Offeror (AUG 2020) FAR 52.204-24, Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (NOV 2021) FAR 52.204-29, Federal Acquisition Supply Chain Security Act Orders-Representation and Disclosures (DEC 2023) FAR 52.209-7, Information Regarding Responsibility Matters (OCT 2018) FAR 52.214-21, Descriptive Literature (APR 2002), Alternate I (JAN 2017) FAR 52.233-2, Service of Protest (SEPT 2006) VAAR 852.209-70, Organizational Conflicts of Interest (OCT 2020) VAAR 852.233-70, Protest Content/Alternative Dispute Resolution (OCT 2018) VAAR 852.233-71, Alternate Protest Procedure (OCT 2018) VAAR 852.239-71, Information System Security Plan and Accreditation (FEB 2023) VAAR 852.239-75, Information and Communication Technology Notice (FEB 2023) VAAR 852.252-70, Solicitation Provisions or Clauses Incorporated by Reference (JAN 2008) End of Addendum to 52.212-1 FAR 52.212-2, Evaluation-Commercial Items (NOV 2021) Refer to ATTACHMENT 3: TAILORED 52.212-2 EVALUATION COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES. FAR 52.212-3, Offeror Representations and Certifications-Commercial Products and Commercial Services (MAY 2024)(DEVIATION FEB 2025) Offerors must complete annual representations and certifications electronically via the System for Award Management (SAM) website located at https://www.sam.gov/portal in accordance with FAR 52.212-3, Offerors Representations and Certifications Commercial Products and Commercial Services. If paragraph (j) of the provision is applicable, a written submission is required. System updates may lag policy updates. The System for Award Management (SAM) may continue to require entities to complete representations based on provisions that are not included in agency solicitations. Examples include 52.222-25, Affirmative Action Compliance, and paragraph (d) of 52.212-3, Offeror Representations and Certifications Commercial Products and Commercial Services. Contracting officers will not consider these representations when making award decisions or enforce requirements. Entities are not required to, nor are they able to, update their entity registration to remove these representations in SAM. The following contract clauses apply to this acquisition: FAR 52.212-4, Contract Terms and Conditions-Commercial Products and Commercial Services (NOV 2023) Addendum to FAR 52.212-4 FAR 52.252-2, Clauses Incorporated by Reference (FEB 1998) FAR 52.203-16, Preventing Personal Conflicts of Interest (JUN 2020) FAR 52.204-9, Personal Identity Verification of Contractor Personal (JAN 2011) FAR 52.204-13, System for Award Management Maintenance (OCT 2018) FAR 52.204-18, Commercial and Government Entity Code Maintenance (AUG 2020) FAR 52.217-8, Option to Extend Services (NOV 1999) FAR 52.217-9, Option to Extend the Term of the Contract (MAR 2000) FAR 52.223-10, Waste Reduction Program (MAY 2024)(DEVIATION FEB 2025) FAR 52.224-1, Privacy Act Notification (APR 1984) FAR 52.224-2, Privacy Act (APR 1984) FAR 52.227-14, Rights in Data-General (MAY 2014) FAR 52.227-17 , Rights in Data-Special Works (DEC 2007) FAR 52.228-5, Insurance-Work on a Government Installation (JAN 1997) CL-120, Supplemental Insurance Requirements FAR 52.232-18, Availability of Funds (APR 1984) FAR 52.237-2, Protection of Government Buildings, Equipment, and Vegetation (APR 1984) VAAR 852.203-70, Commercial Advertising (MAY 2018) VAAR 852.204-70, Personal Identity Verification of Contractor Personal (MAY 2020) VAAR 852.204-71, Information and Information Systems Security (FEB 2023) VAAR 852.211-70, Equipment Operation and Maintenance Manuals (NOV 2018) VAAR 852.211-72, Technical Industry Standards (NOV 2018) VAAR 852.211-76, Liquidated Damages-Reimbursement for Data Breach Costs (FEB 2023) VAAR 852.212-71, Gray Market and Counterfeit Items (FEB 2023) VAAR 852.219-75, VA Notice of Limitations on Subcontracting Certificate of Compliance for Services and Construction (JAN 2023) (DEVIATION) Refer to ATTACHMENT 4: VA Notice of Limitations on Subcontracting Certificate of Compliance for Services and Construction VAAR 852.232-72, Electronic Submission of Payment Requests (NOV 2018) VAAR 852.237-74, Nondiscrimination in Service Delivery (OCT 2019) VAAR 852.237-75, Key Personal (OCT 2019) VAAR 852.239-70, Security Requirements for Information Technology Resources (FEB 2023) VAAR 852.239-73, Information System Hosting, Operation, Maintenance, or Use (FEB 2023) VAAR 852.239-74, Security Controls Compliance Testing (FEB 2023) VAAR 852.239-76, Information and Communication Technology Accessibility (FEB 2023) VAAR 852.242-71, Administrative Contracting Officer (OCT 2020) VAAR 852.246-71, Rejected Goods (OCT 2018) End of Addendum to 52.212-4 FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Products and Commercial Services (JAN 2025) Refer to ATTACHMENT 5: Tailored 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders--Commercial Products and Commercial Services 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. 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, Parris Weidenbach at Parris.Weidenbach@va.gov. The copy of any protest shall be received in the office designated above within one day of filing a protest with the GAO. All quoters shall submit the following: Refer to ATTACHMENT 2: Tailored FAR 52.212-1 INSTRUCTIONS TO OFFERORS COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES When preparing offers/quotes in response to this solicitation offerors shall refer to FAR 52.212-1 (Instructions to Offerors Commercial Items), FAR 52.212-2 (Evaluation-Commercial Items) and Addendum FAR Part 52.212-2. 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. All quotes shall be sent to the Contracting Officer at Parris.Weidenbach@va.gov. Evaluation Award will be based upon a comparative evaluation of quotes in accordance with the Simplified Acquisition Procedures of FAR 13. 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. Refer to ATTACHMENT 3: TAILORED 52.212-2 EVALUATION COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES. The following are the decision factors: Technical specifications and compliance with requirement Delivery schedule, Contractor capability and past performance, Veteran Involvement, and Price The award will be made to the response 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. To facilitate the award process, all quotes must include a statement regarding the terms and conditions herein as follows: "The terms and conditions in the solicitation are acceptable to be included in the award document without modification, deletion, or addition." OR "The terms and conditions in the solicitation are acceptable to be included in the award document with the exception, deletion, or addition of the following:" Quoters shall list exception(s) and rationale for the exception(s), if any. Submission of your response shall be received not later than 11:00pm on April 25, 2025. Responses should be sent to the Contracting Officer, Parris Weidenbach at Parris.weidenbach@va.gov. Late submissions shall be treated in accordance with the solicitation provision at FAR 52.212-1(f). 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 Parris Weidenbach Contracting Officer Network Contracting Office 12 Parris.weidenbach@va.gov