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On behalf of the Lexington VA Health Care System , Network Contracting Office (NCO) 9 is issuing this sources sought notice (SSN) as a means of conducting market research to identify parties having an... On behalf of the Lexington VA Health Care System , Network Contracting Office (NCO) 9 is issuing this sources sought notice (SSN) as a means of conducting market research to identify parties having an interest in, and the resources to support, this requirement for an Indefinite Quantity/Indefinite Quantity (IDIQ), Base plus 4 Options, contract for various radiopharmaceuticals. The result of this market research will contribute to determining the method of procurement. The applicable North American Industry Classification System (NAICS) code assigned to this procurement is 325412 - Pharmaceutical Preparation Manufacturing. THERE IS NO SOLICITATION AT THIS TIME. This request for capability information does not constitute a request for bids, proposals, or quotes; submission of any information in response to this market survey is purely voluntary; and the government assumes no financial responsibility for any costs incurred. If your organization has the potential capacity to perform these services, please provide the following information: Organization name, address, point of contact, email address, web site address, and telephone number. Business size: small, small disadvantaged, woman-owned, Hub Zone, serviced-disabled veteran-owned small business (SDVOSB), veteran owned small business (VOSB), large business, etc. Business type under NAICS 325412, which contains a size standard of 1,250 employees, Commercial And Government Entity (CAGE) Code and Unique Entity Identification (UEI) Number. Under which NAICS code does your company usually provide the requirements described in the Statement of Work (SOW) - Please provide rationale for your answer if different from NAICS 325412. Tailored capability statements addressing the particulars of this effort, with appropriate documentation supporting claims of organizational, and staff capability. Please provide the following information as an attachment to your response: Identify any other companies owned (wholly or in-part) by the owners of this business who provide goods or services under the same or a related NAICS codes. Identify any other companies owned (wholly or in-part) by the owners of this business who provide goods or services that are registered under the same or a related NAICS code with the Center for Veterans Enterprise (CVE); Provide the certification type (SDVOSB/VOSB), Federal Identification Number, and state of incorporation for each. Do you plan on responding to a solicitation for this requirement with a Joint Venture utilizing multiple owned companies as majority or non-majority owner? Yes ___No ___ If yes, please identify which companies are considering a Joint Venture and the ownership of each company. Response to this SSN shall not exceed 10 pages and should include all of the fore-mentioned information. In addition, all submissions should be provided electronically in a Microsoft Word or Adobe Portable Document Format (PDF). The government will evaluate market information to ascertain potential market capacity to: Provide services consistent in scope and scale with those described in this notice and otherwise anticipated. Secure and apply the full range of corporate financial, human capital, and technical resources required to successfully perform similar requirements. Implement a successful plan that includes: compliance with program schedules; cost containment; meeting and tracking performance. Provide services under a firm-fixed-price contract. NOTE: Respondent claiming SDVOSB and VOSB status shall be registered and Center for Veterans Enterprise (CVE) verified in VetBiz Registry www.vetbiz.gov. Based on the responses to this SSN/market research, this requirement may be set-aside for SDVOSBs, VOSBs, small businesses, procured through full and open competition, or sole sourced. Submission Instructions: Interested parties who consider themselves qualified to perform the services are invited to submit a response to this SSN by 16:00 CT, June 29, 2023. All responses under this SSN must be emailed to Martha.Warren1@va.gov. Telephone inquiries will not be accepted or acknowledged, and no feedback or evaluations will be provided to companies regarding their submissions. SAM: Interested parties shall be registered in the System for Award Management (SAM) as prescribed in FAR Clause 52.232-33. SAM information can be obtained by accessing the internet at www.sam.gov or by calling 1-866-606-8220. Disclaimer and Important Notes. This notice does not obligate the government to award a contract or otherwise pay for the information provided in response to this SSN. The government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the government to determine the organization s qualifications to perform the work. Respondents are advised that the government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities (FBO). However, responses to this notice shall not be considered adequate responses to a solicitation. Confidentiality. No proprietary, classified, confidential, or sensitive information should be included in your response. The government reserves the right to use any non-proprietary technical information in any resultant solicitation(s). See SOW below. Radiopharmaceuticals required: Interested vendors must be able to provide ALL of the following items for a Base period plus 4 Option Years: Supplies/Services: Radiopharmaceutical ESTIMATED QTY UNIT F-18 FDG 400 dose Ga-67 (per mCi) 6 per mCi I-123 200uCi Uptake Caps 12 per cap I-131 Diagnostic Cap (5mCi) 20 per cap I-131 Therapeutic dose (per mCi) 1200 per mCi I-131 Uptake Caps 1 per cap In-111 Octreoscan (pentatreotide) 2 dose In-111 WBC Kit/Labeling 1 per kit PYP Vial 15 per vial Kinevac (CCK) 50 per mcg/vial Tc-99m Exametazime * 1 per dose Tc-99m HMPAO WBC Kit/Labeling 1 per kit Tc-99m Macroaggregated Albumin (MAA) 25 dose Tc-99m Mebrofenin (Choletec) 50 dose Tc-99m Medronate (MDP) 250 dose Tc-99m MAG3 (mertiatide) 30 dose Tc-99m Pentetate (DTPA) 30 dose Tc-99m pyrophosphate (Hot PYP) 15 dose Tc-99m sestamibi 50 dose Tc-99m sodium pertechnetate (TcO4) 90 dose Tc-99m sulfur colloid 50 dose Tc-99m sulfur colloid filtered 1 dose Tc-99m TcO4 LINEARITY SOURCE 4 per vial Tc-99m Myoview 1500 dose Tl-201 (per mCi) 16 per mCi Tc-99m UltraTag Kit 1 per kit Hot Lab Management Software 1 per year Statement of Work UNIT DOSE RADIOPHARMACEUTICALS LEXINGTON VA HEALTHCARE SYSTEM LEXINGTON, KY NUCLEAR MEDICINE & PET/CT Contractor must be able to provide same day orders placed during regular work hours (M-F 6:00 am to 4:00pm) to the VAMC Lexington, Ky. DELIVERY/SCOPE: Quantities expressed in the schedule are estimates based on historical usage for one year. However, quantities and types of radiopharmaceuticals may vary based on patient demand. terms All radiopharmaceuticals and pharmaceuticals or kits are to be furnished by the Contractor in strict accordance with the terms and conditions of the contract and all applicable local, State and Federal laws. Contractor/supplier shall abide by (CFR 10) Title Code of Federal Regulations, which states: A Licensee may use for medical use only: By-product material manufactured, labeled, packaged and distributed in accordance with a license issued pursuant to the regulations in Tile 10, Code of Federal Regulations, Part 35 and the equivalent regulations of an Agreement State. Reagent kits that have been manufactured labeled, packed and distributed in accordance with the approval by the Commission pursuant to S32.73 or an Agreement State under equivalent regulations for the preparation of radiopharmaceuticals for medical use. All radiopharmaceutical items, possibly including some not listed, shall be ordered as needed by the Nuclear Medicine staff and delivered with daily routine deliveries. If the ordered radiopharmaceutical is not available and cannot be delivered to the VA when needed, the contractor will notify the VA Nuclear Medicine Department and obtain the needed doses from another source, including another Radiopharmacy, to be delivered as near the requested time to provide timely care to the Veteran patients. The Contractor may only substitute another radiopharmaceutical for the requested one with VA Nuclear Medicine approval. When this is done, the VA will pay for the lower priced radiopharmaceutical. No delivery charge shall be made for additional deliveries up to 5 per day during normal working hours 6:00 am-4:00 pm. The Contractor shall deliver all radiopharmaceuticals with NO added fuel surcharge. Requests for emergency doses during regular work hours (M-F 6:00 am- 4:00 pm) shall be delivered within 2-hours of placing the order. Emergency and priority studies consist of up to 20% of the daily schedule. The first daily delivery shall be made to Nuclear Medicine (Room A-152a) by 6:30a.m. unless prior authorization arrangements have been made. Delivery shall be made directly to a Nuclear Medicine Technologist on duty. Deliveries made before staff arrives shall be made by contacting the Veterans Medical Center Police Department to unlock the Nuclear Medicine Department Night Entry (Room a-152) for placement of the packages. Subsequent deliveries will likewise be made as needed as described above. Delivery personnel shall be bonded by the Contractor. Contractor shall provide evidence of special driver s licenses required for transporting hazardous materials. Contractor shall meet all Nuclear Regulatory Commission, Department of Transportation, FDA, OSHA, and all other State and Federal rules and regulations. Contractor must provide waste disposal at no additional charge of used radioactive dose syringes, vials, i.e. All waste shall be picked up with the next delivery. All radiopharmaceuticals shall be delivered in proper shielded containers with disposal impenetrable biohazard liners. Shipping containers and their labeling must comply with all federal and state regulations. All unit dose radiopharmaceuticals delivered must have a bar code for scanning into a dose tracking system. Any recalled / incorrectly delivered dose for any reason shall be credited for the full amount. It is the offerors responsibility to provide the VA with recall notices on any product that has been delivered to the VA that may be defected. Notification shall be made to the Contracting Officer Representative via the most expedient method. Incorrectly delivered doses shall not exceed one per month. Any doses deemed below standard by the facility shall be credited toward the account and shall not exceed one per quarter, i.e. 4 per year. Weekend delivery (Saturday/Sunday) and all observed Federal Holliday deliveries shall be made by contacting the Veterans Medical Center Police Department to unlock the Nuclear Medicine Department Night Entry (Room A-152) for placement of the packages. New Year s Day Martin Luther King s Birthday Presidents Day Memorial Day Juneteenth Independence Day Columbus Day Veterans Day Thanksgiving Christmas Day Any other day declared a Federal Holiday by the US President. Emergency call back fees shall not be charged for regular work hours (M-F 6:00 am-4:00 pm) on days not observed as a holiday by the VA, i.e. Christmas Eve, Good Friday, etc. Contractor shall provide a quarterly linearity source. The activity requested can range from 25 to 400 mCi. Contractor shall provide leukocyte and platelet labeling services as a same day service. Contractor shall provide 24 hour on-call service for emergency procedures Contractor shall provide any additional technical support deemed necessary for the technical staff, physicians, patient education, etc. The majority if not all technetium products must be compounded using Non- HEU generators whenever possible. Radiopharmaceuticals shall be calibrated and labeled with concentration, calibration time, total volume, total activity and expiration time and date. All technetium products shall be tested for molybdenum contamination and the amount of molybdenum present shall be tested. The Radiopharmacy shall be USP <797> compliant for sterile compounding and shall provide a statement to this effect. Product information including suppliers source of radiopharmaceuticals, package inserts, results of quality control testing performed by supplier and copies of supplier s license and procedures shall be provided upon request at no additional charge. Consultation services regarding radiopharmaceutical applications, problems, controls, etc., shall be provided upon request at no charge. It is preferred that the contractor furnish a VA OIT approved hot lab management system that facilitates required record keeping (and report generation) for regulatory compliance and modernized processes. PERSONNELL AUTHORIZED TO PLACE ORDERS: The following personnel are authorized to telephone and or fax radiopharmaceutical orders: Supervisory Nuclear Medicine Technologist Nuclear Medicine / PET Technologist Other Lexington VA Medical Staff as designated INVOICING: Contracting Officer Representative (COR) shall be provided with a copy of the invoice at the end of each month for approval before submission to the Contract Radiopharmacy s Business Center for processing. Said invoices will be reviewed by the COR for accuracy and any discrepancies corrected and a new invoice sent before invoice is finalized. Contractor shall be paid monthly, in arrears, upon a submission of a properly prepared invoice for services / supplies during the period. All invoices will include the contact number, date of services, and an itemized listing of charges. Invoices shall be submitted electronically to: Jennifer.Coffey@va.gov. PERFORMANCE / QUALITY: Incorrectly delivered doses shall not exceed one per month. Any doses deemed below standard by the facility shall be credited toward the account and shall not exceed one per quarter, i.e. 4 per year. It is the offerors responsibility to provide the VA with recall notices on any product that has been delivered to the VA that may be defective. Notification shall be made to the Contracting Officer Representative via the most expedient method. All technetium products shall be tested for molybdenum contamination and the amount of molybdenum present shall be stated. Contractor shall provide complete documentation of quality control results upon request. Product information including suppliers source of radiopharmaceuticals, package inserts, results of quality control testing performed by supplier and copies of supplier s license and procedures shall be provided at no additional charge. Offeror will perform quality control on each agent dispensed. Contractor shall perform all quality control procedures as required by Federal and State regulatory agencies. Only those products that pass quality control may be sent to the VA Nuclear Medicine Service. The supplier will demonstrate documentation of quality control performance of any item upon request of the VA Nuclear Medicine Service. All products are purchased subject to acceptance by the VA Nuclear Medicine Service. Products that fail to meet quality control criteria of Nuclear Medicine will not be accepted. Products will be rejected and may be discarded if found unsatisfactory by the Nuclear Medicines quality control when they are received, or later if deterioration of the product occurs before the expiration date. The VA will not be financially liable for unacceptable materials. QUALIFICATIONS: Personnel assigned by the contractor to perform the services covered by this contract shall be licensed in a State, Territory, or Commonwealth of the United States or the District of Columbia. The qualifications of such personnel shall also be subject to review by the VA Chief of Staff and approval by VA Facility Director. The contractor, their personnel, and their subcontractors shall be subject to the Federal laws,regulations, standards, and VA Directives and Handbooks regarding information and information system security as delineated in this contract. a. Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights in Data- General, FAR 52.227-14(d) (1). b. VA information should not be co-mingled, if possible, with any other data on the contractors/subcontractor s information systems or media storage systems in order to ensure VA requirements related to data protection and media sanitization can be met. If co-mingling must be allowed to meet the requirements of the business need, the contractor must ensure that VA s information is returned to the VA or destroyed in accordance with VA s sanitization requirements. VA reserves the right to conduct on-site inspections of contractor and subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are in compliance with VA directive requirements. c. Prior to termination or completion of this contract, contractor/subcontractor must not destroy information received from VA, or gathered/created by the contractor in the course of performing this contract without prior written approval by the VA. Any data destruction done on behalf of VA by a contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination of the contract. d. The contractor/subcontractor must receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with the terms of the contract and applicable Federal and VA information confidentiality and security laws, regulations and policies. If Federal or VA information confidentiality and security laws, regulations and policies become applicable to the VA information or information systems after execution of the contract, or if NIST issues or updates applicable FIPS or Special Publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations and policies in this contract. e. The contractor/subcontractor shall not make copies of VA information except as authorized and necessary to perform the terms of the agreement or to preserve electronic information stored on contractor/subcontractor electronic storage media for restoration in case any electronic equipment or data used by the contractor/subcontractor needs to be restored to an operating state. If copies are made for restoration purposes, after the restoration is complete, the copies must be appropriately destroyed. f. If VA determines that the contractor has violated any of the information confidentiality, privacy, and security provisions of the contract, it shall be sufficient grounds for VA to withhold payment to the contractor or third party or terminate the contract for default or terminate for cause under Federal Acquisition Regulation (FAR) part 12. g. If a VHA contract is terminated for cause, the associated BAA must also be terminated and appropriate actions taken in accordance with VHA Handbook 1600.01, Business Associate Agreements. Absent an agreement to use or disclose protected health information, there is no business associate relationship. h. The contractor/subcontractor must store, transport, or transmit VA sensitive information in an encrypted form, using VA-approved encryption tools that are, at a minimum, FIPS 140-2 validated. i. The contractor/subcontractor s firewall and Web services security controls, if applicable, shall meet or exceed VA s minimum requirements. VA Configuration Guidelines are available upon request. j. Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the contractor/subcontractor may use and disclose VA information only in two other situations: (i) in response to a qualifying order of a court of competent jurisdiction, or (ii) with VA s prior written approval. The contractor/subcontractor must refer all requests for, demands for production of, or inquiries about, VA information and information systems to the VA contracting officer for response. k. Notwithstanding the provision above, the contractor/subcontractor shall not release VA records protected by Title 38 U.S.C. 5705, confidentiality of medical quality assurance records and/or Title 38 U.S.C. 7332, confidentiality of certain health records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse, or infection with human immunodeficiency virus. If the contractor/subcontractor is in receipt of a court order or other requests for the above mentioned information, that contractor/subcontractor shall immediately refer such court orders or other requests to the VA contracting officer for response. l. For service that involves the storage, generating, transmitting, or exchanging of VA sensitive information but does not require C&A or an MOU-ISA for system interconnection, the contractor/subcontractor must complete a Contractor Security Control Assessment (CSCA) on a yearly basis and provide it to the COTR. PERSONNEL POLICY: The contractor shall be responsible for protecting the personnel furnishing services under this contract. To carry out this responsibility, the contractor shall provide the following for those personnel: workers compensation professional liability insurance, health examinations, income tax withholding and Social Security payments. Such personnel shall not be considered VA employees for any purpose and shall be considered employees of the contractor. EVALUATION METHODOLOGY: Award shall be made to the quoter whose quotation considering technical capability, past performance, and price. The government will evaluate information based on the following evaluation criteria: (1) technical capability factor "meeting or exceeding the requirement , (2) past performance, and (3) price. The C&A requirements do not apply, the Security Accreditation Package is not required. Any offered Hot Lab Management system will not be connected to the VA network but will house VA sensitive information. We request that the data be available to back up locally, in an OIT approved manner, removing contracting personnel from any security risk.