6550--Brand Name or Equal to Abbott Molecular - Laboratory STI and SARs Reagents

STATEMENT OF NEED (SON) Corporal Michael J. Crescenz Philadelphia VAMC Abbott Alinity PCR testing Background: The Michael J. Crescenz VA Medical Center (CMC VAMC), Philadelphia VAMC Laboratory, located at 3900 Woodland Avenue, Philadelphia, PA 19104 provides accurate, timely, cost-effective laboratory test results and diagnosis for the nation s veterans. Scope: The intent of this solicitation is to do a base plus 4 option year contract for FSS V797D-40222 with Abbott for all supplies related to STI and SARS-COV2 testing on the Alinity M platform. All reagents, consumable supplies, operator maintenance supplies and all shipping costs, during the term of this agreement to support testing for the pandemic. Note: Instrumentation is currently on site, and owned by the VA. Description/Specifications/Statement of Need: Supply Requirements/Quantity /(ea): Alinity m SARS-CoV-2 AMP Kit /53 Alinity m SARS-CoV-2 CTRLKit /10 Alinity m Sample Prep Kit2 /9 Alinity m Lysis Solution /45 Alinity m Diluent Solution /12 Alinity m Vapor Barrier Solution /2 Alinity m Pipette Tips, 50uL /7 Alinity m Pipette Tips, 1000uL /8 Alinity m Integrated Reaction Units (IRU)/210 Alinity m Waste Box/7 Alinity m IRU Waste Container/1 Alinity m sti amp kit 384T/16 Alinity m sti ctrl kit/18 Alinity -m multi-collect 500 kit/13 Alinity m bottle ethanol use/6 Alinity m sample prep kit 1/9 Alinity m amplified waste cntr/7 Alinity m iru waste container/1 Alinity m integrated rxn unit/210 Alinity m transport tube MG Result/1 TV results/1 The instrumentation shall perform all testing with precision as defined by the 1988 Clinical Laboratory Improvement Act (CLIA) and the Clinical and Laboratory Standards Institute (CLSI). Ordering/Delivery Orders for reagents, QC products, consumable supplies, etc. Will be shipped with-in 48 hours after receipt of an order, without additional costs to the Government. All shipments must be complete. Partial shipments shall be minimal and permitted only with prior approval of the lab management before shipping occurs. Partial shipments received without approval will be considered as failure to supply adequate inventory and will result in default. In addition, failure to reserve adequate inventory will result in default. Contractor must furnish a designated point of contract for placing orders and billing issues. The VA delivery terms are FOB DESTINATION for all shipments, deliveries, installations, and training. Deliverables should be shipped to: Corporal Michael J. Crescenz Veterans Affairs Medical Center Pathology & Laboratory Medicine Service 113(W) 3900 Woodland Ave, Philadelphia, PA 19104 Attn: Core Laboratory Supervisor Deliver material to job in manufacturers original sealed container with brand name marked thereon or maintain coverings in place and in good repair. PO# must be on the outside of the shipping box for easy identification. Delivery Days are Monday through Friday during normal business hours which are defined as 7:30am to 3:00pm. National Holidays are excluded. Any delivery service performed for emergency orders may be delivered other than normal business work hours and must be approved. The Contractor is not required to provide delivery services on the following National Holidays, nor shall the Contractor be paid for these Holidays and any other declared national holiday by the President. HOLIDAY New Year s Day Martin Luther King s Birthday President s Day Memorial Day Juneteenth Independence Day Labor Day Columbus Day Veterans Day Thanksgiving Day Christmas Day Invoice/payment The requirements of a proper invoice are as specified in the Federal Supply Schedule contract. MISCELLANEOUS INFORMATION: Payment Net 30 days. Other special requirements or situations If for any reason the scheduled time for a deliverable cannot be met, the contractor is required to formally explain (include the original deliverable due date) in writing to the COR (Contracting Officer Representative) and CO (Contracting Officer) the justification for late delivery. The formal document shall include a firm commitment of when the work shall be completed. This notice to the COR and CO shall cite the reasons for the delay, and the impact on the overall project. The CO will then review the facts and issue a response in accordance with the FAR. CHANGES TO STATEMENT OF WORK Any changes to this SON shall be authorized and approved only through written correspondence from the CO. A copy of each change will be kept in a project folder along with all other products of the project. Costs incurred by the contractor through the actions of contractor s staff, sub-contractors, and all other parties other than the CO shall be the responsibility of the contractor. Influenza Vaccination VHA Directive 1192 requires all health care personnel (HCP) to participate in the seasonal influenza prevention program and outlines the key implementation steps. Health care personnel is defined in VHA Directive 1192 as all VA licensed and unlicensed, clinical and administrative, paid and unpaid, full- and part-time employees, intermittent employees, fee basis employees, VA contractors, students, researchers, volunteers, and trainees who work in VHA locations. HCP covered by the policy are expected to receive annual influenza vaccination. This requirement is extended to all Contractor personnel with potential to come into minimal contact (passing in the corridor) with any patients, visitors, or staff members at VA Medical Center s. Those individuals unable or unwilling to be vaccinated are required to wear a face mask throughout the influenza season. Masks are available at entrances throughout the medical center. It is the responsibility of the contractor to ensure that all contract staff is compliant with the requirements outlined in VHA Directive 1192. The contractor shall maintain the following documentation: - Documentation of vaccination, e.g., signed record of immunization from a health care provider or pharmacy, or a copy of medical records documenting the vaccination. - Completed Health Care Personnel Influenza Vaccination Form (Attachment B of VHA Directive 1192) if unwilling or unable to receive the vaccine. The contractor is required to submit annual certification in the form of a memorandum to the Contracting Officer s Representative (COR) that all contract staff performing services at VA facilities is in compliance with VHA Directive 1192. Tuberculosis Prevention Standard Personnel Testing (PPD, etc.): Contractor shall provide proof of the following tests for personnel within five (5) calendar days after contract award and prior to the first duty shift to the COR and Contracting Officer. Tests shall be current within the past year. TUBERCULOSIS TESTING: Contractor shall provide proof of a negative reaction to PPD testing for all contract personnel. A negative chest radiographic report for active tuberculosis shall be provided in cases of positive PPD results. The PPD test shall be repeated annually. Smoking All VA Philadelphia property is smoke-free. Contractor personnel will comply with VA Philadelphia smoking policies. Violations will result in a warning and possible citation. COVID-19 Upon entering CMCVAMC, per CDC and federal regulations, all personnel must wear the required PPE while on-site; at a minimum this includes a cloth mask. PPE will not be provided by CMCVAMC. All individuals are required to enter through the main entrance for temperature screening. If Contractor s temperature exceeds the designated threshold, they will be asked to leave. In the event of an FSE being forced to vacate the premises, they shall notify the necessary Biomedical Engineering staff and provide a contact for a replacement. Instructions to Vendors: The information identified above is intended to be descriptive, of the Brand Name only - Abbott Molecular Inc., for all supplies related to STI and SARS-COV2 testing on the Alinity M platform, to indicate the quality of the supplies/services that will be satisfactory. It is the responsibility of the interested source to demonstrate to the government that the interested parties can provide the supplies/services that fulfill the required specifications mentioned above. Responses to this RFI should include company name, address, point of contact, phone number, and point of contact e-mail, DUNS Number, Cage Code, size of business pursuant to North American Industrial Classification System (NAICS) 334516. Please answer the following questions: Please indicate the size status and representations of your business, such as but not limited to: Service-Disabled Veteran Owned Small Business (SDVOSB), Veteran Owned Small Business (VOSB), Hubzone, Woman Owned Small Business (WOSB), Large Business, etc.)? Is your company considered small under the NAICS code identified under this RFI? Are you the manufacturer, distributor, or an equivalent solution to the items being referenced above? (4) If you are a large business, do you have any designated distributors? If so, please provide their company name, telephone, point of Contact and size status (if available). (5) Describe how your small business takes ownership of the equipment in the manufacturing, assembly, or delivery process. (6) If you re a small business and you are an authorized distributor/reseller for the items identified above or an equivalent solution, do you alter; assemble; modify; the items requested in any way? If you do, state how and what is altered; assembled; modified? (7) If you intend to subcontract any work on this contract, what portion of the total cost will be self-performed/will be performed by your organization? Please provide estimated detailed percentage breakdowns related to subcontracted work and completion of job. (8) Does your company have an FSS contract with GSA or the NAC or are you a contract holder with any other federal contract? If so, please provide the contract number. (9) If you are an FSS GSA/NAC contract holder or other federal contract holder, are the items/solution you are providing information for available on your schedule/contract? (9) General pricing of your products/solution is encouraged. Pricing will be used for the purpose of market research only. It will not be used to evaluate for any type of award. (10) Please submit your capabilities regarding the brand name equipment. (11) Please review salient characteristics/statement of work (if applicable) and provide feedback or suggestions. If none, please reply as N/A. This RFI will be conducted in accordance with Federal Acquisition Regulation (FAR) Part 8. Responses must be received via e-mail to contact@example.gov no later than, 4 PM Eastern Standard Time (EST) on July 17, 2024, this notice will help the VA in determining available potential sources only. Reference 36C24424Q0836 in the subject of the email response. Do not contact VA Medical Center staff regarding this requirement, as they are not authorized to discuss this matter related to this procurement action. All questions will be addressed by the Contracting Specialist, David Santiago. All firms responding to this Request for Information are advised that their response is not a request for proposal, therefore will not be considered for a contract award. If a solicitation is issued, information will be posted on the beta.SAM web site for all qualified interested parties at a later date and interested parties must respond to this Intent to Sole Source Notice to be considered for a set-aside. This notice does not commit the government to contract for any supplies or services. The government will not pay for any information or administrative cost incurred in response to this Request for Information. Information will only be accepted in writing by e-mail to Contracting Specialist at contact@example.gov DISCLAIMER This RFI is issued solely for information and planning purposes only and does not constitute a solicitation. All information received in response to this RFI that is marked as proprietary will be handled accordingly. Responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI.