SPECIAL NOTICE
65 -- INTENT TO SOLE SOURCE. Brand Name Only. ABIOMED Impella 5.5 Catheters #0550-0008 This is NOT a Request for Quotes.
- Notice Date
- 5/24/2022 1:32:20 PM
- Notice Type
- Special Notice
- NAICS
- 339112
— Surgical and Medical Instrument Manufacturing
- Contracting Office
- 244-NETWORK CONTRACT OFFICE 4 (36C244) PITTSBURGH PA 15215 USA
- ZIP Code
- 15215
- Solicitation Number
- 36C24422Q0768
- Archive Date
- 06/23/2022
- Point of Contact
- David Santiago, Contract Specialist, Phone: 412-822-3746
- E-Mail Address
-
david.santiago2@va.gov
(david.santiago2@va.gov)
- Awardee
- null
- Description
- STATEMENT OF NEED General Scope The Department of Veteran Affairs VISN 04 Network has determined the need to establish a VISN wide strategic sourcing procurement for the purchase of Abiomed Impella 5.5 US Catheters (Part# 0550-0008), which is usually procured under emergent situations. A delivery order will be established for a duration of three years and will be placed against OEM Abiomed, Inc. current Federal Supply Schedule (FSS) 36F79719D0138. The delivery order shall consist of three ordering periods with each ordering period containing ten (10) CLINS with a quantity of one (1) Catheter per Line Item. The delivery order will have an initial purchase of two (2) catheters to activate the first two (2) Line Items and Base ordering period. All other ordering periods and Line Items are optional and are based on the need of the station and the availability of funds and will be placed against the delivery order as a modification to activate the next Line Item or Line Items in sequence depending on the quantity needed by the station. This will allow for an expedited procurement process for the customer and the acquisition force. Background The Abiomed Impella 5.5 with SmartAssist catheter is a disposable component of an Impella driver/controller system currently utilized at the VA Healthcare System. This Item is required/specific for high risk Cardiac/Coronary interventions. These are used in critically ill patients during acute coronary intervention to support the ventricular function of the heart and helping reduce cardiogenic shock. Item Specifications: The Catheter is a sterile tubular device with a built in electrically powered axial flow pump. The distal end designed to provide circulatory assistance to the heart by pumping blood during heart failure. It is inserted through the lumen of the aorta and into the left ventricle, surgically or percutaneously via an artery. Then connected to an external control unit that moves blood from the left ventricle to the aorta across the aortic valve. The Impella 5.5 with SmartAssist heart pump delivers full cardiac support, allowing the heart to rest and enabling the heart to achieve its natural pumping function without additional support. The heart pump is designed for long-duration support, enabling patient mobility, and optimizing recovery by using real-time intelligence. Used during cardiogenic shock, the Impella 5.5 will support the heart s pumping function, providing blood and oxygen to vital organs. This Catheter is typically used emergently post-acute myocardial infarction, electively for high-risk cardiac catheterizations for open chest surgery. This component is used in conjunction with the Impella device and has a clear indication for Cardiogenic Shock and is used as an assist device in such cases to stabilize the patient for transfer to a critical care facility. This catheter must be compatible with the Abiomed Automated Impella Controller. The Automated Impella Controller is the primary user control interface for the Impella platform featuring a 10-inch high-resolution display. It controls the Impella catheter performance, monitors for alarms, and displays real-time hemodynamic and catheter position information. Period of Performance The Delivery Order shall be valid for three years and consist of three ordering periods. Base Ordering Period. Ordering Option Period 1. Ordering Option Period 2. Delivery: Contractor shall complete delivery immediately upon receipt of order unless otherwise specified. Contractor shall deliver to any of the following locations, order will specify exact location. VA Pittsburgh Healthcare System University Drive Campus University Drive C Pittsburgh, PA 15240 VAMC Wilkes Barre, 1111 East End Blvd, Wilkes Barre, PA 18711. Wilmington VA Medical Center 1601 Kirkwood Highway Wilmington, DE 19805 Corporal Michael J. Crescenz Philadelphia VA Medical Center 3900 Woodland Ave. Philadelphia, PA 19104 Lebanon VA Medical Center 1700 South Lincoln Ave. Lebanon, PA 17042 Altoona-James E. Van Zandt VA Medical Center 2907 Pleasant Valley Boulevard Altoona, PA 16602 VA Butler Healthcare 353 N. Duffy Rd, Butler, PA 16001 Erie VA Medical Center 135 East 38th Street, Erie, PA 16504 Coatesville VA Medical Center 1400 Blackhorse Hill Rd, Coatesville, PA 19320 Instructions The information identified above is intended to be descriptive, of the BRAND NAME ONLY - Abiomed Impella 5.5 US Catheters (Part# 0550-0008) 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) 339112. 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? 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? 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 13. Responses must be received via email to david.santiago2@va.gov no later than, 4 PM Eastern Standard Time (EST) on Wednesday June 1, 2022. This notice will help the VA in determining available potential sources only. Reference 36C24422Q0768 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 the solicitation 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 email to Contracting Specialist at david.santiago2@va.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.
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