Impella 2.5 CP Pump and Accessories Ventricular Assist Device System
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65- Sources Sought Notice for Impella 2.5 and Accessories
Sources Sought Notice: 36C25219Q0092
DUE: December 19th, 2018, at 1:00 pm CST
SET ASIDE: Unrestricted until market research closes
NAICS: 339112 (Surgical and Medical Equipment Manufacturing)
SIZE STANDARD: 1,000 employees
REQUESTING AGENCY: Network Contracting Office 12, Great Lakes Acquisition Center, 115 S. 84th Street, Suite 101, Milwaukee, WI 53214
Mail all responses only to: Shari Lee at shari.lee@va.gov
The Great Lakes Acquisition Center, NCO 12, is seeking information regarding this Sources Sought notice. This request is for informational and planning purposes only and shall not be construed as a solicitation or as an obligation or commitment by the Government at this time. This notice is intended strictly for market research. The purpose of this Sources Sought notice is to determine interest and capability of potential qualifications of Small Businesses, Service Disabled Veteran-Owned Small Businesses, and Veteran-Owned Small Business firms relative to the North American Industry Classification Code (NAICS) 339112 (Surgical and Medical Equipment Manufacturing).
The Department of Veteran s Affairs is seeking small business manufacturer or distributors of small business manufacturers, of functionally equivalent equipment to all the following:
1. Items and Parts Needed: (Brand Name or Equal) Ventricle Assist Device System (Impella 2.5 CP Pump Sets and accessories)
Monitors for existing Draeger Fabius Tiro Anesthesia Machines
(Quantity) (Part Number) (Description)
#1. (Quantity of 2) (0048-0003) (Impella CP Pump Set, US)
#2. (Quantity of 2) (0042-0000-US) (Automated Impella Controller, US)
#3. (Quantity of 2) (0042-0020) (Assembly, Cart, Impella Controller)
#4. (Quantity of 2) (0042-0020) (Assembly, Cart, Impella Controller)
#5. (Quantity of 1) (0043-0003) (Purge Cassette 5 Pack)
#6. (Quantity of 1) (0042-0002) (AIC Connector Cable)
The Clement J. Zablocki VA Medical Center located in Milwaukee, WI 53295-1000 has a need to acquire (2) Impella CP Pumps Sets and Accessories. The Impella 2.5 is a Circulatory Support System that will help save Veteran patient lives. The equipment will be used on High Risk PCI (Percutaneous Coronary Intervention) patients that are too risky for intervention surgery (i.e. stent placement). This system will allow the VA to operate on patients who otherwise could not be operated on. The system utilizes a specialized catheter with a pump motor that can hemodynamically stabilize the body during cardiac intervention. It essentially moves blood out of the chambers of the heart to the organs in the body while the heart is operated on or allowed to recover from traumatic stresses. Procurement of this system will allow the VA to see an additional 10-12 patients that could not otherwise be treated in house. Annually, this results in a far better continuity of care for some of our highest risk veterans. This will also be a savings for the Milwaukee VA Medical Center as the VA currently sends candidate patients out for outside medical care due to outdated systems currently in place.
Salient characteristics needed for the Monitors:
EQUIPMENT
The requirement is for a portable, non-bridge care, percutaneously inserted, ventricular assist device system (Quantity of 2) that can provide sufficient hemodynamic support during high risk percutaneous coronary intervention (PCI) in certain subsets of patients who typically have a very high chance of dying or experiencing major complications during surgery. The VA requires this technology to both improve patient outcome in certain heart care patients and retain of segment of patient care services that are typically fee-based out for community care to improve continuity of care and overall patient experience.
The required system must function in multiple scenarios such as high risk PCI, high risk Ventricular tachycardia ablations in cardiomyopathy patients, cardiogenic shock patients, and allow for salvage support in CABG patient that can not be easily wean-able from cardiopulmonary bypass.
The required system must support single vascular access placement (improved recovery for patient) and provide an additional flow/cardiac output of 3-4 l/min (improved outcome for patient) via direct unloading of the left ventricle chamber of the heart. Once placed and in operation, the system must not increase after-load on the heart muscle.
The required system must be FDA-cleared for partial circulatory support, high risk PCI, and AMI cardiogenic shock patients.
The system controller must be battery and line-power operable, with a low battery indicator.
EXTENDED WARRANTY SERVICES
The VA seeks 3 or 4 years of extended warranty and preventative maintenance services, beyond the initial warranty period, as part of this contract.
The extended warranty services shall match the services provided in the base year of the contract. These services, AT MINIMUM, must include:
All preventative and corrective maintenance required
- A PM turnaround time of 2 days or less
- All factory qualified parts
- Service loaner systems if covered equipment is not available for clinical use due to service related issues
- All labor, round trip shipping via FedEx Priority, packaging material
- Ensured compliance to Regulatory requirements
- 24 hour phone support
- Full equipment history including service reports and data sheets, available upon request by VA staff
- Factory revisions implementing up-to-date quality improvements
- One free rental, up to 30 days, per contract year for each covered system
TRAINING:
On site training shall be provided by vendor as required, for an unlimited number and type of VA staff, ranging from physicians, to technologists, to nurses, for the duration of the contract.
The place of performance is Department of Veterans Affairs, Clement J Zablocki VA Medical Center, 5000 W. National Avenue, Milwaukee, WI 53295-1000.
** To prevent Gray Market Items within the VA, the following is also placed within this source sought notice: **
(a) Gray market items are Original Equipment Manufacturers (OEM) goods sold through unauthorized channels in direct competition with authorized distributors. This procurement is for new OEM medical supplies, medical equipment and/or services contracts for maintenance of medical equipment (i.e. replacement parts) for VA Medical Centers.B No remanufactures or gray market items will be acceptable.
B (b) Vendor shall be an OEM, authorized dealer, authorized distributor or authorized reseller for the proposed medical supplies, medical equipment and/or services contracts for maintenance of medical equipment (i.e. replacement parts), verified by an authorization letter or other documents from the OEM, such that the OEM s warranty and service are provided and maintained by the OEM.B All software licensing, warranty and service associated with the medical supplies, medical equipment and/or services contracts for maintenance of medical equipment shall be in accordance with the OEM terms and conditions.
(c) The delivery of gray market items to the VA in the fulfillment of an order/award constitutes a breach of contract.B Accordingly, the VA reserves the right enforce any of its contractual remedies. This includes termination of the contract or, solely at the VA s election, allowing the Vendor to replace, at no cost to the Government, any remanufactured or gray market item(s) delivered to a VA medical facility upon discovery of such items.B
**Offers must respond to this sources sought notice with their authorization letter from the OEM. If you respond favorably with no authorization letter within your email, your response will not and cannot be counted as any possible set-aside. The Contracting Officer will verify that each response is legitimate and verifiable.
THIS IS NOT A SOLICITATION AND DOES NOT OBLIGATE THE GOVERNMENT TO ISSUE A SOLICITATION. Please be advised that the Government will not pay for any information submitted under this announcement. The applicable North American Classification System (NAICS) Code for this requirement is 339112 (Surgical and Medical Equipment Manufacturing), and the small business size standard is 1000 employees. Email should contain the following information: Name of firm, full Socio-Economic category of the firm, complete address, phone & fax number of contact and SAM expiration dates. Please reply to shari.lee@va.gov and place 36C25219Q0092 Impellla 2.5 and Accessories in the title line within the email. All authorized distributors MUST provide authorized distributorship letter when responding, so determination of any set-aside can be made. All responses are due by December 19th, 2018, at 1:00 pm CST. Email to shari.lee@va.gov is the only way to respond to this request.
**Note: All SDVOSB/VOSB vendors who are also authorized distributors who plan on competing for this stated acquisition must be VIP Verified at https://www.vip.vetbiz.gov/. To properly apply the VA Rule of Two 38 U.S.C. 8127 (d) Supplies and Services to procurements for SDVOSB/VOSB set-asides, Contracting Officers are required to verify that all SDVOSB/VOSBs who are interested parties are VIP Verified during entire acquisition process. Thank You**
Shari Lee
shari.lee@va.gov
Contracting Officer
