Impella CP pump

Added: Sep 13, 2017 11:11 am

Page 2 of 6

Table of Contents

SECTION B 2

B.1 PRICE/COST SCHEDULE 2

Item Information 2

B.2 FOB POINT: Destination 3

B.3 DELIVERY SCHEDULE 3

SECTION C 3

C.1 INSTRUCTIONS TO OFFERORS 3

C.2 SALIENT CHARACTERISTIC 5







This document is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation, proposals are being requested, and a written solicitation will not be issued.



The evaluation of offers received in response to the solicitation will use a tiered or cascading order of precedence. Tiered evaluation of offers, also known as cascading evaluation of offers, is a procedure used in negotiated acquisitions when market research is inconclusive for justifying limiting competition to small business concerns or sub-categories of small business concerns. The contracting officer

(1) Solicits offers from both small and other than small business concerns that will be evaluated in the following tier order:

(a) service-disabled veteran-owned small business (SDVOSB);

(b) veteran-owned small business (VOSB);

(c) all other small business concerns;

(d) other than small business.

(2) If an award or a sufficient number of awards cannot be made at the first tier, evaluation of offers will proceed at the next lower tier until an award or a sufficient number of awards can be made.



The proposed contract action is for supplies or services for which the Government intends to solicit. Interested persons may submit offers, and all eligible offers received prior to 1:00 PM PDT September 15th, 2017 will be considered by the Government. The NAICS code is 334510 and the size standard is 500 Employees.

This solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-89 effective, July 14, 2016.

Products shall be supplied in accordance with the specifications, terms and conditions contained herein. In addition, the following FAR and VAAR clauses will also apply. Thank you.



VA San Francisco Healthcare System

4150 Clement Street

San Francisco, CA 94121-1545



requires the following items, Salient characteristics:



SECTION B

B.1 PRICE/COST SCHEDULE



Item Information

ITEM NUMBER

DESCRIPTION OF SUPPLIES/SERVICES

QUANTITY

UNIT

UNIT PRICE

AMOUNT

0001

IMPELLA CP PUMP SET, US

3

EA





















GRAND TOTAL







B.2 FOB POINT: Destination



B.3 DELIVERY SCHEDULE



ITEM NUMBER

QUANTITY

DELIVERY DATE

ALL



VA San Francisco Healthcare System

4150 Clement Street

San Francisco, CA 94121-1545



All Quantities

30 DAYS ARO



SECTION C



C.1 INSTRUCTIONS TO OFFERORS



Only electronic offer will be accepted. Offers are due by 1:00 PM PDT September 15th, 2017.



Alternate system submission: Offerers submitting alternate items must provide technical information sufficient for a lay person to determine acceptability. Information will not be paid for by the government nor returned to the supplying party. The information will be used to determine product acceptability. Lack of sufficient information for our staff to determine product acceptability will result in a negative determination. Any quote will then be found non­responsive to the solicitation and the quote will not be considered.



New Equipment ONLY; NO remanufactured, used/refurbished or "gray market" items. All items must be covered by the manufacturer's warranty. No product in development shall be considered.



Authorized dealers: Experienced firms only who are authorized dealers will be considered in addition to the original equipment manufacturer. A letter from the manufacturer stating your company is an authorized dealer for the line items must be in possession by the due date and be available for submission, if requested.



FAR 52.212-2 EVALUATION--COMMERCIAL ITEMS (OCT 2014)

(a) The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price

and other factors considered. The following factor shall be used to evaluate offers:

The Government will award to the lowest price, technically acceptable offeror. Brand name or equal.

(b) Options. The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option(s).

(c) A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer's specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award.

(End of Provision)

ADDITIONAL SOLICITATION PROVISIONS/CONTRACT CLAUSES:



FAR 52.252-2 Clauses Incorporated by Reference (Feb 1998) For the purpose of this clause, the fill-ins are

http://www.acquisition.gov/far/index.html (FAR) and http://www1.va.gov/oamm/oa/ars/policyreg/vaar/index.cfm (VAAR), respectively.



FAR 52.212-4 Contract Terms and Conditions -- Commercial Items (FEB 2012).



FAR 52.212-5 Contract Terms and Conditions Required To Implement Statutes Or Executive Orders -- Commercial Items For the purposes of this clause, items (b) 4, 8, 14, 21 (if SDVOSB/VOSB),22, 25, 26, 27, 28, 30, 33, 42, 45, 46 (iii), 48, 55 are considered checked and apply.



VAAR 819.7003 Class Deviation from VAAR 819.7003, Eligibility



VAAR 852.203-70 Commercial Advertising (Jan 2008)



VAAR 852.232-72 Electronic Submission of Payment Requests (November 2012)



FAR 52.252-1 Solicitation Provisions Incorporated by Reference (FEB 1998) http://www.acquisition.gov/far/index.html (FAR) and

http://www.va.gov/oamm/oa/ars/policyreg/vaar/index.cfm (VAAR)



FAR 52.212-1 Instructions to Offerors - Commercial Items (Oct 2015).



FAR 52.212-3 Offeror Representations and Certifications -- Commercial Items (Aug 2011): Offerors must return this provision with their proposal. They may either (1)complete all relevant portions of the provision or (2) complete paragraph (b) of the provision and indicate that it has completed official representations and certifications online at https://orca.bpn.gov/login.aspx.





C.2 SALIENT CHARACTERISTIC

Brand Name



Brand Name Item:

JUSTIFICATION FOR SINGLE SOURCE AWARDS IAW FAR 13.106-1

(OVER MICRO-PURCHASE THRESHOLD($3K) BUT NOT EXCEEDING THE SAT ($150K))

IAW FAR13.104, COs must promote competition to the maximum extent practicable to obtain supplies and services from the source whose offer is the most advantageous to the Government, considering the administrative cost of the purchase. When competition is not practicable, IAW FAR13.106-1(b), COs solicit from a single source for purchases not exceeding the simplified acquisition threshold. COs may solicit from one source if the CO determines that the circumstances of the contract action deem only one source reasonably available (e.g., urgency, exclusive licensing agreements, brand-name or industrial mobilization). IAW FAR13.106-3(b)(3),COs are required to include additional statements explaining the absence of competition (see 13.106-1 for brand name purchases) if only one source is solicited and the acquisition does not exceed the simplified acquisition threshold (does not apply to an acquisition of utility services available from only one source) or supporting the award decision if other than price-related factors were considered in selecting the supplier. This template when completed can be used to document single source awards IAW FAR13.106-3(b)(3). Note: Statements such as "only known source" or "only source which can meet the required delivery date" are inadequate to support a sole source purchase.

1. ACQUISITION PLAN ACTION ID:

662-17-2-069-0628

1A. PROJECT/TASK No.

1B. ESTIMATED AMOUNT:

2. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES REQUIRED AND THE INTENDED USE:

This item is used to provide Hemodynamic mechanical support for high-risk cardiac procedures in the cardiac cath lab. The Impella CP offers a high flow rate for patients who require higher levels of hemodynamic support.







3. UNIQUE CHARACTERISTICS THAT LIMIT AVAILABILITY TO ONLY ONE SOURCE, WITH THE REASON NO OTHER SUPPLIES OR SERVICES CAN BE USED:

No other vendor makes a comparable product to the Impella CP Catheter. Abiomed s two primary competitors Heartware and Thoratec Corporation do not offer the needed catheter. Their representatives have confirmed that these products were not offered.



4. REASON THAT SUGGESTED SOURCE IS THE ONLY SOURCE, WHICH CAN PROVIDE THE SUPPLIES OR SERVICES:

The Impella is a unique percutaneous cardiac assist device that allows the safe performance of high-risk cardiac procedures. Abiomed, Inc is the only vendor that manufactures and distributes the Impella devices, so sole source is appropriate for purchasing this equipment.



5. DESCRIPTION OF MARKET RESEARCH CONDUCTED AND RESULTS OR STATEMENT WHY IT WAS NOT CONDUCTED:

Multiple companies were contacted to ensure that none provided a similar product that could be used in place of this product.





6. Contracting Officer's Certification: Purchase is approved in accordance with FAR13.106-1(b). I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief. Note: COs are required to make a determination of price reasonableness IAW FAR 13.106-3. See the Commercial Supply and Service SOP for Price Reasonableness templates.



Signature: ______________________________ Date:____________________

Name:__________________________________

Title:___________________________________ NCO:_________________________________