6515--NX EQ Extracorporeal Perfusion Pumps

Sources Sought Notice

Sources Sought Notice

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Sources Sought Notice

*= Required Field

Sources Sought Notice

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1.0 DESCRIPTION

The Veterans Health Administration (VHA) Non-Expendable Equipment National Program has identified the Terumo Extracorporeal Perfusion Pumps or equal product line as a candidate for an Enterprise-wide (otherwise referred to as national ) single Requirements contract award.

The Department of Veterans Affairs (VA) Office of Procurement, Acquisition and Logistics (OPAL) Strategic Acquisition Center (SAC) on behalf of VHA is issuing this Sources Sought in accordance with the FAR 10.002(b)(2) to determine the availability and technical capabilities of qualified sources.

The SAC in conjunction with VHA is seeking a qualified source to provide Terumo® brand name or equal Extracorporeal Perfusion Pumps on an agency wide basis. VA intends to award a Requirements Contract with Firm-Fixed Price (FFP) orders IAW FAR 16.503, Requirements Contract to a supplier of this equipment. Vendors will be required to deliver Extracorporeal Perfusion Pumps to VA medical centers and facilities throughout the United States.

The anticipated period of performance is for one 12-month base period with four 12-month option periods from the date of award. However, the Government's decision as to whether or not to continue with the contract, upon annual review, will be based upon successful performance during each previous year and continued need.

The associated North American Industrial Classification System (NAICS) code for this procurement is 334510 Electromedical and Eletrotherapeutic Apparatus Manufacturing and the associated size standard is 1250 employees. The FAR Provision found at 52.204-7(b)(1) requires that All interested Offerors must be registered in SAM prior to submitting an offer or proposal. You may access the SAM website at Home | SAM.gov. All offerors must be certified with the appropriate NAICS code on the SAM website. All SDVOSB/VOSB offerors must be verified in the Small Business Administration (SBA) database at Veteran Small Business Certification (VetCert) database at: Veteran Small Business Certification (sba.gov) at the time of proposal submission.

This notice is for planning purposes only and does not constitute a commitment on the part of the Government to award a contract, nor does the Government intend to pay for any information submitted as a result of this notice. This Sources Sought is part of a continuous process for obtaining the latest information on the commercial status of the industry with respect to their current and near-term abilities. The information provided herein is subject to change and in no way binds the Government to solicit for, or award, a competitive contract. It is emphasized that this is a notice solely for planning and informational purposes.

2.0 SCOPE

The Terumo Extracorporeal Perfusion Pumps or equal are designed for extracorporeal gas exchange and reinfusion of blood, typically during heart-lung bypass procedures. These pumps (known as extracorporeal perfusion or arterial pumps) consist of either a mechanism that uses centrifugal force (i.e., centrifugal pump) or rollers that cyclically compress the arterial line tubing (i.e., roller pumps). Extracorporeal Perfusion Pumps typically receive blood from the vena cava and deliver it back through the aorta by means of a plastic cannula after processing the blood in an oxygenator/heat exchanger, bypassing the heart and lungs completely. Both a backup arterial pump and connection to an emergency power system are necessary to ensure reliable pump operation.

The following Contract Line Items are being considered:

Contract Line Item#

Brand

Part Number

Description

0001

Terumo

816571

Roller Pump, 6" (15.2 cm) Diameter

0002

Terumo

816570

Roller Pump, 4" (10.2 cm) Diameter

0003

Terumo

801093

Pole Mount Pump Rest with Bracket

0004

Terumo

816477

Dual Pumps Pole Mount Bracket

0005

Terumo

816483

Descending Pole Mount Pump Bracket

0006

Terumo

164267

Drive Motor

0007

Terumo

816571

Control Unit

0008

Terumo

164268

Manual Drive

0009

Terumo

804372

Pole Mount Centrifugal Display Bracket

0010

Terumo

816620

Flexible Mounting Arm

The VA is seeking vendors who can provide Terumo Extracorporeal Perfusion Pumps or equal as listed above which meet all the following salient characteristics (SC): Vendors may offer any product solution or configuration so long as they meet the SC s. Products offered in the technical volume must be captured on the Vendor s pricing volume (Attachment A, Price Cost Schedule) of the solicitation. Vendors may offer any additional ancillary products which they deem to be essential to the functionality of the proposed solution; these items must be captured in the Vendor s pricing volume with a quantity of zero.

CLIN 0001 applies to SC1

CLIN 0002 applies to SC2

CLINs 0001-0002 applies to SC3

CLINs 0003-0006 applies to SC6

CLINs 0006-0007 applies to SC5

CLIN 0008 applies to SC4

CLINs 0009-0010 applies to SC7

SC #

SALIENT CHARACTERISTICS

METHOD OF EVALUATION

SC 1

Roller pump with 6-inch head diameter capable of a flow rate of 0-10 L/min

Literature Review

SC 2

Roller pump with 4-inch head diameter capable of a flow rate of 0-4 L/min

Literature Review

SC 3

Capable of pulsatile flow

Literature Review

SC 4

Hand crank option for emergency operation

Literature Review

SC 5

Centrifugal pump capability with adjustable RPMs

Literature Review

SC 6

Brackets/hardware for mounting roller pumps to a heart-lung bypass cart

Literature Review

SC 7

Brackets/hardware for mounting centrifugal pump and control unit to a heart-lung bypass cart

Literature Review

Sub-factors

Safety

Safety features and functions of the offered equipment will be evaluated. Areas may include but are not limited to the following:

FDA Approval

Single-Directional Hand Crank for Roller Pumps

Sensors with applicable Visual and Audible Alerts, including Alarm Messages

Design

Design features and functions of the offered equipment will be evaluated. Areas may include but are not limited to the following:

Supports Customization/Modular Configuration for all Major Brands

Supports Pole Mounting and/or Mounting at the Base of the Heart-Lung Bypass System

Localized Control Settings (Directly on Pump) and/or via Heart-Lung Bypass System Control Center

Capable of Pulsatile Flow

Performance

Equipment will be evaluated for its ability to perform its intended function. Areas may include but are not limited to:

Flow Rates

Workflow Integration

Quality/Construction

Aspects of the construction and quality of material of the equipment will be evaluated and may include but not limited to:

Life Span/Warranty

Equipment Integration

Maintenance Requirements

Service Program

Training

For each product (brand name and part number), the response must include descriptive literature demonstrating the product meets or exceeds the SCs specified above.

The Government's intent is to include all ancillary items to ensure the equipment can function as designed by the Original Equipment Manufacturer and as clinically required. Vendors are encouraged to provide any product solution or configuration so long as they meet the SCs. Additionally, responses can include any additional product that may be beneficial. These items must be clearly identified by brand name and part number.

Responses to this Sources Sought Notice shall include the following:

Full name and address of company;

Unique Entity Identifier (UEI) number;

Business Size;

Manufacturer or Distributor;

If distributor provide full name, business size and address of manufacturer .

Country of Origin designation for all products;

Ability to provide uninterrupted supply of products on a national scale;

Technical Literature that clearly shows product(s) meet the identified SCs (if submitting an or-equal item);

Any additional product solution or configuration that would be beneficial to the clinical functionality of the product line identified.

Although not required, vendors responding to this Sources Sought may also submit a Capabilities Statement.