36C10G25Q0075.docx

Sources Sought Notice Sources Sought Notice

GENERAL INFORMATION

SET-ASIDE

OPAL | Strategic Acquisition Center

10300 Spotsylvania Ave | STE 400 Fredericksburg VA 22408-2697

POINT OF CONTACT*

Contract Specialist Levi Russin Levi.Russin@va.gov

PLACE OF PERFORMANCE

POSTAL CODE

ADDITIONAL INFORMATION

AGENCY CONTACT’S EMAIL ADDRESS

EMAIL DESCRIPTION

DESCRIPTION

1.0 DESCRIPTION

The Veterans Health Administration (VHA) Non-Expendable Equipment National Program has identified the Cryotherapy System: Tissue Ablation - Endoscopic product line as a candidate for the Department of Veterans Affairs VA-wide (otherwise referred to as “national”) Non Expendable Equipment (NX) 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 Varian® brand name or equal CryoCare Touch™ Tissue Ablation System 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 Cryotherapy System: Tissue Ablation - Endoscopic 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 Electrotherapeutic Apparatus Manufacturing and the associated size standard is 1,250 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

Cryotherapy Tissue Ablation Systems are used for Cryoablation, a process that uses extreme cold (cryo) to destroy or damage tissue (ablation) whereby producing tissue necrosis at temperatures well below the freezing point of water (typically less than -20 degrees Celsius/-4 degrees Fahrenheit) using minimally invasive procedures. These systems typically consist of a central unit that provides the cryogen and includes electronic and mechanical components to perform and control the ablation; tubing to deliver the cryogen; and a probe (e.g., an applicator, needle, cannula, or catheter) to apply the cryogen directly or indirectly to the tissue. Ablation occurs when the cryogenic substance or cryogenic probe contacts the tissue. As the cells freeze, ice crystals form inside the cell and the subsequent cycle of freezing and thawing that follows actually destroys the tissue cells. Specifically, Cryotherapy System: Tissue Ablation - Endoscopic equipment are intended for use in open, minimally invasive or endoscopic surgical procedures in the areas of general surgery, urology, gynecology, oncology, neurology, dermatology, ENT, proctology, pulmonary surgery, and thoracic surgery for prostate and kidney tissue, liver metastases, tumors, skin lesions, and warts.

The following Contract Line Items are being considered:

The VA is seeking vendors who can provide Varian Medical Systems® CryoCare Touch™ Tissue Ablation System or equal as listed above which meet all the following salient characteristics:

CLIN 0001 applies to SCs 1-5 CLINs 0002-0020 applies to SC 6 CLIN 0031 applies to SC 8

Evaluation Sub-factors:

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

· Power and Temperature Sensors

· Probe/Applicator/Needle Power Settings for Ice Formation Control

· Design – All design features and functions of the offered device will be evaluated. Areas may include but are not limited to the following:

· Centralized Control / Consolidated Touchscreen User Interface

· Availability of Various Probe/Applicator/Needle Sizes (length and gauged thickness)

· Supports the Simultaneous use of Multiple Probes/Applicators/Needles

· Cryo/Cooling System

· Availability of Distal Energy Control and “Ice-Ball” Formation

· Capable of Storing/Retrieving Case Logs

· Space Requirements / Footprint

· Performance – Device will be evaluated for its ability to perform its intended function. Areas may include but are not limited to:

· System Cart Mobility and Functionality

· Ease of Use / Streamlined Workflow

· Ability to be Sanitized Using Hospital Approved Disinfectants/Cleaners

· Quality/Construction – All aspects of construction and quality of material of the device will be evaluated. Areas may include but are not limited to the following:

· Life Span / Durability

· Training

· Service Program

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:

1) Full name and address of company;

2) Unique Entity Identifier (UEI) number;

3) Business Size;

4) Manufacturer or Distributor;

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

5) Country of Origin designation for all products;

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

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

8) 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.

Sources Sought Notice