6515-- NX EQ Thulium Fiber Laser (VA-27-00003102)

DESCRIPTION

The Veterans Health Administration (VHA) Non-Expendable Equipment National Program has identified Olympus SOLTIVE Premium Super Pulsed Laser System: Laser: Thulium Fiber product line as a candidate for a VA-wide (otherwise referred to as national ) single Requirements contract award.

The Department of Veterans Affairs (VA), Office of Acquisition, Logistics, and Construction (OALC) Enterprise Procurement Office (EPO) on behalf of VHA is issuing this Request for Information (RFI) in accordance with the Revolutionary Federal Acquisition Regulation (FAR) Overhaul (RFO) 10.001(b) to determine the availability and technical capabilities of qualified sources. The period of performance will consist of a base of 12-months with four 12-month option periods from the date of award.

The EPO in conjunction with VHA is seeking a qualified source to provide Olympus SOLTIVE Premium Super Pulsed Laser System: Laser: Thulium Fiber or equal on an agency wide basis. The VA intends to award a Brand Name or Equal (BNOE) single award Requirements contract for this requirement in accordance with RFO 16.503. Vendors will be required to deliver Olympus SOLTIVE Premium Super Pulsed Laser System: Laser: Thulium Fiber or equal to VHA facilities throughout the Continental United States (CONUS) and Outside of the Continental United States (OCONUS) (OCONUS includes locations of Alaska, Hawaii, Puerto Rico, Virgin Islands, Guam, Philippines, American Samoa, and Northern Mariana Islands).

The anticipated period of performance is for one (1) 12-month base period with four (4) 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 Contractor must demonstrate the ability to meet all requirements for the solicitation.

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 RFO Provision found at 52.204-7(b)(1) requires that The Offeror shall have an active Federal Government contracts registration in the System for Award Management (SAM) when submitting an offer or quotation in response to this solicitation and at the time of award. 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 quote 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 Notice 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

Laser: Thulium Fiber medical lasers are used for ureteric and kidney stone management, flexible ureteroscope. This has both diagnostic and therapeutic procedure capabilities allowing for minimally invasive stone management without breaking the skin barrier. It conducts procedures to diagnose and treat soft tissue conditions, including the management of benign prostate hyperplasia (BPH). These lasers ablate tissue with minimal hemostasis, little charring, and a thin zone of necrosis.

The following Contract Line Items are being considered:

Contract Line Items

Manufacturer

Part Number

Description

0001

Olympus

TFL-PLS-KIT

Soltive Premium Super Pulsed Laser system with Wired/Wireless FS

0002

Olympus

TFL-SLS-KIT

Soltive Pro Super Pulsed Laser system with Wired/Wireless FS

0002

Olympus

TC-L

Soltive TC-L Compact Trolley Set

0004

Olympus

Training

Training

0005

Olympus

Installation

Installation

0006

Olympus

Warranty

Olympus US Government-Tailored Limited Warranty one-year

The VA is seeking vendors who can provide Olympus SOLTIVE Premium Super Pulsed Laser System or equal as listed above which meet all the salient characteristics listed below. Vendors may quote any product solution or configuration so long as they meet the salient characteristics. Products quoted in the technical volume must be captured on the Vendor s pricing volume (Attachment A, Price Cost Schedule) of the solicitation. Vendors may quote any additional ancillary products which they deem to be essential to the functionality of the quoted solution; these items must be captured in the Vendor s pricing volume with a quantity of zero.

CLIN s 0001-0006 apply to the following SC s 1-6

SC #

SALIENT CHARACTERISTICS

METHOD OF EVALUATION

SC 1

Must offer laser fibers as small as 150 µm.

Literature Review

SC 2

Laser radiation emission must be at a wavelength of 1900 nm to 1990 nm/1.9µm to 1.99µm.

Literature Review

SC 3

Must have a low pulse energy mode in Joules (J) of 1J or less.

Literature Review

SC 4

Must offer a range of pulse frequencies from 1 Hz to at least 2,300 Hz.

Literature Review

SC 5

Must have Footswitch for operation.

Literature Review

SC 6

Must be FDA 510(k) Approved

Literature Review

Evaluation Sub-factors

1. Design: Design features and function will be evaluated based on, but not limited to, the following:

Wireless FootswitchÂ

Password protection Â

Clinical applicationsÂ

Power output adjustability

Size and weight

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

1. Fiber sizes

2. Stone Dusting

3. Fiber tips

4. Pulse width

5. Aiming beam

6. Thermal Effect reduction

7. Wavelength size

8. Ease of use

3. Safety: The device will be assessed for patient safety features, including, but not limited to, the following areas:

Emergency Stop button

Fiber-detection automatic shutter

4. Quality/Construction/Training:

Warranty Terms and Conditions

Extended Warranty options

Maintenance and service optionsÂ

Training Options

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 (OEM) 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:

Does vendor offer an annual service plan, Yes or No?

If Yes:

What does the plan cover?

Does the plan cover software updates only?

Does the plan cover parts repair or replacement only?

Does the plan cover both software and parts?

If applicable, vendors are requested to provide documentation that shows information on their service plan.

Is the service provided by the OEM or a subcontractor?

Full name and address of company

SAM Unique Entity Identifier (UEI) / CAGE Code

Business Size

Manufacturer or Distributor

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

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 salient characteristics and page numbers where each salient characteristic is met.

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

Authorized Distributor Letter Certified by OEM dated within the last 12 months.

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

Contractors submitting capability statements in response to this RFI must specifically address the questions outlined above. Generic capability statements that do not directly pertain to this RFI will not be considered. Additionally, links requesting capability statements or further information will not be accessed. All responses must be submitted as a file attachment.