6515--NX-Autolith Touch EHL Generator-Medical, GI Lab

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR Subpart 12.6 -- Streamlined Procedures for Evaluation and Solicitation for Commercial Items, in conjunction with FAR -- Part 13 Simplified Acquisition Procedures; and supplemented with additional information included in this notice.

This solicitation document and incorporated provisions and clauses are those in effect through the Federal Acquisition Circular 2020-02, dated November 22, 2019.

Solicitation # 36C26221Q0325 is issued as a Request for Quote (RFQ) and constitutes the only solicitation. The Government intends to award a single Firm-Fixed Price (FFP) award.

This procurement will be issued as an unrestricted solicitation in accordance with (IAW) FAR Part 13, Simplified Acquisition Procedures, specifically, Far Part 13.104 (b).

The Department of Veterans Affairs (VA), VISN 22 Network Contracting Office, is seeking sources that can provide Autolith Touch EHL Generator for VA Loma Linda Healthcare System: Delivery 120 Days ARO

M005466800

Autolith Touch EHL Generator

1

Ea.

M00546650

Spyglass DS- Digital Controller

1

Ea.

SALIENT CHARACTERISITCS -STATEMENT OF WORK (SOW)

FOR

SPYGLASS DIGITAL CONTROLLER

&

AUTOLITH TOUCH EHL GENERATOR

VETERANS HEATH ADMINISTRATION

APRL 19, 2021

*ALL ITEMS HEREIN THAT MENTION BRAND NAME PRODUCTS MAY BE SUBSTITUTED FOR A LIKE OR SIMILAR ITEM- AUTOLITH TOUCH ELECTROHYDROLITHOTRIPSY (EHL) GENERATOR AND SPYGLASS DS DIGITIAL CONTOLLER MUST BE COMPATIBLE WITH EACH OTHER*

1. INTRODUCTION

This solicitation is to provide the Veterans Health Administration, Endoscopy Department with one (1) Spyglass DS Digital Controller and one (1) Autolith Touch Electrohydrolithotripsy (EHL) Generator. The Spyglass Digital Controller is needed to allow physicians to perform Chol angioscopy during Endoscopic Retrograde Cholangiopancreatography (ERCP) procedures. The Autolith Touch EHL Generator is needed to be used in conjunction with Spyglass to assist in lithotripsy of large ductal stones. Autolith Touch Electrohydrolithotripsy EHL Generator and Spyglass DS Digital Controller are used together.

2. BACKGROUND

ERCP has been the standard technique for nonsurgical diagnosis and management of pancreaticobiliary disease over the past several decades. This method relies on indirect visualization, and ERCP diagnosis of pathologic lesions via brush cytology and/or intraductal biopsy has poor sensitivity and specificity. Spyglass offers a valuable adjunct to ERCP for the visualization, diagnostic sampling, and treatment biliary and pancreatic diseases. It should be considered for the first-line management of strictures and difficult stone disease prior to major surgery, and for use in presurgical planning.  Biliary Stones: During ERCP, it is not uncommon to find complicated biliary stones that are failed to be removed during mechanical lithotripsy. This is due to impacted stones, or they are wider than the diameter of the distal common bile duct. This may require more invasive removal techniques. However, with the Spyglass system, obstructing biliary duct stones are much more easily cleared because the Spyglass probe can allow directed Electrohydrolithotripsy to be performed which can fragment and remove the stones in a single procedure- all done endoscopically versus invasive surgical measures.  Diagnosing and Mapping Biliary Strictures: In addition to stone lithotripsy, Spyglass can overcome suboptimal visualization of biliary and pancreatic duct strictures. It can provide more accurate diagnostic sampling (where normal ERCP had been unable to detect abnormalities) for malignant strictures. Having the ability to accurately diagnose, target the proper treatment option, and potentially avoid unnecessary procedures through use of the Spyglass system is a clinical advantage.  Pancreatoscopy: Spyglass can facilitate successful pancreatoscopy to examine more advanced pancreatic disease or lesions that cannot be seen on an endoscopic ultrasound.Â

The Endoscopy Department does not currently have the ability to perform Spyglass Chol angioscopy/Pancreatoscopy and/or lithotripsy procedures. The Spyglass DS Digital Controller and Autolith Touch EHL Generator will allow the VA Hospital to perform these cases where they otherwise would have had to transfer the patient to another facility to access this technology. This will allow the VA to treat these patients in house without transfer and potentially reduce the number of procedures the patient endures.

3. SCOPE OF WORK

The contractor shall provide all equipment, tools, materials, supervision, and non-personal services necessary to provide generators and cabling.

4. TECHNICAL REQUIREMENTS

A. Salient Features for Generator:

110VAC

B. Installation:

1. The generators will be installed per the manufacture specifications.

2. All wiring and cables must be routed in a neat and orderly fashion.

3. Autolith Touch Electrohydrolithotripsy EHL Generator and Spyglass DS Digital

Controller must be compatible.

4. Autolith Touch Electrohydolithipsy EHL Generator must be able to use the Autolith

Touch 1.9Fr., 375cm EHL Probe is a single-use deviceÂ

5. DELIVERY & LOCATION INFORMATION

Delivery of generators will be shipped to:

Loma Linda VA Healthcare System

Gastroenterology Section

11201 Benton Street

Loma Linda, Ca 92357

The information identified above is intended to be descriptive, not restrictive and to indicate the quality and services that will be satisfactory. It is the responsibility of the interested source to demonstrate to the government that the interested parties can provide the services that fulfill the required specifications.

Provisions 52.212-1, Instructions to Offerors Commercial and 52.212-2, Evaluation Commercial Items are applicable to this acquisition. Furthermore, Provision 52.212-2 is utilizing the Lowest Price Technically Acceptable (LPTA) on an Acceptable/Unacceptable evaluation process.

Submitting Quote: Offeror(s) shall submit their quote on company letterhead and shall include the completed pricing forms, along with name, address, telephone number of the offeror, firm s DUNS#, total price and a completed copy of FAR Clause 52.212-3 Offerors Representations and Certifications - Commercial Items or a copy of offeror s annual offeror representations and certifications (ORCA) document from www.sam.gov as required by FAR Clause 52.212-3 Offerors Representations and Certifications - Commercial Items. As an alternative, Offeror(s) may use the Price/Cost Schedule of the attached SF 1449 for quote submission.

Submit all question(s) to La Tricia Williams at latricia.williams2@va.gov no later than May 4, 2021 by 12:00 Noon Pacific Standard Time (PST). Ensure to reference solicitation #36C26221Q0325 within subject line of the email.

Quotes must be received by May 5, 2021 by 3:00PM PST. Email your quote to La Tricia Williams at latricia.williams2@va.gov.Ensure to reference solicitation #36C26221Q0325 within subject line of the email. Quote(s)/offer(s) received after the prescribed deadline, shall be considered non-responsive and will not be considered for award.

CLAUSES

FAR Number

Title

Date

52.209-6

PROTECTING THE GOVERNMENT S INTEREST WHEN SUBCONTRACTING WITH CONTRACTORS DEBARRED, SUSPENDED, OR PROPOSED FOR DEBARMENT

AUG 2013

52.212-4

CONTRACT TERMS AND CONDITIONS-- COMMERCIAL ITEMS

FEB 2012

52.212-5

CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS--COMMERCIAL ITEMS ALTERNATE II (JUL 2012)

AUG 2012

52.232-33

PAYMENT BY ELECTRONIC FUNDS TRANSFER SYSTEM FOR AWARD MANAGEMENT

JUL 2013

52.252-2

CLAUSES INCORPORATED BY REFERENCE

FEB 1998

52.232-40

PROVIDING ACCELERATED PAYMENTS TO SMALL BUSINESS SUBCONTRACTORS

DEC 2013

52.233-1

DISPUTES

MAY 2014

52.233-3

PROTEST AFTER AWARD

AUG 1996

852.203-70

COMMERCIAL ADVERTISING

JAN 2008

852.232-72

ELECTRONIC SUBMISSION OF PAYMENT REQUESTS

NOV 2012

852.237-70

CONTRACTOR RESPONSIBILITIES

APR 1984

852.211-73

852.215-70

BRAND NAME OR EQUAL (JAN 2008)

SERVICE-DISABLED VETERAN-OWNED AND VETERAN-OWNED SMALL BUSINESS EVALUATION FACTORS

JAN 2008

JUL 2016

PROVISIONS

52.211-6

52.212-1

BRANDNAME OR EQUAL

INSTRUCTIONS TO OFFERORS-COMMERCIAL ITEMS

AUG 1999

APR 2014

52.212-2

EVALUATION--COMMERCIAL ITEMS

OCT 2014

52.212-3

OFFEROR REPRESENTATIONS AND CERTIFICATIONS--COMMERCIAL ITEMS

NOV 2014