36C10G21Q0035.docx

Contract Opportunity Combined Synopsis/Solicitation Notice

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* = Required Field Contract Opportunity Combined Synopsis/Solicitation Notice NX EQ Cryotherapy Tissue Ablation Systems 22408-2697 36C10G21Q0035 05-28-2021

11:59 PM

EASTERN TIME, NEW YORK, USA

N 339112 U.S. Department of Veterans Affairs OPAL | Strategic Acquisition Center 10300 Spotsylvania Ave | STE 400 Fredericksburg VA 22408-2697 Contract Specialist Ninatile Bacote Ninatile.Bacote@va.gov 202-957-2173 Nationwide https://www.va.gov/opal/sac/index.asp

VA | OALC | OPAL | SAC

Ninatile.Bacote@va.gov Ninatile.Bacote@va.gov Solicitation Number:

36C10G21Q0035

Notice Type:

Combined Synopsis/Solicitation

Synopsis:

COMBINED SYNOPSIS/SOLICITATION

This is a combined synopsis/solicitation for brand name or equal commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, “Streamlined Procedures for Evaluation and Solicitation for Commercial Items,” as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued.

Solicitation number 36C10G21Q0035 is issued for this combined synopsis/solicitation; this solicitation is being issued as a Request for Quote (RFQ). This combined synopsis/solicitation incorporates provisions and clauses in effect through Federal Acquisition Circular (FAC) 2021-05, dated 10 March 2021.

Requirement Description:

VA has a requirement to purchase Cryotherapy Tissue Ablation Systems to deliver patient care at its VA Medical Centers around the country. Cryotherapy Tissue Ablation Systems are used for Cryoablation, a process that uses extreme cold (cryo) to destroy or damage tissue (ablation). Cryoablation is used in a variety of clinical applications using hollow needles (cryoprobes) through which cooled, thermally conductive, fluids are circulated through the system. Cryoprobes are inserted into or placed adjacent to tissue which is determined to be diseased in such a way that ablation will provide correction yielding benefit to the patient. When the probes are in place, the cryogenic freezing unit removes heat ("cools") from the tip of the probe and by extension from the surrounding tissues. Common applications of cryoablation is to ablate solid tumors found in the lung, liver, breast, kidney and prostate and for therapy intended to ablate particular tissues using catheterization procedures (e.g., cardiac). Specifically, Cardiac Cryoablation is a therapy that uses the removal of heat from tissue to treat cardiac arrhythmias. It restores normal electrical conduction by freezing the cardiac tissue or pathways that interfere with the normal distribution of the heart’s electrical impulses. Cardiac Cryotherapy Tissue Ablation Systems are being procured to address this requirement and allow integration and compatibility with current Cryotherapy Tissue Ablation Systems in use.

A single award Requirements contract will be awarded for the purchase of brand name or equal equipment in accordance with all terms, conditions, provisions, specifications, and schedule of this solicitation herein. Quotes shall contain the terms for cost/price and technical capabilities of the band name or equal equipment. The Government reserves the right to award without discussions.

The associated North American Industrial Classification System (NAICS) code for this procurement is 339112 – Surgical and Medical Instrument, Product Service Code: 6515 – Medical and Surgical Instruments, Equipment, and Supplies and the associated size standard is 1,000 employees. This procurement action is issued as full and open competition.

This acquisition is for a single award Requirements contract in accordance with FAR Part 16.5 for Medtronic® brand name or equal Cryotherapy Tissue Ablation Systems and related equipment and accessories as identified in ATTACHMENT A – NX EQ CRYOTHERAPY TISSUE ABLATION SYSTEMS – PRICE COST SCHEDULE. All interested companies shall provide a quote for all Contract Line Item Numbers (CLINs) listed in ATTACHMENT A – NX EQ CRYOTHERAPY TISSUE ABLATION SYSTEMS – PRICE COST SCHEDULE.

The ordering period is for one year with four 12-month option years. Delivery is FOB destination. Firm-Fixed Price Orders will be placed against this contract in writing and will provide the delivery locations, delivery dates and exact quantities.

The FAR provision at 52.212-1, Instructions to Offerors – Commercial, applies to this acquisition including attached addenda to the provision.

The FAR provision at 52.212-2, Evaluation -- Commercial Items, and the specific evaluation criteria as attached addenda also applies to this acquisition The Offeror is to include a completed copy of the provision at 52.212-3, Offeror Representations and Certifications -- Commercial Items, with its offer.

Clause at 52.212-4, Contract Terms and Conditions -- Commercial Items, applies to this acquisition and a statement regarding any addenda to the clause. Addendum is attached.

Clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders -- Commercial Items, applies to this acquisition and a statement regarding which, if any, of the additional FAR clauses cited in the clause are applicable to the acquisition. Addendum is attached.

All interested Offerors must be registered in the System for Award Management (SAM) prior to submitting an offer or quotation. You may access SAM at https://sam.gov/SAM/.

Questions regarding this combined synopsis/solicitation are due via email by 11:59PM EST on May 12, 2021 to Contract Specialist, Ninatile Bacote at Ninatile.Bacote@va.gov and Contracting Officer, Timothy Johnson at Timothy.Johnson13@va.gov. No calls will be accepted.

Quotes are due via email by 11:59PM EST on May 28, 2021 to Contract Specialist, Ninatile Bacote at Ninatile.Bacote@va.gov and Contracting Officer, Timothy Johnson at Timothy.Johnson13@va.gov.

Product Description Salient Characteristics Literature Review

1. SCOPE OF WORK:

The Veterans Health Administration (VHA) Non-Expendable Equipment National Program has identified the Cryotherapy Tissue Ablation Systems product line as a candidate for a VA-wide (otherwise referred to as “national”) single Requirements contract award. Cryotherapy Tissue Ablation Systems are used for Cryoablation, a process that uses extreme cold (cryo) to destroy or damage tissue (ablation). Cryoablation is used in a variety of clinical applications using hollow needles (cryoprobes) through which cooled, thermally conductive, fluids are circulated through the system. Cryoprobes are inserted into or placed adjacent to tissue which is determined to be diseased in such a way that ablation will provide correction yielding benefit to the patient. When the probes are in place, the cryogenic freezing unit removes heat ("cools") from the tip of the probe and by extension from the surrounding tissues.

Common applications of cryoablation is to ablate solid tumors found in the lung, liver, breast, kidney and prostate and for therapy intended to ablate particular tissues using catheterization procedures (e.g., cardiac). Specifically, Cardiac Cryoablation is a therapy that uses the removal of heat from tissue to treat cardiac arrhythmias. It restores normal electrical conduction by freezing the cardiac tissue or pathways that interfere with the normal distribution of the heart’s electrical impulses. Cardiac Cryotherapy Tissue Ablation Systems are being procured to address this requirement and allow integration and compatibility with current Cryotherapy Tissue Ablation Systems in use.

The Contractor must demonstrate the ability to meet all requirements for the solicitation. The objective is to provide Cryotherapy Tissue Ablation Systems to be used by clinicians throughout the VA medical centers and facilities. The period of performance is for one 12-month base period with four 12-month option periods.

2. REQUIREMENT

This requirement will be IAW FAR clause 52.211-6, “Brand Name or Equal” which requires the quoter indicate that each product being offered as an “equal” product to the Medtronic CryoConsole Cardiac Cryoablation System. For each equal product, the offeror must include a description reflecting the salient characteristics (SC) and level of quality that will satisfy the salient physical, functional, or performance characteristics of the equal product(s) specified in the solicitation. The quoter must also clearly identify the item by brand name (if any) and make/model number. Finally, the quoter must include descriptive literature, such as illustrations, drawings, or a clear reference to previously furnished descriptive data or information available to the contracting officer, and clearly describe any modifications it plans to make to a product to make it conform to the solicitation requirements.

Flexcath Steerable Sheath FLEXCATH ADVANCE 12F

The Department of Veterans Affairs (VA) is seeking vendors who can provide Medtronic® Cryoconsole Cardiac Cryoablation System brand name or equal, Cryotherapy Tissue Ablation System as listed above or equal commodities which meet all of the following salient characteristics. Offeror may propose any product solution or configuration so long as they meet the salient characteristics.

OF EVALUATION

PAGE # WHERE SC IS FOUND IN TECHNICAL LITERATURE

See attached document: ATTACHMENT A - PRICE COST SCHEDULE - NX EQ CRYOTHERAPY TISSUE ABLATION SYSTEMS.

See attached document: ATTACHMENT B - CONTRACT ADMINISTRATION - NX EQ CRYOTHERAPY TISSUE ABLATION SYSTEMS.

See attached document: ATTACHMENT C - CONTRACT CLAUSES - NX EQ CRYOTHERAPY TISSUE ABLATION SYSTEMS.

See attached document: ATTACHMENT D - SOLICITATION PROVISIONS - NX EQ CRYOTHERAPY TISSUE ABLATION SYSTEMS.

See attached document: ATTACHMENT E - REPORTING TOOL - NX EQ CRYOTHERAPY TISSUE ABLATION SYSTEMS.