JnA_-_OFOC.pdf

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval For

Other Than Full and Open Competition

1. Contracting Activity: Department of Veterans Affairs, VISN #2, NYHHCS Medical Center, Manhattan Campus.

➢ Nature and/or Description of the Action Being Processed:

This 2237 [ 630-19-1-4422-0005] covering the period 12/1/18 thru 9/30/19 was submitted to request a new long term contract for a base year plus 4 option years. The previous contract expired on 8/31/18. An FY 19 2237 was entered to extend the last contract but it was returned at the last minute because we had been misinformed by the contracting office that the prior contract could be extended for 6 months. As an interim bridge to establish a new contract, a 2237 for a rental agreement/contract for a 3 month period starting 9/1/18 which required $7,500 funding to be paid by purchase card was also entered based on prior lease pricing.

The Excimer CV laser is currently on site in the NY VA O.R. and has been used on an ongoing basis by the cardiac surgeons since January 2008. The excimer laser is a critical piece of equipment that must remain on-site for the safety of cardiac surgery patients. The OR Manager and the Chief of Cardothoracic surgery have confirmed the continued need for this equipment for patient care. Both have also advised that it is more economical to lease this laser than to purchase it and it is absolutely necessary for patient care. NYHHS is the VISN 3 referral center for Cardiothoracic Surgery.

2. Description of Supplies/Services Required to Meet the Agency’s Needs:

There is no other company who makes this equipment with the salient features listed below. As per the Chief of cardio-thoracic surgery, Dr. Grossi, the Excimer Laser System is used to extract infected pacer leads as an alternative to sternotomy and exploratory cardiotomy. Spectranetics manufactures and markets the only Excimer Laser System approved in the United States, Canada, Europe and Japan for use in minimally invasive interventional procedures within the cardiovascular system. The Spectranetics CVX-300 excimer laser in conjunction with proprietary optical fiber catheters is the only excimer laser system approved for use in the removal of cardiac pacemaker and defibrillator leads. An excimer laser produces pulsed bursts of ultraviolet (UV) light energy that are capable of vaporizing plaque and calcium into tiny particles, the majority of which are smaller than a red blood cell, that are easily absorbed into the bloodstream. This energy is transmitted along flexible glass fibers encased in catheters, which can be passed through arteries and veins. The UV light energy is then focused on the blockages that need to be treated.

3. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority):

Spectranetics CVX-300 Excimer Laser System Proven technology for the treatment of multiple cardiovascular procedures and safe removal of plaque, calcium and thrombus. Photoablation is the use of light to break down, vaporize and remove matter. Spectranetics CVX-300® Excimer Laser facilitates photoablation via a variety of Spectranetics catheters to remove arterial plaques and binding scar tissue surrounding cardiac pacemaker ICD leads.

FEATURES

• Photochemical: Breaking molecular bonds o UV light pulse hits tissue for 135-billionths of a second (135ns); the duration of the laser pulse o 50 microns penetration o Billions of molecular bonds fractures per pulse o After 135-billionths of a second, laser energy is not emitted

• Photothermal: Producing thermal energy o Absorption vibrates the molecular bonds of the plaque o Vibration of bonds heats intracellular water o Water vaporizes, molecules break apart, and cells rupture o Expanding vapor bubble forms in 100-millionths of a second (100 µs)

• Photomechanical: Creating kinetic energy o Expansion and collapse of vapor bubble breaks down tissue and clears byproducts away from tip o Byproducts of ablation are water, gas, and small particles o Entire process time per pulse is 400-millionths of a second (400 µs)

SPECIFICATIONS

Wavelength 308 nm Laser Type Excimer

Additional Specifications Active Medium: XeCl, Pulsed Laser System Pulse Width: 125nS - 200 nS, FWHM Long Gas Life: Minimum 3 months gas shelf life.

4. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable.

5. Determination by the Contracting Officer that the Anticipated Cost to the Government will be Fair and Reasonable: THIS IS a SOLE SOURCE REQUEST. The Government will use various analyses and conduct price comparison based on historical data in accordance with FAR 15, 404-1 to ensure market fairness; and acquisition at reasonable, cost-effective value.

6. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market

Research Was Not Conducted:

Excimer laser is used by our cardiothoracic surgeons at our affiliate at NYU and Bellevue. They attest that the requested system is the only vendor who manufactures this laser and they are satisfied with its performance.

Our CV residents have been trained using this equipment therefore their familiarity with the equipment will enable them to provide the necessary patient care without a gap in training., thus new instrument lease must be consistent for staff familiarity, ease of use, and patient safety. It is imperative that the equipment should be standardized when possible to ensure that set up, use, and reprocessing are conducted properly.

This equipment is needed for immediate patient care. Due to NYHHS being a carthoracic surgery referral center for the VISN, the need for this product is high.

7. Any Other Facts Supporting the Use of Other than Full and Open Competition: None Availability of reliable Service to the Hospital Based on Experience with the Company: The system at our affiliate hospitals (NYU) has been outstanding. The ability of the contractor to meet the delivery time and the system past history and functionality.

Gracelyn E_. James 117364 _

8. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition:

Spectranetics was taken over by Philips in January.

The manager Damone James Spectranetics Territory Manager-NYC

(719) 960-6012

9. A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any Barriers to

Competition before Making subsequent acquisitions for the supplies or services required:

There are no barriers to remove or overcome when dealing with this purchase.

10. Requirements Certification: I certify that the requirement outlined in this justification is a Bona Fide Need of the

Department of Veterans Affairs and that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.

September 4, 2018

Name Sally Bashker, RN, MBA, FACHE Date

Title Health System Specialist, Surgical Service

Facility NYHHCS

11. Approvals in accordance with FAR 6.304

a. Contracting Officer's Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Digitally signed by Gracelyn E. James 117364

Date: 2018.12.18 16:12:20 -05'00'

Name: JAMES, EULANDA Date12/18/2018 Title: Contracting Officer Facility: VISN 2