_LSJ - O.R. Elder - Excimer Laser_final_Redacted.pdf

LIMITED SOURCE JUSTIFICATION

1. Defense Logistics Agency (DLA) Troop Support, Medical Supply Chain, Capital Equipment Division, is the contracting activity.

2. This sole source justification is for the purchase of one Alcon Wavelight EX-500 excimer laser with Vario Topolyzer and Wavenet Laptop for Irwin Army Community Hospital (IACH), Ft. Riley, KS.

3. The equipment necessary to meet this requirement is available on the O.R. Elder, Inc.

DLA Electronic Catalog (ECAT) contract SPE2DH-15-D-0012, which expires July 27, 2020. The total estimated dollar value of this acquisition is $362,735.10.

4. The authority waiving competition requirements is FAR 8.405-6(a)(1)(i)(B), only one source is capable of providing the supplies required at the level of quality required because the supplies are unique or highly specialized.

IACH has a requirement for one Alcon Wavelight EX-500 excimer laser package to add to the ophthalmology suite at Irwin Army Community Hospital to treat military members.

The excimer laser utilizes an array of different treatments to perform corrective eye surgeries for low order refractive errors, including all forms of astigmatism, hyperopia (farsightedness) and myopia (nearsightedness).

The Food and Drug Administration (FDA) approved excimer laser to be purchased must be capable of:

Providing a laser pulse duration between 4 to 25ns and a laser repetition rate between 1.5 to 500Hz. This will result in additional patient capacity, increased comfort for patients, reduced corneal dehydration during treatment, decreased risk for patient based errors from movement during ablation, more precise correction and improved clinical workflow.

Providing eye tracking technology to follow the eye’s fastest movements to decrease risk for patient based errors from movement during ablation.

Performing wavefront optimized ablation to minimize the induction of new higher order aberrations (imperfections) in the eye such as, night-glare, halos, and starbursts caused by looking at lights

Performing topography-guided treatments that use a placido disk system with 22,000 elevation points, utilize pupil centroid with shift detection, and must offer precise cyclotorsion control which customizes treatment for each patient allowing for a better and more precise outcome during both LASIK and Photorefractive keratectomy (PRK) procedures.

The excimer laser must also have interoperability with the Alcon FS200 Femtosecond Laser at IACH. Only the Alcon Wavelight EX500 excimer laser, which is offered by O.R. Elder, can meet all of the customer requirements listed above for pulse rates, speed, eye tracking technology, and topography-guided treatments.

LIMITED SOURCE JUSTIFICATION

5. The Alcon Wavelight EX500 excimer laser package is available from the O.R. Elder ECAT contract.

6. Market research was conducted by IACH and DLA Troop Support. Market research consisted of reviews of similar previous procurements and a market survey through search engines of open market contractors, ECAT contract holders and Federal Supply Schedule contractors. The market research indicated that there are other manufacturers with similar ophthalmology excimer lasers including Nidek, Carl Zeiss and Abbott Medical Optic;

however, Nidek and Abbott lasers are not available on ECAT and do not offer wavefront optimized ablation. A Zeiss laser is available on ECAT, however it does not meet the topography-guided treatment requirement that use a placido disk system with 22,000 elevation points. ECAT vendors have the opportunity to add products that fall within scope of the ECAT contract at any time, thereby increasing competition. However, currently there are no other known ECAT vendors that would be able to offer a similar or equivalent product meeting all of the minimum requirements.

7. There are no other facts supporting this justification.

8. For the reasons discussed above in paragraph 4, Alcon is the only manufacturer capable of providing the necessary items, through the O.R. Elder contract. ECAT vendors have the opportunity to add products that fall within the scope of the ECAT contract at any time; however, currently there are no other known ECAT vendors that offer an FDA-approved ophthalmic excimer laser that can meet IACH's requirements.

9. As the Contracting Officer, I hereby certify that this justification is accurate and complete to the best of my knowledge and belief.

Date: Donna M. Kennedy Contracting Officer DLA Troop Support, FSDB

I hereby certify that the requirements which form the basis of this justification are accurate, that these supplies meet the Government’s needs in accordance with applicable specifications and that this justification is accurate and complete to the best of my knowledge and belief.

Date:

Biomedical Engineer DLA Troop Support, FSDB

KENNEDY.DONNA.

MARIE.1228934255

Digitally signed by

KENNEDY.DONNA.MARIE.1228

934255 Date: 2020.04.23 10:46:47 -04'00'