LSJ_-_O.R._Elder_-_Laser_Elmendorf_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 ophthalmic excimer laser for Joint Base Elmendorf-Richardson (JBER), Richardson, AK.

3. The equipment necessary to accommodate this requirement is available on the O.R.

Elder, Inc. DLA Electronic Catalog (ECAT) contract SPE2DH-15-D-0012, which expires October 17, 2020. The total estimated dollar value of this acquisition is $362,735.

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.

JBER has a requirement for one excimer laser package to treat military members.

The excimer laser utilizes an array of different treatment capabilities 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 minimum pulse repetition rate of 500Hz and a speed of 1.5 sec per diopter or better. 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.

Providing non-contact pachymetry. Contact pachmetry requires topical anesthesia or fluorescein dye to be administered to the patient, which requires additional time to administer the anesthesia or the dye. Contact pachymetry also presents contamination risk to the patients and requires additional cleaning supplies and additional time to clean the tool after each exam.

Only the Alcon Wave Eye-Q EX500, which is offered by O.R. Elder, can meet all of the customer requirements listed above for pulse rates, speed, eye tracking technology, and non-contact pachymetry for treatments.

5. The Alcon Laser is available from the O.R. Elder ECAT contract. DLA Troop Support has already determined the price to be fair and reasonabl

6. Market research was conducted by Air Force Medical Operations Agency (AFMOA) from December 2018 through May 2019. Market research consisted of reviews of similar previous procurements and a market survey through search engines of open market

LIMITED SOURCE JUSTIFICATION

contractors and Federal Supply Schedule contractors. Search engines utilized include Google, ECRI sourcebook, and the FDA to find other ophthalmic laser vendors that might meet the minimum requirements needed at JBER. Manufacturers with similar ophthalmology lasers include Nidek, Carl Zeiss and AMO, however, none of these vendors meet the minimum requirement that the laser system must have a minimum pulse repetition rate of 500 Hz.

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 the Government’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: Sean McColgan 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

MCCOLGAN.SEA

N.M.1386255462

Digitally signed by

MCCOLGAN.SEAN.M.1386255462

Date: 2019.07.30 10:38:33 -04'00'