Brand Name Justification_Redacted.pdf

BRAND NAME JUSTIFICATION AND APPROVAL

Purchase Request No:

IAW FAR 13,106(l)(b)

1. Description of the supplies and/or services required to meet the end-user's minimum needs :

The Department requires intraocular lens implants for the patients being treated for cataract surgeries.

Being that said, without these implants being available for the surgeries at the time, the procedure would have to be referred out in town which could potentially lead towards higher complications for the patient's eyesight. These implants replace the cataract and provide the patient with a crystalline lens that will allow the surgeons to restore the vision of the patients with this deficiency. In essence, without the replacement of the cataract with an intraocular implant other ocular complications may arise for the patient.

has been the main distributor for the clinic within past BPA's and offers the supplies required for the surgical procedures. The instlumentation required for cataract surgeries are not distt·ibuted through any of the prime vendors or any other associated government suppliers.

2. Estimated value of the requirement:

The Department requires 25G retinal items. BPA does not exceed

3. Contractor's unique qualifications which make him/her the ONLY source that can truly satisfy the Government's min.imum requirements:

Requirement isfor Blanket Purchase Agreement (BPA) for intraocular lens implants will help complete the mission readiness within the Depaitment, which involves restoration of the patient's sight.

is om main distributor for these types of intraocular implants. All products requested must be FDA approved and should comply with the regulations associated with respect to the delivery of medical items. Requirement was received with large business- - as the suggested source.

Request was received with a valid brand name or equal justification. Establishing this EPA with will allow the Department to have a variety of products that include both standard monofocal IOLs and toric monofocal IOLs.

4. Demonstration of the market search conducted appropriate to the size and complexity of the Government's minimum requirements. Include sources (in Government and industry) contacted and information obtained per source which further supports a sole source acquisition request.:

5. Other facts supporting the use.of other than full and open competition:

is mostly used for almost every surgical and clinical procedure perfo1med within the department.

intraocular lenses are used as a back up of the lenses in case of an emergency within the cataract or

· phacoemulsification procedure that could lead to a series of complications within the anterior p01tion of the eye. Not only are they the new technology recommended for these types of procedures but they are also recommended for patient safety and recovery tin1e.

(Rev 8-19-10)