Brand_Name_Justification_Rev..pdf

BRAND NAME OR EQUAL .

JUSTIFICATION AND APPROVAL

Purchase Request No:

Department:

POC/TeL No.:

Proposed Vendor:

JAW FAR 13.106(1)(b)

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

The RadTag product is a radiation indicator device used by blood banks that use irradiation to prevellt transfusion-associated Graft vs. Host Disease (TAGVHD). RadTag verifies that each unit of blood receives the specified range 0£ radiation absorbed dose.

The Charter Medical Neonatal Syringe Set with 150-micron filter is designed to facilitate delivery of small aliquots of whole blood, cellular (red cells and platelets) components and fresh frozen plasma components for neonatal/pediatric transfusion, and is being sought under a Limited Source Brand Name Justification. The Charter Medical Neonatal Syringe Set provides a safe, cost effective system to administer small aliquots of blood and blood components. Maximizes usage ot adult size blood units. Allows for single . donor exposure for neonates. Use with sterile connection technology to provide closed blood delivery system that maintains original primary unit outdating. Needle-less system eliminates accidental needle sticks. May be used in conjunction with neonatal/pediatric multi-bag aliquot systems. Available in multiple syringe configurations and sizes.

Available in DEHP-free configurations.

2. Estimated value of the requirement:

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

These brand name products are essential to the FDA' s filtering and .irradiation requirements and ANY other brand name syringe set and irradiation labels cannot meet the ageny's need based on the rationale in block 1.

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.:

Performed an internet search and found one other company that supplies the item, Independent Medical Association. IMA utilizing Kentec for Neonatal Syringes.

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

All standard operating procedures/configurations/administration settings existing are set for hardware and software for the Radtag and Neonatal Syringe Set at this time. Changing that would seriously.impact workload and require extensive staff retraining, product validation, and multiple standard operating procedure updates.

6. Statement of the actions that are being taken to remove or overcome any barriers to competition:

None.

(&v8-19-10)

S1gtrature of Direc or/Chairman/Department Head Date

CONTRACTING OFFICER APPROVAL

�d -� Disapproved

Comments:------- - ------------------- -----

(Rev8-/9-IO)