36C77018Q0559-003.pdf

VHAPM Part 806.3 Other Than Full and Open Competition (OFOC) SOP Attachment 2: Request for Sole Source Justification

OFOC SOP Revision 08 Page 1 of 3 Original Date: 03/22/11 Revision 08 Date: 04/18/2018

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition

Acquisition Plan Action ID:_______VA770-18-AP-0649____________________________________

1. Contracting Activity:

Department of Veterans Affairs Network 15 Contracting Office 3450 South 13th Street Leavenworth, KS 66048

The purchase request number is 761-18-1-015-0067 Items are to be delivered to the Chelmsford CMOP.

2. Nature and/or Description of the Action Being Processed:

The Chelmsford-CMOP, 10 Industrial Ave, Chelmsford, MA 01824-3610, Consolidated Mail Outpatient Pharmacy is requesting approval to purchase BRAND NAME specific Med/Surg items.

This is a new procurement and will be a firm fixed price contract.

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

LINE 1 - XH509 – GLUCOSE SENSOR ENLITE MMT-7008

• NDC/PART# MMT-7008A

• QUANTITY OF REQUEST: 384

• SUPPLIER: MEDTRONIC

Enlite Sensor Enlite™ Glucose Sensors have an electrode inserted just under the skin and measure glucose values which are relayed to the pump and CGM monitor. Enlite combines improved performance and is designed for comfort and ease of use.

Please note: The Enlite Sensor must be combined with the Guardian 2 Link transmitter/MiniLink transmitter to wirelessly transmit glucose readings to the MiniMed 640G/VEO insulin pump. You must complete a Continuous Glucose Monitoring (CGM) start with your healthcare professional team before using this product. Be sure to discuss questions specific to your health and treatments with a healthcare professional.

One button insertion process Up to 6 days use

OFOC SOP Revision 08 Page 2 of 3

Revision 08 Date: 04/18/2018

Indicated for Children and Adults

LINE 2 - XJ024 - GLUCOSE SENSOR (3) GUARDIAN MMT-7020

• NDC/PART# - MMT-7020(A)

• Quantity of Request: 192

• SUPPLIER: MEDTRONIC

The Guardian Sensor (3) is intended for use with the Medtronic MiniMed® 670G system to continuously monitor glucose levels in persons with diabetes. It is intended to be used for detecting trends and tracking patterns in persons aged fourteen years and older, and to be used by the MiniMed 670G system to automatically adjust basal insulin levels. It is indicated for use as an adjunctive device to complement, not replace, information obtained from standard blood glucose monitoring devices. The sensor is intended for single use and requires a prescription. The Guardian Sensor (3) is indicated for 7 days of continuous use.

4. Statutory Authority Permitting Other than Full and Open Competition:

( X ) (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements per FAR 6.302-1;

( ) (2) Unusual and Compelling Urgency per FAR 6.302-2;

( ) (3) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services per FAR 6.302-3;

( ) (4) International Agreement per FAR 6.302-4 ( ) (5) Authorized or Required by Statute FAR 6.302-5;

( ) (6) National Security per FAR 6.302-6;

( ) (7) Public Interest per FAR 6.302-7;

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

Products have been prescribed for patients by VA Physicians. Pharmacy employees do not have the training and/or authority to countermand physician orders. “Brand Specific” products are the same thing as “dispense as written” on a physician prescription. No NDC substitutions are permitted. In the VA, Pharmacy Benefits Management (PBM) has determined that CMOP IDs in the National Drug

File (NDF) will most always identify “brand specific” products in the VA PRINT NAME. This is not always inclusive where a particular NDC has been determined to be “formulation specific” by clinical evaluation performed by the PBM or in the case where only one product in the marketplace has been identified to contain the specific ingredients to match the product code.

OFOC SOP Revision 08 Page 3 of 3

Revision 08 Date: 04/18/2018

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

This will be posted on www.fbo.gov as an unrestricted solicitation, and for only for the specific brand.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: This cost will be determined fair and reasonable due to competition.