36C77019Q0278-003.pdf

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

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 (>SAT)

Acquisition Plan Action ID: 766-19-400-0482

1. Contracting Activity:

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

Department of Veterans Affairs, VISN 15, Charleston, SC CMOP; 3725 Rivers Ave, Suite 2 North Charleston, SC 29405-7038. This request is a Justification for Other Than Full and Open Competition for the purchase order# 766-19-2-400-0482. This request is justification for other than full and open competition. The purchase request is for GLUCOSE SENSOR DEXCOM G4 which is a medical device used for the continuous Blood Sugar (Glucose) monitoring.

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

The Charleston-CMOP, 3725 Rivers Avenue, Suite 2, Charleston, NC 29405, Consolidated Mail Outpatient Pharmacy is requesting approval to purchase BRAND NAME specific NDC drug items. The purchase of the GLUCOSE SENSOR DEXCOM G4 from a single source per the Physicians determination of need. Requesting that DEXCOM, INC of 6340 Sequence Drive San Diego, CA 92121, be awarded this new contract. This proposed contract is for a firm-fixed-price for the specific item GLUCOSE SENSOR DEXCOM G4 that is being requested.

This is a new procurement and will be a firm fixed price contract. The total estimated value for this request is

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

GLUCOSE SENSOR DEXCOM G4 is a medical device is used for the continuous Blood Sugar (Glucose) monitoring. The total estimated value for this request is

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

OFOC SOP Revision 08 Page 2 of 3

Revision 08 Date: 04/18/2018

( ) (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):

Within the VHA brand name drugs may be prescribed by physicians when in their clinical judgment the brand name drug will provide a better therapeutic outcome for patients. Brand name drugs are requested when there is a clinical requirement for the drug. In this case, the brand specific drug name is requested on the list above.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: This is still under patent ( see line 3 and 4)

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: The anticipated cost will be fair and reasonable based on competition or on the IGCE which contains the estimated cost.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted:

After searching NAC & GSA, there are no available contracts for any of the items requested. A search of the Center for Veteran Enterprise Vendor Information Pages indicates there are 77 SDVOSB or VOSB vendors which are engaged in the manufacture of pharmaceuticals. A query at the SBA Dynamic Search portal returned 949 possible small business vendors. However, these vendors are not engaged in manufacture, but are distributors for large business wholesalers. Because the Government is not allowed to do business using Wholesale Trade or Retail Trade NAICS codes, searches must be conducted using the manufacture Pharmaceutical Preparation Manufacturing.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: N/A

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: N/A

11. A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any Barriers to

Competition before Making subsequent acquisitions for the supplies or services required:

At this time, the physician has stated the above mentioned name brand drugs are the only brands that will meet the specific needs of the patients, however, we are still competing this amongst distributors.

12. Requirements Certification: I certify that the requirement outlined in this justification is a Bona Fide

Need of the Department of Veterans Affairs and that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.

January 29,2019

OFOC SOP Revision 08 Page 3 of 3

Revision 08 Date: 04/18/2018

Name : Date Title : Inventory Management Specialist Facility: Charleston MOP 766

13. Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

a. Contracting Officer or Designee’s Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Date Contact Specialist Facility

b. One Level Above the Contracting Officer (Required over SAT but not exceeding $700K): I certify the justification meets requirements for other than full and open competition.

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