36C77018Q0190-003.pdf

`DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval

For

Other Than Full and Open Competition

1) Contracting Activity:

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

The purchase request number is 766-18-1-400-0208 Items are to be delivered to the Charleston CMOP.

2) Nature and/or Description of the Action Being Processed: The Charleston-CMOP, 3725 Rivers Avenue, Suite 2, Charleston, SC 29405, Consolidated Mail Outpatient Pharmacy is requesting approval to purchase BRAND NAME specific NDC drug items. This is a new procurement and will be a firm fixed price contract. The total estimated value for this request is $REDACTED.

3) Description of Supplies/Services Required to Meet the Agency's Needs:

GLUCOSE SENSOR DEXCOM G4

• NDC -008627004104 (NO SUBSTITUTES)

• Quantity and Description of request: 4 per box GLUCOSE SENSOR DEXCOM G4

• Supplier: DEXCOM, INC.

• The estimated Purchase Order value is for this request for this item is $REDACTED

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; Brand name description application applies.

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:

The requesting pharmacy indicated this medication could be obtained from this business:

7) Determination by the Contracting Officer that the Anticipated Cost to the Government will be Fair and Reasonable:

The Charleston-CMOP anticipates the cost to the Government will be fair and reasonable.

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 NAICS code of 325413 In-Vitro Diagnostic Substance 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.

Glenda Dame 12/19/2017

Glenda Dame Date Inventory Management Specialist Charleston-CMOP

13) Approvals in accordance with FAR 6.304 and VHAPM Part 806.3 OFOC SOP:

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

Lori Nichols Fellows Date Contract Specialist NCO 15 CMOP Acquisitions Division

b) One Level Above the Contracting Officer (Required over $150K but not exceeding $700K): I certify the justification meets requirements for other than full and open competition.

James D. Justus Date Director of Contracting Network Contracting Office 15