36C77018Q0583-002.pdf

VHAPM Part 806.3 Other Than Full and Open Competition (OFOC) SOP Attachment 2: Request for Sole Source Justification Format >$150K

OFOC SOP Revision 06 Page 1 of 1 Original Date: 03/22/11 Revision 06 Date: 08/30/2017

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>$150K)

Acquisition Plan Action ID:___VA770-18-AP-0011

1. Contracting Activity: 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# 766-18-3-400-0676. This request is justification for other than full and open competition. The purchase request is for MEDTRONIC MINIMED PRODUCTS which is a medical device used for the continuous Blood Sugar (Glucose) monitoring and insulin delivery.

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 Medtronic minimed products per the Physicians determination of need.

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

RESERVOIR, MINIMED #MMT-326A( XV094)

• NDC - 43169077141 (NO SUBSTITUTES)

• Quantity and Description of request: 10 per box RESERVOIR, MINIMED #MMT-326A

• Supplier: Medtronic

SET INFUSION MINIMED #MMT-378 (XZ376)

• NDC -76300037810 (NO SUBSTITUTES)

• Quantity and Description of request: 10 per box RESERVOIR, MINIMED #MMT-399

• Supplier: Medtronic

RESERVOIR, MINIMED #MMT-332A( XZ835)

• NDC - 72190287539 (NO SUBSTITUTES)

• Quantity and Description of request: 10 per box RESERVOIR, MINIMED #MMT-332A

• Supplier: Medtronic

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;

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Revision 06 Date: 08/30/2017

( ) (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;

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.

Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: This will be released on FBO.GOV as a SDVOSB Set Aside.

Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: :

The IGCE contains the estimated cost to the government and serves as the recognition of F&R

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 339112 Pharmaceutical Preparation Manufacturing

Any Other Facts Supporting the Use of Other than Full and Open Competition: NA

Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: NA

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.

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.

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Revision 06 Date: 08/30/2017

GDAME 06/06/2018______________________

Glenda Dame Date Inventory Management Specialist Charleston CMOP 766

Name Julian Lake Date Title Contracting Officer Facility NCO 15 (CMOP)

a. 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.

Name James Justus Date Supervisor (CMOP)

NCO 15 (CMOP)

c. VHA SAO HCA Review and Approval: I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and recommend approval (if over $68 million) or approve ($700K to $68 million) for other than full and open competition.

__________________Not Needed___________ ________________________ Name Date VHA Head of Contracting Activity (HCA)

d. VHA Senior Procurement Executive Approval (over $68 million): I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and approve for other than full and open competition.

_________________Not Needed____________ ________________________ Jan R. Frye Date Deputy Assistant Secretary for Acquisition and Logistics Senior Procurement Executive (SPE) Department of Veterans Affairs