36C77018Q0568-002.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 4 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-0004

Contracting Activity: Consolidated Mail Outpatient Pharmacy Leavenworth, KS the Department of Veterans Affairs Network 15 Contracting Office (NCO), 3450 S. 4th St Trafficway, Leavenworth, KS 66048 is the contracting agency. Supplies will be purchased for the CMOP Chelmsford location at 10 Industrial Avenue Chelmsford, MA 01824-3610.

761-18-3-014-0246

BRIEF DESCRIPTION OF SUPPLIES OR SERVICES REQUIRED AND THE INTENDED USE:

O0346 - ONE TOUCH VERIO (GLUCOSE) TEST STRIP

• NDC – 53885027210

• Quantity of request: 360

• Supplier: LIFESCAN

The OneTouch Verio® test strips provide accuracy your patients can rely on.

Requiring only 0.4 µL of blood, our test strips have achieved 5 years of proven clinical accuracy even at extremely low and high blood glucose levels. For blood glucose testing with the OneTouch Verio® family of meters, including the OneTouch Verio Flex® meter, OneTouch Verio® meter, and OneTouch Verio IQ® meter.

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

OFOC SOP Revision 06 Page 2 of 4

Revision 06 Date: 08/30/2017 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.

XV066 - CATH SET, INTERMIT 14FR H#96144

• NDC/PART# 5096144

• Quantity of Request: 400

• SUPPLIER – HOLLISTER

• Ready-to-use, pre-lubricated, single-use closed system intermittent catheter.

• Latex-Free.

• Unique protective tip.

• No-Touch insertion technique.

• User-regulated gel reservoir.

• 2 Smooth catheter eyelets.

• Color-coded funnel.

• 1500mL collection pouch.

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;

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.

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: Products were searched in the NAC and GSA catalog and none of the items were found to be on contract.

OFOC SOP Revision 06 Page 3 of 4

Revision 06 Date: 08/30/2017

Any Other Facts Supporting the Use of Other than Full and Open Competition: Due to physician prescribed devices, the need to compete for this brand name specific item will result in Veterans receiving the appropriate items for the prescribed use.

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: There were no actions taken to remove or overcome barriers as these are brand name specific items prescribed by a physician and no generic or other item will meet the needs of the government.

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.

_________Not Needed____________________ ________________________ Joseph Sousa Date Distribution Facility Specialist Facility VA CMOP Chelmsford

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.

Name Lori Nichols Fellows Date Title Contracting Officer Facility NCO 15 (CMOP)

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.

Name James Justus Date Supervisor (CMOP)

NCO 15 (CMOP)

http://vaww.pclo.infoshare.va.gov/PMWeb/VHAPM_Part_806.3.aspx

OFOC SOP Revision 06 Page 4 of 4

Revision 06 Date: 08/30/2017

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