36C77018Q0372-003.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 4th Street Leavenworth, KS 66048

The purchase request number is 761-18-2-014-0168 Items are to be delivered to the Chelmsford CMOP.

2) Nature and/or Description of the Action Being Processed: The Chelmsford CMOP, 10 Industrial Avenue, Chelmsford, MA 01824, Consolidated Mail Outpatient Pharmacy is requesting approval to purchase BRAND NAME specific NDC MED SURG 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:

O0346 - ONE TOUCH VERIO (GLUCOSE) TEST STRIP

• NDC – 53885027210

• Quantity of request: 480

• 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.

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

XJ024 - GLUCOSE SENSOR (3) GUARDIAN MMT-7020

• NDC/PART# - MMT-7020(A)

• Quantity of Request: 96

• 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.

XH709 - CATH SET, INTERM 12FR C#28422

• NDC -99050728422 (NO SUBSTITUTES)

• Quantity of request: 576

• Supplier: COLOPLAST

Less than half the size of a standard male catheter, SpeediCath Compact Male can be stored, carried, used and disposed of more discreetly. It can be inserted without touching the coated section. It comes ready to use – for even greater convenience and discretion.

• All-in-one catheter and bag set that is instantly ready to use

• Small enough to keep in a pocket or handbag.

• The only compact and discreet catheter with an integrated and sterile bag

XI429 - CATH, INTERMITTENT VAPRO PLUS 14F H#71144

• NDC/PART# HOLLISTER #71144

• Quantity of request: 400

• Supplier: HOLLISTER

• Easy-to-carry package fits easily into a pocket or backpack

• Protective tip helps shield the sterile catheter from bacteria located within the initial 15 mm of the distal urethra

• Protective sleeve allows the catheter to be gripped anywhere along the length of the catheter

• Ready-to-use hydrophilic catheter with pure catheter hydration technology. Designed to be evenly lubricated for easy insertion

• Large finger hole with tear strip helps facilitate easy opening

• Smooth eyelets help ease of insertion and withdrawal

• Ring cap helps keep protective tip clean and protected until use

• Available in both 16" (40 cm) and 8" (20 cm) lengths

• Not made with natural rubber latex, phthalates-free PVC material

XT868 - SET, INFUSION MINIMED #MMT-387

• NDC/PART# 70524406515/MMT-387

• Quantity of request: 120

• SUPPLIER: MEDTRONIC

The Medtronic Minimed Quick-set® infusion conveniently disconnects at the infusion site and offers a pre-attached adhesive for a discreet, low profile design. The Medtronic Minimed Quick-set® Infusion Set (MMT397) offers a 9mm soft cannula and 23 inch tubing for mostly everyone. The Safe Needle Disposal System of the Medtronic Minimed Quick-set helps prevent accidental sticking when disposing of the introducer needle in your sharps container. This Medtronic Minimed set works with the Quick-serter to provide optimal insertion every time.

XV066 - CATH SET, INTERMIT 14FR H#96144

• NDC/PART# 5096144

• Quantity of Request: 500

• 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.

XZ835 - RESERVOIR,MINIMED #MMT-332A

• NDC/PART# 43169786554/ MMT-332A

• Quantity of request: 864

• SUPPLIER: MEDRONIC

Medtronic MiniMed Paradigm Reservoir is intended for use with the MiniMed Paradigm™ 71x insulin pumps and infusion sets only. It is custom made for Medtronic MiniMed Paradigm™ 7 Series insulin pumps and can be used with all Medtronic MiniMed Paradigm™ infusion sets. User-filled reservoir holds up to 3ml of insulin Reservoir Size: 3.0 ml – MMT332A About MiniMed Paradigm 71x insulin Pumps: Can be hidden and worn under clothing for daily use. It is small and water resistant. Ref #: MMT-332A

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 products may be prescribed by physicians when in their clinical judgment, the brand name product will provide a better therapeutic outcome for patients. Brand name products are requested when there is a clinical requirement for the item. In this case, the brand specific item 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 these items could be obtained from the businesses listed above.

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

The Chelmsford 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 20 SDVOSB vendors which are engaged in the manufacture of med surg items. A query at the SBA Dynamic Search portal returned 519 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 products are the only brands that will meet the specific needs of the patients, however, we are still competing this amongst distributors.

12) 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 Contracting Officer, CMOP Team 2 Network Contracting Office 15

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 Acting Division Chief CMOP Acquisitions Division

Network Contracting Office 15