36C77019Q0381-003.pdf

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

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A)

For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: __ 36C770-19-AP-0493 _______________ _

1. Contracting Activity: Chelmsford VA CMOP

IFCAP 2237# 761-19-2·014-0195

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

BRAND NAME SPECIFIC MEDICATION AS REQUESTED BY THE VA MEDICAL CENTERS THE Chelmsford

VA CMOP SERVES. AS REQUESTED ON 2237# 761-19-2-014-0195

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

XJ430 · GLUCOSE SENSOR (3) GUARDIAN MMT-7020A

• NOC/PART# - MMT-7020(A)

• Quantity of Request: 480

• 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.

XJ454- GLUCOSE SENSOR ENLITE MMT-7008A

• NOC/PART# MMT-7008A

• QUANTITY OF REQEST: 180

• SUPPLIER: MEDTRONIC

Enlite Sensor

OFOC SOP Revision 08

Original Date: 03/22/11 Revision 08 Date: 04/18/2018

Enlite™ Glucose Sensors have an electrode inserted just under the skin and measure glucose values which are relayed to the pump and CGM monitor. Enlite combines improved

· performance and is designed for comfort and ease of use.

Please note: The Enlite Sensor must be combined with the Guardian 2 Link transmitter/Minilink transmitter to wirelessly transmit glucose readings to the MiniMed

640G/VEO insulin pump. You must complete a Continuous Glucose Monitoring (CGM) start with your healthcare professional team before using this product. Be sure to discuss questions specific to your health and treatments with a healthcare professional.

One button insertion process

Up to 6 days use

Indicated for Children and Adults

XV077- PLEURX DRAINAGE KIT D#S0-7500

• NOC/PART# - 99950750010/50-7500B

• QUANTITY of REQUEST - 480

• SUPPLIER- CAREFUSION - POSSIBLY NOW BO?

PleurX drainage kit 50-7500B (500 ml} and 50-7510 (1,000 ml}

The PleurX drainage kit includes a procedure pack that provides the components needed each time the patient drains fluid.

Each drainage kit (50-75008 and 50-7510} contains:

• Plastic vacuum bottle with attached drainage line

Procedure pack components

• Blue wrapping

• Alcohol pads (qty. 3)

• Pair of gloves

• Valve cap

OFOC SOP Revision 08 Original Date: 03/22/11

• Blue emergency slide clamp

• Gauze pads, 4" x 4" {10.2 cm x 10.2 cm, [qty. 4})

• Foam catheter pad

• Self-adhesive ·dressing

XJ313 - GLUCOSE SENSOR DEXCOM G6

• NOC/PART# - 08627005303/STS-OR-003

• Quantity of Request: 480

• SUPPLIER: OEXCOM

• The Dexcom G6 Continuous Glucose Monitoring System (Dexcom G6 System) is a real time, continuous glucose monitoring device indicated for the management of diabetes in persons age 2 years and older.

• The Dexcom G6 System is intended to replace fingerstick blood glucose testing for diabetes treatment decisions. Interpretation of the Dexcom G6 System results should be based on the glucose trends and several sequential readings over time. The Dexcom G6 System also aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments.

• The Dexcom G6 System is also intended to autonomously communicate with digitally connected devices, including automated insulin dosing (AID) systems.

XZ835 - RESERVOIR,MINIMED #MMT-332A

• NOC/PART# 43169786554/ MMT-332A

• Quantity of request: 1440

• SUPPLIER: MEORONIC

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 Paradigmr"'

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

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4. FAR13.5 Simplified Procedures for Certain Commercial Items: The authority for applying the

Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. 1901 and is implemented by for restricting competition on this procurement via FAR 13.106-l{b)(2).

5. Demonstration that the Contractor's Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority):

BRAND NAME JUST/FICA TION DOES ALLOW FOR FULL AND OPEN COMPETITION AS LONG AS THE

VENDOR MEET THE BRAND SPECIFIC REQUIREMENTS AS REQUESTED ON 2237# 761-19-2-014-0195

These types of brand name drugs are prescribed by the Veteran's attending Physician who has the authority to prescribe the method of treatment to best satisfy the medical condition of his/her patient. The physician has determined this item as the best drug to treat the patient's medical condition. Substituting another drug other than that specifically prescribed is beyond the role, competency, and professional functions of the Contract Specialist and would be detrimental to the treatment of the Veteran patient

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable:

Chelmsford VA CMOP IS NOT REQUESTING PURCHASE FROM AND CERTAIN

VENDOR. MULTIPLE VENDORS OFFER THIS PARTICULAR NAME BRAND

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: THE CO anticipates the cost will be considered fair and reasonable based on RFQ is Full &

Open- Open to all interested/responsible parties. CO anticipates bids from 2 or more SB who carry

Guradian in their cataloges. An RFQ with SDVOSB Set-Aside is not possible due NMR Reuirements

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

It is believed that two or more SDVOSB's can provide the same product at a fair and reasonable price.

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

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

Fide Need of the Depart t of Veterans Affairs and that the supporting data under my cognizance, whi a includ in the J st1 ication, are accurate and complete to the best of my knowledge and beli f.

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OFOC SOP Revision 08

Original Date: 03/22/11

Revision 08 Date: 04/18/2018

Date

Ralph R. Crum 547284 Digitally signed by Ralph R. Crum 547284 Date: 2019.03.27 09:53:03 -05'00'