36C77019Q0325-003.pdf

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

OFOC SOP Revision 08 Page 1 of 6 Original Date: 03/22/11 Revision 08 Date: 04/18/2018

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID:____36C770-19-AP-0400_______________________________________

1. Contracting Activity: Chelmsford VA CMOP

IFCAP 2237# 761-19-2-014-0147

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# 761-19-2-014-0147

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

O0346 - ONE TOUCH VERIO (GLUCOSE) TEST STRIP

NDC – 53885027210

Quantity of request: 800 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

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

NDC/PART# - MMT-7020(A)

Quantity of Request: 288

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

OFOC SOP Revision 08 Page 2 of 6 Original Date: 03/22/11 Revision 08 Date: 04/18/2018 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.

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

XV077 – PLEURX DRAINAGE KIT D#50-7500

NDC/PART# - 99950750010/50-7500B

QUANTITY of REQUEST – 800

SUPPLIER – CAREFUSION – POSSIBLY NOW BD?

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 (50-7500B 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

• Blue emergency slide clamp

• Gauze pads, 4" x 4" (10.2 cm x 10.2 cm, [qty. 4])

• Foam catheter pad

• Self-adhesive dressing

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

XH019 - LANCET,ACCU-CHEK FASTCLIX DRUM

NDC/PART# 65702028810

Quantity of Request: 576

SUPPLIER – ROCHE

These special strips are designed to work with all models of Accu-Chek FastClix, the only one-click lancing system available with a drum. Accu-Chek lancets draw blood quickly and effectively for neat and easy application onto test strips. Each package comes with 102 lancets. Accu-Chek FastClix devices and test strips are sold separately.

Accu-Chek FastClix Lancets:

For all models of Accu-Chek FastClix Accu-Check FastClix devices are sold separately The only 1-click lancing system with a drum Designed to reduce the pain of blood glucose testing Proven least painful and overall easiest to use Package contains 102 Roche lancets The estimated Purchase Order value is for this request for this item is

XJ313 - GLUCOSE SENSOR DEXCOM G6

NDC/PART# - 08627005303/STS-OR-003

Quantity of Request: 960

SUPPLIER: DEXCOM

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.

The estimated Purchase Order value is for this request for this item is OFOC SOP Revision 08 Original Date: 03/22/11 Revision 08 Date: 04/18/2018

OFOC SOP Revision 08 Page 4 of 6 Original Date: 03/22/11 Revision 08 Date: 04/18/2018

XT868 - SET,INFUSION MINIMED #MMT-387

NDC/PART# 70524406515/MMT-387

Quantity of request: 288

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.

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

XI079 - INSULIN SYRINGE 0.5ML 31G 6MM

NDC/PART# 08290324911/324911

Quantity of request: 200

SUPPLIER: BD

The NEW BD Insulin Syringe with the BD Ultra-Fine™ 6mm needle is effective as longer needles, are less intimidating, and reduces the risk of a painful injection in the muscle

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

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;

( ) (2) Unusual and Compelling Urgency per FAR 6.302-2;

( ) (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;

OFOC SOP Revision 08 Page 5 of 6 Original Date: 03/22/11 Revision 08 Date: 04/18/2018

5. 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 13.106-1(b)(2).

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

These types of Brand Name Only MedSurg items 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 Medsurg Item to treat the patient's medical condition. Substituting another off Brand MedSurg 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

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

VA CMOP Chelmsford is not requesting a SOLE SOURCE purchase. Multiple Vendors offer these Name Brand MedSurg Supply items at competitive prices.

Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: Price were determined to be fair and reasonable based on past procurements purchased by The Government Purchase card.

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 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

Joseph Sousa Date Logsitics Charleston VA CMOP

11. Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

Joseph Sousa

2-25-2019

OFOC SOP Revision 08 Page 6 of 6 Original Date: 03/22/11 Revision 08 Date: 04/18/2018

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.

Julian Lake Date Contracting Officer

NCO 15

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

Ralph Crum Date

NCO 15

Supervisor, CMOP Acquisition

Julian S. Lake 251184

Digitally signed by Julian S.

Lake 251184 Date: 2019.02.26 07:43:40 -06'00'

Ralph R. Crum 547284 Digitally signed by Ralph R. Crum 547284 Date: 2019.02.26 09:59:51 -06'00'