36C77019Q0631-004.pdf

VHAPM Part 819.7007/7008 Sole Source Awards to a Verified Service-Disabled Veteran-owned Small Business/Veteran-owned Small Business

Attachment 1: Request for SDVOSB/VOSB Sole Source Justification Format >SAT

VHAPM Part 819.7007/7008 Page 1 of 7 Original Date: 08/30/2017 Revision 02 Eff Date: 10/24/2018

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID:___________36C770-19-AP-0771________________________________

1. Contracting Activity:

VA CMOP 761

10 Industrial Ave.

Chelmsford, MA 01824 2237# 761-19-4-014-0380

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

VA Chelmsford CMOP is requesting approval to purchase the Brand name only per Physicians determination of need for the med/Surge product as described below. This is a new procurement and will be a firm fixed price contract. No other contracts are in place. The total estimated value for this request is

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

O0346 - ONE TOUCH VERIO (GLUCOSE) TEST STRIP

• NDC – 53885027210

• Quantity of request: 1200

• 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

XH019 - LANCET,ACCU-CHEK FASTCLIX DRUM

• NDC/PART# 65702028810

• Quantity of Request: 720

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Revision 02 Eff Date: 10/24/2018

• 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

XI079 - INSULIN SYRINGE 0.5ML 31G 6MM

• NDC/PART# 08290324911/324911

• Quantity of request: 300

• 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

XI431 - GLUCOSE SENSOR DEXCOM G4-G5

• NDC/PART# DEXSTS-GL-041

• Quantity of request: 384

• Supplier: DEXCOM

• The Dexcom G4 Platinum Sensor (Box of 4) is the smallest Sensor available — about the size of 2 human hairs. Plus, while other brands have rigid, rectangular probes, the

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Dexcom G4 Platinum Sensor is a round, comfort-design, making it flexible, comfortable, and body-friendly. For use with the Dexcom G4 Platinum Receiver Kit.

• 7-day Sensor - The only Sensor FDA approved for 7 days of wear - a full week - (other brands only last up to 3 or 5 days), which may mean less cost and less fuss with the G4 Platinum

• Sleek Sensor - Smallest and lightest Sensor available = your comfort + discretion 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: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.

XT868 - SET,INFUSION MINIMED #MMT-387

• NDC/PART# 70524406515/MMT-387

• Quantity of request: 330

• 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

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Revision 02 Eff Date: 10/24/2018 your sharps container. This Medtronic Minimed set works with the Quick-serter to provide optimal insertion every time.

XV077 – PLEURX DRAINAGE KIT D#50-7500

• NDC/PART# - 99950750010/50-7500B

• QUANTITY of REQUEST – 670

• 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

XZ835 - RESERVOIR,MINIMED #MMT-332A

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Revision 02 Eff Date: 10/24/2018

• NDC/PART# 43169786554/ MMT-332A

• Quantity of request: 1250

• 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

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

XI326 - LANCET,TRUEDRAW DEVICE

• NDC 56151-0142-01

• Quantity of request:280

• Supplier: Trudraw/Trividia

• TRUEdraw® designed with comfort and ease in mind, the pull-off barrel and universal lancet holder on the TRUEdraw® Lancing Device make the use and disposal of lancets stress-free.

• Ergonomic, tri-lobular design for comfortable grip

• Quick, easy lancet insertion and disposal

• Precise penetration for less pain

• Patented, internal mechanics for ease-of-use

4. Statutory Authority Permitting Other than Full and Open Competition: 41 USC §3304(a)(5), 38 U.S.

Code § 8127(c), as implemented by FAR 6.302-5 (Authorized or Required by Statute). COs may use the non-competitive (sole source) procedures authorized in VAAR 819.7007 or 819.7008 up to $5,000,000. Check the specific VAAR clause used below:

( ) 819.7007 Sole source awards to a verified service-disabled veteran-owned small business; or ( ) 819.7008 Sole source awards to a verified veteran-owned small business

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5. Demonstration that the Contractor’s Unique Qualifications and/or Nature of the Acquisition

Requires the Use of the Authority Cited Above (applicability of authority):

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, including whether a notice was or will be publicized as required by subpart

5.2 and, if not, which exception under 5.202 applies: Chelmsford VA CMOP IS NOT REQUESTING

PURCHASE FROM ANY 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 Guardian in their catalogs. An RFQ with SDVOSB Set-Aside is not possible due NMR Requirements.

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. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: None.

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: None.

12. 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.

(This signature is the requestor’s supervisor, fund control point official, chief of service, someone with responsibility and accountability) https://www.acquisition.gov/sites/default/files/current/far/html/Subpart%205_2.html#wp1107980 https://www.acquisition.gov/sites/default/files/current/far/html/Subpart%205_2.html#wp1107980 https://www.acquisition.gov/sites/default/files/current/far/html/Subpart%205_2.html#wp1107990

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Date Logistics Chelmsford VA CMOP

13. 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.

b. The anticipated cost to the Government will be fair and reasonable.

Prepared By:

Contract Specialist

Date Contracting Officer

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

Date NCO-15, Supervisory Contract Specialist

CMOP Team II https://vaww.pclo.infoshare.va.gov/PMWeb/VHAPM_Part_806.3.aspx