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This document is a justification and approval for other than full and open competition for a federal contract opportunity with the Department of Veterans Affairs. The contract is for four medical surgical items including lancets, catheters, glucose sensors, and related products. The total estimated value is unspecified. The justification cites name brand only and grey market requirements as determined by physician orders, limiting competition to original equipment manufacturers and their authorized distributors and resellers. The solicitation number is 36C77020Q0182 and will be posted on December 30, 2019 with bids due on the listed closing date. The opportunity is set aside for service-disabled veteran-owned small businesses. The justification provides market research showing potential interested vendors and determines the anticipated costs will be fair and reasonable.

36C77020Q0182 P03.1 - JandA - NBO - MedSurg - Dec19_Redacted.pdf

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DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT) ( Name Brand Only, Grey Market Language )

Acquisition Plan Action ID: 36C770-20-AP-0250 –

1. Contracting Activity:

Department of Veterans Affairs Network 15 Contracting Office (NCO 15) 3450 South 13th Street Leavenworth, KS 66048

Department of Veterans Affairs, VA CMOP Leavenworth 5000 S. 13th St Leavenworth KS 66048

Purchase request number: 761-20-1-014-0072 –

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

- J&A addressing limiting sources of competition for MedSurg RFQ due to:

o mandated Grey Market Requirements (GMR) o physician mandated Name Brand Only (NBO)

- GMR specify Original Equipment Manufacturer (OEM) only.

- NBO specify no generic MedSurg item bid accepted

- GMR specify only OEM authorized dealers, and distributors can bid.

- MedSurg Vendor bids without OEM authorization will not be accepted

- GMR limits competition to only OEM authorized Vendors.

- NBO limits competition to only those Vendors who carry Name Brand Only.

- There are more than one OEM/NBO authorized Vendors.

FAR13.5 Simplified Procedures for Certain Commercial Items:

This procurement is for MedSurg Supply Item, in accordance with FAR 13.5 Simplified Procedures for Certain Commercial Items and specifically FAR 13.501 Special Documentation Requirements, where acquisitions conducted under Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6, but still require a justification using the format of FAR 6.303-2.

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

a. Estimated contract value:

Manufacturer #

Brand LANCET, 23G Manufacturer MEDLINE Country of Origin Unknown

Application LANCET UNSPSC Code

NDC 00015551501

• QTY : 1200BX

• Est Value:

• Delivery: 10 Days After Receipt of Order Total Cost =

Manufacturer # MMT-7020A Brand GLUCOSE SENSOR (3) GUARDIAN MMT-7020A

Manufacturer MEDTRONIC Country of Origin Unknown Application GLUCOSE SENSOR UNSPSC Code

NDC 43169070405

• QTY : 960 EA

• Delivery: 10 Days After Receipt of Order

Manufacturer # 28702

Brand

CATH,SPEEDICATH COMPACT

COLOPLAST #28702

Manufacturer COLOPLAST Country of Origin Unknown Application CATHETER

NDC 97621028702

• QTY: 200 BX

Manufacturer # MMT-7008A Brand GLUCOSE SENSOR ENLITE MMT-7008A

Manufacturer MEDTRONIC Country of Origin Unknown Application GLUCOSE SENSOR

NDC 76300700800

• QTY: 216

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;

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).

o VHAPM Part 813.106-1/2 The Grey Market requirements limits competition to Manufacturer authorize distributors, and authorized resellers.

o Only OEM authorized Vendors can submit bids for the MedSurg item listed in the RFQ.

o Only Vendors who carry the MedSurg Name Brand Only items can bid.

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

• This is not a J&A for a Sole Source procurement.

• This a J&A for a Name Brand Only Items - available from multiple suppliers.

• Name Brand Only is designated under Physician’s Orders.

• The attending Physician has prescribed Name Brand MedSurg items - noted above - for Veteran

Patient Use.

• The CMOP facility and CMOP contracting office do not have the authority to arbitrarily change or modify the Physician’s Prescription (i.e. substitute a generic brand for a name brand).

• Within the Veterans Health Administration brand name drugs and medical surgical (MedSurg) products may be prescribed by physicians when in their clinical judgment the brand name Drug/ MedSurg will provide a better therapeutic outcome for patients.

• Brand name drugs and MedSurg are requested when there is a clinical requirement for the drug/ product or there is history of clinical requirements for the drug/product and inventory must be maintained to meet anticipated requirements.

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

Solicitation 36C77020Q0182, MedSurg Items - will be posted to betaSam as a limited competition.

A pre-solicitation notice was posted to betaSam on 30 Dec19.

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 the following:

• CO anticipates bids from two or more SDVOSB Vendors who carry these MedSurg items in their catalogues.

• Comparison against historical purchases.

• Comparison to the IGCE.

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

• Vip.Vetbiz.Va.Gov search NAICS Code 325413 shows 22 SDVOSB’s capable of bidding.

• The CO has a reasonable expectation that two or more SDVOSBs will bid on this RFQ.

• There are authorized vendors who sell the above MedSurg products or can get the product from an authorized source.

• RFQ will be posted as an SDVOSB Set-Aside

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

• These are reoccurring “Name Brand Only” MedSurg procurements.

• MedSurg Vendors have submitted bids in the past on these Name Brand Only RFQs.

• Commercial Vendors understand/agree on the reasoning behind Name Brand Only items.

• At no time have any RFQs with Name Brand Only Items been Protested based on restricting competition.

• Historically Name Brand Only MedSurg RFQs are awarded to SDVOSB Suppliers.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition:

• 3T Federal Solutions – SDVOSB

• Veterans Healthcare Supplies – SDVOSB

• Marathon Medical Corp – SDVOSB

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.

_____Brittany Mejia ___12-18-19___ Brittany Mejia Date Inventory Mgmt Specialist 761 CMOP Logistics Office

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.

Julian Lake Date

Contracting Officer NCO15/CMOP Division

b. One Level Above the Contracting Officer I certify the justification meets requirements for other than full and open competition.

Ralph Crum Date Supervisory Contract Specialist

Julian S. Lake 251184

Digitally signed by Julian S.

Lake 251184 Date: 2019.12.23 14:25:42 -06'00'

Ralph R. Crum 547284

Digitally signed by Ralph R.

Crum 547284 Date: 2019.12.23 15:16:18 -06'00'

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