36C77019Q0645-003.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 4 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-0794 (761-19-4-014-0414)

1. Contracting Activity:

Network Contracting Office 15 3450 S. 4th St. Trafficway Leavenworth, KS 66048-5581

Requesting Activity:

VA CMOP Chelmsford 10 Industrial Ave.

Chelmsford, MA 01824-3610

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

This request is a Justification for BRAND NAME supplies as requested by the VA Medical Centers from the VA

CMOP CHELMSFORD

Drug Name: SENSOR, GLUCOSE, DEXCOM ACTION REQUESTED: 1 (New Requirement)

PR-IFCAP: 761-19-4-014-0414

ACQUISITION PRIORITY: 3 (Emergency) Purchase of: MedSurg Supplies.

PROCUREMENT VEHICLE: Open Market SOCIOECONOMIC CATEGORY: Not Set-Aside

CLASSIFICATION CODE: 65(MEDICAL EQUIPMENT)

PURCHASING SCOPE: 1 (Single Site) FAR13.5 Simplified Procedures for Certain Commercial Items:

This procurement is for Medical Surgical items. 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:

BRAND NAME supplies as requested by the VA Medical Centers from the VA CMOP CHELMSFORD Drug Name: SENSOR, GLUCOSE, DEXCOM

OFOC SOP Revision 08 Page 2 of 4

Revision 08 Date: 04/18/2018

· MedSurg supplies have been prescribed for patients by VA Physician to meet the specific needs of the Veteran.

PRODUCT/SERVICE CODE: 6515(Medical and Surgical Instruments, Equipment, and Supplies) PRINCIPAL NAICS CODE: 325412(Pharmaceutical Preparation Manufacturing)

IGCE Total =

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;

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

Products have been prescribed for patients by VA Physicians. Pharmacy employees do not have the training and/or authority to countermand physician orders. “Brand Specific” products are the same thing as “dispense as written” on a physician prescription. No NDC substitutions are permitted. In the VA, Pharmacy Benefits Management (PBM) has determined that CMOP IDs in the National Drug File (NDF) will most always identify “brand specific” products in the VA PRINT NAME. This is not always inclusive where a particular NDC has been determined to be “formulation specific” by clinical evaluation performed by the PBM or in the case where only one product in the marketplace has been identified to contain the specific ingredients to match the product code. The site is not requesting purchase from any certain vendor. Multiple vendors offer these items.

· Nature of Urgency: ***EMERGENCY***

· Date Needed: 08-22-19

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

This will be posted on FBO (Open Market & Not Set-Aside) so any vendor who can provide this item is welcome to quote.

DESCRIPTION PKG QTY UNIT NDC/SKU# UnitCost Total Cost

1 ITEM ID NO. 14326 SENSOR, GLUCOSE,

DEXCOM G6 #XJ313 PKG: 3 per BX

3 1440 BX DEXSTS-OR-003

OFOC SOP Revision 08 Page 3 of 4

Revision 08 Date: 04/18/2018

SOLICITATION RFQ NUMBER: 36C77019Q0645

ISSUE DATE: 07-30-19

NEED DATE: 08-22-19

RESPONSE DUE DATE: 08-02-19

PROCUREMENT VEHICLE: Open Market SOCIOECONOMIC CATEGORY: Not Set-Aside

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable:

· The CO will determine the anticipated cost to be considered fair and reasonable based on the following:

· Comparison with the IGCE.

· Historical purchases of this pharmaceutical

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

Market research was conducted through Vet Biz under NAICS 325412(Pharmaceutical Preparation Manufacturing). Because the Government is not allowed to do business using Wholesale Trade or Retail Trade NAICS codes, searches must be conducted using the manufacturer NAICS code 325412 (Pharmaceutical Preparation Manufacturing). Despite these results, there are no known SDVOSB, VOSB, HUBZone, 8(a), or small business organizations that manufacture the items required for this procurement. Due to the SBA NMR, as defined in FAR Part 19 and 13 Code of Federal Regulations (CFR) 121.406, an SDVOSB/VOSB/SB set aside of any kind is not feasible as there is no waiver of the Non-Manufacturer Rule from the SBA over the SAT for NAICS code 325412.

· Non-manufacturer rule (NMR) applies to acquisitions OVER the simplified acquisition threshold per 13 CFR 121.406(d).

· There is no Class Waiver for NAICS Code 325412 (Pharmaceutical Preparation Manufacturing) per http://www.sba.gov/content/class-waivers

· This product is not available from the federal prison industry (FPI), Ability One, DLA or GSA.

· The CO is unable to determine that two or more (or a combination) SDVOSB’s, VOSB, or other Small Business can provide the product at a fair and reasonable price within the timeline required to ensure an uninterrupted supply.

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

· None

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:

· Future acquisitions for these MedSurg supplies will continue to be solicited as quantities in available stock stabilize and become available in the open market.

OFOC SOP Revision 08 Page 4 of 4

Revision 08 Date: 04/18/2018

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

MEJIA,BRITTANY R

Inventory Management Specialist VA CMOP Chelmsford - 761

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.

Prepared by:

McAlhaney, Michael W.

Contract Specialist

Eagle, Joetta M.

Contracting Officer

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.

Crum, Ralph R.

Supervisory Contract Specialist

MICHAEL W

MCALHANEY

592393

Digitally signed by MICHAEL

W MCALHANEY 592393

Date: 2019.07.29 15:46:12 -05'00'

Joetta M.

Eagle 399755

Digitally signed by Joetta M. Eagle 399755 Date: 2019.07.30 08:19:33 -05'00'

Ralph R.

Crum 547284

Digitally signed by Ralph R. Crum 547284 Date: 2019.07.30 11:56:53 -05'00'