P03 BRAND NAME JA OVER SAT Med Surg-BrChfSignedpRedacted.pdf

VHAPM Part 813.5 Simplified Acquisition Procedures for Certain Commercial Items Attachment 1: Request for Sole Source Justification Template >SAT-$7M under FAR13.5

PM Part 813.5 SAP for Certain Commercial Items Page 1 of 3 Original Date: 08/30/17 Revision 02 Date: 08/04/2020

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C770-21-AP-0747

Contracting Activity: Department of Veterans Affairs, NCO 15 Contracting, CMOP Division -

CMOP, 2237: #765-21-3-021-0700

Nature and/or Description of the Action Being Processed:

This is an individual brand-name justification to support the procurement of the following items:

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

• NDC: 43169-0704-05

• QTY: 900 BOXES

RESERVOIR,MINIMED #MMT-332A

NDC: 76300-0332-10

QTY: 2100 BOXES

3. BARRIER,BRAVA STRIPS C

NDC: 82112-0731-07

QTY: 1200 BOXES

The Hines CMOP facility requires the above items to be procured with the support of the instant justification and approval for other than full and open competition. The proposed procurement action will be a firm fixed-price contract award for the supplies

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

The items above support Veteran patient prescriptions.

This order is to be delivered in 5 days ARO.

4. Statutory Authority Permitting Restricted Competition:

FAR 13.5 Simplified Procedures for Certain Commercial Items. The statutory authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. § 1901 and is implemented by FAR 13.106-1(b)(2) for restricting competition on this procurement. Competition is restricted on this procurement for the reason below:

( X ) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements

( ) Unusual and Compelling Urgency ( ) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert

Services ( ) International Agreement ( ) Authorized or Required by Statute ( ) National Security

PM Part 813.5 SAP for Certain Commercial Items Page 2 of 3 Original Date: 08/30/17 Revision 02 Date: 08/04/2020

( ) Public Interest

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 National Drug Code (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.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: This will be posted on Contract Opportunities (beta.SAM.gov) as unrestricted so any vendor who can provide this item is welcome to quote.

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

Reasonable: The anticpated cost will be fair and reasonable based off competition and/or the IGCE.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons

Market Research Was Not Conducted: Since the procurement is over SAT then the Non-manufacture rule (NMR) applies. 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 325413. Based on this research and policy, the rule of two cannot be met to set the procurement aside for a socioeconomic subcategory of small business. This will be posted unrestricted.

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

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: The vendors that respond to these types of requests vary from procurement to procurement.

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: N/A

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.

Carlos Araghi Date Inventory Management Specialist CMOP Hines

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

Carlos Araghi 422091

Digitally signed by Carlos Araghi 422091 Date: 2021.06.22 10:41:31 -05'00'

PM Part 813.5 SAP for Certain Commercial Items Page 3 of 3 Original Date: 08/30/17 Revision 02 Date: 08/04/2020

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.

Larry Zaritz Date Contracting Officer CMOP Team 1

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 Supervisory Contract Specialist CMOP Team 1

Larry M.

Zaritz 184054

Digitally signed by Larry M. Zaritz 184054 Date: 2021.06.22 12:12:38 -05'00'

Ralph R. Crum 547284

Digitally signed by Ralph R. Crum 547284 Date: 2021.06.22 16:42:48 -05'00'