36C77019Q0591-005.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 3 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: 760‐19‐4‐050‐1787

1. Contracting Activity:

Department of Veterans Affairs

Network 15 Contracting Office (NCO15) 3450 South 13th Street Leavenworth, KS 66048

Items are to be delivered to the LEAVENWORTH CMOP 760

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

The Leavenworth , Consolidated Mail Outpatient Pharmacy, 5000 S. 13th street Leavenworth, Kansas 66048 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. The total estimated value for this request is $147410.00

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

MINIMED SETS AND RESERVOIRS FOR INSULIN PUMPS MADE BY MEDTRONICS

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;

(x ) (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 2 of 3

Revision 08 Date: 04/18/2018

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).

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.

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

Products were searched in the NAC and GSA catalog and none of the items were found to be on contract.

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

Reasonable:

The IGCE contains the estimated cost to the Government and serves as the recognition of Fair and Reasonable.

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 and DSBS under NAICS 325413. 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 325413 Despite these results, there are no known SDVOSB, VOSB, 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 325413. A request for an individual NMR waiver will take approximately 15 business days to process IAW https://www.sba.gov/contracting/contracting‐officials/non‐manufacturer‐rule/non‐manufacturer‐ waivers. CMOPs are required to fill a prescription within 5 days or the prescription must be returned to the Medical Center for filling. Due to these time frames, I am not afforded the time for the process of requesting an individual waiver and thus delaying critical Veteran patient care. Therefore, OFOC SOP Revision 08 Page 3 of 3

Revision 08 Date: 04/18/2018 based on this research, it is determined this requirement must be solicited as an Unrestricted Procurement (Full and Open Competition), to be posted atwww.fbo.gov.

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: N/A

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:

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.

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.

_____________________________ 7/1/19 Name: Robin Halstead Date Title IMS Facility 760 LV 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.

Name: JOETTA M. EAGLE Date Title Contract Specialist Facility