36C77018Q0782-003.doc

VHAPM Part 806.3 Other Than Full and Open Competition (OFOC) SOP Attachment 2: Request for Sole Source Justification Format >SAT

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT) Acquisition Plan Action ID: 766-18-4-400-1054

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 Charleston CMOP

2. Nature and/or Description of the Action Being Processed: The Charleston-CMOP, 3725 Rivers Avenue, Suite 2, Charleston, NC 29405, Consolidated Mail Outpatient Pharmacy is requesting approval to purchase the Brand name only per Physicians determination of need for the Medtronic Minimed products listed in line item # 1. This is a new procurement and will be a firm fixed price contract. The total estimated value for this request is $REDACTED. The list below does include all drug items included in this request.

FAR13.5 Simplified Procedures for Certain Commercial Items: This procurement is for Glucose Sensor Guardian MMT 7020 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:

GLUCOSE SENSOR GUARDIAN MMT 7020 ( XJ024)

· (NO SUBSTITUTES)

· Delivery on or before 9-16-2018 Quantity and Description of request: 5 per Box GLUCOSE SENSOR GUARDIAN MMT 7020 ( XJ024)

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; Brand name description application applies.

(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;

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):

Once a physician determines that their treatment plan for a patient includes an insulin pump, the Prosthetic Department of the VA Medical Center issues a Medtronic Minimed wearable constant insulin delivery system to the patient. These devices were researched, tested, and approved by the VA as the preferred item for this treatment. Neither Medtronic nor a physician will validate or waive liability of using other than Minimed products in conjunction with the issued pump. Although there are many infusion items designed to be interoperable with all pumps, Medtronic contends that they cannot ensure that the prescribed medicine is delivered when third party parts are used with their pump. According to Medtronic, manufacturer specific, non-interchangeable, parts for administering the insulin are required to ensure proper dosage.

If the CMOP National File entry has a specific brand or item number in the prescription description, the CMOP is ONLY allowed to dispense that exact item match. The VA Doctors writing prescriptions do so based on clinical need and write the prescription accordingly to provide critical patient care. The pump works in conjunction with the associated tubes to deliver the insulin as prescribed by a physician. The manufacturer cannot guarantee that the prescribed medical dose can or will be delivered as prescribed if any part of the Minimed device is NOT manufacturer approved. Not using the entire Minimed package (tubes,pump,and injection ports) could pose a threat to the patient as the prescribed amount cannot be guaranteed. The accessories are a part of a highly specialized insulin delivery system that can use other than manufacturer accessories but it is not recommended. If third party accessories are used, Medtronic cannot ensure the insulin delivery device is delivering insulin as prescribed by a physician. Based on this inability to ensure the prescribed dose is being delivered accurately, using third party accessories can put patient care in jeopardy. Mildly low blood sugar levels are somewhat common for people with diabetes; however, severely low blood sugar levels can be life-threatening. They may lead to seizures and nervous system damage. Immediate treatment is critical. It is imperative that the pump functions correctly.

(Brand-name or equal descriptions and other purchase descriptions that permit prospective contractors to offer products other than those specifically referenced by brand name, provide for full and open competition and do not require justifications and approvals to support their use.)

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: Thorough market research has been conducted and it has been found there were no contract sources for this procurement.

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 servise 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, based on this research, it is determined this requirement must be solicited as an Unrestricted Procurement (Full and Open Competition), to be posted at www.fbo.gov.

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

10. 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.

11. 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.

12. 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.

OFOC SOP Revision 08

Original Date: 03/22/11

Revision 08 Date: 04/18/2018