36C77019Q0529-006.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 6 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-0640____________________________

1. Contracting Activity Consolidated Mail Outpatient Pharmacy Leavenworth, KS the Department of Veterans Affairs Network 15 Contracting Office (NCO), 3450 S. 4th St Trafficway, Leavenworth, KS

66048 is the contracting agency.

Supplies will be purchased for the Chelmsford VA CMOP.

Purchase request number: 761-19-3-014-0296

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

- J&A supporting an RFQ for a - NAME BRAND ONLY - MedSurg Supply item, used in Patient Care.

- “Name Brand Only” meaning - no other like item will do.

- No Generic MedSurg Item from another manufacturer will be accepted.

- “Name Brand Only” originates with the VA Physician treating Veteran Patients

- A VA Physician has prescribed a specific Name Brand MedSurg item for Veteran use/treatment.

- Neither the CMOP nor Contracting Officer have the authority to change a Physician’s prescription.

- This limits the Bids to one manufacturer but does not limit all bids from one source.

- One Manufacturer (Name Brand) – there are several different suppliers/sources.

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:

O0346 - ONE TOUCH VERIO (GLUCOSE) TEST STRIP

NDC – 53885027210

Quantity of request: 1440 Supplier: LIFESCAN

The OneTouch Verio® test strips provide accuracy your patients can rely on.

OFOC SOP Revision 08 Page 2 of 6 Original Date: 03/22/11 Revision 08 Date: 04/18/2018

Requiring only 0.4 L of blood, our test strips have achieved 5 years of proven clinical accuracy even at extremely low and high blood glucose levels. For blood glucose testing with the OneTouch Verio® family of meters, including the OneTouch Verio Flex® meter, OneTouch Verio® meter, and OneTouch Verio IQ® meter.

XJ313 - GLUCOSE SENSOR DEXCOM G6

NDC/PART# - 08627005303/STS-OR-003

Quantity of Request: 1600

SUPPLIER: DEXCOM

The Dexcom G6 Continuous Glucose Monitoring System (Dexcom G6 System) is a real time, continuous glucose monitoring device indicated for the management of diabetes in persons age 2 years and older.

The Dexcom G6 System is intended to replace fingerstick blood glucose testing for diabetes treatment decisions. Interpretation of the Dexcom G6 System results should be based on the glucose trends and several sequential readings over time. The Dexcom G6 System also aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments.

The Dexcom G6 System is also intended to autonomously communicate with digitally connected devices, including automated insulin dosing (AID) systems.

XJ454 – GLUCOSE SENSOR ENLITE MMT-7008A

NDC/PART# MMT-7008A

QUANTITY OF REQEST: 180

SUPPLIER: MEDTRONIC

Enlite Sensor

Enlite™ Glucose Sensors have an electrode inserted just under the skin and measure glucose values which are relayed to the pump and CGM monitor. Enlite combines improved performance and is designed for comfort and ease of use.

Please note: The Enlite Sensor must be combined with the Guardian 2 Link transmitter/MiniLink transmitter to wirelessly transmit glucose readings to the MiniMed 640G/VEO insulin pump. You must complete a Continuous Glucose Monitoring (CGM) start with your healthcare professional team before using this product. Be sure to discuss questions specific to your health and treatments with a healthcare professional.

One button insertion process Up to 6 days use Indicated for Children and Adults

OFOC SOP Revision 08 Page 3 of 6 Original Date: 03/22/11 Revision 08 Date: 04/18/2018

XZ835 - RESERVOIR,MINIMED #MMT-332A

NDC/PART# 43169786554/ MMT-332A

Quantity of request: 1872

SUPPLIER: MEDRONIC

Medtronic MiniMed Paradigm Reservoir is intended for use with the MiniMed Paradigm™ 71x insulin pumps and infusion sets only. It is custom made for Medtronic MiniMed Paradigm™ 7 Series insulin pumps and can be used with all Medtronic MiniMed Paradigm™ infusion sets. User-filled reservoir holds up to 3ml of insulin Reservoir Size: 3.0 ml – MMT332A About MiniMed Paradigm 71x insulin Pumps: Can be hidden and worn under clothing for daily use. It is small and water resistant. Ref #: MMT-332A

4. Statutory Authority Permitting Other than Full and Open Competition:

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 Item - available from multiple suppliers.

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

• The attending Physician has prescribed these Name Brand items 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.

• Accordingly, Mini Med, Dexcom, and One Touch are the only firms capable of manufacturing the supplies, described in Section 3 above, that meet the requirements of the Physician’s prescription.

(x) (1) Only one responsible source and no other supplies or services will satisfy agency requirements.

OFOC SOP Revision 08 Page 4 of 6 Original Date: 03/22/11 Revision 08 Date: 04/18/2018

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

Solicitation 36C77019Q0529, will be posted to FedBizOps as a

. A pre-solicitation notice was posted to FedBizOps on 06/04/2019.

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:

• RFQ is Full and Open to all interested/responsible parties.

• CO anticipates bids from two or more SB who carry the Med S g 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 product or can get the product from an authorized source. It is not certain if vendors can get the product at the same cost as the manufacturer. The manufacturer is a large business and has never offered a quote in past solicitations.

• Med Surg items are made by a large business.

• Procurement exceeds the SAT threshold; nonmanufacturer rules applies therefore prohibiting the use of a set-side. Per the Code of Federal Regulations §121.406, the performance requirements (limitations on subcontracting) and the nonmanufacturer rule do not apply to small business set-aside acquisitions with an estimated value between the micro-purchase threshold and the simplified acquisition threshold (SAT). This allows for a SDVOSB set-aside pharmaceutical procurement, which solicits from SDVOSB vendors who are authorized suppliers but the not the manufacturer of the pharmaceutical. The nonmanufacturer rule, however, applies for pharmaceutical procurements over the SAT. Therefore, without a waiver in place, the solicitation must be released as full and open competition. The same SDVOSB vendors who are authorized suppliers but not the manufacturer of the product may provide a quote along with other business size classes. In order to request a waiver to the nonmanufacturer rule for a pharmaceutical procurement over the SAT, the Code of Federal Regulations §121.1203, (a), states, “Where appropriate, SBA will generally grant waivers for an individual contract or order prior to the issuance of a solicitation, or, where a solicitation has been issued, when the contracting officer provides all potential offerors additional time to respond.” In addition, §121.1203, (a)(4)(i), requires a public notice to be issued on the Commerce Business Daily and the Federal Register seeking information on small business manufacturers or processors, announcing a notice of intent to waive the Nonmanufacturer Rule for that class of products and affording the public a 15-day

OFOC SOP Revision 08 Page 5 of 6 Original Date: 03/22/11 Revision 08 Date: 04/18/2018 comment period is required. In order to avoid pharmaceutical supply shortages at the CMOP facilities, the facilities require an average of 10 days delivery of the pharmaceutical after the receipt of the order. The SBA waiver processing timeline exceeds the CMOPs required delivery timelines. Due to these time frames, contracting is not afforded the time to process a request for an individual waiver for it could possibly delay and negatively affect Veteran patient care.

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

• These are reoccurring “Name Brand Only” 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

• United Drug Supply – WOSB

• Veterans Healthcare Suppy Solutions – 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.

Name Date Title Facility

OFOC SOP Revision 08 Page 1 of 1 Original Date: 03/22/11 Revision 08 Date: 04/18/2018

1. 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.

Kevin Mahoney

Contract Specialist

Name Jul n Lake Title Contracting Officer Facility NCO 15

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.

Date

Name John Fisher Title Branch Cheif Facility NCO 15 CMOP

c. Director of Contracting Approval : I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and approve for other than full and open competition.

Name Scott Fiscus Date Title Director of Contracting Facility 15 Network Contrating Office

d. VHA SAO HCA Review and Approval: I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and recommend approval (if over $68 million) or approve ($700K to $68 million) for other than full and open competition.

Randy L. Hays Date Acting Executive Director, SAO Central SAO Central Head of Contracting Activity

Kevin A Mahoney 494724

Digitally signed by Kevin A Mahoney 494724 Date: 2019.06.04 15:15:31 -05'00'

John C. Fisher 629338

Digitally signed by John C. Fisher 629338 Date: 2019.06.05 08:18:56 -05'00'

Julian S.

Lake 251184

Digitally signed by Julian S. Lake 251184 Date: 2019.06.05 07:24:17 -05'00'

SCOTT R FISCUS 381888 Digitally signed by SCOTT R FISCUS 381888 Date: 2019.06.06 13:54:27 -05'00'

Randy L. Hays 534204

Digitally signed by Randy L. Hays 534204 Date: 2019.06.07 07:54:31 -07'00'