36C77019Q0640-004.pdf

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A)

For

Other Than Full and Open Competition (>SAT)

GLUCOSE Sensor – DEXCOM

Acquisition Plan Action ID: 36C770-19-AP-0640

1. Contracting Activity:

Department of Veterans Affairs

Network 15 Contracting Office (NCO 15)

3450 South 13th Street

Leavenworth, KS 66048

Department of Veterans Affairs

VA CMOP 760

5000 S. 13th Street

Leavenworth, KS 66048

Purchase request number: 760-19-4-050-1952

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:

Manufacturer # STS-OR-003

Brand DEXCOM

Manufacturer DEXCOM INC

Country of Origin USA

Application G6 GLUCOSE SENSORS KIT

UNSPSC Code

NDC 08627-0053-03

• QTY : 400 Boxes (BX)

• PKG : 3 PER BOX

• Delivery: 10 Days After Receipt of Order

Manufacturer # STS-GL-041

Brand DEXCOM

Manufacturer DEXCOM INC

Country of Origin USA

Application G4 Platinum Sensor Kit

UNSPSC Code

NDC 08627-0051-04

• QTY : 400 Boxes (BX)

• PKG : 4 PER BOX

• Delivery: 10 Days After Receipt of Order

•The DEXCOM sensor are used to continuously monitor glucose levels in persons with diabetes.

•The sensors are to be used for detecting trends and tracking glucose patterns.

•DEXCOM sensors automatically adjust basal insulin levels.

•It is indicated for use as an adjunctive device to complement, not replace, information obtained from standard blood glucose monitoring devices.

•The sensor is intended for single use and requires a prescription by Veteran physician.

• Exclusively used with DEXCOM meters

• The VA CMOP requires DEXCOM G4 and G6 sensors for veteran patients as prescribed.

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;

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):

• 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 a Name Brand DEXCOM GLUCOSE SENSORS 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.

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

• Solicitation 36C77019Q0640, DEXCOM Glucose Sensors - will be posted to FedBizOps as other than Full and Open.

• A pre-solicitation notice will be posted to FedBizOps

7. 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:

• Comparison will be made against historical purchases.

• Comparison to the IGCE.

• Internet searches of commercial product prices, which are listed.

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 25 SDVOSB’s capable of bidding.

• The CO has a reasonable expectation that two or more SDVOSBs will bid on this RFQ.

• CO has a reasonable expectation SDVOSB 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.

• Glucose Test Strips are made by BAYER Pharmaceutical – 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 MedSurg procurement, which solicits from SDVOSB vendors who are authorized suppliers but the not the manufacturer of the

MedSurg Item .

• The nonmanufacturer rule, however, applies for MedSurg procurements over the SAT. Therefore, without a waiver in place, the solicitation (RFQ) must be released as Open Market with limited 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/MedSurg 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 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 or MedSurg items 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” MedSurg 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:

• Records of previous historical purchases authorized distributors

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.

Natalie K Johnson Prepared: Contracting Specialist Karen R. Griffin

Logistics Manager

CMOP Leavenworth

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.

Joetta M. Eagle (signature on file)

Contracting Officer

NCO15/CMOP Division

b. One Level Above the Contracting Officer I certify the justification meets requirements for other than full and open competition.

Ralph R. Crum

(signature on file)

Supervisor

Contracting Officer

NCO 15/CMOP Division