36C77020Q0063-003.pdf

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Pharmaceutical (Rx) – CMOP Leavenworth KS

Acquisition Plan Action ID: 36C770-20-AP-0075

1. Contracting Activity:

Department of Veterans Affairs Network 15 Contracting Office (NCO 15) 3450 South 4th Street Leavenworth, KS 66048

Department of Veterans Affairs, VA CMOP Leavenworth 5000 south 13th St Leavenworth, KS 66048

Purchase request number: 760-20-1-050-0091

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

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

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

- No Generic Rx 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 Rx 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 a Pharmaceutical, 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:

Delivery Date – 30Oct19

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 RX - available from multiple suppliers.

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

• The attending Physician has prescribed a Name Brand Rx, ARMOUR THYROID, 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 Rx and Medical Surgical (MedSurg) products may be prescribed by physicians when in their clinical judgment the brand name Rx/MedSurg will provide a better therapeutic outcome for patients.

• Brand name drugs and MedSurg are requested when there is a clinical requirement for the Rx/product or there is history of clinical requirements for the Rx/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 36C77020Q0063, Rx Thyroid - will be posted to FedBizOps as Other Than Full and Open.

A Pre-Solicitation notice will be posted to FedBizOps on 10/24/2019.

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 325412 shows 67 SDVOSB’s capable of bidding.

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

• 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.

• Pharmaceutical is made by ALLERGAN, INC – 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 Pharmaceuticals .

• The Nonmanufacturer Rule, however, applies for Rx 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 Rx 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 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” Rx procurements.

• Rx 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 Rx RFQs are awarded to SDVOSB Suppliers.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition:

• 3T Federal Solutions – SDVOSB

• Nationwide Pharmaceutical – SDVOSB

• Marathon Medical Corp – 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.

Diane Nolting Date Deputy Chief Logistics 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.

Julian Lake Date Contracting Officer CMOP Contracting

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 Supervisor CMOP Team 2

Julian S. Lake 251184

Digitally signed by Julian S.

Lake 251184 Date: 2019.10.24 13:41:13 -05'00'

Ralph R. Crum 547284 Digitally signed by Ralph R. Crum 547284 Date: 2019.10.24 14:19:45 -05'00'