-16385.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 4 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-0421 (770-19-2-801-0079)

1. Contracting Activity:

Department of Veterans Affairs Network 15 Contracting Office (NCO 15) 3450 South 13th Street Leavenworth, KS 66048

Department of Veterans Affairs, VISN 15, VA CMOP National Office – 700, 5049 S. 13th Street, Leavenworth, KS 66048.

This request is a Justification for Other Than Full and Open Competition for requisition # 770-19-2- 801-0079. The purchase request is for Buspirone HCL 5MG, 10MG and 15MG, which is a prescribed medication to treat certain anxiety disorders or to relieve the symptoms of anxiety.

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

Emergency request for 5MG – qty. 1200 bottles; 10MG – qty. 1200 bottles; 15MG – qty. 1200 bottles of Buspirone HCL. The prescribed item will be purchased from the Vendor identified because they are able to meet the Veteran's medical need. The item was prescribed by the Veteran's attending Physician who has the authority to prescribe the method of treatment to best satisfy the medical condition of his/her patient. The physician has determined this item as the best device to treat the patient's medical condition and functional limitations. Requesting that Tri-Pharma, 975 Cobb Place Blvd., Unit 118, Kennesaw, GA 30144 be awarded a contract for the pharmaceutical described above. This is a new procurement and the contract will be a firm-fixed-price contract.

The total estimated value for this request is $630,000.00.

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

a. 5MG - 00093-0053-05 (TEVA 500ct) - approved for B0196 BUSPIRONE HCL 5MG TAB (qty. 1200 bottles) Or 68382-0180-05 (Zydus 500ct) - approved for B0196 BUSPIRONE HCL 5MG TAB (qty. 1200 bottles)

b. 10MG - 64380-0742-07 (Strides Pharma 500ct) – approved for B0195 BUSPIRONE HCL 10MG TAB (qty. 1200 bottles) Or 16729-0202-16 (Accord 500ct) – approved for B0195 BUSPIRONE HCL 10MG TAB (qty. 1200 bottles)

OFOC SOP Revision 08 Page 2 of 4

Revision 08 Date: 04/18/2018

c. 15MG NDC 00093-1003-05 (TEVA 500ct) – approved for B0294 BUSPIRONE HCL 15MG TAB (qty.

1200 bottles)

d. Delivery date is 1-2 weeks after receipt of order.

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

( ) (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;

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority):

The referenced pharmaceutical, Buspirone HCL, has been in high demand across the seven CMOP facilities but in very low supply from vendors. It has been listed as number one (10MG), six (15MG), and eight (5MG) on the on National CMOP’s “Top Ten 007 Prescriptions Canceled” report (see attachment 1). Several competive solicitations have been issued for this pharmaceutical with little or no success in awarding to a vendor due to critical shortages. The list of recent and ongoing solicitations are:

36C77019Q0057 (770-19-1-801-0015) 36C77019Q0047 (762-19-1-040-0079) 36C77019Q0095 (770-19-1-801-0034) 36C77019Q0099 (766-19-1-400-0130) 36C77019Q0197 (770-19-1-801-0051)

Sources sought notice 36C77019Q0236, posted to FBO.GOV on 01/11/2019 and a closing date of 02/28/2019, has received zero responses to date.

Tri-Pharma is the only vendor that has product availability and is able to provide the product immediately (1-2 weeks).

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

Tri-Pharma is the only vendor that has product availability and is able to provide the product immediately (1-2 weeks). Tri-Pharma is an authorized distributor.

Other Actions: See paragraph 5 above.

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

The CO will determine the anticpated cost to be considered fair and reasonable based on the following:

- Comparison with the IGCE.

- Historical purchases of this pharmaceutical

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted:

This is an emergency procurement for Buspirone HCL. The CO is unable to determine that two or more (or a combination) SDVOSB’s, VOSB, or SB can provide the product at a fair and reasonable price within the timeline required to ensure an uninterrupted supply of Buspirone HCL. This product is not available from the federal prison industry (FPI), Ability One, DLA or GSA.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: None.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: None.

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:

Several competive solicitations have been issued for this pharmaceutical with little or no success in awarding to a vendor due to critical shortages. The list of recent and ongoing solicitations are:

36C77019Q0057 (770-19-1-801-0015) 36C77019Q0047 (762-19-1-040-0079) 36C77019Q0095 (770-19-1-801-0034) 36C77019Q0099 (766-19-1-400-0130) 36C77019Q0197 (770-19-1-801-0051)

Sources sought notice 36C77019Q0236, posted to FBO.GOV on 01/11/2019 and a closing date of 02/28/2019.

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.

Peter Carbrey Date National CMOP Logistics Manager

02/22/2019Per email

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VA CMOP National Office – 700

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

NCO15

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 Supervisory Contract Specialist

NCO 15

Julian S. Lake 251184

Digitally signed by Julian S.

Lake 251184 Date: 2019.03.02 11:13:06 -06'00'