-19532.pdf

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A)

For

Other Than Full and Open Competition (›SAT)

Acquisition Plan Action 1E): 36C261-20-AP-0722/ 662-20-1-059-0011

1. Contracting Activity: Department of Veterans Affairs, VISN 21, VA Palo Alto Heath Care System.

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

The purpose Is to establish a purchase order for deliveries of radlopharmaceutica I supplies to SFVA.

Approval is requested for a sole source purchase order with Sofie Co,, the manufacturer of

FlouroDeoxyGlucose (FDG), Sodium Fluoride (F18 - Nan, Neuraceq, There is no authorized distributor, The period of performance shall consist of a base year and one (1) year option. The estimated period of performance is as follows:

Base Period: February 15, 2020 to February 14, 2021 -

Option Year 1: February 15, 7020 to February 14, 2021 -

Estimated total price is( 11111 )for base 4- 1 option year

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

Delivery of PET Radiopharmaceuticals on an as needed basis.

FlouroDeoxyGlucose (FOG)

Sodium Fluoride (F18 - NaF) Neuraceq

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 6,3024;

( ) (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;

OFOC SOP Revision 08

Original Date: 03/22/11

Revision 08 Date: 04/18/2018

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):

The doses for radiopha rmaceutica Is have limited shelf life. The vendor must be able to deliver the doses at least 30 minutes prior to the dose calibration times. Sofie is the only vendor that can make delivery time, and security of providing the radio pharmaceuticals in an expedient manner. Sofle Is the only vendor capable of providing our need of same-day service in the San Francisco area,

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

A Notice of Intent to sole source this requirement was issued on opportunitites under

36C261200,0224 on January 8, 2020. There were no responses from any interested and/or capable vendors.

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

The pricing quoted will be determined fair and reasonable in accordance with (lAW) FAR 13,106-

3(a)(2)(ii) prices found reasonable on previous purchases. The will als 'compared with similar Items in a related industry IAW FAR 13,106-3(a)(2)(1v), s ' Ri'44p

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons

Market Research Was Not Conducted:

VIP search for nuclear medicine resulted in 65 SDVOSB, However, no responses from SDVOSB received from notice of intent posting, 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:

The contract action will be synopsized on FRO within 14 days of award. All acquisitions for this equipment and/or services will continue to be advertised by placing a Notice of Intent to Sole

Source with synopsis of requirement on Oportunitles.

OFOC SOP Revision 08 Page 2 of 3 Original Date; 03/22/11 Revision 08 bate: 04/18/2018

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.

Mark Federspiel Date

Chief Technologist Nuclear Medicine

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.

Mandy L. Thompson 130808

Mandy Thompson Branch Chief, Supply I

NCO 21

Digitally signed by Mandy L.

Thompson 130808 Date: 2020.02.10 09:24:29 -0800'

02/10/2020

Date:

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.

NICHOLAS J. KLUCH

469958

Digitally signed by NICHOLAS J. KLUCH 469958 Date: 2020,02,1009:30:19 -0800'

Nick Kluch Date Deputy Director of Contracting

OFOC SOP Revision 08 Page 3 of 3

Original Date: 03/22/11 Revision 08 Date: 04/18/2018