P03 - LSJ - DaTscan - Signed BC.pdf

VHAPM Part 808.405-6 Limiting Sources Page 1 of 3 Original Date: 08/30/2017 Revision 03 Eff Date: 03/18/2021

LIMITED SOURCES JUSTIFICATION

ORDER >SAT

FAR PART 8.405-6

Acquisition Plan Action ID:36C252-22-AP-1737

(1) Contracting Activity: Department of Veterans Affairs, VISN 12, Hines VAMC Medical Center, along with Network Contracting Office (NCO)12, Great Lakes Acquisition Center (GLAC) 2237 – 578-22-2-735-0078

(2) Description of Action: This acquisition is conducted under the authority of the Multiple- Award Schedule Program (41 U.S.C. 152(3) and 40 U.S.C. 501).

Order against: FSS Contract Number: _36F79720D0182______

Name of Proposed Contractor: Medi-Physics, Inc, dba GE healthcare

Street Address: 100 Results Way

City, State, Zip: Marlborough, MA 01752

Phone: 800-292-8514

(3) Description of Supplies or Services:

The estimated value of the proposed action is $ 493,693.50

Provide RadioPharmaceutical DaTscan (Ioflupane I 123 Injection) as required for patient care.

(4) Identify the Authority and Supporting Rationale (see below and if applicable, a demonstration of the proposed contractor’s unique qualifications to provide the required supply or service.

FAR 8.405-6(a)(1)(A): An urgent and compelling need exists and following the ordering procedures would result in unacceptable delays:

FAR 8.405-6(a)(1)(B): Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized

FAR 8.405-6(a)(1)(C): In the interest of economy and efficiency, the new work is a logical follow-on to an original Federal Supply Schedule order provided that the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.gpo.gov/fdsys/pkg/USCODE-2011-title40/pdf/USCODE-2011-title40-subtitleI-chap5-subchapI-sec501.pdf

VHAPM Part 808.405-6 Limiting Sources Page 2 of 3

Revision 03 Eff Date: 03/18/2021 original order must not have been previously issued under sole source or limited source procedures.

FAR 8.405-6(b): Items peculiar to one manufacturer:

A patent, copyright or proprietary data limits competition. The proprietary data is: Medi-Physics, Inc. is the manufacturer of DaTscan™ (Ioflupane I 123 Injection).

DaTscan. The injection is only available for purchase directly through GE Healthcare’s central distribution center in Arlington Height, IL or through one of the VHA’s pharmacy partners.

(5) Describe Why You Believe the Order Represents the Best Value consistent with FAR 8.404(d) to aid the contracting officer in making this best value determination: The facility can only purchase this drug from Medi-Physics. Pricing provided per the NAC to the VAMC is listed under the Big $ pricing which is less than provided to other government agencies and below the Federal Ceiling Price for this therapy.

(6) Describe the Market Research Conducted among schedule holders and the results or a statement of the reason market research was not conducted. Review of NAC and FCP for the Therapy. GE is the only provider of this drug with no authorized distributors or resellers.

(7) Any Other Facts Supporting the Justification: None

(8) A Statement of the Actions, if any, the agency may take to remove or overcome any barriers that led to the restricted consideration before any subsequent acquisition for the supplies or services is made: None

(9) 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. I understand that processing of this limited sources justification restricts consideration of Federal Supply Schedule contractors to fewer than the number required by FAR Subpart 8.4. (This signature is the requestor’s supervisor, fund control point official, chief of service or someone with responsibility and accountability.)

SIGNATURE DATE

NAME TITLE SERVICE LINE/SECTION

FACILITY

02/22/2022

Lisa Wedoff Supervisor Nuclear Medicine

Edward Hines VA

VHAPM Part 808.405-6 Limiting Sources Page 3 of 3

Revision 03 Eff Date: 03/18/2021

(10) Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

a. Contracting Officer’s Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

CONTRACTING OFFICER DATE

Teresa Beers – Contracting Officer GLAC, NCO 12___________

NAME AND TITLE FACILITY/NCO/PCO

b. One Level Above the Contracting Officer (Required over the SAT but not exceeding $750K):

I certify the justification meets requirements for other than full and open competition.

SIGNATURE DATE

David Picchi- Branch Chief

NAME AND TITLE

NCO12, Branch Chief, Supply Team https://dvagov.sharepoint.com/sites/VHAProcurement/VHAPM/VHAPM_Part_806.3.aspx https://dvagov.sharepoint.com/sites/VHAProcurement/VHAPM/VHAPM_Part_806.3.aspx