P03 LSJ Consignment Terumo Medical Embolication Coils 36C259-26-AP-1631 _Redacted.pdf

Attachment 2: Request for Limited Sources Justification Format >SAT

VHAPG Part 808.405-6 Limiting Sources Page 1 of 4 Revision: 01 Effective Date: 09/01/2024 Acquisition ID#: 36C259-26-AP-1631

LIMITED SOURCES JUSTIFICATION

ORDER >SAT

RFO PART 8.4

Acquisition Plan Action ID:

JOFOC Tracking #:

(1) Contracting Activity: Department of Veterans Affairs Network Contracting Office 19 (NCO19) 6162 S. Willow Drive, Suite 300 Greenwood Village, CO 80111.

Organizational Activity: Department of Veterans Affairs, Oklahoma City VA Health Care System 921 NE 13th St., Oklahoma City OK 73104-5028

(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).

Oklahoma City VA Medical center (OKCVAMC) is requesting a follow-on agreement for Terumo Medical Corporation brand name Azur embolization coils. This procurement will be for a base year plus four option year consignment blanket purchase agreement (BPA) against the FSS contract 36F79721D0159.

Order against: FSS Contract Number: 36F79721D0159

Name of Proposed Contractor: Terumo Medical Corporation

Street Address: 265 Davidson AVE STE 320

City, State, Zip: Somerset, New Jersey 08873

Phone: 732-412-4161

(3) Description of Supplies or Services:

This blanket purchase agreement will be used to expedite the availability for uncertain requirements for Azur embolization coils when specific items, quantities, and prices are not known at the time the agreement is executed. The items required cannot be immediately determined, having a large quantity and variety of Azur Stents in-house on a consignment basis will assure instant availability as needed for patient procedures.

Period of performance for this Consignment will be from May 15, 2026 to May 14, 2031.

Base Year: May 15, 2026 to May 14, 2027 Option Year One: May 15, 2027 to May 14, 2028

VHAPG Part 808.405-6 Limiting Sources Page 2 of 4 Revision: 01 Effective Date: 09/01/2024 Acquisition ID#: 36C259-26-AP-1631

Option Year Two: May 15, 2028 to May 14, 2029 Option Year Three: May 15, 2029 to May 14, 2030 Option Year Four: May 15, 2030 to May 14, 2031

The estimated value of the proposed action is

(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.

RFO Subpart 538.7104-3(b)(1)(i): An urgent and compelling need exists and following the ordering procedures would result in unacceptable delays:

RFO Subpart 538.7104-3(b)(1)(ii): 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;

The embolization coils requested are proprietary to Terumo, the sole manufacturer and authorized distributor of these products. Due to clinical practice which requires surgeons to select the appropriate coil intraoperatively based on real-time findings, a full range of Terumo coils must be available on-site to support immediate patient care. Without access to these coils, procedures could be delayed, creating an unacceptable risk to patient safety and clinical outcomes.

RFO Subpart 538.7104-3(b)(1)(iii): 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 original order must not have been previously issued under sole source or limited source procedures.

RFO Subpart 538.7104-3(b)(1)(iv) It is necessary to place the order with a particular FSS contractor to satisfy a minimum guarantee established in the FSS BPA

RFO Subpart 538.7104-3(b)(1)(v): A law expressly authorizes or requires that the purchase be made from a specified source.

(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 price for the Terumo embolization coils has been reviewed at the FSS contract level and determined to be fair and reasonable. Procuring these coils represents the best value to the Government because they must be stocked in advance to support both emergency and scheduled surgical procedures. Immediate availability ensures patient safety, maintains continuity of care, and supports established clinical protocols. Since the exact coil cannot be

VHAPG Part 808.405-6 Limiting Sources Page 3 of 4 Revision: 01 Effective Date: 09/01/2024 Acquisition ID#: 36C259-26-AP-1631 determined until the time of the procedure, having these items stocked and immediately available is essential to prevent adverse outcomes and provides the overall best value to the Government.

(6) Describe the Market Research Conducted among schedule holders and the results or a statement of the reason market research was not conducted.

A Small Business Administration certification search was completed and did not find any veteran owned small businesses that could provide for embolization coils. Caroline Desantis, Government Contract Analyst for Terumo Medical Corporation, FSS Contract #36F79721D0159, provided a sole manufacturer letter confirming the items requested can only be purchased directly from Terumo Interventional Systems, a Division of Terumo Medical Corporation. The sole source letter has been uploaded into eCMS Briefcase as P03. There are no authorized distributors, and all government purchases must be placed through 36F79721D0159. This is a follow-on consignment agreement to BPA 36C25922A0014. Items are manufactured in the United States. A modification that will exercise the final option of the FSS contract 36F79721D0159 for another 5 years is anticipated extending the expiration date to Nov 14, 2031, current contract expires Nov 14, 2026. Therefore, the agreement will be purchased via a base year plus four (4) additional option-year task order against FSS contract 36F79721D0159 on a consignment basis IAW FAR Part 8.

(7) Any Other Facts Supporting the Justification: This is a follow-on agreement 36C25922A0014. The original FSS contract number was 36F79721D0159.

(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:

This requirement is proprietary to Terumo Medical Corporation, FSS contract 36F79721D0159.

(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 source justification restricts consideration of Federal Supply Schedule contractors to fewer than the number required by RFO Subpart 8.4.

DATE

Radiology Assistant Supervisor Oklahoma City VA Healthcare System

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(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.

DATE

Contracting Officer Supply Services Denver Branch Network Contracting Office 19 (NCO 19) VHA Regional Procurement Office West

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.

DATE

Contracting Officer Branch Chief, Supply 1 Branch Network Contracting Office 19 (NCO 19) VHA Regional Procurement Office West