Penumbra Consignment Agreement SSJ_Redacted.pdf

LIMITED SOURCES JUSTIFICATION ORDER >SAT

FAR PART 8.405-6

Acquisition Plan Action ID: 36C249-26-AP-0593

VHAPG Part 808.405-6 Limiting Sources Page 1 of 6 Revision: 01 Effective Date: 09/01/2024 Acquisition ID#: 36C249-26-AP-0593

(1) Contracting Activity: Department of Veterans Affairs (VA), Veterans Integrated Service Networks (VISN) 09, Network Contracting Office (NCO) 9 located in Murfreesboro, Tennessee in support of Robley Rex VA Medical Center (RRVAMC) located in Louisville, Kentucky.

(2) Description of Action: New requirement for a consignment agreement including implanted detachable coils and delivery catheters. Accomplished via a Blanket Purchase Agreement (BPA) with Consignment Agreement Delivery Method.

Order against: Federal Supply Schedule (FSS) Contract Number: 36F79722D0041

Name of Proposed Contractor: USVetServ, LLC

Street Address: 355 English Oak Rd

City, State, Zip: Simpsonville, SC 29681

Phone: 864-216-9881

(3) Description of Supplies or Services:

Radiology requires implanted detachable coils and delivery catheters in various sizes, lengths, and diameters as appropriate for patient care. The VA anticipates a Five (5) One Year Ordering Periods, BPA with Consignment Agreement as the delivery method.

The estimated value of the proposed action is $472,370.00

Ordering Period 1: $94,474.00 | 12/01/2025 – 11/30/2026

Ordering Period 2: $94,474.00 | 12/01/2026 – 11/30/2027

Ordering Period 3: $94,474.00 | 12/01/2027 – 11/30/2028

Ordering Period 4: $94,474.00 | 12/01/2028 – 11/30/2029

Ordering Period 5: $94,474.00 | 12/01/2029 – 11/30/2030

USVetServ Catalog Description USVS-PXSLIMLAN115STR LANTERN® Delivery Microcatheter 115cm, Straight Tip USVS-PXSLIMLAN115T45 LANTERN® Delivery Microcatheter 115cm, 45° Tip USVS-PXSLIMLAN115T90 LANTERN® Delivery Microcatheter 115cm, 90° Tip USVS-PXSLIMLAN135STR LANTERN® Delivery Microcatheter 135cm, Straight Tip USVS-PXSLIMLAN135T45 LANTERN® Delivery Microcatheter 135cm, 45° Tip USVS-PXSLIMLAN135T90 LANTERN® Delivery Microcatheter 135cm, 90° Tip

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Acquisition ID#: 36C249-26-AP-0593

USVS-PXSLIMLAN150STR LANTERN® Delivery Microcatheter 150cm, Straight Tip USVS-PXSLIMLAN150T45 LANTERN® Delivery Microcatheter 150cm, 45° Tip USVS-PXSLIMLAN150T90 LANTERN® Delivery Microcatheter 150cm, 90° Tip USVS-PXSLIMLAN160STR LANTERN Delivery Microcatheter 160 cm, Straight Tip USVS-PXSLIMLAN160T45 LANTERN Delivery Microcatheter 160 cm, 45° Tip USVS-PXSLIMLAN160T90 LANTERN Delivery Microcatheter 160 cm, 90° Tip USVS-RBY2C0305 Complex Standard, 3mm x 5cm USVS-RBY2C0312 Complex Standard, 3mm x 12cm USVS-RBY2C0320 Complex Standard, 3mm x 20cm USVS-RBY2C0410 Complex Standard, 4mm x 10cm USVS-RBY2C0420 Complex Standard, 4mm x 20cm USVS-RBY2C0435 Complex Standard, 4mm x 35cm USVS-RBY2C0512 Complex Standard, 5mm x 12cm USVS-RBY2C0530 Complex Standard, 5mm x 30cm USVS-RBY2C0620 Complex Standard, 6mm x 20cm USVS-RBY2C0630 Complex Standard, 6mm x 30cm USVS-RBY2C0725 Complex Standard, 7mm x 25cm USVS-RBY2C0825 Complex Standard, 8mm x 25cm USVS-RBY2C0840 Complex Standard, 8mm x 40cm USVS-RBY2C1035 Complex Standard, 10mm x 35cm USVS-RBY2C1260 Complex Standard, 12mm x 60cm USVS-RBY2C1460 Complex Standard, 14mm x 60cm USVS-RBY2C1660 Complex Standard, 16mm x 60cm USVS-RBY2C1857 Complex Standard, 18mm x 60cm USVS-RBY2C2060 Complex Standard, 20mm x 60cm USVS-RBY2C2457 Complex Standard, 24mm x 60cm USVS-RBY2C2860 Complex Standard, 28mm x 60cm USVS-RBY2C3260 Complex Standard, 32mm x 60cm USVS-RBY2C3660 Complex Standard, 36mm x 60cm USVS-RBY2C4060 Complex Standard, 40mm x 60cm USVS-RBY4C0201 Complex Soft, 2mm x 1cm USVS-RBY4C0202 Complex Soft, 2mm x 2cm USVS-RBY4C0204 Complex Soft, 2mm x 4cm USVS-RBY4C0305 Complex Soft, 3mm x 5cm USVS-RBY4C0315 Complex Soft, 3mm x 15cm USVS-RBY4C0406 Complex Soft, 4mm x 6cm USVS-RBY4C0415 Complex Soft, 4mm x 15cm USVS-RBY4C0620 Complex Soft, 6mm x 20cm USVS-RBY4C0630 Complex Soft, 6mm x 30cm

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Acquisition ID#: 36C249-26-AP-0593

USVS-RBY4C0835 Complex Soft, 8mm x 35cm USVS-RBY4C0860 Complex Soft, 8mm x 60cm USVS-RBY4C1650 Complex Soft, 16mm x 50cm USVS-RBY4C2060 Complex Soft, 20mm x 60cm USVS-RBYLP0102 Ruby Coil LP, 1 mm x 2 cm USVS-RBYLP0105 Ruby Coil LP, 1 mm x 5 cm USVS-RBYLP0202 Ruby Coil LP, 2 mm x 2 cm USVS-RBYLP0204 Ruby Coil LP, 2 mm x 4 cm USVS-RBYLP0210 Ruby Coil LP, 2 mm x 10 cm USVS-RBYLP0304 Ruby Coil LP, 3 mm x 4 cm USVS-RBYLP0310 Ruby Coil LP, 3 mm x 10 cm USVS-RBYLP0315 Ruby Coil LP, 3 mm x 15 cm USVS-RBYLP0406 Ruby Coil LP, 4 mm x 6 cm USVS-RBYLP0415 Ruby Coil LP, 4 mm x 15 cm USVS-RBYLP0430 Ruby Coil LP, 4 mm x 30 cm USVS-RBYLP0510 Ruby Coil LP, 5 mm x 10 cm USVS-RBYLP0530 Ruby Coil LP, 5 mm x 30 cm USVS-RBYLP0610 Ruby Coil LP, 6 mm x 10 cm USVS-RBYLP0630 Ruby Coil LP, 6 mm x 30 cm USVS-RBYLP0740 Ruby Coil LP, 7 mm x 40 cm USVS-RBYLP0860 Ruby Coil LP, 8 mm x 60 cm USVS-RBYPCLP03 Packing Coil LP, 3cm USVS-RBYPCLP06 Packing Coil LP, 6cm USVS-RBYPCLP10 Packing Coil LP, 10cm USVS-RBYPCLP15 Packing Coil LP, 15cm USVS-RBYPCLP30 Packing Coil LP, 30cm USVS-RBYPCLP45 Packing Coil LP, 45cm USVS-RBYPCLP60 Packing Coil LP, 60cm

USVS-RBYPOD10 POD® 10

USVS-RBYPOD12 POD® 12

USVS-RBYPOD14 POD® 14

USVS-RBYPOD3 POD® 3

USVS-RBYPOD4 POD® 4

USVS-RBYPOD5 POD® 5

USVS-RBYPOD6 POD® 6

USVS-RBYPOD8 POD® 8

USVS-RBYPODJ15 POD® Packing Coil J-Soft 15 USVS-RBYPODJ30 POD® Packing Coil J-Soft 30 USVS-RBYPODJ45 POD® Packing Coil J-Soft 45

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Acquisition ID#: 36C249-26-AP-0593

USVS-RBYPODJ5 POD® Packing Coil J-Soft 5 USVS-RBYPODJ60 POD® Packing Coil J-Soft 60 USVS-RH1 Coil Detachment Handle USVS-RLPH1 LP Detachment Handle

(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.)

Authorized by statute: The statutory authority permitting other than full and open competition is Title 41 United States Code (U.S.C.) § 3304(a)(5) and 38 U.S.C. § 8123.

Veterans Affairs Acquisition Regulation (VAAR) 806.302-571(b)(1) states contracting activities may procure prosthetic appliances and necessary services required in the fitting, supplying, training and use of prosthetic appliances by purchase, manufacture, contract, or in such other manner as determined to be proper, without regard to any other provision of law once it is determined that 38 U.S.C. § 8123 is applicable.

On October 5, 2017, the Secretary of VA delegated section 8123 authority to the Under Secretary for Health. This authority allows the Veterans Health Administration (VHA) to procure prosthetic appliances and necessary related services without regard to any other provision of law. The Under Secretary has exercised this authority in this class of products due to the critical nature of these items. VHA Directive 1081.01(1) dated October 29, 2018, establishes policy, procedures, and responsibilities for the use of Title 38 U.S.C. § 8123 authority for the procurement of prosthetics surgical implants. This directive states it is VHA policy to utilize the authority of 38 U.S.C. 8123 to optimize the procurement process for surgical implants to provide Veterans with timely access to care. The items included in this BPA with Consignment Agreement are surgical implants.

(5) Describe Why You Believe the Order Represents the Best Value consistent with Federal Acquisition Regulation (FAR) 8.404(d) to aid the contracting officer in making this best value determination:

When compared to other procurement methods available, a BPA with Consignment Agreement established against this VA FSS Contract most-reduces administrative burden and lead-time on items required for surgical procedures, where timeliness is critical for patient care. Thus, it is estimated that the proposed method provides the greatest overall benefit in response to the requirement. Pricing is already determined fair and reasonable at contract award.

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

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Acquisition ID#: 36C249-26-AP-0593

a) The VA Rule of Two and Small Business Administration (SBA) Rule of Two are not met.

Two or more Service-Disabled Veteran Owned Small Businesses (SDVOSB), Veteran Owned Small Businesses (VOSB), or Small Businesses cannot perform the work, and are not likely to submit an offer/quote at a fair and reasonable price that offers best value to the Government.

b) National Acquisition Center (NAC) MedSurg Catalog was queried under keywords Ruby Coil, Packing Coil, and Microcatheter yielding the brand name’s results only from USVetServ LLC’s VA FSS 36F79722D0041

c) General Services Administration (GSA) Advantage was queried under keywords Ruby Coil, Packing Coil, and Microcatheter yielding the brand name’s results only from USVetServ LLC’s VA FSS 36F79722D0041

d) Federal Procurement Data System (FPDS) was queried under keywords Penumbra Consignment and Ruby Coil yielding FPDS entries for previous acquisitions, all of which were awarded to the manufacturer Penumbra, Inc. FPDS was then queried under keywords: Coil Consignment yielding FPDS entries for previous acquisitions, all but three results were awarded to the manufacturer Penumbra, Inc. It yielded three results for Stryker Retriever Coil consignment agreements, which is a different product and manufacturer.

e) Medical Supplies Program Office (MSPO) National Strategic Source Listing was queried under keywords: Coil, and Penumbra yielding no results. It was then queried under keyword Catheter yielding an Electrophysiology Catheters contract. These catheters are solely for diagnostic, research, and ablation heart procedures and not relevant to this requirement.

(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:

The Government will continue to conduct market research to ascertain if there are changes in the marketplace that would enable future actions to be competed.

(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

Acquisition Plan Action ID: 36C249-26-AP-0593

VHAPG Part 808.405-6 Limiting Sources Page 6 of 6 Revision: 01 Effective Date: 09/01/2024 Acquisition ID#: 36C249-26-AP-0593 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.)

(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 SIGNATURE

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.

BRANCH CHIEF SIGNATURE