Redacted Justification.pdf

Simplified Acquisition Procedures for Certain Commercial Items Sole Source Justification >SAT-$7.5M under FAR13.5

Effective Date: 02/01/2022 Page 1 of 5

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR

CERTAIN COMMERCIAL ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C261-25-AP-1357 RPOW JOFOC Tracker:

1. Contracting Activity:

Department of Veterans Affairs, Network Contracting Office (NCO) 21, on behalf of the Veterans Integrated Services Network (VISN) 21, San Francisco VA Medical Center, 4150 Clement Street, San Francisco, CA 94121-1563.

2237:

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

This procurement is for Abiomed Impella Pumps and Accessories in accordance with FAR 13.5 Simplified Procedures for Certain Commercial Items and specifically FAR 13.501 Special Documentation Requirements, where acquisitions conducted under Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6, but still require a justification using the format of FAR 6.303-2.

This is a new requirement that will be awarded as a firm fixed price, five (5) year Indefinite Delivery Indefinite Quantity (IDIQ).

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

The San Francisco VA Medical Center (VAMC) has a requirement for five years of orders for Abiomed Impella CP with Smart Assist Heart Pump Kits to include: (1) Purge Cassette, (1) 14Fr Introducer Sheath - 13cm, (1) 14Fr Introducer Sheath - 25cm, (1) Placement Guidewire - .035'' x 150cm, (1) Placement Guidewire - .018'' x 260cm. Per station point of contact, an estimated quantity of nine (9) kits is being supplied but the actual need is dependent on patient procedures scheduled each year and could be as high as 11 kits. Ordering Periods are planned as follows.

Ordering Period 1 – 04/01/2025 – 03/31/2026 Ordering Period 2 – 04/01/2026 – 03/31/2027 Ordering Period 3 – 04/01/2027 – 03/31/2028 Ordering Period 4 – 04/01/2028 – 03/31/2029 Ordering Period 5 – 04/01/2029 – 03/31/2030

This estimated price for this requirement is over five (5) years. This requirement will include FAR 52.217-8. The projected ceiling for this IDIQ is

Effective Date: 02/01/2022 Page 2 of 5

4. Statutory Authority Permitting Restricted Competition:

FAR 13.5 Simplified Procedures for Certain Commercial Items. The statutory authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. § 1901 and is implemented by FAR 13.106-1(b)(2) for restricting competition on this procurement. Competition is restricted on this procurement for the reason below:

(x) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements

( ) Unusual and Compelling Urgency ( ) Industrial Mobilization, Engineering, Developmental or Research

Capability or Expert Services ( ) International Agreement ( ) Authorized or Required by Statute ( ) National Security ( ) Public Interest

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 Impella heart pump is the only Food and Drug Administration (FDA) approved, non-surgical heart pump for use during stent placement and the only device series appearing under FDA product code OZD for temporary non-roller type left heart support blood pump. No other products currently meet the salient characteristics or necessary approvals that would allow for substitution/inclusion as equal products.

Original Equipment Manufacturer (OEM) is Abiomed, a large business who sells directly through Service-Disabled Veteran Owned Small Business (SDVOSB) distributor, Geo-Med, LLC. Abiomed has confirmed to the San Francisco VA that they no longer sell the Impella heart pumps directly to the Government. Accordingly, Geo-Med, LLC is the only firm capable of providing the supplies and services described in Section III above without the Veteran's Health Administration experiencing unacceptable delays in fulfilling its requirements.

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

A Sources Sought notice was posted to SAM.gov for brand name or equal items to uncover potential equal products and/or additional authorized distributors. The notice was live from 01/13/2025-01/20/2025. The notice was shared via email with the OEM and Geo-Med, LLC as both vendors were uncovered during market research as historical providers of the necessary items. The notice received only one completed response, from SDVOSB distributor Geo-Med, LLC. A notice of interest was received from BHPE LLC, an SDVOSB, but no response was received by 01/20/2025 to include proof of authorized distributor status or showing an ability to meet the limitations on subcontracting.

Effective Date: 02/01/2022 Page 3 of 5

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

Quoted prices will be compared with those deemed fair and reasonable in historical purchases, including comparison to expired contractual pricing and prior awards since Impella Pumps became available under only one source.

8. Description of the Market Research Conducted and the Results:

Considerable market research occurred across multiple Government databases including SBA VetCert (668 results for the subject NAICS), Supply Chain Master Catalog, VA National Acquisition Center (NAC), GSA Advantage, FDA Device Listing and FDA Pre Market Approvals. Additionally, research was conducted on SAM.gov for the Impella Pumps. The Supply Chain Master Catalog showed there are no current contracts from which Impella Pumps can be ordered and the separate search of GSA Advantage and the VA NAC showed the same. This will be an open market procurement.

The FDA databases showed only Impella Pumps within the OZD product code which shows there can be no other FDA approved products serving this specific medical function. Additionally, the FDA databases show that the Smart Assist pumps required for this procurement are manufactured in the USA and would be considered domestic end products. While Abiomed does produce some Impella Pumps outside the US and the Buy American Act (BAA) will apply, BAA is not a concern in this instance although the necessary clauses and provisions will be included in the solicitation for vendor response.

SAM.gov Contract Opportunities was searched for the term Impella and identified multiple notices of Intent to Sole Source to SDVOSB, Geo-Med, LLC as the only authorized distributor for Abiomed. Market research from the station stated that a market research outreach was made to Abiomed who confirmed they no longer sell directly to the Government. This finding was reinforced by market research in the Notice of Intent for 36C24725Q0269 and the redacted JOFOC for 36C241-25-AP- 0667.

Registration for SDVOSB Geo-Med, LLC was verified in SBA VetCert and SAM.gov registrations were confirmed for both the OEM and the SDVOSB distributor.

A sources sought notice was posted to SAM.gov as detailed above in section 6.

The Non-Manufacturer Rule (NMR) applies. Geo-Med, LLC completed and signed 852.219-76, VA Limitations on Subcontracting as a part of their sources sought response so there are no concerns that the NMR can be met.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition:

There are no other facts.

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10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition:

Only Geo-Med, LLC and BHPE LLC expressed interest in this acquisition and BHPE LLC was unable to provide the necessary elements of a response to show that NMR could be met or authorized distributor status.

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 Government will continue to conduct market research to identify any additional sources or products that may meet future requirements.

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.

Effective Date: 02/01/2022 Page 5 of 5

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.

b. One Level Above the Contracting Officer (Required over SAT but not exceeding $750K): I certify the justification meets requirements for other than full and open competition.

c. VHA RPO HCA Review and Approval: I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and approve ($750K to $7.5 million (or $15.0 million for acquisitions described in FAR 13.500(c)) for other than full and open competition.