P03 SSJ Spectrails_Signed_.pdf

PDF 398 KB Posted

Attached to
6530--Spectralis Tracking OCT System - OCT Plus w/OCT2 MultiColor
Solicitation number
36C24826Q0520
Issued by

About this file

This is a Justification and Approval (J&A) document for a sole-source contract award by the Department of Veterans Affairs, James A. Haley Veterans Hospital (JAHVH), VISN 08.

The Ophthalmology Clinic requires a Spectralis Tracking OCT (Optical Coherence Tomography) System to replace existing units that have reached end-of-life and no longer meet operational standards. The Spectralis system provides advanced imaging technology capable of compensating for involuntary eye movements during scans, delivering more reliable and precise diagnostic data and improving the quality of care for Veterans. The procurement will be awarded as a new Firm Fixed Price contract to L1 Enterprises, Inc., a certified Service-Disabled Veteran-Owned Small Business (SDVOSB), under the authority of 38 U.S.C. § 8127(c) and VAAR 819.7008. Market research confirmed that Heidelberg Engineering GmbH is the sole manufacturer of the Heidelberg Engineering product lines, with Heidelberg Engineering, Inc. as the only U.S. source for these products and services. L1 Enterprises, Inc. has been identified as the only authorized distributor of Heidelberg Engineering products for U.S. Government accounts, with products available under ECAT Contract SPE2DH-21-D0050. The Contracting Officer conducted a detailed price analysis using publicly available award data, identifying a comparable VA Boston Healthcare System contract awarded to L1 Enterprises on September 26, 2025, for $492,550.00, which provided a strong benchmark supporting the fair and reasonable determination of the anticipated cost. The anticipated award value falls below the $5 million threshold for SDVOSB sole-source actions. A Notice of Intent to Sole Source will be posted on the Governmentwide Point of Entry to provide maximum visibility and allow other potential sources to respond.

View the file

Other files

File Type Posted
36C24826Q0520.docx DOCX document

On GovTribe

Work with this file

  • Download the original file
  • Contacts named in this file
  • Similar government files
  • Ask GovTribe AI about this file

Text version

Attachment 1: Request for SDVOSB/VOSB Sole Source Justification Format IAW VAAR 819.7008/9

VHAPG Part 819.7008/7009 Sole Source Awards to SDVOSB/VOSB Page 1 of 4 Revision: 05 Effective Date: 12/15/2025

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition

Acquisition Plan Action ID: (36C248-26-AP-2521)

1. Contracting Activity: Department of Veterans Affairs, VISN 08, James A. Haley

Veterans Hospital (JAHVH). 2237 # 673-26-2-084-0102

2. Nature and/or Description of the Action Being Approved: The Ophthalmology

Clinic requires a Spectralis Tracking OCT (Optical Coherence Tomography) System to support ongoing diagnostic and treatment needs. This requirement will be fulfilled under a new Firm Fixed Price contract.

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

Spectralis system provides advanced imaging technology capable of compensating for involuntary eye movements during scans, resulting in more reliable and precise diagnostic data. The clinic’s current OCT units have reached the end of their life cycle and no longer meet operational standards. Replacing them will enhance diagnostic accuracy and significantly improve the quality of care delivered to our Veterans.

4. Statutory Authority Permitting Other than Full and Open Competition: 41 USC

§3304(a)(5), 38 U.S. Code § 8127(c), as implemented by RFO 6.103-5 (Authorized or Required by Statute). COs may use the non-competitive (sole source) procedures authorized in VAAR 819.7008 (DEVIATION) or VAAR 819.7009 (DEVIATION)- up to $5,000,000. Check the specific VAAR clause used below:

( X ) 819.7008 Sole source awards to a certified service-disabled veteran-owned small business; or ( ) 819.7009 Sole source awards to a certified veteran-owned small business

5. Demonstration that the Contractor’s Unique Qualifications and/or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): This procurement will be awarded on a sole-source basis to L1 Enterprises, Inc., a verified [SDVOSB] concern, under the authority of 38 U.S.C.

8127(c). This statutory authority contracting officers to make sole-source awards to eligible service-disabled veteran-owned or veteran-owned small business concerns when the contracting officer determines the firm to be a responsible source capable of meeting the agency’s requirements.

Market research and documentation provided by the manufacturer confirm that Heidelberg Engineering GmbH is the sole manufacturer of the Heidelberg Engineering product lines, and that Heidelberg Engineering, Inc., its wholly owned U.S. subsidiary, is the only source for these products and services in the United

VHAPG Part 819.7008/7009 Sole Source Awards to SDVOSB/VOSB Page 2 of 4

Effective Date: 12/15/2025

States. Additionally, the manufacturer has identified L1 Enterprises, Inc. as the only authorized distributor of Heidelberg Engineering products and services for U.S. Government accounts. The Heidelberg Engineering catalog is available under L1 Enterprises, Inc. ECAT Contract SPE2DH-21-D0050 for Medical Supplies.

Based on this information, L1 Enterprises, Inc. is the only responsible and authorized source capable of providing the required Heidelberg Engineering equipment and associated services in accordance with manufacturer authorization and Government procurement requirements. The business has been verified as meeting the eligibility requirements of VAAR 819.7003 (DEVIATION) prior to award.

Because L1 Enterprises, Inc. is an eligible SDVOSB/VOSB concern, has been determined to be a responsible source with respect to performance, and is the only authorized distributor able to meet the agency’s needs, a sole-source award is justified under 38 U.S.C. 8127(c).

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable, including whether a notice was or will be publicized as required by RFO 6.301 and, if not, which exemption under RFO 5.101(b)(1) applies:

“In accordance with FAR RFO 6.301(d), the contracting officer has solicited offers from as many potential sources as practicable under the circumstances. As this procurement is for a replacement unit and the original equipment manufacturer (OEM) has confirmed only one authorized distributor qualifies as an SDVOSB, the agency intends to award via sole source. A notice of Intent to Sole Source will be posted on Contracting Opportunities (the Governmentwide Point of Entry) to ensure maximum visibility.

Publicizing in this manner satisfies the requirement under FAR RFO 5.101(a) and 5.101(b)(1) for synopsizing or public display, thereby allowing other responsible sources the opportunity to respond. If no other sources respond or qualify, the sole-source procurement will proceed under the justification for “only one responsible source and no other supplies or services will satisfy agency requirements” (FAR

RFO 6.103-1).”

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

The Contracting Officer has made a clear and well-supported determination that the anticipated cost is fair and reasonable. A detailed price analysis was conducted using publicly available award data on AddUps.com. This review identified Contract No. 36C24125P0543, awarded by the VA Boston Healthcare System on September 26, 2025, to L1 Enterprises Incorporated, in the amount of $492,550.00.

VHAPG Part 819.7008/7009 Sole Source Awards to SDVOSB/VOSB Page 3 of 4

Effective Date: 12/15/2025

The items acquired under that award closely match the technical characteristics and functional requirements of the current procurement. This provides a strong and credible benchmark for comparison. Based on this market evidence, the proposed price aligns with recent federal purchasing activity for comparable equipment and is fully justified as fair and reasonable.

No certified cost or pricing data is required, and no additional audit or technical cost review is necessary. The pricing is well-supported and confidently determined to be fair and reasonable.

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

Statement of the Reasons Market Research Was Not Conducted:

Market research was conducted in accordance with RFO Part 10, VAAR Part 810, and VHAPG Part 810.001. This research included reviewing OEM distribution channels, verifying the availability of SDVOSB-eligible sources, and analyzing prior Government purchases for comparable equipment. The OEM confirmed that only one authorized distributor is capable of supplying the required replacement unit and that this distributor meets the eligibility requirements outlined in VAAR 819.7003

(DEVIATION).

The firm’s SDVOSB status was verified through the SBA Small Business Search (SBS) database, as required by current VetCert procedures. The vendor is listed as a certified Service-Disabled Veteran-Owned Small Business, and the anticipated award value falls below the $5 million threshold for SDVOSB sole-source actions.

All market research conducted supports the facts and determinations presented in this document, including confirmation of authorized distribution, SDVOSB eligibility, and alignment with applicable FAR, RFO, VAAR, and VHAPG policies.

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

N/A

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

Firm 1: L1Enterprises (SDVOSB) Firm 2: Heidelberg Engineering (OEM)

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 OEM stated that they are fully satisfied with their established relationship with the authorized distributor and, at this time, do not intend to engage or authorize additional vendors.

VHAPG Part 819.7008/7009 Sole Source Awards to SDVOSB/VOSB Page 4 of 4 Revision: 05 Effective Date: 12/15/2025

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.

Deborah Goode Date Administrative Officer Ophthalmology Clinic

13. Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

14. 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.

Marcus Lewis Date Contracting Officer

NCO 8

a. One Level Above the Contracting Officer (Required over the SAT but not exceeding $900K): I certify the justification meets requirements for other than full and open competition.

Ellen Clark Date Branch Chief

NCO 8

DEBORAH GOODE Digitally signed by DEBORAH GOODE Date: 2026.03.24 08:46:34 -04'00'

2026-03-31T13:56:47-0400
MARCUS LEWIS
2026-03-25T08:04:41-0400
ELLEN CLARK

File details come from the government source that posted it. Updated .