P03 PM_Part813.5_Atch1_FAR13.5_JA_OVER_SAT_593-21-2-136-0097 Heidelberg Spectralis Redacted.pdf

VHAPM Part 813.5 Simplified Acquisition Procedures for Certain Commercial Items Attachment 1: Request for Sole Source Justification Template >SAT-$7.5M under FAR13.5

PM Part 813.5 SAP for Certain Commercial Items Page 1 of 4 Original Date: 08/30/17 Revision 03 Date: 02/11/2021

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS IN ACCORDANCE WITH FAR 13.5 Brand Name Only

Acquisition Plan Action ID: 36C261-21-AP-2550

1. Contracting Activity: Department of Veterans Affairs (VA), Veterans Health Administration, Regional Procurement Office West, Network Contracting Office 21 (NCO 21) on behalf of North Las Vegas Medical Center

2. 2237: 593-21-2-136-0097

3. Nature and/or Description of the Action Being Processed: This procurement is for the Heidelberg Spectralis Coherence Tomography unit. The action being reviewed and approved is for a brand name only procurement. It will be awarded as a new firm fixed price contract.

4. Description of Supplies/Services Required to Meet the Agency’s Needs: The Northern Las Vegas

VA Medical Center requires a Heidelberg Spectralis Optical Coherence Tomography unit. The deice scans patient retinas utilizing a confocal scanning laser ophthalmoscope platform. The device Is capable of multimodal imaging. It has infrared reflectance, BluePeak Autofluorescence, multicolor, and high magnification fundus imaging modalities. The panning camera and widefield imaging modalities are also required. Using fluorescein angiography, ICG angiography, ultrawide field angiography, and OCT angiography modalities allow the physician to accurately map and quickly diagnose issues. This specific system has TruTrack Active Eye Tracking, AutoRescan functionality, integrated noise reduction technology, 10 retinal layer visualization, a and DICOM interface, as well as being compatible with the HEYEX2.

5. 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 Brand Name Only

( ) 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

6. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): The H eidelberg Spectralis

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Revision 03 Date: 02/11/2021

Optical Coherence Tomography is the only device with all these capabilities and compatabilites.

Accordingly, Heidelberg Engineering is the only manufacturer capable of providing the supplies and services described in Section III above without the Veteran’s Health Administration experiencing unacceptable delays in purchasing.

7. 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 Contract Opportunities on 24JUNE2021 with a due date of 29JUNE2021.

8. Determination by the CO that the Anticipated Cost to the Government will be Fair and

Reasonable: The anticipated cost to the Government will be considered fair and reasonable utilizing the information based on a comparison of proposed prices with prices found reasonable on previous purchases as well as ECAT pricing. The final contract price will be fair and reasonable as a comparison will be made with prior contracts.

9. Description of the Market Research Conducted and the Results, or a Statement of the Reasons

Market Research Was Not Conducted: Based on market research pursuant to Federal Acquisition Regulation (FAR) Part 10, Veterans Affairs Acquisition Regulation (VAAR) Part 810 and Procurement Policy Memorandum (PPM) 2016-05(REVISED AUG 2019. and PPM 2016-05, there is no reason to believe that two or more Service Disabled Veteran Owned Small Businesses (SDVOSBs)/ Veteran Owned Small Businesses (VOSBs) have the capability to meet this requirement, and the Supreme Court Kingdomware mandate’s “Rule of Two” will not be met for this requirement. A Vendor Information Page (VIP) search utilizing North American Industry Classification System (NAICS) code 333314 yielded 67 SDVOSBs/VOSBs matches.

Market research efforts also include Federal Procurement Data System (FPDS), Contract Opportunities, VA National Acquisition Center (NAC) Catalog, General Services Administration (GSA), and System for Award Management (SAM).

A query on the VA NAC catalog brought up no relevant results that match all items that are required that this facility can order off. There was also no results on a GSA e-library search utilizing keyword “Spectralis”. There is no reason to believe that the “Rule of Two” exists with any existing contracts.

The procurement history found on FPDS shows that the most recent purchase of this item was from 27MAY2021 awarded to L1 Enterprises, a Service-Disabled Veteran Owned Small Business under 36C25021P1316 for a facility in Network Contracting Office (NCO) 10. According to the record, the requirement was competed as unrestricted under Simplified Acquisition Procedures and resulted in only one quote received. It is also noted at the time of award the manufacturer was Heidelberg Inc.

In consideration of the Buy American Act, this system is excluded under optical sensors. As described in Section 6 above, market research, in accordance with FAR Part 10, was conducted by synopsis of the proposed acquisition, advising industry of the pending acquisition and soliciting inquiries from interested parties

10. Any Other Facts Supporting the Use of Other than Full and Open Competition: Not Applicable.

11. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: L1 Enterprises, Inc.

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12. 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 Department of Veterans Affairs will continue to monitor technology available that meets the needs in the optometry clinic and is cleared for use by FDA. The market will be continually assessed to determine if other vendors can provide the required supplies. Furthermore, market research will be done prior to any exercise of option to assess market capabilities.

13. 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.

14. 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.

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