0202-LSJ-Fallo signed.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

Acquisition Plan Action ID: 36C250-21-AP-3908

1. Contracting Activity:

Nature and/or Description of the Action Being Processed: This procurement is for two Leica Proveo 8 Microscopes for Ophthalmology Surgery procedures in the Operating Rooms at Fort Wayne campus of VA Northern Indiana Health Care System.

Description of Supplies/Services Required to Meet the Agency’s Needs: 2 x Leica Proveo 8

Systems with basic equipment, Lateral Observer, and Documentation System without

Recorder.

The estimated value of the proposed action is $267,713.74

2. 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

3. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): Three highly experienced Ophthalmologists that VA NIHCS uses as Fee providers reviewed available options, and determined on a trial equipment that all three would trial. It was unanimous agreement

Department of Veterans Affairs, VISN 10, Fort Wayne Medical Center 2237: 610-21-3-279-0202

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Revision 03 Date: 02/11/2021 from all three that this particular model and equipment loadout would best suited for patients at VA NIHCS under their care. That another option would not have the quality needed for the patients. An onboarding Fourth Highly-Experienced Fee Ophthalmologist concurred with their assessment.

Key characteristics that they pointed to were:

• 4 Coaxial LED lights for superior Red reflex

• Direct Illumination for low light intensity without fiber optics

• A quad level zoom (magnification moves with the assistant)

• Optics which provides high resolution with high Depth of Field

• Upgradability. Allows to add components in the future as technology advances

• Motorized, individually programmable TILT function for glaucoma applications

4. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: Three Fee Ophthalmologists with unanimous decision that was arrived at after trial and extensive dialogue over potential equipment options and what would be best value for use in Ophthalmic surgery by all three. All other potential sources were evaluated and did not either rank as highly or were dismissed.

5. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: The price was found to be fair and reasonable in comparison to 36C24720P0881 awarded on 6/27/2020 in the amount of $282,821.79, for the same items.

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

Market Research Was Not Conducted: VIP queried using NAICS code 334510 along with keywords “leica proveo” resulted in zero findings. GSA queried using keywords “leica proveo 8” resulted in one large business able to provide the required microscope, but not all required items. A sources sought was posted to GPE for Leica Proveo 8 microscopes. One source responded. Melling LLC (SDVOSB) is a distributor for the required Leica microscopes.

7. Any Other Facts Supporting the Use of Other than Full and Open Competition: All three Fee Ophthalmologists are well known in the community areas they serve, and are highly valued and respected by the community. There service to Veterans at VA NIHCS has been of the best quality, with minimal complications, and stellar surgical times. The National Surgery Office has voiced over the years that VA NIHCS should retain their services as long as possible.

VA NIHCS would be hard pressed to have the Ophthalmologists consider another item. The competition item search and if it makes the cut for eventual consideration would delay the request to such an extent that it would be additional hours spent on trials, and administrative work that would add up. Plus potential risk of losing services from the Fee Ophthalmologists who would feel their medical opinion is not being valued and patients are being put at risk.

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Necisstating an increase into referrals to Care in the Community for Ophthalmology, which some of the patients would be sent to those three in the Community at that rate.

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

Carl Zeiss – manufactuer of current equipment that is at end of life.

Leica Olympus Melling Medical

9. 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: No actions available to remove barriers. Choice was made from available current Ophthalmic equipment based on the review of the three Fee Ophthalmologist conducting the surgeries and agreeing together on a model for replacement of End of Life equipment. It is in best interest for care of patients to go with the equipment chosen by the experienced surgeons who have conducted reviews, and trialed equipment.

10. 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.

_____________________________ 08/23/2021 Angela Lemert Date Nurse Manager, OR/SDS

NIHCS

11. 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.

Erik Fallo Date Contracting Officer Network Contracting Office 10 https://dvagov.sharepoint.com/sites/VHAProcurement/VHAPM/VHAPM_Part_806.3.aspx

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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.

James Hallock Date Contracting Officer

Network Contracting Office 10