J065--Carto3 and SmartAblate Maintenance and Upgrades

Effective Date: 02/01/2022 Page 1 of 9

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C252-23-AP-0928

Contracting Activity:

Department of Veterans Affairs

VISN 12

William S. Middleton Memorial Veterans Hospital

695-23-2-133-0925

$155,000.00 (Base Year)

$465,000.00 (Aggregated Total)

Nature and/or Description of the Action Being Processed:

Carto3 and SmartAblate maintenance and software upgrades for William S. Middleton Memorial Veterans Hospital located in Madison, Wi in accordance with FAR 13.5 Simplified Procedures for Certain Commercial Items. A new follow-on purchase order will be awarded as Firm-Fixed Price with a base year and two (2) one-year option periods.

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

Carto3 and SmartAblate maintenance and software upgrades utlitlizing Biosense Webster ASA service agreement.

The proposed new purchase order for the Carto3 and SmartAblate maintenance and software upgrades utlitlizing Biosense Webster ASA service agreement for William S. Middleton Memorial Veterans Hospital will be a Firm-Fixed Price purchase order with a start date of 03/01/2023, which will include a base year and two (2) one-year option periods with an ultimate completion date of 02/28/2026. To properly maintain the equipment to the OEM specifications, a service agreement is required. The purchase order value for this procurement is estimated at $155,000.00 for the base year and $465,000.00 for the entire value of the purchase order.

Base Year: 03/01/2023-02/29/2024 $155,000.00

Option Year 1: 03/01/2024-02/28/2025 $155,000.00

Option Year 2: 03/01/2025-02/28/2026 $155,000.00

Aggregated Total: $465,000.00

Statutory Authority Permitting Restricted Competition:Â

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

Demonstration that the Contractor s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority):

Biosense Webster does not provide proprietary software license to services through third party distrubutors. Biosense Webster is the only vendor that can provide software upgrades, license, maintenance, and OEM parts to the Carto3 and SmartAblate system.

An authorization letter provided by Derek Johnson, Wisconsin Territory Manager for Biosense Webster on 01/12/2023 states Biosense Webster is the sole service provider for the Biosense Webster CARTO® 3 System, the SMARTABLATE® System, Biosense Webster modules and Biosense Webster accessories. There are no approved third-party service providers for Biosense Webster technologies. Any service rendered on Biosense Webster technologies requires that it be performed by Biosense Webster trained and certified Field Service Engineers and also requires the use of specialized test equipment, both of which are only available from Biosense Webster. Additionally, Biosense Webster is the sole source for purchases of extended warranty agreements for the CARTO® 3 System and SMARTABLATE® System.

It is in the Government s best interest to award a service purchase order to Biosense Webster to ensure scheduled maintenance is completed and to prevent the deterioration of the equipment to limit the replacement rate, along with providing the most up-to-date software which is necessary to provide Cardiologist the most advanced 3D mapping of the heart for cardiology procedures. If a purchase order to provide service was not issued, the equipment would go into disrepair and would need to be replaced more often. Installation of new equipment would create unnecessary downtime within the Cardiology Department, an essential department for the VAMC and ultimately affecting patient care.

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

A Notice of Intent to Sole Source was published on 01/09/2023 with a response date of 01/12/2023 in Contract Opportunities requesting capability statements from interested vendors. One vendor responded, Remi Group. When asked to provide an authorization letter from the OEM, they stated that an authorization letter was not granted from Biosense Webster. Biosense Webster was also contacted to verify Remi Group as a potential service vendor. Biosense Webster stated Biosense Webster does not allow third parties to service our equipment. If that is done, any warranty is null and voided. They also confirmed that they do not subcontract their technicians to third party vendors, nor do they allow third party vendors the license to provide software upgrades. When asked again to provide an authorization letter, Remi Group did not respond.

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

The CO has determined that the anticipated cost to the Government is fair and reasonable. The Advantage Service Agreement (ASA) price is calculated to reflect all future software upgrades which include all new license when Windows is updated (if applicable) in addition to all preventive and corrective maintenance. When comparing Madison VAMC 2023 ASA quoted aggregated total of $465,000.00 to Jesse Brown VAMC 2021 ASA quoted aggregated total of $310,731.56, Madison ASA was $154,268.44 (33.2%) higher. When comparing Madison VAMC ASA to Milwaukee 2021 VAMC ASA quoted aggregated total of $289,540.00, the Madison VAMC ASA was $175,460.00 (37.7%). The increase in price of the Madison VAMC ASA compared to the other VISN 12 VAMCs is due to additional planned upgrades for the next 3 years. In addition, Madison VAMC did not have an ASA in place previously which provided upgrades to the software. Additional costs are necessary to upgrade the software to the latest version.

When comparing the ASA to the most recent FY23 purchase order 36C25623P0026 which was awarded on 10/01/2022 for the Houston VAMC for an aggregated total (base plus two one-year options) of $766,500.00, Madison ASA is $301,500.00 (39.3%) lower.

Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted:

A VIP search was conducted on 01/06/2023 using keywords Carto3 , Carto 3 , and SmartAblate . Zero (0) vendors resulted. SBA was searched on 01/12/2023 using both keywords Carto3 and SmartAblate . Both searches provided zero (0) results. FPDS was also searched on 01/06/2023 with keyword Carto3 , limiting it to Department of Veterans Affairs, and NAICS 811219 (using 2017 NAICS as 811210 is new as of October 2022). Nine (9) actions resulted, all with Biosense Webster, the OEM. FPDS was also searched using keyword SmartAblate , limiting it to Department of Veterans Affairs, and NAICS 811219, twenty-two (22) actions resulted all with Biosense Webster. An Intent to Sole Source was posted on 01/09/2023 with a closing date of 01/12/2023. One vendor, Remi Group responded. When asked for them to provide an authorization letter from the OEM for confirmation of trained technicians and details to provide the ability to provide software upgrades, no response was provided. In addition, Biosense Webster confirmed that they do not allow third party vendors to subcontract their technicians or provide software upgrades.

When confirming with Biosense Webster if Remi Group is an authorized service vendor, they replied Biosense Webster is the only one that is authorized to provide the VA with the Advanced Solutions Agreement. In addition, Biosense Webster included an authorization letter which states There are no approved third-party service providers for Biosense Webster technologies. Any service rendered on Biosense Webster technologies requires that it be performed by Biosense Webster trained and certified Field Service Engineers and also requires the use of specialized test equipment, both of which are only available from Biosense Webster. Additionally, Biosense Webster is the sole source for purchases of extended warranty agreements for the CARTO® 3 System and SMARTABLATE® System.

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

Utilizing any non-authorized vendors would void any warranties and current service agreements

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

Biosense Webster (incumbent, OEM)

Remi Group (was unable to provide details as to how they could provide software upgrades as Biosense Webester is proprietary to the software)

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:

At this time, only one source, Biosense Webster is qualified for the service on the Carto3 and SmartAblate equipment and software and has shown to be reasonable and authorized. The Contract Specialist and Contracting Officer will continue to survey the marketplace during the purchase order period taking under consideration any new and innovative methods for the Carto 3 and SmartAblate maintenance and software upgrades. Continual market research and purchase order administration will assist in determining the next purchase order s procurement strategy.

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.

_____________________________

Andrew Satre

Biomedical Engineer

William S. Middleton Memorial Veterans Hospital

Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

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.

_____________________________

Ashley Johnson

Contracting Officer

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.

_____________________________

Erika Cannaday

Services Team 1 Branch Chief Awarded contract 36C25223P0307 to BIOSENSE WEBSTER, INC. for 465000.00000000 on 2023-02-10.