JA FAR Part 13 - MEDTRONIC v1.pdf

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR

CERTAIN COMMERCIAL ITEMS IN ACCORDANCE WITH FEDERAL ACQUISITION

REGULATION (FAR) 13.5

On the basis of the following justification, I, as the Contracting Officer, hereby approve the use of a sole source proposed contractual action pursuant to the authority of 41 USC 1901 (a)1.

1. Identification of the agency and contracting activity, and specific identification of the document as a “Sole Source Justification Under Simplified Procedures for Certain Commercial Items (FAR Subpart 13.5)”

The Strategic Acquisition Center - Frederick (SAC-F), on behalf of the Department of Veterans Health Administration (VHA), National Gastroenterology and Hepatology Program Office, proposes to enter into a sole source contract with Covidien Sales, LLC., a large business, under simplified acquisition procedures.

2. The nature and/or description of the action being approved, i.e., sole source under procedures for certain commercial items in accordance with FAR 13.5.

This activity proposes to negotiate a non-competitive, firm-fixed price award (sole-source) with Covidien Sales, LLC. to procure service agreements on 115 Artificial Intelligence machines for three years. The estimated value for this acquisition is $690,000.00, and the anticipated performance period for the awarded contract is September 22, 2022, through September 21, 2023.

The contract, 36C10X22C0043, was awarded for the procurement of 115 Artificial Intelligence machines with an effective date of September 22, 2022, for a total amount of $5,272,750.00. This was a competitively awarded contract. Covidien Sales, LLC. is currently the only company that can provide the service and maintenance, under warranty, for these mission-critical medical devices.

3. A description of the supplies and/or services required, including the delivery schedule and/or the period of performance (inclusive of all option periods), and the estimated dollar value of the acquisition.

The Contractor shall provide, install, and furnish all necessary materials and labor needed for installing the medical devices. The scope of this work shall include three-year service agreements to cover any part defects or unintentional damages, customer service capable of responding to issues within three business days, and any software updates will be made available by Covidien Sales, LLC. and installed in accordance with Veterans Affairs Information Technology policies.

Total: The total amount of the base period is $690,000.00.

4. The statutory authority permitting sole source.

The authority is in accordance with FAR 13.501(a)(1)(ii).

The statutory authority permitting other than full and open competition is 41 USC 1901(a)(1) as implemented by FAR 13.501(a).

5. A statement demonstrating the unique qualifications of the proposed contractor or the nature of the action requiring use of the authority.

Covidien Sales, LLC (a Medtronic, Inc., company) is the world-wide sole distributor of its proprietary GI Genius, associated parts, accessories, and applicable licensed software applications (collectively, the “GI Genius Intelligent Endoscopy System”).

6. A description of efforts made to ensure offers/quotes are solicited from as many potential sources as is practicable, including whether a notice was or will be publicized in FEDBIZOPPS (as required by FAR 5.2) and, if not, which exception under 5.202 applies.

The Notice of Intent to a sole source was published on SAM.gov, and vendors were given fifteen days to respond to this notice. This justification and approval will be published to SAM.gov no later than 14 days after the award.

7. The anticipated dollar value of the proposed acquisition, including options if applicable, and a determination by the contracting officer that the anticipated cost to the government will be fair and reasonable.

The anticipated dollar value of this requirement is $690,000.00 for a base year period.

8. A description of the market research conducted and the results or the reason market research was not conducted.

Covidien Sales, LLC. currently provides the service and maintenance contract, under warranty, for the mission-critical GI Genius medical devices. Market research was also conducted by a GSA e-library search. The GSA e-library search revealed 0 vendors when keyword, “Medtronic GI” was searched.

9. Any other facts supporting the use of sole source.

The GI Genius is a complex medical device subject to regulation by the Food and Drug Administration. As such, Covidien Sales, LLC, as the original equipment manufacturer (OEM), cannot certify any repair or service, including preventive maintenance, provided by anyone other than our own field service engineers.

Covidien Sales, LLC does not sell or authorize the sale to customers of any of the SOFTWARE/FIRMWARE CIRCUIT BOARD included in the GI Genius that require software and/or firmware to be reinstalled. These must be installed, serviced, and maintained by Covidien Sales, LLC. Covidien Sales, LLC cannot guarantee the proper performance or results of the GI Genius following any unauthorized service, repair or modification, or the use of any non-OEM parts.

http://farsite.hill.af.mil/reghtml/regs/far2afmcfars/fardfars/far/05.htm#P56_9651 http://farsite.hill.af.mil/reghtml/regs/far2afmcfars/fardfars/far/05.htm#P67_10794

Any unauthorized service, repair or modification will void existing warranties and service agreements. Covidien Sales, LLC assumes no responsibility or liability for any resulting claims, costs, and expenses associated with the use of any GI Genius for which unauthorized service was performed or non-OEM parts have been used for repair or maintenance. Further, Covidien Sales, LLC reserves the right to refuse to service any adulterated equipment if we consider it to be not repairable according to our standards.

10. A listing of the sources, if any, that expressed, in writing, an interest in the acquisition.

Covidien Sales, LLC.

15 Hampshire St., Mansfield, MA 02048 Office 484-667-6911 Medical Surgical Portfolio | Medtronic

11. A statement of any actions the agency will take to remove or overcome any future barriers to competition.

N/A

Certification

Acquisition Initiator:

I certify that the facts and representations under my cognizance that are included in this justification and that form a basis for this justification are complete and accurate.

Signature Date

Contracting Officer:

I certify that this justification is accurate and complete to the best of my knowledge and belief.

Signature Date

09/21/2022

09/21/2022 https://www.medtronic.com/covidien/en-us/index.html