P03 - JOFOC.pdf

DEPARTMENT OF VETERANS AFFAIRS

Office of Procurement, Acquisition and Logistics (OPAL)

Strategic Acquisition Center (SAC) 5202 Presidents Ct, Suite 103

Frederick, MD 21703

JUSTIFICATION AND APPROVAL

FOR OTHER THAN FULL AND OPEN COMPETITION

(1) Identification of the agency and the contracting activity, and specific identification of the document as a "Justification for Other Than Full and Open Competition."

This Justification and Approval (J&A) for Other Than Full and Open Competition is executed by the Strategic Acquisition Center (SAC), on behalf of the Department of Veterans Affairs (VA), Financial Services Center (FSC). Authority FAR 6.302-1, Sole source purchase of a service agreement for Artificial Intelligence (AI) Colonoscopy Machines. This is a new firm-fixed price one-year contract, with two one-year options at the government’s discretion.

(2) Nature and/or description of the action being approved.

This activity proposes to negotiate a non-competitive award firm fixed price sole source award to Covidien Sales, LLC a division of Medtronic, a Large Business, to provide service on 108 AI Genius (AI) Colonoscopy Machines. The requirements estimated total value (including options) is $648,000.00.

(3) A description of the supplies or services required to meet the agency’s needs (including the estimated value).

This requirement is for an annual (12-month) service agreement for 108 AI Genius Colonoscopy Machines. They will be utilized at stations to be determined by the National GI and Hepatology Program (NGHP). The 3-year service agreement will cover any part defects or unintentional damages. The requirement estimated total value (including options) is $648,000.00 for a period of performance of one 12-month base period, with two, 12-month option period. The required delivery date is April 1, 2024.

(4) An identification of the statutory authority permitting other than full and open competition.

The statutory authority permitting other than full and open competition is 41 U.S.C.3304(a)(1) as implemented by the Federal Acquisition Regulation (FAR) Subpart 6.302-1 entitled, “Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements.”

Strategic Acquisition Center (SAC)

(5) A demonstration that the proposed contractor’s unique qualifications or the nature of the acquisition requires use of the authority cited.

The AI algorithms can analyze images and videos with high precision, potentially reducing the chances of human error in interpreting results. This can lead to more accurate detection of abnormalities such as polyps or lesions. The AI algorithms can process images and videos rapidly, allowing for real-time analysis during the colonoscopy procedure. This efficiency can lead to shorter procedure times and reduced patient discomfort. As a result, the machines can serve as a valuable tool to assist clinicians during colonoscopy procedures by providing real-time feedback and highlighting areas of interest for closer examination. This can help clinicians make more informed decisions and improve the quality of the examination. The improved accuracy and efficiency of AI-powered colonoscopy machines may lead to a more comfortable experience for patients, as they may require fewer repeat procedures and experience less anxiety about the accuracy of the examination. In addition, they have the potential to revolutionize colorectal screening and diagnosis by offering enhanced accuracy, efficiency, and accessibility, ultimately leading to better patient outcomes and potentially saving lives through early detection of colorectal diseases.

Medtronic’s product licenses and maintenance support provides a unique solution that is compatible with the existing system and with VHAs healthcare needs. Market research was conducted. The rationale for justification limiting competition to Medtronic is based on the proprietary letter provided by the contractor confirming they have no authorized parties to service their AI Colonoscopy Machines.

Although there are 3 SDVOSBs allowed to distribute the AI Colonoscopy Machines, Covidien Sales, LLC, a division of Medtronic is the only source capable of providing a complete and comprehensive service for the 108 AI Colonoscopy Machines currently being procured. Medtronic does not authorize any repair or service, including preventative maintenance, to be provided by any 3rd party. Only Covidien Sales, LLC field engineers and/or personnel are authorized to service the GI Genius equipment.

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

The ordering activity will make publicly available the justification along with the solicitation in accordance with FAR 6.302-1(c)).

Market research was conducted, details of which are in the market research section of this document. This effort did not yield any additional sources that can meet the https://www.acquisition.gov/far/part-5#FAR_Subpart_5_2 https://www.acquisition.gov/far/part-5#FAR_5_202

Strategic Acquisition Center (SAC)

Government’s requirements. There is no competition anticipated for this acquisition.

Additionally, the proposed action will be synopsized on the Federal Business Opportunities Page in accordance with FAR 5.201. Any proposals that are received shall be evaluated.

(7) A determination by the contracting officer that the anticipated cost to the Government will be fair and reasonable.

No award shall be made until the Contracting Officer determines the cost to the Government to be fair and reasonable. This determination will be based on a comparison of current contract pricing, an Independent Government Cost Estimate, past proposal submissions (if available), and other information as made available.

(8) A description of the market research conducted (see part 10) and the results or a statement of the reason market research was not conducted.

Details of the market research are as follows, previous procurement history was found on SAM.gov; an intent to sole source was issued on April 28, 2023, RFQ# 36C10X23Q0126. No responses were received.

Literature was gathered by conducting internet searches. Some literature was provided by the firm which included produce brochures and sample reports.

Supplies or Services, which are on the Procurement List maintained by the Committee for Purchase from People Who Are Blind or Severely Disabled (see Subpart 8.7): Search of Ability One website: http://abilityone.gov through their services category for “ECRI” and resulted in zero results.

Another method used to conduct market research was to query the GSA eLibrary (http://www.gsaelibrary.gsa.gov/ElibMain/home.do). A query was performed using search criteria “ECRI” and which resulted in zero matches. A search of “Emergency Care Research Institute” yielded 1 result. However, the services listed in this contract schedule do not fully meet the requirement.

Covidien Sales, LLC, a division of Medtronic is the only provider that can meet all the requirements.

Medtronic is a global, independent authority on AI colonoscopy machines. Their products and services help the healthcare community to improve quality, reduce cost, and achieve better outcomes across all care settings through a unique set of capabilities. Medtronic AI Colonoscopy Machines deliver better, safer patient care.

Medtronic is the only known entity that provides the AI Colonoscopy Machines.

These unique services allow healthcare leaders to make confident, data-driven decisions every day to care for veterans.

http://abilityone.gov/ http://www.gsaelibrary.gsa.gov/ElibMain/home.do)

Strategic Acquisition Center (SAC)

(9) Any other facts supporting the use of other than full and open competition.

Covidien was contacted via email during the market research phase to inquire on authorized SDVOSBs and VOSBs distributors of the web-based tools and resources being sought. Exchanged communication with Covidien representative Sean Horan. It was verified that Covidien Sales, LLC is a division of Medtronic is the sole entity authorized to service their AI Genius Colonoscopy Machines.

Covidien, Sean Horan, Director – National Enterprise Accounts, US Federal Government Accounts, sean.p.horan@medtronic.com, 15 Hampshire St, Mainsfield, MA 02048

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

None.

(11) A statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the supplies or services required.

The proposed action will be synopsized on the Contracting Opportunities (https://sam.gov ) website in accordance with FAR 5.201 and made available with the published solicitation in accordance with FAR 6.302-1 Only One Responsible Source and no Other Supplies or Services Will Satisfy Agency Requirements.

Any proposals that are received shall receive consideration and be evaluated as to the extent capable of meeting agency needs. Toward the expiration of this contract, consideration will be given as to whether the future acquisition should be competitive;

however, all future requirements will be handled on a case-by-case basis to determine any future acquisition strategy.

(12) Contracting officer certification that the justification is accurate and complete to the best of the contracting officer ’s knowledge and belief.

I certify that this justification is accurate and complete to the best of my knowledge and belief. As this action does not exceed $648,000.00, the certification below required by FAR 6.304 serves as approval.

mailto:sean.p.horan@medtronic.com

Strategic Acquisition Center (SAC)

Signature: _________________________________ Date: ____________

Andrew Montgomery Contracting Officer Strategic Acquisition Center