P03_AS3-24-061_36C10X24AP0451_JA_VeteransHealthcareSupplySolutions_v0_20240216_AJM (CA Signed)(ejf).pdf

DEPARTMENT OF VETERANS AFFAIRS

Office of Procurement, Acquisition and Logistics (OPAL)

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

Frederick, MD 21703

AS3-24-061

Justification and Approval for Other than Full and Open Competition 6.302-5 – Authorized or Required by Statute

1. Identification of the agency and the contracting activity.

This Justification and Approval (J&A) for Other Than Full and Open Competition is executed by the Strategic Acquisition Center (SAC) in Frederick Maryland, on behalf of the Department of Veterans Affairs (VA), Veterans Health Administration (VHA), National Gastroenterology (GI) and Hepatology Program (NGHP).

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

This contracting activity proposes to negotiate a firm fixed price (FFP), non-competitive sole-source Indefinite Delivery Indefinite Quantity (IDIQ) award with Veterans Healthcare Supply Solutions, Inc. (VHSS), a Service-Disabled Veteran-Owned Small Business (SDVOSB), for the procurement of artificial intelligence commercial off the shelf (COTS) colonoscopy machines that are currently being utilized within some VA facilities.

3. A description of the supplies or services required to meet the agency’s needs.

The VA performs approximately 250,000 colonoscopies each year, largely for indications related to colorectal cancer screening and surveillance. During colonoscopy, one of the major aims is to identify and remove precancerous polyps knows as “adenomas.” Prior research has demonstrated that over 20% of adenomas are missed by the physician performing colonoscopy. The physician’s adenoma detection rate (ADR), defined as the proportion of colonoscopies in which one or more adenomas are identified, has been shown to be strongly associated with the future risk of patients developing and dying from colorectal cancer. Therefore, improving adenoma detection is of great clinical significance. Furthermore, it is the intention of colonoscopy to detect and remove all precancerous polyps. Thus, the adenoma miss rate (AMR), defined as the proportion of adenomas found on back-to-back repeat colonoscopy that were missed on the initial colonoscopy, is also of clinical relevance.

Artificial intelligence (aka “deep learning”) medical devices have been developed to assist the physician in identifying adenomas during colonoscopy. These devices are connected to the current colonoscopy equipment in such a manner as to incorporate a visual alert to the presence of a polyp on the viewing monitor. The estimated value for this acquisition is $4,951,800.00 over a three-year period (one twelve-month Base period plus two twelve-month option periods).

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)(5) as implemented by the Federal Acquisition Regulation (FAR) Subpart 6.302-5 entitled, “Authorized or required by statute”. The applicable statute is Public Law 109- 461: “Veterans Benefits, Health Care, and Information Technology Act of 2006” specifically, the “Veterans First Contracting Program” outlined in 38 USC § 8127(c).

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

VAAR 819.7008(c) states explicitly, “A determination that only one SDVOSB can meet the requirement is not required,” and that using this authority, the following must be verified:

(1) The anticipated award price of the contract (including options) will not exceed $5,000,000.00.

(2) The estimated value is $4,951,800.00 and does not exceed $5,000,000.00.

(3) The justification prepared pursuant to FAR 6.302-5(c)(2)(ii) is posted in accordance with FAR subpart 5.301(d);

This J&A will be posted on SAM.gov.

(4) The SDVOSB concern has been determined to be a responsible source with respect to performance; and VHSS is a registered and verified Service-Disabled Veteran-Owned Small Business (SDVOSB) with recent proven capabilities to perform the required services.

(5) VHSS is registered and certified in VetCert as a SDVOSB with the NAICS code

334510 – Electromedical and Electrotherapeutic Apparatus Manufacturing for this requirement which in accordance with Public Law 109-461 Section 502(c) meets the requirements of this statute to sole source to a SDVOSB.

(6) The Contracting Officer has determined that the use of this authority is in the best interest of the government based upon the fact that VHSS is an SDVOSB which has a satisfactory performance history with VA in providing quality products and services at a fair and reasonable price and has the necessary working knowledge of the VA systems, programs and policies to provide the needed deliverables within the stringent timeline required.

6. A description of efforts made to ensure that offers are solicitated 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.

In accordance with 819.7008, the determination to make a sole source award to a SDVOSB is a business decision wholly within the discretion of the Contracting Officer;

therefore, the requirement to ensure that offers are solicited from as many potential sources as practicable is not applicable to this procurement. In addition, 819.7008(c) further authorizes the Contracting Officer to make the award without first determining that only one SDVOSB source can meet the requirement. A notice of the proposed action will be synopsized via the Government Point of Entry (GPE) in accordance with FAR Section 5.201, and the agency will make publicly available the justification required by 6.305(a) within 14 days after contract award.

7. A determination by the Contracting Officer that the anticipated cost of 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, past proposal submissions, other information made available, and an Independent Government Cost Estimate (IGCE).

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.

VHSS has successfully supported VA in similar efforts and has been determined to be a responsible source with respect to performance. They are registered and verified in VetBiz.gov as a SDVOSB with the NAICS code 334510 for this requirement which in accordance with Public Law 109-461, Section 502(c) meets the requirements of this statute to allow a sole source to a SDVOSB.

In addition, the Federal Awardee Performance, and Integrity Information System (FAPIIS) was reviewed and FAPIIS shows no reports for VHSS that would indicate defective pricing, instances of contractor fault or recipient not- qualified, terminations for default, material failure to comply, or non-responsibility of the contractor.

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

In accordance with Public Law 109-461, codified at 38 USC § 8127, in order to increase contracting opportunities for small business concerns owned and controlled by Veterans and small business concerns owned and controlled by Veterans with service-connected disabilities, Contracting Officers of the VA are given specific statutory authority to award a contract to a small business concern owned and controlled by Veterans using procedures other than competitive procedures (i.e. a “sole source” contract). The Contracting Officer may do so in accordance with

VAAR 819.7008.

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

Veterans Healthcare Supply Solutions, Inc.

2615 Port Industrial Drive, Unit 405 Jacksonville, FL 32226

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.

All future requirements will be handled on a case-by-case basis. Toward the expiration of this contract, consideration will be given as to whether the future acquisition should be competitive.

12. Contracting Officer certification that the justification is accurate and complete to the best of the Contracting Officer’s knowledge and belief.

Pursuant to (FAR 6.303-2(a)(12)), I certify that this justification is accurate and complete to the best of my knowledge and belief.

Andrew Montgomery Date Contracting Officer Strategic Acquisition Center (SAC)

Competitive Advocate Approval

In my role as Contracting Activity Competition Advocate, based on the foregoing justification, I hereby approve this acquisition on an “other than full and open competition” bases pursuant to the statutory authority cited in paragraph four above, subject to availability of funds, and provided that the property and services herein described have otherwise been authorized for acquisition. As this action does not exceed $15,000,000.00, the certification below required by FAR 6.304 serves as approval.

Efrain J. Fernandez Date Director of Contracts, Acquisition Services 1-3 Procuring Activity Advocate for Competition (SAC-Frederick) Strategic Acquisition Center