LSJ_Mammo_Redacted_1.pdf

United States Department of the Interior

INTERIOR BUSINESS CENTER

Washington, DC 20240

SOLE SOURCE JUSTIFICATION

SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL ITEMS

AUTHORITY: FAR 13.501(a), 41 U.S.C. 1901

SOL # 140D0423Q0882

1. Identification of the agency and the contracting activity, and specific identification of the document as a “Sole Source Justification.”

This document is a sole source justification for the Department of the Interior, Interior Business Center, Acquisition Services Directorate Division 2 Branch 3, on behalf of the United States Department of Health and Human Services (HHS) Indian Health Service (IHS), Northern Navajo Medical Center (NNMC), Medical Imaging Department

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

This is a new requirement as the current mammography equipment within the NNMC Medical Imaging Department was purchased by HHS under purchase order HHSI245201700053A to Alko Enterprises, LLC in 2017. This requirement will be a single source purchase order for a new Senographe Pristina mammography unit and Senographe Pristina biopsy unit upgrade to Alko Enterprises Inc, an Indian Small Business Economic Enterprise, IAW HHSAR 326.603-1 and FAR 13.501.

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

The contractor will provide one (1) fully functional mammography unit, one (1) upgrade for an existing biopsy unit that the NNMC has previously purchased, and all equipment necessary for the installation of software and components.

The delivery will be a coordinated date upon award with a 1-year warranty.

4. An identification of the statutory authority permitting sole source acquisition.

This is an acquisition conducted under the authority of the Simplified Procedures for Certain Commercial Items. The statutory authority permitting sole source acquisition is 41 U.S.C 1901 as implemented by FAR 13.501(a)(1)(ii).

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

The Northern Navajo Medical Center (NNMC) previously acquired and currently owns equipment in their Medical Imaging Department and are seeking to purchase additional equipment and to upgrade some of the facility’s current equipment.

To accomplish this, GE Healthcare compatible equipment will need to be purchased so that the facility can remain operational once the one (1) fully functional mammography unit and the one (1) biopsy unit upgrade are put into place.

Market research indicates that GE Healthcare’s Senographe Pristina is the only mammography machine in the industry that can provide the level of quality and service that is needed by the NNMC and other agencies. The Senographe Pristina is the only Food and Drug Administration (FDA) approved 3D mammography that delivers at the same low dose as the lowest patient dose of all FDA approved systems. This ensures patients at the NNMC are receiving the safest form of care available. Further, with the utilization of GE Healthcare specific equipment, certified engineers can get to the NNMC and service equipment , enabling the facility to regain operability and resume service to patients

The GE Healthcare Senographe Pristina was the only system identified by the subject matter expert within the Medical Imaging Department and by market research that would be able to fulfill this requirement at the quality the NNMC needs.

GE Healthcare, the manufacturer, was contacted to determine if the company authorized resellers , confirming that GE Healthcare authorizes distributors and that other sources for GE Healthcare specific equipment exists in the commercial marketplace.

In accordance with HSSAR 326.603-1(c)(2), IHS must use the negotiation authority of the Buy Indian Act to give preference to Indian Economic Enterprises (IEE), giving priority to Indian Small Business Economic Enterprises (ISBEE). Alko Enterprises, LLC was identified as an ISBEE and authorized distributor for GE Healthcare. There are no other known ISBEEs that are authorized distributors for GE Healthcare.

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

A sources sought was posted to SAM.gov seeking ISBEE’s that were interested and capable of fulfilling the requirement IAW HHSAR 326.603-1. The sources sought was posted on July 3, 2023 with responses due on July 12, 2023 and no responses were received. IAW FAR 5.2, a synopsis of the proposed contract action will be posted in accordance with FAR 5.201 providing notice of the intent to sole source.

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

The Contracting Officer anticipates determining the anticipated price fair and reasonable based on comparison to the Independent Government Estimate and historical prices paid for similar products.

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.

Market Research was conducted utilizing a review of the Acquisition History, the Small Business Administration’s (SBA) Dynamic Small Business Search (DSBS), and the System for Award Management (SAM), an interview of knowledgeable individuals, and a sources sought notice.

The market research revealed a previous purchase from Alko Enterprises in 2017 under HHSIS245201700045A for mammography equipment, a determination that a GE Healthcare specific purchase would be most compatible with NNMC’s current medical imaging equipment. Further, a review of federal databases and a sources sought notice posted on SAM.gov with no responses solidified that there were no other Indian Small Business Economic Enterprises (ISBEE) capable of fulfilling the requirement.

The market research concluded that the equipment is available only from Alko Enterprises as award to an ISBEE is required IAW the Buy Indian Act, HHSAR 326.603-1.

9. Any other facts supporting the use of other than full and open competition, such as:

The GE Healthcare specific mammography equipment being requested by the NNMC is compatible with current equipment in the NNMC Medical Imaging Department facility and provides the top level of quality to NNMC patients. As a requirement for a commercial product, this requirement has to be set aside for ISBEEs IAW HHSAR 326.603-1 and Alko Enterprises, LLC was identified as the only ISBEE with the requested products for sale.

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

Alko Enterprises, LLC provided a market research . As they have fulfilled a similar requirement of mammography equipment to HHS in the past, they were deemed capable of fulfilling this requirement.

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.

Until the NNMC refreshes their equipment it is likely that the requirement for GE Healthcare equipment will continue. However, the purchasing and requesting office will continue to make efforts to continue to examine the market for compatible alternatives and will post the justification with the combined synopsis/solicitation in an effort to obtain feedback from potential vendors.

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.

13. Requirements personnel certification.

I certify that the technical data which forms a basis for this justification is complete and accurate and meets the Government’s minimum needs.

14. Reviews and Approvals

Concur

Approve