Laparo_Limited_Sources_Justification_Redacted_(2)_2.pdf

LIMITED-SOURCES JUSTIFICATION

AUTHORITY: FAR 8.405-6 and 40 U.S.C 501

SOL # 140D0423Q0724

This acquisition is conducted under the authority of the Multiple Award Schedule Program.

1. Identification of the agency and contracting activity, and specific identification of the document as a “Limited-Sources Justification.”

Department of the Interior, Interior Business Center, Acquisition Services Directorate Division 2 Branch 3, on behalf of the Northern Navajo Medical Center (NNMC) of the United States Department of Health and Human Services (HHS) Indian Health Service (IHS) Operating Room (OR) Division.

Nature and/or description of the action being approved.

Th

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

The Med X Change Evolution 4K System is an equipment tower of Ultra High Definition (UHD) Medical Display for the surgeon and their surgical team to view the laparoscopic surgical procedure display with the Endocam Logic 4K image camera/video system that brings digital sharpness, clarity & a panoview continuous 4K imaging chain. An Evolution 4K recording, Light Source LED, Fiber Light cable, Adapter projector/endoscope side, equipment of camera head, remote controller, foot power cord, monitor cables connector, patch cable, and reusable telescope of four different sizes will be needed to make the system functional for a demanded favorable Outpatient procedure.

The product features an integrated 12.7 cm touch LCD screen that provides intuitive menu navigation and quick setting changes; a work list function that saves time by allowing cases to be added before they start; simultaneously records 4K UHD video and captures still images, records to an internal hard drive and two USB 3.0 drives at the same time; 1 TB internal storage captures up to 40 hours of 4K UHD surgical footage; DICOM integration: automatic DICOM c-store (PACS storage) and c-find (MWL); and iOS wireless application (MedxStream Plus app) for live still images, recording 4K video (via USB), surgical reports, and media review.

The delivery and installation

4. The authority and supporting rationale (see 8.405-6(a)(1)(i) and (b)(1)) and, if applicable, a demonstration of the proposed contractor’s unique qualifications to provide the required supply or service.

FAR 8.405-6( )(1) -

The NNMC previously acquired and currently owns the Richard Wolf Laparoscopic Towers.

NNMC has determined that additional specialized Richard Wolf equipment is needed to make the current systems utilized by the NNMC functional

A market research inquiry of other Richard Wolf Medical Equipment on FPDS and SAM revealed that RWMIC is the only company that has provided Richard Wolf products and repair and maintenance services for the past decade. Further, after discussion with the vendor, it was determined the RWMIC is the only available offeror for Richard Wolf equipment, the equipment is not available for purchase through any authorized resellers or distributors. As RWMIC is the only authorized United States reseller and servicer for Richard Wolf Equipment, purchasing this brand name equipment directly from the parent company will ensure the purchase of authentic products.

While there is similar laparoscopic equipment available in the commercial marketplace, the purpose of this requirement is to upgrade the existing Richard Wolf Laparoscopic equipment possessed by the NNMC OR, and currently only additional Richard Wolf Equipment can be utilized to carry out the upgrade. If the Richard Wolf specific equipment is not purchased the NNMC OR will be required to purchase a new system.

If new equipment from another company were to be purchased, the government would be required to procure these services under a new contract at additional cost while also maintaining the annual Preventative Maintenance (PM) services for the RWMIC equipment they already possess.

Obtaining the requested Richard Wolf equipment from RWMIC, the only known authorized provider, would allow the Government to continue utilizing the maintenance services provided under their current contract.

5. A determination by the ordering activity contracting officer that the order represents the best value consistent with FAR 8.404(d).

The anticipated contractor, Richard Wolf Medical Instruments Corporation (RWMIC), provided a market research quote based on their Department of Veterans Affairs (VA) Federal Supply Schedule (FSS) # 36F79718D0365 based on firm-fixed price rates negotiated by the FSS program. The prices have already been determined fair and reasonable; however, the Contracting Officer will make efforts to ensure all discounts and FSS prices or lower are adhered to in order to determine that the anticipated prices will be fair and reasonable. Further, the Contracting Officer anticipates the price to be fair and reasonable based on comparison to historical prices paid for similar products. If necessary, the fair and reasonable determination will include comparison of the proposed prices with prices obtained through market research for the same or similar items.

Placing the order directly with RWMIC through their VA FSS represents the best value to the Government.

6. A description of the market research conducted among schedule holders and the results or a statement of the reason market research was not conducted.

Market Research was conducted utilizing the review of Acquisition History, an interview of knowledgeable individuals, a review of commercial sources, pre-solicitation engagement, and a check of the System for Award Management (SAM).

The market research revealed a previous sole source purchase of the Richard Wolf Laparoscopic equipment and a determination that a purchase of the updated equipment would be most compatible with NNMC’s current OR equipment. An intent to sole source notice was posted on SAM.gov on May 16, 2023, with responses due May 23, 2023, and no responses were received.

The market research concluded that the equipment is available only from RWMIC whether purchased via open market procedures or through an established contract. It was determined to be in the best interest of the Government to conduct this acquisition utilizing GSA FSS schedule under FAR 8.405-6 procedures.

7. Any other facts supporting the justification.

The equipment being requested by the requiring activity is compatible with current OR equipment utilized by the NNMC and as the sole proprietor and manufacturer of the equipment, RWMIC is the only viable source for this equipment.

IAW FAR 8.405-6(a)(1)(i)(B), the solicitation will not be released on eBuy and instead will be pursued as a limited sources acquisition due to the market research indicating that RWMIC is the only source capable of fulfilling the requirement.

8. A statement of the actions, if any, the agency may take to remove or overcome any barriers that led to the restricted consideration before any subsequent acquisition for supplies and services is made.

The purchasing and program office will make efforts to remove barriers to competition for subsequent acquisitions by continuing to monitor the market for alternative equipment solutions that are compatible with current NNMC-OR equipment and maintaining dialogue with the equipment manufacturer to locate authorized resellers.

Based on the IHS OR Division being outfitted with this equipment, there is currently no reasonable expectation that this can be competed in the future; however, future justifications will document whether there are new products in the market that provide the capabilities addressed in paragraph 3 of this justification.

9. The ordering activity contracting officer’s certification that the justification is accurate and complete to the best of the contracting officer’s knowledge and belief.

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

10. Evidence that any supporting data that is the responsibility of technical or requirements personnel (e.g., verifying the Government’s minimum needs or requirements or other rationale for limited sources) and which form a basis for the justification have been certified as complete and accurate by the technical or requirements personnel.

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

11. For justifications under 8.405-6(a)(1), a written determination by the approving official identifying the circumstance that applies.

FAR 8.405-6(a)(1)(i)(B) - Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized.

12. Reviews and Approvals

Concur

Approve