C Brand Name Justification Leica 4pages.pdf

SIMPLIFIED ACQUISITION BRAND NAME JUSTIFICATION

FOR ACQUISITIONS UNDER $250K

August 1, 2024

1. Activity. The Department of Health and Human Services, Indian Health Service (IHS) proposes to enter into a contract on a basis of Brand Name competition for the following acquisition as implemented by FAR Subpart 13.106.

2. Nature and/or description of the action being approved. Justification to solicit full and open completion for Brand Name Leica HistoCore Pegasus on SAM.GOV.

3. Description of Supplies or Services required to meet the agency’s needs (including the estimated value). The Phoenix Indian Medical Center (PIMC), Laboratory Department is procuring for Brand Name Leica HistoCore Pegasus Tissue Processor and Warranty/Service agreement. This equipment is used for processing different types of tissues that need different types of treatments and is flexible to run parallel protocols with consistent quality and processes up to 400 samples simultaneously. The current tissue processors (Serial #7845/Model #ASP300S/Tag #40-73452 & Serial #7862/Model #ASP300S/Tag #40-73453) have been malfunctioning and unable to run protocols with consistent quality. The runs have to be done one by one (manually) which causes delay in patient test results. Also, the current processors are no longer being made therefore the service agreement will no longer be valid.

4. Identification of the statutory authority permitting other than full and open competition. 6.302-1 Only one responsible source and no other supplies or services will satisfy agency requirement

Demonstration that the proposed contractor’s unique qualifications or the nature of the acquisition requires use of the authority cited. The Leica HistoCore Pegasus are unique in working with Leica HistoCore Microtomes to perform different types of tissues that need different types of treatments and is flexible to run parallel protocols with consistent quality and processes up to 400 samples simultaneously. The Leica Representative has recommended a second Leica HistoCore Pegasus because the older model Leica Tissue Processor/Autocut will not work alongside the newer Leica HistoCore Pegasus. We have purchase two new Leica HistoCroe Microtomes SN #04723 and SN #048479 and one Leica HistCore Pegasus SN #G0854. We need one additional Leica HistoCore Pegasus to work with the second Leica HistoCore Microtome.

5. 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. Based on our market research conducted, we received two Small Businesses from SAM.GOV that have the capability to meet our requirement, therefore we will solicit our RFQ on SAM.GOV and set-aside to Small Business.

6. Determination by the contracting officer that the anticipated cost to the Government will be fair and reasonable. We will determine price fair and reasonableness by competing this requirement on

SAM.GOV.

7. Description of the market research conducted (see part 10) and the results or a statement of the reason market research was not conducted. Based on our market research conducted, we received two Small Businesses from SAM.GOV that have the capability to meet our requirement, therefore we will solicit our RFQ on SAM.GOV and set-aside to Small Business.

8. Any other facts supporting the use of other than full and open competition. We are soliciting full and open competition for Brand Name Leica HistCore Pegasus.

9. List of sources. 1. Government Scientific Source and 2. Histology Partners

10. 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. We are going to solicit this requirement on SAM.GOV to remove any barriers.

11. Program Office Certification. This is to certify that the portions of this justification that have been developed by the undersigned program office personnel, including supporting information and/or data verifying the Government’s minimum needs or requirements, or other rationale for limited sources, are accurate and complete.

12. Contracting Officer Certification. This is to certify that the justification for the proposed acquisition has been reviewed and that to the best of my knowledge and belief the information and/or data provided to support the rationale and recommendation for approval is accurate and complete.

Official Name Signature Date Contracting Officer

6.302-1 Only one responsible source and no other supplies or services will satisfy agency requirements.

(a) Authority. (1) Citations: 10 U.S.C. 3204(a)(1) or 41 U.S.C.3304(a)(1).

(2) When the supplies or services required by the agency are available from only one responsible source, or, for DoD, NASA, and the Coast Guard, from only one or a limited number of responsible sources, and no other type of supplies or services will satisfy agency requirements, full and open competition need not be provided for.

(i) Supplies or services may be considered to be available from only one source if the source has submitted an unsolicited research proposal that-

(A) Demonstrates a unique and innovative concept (see definition at 2.101), or, demonstrates a unique capability of the source to provide the particular research services proposed;

(B) Offers a concept or services not otherwise available to the Government; and

(C) Does not resemble the substance of a pending competitive acquisition. (See 10 U.S.C. 3204(b)(A) and 41 U.S.C.

3304(b)(1).)

(ii) Supplies may be deemed to be available only from the original source in the case of a follow-on contract for the continued development or production of a major system or highly specialized equipment, including major components thereof, when it is likely that award to any other source would result in-

(A) Substantial duplication of cost to the Government that is not expected to be recovered through competition; or

Official Name & Title Signature Date Point of Contact Signed

Signed

(B) Unacceptable delays in fulfilling the agency’s requirements. (See 10 U.S.C. 3204(b)(B) or 41 U.S.C. 3304(b)(2).)

(iii) For DoD, NASA, and the Coast Guard, services may be deemed to be available only from the original source in the case of follow-on contracts for the continued provision of highly specialized services when it is likely that award to any other source would result in-

(A) Substantial duplication of cost to the Government that is not expected to be recovered through competition; or

(B) Unacceptable delays in fulfilling the agency’s requirements. (See 10 U.S.C. 3204(b)(B)).

(b) Application. This authority shall be used, if appropriate, in preference to the authority in 6.302-7; it shall not be used when any of the other circumstances is applicable. Use of this authority may be appropriate in situations such as the following (these examples are not intended to be all inclusive and do not constitute authority in and of themselves):

(1) When there is a reasonable basis to conclude that the agency’s minimum needs can only be satisfied by-

(i) Unique supplies or services available from only one source or only one supplier with unique capabilities; or

(ii) For DoD, NASA, and the Coast Guard, unique supplies or services available from only one or a limited number of sources or from only one or a limited number of suppliers with unique capabilities.

(2) The existence of limited rights in data, patent rights, copyrights, or secret processes; the control of basic raw material;

or similar circumstances, make the supplies and services available from only one source (however, the mere existence of such rights or circumstances does not in and of itself justify the use of these authorities) (see part 27).

(3) When acquiring utility services (see 41.101), circumstances may dictate that only one supplier can furnish the service (see 41.202); or when the contemplated contract is for construction of a part of a utility system and the utility company itself is the only source available to work on the system.

(4) When the agency head has determined in accordance with the agency’s standardization program that only specified makes and models of technical equipment and parts will satisfy the agency’s needs for additional units or replacement items, and only one source is available.

(c) Application for brand-name descriptions. (1) An acquisition or portion of an acquisition that uses a brand-name description or other purchase description to specify a particular brand-name, product, or feature of a product, peculiar to one manufacturer-

(i) Does not provide for full and open competition, regardless of the number of sources solicited; and

(ii) Shall be justified and approved in accordance with 6.303 and 6.304.

(A) If only a portion of the acquisition is for a brand-name product or item peculiar to one manufacturer, the justification and approval is to cover only the portion of the acquisition which is brand-name or peculiar to one manufacturer. The justification should state it is covering only the portion of the acquisition which is brand-name or peculiar to one manufacturer, and the approval level requirements will then only apply to that portion;

(B) The justification should indicate that the use of such descriptions in the acquisition or portion of an acquisition is essential to the Government’s requirements, thereby precluding consideration of a product manufactured by another company; and

(C) The justification shall be posted with the solicitation (see 5.102(a)(6)).

(2) Brand-name or equal descriptions, and other purchase descriptions that permit prospective contractors to offer products other than those specifically referenced by brand-name, provide for full and open competition and do not require justifications and approvals to support their use.

(d) Limitations. (1) Contracts awarded using this authority shall be supported by the written justifications and approvals described in 6.303 and 6.304.

(2) For contracts awarded using this authority, the notices required by 5.201 shall have been published and any bids, proposals, quotations, or capability statements must have been considered.