04a-Brand Name Justification mw Redacted.pdf

Justification for Other than Full and Open Competition

Brand Name Justification

Program Office/Service Unit: HTM/CE; Belcourt, ND Requisition: Pending UFMS Entry

1. Nature and/or Description of action being approved:

CALLTSK0123387 to address medical equipment remediation needs that need to be performed in conjunction with services to be performed under award 75H70624P00713 with timeframes set forth by BD (Carefusion) which is the Original Equipment Manufacturer (OEM)

2. Description of Product, Supplies or Services required to meet the agency’s need:

Remediation of 3rd party acquired BD (Carefusion) Alaris infusion systems currently located at Quentin N Burdick Memorial Healthcare in Belcourt, ND.

3. Estimated Value of Procurement (to include options): $42,509.82

4. Recommended Source:

a. Contractor Name: Carefusion Solutions, LLC

b. UEI Number: JEC9J3E8QBJ7

c. Address: 3750 Torrey View CT, San Diego, CA 92130

d. POC: Tara Clopton; 405-397-6532, tara.clopton@bd.com

5. Reason for Sole Source/Limited Sources/Expedited Processing: Check one

☒ Brand Name essential to the Government’s needs. FAR 11.104 (b) Brand name or equal purchase descriptions must include, in addition to the brand name, a general description of those salient physical, functional, or performance characteristics of the brand name item that an "equal" item must meet to be acceptable for award. Use brand name or equal descriptions when the salient characteristics are firm requirements.

☐ Items peculiar to one manufacture. FAR 11.105 (a) The particular brand name, product, or feature is essential to the Government’s requirements, and market research indicates other companies’ similar products, or products lacking the particular feature, do not meet, or cannot be modified to meet, the agency’s needs

6. Justification Narrative:

BD (Carefusion) Alaris infusion systems are active medical devices within the Great Plains Area.

The services required are to address remediation needs that have been identified by the OEM.

7. Impact to the Government if not awarded in accordance with above:

The medical devices associated with this request account for approximately 25% of Belcourt’s active Alaris infusion system inventory. If remediation commences without taking these devices into account, they will no longer be available for clinical staff use as they will not stand alone, be interchangeable, nor communicate with the GuardRails Pharmacy drug library. This will have a detrimental impact on patient care for this Service Unit.

mailto:tara.clopton@bd.com

Dustin Pitlick -S

Mona R. Weinman -S

8. Synopses of proposed contract action (SAM.gov): Yes ☒ No ☐ In the case of a brand name justification under 6.302-1(c), the justification shall be posted with the solicitation (see 5.102(a)(6)). Yes ☒ No ☐

9. A determination the anticipated cost to the Government will be fair and reasonable:

Remediation cost to replace 3rd party acquired medical devices are in line with historical purchases of similar medical devices (data available in Nuvolo CMMS program).

Program/Project Manager:

Digitally signed by Dustin Pitlick -S Date: 2024.10.23 0_9:24:27 -05'00' Name, Title Date

Acquisition: Prepared by

Digitally signed by Mona R. Weinman -S Date: 2025.07.02 09:5_8:56 -05'00'

Name, Contract Specialist/Purchasing Agent Date

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.

Name, Contracting Officer Date

Competition Advocate Approval: Competition Advocate Approval: over $750,000 but not exceeding $15 million 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.

IAW FAR 13.501(a) (2)(ii)

Name, Competition Advocate Date

*See Attached Applicable FAR References 11.104, 11.105, 6.302-1, 6.303-1 & 6.303-2

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

(a) Authority.

https://www.acquisition.gov/far/part-6#FAR_6_302_1 https://www.acquisition.gov/far/part-5#FAR_5_102

(1) Citations: 10 U.S.C. 2304(c) (1) or 41 U.S.C. 253(c) (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.

2304(d)(1)(A) and 41 U.S.C. 253(d)(1)(A).)

(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

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

2304(d)(1)(B) or 41 U.S.C. 253 (d)(1)(B).)

(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. 2304(d)(1)(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. 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 does not provide for full and open competition regardless of the number of sources solicited. It shall be justified and approved in accordance with FAR 6.303 and 6.304. The justification should indicate that the use of such descriptions in the acquisition is essential to the Government's requirements, thereby precluding consideration of a product manufactured by another company. (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 and proposals must have been considered.