BNJ mw_Redacted.pdf
PDF 250 KB Posted
- Attached to
- Great Plains Area Hologic Imaging
- Solicitation number
- 75H70625Q00157
About this file
This Justification for Other than Full and Open Competition document seeks brand name approval for comprehensive service and support of Hologic Imaging devices within the Great Plains Service Area. The specific services cover Hologic Selenia Mammography Imaging Systems, including base units and associated SecurView, TechMate, and R2 CAD workstations located in Pine Ridge, Rosebud, Belcourt, and Sisseton Service Unit Radiology Departments. The document justifies the need for brand-specific maintenance by emphasizing that these sophisticated medical devices require scheduled preventive maintenance as specified by the Original Equipment Manufacturer (OEM), and that any services must be conducted by entities certified or authorized by Hologic.
The procurement aims to ensure proper equipment functionality and extend the useful life of the imaging systems, with the understanding that improper maintenance could lead to failed accreditation, damaged medical equipment, and potential patient harm. The agency anticipates commencing evaluation of replacement mammography platforms in FY2026, with an estimated 3-4 year research and acquisition process. The justification is filed under FAR 11.104(b) for brand name essential to government needs, indicating that only Hologic-certified service providers can adequately maintain these specific imaging systems.
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Other files
| File | Type | Posted |
|---|---|---|
| 06-SOW_Updated.pdf | ||
| 75H70625Q00157 SF1449.pdf | ||
| Bid Schedule.pdf | ||
| Combined synopsis 25Q00157.pdf |
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Text version
Justification for Other than Full and Open Competition
Brand Name Justification
Program Office/Service Unit: Healthcare Technology Management/ Clinical Engineering (HTM/CE)
Requisition:
1. Nature and/or Description of action being approved:
Other than Full and Open Competition to provide comprehensive service and support on existing Hologic Imaging devices located within the Great Plains Service Area
2. Description of Product, Supplies or Services required to meet the agency’s need:
Comprehensive service and support for Hologic Selenia Mammography Imaging Systems, to include base unit and associated SecurView, TechMate, and R2 CAD work stations located in the Pine Ridge, Rosebud, Belcourt, and Sisseton Service Unit Radiology Departments.
3. Estimated Value of Procurement (to include options): $
4. Recommended Source:
a. Contractor Name: TBD
b. UEI Number: TBD
c. Address: TBD
d. POC: TBD
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:
The Hologic Imaging Systems are sophisticated medical devices which require scheduled Preventive Maintenance (PM) as set by the Original Equipment Manufacturer (OEM). Scheduled services on these devices ensures that equipment is in proper working order and extends the useful life. No notification from the OEM stating that the Hologic equipment currently in use within the Great Plains Area is no longer supported. Reported malfunctions must be addressed expeditiously to minimize downtime as this would have a direct impact on patient diagnosis and treatment and may lead to diversion. Any services conducted on these devices must be conducted by entities either certified through the OEM to conduct such services, authorized by the OEM to conduct such services, or the OEM.
7. Impact to the Government if not awarded in accordance with above:
Failure to ensure that sources are capable of performing the services requested per OEM guidelines may result in failed accreditation requirements for each Service Unit, damaged medical equipment, potential patient harm.
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:
There are many Contracts listed on the FSS which would be the best value for the government
Program/Project Manager:
Name, Title Date
Acquisition: Prepared by
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)
-S by -S
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.
(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.
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