SAP Sole Source Roche Benchmark Ultra CO Signed Sam.Gov.pdf

SIMPLIFIED ACQUISITION SOLE SOURCE JUSTIFICATION

FOR ACQUISITIONS USING SIMPLIFIED ACQUISITIONS

Activity: The Department of Health and Human Services, Indian Health Service (IHS) proposes to enter into a purchase order on a basis of other than full and open competition for the following acquisition as implemented by FAR Subpart 13.5.

1. Requisition Number: IHS1489132

2. Description of Supplies or Services:

The contractor shall provide a Service Agreement for the Roche Benchmark Ultra Serial No. 317507 and Special Stainer Serial No. 5112172 and Roche Laboratory Consumable and Reagent Supplies for one base year and four option years for the Pathology Department at the Phoenix Indian Medical Center located Phoenix, AZ.

Current contract number GS-07F-0446V/75H71219F80033 will expire on 06/30/2024. We are procuring for a new five(5) year contract for consumable supplies, reagent supplies and service agreements for Roche Benchmark Ultra, Serial #317507 and Benchmark Special Stainer, Serial #5112172 for the Laboratory/Pathology Department. The contractor shall provide high quality consumables and reagents required to perform special staining on human tissue for fungus, iron, immunoperoxidease, and histo chemical. The special staining is completed for Pathologists to review under microscopes and make a patient diagnosis i.e. cancer, etc. The contractor shall provide support services, service, parts, & maintenance as required/needed, phone support, on-site services, & software updates if necessary or as required. Due to proprietary rights, Roche Diagnostics Corporation is the only vendor that can provide service at the level of quality required for their Roche equipment.

3. Estimated Value of Procurement with Options:

Base Year: $155,447.17 Option Year 1: $155,447.17 Option Year 2: $155,447.17 Option Year 3: $155,447.17 Option Year 4: $155,447.17 Total Estimated Value of Contract: $777,235.85

4. Recommended Sources:

Roche Diagnostics Corporation 9115 Hague Road Indianapolis, IN 46256-1025

UEI SAM: JDMDFEZBYH36

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

[X] Only one source (unique capabilities) [ ] Proprietary drawings, specifications, and/or engineering data, patents, copyrights.

[ ] Brand Name essential to the Government’s needs.

[ ] Standardization Program supported by Agency Head Determination and Findings (D&F).

[ ] Unusual and Compelling Urgency (limited sources) [ ] Authorized or required by statute

6. Justification Narrative:

The Roche Benchmark Consumables and Reagents are unique in performing staining testing using the Roche BenchMark Ultra Instrument System and Roche Ventana BenchMark Special Stainer. Roche is the sole manufacturer and distributor for their Roche BenchMark Ultra Instrument System and Roche Ventana BenchMark Special Stainer. Roche Diagnostics has provided us a Sole Source Justification letter stating the Roche Benchmark Consumables, Reagents and Service Agreements are only available through Roche Diagnostics.

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

This contract is necessary to avoid a break in service for this critical mission requirement. Roche Diagnostics Corporation possesses the capability to provide Roche BenchMark Consumable, Reagents and Service Agreements to the existing Roche BenchMark Ultra Instrument System and Roche Ventana BenchMark Special Stainer required to perform this requirement. An open competition to complete the work would cause intolerable delays to the Laboratory Program and would cause undiagnosed patient health risk to the Indian Health Service patients. The requirement cannot be modified in any manner to increase competition due to patient health risk.

8. 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.

Official Name & Title Signature Date Project Officer Health System

Specialist

Project Officer’s Immediate Supervisor

Laboratory Manager

9. 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

10. OPDIV Competition Advocate Approval This is to certify that the justification and find that it adequately supports other than full and open competition.

Official Name Signature Date

Signed 05/09/2024

Signed 05/09/2024

Signed 05/09/2024

*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.