2083471 - JA for Tecan 780 Flue_Redact.pdf

HHS Template and Instructions for a

Justification for Other than Full and Open Competition

“Source Selection Information – see FAR 2.101 and 3.104”

1. Identification of the agency and contracting activity.

• Federal agency and contracting activity. HHS.

Health and Human Services (HHS), National Institutes of Health (NIH)

• Sponsoring organization.

NIH/NIAID/DIR/Center for Human Immunology, Autoimmunity, and Inflammation

• Project Officer information.

2. Nature and/or description of the action being approved.

• Acquisition purpose and objectives.

The Center for Human Immunology, Autoimmunity, and Inflammation (CHI) at the National Institute of Allergy and Infectious Diseases (NIAID) develops and applies systems immunology-based approaches—combining computation, modeling, and experiments—to study the immune system at the organismal, cellular, and molecular levels.

Since 2015, the CHI has performed the SomaScan HTS v3 Assay for use in its own research, and as a fee-for-service to the entire intramural research program at the National Institutes of Health. The instrument has proven paramount to the CHI and to investigators across 12 institutes at the NIH.

This version of the assay has now been replaced by SomaLogic with its latest version of the assay (SomaScan Assay 7K). In order to be able to run the updated version of the SomaScan Assay, the CHI requires a Fluent 780 automation system designed specifically to perform the SomaScan Assay 7K, available from Tecan.

• Project background.

The CHI is studying the biology of the immune system on a global scale, including at the proteomic level. The CHI aims to study and characterize both the normal and pathogenic immunome. Characterizing the serum proteome is fundamental to understanding these systems. Using computational biological approaches coupled with more traditional biological experimentation, the CHI strives to build models of how the mammalian immune system responds to pathogens, disease progression, treatments, and vaccines. These models allow the CHI to make informed predictions as to how the body will respond to immunological events. The SOMAscan Assay allows fast proteomic profiling of more than 7,000 protein markers in serum, plasma, cell lysates, tissue homogenates, conditioned media, cerebrospinal fluid, and bronchioalveolar lavage fluid. This assay is designed and authorized by the manufacturer to be performed only on the custom Tecan Fluent 780 liquid handling platform.

3. Description of the supplies or services required to meet the agency’s needs (including the estimated value).

• Project title. Center for Human Immunology Tecan Fluent 780 System Purchase

• Project description. The contractor shall manufacture, deliver and install the Fluent 780 System according to the following specifications:

• Requirement type.

Research & development (R&D)

R & D support services Support services (non-R&D) ☒ Supplies/equipment Information technology (IT) Construction Architect-engineer (A & E) services Design-build Other (specify): ____________________

• Type of action.

☒ New requirement Follow-on Other (specify): ______________________

• Proposed contract/order type.

☒ Firm-fixed-price Other fixed-price (specify, e.g., fixed-price award-fee, fixed-price incentive-fee): __________ Cost-plus-fixed-fee Other cost reimbursement (specify, e.g., cost-plus-award-fee, cost-plus-incentive-fee): ___________ Time and materials Indefinite delivery (specify whether indefinite quantity, definite quantity, or requirements): ___________ Other (specify): ___________ Completion Form Term form

• Acquisition identification number. AMBIS # 2083471

c. Total estimated dollar value and performance/delivery period.

Identification of the statutory authority permitting other than full and open competition.

☒ This acquisition is conducted under the authority of 41 United States Code (U.S.C.) 253(c)(1) as set forth in Federal Acquisition Regulation (FAR) 6.302-1 – Only one responsible source.

This acquisition is conducted under the authority of section 4202 of the

Clinger-Cohen Act of 1996.

This acquisition is conducted under the authority of the Services

Acquisition Reform Act of 2003 (41 U.S.C. 428a).

4. Demonstration that the proposed contractor(s) unique qualifications or the nature of the acquisition requires use of the authority cited.

• Name and address of the proposed contractor(s).

Tecan U.S. Inc.

9401 Globe Center Drive Suite 140 Morrisville, NC 27560 Phone: 919-361-5200

• Nature of the acquisition and proposed unique qualifications of the contractor(s).

The research performed at the Center for Human Immunology (CHI) involves characterizing the analytes present in serum and other biological matrices. The SomaLogic SomaScan assay and SomaSignal tests performed exclusively on the Fluent 780 platform from Tecan are proprietary proteomic assays based on individual SOMAmer reagents used for the discovery of biomarkers in biospecimens (like human serum). The more than 7,000 targets probed in the assay represent a broad variety of proteins including cytokines, growth factors, receptors, proteases, protease inhibitors, kinases, structural proteins, and hormones known to be important in human diseases and immunological responses. Assay qualification studies show that the SOMAscan Assay performs with median sensitivity of 100 fM (limit of detection) and median coefficient of variation (CV) of approximately 5% across all analytes measured repeatedly in replicate runs of biospecimens. In addition, the overall detection range of the platform spans 8 logs of dynamic range in serum. The Assay provides high throughput (96 samples per plate), highly multiplexed (>7,000 analytes), rapid (<48 hour turnaround) results.

No other kit or technology can measure as many analytes in serum as quickly, precise, with lower serum volume requirements. Additionally, the CHI and NIH IRP investigators have used the SOMAscan Assay in previous projects, and this will ensure on-going research/experiments are not compromised with changing variables. Maintaining existing protocols is paramount to the success of these longitudinal studies.

Tecan is the only manufacturer of liquid handling systems authorized to perform the SomaScan Assay. The use of another liquid handling system has not been validated nor is authorized to perform the SomaScan Assay 7K. Additionally, the use of a different platform will not produce results that meet the assay validation requirements of the SomaScan Assay. Tecan will build, assemble, and validate (installation qualification and operational qualification) to the specifications required to meet the SomaScan Assay 7K acceptance criteria.

5. Description of the efforts made to ensure that offers are solicited from as many potential sources as practicable. Indicate whether a FedBizOpps notice was or will be publicized as required by FAR Subpart 5.2 and, if not, which exception under FAR 5.202 applies.

Based on the market research, only one vendor is capable of providing the equipment that can satisfy Program’s needs. Somalogic confirmed that the Tecan Fluent 780 equipment that is compatible with Somalogic assay kits is only manufactured by Tecan. Due to the close business relationship between Tecan and Somalogic, only Tecan equipment is authorized and verified by Somalogic to be compatible.

Pre-solicitation (Notice of Intent to Sole Source) was publicized via SAM.gov (formerly FedBizOpps) under the following Record ID: NIAID-NOI21-2078989, with the following results: No vendors responded to the posting.

Thus, this acquisition shall be a sole source acquisition under FAR 6.302-1.

6. Determination by the Contracting Officer that the anticipated cost/price to the Government will be fair and reasonable.

The cost is within industry norms and is fair and reasonable

7. Description of the market research conducted (see FAR Part 10) and the results, or a statement of the reasons market research was not conducted.

Several market research techniques were used to identify other possible sources, including review of acquisitions on similar items, queries of internet information sources, correspondence with people in the government and in the industry, and review of catalogs and product literature. The results of this research indicated there is likely only one manufacturer/source for this specific product that could meet Program’s requirements.

Only the Tecan Fluent 780 equipment is capable of fulfilling Program’s needs, and only Tecan US Inc. produces this equipment.

See Market Research + PreSolicitation Memo for more details.

8. Any other facts supporting the use of other than full and open competition.

This requirement can only be satisfied by one responsible source Tecan US Inc. because no other vendor produces the Tecan Fluent 780. Only this equipment is verified to be compatible with Somalogic’s assay kits because Tecan US Inc. and Somalogic Inc. have a close working business relationship. Although there have been previous acquisitions of the Tecan Fluent 780 across the government and in other departments at NIH, there will be no duplication of work as the Program office needs this Tecan Fluent 780 to perform their research.

10. Listing of sources, if any, that expressed, in writing, an interest in the acquisition.

No other sources have expressed an interest in providing a formal response to the proposed acquisition.

11. Statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the required supplies or services.

It is the policy of NIAID to promote the use of competitive procedures whenever and wherever possible. In an effort to remove or overcome barriers to competition in the future, the market will be scanned frequently for new companies and products that could satisfy the Government’s requirement. The staff meets regularly with products manufacturers and vendors and attends manufacturer and industry training to keep current on technology.

Vendor and trade magazines are scanned for new, open technologies that can satisfy future infrastructure requirements. The agency will continually re-evaluate the products currently being used and will research for the manufacturers and products that will be in the Government’s best interest as best value for future replacement products at the agency’s site and at sites the agency supports. The current situation requires a sole source justification to satisfy requirements. Since there is a continual re-evaluation to products currently being used by the agency for the present requirement, if/when alternatives become available, they will be evaluated for use.

12. 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, schedule requirements and other rationale for other than full and open competition, are accurate and complete.

Official Name & Title Signature Date

Project Officer

Project Officer’s Immediate Supervisor

Head of the Sponsoring

Program Office

13. Contracting Officer certification. The CO shall complete the information required below and sign the certification in the block provided. [NOTE: The CO’s signed certification may serve as approval of a JOFOC over $100,000 but not exceeding $550,0001, depending on OPDIV procedures.)

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 & Title Signature Date

Contracting Officer

14. Chief of the Contracting Office and Head of the Contracting Activity signature(s).

The Chief of the Contracting Office (CCO), if applicable, and the HCA shall indicate review of, and concurrence with, any JOFOC over $550,0002 by providing the information required below and signing in the applicable block.

Official Name & Title Signature Date

Chief of the

Office

Head of the

Activity

1 This dollar range is current as of the date of issuance of interim acquisition policy memorandum No. 2008-03, but is subject to change – see FAR 6.304(a)(1) and 13.501(a)(2)(i). See HHSAR 306.304(a)(1) and 313.501(a)(2)(i) for additional information regarding CO approval of a JOFOC in this dollar range.

2 This review and concurrence requirement is applicable to the dollar ranges over $550,000 cited in the FAR, specifically: (i) over $550,000 but not exceeding $11.5 million; (ii) over $11.5 million but not exceeding $57 million; and (iii) over $57 million – see FAR 6.304(a)(2) through (4) and 13.501(a)(2)(ii) through (iv). See HHSAR 306.304 and 313.501(a)(1)(iii) for additional information regarding CCO/HCA review of and concurrence with a JOFOC in these dollar ranges. These dollar ranges are current as of the date of issuance of interim acquisition policy memorandum No.

2008-03, but are subject to change.

15. Competition Advocate signature. The designated OPDIV Competition Advocate (CA), upon acceptance of the rationale provided in the JOFOC, shall complete the information required below and sign in the block provided as the approving official for any JOFOC over $550,000 but not exceeding $57 million3. However, if the CA does not meet the requirements of FAR 6.304(a)(3)(ii) for a JOFOC over $11.5 million, but not exceeding $57 million, an individual other than the CA shall exercise the approval authority.

The signature of the CA, or that of an individual meeting FAR 6.304(a)(3)(ii) requirements for a JOFOC over $11.5 million, but not exceeding $57 million, shall serve as concurrence on any JOFOC over $57 million that requires the approval of the HHS

SPE.

Official Name & Title Signature Date

Competition Advocate

16. HHS Senior Procurement Executive signature. The HHS SPE, upon acceptance of the rationale provided in the JOFOC, shall complete the information required below and sign in the block provided as the approving official for any JOFOC over $57 million4.

Official Name & Title Signature Date

HHS Senior Procurement

Executive

3 This approval authority is applicable to the following dollar ranges cited in the FAR, specifically:

(i) over $550,000, but not exceeding $11.5 million; and (ii) over $11.5 million, but not exceeding $57 million – see FAR 6.304(a)(2) and (3) and 13.501(a)(2)(ii) and (iii). See HHSAR 306.304(a)(2) and (3) and 313.501(a)(ii) and (iii) for additional information regarding this approval authority, including when the CA does not meet the requirements of FAR 6.304(a)(3)(ii). These dollar ranges are current as of the date of issuance of interim acquisition policy memorandum No.

2008-03, but are subject to change.

4This dollar range is current as of the date of issuance of interim acquisition policy memorandum No. 2008-03, but is subject to change – see FAR 6.304(a)(4) and 13.501(a)(2)(iv). See HHSAR 306.304(a)(4) and 313.501(a)(2)(iv) for additional information regarding SPE approval of a JOFOC in this dollar range.