1919357_J&A.pdf

Attachment 5 Page 1

Justification for Other than Full and Open Competition Sole Source

“Source Selection Information – see FAR 2.101 and 3.104”

1. Identification of the agency and contracting activity.

a. Federal agency and contracting activity. DHHS/National Institutes of Health (NIH)/National Institute of Allergy & Infectious Diseases (NIAID)/Acquisitions Management Operations Branch (AMOB)

b. Sponsoring organization. Division of Intramural Research (DIR), Laboratory of Immune Systems Biology (LISB)

c. Project Officer Information:

Project Officer Name. Mr. Derek Einhaus

Mailing address. 4 Memorial Drive, Bethesda, MD 20892

E-mail address.

Telephone number. (301) 761-5317

d. Contract Specialist: Bradley C. Engel, (301) 761-6795, brad.engel@nih.gov

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

a. Acquisition purpose and objectives.

Two Becton, Dickinson, and Company (BD) LSRForetessa flow cytometer are required to analyze cells and determine which cells are present in a given sample.

More specifically to detect a rate immune cell populations which LISB studies in both human and mouse samples. The Special BD LSRFortessa flow cytometer is used to analyze cells of specific phenotype based on their cell surface marker or protein of interest. The existing BD flow cytometer/cell analysis systems cannot meet the ever-increasing cell analysis demands. This equipment will add 5 additional cell analysis lasers with the ability to detect 18 colors. This cell analysis capability is required as soon as possible, the existing LSRFortessa cell analysis system cannot meet current demand. The cell analysis aspect has become a bottle neck in our research efforts.

The BD cell analysis systems are overtasked and cannot keep up with the ever-increasing demand. We have also, been utilizing Laboratory of Parasitic Diseases (LPD) BD cell analysis systems, however, these systems are also in high demand and cannot meet research demands.

This equipment must be compatible with the existing system. The LSRForetessa equipment must utilize the same BD equipment, software, and consumables.

This BD equipment is crucial LISB research into functions of the innate and adaptive immune functions. With that being said, this increased cell analysis capability/equipment is essential for research efforts.

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b. Project background

The major research activities of LISB are focused on the basic genetics, molecular biology, and cell biology of the immune system, as well as on human disease informed by these more basic studies. How dysregulation of the immune system results in immunodeficiencies, autoimmunity, inflammation, allergy, chronic infections, and lymphoproliferative diseases and what strategies might be valuable for therapeutic or vaccine development related to these conditions as well as cancer are important topics of interest, as is the behavior of the meta-organism (the combination of the host and the commensal microbiota).

A key aspect of LISB research is the development and application of systems and quantitative approaches to dissect how the molecules, cells, and commensals studied by LISB investigators together shape emergent immune system behavior.

Modern technology now allows the analysis of immune responses and host-pathogen interactions at a global level, across scales ranging from molecular interactions to intracellular signaling and gene regulatory networks to individual cell behavior to the functioning of a tissue, an organ, and the whole organism.

The challenge is to organize and integrate this information to extract biological insights that can help enhance our understanding of how the immune system operates in health or disease or how pathogens affect their hosts. To move towards these goals, LISB scientists seek to collect detailed quantitative as well as qualitative data on the state, organization, and operation of the immune system to develop computational models (mechanistic, statistical, and machine-learning) that can be used to predict the behavior of a complex biological system, uncover the components involved, and help explain the mechanistic basis for physiological and pathological responses to infection or vaccination or to design new therapies or vaccines.

Currently there is a high priority/emphasis on applying imaging methods to analysis of the innate and adaptive immune systems. This priority has a high demand on our BD cell analysis systems. Current BD cell analysis system is heavily utilized and cannot keep up with ongoing research efforts. Equipment is needed as soon as possible.

This is a follow-on requirement to increase cell analysis capacity. The manufacturer of this equipment is Becton, Dickinson, and Company. This company sells directly to the public and does not have any resellers. Previous purchases for similar requirements were sole source acquisitions through open market and awards.

# Contract/Order Number Vendor Date Dollor Amount

1 HHSN272201600738P BECTON, DICKINSON AND COMPANY 6/3/2016 $699,999.00

2 HHSN272201601077P BECTON, DICKINSON AND COMPANY 8/11/2016 $412,402.50

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

a. Project title. Two BD Cell Analysis Equipment

b. Project description.

Two Becton, Dickinson, and Company LSRFortessa cell analysis equipment/systems are required. With the intensified ongoing research efforts, the processing and analyzing of sample via the BD cell analysis system is a key, critical component to the analysis of the innate and adaptive immune systems.

With that being said, this increased cell analysis capability/equipment upgrade is essential for research efforts.

Requirement type.

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

Type of action.

New requirement X Follow-on to # Contract/Order Number Vendor Date Dollor Amount

1 HHSN272201401137P BECTON, DICKINSON AND COMPANY 9/16/2014 71,725.00

2 HHSN272201400938P BECTON, DICKINSON AND COMPANY 9/29/2014 473,905.00

Other (specify): ______________________

Proposed contract/order type:

X 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. ABMIS 1919357 – FedBizOpps

NIAID-NOI18-1900422

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c. Total estimated dollar value is $679,200.22. This price includes the following:

Two LSRFortessa cell analysis system; installation and training; and 2-year warranty.

Performance/delivery period is must be delivered 45 days after award.

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

X This acquisition is conducted under the authority of 41 USC 3304(a)(1) and FAR Part 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).

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

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

Becton, Dickinson, and Company, 2350 Qume Dr., San Jose, CA 95131

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

Becton, Dickinson, and Company is the manufacturer of the LSRFortessa equipment and they do not have any resellers for this product. This BD equipment must utilize the same equipment and software currently being utilized to maintain continuity and data integrity. With that being said, to maintain research/project parameters and perform proper analysis/manipulation of experimental samples, it is essential to utilize the same equipment, biologicals, chemicals, and consumables throughout the life span of the research efforts.

Products, reagents, and materials may appear to be similar, however, small factors in their production can lead to vastly different and inconsistent results. A change in the equipment and/or reagents used in the project might therefore cause an unacceptable variation in results. In addition to the significant loss in time and effort this would cause, the experimental samples being used are extremely limited and, in many cases, cannot be replaced. The use of other products, supplies, and reagents may put these experiments at risk.

Current BD cell analysis system does not have enough capacity to meet research analysis requirements. This capacity is far below what is required. Two BD cell analysis systems are required.

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6. 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.

Pre-solicitation was publicized via FEDBIZOPPS on April 24, 2018. No responses were received.

7. Determination by the Contracting Officer that the anticipated cost/price to the Government will be fair and reasonable based on comparison to similar equipment.

The cost is within industry norms and is fair and reasonable. The two BD LSRFortessa systems for this acquisition is priced at $679,200.21, while the similar sample analysis systems like the Perkin Elmer cell imaging system is priced at $790,535.26; and the GE Healthcare cell imaging system is priced at $759,234.26. Becton, Dickinson, and Company system is on the lower end of the spectrum and is priced fair and reasonable.

8. 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, contact of knowledgeable individuals in the government and in industry, and review of catalogs and product literature. The results of this research indicated there is only one manufacturer/source for this product.

Market research was conducted on August 7, 2018. Some of the venues researched are as follows:

Vendor Person Description

1 Becton, Dickinson, and Company Mr. Mike Hogenkamp Discussed sole source aspect

2 NIAID Federal Employee IT

In regards to IT clearance. Software/equipment compatible with existing system. Past history.

3 NIAID Federal Employee Mr. Derek Einhaus Info in regards to system requirements. Required documentation.

Government Scientific Sources

(GSS) Inc GSA Advantage Reviewed different systems from GE Healthcare

5 Franklin Young International, Inc. GSA Advantage Reviewed different systems from Perkin Elmer

6 AMBIS

Researched previous history

Research revealed Laboratory utilized Becton, Dickinson, and

Company for cell analysis portion of the research.

7 NIAID Federal Employee Mrs. Gayle Sunde Acquisition strategy

8 DCIS Reviewed orders within DCIS

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Search of DCIS was conducted with the following results:

# Contract ID Vendor Name Contracting Agency Date Signed Obligation ($)

1 HHSN272201700948P BECTON, DICKINSON AND COMPANY NATIONAL INSTITUTES OF HEALTH 7‐Aug‐17 $123,057.50

2 HHSN261201700016A BECTON, DICKINSON AND COMPANY NATIONAL INSTITUTES OF HEALTH 11‐Apr‐17 $402,814.00

3 W81XWH16P0299 BECTON, DICKINSON AND COMPANY DEPT OF THE ARMY 16‐Sep‐16 $579,434.00

4 HHSN261201600503P BECTON, DICKINSON AND COMPANY NATIONAL INSTITUTES OF HEALTH 28‐Jul‐16 $750,000.00

5 HHSN268201600209A BECTON, DICKINSON AND COMPANY NATIONAL INSTITUTES OF HEALTH 28‐Jul‐16 $244,775.00

6 HHSN272201600929P BECTON, DICKINSON AND COMPANY NATIONAL INSTITUTES OF HEALTH 19‐Jul‐16 $379,912.00

7 HHSN272201600923P BECTON, DICKINSON AND COMPANY NATIONAL INSTITUTES OF HEALTH 18‐Jul‐16 $187,680.00

8 HHSN272201600803P BECTON, DICKINSON AND COMPANY NATIONAL INSTITUTES OF HEALTH 21‐Jun‐16 $278,555.00

9 HHSN272201600738P BECTON, DICKINSON AND COMPANY NATIONAL INSTITUTES OF HEALTH 2‐Jun‐16 $699,999.00

10 HHSN272201600702P BECTON, DICKINSON AND COMPANY NATIONAL INSTITUTES OF HEALTH 25‐May‐16 $339,440.00

11 HHSN268201600056A BECTON, DICKINSON AND COMPANY NATIONAL INSTITUTES OF HEALTH 25‐Jan‐16 $88,004.44

12 W81XWH15P0460 BECTON, DICKINSON AND COMPANY DEPT OF THE ARMY 30‐Sep‐15 $320,290.00

13 HHSN272201401137P BECTON, DICKINSON AND COMPANY NATIONAL INSTITUTES OF HEALTH 16‐Sep‐14 $71,725.00

14 HHSN272201401093P BECTON, DICKINSON AND COMPANY NATIONAL INSTITUTES OF HEALTH 11‐Sep‐14 $259,690.00

15 N6264514P2063 BECTON, DICKINSON AND COMPANY DEPT OF THE NAVY 20‐Aug‐14 $190,041.00

16 HHSN261201400423P BECTON, DICKINSON AND COMPANY NATIONAL INSTITUTES OF HEALTH 17‐Jul‐14 $393,936.30

17 HHSF223201301183P BECTON, DICKINSON AND COMPANY FOOD AND DRUG ADMINISTRATION 16‐Sep‐13 $78,543.75

18 HHSF223201210096A BECTON, DICKINSON AND COMPANY FOOD AND DRUG ADMINISTRATION 20‐Jul‐12 $358,030.20

19 N6264510P2208 BECTON, DICKINSON AND COMPANY DEPT OF THE NAVY 21‐Sep‐10 $355,481.00

20 HHSN272200900882P BECTON, DICKINSON AND COMPANY NATIONAL INSTITUTES OF HEALTH 22‐Sep‐09 $250,000.00

21 HHSN272200900841P BECTON, DICKINSON AND COMPANY NATIONAL INSTITUTES OF HEALTH 17‐Sep‐09 $245,000.00

22 HHSN272200900796P BECTON, DICKINSON AND COMPANY NATIONAL INSTITUTES OF HEALTH 10‐Sep‐09 $245,000.00

Search of AMBIS was conducted with the following results:

# Contract/Order Number Vendor Date Dollor Amount

1 HHSN272201600965P BECTON, DICKINSON AND COMPANY 7/6/2016 379693.5

2 HHSN272201600738P BECTON, DICKINSON AND COMPANY 4/19/2016 699999

3 HHSN272201600702P BECTON, DICKINSON AND COMPANY 4/6/2016 339440

4 HHSN272201601077P BECTON, DICKINSON AND COMPANY 4/6/2016 412402.5

5 HHSN272201400938P BECTON, DICKINSON AND COMPANY 7/30/2014 473905

6 HHSN272201400190P BECTON, DICKINSON AND COMPANY 10/22/2013 200238

7 HHSN272201001104P BECTON, DICKINSON AND COMPANY 6/30/2010 543000

8 HHSN272200900882P BECTON, DICKINSON AND COMPANY 7/8/2009 250000

9 HHSN272201000131P BECTON, DICKINSON AND COMPANY 6/8/2009 297500

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

In addition to the requirement for equipment and software to be compatible with existing systems, this system must compatible and consistent with other laboratories. Equipment must operate software that is identical to existing flow cytometers currently maintained in numerous other laboratories within the NIAID and therefore provides the required compatibility and continuity between current experimental protocols and facilitates transition to the new technology. Data must be interchangeable between laboratories and to ensure data integrity the same equipment, software, and consumables must be utilized.

Small changes to equipment, software, and consumables would have a serious adverse effect on sample analysis results and the ability to verify/collaborate information between laboratories. Upgrade must utilize the same equipment, software, and consumables to ensure data integrity for various research efforts.

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

No other sources have expressed an interest in the proposed acquisition.

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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.