1920135_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 Allergic Diseases (LAD)

c. Project Officer Information:

Project Officer Name. Ms. Jane Hu-Li

Mailing address. 10 Center Drive, Bethesda, MD 20892.

E-mail address. jhli@niaid.nih.gov

Telephone number. (301) 761-6686

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 additional Becton, Dickinson, and Company (BD) LSRForetessa flow cytometer are required to analyze cells for their size and shape and also by their labeled surface and intracellular proteins. 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 additional cell analysis capability is required as soon as possible, the existing LSRFortessa cell analysis system cannot meet current demand.

This additional equipment must be compatibility with the existing system. The additional LSRForetessa equipment must utilize the same BD equipment, software, and consumables. This additional BD equipment is crucial LAD research into functions of the immune systems and immunological diseases.

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

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b. Project background.

The LAD conducts basic and clinical research on the function of the immune system with emphasis on immunological diseases. The studies are aimed at understanding the physiological control of lymphocyte proliferation, survival, signal transduction pathways in inflammation and understanding pathogenesis of allergic inflammation; of induction of lymphocyte effector functions in tissues;

and to identify novel immunomodulatory and anti-inflammatory approaches to the treatment of allergic and immunologic disorders. The information gained by these studies will benefit public health by providing a better understanding of how lymphocytes respond to foreign substances, and as to how adverse responses to self, such as auto-immune diseases, are avoided. Such an understanding will be of great importance in treatment strategies for various allergic diseases and autoimmune diseases. BD LSRFortessa system is invaluable in this effort as it can simultaneously provide data on many of the surface markers and protein expression involved in T cell differentiation in a single experiment, which markedly improves data collection. Current BD cell analysis system heavily utilized and cannot keep up with ongoing research efforts. Additional 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 HHSN272201401137P BECTON, DICKINSON AND COMPANY 9/16/2014 71,725.00

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

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

a. Project title. Two Additional BD Cell Analysis Equipment

b. Project description.

Two additional Becton, Dickinson, and Company LSRFortessa cell analysis equipment/systems are required. With the intensified ongoing research efforts, the processing and analyzing of the BD flow cytometry data is a key, critical component to the LAD efforts. These efforts are to identify and define specific pathophysiological pathways causing atopic dermatitis (AD) and treat accordingly. A number of rare immunodeficiencies have been very instructive in demonstrating the role of a variety of T cell related pathways in the pathogenesis of the dermatitis associated with these diseases. These pathways include disruption of STAT3 signaling, TCR signaling, and regulatory T cell specificity and function. We therefore wish to define a patient cohort with significant atopic dermatitis or allergic inflammation, a subset of which will have associated disruptions of these pathways, in order to apply a series of in vitro screening assays to be used to interrogate the efficacy of the individual pathways and determine the extent to which they are associated with typical atopic disease.

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Finally, the use of wet-wrap therapy allows us to measure acute biomarker changes before and after the treatment of severe eczema, and to follow those changes over long periods of time. These are both circulating measurements as well as skin biopsy and microbiome measurements. 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 1920135 – FedBizOpps

NIAID-NOI18-1920135

c. Total estimated dollar value is $736,565.48. This price includes the following:

Two LSRFortessa cell analysis system; installation and training; and 4-year warranty.

Performance/delivery period is September 14, 2018.

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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 additional 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 additional BD cell analysis systems are required.

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 August 8, 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 $736,565.48, while the similar sample analysis

Attachment 5 Page 5 systems like the Life Technologies cell imaging system is priced at $854,800.00; 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 3, 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 Ms. Jane Hu‐Li Info in regards to system requirements. Required documentation.

Government Scientific Sources

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

5 Fisher Scientific Company LLC GSA Advantage Reviewed different systems from Life Technologies HCA

6 AMBIS

Researched previous history

Research revealed Laboratory utilized Becton, Dickinson, and

Company for cell analysis portion of the research.

7 NIAID Federal Employee Mr. Phillip DeCastro Acquisition strategy

8 DCIS Reviewed orders within DCIS

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

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Search of AMBIS was conducted with the following results:

# Contract/Order Number Vendor Date Dollor Amount

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

2 HHSN272201401137p BECTON, DICKINSON AND COMPANY 7/31/2014 71725

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

4 HHSN272201701210P BECTON, DICKINSON AND COMPANY 7/7/2017 590522.79

5 HHSN272201800978P BECTON, DICKINSON AND COMPANY 3/28/2018 778221.89

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. Additional equipment operates software that is identical to existing flow cytometers currently maintained by 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.

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.