2117135 - JA Redacted.pdf

Justification and Approval Justification Under Simplified Procedures for Certain Commercial Items in Accordance with FAR 13.5

This acquisition is conducted in accordance with Federal Acquisition Regulation (FAR) 13.106-1(b)(1), Soliciting from a single source, under the authority of Simplified Acquisition Procedures (41 U.S.C. 1901).

1. Identification of the agency and the contracting activity.

a. Federal Agency and Contracting Activity Health and Human Services (HHS), National Institutes of Health (NIH)

b. Sponsoring Organization

National Institute of Allergy and Infectious Diseases (NIAID), Research Technologies Branch (RTB), Flow Cytometry Section (FCS)

c. Project Officer

Project Officer name. Iyadh Douagi

Mailing address. 4 Memoria Drive, Room B138,Bethesda, MD 20892

E-mail address, iyadh.douagi@nih.gov

Telephone number. 301.761.6448

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

a. Brief Summary and Program Background

The National Institute of Allergy and Infectious Diseases (NIAID)’s Research Technologies Branch (RTB) requires a service plan for various instruments and equipment (eg. flow cytometers and lasers) manufactured by Becton, Dickinson, and Company (“BD” or “BD Bioscience”). BD cytometers and lasers provide flow cytometric analysis and sorting for all the Intramural program within the National Institute of Allergy and Infectious Diseases (NIAID). Each instrument is fully utilized and supports multiple complex and varied research and experiments every day. Equipment must be maintained in order to provide for a wide range of applications that includes the ability to modify and adapt capabilities as new applications are developed. The RTB-FCS provides flow cytometric analytical and cell sorting technologies to the Division of Intramural Research (DIR) of NIAID. The facility is equipped with specialized instrumentation dedicated to the science of the flow cytometry, which entails answering biological questions by analysis of multiparameters at the individual cell level. Due to heavy usage of equipment, equipment must be constantly maintained to prevent failures, as well as constantly repaired, recalibrated, and returned to operation as soon as possible after any potential failures. If the systems were put out of action due to the lack of maintenance or mechanical failure, then the ability of the investigators in the Flow Cytometry Section (FCS) to conduct their research would be severely handicapped. Therefore, the FCS requires a service agreement in place to ensure that instruments are regularly maintained to prevent failure and/or serviced as quickly as possible after a failure. The acquisition of this service agreement will guarantee the optimal function and reliability of data of the flow cytometry analysis and sorting for the customers of FCS. Modern Immunology research has seen an ever-increasing demand for identification of cellular subsets important in normal and disease states; this is turn has demanded the identification of an ever-increasing number of cell surface and intracellular markers. This acquisition addresses this mission by providing flow cytometers and other equipment operating at peak performance.

b. Project Title

Service Agreement for BD Bioscience equipment

c. Nature of the Action

Requirement type.

Support services (non-research & development) Supplies/equipment Information technology (IT) Other (specify): ______________________

Type of action. Check the appropriate box:

New requirement Follow-on Short-term Bridge

Proposed contract/order type. Check all that apply:

Firm-fixed-price Other fixed-price

Type: (specify e.g., fixed-price award-fee, fixed-price incentive-fee) Time and materials Indefinite delivery

Type: (specify whether indefinite quantity, definite quantity, or requirements)

Acquisition Identification Number

AMBIS #2117135

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

a. Description of the Required Supplies/Services

The FCS, RTB requires a service agreement plan for BD equipment including flow cytometers, high throughput samplers, flow supply systems, and associated lasers. See the Statement of Work (SOW) for description of services and see Bill of Materials (BOM) for the complete list of equipment to be serviced.

The requested service agreement for the abovementioned cytometers includes the following:

Parts, labor and travel for remedial repair, 2 Preventative Maintenance Inspections to be performed during twelve-month period, 2 PM Kits, Software Revisions released during the period of performance, Unlimited service visits, Monday-Friday, 48 hour-guaranteed response to a request for emergency on-site service Monday-Friday, and Unlimited telephone support for instruments, reagents, and applications will be provided at no additional charge.

The requested service agreement for the High Throughput Sample that includes the following:

Depot Level Repair between BD Biosciences Repair Center, San Jose, CA and Customer, 1 Preventative Maintenance Inspection to be performed during the twelve-month period, 1 PM Kit, An emergency replacement will be provided within two (2) working days. The use of new or like new parts will be at the discretion of BD Biosciences, User agrees to return the malfunctioning High Throughput Sampler within 5 business days upon receipt of replacement to the BD Biosciences Repair Center, San Jose, CA. If the High Throughput is not received customer will be invoiced for the full value, Unlimited telephone support for instruments, reagents and applications will be provided at no additional charge, and

BD Biosciences will assume all cost associated with labor, shipping and parts, excluding consumables items.

The requested service agreement for the FACS Flow Supply System that includes the following:

parts, labor and travel for remedial repair, Unlimited service visits, Monday – Friday, and Unlimited telephone support for instruments, reagents and applications will be provided at no additional charge.

b. Total estimated dollar value and performance/delivery period

Estimated dollar value inclusive of options: $321,021.55

Performance period: 05/18/2022 to 04/21/2023.

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

a. Acquisition authority: FAR 13.106-1(b)(1), in accordance with FAR 13.501(a)(1)(ii), as authorized by:

41 U.S.C. 1901 Simplified Acquisition Procedures

41 U.S.C. 1903 Special Emergency Procurement Authority

5. A demonstration that the proposed contractor’s unique qualifications or the nature of the acquisition requires use of the authority cited.

a. Exclusive and Required Nature of the Product(s) and/or Service(s)

NIAID requires a service plan for certain equipment that are currently in use in the DIR/RTB lab, and Becton, Dickinson and Company (“BD” and d.b.a. BD Bioscience) is the original equipment manufacturer (OEM) of this equipment that consists of flow cytometers, high throughput samplers (HTSs), flow supply system, and associated lasers. To ensure their optimal performance and reliability, NIAID requires maintenance by specially trained, experienced, and certified service engineers who are trained to troubleshoot and repair the flow cytometers and lasers in an expeditious manner, have access to official software & technical data, and have access to OEM components. These requirements will ensure the proper functionality and consistent operation of BD-manufactured equipment throughout the lab.

Only BD authorized services have the required spare parts (OEM parts) and controlling software to provide the services required to upgrade, repair, and maintain these instruments. No other company’s technicians have access to the OEM parts, software, or receive up-to-date training for BD’s equipment. Therefore, only BD’s authorized technicians and engineers can provide the services and quality standards required to meet the Government’s need. Further, while other vendors may be able to purchase access to BD technicians, they cannot meet the additional requirements of providing instrument software revisions along with preventative maintenance inspections, technical telephone consulting, and unlimited on-site visits. Other vendors will not be able to provide the required services with the required minimum level of service and response times since they will have to first contract with BD and process requests through BD’s services before being able to respond to an issue.

b. Only one Source Available

Name and address of the proposed contractor(s) if applicable

Becton, Dickinson & Company USBDB Service Contract Admin 2350 Qume Drive San Jose, CA 95131 877-232-2995 POC: Chris Ruggiero Chris.Ruggiero@bd.com

Proposed contractor(s) unique qualifications

BD is manufacturer of these equipment and BD is also the direct provider of BD service agreements specific to their manufactured instruments. According to BD’s sole source letter, BD does not certify third party organizations to perform official service on its equipment in the USA. Because BD does not authorize nor recognize any 3rd party technicians to service their instruments, only BD can provide BD-service agreements with BD’s authorized technicians, engineers, and OEM parts..

6. A description of efforts made to ensure that offers are solicited from as many potential sources as is practicable, including whether a notice was or will be publicized as required by subpart 5.2 and, if not, which exception under 5.202 applies.

Based on the market research, only one vendor is capable of providing the equipment that can satisfy Program’s needs. Only Becton, Dickinson and Company can provide the engineers and technicians with the necessary expertise and spare parts to upgrade, repair, and maintain the BD instruments currently in use by Program’s lab.

Pre-solicitation (Notice of Intent to Sole Source) was publicized via SAM.gov (formerly FedBizOpps) under the following Record ID: NIAID-NOI-2117135 that closed on April 8th, 2022, with the following results: No Vendors responded to the notice.

7. Determination by the contracting officer that the anticipated cost to the Government will be fair and reasonable.

The Independent Government Estimate (IGE) is approximately $321,021.55. The IGE is based on calculations of prices from previous BD service agreements for the same line items (specifically from 2021 prices), with the addition of several additional 2022 items for service. This figure accounts for inflation and is adjusted to 2022 dollars. This IGE is not significantly different from the current quoted market price of $320,949.41.

Since the actual 2022 quoted price of this service agreement from BD is slightly lower than the IGE, then the current quoted price can be considered fair and reasonable.

8. A description of the market research conducted (see part 10) and the results or a statement of the reason market research was not conducted.

Based on the market research, only one vendor is capable of providing the equipment that can satisfy Program’s needs. Only Becton, Dickinson and Company can provide the engineers and technicians with the necessary expertise and spare parts to upgrade, repair, and maintain the BD instruments currently in use by Program’s lab.

See Market Research Memo for more details.

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

Becton, Dickinson and Co., has many service engineer/technicians available immediately to provide repair services for the various flow cytometers and lasers. This will minimize down time in the busy facility of the FCS, RTB. BD’s service includes a 48-hour guaranteed response to a request for emergency on-site service M-F. This fast response time is a crucial requirement.

Becton, Dickinson and Co., does not authorize nor recognize 3rd Party technicians to service their instruments.

Fully functional equipment is critically important due to the nature of the work in the FCS, RTB. If a flow cytometer or laser malfunctions, and cannot be repaired within reasonable hours experiments can be lost.

Using another vendor other than Becton, Dickinson and Co., could lead to the instruments becoming non-functioning and irreparable causing the Government to spend additional funds to repurchase needed equipment for the labs experimenting processes.

10. A listing of the 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. A statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the supplies or services required.

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.

Certifications1

Program office certification. The program officials cited shall complete the information required below and sign the certification in the blocks provided.

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

Iyadh Douagi, PhD, Chief, FCS, RTB

Project Officer’s Immediate Supervisor

James Cherry, PhD, Chief RTB

Contracting Officer certification. The CO shall complete the information required below and sign the certification in the block provided. [Sufficient for actions not exceeding $750,000]

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

Christine Illanes, Contracting Officer

1 In accordance with FAR 13.501(a)(2), updated 7/1/2021

Iyadh Douagi -SR1

Digitally signed by Iyadh Douagi -SR1 Date: 2022.04.19 19:23:50 -04'00'

James M.

Cherry -S

Digitally signed by James M. Cherry -S Date: 2022.04.22 17:07:04 -04'00'