Leica_JA_Redacted.pdf

“Source Selection Information – see FAR 2.101 and 3.104”

1. Identification of the agency and contracting activity.

a. Federal agency and contracting activity. HHS.

Health and Human Services (HHS), National Institutes of Health (NIH), National Institute of Allergy & Infectious Diseases (NIAID), Division of Extramural Activities (DEA), Office of Acquisitions (OA), Acquisitions Management Operations Branch (AMOB)

b. Sponsoring organization.

National Institute of Allergy and Infectious Diseases (NIAID), Division of Intramural Research (DIR), Research Technologies Branch (RTB)

c. Project Officer information.

Project Officer name.

Mailing address.

E-mail address.

Telephone number.

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

a. Acquisition purpose and objectives.

The Division of Intramural Research (DIR), Research Technologies Branch (RTB) (collectively “Program”) requires a service plan for various instruments/equipment (e.g., microscopes) manufactured by Leica Microsystems Inc. (“Leica”). These instruments are able to obtain high resolution optical images with depth selectivity. These Leica instruments are constantly in use, and if they were disabled due to lack of maintenance or mechanical failure then the ability of the investigators in the DIR to conduct their research would be severely handicapped. To this end, the DIR requires a service agreement in place in the event an instrument should fail. Instrument downtime has a significant, adverse impact on research that must be reduced as much as possible.

These instruments are critical to DIR research efforts and must be maintained at a high standard operability which requires preventative maintenance, calibrations, parts replacement, and software updates.

Justification and Approval Simplified Acquisition

Procedures Soliciting from a Single Source

b. Project background.

For more than sixty years, DIR has been at the forefront of research on immunologic, allergic, and infectious diseases. Its purpose is to make scientific discoveries that promote the development of new vaccines, diagnostics, and therapeutics that improve human health. DIR Research goals are to expand knowledge of normal immune system components and functions, define mechanisms responsible for abnormal immune function (immunodeficiency, allergy, and autoimmunity), understand the biology of infectious agents (viruses, bacteria, fungi, and parasites) and the host response to infection, and develop strategies to prevent and treat immunologic, allergic, and infectious diseases. DIR scientists study all aspects of infectious diseases, including the causative agent, vectors, and pathogenesis in human and animal hosts. Clinical research also is integral to the DIR mission, enabling key lab discoveries to be rapidly translated into methods to prevent, diagnose, or treat disease. DIR researchers conduct more than 100 clinical trials at the NIH Clinical Center on the Bethesda, Maryland, campus and at collaborating U.S.

and international sites.

The RTB allows investigators in the DIR access to state-of-the-art research technologies. During the past thirty years, the advent of the biotechnology industry and the development of new scientific disciplines have resulted in an explosion of innovative technologies. In addition, advances in optics, lasers, and computer technology have revolutionized well-established disciplines such as microscopy (both light and electron), flow cytometry, and genomics. This acquisition directly addresses this mission by providing for a service agreement for the repair and upgrade of various confocal microscopes within DIR.

This is a follow-on requirement to ensure maintenance and availability of this crucial equipment to research efforts. This company sells directly to the public and is the sole source for these services . Previous purchases for similar requirements were sole non-competitive acquisitions made to Leica Microsystems through the open market:

Contract: 75N93022P00375 Vendor: Leica Microsystems, Inc.

Award Date: 02/18/2022 Period of Performance: 03/01/2022 – 02/28/2023 Amount: $588,145.32

Contract: 75N93021P00102 Vendor: Leica Microsystems, Inc.

Award Date: 11/30/2020 Period of Performance: 12/01/2020 – 11/30/2021 Amount: $613,858.04

Contract: 75N93020P00099 Vendor: Leica Microsystems, Inc.

Award Date: 11/25/2019 Period of Performance: 12/01/2019 – 11/30/2020 Amount: $570,003.92

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

a. Project title. Renewal of Leica Microsystems Maintenance for the Division of Intramural Research (DIR)

b. Project description.

Leica Microscope equipment and service is listed in Appendix A- Bill of Material. The DIR/RTB requires a service agreement plan for various Leica microscopes. The microscopes are used daily and must be repaired and/ or upgraded immediately to prevent the loss of research and maintain the continuity of experiments. The contractor will provide perform the following service and maintenance: unlimited service visits by Leica-Microsystems trained and qualified field service engineer, unlimited Original Equipment Manufacturer (OEM) replacement service parts, components, and modules necessary for repairs; excluding multiphoton lasers, one (1) annual on-site planned maintenance visit, to ensure the system(s) are performing to factory specifications, unlimited access to expert applications and technology support center (M-F 8 am – 5 pm), targeted 24-hour on-site response time, unlimited access to remote technical support services, proprietary firmware and software updates, and priority on-site response time scheduling equal to or better than manufacturers direct contract, to ensure minimal down time of instrumentation, Biosafety Level 3 included.

Requirement type.

Research & development (R&D) R & D support services

X 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 X Follow-on

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. AMBIS # 2151970 Other acquisition identification number: NOI-NIAID-2151970

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

The total estimated dollar value:

The period of performance: March 1, 2023 – February 29, 2024

4. 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_.

This acquisition is conducted under the authority of 41 United

States Code (U.S.C. 3304(a)(1) as set forth in Federal Acquisition Regulation (FAR) 13.106-1(b)(2) and 13.501(a).

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).

Leica Microsystems Inc.

1700 Leider Lane.

Buffalo Grove, IL 60089 Telephone (800) 248-0123

b. Nature of the acquisition and proposed unique qualifications of the company.

NIAID requires a service plan for the microscopes manufactured by Leica that are currently in use in the DIR/RTB lab. To ensure their optimal performance and reliability, they require maintenance by specially trained, experienced, and certified service engineers. Leica is the original manufacturer of the microscopes and the direct provider of service agreements specific to their instruments. There are no authorized third-party service providers. Only Leica’s authorized technicians and engineers have the most up-to-date knowledge and have access to the required original equipment manufacturer parts to provide the services needed to upgrade, repair, and maintain these instruments. Non authorized technicians do not have access to all of the required parts to maintain Leica’s machinery. Leica has a targeted 24-hour response time which meets the needs of NIAID to minimize downtime of critical instrumentation. Furthermore, according to Leica Microsystem’s sole source letter, failure to utilize Leica or Leica Authorized Partners for service may result in the voiding of the Leica Microsystems equipment warranty, if applicable, or the exclusion from any post-warranty service coverage of the parts, costs, repairs, or adjustments necessary for the equipment.

Thus, only Leica Microsystems Inc. has the engineers and technicians who have the skills, expertise, and authorization to work on Leica manufactured equipment, and only Leica has OEM parts.

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.

As required by FAR Subpart 5.2, a Pre-Solicitation (Notice of Intent to Sole Source) was publicized via SAM.gov (formerly FedBizOpps) under the following Record ID: NOI-NIAID-2151970. The notice announced the Government’s intent to obtain maintenance services for Leica Microsystems instruments on a non-competitive basis. Responsible sources who could provide comparable services were provided an opportunity to respond with a capability statement. If a reasonable capability statement from another source was provided, the intent was then to post a Request for Quotations on a full and open competition basis.

NIAID received one response from the NOI. After review of the information submitted, it was determined that this company does not meet NIAID’s minimal technical requirements.

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

The techniques identified at FAR 13.106-3(a)(2) will be used to ensure award will be at a fair and reasonable price. NIAID will consider the Independent Government Estimate, market research, comparison with similar items in the marketplace, and quoted prices found reasonable on previous purchase as determining factors for price reasonableness. A final determination by the Contracting Officer will be conducted prior to award of a purchase order.

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.

The Program Office conducted the initial market research by reviewing RTB’s existing Leica instruments and their maintenance agreements. After scanning the market for alternatives, their research concluded that Leica is the only source that can meet RTB’s requirements. The Contract Specialist viewed the required sources, Federal Supply Schedules, NIH strategic sources, and commercial websites and found that Leica Microsystems is the only known source for these maintenance services. Additional market research by the Contract Specialist included reviewing previous purchases for similar requirements, contacting knowledgeable Government and Industry professionals. Leica confirmed that they do not allow third party vendors to service their instruments. Additionally, the NOI did not reveal alternative sources that could meet NIAID’s minimal technical requirements for these maintenance services. In conclusion, the market research supports a sole source award to Leica Microsystems, Inc. as the only source available to the Government for this requirement.