2099092 - JandA Redact.pdf

Justification and Approval

“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), 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.

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 (eg. 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 RTB research efforts and must be maintained at a high standard operability which requires preventative maintenance, calibrations, parts replacement, and software updates.

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 Research Technologies Branch (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 maintenance, 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 this product. Previous purchases for similar requirements were sole source acquisitions made to Leica Microsystems through the open market:

Award 75N93021P00102 made to Leica Microsystems on 11/30/2020 in the amount of $613,858.04

Award 75N93020P00099 made to Leica Microsystems on 11/26/2019 in the amount of $570,003.92

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

a. Project title. Service Agreement for instruments manufactured by Leica Microsystems Inc.

b. Project description.

The DIR/RTB requires a service agreement plan for various microscopes from Leica Microsystems Inc.

Because these instruments are in constant use, agreements for repair and/or upgrades must be continuously reacquired and must not lapse in order to prevent a potential loss of equipment functionality, prevent delays in research, and to maintain continuity of experiments.

Leica’s Premium Care Service Plan coverage includes:

-Unlimited service visits by Leica-Microsystems trained and qualified field service engineer -Unlimited OEM Replacement service parts, components, or modules necessary for repairs; excluding multiphoton lasers -1 Annual on-site Planned Maintenance visit, to ensure the system is performing to factory specifications.

-Unlimited access to expert Applications and Technology Support Center (M-F 8am-5P) -Biosafety Level 2 included -Software Updates -10% discount on non-contract related.

This request is a renewal of a previous contract HHSN 75N93021P00102 where the service agreement had period of performance 12/1/2020– 11/30/2021, extended to 02/28/2022.

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 #2099092

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

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

This acquisition is conducted under the authority of 41 U.S.C. 1901 as implemented by FAR 13.106-1(b)(1), in accordance with FAR 13.501 (a) – Sole Source (including brand name) acquisitions.

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

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. 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 Original Equipment Manufacturer (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.

Based on the market research, only one vendor is capable of providing the equipment that can satisfy Program’s needs. Only Leica Microsystems Inc. can provide the engineers and technicians with the necessary expertise and spare parts to upgrade, repair, and maintain the Leica 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-2099092, with the following results:

Two vendors responded to the NOI with capability statements: 1) CenMed and 2) RemiGroup

Program evaluated their capability statements and concluded that they are not technically acceptable for two reasons:

1) Labor must be exclusively provided by OEM Leica Microsystem or officially authorized Leica Microsystems sources. However, both RemiGroup and CenMed states in their capability statements that they may use Independent Service Organizations (ISO) and/or independent service organization technicians.

2) A Bill of Materials was provided in the NOI stating that the equipment service must be PremiumCare.

PremiumCare is a Leica Microsystems branded service that includes elements such as Hotline Response Targets of within 2 hours and On-Site Response Targets of within 3 days. Neither RemiGroup nor CenMed addressed this Premium Care requirement and neither acknowledged that they could meet these response times for service.

Determination by the Contracting Officer that the anticipated cost/price to the Government will be 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.

Market research was conducted in accordance with FAR Part 10. The Program Office conducted the initial market research by reviewing NIAID’s existing service and scanning the market for technology/service that could satisfy the Government’s requirement for this service. Contract Specialist corresponded with the manufacturer Leica Microsystems, and reviewed GSA Advantage/Federal Supply Schedules, mandatory sources, and open market sources. The results of this research indicated there is likely only one manufacturer/source for this specific product that could meet Program’s requirements. Contract Specialist also posted a Notice of Intent to Sole Source NIAID-NOI-2099092 on SAM.gov, and two vendors responded to the posting as specified above. Since these two vendors were considered to be not technically capable, only Leica Microsystems can provide these services for Leica manufactured equipment.

See Market Research memo for more details.

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

Leica is the manufacturer of the microscopes in use by Program. Leica provides a dedicated team of service professionals ensuring each instrument provides optimum performance and results regardless of its application and where it is located. Using another vendor to provide maintenance services where their engineers do not have the right credentials and authorization to repair the microscopes could void the warranty. Warranties do not cover damages due to misuse, negligence, or accidents due to installations, repairs or adjustments not specifically authorized by a certified Leica engineer. Furthermore, using vendor other than Leica could lead to the microscopes becoming non-functioning and unrepairable causing the Government to spend additional funds to repurchase needed equipment for the labs experimenting processes. Using unauthorized third party vendors to service Leica instruments may void Leica’s manufacturer warranties.

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/services 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.

13. Contracting Officer certification.

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.