JA_Final_Redacted.pdf

ADVFY19RD100036 J&A No. 19-10026

Form 02.4G.AB 18 Apr 2016

JUSTIFICATION AND APPROVAL

OTHER THAN FULL AND OPEN COMPETITION

1. Identification of the agency and the contracting activity, and specific identification of the document as a

“Justification for other than full and open competition.”

This justification is executed by the Naval Medical Logistics Command (NMLC), Fort Detrick, MD, on behalf of the Navy to meet the Naval Medical Research Unit San Antonio (NAMRU-SA) requirements.

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

Award of a contract on a sole source basis for one (1) electron microscope (microscope, electron, scanning/transmission [18-091]) for Naval Medical Research Unit San Antonio (NAMRU-SA). The Government intends on awarding a Firm, Fixed-Price (FFP) contract. The proposed source is Delong America, Inc. of 4020 St.

Ambroise, Suite 473, Montreal, Quebec, Canada H4C 2C7.

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

The Naval Medical Logistics Command (NMLC) has a requirement for one (1) electronic microscope (microscope, electron, scanning/transmission [18-091]) for Naval Medical Research Unit San Antonio (NAMRU-SA).

The electron microscope shall be capable of imaging particles at low voltage, equal to or less than 25 kV. The electron microscope shall be capable of imaging particles equal to or less than 1 nm. The electron microscope shall be able to perform both conventional transmission electron microscopy (TEM), as well as scanning transmission electron microscopy (STEM). The electron microscope shall also be capable of multi-modal scanning electron microscopy (SEM) imaging. The electron microscope shall include a stand-alone glow discharge treatment unit capable of pretreating and modifying TEM grids, and capable of optimizing adsorption of aqueous solutions, to allow for uniform spreading of specimens and to obtain sharper resolution specimen images. Additionally, the glow discharge treatment unit shall provide the capability to image biological samples (e.g. cell suspensions) and electro-spun samples.

The electron microscope shall include, but not be limited to, the following additional equipment and workstation accessories for full system functionality: field emission gun (FEG), integrated imaging column and airlock pumps, two (2) liquid crystal display (LCD) monitors, toolkit (i.e. Allen keys, square valve key, spare o-ring, and vacuum grease), Windows 10 personal computer (PC) configured with electron microscope software, worktable and wheeled cart. The FEG shall provide spatial resolution and improved signal-to-noise ratio to obtain clearer images. The electron microscope shall be designed as a benchtop, modular microscope. The microscope, including additional equipment (e.g. pumps) and workstation accessories (e.g. work table and wheeled cart, monitors) shall have maximum height x width x depth dimensions of 60 in. x 88.6 in. x 37.4 in.

The vendor shall provide on-site operator training for four (4) personnel. The vendor shall provide biomedical technician (BMET) training for two (2) personnel. The vendor shall include at least one (1) year warranty, and provide on-site local maintenance and support for calibration, preventive maintenance and corrective maintenance. The proposed solution shall include surge protection for the microscope. The vendor shall provide two (2) operator manuals and two (2) service manuals. The power requirements are 120 VAC, 50/60 Hz.

Vendor shall be an Original Equipment Manufacturer (OEM) authorized dealer, authorized distributor, or authorized reseller for the proposed equipment, such that OEM warranty and service are provided and maintained by the OEM.

All software licensing, warranty, and service associated with the equipment shall be in accordance with the OEM terms and conditions.

The equipment, including claims made for the product, shall be compliant with Food and Drug Administration (FDA) regulations, with respect to marketing and delivering medical products for use in the United States of America. These requirements shall apply even if delivery is requested outside of the United States of America. The system shall be installed in compliance with Occupational Safety and Health Administration (OSHA) requirements. The contractor shall comply with Risk Management Framework (RMF) requirements, as specified by the Defense Health Agency (DHA) that meet appropriate DoD, DHA and Navy Cybersecurity requirements.

Upon delivery, the contractor shall be responsible for uncrating the equipment, transporting it through the facility to the location of intended use for installation, and removing of all trash created in this process. If interim storage is required, the vendor shall make arrangements for the storage. The vendor is also responsible for conducting initial calibration, and operational and performance tests for the electron microscope unit.

The estimated award date is June 2019 with a delivery date three (3) to six (6) months later, to allow sufficient time for vendor lead time. The award will include a 12 month period of performance for warranty services to include on-site local maintenance and support for calibration, preventive maintenance and corrective maintenance. The operator training and BMET training shall occur within 30 days of installation.

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

The statutory exception permitting other than full and open competition for this acquisition is 41 U.S.C. 1901 (see also FAR 13.501(a)).

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

Delong America, Inc. (Delong) is the only vendor capable of providing an electron microscope that meets the dimensions specified in the Government’s minimum requirements and includes a FEG and glow discharge treatment unit. Other vendors, i.e. Hitachi High Technologies America, Inc. and Jeol USA, Inc., provide microscopes with footprints larger than the maximum dimensions outlined in the minimum requirements. Although Thermo Fisher Scientific, Inc. manufactures an electron microscope with a benchtop design, the microscope model does not include an FEG to obtain clearer images or a glow discharge treatment unit to fix and stain the samples on the TEM grids.

Delong’s electron microscope, the LVEM25, is the only electron microscope on the market capable of meeting all of the Government’s minimum requirements. No other vendor can meet all the Government’s minimum requirements.

Thus, Delong is the only vendor that can meet the minimum requirements of the Government.

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.

Market research was performed, the results of which are in paragraph 8. This requirement will be posted to FedBizOpps in accordance with FAR 5.202.

7. A determination by the Contracting Officer that the anticipated cost to the Government will be fair and reasonable.

The Contracting Officer shall determine the anticipated cost to the Government of the supplies covered by this Justification and Approval will be fair and reasonable by conducting a price analysis before an award is made. In addition, the Government anticipates that the negotiated contract price will reflect a discount from the vendor’s commercial price list and will be determined fair and reasonable.

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

Market research was conducted in February 2019 to March 2019. Research included references and information derived from Internet searches via Google, GSA Advantage, and ECRI Sourcebook. It was determined that scanning/transmission electron microscopes can be provided by the following vendors: Delong America, Inc. (Delong America), Hitachi High Technologies America, Inc. (Hitachi), Jeol USA, Inc. (Jeol USA), and Thermo Fisher Scientific, Inc. (Thermo Fisher).

Hitachi and Jeol USA manufacture transmission electron microscopy (TEM) products, HT7800 and JEM-1400 respectively, with the following electron microscope footprint, which includes the microscope unit, additional equipment (e.g. pumps), and workstation accessories (e.g. work table and wheeled cart, monitors), dimensions (height x width x depth):

• Hitachi’s HT7800 TEM footprint: 80.3in. x 141.7 in. x 189.0 in.

• Jeol USA’s JEM-1400 TEM footprint: 98.0 in. x 106.3 in. x 118.1 in.

Given that the proposed solution is for a benchtop, modular microscope design with maximum dimensions for the electron microscope footprint of 60 in. x 88.6 in. x 37.4 in., the TEM microscope units and accessories provided by Hitachi and Jeol USA do not meet the minimum requirements of the Government. Because of the limited laboratory space, a microscope with a footprint larger than the maximum dimensions requested would limit the space, and ease-of-access of the microscope and surrounding laboratory equipment, thus impacting the workflow of the NAMRU-SA staff.

Although Thermo Fisher manufactures an electron microscope, i.e. Talos L120C, that meets the benchtop, modular microscope design requirement, it does not include a field emission gun (FEG) to obtain clearer images or a glow discharge treatment unit to fix and stain the samples on the TEM grids. To achieve quality imaging, the Talos L120C requires an additional cryo-system, which would require additional maintenance actions, costs, and could lead to additional downtime within the daily clinical workflow of the NAMRU-SA personnel. The cryo-system is not capable of pretreating and modifying TEM grids for uniform spreading of specimens, and providing capability to image biological samples that the glow discharge are capable of completing. The cryo-system is also not capable of providing spatial resolution and improved signal-to-noise ratio to obtain clearer images that the FEG is capable of completing. Thus, Thermo Fisher does not meet the minimum requirements of the Government.

Delong’s electron microscope, the LVEM25, is the only electron microscope on the market capable of meeting all of the Government’s minimum requirements. Furthermore, there are no authorized resellers or distributors for the Delong LVEM25 electron microscope; Delong is the manufacturer and sole provider of the LVEM25. Thus, Delong is the only vendor that can meet the minimum requirements of the Government.

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

None.

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

To date, no other sources have written to express an interest. Any sources expressing interest in response to the synopsis will receive consideration.

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.

Future requirements will be synopsized in accordance with FAR 5.203. For the reasons set forth in Paragraph 5, Naval Medical Logistics Command has no plans at this time to compete future contacts for the types of supplies covered by this document. If another potential source emerges, NMLC will assess whether competition for future requirements is feasible.

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