N6264519RCES050-Attachment_V-_JA-Slide_Stainers-Agilent-SD_Redacted.pdf

LOG# 19-10016

N6264519RCES050

Slide Stainers-Agilent-NMCSD Page 1 of 4 1 Nov 12

JUSTIFICATION AND APPROVAL

FOR OTHER THAN FULL AND OPEN COMPETITION

1. Identification of the agency and the contracting activity.

This justification is executed by the Naval Medical Logistics Command, Fort Detrick, MD on behalf of Naval Medical Center (NMC) San Diego to meet their requirements.

2. Nature and/or description of the action.

The proposed action is for two (2) slide stainers, cytology/histology [15-183] for NMC San Diego. The Government intends on awarding a cost per test or cost per reportable contract. The proposed source is Agilent Technologies, Inc.

5301 Stevens Creek Boulevard, Santa Clara, CA 95051.

3. Description of the supplies/services required.

The requirement is for a contract for reagents, quality control, maintenance, consumables, and two (2) Slide Stainers, Cytology/Histology [15-183] for NMC San Diego. The contracted units shall be a single model platform.

The contract shall include all of the stains in the table below:

Table 1: Stain Type Acid-Fast Bacteria (AFB) Stain Alcian Blue (AB)/Periodic Acid-Schiff (PAS) Stain Alcian Blue Stain Congo Red Stain Alpha-Amylase Stain Elastic Stain Grocott’s Methenamine Silver (GMS) Stain Gram Stain Iron Stain Jones Stain Mucicarmine Stain PAS Stain Reticulin Stain Trichrome Stain Warthin-Starry Stain Giemsa Stain AB/PAS/H&E Stain Wright/Giemsa Stain Colloidal Iron Stain PAS Green Stain

The provided system shall allow for multiple staining protocols for each type of stain. The system must be fully automated, from deparaffinization to completion of staining. The system shall be capable of running at least 10 protocols at one time. The system shall be capable of running multiple stains at one time with no exceptions (i.e. any stain can be run simultaneously with any other stain). The stainers shall be capable of multiparameter staining (i.e.

utilizing multiple staining kits on the same slide).

The system shall have a capacity of at least 30 slide positions with continuous access to each individual slide.

Continuous access allows the ability to add slides to unoccupied slide positions and the ability to remove completed

Slide Stainers-Agilent-NMCSD Page 2 of 4 1 Nov 12 slides for analysis without the need to wait for entire batches to be completed, thus increasing the throughput for each individual slide. Each slide position shall have independent temperature control. The system shall include a reagent carousel with 50 positions.

The system shall have a free-standing configuration. The instrument shall have a waste management system;

hazardous waste, water-soluble waste, trace metal waste, and alcohol shall all be kept separate for appropriate disposal. The vendor shall perform all necessary repairs and software updating for the duration of the contract. The system shall include a UPS, as well as a label and report printer. The electrical requirements for this system are 120V, 60 Hz.

System installation, validation, correlation, onsite and offsite training, corrective and preventive maintenance coverage shall be included. Corrective system maintenance coverage shall include response times as specified in any resultant contract. Training shall be provided by the vendor, as specified in any resultant contract. The vendor shall provide two (2) operational manuals for each analyzer and two (2) service manuals for each analyzer, each in English. Support shall be provided for a period of performance from 01 October 2019 to 30 September 2020.

Subsequent, individual 1 year option periods shall be available starting on 01 October 2020, with the final expiring 30 September 2024.

The units shall be compliant with the Food and Drug Administration (FDA) requirements to market and deliver medical products for use in the United States of America, even should delivery be requested outside of the United States. The claims made for the product shall comply with the regulations of the FDA with respect to products for marketing and delivery of a medical product for use in the United States of America, even should delivery be requested outside of the United States. The system shall be installed in compliance with OSHA requirements.

Vendor shall be an Original Equipment Manufacturer (OEM) authorized dealer, authorized distributor, or authorized reseller for the proposed equipment/system such that OEM warranty and service are provided and maintained by the OEM. All software licensing, warranty, and service associated with the equipment/system shall be in accordance with the OEM terms and conditions.

Upon delivery, the contractor shall be responsible for uncrating the unit/system, 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.

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

The statutory exception permitting other than full and open competition for this acquisition is 10 USC 2304(c)(1) and FAR 13.501(a), Only One Responsible Source.

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

Agilent Technologies is the only vendor that can supply a fully automated slide stainers system that can utilize all of the required special stains. These stains are required to identify tissue structure and morphology and/or to identify the presence of pathogens that cannot be seen using routine staining techniques. No other vendor can provide a slide stainers that can use all of the clinically required stains; the automated Warthin-Starry stain is unique to Agilent Technologies. Additionally there are several other stains that are not offered by other vendors, including the Alpha- Amylase and Alcian Blue/PAS/Hematoxylin stains. Only Agilent can offer a system that can utilize all of the required stains. Additionally only Agilent can provide a system that includes at least 30 individual slide drawers.

Thus, only the Agilent Technologies can meet all the minimum requirements of the Government.

6. Description of efforts made to ensure that offers are solicited from as many potential sources as practicable.

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Market research was performed, the results of which are in paragraph 8. This requirement will be posted to the Federal Business Opportunities (FBO) in accordance with FAR 5.201. A Request for Information (RFI) was posted on FBO from 17 April 2019 to 22 April 2019. A response was received from Roche on 22 April 2019. The response was reviewed and it determined unacceptable as the vendor does not have the ability to provide all of the required stains. A Notice of Intent (NOI) was posted from 24 April 2019 to 09 May 2019. On 29 April 2019, a response from VHSS was received asking about proposing used equipment. This responses was determined unacceptable and does not meet the minimum requirement. Lastly, on 30 April 2019, a response was received from Grifols. This response was determined to be unacceptable as it was not for the appropriate equipment.

7. 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/services covered by this Justification and Approval will be fair and reasonable by conducting a price analysis before an award is made.

8. Description of the market survey conducted and the results, or statement of the reasons a market survey was not conducted.

Market research was conducted in February 2019. It included a search of the Internet using Google, General Services Administration (GSA) Advantage, and the ECRI Sourcebook. Vendors that can provide slide stainers, cytology/histology units include Roche Diagnostics Corporation (Roche), Leica Biosystems (Leica), Biocare Medical (Biocare), Biogenex Laboratories (Biogenex), Sakura Finetek USA, Inc. (Sakura), and Agilent Technologies, Inc. (Agilent).

Systems that can be provided by Roche, Leica, Biogenex, Biocare and Sakura cannot offer all of the required stains.

Roche is not able to provide the following required stains: Alpha-Amylase, Warthin-Starry, Hematoxylin and eosin (H&E), Wright/Giemsa, and Colloidal Iron. Leica is not able to provide the following required stains: Alpha- Amylase, Elastic, Gram, Jones, Mucicarmine, Reticulin, Warthin-Starry, Giemsa, H&E, Wright/Giemsa, Colloidal Iron, and PAS green. Biogenex is not able to provide the following required stains: Alpha-Amylase, Warthin-Starry, Wright/Giemsa, and PAS green. Biocare offers 259 primary antibodies intended for use in in-vitro diagnostics, but does not offer any of the required special stain kits. Sakura only offers stain kits for H&E.

Additionally, Biocare system is not fully automated, requiring manual deparaffinization prior to staining. Manual deparaffinization requires about 30 minutes through a precise series of short washes and would require FTE oversight. Sakura systems have a total of 24 reagent containers, this does not meet the minimum of a reagent carousel with 50 positions. The Leica, Biogenex and Biocare systems do not allow continuous access to individual slide drawers. Access to individual slide drawers allows for a staggered and more continuous workflow, preventing need for lengthier batch staining. Due to the inability of other Vendors to accommodate all of the required stains, only Agilent can meet the minimum requirements of the Government.

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

N/A

10. Listing of Sources, if any, which expressed, in writing, an interest in the acquisition.

To date, no other sources have written to express an interest. This requirement will be posted on FBO in accordance with FAR 5.202. Any sources expressing interest in response to the synopsis will receive consideration.

11. Statement of 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.

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TECHNICAL AND REQUIREMENTS CERTIFICATION REQUIRED

BY FAR 13.501(a)(2)

I certify that the facts and representations under my cognizance which are included in this justification and approval and which form a basis for this justification are complete and accurate.

Technical/Requirements Cognizance

Requirements Cognizance

CONTRACTING OFFICER CERTIFICATION

I certify that this justification is accurate and complete to the best of my knowledge.

LEGAL SUFFICIENCY REVIEW AND CONCURRENCE

I have reviewed the facts set forth in the above Justification and Approval and find this J & A to be legally sufficient, based on these facts, to the best of my knowledge and belief.

APPROVAL BLOCK COMPETITION ADVOCATE

($700,000-$12.5M)