N0025919RCE0082-Attachment_V-J&A-Slide_Stainers-Roche-Ventana_NMCSD_Redacted.pdf

LOG# 18-10062

Form 02.4G.AA / N0025919RCE0082 Page 1 of 4 18 Apr 16

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 requirements of Naval Medical Center (NMC) San Diego.

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

The proposed action is for two (2) slide strainers, immunohistochemistry [23-459] for NMC San Diego.

The Government intends on awarding a cost per test contract. The proposed source is Ventana Medical Systems 1910 E Innovation Park Dr, Tucson, AZ, 85737-1962.

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

The Naval Medical Logistics Command has a requirement for a contract for two (2) Slide Stainer, Immunohistochemistry [23-459], reagents, quality control, maintenance, and consumables for Naval Medical Center (NMC) San Diego. The contracted units shall be a single model platform.

The contract shall accommodate an annual workload of 16,000 immunohistochemical (IHC) slides. The system shall support staining of immunohistochemistry, fluorescent staining and in-situ hybridization (ISH) using the same detection system for all testing methodologies on continuous and random access platform. The system must be fully automated from deparaffinization, through antigen retrieval, to completion of staining. The system shall have individual slide processors and shall allow the user to stain the slides independently. The system shall have a capacity of at least 30 slides with continuous access to each individual slide.

The system shall be able to use antibodies from various manufacturers. The system shall be capable of single, dual, and triple IHC staining and immunofluorescent (IF) staining concurrently. The system shall be able to use the FDA-approved antibodies, including estrogen receptor (ER) antibodies, progesterone receptor (PR) antibodies, human epidermal growth factor receptor 2 (HER2) antibodies, and P16. The system shall be capable of independent processing and slide drawer temperature control. The system shall have a free-standing configuration. The electrical requirements for this system are 120V, 60 Hz.

System installation, validation, correlation, onsite and offsite training, and preventive maintenance coverage shall be included. Corrective system maintenance coverage shall include response times as specified in the Statement of Work. Support shall be provided for a period of performance from 03 December 2018 to 02 December 2019. Subsequent, individual 1 year option periods shall be available starting on 03 December 2019, with the final expiring 03 December 2023.

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.

Contractor 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

Form 02.4G.AA / N0025919RCE0082 Page 2 of 4 18 Apr 16 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. 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 10 U.S.C.

2304(c)(1) and FAR 6.302-1 sole source (including brand name) acquisitions OR FAR 13.106-1(b)(1) soliciting from a single source.

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

The Ventana Benchmark Ultra is the only fully automated, single, continuous and random access immunohistochemistry slide stainer that is FDA approved for cases that require estrogen receptor (ER), progesterone receptor (PR) and human epidermal growth factor receptor 2 (HER2). Ventana is also the only vendor capable of providing a system that allows for continuous access to individual slides during the staining process. Thus, only the Ventana Benchmark Ultra can meet all 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/services 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 September 2018. It included a search of the Internet using Google, GSA Advantage, and the ECRI Sourcebook. Vendors that can provide slide stainer, immunohistochemistry units include Ventana Medical (a Roche Diagnostics subsidiary), Leica Biosystems (Leica), and Biocare Medical (Biocare). Although Biocare and Leica can provide slide stainer systems, they are not FDA approved to use the required antibodies: estrogen receptor (ER), progesterone receptor (PR), human epidermal growth factor receptor 2 (HER2), and P16. The Biocare system is also not fully automated, and requires manual deparaffinization and antigen retrieval prior to staining.

Additionally, the Leica and Biocare systems do not allow continuous access to individual slide drawers.

Due to inability to accommodate the required antibodies and continuously access slides, the slide staining systems provided by Leica and Biocare do not meet the minimum requirements of the government. Thus, only Ventana Medical Systems can meet the minimum requirements of the Government.

Form 02.4G.AA / N0025919RCE0082 Page 3 of 4 18 Apr 16

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/services covered by this document. If another potential source emerges, (NMLC) will assess whether competition for future requirements is feasible.

Form 02.4G.AA / N0025919RCE0082 Page 4 of 4 18 Apr 16

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 Cognizance

Phone Date

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

($750,000-$12.5M)