J A_Redacted.pdf

Form 02.4G.AB / N0025914RCE0059 / TDP 13-171 Page 1 of 4 1 Nov 2012

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 (NMLC), Fort Detrick, MD on behalf of Naval Medical Center San Diego (NMCSD) to meet their requirements.

2. Nature and/or description of the action.

The proposed action is for cost per test contract for Immunohistochemistry slide stainers. The

Government intends on awarding a Firm Fixed Price (FFP) contract. The proposed source is

Ventana Medical Systems, Inc 1910 E Innovation Park Dr, Tucson, AZ, 85737-1962.

3. Description of the supplies or services.

The requirement is for a cost per test contract for two immunohistochemistry slide stainers for

NMCSD. The systems shall be fully automated from dewaxing to counterstaining. The system shall support staining of immunohistochemistry and in-situ hybridization (ISH) using the same detection system for both testing methodologies on continuous and random access platform. The system shall have individual slide processors and shall allow the user to stain the slides independently. The system shall also be capable of fluorescein isothiocyanate (FITC) staining. The system shall be able to use antibodies from various manufacturers. The system shall be able to process at least 30 slides at one time. The system shall have an updated chromogenic detection method. The system shall be capable of performing single, double, triple and immunofluorescent stains in any combination. The system shall be capable of completing at least 45 slides per 8 hour shift. The system shall use FDA approved specialized breast pathology antibody markers for estrogen receptor (ER) and progesterone receptor (PR) as well as human epidermal growth factor receptor 2 (HER2) and chromosome 17. The system shall be able to use biomarker P16 for clinical use. The system shall have a methodology to minimize tissue loss. The system shall be floor model and shall not exceed

72” wide x 46” deep x 68” in height.

The system and all of the components, 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 equipment and reagents shall be 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 vendor shall be responsible for uncrating the unit/system and transporting it through the facility to the location of intended use for installation. If interim storage is required, the vendor will make arrangements for the storage.

FY14 funds in the amount of will be used. The total contract value (TCV) inclusive of all five (5) years is estimated at .

Form 02.4G.AB / N0025914RCE0059 / TDP 13-171 Page 2 of 4 1 Nov 2012

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 13.5.

5. 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 to run a test for both human epidermal growth factor receptor 2 (HER2) and chromosome 17 on a single slide. This capability enables the user to follow the status of HER2 in an aggressive cancer tumor. Also, only Ventana Medical

Systems, Inc is FDA approved to provide P16 biomarkers for clinical use. No other unit can meet the minimum requirements of the government.

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

Market research was performed, the results of which are in paragraph 8. This requirement will be posted to the Federal Business Opportunities (FBO) web site in accordance with FAR 5.202.

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. In addition, the Government anticipates that the negotiated contract price will reflect a discount from the Ventana Medical Systems, Inc commercial price list and will be determined fair and reasonable

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 by technical experts in June 2013. This research consisted of a market survey through search engines of open market contractors and Federal Supply Schedule contractors. Search engines utilized include Google, Lab Compare, GSA Advantage and ECRI sourcebook catalog. It was identified that no vendor other than Ventana Medical Solutions Inc. can provide Immunohistochemistry slide stainer that is FDA approved to run a test for both human epidermal growth factor receptor 2 (HER2) and chromosome 17 on a single slide and is FDA approved to provide P16 biomarkers for clinical use. Only Benchmark Ultra by Ventana Medical

Solutions Inc can meet the minimum requirements of the Government. Abbott Laboratories, Dako and Leica Microsystems provide immunohistochemistry slide stainers but none of the products is

FDA approved to run a test for both human epidermal growth factor receptor 2 (HER2) and chromosome 17 on a single slide. None are FDA approved to provide P16 Biomarkers for clinical use; therefore the products do not meet the minimum requirements of the government. Only

Ventana Medical Solutions Inc can meet the minimum requirements of the government. No other sources were identified that meet all of the government’s requirements.

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

None

Form 02.4G.AB / N0025914RCE0059 / TDP 13-171 Page 3 of 4 1 Nov 2012

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. 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.

12. Point of Contact

The point of contact at the NMLC, Fort Detrick, Frederick, MD, regarding the contents of the sole source Justification is , who may be reached at .

Form 02.4G.AB / N0025914RCE0059 / TDP 13-171 Page 4 of 4 1 Nov 2012

TECHNICAL AND REQUIREMENTS CERTIFICATION

Required by FAR 13.501

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

Phone Date

Technical Reviewer

Code 03

Requirements Cognizance

Code 03

CONTRACTING OFFICER CERTIFICATION

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

Contracting Officer Code 02

LEGAL SUFFICIENCY REVIEW AND CONCURRENCE

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

Code 00L

APPROVAL BLOCK COMPETITION ADVOCATE

($650,000-$12.5Million)

Competition Advocate