JA-N62645-15-D-5047_Redacted.pdf

LOG# 15-10192

TDP 15-043-15/PR N0018315RQLA020 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) Portsmouth to meet their requirements.

2. Nature and/or description of the action.

The requirement is for cost per test contract for Immunohistochemistry slide stainers. The Government intends on awarding a Firm Fixed Price contract. The proposed source is Roche Diagnostics Corporation

9115 Hague Rd, Indianapolis, IN 46256-1025.

3. Description of the supplies/services required.

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

Portsmouth. The contract shall accommodate an estimated annual workload of 11,000 immunohistochemical (IHC) slides and 2,750 special stains slides. 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 be able to use antibodies from various manufacturers. The system shall be capable of single, dual and triple multiparameter IHC staining. The system shall be capable of using anti-p63 and anti-CD10 primary antibodies for in vitro diagnostics. The system shall be capable of using anti-ALK1 primary antibodies to detect the presence of p80 protein in human tissue. The system shall be able to use biomarker P16 for clinical use. The system shall use FDA approved 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 capable of independent processing and temperature control per slide drawer. The system shall be capable of temperature control ranging from room temperature to 100 degree Celsius per slide drawer. The systems slides shall have the dimensions of 1” x 3” when positively charged. 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 of five (5) years.

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

TDP 15-043-15/PR N0018315RQLA020 Page 2 of 4 1 Nov 12 make arrangements for the storage.

This is an indefinite delivery indefinite quantity contract; therefore, all funding will be provided on individual delivery orders.

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), Sole Source Acquisitions. This acquisition is being conducted under simplified acquisition procedures FAR 13.501 under the authority of the test program for commercial items (section 4202 of the Clinger-Cohen Act of 1996).

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

The Roche 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 allows interpretation using a standard light microscope by the pathologist to screen the entire tissue sample for HER2 in an aggressive cancer tumor. The only commercially available alternative to the unique capability of the

Roche system is the FISH assay method, which requires a skilled technologist to run manually, making the process labor intensive and requiring a turnaround time to 2 -3 days. Also, only Roche Diagnostics

Corporation 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 NECO and/or FedBizOpps 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 vendor’s 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 February 2015. 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 Roche Diagnostics Corporation can

TDP 15-043-15/PR N0018315RQLA020 Page 3 of 4 1 Nov 12 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 Roche Diagnostics Corporation can meet the minimum requirements of the Government. 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 Roche Diagnostics Corporation 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.

The requirement for Immunohistochemistry slide stainers was competed full and open based on the minimum salient characteristics in July 2010. The contract was awarded to Ventana Medical Systems, Inc. through contract N00189-10-P-1462 totaling $309,448.62. This purchase was done by NMC

Portsmouth. Ventana Medical Systems, Inc. has since been purchased by Roche Diagnostics Corporation.

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

FedBizOpps 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.

12. Point of Contact

TDP 15-043-15/PR N0018315RQLA020 Page 4 of 4 1 Nov 12

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

($650,000-$12.5M)