J A-Redacted_Redacted.pdf

LOG # 10407-13

Form 02.4G.AB/TDP 13-172 / PR N0025914RCE0004/Page 1 of 5 1 Nov 12

JUSTIFICATION AND APPROVAL

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 San Diego to meet their requirements.

2. Nature and/or description of the action.

The proposed action is for an IDIQ of assays and consumables. The Government intends on awarding a Firm Fixed Price contract. The proposed source is Nanosphere, 4088 Commercial

Avenue Northbrook, IL, 60062-1829

3. Description of the supplies or services.

The Naval Medical Center San Diego has a requirement for an IDIQ of assays and consumables to be used by the microbiology department for multiplex detection of respiratory viruses. The assays and consumables shall be compatible with the Nanosphere Verigene system that NMC San Diego currently owns. The assays shall be able to be used for detection of respiratory viruses from human nasopharyngeal and respiratory samples and for the identification of genus, species and genetic resistance of the most common gram-positive microorganisms in blood cultures. The assays shall be able to detect viruses from swabs, aspirates and washes as well as sputum to detect influenza A, influenza A subtype H1, H3 and 2009 Novel H1N1, influenza B, and Respiratory Syncytial Virus

(RSV). The panel should be capable of simultaneous detection of other respiratory viruses associated with influenza-like infections and shall be at least in the process of FDA-approval for the additional viruses. These additional viruses shall include rhinovirus, adenovirus, parainfluenza 1, 2, 3, and human metapneumovirus. The target detection shall have specificity and differentiation of at least 93% for each individual targets included in the panel. The assays shall be able to detect a range of viral titers to a very early infection, fulminant infection, and convalescing infections. The

Gram-Positive blood culture shall be able to identify the genus, species and genetic resistance determinants of the most common gram-positive blood culture isolates in at most 6 hours of blood culture positivity.

The assay shall not require specialized expertise or experience outside of training provided by the manufacturer. All reagents for extraction, amplification, and detection should be pre-aliquotted into testing cartridge to simplify the testing process and prevent technician-associated errors. The reagents shall be FDA approved and shall have a shelf life of at least six months upon receipt.

Supplies/items that require special handling shall be marked in a clear manner with a label that can easily be read, understandable and larger than 3”x3” (9 sq inches). The label shall be placed in three or more locations on the container. Supplies/items that require refrigeration shall have both the required Celsius and Fahrenheit temperature identified.

Form 02.4G.AB/TDP 13-172 / PR N0025914RCE0004/Page 2 of 5 1 Nov 12

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.

Only the Verigene RV+, RV+ amplification Kit and Verigene Gram-positive blood culture test kits can be used with Nanosphere Verigene laboratory instruments manufactured by Nanosphere, Inc.

NMC San Diego currently owns the Nanosphere Verigene processors and readers and the requested

Verigene assays are the only ones that are FDA approved to be used with these instruments. No other vendor can provide assays and consumables that are configured to be used with the installed base of Nanosphere Verigene processors and readers. At this point another manufacturers system is unable to replace the one currently onsite because NMCSD would lose their FDA licensure. 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 Nanosphere’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 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. The research shows that other than Nanosphere, Biomerleux, Inc and Cepheid may be able to provide the assays and consumables to detect respiratory viruses, but neither of the companies can provide assays that are FDA approved to be used on the Nanosphere Verigene system. Only Nanosphere, Inc meets all of the government requirements. No other sources were identified that meet all of the government requirements.

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

Form 02.4G.AB/TDP 13-172 / PR N0025914RCE0004/Page 3 of 5 1 Nov 12

None

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.

For the reasons set forth in Paragraph 5, NMLC has no plans at this time to compete future contracts 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.

12. Point of Contact

Form 02.4G.AB/TDP 13-172 / PR N0025914RCE0004/Page 4 of 5 1 Nov 12

TECHNICAL AND REQUIREMENTS CERTIFICATION REQUIRED

BY NAVSUP 4200.83 series

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

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 found to be legally sufficient, based on these facts, to the best of my knowledge and belief.

APPROVAL BLOCK COMPETITION ADVOCATE

Form 02.4G.AB/TDP 13-172 / PR N0025914RCE0004/Page 5 of 5 1 Nov 12