J A-N62645-15-D-5032_Redacted.pdf

LOG# 10222-14

Form 02.4G.AB/TDP 14-091-14 / PR N0025915RCE0047/Page 1 of 3 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 to meet the requirements of Naval Medical Center San Diego.

2. Nature and/or description of the action.

The requirement is for a cost-per-test contract for a spectrometer, mass, laboratory (device code: 17-199) and analyzer, laboratory, microbiology, susceptibility (device code: 15-091). The Government intends on awarding a Firm Fixed Price contract. The proposed source is bioMerieux, Inc., 100 Rodolphe St., Durham, NC, 27712-9402.

3. Description of the supplies/services required.

The Naval Medical Center San Diego has a requirement for an IDIQ for a cost-per-test contract for the identification of microorganisms, which will include a spectrometer, mass, laboratory and an analyzer, laboratory, microbiology, susceptibility. The cost-per-test contract shall include up to 24,000 tests per option year using Matrix-Assisted Laser Desorption Time of Flight Mass Spectrometry (MALDI-TOF-

MS) and 9,000 tests using Antibiotic Susceptibility Testing (AST). The cost-per-test contract shall include equipment, delivery, training, maintenance, and consumables as outlined in the statement of work.

The contract shall have a period of performance of five (5) years.

Vendor shall be an Original Equipment Manufacturer (OEM) authorized distributor for the proposed equipment and supplies.

The systems 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.

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.

bioMerieux, Inc. is the only vendor that can provide a cost-per-test contract which provides a spectrometer, mass, laboratory and an analyzer, laboratory, microbiology, susceptibility. bioMerieux is the only vendor that is FDA approved for the use of Matrix-Assisted Laser Desorption Ionization Time

Form 02.4G.AB/TDP 14-091-14 / PR N0025915RCE0047/Page 2 of 3 1 Nov 12 of Flight Mass Spectrometer (MALDI-TOF-MS) capable of the identification of gram positive bacteria, gram negative bacteria, and clinically relevant species of yeast. Identification of all of these types of microorganisms is required for the accurate and timely diagnosis of microbial pathogens. Only bioMerieux, Inc. can meet the 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 FedBizOpps in accordance with FAR 5.202. The Government will evaluate any responses received.

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 in April 2014. The market research included a search of the Internet using

Google, Bing, GSA Advantage, and the ECRI Sourcebook. Manufacturers that can provide an FDA approved system that uses MALDI-TOF-MS for the identification of microorganisms include bioMerieux, Inc. and Bruker Daltonics, Inc. Bruker cannot provide identification of gram positive bacteria and clinically relevant species of yeast and therefore does not meet the requirements of the

Government. bioMerieux, Inc. is the only vendor that can meet the minimum requirements of the

Government.

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

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. 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

Form 02.4G.AB/TDP 14-091-14 / PR N0025915RCE0047/Page 3 of 3 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)