Attachment_VI-J&A-N6264516RCES059-Base-CPRR-IVD-NMCSD_Redacted.pdf

LOG# 16-10143

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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 San Diego (NMCSD) to meet their requirements.

2. Nature and/or description of the action.

The requirement is for a cost-per-test contract for one (1) IVD Test Reagent/Kit, Molecular Assay, Nucleic Acid Processing, Replication, Thermal Cycle [27-233] for Naval Medical Center San Diego. The

Government intends on awarding a firm, fixed-price contract. The proposed manufacturer is Cepheid, 904 Caribbean Dr, Sunnyvale, CA, 94089-1189.

3. Description of the supplies/services required.

The proposed acquisition is for a cost-per-test contract for one (1) IVD Test Reagent/Kit, Molecular

Assay, Nucleic Acid Processing, Replication, Thermal Cycle [27-233] Brand Name Only (BNO)to the

Cepheid GeneXpert® XVI (16 Site) manufactured by Cepheid.

The requirement is for a cost-per-test contract for one (1) IVD Test Reagent/Kit, Molecular Assay, Nucleic Acid Processing, Replication, Thermal Cycle [27-233] for Naval Medical Center San Diego. The system shall be capable of performing fully-integrated and automated molecular diagnostics for an annual workload shown in the table below.

Test Annual Workload

GXMRSA-100N-10 3600

GXCDIFF/EPI-10 1800

GXEV-100N-10 240

GXMTB/RIF-US-10 240

GXCARBAR-10 240

The system shall be a fully-integrated and automated system capable of preforming real-time Polymerase

Chain Reaction (PCR) analysis directly from unprocessed patient samples (nasal and wound swabs for

Methicillin-resistant Staphylococcus aureus (MRSA), stool samples for C. difficile, sputum for

Mycobacterium tuberculosis, CSF for Enterovirus, and whole blood for Factor II and V Leiden mutations). The system shall perform on-board sample preparation for purification and concentration of nucleic acids combined with real-time PCR amplification and detection functions to identify targeted nucleic acid sequences. The system shall not require the user to transfer samples or reagents during order processing. The sample preparation and PCR detection shall be combined into a closed container system.

The system shall not require specialized expertise outside of training provided by the manufacturer. The system shall allow the user to process samples on an individual basis and to provide results in fewer than

2 hours for most assays. All assays shall have approximately 10 minutes or less of operator hands-on time. Each assay shall contain controls for sample processing, amplifications and probe detection. The system shall be capable of running multiple samples at the same time and different assay protocols concurrently. The reagents shall be compatible with storage at room temperature and have a shelf-life of no less than 6 months after receipt. Each test module of the system shall be independent of other modules such that if it breaks down the other modules on the instrument will continue to function.

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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 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. 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.

Only products manufactured by Cepheid are capable of meeting the minimum requirements of the

Government. Cepheid is the only manufacturer capable of providing an automated system capable of performing real-time Polymerase Chain Reaction (PCR) analysis directly from unprocessed patient samples (nasal and wound swabs for MRSA, stool samples for C. difficile, sputum for Mycobacterium tuberculosis, CSF for Enterovirus, and whole blood for Factor II and V Leiden mutations). Only Cepheid is capable of meeting the minimum requirements of the Government. There are multiple Cepheid authorized distributors that could potentially 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.

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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 December 2015- March 2016. This research consisted of reviews of similar previous procurements and a market survey through search engines of open market contractors and Federal Supply Schedule contractors. Search engines utilized include

Google, Bing, GSA Advantage and ECRI sourcebook catalog. There is a requirement for an automated system capable of preforming real-time Polymerase Chain Reaction (PCR) analysis directly from unprocessed patient samples (nasal and wound swabs for MRSA, stool samples for C. difficile, sputum for Mycobacterium tuberculosis, CSF for Enterovirus, and whole blood for Factor II and V Leiden mutations). Becton Dickinson, BioFire Diagnostics, LLC, Gen-Probe, Meridian Bioscience, Nanosphere, Qiagen and Quidel Corporation offer systems that are capable of MRSA and c. difficile testing in rapid-testing format with on-board purification and concertation of nucleic acids, combined with amplification and detection in a single disposable sealed cartridge, but they do not offer the same systems that can test for M. tuberculosis, Enterovirus and Factor II and V. Becton Dickinson, BioFire Diagnostics, LLC, Gen-

Probe, Meridian Bioscience, Nanosphere, Qiagen and Quidel Corporation offer systems capable of testing for M. tuberculosis, and Factor II and V, but they are not self-enclosed rapid tests that require minimal use hands-on time, requiring more hands-on operator time and not CLIA-waived. Only the manufacturer

Cepheid, and authorized distributors: BioGX, Inc., Fisher Scientific, Laboratory Supply Company and

VWR International can provide a system capable of preforming all required tests. No manufacturer other than Cepheid, and authorized distributors: BioGX, Inc., Fisher Scientific, Laboratory Supply Company and VWR International meets the minimum requirements of the Government.

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

N/A

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

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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

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)