Redacted JA.pdf

LOG #: 20-00020

PR N6809420RC33112 Page 1 of 4 1 Nov 12

JUSTIFICATION AND APPROVAL

FOR OTHER THAN FULL AND OPEN COMPETITION

1. Contracting Activity.

This justification is executed by the Naval Medical Logistics Command (NMLC), Fort Detrick, MD, on behalf of the Navy to meet the requirements of Naval Hospital (NH) Camp Pendleton

2. Description of the Action Being Approved.

Award of a sole source cost per test (CPT) contract is anticipated for one (1) analyzer, laboratory, molecular assay, infectious microorganism [device code: 20-802] reagents, quality control, annual maintenance coverage, and consumables for Naval Hospital (NH) Camp Pendleton. The Government intends on awarding a Firm, Fixed-Price (FFP) contract. The proposed source is BioFire Diagnostics, LLC of 515 Colorow Dr, Salt Lake City, UT, 84108- 1248.

3. Description of Supplies/Services.

The automated molecular diagnostic laboratory analyzer shall be able to analyze polymerase chain reaction (PCR) samples to identify molecules of microorganisms within various pathogens. The analyzer shall be capable of testing specifically for respiratory targets, blood culture targets, gastrointestinal (GI) targets and meningitis/encephalitis (ME) targets. The automated molecular diagnostic laboratory analyzer shall be capable of performing at least, but not be limited to, the tests listed below.

The PCR analyzer shall be a single-platform walkaway analyzer capable of integrated sample preparation, thermocycle amplification, detection and nested multiplex PCR analysis. The analyzer shall be capable of deoxyribonucleic acid (DNA) and ribonucleic acid (RNA) extraction and purification. The analyzer shall have a minimum of a twelve (12) sample load capacity. The analyzer shall be able to identify molecules of microorganisms in the following type of samples: swab, positive blood culture, stool, cerebrospinal fluid (CSF), bronchoalveolar lavage (BAL), or sputum.

The analyzer shall be capable of amplifying and detecting a minimum of twenty (20) targets per respiratory panel assay, twenty-four (24) organisms that cause blood stream infections per blood culture identification (BCID) panel assay, three (3) genetic markers that are known to confer antimicrobial resistance per BCID panel assay, twenty-two

(22) targets per GI panel assay, and fourteen (14) targets per ME panel assay. The PCR analyzer shall include bar-code reading capability. The analyzer shall be able to generate, detect and analyze PCR melting curves. The unit shall be able to provide real-time analysis. The analyzer shall perform automatic quality control (QC) and routine operator maintenance without manual intervention. The PCR analyzer shall contain onboard diagnostics and help functions. The dimensions for the molecular assay analyzer shall not exceed 34x24x36 inches (HxWxD). The electrical requirements are 120 VAC and 60 Hz. The analyzer shall be a self-contained unit and shall not require facility hook-ups for water, drainage or heat dissipation.

The vendor shall provide installation, validation testing, onsite a user training and preventive maintenance coverage.

The vendor shall provide the validation reagent kit and complete validation of the analyzer upon installation.

Corrective maintenance coverage shall be provided and include response times. On-site training shall be provided by the vendor. The vendor shall provide two (2) operational and two (2) service manuals, each in English. Support shall be provided for a period of five (5) years.

TEST TESTS/YEAR

Respiratory Panel Assay 175

Blood Culture Identification (BCID) 10

Meningitis/Encephalitis Panel Assay (ME) 10

Gastrointestinal Panel Assay (GI) 10

PR N6809420RC33112 Page 2 of 4 1 Nov 12

The analyzers, including claims made for the product, shall be compliant with Food and Drug Administration (FDA) regulations, with respect to marketing and delivering medical products for use in the United States of America.

These requirements shall apply even if delivery is requested outside of the United States of America. The analyzers 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 analyzers, such that OEM warranty and service are provided and maintained by the OEM. All software licensing, warranty, and service associated with the analyzers 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. The vendor is also responsible for the initial instrument operational and performance validations.

4. Statutory Authority Permitting Other Than Full and Open Competition.

The statutory exception permitting other than full and open competition for this acquisition is 41 U.S.C. 1901 (see also FAR 13.501(a)).

5. Rationale Justifying Use of Cited Statutory Authority.

Biofire is the only vendor that can provide a molecular diagnostic laboratory analyzer capable of integrated sample preparation, thermocycle amplification, detection and nested multiplex PCR analysis. No other vendors can provide a molecular diagnostic laboratory analyzer capable of integrated sample preparation, thermocycle amplification, detection and nested multiplex PCR analysis of the required targets stated in the minimum requirements. Nested multiplex PCR analysis allows for several tests to be conducted at once in one (1) channel. Other vendors are not capable of isolating and amplifying multiple targets in a single sample test. The molecular diagnostic laboratory analyzers provided by other vendors are limited to the number of tests that can be run dependent on the number of channels the analyzer has. The workflow of the molecular diagnostic laboratory analyzers provided by the previously stated vendors will increase the time required per test, and potentially require additional analyzers to maintain the workload of NH Camp Pendleton. The increase time required per test, and potential requirement for additional analyzers will increase the overall contract value. Biofire is the only vendor that can provide a molecular diagnostic laboratory analyzer capable of integrated sample preparation, thermocycle amplification, detection and nested multiplex PCR analysis. Biofire is the only vendor that meets the needs of the Government.

6. Description of Efforts Made to Solicit Offers from as Many Offerors as Practicable.

Market research was conducted from October 2019 to December 2019. It included a search of the Internet using Google, GSA Advantage, and the ECRI Sourcebook. Vendors who can potentially provide a contract for molecular diagnostic laboratory analyzer include BioFire Diagnostics LLC (BioFire), Cepheid, GenMark Diagnostics, Inc.

(GenMark), Luminex Molecular Diagnostics, Inc. (Luminex), Becton Dickinson (BD), Hologic, Abbott Molecular, Analytik Jena, BioRad Laboratories, Labnet International, Roche Molecular, Cole-Parmer, ThermoFisher Scientific, and Wealtec Corporation.

The molecular diagnostic laboratory analyzer provided GenMark is only capable of respiratory and BCID testing.

The molecular diagnostic laboratory analyzer provided GenMark is not capable of GI or ME testing, thus GenMark does not meet the minimum requirements of the Government.

Hologic can provide a molecular diagnostic laboratory analyzer, although the analyzer will not adhere to the required cybersecurity language. Thus, Hologic does not meet the minimum requirements of the Government.

The molecular diagnostic laboratory analyzers provided by Cepheid, Luminex, BD, Abbott Molecular, Analytik Jena, BioRad Laboratories, Labnet International, Roche Molecular, Cole-Parmer, ThermoFisher Scientific, and Wealtec Corporation are not capable of integrated sample preparation, thermocycle amplification, detection and

PR N6809420RC33112 Page 3 of 4 1 Nov 12 nested multiplex PCR analysis. Thus, Cepheid, Luminex, BD, Abbott Molecular, Analytik Jena, BioRad Laboratories, Labnet International, Roche Molecular, Cole-Parmer, ThermoFisher Scientific, and Wealtec Corporation do not meet the minimum requirements of the Government.

Biofire is the only vendor that can provide a molecular diagnostic laboratory analyzer capable integrated sample preparation, thermocycle amplification, detection and nested multiplex PCR analysis. Biofire can provide products via their Federal Supply Schedule (FSS) contract, V797D-30085. The Biofire products provided available on V797D-30085 are only offered for procurement and not offered for a contract for one (1) molecular diagnostic laboratory analyzer, reagents, quality control, annual maintenance coverage, and consumables. Thus, utilizing FFS contract V797D-30085 is not recommended. Biofire can provide a contract for one (1) molecular diagnostic laboratory analyzer, reagents, quality control, annual maintenance coverage, and consumables open market. Biofire is the only vendor that can provide a contract for one (1) molecular diagnostic laboratory analyzer, reagents, quality control, annual maintenance coverage, and consumables. Biofire is the only vendor that meet the minimum requirements of the Government. This requirement will be posted to betaSAM in accordance with FAR 5.202. A Notice of Intent is projected to be posted on or about 16 March 2020. Any sources expressing interest in response to the synopsis will receive consideration. A response was received from a company called QIAGEN but it was received after both the NOI and 1 Day solicitation had closed and was not consider timely.

7. Determination of Fair and Reasonable Cost.

The Contracting Officer has determined the anticipated cost to the Government of the supplies/services covered by this J&A will be fair and reasonable.

8. Actions to Remove Barriers to Future Competition.

For the reasons set forth in Paragraph 5, NMLC has no plans at this time to compete future contacts 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. Future requirements will be synopsized in accordance with FAR 5.203.

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.

PR N6809420RC33112 Page 4 of 4 1 Nov 12

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 Authority (J&A) 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