JA for BioFire Redacted.pdf

J&A #20-00036

JUSTIFICATION AND APPROVAL

FOR USE OF OTHER THAN FULL AND OPEN COMPETITION

1. Contracting Activity.

Naval Medical Logistics Command (NMLC), Fort Detrick, MD

2. Description of the Action Being Approved.

Modification of a cost per test (CPT) contract (N6264520P0020) for an automated molecular diagnostic laboratory analyzer for Naval Hospital Camp Pendleton, CA (NHCP) to add equipment for NMCP. N6264520P0020 is a firm-fixed-price contract that was awarded on a sole source basis to BioFire Diagnostics, LLC (CAGE Code 72GV2), 515 Colorow Dr, Salt Lake City, UT, 84108-1248 (herein referred to as BioFire). The modification will be executed using the authority of FAR 52.212-4(c) Changes (Oct 2018).

3. Description of Supplies/Services.

NMCP has a requirement for the same equipment purchased on Contract N6264520P0020, specifically one (1) analyzer, laboratory, molecular assay, infectious microorganism [ECRI device code: 20-802] reagents, quality control, annual maintenance coverage, and consumables. The contract is a CPT contract, meaning the Government agrees to pay a certain price for each test and that prices include the equipment, reagents, all maintenance, and consumables.

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 analyzer shall be capable of testing for the Coronavirus Disease 2019 (COVID-19). 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 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 20 targets per respiratory panel assay, 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, 22 targets per GI panel assay, and 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 (height by width by depth (HxWxD)). The electrical requirements are 120 volts AC power (VAC) and 60 hertz (Hz). The analyzer shall be a self-contained unit and shall not require facility hook-ups for water, drainage or heat dissipation.

TEST TESTS/YEAR

Respiratory Panel Assay 1,500 Blood Culture Identification (BCID) 450 Meningitis/Encephalitis Panel Assay (ME) 150 Gastrointestinal Panel Assay (GI) 600 Pneumonia Panel Assay 300

The Contractor shall provide installation, validation testing, on-site user training and preventive maintenance coverage. The Contractor shall provide the validation reagent kit and complete validation of the analyzer upon installation. Corrective maintenance coverage shall be provided and include response times. Training shall be provided by the Contractor. The Contractor shall provide two (2) operational and two (2) service manuals, each in English. Support shall be provided for a period of one-year from the date of installation with four (4) subsequent one-year option periods.

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 Occupational Safety and Health Administration (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 Contractor shall make arrangements for the storage. The Contractor shall also be responsible for the initial instrument operational and performance validations.

Defense Health Program (DHP) Operation and Maintenance Fiscal Year 2020 funds in the amount of $536,016.00 will be used to fund the base period.

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

FAR § 13.106-1(b)(1)(i) Soliciting from a single source.

The procedures in FAR Part 13 will be used in accordance with 41 U.S.C. 1901.

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. Nested multiplex PCR analysis allows for several tests to be conducted at once in one (1) channel. Units without the above capabilities will increase the time required per test, and potentially require additional analyzers to maintain the increased workload due to COVID-19 testing demand*. 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.

*At this time, the COVID-19 testing kits can only be procured from BioFire Defense; however, the analyzer itself needs to be purchased through BioFire Diagnostics. The individual test kits for COVID-19 will be procured separately by each Military Treatment Facility.

Only BioFire can meet the requirements noted above. Accordingly, BioFire is the only qualified source for this procurement. As a contract was just awarded for the same system, it was determined that a new contract action would represent an unnecessary duplication of effort.

The NHCP contract was awarded for a base period of one-year and four one-year option periods for a total estimated value of $3,730,136.05. The total five-year estimate for NMCP is $2,680,080.00, which would raise the total value of the contract to $6,410,216.05.

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

Market research was conducted from March 2020 to April 2020. It included a search of the Internet using Google, General Services Administration (GSA) Advantage, and the ECRI Sourcebook. Vendors that 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.

The molecular diagnostic laboratory analyzers provided by Hologic, Cepheid, Luminex, BD, Abbott Molecular, Analytik Jena, BioRad Laboratories, Labnet International, Roche Molecular, Cole-Parmer, ThermoFisher Scientific, and Wealtec Corporation are not capable integrated sample preparation, thermocycle amplification, detection and nested multiplex PCR analysis. Thus, Hologic, 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. Thus, only BioFire can meet the minimum requirements of the Government.

No other sources have expressed an interest in this acquisition. A notice of intent to modify the contract was posted to the Contract Opportunities website (beta.sam.gov) on 14 April 2020 with a response date of 29 April 2020. No responses were received.

In addition, a notice of intent to award a sole source contract was posted for the initial procurement to the Contract Opportunities website (beta.sam.gov) for 15 days and no timely responses were received.

7. Determination of Fair and Reasonable Cost.

Prior to issuance of the modification, the Contracting Officer will make a determination that the price is fair and reasonable. It is anticipated that the price analysis conducted will consider prices for the same items at NHCP.

8. Actions to Remove Barriers to Future Competition.

Future requirements will be competed in accordance with FAR, DFARS, and local regulations. Market research will be conducted before each acquisition to see if market conditions have changed.

CERTIFICATIONS AND APPROVAL

TECHNICAL/REQUIREMENTS CERTIFICATION

I certify that the facts and representations under my cognizance which are included in this Justification and its supporting acquisition planning documents, except as noted herein are complete and accurate to the best of my knowledge and belief.

Adam Belanger, Clinical Engineer Code 03 301-619-8271 Date Technical Cognizance

Anthony Angelo, Senior Clinical Engineer Code 03 301-619-7002 Date Requirements Cognizance

LEGAL SUFFICIENCY REVIEW

I have determined this Justification is legally sufficient.

Office of Counsel Code 00L Date

CONTRACTING OFFICER CERTIFICATION below $700,000

Contracting Officer Certification.

I certify that this Justification is accurate and complete to the best of my knowledge and belief.

Tameka N. Davis Code 05 301-619-1677 Date Contracting Officer

COMPETITION ADVOCATE/APPROVING OFFICIAL $700,000 or above

Upon the basis of the above Justification, I hereby approve, as Competition Advocate, the solicitation of the proposed procurements described herein using other than full and open competition, pursuant to the authority of 41 U.S.C. 1901.

Darin L. Callahan Code 00 301-619-3095 Date Competition Advocate

Digitally signed by

BELANGER.ADAM.G.140986513

Date: 2020.04.30 07:44:31 -04'00'

ANGELO.ANTHON

Y.JAMES.13678804

Digitally signed by

ANGELO.ANTHONY.JAMES.136

7880496 Date: 2020.04.30 07:50:40 -04'00'

DAVIS.TAMEKA

.N.1287388680

Digitally signed by

DAVIS.TAMEKA.N.1287388680

Date: 2020.04.30 08:09:01 -04'00'

CALLAHAN.DAR

IN.L.1090927929

Digitally signed by

CALLAHAN.DARIN.L.109092792

Date: 2020.05.01 09:40:20 -04'00'

04/30/2020

4/30/2020

4/30/2020

HATCH.JULIA.

P.1054172059

Digitally signed by

HATCH.JULIA.P.1054172059

Date: 2020.04.30 08:26:45 -04'00'