REDACTED JA.pdf

LOG #: 20-00047

Mass. Spec.-NMCSD Page 1 of 3 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 Medical Center San Diego (NMCSD).

2. Description of the Action Being Approved.

Award of a contract on a sole source basis for one (1) analyzer, laboratory, microbiology, susceptibility, automated [15-306], one (1) analyzer, laboratory, mass spectrometry, microorganism identification [34-062], reagents, quality control, maintenance, and consumables for NMCSD is anticipated. The Government intends on awarding a Firm, Fixed-Price (FFP) contract. The proposed source is BioMerieux, Inc. (Biomerieux) of 100 Rodolphe St, Durham, NC 27712.

3. Description of Supplies/Services.

NMLC has a requirement for a contract for one (1) analyzer, laboratory, microbiology, susceptibility, automated [15-306], one (1) analyzer, laboratory, mass spectrometry, microorganism identification [34-062], reagents, quality control, maintenance, and consumables for NMCSD.

The vendor solution shall include one (1) microorganism identification mass spectrometry analyzer, one (1) automated microbiology susceptibility analyzer, and an electronic database.

a) The mass spectrometry analyzer shall be capable of matrix-assisted laser-desorption-ionization time of flight mass spectrometry (MALDI-TOF-MS) for the identification of microorganisms.

b) The mass spectrometry analyzer shall be capable of identification of a minimum of 20,000 microorganisms per year.

c) The mass spectrometry analyzer shall be able to identify microorganisms directly from culture media through the generation of MALDI-TOF mass spectra and comparison with a vendor provided database of clinically relevant microorganisms.

d) The mass spectrometry analyzer shall be FDA approved for identification of gram positive and gram negative bacteria, yeast, nocardia, mycobacterium, and mold: the most commonly encountered clinical isolates to the species level; and the less common isolates to at least the genus level.

e) The mass spectrometry analyzer shall use single-use disposable materials to avoid identification errors due to cross-contamination.

f) The mass spectrometry analyzer shall include a computer and in-vitro diagnostics (IVD) database that provides interpretation of mass spectra leading to an identification of the most common test organisms with statistical analysis of confidence in the identification.

g) The mass spectrometry analyzer shall include a research use only (RUO) database from which off-label validations may be performed for less common test organisms.

h) The mass spectrometry analyzer shall require minimal daily maintenance of less than 60 minutes downtime per day.

i) The mass spectrometry analyzer shall have the power requirements of 208V 60Hz

j) The vendor provided solution shall be capable of automated antibiotic susceptibility testing (AST) for appropriate bacterial isolates.

k) The microbiology susceptibility analyzer shall be capable of performing a minimum of 9,000 AST per year.

l) The microbiology susceptibility analyzer shall be able to determine in vitro antibiotic susceptibilities of clinically relevant bacteria isolated in the laboratory.

m) The microbiology susceptibility analyzer shall be automated, capable of processing isolated colonies directly from microbiology culture media, with minimal requirements for manual set up procedures.

n) The microbiology susceptibility analyzer shall include a computer and IVD database that provides interpretation of antibiotic susceptibility breakpoints in accordance with Clinical Laboratory Standards Institute (CLSI) and/or FDA standards.

o) The microbiology susceptibility analyzer shall have the power requirement of 110V 60Hz.

p) The vendor solution shall include an electronic database capable of documenting and tracking the work-up of each microbiological specimen tested in the laboratory.

q) The database shall be able to track the following information for each specimen:

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a. CHCS accession number

b. Type and site of specimen

c. Genus and species designations of all microorganisms isolated

d. Antimicrobial susceptibility results for each isolate tested

e. Additional testing utilized in identification or supplemental AST (e.g. oxidase test, PYR, bile solubility, ceftaroline e-test)

f. Reference to additional ordered tests on the same specimen

r) The database shall be capable of connecting to up to ten (10) workstations currently installed at individual benches or offices in the NMC San Diego laboratory from maintenance of current and queries of past specimen work-ups.

s) The database shall be capable of archiving testing information for all specimens for future access.

t) The database shall be capable of generating antibiograms based upon various specimen identifiers.

u) The analyzers shall be capable of specimen storage stability of at least seven (7) days in a transport container for urine and swab samples stored at a minimum range of 2ºC to 30ºC.

v) Samples shall be able to be kept at -20ºC for up to 90 days if the time of transport/storage exceeds 30 days.

w) The analyzer units shall have integrated software that allows for on-board maintenance/error code generation and automated troubleshooting procedures.

x) The software shall document procedures.

y) The vendor solution shall bi-directionally interface with the Composite Health Care System (CHCS) and with the laboratory information system (LIS), as specified in the Statement of Work (SOW).

z) The analyzer units shall meet the performance characteristics for accuracy and precision, as defined by the 1988 Clinical Laboratory Improvement Act (CLIA). The analyzer equipment shall include sufficient safety features to avoid unnecessary exposure to biohazardous and chemical material.

aa) The units shall include an uninterruptable power supply (UPS) capable of providing all necessary electrical power to each analyzer.

The vendor shall provide installation, validation testing, user training, and preventive maintenance coverage. The vendor shall provide validation of the analyzers, including normal range verification, demonstration of linearity, reportable range, replication studies, recovery studies, and establishment of initial control ranges using control materials. Reagent and supply delivery shall be provided by the vendor, as specified in the SOW. System maintenance coverage and support shall include response times, as specified in the SOW. Training shall be provided by the vendor, as specified in the SOW. The vendor shall provide two (2) operational and two (2) service manuals, each in English. The government anticipates a contract with a Five (5) year ordering period.

The system, 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 system shall be installed in compliance with the 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 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. 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 10 U.S.C. 2304(c)(1) One Source or Limited Sources. See also, 41 U.S.C. 1901 supporting the use of FAR 13.5 procedures.

5. Rationale Justifying Use of Cited Statutory Authority.

Only BioMerieux, Inc. can provide a system that includes both a microorganism identification mass spectrometry analyzer, and is FDA-approved for identification of mold, nocardia, and mycobacterium. No other vendor can

Mass. Spec.-NMCSD Page 3 of 3 1 Nov 12 provide a system that is able to connect with the existing MYLA software and is FDA-approved for identification of mold, nocardia, and mycobacterium. Only BioMerieux, Inc. can meet the minimum requirements of the Government.

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

Market research was conducted in April and May 2020. Research included references and information derived from Internet searches via Google, Defense Medical Logistics Standard Support (DMLSS), FDA 510(k), and the ECRI Sourcebook. It was determined that microorganism identification mass spectrometry analyzers and microbiology susceptibility analyzers can be provided by the following vendors: Becton, Dickinson and Company (BD), Biomerieux, Beckman Coulter, Inc. (Beckman), Bruker Scientific LLC. (Bruker). BD and Beckman can provide automated microbiology susceptibility analyzers but cannot provide a microorganism identification mass spectrometry analyzer capable of MALDI-TOF-MS. Bruker is able to provide a microorganism identification system capable of MALDI-TOF-MS but does not provide an automated microbiology susceptibility analyzer.

Additionally, BD, Beckman, and Bruker are not able to provide a system that is FDA approved for the identification of molds. Therefore, BD, Beckman, and Bruker cannot meet the minimum requirements of the Government. Only Biomerieux can provide a system that includes both an automated microbiology susceptibility analyzers and a microorganism identification mass spectrometry analyzer capable of MALDI-TOF-MS that is FDA approved for the identification of molds. Therefore, only Biomerieux can meet the minimum requirements of the Government. This requirement will be posted to betaSAM in accordance with FAR 5.201(b)(1)(i).

A Notice of Intent (NOI) was posted to beta SAM from 09 July 2020 to 24 July 2020. An email from Bruker Scientific, LLC. was received on 16 July 2020 asking if they could bid on the Mass Spectrometry portion only of the requirement. A response to this inquiry was provided to Bruker Scientific, LLC. on July 16 2020 stating that to be considered for award a bid would need to include both a susceptibility analyzer and a MALDI-TOF-MS system. A capability statement was submitted by Beckman Coulter on 17 July 2020. A response was provided to Beckman Coulter on 20 July 2020 stating that after a review the Bruker MALDI-ToF system included in the capability statement does not have FDA clearance for the identification of Mcyobacteria, Nocardia, and mold species. Thus, this capability statement cannot meet the requirement. Another capability statement was provided by Bruker on 20 July 2020. A response was provided to Bruker on 21 July 2020 stating that after a review the research use only (RUO) comprehensive library cannot be used for diagnosis and does not meet the minimum requirement. Lastly, a response was received from BD on 20 July 2020 which noted and additional solution providing the BDPhoenix, and the Bruker MALDI for this requirement. The solution was reviewed and a response to BD was provided on 21 July 2020 stating that the Bruker MALDI system does not have FDA clearance for the identification of Mycobacteria, Nocardia, and mold species and thus cannot meet this requirement.

Since none of the responses received to the NOI were determined capable of meeting the requirement, a one (1) day solicitation was posted to beta SAM from 27 July 2020 to 28 July 2020. No responses were received to this posting.

7. Determination of Fair and Reasonable Cost.

The Contracting Officer has determined the anticipated cost to the Government of the supplies 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 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.