NHJ Panther Analyzer J and A - Redacted.pdf

NMCARS ANNEX 1 - JUSTIFICATION AND APPROVAL

ANNEX 1 - JUSTIFICATION AND APPROVAL

J&A No. 21-00024

(CLASS) JUSTIFICATION AND APPROVAL

FOR USE OF 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 Naval Hospital (NH) Jacksonville.

2. Description of the Action Being Approved.

The proposed action is for one (1) analyzer, laboratory, molecular assay, infectious microorganism

[20-802] for Naval Hospital (NH) Jacksonville. The procedures in FAR subpart 13.5 will be implemented for this requirement for the procurement of molecular assay analyzers to support fleet concentrated areas for surge testing of COVID-19. The Government intends on awarding a Firm, Fixed-Price (FFP) contract. The proposed source is Hologic, Inc. of 250 Campus Drive, Marlborough, MA 01752.

3. Description of Supplies/Services.

The Naval Medical Logistics Command has a requirement for one (1) analyzers, laboratory, molecular assay, infectious microorganism [20-802] for Naval Hospital (NH) Jacksonville.

The analyzers shall be automated analyzers capable of analyzing nucleic acids from nasopharyngeal, nasal, oropharyngeal swab specimens, urine, and swab samples. The analyzers shall be capable of testing for COVID-19, chlamydia trachomatis (CT), Neisseria gonorrhoeae

(GC), human papillomavirus (HPV), Hepatitis B Virus (HBV), and Hepatitis C Virus (HCV).

a) The analyzers shall be able to accommodate a total throughput of at least 1,000 tests over a 24 hour period.

b) The analyzers shall be a fully automated, random access robotic system.

c) The analyzers shall be capable of analyzing nucleic acids from male and female urine samples, endocervical samples, vaginal samples, and male urethral swabs.

d) The analyzers shall utilize Food and Drug Administration (FDA)-approved tests to test for

CT, GC, HPV, HBV, and HCV.

e) The analyzers shall be capable of conducting FDA-approved assays for HPV Genotype 16 and HPV Genotype 18.

f) The analyzers shall have an FDA Emergency Use Authorization (EUA) for testing for

COVID-19.

g) The analyzers shall be capable of simultaneously testing for the presence of CT, GC, and

HPV in the same sample.

h) The analyzers shall utilize nucleic acid amplification testing (NAAT) technology to perform simultaneous amplification and detection of target DNA or rRNA for CT, GC, and

E6/E7 mRNA for HPV.

i) Once loaded the vendor provided solution shall be capable of directly sampling from tubes without removing caps, automatically dispensing all reagents, and performing all automated steps for NAAT.

j) Specimen flow from start to finish shall be fully-automated to include waste collection.

k) The analyzers shall be able to read Code 39 barcodes.

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

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

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

o) The analyzers shall be capable of bi-directionally interfacing with the Composite Health

Care System (CHCS) and with the laboratory information system (LIS).

p) The analyzers 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.

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

r) The analyzers shall be capable of operating in the 120V, 60Hz range.

s) The analyzers shall not exceed a dimensional footprint greater than 80”x48” (WxD).

t) The analyzers shall not exceed a maximum weight of 1,500 lbs

The analyzer shall be capable of testing for Influenza A/B, and Influenza respiratory syncytial virus (RSV). The analyzers shall utilize Food and Drug Administration (FDA)-approved tests to test for Influenza A/B/RSV.

The vendor shall provide two (2) operational and two (2) service manuals, each in English.

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 shall provide initial instrument training. The vendor shall provide initial instrument operational and performance validations

Navy Operation and Maintenance Fiscal Year 21 funds will be used to procure the Molecular

Analyzer.

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

The statutory exception permitting other than full and open competition for this acquisition is

FAR 13.501(a) Sole source (including brand name) acquisitions. The procedures in FAR subpart

13.501 were used in accordance with 41 U.S.C. 1901.

5. Rationale Justifying Use of Cited Statutory Authority.

Only Hologic, Inc. can provide a molecular analyzer that is able to test for CT/NG, HPV, HBV, HCV, Influenza A/B/RSV, and COVID-19. It is critical that the analyzers are able to test for all the listed infectious diseases at the specified throughput to support fleet concentrated areas during normal testing conditions and surge testing conditions. Additionally only Hologic can provide an analyzer that does not exceed the maximum allowable footprint or weight limitations and thus would not require facility modifications. The procurement of an alternative analyzer would require facility modifications that could potentially include wall modifications, electrical modifications and plumbing modifications. Any facility modifications would require additional funding and an increased installation timeline, resulting in an inability to treat patients. Thus, only Hologic, Inc.

is able to meet the minimum requirement of the Government.

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

Market research was conducted in April 2021. 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 infectious microorganism analyzers that can test patient samples for COVID-19 can be provided by the following vendors: Abbott Laboratories (Abbott), Becton, Dickinson and Company (BD), Biofire Diagnostics, LLC (Biofire), Cepheid, Hologic, Inc., Qiagen, Inc., Roche Diagnostics

Corp. (Roche), and Thermo Fisher Scientific, Inc. (Thermo Scientific).

Abbott, BD, Biofire, and Qiagen can provide analyzers capable of testing for COVID-19, but the analyzer are not able to meet the throughput requirement of 1,000 test over a 24 hour period.

Thus, Abbott, BD, Biofire, and Qiagen does not meet the minimum requirements of the

Government. Cepheid and Roche can provide analyzers capable of testing for COVID-19 and meet the throughput requirements. The analyzers that can be provided by Cepheid are not capable of testing for HBV, HCV, nor HPV. The analyzers that can be provided by Roche are not capable of testing for Influenza A/B/RSV. Additionally, the analyzers from both Cepheid and

Roche exceed the maximum allowable footprint and weight limitations and would require facility modifications. Thus, Cepheid and Roche do not meet the minimum requirements of the

Government.

Only Hologic is able to provide a molecular assay analyzer that is capable of all required tests at the required throughput and does not exceed the maximum footprint or weight limitations. Thus, only Hologic is able to meet the minimum requirements of the Government.

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 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. Actions to Remove Barriers to Future Competition.

Future requirements will be synopsized in accordance with FAR 5.203. For the reasons set forth in Paragraph 5, Naval Medical Logistics Command 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.