LSJ TDP 20-147_Redacted.pdf

Log #20-00030

Form 02.4G.AA 18 Apr 2016

LIMITED SOURCE JUSTIFICATION

FOR FEDERAL SUPPLY SCHEDULE ORDER

1. Identification of agency and contracting activity, and specific identification of the document as a

“Limited Source Justification (LSJ).”

This is a Limited Source Justification. The requiring activity is United States Naval Hospital (USNH) Guam; the contracting activity is the Naval Medical Logistics Command, Ft. Detrick, MD.

2. Nature and/or description of contract action being approved.

The proposed action is conducted under the authority of the Multiple Award Schedule Program (Title III of the Federal Property and Administrative Services Act of 1949 (41 U.S.C. 251, et seq.) and Title 40 U.S.C.

501, Services for Executive Agencies). This is a limited source action to be awarded as a new Federal Supply Schedule (FSS) order. The placement of a Firm, Fixed-Price order is anticipated.

3. Description of the supplies or services required to meet the agency's needs (including the estimated value).

The Naval Medical Logistics Command has a requirement for a contract for one (1) analyzer, laboratory, molecular assay, infectious microorganism [20-802], for United States Naval Hospital (USNH) Guam. The analyzer shall be an automated analyzer capable of analyzing nucleic acids from nasopharyngeal swab or nasal wash/aspirate samples.

a) The analyzer unit shall be able to accommodate a total throughput of at least 1,100 tests within a 24 hour period.

b) The analyzer unit shall have an FDA Emergency Use Authorization (EUA) for testing for COVID- 19.

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

d) The included software shall document procedures.

e) The analyzer shall be capable of bi-directionally interfacing with the Composite Health Care

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

f) The analyzer 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.

g) The unit shall include a desktop computer and a printer.

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

i) The power requirements are 200/240 V, 60Hz.

j) The analyzer shall not exceed a dimensional footprint greater than 85”x35” (LxW).

k) The analyzer shall not exceed a maximum weight of 1,600 lbs.

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

The analyzer, 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 analyzer 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 analyzer such that OEM warranty and service are provided and maintained by the OEM. All software licensing, warranty, and service associated with the analyzer shall be in accordance with the OEM terms and conditions.

The proposed source is Cepheid of 904 Caribbean Dr., Sunnyvale, CA 94089-1189.

Upon delivery, the contractor shall be responsible for uncrating the analyzer, 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. The authority and supporting rationale (see 8.405-6(a)(1)(i) and (b)(1)) and, if applicable, a demonstration of the proposed contractor's unique qualifications to provide the required supply or service.

The statutory authority which permits restricting consideration of schedule contractors to fewer than that required in FAR 8.405-1 is 41 U.S.C. 251, as implemented by FAR 8.405-6.

Cepheid is the only vendor that can provide a molecular assay analyzer via the Federal Supply Schedule (FSS) capable of testing for COVID-19 that meets the throughput requirement of 1,100 tests within a 24 hour period. No other vendor is able to provide a molecular assay analyzer capable of testing for COVID- 19 that meets the throughput requirement of 1,100 tests within a 24 hour period available via the FSS. Thus, Cepheid is the only vendor that meets the minimum requirements of the Government and is available on the Federal Supply Schedule.

5. A determination by the ordering activity contracting officer that the order represents the best value consistent with 8.404(d).

GSA has determined the prices of supplies and the schedule contracts to be fair and reasonable for the purpose of establishing the schedule contract. Therefore, ordering activities are responsible to make a separate determination of fair and reasonable pricing for individual orders. The Naval Medical Logistics Command Contracting Officer will determine, using the procedures in FAR 15.404-1, that the prices are fair and reasonable and will document such determination with a level of detail commensurate with the complexity and circumstances of each order.

6. A description of the market research conducted among schedule holders and the results or a statement of the reason market research was not conducted.

Market research was conducted in April 2020 and June 2020. Research included a search of the Internet using Google, GSA Advantage, and the ECRI Sourcebook. Vendors that can provide molecular assay analyzers via the Federal Supply Schedule are Thermo Fisher Scientific, Inc. (Thermo Scientific), Cepheid, Biofire Diagnostics, LLC (Biofire), Becton Dickinson (BD), and Qiagen, Inc. (Qiagen). Although Thermo Scientific, Biofire, BD, and Qiagen manufacture analyzers capable of testing for COVID-19 available on FSS, they are not able to meet the throughput requirement of 1,100 test within a 24 hour period. The analyzer provided by Thermo Scientific has a throughput of 384-480 per day. The analyzer provided by Biofire has a throughput of up to 175 samples per day. BD has a throughput of 96-120 samples per 8 hour shift. Qiagen can provide the QIAstat-DX Analyzer which uses single use SARS-CoV-2 Panel cartridges with results available in approximately one hour, not a high throughput system. Therefore, Thermo Scientific, Biofire, BD, and Qiagen cannot meet the minimum requirements of the Government.

Hologic and Roche are able to provide analyzers capable of testing for COVID-19 and able to meet the throughput requirements, but the analyzers are not available via the FSS. In accordance with FAR 8.002 http://farsite.hill.af.mil/reghtml/regs/far2afmcfars/fardfars/far/08.htm#P286_49080 http://farsite.hill.af.mil/reghtml/regs/far2afmcfars/fardfars/far/08.htm#P83_13798 and 8.004, the FSS is a mandatory source. Since Hologic and Roche are not on FSS and at least one other vendor is, Hologic and Roche are not able to meet the needs of the Government.

Only Cepheid can provide a molecular assay analyzer available on FSS that is able to meet the minimum requirements of the Government.

7. Any other facts supporting the justification.

This procurement uses a GSA Schedule and will be solicited and awarded in accordance with FAR Subpart 8.4.

8. A statement of the actions, if any, the agency may take to remove or overcome any barriers that led to the restricted consideration before any subsequent acquisition for the supplies or services is made.

All future requirements will be handled on a case-by-case basis.

Technical Cognizance