JA - Sole Source Redacted.pdf

J&A #20-00038

Form 02.4G.AB 30 Aug 2018

JUSTIFICATION AND APPROVAL

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 needs of multiple Medical Treatment Facilities (MTFs) requirements.

2. Description of the Action Being Approved.

The proposed action is for Corona Virus Disease 2019 (COVID-19) assays for multiple Naval MTFs, including but not limited to Naval Medical Center (NMC) Portsmouth, NMC San Diego, and Naval Hospital (NH) Jacksonville.

The MTFs have an immediate need for the COVID-19 assays. On March 13, 2020, the United States issued a Presidential Proclamation declaring the COVID-19 outbreak to be a national emergency. The assays will help identify patients with similar COVID-19 symptoms to help prevent further outbreaks. Any delay in providing the assay could cause lasting harm and increase the risk of transmission and exposure.

The yearly projection of assays for NH Jacksonville, NMC Portsmouth, NMC San Diego, and other navy MTFs are listed below.

Base Year

MTF Max Quantity NH Jacksonville 17,000 NMC Portsmouth 40,000 NMC San Diego 20,000 Other Navy MTFs 189,667 266,667

Option Year MTF Max Quantity NH Jacksonville 2,125 NMC Portsmouth 5,000 NMC San Diego 2,500 Other Navy MTFs 23,708 33,333

The Government intends on awarding a single Firm Fixed Price (FFP) Indefinite Delivery Indefinite Quantity (IDIQ) contract with a one (1) year base period and a six (6) month option period commencing 1 July 2020 with a possible extension through 31 January 2022. The proposed source is Hologic, Inc. (Hologic), 250 Campus Drive, Marlborough, MA 01752 (Cage Code 0UJ21).

3. Description of Supplies/Services

The requirement is for COVID-19 assays. The COVID-19 assays shall be capable of performing COVID-19 testing on Hologic’s base Panther system analyzers currently installed at Navy MTFs. NMC Portsmouth, NMC San Diego, and NH Jacksonville have an immediate need for the COVID-19 assays.

The assays shall be compatible with the optimal throughput of the Panther analyzer systems and shall not interfere with the optimum performance of the other immunoassay procedures performed on these instruments.

The assays shall not impose additional maintenance, servicing, or calibration requirements for the optimum performance of the contractor’s reagent on the analyzer.

Vendor 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.

Prior to delivery, the assays shall have obtained Food and Drug Administration (FDA) Emergency Use Authorization (EUA).

Operations & Maintenance (O&M), Defense Health Program (DHP) funds will be used to fund the minimum guarantee.

Cost Breakout of Base Year and Six Month Option

Base Year

FY 2020

Option

FY 2021

Total

$8,000,010.00

$999,990.00

$9,000,000

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), Sole Source Acquisitions.

This acquisition is in support of COVID-19. Pursuant to Class Deviation 2018-O0018, "Micro- Purchase Threshold, Simplified Acquisition Threshold, and Special Emergency Procurement Authority", the following applies to DoD acquisitions of supplies or services funded by DoD appropriations that the Head of the Contracting Activity determines are to be used to support COVID-19 emergency assistance activities:

The "micro-purchase threshold" and the "simplified acquisition threshold" are increased as follows:

- For any contract to be awarded and performed, or purchase to be made, inside the United States, the "micro-purchase threshold" is $20,000 and the "simplified acquisition threshold" is $750,000;

- For any contract to be awarded and performed, or purchase to be made, outside the United States, the "micro-purchase threshold" is $30,000 and the "simplified acquisition threshold" is $1,500,000; and

- For the acquisition of commercial items, the threshold for use of simplified acquisition procedures for certain commercial items is $13M.

5. Rationale Justifying Use of Cited Statutory Authority.

The Department of the Navy is required to be mission ready at all times. Failure to procure COVID-19 testing equipment, ventilators, and Personal Protective Equipment (PPE) would result in our inability to maintain a healthy and fit to fight medical corps. A delay in award not only compromises the Department’s ability to respond to this potentially lethal and highly contagious virus, but ultimately may compromise the life and safety of Navy personnel conducting missions both domestically and overseas.

The statutory authority permitting other than full and open competition is relevant to this procurement because the COVID-19 assays will help identify patients with similar COVID-19 symptoms to help prevent further outbreaks. Any delay in providing the assay could cause lasting harm and increase the risk of transmission and exposure.

Hologic is the only vendor that can provide COVID-19 assays that are compatible with the base Panther system analyzer (see paragraph 6 for details). Thus, Hologic is the only manufacturer who can meet the Government’s essential characteristic.

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

Market research was conducted in April 2020 by technical experts in accordance with FAR Part

10. This research included a search of the internet via Google, Defense Medical Logistics Standard Support (DMLSS), Food and Drug Administration (FDA), Emergency Use Authorizations (EUA), ECRI Sourcebook, beta.SAM.gov, General Services and Administration Advantage (GSA Advantage!) and Federal Procurement Data System - Next Generation (FPDS- NG) at https://www.contractdirectory.gov/contractdirectory/ for the purpose of identifying available sources.

On 22 April 2020, General Services Administration (GSA) Advantage! was checked for availability of COVID-19 assays. The search resulted in no schedules for COVID-19 assays that are compatible with Hologic’s base Panther system analyzer.

A search on 22 April 2020 of Interagency Contract Directory, FPDS-NG, EDA and WAWF yielded no contracts for COVID-19 assays that are compatible with Hologic’s base Panther system analyzer.

Several vendors can provide COVID-19 assays but their assays are not approved by the Food and Drug Administration (FDA) and they are not compatible to Hologic’s base Panther system analyzer. Emails were sent to Thermo Fisher Scientific, Chembio Diagnostic Systems Inc., https://www.contractdirectory.gov/contractdirectory/

Ortho-Clinical Diagnostics, Inc., Inbios International Inc., Luminex Corporation, Becton, Dickinson And Company, Qiagen, LLC, Perkinelmer Genetics, Inc., Diasorin Inc., Abbott Molecular Inc., and Quidel Corporation inquiring if their assays are compatible with Hologic’s base Panther system analyzer. Responses from the vendors confirmed that none of the assays are compatible with Hologic’s base Panther System.

A notice of intent to sole source to Hologic was posted to beta.SAM.gov in accordance with FAR 5.202. The notice of intent was posted on 24 April 2020 and closed on 11 May 2020.

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7. Determination of Fair and Reasonable Cost.

The Contracting Officer shall determine the cost to the Government of the supplies covered by this Justification and Approval 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.

CERTIFICATIONS AND APPROVALS

TECHNICAL 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.

Requirements Cognizance:

XXXXXXXXXXXXX Date Phone Senior Clinical Engineer, NMLC

LEGAL SUFFICIENCY REVIEW AND CONCURRANCE

I have determined this Justification is legally sufficient.

XXXXXXXXXXX Date Phone Legal Counsel

CONTRACTING OFFICER'S CERTIFICATION

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

XXXXXXXXXXXX Date Phone Contracting Officer

APPROVAL BLOCK COMPETITION ADVOCATE

($650,000 to $12.5M)

XXXXXXXXXXXXX Date Phone Competition Advocate

APPROVAL BLOCK COMPETITION ADVOCATE