Notice of Intent - Panther Analyzers .pdf

NOTICE OF INTENT

The Naval Medical Logistics Command (NMLC) intends to negotiate on a sole source basis in accordance with

FAR 13.501(a), Sole source (including brand name) acquisitions. The proposed source is Hologic, Inc. of 250

Campus Drive, Marlborough, MA 01752. Only one award will be made as a result of this synopsis.

NMLC has a requirement for one (1) analyzer, laboratory, molecular assay, infectious microorganism [20-802] for

Naval Hospital (NH) Jacksonville.

The analyzer shall be an automated analyzer capable of analyzing nucleic acids from nasopharyngeal, nasal, oropharyngeal swab specimens, urine, and swab samples. The analyzer 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).

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

There are no set-aside restrictions for this requirement. The intended procurement will be classified under North

America Industry Classification System (NAICS) 334516. This notice of intent is not a request for competitive proposals and no solicitation document exists for this requirement. However, parties interested in responding to this notice will need to submit technical data sufficient to determine capability in providing the same product. All capability statements received by the closing date of this synopsis will be considered by the Government. A determination by the Government not to compete based on response to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement.

If a vendor challenges the basis of this requirement, please email product capability statements (formats for submission: PDF, MS Word, or MS Excel) to Benjamin Marcus at Benjamin.t.marcus2.civ@mail.mil, reference

NOI number N6264521RC81020. The closing date for challenges is not later than, 1100pm EST on 07 May, 2021. No phone calls will be accepted.

mailto:Benjamin.t.marcus2.civ@mail.mil