Slide Stainer

The Naval Medical Logistics Command (NMLC) intends to negotiate on a sole source basis (IAW FAR 13.501(a), Only One Responsible Source. The proposed source is Ventana Medical Systems, Inc. 1910 E Innovation Park Dr., Tucson, AZ, 85737-1962).

The Naval Medical Logistics Command has a requirement for a contract for two (2) Slide Stainer, Immunohistochemistry [23-459], reagents, quality control, maintenance, and consumables for Naval Medical Center (NMC) San Diego. The contracted units shall be a single model platform.

The contract shall accommodate an annual workload of 16,000 immunohistochemical (IHC) slides. The system shall support staining of immunohistochemistry, fluorescent staining and in-situ hybridization (ISH) using the same detection system for all testing methodologies on continuous and random access platform. The system must be fully automated from deparaffinization, through antigen retrieval, to completion of staining. The system shall have individual slide processors and shall allow the user to stain the slides independently. The system shall have a capacity of at least 30 slides with continuous access to each individual slide.

The system shall be able to use antibodies from various manufacturers. The system shall be capable of single, dual, and triple IHC staining and immunofluorescent (IF) staining concurrently. The system shall be able to use the FDA-approved antibodies, including estrogen receptor (ER) antibodies, progesterone receptor (PR) antibodies, human epidermal growth factor receptor 2 (HER2) antibodies, and P16. The system shall be capable of independent processing and slide drawer temperature control. The system shall have a free-standing configuration. The electrical requirements for this system are 120V, 60 Hz.

System installation, validation, correlation, onsite and offsite training, and preventive maintenance coverage shall be included. Corrective system maintenance coverage shall include response times as specified in the Statement of Work. Support shall be provided for a period of performance from 03 December 2018 to 02 December 2019. Subsequent, individual 1 year option periods shall be available starting on 03 December 2019, with the final expiring 03 December 2023.

The units shall be compliant with the Food and Drug Administration (FDA) requirements to market and deliver medical products for use in the United States of America, even should delivery be requested outside of the United States. The claims made for the product shall comply with the regulations of the FDA with respect to products for marketing and delivery of a medical product for use in the United States of America, even should delivery be requested outside of the United States. The system shall be installed in compliance with 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.

There are not 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 responses 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 Derek Bell at derek.j.bell.civ@mail.mil. Closing date for challenges is no later than 3:00 PM ET on 26 October 2018. No phone calls will be accepted.

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