Slide stainers, immunohistochemistry

Added: Sep 06, 2013 1:07 pm The Naval Medical Logistics Command (NMLC) intends to negotiate on a sole source basis (IAW FAR Part 13.501(a)). The proposed source is Ventana Medical Systems, Inc 1910 E Innovation Park Dr, Tucson, AZ, 85737-1962. Naval Medical Center San Diego (NMCSD) has a requirement for a cost per test contract for two immunohistochemistry slide stainers for NMCSD. The systems shall be fully automated from dewaxing to counterstaining. The system shall support staining of immunohistochemistry and in-situ hybridization (ISH) using the same detection system for both testing methodologies on continuous and random access platform. The system shall have individual slide processors and shall allow the user to stain the slides independently. The system shall also be capable of fluorescein isothiocyanate (FITC) staining. The system shall be able to use antibodies from various manufacturers. The system shall be able to process at least 30 slides at one time. The system shall have an updated chromogenic detection method. The system shall be capable of performing single, double, triple and immunofluorescent stains in any combination. The system shall be capable of completing at least 45 slides per 8 hour shift. The system shall use FDA approved specialized breast pathology antibody markers for estrogen receptor (ER) and progesterone receptor (PR) as well as human epidermal growth factor receptor 2 (HER2) and chromosome 17. The system shall be able to use biomarker P16 for clinical use. The system shall have a methodology to minimize tissue loss. The system shall be floor model and shall not exceed 72" wide x 46" deep x 68" in height.

The system and all of the components, 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 equipment and reagents shall be compliance with OSHA requirements.

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.

Upon delivery, the vendor shall be responsible for uncrating the unit/system and transporting it through the facility to the location of intended use for installation. If interim storage is required, the vendor will 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) 339112 with a small business size standard of 500. 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 Brian Miller at brian.miller4@med.navy.mil. In addition, challenges can be faxed to 301-619-1132 Attn: Brian Miller, Reference solicitation number N0025914RCES0059. Email challenges are preferred. Closing date for challenges is no later than 10:00 AM. ET on 23 September 2013. No phone calls will be accepted.