SOLICITATION NOTICE
65 -- Immunohistochemistry slide stainers
- Notice Date
- 7/14/2015
- Notice Type
- Presolicitation
- NAICS
- 334516
— Analytical Laboratory Instrument Manufacturing
- Contracting Office
- Department of the Navy, Bureau of Medicine and Surgery, Naval Medical Logistics Command, 693 Neiman Street, FT Detrick, Maryland, 21702-9203, United States
- ZIP Code
- 21702-9203
- Solicitation Number
- N0018315RQLA020
- Archive Date
- 9/30/2015
- Point of Contact
- Derek J. Bell, Phone: 3016196914
- E-Mail Address
-
derek.j.bell.civ@mail.mil
(derek.j.bell.civ@mail.mil)
- Small Business Set-Aside
- N/A
- Description
- The Naval Medical Logistics Command intends to negotiate on a sole source basis (IAW FAR 13.501) with Roche Diagnostics Corporation 9115 Hague Rd, Indianapolis, IN 46256-1025. The requirement is for a cost per test contract for two immunohistochemistry slide stainers for NMC Portsmouth. The contract shall accommodate an estimated annual workload of 11,000 immunohistochemical (IHC) slides and 2,750 special stains slides. 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 be able to use antibodies from various manufacturers. The system shall be capable of single, dual and triple multiparameter IHC staining. The system shall be capable of using anti-p63 and anti-CD10 primary antibodies for in vitro diagnostics. The system shall be capable of using anti-ALK1 primary antibodies to detect the presence of p80 protein in human tissue. The system shall be able to use biomarker P16 for clinical use. The system shall use FDA approved 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 capable of independent processing and temperature control per slide drawer. The system shall be capable of temperature control ranging from room temperature to 100 degree Celsius per slide drawer. The systems slides shall have the dimensions of 1" x 3" when positively charged. 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 of five (5) years. 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. This acquisition is being conducted under simplified acquisition procedures FAR 13.501 under the authority of the test program for commercial items (section 4202 of the Clinger-Cohen Act of 1996). There are not set-aside restrictions for this requirement. The intended procurement will be classified under North America Industry Classification System (NAICS) 334516 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. Capability statements shall be submitted by email only as a MS Word or Adobe PDF attachment to Derek Bell at derek.j.bell.civ@mail.mil. Statements are due not later than 1:00 PM EST on 29 Jul 15. No phone calls accepted.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/DON/BUMED/N62645/N0018315RQLA020/listing.html)
- Record
- SN03796560-W 20150716/150714235732-07dbb94066a09cbd4223d9661fac023f (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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