SPECIAL NOTICE
66 -- Notice of intent to Sole Source
- Notice Date
- 8/26/2020 7:37:51 AM
- Notice Type
- Special Notice
- NAICS
- 334516
— Analytical Laboratory Instrument Manufacturing
- Contracting Office
- NAVAL MEDICAL LOGISTICS COMMAND FORT DETRICK MD 21702-9203 USA
- ZIP Code
- 21702-9203
- Solicitation Number
- N6264520R0081
- Response Due
- 9/3/2020 8:00:00 AM
- Archive Date
- 09/18/2020
- Point of Contact
- Ronald Govans, Phone: 3016193022, Kara E. Williams
- E-Mail Address
-
ronald.d.govans2.civ@mail.mil, kara.e.williams5.civ@mail.mil
(ronald.d.govans2.civ@mail.mil, kara.e.williams5.civ@mail.mil)
- Description
- � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � �Notice of Intent The Naval Medical Logistics Command (NMLC) intends to award on a sole source basis (IAW FAR 13.501(a), Only One Responsible Source. The proposed source is Roche Diagnostics Corporation., 9115 Hague Rd, Indianapolis, Indiana 46256-1025. The requirement is an Indefinite Delivery Indefinite Quantity (IDIQ) Cost Per Test (CPT) contract for three (3) Slide Stainer, Cytology/Histology [ECRI Device Code: 15-183], reagents, quality control, maintenance, and consumables for Naval Medical Center (NMC) Portsmouth, VA. Two (2) of the contracted cytology/histology slide stainers shall be primarily used for Immunohistochemical (IHC) slides, and one (1) shall be used for primarily special stain slides. The contracted units shall be a single model platform.�� The contract shall accommodate an historical workload of 11,000 immunohistochemical (IHC) slides and 2,750 special stain slides. The system shall support staining of immunohistochemistry, and special stains 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 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. The system shall be capable of performing the stains listed in the chart below with an expected annual workload of 11,000 immunohistochemical (IHC) slides, and 2,750 special stain slides: (SEE ATTACHMENT FOR STAIN CHART)� System installation, validation, correlation, training, and preventive maintenance coverage shall be included.� 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. Vendor shall provide its Original Equipment Manufacturer (OEM) list if it is the only authorized dealer, authorized distributor or authorized reseller when submitting its proposal. The equipment/system must provide warranty and service to its proposal maintained by their 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 storage, arrangements for the storage. �The intended initial base ordering period will be from 01 October 2020 to 30 September 2021.� Subsequent, individual 1 (one) year ordering periods shall be available starting on 01 October 2021, with the final expiring 30 September 2025. The Ordering Period for this contract is anticipated to be 60 months. The contractor shall provide telephonic and e-mail technical support during standard business hours (Monday�Friday, 8:00 AM�5:00PM, Eastern Time. This contract shall provide unscheduled support/service coverage between the hours of 8:00AM and 5:00PM, Eastern Time, from Monday through Friday. The vendor and COR or Biomedical Equipment Repair Department (BIOMED) Technical Liaison shall agree upon such a time to conduct preventive maintenance service instances at least one (1) month in advance. The Contractor shall maintain the equipment within the original equipment manufacturer�s specifications, in accordance with all US, State, and Local law and regulations, US Navy regulations, instructions, and Joint Commission requirements. The contractor must maintain the system, such that it meets Navy and DHA Cybersecurity requirements. NAICS Code: 334516- Analytical Laboratory Instrument Manufacturing. The small business size standard, for NAICS Code 334516, is 1,000 employees. There are no set aside restrictions for this requirement.� This notice of intent is not a request for competitive proposals and no solicitation document exists for the requirement. However, parties interested in responding to this notice are required to submit a capability statement that includes management and technical data and cost information, in sufficient detail and with convincing evidence that clearly demonstrates the capability to perform the required work. Capability statements shall not exceed 1 (8.5 x 11 inch) page using a font size no smaller than 10-point. All capability statements received by the due date of this notice will be considered by the Government. A request for documentation or additional information will not be considered as an affirmative response. 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 or to proceed with a sole source contract. If a vendor wishes to provide a capability statement please email product capability statements to Ronald.d.govans2.civ@mail.mil. �The closing date for challenges is no later than 11:00 AM Eastern Time, 03 September 2020. Capability statements shall be submitted by e-mail ONLY as a Microsoft Word, Microsoft Excel or Adobe PDF attachment. No phone calls will be accepted.
- Web Link
-
SAM.gov Permalink
(https://beta.sam.gov/opp/4726f02067db400ca4095307a4ba68a9/view)
- Place of Performance
- Address: Portsmouth, VA 23708, USA
- Zip Code: 23708
- Country: USA
- Zip Code: 23708
- Record
- SN05773953-F 20200828/200826230154 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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