SPECIAL NOTICE
65 -- ACL TOP 350 CTS Hemostatsis Diagnostics Systems
- Notice Date
- 6/16/2021 1:34:11 PM
- Notice Type
- Special Notice
- NAICS
- 339112
— Surgical and Medical Instrument Manufacturing
- Contracting Office
- NAVAL MEDICAL LOGISTICS COMMAND FORT DETRICK MD 21702-9203 USA
- ZIP Code
- 21702-9203
- Solicitation Number
- N6264521RC6C03
- Response Due
- 7/1/2021 2:00:00 PM
- Archive Date
- 08/01/2021
- Point of Contact
- Marc Mitchell
- E-Mail Address
-
marc.l.mitchell.civ@mail.mil
(marc.l.mitchell.civ@mail.mil)
- Description
- The Naval Medical Logistics Command (NMLC) intends to negotiate on a sole source basis in accordance with FAR 13.106-1(b), Soliciting from a single source, in support of the USNS MERCY (T-AH 19). The proposed source is Werfen USA, LLC, 180 Hartwell Road, Bedford, MA 01730-2443. This acquisition is for two (2) ACL TOP 350 (Closed-Tube-Sampling) CTS hemostasis diagnostics systems to be installed in the laboratory aboard the USNS MERCY (T-AH 19). This acquisition also includes required accessories, services, training, and trade-in allowance of two (2) Coagulation TOP, ACL Elite PRO systems. The Government intends on awarding a single Firm-Fixed-Price (FFP) contract.� Instrument dimensions shall not exceed a depth of 33 inches, a width of 32 inches, a height of 29 inches; and weight of 200 pounds, and allow for HemosIL INR validating. The analyzer must have reagent barcode reader and the reagent bar-coding tracking should include lot numbers, expiration date and vial size, hold 40 samples onboard (10/sample rack), 26 reagents onboard (refrigerated), and include patient samples (configurable) results database. The analyzer must be capable of performing Prothrombin Time and Activated Partial Thromboplastin Time, throughput tests includes up to 110 tests/hour. The ACL TOP 350 CTS hemostasis system must be able to perform the following tests: automated assay-specific pre-analytical sample integrity checks, advanced quality management, and lab accreditation support. Vendor must be an Original Equipment Manufacturer (OEM) authorized dealer, authorized distributor or authorized reseller for the proposed equipment/system, such that OEM warranty and services are provided and maintained by the OEM.� All software licensing, warranty, and service associated shall be in accordance with OEM terms and conditions. The equipment, 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 equipment shall be installed in compliance with Occupational Safety and Health Administration (OSHA) Werfen USA, LLC is the parent company of Instrumentation Laboratory, the OEM. Only Werfen USA, LLC/ Instrumentation Laboratory certified technicians are authorized to perform services, installation, and provide operator training on equipment manufactured by Werfen USA, LLC/ Instrumentation Laboratory. �As such, Werfen USA, LLC is the only source able to meet the requirements of the Government. This notice of intent is not a request for competitive proposals and no solicitation document exists for the requirement.� Sources 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 5 (8.5 x 11 inch) pages 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 or submissions that only ask questions 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 procurement. Capability statements are due by 5:00 PM Eastern Time, 01 July 2021.� Capability statements shall be submitted by e-mail ONLY as a Microsoft Word or Adobe PDF attachment to the following address: marc.l.mitchell.civ@mail.mil.� No phone calls will be accepted.
- Web Link
-
SAM.gov Permalink
(https://beta.sam.gov/opp/78f0c53af0774a0daac6e16a3b98df29/view)
- Place of Performance
- Address: San Diego, CA 92136, USA
- Zip Code: 92136
- Country: USA
- Zip Code: 92136
- Record
- SN06033242-F 20210618/210616230117 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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