Blood Grouping

The Naval Medical Logistics Command intends to negotiate on a sole source basis (IAW FAR 13.501) with Ortho Clinical Diagnostics, 1001 US Highway 202, Raritan, NJ 08869.

The requirement is for a contract which includes equipment, maintenance support, and consumable supplies for one (1) Analyzer, Laboratory, Hematology, Blood Grouping, Automated [16-817] for Naval Hospital Bremerton and one (1) Analyzer, Laboratory, Hematology, Blood Grouping, Automated [16-817] for Naval Hospital Oak Harbor. The system shall be capable of performing at least the tests listed below for a minimum annual workload of 9,200 specimens for Naval Hospital Bremerton and 5,000 specimens for Naval Hospital Oak Harbor.

TEST
ABO/Rh Grouping
ABO/Rh Confirmation
Antibody Screens
Antibody Identification
Selected Cell Panel
Rh Phenotype (C,c,E,c)
Donor Confirmation
Crossmatch (AHG)
Antigen Typing
Serial Dilutions for Titration Studies
DAT (Polyspecific)
DAT (IGG)
Cord Blood Testing

The system shall be capable of performing blood bank testing using gel technology. The system shall be fully automated and provide functions including liquid pipetting, serial dilution, reagent handling, incubation, reaction grading, reaction interpretation, and data management. The system shall provide critical process monitoring and allow for management of system maintenance and quality control. The system shall be capable of using the following sample types: centrifuged whole blood, plasma, serum, and packed red blood cells. The system shall be capable of barcode tracking. The system shall be capable of identifying reagents and specimens. The system shall be capable of continuous, random, STAT access, and batch specimen processing modes. The system shall accommodate batch processing interruptions to insert STAT specimens into the workflow. The system shall be capable of holding test tubes of various sizes. The system shall include a manual backup workstation. The system shall be benchtop with maximum physical dimensions of 36" tall, 42" wide, 32" deep, and shall weigh at most 450 lbs. The electrical requirements are 100VAC, 60 Hz. System installation, validation, correlation, onsite and offsite training, and preventive maintenance coverage shall be included. Yearly off-site training for key operator staff shall be provided. On-site assistance during validation shall be provided. Corrective system maintenance coverage shall include response times as specified in the Statement of Work. Support shall be provided for a period of performance for one year with option years available for four (4) consecutive year terms after the base year term.

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.

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) 325413 with a small business size standard of 1250. 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 11:00 AM EST on 12 Aug 16. No phone calls accepted.