NOI_Analyzer_Lab_Clinical_Final.doc

DEPARTMENT OF THE NAVY

NAVAL MEDICAL LOGISTICS COMMAND

NOTICE OF INTENT

The Naval Medical Logistics Command (NMLC) intends to negotiate on a sole source basis (IAW FAR 13.501(a)) Sole source (including brand name) acquisitions. The proposed source is Ortho Clinical Diagnostics, 1001 US Highway 202, Raritan, NJ 08869-1424. The requiring activity is the NATO Role III Multinational Medical Unit (MMU) in Kandahar, Afghanistan. The proposed acquisition is for an Analyzer, Laboratory, Clinical Chemistry.

The analyzer shall be a semi-automated discrete random access sample processing unit. The unit shall be an integrated chemistry and immunology analyzer. The analyzer shall measure levels of dissolved metabolic, renal, liver, cardiac, therapeutic drug and iron analytes in patient’s scrum/plasma by measuring colorimetric rate. The analyzer shall:

1. The analyzer shall be capable of advanced immunochemistry assay measurements of BNP, Ck, CK-MB, Troponin 1 and TSH via enhanced chemiluminescence testing methodology.

2. The analyzer shall not require an external water source for operation.

3. The analyzer shall include software for extrapolation and plotting on a Levy-Jennings graph.

4. The analyzer shall have direct Ion-Selective Electrode (ISE) potentiometric and turbidimetric reactions with “dry” integrated reagent slides.

5. The system shall have sufficient onboard storage to accommodate daily workload.

6. The system shall complete STAT (urgent) requests in at most 60 minutes.

7. Unit reagents shall be capable of being procured via Defense Medical Logistics Standard Support (DMLSS).

8. The analyzer shall have built-in sampling and processing error detection.

9. The analyzer shall be self-contained for reagent and liquid waste.

10. The analyzer shall be mounted on a cart with locking wheels to allow access for routine and non-routine maintenance and IT troubleshooting.

11. The analyzer shall include a UPS unit to prevent momentary loss of power during power outages and generator lag time.

12. The analyzer shall include a hand held barcode scanner.

13. The analyzer shall be capable of utilizing sample tube bar codes for accurate sample identification.

14. The analyzer shall include two operator and service manuals.

15. The analyzer shall include programmable panels to accommodate in-house needs.

16. The analyzer shall be capable of interfacing with the DOD Laboratory Information System (LIS).

17. The analyzer shall be capable of interfacing with the Composite Health Care System (CHCS), through the Data Innovations, Inc. (DII) – Instrument Manager (IM) version 8.12 software using a serial or direct Ethernet connection.

18. The analyzer shall be in compliance with the Navy Risk Management Framework (RMF) requirements.

19. The vendor shall provide 24/7 phone and online technical support to assist the certified Field Service Engineers for the delivery and installation of the equipment.

20. The vendor shall provide biomedical engineer technician training for three (3) personnel, certifying the three (3) personnel as a Field Service Engineers for the analyzer. The training shall be provided at the Ortho Clinical Diagnostics training center. The certified Field Service Engineers shall be capable of on-site installation/training, on-site service for repair/periodic maintenance and the setup of bi-directional interface.

21. The certified Field Service Engineers shall be members of the FRA-M team (US Army Medical Material Agency Medical Maintenance Operations Division).

22. The analyzer shall include all necessary parts (replacement items included in a Parts Bank on site) for minor maintenance repairs to be completed by the certified Field Service Engineer.

23. The analyzer shall have maximum dimensions of 72”x115”x36” (HxWxD).

24. The analyzer shall have a maximum weight of 2450lbs.

25. The electrical requirements are 240 VAC, 60Hz, 20 Amp, single phase.

The system, 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.

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 certified Field Service Engineer 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 certified Field Service Engineer shall make arrangements for the storage. The certified Field Service Engineer is also responsible for the initial instrument operational, performance validations and instrument correlation.

This acquisition is being conducted in accordance with FAR Part 12 and FAR 13. There are no set-aside restrictions for this requirement. The intended procurement will be classified under North American Industry Classification System (NAICS) 334516 with a Small Business Size Standard of 1,000. 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 technical data and price 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 purchase order.

If a vendor challenges the basis of this requirement, please email product capability statements (formats for submission: PDF, MS Word, or MS Excel) to Andrew Hampton at andrew.a.hampton3.civ@mail.mil. Closing date for challenges is no later than 3:00 PM. ET on 13 Sep 2017. No phone calls will be accepted.