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The Naval Medical Logistics Command (NMLC) intends to negotiate on a sole source basis (IAW FAR 13.501(a), Sole Source Acquisitions). The proposed source is Siemens Healthcare Diagnostics, Inc., Ronda de Europa, 5 28 760 Tres Cantos.
The proposed action is for a cost-per-reportable-result contract for two (2) Analyzers, Laboratory, Clinical Chemistry, Automated for US Naval Hospital Rota. The units shall be a single platform capable of performing general chemistry, special chemistry, analyzing urine, serum, plasma, Cerebrospinal fluid (CSF), whole blood, hemolysate, therapeutic drugs, other hormones as defined below. The requirement is for two (2) units which are the same model having the same configuration. The units shall not require facility modification for the installation of new units. The units shall not require sample splitting between general chemistry tests and immunoassays. The units shall be installed in a 180" L x 54" W space. The units shall be capable of using the same software, parts, and reagents. The contractor shall be capable of providing on site repair within one (1) day of trouble ticket submission. The contractor shall be available for telephone consult 24/7, 365 days per year.
1.
The system shall be capable of performing at least, but not limited to, the tests listed below with the minimum workload indicated.
| Luteinizing Hormone(LH), S |
| 2 |
| Estrogens Fractionated, S |
| 10 |
| Lactic Acid (lactate), Plasma |
| 18 |
2.
The systems shall be capable of adding new third party tests as they are needed.
3.
The units shall be capable of utilizing the following sample types without the need for manual pretreatments: serum, plasma, urine, CSF.
4.
The units shall be capable of hydrating and storing reagents onboard the unit.
5.
The units shall have sufficient onboard storage to accommodate daily workload as outlined above.
6.
The units shall complete STAT requests in at most 60 minutes.
7.
The units shall be capable of auto dilution.
8.
The units shall be capable of accommodating 5 mL, 7 mL, 10 mL collection tubes; 1.0 mL microsample.
9.
The systems shall be capable of identifying and quantifying hemolysis, icterus, and lipemia (HIL) as it relates to sample interference, and identifying the results effected.
10. The units shall be capable of utilizing sample tube bar codes for accurate sample identification.
11. The system shall be capable of interfacing with the currently installed laboratory information management system: Composite Health Care System (CHCS)
12. The system shall be capable of interfacing with Cerner information management system for the future rollout.
13. The units shall include user-defined serum index (HIL) for in-house testing.
14. The units shall be capable of performing sample integrity checks with the capability of identifying specimens that are clotted, contaminated with foreign material, of insufficient quantity, or other situations which would lead to erroneous results.
15. The reagent system shall not require any special preparation, mixing, or reconstitution by the operator.
16. The units shall be capable of starting up without priming or washes.
17. The units shall be capable of external data storage in compliance with Navy IA regulations.
18. The maximum dimension of the entire system is 180" Length, 54" width, and 625 lbs.
19. The electrical requirements are 110VAC, 60 Hz.
The unit 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.
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 1000. 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.
If a vendor challenges the basis of this requirement, please email product capability statements (formats for submission: PDF, MS Word, or MS Excel) to Derek Bell at derek.j.bell.civ@mail.mil. Closing date for challenges is no later than 2:00 PM ET on 02 Jun 16. No phone calls will be accepted.
