TEST
Color
Clarity
Ascorbic Acid
pH
Protein
Glucose
Ketone
Bilirubin
Blood
Nitrite
Urobilinogen
Leukocytes
Specific gravity
Formed Elements - Red Blood Cells
Formed Elements - Squamous Epithelial Cells
Formed Elements - Yeast
Formed Elements - Crystals
Formed Elements - Sperm
Formed Elements - White Blood Cells
Formed Elements - Bacteria
Formed Elements - Casts
Formed Elements - Non-squamous Epithelial Cells
Formed Elements - Mucous
Body fluids

The units shall be fully automated and capable of performing both macroscopic and microscopic testing. The system shall be capable of performing high detection of urine sediments. The system shall be capable of auto correcting for abnormal urine colors. The system shall provide reagent barcode reading capability and inventory control including archiving and active reagent volume monitoring and warning. The system shall be capable of reading bar coded patient samples using the VistA Universal Identification system.

The system shall include a computer workstation with the ability to locate patient samples using patient name, SSN, or unique ID, and determine when results will be available. The workstation shall be capable of generating and printing patient reports. The system shall allow for reviewing abnormal results on the instrument. The system shall be capable of providing true STAT interrupt. The system shall be capable of a throughput of at least sixty (60) microscopy samples per hour; the system shall also have 60 sample "walk way" or pre-loading capability. The system shall be capable of a throughput of at least one hundred (100) chemistry samples per hour. If calibration activities are required, they shall be required at a frequency of no more than monthly. The analyzer shall compile all calculations. Calculation factors shall be stored internally and activated internally at the operator's discretion. The system shall be capable of providing microscopic images on the instrument screen. The electrical requirements are 120VAC, 60 Hz.

The vendor shall provide installation and validation testing. The vendor shall provide validation of the analyzers, including normal range verification, demonstration of linearity, reportable range, replication studies, recovery studies and establishment of initial control ranges using control materials. The vendor shall provide preventive maintenance coverage and all necessary user training for four (4) key operators to be used within the first twelve (12) months of the contract, if requested. Corrective system maintenance coverage shall be included. Training shall be provided by the vendor. The system shall bi-directionally interface with the Composite Health Care System (CHCS), Military Healthcare System (MHS) Genesis and the laboratory information system (LIS). The vendor shall provide two (2) operational manuals for each analyzer and two (2) service manuals for each analyzer, eight (8) in total, each in English. Support shall be provided for a period of performance from 1 October 2019 - 30 September 2020, with four (4) subsequent option years.

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.

There are not set-aside restrictions for this requirement. The intended procurement will be classified under North America Industry Classification System (NAICS) 334516. This RFI 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 [email protected]. Closing date for information is no later than 9:00 AM ET on 01 May 2019. No phone calls will be accepted.