Sources Sought Notice - Urinalysis Analyzer Systems & Reagents

Analyzers:All three (3) automated analyzers should include a fully automated urine chemistry analyzer coupled with an automated microscopy (sediment) analyzer, where appropriate, using flow cytometry and/or digital microscopy, equipped with integrated barcode readers, and tube rack-based sample processors that have the capability to be connected to each other. Semi-automated analyzer systems must include barcode reader and internal printer.Individual automated analyzers shall have fully automated, discrete random-access capabilities within the same instrument.For fully automated analyzers, there shall be a single point of specimen entry for the routine analysis of all required tests. It is preferred to have an optional separate specimen point of entry for STAT specimens.The fully automated analyzers instruments provided will be capable of the following:Must fit in the laboratory’s current workspace without any alterations to the location. Analyzer must fit in a 137 x 36 inches (LxD)

for Core lab, 95 x 29 inches (LxD) for ED lab, 96 x 28 inches (LxD) for Moreno Clinic and 24x24 inches (LxD) for Schertz Medical Home, Taylor Burk and Westover Clinics. Instrument with throughput between 20 (ED Stat Lab/Clinic)-80(Core Lab) complete urinalysis including microscopic per hour, where appropriate.Sample size is no more than 2 mls in all modes.Recognize MHS Genesis generated bar-code labels on primary sample tubes.Must have the ability to perform bi-directional transferal of information to and from the analyzer and MHS GenesisPossesses a touch screen/flat screen monitor for operator interface.Initial startup from shutdown within 20 minutes.Technician maintenance time shall not be greater than 5-10 minutes per day.Comes equipped to perform continuous, random and statistical analysis; capable of real time or (on-line) Quality Control.Capable of handling 16mm X 100mm disposable plastic tube in the standard specimen rack and also in the STAT modeTen (10) part Chemical analysis that includes color, clarity, specific gravity, glucose, protein, nitrite, leukocyte esterase, blood, bilirubin, urobilinogen, pH and ketones.Provide rapid results within 3 minutes of sampling.Microscopic urine sediment identification that includes red blood cells, white blood cells, bacteria, budding yeast, hyphenated yeast, squamous epithelial cells, transitional epithelial cells, renal tubular epithelial cells, oval fat bodies, mucus, sperm, trichomonas vaginalis, unclassified casts, hyaline casts, epithelial cell casts, white blood cells casts, red blood cell casts, granular casts, cellular casts, broad casts, fatty casts, waxy casts, unclassified crystals, triple phosphate crystals, calcium oxalate crystals, calcium phosphate crystals, calcium carbonate crystals, uric acid crystals, leucine crystals, tyrosine crystals, cystine crystals, and amorphous sediment crystals.Directly measure specific gravity using an integrated refractometer.Analyze urine sediment particles in their near-native state so as not to physically or biochemically alter their morphology.Ability to scan a minimum of 40 High Power Fields to increase the identification of rare elements.Capable of performing automatic identification and categorizing of urine sediment particles.For digital microscopy, provide retrievable digital images of urine sediment particles specific to each sample that can be manually edited as required by individual laboratory parameters.Must use a 2D compatible digital barcode reader to provide a positive identification for all specimen tube IDs in the form of an image. Tube rack and specimen IDs must be read twice prior to aspiration.Positive sample tube identification required to ensure patient sample identification (e.g. sample tube bar-code must be read before, during and after aspiration).Positive tube rack position identification (tube rack and position bar-code read at time of aspiration).Should have the ability to monitor/manage barcoded consumables.Semi-automated analyzers provided will include the following:The Contractor shall provide (4) semi- automated Urine Chemistry analyzer systems that test for all required chemistry assays only. The analyzer system will be provided from a single contractor. The system shall provide redundancy to ensure continuous operations. Full capacity back-up system not required. All equipment displays and supporting literature must be in the English language.Must be compatible with MHS Genesis and will allow for automatic transfer of results from the analyzer to MHS Genesis. Bi-directional is highly pre-preferred but not mandatory.Twelve (12) part Chemical analysis that includes color, clarity, specific gravity, glucose, protein, nitrite, leukocyte esterase, blood, bilirubin, urobilinogen, pH and ketones.Must fit in the laboratory’s current workspace without any alterations to the location. Analyzer must fit in a 24x24 (LxD) inch spaceShall have autostart when strip is placed on the analyzer and allows for continuous throughput and placement of strips.Shall have the ability to correct misaligned strips.Must have the ability to prompt technicians of QC requirements and QC lock-out capabilities to ensure College of American Pathologist compliance.Both the fully automated and semi-automated analyzer systems shall provide users with rapid, reliable test results that are critical for patient care. The analyzer system shall (must) be capable of performing in low, medium, and high-volume work periods to produce results that are accurate and precise throughout the manufacturer’s stated linearity/analytic measurement range.Minimum actual through-put shall be 30-80 complete urinalysis with microscopic examination per hour for fully automated analyzers and 30 samples per hour for semi-automated analyzers.All analyzer/data management system displays and supporting literature shall be in the English language.Initial startup from the shutdown state shall (must) not exceed 20 minutes.Each fully automated analyzer system shall (must) come equipped with an un-interruptible power supply (UPS) capable of providing all necessary electrical power to each analyzer system, to include the data management system for 15 to 20 minutes.The analyzer systems and all reagents shall be approved by the Food & Drug Administration (FDA). All analyzers and associated parts and accessories shall be new. No used, refurbished, or like-new equipment shall be provided in support of this contract at any timeReagents:The analyzer shall (must) have the on-board ability to maintain reagents at the proper storage temperatures for assays. All assays must be FDA approved.Reagents must have a shelf life not less than 3 months upon receipt at the Receiving Activity (consignee), or as stated within the individual line item (i.e. Delivery Ticket, Invoice).Controls will have shelf life of not less than 4 weeks.An alternate quality control material must be provided by the contractor if the new lot of controls cannot be delivered two weeks prior to the expiration date of the lot currently in use.All test kits will be provided as follows:Inclusive of an English language package insert.Be provided by the manufacturer of the equipment.Delivered on time, at the appropriate storage temperature, and marked with any required temperature controls as necessary.Routine or scheduled orders will arrive within one week before or after the scheduled date of delivery. Emergency orders will be delivered within 24 hours after the order is placed.Be compatible with all reagent packs used with the Analyzers.Preservation and packing - preservation and packing shall be performed in accordance with the best commercial practice and in such a manner to afford adequate protection against any damage during shipment from source to destination.All reagents provided will be identical to those used in the FDA 510K approval application. If the bulk reagents are produced overseas, they will be manufactured in conformance with ISO or CE standards AND must be equal to or better than the U.S. products in quality/manufacturing. Documentation of item equivalency must be provided.Information Management:The analyzer system must include a data management system for control of the operation of the analyzer system, management of the quality control program, management of the on-instrument useful life of the reagents/reagent packs, and management of patient results; and a printer for the production of hard copy patient reports and other reports generated via the analyzer system’s data management system. The Data Management system shall have a comprehensive, fully integrated Quality Control (QC) software module that stores and evaluates quality control results. Results can be viewed in a variety of formats including Levy-Jennings charts, and statistical summaries. The application shall validate QC results by checking them against user selected rules and automatically alert the operator when a rule violation has occurred.The QC software shall have a large capacity to store graphics and results, cumulative patient reports and quality control files with statistics - all available to user.The QC software shall provide the capability to write user defined Westgard QC Rules. In addition, it shall integrate with the result manager for auto verification of results as applicable, allow viewing and maintaining of QC data across multiple levels and lots for connected analyzers, provide a mechanism to maintain an action log of comments from QC review, provide real-time access to QC charts, graphs (Levy-Jennings) and provide the ability to add comments, and eliminate data point(s) from statistics. The QC software shall (must) include the ability to apply Westgard quality control result decision rules in real-time.Data Management system shall (must) have a user friendly "Windows Based" interface that shall include a data management system for operational control of the analyzer system, management of the QC program, on-instrument useful life of the reagents/reagent packs, and management of patient results.