A.02 Salient Characteristics.docx

W91YTZ-20-R-0071

Salient Characteristics

1. Provide a fully automated track platform of handling the following components to accommodate the work-flow of the DDEAMC core laboratory:

a. Specimen input/output module

i. Automation line shall include a module that allows for the loading and unloading of specimens from the automation line to include a wait area for reflex testing specimens to wait for the initial result.

b. Barcode system

i. Automation line shall include a barcode reading system that tracks specimens, reagents, quality control, and calibrators throughout the platform.

c. Specimen routing track system

i. Automation line shall utilize a tube carrier transport system and have the capability to load up to 200 specimen tubes at one time. There shall be the ability to move stat specimens to the front of the line so that they are sampled before lesser-priority specimens.

ii. The automated track line shall be a scalable design that can be designed to implement multiple track options and the ability to expand via a contract modification to include additional instruments or modules if needed.

d. Refrigerated storage system

i. Automation line shall include a 2-8 degree Celsius refrigeration storage module for specimen tubes that is capable of maintaining an inventory using barcode technology. The specimens within the storage module shall be retrievable using software and integrated into the automation line. The specimen shall be automatically sealed and delivered to storage after an aliquot removed at the instrument.

e. Centrifuge

i. Automation line shall include a centrifuge capable of at least 300 samples per hour with selective centrifugation.

f. Decapper

i. Automation line shall include a specimen tube decapper capable of > 500 tubes per hour.

g. Sealer

i. Automation line shall include a specimen tube sealer.

h. Hardware

i. Provide all required hardware to operate the automated track platform and components.

ii. Provide a device, such as an Uninterrupted Power Supply (UPS), to serve as a back-up in case of power instability or power failure.

iii. Provide all necessary supplemental equipment for full functionality to include compressors and water purification systems.

i. Software

i. Provide all required software to operate the automated track platform and components.

j. Middleware

i. Provide all required middleware to operate the automated track platform and components.

ii. Middleware shall be capable of programming rules for routing specimens, reflex testing and performing calculations.

k. Instruments/analyzers:

i. Two (2) duplicate chemistry analyzers and two (2) duplicate immunoassay analyzers

ii. Analyzers shall be capable of manually loading specimens in the event the automation line is inoperable. The instruments must function independently in the event the automation line is inoperable.

iii. Platform shall include an automated process capable of tracking on-board consumables for the purposes of usage prediction, reagent management, expiration date management and lot management.

iv. Reagents, calibrators, and controls can be continuously loaded and unloaded with minimal impact to patient testing.

v. Analyzers shall eliminate cross-over contamination with probe washing capabilities and no need for disposable pipette tips.

vi. Cardiac Reagents shall include Troponin approved by the American College of Cardiology and/or the World Health Organization (ACC/WHO) and adhere to a less than 16 minute total testing time.

vii. Total solution shall provide no less than 1300 chemistry tests per hour and no less than 200 immunoassay tests per hour.

viii. All chemistry/immunoassay tests must be FDA cleared and STAT assays free of potential biotin interference.

ix. Analyzers shall support at a minimum 60 chemistry and 40 immunoassay reagents per module.

x. Analyzers shall include reagent bubble and foam detection.

xi. Analyzers shall test for hemolysis, icterus and lipemia and provide the HIL interference indices.

xii. Analyzers shall utilize reaction vessels or cuvettes that are automatically processed.

xiii. Onboard automatic calibration and quality control capability.

2. Turnaround Times:

a. Release of primary specimen tube less than 30 minutes for STAT and less than 60 minutes for routine specimens, re-testing, or add-on tests.

b. Platform shall include a “super STAT” capability that when utilized ensures the next specimen loaded onto the analyzer is processed ahead of all other specimens.

c. Platform shall include mechanism for prioritizing STAT samples.

3. Inventory management system and consumables:

a. Provide monthly replenishment shipments based upon metering as well as no-charge requests as needed on demand.

b. Reagents for the chemistry and immunochemistry systems and all chemistry calibrators shall be liquid ready-to-use requiring no mixing and no reconstitution.

c. Contract shall include the use of an automated inventory management system capable of monitoring consumables using either Radio Frequency Identification Data (RFID) tags or QR barcodes to generate inventory reports, ordering lists, expiration date monitoring, lot management and minimum/maximum inventory data.

d. Assayed quality control from the vendor or third-party will be provided.

e. Water systems and service will be provided.