Technical Specification.pdf
PDF 121 KB Posted
- Solicitation number
- 0012266409
- Issued by
-
Department of the Army Medical Command
About this file
This Technical Specifications document details requirements for an Automation Clinical Chemistry and Immunodiagnostic System for Martin Army Community Hospital. The system must be FDA-approved, capable of testing whole blood, serum, plasma, urine, and body fluid samples using electrochemiluminescence, potentiometry, and photometry measuring principles. Key technical requirements include random access functionality, barcode reader, USB port, water filtration units, compatibility with Windows 10, and interface capabilities with DoD Electronic Health Record system MHS Genesis and Cerner Laboratory Information System.
The specification mandates comprehensive service provisions, including on-site technical support, installation, training, equipment repairs, 24-hour telephonic troubleshooting, and compliance with DOD Risk Management Framework cybersecurity certification requirements. Vendor obligations include providing ready-to-use FDA-approved reagents with at least 6 months of shelf life, responding to service calls within four hours, providing temporary analyzers if equipment cannot be repaired within 72 hours, and ensuring all shipments arrive Monday through Friday between 8:00am and 3:00pm EST. The system must be capable of performing all tests listed in the annual CPRR workload list.
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Other files
| File | Type | Posted |
|---|---|---|
| Statement of Objectives.pdf | ||
| Test.Menu.xlsx | XLSX spreadsheet |
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Technical Specifications for Automation Clinical Chemistry and Immunodiagnostic System:
-Provide automation clinical chemistry and immunodiagnostic systems that are FDA approved and use FDA approved software for FDA approved testing reagents.
-Provide system that uses electrochemiluminescence, potentiometry and photometry measuring principles.
-provide system that has random access, continuous random access, auto-dilution, and auto-rerun
-Provide system that has sample input, decapper, recapper, double centrifugation, stat, port, output and both single and multiple specimen carrier capacity, refrigerated storage unit.
-Provide system that has audible alarm and visual alarm for sample input unit.
-Provide system that capacity for 16, 13x100mm; 16, 13x75mm; 11.5x65mm; 15x108mm specimen tubes
-Provide system that can test whole blood, serum, plasma, urine and body fluid samples.
-Analyzer must have barcode Reader and disk drive with read and write and USB port for loading and downloading data and on-board operator's/ troubleshooting manuals.
-Provide water filtration units for deionized bacteria free water required to run systems that do not exceed 30L per hour per unit.
-Facility will not meet requirements that exceed current environmental capabilities:
Relative Humidity cannot exceed-45-85 and must be non-condensing Operating temperature-15-32 degrees Celsius.
-Analyzer must interface with the DoD Electronic Health Record system MHS Genesis.
-Analyzer must interface with Laboratory Information System (LIS) Cerner for 2-way communication with broadcast download and host.
-Analyzer Operating system must be compatible with Windows 10 or higher.
-Analyzer must provide capability for data and information storage and data management with touch screen technology.
-Provide equipment repairs scheduled and unscheduled as well as preventive maintenance and alternate testing or validation for extended downtime.
-Provide on-site technical support for installation of automation clinical chemistry and immunodiagnostic systems to bring to and maintain a fully operational status including required reagents and supplies.
-Provide training at vendor’s facility for two personnel and on-site training as needed.
-Ensure proper packaging of reagents, supplies, and equipment and that they are shipped at proper refrigerated or frozen temperatures according to manufacturer specifications.
-Provide FDA approved reagents for use with expiration dates no less than 6 months of delivery date that function properly and pass lot to lot testing.
-Reagents must be ready to use and do not have to be prepared.
-Notify the laboratory if there is a recall on any reagents or equipment within 24 hours.
-Ensure all shipments arrive Monday through Friday between the hours of 8:00am and 3:00pm EST;
excluding holidays and weekends.
-Respond to phone calls regarding shipment discrepancies the same day of notification and discrepancy will be corrected within 24 hours.
-Provide customer notification of updates on any reagents in writing within 5 business days and ensure continuity of services and availability of reagents during reagent revision when required.
-Provide all software and part upgrades at no additional cost.
-Respond to service calls within four hours or the morning of the next duty day if after 5:00pm Monday- Friday and correct deficiencies within 24 hours after arrival on-site.
-Provide temporary analyzer until the original analyzer is repaired or permanently if the original analyzer can’t be repaired within 72 hours.
-Provide on-site scheduled preventive maintenance service as specified by the manufacturers published maintenance manual as necessary to keep system in good condition including lubrications, cleaning (other than those performed at the operator’s level), calibrations, and diagnostics during the lease period as well as provide an onboard maintenance module at no additional cost.
-Provide 24-hour telephonic troubleshooting.
-Must meet DOD Risk Management Framework (RMF) IT cybersecurity certification requirements.
-Provide systems capable of all tests listed in test menu technical exhibit 2. Annual CPRR workload list.
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