Test Requirements:
Estimated Tests/yr.
Prothrombin Time (PT) 825
Activated Partial Thromboplastin Time (PTT) 550
The Coagulation Instrument Must:
• Utilize a Prothrombin Time reagent with an ISI value of 1.00 or as near to this as possible. The maximum acceptable ISI for this reagent may not be above 1.05.
• Utilize a bar code reader for patient identification and safety.
• Utilize a bar code reader for reagent identification and tracking. This will help eliminate the human error associated with manual entry.
• Allow for programmable patient limits and panic values.
• Be capable of providing routine and STAT testing.
• The instrument must have on-board tracking of reagent and controls.
• Require minimal maintenance (daily, weekly, and monthly). Operator performed maintenance should not exceed 20 minutes on any given day.
• Allow for the submission of peer-data with a reporting group of >25 users.
• Have an analyzer available for installation within a maximum of 45 days after acceptance of this contract.
• Must have attained FDA approval for installation of exact model of analyzer at least 6 month prior to acceptance of contact.
• Be able to show successful installation and integration of, at minimum, 10 analyzers of same exact model.
Other Stipulations Included in this Agreement:
• Must have an interface readily available and be able to link the Laboratory Information System (LIS), Composite Healthcare System (CHCS).
• Provide one Uninterruptible Power Supply unit with the instrument.
• All reagents for a year must include the sequestration of a single lot number that will be made available for shipment at a minimum of three month intervals or when requested.
• Must offer the ability to use bar coded specimens and host-query bidirectional or unidirectional interface between instrument and CHCS.
• Provide documentation that the instrument and its reagents have necessary FDA approval. The laboratory must meet appropriate agency regulations.
• Provide service for the instrument during normal business hours, excluding holidays and weekends for the duration of the contract. Technical support via telephone must be available for any reagent, software, and instrument problems between the hours of 8:00 AM and 4:00 PM CST. On-site service must be available within 24 hours (M-F) of notification. Defective parts and software shall be replaced at no charge.
• Provide preventative maintenance according to the manufacture stated requirements for the duration of the contract at no additional charge. There will be no less than 1 visit for annual maintenance.
• Provide instrument software upgrades at no cost during the term of the contract.
• Off-site training for one- (1) individual to include transportation, food, and lodging during the first year. Additional slots of (1) individual annually for the duration of the contract can be added.
• On-site training shall be provided at installation and as necessary and at no extra charge.
• Perform correlation, precision, and normal range studies required during installation of system.