Clinical laboratories require error free traceability of data to patients or subjects while retaining confidentiality. This implies absolute sample identification procedures. Data integrity features are essential to insuring data that is above reproach. Easy and usable access to patient/subject history is required to evaluate results and determine subsequent testing strategies. Planning tools are required to enforce/enable proper execution of protocols such as in clinical trials. Predictable turnaround, airtight QC, and prompt and accurate notification are required.
BlazeLIMS improves performance in this mission via the following features:
- Patient/Subject records with confidentiality features.
- Patient/Subject identification and sample identification features to support clinical protocols.
- Easy and error free entry of testing requests and protocols, including use of panels and proper automatic differentiation and tracking of multiple sample containers including backup stores.
- Automated bi-directional interfaces to clinical analyzers to insure air-tight and error free processing/traceability.
- Complete traceability to reagents, standards, consumables, instrument metrology, etc.
- Patient/subject history displays and reports.
- Planning tools to manage clinical trial protocols, distribution of sample kits, receipt of samples, etc.
- Secure chain of custody.
- Multiple levels of approval.
- Complete audit trails and security for data integrity and 21CFR Part 11 compliance.