Laboratory Operations

Laboratory Operations

1. Contamination

   • Prevention
   • Monitoring and detection
   • Elimination

2. Quality Assurance

   • Specimen processing, preparation, transport, and storage
     • Evaluate quality and quantity of specimen
     • Evaluate quality and quantity of nucleic acid
   • Reagent selection, prep (calculations), storage, disposal, documentation
   • Assay performance and validation
   • Assay troubleshooting
   • Result calculation, interpretation, reporting
   • Quality control and proficiency testing
     • Assay controls
     • Proficiency testing
   • Equoment and instrumentation
     • principles
     • calibration
     • maintenance
     • troubleshooting
     • validation

3. Guidelines and Regulations

   • Test system categories
     • analyte-specific reagent
     • Research use only
     • in vitro diagnostics
     • Lab developed test
   • Regulations and Standards

4. Personnel

   • CEs
   • Competency

5. Safety

   • Handling/disposal of hazardous materials
     • Biological
     • Chemical