essays Flashcards
ADD TO ESSAY PLAN How does your quality management system contribute to the quality of results obtained in the laboratory?
-Ensuring the correct samples are analysed - lab management database, patient identifiers, reduce sample mix up - one sample at a time, witnessed sample transfers
- Documentation - SOPS + document control system (Q pulse)
- Preanalytical - tests offered (website), sample collection, storage, transport. acceptance policy. storage of samples prior to testing.
- examination - All tests, equipment and software need validation and verification and measurement uncertainty, reproducibility, repeatability, sensitivity, specificity, performance criteria, IQC positive/negative controls and size standards, acceptance testing and audit of all consumables, equipment calibration,
- post-analytical: all results checked by two people, report templates, monitor errors
- training/competency - training policy, ongoing competency, CPD, HCPC registration
- incident reporting: continuous improvement, ‘no blame culture’, must include remedial action, root cause analysis, corrective actions, preventative actions
- audit schedule: vertical, horizontal, witness/examination. the quality standards need auditing
- EQA - lab accreditation UKAS- ISO 15189, GenQA, BPGs,
- suppliers: approved list of suppliers who are accredited and regular review
