Professional skills - Quality Flashcards
Quality management systems contain a number of documents some of which are?
- Timetables and documentation for both clinical and laboratory audit.
- COSHH records.
- Health and safety documents.
- IQA/IQC/EQA records.
- Equipment/reagent record logs.
- Staff training competencies.
What is our quality management system (Q-Pulse) used for?
- Documentation control.
- Documentation distribution.
- Management and security of records.
What to consider when developing a new test?
- Establish clinical utility/validity (going to provide useful results?).
- Consider ethical/social implications (appropriate?).
- Funding (do we have money?).
- Select suitable methodology.
- Risk assessment (COSHH?).
- Establish performance specifications and define quality processes for IQC.
- Evaluate cost/turnaround time.
- Establish reporting parameters (interpretation and limitations like measurement of uncertainty).
- Train staff until competent.
- Documentation needs to be created (worksheets, SOP, validation/verification traceability).
- Continual evaluation and audit.
- EQA.
What are the performance specifications for a test?
It is essential you know the limitations of your test.
- Accuracy.
- Precision.
- Sensitivity.
- Specificity.
How would you ensure the quality of a test?
- Include controls (should be treated the same as the sample).
- Evaluate error whether it be random (imprecise) or systematic (test bias).
- Work out levels of uncertainty (should be low).
- Review it regularly.
Process of when a sample is sent from an external quality assurance company (UK NEQAS)?
- Sample sent with specific request and target date.
- Test carried out using standard procedures and reported using standard format.
- Anonymised reports evaluated by peer assessors, with reports scored according to defined criteria.
- Lab informed of result, if poor performance lab will be offered assistance/advice.
What do we do during the audit process?
Audit is a systematic process.
- Appropriate standards identify aims and objectives.
- Schedule audit.
- Carry out audit, write brief report and non-compliance notes.
- Meet with auditee, discuss non-compliances and suggest corrective action deadline. Arrange a reaudit after this deadline.
- Auditee should address problem within this time frame.
- Reaudit should be carried out.
What do we mean by audit standards?
Appropriate standards to compare practice against, these may be published national, regional or local standards or guidelines, ISO standards or SOPs (dependent on the audit taking place).
In terms of audit, what are corrective actions and root cause analysis?
- Corrective actions - actions necessary to rectify the non-conformance.
- Root cause analysis - actions necessary to prevent non-conformance.
What are the three main types of laboratory audit?
Examination, vertical and horizontal.
What is an examination audit?
Examines a person undertaking a task and ensures that what is being done reflects the SOP and that the person carrying out the task has a good understanding of all aspects.
What is a vertical audit?
Examines all elements associated with a test process, e.g. Follows one sample from request to report.
What is a horizontal audit?
Examines an element in the process - on more than one item (this could be on training, equipment or documentation)
E.g review 100 consecutive request forms to audit how many are meeting acceptance criteria.
What is the difference between a clinical and a laboratory audit?
- Clinical audit: things like cost effectiveness, turnaround times, are national guidelines being met for the service, trust and laboratory priorities. Most likely carried out by the nhs looks more at the service as a whole.
- Laboratory audit: things like checking equipment, are staff competent etc, so looking more at what goes on in the lab.
What is clinical governance?
Is the system through which nhs organisations are accountable for continuously motoring and improving the quality of their care and services and safe guarding high standards of care and services.
