Good scientific practice Flashcards
What is the difference between remedial action, corrective action and preventative action?
Remedial action = an action performed immediately to stop the error occurring
Corrective action = an action performed to stop the error re-occurring
Preventative action = an action performed before an error has occurred to prevent the error from ever occurring
What is the difference between a non-conformity, minor error, moderate error and major error?
Non-conformity = “non-fulfilment of a requirement”
All non-conformities need investigating and recording in QMS (if available), some only internally within the department, whilst others must be escalated to hospital incident reporting system.
Minor error/non-conformity = internal error only e.g. some data on report incorrect, but noticed and rectified before report issued.
Moderate error/non-conformity = more serious internal error or minor errors affecting patient e.g. error in lab processes led to repeat testing and wasted staff time and resources, or a report was released with a typographic error or after the date expected, but the patients’ treatment was not affected in any way.
Major error/non-conformity = serious errors affecting external service users/patients. Must be escalated with senior management who may decide to halt reports until issue non-conformity resolved and must be escalated to hospital adverse incident reporting system.
What is the difference between reproducibility and repeatability?
Reproducibility = Same results obtained but different operator/patient/method/instrument used.
Repeatability = Same results obtained when the same operator/patient/method/instrument used.
What is sensitivity and specificity and how do they differ to positive predictive value and negative predictive value?
Sensitivity = Proportion of those with a disease that will be identified as having the disease
Specificity = Proportion of those without a disease that will be identified as not having the disease
PPV = Proportion of those with a positive test that truly do have the disease
NPV = Proportion of those with a negative test that truly don’t have the disease
