Monitoring performance of external quality control

Abstract

Aim In 2010 the Royal College of Pathologists of Australasia Quality Assurance Programs (RCPA QAP), received Quality Use of Pathology Program funding to determine if regular external quality assurance that laboratories perform could be used to identify unacceptable performance earlier than the usual 3 year NATA accreditation cycle, to help minimise risk to patients. Method Criteria for unacceptable performance have been established to identify laboratories that maybe underperforming in external quality assurance (EQA). New frameworks have also been developed that outline the process of actions to be taken by the RCPA QAP when participant results and IVDs fall outside levels of acceptable performance. The frameworks proactively notify participants or manufacturers or their sponsors to assist them early. Results When unacceptable performance is identified, according to the set criteria, a letter will be sent to the participant outlining the result(s) falling outside the criteria for acceptable performance and offer assistance to review the QAP results. Persisting unacceptable performance will be referred to a Committee for review and results referred to the National Association of Testing Authorities (NATA) or Therapuetic Goods Administration (TGA) for follow-up. Conclusion The RCPA QAP has established a performance monitoring system using the EQA results. The early warning system will identify laboratories of concern and assist them to obtain their accreditation. Conflict of interest statement This research was supported by the Department of Health and Ageing. The Department had no role in analysing the data or preparing the abstract.