8. DISCUSSION

External Quality Assurance is one aspect of a quality management system in a laboratory and accreditation requirements. This project was designed to determine if the regular EQA that laboratories perform can be used to identify unacceptable performance earlier than the usual 3 year NATA accreditation cycle, to help to minimise risk to patients. A more ‘real time’ review of performance.

Establishing an early warning system, based on minimum benchmarks that would be expected for corrective action or relative unacceptable performance compared to peers, identifies laboratories of concern early. Review of corrective action of persisting suboptimal performance by NATA at the time it was completed is also beneficial and assists in prevention of risk to patients.

Monitoring performance of EQA brings with it a level of anxiety and this must be balanced with the increased risk of collusion. While EQA is one of the most objective mechanisms of assessing performance, the fear of being ‘penalised’ continues to some degree and needs to continue to be addressed. In addition, stakeholder feedback indicates that enrolments for 2012 (for Anatomical Pathology) have decreased as a direct result of the Performance Monitoring project and therefore has impacted on business revenue. RCPA QAP would not want to be placed at an unfair disadvantage in an open market environment.

A framework was developed and an extensive consultation process highlighted several internal operational issues that need to be addressed by RCPA QAP such as selection of suitable cases for assessment and separate cases for educational purposes. More significantly the issue of enrolment for anatomical pathology laboratories needs addressing urgently and this should be done through the regulatory framework, in particular through NPAAC standards.

One major difficulty encountered during this project was the inability to send or receive any data from NATA, to validate the benchmarks and the process. Correlation of Chemical Pathology KPI data with NATA on‐site assessment records could not to be achieved. A further barrier is that RCPA QAP was unable to refer any results to NATA that met the established benchmarks. The Legal view received from Norton and Rose lawyers was that the RCPA QAP is not currently authorised to release quality assurance results of an Australian laboratory enrolled in a programme run by RCPA QAP to NATA. This barrier needs to be addressed at a regulatory level by the Department.

Further work needs to be undertaken to review and make the relevant changes to the Chemical Pathology KPI report by the PRC and key stakeholders. Similarly, anatomical pathology internal processes need to be reviewed and revised to ensure a fair and equitable assessment process for performance monitoring and this should be with key stakeholders. In addition a review of the regulatory requirement for enrolment in EQA for anatomical pathology laboratories/pathologists should be addressed, urgently, by the Department.

If these issues are addressed and barrier are removed then the proposed electronic platform, where the performance data of each laboratory was maintained in one area and both the laboratory and NATA could have access, would be a resource of great value. Performance issues would be highlighted and corrective actions could be recorded and signed off on the platform. Laboratory Directors, assessors and NATA could all view this information, easily and efficiently, all the while providing laboratories with real time monitoring of performance. This will enable laboratories to address problems immediately they occur and the end result should be improved quality which in turn should increase patient safety. In order to realise this great initiative which the RCPA QAP has had very positive feedback on, a considerable amount of software development is required.

Finally, RCPA QAP recommend that a further pilot phase of a minimum of two years is required to test the framework and benchmarks, which will give further time to overcome the barriers of validation of data with NATA and allow resolution of other internal RCPA issues within the Anatomical Pathology QAP.

Work has also begun in preparing performance benchmarks in Microbiology, Serology, Haematology and Immunology. It would be appropriate that any future continuation of the project includes these areas.