The HRI Working Group met again in December 2013 in Sydney to finalise the Paediatric Reference intervals and further review additional data on the Adult Reference Intervals including the potential impact on flagging rates as presented by Dr Ken Sikaris from Sonic Pathology, a major private pathology lab. HRIWG convened in February 2014 to finalise the program and speakers for the 3rd Stakeholder Harmonisation Workshop that was held in Sydney on 30 April and 1 May. 55 delegates representing all the major public and private pathology networks across Australia were presented. This meeting also coincided with a meeting attended by international harmonisation experts who kindly agreed to present at the workshop. Further analysis and group discussions achieved final consensus on the majority of adult and paediatric reference intervals under consideration A full listing of all the Workshop presentations and related outcomes is available on the AACB Website under the Professional Development, Scientific Regulatory Affairs Committee (SRAC) and Harmonisation tab. See also: Project Activity Plan – Appendix 1 Figures 1A and 1B summarise the above evidence based methodologies employed by the Adult and Paediatric HRI Committees. 5.3 Analysis of proposed reference intervals with checklist/ spreadsheet tools and validation of proposed reference intervals A spreadsheet tool (developed by Graham Jones) was disseminated to laboratories across Australia and New Zealand. Laboratories were asked to extract their own data from their laboratory information systems and use the spreadsheet to analyse. The spreadsheet had embedded formulas to enable Bhattacharya analysis of the extracted laboratory data and proved to be a valuable tool for validating the proposed HRI’s.13 The spreadsheet data was then compiled into a master document for further review by the HRIWG. 5.4 Flagging rates An additional tool was introduced at the May 2014 Workshop by Ken Sikaris when he presented an analysis of the impact of the proposed HRI’s on “flagging rates” for Sonic patients. In theory, a workable (95%) reference interval should only flag an abnormal result for 5% (2.5% low and 2.5% high) of the “normal” population. Figure 1A. based / consultation approach for Harmonised Adult Reference Intervals
The HRI Working Group met again in December 2013 in Sydney to finalise the Paediatric Reference intervals and further review additional data on the Adult Reference Intervals including the potential impact on flagging rates as presented by Dr Ken Sikaris from Sonic Pathology, a major private pathology lab. HRIWG convened in February 2014 to finalise the program and speakers for the 3rd Stakeholder Harmonisation Workshop that was held in Sydney on 30 April and 1 May. 55 delegates representing all the major public and private pathology networks across Australia were presented. This meeting also coincided with a meeting attended by international harmonisation experts who kindly agreed to present at the workshop. Further analysis and group discussions achieved final consensus on the majority of adult and paediatric reference intervals under consideration A full listing of all the Workshop presentations and related outcomes is available on the AACB Website under the Professional Development, Scientific Regulatory Affairs Committee (SRAC) and Harmonisation tab. See also: Project Activity Plan – Appendix 1 Figures 1A and 1B summarise the above evidence based methodologies employed by the Adult and Paediatric HRI Committees. 5.3 Analysis of proposed reference intervals with checklist/ spreadsheet tools and validation of proposed reference intervals A spreadsheet tool (developed by Graham Jones) was disseminated to laboratories across Australia and New Zealand. Laboratories were asked to extract their own data from their laboratory information systems and use the spreadsheet to analyse. The spreadsheet had embedded formulas to enable Bhattacharya analysis of the extracted laboratory data and proved to be a valuable tool for validating the proposed HRI’s.13 The spreadsheet data was then compiled into a master document for further review by the HRIWG. 5.4 Flagging rates An additional tool was introduced at the May 2014 Workshop by Ken Sikaris when he presented an analysis of the impact of the proposed HRI’s on “flagging rates” for Sonic patients. In theory, a workable (95%) reference interval should only flag an abnormal result for 5% (2.5% low and 2.5% high) of the “normal” population. Figure 1A. based / consultation approach for Harmonised Adult Reference Intervals
Harmonisation.docx