Sequence of events | Adult common RIs (1st group) | Paediatric common RIs |
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Identify problem | Lack of a nationally co-ordinated review of common RIs for routine pathology analytes for both adult and paediatric populations in Australasia. | |
Agree to address | Pathologists and Medical Scientists agreed to address common RIs at the same time as the RCPA PUTS and PITUS initiatives for standardisation of pathology units, terminology, and report formatting and flagging. | |
Identify relevant groups | In 2011 AACB formed a Harmonisation Committee consisting of both Chemical Pathologists and Medical Scientists from large public and private pathology networks to address various harmonisation issues including common RIs, management of critical laboratory results, biochemistry units and terminology, test panels, etc. | |
Seek formal co-operation (if external bodies involved) | AACB wrote to RCPA as well as to In Vitro Diagnostics Industry inviting their input into the Harmonisation Common RIs initiative. | |
Form working group | In 2012 the AACB Common RIs working party was revamped to include Chemical Pathologists, Medical Scientists, and RCPAQAP and industry representatives. | In 2012 the AACB Paediatric Biochemistry working party was formed and consisted of Chemical Pathologists from the 9 major paediatric laboratories in Australia and New Zealand. |
Describe problem in detail | The aim was to derive and validate common RIs through an evidence-based approach and extensive data analysis. | The aim was to survey paediatric RIs in use across Australasia and through a data mining approach to develop RIs covering birth to adulthood. |
Allocate a budget and determine sources of funding | Funding was provided by AACB, by Harmonisation workshops, and through an Australian Government’s Department of Health Quality Use of Pathology Project grant of A$60,000. | |
Gather information (surveys, RI studies, data mining, bias study, calibration traceability, RI verification laboratory information, flagging rates) | AACB Common RIs working party gathered evidence from the following sources:
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An extensive data mining exercise was conducted of over 1.8 million results received from 15 paediatric laboratories. |
Consider solutions | In May 2012 preliminary data from the Aussie Normals, bias and Sonic RI studies were reviewed and an initial set of adult common RIs developed at a 1-day meeting by the AACB Common RIs working party. Further data analysis was requested for some of the more difficult analytes; work continues for a second group of chemistry analytes. | Results of the Bhattacharya analysis were reviewed by the AACB Paediatric Biochemistry working party. |
Produce discussion paper, etc. | Preliminary information about harmonised RIs was disseminated through various publications in the AACB Clinical Biochemist Newsletter and 2012 harmonisation issues of the Clinical Biochemist Reviews, and by various lectures and posters including those given by Dr Ken Sikaris in the 2012 Current Concepts tour, at RCPA Pathology Update conference and at the 2012 and 2013 AACB Annual Scientific Conferences. harmonisation of RIs within Australasia. | |
Seek feedback from stakeholders | Representatives from all of the major laboratory networks together with invited clinicians and industry attended a series of three Harmonisation workshops convened by AACB in May 2012, July 2013 and April 2014 to discuss the evidence supporting common RIs. In late 2013 an Adult common RIs adoption spreadsheet was developed and sent to laboratories requesting confirmation of their intent to adopt the proposed general chemistry RIs. |
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Revise recommendations | AACB Common RIs working party met several times in 2013 and 2014 to review additional data and to plan for the workshops. | AACB Paediatric Biochemistry working party met before the workshops to discuss the paediatric RI data. |
Obtain formal endorsement | The first group of Adult and Paediatric common RIs was ratified at the 2014 workshop by the 55 delegates attending the meeting. Formal endorsement was received from the AACB Executive, the RCPA Chemical Pathology Advisory Committee and RCPA Board. |
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Publish | The tables of common RIs will be available through the RCPA website. Information about the common RIs is published in this issue of The Clinical Biochemist Reviews and more details are available on the AACB website at: http://www.aacb.asn.au/professionaldevelopment/harmonisation. |
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Promote | AACB and RCPA will continue to promote and update common RIs through their working parties. | |
Monitor introduction | RCPAQAP Liquid Serum Chemistry program provides a mechanism to audit the uptake of common RIs by laboratories. Future harmonisation workshops are planned to develop common RIs for other chemistry and endocrine analytes. |