What does 10.09 require?

A waste management policy is in place and the disposal of biological material from testing complies with the rules of each jurisdiction.

Australia National Pathology Standards (First Edition...

Other controls in Standard 10: Specimen testing – Australia National Pathology Standards (First Edition 2027)

10.01 Analytical and clinical performance requirements: document for every area of testing the analytical and clinical performance requirements using key indicators for quantitative analysis (including accuracy, precision, limits of detection, units of measure and common interferences) and for qualitative analysis
10.02 Analytical and clinical performance: ensure analytical performance meets the assay's clinical application, support morphological and interpretive diagnostic performance through peer review, internal and external quality assurance, confine unverified tests to exceptional circumstances or rare or new diseases, use peer consultation for new or uncommon morphological assessments, confirm comparability across methods and devices, support morphological comparability through documented peer review and case comparison, and keep authorised test procedures available including which specimen types or diagnoses need mandatory peer review, the peer review process and the handling of discordant diagnoses
10.03 Measurement uncertainty process: for quantitative assays define the measurand, indicate the laboratory's confidence in each measurement, provide information for interpreting results and comparing them over time, set clinically appropriate imprecision goals, identify significant uncertainty sources and reduction opportunities, and use statistically adequate replicate numbers or statistical methods that account for fewer replicates
10.04 Measurement uncertainty use: match the effort spent on uncertainty to the clinical quality requirements, set routine performance goals and reduce uncertainty sources when goals are missed, use the process to show assays meet acceptable performance goals and are clinically applicable and to identify tests where estimation is not possible and minimise their risks, make uncertainty data available to requesters and other providers, and use it for data monitoring and troubleshooting of specific tests
10.05 Quality control process: the designated person oversees quality control, every assay has a documented quality control process assessing performance, the process specifies the criteria for control targets at clinical decision levels and acceptable results for patient testing and alternative mechanisms when internal controls are unavailable, a documented escalation procedure on control failure reviews specimens measured between the last successful and first failed control, performance is monitored with corrective action and reports, and control results are documented and retained per the relevant standards
10.06 Frequency of quality control testing: test control samples at a frequency based on the stability and robustness of the method and the risk of patient harm, and additionally when critical consumables change, when confidence in a result's reliability or accuracy is in question, and after substantial equipment maintenance or damage
10.07 Test procedures: align with best practice guidelines, follow the manufacturer's instructions or the practice's validated and authorised variation, maintain specimen integrity through testing, reporting and disposal, follow a documented standard procedure traceable to the specimen tested, stay readily available to the workforce, and be reviewed regularly
10.08 Test results: ensure the workforce determining results are competent, work in optimal conditions with appropriate equipment for interpretation, have evidence-based reference intervals and clinical decision limits; ensure results are correct, evaluated against internal controls, timely, unambiguous, clinically relevant and traceable to the request; flag on the report that diagnostic validity is not established for clinically non-validated tests; and document critical result thresholds and escalation processes

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The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.

MCP endpoint All Australia National Pathology Standards (First Edition 2027) controls