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

Australia National Pathology Standards (First Edition 2027) 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

What does 10.05 require?

Quality control is overseen by the designated person. Every assay has a written control procedure that tests its performance and that sets control targets at clinical decision levels, the results that make patient testing acceptable, and fallback controls where no internal control material exists. When a control fails, a written escalation procedure is followed and the patient specimens run between the last passing control and the first failing one are reviewed. Control performance is monitored, corrective action taken and reported, and control results are recorded and kept as the relevant standards require.

Maintained by Gerard Blokdyk

What else in your programme already covers this

This control maps to 1 controls across 1 other frameworks. If you already hold one of them, the evidence you collected for it is the starting point here rather than new work.

Every mapping shown was judged rather than inferred from wording similarity, and the ones that failed review are published too. See the coverage reports and what was rejected.

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

Query this from an agent

The graph holds this control, the 1 it maps to, and the evidence behind each claim, over MCP and REST.