their direction and control. This plan must be documented as part of the laboratory Quality System. C1.3(i) The risk management plan must document major patient safety risks, the strategies proposed to mitigate those risks, and the implementation status of each mitigation strategy. C1.3(ii) Operation of this plan must be monitored and supported by compliance and reporting processes so that any material breach, non-compliance or failure of operation is notified to the Designated Person. This plan must be reviewed regularly for effectiveness and whenever there is a material change to the operation of the laboratory. The scope of the risk management plan required for the purposes of these is Requirements restricted to supervision arrangements S1.4 The Designated Person must perform a risk assessment of supervision arrangements that includes an assessment of the complexity of the tests performed, the number of tests performed, the qualifications and experience of scientific staff and the level of Pathologist supervision required when assessing potential risks to patient safety and resourcing of supervision within the laboratory. S1.5 The laboratory must have a documented clinical incident management system that includes requirements and processes for reporting, investigating and following up of clinical incidents, including open disclosure. C1.5(i) Responsibility and timeframes for actions arising from investigations must be clearly designated with actions commensurate with the level of risk to patient safety. S1.6 The Designated Person and all Pathologists and Clinical Scientists who are appointed as delegates must meet Continuing Professional Development requirements applicable to Scope of Practice. C1.6(i) Medical Practitioners must meet the Medical Board of Australia’s requirements for CPD. C1.6(ii) Clinical Scientists must provide evidence of their participation in CPD. 2. Categories of Medical Pathology Laboratories For the purposes of accreditation, pathology services are allocated one of the categories of accreditation specified in the Health Insurance (Accredited Pathology Laboratories – Approval) Principles 2002. The categories are summarised as: Category GX (General) A Medical Pathology Service comprising a laboratory, or a number of co-located laboratories, performing services in one or more Groups of Pathology Testing: under the full time supervision and clinical governance of a Designated Person who must be a Pathologist, and
their direction and control. This plan must be documented as part of the laboratory Quality System. C1.3(i) The risk management plan must document major patient safety risks, the strategies proposed to mitigate those risks, and the implementation status of each mitigation strategy. C1.3(ii) Operation of this plan must be monitored and supported by compliance and reporting processes so that any material breach, non-compliance or failure of operation is notified to the Designated Person. This plan must be reviewed regularly for effectiveness and whenever there is a material change to the operation of the laboratory. The scope of the risk management plan required for the purposes of these Requirements is restricted to supervision arrangements S1.4 The Designated Person must perform a risk assessment of supervision arrangements that includes an assessment of the complexity of the tests performed, the number of tests performed, the qualifications and experience of scientific staff and the level of Pathologist supervision required when assessing potential risks to patient safety and resourcing of supervision within the laboratory. S1.5 The laboratory must have a documented clinical incident management system that includes requirements and processes for reporting, investigating and following up of clinical incidents, including open disclosure. C1.5(i) Responsibility and timeframes for actions arising from investigations must be clearly designated with actions commensurate with the level of risk to patient safety. S1.6 The Designated Person and all Pathologists and Clinical Scientists who are appointed as delegates must meet Continuing Professional Development requirements applicable to Scope of Practice. C1.6(i) Medical Practitioners must meet the Medical Board of Australia’s requirements for CPD. C1.6(ii) Clinical Scientists must provide evidence of their participation in CPD. 2. Categories of Medical Pathology Laboratories For the purposes of accreditation, pathology services are allocated one of the categories of accreditation specified in the Health Insurance (Accredited Pathology Laboratories – Approval) Principles 2002. The categories are summarised as: Category GX (General) A Medical Pathology Service comprising a laboratory, or a number of co-located laboratories, performing services in one or more Groups of Pathology Testing: under the full time supervision and clinical governance of a Designated Person who must be a Pathologist, and