What does 4.14 require?

M laboratory testing is confined to four disciplines, haematology without immunohaematology, chemical pathology, microbiology (identifying clinically significant organisms and their antimicrobial susceptibility) and immunology, and uses only IVD devices that are included in the ARTG or otherwise lawfully supplied under the therapeutic goods regime.

Australia National Pathology Standards (First Edition...

Other controls in Standard 4: Pathology laboratory supervision – Australia National Pathology Standards (First Edition 2027)

4.01 GX laboratory designated person: a full-time pathologist appointee who supervises only within scope, delegates supervision of tests outside their scope to pathologists with the relevant scope at GX, GY and B laboratories in the network, and may delegate supervision of laboratory operations and the preanalytical and analytical phases to scientists and clinical scientists with an appropriate scope
4.02 GX laboratory pathologist and clinical scientist supervision: at least one full-time equivalent pathologist with the relevant scope who is onsite in a laboratory 80 percent of the time and readily available with delegated supervision for each test, a risk assessment of complex tests to decide whether adding a clinical scientist would improve quality, at least one clinical scientist with delegated responsibility for the analytical phase of each tissue typing, complex toxicology and complex genomics test, and a process to set the clinical scientist's full-time equivalency
4.03 GY and B laboratories are associated with the GX laboratory in the same pathology network, and the GX designated person holds responsibility for their clinical governance
4.04 GY and B laboratories operate under the network supervision framework the designated person developed, with onsite supervising pathologists of appropriate scope providing supervision where possible and network pathologists covering supervisory gaps
4.05 GY and B laboratories: undertake a documented, ongoing risk assessment of the adequacy of onsite supervision covering test volume, complexity and acuity, workforce composition and capability, error and incident data and feedback and complaints, and implement onsite supervision commensurate with the risk where patient safety, quality or service integrity may be compromised
4.06 GX, GY and B clinical governance: run a common clinical governance system across GX, GY and B laboratories
4.07 GY and B laboratories receive effective virtual supervision through at least monthly meetings with time for safety, quality and operational performance, annual visits by skilled and qualified workforce members delegated by the designated person to review operations, onsite managers integrated into the network management structure, and onsite managers who spend at least two full-time equivalent days a year in supervised training or professional development in another laboratory
4.08 S laboratory: perform a limited range of tests for a target population related to the designated person's qualifications, skills and scope, apply for GX status if wider testing is planned, and have a designated person who is a specialist medical practitioner (not a pathologist) able to supervise SB laboratories in the network when onsite supervision is unavailable and to delegate operations and preanalytical and analytical phases to scientists and clinical scientists with appropriate scope

Query this from an agent

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