Back to Frameworks
Australia National Pathology Standards (First Edition 2027)
Australia
vFirst Edition 2027, published by the Australian Commission on Safety and Quality in Health Care in 2026 (ISBN 978-1-922563-63-7), 74 pages; held copy National-Pathology-Standards-first-edition-2027-2.pdf
11 domains
88 controls
Australia's National Pathology Standards, First Edition 2027: the eleven accreditation standards and eighty-eight actions a pathology practice must meet under the National Pathology Accreditation Scheme, from clinical governance and supervision by laboratory category to specimen collection, testing quality, medical devices including AI, and point of care testing.
Verified
Australia National Pathology Standards (First Edition 2027) is a compliance framework from Australia with 11 domains and 88 controls that map to 5 other frameworks. The largest domains are Standard 4: Pathology laboratory supervision – Australia National Pathology Standards (First Edition 2027) (17 controls), Standard 10: Specimen testing – Australia National Pathology Standards (First Edition 2027) (12 controls), Standard 2: Safety and quality systems – Australia National Pathology Standards (First Edition 2027) (10 controls). Every control below carries what it requires and what an assessor expects to see.
Maintained by Gerard Blokdyk
Framework summaries on this platform are interpretations grounded in the published source, for educational and compliance planning purposes. They do not reproduce or replace the official standards. Refer to the authoritative source for the definitive text. Framework names and trademarks belong to their respective organisations.
Framework Domains (11)
Standard 10: Specimen testing – Australia National Pathology Standards (First Edition 2027)
12 controls
| Code | Title |
|---|---|
| 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 |
| australia-national-pathology-standards-first-edition-2027::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 |
| australia-national-pathology-standards-first-edition-2027::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 |
| australia-national-pathology-standards-first-edition-2027::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 |
| 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 |
| australia-national-pathology-standards-first-edition-2027::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 |
| australia-national-pathology-standards-first-edition-2027::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 |
| australia-national-pathology-standards-first-edition-2027::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 |
| australia-national-pathology-standards-first-edition-2027::10.09 | Disposal of biological material: hold a waste management policy and comply with jurisdictional regulations on the disposal of biological material from pathology testing |
| australia-national-pathology-standards-first-edition-2027::10.10 | External quality assurance programs: participate in EQA for the preanalytical, analytical and postanalytical phases of every test or test group with an available program, assess program suitability against predefined criteria including ISO 17043, keep the supervising medical practitioner in oversight, test and report EQA material like routine specimens wherever possible, document acceptable performance criteria, review results for acceptability against the practice's risk analysis, investigate discordance promptly and assess and correct any impact on patient results, and notify the designated person of serious and persistent poor performance |
| australia-national-pathology-standards-first-edition-2027::10.11 | Morphological external quality assurance: ensure every workforce member involved in morphological diagnosis takes part in at least one relevant EQA program a year, retain individual participation records, review results and follow up discordance, and state clearly where submissions are collegiate |
| australia-national-pathology-standards-first-edition-2027::10.12 | Internal quality assurance: where no suitable EQA exists, use alternative internal quality assurance for the preanalytical, analytical and postanalytical phases, addressing high-risk collection and testing areas through comparison with other accredited laboratories, demonstrating result validity through reference material or interlaboratory comparison such as sample exchange, and using peer review through formal sample exchange, formal second opinion or informal second opinion to compare diagnoses |
Standard 11: Point of care testing – Australia National Pathology Standards (First Edition 2027)
7 controls
| Code | Title |
|---|---|
| australia-national-pathology-standards-first-edition-2027::11.01 | Contracted PoCT services: where the practice coordinates point of care testing for a health service, hold an agreement that specifies each party's roles and responsibilities |
| australia-national-pathology-standards-first-edition-2027::11.02 | PoCT roles and responsibilities: ensure the workforce performing point of care testing are skilled, competent and within scope, can perform, interpret, monitor and produce reliable results, and understand their PoCT roles, responsibilities and accountabilities with support to fulfil them |
| australia-national-pathology-standards-first-edition-2027::11.03 | PoCT training: scale training to device complexity, test volume, operator frequency and quality assessment findings; have a qualified person deliver defined training covering at minimum specimen labelling, collection, testing procedure, result interpretation and follow-up, critical result recognition, documentation, causes of inaccurate results, troubleshooting, alternative methods, device cleaning and maintenance, quality control, and ordering and storage of reagents and controls; deem operators competent before testing; keep them current and recertified; review training periodically; and review roles, knowledge and skills regularly and when a device or service changes |
| australia-national-pathology-standards-first-edition-2027::11.04 | PoCT performance management: review the performance of workforce members undertaking point of care testing to ensure competence, and identify their training, development and supervision needs |
| australia-national-pathology-standards-first-edition-2027::11.05 | Interprofessional collaboration: when coordinating point of care testing for health services, provide opportunities for collaboration between the practice's workforce and the clinicians using PoCT |
| australia-national-pathology-standards-first-edition-2027::11.06 | PoCT procedures: in addition to the practice's test procedures, ensure PoCT procedures include traceability of samples to the original specimen, patient and device, include reference intervals for identifiable patient groups, and are audited regularly for workforce compliance |
| australia-national-pathology-standards-first-edition-2027::11.07 | PoCT test results: ensure results and related information from point of care devices are included in the patient's healthcare record, automatically where possible |
Standard 1: Clinical governance – Australia National Pathology Standards (First Edition 2027)
9 controls
| Code | Title |
|---|---|
| australia-national-pathology-standards-first-edition-2027::1.01 | Governance, leadership and culture: the governing body endorses the clinical governance and risk frameworks, puts patient safety and appropriate test use ahead in business and continuity decisions, is trained for its role, ensures lawful and ethical operation, appoints the designated person, sets strategic priorities, manages conflicts of interest, monitors performance and acts on commercial pressures that could compromise quality |
| australia-national-pathology-standards-first-edition-2027::1.02 | Designated person: the governing body places delivery of pathology services under the direction and control of an Ahpra-registered medical practitioner residing in Australia with the authority and scope to perform the role, whose responsibilities span the clinical governance framework, supervision delegation, risk management, quality systems, workforce oversight and competence, the test repertoire and methods, test volumes sufficient for competence, referral laboratory suitability and critical result policies |
| australia-national-pathology-standards-first-edition-2027::1.03 | Delegations: operate an authorisation process that delegates responsibility for aspects of the practice only to workforce members with the qualifications and skills for the task who work within their scope of practice |
| australia-national-pathology-standards-first-edition-2027::1.04 | Legislation and standards: comply with applicable Commonwealth, state and territory legislation and regulations, the relevant NPAAC standards and, where no NPAAC standard covers a matter, ISO 15189 |
| australia-national-pathology-standards-first-edition-2027::1.05 | Contracted services: where the practice subcontracts or coordinates pathology services for other organisations, ensure subcontractors are accredited to the relevant NPAAC standards or a recognised equivalent such as ISO 17025 where NPAAC standards do not apply, and liaise with the subcontractor's scientific, clinical and administrative staff |
| australia-national-pathology-standards-first-edition-2027::1.06 | Referral laboratories: ensure Australian referral laboratories are accredited to the relevant NPAAC standards and ISO 15189, prefer accredited international laboratories, communicate costs and consequences such as data security to clinicians and patients, keep responsibility for packaging, transport and handover of international specimens, manage turnaround risks, receive reports and agree in writing who communicates critical results |
| australia-national-pathology-standards-first-edition-2027::1.07 | Environmental sustainability: use the governance systems to implement best practice strategies that reduce the practice's environmental impact |
| australia-national-pathology-standards-first-edition-2027::1.08 | Information governance: implement interoperable health information systems conformant with national digital health standards and legislation, monitor data quality, keep laboratory information systems lawful, secure and privacy-compliant, run an information security management system with role-based access, protection in transit and at rest, regular vulnerability assessment, reporting to the governing body and data breach response, orient and monitor the workforce, and mitigate patient safety risk from delayed adoption of new digital standards |
| australia-national-pathology-standards-first-edition-2027::1.09 | Artificial intelligence governance: implement an AI management system consistent with relevant international standards such as ISO/IEC 42001 |
Standard 2: Safety and quality systems – Australia National Pathology Standards (First Edition 2027)
10 controls
| Code | Title |
|---|---|
| australia-national-pathology-standards-first-edition-2027::2.01 | Policies and procedures: establish policies and processes for every laboratory and service, make them readily available to the workforce and support their use, monitor and improve workforce performance, review them for currency and effectiveness, and keep them compliant with legislation, regulation and jurisdictional requirements |
| australia-national-pathology-standards-first-edition-2027::2.02 | Risk management: establish and operate a risk management system that identifies, reviews and mitigates risks, records safety and quality risks in the risk plan, uses clinical and other data in assessments, acts on risks through the quality and other systems, involves the workforce, reports risks to the governing body, designated person and workforce, evaluates the system's effectiveness and audits it |
| australia-national-pathology-standards-first-edition-2027::2.03 | Ongoing service provision: maintain business continuity plans, reviewed regularly and improved, that keep pathology services running through disruptions, emergencies and disasters |
| australia-national-pathology-standards-first-edition-2027::2.04 | Adaptable and resilient systems: manage software updates and system changes through a change control process, validate and test changes affecting regulated software before clinical use, communicate outages to staff and users, and keep systems reviewed and updated to industry standards |
| australia-national-pathology-standards-first-edition-2027::2.05 | Interoperable information systems: use national healthcare identifiers for patients, organisations and providers, apply standard information structures and national terminologies including the SPIA guidelines, align with jurisdictional and industry interoperability standards such as the Australian HL7 diagnostic messaging standard, and have processes to adopt new versions and standards as they emerge |
| australia-national-pathology-standards-first-edition-2027::2.06 | Appropriate care: identify, assess and implement contemporary evidence-based pathology services and technologies that improve clinical care, and identify and reduce pathology services that are unnecessary or fall short of quality standards |
| australia-national-pathology-standards-first-edition-2027::2.07 | Quality management systems: collect and interpret safety and quality data on specimen collection, integrity, traceability and testing, equipment testing, result interpretation and reporting, incident and error rates and turnaround times; monitor and report performance and improvement activities; give the governing body, designated person and workforce access to the data; involve the workforce in improvement reviews; and audit the system's effectiveness |
| australia-national-pathology-standards-first-edition-2027::2.08 | Incident management: support the workforce to recognise and report incidents and involve them in review, let consumers and requesters raise concerns, nominate investigators with risk-proportionate timeframes, escalate significant incidents to the designated person, document incidents, investigations, corrective actions and whether risk fell, report to the designated person, workforce and governing body, use analysis to improve, and review the system's effectiveness |
| australia-national-pathology-standards-first-edition-2027::2.09 | Open disclosure: use an open disclosure process consistent with the Australian Open Disclosure Framework and monitor and improve its use and effectiveness |
| australia-national-pathology-standards-first-edition-2027::2.10 | Feedback and complaints management: document feedback and complaints from requesters, patients, families and carers, inform the designated person, escalate and correct where communications suggest adverse clinical impact, respond in a timely way and tell complainants the outcome, provide information on the healthcare complaints authority, record timeliness and improvements, and analyse feedback to improve safety and quality |
Standard 3: Pathology test supervision – Australia National Pathology Standards (First Edition 2027)
4 controls
| Code | Title |
|---|---|
| australia-national-pathology-standards-first-edition-2027::3.01 | Supervision requirements: ensure the workforce delegated to supervise pathology tests understand their responsibilities and are trained for them, support requesters with enquiries, test selection and result interpretation, manage the performance, development and education of the workforce they supervise, oversee incident management, identify and manage risk, manage internal and external quality assurance and internal quality control, manage feedback and complaints, manage equipment and medical devices across their lifecycle, and take part in auditing supervision effectiveness |
| australia-national-pathology-standards-first-edition-2027::3.02 | Supervision framework: document a supervision framework that delegates supervision of every pathology test to supervising medical practitioners within their scope of practice, ensures the workforce mix gives appropriate oversight of all tests, records the aspects of testing delegated to clinical scientists within scope, identifies who is responsible for supervision during operational hours, and audits compliance regularly |
| australia-national-pathology-standards-first-edition-2027::3.03 | Workforce and supervision risks: record and rate supervision risks from vacancies and extended leave in the risk system, rate skills and supervisory gaps from vacancy or extended leave as critical risks, act to mitigate them, set the risk level for supervising tests from workforce qualifications and experience, test volume, complexity and acuity, and error, feedback, complaint and outcome data, and have the designated person periodically review supervision arrangements and mitigate gaps when they occur |
| australia-national-pathology-standards-first-edition-2027::3.04 | Mitigating supervision risks: actively recruit to vacancies and give supervising medical practitioners, clinical scientists and scientists access to training and experience that maintains or extends their scope of practice |
Standard 4: Pathology laboratory supervision – Australia National Pathology Standards (First Edition 2027)
17 controls
| Code | Title |
|---|---|
| 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 |
| australia-national-pathology-standards-first-edition-2027::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 |
| australia-national-pathology-standards-first-edition-2027::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 |
| australia-national-pathology-standards-first-edition-2027::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 |
| australia-national-pathology-standards-first-edition-2027::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 |
| australia-national-pathology-standards-first-edition-2027::4.06 | GX, GY and B clinical governance: run a common clinical governance system across GX, GY and B laboratories |
| australia-national-pathology-standards-first-edition-2027::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 |
| australia-national-pathology-standards-first-edition-2027::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 |
| australia-national-pathology-standards-first-edition-2027::4.09 | Complex genomic testing in S laboratories: where an S laboratory performs complex genomic testing, both a genetic pathologist and a clinical scientist with relevant scope supervise comprehensive genome, exome and large panel sequencing, non-invasive prenatal testing, embryo genomic profiling and cytogenetics |
| australia-national-pathology-standards-first-edition-2027::4.10 | SB laboratories are associated with an S laboratory in the same pathology network |
| australia-national-pathology-standards-first-edition-2027::4.11 | Each SB laboratory has full-time supervision and clinical governance from an S laboratory designated person, a supervision framework that person developed, supervising specialist medical practitioners with appropriate scope for each test, and network specialists to cover supervisory gaps |
| australia-national-pathology-standards-first-edition-2027::4.12 | S and SB clinical governance: run a common clinical governance system across S and SB laboratories, give SB laboratories effective virtual supervision through at least monthly meetings with time for safety, quality and operations and annual visits by qualified, experienced and authorised reviewers, and have onsite managers spend at least two full-time equivalent days a year in supervised training or professional development at another laboratory |
| australia-national-pathology-standards-first-edition-2027::4.13 | M laboratory: perform a limited range of tests only for patients of the associated medical practice, consistent with the designated person's qualifications, skills and defined scope |
| australia-national-pathology-standards-first-edition-2027::4.14 | M laboratory test scope: provide tests using IVD medical devices included in the ARTG or otherwise permitted under the therapeutic goods framework, from haematology (excluding immunohaematology), chemical pathology, microbiology and immunology only |
| australia-national-pathology-standards-first-edition-2027::4.15 | M laboratory designated person: a medical practitioner competent to provide the tests performed, who has completed a training program in the operation, monitoring and use of the instruments as described in manufacturer and laboratory manuals and any legislative requirements, and who has scientific knowledge and experience with the laboratory's equipment and analytical procedures |
| australia-national-pathology-standards-first-edition-2027::4.16 | M laboratory supervision framework: delegations clearly set out who holds authority for pathology tests during operational hours |
| australia-national-pathology-standards-first-edition-2027::4.17 | M laboratory competence: the designated person assesses the skills and competence of the workforce performing pathology tests every year |
Standard 5: Workforce performance and effectiveness – Australia National Pathology Standards (First Edition 2027)
3 controls
| Code | Title |
|---|---|
| australia-national-pathology-standards-first-edition-2027::5.01 | Pathology workforce roles and responsibilities: confirm qualifications, knowledge, experience, skills and recency of practice, define functions and responsibilities and support their fulfilment, implement mandatory professional practice training and competency assessment for the non-medical workforce, support quality assurance participation and continuing professional development, monitor that staff work within defined roles and scope, and review roles periodically and when devices or services change |
| australia-national-pathology-standards-first-edition-2027::5.02 | Training to improve the quality of patient care: orient and train the workforce in their safety and quality roles on commencement and when those responsibilities change, provide access to training to meet the NPAAC standards, and monitor participation |
| australia-national-pathology-standards-first-edition-2027::5.03 | Evidence-based care: give the workforce ready access to professional and best practice guidelines, decision-support tools and resources relevant to their practice, and support their use to improve practice |
Standard 6: Partnering with consumers – Australia National Pathology Standards (First Edition 2027)
5 controls
| Code | Title |
|---|---|
| australia-national-pathology-standards-first-edition-2027::6.01 | Healthcare rights: deliver person-centred care aligned to a charter of rights consistent with the Australian Charter of Healthcare Rights, support the workforce to apply its principles, and make the charter available wherever staff interact directly with patients and carers |
| australia-national-pathology-standards-first-edition-2027::6.02 | Informed consent: ensure consent processes comply with legislation, enable patients to consent to specimen collection and, where required, to testing, give transparent financial information including out-of-pocket costs before collection where known, and undertake privacy assessments on the collection, storage and distribution of identifiable and de-identified data and results |
| australia-national-pathology-standards-first-edition-2027::6.03 | Decision-making: at collection centres identify patients who need support to make decisions, give them access to that support and involve supporters and substitute decision-makers in line with the patient's preferences and legislation, and communicate in ways that meet individual needs |
| australia-national-pathology-standards-first-edition-2027::6.04 | Accessing specimen collection services: make information available to patients and carers on the collection services offered, contact details, locations, opening hours, bookings and access, access limitations, prerequisites and preparation, follow-up and aftercare, easy-to-understand self-collection instructions aligned to the collection manuals, and how to give feedback and complain |
| australia-national-pathology-standards-first-edition-2027::6.05 | People with diverse care needs: provide a safe environment and deliver person-centred, culturally safe care when collecting specimens and communicating results |
Standard 7: Communicating for safety – Australia National Pathology Standards (First Edition 2027)
6 controls
| Code | Title |
|---|---|
| australia-national-pathology-standards-first-edition-2027::7.01 | Supporting requesters: advise on available services, request requirements including the clinical information needed, appropriateness, limitations, prerequisites and preparation, communicate accurate and complete information in a timely manner, keep a competent workforce member available to answer enquiries, and make the designated person or delegated supervisors available for virtual consultation |
| australia-national-pathology-standards-first-edition-2027::7.02 | Patient identification and service matching: define and approve at least three patient identifiers for the record and primary specimen label, include national health identifiers when available, match the patient to specimen and service, have patients confirm label accuracy where able, label the primary specimen and report with the approved identifiers, link primary and secondary samples, handle anonymous patients and merge duplicate records, use approved identifiers at collection, electronic request, testing, interpretation and reporting, correct discrepancies promptly and document them in the healthcare record and incident system |
| australia-national-pathology-standards-first-edition-2027::7.03 | Communicating results: use a results system that supports interoperability through SPIA-aligned terminology and structures, addresses report structure and content, delivers accurate, clear, concise and verified reports to requesters, patients and other providers within clinically appropriate timeframes, keeps a competent person available to interpret results, identifies and documents provisional reports, completes final reports before release, provides reports directly to patients on request and uploads to the national health record as regulation requires, retains specimens and reports for the defined periods, and keeps report amendments documented and traceable |
| australia-national-pathology-standards-first-edition-2027::7.04 | Reporting critical results: use processes that promptly recognise critical results (preferably automated), interpret and report them in a timely manner across all operational periods including after hours and handovers, notify the requester promptly and otherwise a responsible clinician and where appropriate the patient or carer, document the escalation steps, monitor, audit and review the process including failures, delays and near misses, and identify and communicate critical results during system failure or downtime |
| australia-national-pathology-standards-first-edition-2027::7.05 | Healthcare records: collect, store and share patient information and pathology records in line with national and jurisdictional legislation including sharing-by-default requirements, create and maintain complete, accurate and current records aligned to patient consent, use standard information structures and terminology, manage records lawfully on amalgamation, merger or closure, and train the workforce in record-keeping requirements |
| australia-national-pathology-standards-first-edition-2027::7.06 | Notifiable diseases: document and report notifiable diseases to the relevant authorities and disease registries in accordance with jurisdictional requirements |
Standard 8: Medical devices – Australia National Pathology Standards (First Edition 2027)
7 controls
| Code | Title |
|---|---|
| australia-national-pathology-standards-first-edition-2027::8.01 | Medical device implementation and replacement: ensure devices are on the ARTG or, if developed in-house, validated to ISO 15189 and compliant with NPAAC and regulatory requirements; consult and manage change; assess suitability for patient care; evaluate and verify against the manufacturer's claimed specifications; validate performance with recognised reference standards or methods; complete calibration, quality control and quality assurance before implementation; manage ageing or underperforming devices; and monitor and periodically review performance with revalidation after significant change, new evidence or identified risk |
| australia-national-pathology-standards-first-edition-2027::8.02 | Medical device use: use devices for their intended purpose per the manufacturer's instructions for use, classify commercial IVDs used outside their intended purpose (such as unspecified specimen types) as in-house IVDs, and comply with the relevant NPAAC standards and TGA requirements |
| australia-national-pathology-standards-first-edition-2027::8.03 | Medical device maintenance: keep a current and complete device inventory, store devices per the manufacturer's instructions, use in-date reagents and consumables per the instructions for use, perform planned maintenance and repair per the instructions using qualified personnel, performance-test devices after maintenance and repair, and maintain each device's maintenance and repair log |
| australia-national-pathology-standards-first-edition-2027::8.04 | In-house IVD medical devices: validate clinical and analytical performance, comply with TGA requirements for in-house IVDs, assess against the NPAAC in-house IVD requirements, demonstrate through validation that performance is fit for purpose and supports safe care, hold documented validation evidence covering methodology, performance characteristics and acceptance criteria, and keep in-house IVDs under ongoing quality assurance |
| australia-national-pathology-standards-first-edition-2027::8.05 | Adverse medical device events: report adverse events involving commercial and in-house IVD medical devices to the TGA within the specified timeframes, in the required format and in line with regulatory requirements |
| australia-national-pathology-standards-first-edition-2027::8.06 | IVD software and AI governance and implementation: ensure commercial IVD software is on the ARTG and in-house IVD software including diagnostic AI is managed as an in-house IVD under NPAAC, TGA and best practice requirements; govern selection, implementation and use within the clinical governance and risk framework including privacy, cybersecurity and data integrity; undertake a privacy impact assessment covering third-party processing; confirm performance for intended use, population and context through acceptance testing and commissioning; evaluate AI performance before clinical use and monitor it over time; and evaluate performance on data relevant to the intended population where training data are not Australian |
| australia-national-pathology-standards-first-edition-2027::8.07 | IVD software and AI clinical use and oversight: use IVD software and AI only for their intended purpose and with evidence of clinical benefit or improved accuracy, efficiency or decision-making; train the workforce to use them, understand limitations and apply clinical judgement to AI-assisted outputs; monitor that staff stay within role and scope; define responsibility for reviewing, correcting and approving AI-assisted results within the supervision framework; communicate AI use to patients transparently where clinically appropriate without diminishing the medical practitioner's responsibility; and document, investigate and report significant AI incidents |
Standard 9: Specimen collection – Australia National Pathology Standards (First Edition 2027)
8 controls
| Code | Title |
|---|---|
| australia-national-pathology-standards-first-edition-2027::9.01 | Specimen collection environment: comply with regulations and jurisdictional requirements, design, maintain and equip facilities to support safe care, provide fit-for-purpose and well-maintained facilities and devices that meet patient needs, give clear signage and directions, protect privacy, dignity and safety, have fall prevention in place, plan for unpredictable behaviour, and separate collection from testing so patients cannot enter testing areas or reach supplies, devices and specimens |
| australia-national-pathology-standards-first-edition-2027::9.02 | Infection prevention and control in collection centres: keep a clean, safe and hygienic environment consistent with the national infection control guidelines and state or territory requirements, clean and disinfect devices with ARTG-listed products per the manufacturer's instructions and frequencies, comply with work health and safety regulations on infection control, apply standard and transmission-based precautions, follow the National Hand Hygiene Initiative, and meet the Australian Immunisation Handbook and jurisdictional vaccination requirements for the workforce |
| australia-national-pathology-standards-first-edition-2027::9.03 | Recognising acute deterioration and escalating care: implement processes to respond promptly when a patient's physical or cognitive state deteriorates acutely, have referral pathways and escalation processes matched to the identified risks, keep collectors' skills current in recognising and responding to deterioration, and notify the requester or responsible provider when a patient's care is escalated |
| australia-national-pathology-standards-first-edition-2027::9.04 | Request assessment: perform services only on a documented request naming the patient, requesting practitioner and services, assess Medicare-funded requests for compliance with the Health Insurance Act, manage requests with insufficient or incorrect information, and document verbal requests for further testing and receipt of the confirmatory written request |
| australia-national-pathology-standards-first-edition-2027::9.05 | Specimen collection processes: describe each service, its purpose, the standard collection procedure, temperature-controlled storage needs and maximum storage time; keep processes documented, regularly reviewed and readily accessible; adhere to the equipment's instructions for use; align with best practice guidelines; and include processes for collection in a patient's residence and for patient self-collection |
| australia-national-pathology-standards-first-edition-2027::9.06 | Optimising specimen collection: keep consumables available, in date and easy to find and use, have the collection workforce maintain specimen integrity through correct preparation, collection, packaging and transport, and have processes for inadequately labelled specimens and specimen integrity failures |
| australia-national-pathology-standards-first-edition-2027::9.07 | Specimen storage: provide dedicated, suitable and secure storage at the required temperature, follow and document safety, stability and security requirements for specimens retained at a collection centre, and store specimens at the collection centre for the shortest possible time before transport to the laboratory |
| australia-national-pathology-standards-first-edition-2027::9.08 | High acuity settings and critical requests: ensure high acuity settings know who collects and transports specimens, use evidence-based approaches so testing occurs within the clinically optimal timeframe, identify, track and monitor high acuity and critical request samples through the laboratory, give high acuity requesters access to turnaround times and the critical result process, and let requesters flag a suspected or confirmed critical request so testing and reporting are expedited |
Your Compliance Coverage
If you comply with Australia National Pathology Standards (First Edition 2027), you already cover:
ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence
50%
44 controls mapped
Compare →Australia National Safety and Quality Health Service (NSQHS) Standards Second Edition
26%
23 controls mapped
Compare →Australia Health Insurance (Accredited Pathology Laboratories, Approval) Principles 2017
8%
7 controls mapped
Compare →+ 2 more: ISO/IEC 42001:2023 (1%), ISO 14001:2015 (1%)
See all 5 mapped frameworks ↓Maps to 5 other frameworks
88 total controls
ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence
44 source controls mapped|34 target controls covered
50%
Australia National Safety and Quality Health Service (NSQHS) Standards Second Edition
23 source controls mapped|16 target controls covered
26%
Australia Health Insurance (Accredited Pathology Laboratories, Approval) Principles 2017
7 source controls mapped|9 target controls covered
8%
ISO/IEC 42001:2023
1 source controls mapped|1 target controls covered
1%
ISO 14001:2015
1 source controls mapped|1 target controls covered
1%
Coverage is not the same as your position
This page shows what Australia National Pathology Standards (First Edition 2027) overlaps with in general. Where your organisation actually stands, against the standard you are going for and the certifications you already hold, is a different question. Same graph and the same recorded refutations, scoped to you rather than to a pair.
The Compliance Position Diagnostic, $5,000 fixed, ten business daysWhat is Australia National Pathology Standards (First Edition 2027) and who does it apply to?
Australia National Pathology Standards (First Edition 2027) is a compliance framework from Australia with 11 domains and 88 controls. Australia's National Pathology Standards, First Edition 2027: the eleven accreditation standards and eighty-eight actions a pathology practice must meet under the National Pathology Accreditation Scheme, from clinical governance and supervision by laboratory category to specimen collection, testing quality, medical devices including AI, and point of care testing. It is used by organisations to establish and maintain compliance with industry standards and regulatory requirements.
What does Australia National Pathology Standards (First Edition 2027) actually require?
Australia National Pathology Standards (First Edition 2027) has 88 controls organised across 11 domains. The largest domains are Standard 4: Pathology laboratory supervision – Australia National Pathology Standards (First Edition 2027) (17 controls), Standard 10: Specimen testing – Australia National Pathology Standards (First Edition 2027) (12 controls), Standard 2: Safety and quality systems – Australia National Pathology Standards (First Edition 2027) (10 controls). Each control defines specific requirements that organisations must implement to achieve compliance.
If I already comply with another framework, how much of Australia National Pathology Standards (First Edition 2027) do I already cover?
Australia National Pathology Standards (First Edition 2027) maps to 5 other compliance frameworks. The top mapping partners are ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence (50% coverage), Australia National Safety and Quality Health Service (NSQHS) Standards Second Edition (26% coverage), Australia Health Insurance (Accredited Pathology Laboratories, Approval) Principles 2017 (8% coverage). Use our comparison tool to explore control-level mappings between frameworks.
How do I implement Australia National Pathology Standards (First Edition 2027)?
Start your Australia National Pathology Standards (First Edition 2027) compliance journey by running a self-assessment on our platform to identify your current compliance posture. Our AI advisory can answer specific questions about Australia National Pathology Standards (First Edition 2027) requirements, and cross-framework mapping helps you leverage existing controls from other frameworks you may already comply with. Create a free account to access all 88 controls and track your progress.
Start Your Compliance Journey
Create a free account to run self-assessments, get AI advisory, and track your compliance progress across 1,048 frameworks.
Get Started Free →Free forever, no credit card required