Pathology Standards

• Health Insurance (Accredited Pathology Laboratories - Approvals) Principles 2017

• Requirements for medical pathology services (Third Edition 2018)

• Requirements for supervision in the clinical governance of medical pathology laboratories (Eighth Edition 2025)
• Requirements for the communication of high risk pathology results (First Edition 2020)

• Requirements for the estimation of measurement of uncertainty (2007 Edition)
• Requirements for the packaging and transport of pathology specimens and associated materials (Fifth Edition)
• Requirements for quality control, external quality assurance and method evaluation (Sixth Edition 2018)
• Requirements for the retention of laboratory records and diagnostic material
• Requirements for Information Communication and Reporting (sixth edition, 2026)
• Requirements for the Development and Use of In-House In Vitro Diagnostic Medical Devices (Fifth Edition)
• Guidelines for Approved Pathology Collection Centres (Requirements for medical pathology specimen collection) (Third Edition 2013)

Anatomical pathology

• Requirements for the performance of anatomical pathology cut-up (Fourth Edition 2013)
• Requirements for the facilities and operation of mortuaries (Third Edition 2013)
• Requirements for use of digital images as alternative to direct microscopy (First Edition 2021)

Cervical Screening Standards

• Requirements for cervical screening (Third edition 2025)

Genetic pathology

• Requirements for Medical Testing for Human Genetic Variation (Fourth Edition, 2025)
• Requirements for human medical genome testing utilising massively parallel sequencing technologies (First Edition 2017)

Haematology

• Requirements for transfusion laboratory practice (Fifth Edition)
• Requirements for procedures related to the collection, processing, storage and issue of human haemopoietic progenitor cells (Sixth Edition 2021)

Microbiology

• Requirements for laboratory testing for human immunodeficiency virus (HIV) and hepatitis C virus (HCV) (Fifth Edition, 2025)
• Requirements for medical testing of microbial nucleic acids (Second Edition 2013)

Reproductive technologies

• Requirements for semen analysis (First Edition 2017)

Point of care

• Requirements for point of care testing (Second Edition 2021)

• Executive Summary of the Point of Care Testing (PoCT) in Health Care: A Rapid Review, March 2024
• Fact sheet - Retention period for deceased donor samples
• The provision of direct to consumer genetic tests

• Requirements for information communication and reporting (Fifth Edition)
• Requirements for the development and use of in-house in vitro diagnostic medical devices (IVDs) (Fourth Edition 2018)
• Requirements for medical testing for human genetic variation (Third Edition)
• Requirements for laboratory testing for human immunodeficiency virus (HIV) and hepatitis C virus (HCV) (Fourth Edition)

Pathology laboratories must retain records, specimens and diagnostic material for periods specified in relevant standards and legislation. Retention requirements support patient care, traceability, quality assurance, accreditation, investigations and medico-legal obligations.

Where standards do not specify a retention period, laboratories should apply a risk-based approach, considering factors such as:

• patient safety
• clinical need
• traceability
• legal obligations
• technological limitations
• storage capacity 
• the potential need for future review or investigation.

Laboratories should have documented policies that are informed by relevant NPAAC standards, applicable legislation and contemporary evidence-based practice. Any local retention or disposal decisions should be supported by appropriate risk assessment and incorporated into the laboratory's quality management system.

Examples include:

• Transport-level acknowledgements are considered a quality management records with a four-year retention period. 
• Blood specimens are retained for seven days to support specimen identification, traceability and additional testing where appropriate.
• Perinatal autopsy specimens, including placentas, should be retained for one month after the autopsy report is issued.
• Digital images, cytology slides and other diagnostic materials may be subject to different retention periods depending on their clinical use and the relevant NPAAC standard. For example, digital cytology images used for diagnostic analysis (e.g., semi-automated ThinPrep screening images) requires retention for six years, while cervical cytology slides are retained for ten years.  
• Mortuary admission and release records can also be considered as relating to a final episode of care for a patient and the rules for health information then apply. Jurisdictional requirements that legislate this require retention periods of at least seven years after the last entry for adults, or until a person would have reached 25 years of age for records relating to minors. 

Accredited pathology laboratories must have appropriate clinical governance and supervision arrangements in place to ensure pathology services are provided safely, effectively and by suitably qualified and trained personnel. 

A key requirement is that every laboratory is under the direction and control of a Designated Person (DP) who is responsible and accountable for the clinical governance of the pathology services provided. The Designated Person must ensure that staff have the qualifications, competence and scope of practice necessary to perform their roles safely and effectively. 

The standards focus on scope of clinical practice, competence and risk management, rather than prescribing detailed organisational structures or workforce titles. This allows pathology practices flexibility to implement supervision models that are appropriate to their service context, while ensuring patient safety and quality are maintained.

Where standards are not prescriptive, pathology practices should apply documented risk management principles to demonstrate that supervision arrangements are appropriate, effective and support the safe delivery of pathology services.

Supervision arrangements should be informed by a risk-based assessment that considers factors such as:

• the complexity and clinical risk of testing performed
• workforce qualifications, experience and competence
• availability of appropriately qualified supervisors
• services delivered across multiple sites or laboratory networks
• temporary vacancies, workforce shortages or alternative supervision arrangements
• the potential impact on patient safety and quality of care.

Laboratories should maintain documented processes for:

• clinical supervision and delegation of responsibilities
• workforce competency assessment and ongoing training
• credentialing and scope of clinical practice
• management of alternative supervision arrangements
• clinical governance across laboratory networks and multiple sites.

NPAAC standards are designed to support safe, high-quality pathology services across a wide range of laboratory settings. While the standards establish mandatory requirements and expected outcomes, they may not prescribe exactly how every situation should be managed. 

Where a standard does not specify exactly how a requirement must be achieved, pathology practices should apply a documented risk-based approach that is consistent with the intent of the standard and supports patient safety, quality of care and effective clinical governance.

When interpreting and applying a standard, laboratories should:

• consider the intent of the requirement and its contribution to patient safety and quality of care
• review any associated commentary, guidance documents or discipline-specific NPAAC standards
• use a documented risk-based approach where the standard does not prescribe a specific method or process
• ensure decisions are supported by evidence, validation, verification or other appropriate quality assurance activities
• be able to justify and document the rationale for local procedures during accreditation assessments. 

A risk-based approach recognises that there may be more than one way to meet the intent of a standard. For example, pathology practices may adopt different workforce models, supervision arrangements, technologies or operational processes, provided they can demonstrate that risks have been appropriately identified, assessed and managed.

Laboratories should be able to demonstrate during accreditation assessments that decisions made under local policies and procedures are supported by documented risk assessments, are proportionate to the level of risk involved, and remain consistent with the objectives of the relevant standard.

Where uncertainty exists regarding the interpretation of a requirement, laboratories should consult the relevant NPAAC standard, review available guidance material and consider seeking advice from the Commission. Emerging technologies, novel testing methods and new models of care may require additional risk assessment and professional judgement to ensure the intent of the standards continues to be met.

Accurate specimen identification is critical to patient safety and the reliability of pathology results. Specimens must be correctly identified at the time of collection and laboratories must have documented procedures to manage specimens that are unlabelled, mislabelled or inadequately labelled.

To maintain traceability, changes should not be made by writing over existing patient identification details on a printed label. Where corrections are required, laboratories should follow documented procedures that preserve specimen integrity, traceability and patient identification throughout the testing process.

Not every labelling or identification scenario is specifically addressed within pathology standards. In these circumstances, laboratories should apply a documented risk-based approach that focuses on identifying, assessing and managing risks to patient safety, specimen integrity and result accuracy.

When making local decisions about specimen acceptance, correction or rejection, laboratories should consider factors such as:

• the risk of patient misidentification
• the clinical significance of the test result
• whether the specimen is replaceable or irreplaceable
• the impact of proceeding with, delaying or rejecting testing
• the ability to maintain traceability and chain of custody
• the effectiveness of available risk controls.

Laboratories should ensure that decisions are supported by documented policies, risk assessments and governance processes within their quality management system. They should also be able to demonstrate during accreditation assessments that identified risks have been appropriately assessed, mitigated and reviewed, and that their approach remains consistent with the intent of the relevant standards.

Ultimately, the goal is to ensure that specimen identification processes support safe, accurate and reliable pathology testing while minimising the risk of patient harm.

SMS notifications may be used as part of a laboratory's process for communicating high-risk pathology results. However, laboratories should apply a risk-based approach to ensure that communication processes effectively support the timely receipt, acknowledgement and escalation of high-risk results.

The key consideration is not the communication technology itself, but whether the laboratory can demonstrate that the high-risk result has been successfully received by an appropriate clinician or authorised recipient and that risks to patient safety have been appropriately managed.

Laboratories should have documented procedures that:

• identify risks associated with different communication methods
• define how receipt of high-risk results will be confirmed
• establish timeframes for acknowledgement
• include escalation processes where acknowledgement is not received
• ensure communication arrangements remain effective, reliable and appropriate for the level of clinical risk involved.

Where acknowledgement of a high-risk result is not obtained within defined timeframes, laboratories should follow their documented escalation procedures, which may include direct telephone contact or other methods designed to mitigate the risk of delayed clinical action.

Laboratories should be able to demonstrate that their communication processes are supported by risk assessment, are regularly reviewed, and remain consistent with the intent of the standard to ensure the safe and timely management of high-risk pathology results.

Pathology practice continues to evolve through the introduction of new technologies, digital systems, point of care testing (PoCT), automation, artificial intelligence (AI) assisted tools and new models of service delivery. NPAAC standards are intended to support innovation while maintaining patient safety, quality of care and effective clinical governance.

Where standards do not specifically address a new technology or model of care, laboratories should apply a documented risk-based approach to determine how the intent of the relevant standards can be achieved.

This includes:

• identifying and assessing risks associated with the technology, process or service model
• evaluating the potential impact on patient safety, quality of results and service delivery
• implementing controls to mitigate identified risks
• validating and verifying that the technology is fit for its intended purpose
• ensuring workforce competency, training and appropriate supervision
• establishing governance, monitoring and review processes to ensure ongoing effectiveness.

Laboratories should ensure that decisions are supported by documented risk assessments, evidence-based practice and appropriate quality management processes. As technologies and models of care evolve, risk assessments should be reviewed periodically to confirm that controls remain effective and continue to support safe and reliable pathology services.

During accreditation assessments, laboratories should be able to demonstrate that new technologies and emerging practices have been systematically evaluated, that risks have been appropriately managed, and that the approach remains consistent with the intent of the relevant standards. 

Ultimately, pathology standards are intended to support innovation while ensuring that risks to patients, staff and service quality are identified, assessed and managed through effective clinical governance and risk management systems.