and the facilitation of surveillance activities. The implementation of these Requirements is necessary to avoid public health risks. The purpose of this document is to assist medical and scientific Laboratory professionals in finding relevant information and to reduce the need for constant cross referencing of other documents. These Requirements are intended to serve as minimum standards in the accreditation process and have been developed with reference to current and proposed Australian regulations and other standards from the International Organization for Standardization including: AS ISO Medical laboratories Requirements for quality and competence – These Requirements should be read within the national pathology accreditation framework including the current versions of the following NPAAC documents: Tier 2 Document Requirements for Medical Pathology Services All Tier 3 Documents Tier 4 Document Requirements for the Medical Testing of Human Nucleic Acids In addition to these Standards, Laboratories must comply with all relevant state and territory legislation (including any reporting requirements). These Requirements are written as specific principles and are designed to serve without alteration until the next revision date. The following principles cover the entire document: Laboratories must be able to demonstrate continued compliance with NPAAC Standards in their assessment history. Failure to meet these minimum Standards poses a potential risk to public health and patient safety. In each section of this document, points deemed important for practice are identified as either or ‘Standards’ ‘Commentaries’. A Standard is the minimum requirement for a procedure, method, staffing resource or facility that is required before a Laboratory can attain accreditation Standards are – printed in bold type and prefaced with an (e.g. S2.2). The use of the word ‘S’ ‘must’ in each Standard within this document indicates a mandatory requirement for pathology practice. A Commentary is provided to give clarification to the Standards as well as to provide examples and guidance on interpretation. Commentaries are prefaced with a (e.g. ‘C’ C1.2) and are placed where they add the most value. Commentaries may be normative or informative depending on both the content and the context of whether they are associated with a Standard or not. Note that when comments are expanding on a Standard or referring to other legislation, they assume the same status and importance
and the facilitation of surveillance activities. The implementation of these Requirements is necessary to avoid public health risks. The purpose of this document is to assist medical and scientific Laboratory professionals in finding relevant information and to reduce the need for constant cross referencing of other documents. These Requirements are intended to serve as minimum standards in the accreditation process and have been developed with reference to current and proposed Australian regulations and other standards from the International Organization for Standardization including: AS ISO Medical laboratories – Requirements for quality and competence These Requirements should be read within the national pathology accreditation framework including the current versions of the following NPAAC documents: Tier 2 Document Requirements for Medical Pathology Services All Tier 3 Documents Tier 4 Document Requirements for the Medical Testing of Human Nucleic Acids In addition to these Standards, Laboratories must comply with all relevant state and territory legislation (including any reporting requirements). These Requirements are written as specific principles and are designed to serve without alteration until the next revision date. The following principles cover the entire document: Laboratories must be able to demonstrate continued compliance with NPAAC Standards in their assessment history. Failure to meet these minimum Standards poses a potential risk to public health and patient safety. In each section of this document, points deemed important for practice are identified as either ‘Standards’ or ‘Commentaries’. A Standard is the minimum requirement for a procedure, method, staffing resource or facility that is required before a Laboratory can attain accreditation – Standards are printed in bold type and prefaced with an ‘S’ (e.g. S2.2). The use of the word ‘must’ in each Standard within this document indicates a mandatory requirement for pathology practice. A Commentary is provided to give clarification to the Standards as well as to provide examples and guidance on interpretation. Commentaries are prefaced with a ‘C’ (e.g. C1.2) and are placed where they add the most value. Commentaries may be normative or informative depending on both the content and the context of whether they are associated with a Standard or not. Note that when comments are expanding on a Standard or referring to other legislation, they assume the same status and importance
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