(NPAAC) – NEW AND REFORMATTED PUBLICATIONS The

MDP 951
GPO Box 9848
CANBERRA ACT 2601
http://www.health.gov.au/npaac
Dear Pathology Stakeholder
Telephone 02 6289 4017
Facsimile 02 6289 4028
E-mail: npaac@health.gov.au
NATIONAL PATHOLOGY ACCREDITATION ADVISORY COUNCIL (NPAAC) –
NEW AND REFORMATTED PUBLICATIONS
The National Pathology Accreditation Advisory Council (NPAAC) develops and maintains
the Standards for pathology laboratory accreditation.
This letter is to advise that the following revised NPAAC documents, together with the new
publication, Requirements for Medical Pathology Services, are available on the NPAAC
website (http://www.health.gov.au/internet/main/publishing.nsf/Content/health-npaacpublication.htm)
for your reference:
Guidelines for Approved Pathology Collection Centres (Requirements for Medical
Pathology Specimen Collection)
Requirements for Cytogenetic Testing
Requirements for Enrolment and Participation in External Quality Assessment
Requirements for Laboratory Testing for Human Immunodeficiency Virus (HIV) and
Hepatitis C Virus (HCV)
Requirements for the Facilities and Operation of Mortuaries
Requirements for Information Communication
Requirements for Medical Testing of Human Nucleic Acids
Requirements for Medical Testing of Microbial Nucleic Acids
Requirements for the Retention of Laboratory Records and Diagnostic Material
Requirements for the Performance of Anatomical Pathology Cut-Up
Requirements for Transfusion Laboratory Practice
Requirements for the Packaging and Transport of Pathology Specimens and Associated
Materials
Requirements for Procedures Related to the Collection, Processing, Storage and Issue of
Human Haemopoietic Progenitor Cells
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These documents do not include any new or additional requirements or major changes but
have been revised to bring them into line with the new NPAAC format, incorporating the
overarching Requirements for Medical Pathology Services (RMPS) document.
Requirements for Medical Pathology Services (RMPS) document
As part of its ongoing process of refining the accreditation requirements, NPAAC has
recently finalised its review of the accreditation standards to more clearly identify core
elements of safe, quality pathology practice and reducing any duplication and wordiness that
may have developed over time within the requirements framework.
The Requirements for Medical Pathology Services is an overarching document that outlines
the core standards for good medical pathology practice, where the primary consideration is
patient welfare, and where the needs and expectations of patients, laboratory staff and
referrers (both for pathology requests and inter-laboratory referrals) are safely and
satisfactorily met in a timely manner.
The document is based on existing standards from NPAAC documents and AS ISO 15189
Medical laboratories – Requirements for quality and competence. In addition, these
Requirements ensure the alignment of the pathology accreditation framework with the
Australian Commission on Safety and Quality in Healthcare’s National Safety and Quality
Health Service Standards.
The RMPS document is supported by the more streamlined technical requirements in specific
areas of pathology testing and supersedes the Requirements for Pathology Laboratories and
Requirements for Quality Management in Medical Laboratories documents.
Providers of pathology services must adhere to these and all other NPAAC Requirements in
order to achieve accreditation and to ensure the safety, efficacy and quality of all medical
pathology testing.
Review of NPAAC technical documents
As part of the initiative to develop the Requirements for Medical Pathology document, the
NPAAC technical documents were reviewed and reformatted to be read in conjunction with
the RMPS document. There was also the intention to remove any duplication and
inconsistencies between individual technical documents, and to reformat and merge the
existing documents into the new streamlined framework. The technical documents do not
include any new or additional compliance requirements, obligations or major changes but
have only been revised to bring them into line with the new NPAAC format.
As per the usual NPAAC protocols, the draft documents were widely circulated for public
consultation to:
all Approved Pathology Authorities, Approved Pathology Practitioners and
Accredited Pathology Laboratories
pathology and scientific professional organisations;
State and territory health departments; and
NPAAC members, including state and territory representatives.
Comments from the public consultation submissions were considered as part of the
finalisation of documents.
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The NPAAC technical documents currently under review will be reformatted as part of the
normal document review schedule.. Notifications of any new document reviews will be
notified on the NPAAC website - http://www.health.gov.au/npaac
The RMPS and the revised NPAAC technical documents have recently been included in
Schedule 1 of the Health Insurance (Accredited Pathology Laboratories – Approval)
Principles 2002 with a date of effect of 1 December 2013.
National Association of Testing Authorities (NATA)
AS ISO 15189 Medical Testing Field Application Document – Requirements for
Accreditation, July 2013
The NATA Field Application Document (NATA FAD) provides explanatory notes on the
application of NPAAC Requirements and AS ISO 15189 Medical laboratories –
Requirements for quality and competence to the various disciplines of pathology testing,
together with a description of the applicable NATA/Royal College of Pathologists of
Australasia accreditation procedures.
The NATA FAD has been comprehensively reviewed by members of the NATA Medical
Testing Accreditation Advisory Committee, the Royal College of Pathologists of Australasia
and the National Pathology Accreditation Advisory Council. There were minor edits that
provided clarification on issues incorporated in the revised document.
The document was recently endorsed by NPAACC for inclusion in the list of supplementary
accreditation materials in Schedule 1 of the Health Insurance (Accredited Pathology
Laboratories – Approval) Principles 2002 with a date of effect of 1 December 2013.
The NATA FAD may be accessed from http://www.nata.asn.au
Should you have any queries, please contact the NPAAC Secretariat on (02) 6289 4017 or
Email – npaac@health.gov.au
(signed)
Associate Professor Paul McKenzie
NPAAC Chair
27 November 2013
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