Dear Pathology Stakeholder

NATIONAL PATHOLOGY ACCREDITATION ADVISORY COUNCIL (NPAAC)

DRAFT ACCREDITATION STANDARDS FOR PUBLIC CONSULTATION

This letter is to advise you that NPAAC has released the following draft documents for your early consideration and comment:

·  Requirements for Medical Pathology Services (Second Edition 20xx)

·  Requirements for the Retention of Laboratory Records and Diagnostic Material (Seventh Edition 20xx)

·  The Requirements for the Development and Use of In-House Diagnostic Medical Devices (Fourth Edition 20xx)

·  Requirements for Quality Control, External Quality Assurance and Method Evaluation (Sixth Edition 20xx)

Copies of the draft documents are available from the NPAAC website (Draft documents for public consultation).at http://www.health.gov.au/internet/main/publishing.nsf/content/health-npaac-publications-draft.htm

To facilitate the consideration process, it would be appreciated if all comments could be submitted using the NPAAC public consultation submissions template that can be accessed from the aforementioned webpage.

The public consultation period closes Friday, 4 August 2017.

Background

NPAAC is a ministerially-appointed expert committee that provides advice to all levels of government on matters relating to pathology accreditation, including pathology quality issues. One of its key responsibilities is the development, maintenance and monitoring of pathology accreditation materials. In performing this role, NPAAC establishes expert, technical drafting committees to develop new or to revise existing accreditation standards. Part of the usual document review process is to release the draft documents for public consultation to facilitate the finalisation of the standard(s).

Requirements for Medical Pathology Services (Second Edition 20xx)

The Requirements for Medical Pathology Services (Second Edition 20xx) is the overarching document outlining the standards for good medical pathology practice that apply to all medical pathology testing. The Requirements reflect a risk-based approach and current best practice with the aim of ensuring the safe performance of pathology testing and delivery of quality results for the benefit of patients.

Some of the key issues considered as part of the review process for the revised document include:

·  the relationship between NPAAC standards and AS ISO 15189 for the purposes of pathology accreditation in the Australian context

·  a risk based approach to pathology practice, with a primary consideration of ensuring patient welfare

·  the role of clinical governance and supervision

·  best practice and strategies for risk management relating to send-away tests

·  the reporting of critical values.

Requirements for the Retention of Laboratory Records and Diagnostic Material (Seventh Edition 20xx)

The Requirements for the Retention of Laboratory Records and Diagnostic Material (Seventh Edition 20xx) represents the minimum standards for retention of laboratory records and materials. These principles have been developed with a risk-based approach and are important for medical pathology services in assuring the provision of quality pathology services.

The revised Retention Requirements outlines:

·  current minimum standards for the retention times of specimens and records

·  clarification of retention times for forensic specimens

·  an acknowledgement of digital technologies for the retention and storage of specimens

·  acknowledgement of responsibilities for the retention and storage of specimens in the event of a laboratory closure.

The Requirements for the Development and Use of In-House Diagnostic Medical Devices (Fourth Edition 20xx)

The Requirements for the Development and Use of In-house Diagnostic Medical Devices (Fourth Edition 20xx) outlines the principles and assessment criteria by which in-house IVDs must be designed, developed, produced, validated and monitored for use by medical laboratories in Australia.

The revised Requirements have been reviewed to reflect the current regulatory requirements for in house IVDs and provide some clarification of the levels of evidence for scientific validity.

Requirements for Quality Control, External Quality Assurance and Method Evaluation (Sixth Edition 20xx)

The Requirements for Quality Control, External Quality Assurance and Method Evaluation outlines the general features that an internal quality control system and an external quality assessment program must have in order to provide an effective monitoring strategy for the various pathology disciplines. This document also provides guidance on method evaluation for laboratories.

The Requirements reflect a risk based approach to the accreditation framework, with primary consideration given to ensuring patient welfare through the interrelationship and contemporary practice of Quality Control, Internal Quality Assurance and External Quality Assurance.

This revised standard will supersede the Requirements for Enrolment and Participation in External Quality Assessment.

Submissions

NPAAC is seeking views from the pathology sector and interested parties on these draft Requirements to assist with the finalisation of the pathology accreditation standards. It would be appreciated if you could provide:

·  an indication of whether the document is acceptable in its current form

·  technical comments and/or suggestions on any possible revisions to the document

·  comments on potential associated costs and supporting documentation, if any, in relation to compliance with proposed requirements, or

·  a nil response if your organisation has no comment on the draft document.

Submissions should identify the relevant NPAAC document and be forwarded to the NPAAC Secretariat using the Public Consultation Phase Submission Form available from –

http://www.health.gov.au/internet/main/publishing.nsf/content/health-npaac-publications-draft.htm and emailed to

All comments must be received by 4 August 2017 to ensure that feedback can be considered by the technical drafting committee. Please note that late submissions will not be considered in the current round of public consultation.

Should you have any further queries, please contact Ms Suzanne Petrie, Director, Pathology Quality Section via Email – or the NPAAC Secretariat at –

Yours sincerely

(authorised for electronic transmission)

Associate Professor Beverley Rowbotham

Chair, NPAAC

21 June 2017

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