1. No category

Technical Note 37 — October 2014
Issued: June 2014, Reissued October 2014
Guidelines for Laboratory Accreditation of
Massively Parallel Sequencing (Next Generation
Sequencing)
© Copyright National Association of Testing Authorities, Australia 2014
This publication is protected by copyright under the Commonwealth of Australia Copyright Act
1968.
NATA’s accredited facilities or facilities seeking accreditation may use or copy this publication or
print or email this publication internally for accreditation purposes.
Individuals may store a copy of this publication for private non-commercial use or copy a
reasonable portion of this publication in accordance with the fair dealing provisions in Part III
Division 3 of the Copyright Act 1968.
You must include this copyright notice in its complete form if you make a copy of this publication.
Apart from these permitted uses, you must not modify, copy, reproduce, republish, frame, upload
to a third party, store in a retrieval system, post, transmit or distribute this content in any way or
any form or by any means without express written authority from NATA.
Technical Note 37 – Guidelines for the Laboratory Accreditation of Massively Parallel Sequencing (Next Generation
Sequencing)
Guidelines for the Laboratory Accreditation of Massively
Parallel Sequencing (aka Next Generation Sequencing)
Purpose
This technical note is applicable to accredited facilities and those seeking accreditation for
analysis which employs Massively Parallel Sequencing (MPS) (aka Next Generation
Sequencing).
The Royal College of Pathologists, Australasia (RCPA) has prepared the Guidelines for
the Implementation of Massively Parallel Sequencing which can be sourced from the
following link: http://www.rcpa.edu.au/Library/College-Policies/Guidelines/Implementationof-Massively-Parallel-Sequencing
The Guidelines primarily relate to facilities performing clinical human testing (Medical
Testing facilities). It is expected that such facilities adopt the guidelines as good practice.
In lieu of any other appropriate documentation, these Guidelines should also be
considered, as appropriate, by other facilities outside of a clinical human service
performing MPS.
Scope of Services provided and accreditation
It is recognised that the extent of services offered by MPS can vary greatly between
facilities. These range from the provision of a full MPS service to an interpretative and
reporting service only with little or no testing or control over the testing activities.
The provision of an MPS service includes multiple variables that need to be tested and
several parameters to be defined empirically. These are then incorporated into the
specimen QC, library preparation, sequencing, bioinformatics analysis, interpretation and
reporting pipeline to arrive at diagnostically acceptable levels of accuracy.
It is an iterative process and control of the process is required to fully understand the
issues and to adjust the parameters at each stage to achieve the desired confidence limits.
After consultation with the Royal College of Pathologists of Australasia and the Medical
Testing Accreditation Advisory Committee NATA has defined the limitations for which
accreditation can be offered in this area. These are described below:
a) Accreditation can be sought by facilities that perform the entire MPS service.
b) Accreditation can be sought by facilities which offer a sequencing service to
referring facilities.
c) Accreditation can be sought by facilities that sub-contract the sequencing service
provided they have a documented procedure for selecting and evaluating referral
facilities as documented in ISO 15189 Medical Laboratories - requirements for
quality and competence and the relevant NPAAC requirements.
d) Accreditation cannot be sought by facilities who only offer interpretation and
reporting services for MPS i.e. who sub-contract the sequencing and bioinformatics
analysis.
October 2014
Page 3 of 4
Technical Note 37 – Guidelines for the Laboratory Accreditation of Massively Parallel Sequencing (Next Generation
Sequencing)
Where any portion of the MPS service is sub-contracted the identity of the referral facility
performing the sub-contracted work must be included in the test report.
The scope of accreditation will be defined to identify which elements of the MPS service
each facility performs in house.
Further information
Any questions regarding this technical note may be directed to Andrew Griffin, Deputy
Sector Manager – Life Sciences in the NATA Melbourne office on (03) 9274 8200, or by
email at [email protected]
Any questions regarding the RCPA Guidelines for the Implementation of Massively Parallel
Sequencing should be directed to the RCPA.
AMENDMENTS
The table below provides a summary of changes made to the document with this issue.
Section
Amendment
Scope of Services
Inclusion of the scope of MPS services for which NATA is able to offer
provided and
accreditation.
accreditation
October 2014
Page 4 of 4