The areas identified included inconsistency in verification studies and inconsistency in the expectations of the technical assessors. These inconsistencies included:
- Nil or insufficient authorization
- Laboratories not adhering to their own protocols
Verification studies needing to expand to include:
- More samples required to be tested – is 1 sample enough?
- Patient samples needed not just QC
- Samples at clinically significant decision points needed
- Precision and linearity studies needed
- Comparison with existing methods needed
Type of non-conformance identified
- No verification performed
- No records available
- No stated performance criteria available
- Laboratories relying on manufacturer’s verification data as a sole source of verification
To help address this the Australasian Association for Clinical Biochemistry (AACB) Harmonisation Committee and the Australian Institute of Medical and Clinical Scientists (AIMS) agreed to document guidelines to provide support for laboratories and technical assessors in the area of routine pathology testing.
The AACB and AIMS went back to basics asking the question: What is verification?
- It is “provision of objective evidence that a given item fulfils specified requirements.”
- This is undertaken by obtaining objective evidence (in the form of performance characteristics) that the performance claims for the examination procedure have been met. The performance claims for the examination procedure confirmed during the verification process shall be those “relevant to the intended use of the examination results.”
With significant input from a number of technical experts including Pathologists and Scientists over the course of 12 months, including discussions at the AACB Harmonisation National Meeting and the AACB Annual Scientific Meeting, guidelines to provide that objective evidence were developed.
A verification matrix was included in the document to allow laboratories to determine what verification should be undertaken in their particular circumstance. Whilst the matrix does indicate when validation should be undertaken the document DOES NOT address or discuss validation.
Once agreed by the AACB Harmonisation Committee this draft guideline was then posted on the AACB website for 3 months to allow the AACB membership to make comments. Similarly, the membership of AIMS was also encouraged to give feedback on this document. A number of comments were received which facilitated some minor amendments to the document including a review period to enable updates in a timely manner.
After this 3-month review period expired, the document was sent to the AACB executive for ratification prior to posting as an official AACB guideline on the AACB website. This was finalized in March 2024.
The assays which are relevant to this document are those that are performed on:
- automated clinical biochemistry instrumentation, (there should be no differences in the undertaking of verification studies whether wet or dry chemistry is used.
- point of care instrumentation including handheld and small benchtop analysers.
- routine haematology cell counters.
- analytical instrumentation to perform routine haemostasis (coagulation) studies.
At this point the guideline does not attempt to provide guidance for “Validation”. There are excellent international standards (e.g. CLSI H26 and EP15) for this, and the Human Pathology Accreditation Advisory Committee (HPAAC) felt the immediate priority was greater clarity for performance and documentation of verification processes.
As a Version 1.0 release, there may be room for improvements or additional information in the future. A common misunderstanding of the harmonisation process is that it tries to make all laboratories do the same thing, which is rarely the case – this document initially seeks to help laboratories and technical assessors recognise outlier laboratories where there may be significant risk or under-evaluation of new assays, and then request a plan from the laboratory to address these concerns.
The document can be found at: Guidelines and Position Statements (aacb.asn.au)
AACB-Endorsed Harmonisation Guidelines
For further information on these Guidelines please contact
Gus Koerbin guskoerbin@gmail.com
Robert Flatman Robert_Flatman@snp.com.au
