This document provides information for laboratories currently accredited to AS/NZS 4308:2001 to AS/NZS 4308:2008 

• Section 4 Initial testing; and
• Section 5 Confirmatory testing procedures

who wish to update to AS/NZS 4308:2008

• Section 4 Laboratory screening procedures; and
• Section 5 Laboratory confirmatory procedures.

For accreditation to be updated from AS/NZS 4308:2001 to AS/NZS 4308:2008 for the above sections outside of the routine reassessment cycle a desk top review will be conducted.

To facilitate the desk top review, laboratories must submit the following information as a number of changes and/or additions have been identified between the two versions of the Standard. The information provided will be de-identified and submitted for technical review.

Personnel
Details of the current staff, including qualifications and experience.
Details of training provided to staff when moving to use the 2008 Standard.  An example of training records for senior staff in the toxicology section is requested.

Methods
The laboratory's methods for specimen integrity testing, initial screening and confirmatory testing.

Verification data
Data to support the laboratory's capability to reliably detect drugs at the cut-offs listed in Table 1 and 2 of the Standard for initial screening and confirmatory testing; and
Data that confirms compliance with the quality control requirements i.e. that the reported value is within 20% of the expected value.

Reporting

Detail as to how 'detected' and 'not detected' drugs will be reported. This must include acceptance criteria for 'detected' drugs.  See 5.13 of the Standard.

Detail as to how 'detected' drugs/ metabolites not listed in Table 2 will be reported.

Detail as to how measurement uncertainty (MU) will be reported.

Where a collection is received from a collection site which is not under the direct control of the laboratory and is received from an non-accredited collection agency, the report that is issued must make this clear in a statement included on the test report that the result relates only to sample analysis and that collection (and screening where applicable) to AS/NZS 4308 is not covered by the accreditation.  Suggested wording below:

"The sample was received from a collection facility which is not accredited for compliance with AS/NZS 4308:2008 Section 2: Specimen collection, storage, handling and dispatch."

Once the variation to the scope of accreditation has been granted the facility's scope of accreditation will be amended to reflect the sections of the Standard for which the facility has been accredited, as shown below:

10.60 - Chemical pathology
10.61 - General chemistry
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Drugs for toxicological purposes to AS/NZS 4308:2008
Section 4 Laboratory screening procedures
and/or
Section 5 Laboratory confirmatory procedures

A technical visit will be required for facilities wishing to extend their current scope to include:

Section 2 Specimen collection, storage, handling and dispatch; or
Section 2 (including Appendix A) Specimen collection, storage, handling, dispatch and on-site screening procedure
Should you have any questions please do not hesitate to contact Ms Megan Nelson, Manager, Medical Testing, NATA or Mr Andrew Griffin, Deputy Field Manager - Technical, Medical Testing, NATA.