A new version of AS/NZS4760 has now been released, and contains a number of changes to the requirements for accredited testing for drugs of abuse in oral fluid (saliva).
As with any new standard in workplace drug testing, the change to the new requirements will evolve over the coming months as device manufacturers, on-site testing providers, regulatory bodies and others respond to the updated standard.
There are a number of significant as well as minor changes required to how an on-site saliva test for drugs of abuse is tested, collected, transported and analysed in a laboratory. We have listed the major impacts below, but if you do require greater detail please contact us directly, or purchase a copy of the new standards from HERE.
What are the biggest changes in the new saliva drug testing standard that I need to be aware of?
New cut-offs for initial testing and laboratory confirmation of THC.
THC (Cannabis or marijuana) has seen a reduction in the threshold required to be considered “non-negative” (ie a positive on-site screening result). For the previous version of AS4760 anything over 25ng/mL was to be referred to a laboratory for confirmation testing, however this cut-off has now been lowered to 15ng/mL.
In addition, the level in the laboratory required to be considered positive for THC has been lowered to 5 ng/mL from the existing 10ng/mL.
Addition of Oxycodone as a mandatory test
Oxycodone is a prescription only, strong pain relief drug. There is a new requirement in the standard for this to be tested on all samples with a cut-off of 40ng/mL, whereas previously this was not required.
At the time of writing there are no devices currently being sold in the Australian market with the new THC cut-off and Oxycodone assays available.
Safework Laboratories will be assessing a number of new devices over the coming months to find a product which meets our requirements for accuracy, reliability and conformance to the new standard before making any changes to our existing client service.
Chain of custody (CoC) form modifications
The existing CoC will need to be modified to include a number of additional consents from the donor (particularly regarding privacy of results and information around dispute resolution). Additionally, more information must be captured on the form (reason for test, recording information on the transport device).
A new requirement is also that any incorrect or missing information on the CoC form will now constitute a ‘fatal error’.
The Chain-of-Custody form cannot be corrected for fatal errors (wrong name/ID; incomplete form, incompletely or un-labelled specimens etc) post collection.
In such cases Safework Laboratories will be required to report that the Chain-of-Custody was not intact. Any case where the Chain-of-Custody is not intact cannot be used as viable evidence in a Court of Law.
Apart from including Oxycodone and the new, lower THC cut-offs mentioned above, any device used on site for testing, transport or collection will have to have an external laboratory assess the performance of the device to the strict criteria required in the standard. If the device has the correct cut-offs and test menu, and has passed this assessment, it will be ‘verified’ to AS/NZS4760.
Again, at the time of writing there are no devices currently verified. Safework Laboratories are in discussion with a number of providers and will update you as more information and timelines become available.
We hope to see devices able to be meeting the criteria of the new standard later this year.
We currently do saliva testing – what do I need to do or change right now?
In the immediate term you do not need to change any procedures, devices or methods for your saliva drug testing program. Any tests currently conducted by, or referred to, Safework Laboratories are accredited to AS4760:2006 and will continue to be so for the foreseeable future.
Safework Laboratories will not be making any changes to cut-offs, test methods or any other testing process without your full consent and approval of any change.
It may be wise to review your fit for work policy for any reference to cut-offs or AS4760:2006 as these may need to be updated in future as the new standard is rolled out across the industry in the coming months, but we will keep you updated to any progress as this process occurs.
As always, feel free to contact us if you have any questions or wish to discuss in more depth.