Press Release – Updated Oral Fluid Standard AS/NZS4760:2019
“After an extensive development and deliberation period Standards Australia has released the new joint Standard AS/NZS4760:2019 – Procedure for specimen collection and the detection and quantitation of drugs in oral fluids which supersedes the previous Standard AS4760:2006” stated Tony Calder, Business Development Manager at CMM Technology.
“The Standard mostly relates to the methodology and process around collection, handling, testing and storage of Oral Fluid samples but does also cover such areas as device criteria and verification of devices which include onsite test devices” remarked Calder.
“This revision process commenced in 2013 and had a number of submissions and retractions relating to detection levels and the inclusion of various other drug compounds. It was a very frustrating period, for CMM Technology as a device supplier. The product manufacturers were also frustrated as they were unable to implement any changes until the Standard was actually released” Calder commented.
What has changed in the short term?
“Nothing, the status quo is this same as it was last week, and the week before that and the week before that” Calder answered.
“Whilst there are a number of key changes that need to be made in terms of onsite testing product parameters, nothing at this stage has changed and for that matter not likely to in the next 3-6 moths in that there is not one product that is currently available that meets AS/NZS4760:2019”. Noted Calder
“As with any new or revised Standard there is always a lead time to allow manufacturers to conduct their R&D and produce devices with the new drug configurations and in the mean time because the devices that we distribute mostly comply there will be no interruption to supply”. “Essentially our clients can continue with confidence and our full support”, claimed Calder.
“So yes changes are imminent and we have had discussion with the Leading Global manufacturers (Abbott/Alere and Draeger) of the Oral Fluid Test device options that we supply, and they have committed to implement the required changes as soon as possible, but this will not happen overnight” stated Calder.
What are the significant changes required for onsite testing products under AS/NZS4760:2019? Calder sees the most significant changes to the onsite testing devices as being:-
- Implementation of stipulated Cut-Off detection levels whereas previous standard listed Target Concentrations levels where the manufacturer could opt to select their own levels of detection;
- Introduction of Oxycodone as a mandated compound to be tested for – an Oxycodone test has not previously been incorporated into any on-site devices that is currently available in the Australian Market ; and
- Devices are required to be verified by an accredited facility that is independent of the manufacturer, distributor or vendor to ensure that a device is fit for purpose in accordance with Appendix C of the Standard.
For anyone who is unsure of the status quo or who has concerns about product claims and/or verification of devices they should discuss it with their trusted advisors or contact Calder or colleagues at CMM Technology for assistance or a second opinion.
Calder goes further to suggest that with any change it is a good time for workplaces to review their existing Procedures, which is a service also available through CMM Technology (charges apply).
Other changes that sites should also be considering
“Potentially the biggest change in the new Standard for work sites that elect to complete testing / screening revolves around the role and responsibilities of the collection facility”. “The Standard defines the collection facility as ‘an organisation assuming professional, organizational, educational and administrative responsibility for collection, onsite screening (if applicable), storage and dispatch of the oral fluid specimen” explains Calder.
“Whilst this may not sound too onerous one must consider the impact these responsibilities may have, the responsibilities including but not limited to the following ”:
- Having access to an Expert (as defined in the Standard);
- Disclosure to the requesting authority (as defined in the standard) any limitations regarding the detection of any drugs/metabolites within a class being tested and specified in Table A1;
- Shall ensure that the verification of the device has been performed in accordance to Appendix C as specified in Paragraph A1 of the Standard. Re-verification of devices in accordance of Appendix C is required and shall be performed at intervals of no more than 36 months;
- Shall be able to demonstrate that the collector is proficient in the use of the device to carry out the on-site test;
- Shall participate in and demonstrate a satisfactory level of performance in a suitable proficiency testing program;
- Once control fluids for onsite oral fluid drug testing devices are commercially available, to be responsible for evidence that the devices are working as intended and that this evidence is recorded in their permanent records register; and
- The process for reconciling the initial drug test results and confirmatory test results via agreement between the collection facility and requesting authority.
Calder suggests that “Sites may look to investigate and appoint an external facility” and went on to say “CMM Technology, as a responsible supplier of quality products, currently provides this service for a number of our clients”. “In line with the above requirements CMM provides free Product Training (with course records stored on our secure training portal) right through to participating in an existing external Quality Assurance Programs (both Oral Fluid and Urine) through the Royal College of Pathologists of Australasia (RCPA)”.
CMM Technology commenced trading in 2002 and their head office is based in Osborne Park, Western Australia.
CMM Technology specialise in the supply of Drug, Alcohol and Hydration screening devices.
CMM Technology do not manufacturer products but are authorised distributors for brands that include Abbott (formerly Alere), Alcolizer, Atago, Draeger, Lifeloc, Lion and Medix.
CMM Technology is accredited and/or registered as follows:-
- NATA accredited Chemical Testing Laboratory (ISO/IEC 17025 (calibrations & measurements - full scope available on request). Acc. No. 18743)
- ISO 9001:2015 Quality Management Systems
- ISO 14001:2015 Environmental Management Systems
- OHSAS18001:2007 OHS Management Systems
- RCPAQAP Chemical Pathology Quality Assurance Programs
CMM Technology is a member of:-
- FACTA (Forensic & Clinical Toxicology Association)
- WDTA (Workplace Drug Testing Association of Australia)