Changes to Australian Standard AS4308:2008

The updated AS4308-2008 Standard has made fundamental changes in sample collection and Laboratory confirmation testing.

Here are some of the key points:

Summary:
The standard requires collectors to have completed a nationally accredited course in drug screen collection and/or onsite testing. What is evident is that clients performing their own collections will need to have their staff sign off if they wish to collect samples and/or do onsite tests in accordance with Section 2 of the new standard.

The standard and NATA also requires laboratories to state unequivocally on the report the status of collections and their compliance to Section 2

Where a collection is not performed by a registered WDP collector the following will appear on the WDP report.

‘This sample has not been collected by a registered WDP collector. Cannot be verified compliant with AS4308:2008Section 2’.

The New Collection Procedure

The changes to collection are to do with the mandatory splitting of samples into 2 (therefore creating a referee sample) and the requirement for an onsite creatinine test, (check if the sample is diluted).

The referee sample is available in the case of any dispute.

The creatinine test is a check the dilute nature of the urine before it is sent off for testing. This can be done by a dipstick creatinine method or a creatinine adulterant strip in the cup.

Note that both of these changes have no bearing on the chain of custody.

If these two items were not completed by a client then it does not invalidate the immunoassay or GCMS results. If the donor has signed that the sample is indeed theirs, and the other parts of the collection are fulfilled then action can still be taken on the final results even if these two items are absent.

The important area to note on-site is where the volume delivered by the donor is not enough to safely split the sample, especially given the volume required for GCMS analysis.

Donor ID

Additionally, the change in acceptable ID criteria may be an issue. The standard now states that a collection should not be done at all if the ID cannot be established unequivocally.

This lack of ID is not necessarily a problem for some clients,however it means that the collection cannot be stated as being collected according to the new standard.

GCMS Confirmatory Changes

There have been some changes to the GCMS cut-offs, most notably the amphetamines and some of the benzodiazepines. This was an interesting change.

The benzodiazepines were changed because each benzodiazepine reacts differently in the immunoassay and some can cause a positive immunoassay in combination but be below the GCMS cut-off for each metabolite. The change means that the chance of not confirming a benzodiazepine immunoassay screen are now less.

The amphetamine change was due, reason being, the rise in methamphetamine use in the community. This was interesting because to improve the detection rate for abuse of these substances would have required a drop in the immunoassay cut-off not the GCMS! The drop in the GCMS cut-offs from 300 to 150 for the amphetamines will not lead to a large increase in detection, since most abusers have urine levels far in excess of the old 300 cut-offs.

For the on-site collector these changes make little difference. The main points are that if their drug policy contains these cut-offs then they will need to be amended. Or alternatively the Drug Policy simply refers to the cut-offs specified under AS/NZS4308-2008 not the specific cut-offs.

Dilute Urine

Laboratories will confirm dilute urines with creatinines <=0.4 mmol/L using freeze point depression (Urine Osmolality). A new code will appear on those reports stating that the sample is not consistent with human urine.

Laboratories are obliged to do this under the Standard

Details of Changes:

Section 1.

Collector

The collector as defined now needs to have completed a nationally accredited course in collection and/or on-site testing

Section 2.

Specimen Collection, Storage, Handling Dispatch.

General

The procedure requires the provision of a referee specimen in case the resolution of disputed results is required.

Privacy

Procedures must allow for individual privacy. Observed collections may be conducted in situations where there is an unacceptable risk to the integrity of the specimen.

Chain of Custody

The minimum requirements of a chain of custody form have been listed. The only change is the need to document the onsite creatinine result.

Precautions

A paragraph has been added to state that if ID of the donor cannot be established unequivocally then the collector shall not proceed with the collection.

Collection Procedure

• Donor does not flush toilet until sample has been handed over
• Integrity checks are now : colour, temperature (33-38) and on-site creatinine test.

If integrity is an issue then you take another sample and forward both to the lab.
Preparation for Dispatch - The specimen is now split between two containers

Appendix A

On Site Screening Procedure

This is a whole new section. Major Points are :

• Cut-offs for on-site testing to be the same as Immunoassay Screen
• Device must have verification data, any modifications then it has to be done again.
• Collector must be competent in doing on-site test (assume documentation must be available)
• Device must be within expiry date (need evidence of lot number and expiry date).
• Have to run negative and positive control for each batch of device
• Run a quality control with every 25 tests, alternate positive and negative.
• On-site test must be done in presence of donor.
• Interpret according to manufacturers’ guideline.
• Record the result in permanent record.
• Positives dispatched to lab.
• Collectors must participate in external QA or similar system
• All QA and double check data to be keep for viewing by accrediting authority.

For all details we suggest you obtain a new copy of the Standards.