AS/NZS 4308:2008
Procedures for Specimen Collection
and the Detection & Quantitation of
Drugs of Abuse in Urine
Compliance & Frustrations
in the First Year
Sue Nolan
DrugFree Sites
Ph: 021 877606
sue@drugfreesites.co.nz
www@drugfreesites.co.nz
Introduction
• Legal requirements
• History & changes
• Relevance to Collecting and “on-site”
screening
• Compliance & Frustrations
• Where to from here
Drug Testing Is Lawful
Air NZ Employment Court Judgement; April 04
• Random: Safety Sensitive Jobs
• Post Incident/ For Cause: All Staff
• AS/NZS 4308: Latest Version
• Comprehensive programme adopted
Drug & Alcohol Free Workplace Model
Policy and
Procedures
EAP,
Rehabilitation
and Case
Management
Education
and Training
Outcome:
Testing
AS/NZS
4308:2008
Management Commitment
&
Leadership
Change of behaviour
leading to a
Safer Workplace
History
AS 4308: 1995
– Screening & confirmation: lab based: same laboratory
– Option: duplicate or single samples
AS/NZS 4308: 2001
–
–
–
–
Joint standard
Ambiguities removed
Duplicate specimens only
Accredited laboratories
2008
Standard
AS/NZS 4308: 2008
• Significant changes from 4308:2001
– 5 years/ 15 meetings
– Public comment x 2
• On-site screening
• Laboratories performing screening only
• Screen result: “negative” or “not-negative”
• “not-negative” screen must  laboratory confirmation
• More responsibility on collectors
• Some confirmation cut-off concentrations lowered
– MA (“P”), MDMA/MDA (“E”), benzodiazepines
AS/NZS 4308:2008
• S1: scope & definition
• S2: collection, storage, handling, dispatch  NZQA
• S3: general laboratory requirements
• S4: laboratory screening procedures  IANZ accreditation
• S5: laboratory confirmatory procedures  IANZ accreditation
• App.A: optional on-site screening  NZQA (collection &
screening) & IANZ accreditation (agency)
• App.B: verification of performance of on-site devices
• App.C (& S2.2.4): chain of custody forms
What Drug Classes & Substances?
• Cannabis metabolites
• Opiates: morphine, codeine
• Amphetamine type substances:
–
–
–
–
methylamphetamine (P)
methylenedioxyamphetamine (E)
pseudoephedrine, phentermine
Benzylpiperazine (BZP): not “on site” screen
• Cocaine metabolites
• Benzodiazepines: diazepam, temazepam, clonazepam
Other Drugs
The detection & reporting of drugs other
than those listed in Table 2 is not precluded
– LSD
– Other party pills (eg DMAA)
– Magic mushrooms (psilocybin)
Laboratory testing only
Mass spectrometry confirmation  detected
Laboratory determines cut-offs
Compliance and
Frustrations
Principal Frustration
• How do I distinguish expert advice
From
• Plethora of
– Half truths
– Non truths
– Absolute nonsense fuelled by the avaricious
need to make sales of products & services
Compliance No.1
NZQA Certification
1.3.14: Collector
A person who has successfully completed
a course of instruction for specimen
collection and on-site screening, handling,
storage and dispatch of specimens and
who has received a statement of
attainment in accordance with NZQA.
Frustrations
• 9-12 months for units standards to emerge
• Another 3-6 months for courses to get
authored, moderated, assessed, accepted
by training organisations (ITOs, PTEs,
polytechs etc)
Unit Standards
• 25458 : “Perform urine specimen collection in
the workplace for drug testing” (level 3, credits 2)
• 25511: “Perform urine drug screening in the
workplace” (level 4,credits 4)
• NZQA Courses run by
– DrugFree Sites: Sue Nolan (25458 & 25511)
– InScience: Ann-Louise Weaver (25458 & 25511)
– ESR (25458 only)
Excuses for Non Compliance
Compliance No.2
Verified Screening Device
• Process, independent of the manufacturer,
for ensuring trueness of results with
respect to the screen cut-offs & the device
is “fit for purpose.”
• Performed by accredited AS/NZS 4308
laboratory (or equivalent)
Frustrations
• No “on-site” devices available in Aus/NZ
passed verification
BUT
• Microcheck :verified Sep 2008
• Proscreen: verified Nov 2008
• Surestep:
verified Feb 2009
Excuses for Non Compliance
Legal Rights
• Company & Donor request
– evidence of NZQA certification of collectors &
screeners
– copy of verification certificate: “on-site” device
• Donor can
– refuse to have test conducted if NZQA
certification and proof of verification of “onsite” device is not evident
Compliance No.3
Integrity Tests
2.3.3 Collection Procedure
(f) The integrity of the specimen shall be checked
I. Visual inspection (colour)
II. Temperature measurement (330C & 380C)
III. On-site creatinine test
Additional integrity testing may be performed
(h) If integrity cannot be established, another
urine shall be collected and both forwarded to
laboratory for drug and integrity tests
Ways to cheat ?
• Drinking excessive fluid
– Dilute specimen: creatinine test mandatory
• Adding fluid to specimen
• Substitution
Temperature mandatory
• Dehydrated urine
• In vivo: diuretics, herbal: PH, creatinine
• In vitro: bleach, detergents, nitrite
• Collection: PH, nitrite, oxidant tests recommended
• Artificial bladders
Artificial Bladders
Frustrations
• Setting up collection site to minimise
cheating
• Mandatory to test creatinine  extra step
• Sometimes colours on integrity panels or
dipsticks difficult to distinguish
Principle: When in doubt, collect another
specimen both to laboratory
Excuses for Non Compliance
Compliance No.4
Chain of custody & forms
• 1.3.9: A series of procedures to account for the
integrity of each specimen by tracking its
handling and storage from the point of specimen
collection to final disposal of the urine.
• 1.3.10: A form to be used from time of collection
of the specimen to its receipt by the laboratory.
Thereafter, appropriate documentation accounts
for the urine or aliquots within the laboratory.
Chain of Custody Minimal Information
(2.2.4)
• Verification of donor’s ID (photo not essential)
– Unequivocal and independent
• Two unique identifiers
• Date & time of collection
• Name & signature of collector
• Requesting authority details
• Results of specimen integrity checks
• Declaration by collector: compliance with Standard
– Specimen collected & Tested on-site (if applicable)
• Signature from donor confirming
– Their own specimen & correctly taken
– NB: This is the last step
Chain of Custody
Other Information
• Reason for the test
• Drug classes
• Medications : Must not be on employer/
collector copy
• On-site screen results: Must not be on
employer copy
Frustrations
• Previous COC forms out of date
• Requirement for single COC set covering
–
–
–
–
–
On-site collection & screening
Dispatch to laboratory if required
Laboratory receipt
Risk of error too high with two forms
Time consuming
• Companies must address “verification of donor
identity” issue
Excuses for Non Compliance
Compliance No.5
Quality Controls
+ve and –ve QCs conducted
– each day prior to 1st urine screen
– after each batch of 25 tests (alternate)
– at each testing site
QC failure
– remaining collections sent to laboratory
– corrective action
Frustrations
• QCs: only recently available
• Still questions around reliability
• Need to match QCs to “on-site” device
– Advice from supplier
– Dont shop around for best deal
• Adds cost
Confusion
• Physical control line on device vs QC
Excuses for Non Compliance
Compliance No.6
Language & Reporting
• Screen result
– Negative or “Not Negative”
– Word “positive” prohibited
• “Adulteration” replaced by “specimen integrity”
• Screen not negative or specimen integrity ??
– Interim report may be issued that can only
advise that the specimen requires further testing
Frustrations
• Adopting the new language
• Changing reporting practices
• Educating companies of compliance
requirements
• Reviewing company policies
Excuses for Non Compliance
Compliance 7
Accreditation
1.3.12: Collecting agency
An organisation assuming professional, organisational,
educational and administrative responsibility for
collection, on-site screening (if applicable), storage and
dispatch of the urine specimen
– If on-site screening is performed, the collecting
agency shall be accredited against AS/NZS 4308
(by IANZ).
–
Where the collecting agency does not perform on-site testing it should
seek accreditation when such accreditation exists.
–
The requesting authority also may operate as a collecting agency.
Frustrations
•
•
•
•
Final process to be put in place
IANZ accreditation: just established
Initial inspection  advice on “what to do?”
Accreditation assessment (initial and 4 yearly)
–
–
–
–
1 day
$2500-3000 (+travel costs)
$500 annual fee
Annual inspection
• Laboratories
– 2008 accredited: CHL, A+
ESR (assessed)
Excuses for Non Compliance
Compliance 8
Proficiency Tests
A3.2 (j): The collecting agency shall
participate in an external proficiency
program. Where such a program is not
available, the CA shall arrange a program
with a laboratory to demonstrate ongoing reliability of the screening process.
– 5% urine negatives  Laboratory
– Program available from Australia ???
Frustrations
• Establishing proficiency program with Lab
• Cost built in to operation
• Managing proficiency variances
Excuses for Non Compliance
Conclusion
Compliance
Yes
1 NZQA Certification

2 Verified screening devices

3 Integrity tests

Possible
4 Chain of custody forms

5 Quality controls

6 Language & reporting

7 Proficiency tests

8 Accreditation
In Progress
