Student Handbook...Alere iScreen® OFD Drug Test Device 23-31 Urine & Oral Fluid – Confirmatory...

Student HandbookAS/NZS4308 & AS4760

Certified Drug & Alcohol Screening Officer TrainingCourse

HLTPAT304D – Collect pathology specimens other than blood

Drug Testing Solutions2 Melville Terrace

Wynnum QLD 4178Australia

[email protected]

This course is provided in association with Churchill Education Pty. LtdA REGISTERED TRAINING ORGANISATION –NATIONAL PROVIDER NUMBER 31430






[email protected]







[email protected]


CONTENTSIntroduction 2-3

Australian Standards 3-5

Workplace Health and Safety 5

Overview of Alcohol and Other Drug (AOD) Testing 5

Drug Types, Effects & Detection Times 6-8

Drug Testing Methods 8-10

Preparation - Drug Tests 11

Equipment & Instructions for Testing 12-13

Innovacon Multi-Drug Cup 14-22

Alere iScreen® OFD Drug Test Device 23-31

Urine & Oral Fluid – Confirmatory Testing at the Laboratory 31-32

Chain of Custody PROCEDURES 32-35

Drug Testing Process Integrity 35

URINE DRUG TEST PROCEDURES 35-36

Conducting a Urine Drug Screening Test 36-38

Chain of Custody - Urine 37-38

Conducting an Oral Fluid Drug Test 39-40

Chain of Custody – Oral Fluid 40-42

Practical Assignment 42-44

Appendix 45

COPYRIGHT

(No part of this training Manual may be copied or reproduced in any form, or by any means,without the written consent of Drug Testing Solutions Pty Ltd.)




















Appendix 45

COPYRIGHT





















Appendix 45

COPYRIGHT


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INTRODUCTIONThis certified drug test collector course has been developed by Drug Testing Solutions PtyLtd in association with Churchill Education Group.

This course has been developed by experienced industry professionals and is nationallyrecognised under what was formerly the Australian Quality Training Framework (AQTF),now the Vocational Education and Training (VET) system.

The course will assist persons who wish to comply with recommendations under therelevant Australian Standards for WORKPLACE, MEDICO-LEGAL OR COURT-DIRECTEDdrug testing. Persons from any industry in which drug testing is conducted will benefitfrom this course.

Current drug testing standards are the key drivers for this course since alcohol testingstandards apply only to the equipment used, not the persons conducting tests.

Industries which typically conduct drug testing include:

• Mining

• Construction

• Transportation

• Medical

• Energy

• Health & Safety

Typical roles of persons best suited to this course may include:

• Risk, safety and compliance

• Health and Environment

• Human Resources

• Drug and alcohol testing consultants

• Paramedics, nurses and other health professionals

• Casual or full time workplace drug and alcohol testers

The course covers the general competencies required to correctly use and interpret drugtesting equipment, collect oral fluid/urine samples for onsite screening tests, along withpackaging samples to dispatch to an approved laboratory for confirmation testing.

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• Mining

• Construction

• Transportation

• Medical

• Energy

• Health & Safety




• Human Resources





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• Mining

• Construction

• Transportation

• Medical

• Energy

• Health & Safety




• Human Resources





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Industry standards encourage refresher training sessions every 2 years to ensure up-to-date industry standards. On completion of this course, students will be issued with a‘Statement of Attainment’ recognised under the Vocational Education and Training (VET)system.

This course is copyrighted to Drug Testing Solutions Pty Ltd.

AUSTRALIAN STANDARDSThis course is specifically concerned with the requirements of:

• AS/NZS 4308-2008 Procedures for specimen collection and the detection andquantitation of drugs of abuse in Urine

• AS 4760-2006 Procedures for specimen collection and the detection andquantitation of drugs in Oral fluid

Qualifications available within this course will enable successful participants to conductdrug testing either as a “Collector” or “Technician” as defined within the relevantstandards.

It is recommended that all workplaces conducting drug testing make a copy of therelevant Australian Standard available for Collectors and Technicians to review.

Course participants are encouraged to familiarise themselves with relevant AustralianStandards either for Urine or Oral Fluid. It is useful to consider the key requirements orrecommendations of the standards and prepare a summary for use in the field whilstconducting testing. Copies are available for purchase from SAI Global atwww.saiglobal.com

Cut-off levels and Target Concentrations.

The initial screening test cut-off levels for AS/NZS 4308-2008 “Procedures for specimencollection and the detection and quantitation of drugs of abuse in urine are”:

Class of Drug Cut-off level ug/L

Opiates 300

Amphetamine Type substance 300

Cannabis metabolites 50

Cocaine metabolites 300

Benzodiazepines 200

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Opiates 300




Benzodiazepines 200

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Opiates 300




Benzodiazepines 200

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Reference for above is Table 1 in AS/NZS 4308-2008. Unit ug/L and mcg/L are differentsymbols for the same unit of measurement, being micrograms per litre. The morecommon symbol used appears to be ug/L.

The initial screening test levels for AS 4760-2006 Procedures for specimen collection andthe detection and quantitation of drugs in oral fluid are referred to as “targetconcentrations” rather than “cut-off” levels. Whilst urine “cut-off” levels are chosen withreference to the sensitivity of current testing equipment, “targets” are chosen as theaccepted “cut-offs” for oral fluid since they are concentrations expected to be found in thehours following common use of drugs. The “target” concentrations for oral fluid are asfollows:

Class of drug Target levels ng/mL

Opiates 50

Amphetamine Type Stimulants 50

THC 25

Cocaine and metabolites 50

Reference for above is Table 3.1 in AS 4760-2006. Unit ng/mL is nanograms per millilitreand is sometimes expressed as ug/L (or mcg/L) which is micrograms per litre. These arethe same unit of measurement in real terms so 1ng/mL = 1ug/L.

(Following the on-site immunoassay processes above, the laboratory confirmation cut-offsand targets, which are the reportable levels, may be less for some drug types. Refer tothe relevant Australian Standards for full details.)

Further Notes:

A metabolite is the form a drug takes after it has been broken down and processed by thebody. The original drug substance itself is often referred to as the “parent” drug.

Oral fluid cut-off levels may refer to the parent drug types as well as metabolites. It isimportant to note that the AS4760-2006 target concentration for THC (cannabis) is for theparent drug, commonly referred to as “delta-9”.

Urine testing by its very nature detects only the metabolites.

An initial on-site positive test result may be referred to as a presumptive positive or non-negative test result. It suggests the presence of drugs in the oral fluid or urine is abovethe cut-off or target levels listed above. A negative test result suggests that the level ofdrug in the oral fluid or urine is below the cut-off and target levels listed above or notpresent in the donor's system at all

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Opiates 50


THC 25




Further Notes:





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Opiates 50


THC 25




Further Notes:





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The cut-off and target levels designated in the Australian Standards for oral fluid, AS4760-2006 have been determined by a panel of industry experts to be the levels at which aperson is deemed 'unfit for duty' or possibly ‘under the influence' of a drug.

Drug test devices include claimed target and cut off levels for each drug type tested for.Whilst these levels may not match the Australian Standard levels in all cases attentionshould be paid to ensure the device chosen is acceptable to the user’s desired outcomes.

WORKPLACE HEALTH & SAFETY (WHS)WHS legislation and regulations, whether state based or National, in most cases do nothave specific requirements relating to drugs and alcohol. However, they do specificallyrequire risks to be managed, eliminated or reduced wherever possible.

With the prevalence of drugs and alcohol in Australian society it is reasonable to alwaysconsider drugs and alcohol as risks to be managed in the workplace.

OVERVIEW OF ALCOHOL AND OTHER DRUG(AOD) TESTINGBest practice drug and alcohol risk management programs should include:

AOD Policy and Procedure relevant to the workplace in which it is implemented.

Inductions and/or lengthier education and awareness training to ensure all workersunderstand the requirements of the AOD Policy and Procedure.

AOD Testing conducted at random, for reasonable suspicion cases or postincidents.

Assistance available for workers who breach the policy and procedure or otherwiseseek support relevant to drugs and alcohol use.

The philosophy behind conducting random and other testing will often be to create adeterrent effect so workers are motivated to more effectively manage their use of AOD.

In cases where workers breach the AOD Policy and/or Procedure, approaches intended tosupport and if necessary rehabilitate the worker are encouraged. Such approaches mayinclude, for example, two or three “strike” Procedures or alcohol limits more in line withroad use rather than the 0.00% commonly observed in workplaces.

Some workplaces, either due to their “zero tolerance” approach or high risk occupationswithin them, may seek to dismiss workers following their first breach of Policy and/orProcedure.

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DRUG TYPES, EFFECTS & DETECTION TIMESAn overview of drug types is included in the product information for one of the drug testkits used in this course. Within that information they include approximate detection timesfor the drugs listed. It is important to note that the claimed detection times ofmanufacturers often relate to laboratory controlled studies or trials and may differ fromwhat is experienced in the field when testing on-site at workplaces. To provide a balancedview we have included detection times below which are more commonly observed in thefield with on-site testing.

Amphetamine (Amp) - May be legal- Examples: ADHD medication - dexamphetamine / Cold & Flu - pseudoephedrine /

Weight Management - Duromine

Synthesis is achieved by chemical reaction of pre-cursor ingredients, withpseudoephedrine being a common one.

High doses of amphetamine lead to enhanced stimulation of the central nervous systeminducing euphoria, alertness, reduced inhibition, a sense of increased energy/power and areduced appetite.

Cardiovascular responses to amphetamines include increased blood pressure and cardiacarrhythmias. Long term use responses include paranoia, hallucinations, psychotic behaviorand anxiety.

DETECTION TIMES IN THE FIELD

Oral Fluid : Up to 24 hours (studies claim up to 72 hours)

Urine : Up to 3 days

Methamphetamines (Met) - Always illegal- Examples: Ice, speed (Ecstasy is sometimes included when drug testing within

this class of drugs although it is technically another substance, MDMA)

Synthesized similar to Amphetamines

Effects are similar to Amphetamine.

DETECTION TIMES



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DETECTION TIMES



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DETECTION TIMES



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Cocaine (coc) – Always illegal-Examples: Coke, crack

Synthesised and processed from the leaves of the Coca plant.

Cocaine is a potent central nervous system stimulant along with a local anesthetic.


Oral Fluid : Up to 24 hours (Studies also claim 24 hours)


Marijuana (thc)-Examples: Joints, hash

The Cannabis Sativa plant produces leaves and flowers for Marijuana.

THCΔ9-tetrahydrocannabinol (Delta 9) is the main active ingredient in cannabis and theone which caused the “high” effect.

Immediate effects include mild euphoria, reduced short term memory, dry mouth,impaired motor skills, reddening of the eyes, increased appetite, and increased heart rate.

Long-term effects may include behavioral changes, schizophrenia, and diseases of thelungs and other organs.

The peak effect of marijuana administered by smoking occurs in 15-30 minutes aftersmoking and the duration of effects may last up to 5 hours.


Oral Fluid : Up to 12 hours (Studies claim up to 14 hours)

Urine : Up to 6 weeks depending upon usage frequency

Opiates (opi)Examples: Morphine, codeine, heroin

Opiate refers to any drug derived from opium poppy, including the natural products suchas morphine/codeine.

Semi-synthetic drugs derived from the opium poppy include heroin. Opioid analgesicscomprise a large group of substances that control pain by depressing the central nervoussystem.

Immediate effects include pleasure, drowsiness, nausea and a “high” effect if sufficientlevels are consumed.

Long term effects include dependence, malnutrition.

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Oral Fluid : Codeine up to 24 hours (Studies claim up to 48 hours for codeine)

Morphine up to 24 hours (Studies agree up to 21 hours)


Benzodiazepines (bzo)Examples: Diazepam, Valium

Benzodiazepines are synthesised from other chemicals and are psychoactivemedicationstypically prescribed for anxiety and sleep disorders.

Immediate effects include sedative and muscle relaxant properties.


Oral Fluid : Not included under current Australian Standards.

Urine : 1-5 days

DRUG TESTING METHODSWithin the framework of Australian Standards there are 2 main methods used forWORKPLACE, MEDICO-LEGAL OR COURT DIRECTED Drug test screening: Urine Testingand Oral Fluid Testing.

Each method of testing may be used for

• pre-employment drug testing

• random workplace drug testing

• incident testing

• cause or suspicion testing

• return to work testing

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Urine : 1-5 days








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Urine : 1-5 days








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Advantages of URINE TESTING Challenges for URINE TESTING

• Historical use of drugs (up to 6weeks) is useful for pre-employmenttesting and indicates in the case ofTHC that subjects are generally freeof that drug.

• Laboratory confirmation is morewidely available& lower cost than oralfluid

• Urine test cups are relatively cheap

• Accreditation of urine cups isavailable which provides an indicationof quality.

• Toilet facilities are required

• Not relevant to “fitness for work” aspresence of drug in urine does notindicate recent use

• Considered invasive and not “genderfriendly”

• Collection not observed - supervisedonly.

• Adulteration, substitution or othertampering of samples is possibleand products to facilitate this areactively marketed.

Advantages of ORAL FLUID TESTING Challenges for ORAL FLUID TESTING

• More easily accepted by employeesand some workers unions as it doesnot test for history of use and exposewhat a person may do in their privatetime outside of working hours.

• Testing can be performed in anyprivate room, by the roadside orother places as needed.

• Gender friendly.

• Observation of Saliva collectionmakes it difficult to tamper, substituteor adulterate the sample

• Drug levels in saliva correlate withblood levels providing indications ofrecent use and potential affect uponperformance.

• Oral test kits are generally moreexpensive than urine test kits.

• No current accreditation availablefor drug test kits suggests themethod is inferior to urine testing.However a range of criteria shouldbe used to choose the best methodfor purpose intended.

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Testing Types - Further Explanation:

→ Pre-employment Testing –many companies will use urine testing as part of a pre-employment medical to check if a potential employee has a history of drug use.This is particularly useful for THC users since this drug will be detected in urine forweeks depending on frequency of use.

→ Random Testing –intended to deter employees from using drugs in the case ofurine testing or attending work after recent use of drugs in the case or oral fluidtesting. A random testing program can be conducted either in-house or by anexternal provider with frequency of testing determined by factors such as safetyrisk profile of the business, budget, desired outcome and contractual requirements.

→ Incident Testing - employees are tested when an incident occurs depending uponthe policy in place this could be as a result of a “near miss “or it may only occurwhen damage to property or personnel injury occurs.

→ For Cause Testing –employees are tested when there is a reasonable suspicion thatthey may be affected by, or under the influence, of drugs. Many workplaces chooseto adopt a procedure here requiring signs and symptoms to be recorded and aproper process followed to avoid victimisation.

Recently in Australia the preference for workplace random drug testing programs formajor corporates appears to be moving towards oral fluid. This is likely due to oral fluidbeing less intrusive into employee lifestyles and also its relevance to fitness for work sinceit detects recent use of drugs.

In general, each workplace still determines their own needs based upon their risk profiles,industry regulations and overall goals for a drug testing program. Both urine and oral fluidtesting will continue to have a role well into the future.

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PREPARATION - DRUG TESTSKey factors to consider prior to commencement of any drug testing include:

“In-House” Testing at your own Workplace

→ Refer to your Company or relevant drug & alcohol policy and procedures.Adherence to policy and procedure is key to avoiding issues and disputes. Be sureto keep the relevant policy/procedure in your kit of equipment or know where toaccess it if required.

→ Arrange access to facilities as required (particularly in the case of urine testingwhere a bathroom will be required). Other requirements may include temporarystorage of specimens prior to transport to the laboratory. Security of the specimensshould be considered also.

→ Location of testing must consider privacy & confidentiality including visibility andability for others to overhear proceedings.

→ Random selection method to be adopted should be fair, unbiased and maintainintegrity. Various methods can be used with examples including specialisedsoftware, electronic number generators (such as a smart-phone), random numberlists and multi-colored objects to be drawn from a bag.

“External Testing” - In addition to the above factors further considerations arerequired for a client / customer or third party controlled site.

→ Site access - Ensure permission has been provided and manner of site access isknown prior to attending.

→ On-site representative –Your customer or third party should provide arepresentative to assist in coordinating test subjects. This may be the same personwho manages any presumptive positives which occur on site.

→ How persons will be managed, including safety of those persons maintainedfollowing presumptive positive results on site.

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EQUIPMENT & INSTRUCTIONS FOR TESTING

DOCUMENTATIONDocumentation should be prepared with consideration to the oral fluid and urine testingAustralian Standards.

The Australian Standards refer to a 'permanent record system'. These may consist of abook or other system able to collect and store test records for each subject tested.

Important features in such test records are confirmation of identity of the donor, Collectordetails, date of sample collection and consent. Records should be all in the sequence ofcollection.

There are two different approaches in use in the market place and both may demonstratecompliance with the guidelines.

1 - Use a single document for all drug testing conducted. This would be a chain ofcustody form which can be used for all initial on-site testing with additional sectionscompleted in the event of a non-negative /presumptive positive.

2 - Use two documents. Firstly, a Test Record Form will record all necessary informationas required by a “permanent record system” as outlined in the Australian Standards.Secondly, use a separate chain of custody form in the event of a non-negative /presumptive positive.

For the purposes of this course, we have adopted the two form approach, with a testrecord form and a chain of custody form approach taken.

Copies of completed documentation may be required. For a Test Record Form one copymay often suffice however for a chain of custody form a second copy will be required inevery instance (one for records and one to transport with samples to the laboratory).

In some cases a digital or electronic copy of completed documentation such as aphotograph may be sufficient. Duplicate or triplicate books can also be printed and used ifrequired.

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Note: A common practice within the industry has also been to include questions during theinitial testing of donors regarding their recent use of drugs, alcohol and medications. Thisis not necessarily best practice and in some cases may represent breach of privacy. Suchinformation should be considered need to know only and really only becomes relevantonly following an initial non-negative / presumptive positive. At that time additionalinformation can be more reasonably requested. Students should exercise caution andcarefully review or question any workplace drug and alcohol procedure or document whichrequests specific information about recent use of these substances. Medication can stillbe effectively managed without demanding details from every employee in the workplace.The Test Record Form used in this course does not include questions regarding recentuse.

URINE TEST CUPSUrine drug test cups are single use and disposable. They typically are a plastic cup with asealable lid and contain a set of test strips built into the cup. Technology employed isreferred to as lateral flow immunoassay.

The test donor (person being tested) will provide a specimen of urine inside the cup to therequired fluid level and reseal the cup. The test strips will automatically absorb the fluid,reactions take place and the test results will appear.

For the purpose of this training course we will use the Alere Innovacon Multi-Drug Cup, which is certified under AS4308.

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INNOVACON MULTI-DRUG CUPUrine Drug Screening Device

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INNOVACON MULTI-DRUG URINE CUP

PrincipleThe Multi-Drug One Step Multi-Line Screen Test Panel Activation Cup (Urine) is animmunoassay based on the principle of competitive binding. Drugs which may be presentin the urine specimen compete against their respective drug conjugate for binding sites ontheir specific antibody.

During testing, a urine specimen migrates upward by capillary action. A drug, if present inthe urine specimen below its cut-off concentration, will not saturate the bindingsites of its specific antibody coated on the particles. The antibody coated particleswill then be captured by the immobilized drug conjugate and a visible colored line willshow up in the test line region of the specific drug strip. The colored line will not form inthe test line region if the drug level is above its cut-off concentration because it willsaturate all the binding sites of the antibody coated on the particles.

A drug-positive urine specimen will not generate a colored line in the specific test lineregion of the strip because of drug competition, while a drug-negative urine specimen or aspecimen containing a drug concentration less than the cut-off will generate a line in thetest line region. To serve as a procedural control, a colored line will always appear at thecontrol line region indicating that proper volume of specimen has been added andmembrane wicking has occurred.

Specimen Validity Tests (S.V.T.) SummaryEach S.V.T. strip contains chemically treated reagent pads. Three to five minutesfollowing the activation of the reagent pads by the urine sample, the colors that appear onthe pads can be compared with the printed color chart card.

The color comparison provides a semi-quantitative screen for any combination ofoxidants, pH and creatinine in human urine which can help assess the integrity of theurine sample.

S.V.T. PrincipleAdulteration is the tampering of a urine specimen with the intention of altering the testresults. The use of adulterants can cause false negative results in drug tests by eitherinterfering with the screening test and/or destroying the drugs present in the urine.Dilution may also be employed in an attempt to produce false negative drug test results.One of the best ways to test for adulteration or dilution is to determine certain urinarycharacteristics such as oxidants, creatinine and pH in urine. Whilst the Innovacon UrineCup used for this course includes the aforementioned SVT’s, other possible substances areexplained below.

Oxidants/PCC (OX) (Pyridiniumchlorochromate) tests for the presence ofoxidizing agents such as bleach and hydrogen peroxide. Pyridinium Chlorochromate

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is a commonly used adulterant. Normal human urine should not contain oxidants orPCC.

Specific gravity (SG) tests for sample dilution. The normal range is from 1.003 to1.030. Values outside this range may be the result of specimen dilution oradulteration.

PH tests for the presence of acidic or alkaline adulterants in urine. Normal PHlevels should be in the range of 4.0 to 9.0. Values outside of this range mayindicate the sample has been altered.

Nitrite (NIT) tests for commonly used commercial adulterants such as Klear orWhizzies. They work by oxidizing the major cannabinoid metabolite THC-COOH.3Normal urine should contain no trace of nitrite. Positive results generallyindicate the presence of an adulterant.

Glutaraldehyde (GLUT) tests for the presence of an aldehyde. Adulterants suchas UrinAid and Clear Choice contain glutaraldehyde which may cause falsenegative screening results by disrupting the enzyme used in someimmunoassay tests.2Glutaraldehyde is not normally found in urine; therefore,detection of glutaraldehyde in a urine specimen is generally an indicator ofadulteration.

Creatinine (CRE) is a waste product of creatine, an amino acid contained inmuscle tissue and found in urine.1A person may attempt to foil a test by drinkingexcessive amounts of water or diuretics such as herbal teas to “flush” the system.Creatinine and specific gravity are two ways to check for dilution and flushing,which are the most common mechanisms used in an attempt to circumvent drugtesting. Low creatinine and specific gravity levels may indicate dilute urine. Theabsence of creatinine (< 5 mg/dL) is indicative of a specimen not consistent withhuman urine. Creatinine is an adulterant requiring testing under the currentAustralian Standard AS4308 (use correct terms for the AS4308)

Specimen Collection & PreparationUrine Assay

The urine specimen must be collected in a clean and dry container. Urine collected at anytime of the day may be used. Urine specimens exhibiting visible precipitates should becentrifuged, filtered, or allowed to settle to obtain a clear supernatant for testing.

Specimen Storage

Urine specimens may be stored at 2-8°C for up to 48 hours prior to testing. For prolongedstorage, specimens may be frozen and stored below -20°C. Frozen specimens should bethawed and mixed well before testing. When tests include S.V.T., storage of urinespecimens should not exceed 2 hours at room temperature or 4 hours refrigerated prior totesting. For best results, specimens should be tested immediately following collection.

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Specimen Storage


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Specimen Storage


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Precautions For medical and other professional in vitro diagnostic use only. Do not use after the

expiration date. The test cup should remain in the sealed pouch until use. All specimens should be considered potentially hazardous and handled in the same

manner as an infectious agent. The used test cup should be discarded according to local regulations.

Storage & StabilityStore as packaged in the sealed pouch either at room temperature or refrigerated (2-30°C). The test cup is stable through the expiration date printed on the sealed pouch. Thetest cup must remain in the sealed pouch until use. DO NOT FREEZE. Do not use beyondthe expiration date.

How to Perform the Procedure (Manufacturer’s Instructions)

The manufacturer’s instructions for this product are included for the sake ofcompleteness however, the procedures upon which the assessment is basedare detailed later in this handbook.

Allow the test cup, urine specimen, and/or controls to equilibrate to roomtemperature (15-30°C) prior to testing.

1. Bring the pouch to room temperature before opening it. Remove the cup from thesealed pouch and use it as soon as possible.

2. Collect specimen in the cup and secure the cap tightly.

3. Peel off the activation lock wrapped around the activation button.

4. Check the temperature label (Temp Label) up to 4 minutes after specimencollection. A green color will appear to indicate the temperature of the urinespecimen. The proper range for an unadulterated specimen is 33-38°C (91-100°F).

5. Date and initial the security seal label then place it over the cap. (Ignore thissince procedure in this course requires access to the original samplewhich is then split into two samples)

6. Place the cup on a flat surface and push the activation button into the socket of thecup to initiate the test. A green indicator located below the test window will appearto ensure accurate activation. If the green indicator is not visible then the activationbutton is not pushed in completely. Start the timer.

7. Remove the peel off label covering the test results. Read the adulteration stripbetween 3 and 5 minutes.

8. Compare the colors on the adulteration strip to the enclosed color chart. If theresult indicates adulteration, do not interpret the drug test results. Either retest theurine or collect another specimen.

9. Read the drug strip results at 5 minutes. The drug strip results remain stable for upto sixty minutes.

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Quality Control

A procedural control is included in the test. A colored line appearing in the control lineregion (C) is considered an internal procedural control. It confirms sufficient specimenvolume, adequate membrane wicking and correct procedural technique.

(Control standards are not supplied with the Innovacon kit; however, it is recommendedthat positive and negative controls be tested as good laboratory practice to confirm thetest procedure and to verify proper test performance.)

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Quality Control



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Quality Control



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Interpretation of Results

NEGATIVE:* A colored line in the control line region (C) and a colored line in the test lineregion (T) for a specific drug indicate a negative result. This indicates that the drugconcentration in the urine specimen is below the designated cut-off level for that specificdrug.

*NOTE: The shade of color in the test region (T) may vary, but it should beconsidered negative whenever there is even a faint colored line.

POSITIVE: A colored line in the control line region (C) but no line in the test line region(T) for a specific drug indicates a positive result. This indicates that the drug concentrationin the urine specimen exceeds the designated cut-off for that specific drug.

INVALID: Control line fails to appear. Insufficient specimen volume or incorrectprocedural techniques are the most likely reasons for control line failure. Review theprocedure and repeat the test using a new test cup. If the problem persists, discontinueusing the lot immediately and contact your local distributor.

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Limitations1. The Multi-Drug One Step Multi-Line Screen Test Panel Activation Cup (Urine)

provides only a preliminary analytical result. A more specific chemical methodmust be used to obtain a confirmed result. Gas chromatography/massspectrometry (GC/MS) is the preferred confirmatory method. (DTS note – Or LC/MSand both with a NATA Accredited Lab)

2. It is possible that technical or procedural errors, as well as other interferingsubstances in the urine specimen may cause erroneous results.

3. Adulterants, such as bleach and/or alum, in urine specimens may produceerroneous results regardless of the analytical method used. If adulteration issuspected, the test should be repeated with another urine specimen.

4. A positive result indicates presence of the drug or its metabolites but doesnot indicate level of intoxication, administration route or concentration in urine.

5. A negative result may not necessarily indicate drug-free urine. Negative results canbe obtained when drug is present but below the cut-off level of the test.

6. The test does not distinguish between drugs of abuse and certain medications.

7. A positive result might be obtained from certain foods or food supplements.

S.V.T. Adulteration Limitations1. The adulteration tests included with this product are meant to aid in the

determination of abnormal specimens. While comprehensive; these tests are notmeant to be an “all-inclusive” representation of possible adulterants.

2. Oxidants/PCC: Normal human urine should not contain oxidants or PCC. Thepresence of high levels of antioxidants in the specimen, such as ascorbic acid, mayresult in false negative results for the oxidants/PCC pad.

3. Specific Gravity: Elevated levels of protein in urine may cause abnormally highspecific gravity values.

4. Nitrite: Nitrite is not a normal component of human urine. However, nitrite found inurine may indicate urinary tract infections or bacterial infections. Nitrite levels of >20 mg/dL may produce false positive glutaraldehyde results.

5. Glutaraldehyde: Is not normally found in urine. However certain metabolicabnormalities such as ketoacidosis (fasting, uncontrolled diabetes or high-proteindiets) may interfere with the test results.

6. Creatinine: Normal creatinine levels are between 20 and 350 mg/dL. Under rareconditions, certain kidney diseases may show dilute urine.

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ORAL FLUID TESTS

Oral fluid drug test devices are single use and disposable. They typically comprise of acollector absorbent pad or “swab” and test strips built into the device. Technology again islateral flow immunoassay although other technologies in development may be available inthe near future.

Current oral fluid drug test devices from some manufacturers also include electronicsystems which read test results from the consumable kit. These types of kits arefrequently used by police in Australia in part due to their ability to record results andgenerate test identification numbers.

The oral fluid drug test donor (person being tested) will place the collection swab in theirmouth to collect oral fluid. The collector will then place the swab into the collectionchamber. The test strips will automatically absorb the fluid and the test results will appear.

It is important to note that saliva is not classified as a biological fluid unless it is obtainedfrom a dental procedure.

For the purposes of this course we will use the Alere iScreen OFD (Oral Fluid Device).

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ORAL FLUID TESTS






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ORAL FLUID TESTS






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ALERE iSCREEN OFDOral Fluid Drug Screening Device

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How the Alere iScreen OFD Works – ManufacturerInstructions and InformationThe manufacturer’s instructions for this product are included for the sake ofcompleteness however; the procedures upon which the assessment is basedare detailed later in this handbook.

PrincipleThe Alere iScreen® OFD Drug Test Device for AMP/mAMP/COC/OPI/THC is animmunoassay based on the principle of competitive binding. Drugs that may be present inthe oral fluid specimen compete against their respective drug conjugates for binding siteson their specific antibody.

During testing, a portion of the oral fluid specimen migrates upward by capillary action. Adrug, if present in the oral fluid specimen below its cut-off concentration, will notsaturate the binding sites of its specific antibody. The antibody will then react with thedrug-protein conjugate and a visible coloured line will show up in the test line region ofthe specific drug strip. The presence of drug above the cut-off concentration in the oralfluid specimen will saturate all the binding sites of the antibody. Therefore, the coloredline will not form in the test line region.

A drug-positive oral fluid specimen will not generate a colored line in the specific test lineregion of the strip because of drug competition, while a drug-negative oral fluid specimenwill generate a line in the test line region because of the absence of drug competition.

To serve as a procedural control, a colored line will always appear at the control lineregion, indicating that proper volume of specimen has been added and membrane wickinghas occurred.

ReagentsThe test contains membrane strips coated with drug-protein conjugates on thetest line, polyclonal antibody against gold-protein conjugate at the control line, and a dyepad which contains colloidal gold particles coated with antibody specific to Amphetamine,Methamphetamine, Benzoylecgonine, Morphine, and THC as11-nor-∆9– THC -9 COOH.

The Alere iScreen®OFD Drug Test Device for AMP/mAMP/COC/OPI/THC/PCP/OXY andtheir metabolites is a rapid, oral fluid screening test that can be performed without theuse of an instrument. The test utilizes antibodies to selectively detect elevated levels ofspecific drugs in human oral fluid.

The manufacturer also includes explanation of the below drug groups tested, detectionwindows and target concentrations which can be detected. Note that the claimeddetection times of the drugs are based upon referenced studies however may differ fromwhat is experienced in the field such as the workplace.

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Amphetamine (AMP)

Amphetamine is a sympathomimetic amine with therapeutic indications. The drug is oftenself-administered by nasal inhalation or oral ingestion. Depending on the route ofadministration, amphetamine can be detected in oral fluid as early as 5-10 minutes and upto 72 hours after use.1

The Amphetamine assay contained within the Alere iScreen® OFD Drug Test Device yieldsa positive result when the amphetamine concentration in oral fluid exceeds 50 ng/mL.

Methamphetamine (mAMP)

Methamphetamine is a potent stimulant chemically related to amphetamine but withgreater central nervous system (CNS) stimulation properties. The drug is often self-administered by nasal inhalation, smoking or oral ingestion. Depending on the route ofadministration, methamphetamine can be detected in oral fluid as early as 5-10 minutesand up to 72 hours after use.1

The Methamphetamine assay contained within the Alere iScreen® OFD Drug Test Deviceyields a positive result when the methamphetamine concentration in oral fluid exceeds 50ng/mL.

Cocaine (COC)

Cocaine is a potent CNS stimulant and a local anesthetic derived from the coca plant(erythroxylum coca). The drug is often self-administered by nasal inhalation, intravenousinjection and free-base smoking. Depending on the route of administration, cocaine andits metabolites, benzoylecgonine and ecgoninemethylester, can be detected in oral fluid asearly as 5-10 minutes and up to 24 hours after use.The Cocaine assay contained within the iScreen®OFD Drug Test Device yields a positiveresult when the cocaine metabolite concentration in oral fluid exceeds 20 ng/mL.

Opiates (OPI)

The drug class opiates refers to any drug that is derived from the opium poppy, includingnaturally occurring compounds such as morphine and codeine and semi-synthetic drugssuch as heroin. Opiates act to control pain by depressing the central nervous system. Thedrugs demonstrate addictive properties when used for sustained periods of time;symptoms of withdrawal may include sweating, shaking, nausea and irritability. Opiatescan be taken orally or by injection routes including intravenous, intramuscular andsubcutaneous; illegal users may also take the drug intravenously or by nasal inhalation.Using an immunoassay cutoff level of 40 ng/mL, codeine can be detected in the oral fluidwithin 1 hour following a single oral dose and can remain detectable for 7-21 hours afterthe dose.2 6-Monoacetylmorphine (6-MAM) is found more prevalently in oral fluid, and is ametabolic product of heroin. Morphine is a major metabolic product of codeine and heroin,and is detectable for 24-48 hours following an opiate dose.

The Opiates assay contained within the Alere iScreen® OFD Drug Test Device yields apositive result when the morphine concentration in oral fluid exceeds 40 ng/mL.

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Amphetamine (AMP)






Cocaine (COC)


Opiates (OPI)



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Amphetamine (AMP)






Cocaine (COC)


Opiates (OPI)



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Marijuana (THC)

Tetrahydrocannabinol (THC), the active ingredient in the marijuana plant (cannabissativa), is detectable in oral fluid shortly after use. The detection of the drug is thought tobe primarily due to the direct exposure of the drug to the mouth (oral and smokingadministrations) and the subsequent sequestering of the drug in the buccalcavity.3Historical studies have shown a window of detection for THC in oral fluid of up to14 hours after drug use.

The THC assay contained within the Alere iScreen® OFD Drug Test Device yields apositive result when the 11-nor-∆3– THC -9 COOH concentration in oral fluid exceeds12ng/mL.

Precautions (as per the Manufacturer) The device is for forensic use only. Do not use after the expiration date. The oral fluid test device should remain in the sealed pouch until use. Saliva is not classified as biological hazard unless derived from a dental procedure. The used collector and device should be discarded according to federal, state and

local regulations.

Storage and StabilityStore as packaged in the sealed pouch at 2-30°C. The test is stable through the expirationdate printed on the sealed pouch. The test devices must remain in the sealed pouch untiluse. DO NOT FREEZE. Do not use beyond the expiration date.

Specimen and Collection SeparationThe oral fluid specimen should be collected using the collector provided with the kit,following the detailed instructions under Directions for Use. No other collection devicesshould be used with this assay. Oral fluid collected at any time of the day may be used.

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Marijuana (THC)




local regulations.



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Marijuana (THC)




local regulations.



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How to Perform the Procedure

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NB: For the purposes of this training course new sampleswill need to be collected and be prepared for Laboratoryconfirmation.

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NEGATIVE:* All test lines appear. One colored line should be in the control region(C), and other apparent colored line should be adjacent in the test region (Drug/T).This negative result indicates that the drug concentration is below the detectable levelor drug free.

*NOTE: The shade of color in the test region (Drug/T) will vary, but the test resultshould be considered negative whenever there is even a faint colored line.

POSITIVE: One colored line appears in the control region (C). Any test line notappears in the test region (Drug/T). This positive result indicates that the drugconcentration is above the detectable level.

INVALID: Control line fails to appear. Insufficient specimen volume or incorrectprocedural techniques are the most likely reasons for control line failure. Review theprocedure and repeat the test using a new test panel. If the problem persists,discontinue using the lot immediately and contact the manufacturer.

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Quality ControlA procedural control is included in the test. A colored line appearing in the controlregion (C) is considered an internal procedural control. It confirms sufficient specimenvolume, adequate membrane wicking and correct procedural technique.

Limitations1. The Alere iScreen® OFD Drug Test Device provides only a qualitative,

preliminary analytical result. A secondary analytical method must be used toobtain a confirmed result. Gas chromatography/mass spectrometry (GC/MS) orgas chromatography/tandem mass spectrometries (GC/MS/MS) are preferredconfirmatory methods.

2. A positive test result does not indicate the concentration of drug in the specimenor the route of administration.

3. A negative result may not necessarily indicate a drug-free specimen. In suchcases Drug may be present in the specimen but below the cutoff level of theassay.

Specimen Validity / AdulterantsTesting for the above is not required for oral fluid drug testing since the collection isfully observed. It is difficult to successfully adulterate a saliva sample in thecircumstances encountered in workplace drug testing.

URINE & ORAL FLUID – CONFIRMATORYTESTING AT THE LABORATORYFor any non-negative/presumptive positive results a specimen will need to be sent to alaboratory for confirmation.

Chain of Custody procedures must be adopted to manage and transport thespecimens to the laboratory. Specific procedures are detailed in this course.

Standard procedure would require two specimens to be transported to the laboratory.The second (B sample) is referred to as the “Referee” sample. In most cases theequipment or specimen used for the initial drug test or a secondary collectionspecifically for the laboratory will then be split into the “A” and “B” sample. Someindustries, workplaces or testing providers may choose to prepare a third sample to bestored separately in case required.

The laboratory needs at least 1ml of oral fluid or 5ml (absolute minimum) of urine, persample, to perform the confirmatory test. In most cases urine in quantities of 20ml to25ml or more is provided in each sample.

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Providing a referee sample is a requirement under both Australian Standardsfor Urine and Oral fluid.

The laboratory will conduct confirmation testing to confirm presence of specific drugsand in what quantity. (Initial presumptive positive / non-negative results do not providea quantitative reading)

On-site drug test screening results will only provide details of the Class of drugspotentially present. This can be straight forward with single Class drugs such as THCand Cocaine; however for detection of Opiates and Amphetamines further analysis willthen identify the more specific drugs detected.

Units of quantity measurement used may be micrograms per litre (ug/l) or nano gramsper milliliter (ng/ml). These are the same unit, for example 30 ug/l = 30 ng/ml.

Laboratory confirmation involves a type of mass spectrometry or a chromatographytest. The most common types are GCMS (Gas Chromatography/Mass Spectrometry)and LCMS (Liquid chromatography/Mass Spectrometry). Generally GCMS is used fortesting urine and LCMS is used for testing oral fluids.

A certificate will be provided by the laboratory detailing the results of the confirmationtest including all required reference information.

Selection of a NATA Accredited laboratory ensures that the Australian Standards, thesubject of this course, are upheld and integrity maintained for the confirmationprocess.

CHAIN OF CUSTODY PROCEDURESChain-of-custody refers to the procedures that ensure integrity of each test specimen ismaintained by tracking its handling, storage and transport from donor collection toreceipt at the laboratory.

A chain of custody form is completed as part of this process. This form is to be usedfrom time of sample collection until receipt of specimens by the laboratory, includingtransport from one laboratory to another.

Chain-of-custody is one of the most important considerations when conducting drugtesting. Correct procedures must be established and adhered to at all time.

Failure to do so may result in confirmatory testing being void or not conducted by thelaboratory.

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A chain-custody form must collect/confirm the following:

→ Donor identification and how it was confirmed.

→ Donor name may be used however other identifiers may be used such as areference number from the initial on-site test, date of birth, or driver licensenumber.

→ the donor's signed consent to testing

→ the collector's name

→ the collector's signed declaration

→ testing equipment details including lot/batch number and expiry date

→ Initial on-site test results

→ Security seal references.

Clarifications for THE CHAIN-OF-CUSTODY FORM / Process

SAMPLE TUBE/CONTAINER LABEL DETAILS

Labels should detail the date and time of collection. Two unique identifiers should beincluded on the labels for each sample. This may be any two of the initial test recordnumber, the donor’s initials, date of birth or the chain of custody number. The donor’sname can be used although affords less privacy than other identifiers.

CHAIN OF CUSTODY FORM COMPLETION – General information required.

DONOR DETAILS

Identification numbers and other reference information is detailed at the beginning ofthe form.

MEDICATION

Details volunteered by the test subject of any relevant medication consumed, usuallywithin the last 24 hours, can be included here to assist the Laboratory in the analysis.

INITIAL TEST RESULTS

This section is required under the Australian Standards and confirms PresumptivePositives and / or Negative results were observed on the initial test prior to laboratoryconfirmation.

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DONOR DETAILS


MEDICATION




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DONOR DETAILS


MEDICATION




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REQUESTING AUTHORITY / CONTACT NAMES

“External” Service Provider testing for a client - Include details here of the ServiceProvider you work for. Contact name for Laboratory reports should be your nominatedmanager.

“In-house” Employer testing staff – include details here of the Employer. Contactname for Laboratory Reports should be the nominated contact at your Employer’sbusiness.

SPECIMEN TYPE / METHOD OF CONFIRMATION REQUIRED

This section provides instructions to the Laboratory on the type of sample collected andconfirmation type required. GCMS is used for urine and LCMS for oral fluid.

SECURITY SEAL REFERENCES

Duplicate security seals can be attached to the chain of custody form or otherwise thereference numbers/letters can be written in the relevant section of the form.

DONOR CERTIFICATION

This section is self-explanatory on the example chain of custody form provided withthis course. Importantly this section also includes consent for the sample to beanalysed and results provided to the employer. Signature is essential.

DONOR IDENTIFICATION

Identification of the donor should be made unequivocally so photo identification suchas a driver’s licence or photo employee ID card is preferred. Otherwise it is acceptablefor an employer, manager or supervisor to identify the donor. Only one form ofacceptable identification is required.

(There appears to be some misinterpretation in the Industry suggesting two forms ofidentification are required. This likely stemmed from the requirement that at least twounique identifiers are used on for the chain of custody process).

COLLECTOR CERTIFICATION

This section is again self-explanatory on the chain of custody form provided with thiscourse. Most importantly it certifies the sample collected was provided by the donor asidentified on the chain of custody form.

CHAIN OF CUSTODY SECTION AT BASE OF FORM

This section is completed by Laboratory personnel upon receipt of samples.

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DONOR CERTIFICATION









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DONOR CERTIFICATION









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RECORDS OF TESTING

Australian Standard AS4760 for oral fluid requires all testing records to be stored for 7years in a secure location unless the requesting authority and donor make writtenagreement for earlier disposal.

Australian Standard AS4308 for urine requirements are the same as above except onlytwo years storage is required.

LABORATORY STORAGE OF REFEREE SAMPLES

Australian Standard AS4760 for oral fluid requires the laboratory to store refereesamples for 6 months, unless otherwise instructed by a donor.

Australian Standard AS4308 for urine requirements are the same as above except 12months and early disposal requires written authority of both the donor and therequesting authority.

Should a test subject disagree with a result they may request to proceed with a secondconfirmation test at the employee’s/contractor’s expense.

DRUG TESTING PROCESS INTEGRITYCollectors should take all reasonable precautions to protect samples fromcontamination and to ensure all procedures are followed correctly. Mistakes oromissions may affect integrity of results. The Laboratory may have to void a result ifthere is evidence which suggests tampering of the sample/s has occurred at some timeduring the chain of custody process.

Contamination can be avoided by use of clean gloves as an when required, cleaning ofsurfaces upon which you are working and use of a mat or underlay on tables/desks.

URINE DRUG TEST PROCEDURESPreparation of the Test Area

Ensure you have a suitable location such as a private room to conduct thetest. Furniture should include a table or desk and two chairs.

Bathroom access must be available, ideally in close proximity to the testingroom that is selected.

Prevent dilution or adulteration of samples. Preparation here will includeremoving access to water sources (use tape or plastic wraps if necessary)and add blue dye to the toilet bowl/cistern.

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RECORDS OF TESTING













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RECORDS OF TESTING













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Equipment Required:

Permanent record system (A test record form unless a single document isused for both chain of custody form and test record form)

Stationery as needed An under pad (absorbent mat) is recommended Urine test cup (Innovacon cup is provided in your practical kit) Watch or timer Gloves for yourself (You may choose to use a fresh pair of gloves for each

collection with a new donor) One large biohazard bag for disposal

Additionally, for a non-negative/presumptive positive test you will need:

Chain of custody form 2 x urine specimen tubes/containers (or 3 if a third is required) 1 x biohazard bags for the filled specimen containers. 2 x tamper evident security seals (or 3 if a third is required). 1 x laboratory specimen box &security seal. A chain of custody bag. A lockable refrigerator or esky to place the sample in while waiting for

courier pickup (or alternatively a secure or supervised location). Courier bag or mail bag if required for transport to the laboratory.

CONDUCTING A URINE DRUG SCREENINGTEST – ASSESSMENT PROCEDUREBelow procedure is indicative of the typical chronological order of events. In practicethe exact order of the steps may vary depending upon test kits used, design of the testrecord form and other factors.

1. Greet the donor and advise they are about to undergo a urine drug test.2. Confirm identity unequivocally, ideally with photo ID or via a manager/supervisor.3. Complete the relevant sections of the Test Record Form including donor details.4. Depending upon the drug policy and procedure you may ask the donor whether

they have consumed any prescription or over the counter medications, or illicitdrugs in the past several days.

5. Obtain a signed consent. (Should a subject refuse to sign consent and thusundergo a test you may advise them that this action MAY be considered a breachof their employer’s AOD policy and some policy/procedures will consider thisrefusal a “positive” result. Continued non co-operation may require you to referthe subject to the Company contact)

6. Prepare to collect the sample by putting on gloves.7. Check the urine drug test packet for evidence of damage.8. Record relevant drug test kit details on Test Record Form including batch

number and expiry date.9. Open the drug test package and check the contents also to ensure there is no

damage of loss of integrity of the kit.

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Equipment Required:














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Equipment Required:














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10.Explain to the donor that they need to provide a urine sample to quantityrequired as per the indicator line on the cup.

11.Escort donor to the toilet and ensure they wash their hands.12.Individual privacy should be allowed and you do not have to observe the donor

urinating into the cup.13.Retrieve the urine test cup from the donor which now contains the specimen.14.When the donor returns sit them down and place the test cup on the under pad15.Check the temperature indicator which for a urine sample should be between 33-

38 degrees Celsius. If temperature suggests the sample may have beenadulterated or substituted, ask the donor to provide another sample.

16.Check the adulterants are within the normal range. If not, ask the donor torepeat the test. If the new sample provided is still abnormal proceed to send thesample to the laboratory for confirmation.

17.For a valid test the urine must fully absorb along the test strips and a line shouldappear in the “C” area to indicate the control level has been reached.

18.If the Control line is not evident then the test is invalid and should be conductedagain using a new Innovacon drug test kit and a new specimen collection.

19.Peel off the paper covering the test strips.20.Wait the time allocated by the manufacturer of the device prior to reading the

result from the test strips and note the results on the test record form. In thecase of the Innovacon urine test cup this wait time is 5 minutes.

21.If all results are negative advise the donor the test is complete and they maycontinue with their duties.

22.If any drug type produces a non-negative/presumptive positive then the chain ofcustody process should be commenced with specimens being prepared fortransport to a laboratory for confirmation testing.

23.For negative test results empty the urine specimen into the toilet and dispose ofthe cup in the biohazard disposal bag.

24. Under no circumstance should a urine cup be re-used.

CHAIN OF CUSTODY - PREPARING URINE TO SEND TOA LABORATORY FOR CONFIRMATION(A photographic guide has been provided as part of the course materials)

1. Advise the donor that the test has returned a non-negative result and thatspecimens must be sent to a laboratory for confirmation.

2. The chain of custody kit provided includes three specimen tubes/containers, acollector cup (not needed for this procedure unless a further collection of urineis needed in addition to the Innovacon initial collection), four security chain ofcustody seals, a biohazard bag and a chain of custody bag.

3. Decant half of the original specimen into one container and another half into thesecond container. (If you need a third sample to comply with specific policy orprocedure requirements and need greater quantity of urine ask the donor toprovide a further sample.)

4. The quantity of each specimen should ideally be at least 20-25ml. Absoluteminimum is 5ml each specimen (this is approximately half of the specimen tubesprovided with the course materials).

5. Tighten the lids securely to avoid spillage.

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6. Complete the required details on the labels for each specimen container. Theselabels should include date/time of collection, two unique identifiers of the donorsuch as test record form number, date of birth, chain of custody number (forthe purpose of this course this number is the one affixed to the chain of custodybag). Ask the donor to sign and date the 2 security seals (or 3 if using a thirdspecimen).

7. Place a security seal on each container. Record the security seal referencenumbers or letters on the relevant section of the chain of custody form.

8. Place both (or all three) of the specimen tubes/containers into the biohazardbag provided.

9. The Chain of Custody form should now be completed using the test recordnumber (from the initial test documentation) as the subject’s identification. Forthe purposes of this course use the reference DTS002014

10.The chain of custody number on the chain of custody bag must be recordedalong with the security seal numbers on the chain of custody form.

12.Review the chain of custody form to ensure all relevant sections are nowcomplete, including the tick beside the GCMS analysis request since thespecimens are for urinalysis.

13.Ensure the donor has signed the declaration and consent section. This outlinesthat the specimens are being referred for laboratory confirmation.

14.Ensure you as the collector have signed the certification section.15.Place the completed chain of custody form into the biohazard bag provided

which includes a second pouch in the same bag containing the urine specimentubes/containers.

16.Dispose of the initial urine test cup in the disposal bag followed by your gloves.17.Fold up the biohazard bag and seal. No security seal is required due to the

tamper proof nature of the seal.18.Place both (or all three) samples in the laboratory specimen box. Use the fourth

security seal across the opening.19.Place the box inside the chain of custody bag and seal.20.Proceed to follow the relevant policy and procedure of the testing location, client

or employer. This may include contacting a nominated person to manage thedonor through the remainder of the process.

21.Store the laboratory samples in a locked or supervised refrigerator until acourier arrives to pick them up or keep them in an esky if you need to transportthem from a remote location. Ensure they are not exposed to heat and stored atlow temperatures.

22.Send to the laboratory via a courier approved to transport biological specimensor by mail following IATA 650 packaging Guidelines (this procedure complieswith all IATA requirements).Alternatively, if you have a laboratory nearby youcan deliver it yourself.

23.You can use one courier or mail bag for multiple donor specimens inside theirboxes.

24.Turnaround time for laboratory confirmation will usually be 24 to 48 hours fromwhen specimens are received by that laboratory.

25.Review the chain of custody form to ensure all relevant sections are nowcomplete, including the tick beside the LCMS analysis request since thespecimens are saliva.

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Note:A Positive confirmed by the Laboratory verifies the presence of a drug metabolite. Thisdoes not determine the level of impairment or extent the donor is affected by the drug.

CONDUCTING AN ORAL FLUID DRUG TESTPreparation of the Test Area

Ensure you have a suitable location such as a private room to conduct the test.Furniture should include a table or desk and two chairs.

Equipment required:

Chain of custody paperwork Permanent record system (A test record form if the chain of custody form is not

the only form used) Stationery as needed An under pad (absorbent mat) may be used. Oral fluid drug test kit Watch or timer Gloves for yourself (You may continue to wear the same gloves for multiple

collections). A large bag for disposal of used consumables


• 2 x oral fluid specimen containers• 1 x evidence or biohazard bag• 2 x tamper evident security seals• Chain of custody bag• A lockable refrigerator or esky to place the sample while waiting for courier

pickup• Courier bag or mail bag if required for transport to the laboratory. Note that no

special transport requirements will apply for saliva although the proceduresprovided in this course mirror those for urine specimens for the sake ofstrengthening sample integrity.

CONDUCTING AN ORAL FLUID DRUG SCREENINGTEST – ASSESSMENT PROCEDURE

1. Greet the donor advise they are about to undergo an oral fluid/saliva drug test.2. Confirm identity unequivocally, ideally with photo ID or via a

manager/supervisor.3. Complete the relevant sections of the Test Record Form including donor details.4. Depending upon the drug policy and procedure you may ask the donor whether

they have consumed any prescription or over the counter medications, or illicit

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Equipment required:












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Equipment required:












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drugs in the past 24 hours (shorter time period than urine testing).5. Ask donor if they have consumed any food or drink or taken anything orally in

the past 10 minutes. If they have, they will need to wait another 10 minutesbefore the test can be conducted. If they haven't you can proceed with the test.

6. Obtain a signed consent.(Should a subject refuse to sign consent and thusundergo a test you may advise them that this action MAY be considered abreach of their employer’s AOD policy and some policy/procedures will considerthis a “positive” result. Continued non co-operation may require you to refer thesubject to the Company contact)

7. Prepare to collect the sample by putting on gloves (if they are not already beingworn).

8. Check the oral fluid drug test kit packet for signs of damage.9. Record relevant drug test kit details on Test Record Form including batch


damage of loss of integrity of the kit.11. Explain to the donor how to provide a sample of oral fluid/saliva. For the

purposes of this course the iScreen OFD collector should be actively swabbedaround the mouth for three minutes as per the product insert instructions.

12. Some oral fluid devices may include an adequacy indicator which releases bluedye once the required amount of saliva has been absorbed.

13. This collection of oral fluid is fully observed by you, the collector.14. Process the sample of oral fluid as required by the kit being used and then wait

the allocated time as per the manufacturers product insert. In the case of theAlere iScreen the wait time is 10 minutes. Results should not be read before thisspecified time has elapsed.

15. For a valid test the oral fluid must fully absorb along the test strips and a lineshould appear in the “C” area to indicate the control level has been reached.

16. If the Control line is not evident then the test is invalid and should be conductedagain using a new iScreen drug test kit and a new sample collection.

17. Read the results and note the results in the relevant section of the testingrecord form.

18. If all results read negative advise the donor the test is complete and they maycontinue with their duties.

19. If any drug type produces a non-negative/presumptive positive then the chain ofcustody process should be commenced with samples being prepared fortransport to a laboratory for confirmation testing.

20. For negative test results dispose of the used oral fluid kit and other componentsin the biohazard disposal bag.

CHAIN OF CUSTODY - PREPARING ORAL FLUID TOSEND TO A LABORATORY FOR CONFIRMATION(A photographic guide has been provided as part of the course materials)

1. Advise the donor that the test has returned a non-negative result and thatsamples must be sent to a laboratory for confirmation.

2. Some oral fluid test kits may allow for the initial sample collected to be usedas one of the samples to be sent to the laboratory. For the purposes of this

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course we have adopted a process of a further sample collection which allowsfor two new samples to be forwarded to the laboratory.

3. The chain of custody kit provided includes two collectors, two collection tubes(both containing buffer solution), evidence or biohazard bag, two chain ofcustody seals, two identifier labels and a chain of custody bag. Confirmationkits should be maintained at room temperature between 18 and 25 Celsius.

4. The adequacy indicator built into the Quantisal collector ensures a suitableamount of oral fluid is obtained. It will collect 1ml (+/- 10%)

5. Note that the minimum of oral fluid required for laboratory LCMS analysis is atleast 1ml. The sample collected with the Quantisal collector when added to thebuffer solution contained in the collection tube, ensures greater than 1ml isavailable for both the A and B samples.

6. Check to ensure the expiry dates are valid and if beyond expiry use a new kit.7. Open both collector packets at the top exposing the collector stems. Request

the test subject to take hold of both collectors and gently swab inside theirgums, tongue and cheek until the volume adequacy indicator turns blue onboth collectors.

8. The test subject must not chew or suck on the collectors.9. Request the test subject to place each collector; pad first, into the collection

tubes containing the buffer solution. Ensure the collector is completelysubmersed in the solution and replace the caps, tightening them securely toavoid spillage. These samples will now be referred to as primary sample Aand secondary sample B.

10. Complete the required details on the labels for each specimen container andplace them over the existing labels. These labels should include date/time ofcollection, two unique identifiers of the donor such as test record formnumber, date of birth, chain of custody number (for the purpose of this coursethis number is the one affixed to the chain of custody bag).

11. Ask the donor to sign and date the 2 security seals (or 3 if using a thirdspecimen).

12. Place a security seal on each container. These seals can be placed either overor around the lid. This course instruction recommends over the lid as per thepicture guide shown.

13. The Chain of Custody form should now be completed using the test recordnumber (from the initial test documentation) as the subject’s identification.For the purposes of this course use the reference DTS002014

14. The chain of custody number on the chain of custody bag must be recordedalong with the security seal numbers on the chain of custody form.

15. Ensure the donor has signed the declaration and consent section. This outlinesthat the specimens are being referred for laboratory confirmation.

16. Ensure you as the Collector have signed the certification section.17. Check to ensure all fields have been completed on the chain of custody form

including the tick beside the LCMS analysis request since the specimens areoral fluid.

18. Place the completed chain of custody form into the evidence or biohazard bagprovided which has a second pouch in the same bag containing the specimentubes/containers. Add the two samples and seal the bag ready for transport tothe laboratory.

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19. Dispose of the wrappers and label waste using either regular rubbish disposalor a biohazard bag. Gloves should ideally be disposed of in a biohazard bag.

20. Proceed to follow the relevant policy and procedure of the testing location,client or employer. This may include contacting a nominated person tomanage the donor through the remainder of the process.

21. Finally seal the chain of custody bag into the courier or mail bag ready fortransport. Multiple chain of custody bags can be transported in the one courieror mail bag.

22. Store the laboratory samples in a locked or supervised refrigerator until acourier arrives to pick them up or keep them in an esky if you need totransport them from a remote location. Ensure they are not exposed to heatand stored at low temperatures.

23. Send to the laboratory via a courier able to transport temperature sensitivespecimens or regular mail. The procedures and equipment supplied in thiscourse allow oral fluid to be transported by Australia Post. Alternatively, if youhave a laboratory nearby you can deliver it yourself.

24. Turnaround time for laboratory confirmation will usually be 24 to 48 hoursfrom when specimens are received by that laboratory.

25. It is imperative that confirmation samples are forwarded promptly to theLaboratory. Samples stored at room temperature (less than 25 degrees) willbegin to deteriorate after 3 days.

ASSESSMENTS

This course can be completed via handwritten assessment or by using the onlineassessments as provided to you following enrolment.

Answers to all questions and assessments can be found in this student handbook andthe attachments/presentations. Familiarising yourself with the Australian StandardsAS/NZS4308:2008 and AS4760:2006 is recommended although not essential.

Practical Assignment

All students must demonstrate they are able to successfully complete the Chain ofCustody process for either a urine or oral fluid sample collection.

The Chain of Custody process must be completed using real equipment anddocumentation which are to be forwarded to Drug Testing Solutions as part of youroverall assessment.

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ASSESSMENTS






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ASSESSMENTS






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You have been supplied with the following 2 kits to complete this assignment:

Oral fluid drug confirmation test kit Urine drug test kit

The practical component of this course requires you to complete the oral fluidsample collection Chain of Custody process.

We recommend you practise with the Urine test kit at home using actual urine to seethe adulterants colours and the temperature strip indicators

For the purposes of completing your Chain of Custody practical assignment we haveincluded a scenario below in which you are a conducting drug testing as a serviceprovider for a workplace.

You may wish to conduct the sample collection on yourself but preferably withassistance from a willing colleague, friend or family member.

Test Subject Name: James Brown

Customer Information: A1 Engineering

Site Address: 432 Boundary Road, Morway, QLD4444

Service Provider Information(Your employer):

Safely Testing111 Monroe Avenue, Brisbane QLD4000

Laboratory Information:Fast PathologySuite 5, 353 Johnson Road, NSW2000

The scenario continues below.

You have attended the above site at 0500 hours on today’s date. Ten donors arerandomly selected for testing and on your third test, at 0535hrs; the donor returns apresumptive positive non-negative result for THC.

Complete the test record form provided. This is the form you would complete as youconduct the initial drug (and alcohol) test on the test subject. The reference to beused is DTS002014. Complete all required fields. Note that this reference number isthe “test record number” to be added to the Chain of Custody form.

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Once you are satisfied with the test record form and you have recorded the result ofyour fictional initial drug test, proceed to follow the Chain of Custody procedure asoutlined in the handbook.

Collect the further sample, prepare the referee sample, label all as required, affixsecurity seals, place in sealed bags and the chain of custody bag to prepare fortransportation. Be sure to correctly complete the Chain of Custody form and encloseinside the pouch in the bags provided.

Checklist of Practical Assignment:

Complete all fields on test record form as required. As a “tester” youcomplete all fields with exception of the consent area to be signed by the testsubject / donor. (Imagine you have conducted the initial drug test andalcohol test on the test subject/donor detailed in the scenario.)

Sign the required fields yourself if you do not have another person acting asthe test subject.

Once you are ready to proceed with the Chain of Custody, commencesecondary sample collection.

Once the confirmation sample is collected ensure you transfer some to thesecond tube/container provided.

As you proceed complete the required fields on the Chain of Custody form.

Ensure labels are completed with the required information and then affixed tothe tubes/containers as required.

Record details of the chain of custody number and security seals in therequired fields.

Attach the security seals to the lids of the containers as per examples shownin guides provided.

Add the two completed tube/containers to the bag provided and seal.

Add the Chain of Custody form to the bag in the correct pouch.

Finally seal the ready to go samples inside the chain of custody bag.

Address the bag to the laboratory.

"A copy of the above instructions will be sent to students with the practical assignmentequipment.”

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APPENDIX

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APPENDIX

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APPENDIX

Student Handbook...Alere iScreen® OFD Drug Test Device 23-31 Urine & Oral Fluid – Confirmatory...

Documents

Transcript of Student Handbook...Alere iScreen® OFD Drug Test Device 23-31 Urine & Oral Fluid – Confirmatory...