LABORATORY TECHNICAL SPECIFICATIONS MANUAL · 2017-09-01 · LABORATORY TECHNICAL SPECIFICATIONS...

LABORATORY TECHNICAL

SPECIFICATIONS MANUAL

Produced by SYNLAB Laboratory Services

Controlled Document – ID 103.0025

May 2017 - Version 14

Laboratory Technical Specifications Manual Controlled Document ID 103.0025 V 14 of 22

Purpose of Procedure

This document outlines the technical specifications to which this laboratory works.

Laboratory procedures are designed to comply with the current recommendations of the

United Kingdom Laboratory Guidelines for Legally Defensible Workplace Drug Testing

(2001) and subsequent amendments and the European Laboratory Guidelines for Legally

Defensible Workplace Drug Testing (2002). Onsite testing by breathalyser or Near Donor

kit is not included in these guidelines but follows best practice and is designed to be legally

defensible.

The laboratory holds UKAS accreditation to ISO17025:2005 for most laboratory aspects of

toxicology and for the collection of hair, saliva and urine on client sites. These techniques

may be amended from time to time for process improvement and method development, and

all modified methods will be submitted for validation by UKAS. ISO 17025 (UKAS)

accredited tests are highlighted with an ‘+’ beside the test. The Near Donor kits and

breathalyser testing are not currently UKAS accredited. A copy of our current schedule of

accreditation can be accessed from the UKAS website.

Collection Service

SAMPLE COLLECTION

Samples are collected for either urine, saliva or hair by our Collection Technicians according

to the UK and European guidelines. SYNLAB Laboratory Services has over 50 Collection

Technicians based across the country who can provide collection day or night for 365 days

per year to the ISO 17025 standard. SYNLAB Laboratory Services has strict step by step

checklists and documentation to ensure that these samples are collected to a legally

defensible standard.

The collection service booking line is available for bookings 24 hours a day 365 days of the

year. For “For Cause” testing we aim to arrive at the client site within 2 hours of the call,

which is achieved in over 95% of cases.

CALL BOOKING (FOR CAUSE AND SHORT NOTICE)

Drug and Alcohol tests can be booked through the Duty Manager, manned 24 hours a day

for urgent calls, with an answerphone for messages when the Duty Manager is on another


call. If unable to get through to the Duty Manager, there is an emergency backup phone

which can be contacted 24/7. Both telephone numbers are given to relevant customer

contacts when the account is set up.

When calling the Duty Manager, customers need to have their PIN number to quote to the

Duty Manager, as well as the location and site contact for testing and any special

instructions.

After a Collection Technician is assigned the call, the customer will be telephoned with the

name and estimated arrival time of the Collection Technician. If there is any significant delay,

this will be communicated to the site contact.

Once a Collection Technician has been despatched, cancellation of the call will incur the full

charge of the call.

CALL BOOKING (PRE-ARRANGED)

Drug and Alcohol tests can be booked through the Duty Manager, preferably between

9:00am and 4:00pm, with an answerphone for messages when the Duty Manager is on

another call. If unable to get through to the Duty Manager, contact SYNLAB Laboratory

Services on 01873 856688.

LOCATION OF TEST SITE

Sample collections can be made virtually anywhere in the UK, as long as there are proper

facilities as described below. On arrival at your worksite/premises, our collector will contact

your nominated representative.

ON-SITE FACILITIES

It is essential that collection sites are suitable and secure, for urine collections lockable

storage should be provided for the donor to hold valuables / pockets contents whilst the

collection takes place. The facilities should afford visual and aural privacy for the donor and

allow access only to authorised persons. For urine collections, there must be a toilet and

wash basin for the exclusive use of the donor(s).

Our collector will advise your on-site representative about the fine detail and take

precautions in accordance with best practice. For example, he/she will add a coloured dye


to the toilet cistern and bowl, and tape up any taps so that the urine sample cannot be

diluted. They will also remove any potential adulterants such as bleach and cleaning fluids.

Access to the site will be secured using signs.

Finally, a quiet area will be required so that the documentation, including details of

medication taken, can be completed in private. This could be a small office or a quiet corner

of a larger one.

It usually takes about 20 minutes to collect one sample from one donor; therefore a

combination of tests (e.g. urine and breath test) will take about 30 minutes to complete so

you should arrange for donors to arrive for testing at these intervals. You should provide a

suitable waiting area for them.

Sometimes, a donor will have a ‘shy bladder’ i.e. they will be unable to provide a sufficient

sample. In this case, the donor will be asked to go to the waiting area and drink sufficient

fluid to enable them to provide enough urine, i.e. up to 250mls of water every 20 minutes

with a maximum consumption of one litre. During the waiting period a member of your staff

should remain with the donor.

COMPLIANCE WITH YOUR WORKING PRACTISES

In addition to complying with SYNLAB Laboratory Services own policies and procedures, we

require our collectors to comply with your rules and regulations, so far as they are known,

including:

• Health and Safety

• Smoking at work – no smoking

• Self-identification (photo-ID badge)

• Booking in and out on your premises

• Parking on site

• Equal opportunities in service delivery

If you have any other special requirements that have not been addressed, please

advise us as soon as possible.


DONOR IDENTIFICATION

Before our collector takes a sample, he/she will seek positive identification from the donor to

ensure that they are whom they say they are, and that someone else isn’t giving the sample

for them in order to ‘beat the test’. Photo identification must be provided by the donor (e.g.

Passport or Driving License).

Donors will also need to have with them details of any medication they have taken within the

last 14 days.

Network Rail workers will also need to have with them their National Insurance number or

Sentinel number.

COMPUTERISED RANDOM SELECTION OF DONORS

If required SYNLAB Laboratory Services can provide free of charge a computerised

selection of employees for ‘random’ testing. Most organisations that incorporate random

testing into their programme take advantage of our expertise, thus removing most of the

administrative burden and enabling them to be free of allegations of bias during selection.

SERVICES SPECIFICATION

The service provided will comprise, as appropriate:

• Collection and on-the-spot analysis of breath sample to measure blood alcohol

level using Drager-6810 or Drager-6820 Breath Alcohol Monitor supplied by SYNLAB

Laboratory Services.

Our collector will take one breath sample from the donor. If the reading on the monitor is

zero, there will be no further testing.

However, if the reading is other than zero, a second sample will be collected approximately

15-20 minutes later. This will determine whether the donor’s blood alcohol level is rising or

falling and your on-site representative will be able to make an informed decision about the

donor’s suitability to return to work, and the nature of the duties that the donor can safely

undertake. Some policies allow for a third sample to be taken a further 15-20 minutes later if

the second reading is higher than the first.

A new mouthpiece will be used for each breath sample, even for the same donor.


The breath test will measure the amount of alcohol in the donor’s breath. For reporting

purposes, this will be converted to an equivalent blood alcohol level, there being a direct

relationship between alcohol in breath and in blood.

The result on the Dräger instrument used will be expressed in ‘per mil’ units (grams per

litre). For comparison purposes, the UK drink drive limit is 80 milligrams per 100 millilitres,

sometimes referred to as 80 milligrams per cent. On a Drager-6810 or Drager-6820 monitor,

this would be equivalent to a reading of ‘0.80 per mil’ (0.80‰).

The default cut-off limit for alcohol will be a reading of ‘0.8 mg per mil’.

If a donor exceeds this limit and you feel that circumstances warrant it, you may request our

collector to arrange for the concentration of alcohol in the donor’s body to be confirmed

through laboratory analysis of a urine sample. Our collector would take appropriate

precautions to ensure the integrity of the sample by having the donor void his / her bladder

prior to collection of the sample that is to be analysed for alcohol. This will ensure that the

sample is fresh and is not contaminated by stale alcohol left in the bladder.

Other cut-offs can also be requested on the client registration form and are as follows:

Blood mg/ml Urine mg/ml

UK Drink Drive Limit (default) 0.80 1.07

UK Drink Drive / Warning Level / Scottish Drink Drive Limit 0.80/0.50 1.07 / 0.67

Network Rail 0.30 0.40

Aviation 0.20 0.27

Any Alcohol present (Medical screening) 0.15 0.15

There would be an extra charge for collecting the fresh urine sample, to take account of the

inevitable delay before the donor is able to produce sufficient fresh urine.

• Collection of Urine Sample using SYNLAB Laboratory Services certified drug-free

collection kits, adhering to a strict ‘Chain of Custody’ regime.

All urine samples for laboratory analysis will be sent by first-class letter post unless we are

instructed otherwise. A courier service is available, full details being available upon request.

If you wish to use the courier service, you or your representative must tell us when you place the order.


FULL CHAIN OF CUSTODY TESTING

The sample collection processes carried out by SYNLAB Laboratory Services’ Collection

Technicians for full laboratory analysis, whether urine, saliva or hair, are accredited by UKAS

under ISO17025. For details of accredited laboratory tests following collection refer to

Laboratory Testing section on page 9.

NEAR DONOR TESTING

SYNLAB Laboratory Services’ Collection Technicians carry a range of Near Donor Testing

kits for both urine and saliva which allow for instant screening results to be obtained onsite,

with the ability for any ‘non negative’ samples to be sent back to the laboratory for

confirmation (LCMSMS) analysis. It should be noted that the test for Cannabis are at a

much higher level than the laboratory cut-off of 10ng/ml and therefore the detection time for

cannabis in saliva using these Near Donor Testing kits could be less than 4 hours.

The following range of NDT tests are available for Urine and Saliva:

Urine NDT Tests Available

Drug Group Calibrated against Cut-Offs available

Amphetamines Amphetamine, 300, 500, 1000

Methamphetamine Methamphetamine 300, 500, 1000

MDMA MDMA 500

Opiates Morphine 300, 2000

Cannabis 11-nor-∆9-THCC 20, 50, 150

Cocaine Benzoylecgonine 150, 300

Benzodiazepines Oxazepam 200, 300

Barbiturates Secobarbital 300

Ketamine Ketamine 1000

Phencyclidine (PCP) Phencyclidine 25

Methadone Methadone 300

EDDP EDDP 100, 300

Buprenorphine Buprenorphine 5, 10

Propoxyphene Propoxyphene 300

Other Drugs

Tramadol Tramadol 100

Cotinine Cotinine 100

Oxycodone Oxycodone 100

Alcohol Ethanol 0.4mg/ml (0.04%)


Fentanyl Fentanyl 20

Tricyclic Antidepressants Nortriptyline 1000

Adulteration tests available

Creatinine Nitrite

pH Oxidants

Specific Gravity Gluteraldehyde

Saliva NDT Tests Available

Drug Group Calibrated against Cut-offs available

Amphetamines Amphetamine, 25/50

Methamphetamine Methamphetamine 25/50

Opiates Morphine 10/40

Cannabis ∆9-THC 40/ 100

Cocaine Benzoylecgonine 20

Benzodiazepines Oxazepam 5/10

Phencyclidine (PCP) Phencyclidine 4/10

Methadone Methadone 30

Alcohol Ethanol 0.2mg/ml (0.02%)


Laboratory Testing

TRANSPORT OF SAMPLES

Samples are normally received in the laboratory by 1st class post, although we also accept

deliveries from major delivery companies. Samples should be packaged to either the IATA

PI650 guidelines, labelled “Biological Substance – Category B” with the UN3373 diamond or

packaged to prevent damage or leaks and labelled “Fragile – Exempt Human Specimen”.

Inadequately packaged and labelled samples may be rejected by Royal Mail or the courier

company.

Postal delays do not affect the quality of urine samples or hair, and samples can be safely

analysed even if delayed. Saliva samples may degrade if not received in the laboratory

promptly, and will be rejected if more than 7 days old. All samples are kept for a minimum of

5 working days with samples that require confirmation being kept for a minimum of a year.

MINIMUM LABELLING CRITERIA

All samples must be labelled so that there is an unequivocal match between the sample and

the request form, normally through the use of a unique Chain of Custody number. The

request form must also contain (as a minimum) the name of the requesting company,

identification of the collector and the donor and the donor’s consent to test.

CHAIN OF CUSTODY CHECKS

Samples received in the laboratory will be checked to ensure that the chain of custody is

intact and that there are no errors or signs of tampering.

Tamper evident bags will be opened and the samples inside compared with the paperwork

to ensure consistency. The paperwork will be checked to ensure correct completion before

the sample will be logged in to the computer system.

If there is no donor consent to test, SYNLAB Laboratory Services staff will contact the

customer to request the original signature of the donor before completing analysis. In all

other cases where there is a flaw in the chain of custody, the customer will be contacted for

further instruction. In these cases the flaw in the paperwork may not prevent analysis but

could make the results open to challenge. Where there is an error in the chain of custody,

the normal turnaround time may be extended if there is a delay in authorising analysis.


If there is evidence of deliberate tampering of the sample, it will not be opened to preserve

the evidence of tampering.

ADULTERATION CHECKS

A series of adulteration checks may be performed on the sample to identify attempts to

affect the process. This will include creatinine and pH (for urine samples), CEDIA sample

check (for urine and saliva tests) and other tests as required to guarantee the authenticity of

the sample as far as is possible in the laboratory.

These will be reported as part of the ‘Test for Adulterants.’

Where a urine sample is reported as dilute, and a result is above 50% of the cut-off, a repeat

sample may be suggested without a reason being given.

Where a sample fails on-site adulteration tests and has been referred to the laboratory, it will

be tested for adulterants in the laboratory. If the sample is considered weak, it will be

analysed by immunoassay to identify attempts to hide drug use by dilution.

PRIMARY SCREENS

Urine The primary screen is performed using CEDIA, DRI and ELISA immunoassay reagents.

Each assay is calibrated weekly or after a QC failure, with a minimum of 5% of the samples

run each day being QCs. The standard cut-offs used for each drug group are specified

below:

Drug Group Calibrated against SOP Reference No.

Method

Cut-off ng/ml (unless stated)

On UKAS schedule

Amphetamines Methamphetamine 9.0103 CEDIA 300 Y

Barbiturates Secobarbital 9.0104 CEDIA 200 Y

Benzodiazepines Nitrazepam 9.0105 CEDIA 200 Y

Buprenorphine Buprenorphine 9.0113 CEDIA 5 Y

Cannabis 11-nor-∆9-THCC 9.0102 CEDIA 50 Y

Cocaine Benzoylecgonine 9.0106 CEDIA 300 Y

Ethyl Glucuronide* Ethyl Glucuronide 9.0124 DRI 500 Y

Ketamine Ketamine 9.0125 DRI 300 Y


LSD LSD 9.0115 ELISA 1 Y

Methadone Methadone 9.0109 CEDIA 300 Y

Methaqualone Methaqualone 9.0112 CEDIA 300 Y

Opiates Morphine 9.0107 CEDIA 300 Y

Oxycodone Oxycodone 9.0121 DRI 100 N

6-Monoacetylmorphine 6-Monoacetylmorphine 9.0114 CEDIA 10 Y

Phencyclidine (PCP) Phencyclidine 9.0111 CEDIA 25 Y

Propoxyphene Propoxyphene 9.0110 CEDIA 300 Y

Tramadol Tramadol 9.0126 ELISA 200 Y

Alcohol Ethanol 9.0108 DRI 10 Y

Creatinine Creatinine 9.0117 DRI <1.77m

mol/l Y

pH pH 9.0116 DRI Range

3-11 Y

Specific gravity NaCl standard 9.0119 DRI 1.0003-

1.0035g/l Y

* Screening for Ethyl Glucuronide (to confirm ethanol and not as a marker for alcohol abuse).

Saliva The primary screen is performed using CEDIA immunoassay reagents. Each assay is

calibrated weekly or after a QC failure, with a minimum of 5% of the samples run each day

being QCs. The standard cut-offs used for each drug group are specified below:

Drug Group Calibrated against SOP Reference No.

Method Cut-off ng/ml

On UKAS schedule

Amphetamines Methamphetamine 9.0135 CEDIA 40 Y

Barbiturates Secobarbital 9.0131 CEDIA 60 Y

Benzodiazepines Nitrazepam 9.0132 CEDIA 10 Y

Cannabis THC 9.0128 CEDIA 4 Y

Cocaine Benzoylecgonine 9.0130 CEDIA 20 Y

Methadone Methadone 9.0133 CEDIA 20 Y

Opiates Morphine 9.0129 CEDIA 40 Y


Hair

The primary screen is performed using ELISA immunoassay reagents. Each assay is

calibrated weekly or after a QC failure, with a minimum of 5% of the samples run each day

being QCs. The standard cut-offs used for each drug group are specified below:

Drug Group Calibrated against SOP Reference No

Method Cut-off pg/mg

On UKAS schedule

Amphetamines Methamphetamine 9.0155 ELISA 200 Y

Barbiturates Secobarbital 9.0155 ELISA 200 Y

Benzodiazepines Nitrazepam 9.0155 ELISA 50 Y

Cannabis ∆ 9-THC 9.0155 ELISA 50 Y

Cocaine Benzoylecgonine 9.0155 ELISA 500 Y

Ketamine Ketamine 9.0155 ELISA 200 Y

Methadone Methadone 9.0155 ELISA 200 Y

Opiates Morphine 9.0155 ELISA 200 Y

Phencyclidine Phencyclidine 9.0155 ELISA 200 Y

It is possible to use cut-offs other than those specified in the SAMHSA, UK or European

Guidelines. If this service is required both the cut-off level and a Negative (Below cut-off) /

Non Negative (above cut-off) result will be reported. For details of our lowest validated cut-

off level for each drug/ matrices please contact the laboratory. Any bespoke requirements

will be specified in the customers Service Level Agreement.

Screening results will normally be reported on the day of receipt by email, fax or post. The

customer has the choice as to whether they wish to receive the unconfirmed primary screen

results or simply notification that the sample has been sent for further testing.

MEASUREMENT UNCERTAINTY FOR PRIMARY SCREENING

Primary screen analysis has a different response for different drugs within a class, such that

the measured value may differ from the calibrated value by a small percentage. The drug

giving 100% response is listed in the table above, and the relative responses of metabolites

and other drugs in each class are available on request.

The primary screening methods are semi-quantitative and the laboratory is aware of (but

does not report) the relative concentrations of drugs in a sample, although the response is


only approximately linear in the range of the cut-off values. The response measured is then

accurate to ±20% (with 95% confidence).

Samples that are below the cut-off value but within the 95% confidence interval are treated

as non-negative and carried through to confirmation testing.

CONFIRMATORY TESTING

URINE The standard turnaround time for confirmatory testing is 3 working days for samples

received by 12:00 midday, unless waiting for authority to proceed. For an additional fee,

samples may be Fast Tracked to enable results to be reported by 5:00pm on the next

working day after receipt.

All confirmatory assays are performed by liquid chromatography coupled to a tandem mass

spectrometer for detection after solid phase extraction and using deuterated/ isotopically

labelled internal standards.

Every sample is analysed with a set of 6 calibration standards, traceable to international

reference materials, a blank sample and at least one quality control sample.

Tests are only accepted if a calibration containing at least 4 calibrators and a calibration

coefficient of >0.990 is obtained. Additionally, the QC sample must pass a set of rules for

accepting QC samples.

When a batch is accepted, individual analytes must have a retention time of ±2.5 percent of

the deuterated internal standard, and the ion intensity ratio of the primary (quantification) ion

to the secondary (qualifier) ion must be within a defined percentage of the ratio of the

nearest standard value, following European guidelines on ion intensity ratios.

Drug Cut-off ng/ml

SOP Ref Expanded

Uncertainty at cut-off 95% CI (%)

On UKAS Schedule

Y/N Opiates Group

Morphine 300 12.0262 11 Y

Codeine 300 12.0262 15 Y

Dihydrocodeine 300 12.0262 20 Y

6 Mam 10 12.0264 20 Y

*Papaverine 5 12.0262 29 Y


*Noscapine 5 12.0262 36 Y *Thebaine 5 12.0262 31 Y *Desmethyl papaverine

5 12.0262 22 Y

*Dihydromorphone 100 12.0262 45 Y *Hydrocodone 500 12.0262 40 Y *Pholcodine 100 12.0262 22 Y Cannabis

THCC 15 12.0261 24 Y

Cocaine

Benzoylecgonine 150 12.0263 10 Y

Amphetamines

Amphetamine 200 12.0263 17 Y

Methamphetamine 200 12.0263 16 Y

MDA 200 12.0263 11 Y

MDMA 200 12.0263 12 Y

MDEA 200 12.0263 11 Y

Benzodiazepines

Diazepam 10 12.0265 39 Y

Temazepam 100 12.0265 15 Y

Oxazepam 100 12.0265 18 Y

Desmethyl Diazepam 100 12.0265 50 Y

Flunitrazepam 10 12.0265 14 Y

Aminoflunitrazepam 10 12.0265 20 Y

Aminonitrazepam 100 12.0265 26 Y

Methadone

Methadone 250 12.0271 13 Y

EDDP 250 12.0271 17 Y

Ketamine

Ketamine 200 12.0269 8 Y

Nor Ketamine 200 12.0269 11 Y

Propoxyphene

Propoxyphene 250 12.0267 25 N

Nor propoxyphene 250 12.0267 32 N

Mephedrone

Mephedrone 200 12.0274 13 N

Buprenorphine

Buprenorphine 5 12.027 10 Y

Nor Buprenorphine 5 12.027 4 Y

Barbiturates

Pentobarbital 150 12.0273 19 Y

Phenobarbital 150 12.0273 47 Y

Secobarbital 150 12.0273 26 Y

Amobarbital 150 12.0273 18 Y

Butabarbital 150 12.0273 45 Y

*Used to assist in the interpretation of results and not normally reported

As for screening tests, non-standard cut-offs should only be used where sufficient

justification has been made for the use of other reference values.

Results will normally be reported as either POSITIVE for a named drug or drugs or Negative

for all drugs tested using the cut-off level stated and allowing a coverage factor of 3


Standard deviations above the cut-off before reporting a result as positive, this ensures that

positive results have at least a 99.7% degree of certainty.

An appropriate comment will be added to assist in the interpretation of results obtained and

the medication declared. For accredited analytes, this interpretation relating to consistency

of results with medication is covered by ISO17025:2005 accreditation. Opinion and

interpretations outside of this are not covered by the ISO17025 accreditation. Customers

may receive the numerical results of positive drug tests to support disciplinary and appeal

procedures.

SALIVA

The standard turnaround time for confirmatory testing is 3 working days for samples

received by 12:00 midday, unless waiting for authority to proceed. All confirmatory assays

are performed by liquid chromatography coupled to a tandem mass spectrometer, and using

deuterated/ isotopically labelled internal standards.










As part of the validation process samples collected by our UKAS accredited collection

service were compared with samples collected by non SYNLAB Laboratory Services

collectors and this data has been incorporated into the expanded uncertainty and tabulated

as SYNLAB Laboratory Services collectors and non SYNLAB Laboratory Services collectors.


Drug Cutoff ng/ml

SOP Ref

95% CI (%) with SYNLAB

Laboratory Services collector

at cut-off

95% CI (%) with non SYNLAB Laboratory

Services collector at cut-off

On UKAS Schedule

*Y/N

Opiates Group

Morphine 40 12.0271 42.7% 54.1% Y

Codeine 40 12.0271 46.8% 57.4% Y

Dihydrocodeine 40 12.0271 45.3% 56.2% Y

6 Mam 4 12.0271 33.4% 47% Y

Heroin 22 12.0271 99.8% 105.2% N

Acetyl codeine 13 12.0271 97.2% 102.7% N

Cocainoics

Cocaine 23 12.0271 43.3% 54.6% Y

Benzoylecgonine 8 12.0271 42.4% 53.8% Y

Norcocaine 8 12.0271 96.7% 102.3% N

Cocaethylene 8 12.0271 48.9% 59.1% Y

Ketamine

Ketamine 30 12.0271 42% 53.5% Y

Nor Ketamine 30 12.0271 48.6% 58.8% Y

Propoxyphene

Propoxyphene 40 12.0271 16.5% 37.1% Y

Nor propoxyphene 40 12.0271 25.6% 41.9% Y

Z Drugs

Zolpidem 10 12.0271 81.7% 88.2% N

Zopiclone 10 12.0271 88.8% 94.8% N

Mephedrone

Mephedrone 30 12.0271 47.8% 58.2% Y

Amphetamines

Amphetamine 30 12.0271 29.7% 44.6% Y

Methamphetamine 30 12.0271 43% 54.3% Y

MDA 30 12.0271 135.2% 139.2% N

MDMA 30 12.0271 21.1% 39.3% Y

MDEA 30 12.0271 22.5% 40.1% Y

Tramadol

Tramadol 40 12.0271 38.2% 50.6% Y

Methadone

Methadone 20 12.0271 49.1% 59.3% Y

EDDP 20 12.0271 47.1% 57.6% Y

Benzodiazepines

Diazepam 10 12.0271 36.2% 49.1% Y

Temazepam 10 12.0271 42.6% 54% Y

Oxazepam 10 12.0271 47.4% 57.9% Y

Desmethyl Diazepam 10 12.0271 35.7% 48.8% Y

Nitrazepam 10 12.0271 194% 196.8% N

Alpazolam 10 12.0271 37.3% 49.9% Y

Lorazepam 10 12.0271 42.8% 54.2% Y

Flunitrazepam 10 12.0271 39.5% 51.6% Y


* Accreditation only applies when samples are collected by SYNLAB Laboratory Services’

Collection Technicians when working to the accredited saliva collection procedure using the

Quantisal saliva collection device






positive results have at least a 95% degree of certainty.



of results with medication is covered by ISO17025:2005 accreditation (when collected with

Quantisal saliva collection device). Opinion and interpretation outside of this are not covered

by the ISO17025 accreditation. Customers may receive the numerical results of positive

drug tests to support disciplinary and appeal procedures.

HAIR

The standard turnaround time for confirmatory testing is 5 working days for samples

received by 12:00 midday, unless waiting for authority to proceed. All confirmatory assays

are performed by liquid chromatography coupled to a tandem mass spectrometer, and using

deuterated/ isotopically labelled internal standards.











Drug Cut off pg/mg

SOP Ref

Expanded Uncertainty (95 CI %) at cut-off

Experimental Bias at cut-off

On UKAS Schedule Y/N

Opiates Group

Morphine 200 12.0285 55.5 -1 Y

Codeine 200 12.0285 42.7 +11 Y

Dihydrocodeine 200 12.0285 38.6 -2 Y

6 Mam 200 12.0285 51.2 +1 Y

Heroin 200 12.0285 59.0 +6 Y

Acetyl codeine 200 12.0285 55.9 +10 Y

Cocainoics Group

Cocaine 500 12.0285 52.1 +8 Y

Benzoylecgonine 50 12.0285 55.7 +3 Y

Norcocaine 50 12.0285 41.7 -18 Y

Cocaethylene 50 12.0285 37.4 -20 Y

Ketamine

Ketamine 200 12.0285 24.7 +6 Y

Nor Ketamine 200 12.0285 52.8 +10 Y

Propoxyphene

Propoxyphene 200 12.0285 30.7 +2 Y

Nor propoxyphene 200 12.0285 50.8 -15 Y

Z Drugs

Zolpidem 50 12.0285 30.9 +10 Y

Zopiclone 50 12.0285 68.7 +10 N

Mephedrone

Mephedrone 200 12.0285 54.9 +3 Y

Amphetamines

Amphetamine 200 12.0285 51.0 +3 Y

Methamphetamine 200 12.0285 90.7 +9 N

MDA 200 12.0285 75.3 +8 N

MDMA 200 12.0285 51.6 +27 Y

MDEA 200 12.0285 49.6 +13 Y

Tramadol

Tramadol 200 12.0285 57.4 -4 Y

Methadone

Methadone 200 12.0285 57.6 +4 Y

EDDP 200 12.0285 60.2 -4 N

Benzodiazepines

Diazepam 50 12.0285 42.3 +16 Y

Temazepam 50 12.0285 32.7 +16 Y

Oxazepam 50 12.0285 30.2 +8 Y

Desmethyl Diazepam 50 12.0285 40.4 +19

Y

Nitrazepam 50 12.0285 119.3 -62 N

Alpazolam 50 12.0285 64.2 +27 N

Lorazepam 50 12.0285 42.1 +27 Y

Flunitrazepam 50 12.0285 31.2 +14 Y







positive results have at least a 95% degree of certainty.



of results with medication is covered by ISO17025:2005 accreditation. Opinion and

interpretation outside of this are not covered by the ISO17025 accreditation. Customers

may receive the numerical results of positive drug tests to support disciplinary and appeal

procedures.

MEASUREMENT UNCERTAINTY FOR CONFIRMATION TESTING

There is always a degree of variation in any analytical method, and the laboratory takes

steps to minimise this variation. Typically the urine results reported have a Uncertainty of

Measurement at the 95% confidence interval of ±25% at the cut-off value, with hair and

saliva testing these are typically ±25 to 60%. Results may also be truncated to integers

and/or 2 significant figures for ease of reading.


for all drugs tested using the cut-off level stated and allowing a coverage factor before

reporting a result as positive. Due to the higher uncertainties associated with saliva and hair

testing a different coverage factor is used. The coverage factor for each matrix is given

below:

• Urine: 3 standard deviation this ensures that positive results have at least a 99%

degree of certainty

• Saliva: 2 standard deviation this ensures that positive results have at least a 95%

degree of certainty

• Hair: 2 standard deviation this ensures that positive results have at least a 95%

degree of certainty


MEASUREMENT UNCERTAINTY FOR CLINICAL TOXICOLOGY

SPMA (ISO17025 accredited) – The Uncertainty of Measurement at the 95% confidence

interval for 12µmol/mol creatinine is ±2.28µmol/mol creatinine.

Clozapine (ISO17025 accredited) - The Uncertainty of Measurement at the 95%

confidence interval for clozapine and norclozapine applicable to samples within the

therapeutic target range of 0.35-0.60mg/L:

• Clozapine ±15%

• Norclozapine ±12%

Above 0.60mg/L (clozapine) and 0.50mg/L (norclozapine):

• Clozapine ±10.3%

• Norclozapine ±16.8%

NETWORK RAIL CERTIFICATES

Network Rail samples collected by SYNLAB Laboratory Services collection Technicians that

are negative for all drugs will be reported as a “PASS” and will be uploaded to sentinel within

24 hours of the final report. Samples that require review by a Medical Review Officer (MRO)

may take additional time. Dilute and Positive results will be uploaded to Sentinel following

MRO review.

MEDICAL REVIEW OFFICER

No interpretation of results in relation to fitness to practice will be made by laboratory staff. A

company doctor or MRO may discuss a case to ascertain fitness to practice, and SYNLAB

Laboratory Services can supply MRO services if required. The MRO may need to discuss

the results confidentially with the donor, in which case contact details will be requested.

REPORT FORMAT

Test reports comply with the simplified test report format option allowed by ISO17025. This

simplified report does not include all of the information on the report by ISO17025 but as

stated in the standard this data is held by the laboratory and available if requested.


WITNESS STATEMENTS / TRIBUNAL / COURT ATTENDANCE

If required, a witness statement can be prepared that can be submitted to tribunals or other

proceedings. Witness statements will give more detail and background to the testing and

interpretation, and can include answers to specific questions and statements that a tribunal

might need.

Attendance of an expert witness at tribunals or other proceedings is also available upon

request. SYNLAB Laboratory Services can also provide independent expert witness

statements relating to all aspects of drugs of abuse testing

UNKNOWN SUBSTANCES

Drug paraphernalia, tablets and powders found on site can also be sent to the laboratory for

drugs of abuse. The laboratory must be contacted before these samples are sent to

determine what analysis can be done and the cost involved as this will vary depending on

what has been found. All samples must be safely and securely packaged before sending to

the laboratory.

RECORD RETENTION AND STORAGE

Samples that are negative for all drugs during primary screening are disposed of 1 week

from receipt. During this period it may be possible to request additional testing. Samples will

be discarded without further notice.

All other samples are stored frozen (except for hair samples that are kept at room

temperature) for 1 year from the date of receipt, with the unopened ‘B’ sample stored with

the ‘A’ sample so that they may be re-analysed if there is a challenge to the results.

Chain of Custody forms are stored for 7 years after analysis and all quality and training

records are stored for a minimum of 10 years.

CHALLENGES TO THE ANALYTICAL PROCESS

If a donor wishes to challenge an analytical result, they should make arrangements through

an alternative laboratory accredited to ISO 17025:2005.


When requested by the referral laboratory, the ‘B’ sample will be released to that laboratory

after authorisation has been received from both the donor (or donor’s representative) and a

company representative.

REFERRAL TO OTHER LABORATORIES

There may be occasions where samples are sub-contracted to other laboratories to

complement the range of analytes offered by SYNLAB Laboratory Services. Samples will be

referred to laboratories accredited to ISO17025:2005 or to other appropriate providers.

Referral laboratories will be assessed for the suitability of testing, and a full Chain of Custody

will be maintained where appropriate. Where a referral laboratory is used, this will be made

clear on the Certificate of Analysis.

LABORATORY TECHNICAL SPECIFICATIONS MANUAL · 2017-09-01 · LABORATORY TECHNICAL SPECIFICATIONS...

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