Medical Bureau of Road Safety Health Sciences Centre, University College Dublin, Belfield, Dublin 4 Testing Laboratory Registration number: 030T is accredited by the Irish National Accreditation Board (INAB) to undertake testing as detailed in the Schedule bearing the Registration Number detailed above, in compliance with the International Standard ISO/IEC 17025:2005 2nd Edition “General Requirements for the Competence of Testing and Calibration Laboratories” (This Certificate must be read in conjunction with the Annexed Schedule of Accreditation) Date of award of accreditation: 13:09:2002 Date of last renewal of accreditation: 13:08:2012 Expiry date of this certificate of accreditation: 13:08:2017 This Accreditation shall remain in force until further notice subject to continuing compliance with INAB accreditation criteria, ISO/IEC 17025 and any further requirements specified by the Irish National Accreditation Board. Manager: Chairperson: Dr Adrienne Duff Mr Tom O’Neill Issued on 13 August 2012 Organisations are subject to annual surveillance and are re-assessed every five years. The renewal date on this Certificate confirms the latest date of renewal of accreditation. To confirm the validity of this Certificate, please contact the Irish National Accreditation Board. The INAB is a signatory of the European co-operation for Accreditation (EA) Testing Multilateral Agreement (MLA) and the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement. Edition 28, 13/07/2016 030T Page 1 of 7 Schedule of Accreditation (Annex to Accreditation Certificate) Permanent Laboratory: Category A & B MEDICAL BUREAU OF ROAD SAFETY Chemistry Testing Laboratory Initial Registration Date : Postal Address: (Address of other locations as they apply) 14-October-1992(Category A) 25-September-2003 (Category B) Medical Bureau of Road Safety Health Sciences Centre UCD Belfield Dublin 4 Telephone: +353 (1) 7165555 Fax: +353 (1) 7165511 E-mail: Contact Name: Helen Kearns Facilities: Normally not available for Public testing Edition 28, 13/07/2016 030T Page 2 of 7 Schedule of Accreditation Permanent Laboratory: Category A & B THE IRISH NATIONAL ACCREDITATION BOARD (INAB) is the Irish body for the accreditation of organisations including laboratories. Laboratory accreditation is available to testing and calibration facilities operated by manufacturing organisations, government departments, educational institutions and commercial testing/calibration services. Indeed, any organisation involved in testing, measurement or calibration in any area of technology can seek accreditation for the work it is undertaking. Each accredited laboratory has been assessed by skilled specialist assessors and found to meet criteria which are in compliance with ISO 17025 or ISO 15189 (medical laboratories). Frequent audits, together with periodic inter-laboratory test programmes, ensure that these standards of operation are maintained. Testing and Calibration Categories: Category A: Permanent laboratory calibration and testing where the laboratory is erected on a fixed location for a period expected to be greater than three years. Category B: Site calibration and testing that is performed by staff sent out on site by a permanent laboratory that is accredited by the Irish National Accreditation Board. Category C: Site calibration and testing that is performed in a site/mobile laboratory or by staff sent out by such a laboratory, the operation of which is the responsibility of a permanent laboratory accredited by the Irish National Accreditation Board. Category D: Site calibration and testing that is performed on site by individuals and organisations that do not have a permanent calibration/testing laboratory. Testing may be performed using (a) portable test equipment (b) a site laboratory (c) a mobile laboratory or (d) equipment from a mobile or site laboratory Standard Specification or Test Procedure Used: The standard specification or test procedure that is accredited is the issue that is current on the date of the most recent visit, unless otherwise stated. Glossary of Terms Facilities: Public calibration/testing service: Commercial operations which actively seek work from others. Conditionally available for public calibration/testing: Established for another primary purpose but, more commonly than not, is available for outside work. Normally not available for public calibration/testing: Unavailable for public calibration/testing more often than not. Laboratory users wishing to obtain assurance that calibration or test results are reliable and carried out to the Irish National Accreditation Board criteria should insist on receiving an accredited calibration certificate or test report. Users should contact the laboratory directly to ensure that this scope of accreditation is current. INAB will, on request, verify the status and scope. Edition 28, 13/07/2016 030T Page 3 of 7 Scope of Accreditation Permanent Laboratory: Medical Bureau of Road Safety Category A Chemical Testing Laboratory INAB Classification number (P9) Materials/products tested 1202 Type of test/properties measured Range of measurement Toxicology Standard specifications Equipment/techniques used Documented In-house method Analysis by head space gas .01 Blood alcohol Urine .02 Breath Alcohol Measurements 1202 . Toxicology 03 Drugs in drivers Ethanol in the range chromatographic technique 0.01% to 0.6% w/v Dual limit PBT Ethanol in the range - Test method 5-25µg/100ml Amphetamine Blood Urine 25 - 2500 ng/ml 25 - 2500 ng/ml Methamphetamine Blood 25 - 2500 ng/ml Urine 25 - 2500 ng/ml Cannabinoids Blood Urine Documented In-house Method Detection of drugs, based on the instructions for use of Microplate EIA kit, Best 2000 2.5 - 250 ng/ml 2.5 - 250 ng/ml Elisa System. Methadone Blood 12.5 - 500 ng/ml Urine 12.5 - 500 ng/ml Opiates Blood 12.5 - 2500 ng/ml Urine 12.5 - 2500 ng/ml Benzodiazepines Blood 12.5 - 2500 ng/ml Urine 12.5 - 2500 ng/ml Cocaine Metabolites Blood 25 - 1500 ng/ml Urine 25 - 1500 ng/ml Cannabis Blood 5 -300ng/ml Urine -2 - 50 ng/ml Edition 28, 13/07/2016 030T Page 4 of 7 Scope of Accreditation Medical Bureau of Road Safety Permanent Laboratory: Category A Chemical Testing Laboratory INAB Classification number (P9) Materials/products tested Type of test/properties measured Range of measurement Standard specifications Equipment/techniques used 1202 Benzodiazepines in Blood Documented In-house method Quantitation of (range) Benzodiazepine Confirmation .03 Toxicology Drugs in drivers Test Method by LCMSMS (Blood Diazepam (10 - 1000 ng/ml), and Urine) Oxazepam (10 - 500 ng/ml), Nordiazepam (10 - 1000 ng/ml), Temazepam (10 - 500 ng/ml), Alprazolam (5 - 250 ng/ml), Alpha Hydroxyalprazolam (5 - 100 ng/ml), Desalkyl Flurazepam (ranges 5 500 ng/ml) Edition 28, 13/07/2016 030T Page 5 of 7 Scope of Accreditation Medical Bureau of Road Safety Permanent Laboratory: Category A Chemical Testing Laboratory INAB Classification number (P9) Materials/products tested Type of test/properties measured Range of measurement Standard specifications Equipment/techniques used 1202 Toxicology Quantitation of Δ9 - Cannabis Test Method .03 Drugs in drivers * tetrahydrocannabinol (range 2- by GC-MS 50ng/ml) and 11-nor-9-carboxy-Δ9tetrahydrocannabinol (range 5300ng/ml) in whole blood Quantitation of 11-nor-9- Carboxy- Cannabis Test Method Δ9- tetrahydro-cannabinol (range by GC-MS 10-300ng/ml) in urine Quantitation of Diazepam, Benzodiazepine Confirmation Oxazepem, Nordiazepam, Test Method by LCMSMS (Blood Temazepam, Alprazolam, Alpha and Urine) Hydroxy Alprazolam, Desalkyl flurazepam (ranges 20-500ng/ml) in urine THC in oral fluid Quantitation of Δ9 - Confirmation Test Method by tetrahydrocannabinol (range 1- GC-MSMS 50ng/ml) in oral fluid Quantitation of Cocaine (range 5- Cocaine and Benzoylecgonine in 60ng/ml) and Benzoylecgonine oral fluid confirmation Test (range 5-60ng/ml) in oral fluid Method by LC-M *Flexible scope: Additional drugs and matrices may be added and ranges extended in accordance with the laboratory's approved and documented procedures (‘MBRS Flexible scope procedure version 1.0’). For details refer to the laboratory's List of Additionally Accredited tests, available from the laboratory. Edition 28, 13/07/2016 030T Page 6 of 7 Scope of Accreditation Medical Bureau of Road Safety Permanent Laboratory: Category B Chemical Testing Laboratory INAB Classification number (P9) Materials/products tested Type of test/properties measured Range of measurement 1202 Quantitation of Benzodiazepines, Toxicology .03 Standard specifications Equipment/techniques used Amphetamines, Opiates (range 5-60ng/ml) in Opiates, Amphetamines and oral fluid. Benzodiazepines in oral test method by LC-MSMS. Quantitation of Diazepam and Temazepam (range 1-40 ng/ml) in oral fluid. Diazepam and Temazepam in oral fluid confirmation by LCMSMS .02 Breath Alcohol Record of measurement of linearity and Performance testing repeatability in range of EvidenzerIRL 0µg - 200µg/100ml ethanol Documented in house method EBT test method Evidenzer IRL Time Barometric pressure Interfering substances 9µg/100ml ethanol + 10µg /100ml acetone 22µg/100ml ethanol+ 2µg/100ml methanol Failure to return to zero Minimum flow rate Minimum discard volume Test simulating the presence of ethanol in the upper respiratory tract Edition 28, 13/07/2016 030T Page 7 of 7
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