Medical Bureau of Road Safety

Transcription

1 Health Sciences Centre, University College Dublin, Belfield, Dublin 4 Testing Laboratory Registration number: 030T is accredited by the Irish National 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: nd Edition General Requirements for the Competence of Testing and Calibration Laboratories (This Certificate must be read in conjunction with the Annexed Schedule of ) 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 shall remain in force until further notice subject to continuing compliance with INAB accreditation criteria, ISO/IEC and any further requirements specified by the Irish National Board. Manager: Dr Adrienne Duff Chairperson: Issued on 13 August 2012 Mr Tom O Neill 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 Board. The INAB is a signatory of the European co-operation for (EA) Testing Multilateral Agreement (MLA) and the International Laboratory Cooperation (ILAC) Mutual Recognition Arrangement. Edition 27, 30/04/ T Page 1 of 7

2 Schedule of (Annex to Certificate) Category A & B MEDICAL BUREAU OF ROAD SAFETY Chemistry Testing Laboratory Initial Registration Date : 14-October-1992(Category A) 25-September-2003 (Category B) Postal Address: Health Sciences Centre (Address of other locations UCD as they apply) Belfield Dublin 4 Telephone: +353 (1) Fax: +353 (1) Contact Name: Facilities: Helen Kearns Normally not available for Public testing Edition 27, 30/04/ T Page 2 of 7

3 Schedule of 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/IEC or ISO/IEC (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: Category C: Category D: Site calibration and testing that is performed by staff sent out on site by a permanent laboratory that is accredited by the Irish National Board. 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 Board. 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) (b) (c) (d) portable test equipment a site laboratory a mobile laboratory or 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: Conditionally available for public calibration/testing: Normally not available for public calibration/testing: Commercial operations which actively seek work from others. Established for another primary purpose but, more commonly than not, is available for outside work. 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 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 27, 30/04/ T Page 3 of 7

4 Scope of Category A INAB Classification number (P9) Type of test/properties measured Documented In-house method.01 Blood alcohol Ethanol in the range Analysis by head space gas Urine 0.01% to 0.6% w/v chromatographic technique.02 Breath Alcohol Ethanol in the range Dual limit PBT Measurements 5-25µg/100ml - Test method.03 Drugs in drivers Amphetamine Blood ng/ml Urine ng/ml Methamphetamine Blood ng/ml Urine ng/ml Cannabinoids Blood ng/ml Urine ng/ml Methadone Blood ng/ml Urine ng/ml Opiates Blood ng/ml Urine ng/ml Benzodiazepines Blood ng/ml Urine ng/ml Cocaine Metabolites Blood ng/ml Urine ng/ml Documented In-house Method Detection of drugs, based on the instructions for use of Microplate EIA kit, Best 2000 Elisa System. Edition 27, 30/04/ T Page 4 of 7

5 Scope of Category A INAB Classification number (P9).03 Drugs in drivers Type of test/properties measured Benzodiazepines in Blood Quantitation of (range) Diazepam ( ng/ml), Oxazepam ( ng/ml), Nordiazepam ( ng/ml), Temazepam ( ng/ml), Alprazolam (5-250 ng/ml), Alpha Hydroxyalprazolam (5-100 ng/ml), Desalkyl Flurazepam (ranges ng/ml) Documented In-house method Benzodiazepine Confirmation Test Method by LCMSMS (Blood and Urine) Edition 27, 30/04/ T Page 5 of 7

6 Scope of Category A INAB Classification number (P9).03 Drugs in drivers * Type of test/properties measured Quantitation of Δ9 - tetrahydrocannabinol (range 2-50ng/ml) and 11-nor-9-carboxy- Δ9-tetrahydrocannabinol (range 5-300ng/ml) in whole blood Cannabis Test Method by GC-MS Quantitation of 11-nor-9- Carboxy-Δ9- tetrahydrocannabinol (range ng/ml) in urine Cannabis Test Method by GC-MS Quantitation of Diazepam, Oxazepem, Nordiazepam, Temazepam, Alprazolam, Alpha Hydroxy Alprazolam, Desalkyl flurazepam (ranges ng/ml) in urine Benzodiazepine Confirmation Test Method by LCMSMS (Blood and Urine) *Flexible scope: Additional drugs may be added and ranges extended in accordance with the laboratory's approved and documented procedures ( Flexible scope procedure ). For details refer to the laboratory's List of Additionally Accredited tests, available from the laboratory Scope of Edition 27, 30/04/ T Page 6 of 7

7 Category B INAB Classification number (P9).02 Breath Alcohol Performance testing of EvidenzerIRL Type of test/properties measured Record of measurement of linearity and repeatability in range 0µg - 200µg/100ml ethanol Time Barometric pressure Documented in house method EBT test method Evidenzer IRL 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 27, 30/04/ T Page 7 of 7