Public Health Laboratory

Transcription

1 Public Health Laboratory Health Service Executive (Dublin Mid Leinster) Cherry Orchard Hospital, Ballyfermot, Dublin 10 Testing Laboratory Registration number: 101T 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: 02:05:2002 Date of last renewal of accreditation: 08:05:2017 Expiry date of this certificate of accreditation: 08:05:2022 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: Chairperson: Dr Adrienne Duff Issued on 08 May 2017 Ms. Ita Kinahan 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, 08/05/ T Page 1 of 17

2 Schedule of (Annex to Certificate) PUBLIC HEALTH LABORATORY Health Service Executive, Dublin Mid Leinster Initial Registration Date : 30-November-1998 Postal Address: Public Health Laboratory (Address of other locations Health Service Executive as they apply) Dublin Mid Leinster Cherry Orchard Hospital Ballyfermot Dublin 10 Telephone: +353 (1) Fax: +353 (1) phl.dublin@hse.ie Contact Name: Dr Eleanor Mc Namara Facilities: Public testing service Edition 27, 08/05/ T Page 2 of 17

3 Schedule of 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 (medical laboratories). Frequent audits, together with periodic inter-laboratory test programmes, ensure that these standards of operation are maintained. Testing and Calibration Categories: : 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, 08/05/ T Page 3 of 17

4 Public Health Laboratory HSE-Dublin Mid Leinster INAB Classification number (P9) Microbiological tests on foods Dairy Products Egg and egg products Meat & meat products, game and poultry Fish, shellfish and molluscs Fats and oils Soups, broths & sauces Cereals and bakery products Fruit and vegetables Herbs and spices Non-alcoholic beverages Ices and desserts Cocoa and cocoa preparations, coffee and tea Confectionary Nuts and nut products, snacks Prepared dishes Foodstuffs intended for special nutritional uses Pet Foods Type of test/properties measured Total viable counts at 30 C (Spiral plate) Enumeration and confirmation of Escherichia coli by TBX agar (Spread plate / chromogenic agar TBX) Enumeration and confirmation of coagulase positive staphylococci (Staphylococcus aureus & other species) (Spread plate) Enumeration and confirmation of Bacillus species including presumptive Bacillus cereus (Spiral plate) Enumeration & confirmation of Clostridium perfringens (Spread plate / Pour plate) Detection & confirmation of Salmonella species (Enrichment/selective media) Documented in house method: SFM 001 based on ISO 13559:2002 ISO 4833:2013 SFM 002 based on ISO :2001 SFM 003 based on ISO :1999/Amd 1:2003 SFM 004 based on ISO 7932:2005 SFM 005 based on ISO 7937:2004 *The Microbiology of Drinking Water (2010) Part 6. *Refers to confirmation stage only SFM 006 (Culture) based on:- ISO 6579:2002/Amd 1:2007 ISO 6785:2007(dairy only) Edition 27, 08/05/ T Page 4 of 17

5 Public Health Laboratory HSE-Dublin Mid Leinster Type of test/properties measured 811 Microbiological tests Documented in house method:- on foods Enumeration, detection and SFM 007 based on.01 Dairy Products confirmation of Listeria species ISO :1997/Amd 1: Egg and egg products including Listeria monocytogenes ISO :1999/Amd 1: Meat & meat products, (Spread plate/enrichment) game and poultry.04 Fish, shellfish & Detection and confirmation of SFM 008 based on molluscs Campylobacter species ISO : Fats and oils (Enrichment) (Culture).06 Soups, broths & sauces.07 Cereals and bakery Enumeration and confirmation of SFM 009 based on products Enterobacteriaceae ISO : Fruit and vegetables (Pour plate) ISO : Herbs and spices.10 Non-alcoholic Detection and confirmation of SFM 011 based on beverages E.coli O157 ISO 16654: Ices and desserts (Enrichment/IMS).14 Cocoa and cocoa preparations, coffee Detection and confirmation of SFM 015 (Vidas) based on:- and tea Salmonella species Association Francaise de Normalisation.15 Confectionary (Enrichment /Vidas) AFNOR (Bio-12/1-04/94): Nut and nut products, ISO 6579:2002/Amd 1:2007 snacks ISO 6785:2007 (dairy only).17 Prepared dishes.18 Foodstuffs intended for special nutritional uses.22 Pet Foods Edition 27, 08/05/ T Page 5 of 17

6 Public Health Laboratory HSE-Dublin Mid Leinster Microbiological tests on foods Meat and meat products, game and poultry Fruit and vegetables Type of test/properties measured Detection and confirmation of E. coli O26 Documented in house method: SFM 022 based on ISO 16654:2001 (Enrichment/IMS).09 Herbs and spices.10 Non-alcoholic beverages - Bottled waters Enumeration and confirmation of Coliforms [cfu/250ml] Enumeration & confirmation of Escherichia coli [cfu/250ml] SWM 001 based on ISO : 2014 Enumeration of coliform bacteria and E.coli by membrane filtration SWM 001 based on ISO : Enumeration of Escherichia coli and coliforms ISO 8199: General guidance on the enumeration of microorganism by culture Edition 27, 08/05/ T Page 6 of 17

7 Public Health Laboratory HSE-Dublin Mid Leinster 811 Microbiological tests on foods Type of test/properties measured Documented in house method:.10 Non-alcoholic Enumeration & confirmation of SWM 003 based on beverages Enterococci [cfu/250ml] ISO : Bottled waters (membrane filtration) Enumeration and confirmation of Clostridium perfringens SWM 004 based on [cfu/50ml] The Microbiology of Drinking Water (2010) Part 6. (membrane filtration) Enumeration and confirmation of Pseudomonas aeruginosa SWM 008 based on [cfu/250ml] The Microbiology of Drinking Water (2010) Part 8 (membrane filtration) Colony count at 22 C and 37 C [cfu/ml] (Excluding bathing SWM 006 and SWM 007 based water) on ISO 6222:1999 (Pour plate) Edition 27, 08/05/ T Page 7 of 17

8 Public Health Laboratory HSE-Dublin Mid Leinster Microbiological tests for factory hygiene purposes Surfaces Type of test/properties measured Detection and enumeration of Aerobic colony count (surface swabs) SFM 001 based on ISO 18593:2004 ISO 4833:2003 (Spiral plate) Detection and enumeration of E.coli (surface swabs) SFM 002 based on ISO :2001 ISO 18593:2004 (Spiral plate / Pour Plate) 819 Microbiological tests Detection of Pseudomonas SEM.001 based on UK Dept. on other materials aeruginosa (environmental of Health, Health Technical.99 Other Materials swabs) Memorandum Environmental swabs Addendum: Pseudomonas including those from aeruginosa - advice for healthcare facilities augmented care units ISO 18593: 2004 Microbiology of food and animal feeding stuffs- Horizontal methods for sampling techniques from surfaces using contact plates and swabs. I.S. EN ISO 16266:2008 Water Quality - Detection and enumeration of Pseudomonas aeruginosa- Method by membrane Edition 27, 08/05/ T Page 8 of 17

9 Public Health Laboratory HSE-Dublin Mid Leinster INAB Classification number (P9) Waters condition of potable water condition of swimming pools and spas condition of environmental waters Other tests Source water Type of test/properties measured Enumeration and confirmation of Coliforms [cfu/100ml] Enumeration & confirmation of Escherichia coli [cfu/100ml] Enumeration & confirmation of Enterococci [cfu/100ml] Documented in house method: based on The Microbiology of Drinking Water. Methods for the examination of waters and associated materials. SWM 001 based on ISO :2014 SWM 003 based on ISO :2000 (membrane filtration) Enumeration and confirmation of Clostridium perfringens [cfu/100ml or cfu/50ml] SWM 004 based on The Microbiology of Drinking Water (2010) Part 6. (membrane filtration) Enumeration and confirmation of Pseudomonas aeruginosa [cfu/100ml] SWM 008 based on The Microbiology of Drinking Water (2010) Part 8 (membrane filtration) Edition 27, 08/05/ T Page 9 of 17

10 Public Health Laboratory HSE-Dublin Mid Leinster Waters condition of potable water condition of swimming pools and spas condition of environmental waters Other tests Source water Bathing water Type of test/properties measured Enumeration of Coliforms and Escherichia coli [cfu/100ml] Colony count at 22 C and 37 C [cfu/ml] (Excluding bathing water) Documented in house methods SWM 009 based on ISO : 2012 Water Quality - Enumeration of E.coli and Coliform Bacteria. Part 2: Most probable number method. The Microbiology of Drinking Water (2009) Part 4 (IDEXX (Colilert 18) Quantitray TM ) ( Most probable number) SWM 006 and SWM 007 based on ISO 6222:1999 (Pour plate) 870 Waters Documented in house.11 Detection and confirmation of method condition of potable E.coli O157 SWM 010 based on.16 water (Membrane The Microbiology of Drinking filtration/enrichment/ims) Water (2009) Part 4. condition of [Detected per Litre] environmental waters Detection and confirmation of SWM 020 based on The E.coli O26 (membrane Microbiology of Drinking filtration/enrichment/ims) Water (2009) Part 4 [Detected per Litre] Edition 27, 08/05/ T Page 10 of 17

11 Public Health Laboratory HSE-Dublin Mid Leinster 881 DNA Analysis Type of test/properties measured Detection of Verotoxigenic E. coli (VTEC) in water samples using automated DNA extraction and Real-Time PCR Documented in house method SMM003 based on 1) ISO 13136: ) Technical specification for the monitoring and reporting of VTEC on animals and foods (VTEC surveys on animal and food). Scientific report of EFSA. EFSA Journal 2009:7 (11):1366 3) Identification of three vtx1 and seven vtx2 subtypes of verotoxin encoding genes of E. coli by conventional PCR amplification. WHO collaborating centre for reference and research on Escherichia and Klebsiella. Circulated by ECDC The Microbiology of Drinking Water (2002)-Part 3-Practices and procedures for laboratories Edition 27, 08/05/ T Page 11 of 17

12 Public Health Laboratory HSE-Dublin Mid Leinster Waters condition of potable waters condition of industrial waters (treated, recirculating) condition of swimming pools and spas condition of environmental waters Other tests Source Water Type of test/properties measured Detection and confirmation of Salmonella species (Membrane filtration/enrichment/vidas) [Detected per Litre) SWM 005 based on ISO 19250:2010 (Culture) SWM 011 (Vidas) based on Association Francaise de Normalisation AFNOR (Bio-12/1-04/94):2004 ISO 19250: condition of potable waters.99 Other tests - Well waters - Hydrotherapy waters.99 Other tests - Waters for Dialysis Enumeration of coliform bacteria and E.coli by membrane filtration Total Viable Count / ml for Dialysis by membrane filtration SWM001 based on ISO : Enumeration of Escherichia coli and coliforms ISO 8199: General guidance on the enumeration of microorganism by culture SWM023 based on ISO 23500:2014, ISO 13959:2014 Edition 27, 08/05/ T Page 12 of 17

13 Public Health Laboratory HSE-Dublin Mid Leinster INAB Classification number (P9) Waters condition of environmental waters Other tests Endoscopy rinse waters Type of test/properties measured Total viable count at 30 C [cfu/100ml] Documented in house methods SWM 017 based on ISO 15883: Part 4 Requirements and tests for washer disinfectors employing chemical disinfection for thermolabile endoscopes. ISO 15883: Part 1 General requirements, terms and definitions and tests. SWM017 Total Viable Count/100 ml for Environmental/Endoscop y waters Enumeration and confirmation of Pseudomonas aeruginosa [cfu/100ml] SWM 008 based on The Microbiology of Drinking Water (2010) Part 8 (membrane filtration ) Detection of slow-growing Mycobacterium spp. From waters from heater-cooler units SWM 018M base on ISO Requirements and tests for washer disinfectors employing chemical disinfection for thermolabile endoscopes Edition 27, 08/05/ T Page 13 of 17

14 Public Health Laboratory HSE-Dublin Mid Leinster INAB Classification number (P9) 870 Waters Type of test/properties measured.99 Other tests Enumeration and confirmation of SWM 001 based on ISO :2014 Bathing waters Coliforms and E.coli by membrane filtration [cfu/100ml] Enumeration and confirmation of SWM 003 based on Enterococci by membrane filteration ISO :2000 [cfu/100ml] Detection and confirmation of SWM 005 based on Salmonella species ISO 19250:2010 (Culture) [Membrane filtration-detected per Litre] SWM 011 (Vidas) based on:- Association Franchaise de Normalisation AFNOR (Bio-12/1-04/94):2004 ISO 19250:2010 Edition 27, 08/05/ T Page 14 of 17

15 Public Health Laboratory HSE-Dublin Mid Leinster Waters condition of potable waters condition of industrial waters (treated, recirculating) condition of swimming pools and spas condition of environmental waters Other tests Endoscopy rinse waters.99 Other tests Endoscopy rinse waters Type of test/properties measured Detection and Enumeration of Legionella pneumophila Serogroup 1 Serogroup 2-14 Legionella species Detection of Mycobacterium species in Endoscopy Waters Documented in house methods SWM 012 based ISO 11731: 1998 (membrane filtration) SWM 018 based on Method for Analysis of Endoscopy Waters D. Stokely (2003) (membrane filtration) Edition 27, 08/05/ T Page 15 of 17

16 Public Health Laboratory HSE-Dublin Mid Leinster Type of test/properties measured 881 DNA Analysis Detection of verotoxigenic E.coli (VTEC) by PCR (including serogroups O26, O103,O104,O111, O145, O157 and verotoxins vt1, vt2, vt2f) 881 DNA Analysis Detection of verotoxigenic E.coli (VTEC) by automated DNA extraction and PCR (including serogroups O26, O103, O104,O111, O145,O157 and verotoxins vt1, vt2, vt2f) SMM001 based on :- Scientific report of EFSA. EFSA journal 2009:7(11):1366 Clinical Laboratory Standards Institute, MM17- A: verification and validation of multiplex nucleic acid assays: Approved guideline SMM002 based on :- 1) ISO 13136: ) Scientific report of EFSA. EFSA journal 2009:7(11):1366 3) Clinical Laboratory Standards Institute, MM17- A: verification and validation of multiplex nucleic acid assays: Approved guideline Edition 27, 08/05/ T Page 16 of 17