public health laboratory dublin

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Edition 27, 08/05/2017 101T Page 1 of 17 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 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 2 nd 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: 02:05:2002 Date of last renewal of accreditation: 08:05:2017 Expiry date of this certificate of accreditation: 08:05:2022 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 Ms. Ita Kinahan Issued on 08 May 2017 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.

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Page 1: Public Health Laboratory Dublin

Edition 27, 08/05/2017 101T Page 1 of 17

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 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: 02:05:2002

Date of last renewal of accreditation: 08:05:2017

Expiry date of this certificate of accreditation: 08:05:2022

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 Ms. Ita Kinahan

Issued on 08 May 2017

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.

Page 2: Public Health Laboratory Dublin

Edition 27, 08/05/2017 101T Page 2 of 17

Schedule of Accreditation

(Annex to Accreditation Certificate) Permanent Laboratory:

Category A

PUBLIC HEALTH LABORATORY

Health Service Executive, Dublin Mid Leinster

Biological Testing Laboratory

Initial Registration Date : 30-November-1998

Postal Address:

(Address of other locations

as they apply)

Public Health Laboratory

Health Service Executive

Dublin Mid Leinster

Cherry Orchard Hospital

Ballyfermot

Dublin 10

Telephone: +353 (1) 07669 55175

Fax: +353 (1) 6231908

E-mail: [email protected]

Contact Name: Dr Eleanor Mc Namara

Facilities: Public testing service

Page 3: Public Health Laboratory Dublin

Edition 27, 08/05/2017 101T Page 3 of 17

Schedule of Accreditation

Permanent Laboratory: Category A

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 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.

Page 4: Public Health Laboratory Dublin

Edition 27, 08/05/2017 101T Page 4 of 17

Scope of Accreditation

Public Health Laboratory HSE-Dublin Mid Leinster Permanent Laboratory:

Category A

Biological Testing Laboratory

INAB Classification number

(P9)

Materials/products tested

Type of test/properties measured

Range of measurement

Standard specifications

Equipment/techniques used

811

.01

.02

.03

.04

.05

.06

.07

.08

.09

.10

.13

.14

.15

.16

.17

.18

.22

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

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 16649-2:2001

SFM 003 based on

ISO 6888-1:1999/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)

Page 5: Public Health Laboratory Dublin

Edition 27, 08/05/2017 101T Page 5 of 17

Scope of Accreditation

Public Health Laboratory HSE-Dublin Mid Leinster Permanent Laboratory:

Category A

Biological Testing Laboratory

INAB Classification number (P9)

Materials/products tested

Type of test/properties measured

Range of measurement

Standard specifications

Equipment/techniques used

811

.01

.02

.03

.04

.05

.06

.07

.08

.09

.10

.13

.14

.15

.16

.17

.18

.22

Microbiological tests

on foods

Dairy Products

Egg and egg products

Meat & meat products,

game and poultry

Fish, shellfish &

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

Nut and nut products,

snacks

Prepared dishes

Foodstuffs intended

for special nutritional

uses

Pet Foods

Enumeration, detection and

confirmation of Listeria species

including Listeria monocytogenes

(Spread plate/enrichment)

Detection and confirmation of

Campylobacter species

(Enrichment)

Enumeration and confirmation of

Enterobacteriaceae

(Pour plate)

Detection and confirmation of

E.coli O157

(Enrichment/IMS)

Detection and confirmation of

Salmonella species

(Enrichment /Vidas)

Documented in house method:-

SFM 007 based on

ISO 11290-1:1997/Amd 1:2004

ISO 11290-2:1999/Amd 1:2004

SFM 008 based on

ISO 10272-1:2006

(Culture)

SFM 009 based on

ISO 21528-1:2004

ISO 21528-2:2004

SFM 011 based on

ISO 16654:2001

SFM 015 (Vidas) based on:-

Association Francaise de Normalisation

AFNOR (Bio-12/1-04/94):2004

ISO 6579:2002/Amd 1:2007

ISO 6785:2007 (dairy only)

Page 6: Public Health Laboratory Dublin

Edition 27, 08/05/2017 101T Page 6 of 17

Scope of Accreditation

Public Health Laboratory HSE-Dublin

Mid Leinster

Permanent Laboratory:

Category A

Biological Testing Laboratory

INAB Classification number (P9)

Materials/products tested

Type of test/properties

measured

Range of measurement

Standard specifications

Equipment/techniques used

811

.03

.08

.09

Microbiological tests

on foods

Meat and meat

products, game and

poultry

Fruit and vegetables

Herbs and spices

Detection and confirmation of

E. coli O26

Documented in house method:

SFM 022 based on

ISO 16654:2001

(Enrichment/IMS)

.10

Non-alcoholic

beverages

- Bottled waters

Enumeration and confirmation

of Coliforms [cfu/250ml]

Enumeration & confirmation of

Escherichia coli [cfu/250ml]

Enumeration of coliform

bacteria and E.coli by

membrane filtration

SWM 001 based on

ISO 9308-1: 2014

SWM 001 based on ISO 9308-

1:2014 - Enumeration of

Escherichia coli and

coliforms

ISO 8199: 2005 - General

guidance on the enumeration

of microorganism by culture

Page 7: Public Health Laboratory Dublin

Edition 27, 08/05/2017 101T Page 7 of 17

Scope of Accreditation

Public Health Laboratory HSE-Dublin

Mid Leinster

Permanent Laboratory:

Category A

Biological Testing Laboratory

INAB Classification number (P9)

Materials/products tested

Type of test/properties

measured

Range of measurement

Standard specifications

Equipment/techniques used

811

.10

Microbiological tests

on foods

Non-alcoholic

beverages

- Bottled waters

Enumeration & confirmation of

Enterococci [cfu/250ml]

Enumeration and confirmation

of Clostridium perfringens

[cfu/50ml]

Enumeration and confirmation

of Pseudomonas aeruginosa

[cfu/250ml]

Colony count at 22°C and 37°C

[cfu/ml] (Excluding bathing

water)

Documented in house method:

SWM 003 based on

ISO 7899-2:2000

(membrane filtration)

SWM 004 based on

The Microbiology of Drinking

Water (2010) Part 6.

(membrane filtration)

SWM 008 based on

The Microbiology of Drinking

Water (2010) Part 8

(membrane filtration)

SWM 006 and SWM 007 based

on

ISO 6222:1999 (Pour

plate)

Page 8: Public Health Laboratory Dublin

Edition 27, 08/05/2017 101T Page 8 of 17

Scope of Accreditation

Public Health Laboratory HSE-Dublin

Mid Leinster

Permanent Laboratory:

Category A

Biological Testing Laboratory

INAB Classification number (P9)

Materials/products tested

Type of test/properties

measured

Range of measurement

Standard specifications

Equipment/techniques used

818

.01

Microbiological tests

for factory hygiene

purposes

Surfaces

Detection and enumeration of

Aerobic colony count (surface

swabs)

Detection and enumeration of

E.coli (surface swabs)

SFM 001 based on

ISO 18593:2004

ISO 4833:2003

(Spiral plate)

SFM 002 based on

ISO 16649-2:2001

ISO 18593:2004

(Spiral plate / Pour Plate)

819

.99

Microbiological tests

on other materials

Other Materials

Environmental swabs

including those from

healthcare facilities

Detection of Pseudomonas

aeruginosa (environmental

swabs)

SEM.001 based on UK Dept.

of Health, Health Technical

Memorandum 04-01

Addendum: Pseudomonas

aeruginosa - advice for

augmented care units 2013.

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

Page 9: Public Health Laboratory Dublin

Edition 27, 08/05/2017 101T Page 9 of 17

Scope of Accreditation

Public Health Laboratory HSE-Dublin Mid Leinster Permanent Laboratory:

Category A

Biological Testing Laboratory

INAB Classification

number (P9)

Materials/products tested

Type of test/properties measured

Range of measurement

Standard specifications

Equipment/techniques used

870

.11

.15

.16

.99

Waters

Bacteriological

condition of

potable water

Bacteriological

condition of

swimming pools

and spas

Bacteriological

condition of

environmental

waters

Other tests

Source water

Enumeration and confirmation of Coliforms

[cfu/100ml]

Enumeration & confirmation of Escherichia

coli [cfu/100ml]

Enumeration & confirmation of Enterococci

[cfu/100ml]

Enumeration and confirmation of

Clostridium perfringens

[cfu/100ml or cfu/50ml]

Enumeration and confirmation of

Pseudomonas aeruginosa

[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 9308 1:2014

SWM 003 based on

ISO 7899-2:2000

(membrane filtration)

SWM 004 based on

The Microbiology of Drinking

Water (2010) Part 6.

(membrane filtration)

SWM 008 based on

The Microbiology of Drinking

Water (2010) Part 8

(membrane filtration)

Page 10: Public Health Laboratory Dublin

Edition 27, 08/05/2017 101T Page 10 of 17

Scope of Accreditation

Public Health Laboratory HSE-Dublin

Mid Leinster

Permanent Laboratory:

Category A

Biological Testing Laboratory

INAB Classification number (P9)

Materials/products tested

Type of test/properties

measured

Range of measurement

Standard specifications

Equipment/techniques used

870

.11

.15

.16

.99

Waters

Bacteriological

condition of potable

water

Bacteriological

condition of swimming

pools and spas

Bacteriological

condition of

environmental waters

Other tests

Source water

Bathing water

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 9308-

2: 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)

QuantitrayTM)

( Most probable number)

SWM 006 and SWM 007

based on

ISO 6222:1999 (Pour plate)

870

.11

.16

Waters

Bacteriological

condition of potable

water

Bacteriological

condition of

environmental waters

Detection and confirmation of

E.coli O157

(Membrane

filtration/enrichment/IMS)

[Detected per Litre]

Detection and confirmation of

E.coli O26 (membrane

filtration/enrichment/IMS)

[Detected per Litre]

Documented in house

method

SWM 010 based on

The Microbiology of Drinking

Water (2009) Part 4.

SWM 020 based on The

Microbiology of Drinking

Water (2009) Part 4

Page 11: Public Health Laboratory Dublin

Edition 27, 08/05/2017 101T Page 11 of 17

Scope of Accreditation

Public Health Laboratory HSE-Dublin

Mid Leinster

Permanent Laboratory:

Category A

Biological Testing Laboratory

INAB Classification number (P9)

Materials/products tested

Type of test/properties

measured

Range of measurement

Standard specifications

Equipment/techniques used

881

DNA Analysis

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: 2012

2) 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 2010.

The Microbiology of Drinking Water

(2002)-Part 3-Practices and procedures

for laboratories

Page 12: Public Health Laboratory Dublin

Edition 27, 08/05/2017 101T Page 12 of 17

Scope of Accreditation

Public Health Laboratory HSE-Dublin

Mid Leinster

Permanent Laboratory:

Category A

Biological Testing Laboratory

INAB Classification number (P9)

Materials/products tested

Type of test/properties

measured

Range of measurement

Standard specifications

Equipment/techniques used

870

.11

.12

.15

.16

.99

Waters

Bacteriological condition

of potable waters

Bacteriological condition

of industrial

waters (treated,

recirculating)

Bacteriological condition

of swimming pools and

spas

Bacteriological condition

of environmental waters

Other tests

Source Water

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 19250:2010

.11

.99

Bacteriological condition

of potable waters

Other tests

- Well waters

- Hydrotherapy waters

Enumeration of coliform

bacteria and E.coli by

membrane filtration

SWM001 based on

ISO 9308-1:2014 -

Enumeration of Escherichia

coli and coliforms

ISO 8199: 2005 - General

guidance on the

enumeration of

microorganism by culture

.99 Other tests

- Waters for Dialysis

Total Viable Count / ml for

Dialysis by membrane

filtration

SWM023 based on ISO

23500:2014, ISO 13959:2014

Page 13: Public Health Laboratory Dublin

Edition 27, 08/05/2017 101T Page 13 of 17

Scope of Accreditation

Public Health Laboratory HSE-Dublin Mid Leinster Permanent Laboratory:

Category A

Biological Testing Laboratory

INAB Classification number

(P9)

Materials/products tested

Type of test/properties measured

Range of measurement

Standard specifications

Equipment/techniques used

870

.16

.99

Waters

Bacteriological

condition of

environmental

waters

Other tests

Endoscopy

rinse waters

Total viable count at 30°C

[cfu/100ml]

Enumeration and confirmation of

Pseudomonas

aeruginosa [cfu/100ml]

Detection of slow-growing

Mycobacterium spp. From waters

from heater-cooler units

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

SWM 008 based on

The Microbiology of Drinking Water

(2010)

Part 8 (membrane filtration )

SWM 018M base on ISO 15883-4

Requirements and tests for washer

disinfectors employing chemical

disinfection for thermolabile

endoscopes

Page 14: Public Health Laboratory Dublin

Edition 27, 08/05/2017 101T Page 14 of 17

Scope of Accreditation

Public Health Laboratory HSE-Dublin Mid Leinster Permanent Laboratory:

Category A

Biological Testing Laboratory

INAB Classification number

(P9)

Materials/products tested

Type of test/properties measured

Range of measurement

Standard specifications

Equipment/techniques used

870

.99

Waters

Other tests

Bathing waters

Enumeration and confirmation of

Coliforms and E.coli by membrane

filtration [cfu/100ml]

Enumeration and confirmation of

Enterococci by membrane filteration

[cfu/100ml]

Detection and confirmation of

Salmonella species

[Membrane filtration-Detected per

Litre]

SWM 001 based on ISO 9308-1:2014

SWM 003 based on

ISO 7899-2:2000

SWM 005 based on

ISO 19250:2010 (Culture)

SWM 011 (Vidas) based on:-

Association Franchaise de Normalisation

AFNOR (Bio-12/1-04/94):2004

ISO 19250:2010

Page 15: Public Health Laboratory Dublin

Edition 27, 08/05/2017 101T Page 15 of 17

Scope of Accreditation

Public Health Laboratory HSE-Dublin

Mid Leinster

Permanent Laboratory:

Category A

Biological Testing Laboratory

INAB Classification number (P9)

Materials/products tested

Type of test/properties

measured

Range of measurement

Standard specifications

Equipment/techniques used

870

.11

.12

.15

.16

.99

Waters

Bacteriological

condition of potable

waters

Bacteriological

condition of industrial

waters (treated,

recirculating)

Bacteriological

condition of swimming

pools and spas

Bacteriological

condition of

environmental waters

Other tests

Endoscopy

rinse waters

Detection and Enumeration of

Legionella pneumophila

Serogroup 1

Serogroup 2 - 14

Legionella species

Documented in house

methods

SWM 012 based

ISO 11731: 1998

(membrane filtration)

.99 Other tests

Endoscopy rinse

waters

Detection of Mycobacterium

species in Endoscopy Waters

SWM 018 based on

Method for Analysis of

Endoscopy Waters

D. Stokely (2003)

(membrane filtration)

Page 16: Public Health Laboratory Dublin

Edition 27, 08/05/2017 101T Page 16 of 17

Scope of Accreditation

Public Health Laboratory HSE-Dublin

Mid Leinster

Permanent Laboratory:

Category A

Biological Testing Laboratory

INAB Classification number (P9)

Materials/products tested

Type of test/properties

measured

Range of measurement

Standard specifications

Equipment/techniques used

881

DNA Analysis

Detection of verotoxigenic

E.coli (VTEC) by 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

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)

SMM002 based on :-

1) ISO 13136: 2012

2) 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