West North West Hospital Group Galway University Hospitals Registration number:

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West North West Hospital Group
Galway University Hospitals
Laboratory Medicine Diagnostics Directorate
Medical Testing Laboratory
Registration number: 223MT
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 15189:2007 2nd Edition
“Medical laboratories – Particular requirements for quality and competence”
(This Certificate must be read in conjunction with the Annexed Schedule of
Accreditation)
Date of award of accreditation: 07:04:2009
Date of last renewal of accreditation: 12:03:2014
Expiry date of this certificate of accreditation: 12:03:2019
This Accreditation shall remain in force until further notice subject to continuing compliance
with INAB accreditation criteria, ISO/IEC 15189 and any further requirements specified by the
Irish National Accreditation Board.
Manager:
Chairperson:
Dr Adrienne Duff
Mr Tom O‘Neill
Issued on 12 March 2014
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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Wilton Park House, Wilton Place, Dublin 2, Ireland
Tel +353 1 607 3003 Fax +353 1 607 3109
E-mail [email protected] Web www.inab.ie
Schedule of
Accreditation
(Annex to Accreditation Certificate)
Permanent Laboratory:
Category A
GALWAY UNIVERSITY HOSPITALS
Laboratory Medicine Diagnostics Directorate
Division of Clinical Microbiology
Clinical Microbiology Testing Laboratory
Initial Registration Date :
7-April-2009
Postal Address:
Newcastle Road
(Address of other locations
Galway
as they apply)
Telephone:
+353 (91) 544429
Fax:
+353 (91) 544899
E-mail:
[email protected]
Contact Name:
Ms Frances Higgins
Facilities:
Public testing service
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Wilton Park House, Wilton Place, Dublin 2, Ireland
Tel +353 1 607 3003 Fax +353 1 607 3109
E-mail [email protected] Web www.inab.ie
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/IEC 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.
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Scope of
Accreditation
Permanent Laboratory:
Galway University Hospital
Category A
Clinical Microbiology Testing Laboratory
INAB Classification number (P9)
Materials/products tested
Type of test/properties
measured
Range of measurement
Standard specifications
Equipment/techniques used
MICSOP025
1011
Bacteriology
.01
Preparation of films
Investigation of Urine
for microscopic
specimens- Microscopy and
examination
culture and sensitivity
National Standard Methods,
.02
Inoculation of cultures
Health Protection Agency,
.03
Microscopic
UK
examination of
Clinical Specimens
.04
Identification of
organisms
including antibiotic
sensitivity testing
.06
Detection of bacterial
antigens
.07
Specialised antibiotic
procedures
.08
Detection and
characterisation of
microbial DNA/RNA
.99
Miscellaneous tests
Specimen Type: Urines
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Scope of
Accreditation
Permanent Laboratory:
Galway University Hospital
Category A
Clinical Microbiology Testing Laboratory
INAB Classification number (P9)
Materials/products tested
Type of test/properties
measured
Range of measurement
Standard specifications
Equipment/techniques used
1011
Bacteriology
.01
Preparation of films
Investigation of superficial and
MICSOP010
for microscopic
deep seated wound infections,
MICSOP011
examination
intravascular cannulae and
MICSOP014
.02
Inoculation of cultures
fluids from normally sterile
MICSOP015
.03
Microscopic
body sites
.04
examination of
National Standard Methods,
Clinical Specimens
Health Protection Agency,
Identification of
UK
organisms including
antibiotic sensitivity
testing
.06
Detection of bacterial
antigens
.07
Specialised antibiotic
procedures
.08
Detection and
characterisation of
microbial DNA/RNA
.99
Miscellaneous tests
Specimens:
Swabs other than
genital
tract and associated
specimens
Pus
Catheter tips
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Scope of
Accreditation
Permanent Laboratory:
Galway University Hospital
Category A
Clinical Microbiology Testing Laboratory
INAB Classification number (P9)
Materials/products tested
Type of test/properties
measured
Range of measurement
Standard specifications
Equipment/techniques used
1011
Bacteriology
.99
Miscellaneous tests
Investigation of superficial and
MICSOP010
Specimens:
deep seated wound infections,
MICSOP011
Bile
intravascular cannulae and
MICSOP014
Fluids
fluids from normally sterile
MICSOP015
Tissues
body sites
Bone
National Standard Methods,
Biopsies
Health Protection Agency,
CSFs
UK
Corneal lens and
intraocular
fluids
Corneal lens
Prosthetic devices
Products of conception
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Scope of
Accreditation
Permanent Laboratory:
Galway University Hospital
Category A
Clinical Microbiology Testing Laboratory
INAB Classification number (P9)
Materials/products tested
Type of test/properties
measured
Range of measurement
Standard specifications
Equipment/techniques used
1011
Bacteriology
.01
Preparation of films
Investigation of genital tract
MICSOP010
for microscopic
and associated specimens
MICSOP013
examination
.02
Inoculation of cultures
National Standard Methods,
.03
Microscopic
Health Protection Agency,
examination of
UK
Clinical Specimens
.04
Identification of
organisms
including antibiotic
sensitivity testing
.06
Detection of bacterial
antigens
.07
Specialised antibiotic
procedures
.08
Detection and
characterisation of
microbial DNA/RNA
.99
.99 Miscellaneous tests
Specimens:
Vaginal swabs,
Vulval / Labial swabs
Endocervical/cervical
swabs
Penile swabs
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Scope of
Accreditation
Permanent Laboratory:
Galway University Hospital
Category A
Clinical Microbiology Testing Laboratory
INAB Classification number (P9)
Materials/products tested
Type of test/properties
measured
Range of measurement
Standard specifications
Equipment/techniques used
1011
Bacteriology
.99
Miscellaneous tests
Investigation of genital tract
MICSOP010
Specimens:
and associated specimens
MICSOP013
Urethral swabs
Rectal swabs
National Standard Methods,
Bartholins gland
Health Protection Agency,
aspirate
UK
Products of conception
IUD
Fallopian tube
aspirate
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Scope of
Accreditation
Permanent Laboratory:
Galway University Hospital
Category A
Clinical Microbiology TestingLaboratory
INAB Classification number (P9)
Materials/products tested
Type of test/properties
measured
Range of measurement
Standard specifications
Equipment/techniques used
MICSOP011
1011
Bacteriology
.01
Preparation of films
Investigation of respiratory
for microscopic
specimens for bacterial
examination
pathogens other than
National Standard Methods,
.02
Inoculation of cultures
Mycobacteria
Health Protection Agency,
.03
Microscopic
UK
examination of
Clinical Specimens
.04
Identification of
organisms
including antibiotic
sensitivity testing
.06
Detection of bacterial
antigens
.07
Specialised antibiotic
procedures
.08
Detection and
characterisation of
microbial DNA/RNA
.99
Miscellaneous tests
Specimens:
Sputum
Bronchial
Lavage/Brushings/
aspirates/washings
Pleural Fluids
Cough swabs
Nasopharyngeal aspirates
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Page 9 of 35
Scope of
Accreditation
Permanent Laboratory:
Galway University Hospital
Category A
Clinical Microbiology Testing Laboratory
INAB Classification number (P9)
Materials/products tested
Type of test/properties
measured
Range of measurement
Standard specifications
Equipment/techniques used
MICSOP022
1011
Bacteriology
.01
Preparation of films
Investigation of faeces
for microscopic
specimens for bacterial
examination
pathogens
National Standard Methods,
.02
Inoculation of cultures
Health Protection Agency,
.03
Microscopic
UK
examination of
Clinical Specimens
.04
Identification of
organisms
including antibiotic
sensitivity testing
.06
.07
Detection of bacterial
Detection of Helicobacter
antigens
pylori antigen detection in
Specialised antibiotic
faeces
Coris Bioconcept
procedures
.08
.09
.99
MICSOP053
Immunostat Meridian
Detection and
characterisation of
Identification and
GeneXpert System Operator
microbial DNA/RNA
characterisation of Clostridium
manual Xpert C.difficile
Helicobacter pylori
difficle using GeneXpert system
Assay Instructions
antigen detection
from Cepheid
Miscellaneous tests
Specimens: Faeces
Rectal swabs
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Scope of
Accreditation
Permanent Laboratory:
Galway University Hospital
Category A
Clinical Microbiology Testing Laboratory
INAB Classification number (P9)
Materials/products tested
Type of test/properties
measured
Range of measurement
Standard specifications
Equipment/techniques used
MICSOP016
1011
Bacteriology
.01
Preparation of films
Screening of specimens for
for microscopic
Methicillin Resistant Staph
examination
aureus (MRSA)
National Standard Methods,
.02
Inoculation of cultures
Health Protection Agency,
.03
Microscopic
UK
examination of
Clinical Specimens
.04
Identification of
organisms
including antibiotic
sensitivity testing
.06
Detection of bacterial
antigens
.07
Specialised antibiotic
procedures
Detection and
characterisation of
microbial DNA/RNA
.99
Miscellaneous tests
Specimens: Nasal
swabs
Throat swabs
Perineal swabs
Wound swabs
Swabs from other sites
as clinically indicated
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Scope of
Accreditation
Permanent Laboratory:
Galway University Hospital
Category A
Clinical Microbiology Testing Laboratory
INAB Classification number (P9)
Materials/products tested
Type of test/properties
measured
Range of measurement
Standard specifications
Equipment/techniques used
MICSOP017
1011
Bacteriology
.01
Preparation of fims for
Screening of specimens for
microscopic
Vancomycin Resistant
examination
Enterococci (VRE)
National Standard Methods,
.02
Inoculation of cultures
Health Protection Agency,
.03
Microscopic
UK
examination of
Clinical Specimens
.04
Identification of
organisms including
antibiotic sensitivity
testing
.06
Detection of bacterial
antigens
.07
Specialised antibiotic
procedures
.08
Detection and
characterisation of
microbial DNA/RNA
.99
Miscellaneous tests
Specimens:
Rectal swabs
Stoma site swab
Swabs from other sites
as clinically indicated
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Scope of
Accreditation
Permanent Laboratory:
Galway University Hospital
Category A
Clinical Microbiology Testing Laboratory
INAB Classification number (P9)
Materials/products tested
Type of test/properties
measured
Range of measurement
Standard specifications
Equipment/techniques used
MICSOP018
1011
Bacteriology
.01
Preparation of films
Screening of specimens for
for
Extended Spectrum Beta
microscopic
lactamases (ESBL)
National Standard Methods,
.02
examination
Health Protection Agency,
.03
Inoculation of cultures
UK
Microscopic
.04
.06
.07
examination of
Screening of specimens for
MICL0153 Laboratory
Clinical Specimens
Carbapenem Resistant
Protocol for detection of
Identification of
Enterobacteriaceae
Carbapenem-Resistant or
organisms including
Carbapenemase-Producing,
antibiotic sensitivity
Klebsiella spp. and Ecoli
testing
from Rectal Swabs - CDC
Detection of bacterial
Atlanta.
antigens
Specialised antibiotic
.08
procedures
Detection and
characterisation of
.99
microbial DNA/RNA
Miscellaneous tests
Specimens:
Rectal swabs
Swabs from other sites
as clinically indicated
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Scope of
Accreditation
Permanent Laboratory:
Galway University Hospital
Category A
Clinical Microbiology Testing Laboratory
INAB Classification number (P9)
Materials/products tested
Type of test/properties
measured
Range of measurement
Standard specifications
Equipment/techniques used
MICSOP002
1011
Bacteriology
.04
Identification of
Antimicrobial resistance testing
organisms including
using disk diffusion and Vitek
antibiotic sensitivity
Compact from Biomerieux
.07
-Performance standards for
testing
Antimicrobial Susceptibilty
-
Testing, using EUCAST and
Specialised antibiotic
Clinical and Laboratory
procedures
Standards Institute (CLSI),
U.S.
.99
Miscellaneous tests
- Guidance notes, HPA, UK
- Vitek Compact User's
Guide
.04
Identification of
Screening of
MICSOP066 Procedure for
organisms including
Enterobacteriaceae isolates for
CPE Reference Laboratory
antibiotic sensitivity
Carbapenamase production
MICSOP061 – RT PCR
testing
using phenotypic and Molecular
Procedure
Methods
MICSOP060 – Procedure for
manual DNA extraction using
Qiagen DNA
.08
Detection and
RT-PCR for the detection of
MICSOP067 – Procedure for
characterisation of
Pneumocyctis jirovecii in
Detection of Pneumocystis
microbial DNA/RNA
respiratory specimens
jirovecii by RT-PCR
MICSOP061 – RT PCR
Procedure
MICSOP060 – Procedure for
manual DNA extraction using
Qiagen DNA
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Page 14 of 35
Scope of
Accreditation
Permanent Laboratory:
Galway University Hospital
Category A
Clinical Microbiology Testing Laboratory
INAB Classification number (P9)
Materials/products tested
Type of test/properties
measured
Range of measurement
Standard specifications
Equipment/techniques used
1011
Bacteriology
.08
Detection and
Screening of
MICSOP066 Procedure for
characterisation of
Enterobacteriaceae isolates for
CPE Reference Laboratory
microbial DNA/RNA
Carbapenamase production
MICSOP061 – RT PCR
using phenotypic and Molecular
Procedure
Methods
MICSOP060 – Procedure for
manual DNA extraction using
Qiagen DNA
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Page 15 of 35
Scope of
Accreditation
Permanent Laboratory:
Galway University Hospital
Category A
Clinical Microbiology Testing Laboratory
INAB Classification number (P9)
Materials/products tested
Type of test/properties
measured
Range of measurement
Standard specifications
Equipment/techniques used
1011
.06
Bacteriology
Qualitative detection of
VIR/SOP/021
Detection of bacterial
Clostridium difficile Toxins A
Clostridium difficile Toxins
antigens
and B, in human faeces, using
A and B detection using
the Techlab C. Difficile TOX
Techlab EIA assay
SOP for
A/B II ELISA assay
.06
Specialised Antibiotic
Rapid detection of B-lactamase
Remel Nitrocefin disk kit
Procedures
producing bacteria
insert
Determination of Minimum
MICSOP002
Bacterial cultures
inhibitory concentrations using
Etest
E Test Procedure,
Biomerieux
Detection of Legionella antigen
VIR/SOP/052
SOP for
in urine samples using the Binax
Legionella Urinary Antigen
NOW Legionella Urinary Antigen
detection using the Binax
kit.
NOW Legionella Urinary
Antigen kit (852-000)
.08
Detection and
Real - Time PCR for CoA in
MICSOP061
Characterisation of
S.aureus
MICSOP060
microbial
Real-Time PCR for Group A
VIR/LD/086
DNA/RNA
Streptococci
Applied Biosystems
Real - Time PCR for MecA in
Real-Time PCR System
S.aureus
plus/minus Assay Getting
Real - Time PCR for the
Started guide
detection of S.pneumoniae and
determination of penicillin
susceptibility
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Scope of
Accreditation
Permanent Laboratory:
Galway University Hospital
Category A
Clinical Microbiology Testing Laboratory
INAB Classification number (P9)
Materials/products tested
Type of test/properties
measured
Range of measurement
Standard specifications
Equipment/techniques used
1011
Bacteriology
.08
Detection and
RT-PCR Assay for the detection
MICSOP061 – RT PCR
Characterisation of
of blaCTX-M group 1, group 2 &
Procedure
microbial
group 9 in Enterobacteriaceae
MICSOP060 – Procedure for
DNA/RNA
isolates.
manual DNA extraction using
Qiagen DNA
MICSOP066
.05
Identification of
Identification of bacterial and
MICSOP068 – Identification
organisms excluding
fungal isolates using the Bruker
of organisms using the
antibiotic sensitivity
MALDI Biotyper
MALDI Biotyper from Bruker
testing
1014
Mycology
.04
Definitive
Identification of bacterial and
MICSOP068 – Identification
identification of
fungal isolates using the Bruker
of organisms using the
isolates
MALDI Biotyper
MALDI Biotyper from Bruker
Sensitivity tests to
Antifungal susceptibility testing
MICSOP002 – Antimicrobial
antifungal agents
using Etest® from Biomerieux
Susceptibility testing
.05
procedure
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Page 17 of 35
Scope of
Accreditation
Permanent Laboratory:
Galway University Hospital
Category A
Clinical Microbiology Testing Laboratory
INAB Classification number (P9)
Materials/products tested
1012
.01
Type of test/properties
measured
Range of measurement
Standard specifications
Equipment/techniques used
Detection and identification of
MICSOP023
parasites
MICSOP024
Parasitology
Detection and
provisional
identification of
.02
parasites
National Standard Methods,
Definitive
Health Protection Agency,
identification of
UK
parasites
.99
Miscellaneous tests
Specimens:
Faeces
Sellotape slides
Duodenal/Jejunal
aspirates
Urine
Liver/spleen aspirates
BALs
Blood
1013
Virology
.01
Non-cultural methods
Investigation of faeces
of detection
specimens for rota and
Definitive
adenovirus using an
identification of
Immunochromatographic test
viruses
kit
MICSOP026
Kit insert
Specimen:
CSF
Real - Time PCR for Herpes
Simplex Virus 1 and 2
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Scope of
Accreditation
Permanent Laboratory:
Galway University Hospital
Category A
Clinical Microbiology Testing Laboratory
INAB Classification number (P9)
Materials/products tested
1013
Type of test/properties
measured
Range of measurement
Standard specifications
Equipment/techniques used
RT-PCR for the detection of
MICSOP064- RT PCR for the
Enterovirus RNA in CSF
detection of HSV-1, HSV2
specimens
and Enterovirus
Virology
.04
MICSOP061 – RT PCR
Procedure
MICSOP060 – Procedure for
manual DNA extraction using
Qiagen DNA
1014
Mycology
.01
Microscopic
Investigation of specimens for
MICSOP002
examination of
superficial mycoses
MICSOP048
Clinical Specimens
MICSOP032
.02
Culture of Specimens
National Standard Methods,
.03
Limited identification
Health Protection Agency,
of isolates
UK
.04
.05
.99
Definitive
identification of
Clinical Laboratory
isolates
Standards Institute (CLSI)
Antifungal
and
susceptibility testing
EUCAST susceptibility
using Vitek 2
testing methodologies
Miscellaneous tests
Vitek 2 User Manual,
Skin
Biomerieux
Hair
Nail
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Page 19 of 35
Scope of
Accreditation
Permanent Laboratory:
Galway University Hospital
Category A
Clinical Microbiology Testing Laboratory
INAB Classification number (P9)
Materials/products tested
1015
Mycobacteriology
.01
Microscopic
examination of
.02
.03
.05
.99
Type of test/properties
measured
Range of measurement
Standard specifications
Equipment/techniques used
Investigation of specimens for
MICSOP007
Mycobacteria using the MGIT 960
MICSOP008
from Becton Dickinson
MICSOP057
clinical specimens
MICSOP062
Culture and isolation
National Standard Methods,
of mycobacteria
Identification of M. tuberculosis
Health Protection Agency,
Limited detection of
Complex using Becton Dickinson
UK
isolates
(BD) MGIT TBc identification test
Becton Dickinson MGIT 960
Susceptibility testing
User’s Guide
Miscellaneous tests
Becton Dickinson MGIT TBc
Specimen Types:
identification test kit insert
Sputum
Identification and susceptibility
Cough swabs
testing of Mycobacteria using
Bronchial
the Genotype MTBDRplus assay
Lavage/Brushings
from HAIN Gmbh
Hain kit insert
CSFs
Other body fluids
Pus
Molecular detection of M.
GeneXpert System Operator
Pleural Fluids
tuberculosis Complex and
Manual
Sputum
Rifampicin resistance using
Tissue
GeneXpert (Cepheid)
Early morning urine
GeneXpert MTB/RIF Assay
instructions
Blood Cultures
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Page 20 of 35
Scope of
Accreditation
Permanent Laboratory:
Galway University Hospital
Category A
Clinical Microbiology Testing Laboratory
INAB Classification number (P9)
Materials/products tested
Type of test/calibration or
property measured, and range of
measurement
Relevant standard or
documented procedure
used
1013
Virology
Detection of Influenza A virus
VIR/SOP/019 Detection of
.04
Detection and
RNA, in nose and throat swabs,
Influenza A RNA;
characterisation of
using in-house real-time RT-PCR.
VIR/SOP/045
viral DNA/RNA
Nucleic acid extraction is
Operation of the Easy/Mag;
performed using the BioMerieux
VIR/SOP/051 Operation of
EasyMag instrument and real-
the AB7500
time PCR is performed using the
AB7500 real-time PCR
instrument
Detection of swine-lineage
VIR/SOP/068 Detection of
Influenza A virus (H1N1) RNA, in
swine-lineage Influenza A
nose and throat swabs, using in-
(H1N1) RNA; VIR/SOP/045
house real-time RT-PCR. Nucleic
Operation of the EasyMag;
acid extraction is performed
VIR/SOP/051 Operation of
using the BioMerieux EasyMag
the AB7500
instrument and real-time PCR is
performed using the AB7500
real-time PCR instrument
H3 subtyping, of seasonal
VIR/SOP/067 subtyping of
Influenza A virus, in nose and
seasonal Influenza A
throat swabs. Nucleic acid
strains; VIR/SOP/045
extraction is performed using
Operation of the EasyMag;
the BioMerieux EasyMag
VIR/SOP/01 Operation of
instrument and real-time PCR is
the AB7500
performed using the AB7500
real-time PCR instrument
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Page 21 of 35
Scope of
Accreditation
Permanent Laboratory:
Galway University Hospital
Category A
Clinical Microbiology Testing Laboratory
INAB Classification number (P9)
Materials/products tested
Type of test/calibration or
property measured, and range of
measurement
Relevant standard or
documented procedure
used
1013
Virology
Detection of Respiratory
VIR/SOP/069 Detection of
.04
Detection and
Syncytial Virus A virus RNA, in
RSV A RNA; VIR/SOP/045
characterisation of
nose and throat swabs, using in-
Operation of the Easy/Mag;
viral DNA/RNA
house real-time RT-PCR. Nucleic
VIR/SOP/051 Operation of
acid extraction is performed
the AB7500
using the BioMerieux EasyMag
instrument and real-time PCR is
performed using the AB7500
real-time PCR instrument
Detection of Respiratory
VIR/SOP/070 Detection of
Syncytial Virus B virus RNA, in
RSV B RNA; VIR/SOP/045
nose and throat swabs, using in-
Operation of the EasyMag;
house real-time RT-PCR. Nucleic
VIR/SOP/051 Operation of
acid extraction is performed
the AB7500
using the BioMerieux EasyMag
instrument and real-time PCR is
performed using the AB7500
real-time PCR instrument
Detection of Influenza B virus
VIR/SOP/020 Detection of
RNA, in nose and throat swabs,
Influenza B RNA;
using in-house real-time RT-PCR.
VIR/SOP/045 Operation of
Nucleic acid extraction is
the EasyMag; VIR/SOP/051
performed using the BioMerieux
Operation of the AB7500
EasyMag instrument and realtime PCR is performed using the
AB7500 realtime PCR instrument
Edition 10, 09/05/2014
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Page 22 of 35
Scope of
Accreditation
Permanent Laboratory:
Galway University Hospital
Category A
Clinical Microbiology Testing Laboratory
INAB Classification number (P9)
Materials/products tested
Type of test/calibration or
property measured, and range of
measurement
Relevant standard or
documented procedure
used
1013
Virology
.04
Detection and
Detection of Norovirus
VIR/SOP/065 Detection of
characterisation of
Genogroup I & II RNA. This is
Norovirus Genogroup I & II
viral DNA/RNA
achieved using an in-house real-
RNA using Real Time RT-
time reverse transcription
PCR
polymerase chain reaction (RTPCR) and the AB7500 Sequence
Detection System
Detection of HIV RNA using the
VIR/SOP/085 SOP for the
Abbott RealTime HIV-1 assay.
Abbott RealTime HIV-1
This is an in vitro reverse
assay using the Abbott
transcription-polymerase chain
m2000sp and the Abbott
reaction (RT-PCR) assay for the
m2000rt systems.
quantitation of Human
Immunodeficiency Virus type 1
(HIV-1) in human plasma from
HIV-1 infected individuals.
Detection of HCV RNA using the
VIR/SOP/086 SOP for the
Abbott RealTime HCV assay.
Abbott RealTime HCV assay
This is an in vitro reverse
using the Abbott m2000sp
transcription-polymerase chain
and the Abbott m2000rt.
reaction (RT-PCR) assay for the
quantitation of hepatitis C viral
ribonucleic acid (HCV RNA) in
human serum and plasma from
HCV-infected individuals.
Edition 10, 09/05/2014
223MT
Page 23 of 35
Scope of
Accreditation
Permanent Laboratory:
Galway University Hospital
Category A
Clinical Microbiology Testing Laboratory
INAB Classification number (P9)
Materials/products tested
Type of test/calibration or
property measured, and range of
measurement
Relevant standard or
documented procedure
used
1011
Bacteriology
Detection of Chlamydia
VIR/SOP/085
.08
Detection and
trachomatis DNA and Neisseria
characterisation of
gonorrhoeae DNA using the
microbial
Abbott RealTime CT/NG assay
DNA/RNA
and the m2000sp and m2000rt
instruments.
Detection of Chlamydia
MICSOP062
trachomatis DNA and Neisseria
gonorrhoeae DNA using the
Cepheid Xpert CT/NG assay and
the GeneXpert instrument.
1016
Serology of Infection
Qualitative detection of
VIR/SOP/066 Detection of
.02
General serological
Hepatitis B virus Surface Antigen
HBs-Ag using the Architect
testing
in human serum and plasma,
HBsAg Qualitative Assay
using the Abbott Architect
HBsAg Qualitative assay, and
Chemiluminescent Microparticle
Immunoassay (CMIA) technology.
Confirmation of the presence of
VIR/SOP/055 Confirmation
Hepatitis B virus Surface
of the presence of HBsAg
Antigen, in human serum and
using the Abbott Architect
plasma, using the Abbott
HBsAg Qualitative
Architect HBsAg Qualitative
Confirmatory assay.
Confirmatory assay and CMIA
technology.
Edition 10, 09/05/2014
223MT
Page 24 of 35
Scope of
Accreditation
Permanent Laboratory:
Galway University Hospital
Category A
Clinical Microbiology Testing Laboratory
INAB Classification number (P9)
Materials/products tested
Type of test/calibration or
property measured, and range of
measurement
Relevant standard or
documented procedure
used
1016
Serology of Infection
.02
General serological
Semi-quantitative detection of
VIR/SOP/053
testing
antistreptolysin-O antibodies, in
Antistreptolysin-O latex
human serum, using the Biokit
agglutination test.
rheumajet ASO Latex
agglutination test.
Qualitative detection of
VIR/SOP/034 ~Detection of
Hepatitis B Core Antibody, in
anti-HBc using the Abbott
human serum and plasma, using
Architect Anti-HBc II assay
the Abbott Architect Anti-HBc II
assay and CMIA technology.
Qualitative detection of
VIR/SOP/048 Detection of
Hepatitis B virus Core Antibody,
anti-HBc using the
in human serum and plasma,
BioMerieux VIDAS Anti-HBc
using the Biomerieux VIDAS Anti-
Total II assay
HBc Total II assay
Qualitative detection of
VIR/SOP/031 ~Detection of
Hepatitis B virus Surface
anti-HBs using the Abbott
Antibody, in human serum and
Architect Anti-HBs assay
plasma, using the Abbott
Architect Anti-HBs assay and
CMIA technology.
Edition 10, 09/05/2014
223MT
Page 25 of 35
Scope of
Accreditation
Permanent Laboratory:
Galway University Hospital
Category A
Clinical Microbiology Testing Laboratory
INAB Classification number (P9)
Materials/products tested
Type of test/calibration or
property measured, and range of
measurement
Relevant standard or
documented procedure
used
1016
Serology of Infection
.02
General serological
Qualitative detection of
VIR/SOP/055 Detection of
testing
Cytomegalovirus IgG antibodies,
Cytomegalovirus IgG
in human serum and plasma,
antibodies using the Abbott
using the Abbott Architect CMV
Architect CMV IgG assay
IgG assay and CMIA technology
Qualitative detection of
VIR/SOP/074 Detection of
Hepatitis C Antigen, in human
Hepatitis C Antigen using
serum and plasma using the
the Abbott Architect HCV
Abbott Architect HCV Ag assay
Ag assay
and CMIA technology
Qualitative detection of
VIR/SOP/029 Detection of
antibody to Hepatitis C virus, in
anti-HCV using the Abbott
human serum and plasma using
Architect Anti-HCV assay
the Abbott Architect Anti HCV
assay and CMIA technology
Qualitative detection of
VIR/SOP/054 Detection of
antibody to Hepatitis Be virus,
Hepatitis BE antibody using
in human serum and plasma
the Abbott Architect Anti-
using the Abbott Architect Anti
HBe assay
HBe assay and CMIA technology
Edition 10, 09/05/2014
223MT
Page 26 of 35
Scope of
Accreditation
Permanent Laboratory:
Galway University Hospital
Category A
Clinical Microbiology Testing Laboratory
INAB Classification number (P9)
Materials/products tested
Type of test/calibration or
property measured, and range of
measurement
Relevant standard or
documented procedure
used
1016
Serology of Infection
.02
General serological
Qualitative detection of IgG
VIR/SOP/030a Detection of
testing
antibody to Hepatitis A virus, in
Hepatitis A IgG antibody
human serum and plasma, using
using the Abbott Architect
the Abbot Architect HAVAb-IgG
HAVAB-IgG assay
assay, and CMIA technology.
Qualitative detection of IgM
VIR/SOP/030b Detection of
antibody to Hepatitis A virus, in
Hepatitis A IgM antibody
human serum and plasma, using
using the Abbott Architect
the Abbott Architect HAVAb-IgM
HAVAB-IgM assay
assay, and CMIA technology.
Qualitative detection of
VIR/SOP/033 Detection of
antibody to Treponema
antibody to Treponema
pallidum, in human serum and
pallidum using the Abbott
plasma, using the Abbott
Architect Syphilis TP assay.
Architect Syphilis TP assay, and
CMIA technology.
Qualitative detection of HIV p24
VIR/SOP/027 HIV type 1
antigen, HIV-1 antibody and HIV-
and HIV type 2 Ag/Ab
2 antibody, in human serum and
detection using the
plasma, using the Abbott
Architect HIV Ag/Ab Combo
Architect HIV Ag/Ab combo
assay
assay , and CMIA technology.
Edition 10, 09/05/2014
223MT
Page 27 of 35
Scope of
Accreditation
Permanent Laboratory:
Galway University Hospital
Category A
Clinical Microbiology Testing Laboratory
INAB Classification number (P9)
Materials/products tested
Type of test/calibration or
property measured, and range of
measurement
Relevant standard or
documented procedure
used
1016
Serology of Infection
.02
General serological
Qualitative detection of HIV p24
VIR/SOP/027 HIV type 1
testing
antigen, HIV-1 antibody and HIV-
and HIV-type 2 Ag/Ab
2 antibody, in human serum and
Combo assay
plasma, using the Abbott
Architect HIV Ag/Ab Combo
assay, and CMIA technology.
Qualtiative detection of HIV p24
VIR/SOP/050 Detection of
antigen, HIV-1 antibody and HIV-
HIV p24 antigen, HIV-1
2 antibody, in human serum and
antibody and HIV-2
plasma, using the BioMerieux
antibody, using the
VIDAS HIV DUO Ultra assay
BioMerieux VIDAS HIV DUO
Ultra assay
Quantitative detection of
VIR/SOP/032 Rubella IgG
Rubella virus IgG using the
detection using the Abbott
Abbott Architect Rubella IgG
Architect Rubella IgG assay
assay and CMIA technology
Qualitative detection of
VIR/SOP/10 Detection of
Hepatitis B Core IgM virus using
Hepatitis B Core IgM
the Abbott Architect Anti-HBc
antibodies using the Abbot
IgM and CMIA technology
Architect Anti-HBc IgM
assay.
Edition 10, 09/05/2014
223MT
Page 28 of 35
Scope of
Accreditation
Permanent Laboratory:
Galway University Hospital
Category A
Clinical Microbiology Testing Laboratory
INAB Classification number (P9)
Materials/products tested
Type of test/calibration or
property measured, and range of
measurement
Relevant standard or
documented procedure
used
1016
Serology of Infection
.02
General serological
Qualitative detection of IgM
VIR/SOP/082 SOP for the
testing
antibody to Parvovirus B19,
operation and management
using the LIAISON Biotrin
of LIAISON analyser
Parvovirus B19 IgM and the
LIAISON instrument
Qualitative detection of IgG
VIR/SOP/082 SOP for the
antibody to Parovirus B19, using
operation and management
the LIAISON Biotrin Parvovirus
of LIAISON analyser
B19 and IgG assay and the
Liaison instrument
Quantitative detection of IgG
VIR/SOP/082 SOP for the
antibody to Varicella Zoster
operation and management
virus using the LIAISON VZV IgG
of the LIAISON analyser
assay and the LIAISON
instrument
Qualitative detection of
VIR/SOP/078 Detection of
Toxoplasma gondii IgM
Toxoplasma gondii IgM
antibodies, using the Abbott
antibodies using the Abbott
Architect Toxoplasma IgM assay
Architect Toxo IgM assay
and CMIA technology
Edition 10, 09/05/2014
Qualitative detection of
VIR/SOP/079 Detection of
Cytomegalovirus IgM antibodies
Cytomegalovirus IgM
using the Abbott Architect CMV
antibodies using the Abbott
IgM assay and CMIA technology
Architect CMV IgM assay
223MT
Page 29 of 35
Scope of
Accreditation
Permanent Laboratory:
Galway University Hospital
Category A
Clinical Microbiology Testing Laboratory
INAB Classification number (P9)
Materials/products tested
Type of test/calibration or
property measured, and range of
measurement
Relevant standard or
documented procedure
used
1016
Serology of Infection
.02
General serological
Quantitative detection of
VIR/SOP/080 Detection of
testing
Rubella virus IgM using the
Rubella IgM antibodies
Abbott Architect Rubella IgM
using the Abbott Architect
assay and CMIA technology
Rubella IgM assay
Qualitative detection of
VIR/SOP/063 ~Detection of
antibodies to Treponema
antibodies to Treponema
pallidum in human serum or
pallidum using the Serodia-
plasma, using the Serodia-TP-PA
TP-PA particle
particle agglutination test.
agglutination test.
Semi-quantitative detection of
VIR/SOP/064 RPR Card test
anti-cardiolipin antibodies, in
human serum, using the BD RPR
Card Antigen flocculation test
Qualitative detection of IgG
VIR/SOP/082 SOP for the
antibodies to Borrelia
operation and management
burgdorferi, using the LIAISON
of the LIAISON analyser
Borrelia IgG assay and the
LIAISON instrument.
Qualitative detection of IgM
VIR/SOP/082 for the
antibodies to Borrelia
operation and management
burgdorferi, using the LIAISON
of the LIAISON analyser
Borrelia IgM II assay and the
LIAISON instrument.
Edition 10, 09/05/2014
223MT
Page 30 of 35
Scope of
Accreditation
Permanent Laboratory:
Galway University Hospital
Category A
Clinical Microbiology Testing Laboratory
INAB Classification number (P9)
Materials/products tested
Type of test/calibration or
property measured, and range of
measurement
Relevant standard or
documented procedure
used
1016
Serology of Infection
.02
General serological
Qualitative detection of IgM
VIR/SOP/082 for the
testing
antibodies to Varicella Zoster
operation and management
virus using the Liaison VZV IgM
of the LIAISON analyser
assay and the LIAISON
instrument
Qualitative detection of IgG
VIR/SOP/082 SOP for the
antibody to Measles Virus, using
operation and management
the LIAISON Measles IgG assay
of the LIAISON analyser
and the LIAISON instrument
Qualitative detection of IgG
VIR/SOP/082 SOP for the
antibody to Mumps Virus, using
operation and management
the LIAISON Mumps IgG assay
of the LIAISON analyser
and the LIAISON instrument
Qualitative detection of anti-
VIR/SOP/075 Detection of
EBV VCA IgM in human serum
EBV VCA IgM using the
using the VIDAS EBV VCA IgM
Vidas
Enzyme Linked Fluorescent
Assay
Qualitative detection of anti-
VIR/SOP/076 Detection of
EBV VCA IgG and anti-EBV EA IgG
EBV VCA/EA/IgG using the
in human serum using the VIDAS
VIDAS
EBV VCA/EA IgG Enzyme Linked
Fluorescent Assay
Edition 10, 09/05/2014
223MT
Page 31 of 35
Scope of
Accreditation
Permanent Laboratory:
Galway University Hospital
Category A
Clinical Microbiology Testing Laboratory
INAB Classification number (P9)
Materials/products tested
Type of test/calibration or
property measured, and range of
measurement
Relevant standard or
documented procedure
used
1016
Serology of Infection
Qualitative detection of
VIR/SOP/083
.02
General serological
Clostridium difficile toxin A and
CDT testing on the Vidas
Testing
toxin B in stool specimens using
SOP for
the VIDAS® C. difficile Toxin A &
B assay.
Quantitative detection of IgG
VIR/SOP/084
SOP for
antibody to Rubella virus using
RUG testing on the Vidas
the VIDAS®RUB IgG II assay.
Qualitative detection of IgM
VIR/SOP/015
SOP for
antibody to Measles Virus, in
detecting Measles IgM
human serum and plasma, using
using the microimmune
the Microimmune Measles IgM
Measles IgM capture EIA
Capture EIA assay.
assay (MeVM010)
Qualitative detection of IgM
VIR/SOP/016
antibody to Mumps Virus, in
Mumps IgM detection using
human serum and plasma, using
Microimmune Mumps IgM
the Microimmune Mumps IgM
capture EIA assay (Ref:
Capture EIA assay.
MuVM004)
Qualitative detection of IgM
VIR/SOP/009
antibodies to Coxiella burnetti
Fever
SOP for
SOP for Q
in human serum and plasme
using the Panbio Coxiella
Burnetti (Q Fever) IgM ELISA
assay.
Edition 10, 09/05/2014
223MT
Page 32 of 35
Scope of
Accreditation
Permanent Laboratory:
Galway University Hospital
Category A
Clinical Microbiology Testing Laboratory
INAB Classification number (P9)
Materials/products tested
Type of test/calibration or
property measured, and range of
measurement
Relevant standard or
documented procedure
used
1016
Serology of Infection
Qualitative detection of
VIR/SOP/047 Detection of
.02
General serological
Hepatitis B virus e antigen, in
Hepatitis Be antigen using
testing
human serum and plasma, using
the Biomerieux VIDAS
the Biomerieux VIDAS HBe/Anti-
HBe/Anti-HBe assay
HBe assay
Qualitative detection of anti-
VIR/SOP/077 Detection of
EBV EBNA IgG in human serum
EBV EBNA IgG using the
using the VIDAS EBV EBNA IgG
VIDAS
Enzyme Linked Fluorescent
Assay
Qualitative detection of
Toxoplasma gondii IgG
VIR/SOP/-72 Dectection of
antibodies in human serum and
Toxoplasma gondii IgG
plasma, using the Abbott
antibodies using the Abbott
Architect Toxoplasma IgG assay
Architect Toxo IgG assay
and CIMA technology
Edition 10, 09/05/2014
223MT
Page 33 of 35
Scope of
Accreditation
Permanent Laboratory:
Galway University Hospital
Category A
National Salmonella Shigella & Listeria
Reference Laboratory (NSSLRL)
INAB Classification number (P9)
Materials/products tested
Type of test/properties measured
Range of measurement
1011 Bacteriology
.06 Detection of Bacterial
Antigens
Serotyping of Salmonella species
and
Identification and typing of
Typhoidal salmonella
Listeria monocytogenes serotyping
.05 Bacteriology
Biochemical differentiation of
Identification of organisms
Salmonella subspecies
including antibiotic
and
sensitivity testing
Susceptibility testing using the
Sensititre from TREK diagnostic
and the EUCAST Disk diffusion
methods
.08 Bacteriology
RT-PCR
assay
for
the
Detection and
identification
of
Salmonella
characterisation of
tartrate positive isolates
microbial DNA/RNA
Standard specifications
Equipment/techniques
used
NSRLSOP002
NSRLSOP005
NSRLSOP009
NSRLSOP003
and
NSRLSOP008
NSRLSOP029
RT-PCR for detection of IpaH
(Shigella) and 16s RNA (bacterial
DNA)
.06 Bacteriology
Detection of Bacterial
Antigens
and
Bacteriology
Identification of organisms
including antibiotic
sensitivity testing
Edition 10, 09/05/2014
Phage typing of Salmonella
Typhimurium/S.Enteritidis
and
Molecular Subtyping of nontyphoidal Salmonella serotypes
and Shigella sonnei by Pulsed
Field Gel Electrophoresis (PFGE)
and
S. Typhimurium MLVA
and
Multiplex PCR protocols for
Salmonella and Shigella species
NSRLSOP004
Identification and typing of
Shigella spp
NSRLSOP010
and
NSRLSOP013
and
NSRLSOP007
and
NSRLSOP011
NSRLSOP018
and
Suscptibility testing using the
Sensititre from TREK diagnostic
And the EUCAST disk diffusion
methods
223MT
Page 34 of 35
Scope of
Accreditation
Permanent Laboratory:
Galway University Hospital
Category A
National Salmonella Shigella & Listeria
Reference Laboratory (NSSLRL)
INAB Classification number (P9)
Materials/products tested
.08
Bacteriology
Detection and
characterisation of
microbial DNA/RNA
Edition 10, 09/05/2014
Type of test/properties measured
Range of measurement
Molecular Subtyping of Listeria
monocytogenes by Pulse-Field Gel
Electrophoresis (PFGE)
223MT
Standard specifications
Equipment/techniques
used
NSRLSOP014
Page 35 of 35
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