Our Lady's Children's Hospital
Department of Paediatric Laboratory Medicine, Crumlin, Dublin 12.
Medical Testing Laboratory
Registration number: 325MT
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 15189:2012 3rd Edition
“Medical laboratories – Requirements for quality and competence”
(This Certificate must be read in conjunction with the Annexed Schedule of Accreditation)
Date of award of accreditation: 09:09:2014
Date of last renewal of accreditation: n/a
Expiry date of this certificate of accreditation: 09:09:2019
This Accreditation shall remain in force until further notice subject to continuing compliance
with INAB accreditation criteria, ISO 15189 and any further requirements specified by the Irish
National Accreditation Board.
Manager:
____________________
Chairperson:
Dr Adrienne Duff
____________________
Mr Tom O’Neill
Issued on 10 June 2015
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.
INAB is a signatory of the European co-operation for Accreditation (EA) Multilateral Agreement (MLA) and the
International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement, for Testing.
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325MT
Page 1 of 25
Schedule of
Accreditation
(Annex to Accreditation Certificate)
Permanent Laboratory:
Category A
Our Lady's Children's Hospital, Crumlin
Department of Paediatric Laboratory Medicine.
Medical Testing Laboratory
Department: Microbiology, Haematology, Clinical Chemistry,
Histopathology.
Initial Registration Date :
9-September-2014
Histopathology
9-June 2015
Postal Address:
Department of Paediatric Laboratory Medicine,
(Address of other locations
Crumlin,
as they apply)
Dublin 12
Telephone:
+353 (1) 4096430
Fax:
+353 (1) 4096218
E-mail:
[email protected]
Contact Name:
Mr. Kevin Read
Facilities:
Public testing service
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Page 2 of 25
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.
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325MT
Page 3 of 25
Scope of
Accreditation
Permanent Laboratory:
Our Lady’s Children’s Hospital
Category A
Microbiology Laboratory
INAB
Classification
Number (P9)
1011 Bacteriology
.02
.04
.05
.02
.04
.05
.02
.04
.05
.02
.04
.05
.02
.04
.05
.02
.05
Test/Assay Name
Nasal specimens
Eye and canalicular
specimens
LP-MIC-THROAT
Nasal swabs
Culture and
susceptibility
testing
Culture and
susceptibility
testing
Culture and
susceptibility
testing
Culture and
susceptibility
testing
Culture and
susceptibility
testing
PCR
LP-MIC-Nasal
PCR
LP-MIC-PCR-BORDSP
PCR
LP-MIC-PCR-BORDSP
PCR
LP-MIC-PCR-BORDSP
Mouth specimens
Gastric aspirates
Gastric aspirates
Bordetella
Nasopharyngeal
aspirate/pernasal
swab
Nasopharyngeal
aspirate/pernasal
swab/Sputum
Nasopharyngeal
aspirate/pernasal
swab/ Sputum
Detection of
Bordetella
bronchiseptica
Detection of
Bordetella holmesii
Edition 7, 29/03/2017
SOP
Culture and
susceptibility
testing
Eye and
canalicular
specimens
Mouth swabs
Detection of
Bordetella
parapertussis
Method
Throat swabs
Throat specimens
Detection of
Bordetella pertussis
.08
Specimen Type
Nasopharyngeal
aspirate/pernasal
swab/Sputum
Nasopharyngeal
aspirate/pernasal
swab/Sputum
325MT
LP-MIC-EYE
LP-MIC-mouth
LP-MIC-GasAsp
LP-MIC-Bordetella
LP-MIC-PCR-BORDSP
Page 4 of 25
Scope of
Accreditation
Permanent Laboratory:
Our Lady’s Children’s Hospital
Category A
Microbiology Laboratory
INAB
Classification
Number (P9)
1011 Bacteriology
.02
.03
.04
.02
.04
.01
.02
.03
.04
Test/Assay Name
Diphtheriae
Transfusion reaction
culture of donated
blood unit
Deep wound culture
Specimen Type
Swab or tissue
Blood sample
Swabs/ pus
Aspirates
Ear swabs and
associated
specimens
Swabs
Peritonitis
Swabs/Fluid
.02
.03
.04
Fluids from sterile
sites
fluids
.01
.02
.03
.04
.01
.02
.03
.04
Tissues and biopsies
Tissue and Biopsy
Sinus aspirates
Fluids
Cannulae and
associated
specimens
Removed IV and
arterial cannulae/
line
.02
.04
.02
.03
.04
.02
.04
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325MT
Method
SOP
Culture and
susceptibility
testing
LP-MIC-Diphtheria
Culture and
susceptibility
testing
Culture,
Microscopy and
susceptibility
testing
Culture and
susceptibility
testing and
microscopy
Culture and
susceptibility
testing and
microscopy
Culture and
susceptibility
testing and
microscopy
Culture and
susceptibility
testing and
microscopy
Culture and
susceptibility
testing and
microscopy
Culture and
susceptibility
testing and
microscopy
LP-MIC-TransReact
LP-MIC-WOU-DEEP
LP-MIC-EAR
LP-MIC-PERITONIT
LP-MIC-FLUID
LP-MIC-Tissue
LP-MIC-SinusAsp
LP-MICIVCANNULAE
Page 5 of 25
Scope of
Accreditation
Permanent Laboratory:
Our Lady’s Children’s Hospital
Category A
Microbiology Laboratory
INAB
Classification
Number (P9)
Test/Assay Name
Specimen Type
Method
SOP
Identification of H.
pylori
Biopsy sample
Culture and
susceptibility
testing
LP-MIC-HP
.06
H. pylori antigen
assay
Faeces
Immunoassay
LP-MIC-HPANTI
.02
.04
Bile
Bile
Genital and
associated
specimens
Swabs
Skin and superficial
wounds
Swabs
Culture and
susceptibility
testing
LP-MIC-WouSup
.02
.04
Homograft tissue and
fluid
Homograft tissue
and fluid
Culture and
susceptibility
testing
LP-MIC-Homograft
.01
.02
.03
.04
Continuous
Ambulatory
peritoneal dialysis
fluid
Culture and
susceptibility
testing
LP-MIC-PDF
.02
.04
Allograft bone
culture
Allograft bone
.02
.03
.04
Urine
Urine
1011 Bacteriology
.02
.04
.01
.02
.03
.04
.01
.02
.03
.04
Edition 7, 29/03/2017
CAPD fluid
325MT
Culture and
susceptibility
testing
Culture,
susceptibility
testing and
microscopy.
Culture and
susceptibility
testing
Culture and
susceptibility testing
and microscopy
LP-MIC-Bile
LP-MIC-Genital
LP-MIC-BoneAllo
LP-MIC-urine
Page 6 of 25
Scope of
Accreditation
Permanent Laboratory:
Our Lady’s Children’s Hospital
Category A
Microbiology Laboratory
INAB
Classification
Number (P9)
1011 Bacteriology
.01
.02
.03
.04
.01
.02
.03
.04
Test/Assay Name
Bronchoalveolar
Lavage and
Associated
specimens
Specimen Type
Bronchoalveolar
Lavage and
Associated
specimens
Method
Culture, Susceptibility
Testing and
microscopy
Culture,
Susceptibility
Testing and
microscopy
Culture,
Susceptibility
Testing and
microscopy
SOP
LP-MIC BAL
Sputa
Sputa
.02
.03
.04
Cystic fibrosis sputa
Cystic fibrosis
sputa and Throat
swabs
.01
.02
.03
.04
Investigation of CSF
Cerebrospinal
fluid
Culture, Susceptibility
Testing and
microscopy
LP-MIC-CSF
Sputa and Throat
swabs
PCR
LP-MIC-PCRPAER
Detection of
Pseudomonas
aeruginosa
Detection of
Pseudomonas
aeruginosa clonal
strain IRL-CS-1
.08
Detection of
Salmonella Shigella
Detection of
Campylobacter
Detection of
Escheria Coli STEC
Cystic fibrosis
sputa and Throat
swabs
LP-MIC-CFSputa
LP-MIC-PCRPACS
PCR
Faeces
Faeces
LP-MIC-EBIOGP2
PCR
LP-MIC-EBIOGP2
Faeces
PCR
LP-MIC-EBIOGP2
Detection of
Mycoplasma
pneumoniae
Sputa,
Naspharyngeal
Aspirate. Pernasal
swab
.99
CSF Protein
Cerebrospinal
fluid
.02
.04
Cerobrospinal fluid
shunt
.01
.02
.04
Blood cultures
Edition 7, 29/03/2017
PCR
LP-MIC-Sputum
Removed
Cerobrospinal
fluid shunt
Aerobic and
anaerobic blood
cultures
325MT
PCR
Randox Total Protein
Culture and
Susceptibility
Testing
Culture and
Susceptibility
Testing/microscopy
LP-MIC-PCRMYCO
LP_MIC-CSFPR
LP-MIC-CSFshunt
LP-MIC-BC
BacT/ALERT 3D
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Scope of
Accreditation
Permanent Laboratory:
Our Lady’s Children’s Hospital
Category A
Microbiology Laboratory
INAB
Classification
Number (P9)
1011 Bacteriology
.01
.02
.03
.04
.06
Test/Assay Name
Specimen Type
Method
SOP
Faeces
Faeces
Culture and
Susceptibility
Testing and
microscopy
Isolation and or
identification of
VTEC
Faeces
Culture and
identification
LP-MIC-O157
Clostridium difficle
antigen
Faeces
Rapid membrane
immunoassay
LP-MIC-F-CDT
Clostridium difficle
toxin and antigen
Faeces
Rapid membrane
immunoassay
LP-MIC-F-CDT
Faecal occult blood
Faeces
Stool Blood test
Trislide - Cenogenics
LP-MIC-F-FOB
VRE screening
Swab
.02
.04
MRSA
Swab
.02
.04
Carbapenamase
Producing
Enterobacteriae
Faeces
.02
.04
.99
.02
.04
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325MT
Culture and
Susceptibility
Testing
Culture and
Susceptibility
Testing
Culture and
Susceptibility
Testing
LP-MIC-Faeces
LP-MIC-ECC
LP-MIC-MRSA
LP-MIC CRE
Page 8 of 25
Scope of
Accreditation
Permanent Laboratory:
Our Lady’s Children’s Hospital
Category A
Microbiology Laboratory
INAB
Classification
Number (P9)
1011
Bacteriology
.02
.04
.99
.04
1012
Test/Assay Name
Specimen Type
Method
Culture and
identification
SOP
ESBL screening
Faeces
Antibiotic Assay
Gentamicin and
Vancomycin
Blood
EDTA/Heparin
sample
Antibiotic and antifungal susceptibility
testing
Bacterial or
fungal Isolate
Automated
susceptibility testing
LP-MICVITEK2XL using
EUCAST
guidelines
Bacterial isolate
Susceptibility testing
LP-MIC-AMUST
EUCAST
Bacterial isolate
MIC determination
by E test
LP-MIC-Etest
Bacterial
/Yeast/fungal
isolate
Vitek
LP-MIC-VITEKMS
Antibiotic
susceptibility testing
by disc diffusion
Determination of
the MIC(minimum
inhibitory
concentration) by E
test
Identification of
bacteria, yeast and
fungi
Investigation of
specimens other
than blood for
parasites
Edition 7, 29/03/2017
Immuno assay
Microscopy
LP-MIC-AMUST
LP-MICArchitect
LP-MICPARASITE
Faeces
325MT
Page 9 of 25
Scope of
Accreditation
Permanent Laboratory:
Our Lady’s Children’s Hospital
Category A
Virology Laboratory
INAB Classification
Number (P9)
1013 Virology
.01
.01
.03
Test/Assay Name
Specimen
Type
Method
SOP
RSV rapid screening
Nasopharyngeal
aspirate
Immunochromatographic
assay
LP-MIC-RSVNOW
Investigation of
viral gastroenteritis
(rotavirus,
adenovirus)
Faeces
Diarlex Rota-Adeno
Cat no 67491 rapid
latex agglutination kit
LP-MIC-F-VIR
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325MT
Page 10 of 25
Scope of
Accreditation
Permanent Laboratory:
Our Lady’s Children’s Hospital
Category A
Microbiology Laboratory
INAB Classification
Number (P9)
1014 Mycology
.01
.02
.03
.05
Test/Assay Name
Systemic and
superficial fungal
infections
Specimen
Type
SOP
Skin Nail Hair
samples
Culture,identification,
LP-MIC-Fungi
Fungal isolate
Automated
Antifungal
susceptibility testing
LP-MICVITEK2XL
Fungal isolate
MICs using Yeast One
LP-MICYeastone
Galactomannan
Assay
Clotted blood
sample
Immunoassay
LP-MIC-GALACT
Aspergillis
EDTA Blood
sample
Extraction
Amplification and
detection of target
DNA
LP-MIC-PCR-ASP
Bordatella pertussis
serology
Clotted blood
sample
Immunoassay
LP-MIC-ELISAP
Anti-streptolysin O
Clotted blood
sample
Latex agglutination
slide test
LP-MICRANDOXASO
Anti fungal
susceptibility testing
.99
1016 Serology of
Infection
.01
Method
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325MT
Page 11 of 25
Scope of
Accreditation
Permanent Laboratory:
Our Lady’s Children’s Hospital
Category A
Haematology Laboratory
INAB Classification
Number (P9)
1030 Haematology
.41
Specimen Type
Test/Assay Name
Blood/Plasma
Prothrombin
Time (PT)
Blood/Plasma
International
Normalised Ratio
(INR)
Activated Partial
Thromboplastin
Time (APTT)
Activated Partial
Thromboplastin
Time Ratio
(APTR)
Blood/Plasma
Blood/Plasma
Method
SOP
Photo- Optical
Technology
LPHAE_ACLCoagS
Photo- Optical
Technology
LPHAE_ACLCoagS
Photo- Optical
Technology
LPHAE_ACLCoagS
Photo- Optical
Technology
LPHAE_ACLCoagS
Blood/Plasma
Fibrinogen
(Clauss)
Photo- Optical
Technology
LPHAE_ACLCoagS
Blood/Plasma
Thrombin Time
(TT)
Photo- Optical
Technology
LPHAE_ACLCoagS
D-Dimer
Photo- Optical
Technology
LPHAE_ACLDDimer
Blood/Plasma
PT Correction
Test
Photo- Optical
Technology
LP-HAE-ACLCorr
Blood/Plasma
APTT Correction
Test
Photo- Optical
Technology
LP-HAE-ACLCorr
Blood/Plasma
Prothrombin
Time (PT)
Manual-semi
quantitative
LP-HAE-ManPT
Blood/Plasma
Activated Partial
Thromboplastin
Time (APTT)
Manual-semi
quantitative
LP-HAEManAPTT
Reptilase
Photo- Optical
Technology
LP-HAE-ACLREP
Blood/Plasma
Blood/Plasma
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325MT
Page 12 of 25
Scope of
Accreditation
Permanent Laboratory:
Our Lady’s Children’s Hospital
Category A
Haematology Laboratory
INAB
Classification
Number (P9)
1030
Haematology
.40
Specimen Type
Test/Assay Name
Blood/Plasma
Method
SOP
Factor II (FII)
Photo- Optical
Technology
LP-HAEACLEFS
Factor V (FV)
Photo- Optical
Technology
LP-HAEACLEFS
Factor VII (FVII)
Photo- Optical
Technology
LP-HAEACLEFS
Blood/Plasma
Factor VIII, 1stage(FVIII clot)
Photo- Optical
Technology
LP-HAEACLIFS
Blood/Plasma
Factor VIII,
Chromogenic(FVIIIChr)
Photo- Optical
Technology
LP-HAEACLChroF8
Factor IX (FIX)
Photo- Optical
Technology
LP-HAEACLIFS
Factor X (FX)
Photo- Optical
Technology
LP-HAEACLIFS
Factor XI (FXI)
Photo- Optical
Technology
LP-HAEACLIFS
Factor XII (FXII)
Photo- Optical
Technology
LP-HAEACLIFS
Von Willebrand Factor
Antigen (VWF:Ag)
Photo- Optical
Technology
LP-HAEACLVWF
Blood/Plasma
Blood/Plasma
Blood/Plasma
Blood/Plasma
Blood/Plasma
Blood/Plasma
Blood/Plasma
Blood/Plasma
Factor VIII Inhibitor
Blood/Plasma
Factor IX Inhibitor
Blood/Plasma
Photo- Optical
Technology/
Semi
Quantitative
Photo- Optical
Technology/
Semi
Quantitative
LP-HAEF8Inhib
LP-HAEF9Inhib
AntiThrombin
Photo- Optical
Technology
LP-HAEACLATIII
Activated Protein C
Resistance (APCR)
Photo- Optical
Technology
LP-HAEACLPCR
Blood/Plasma
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325MT
Page 13 of 25
Scope of
Accreditation
Permanent Laboratory:
Our Lady’s Children’s Hospital
Category A
Haematology Laboratory
INAB
Classification
Number (P9)
1030
Haematology
.40
Specimen
Type
Blood/Plasma
SOP
Photo- Optical
Technology
LP-HAE-ACLPC
Protein S Ag (Free)
Photo- Optical
Technology
LP-HAE-ACLFPS
Protein S activity
Photo- Optical
Technology
LP-HAE-ACLPPS
Lupus
Anticoagulant
Photo- Optical
Technology
LP-HAE-ACLLA
Anti Factor Xa
Photo- Optical
Technology
LP-HAE-ACLAXA
Blood/Plasma
Platelet
Aggregation Studies
Optical Impedance
Blood-EDTA
Staining Procedure
for HbH / Heinz
Body Inclusions
Staining/Microscopy
Solubility Testing
For Haemoglobin-S
Qualitative
Solubility Test
LP-HAE-STREKSDX
Haemoglobinopathy
Screening
Quantitative High
Performance Liquid
Chromatography
LP-HAE-VARIANT2
Blood-EDTA
Cord Blood
Blood Spot
Blood-EDTA
Neonatal
Haemoglobinopathy
Screening
Sebia Capillarys 2
Flex-Piercing
Haemoglobinopathy
Screening
Capillary
Electrophoresis
Sebia Cabillary 2
Blood-EDTA
Iso-Electric
Focusing for
haemoglobinopathy
confirmatory
testing
Qualitative IsoElectric Focusing
Blood/Plasma
Blood/Plasma
Blood/Plasma
.08
Blood-EDTA
Blood-EDTA
.30
Method
Protein C
Blood/Plasma
.45
Test/Assay Name
Blood-EDTA
Edition 7, 29/03/2017
G6PDH Deficiency
Screening
325MT
Qualitative Visual
Fluorescence
LP-HAE-PFT
LP-HAE-RIPA
LP-HAE-HBH
LP-HAE-CAPILLARYS
LP-HAE-CAPILLARYS
LP-HAE-HBRESOLVE
LP-HAE-G6PDSCREEN
Page 14 of 25
Scope of
Accreditation
Permanent Laboratory:
Our Lady’s Children’s Hospital
Category A
Haematology Laboratory
INAB
Classification
Number (P9)
1030
Haematology
.01
Specimen
Type
Blood-EDTA
Test/Assay
Name
Automated
differential
leucocyte
count
Method
Flow Cytometry
SOP
LP-HAE-XN20
CSF
Blood-EDTA
Manual cell
count
Stain/microscopy
Automated
Reticulocyte
count
Flow Cytometry
LP-HAE-XN20
Microscopy
LP-HAE-BFILM
.06
Blood-EDTA
Body Fluid
Blood Film microscopy
.02
Blood EDTA
Erythrocyte
Sedimentation
Rate (ESR)
Malaria
parasite
/parasite film
examination
Malaria kit
detection NOW
detection kit
Malaria kit
detection OPTIMAL
detection kit
.08
Blood Film
Blood-EDTA
Blood-EDTA
.09
Blood-EDTA
.99
Photometric reading
LP-HAE-SEDIPLUS
Staining, microscopy
LP-HAE-MALARIA
Antigen detection
LP-HAE-NOWMALKIT
Immuno-chromatic
(pLDH)
LP-HAE-OPTIMALKIT
Bone
marrow
Bone marrow
examination
Microscopy
Blood-EDTA
Infectious
Mononucleosis
screen
Heterophile
antibody detection
.20
LP-HAE-CSF
LP-HAE-BME
LP-HAE-CLEARVIEW
.57
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325MT
Page 15 of 25
Scope of
Accreditation
Permanent Laboratory:
Our Lady’s Children’s Hospital
Category A
Haematology Laboratory
Specimen type
INAB Classification
Number (P9)
Test/Assay Name
Method
SOP
Blood/Bone
marrow/Fluid
1030 Haematology
.70
Blood/Bone
marrow/Fluid
Acute Leukaemia
Flow cytometry
panel
Flow Cytometry/
Fluoresence
LP-HAE-LeukCANTO
Blood/Bone
marrow/Fluid
Chronic Leukaemia/
Lymphoma typing
Flow Cytometry/
Fluoresence
LP-HAE-LYMPHPHEN
PNH Screening
Flow Cytometry/
Fluoresence
LP-HAE-PNH
Eosin-5-Maleimide
Screening for
Hereditary
Spherocytosis
Flow Cytometry/
Fluoresence
LP-HAE-EMA HS
CD34 count
Flow Cytometry/
Fluoresence
LP-HAE-CD34STEM
Blood/Bone marrow
Blood-EDTA
Blood-EDTA
Haematology
1040.60
Human Blood
Edition 7, 29/03/2017
Rheumatoid Factor
Qualitative Latex
Screening
A Agglutination
325MT
LP-HAE-RF.06
Page 16 of 25
Scope of
Accreditation
Permanent Laboratory:
Our Lady’s Children’s Hospital
Category A
Clinical chemistry Laboratory
INAB Classification
Number (P9)
1061 Clinical Chemistry
.01
Edition 7, 29/03/2017
Test/Assay Name
Specimen
Type
Method
SOP
Albumin
LITH.HEP.
PLASMA
Automated
Photometric Assay
LP-BIO-ALBUMIN
Alkaline
Phosphatase
LITH.HEP.
PLASMA
Automated
Photometric Assay
LP-BIO-ALP
Ammonia
BLOOD GAS
SYRINGE ON
ICE
Automated
Photometric Assay
LP-BIO-Ammonia
Amylase
LITH.HEP.
PLASMA
Automated
Photometric Assay
LP-BIO-Amylase
Aspartate
Amino
Transferase
LITH.HEP.
PLASMA
Automated
Photometric Assay
LP-BIO-AST
Bilirubin-Direct
LITH.HEP.
PLASMA
Automated
Photometric Assay
LP-BIO-BILI
Bilirubin-Total
LITH.HEP.
PLASMA
Automated
Photometric Assay
LP-BIO-BILI
Calcium-Total
LITH.HEP.
PLASMA
Automated
Photometric Assay
LP-BIO-Calcium
Carbamazepine
LITH.HEP.
PLASMA/SERUM
Chemiluminescence
Immunoassay
LP-BIO-CARB
Chloride
LITH.HEP.
PLASMA
Indirect ISE
LP-BIO-NAKCL
Cholesterol
LITH.HEP.
PLASMA
Automated
Photometric Assay
LP-BIO-Cholest
C-Reactive
Protein
LITH.HEP.
PLASMA
Automated
Photometric Assay
LP-BIO-CRP
Creatinine
LITH.HEP.
PLASMA
Automated
Photometric Assay
LP-BIOCreatinine
325MT
Page 17 of 25
Scope of
Accreditation
Permanent Laboratory:
Our Lady’s Children’s Hospital
Category A
Clinical chemistry Laboratory
INAB Classification
Number (P9)
1061 Clinical
Chemistry
.01
Test/Assay Name
Specimen Type
Method
SOP
Cyclosporine
EDTA BLOOD
Chemiluminescent
Immunoassay
LP-BIO-CYSA
Glucose
FLUORIDE
PLASMA
Automated
Photometric Assay
LP-BIO-Gluc
LDH
LITH.HEP.
PLASMA
Automated
Photometric Assay
LP-BIO-LDH
Magnesium
LITH.HEP.
PLASMA
Automated
Photometric Assay
LP-BIOMagnesium
Methotrexate
LITH. HEP.
PLASMA/PROTECT
FROM LIGHT
Fluorescent
Immunoassay
LP-BIO-MTX
Sodium
LITH.HEP.
PLASMA
Indirect ISE
LP-BIO-NAKCL
Paracetamol
(Acetaminophen)
LITH.HEP.
PLASMA
Automated
Photometric Assay
LP-BIOPARACET
Phosphate
LITH.HEP.
PLASMA
Protein(Total)
LITH.HEP.
PLASMA
Automated
Photometric Assay
LP-BIO-Protein
Triglycerides
LITH.HEP.
PLASMA
Automated
Photometric Assay
LP-BIO-TG
Urea
LITH.HEP.
PLASMA
Automated
Photometric Assay
LP-BIO-UREA
Urate
LITH.HEP.
PLASMA
Automated
Photometric Assay
LP-BIO-URATE
Edition 7, 29/03/2017
325MT
Automated
Photometric Assay
LP-BIOPHOSPHATE
Page 18 of 25
Scope of
Accreditation
Permanent Laboratory:
Our Lady’s Children’s Hospital
Category A
Clinical Chemistry Laboratory
INAB Classification
Number (P9)
.02
Test/Assay Name
SOP
LITH.HEP.
PLASMA
Automatic
Photometric Assay
LP-BIO-CK
Alananine amino
transferase
LITH.HEP.
PLASMA
Automatic
Photometric Assay
LP-BIO-ALT
Potassium
LITH.HEP.
PLASMA
Indirect ISE
Gamma Glutamyl
Transferase
LITH.HEP.
PLASMA
Automatic
Photometric Assay
LP-BIO-GGT
Albumin (Urine)
URINE
Nephelometry
LP-BIOURINALB
Chemiluminescent
Immunoassay
LP-BIO-Cortisol
Chemiluminescent
Immunoassay
LP-BIO-FSH
Chemiluminescent
Immunoassay
LP-BIO-GH
Chemiluminescent
Immunoassay
LP-BIO-IGF1
Chemiluminescent
Immunoassay
LP-BIO-IGFBP3
Chemiluminescent
Immunoassay
Chemiluminescent
Immunoassay
LP-BIO-LH
Chemiluminescent
Immunoassay
LP-BIO FREET4
Follicle
Stilmuating
Hormone
Growth Hormone
IGF1
IGFBP3
Luteinising
Hormone
Thyroid
Stimulating
Hormone
Thyroxine (free)
17 Alpha
HydroxyProgestero
ne
Edition 7, 29/03/2017
Method
Creatine Kinase
Cortisol
.20
Specimen
Type
LITH.HEP.
PLASMA/
SERUM
LITH.HEP.
PLASMA/
SERUM
LITH.HEP.
PLASMA/
SERUM
LITH.HEP.
PLASMA/
SERUM
LITH.HEP.
PLASMA/
SERUM
LITH.HEP.
PLASMA/
SERUM
LITH.HEP.
PLASMA/
SERUM
LITH.HEP.
PLASMA/
SERUM
LITH.HEP.
PLASMA/
SERUM
325MT
Radioimmunoassay
LP-BIO-NAKCL
LP-BIO-TSH
LP-BIO17OHPROG
Page 19 of 25
Scope of
Accreditation
Permanent Laboratory:
Our Lady’s Children’s Hospital
Category A
Clinical Chemistry Laboratory
INAB Classification
Number (P9)
Test/Assay Name
Specimen
Type
Method
SOP
1061 Clinical
Chemistry
.03
Sweat Chloride
SWEAT
Coulometric
Titration
LP-BIOSWEATTEST
.04
Iron
LITH.HEP.
PLASMA
Automated
Photometric Assay
LP-BIO-IRON
Alpha-fetoprotein
LITH.HEP.
PLASMA
Chemiluminescent
Immunoassay
LP-BIO-AFP
Carboxyhaemoglobin
BLOOD GAS
SYRINGE
Co-oximetry
LP-BIO-ABL825
pH
BLOOD GAS
SYRINGE
pH sensitive glass
electrode
LP-BIO-ABL825
CO2
BLOOD GAS
SYRINGE
Amperometric
electrode
pCO2
BLOOD GAS
SYRINGE
CO2 sensitive
electrode
.05
.06
Calculated
LP-BIO-ABL825
Base excess
Edition 7, 29/03/2017
LP-BIO-ABL825
LP-BIO-ABL825
Bicarbonate
(Standard)
Calculated
Calcium –ionised
BLOOD GAS
SYRINGE
Direct ISE
Chloride
BLOOD GAS
SYRINGE
Direct ISE
Glucose
BLOOD GAS
SYRINGE
Lactate
BLOOD GAS
SYRINGE
Potassium
BLOOD GAS
SYRINGE
Sodium
BLOOD GAS
SYRINGE
.07
LP-BIO-ABL825
325MT
LP-BIO-ABL825
LP-BIO-ABL825
LP-BIO-ABL825
Amperometry
LP-BIO-ABL825
Amperometry
LP-BIO-ABL825
Direct ISE
LP-BIO-ABL825
Direct ISE
Page 20 of 25
Scope of
Accreditation
Permanent Laboratory:
Our Lady’s Children’s Hospital
Category A
Clinical Chemistry Laboratory
Glucose
Urine
Ketones
Urine
Lipid index
LITH.HEP.
PLASMA
1061.76
1061.99
Edition 7, 29/03/2017
325MT
Automated
photometric assay
LP-BIOURGLUKET
Dipstick
LP-BIOURGLUKET
Automated
turbidometric assay
LP-BIOLipaemia
Page 21 of 25
Scope of
Accreditation
Permanent Laboratory:
Our Lady’s Children’s Hospital
Category A
Histopathology Laboratory
INAB Classification
Number (P9)
Test/Assay Name
Specimen Type
SOP
1051 Histopathology
.01
Processing fixed
specimens for
histopathological
examination
Cut up
Tissue processing
Embedding
Microtomy
Automated Haematoxylin and Eosin
Staining
Coverslipping
.02
Processing fresh
specimens for frozen
section examination
Cut-up
Frozen section cryotomy and staining
.03 Histochemistry
Edition 7, 29/03/2017
Alcian Blue
Alcian Blue/PAS
Congo Red
Fouchet
Gram
Grocott
Haematoxylin Van Gieson
Masson Trichome
Masson Fontana
Millers Elastic
Martius Scarlet Blue
Oil Red O
PAS/DPAS
Perls Prussian Blue
Reticulin Gordon &Sweets
Rhodanine
ZN
Von Kossa
325MT
Human tissue
LP-HISSpreccutup,
Tissproc,
tissmb
Microtomy,
H&E,
intqcstain,
coverslipper
Human tissue
LP-HISspreccutup,
microtomy
Human tissue
LP-HISname of
stain
Page 22 of 25
Scope of
Accreditation
Permanent Laboratory:
Our Lady’s Children’s Hospital
Category A
Histopathology Laboratory
.04 Histological
interpretation
Diagnostic Interpretation and reporting
of Human tissue specimens
Specialist areas included:
Paediatric Pathology
Specialist areas excluded:
Medical Renal Pathology
Perinatal Pathology
Neuropathology
Breast screening Pathology
Immunohistochemistry staining methods
Edition 7, 29/03/2017
325MT
Human tissue
Human tissue
MP-HIS
REPORTING
LP-HIS
CRITIAGCOM
LP-HISIMMPRO
Page 23 of 25
Scope of
Accreditation
Permanent Laboratory:
Our Lady’s Children’s Hospital
Category A
Histopathology Laboratory
.05
Immunohistochemistry
Edition 7, 29/03/2017
Actin Sm. Muscle
Adenovirus
Alk-1
Alpha-Fetoprotein
BCL-2
Calretinin
CD10
CD117
CD15
CD20
CD3
CD30
CD31
CD34
CD45 (CLA)
CD5
CD56
CD61
CD68
CD79a
CD1A
CD99
Chromogranin A
CK7
CMV
CytoKer Ae1/Ae3
D2-40
Desmin
EMA
Factor X111A
GFAP
Glut 1
Glycophorin A
H pylori
HCG
Herpes simplex
HMB45
INI (BAF47)
Ki-67
MUM-1
Myeloperoxidase
Myogenin
NB84
PLAP
P53
PAX-5
S100
Synaptophysin
Tdt
Vimentin
WT-1(C and N -terminus)
325MT
Human tissue
LP-HISIMMPRO
Page 24 of 25
Scope of
Accreditation
Permanent Laboratory:
Our Lady’s Children’s Hospital
Category A
Histopathology Laboratory
INAB Classification
Number (P9)
Test/Assay Name
Specimen Type
SOP
Chromosomal translocation analysis
for the following :
t(2;13) PAX3-FKHR
t(1;13) PAX3-FKHR
t(11;21) EWSFli1
t(21;22) EWSERG
t(X;18) (SYT-SSX1, SYT-SSX2, SYT-SSX4)
t(11;22) EWSWT1
t(12;15) ETV6-NTRK
TLE-1
T(21:22) EWSERG
t(1-13) PAX-7 - FKHR
Human tissue
LP-RTPCR
paraffin
1051 Histopathology
.06 Flourescence In
Situ Hybridisation
Edition 7, 29/03/2017
325MT
Page 25 of 25