inab scope is0 15189 - blackrock clinic typing, red blood cells direct antiglobulin test, red blood...
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Edition 6, 28/10/2014 212MT Page 1 of 15
Blackrock Clinic Pathology Laboratory
Medical Testing Laboratory
Registration number: 212MT
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 15189:2012 3rd 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: 17:02:2009
Date of last renewal of accreditation: 31:10:2013
Expiry date of this certificate of accreditation: 31:10:2018
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 28 October 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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Schedule of Accreditation
(Annex to Accreditation Certificate) Permanent Laboratory:
Category A
BLACKROCK CLINIC
Co Dublin
Blood Transfusion Testing Laboratory
Initial Registration Date :
Haematology:
Clinical Chemistry:
Microbiology:
Histopathology:
17- February -2009
28 - October - 2014
28 - October – 2014
28 - October – 2014
28 - October - 2014
Postal Address:
(Address of other locations
as they apply)
Rock Road
Blackrock
Co Dublin
Telephone: +353 (1) 2064358
Fax: +353 (1) 2064314
E-mail: [email protected]
Contact Name: Ms Christine Cranmer
Facilities: Public testing service
Edition 6, 28/10/2014 212MT Page 3 of 15
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
Blackrock Clinic Permanent Laboratory:
Category A
Blood Transfusion Testing Laboratory
INAB Classification number (P9)
Materials/products tested
Type of test/properties
measured
Range of measurement
Standard specifications
Equipment/techniques used
1020
.01
Immunohaematology
Blood Grouping
including ABO, Rh(D)
Blood grouping (ABO & RhD)
Typing). Red Blood Cells.
LM-BT-0016
Manual Method ,Gel Cards
1020
.03
Immunohaematology
Blood Group Antibody
screen
Antibody Screening, Plasma
LM-BT-0016
Manual method using Gel
Cards
1020
.04
Immunohaematology
Identification of blood
group antibodies
Antibody Identification, Plasma
LM-BT-0005
Manual method using Gel
IAT and enzyme cards
1020
.05
Immunohaematology
Determination of
Compatability of
donor units (the
investigation of
transfusion reactions)
Crossmatch Testing, plasma
Antigen Typing, red blood cells
Direct Antiglobulin test, red
blood cells
LM-BT-0010
Manual method using Gel
Cards
LM-BT-0009
Manual method using Gel
Cards
LM-BT-0011
Manual method using Gel
Cards
Note: Blackrock Clinic Blood Bank has been assessed and is competent to comply with articles 14
and 15 of the EU Directive 2002/98/EC (S.I.No. 360 of 2005 and S.I. No. 547 of 2006)
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Scope of Accreditation
Blackrock Clinic Permanent Laboratory:
Category A
Medical Testing Laboratory
Haematology DEPARTMENT
INAB Classification Number (P9)
Test / Assay Name
Specimen Type Method
Equipment
SOP
1030 Haematology .01 .05
Full Blood Count with automated differential leucocyte count including:
White Cell Count LM-HAEM-0025
LP-HAEM-0013
Red Cell Count
LM-HAEM-0025 LP-HAEM-0013
Haemoglobin LM-HAEM-0025
LP-HAEM-0013
Haematrocrit
LM-HAEM-0025 LP-HAEM-0013
Mean Cell Volume
LM-HAEM-0025 LP-HAEM-0013
MCH
LM-HAEM-0025 LP-HAEM-0013
MCHC
LM-HAEM-0025 LP-HAEM-0013
Platelet Count
LM-HAEM-0025 LP-HAEM-0013
Neutrophilis
LM-HAEM-0025 LP-HAEM-0013
Lymphocytes
LM-HAEM-0025 LP-HAEM-0013
Monocytes
LM-HAEM-0025 LP-HAEM-0013
Eosinophils LM-HAEM-0025
LP-HAEM-0013
Basophils LM-HAEM-0025
LP-HAEM-0013
.02
Blood Film Examination and differential leucocyte count
LM-HAEM-0017 LM-HAEM-0018 LP-HAEM-0004
.03 Erythrocyte Sedimentation Rate
LM-HAEM-0011
.09 Examination for Malarial Parasites
LM-HAEM-0010
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Scope of Accreditation
Blackrock Clinic Permanent Laboratory:
Category A
Medical Testing Laboratory
Haematology DEPARTMENT
INAB Classification Number (P9)
Test / Assay Name
Specimen Type Method
Equipment
SOP
1030 Haematology .41
Full Blood Count with automated differential leucocyte count including:
Prothrombin Time LM-HAEM-0024
LP-HAEM-0012
Activated Partial Thromboplastin Time
LM-HAEM-0024 LP-HAEM-0012
Fibrinogen LM-HAEM-0023
LP-HAEM-0012
D Dimer
LM-HAEM-0022 LP-HAEM-0011
.57 Infectious Mononucleosis Screen
LM-HAEM-0016
.03 Erythrocyte Sedimentation Rate
LM-HAEM-0011
.09 Examination for Malarial Parasites
LM-HAEM-0010
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Scope of Accreditation
Blackrock Clinic Permanent Laboratory:
Category A
Medical Testing Laboratory
Clinical Chemistry DEPARTMENT
INAB Classification Number (P9)
Test / Assay Name
Specimen Type Method
Equipment
SOP
1061 Clinical Chemistry .01
Alanine Aminotransferase (ALT)
LM-BIO-0004
Albumin
Alkaline Phosphatase (ALP)
Amylase
Asparate Aminotransferase (AST)
Bilirubin Total
Calcium
Carbon Dioxide
Cholesterol
C Reactive Protein
Creatine Kinase
Creatinine (Enzymatic)
Electolytes Na+ K+ Cl-Gamma-Glutamyl
Transferase (GGT)
LDL-cholesterol
Lactate Dehydrogenase (LDH)
Magnesium
Phosphorus
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Scope of Accreditation
Blackrock Clinic Permanent Laboratory:
Category A
Medical Testing Laboratory
Clinical Chemistry DEPARTMENT
INAB Classification Number (P9)
Test / Assay Name
Specimen Type Method
Equipment
SOP
1061 Clinical Chemistry .01 .02
Total Protein
LM-BIO-0004
Triglyceride
Urea Nitrogen
Uric Acid
Urinary/CSF Protein
.01 BNP Troponin I
LM-ENDO-0002
.10 Drugs for therapeutic monitoring
Lithium Gentamicin Vancomycin
LM-BIO-0004
.65 Pregnancy test qualitive
Urine hCG
LM-BIO-0003
.45 Vitamin B12 Folate
LM-ENDO-0002
.40 Iron Transferrin
LM-BIO-0004
.40 Ferritin
LM-ENDO-0002
.50 Protein and peptide tumour markers
CA125 CA153 CEA Free PSA Total PSA
LM-ENDO-0002
.20 Hormones
FSH Free T4 LH TSH
LM-ENDO-0002
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Scope of Accreditation
Blackrock Clinic Permanent Laboratory:
Category A
Medical Testing Laboratory
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 and Manual Haematoxylin and Eosin Staining Coverslipping
Human tissue
LP-HIST-0001 LP-HIST-0004 LP-HIST-0008 LP-HIST-0013 LP-HIST-0014 LP-HIST-0016 LM-HIST-0002 LM-HIST-0003 LM-HIST-0004 LM-HIST-0005 LM-HIST-0006 LF-HIST-0011 LF-HIST-0012 LF-HIST-0013 LF-HIST-0021 LF-HIST-0029 LF-HIST-0055 LF-HIST-0061 WI-HIST-0003 WI-HIST-0005 WI-HIST-0006 WI-HIST-0008 WI-HIST-0009 WI-HIST-0010 WI-HIST-0017 WI-HIST-0018 WI-HIST-0019
Edition 6, 28/10/2014 212MT Page 10 of 15
Scope of Accreditation
Blackrock Clinic Permanent Laboratory:
Category A
Medical Testing Laboratory
Histopathology Laboratory
INAB Classification Number (P9)
Test/Assay Name Specimen Type SOP
1051 Histopathology .02 Processing fresh specimens for frozen section examination
Cut-up Frozen section cryotomy and staining
Human tissue
LP-HIST-0001 LP-HIST-0004 LP-HIST-0008 LP-HIST-0013 LP-HIST-0014 LP-HIST-0016 LM-HIST-0001 LM-HIST-0002 LM-HIST-0003 LM-HIST-0004 LM-HIST-0005 LM-HIST-0006 LF-HIST-0011 LF-HIST-0012 LF-HIST-0013 LF-HIST-0021 LF-HIST-0022 LF-HIST-0029 LF-HIST-0054 LF-HIST-0055 LF-HIST-0061 WI-HIST-0003 WI-HIST-0005 WI-HIST-0007 WI-HIST-0017 WI-HIST-0018 WI-HIST-0019 LP-HIST-0005 LP-HIST-0007 LP-HIST-0008 LP-HIST-0013 LP-HIST-0014 LP-HIST-0016 LM-HIST-0008 LF-HIST-0053 WI-HIST-0001 WI-HIST-0004 WI-HIST-0014 WI-HIST-0015 WI-HIST-0023
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Scope of Accreditation
Blackrock Clinic Permanent Laboratory:
Category A
Medical Testing Laboratory
Histopathology Laboratory
INAB Classification Number (P9)
Test/Assay Name Specimen Type SOP
1051 Histopathology .03 Histochemistry
Special stains – automated: H&E (Tissue) Papanicolaou Stain H&E (Cytology) Giemsa Stain Periodic Acid-Schiff’s (PAS) counterstain Special stains – manual: Alcian Blue Stain Giemsa Stain for Helicobacter Pylori Giemsa Stain for bacteria Grocott Stain Haematoxylin-Van Gieson Stain Highman’s Congo Red Stain Masson Trichrome Stain Masson Fontana Stain Mauritus Scarlet Blue Stain Miller’s Elastin Stain Periodic Acid-Schiff (PAS) Stain Perl’s Prussian Blue Stain Reticulin Stain Von Kossa Stain Ziehl Neelsen (Kinyouin) Stain Coverslipping – automated Coverslipping – manual Slide issue
Human tissue
LP-HIST-0047
LM-HIST-0007
LP-HIST-0047 LP-HIST-0008 LP-HIST-0005
.04 Histological interpretation
Diagnostic Interpretation and reporting of Human tissue specimens Specialist areas excluded: Medical Renal Pathology Paediatric Pathology Perinatal Pathology Neuropathology Breast screening Pathology
Human tissue
LP-HIST-0003 LP-HIST-0006 LP-HIST-0009 LP-HIST-0016
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Scope of Accreditation
Blackrock Clinic Permanent Laboratory:
Category A
Medical Testing Laboratory
Histopathology Laboratory
INAB Classification Number (P9)
Test/Assay Name Specimen Type SOP
1052 Cytopathology .02 Non-gynaecological cytology
Cytology sample preparation and description
Human tissue or fluid
Diagnostic Interpretation and reporting of non-gynae samples Registration and labelling Gross description Thin Prep Direct smears Cell blocks Processing Embedding Microtomy Storage Disposal
Human tissue or fluid
LP-HIST-0001 LP-HIST-0004 LP-HIST-0008 LP-HIST-0013 LP-HIST-0014 LP-HIST-0016 LM-HIST-0005 LM-HIST-0006 LM-HIST-0010 LF-HIST-0029 LF-HIST-0055 WI-HIST-0017 WI-HIST-0019
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Scope of Accreditation
Blackrock Clinic Permanent Laboratory:
Category A
Medical Testing Laboratory
MICROBIOLOGY DEPARTMENT
INAB Classification Number (P9)
Test / Assay Name
Specimen Type Method
Equipment
SOP
1011 Bacteriology .01 .02 .03 .04 .05 .07 .99
Identification of Organisms
LM-MICRO-0017
Investigation of Abscesses, Post-Operative wounds and Deep Seated Infections
LM-MICRO-0022
Investigation of Bronchoalveolar Lavage and Associated Specimens
LM-MICRO-0025
Investigation of Cerebrospinal Fluid
LM-MICRO-0026
Investigation of Continuous Ambulatory Peritoneal Dialysis Fluid
LM-MICRO-0027
Investigation of Ear Swabs and Associated Specimens
LM-MICRO-0028
Investigation of Eye Swabs and Canalicular Pus
LM-MICRO-0029
Investigation of Faeces Specimens for Bacterial Pathogens
LM-MICRO-0031
Investigation of Fluids from Normally Sterile Sites
LM-MICRO-0032
Investigation of Intraocular Fluids and Corneal Scrapings
LM-MICRO-0035
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Scope of Accreditation
Blackrock Clinic Permanent Laboratory:
Category A
Medical Testing Laboratory
MICROBIOLOGY DEPARTMENT
INAB Classification Number (P9)
Test / Assay Name
Specimen Type Method
Equipment
SOP
1011 Bacteriology .01 .02 .03 .04 .05 .07 .99
Identification of Intravascular Cannulae and Associated Specimens
LM-MICRO-0036
Investigation of Mouth Swabs
LM-MICRO-0037
Investigation of Nasal Swabs and Groin Swabs for S. aureus Carriage
LM-MICRO-0038
Investigation of Sinus Aspirate
LM-MICRO-0039
Investigation of Skin and Superficial Wound Swabs
LM-MICRO-0040
Investigation of Swabs and other Specimens for MRSA
LM-MICRO-0042
Investigation of Rectal Swabs for VRE
LM-MICRO-0043
Investigation of Throat Swabs
LM-MICRO-0044
Investigation of Tissues and Biopsies
LM-MICRO-0045
Investigation of Urine
LM-MICRO-0046
Investigation of Genital Tract and Associated Specimens
LM-MICRO-0058
Susceptibility Testing
LM-MICRO-0060
Investigation of Swabs and other Specimens for Carbapenemase Resistant Enterobacteriaceae
LM-MICRO-0087
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Scope of Accreditation
Blackrock Clinic Permanent Laboratory:
Category A
Medical Testing Laboratory
MICROBIOLOGY DEPARTMENT
INAB Classification Number (P9)
Test / Assay Name
Specimen Type Method
Equipment
SOP
1011 Bacteriology .06
Legionella Pneumophilia Antigen Detection
LM-MICRO-0073
Streptococcus Pneumonia Urinary Antigen Detection
LM-MICRO-0074
Processing of Faeces for Clostridium Difficile
LM-MICRO-0081
.08 MRSA Confirmation testing with Mastalex
LM-MICRO-0082
1012 Parasitology .01 .02 .99
Investigation of Specimens other than Blood for Parasites
LM-MICRO-0070
1014 Mycology .01 .02 .03 .04 .05 .99
Investigation of Fungal Specimens
LM-MICRO-0033
.01
.02
.03
.04
.05
.99
Microscopic Investigation for Fungi
LM-MICRO-0008
1016 Serology of Infection .01 .02
Detection of Measles IgG, Mumps IgG, Rubella IgG Antibodies on the Mini Vidas
LM-MICRO-0075
1019 Miscellaneous
Investigation of Joint Fluid for Presence of Crystals by Polarising Microscopy
LM-MICRO-0085