Blackrock Clinic...Histopathology Laboratory INAB Classification Number (P9) Test/Assay Name Specimen Type SOP 1051 Histopathology LP.01 Processing fixed specimens for histopathological

Edition 11, 25/01/2017 212MT Page 1 of 18

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 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: 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.


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

Smurfit Building, Beaumont Campus, Dublin 9

Telephone: +353 (1) 2064357

Fax: +353 (1) 2064314

E-mail: [email protected]

Contact Name: Mr. Eoin O’Rourke

Facilities: Public testing service

mailto:[email protected]


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.


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

LP-BT-0041

Manual Method ,Automated Method

using Gel Cards

1020

.03

Immunohaematology

Red Cell Antibody

screen

Antibody Screening, Plasma

LM-BT-0016

LP-BT-0041

Manual method and Automated

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

Compatibility 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 - EXT-

BT-0055

Electronic Issue

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)




Category A


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

EDTA Blood Automated

Beckman

Coulter Unicel DxH 800

LM-HAEM-0025 LP-HAEM-0013




Category A


Haematology DEPARTMENT INAB Classification Number (P9)

Test / Assay Name


Equipment

SOP

.02

Blood Film Examination and differential leucocyte count

EDTA Blood Manual Microscopy

Microscope

LM-HAEM-0017 LM-HAEM-0018 LP-HAEM-0004

.03 Erythrocyte Sedimentation Rate

Sodium Citrate/EDTA

Automated Sedimentation

Diesse

Vesmatic


.09 Examination for Malarial Parasites

EDTA Blood Manual Microscopy

Immuno-Chromatographic Kit

Microscope

LM-HAEM-0010 LM-HAEM-0012

.57 Infectious Mononucleosis Screen

EDTA Blood Serum/Plasma

Manual Immunoassay N/A LM-HAEM-0016

.41

Prothrombin Time Sodium Citrate Photo optical

detection ACL Top


Activated Partial Thromboplastin Time

Sodium Citrate Photo optical

detection

ACL Top

Fibrinogen Sodium Citrate Photo optical

detection ACL Top LM-HAEM-0023

LP-HAEM-0012

D Dimer Sodium Citrate Enzyme Linked Fluorescence

Mini Vidas





Category A


Clinical Chemistry DEPARTMENT


Test / Assay Name


Equipment

SOP

1061 Clinical Chemistry .01

Alanine Aminotransferase (ALT)

Plasma

NADH (with P-5’-P)

Architect c8000

LM-BIO-0004

Alkaline Phosphatase (ALP)

Plasma Para-nitrophenyl Phosphate

Architect c8000

Amylase Plasma CNPG3 Substrate Enzymatic

Architect c8000

Asparate Aminotransferase (AST)

Plasma Enzymatic Architect c8000

Bilirubin Total Plasma Diazonium salt Architect c8000

Calcium Plasma/urine Arsenazo III Architect c8000

Carbon Dioxide Plasma PEP Carboxylase Enzymatic

Architect c8000

Cholesterol Plasma Enzymatic Architect c8000

C Reactive Protein Plasma Immunoturbidimetric Architect c8000

Creatine Kinase Plasma Enzymatic Architect c8000

Creatinine (Enzymatic)

Plasma/urine Enzymatic Architect c8000

Electolytes Na+ K+ Cl

Plasma/Urine Ion selective electrode (indirect)

Architect c8000

Gamma Glutamyl Transferase (GGT)


LDL-cholesterol Plasma Enzymatic Architect c8000

Lactate Dehydrogenase (LDH)


Magnesium Plasma Enzymatic Architect c8000

Phosphorus Plasma Colorimetric Phosomolybdate

Architect c8000




Category A




Test / Assay Name


Equipment

SOP

1061 Clinical Chemistry .01 .02

Total Protein

Plasma

Colorimetric Architect c8000 LM-BIO-0004

Triglyceride

Plasma

Enzymatic Architect c8000

Urea Nitrogen

Plasma

Urease Architect c8000

Uric Acid

Plasma

Uricase Architect c8000

Urinary/CSF Protein

Urine/CSF

Turbidimetric Assay Benzethonium chloride

Architect c8000

.01 BNP High Sensitivity Troponin I

Plasma Plasma

CMIA CMIA

Architect i2000SR

LM-ENDO-0002

.10 Gentamicin Vancomycin

Serum Plasma/Serum Plasma/Serum

Colorimetric Particle Enhanced Turbidimetric Assay Particle Enhanced Turbidimetric Assay

Architect c8000 Architect i2000SR Architect i2000SR

LM-BIO-0004

.45

Vitamin B12 Folate

Plasma/Serum

CMIA Architect i2000SR

LM-ENDO-0002

.40 Iron Transferrin

Plasma/Serum Plasma/Serum

Ferene Immunoturbidimetric

Abbott Architect c8000

LM-BIO-0004

.40 Ferritin

Plasma/Serum

CMIA Architect i2000SR

LM-ENDO-0002

.50 Protein and peptide tumour markers

CA 19.9 CA125 CA153 CEA Free PSA Total PSA

Plasma/Serum Plasma/Serum Plasma/Serum Plasma/Serum Serum Serum

CMIA CMIA CMIA CMIA CMIA CMIA

Architect i2000SR

LM-ENDO-0002




Category A




Test / Assay Name


Equipment

SOP

1061 Clinical Chemistry .20 Hormones FSH

Free T4 LH TSH

Plasma/Serum Plasma/Serum Plasma/Serum Plasma/Serum

CMIA CMIA CMIA CMIA

Architect i2000SR

LM-ENDO-0002

.01 Glucose Plasma/CSF Hexokinase

Abb8000 Architect c8000 C800

LM-BIO-0004

.01 HDL-cholesterol Plasma

Accelerator Selective Detergent

Architect c8000 LM-BIO-0004




Category A


Histopathology Laboratory


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




Category A





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




Category A





1051 Histopathology .03 Histochemistry

Special stains – automated: H&E (Tissue) Papanicolaou Stain 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




Category A





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




Category A


MICROBIOLOGY DEPARTMENT


Test / Assay Name


Equipment

SOP

1011 Bacteriology .01 .02 .03 .04 .05 .07 .99

Identification of Organisms

Bacterial isolate Biochemical tests BioMerieux Vitek 2 Compact

LM-MICRO-0017 LP-MICRO-0021 LP-MICRO-0022

Investigation of Abscesses, Post-Operative wounds and Deep Seated Infections

Wound swabs Pus Fluid Tissue Biopsies

Microscopy, Culture, Identification & Susceptibility

BioMerieux Vitek 2 Compact


Investigation of Bronchoalveolar Lavage and Associated Specimens

BAL, Respiratory Specimens




Investigation of Cerebrospinal Fluid

Cerebrospinal Fluid




Investigation of Continuous Ambulatory Peritoneal Dialysis Fluid

CAPD Fluid Microscopy, Culture, Identification & Susceptibility



Investigation of Ear Swabs and Associated Specimens

Ear swabs Microscopy, Culture, Identification & Susceptibility



Investigation of Eye Swabs and Canalicular Pus

Eye swabs Conjunctival swabs




Investigation of Faeces Specimens for Bacterial Pathogens

Faeces Colonic aspirates




Investigation of Fluids from Normally Sterile Sites

Fluids Microscopy, Culture, Identification & Susceptibility



Investigation of Intraocular Fluids and Corneal Scrapings

Aqueous/Vitreous fluids Corneal Scrapings







Category A




Test / Assay Name


Equipment

SOP

1011 Bacteriology .01 .02 .03 .04 .05 .07 .99

Identification of Intravascular Cannulae and Associated Specimens

Tips Culture, Identification & Susceptibility

BioMerieux Vitek 2 Compact LM-MICRO-0036

LP-MICRO-0021 LP-MICRO-0022

Investigation of Mouth Swabs

Mouth swabs Microscopy, Culture, Identification & Susceptibility



Investigation of Nasal Swabs and Groin Swabs for S. aureus Carriage

Nasal swabs Groin swabs

Culture, Identification & Susceptibility

BioMerieux

Vitek 2

Compact


Investigation of Sinus Aspirate

Aspirates Fluids

Microscopy, Culture,

Identification &

Susceptibility

BioMerieux

Vitek 2

Compact


Investigation of Skin and Superficial Wound Swabs

Skin

Culture, Identification

& Susceptibility BioMerieux

Vitek 2

Compact


Investigation of Swabs and other Specimens for MRSA

Nasal swab Groin swab Axilla swab Throat swab


& Susceptibility N/A

LM-MICRO-0042

Investigation of Rectal Swabs for VRE

Rectal swabs


& Susceptibility BioMerieux Vitek 2 Compact


Investigation of Throat Swabs

Throat swabs


Identification &

Susceptibility



Investigation of Tissues and Biopsies

Tissues Biopsies Artificial devices


Identification &

Susceptibility






Category A




Test / Assay Name


Equipment

SOP

1011 Bacteriology .01 .02 .03 .04 .05 .07 .99

Investigation of Urine

Urine Supra-pubic aspirate


Identification &

Susceptibility



Investigation of Genital Tract and Associated Specimens

High Vaginal Swabs Endocervical Swabs Cervical swabs Urethral swabs Rectal swabs Pharyngeal swabs


Identification &

Susceptibility



Susceptibility Testing

Bacterial isolates

Zone measurements Broth MIC Minimum inhibitory concentration strip diffusion



Investigation of Swabs and other Specimens for Beta Lactamases and Carbapenemase Resistant Enterobacteriaceae

Rectal swabs Culture, Identification & Susceptibility

BioMerieux Vitek 2 Compact LM-MICRO-0087

LP-MICRO-0021 LP-MICRO-0022




Category A




Test / Assay Name


Equipment

SOP

1011 Bacteriology .06

Legionella Pneumophilia Antigen Detection

Urine

Qualitative detection of Legionella pneumophila serogroup 1 antigen using the BINAX Legionella Urinary Antigen EIA Kit

N/A

LM-MICRO-0073

Streptococcus Pneumonia Urinary Antigen Detection

Urine

Qualitative detection of Streptococcus pneumoniae antigen using the BINAX Streptococcus pneumoniae Urinary Antigen EIA Kit

N/A

LM-MICRO-0074

Processing of Faeces for Clostridium Difficile

Faeces

Qualitative detection of GDH and Toxin using TechLab C.Diff Quik Chek Complete Kit

N/A

LM-MICRO-0081

.08 MRSA Confirmation testing with Mastalex

Bacterial isolate

Qualitative detection of Penicillin Binding Protein 2 using MASTALEX – MRSA Kit

N/A

LM-MICRO-0082

1012 Parasitology .01 .02 .99

Investigation of Specimens other than Blood for Parasites

Faeces, Worms, Sellotape slides, Duodena/Jejunal aspirates, Urine, Liver and Spleen aspirates, Sputum, Bile, CSF

Microscopy

N/A

LM-MICRO-0070

1014 Mycology .01 .02 .03 .04 .05 .99

Investigation of Fungal Specimens

Skin, Hair, Nail, Tissue

Microscopy & Culture

N/A

LM-MICRO-0033




Category A




Test / Assay Name


Equipment

SOP

1014 Mycology .01 .02 .03 .04 .05 .99

Microscopic Investigation for Fungi

Skin, Hair, Nail, Tissue

Microscopy

N/A LM-MICRO-0008

1016 Serology of Infection .01 .02

Detection of Measles IgG, Mumps IgG, Rubella IgG Antibodies on the Mini Vidas

Serum Quantitative serology testing using BioMerieux Mini Vidas

BioMerieux Mini Vidas

LM-MICRO-0075 LP-HAEM-0011

1016 Serology of Infection .02

HIV Ag/Ab Syphilis Hep B SAg Anti-HBs Hep C

Serum CMIA

Architect i2000SR

LM-ENDO-0002

1019 Miscellaneous

Investigation of Joint Fluid for Presence of Crystals by Polarising Microscopy

Joint Fluids Microscopy

N/A

LM-MICRO-0085

Documents

Blackrock Clinic...Histopathology Laboratory INAB Classification Number (P9) Test/Assay Name Specimen Type SOP 1051 Histopathology LP.01 Processing fixed specimens for histopathological