INAB Scope IS0 15189 - Blackrock Clinic...Histopathology Laboratory INAB Classification Number (P9) Test/Assay Name Specimen Type SOP 1051 Histopathology LP.01 Processing fixed specimens

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.


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


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

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


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


Cards

LM-BT-0009


Cards

LM-BT-0011


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 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


Mean Cell Volume


MCH


MCHC


Platelet Count


Neutrophilis


Lymphocytes


Monocytes


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




Category A


Haematology DEPARTMENT


Test / Assay Name


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


Fibrinogen LM-HAEM-0023

LP-HAEM-0012

D Dimer


.57 Infectious Mononucleosis Screen

LM-HAEM-0016

.03 Erythrocyte Sedimentation Rate

LM-HAEM-0011

.09 Examination for Malarial Parasites

LM-HAEM-0010




Category A


Clinical Chemistry DEPARTMENT


Test / Assay Name


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




Category A


Clinical Chemistry DEPARTMENT


Test / Assay Name


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




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 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




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

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




Category A




Test / Assay Name


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




Category A




Test / Assay Name


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

Documents

INAB Scope IS0 15189 - Blackrock Clinic...Histopathology Laboratory INAB Classification Number (P9) Test/Assay Name Specimen Type SOP 1051 Histopathology LP.01 Processing fixed specimens