RSCI Group, Our Lady of Lourdes Hospital Drogheda, · PDF fileOur Lady of Lourdes Hospital...

Edition 14, 23/10/2017 295MT of 20

RSCI Group,

Our Lady of Lourdes Hospital Drogheda,

Pathology Laboratory, Drogheda

Testing Laboratory

Registration number: 295MT

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 – Particular requirements for quality and competence”

(This Certificate must be read in conjunction with the Annexed Schedule of

Accreditation)

Date of award of accreditation: 25:10:2011

Date of last renewal of accreditation: 25:10:2016

Expiry date of this certificate of accreditation: 25:10:2021

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 25 October 2016

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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Schedue of Accreditation

(Annex to Accreditation Certificate) Permanent Laboratory:

Category A

OUR LADY OF LOURDES HOSPITAL

Drogheda, Co. Louth

Pathology Laboratory

Blood Transfusion 25-October-2011

Haematology

Histopathology

Clinical Chemistry

Microbiology

Postal Address:

(Address of other locations

as they apply)

11-September-2012

11-September-2012

9-September-2014

9-September-2014

Drogheda

Co. Louth

Telephone: +353 (41) 9837601

Fax: +353 (41) 9838092

E-mail: [email protected]

Contact Name: Ms. Sally Byrne

Facilities: Public testing service

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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 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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Scope of Accreditation

Our Lady of Lourdes Hospital 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 (ABO

and RhD Typing)

Blood grouping (ABO & RhD

Typing)

Red blood cells, plasma

1. Automated method using

column agglutination technology

(CAT) (Ortho BioVue)

2. Manual Method using CAT and

tubes (Ortho BioVue)

.03 Blood Group

Antibody screen

Antibody Screening, Plasma 1.Automated method using CAT

(Ortho BioVue on Autovue Innova)

2. IAT manual method using CAT

(Ortho BioVue)

.04 Identification of

blood group

antibodies

Antibody Identification, Plasma 1. Manual method using CAT

(Ortho BioVue)

2. IAT and Enzyme Method

.05 Determination of

compatibility of

donor units using

appropriate

techniques including

the investigation of

transfusion reactions

Crossmatch Testing, Plasma

Antigen Typing, Red Blood Cells

Direct Antiglobulin Testing, Red

Blood Cells

Compatibility analysis for the

release of compatible blood by

electronic means

1. Manual CAT (Ortho BioVue)

2. Manual method using CAT

(Ortho BioVue) or tube techniques

as per manufacturer’s instructions

3. Automated & Manual method

using monospecific CAT (Ortho

BioVue) or tube techniques

Winpath LIS 5.3.2 EI function

Note 1: Our Lady of Lourdes Hospital 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)

Note 2: Included also is fridge in Louth County Hospital

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Category A

Haematology Testing Laboratory







1030

Haematology

Full Blood Count

(Whole Blood)

White Blood Cell Count

Red Blood Cell Count

Haemoglobin (Hb)

Mean Cell Volume (MCV)

Mean Cell Volume haemoglobin

(MCH)

Mean Cell Volume haemoglobin

Concentration (MCHC)

Haematocrit (hct)

Platelets

Nucleated Red Blood Cell’s (NRBCs)

Automated method using

Sysmex XN-1000 and XN-2000

LP-HAEM-0032 Operation and

Maintenance of Sysmex XN-

1000 and XN-2000.

LP-HAEM-0005 Full Blood Count

Testing, Authorisation,

Reporting of Results (Critical

Values) and Criteria for Blood

Films

.02

.20

Visual examination of

blood film

Bone marrow aspirate

morphology

(Whole Blood / Bone

Marrow aspirate)

Red blood cell, white blood cell

and platelet morphology in

peripheral blood and bone

marrow aspirate.

Manual preparation, staining

and visual examination of

blood films.

LP-HAEM-0006 Preparation,

Staining and Examination of

Blood Films and Bone

Marrow Aspirates

LP-HAEM-0007 Operation

and Maintenance of the

WESCOR 7120 Aerospray

Stainer

LP-HAEM-0008 Operation

and Maintenance of the

Nikon Eclipse 50i

microscope

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Category A








.03

Erythrocyte

Sedimentation Rate

(Whole Blood)

Photometrical capillary stopped

flow kinetic analysis

Automated analysis of whole

blood

LP-HAEM-0004

Operation and Maintenance

of the Alifax Test 1 ESR

Analyser

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Category A








1030

.05

Haematology

Automated differential

leucoyte counts

(whole Blood)

Neutrophils

Lymphocytes

Monocytes

Eosinophils

Basophils


Sysmex XN-1000 and XN-

2000

LP-HAEM-0032


of the Sysmex XN 1000 and

XN 2000

LP-HAEM-0005 Full Blood

Count Testing, Authorisation,



Films

.06 Auotmated

reticulocyte counts

(Whole Blood)

Reticulocyte Count


Sysmex XN-1000 and XN-

2000

LP-HAEM-0032


of the Sysmex XN 1000 and

XN 2000

LP-HAEM-0005 Full Blood

Count Testing, Authorisation,



Films

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Category A








.09 Examination for

Malarial Parasites

Immunochromatographic test

for qualitative detection of

malarial antigens using Binax

NOW Malaria Test Kit and

malarial parasitic morphology

by thick and thin blood Film

Manual serological test for

malarial antigens and

manual blood film

preparation, staining and

morphological examination.

LP-HAEM-0012 Serological

Testing and Blood Film

Staining and Examination for

Malarial Parasites

.30 Tests for haemoglobin

S (Whole Blood)

Sickledex (HbS) test uses the

principle that Sodium

Hydrosulphite present in the

working solubility buffer

reduces haemoglobin. Reduced

HbS is insoluble in the buffer

and forms a cloudy, turbid

suspension.

Positive/Negative result

Manual method.

LP-HAEM-0013 Preparation

of Reagent and Performance

of Sickledex Test

Test for fetal maternal

haemorrhage (FMH) –

Acid Elution Test

(Whole Blood)

Acid elution test whereby fetal

haemoglobin (HbF) is more

resistant than adult

haemoglobin (HbA) to both

alkali denaturation and acid

elution.

Manual method of film

preparation, staining and

examination for fetal red

cells in maternal

circulation.

LP-HAEM-0014 Performance

of the Kleihauer Test (Acid

Elution Test)

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Category A




Type of test/properties

measured




1030

.41

Haematology

General haemostasis

tests (Plasma)

Prothrombin time

International normalised ratio

Activated Thromboplastin time

APTT / Ratio

Fibrinogen Clotting assay

(clauss method)

D-Dimer


Stago STA-R Evolution

LP-HAEM-0016


of the Stago STA-R Evolution

LP-HAEM-0022 Coagulation

Testing, Authorisation and

Reporting of Coagulation

Results (Critical Values)

.55 Iron Stain (Bone

Marrow Aspirate)

Examination of bone marrow

aspirate film for iron using

Perl’s Prussian Blue staining

method

Manual staining method.

LP-HAEM-0006 Preparation,

Staining and Examination of

Blood Films and Bone

Marrow Aspirates

.57 Screening test for

infectious

mononucleosis

(Plasma)

Qualitative detection of IM-

specific heterophile antibodies

Manual method.

LP-HAEM-0009

Performing the Clearview IM

II Test for Infectious

Mononucleosis

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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 .02 Processing fresh specimens for frozen section examination .03 Histochemistry Manual Automated

Cut up Tissue processing Embedding Microtomy Automated and Manual Haematoxylin and Eosin Staining Coverslipping Cytology Sample Preparation

Human tissue

LP-HIST-0001, 0002, 0003, 0004, 0007, 0008, 0010, 0015, 0017, 0031, 0034, 0035, 0036, 0055, 0057

LP-HIST-0016, LP-HIST-0038 LP-HIST-0033 LP-HIST-0034 LM-HIST-0035 LM-HIST-0036 LM-HIST-0037 LM-HIST-0038 LM-HIST-0039

Cut-up Frozen section cryotomy and staining

Human tissue LP-HIST-0037

Special stains List each stain as appropriate for each laboratory. Alican Blue Congo Red Gram-Twort Haematoxylin Van Gieson Masson Fontana Millers Strain Ziehl-Neelsen Alican Blue-Periodic Gordon and Sweet Grocotts Hexamine Silver Haematoxylin and Eosin Martius Scarlet Blue Masson Trichrome Periodic Acid Schiff Perls Prussian Blue Pananicolaou Stain for Cytological Preparations MGG Stain for Cytological Preparations Diastase Periodic Acid Schiff for Glycogen Warthin Starry

Human tissue LP-HIST-0015

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Category A





.04 Histological interpretation .041 Medical Renal Path .042 Paediatric Pathology .043 Perinatal Pathology .044 Neuropathology .045 Breast screening Pathology (Breastcheck programme) .05 Immunohistochemistry

Diagnostic Interpretation and reporting of Human tissue specimens Specialist areas excluded: Medical Renal Pathology Paediatric Pathology Perinatal Pathology Neuropathology Breast screening Pathology (Breast Check designated laboratories only) Specialist areas included: (Added as demonstration of EQA participation is presented)

Human tissue LMn-HIST-0001 LP-HIST-0012

Programmed automated application of reagents Actin Actin BCL2 Calretenin CA125 CD3 CD5 CD10 CD15 CD20 CD30 CD31 CD34 CD45 CD56 CD68 CD79a CD117 CD138 Chromogranin A Cyclin D1 Cytokeratin AE1/3 Cytokeratin CAM 5.2 Cytokeratin MNF116

Human tissue

LP-HIST-0022 LP-HIST-0024 LP-HIST-0049

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Category A





.05 Immunohistochemistry

Programmed automated application of reagents Cytokeratin 7 Cytokeratin 20 Cytokeratin 34BE12 CEA Desmin EMA Factor VIII BerEP4 Hmb45 Ki67 Mart1/Tyrosinase PSA P16 P53 Synaptophysin S100 TTF Vimentin

Human tissue

LP-HIST-0022 LP-HIST-0024 LP-HIST-0049

.06 Immunocytochemistry Ventana System

iView Detection System Ultra Detection System Optiview Detection System

LP-HIST-0024

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Category A

Clinical Chemistry Testing Laboratory

INAB Classification

Number (P9) Test/Assay Name Specimen Type Equipment SOP

1061

.01

Clinical Chemistry

Alanine Amino

Transferase (ALT)

Serum,

Li Heparin Plasma Architect Ci16200 LP-BIO-0001

Alkaline

Phosphatase (ALP)

Serum

LI Heparin Plasma Architect Ci16200 LP-BIO-0001

Amylase

Serum,

Li Heparin Plasma

Urine

Architect Ci16200 LP-BIO-0001

Aspartate

Aminotransferase

(AST)

Serum,


Cholesterol Serum,


Calcium Serum, Urine


Glucose Fluoride EDTA

CSF Architect Ci16200 LP-BIO-0001

Creatinine Serum, Urine


Creatine Kinase Serum,


Cholesterol HDL Serum,


Cholesterol LDL Serum,


Iron Serum Architect Ci16200 LP-BIO-0001

Magnesium Serum,


Phosphate Serum


HS Troponin Li Heparin Plasma Architect Ci16200 LP-BIO-0001

Ferritin Serum Architect Ci16200 LP-BIO-0001

Transferrin Serum Architect Ci16200 LP-BIO-0001

Ammonia Li Heparin Plasma Architect Ci16200 LP-BIO-0001

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Category A


INAB Classification


1061

.01

Clinical Chemistry

Total Protein

Urinary Protein

Serum

Li Heparin Plasma

Urine

CSF

Architect Ci16200 LP-Bio-0001

Urea Serum

Li Heparin Plasma Architect Ci16200 LP-Bio-0001

Uric Acid Serum


Glycated

Haemoglobin (HbA1c) EDTA AdamsHA 8180 LP-Bio-0012

Albumin Serum

Li Heparin Plasma Architect Ci6200i LP-Bio-0001

Sodium (Na)

Serum

Li Heparin Plasma

Urine

Architect Ci6200i LP-Bio-0001

Potassium (K)

Serum

Li Heparin Plasma

Urine


Chloride (Cl)

Serum

Li Heparin Plasma

Urine


Gamma Glutamyl

Transferase (GGT)

Serum


Lactate

Dehydrogenase (LDH)

Serum


Triglycerides Serum


C Reactive protein

(CRP)

Serum


Microalbumin Urine Architect Ci16200 LP-Bio-0001

Direct Bilirubin Serum


Total Bilirubin Serum


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Category A


INAB Classification


1061

.01

Clinical Chemistry

Vitamin D Serum

Architect Ci 16200 LP-Bio-0001

Bicarbonate Serum Architect Ci 16200 LP-Bio-0001

Lactate Fluoride EDTA Architect Ci 16200 LP-Bio-0001

Bile Acid Serum Architect Ci 16200 LP-Bio-0001

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Category A


INAB Classification


1061

.10

Clinical Chemistry

Digoxin Serum Architect Ci16200 LP-Bio-0001

Gentamicin Serum Architect Ci16200 LP-Bio-0001

Lithium Serum Architect Ci16200 LP-Bio-0001

Phenytoin Serum Architect Ci16200 LP-Bio-0001

Vancomycin Serum Architect Ci16200 LP-Bio-0001

Valproic Acid Serum Architect Ci16200 LP-Bio-0001

.15 Paracetamol Serum Architect Ci16200 LP-Bio-0001

Salicyate Serum Architect Ci16200 LP-Bio-0001

.20 B-HCG Serum Architect Ci16200 LP-Bio-0001

Cortisol Serum Architect Ci16200 LP-Bio-0001

Free T4 Serum Architect Ci16200 LP-Bio-0001

Free T3 Serum Architect Ci16200 LP-Bio-0001

Progesterone Serum Architect Ci16200 LP-Bio-0001

Prolactin Serum Architect Ci16200 LP-Bio-0001

TSH Serum Architect Ci16200 LP-Bio-0001

FSH Serum Architect Ci16200 LP-Bio-0001

LH Serum Architect Ci16200 LP-Bio-0001

Oestradiol Serum Architect Ci16200 LP-Bio-0001

.45 Vitamin B12 Serum Architect Ci16200 LP-Bio-0001

Folate Serum Architect Ci16200 LP-Bio-0001

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Category A


INAB Classification


1061 CLINICAL

CHEMISTRY

.50

AFP Serum Architect

Ci16200 LP-Bio-0001

CA 15-3 Serum Architect

Ci16200 LP-Bio-0001

CA 19-9 Serum Architect

Ci16200 LP-Bio-0001

CA 125 Serum Architect

Ci16200 LP-Bio-0001

CEA Serum Architect

Ci16200 LP-Bio-0001

PSA total Serum Architect

Ci16200 LP-Bio-0001

.80

Immunoglobulin A Serum Architect

Ci16200 LP-Bio-0001

Immunoglobulin M Serum

Architect

Ci16200 LP-Bio-0001

Immunoglobulin G Serum

Architect

Ci16200 LP-Bio-0001

.83 Rheumatoid factor Serum Architect

Ci16200 LP-Bio-0001

.99

Anti-TPO Antibodies Serum Architect

Ci16200 LP-Bio-0001

Osmolality

Serum

Li Heparin Plasma

Urine

3320

Osmometer LP-Bio-0015

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Category A

Microbiology Testing Laboratory


Test/Assay Name Specimen Type Method SOP

1011 Bacteriology .01 .02 .03 .04 .05 .06 .07 .08 .99

Investigation for pathogens other than parasites

Faecal samples Microscopy, Vitek 2 Gene expert Maldi Tof Manual AMS Culture

LP-MIC-0008 LP-MIC-0001

.01

.02

.03

.04

.05

.06

.07

.99

Identification and susceptability testing

Genital tract specimens

Microscopy, Vitek 2 Maldi Tof Manual AMS Culture

LP-MIC-0006

.01

.02

.04

.05

.07

.99

MRSA testing Various sample types


LP-MIC-0005

.01

.02

.03

.04

.05

.06

.07

.99

Investigation of respiratory specimens

Respiratory specimens


LP-MIC-0006

.01

.02

.03

.04

.05

.06

.07

.99

Investigation of cerebrospinal fluid specimens

Cerebrospinal fluid


LP-MIC-0002

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Category A



Test/Assay Name Specimen

Type Method SOP

1011 Bacteriology .01 .02 .03 .04 .05 .06 .07 .08 .99

Investigation of fluids

Various fluid types


LP-MIC-0011

.01

.02

.03

.04

.05

.06

.07

.99

Investigation of Urine

Urine samples


LP-MIC-0003

.01

.02

.03

.04

.05

.07

.99

Investigation of wounds / abscesses

Various wound sites


LP-MIC-0009 LP-MIC-0010

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

Legionella & Pneumococcal Antigen Testing

Urine Samples

Immunochromatographic LP-MIC-0008 LP-MIC-0005 LP-MIC-0019

1012 Parasitology .01 .02

Detection and identification of parasites

Various Manual, Microscopy

LP-MIC-0015

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Category A



Test/Assay Name Specimen

Type Method SOP

1013 Virology .01

Detection of Rotavirus or adenovirus Detection of RSV Syncytical virus fusion protein antigen

Faecal specimens Respiratory Samples Urine

Manual, Immunochromatographic

LP-MIC-0008 LP-MIC-0005 LP-MIC-0019

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