Schedule of Accreditation United Kingdom … Testing performed by the Organisation at the locations specified below Locations covered by the organisation and their relevant activities

Assessment Manager: DE 1 of 12

Schedule of Accreditation issued by

United Kingdom Accreditation Service

2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK

8673

Accredited to

ISO 15189:2012

Imperial College Healthcare NHS Trust operating as North West London Pathology

Issue No: 002 Issue date: 14 June 2018

St Mary’s Hospital

2nd Floor Mint Wing

South Wharf Road

London

W2 1NY

Contact: Pauline Macmillan

E-Mail: [email protected]

Website: www.imperial.nhs.uk/about-us

Testing performed by the Organisation at the locations specified below

Locations covered by the organisation and their relevant activities

Laboratory locations:

Location details Activity Location code

Address Clinical Biochemistry Department St Mary’s Hospital 2nd Floor Mint Wing South Wharf Road London W2 1NY

Local Contact Pauline Macmillan

Clinical Biochemistry

A

Address Clinical Biochemistry Department G Block Hammersmith Hospital London W12 0HS



B

Address Gut Hormone Laboratory Commonwealth Building Imperial College Hammersmith Hospital London W12 0HS



C

Address Clinical Biochemistry Department (CX1/G) Charing Cross Hospital Fulham Palace Road London W6 8RF



D

Address Clinical Biochemistry Department (CX8/12) Charing Cross Hospital Fulham Palace Road London W6 8RF



E

8764

Accredited to

ISO 15189:2012


United Kingdom Accreditation Service 2 P ine Trees , Cher t sey Lane, S ta i nes -upon-Thames , TW 18 3HR, UK



Testing performed by the Organisation at the locations specified

Assessment Manager: DE Page 2 of 12

Location details Activity Location code

Address Clinical Biochemistry Department 2nd Floor Pathology Block Chelsea & Westminster Hospital Fulham Road London SW10 9NH



F

Address Operating Theatre 1 Hammersmith Hospital London W12 0HS



G

Address Andrology Laboratory Area C, South Corridor Hammersmith Hospital W12 0HS


Andrology

H

8764

Accredited to

ISO 15189:2012







DETAIL OF ACCREDITATION

Materials/Products tested

Type of test/Properties measured/Range of measurement

Standard specifications/ Equipment/Techniques used

Location

HUMAN BODY FLUIDS

Biochemistry examination activities for the purposes of clinical diagnosis:

In house documented procedures based on Abbott Architect manuals and as specified below:

Serum/plasma, urine Albumin

Amylase Calcium Chloride Creatinine Phosphate Potassium Protein (Total) Sodium Urate Urea

CHM-LP-101-IMP ABDF

Serum/plasma Alanine Transaminase (ALT)

Alkaline Phosphatase (ALP) Aspartate Transaminase (AST) Bicarbonate (TCO2) Bilirubin (conjugate) Bilirubin (total) C Reactive Protein Cholesterol Cholesterol:HDL ratio Creatine Kinase Gamma Glutamyl Transferase (GGT) Globulin Glomerular Filtration Rate High Density Lipoprotein – Cholesterol (HDL cholesterol) Lactate Dehydrogenase (LDH) Magnesium Triglyceride (fasting)

CHM-LP-101-IMP ABDF

Serum/plasma Bile acids (total) CHM-LP-101-IMP AB EDTA plasma B-type Natriuretic Peptide (BNP)

High sensitivity Troponin I CHM-LP-101-IMP ABDF

8764

Accredited to

ISO 15189:2012










Location

HUMAN BODY FLUIDS (CONT’D):

Biochemistry examination activities for the purposes of clinical diagnosis (cont’d):


Serum Cortisol

Digoxin Ferritin Folate Follicle Stimulating Hormone (FSH) Free Thyroxine (FT4) Free Triiodothyronine (FT3) Human Chorionic Gonadotrophin (HCG) Immunoglobulins A, G, M Iron Luteinising Hormone (LH) Oestradiol Paracetamol (Site B to be taken off) Phenytoin Progesterone Salicylate (Site B to be taken off) Thyroid Stimulating Hormone Transferrin saturation with iron Vitamin B12

CHM-LP-101-IMP ABDF

Serum Angiotensin Converting Enzyme

(ACE) Carbamazepine Phenobarb Testosterone Valproate

CHM-LP-101-IMP AD

Serum Vitamin D (total)

Lithium CHM-LP-101-IMP ADF

Serum Prolactin CHM-LP-101-IMP ABD Serum %free PSA (FPSA)

Alphafetoprotein (AFP) CA125 CA153 Carcinoembryonic antigen (CEA) Prostate specific antigen (PSA) Squamous Cell Carcinoma Ag (SCC)

CHM-LP-101-IMP D

8764

Accredited to

ISO 15189:2012










Location




Urine

Micro Albumin Urine Protein

CHM-LP-101-IMP ABDF

Urine Magnesium CHM-LP-101-IMP D CSF Protein (Total) CHM-LP-101-IMP ABDF CSF Angiotensin Converting Enzyme

(ACE) CHM-LP-434-X D

Plasma Ammonia CHM-LP-101-IMP ABD Fluoride oxalate plasma/CSF

Glucose Lactate

CHM-LP-101-IMP

ABDF

Fluoride oxalate plasma Ethanol CHM-LP-101-IMP AF EDTA plasma Parathyroid hormone (PTH) CHM-LP-101-IMP ABD Urine Drugs of Abuse screen:

Amphetamines Benzodiazepines Cannabinoids Cocaine Opiates Methadone&eddp

Abbott Architect i2000SR with specific reference to: CHM-LP-587-IMP

E

8764

Accredited to

ISO 15189:2012










Location



In house documented procedures based on manufacturers manuals and as specified below:

Special Endocrinology assays by

Abbott Architect i2000SR

Serum/Plasma Homocysteine (HCY) CHM-IS-347-IMP E Serum/Plasma Insulin CHM-IS-345-IMP E Serum/Plasma C-peptide CHM-IS-346-IMP E EDTA whole blood Folate (red cell) (RCF) CHM-LP-233-IMP E CSF Xanthochromia Spectrophotometry (Evolution

300/100): Evolution 201 CHM-LP-601-X, CHM-LP-640-M

AD

Heparinised blood gas syringe/capillary

Blood gases: pH, pCO2 and pO2

IL GEM Blood Gas Analyser: POCT-LP-014-IMP GEM 4000

BDF

EDTA whole blood Blood gases:

Carboxyhaemoglobin IL GEM Blood Gas Analyser: POCT-LP-014-IMP GEM 4000

BDF

EDTA whole blood HbA1C TOSOH G8 measurement by HPLC:

CHM-LP-619-IMP ABDF

Serum, urine Osmolality Advanced Instruments Micro

Osmometer: CHM-LP-383-IMP Osmometry

ABDF

In house documented procedures

based on In house RIA

EDTA plasma Gastrin CHM-LP-302-H C EDTA plasma Somatostatin CHM-LP-253-H C EDTA plasma VIP CHM-LP-255-H C EDTA plasma Pancreatic polypeptide CHM-LP-252-H C EDTA plasma Glucagon CHM-LP-243-H C EDTA plasma Chromogranin A CHM-LP-239-H C

8764

Accredited to

ISO 15189:2012










Location





based on In house RIA:

EDTA plasma Chromogranin B CHM-LP-240-H C EDTA plasma CART CHM-LP-456-H C Serum, CSF, urine Total' hCG (HCGTM) CHM-LP-408-X D ICP-MS (Agilent 7700, 7900 &

Element 2):

EDTA whole blood, urine

Arsenic Cadmium Lead Mercury Thallium

CHM-LP-589-IMP, CHM-MP-042-X D

Serum/plasma (trace element free tube)urine

Copper Zinc

CHM-LP-589-IMP, CHM-MP-042-X D


Cobalt CHM-LP-477-X, CHM-LP-589-IMP, CHM-MP-042-X

D


Chromium Manganese Selenium

CHM-LP-477-X, CHM-MP-042-X D

Urine Iron ICP-MS (Agilent 7700, 7900 &

Element 2): CHM-LP-589-IMP, CHM-MP-042-X

D

Urine Drugs of Abuse confirmation:

amphetamines opiates

Zymark Rapid Trace and Shimadzu QP2010 SE GC-MS: CHM-LP-275-IMP

E

8764

Accredited to

ISO 15189:2012










Location




Tandem mass spectrometry Liquid

Chromatography-Mass spectrometry-Mass spectrometry:

Serum Testosterone (Female) CHM-LP-482-IMP E Serum Androstenedione

17(OH)Progesterone CHM-LP-582-IMP E

Serum 25-Hydroxy Vitamin D CHM-LP-203-IMP E Plasma

Aldosterone Renin

CHM-LP-613-IMP

E


based on High Performance Liquid Chromatography:

Urine Catecholamines (Urine) CHM-LP-230-IMP, CHM-LP-592-IMP E Urine Metanephrines (Urine) CHM-LP-598-IMP, CHM-LP-592-IMP E Urine 5HIAA (5-hydroxyindole acetic

acid) (Urine) CHM-LP-229-IMP, CHM-LP-592-IMP E

Roche Cobas e411 and CHM-LP-

096-IMP with specific reference to:

Serum/Plasma Total Procollagen Type 1 N-

Terminal proPeptide (P1NP) CHM-IS-400-IMP E

Serum Anti-Mullerian Hormone (AMH) CHM-IS-423-IMP E

Serum

Serum Bone Alkaline Phosphatase (BALP)

ELISA kit (Metra/Quidel, Activity) CHM-LP-016-IMP

E

Urine Urine N-Telopeptide of Type 1

Collagen ELISA kit (Osteomark): CHM-LP-015-IMP

E

8764

Accredited to

ISO 15189:2012










Location




Sebia Capillarys and as specified

below:

Serum ALP Isoenzyme Analysis CHM-LP-034-X E Serum CK Isoenzyme Analysis CHM-LP-107-X E Plasma and Serum Cryoglobulins CHM-LP-390-X E Serum Paraprotein quantitation & typing Serum Electrophoresis using

Hydrasys: CHM-LP-361-X E

Urine Bence Jones Proteins CHM-LP-333-IMP

CHM-LP-032-X E

Beckman Immage 800 and as

specified below:

Serum/Urine/CSF/Fluid Albumin CHM-LP-343-X E Serum Alpha-1-Antitrypsin CHM-LP-343-X E Serum Apolipoprotein A1 CHM-LP-343-X E Serum Apolipoprotein B CHM-LP-343-X E CSF, Fluid Beta-2/Asialo Transferrin/CDT CHM-LP-360-X E Serum/ Immunoglobulin IgG CHM-LP-343-X E Serum/ Lipoprotein (a) CHM-LP-343-X E Serum/ Caeruloplasmin CHM-LP-343-X E Serum/, Free Light Chains SOPs using Binding Site Optilite and

CHM-LP-627-IMP E

Serum/plasma, CSF Identification of Oligoclonal bands In house method by Isoelectric

focussing CHM -LP-359-X E

Faeces Calprotectin Calprotectin 2 EliA Assay on Phadia

ImmunoCAP 250 CHM-LP-631-X E

8764

Accredited to

ISO 15189:2012










Location




Beckman Immage 800 and as

specified below:

B.R.AH.M.S KRYPTOR and as

specified below: CHM-LP-406-X

Serum

Neurone Specific Enolase(NSE) (Kryptor)

CHM-LP-414-X D

Serum Placental Alk. Phos (PLAP) CHM-LP-405-X D Serum CA199 CHM-LP-407-X D

Beckman Coulter ELISA and

specified below:

Serum Inhibin B CHM-LP-404-X D

Siemens Immulite and as specified below CHM-LP-263-X:

Serum, Rapid 'Total' hCG (HCGE) CHM-IS-427-IMP E EDTA plasma ACTH (Adrenocorticotrophic

hormone) CHM-IS-349-IMP E

Serum DHEAS (Dehydroepiandrosterone

sulphate) CHM-IS-351-IMP E

Serum SHBG (Sex Hormone Binding

Globulin) CHM-IS-354-IMP E

Serum Growth Hormone CHM-IS-353-IMP E Serum Erythropoietin (EPO) CHM-IS-352-IMP E Serum/plasma Thyroglobulin CHM-IS-355-IMP E Serum/plasma Thyroglobulin Ab CHM-IS-355-IMP E

8764

Accredited to

ISO 15189:2012










Location




Siemens Immulite and as specified

below CHM-LP-263-X:

Urine Cortisol (Urine Free Cortisol

(UFC) CHM-LP-362-IMP E

Urine, faeces Reducing Substances/ Sugar

Chromatography Thin layer chromatography CHM-LP-388-IMP

E

Urine Porphyrins Hitachi U1800 spectrophotometer

and as specified below: CHM-LP-148-IMP, CHM-LP-198-IMP

E

(CLIA) Diasorin Liaison XL and as

specified below CHM-LP-579-IMP:

Serum Calcitonin CHM-IS-051-IMP E Serum, S 100 (serum) CHM-IS-070-IMP E Serum, IGF-1 CHM-IS-330-IMP E Serum, Macroprolactin estimation (MPrl)

PEG and Abbott Architect i2000SR CHM-LP-234-IMP

E

EDTA plasma Parathyroid hormone (PTH) Future Diagnostics IO-PTH System:

CHM-LP-480-H G

Beckman Haemoccult and as

specified below:

Faeces Faecal occult blood CHM-LP284-C F Faeces Faecal occult blood CHM-LP395-X D

Urine BhCG (pregnancy test) Alere Pregnancy Kit: CHM-LP-088-C F Calcium adjusted for albumin

(CADJ) Calculation using CHM-ED-016-IMP, CHM-LP-101-IMP

ABDF

8764

Accredited to

ISO 15189:2012










Location


Andrology examination activities for the purposes of clinical diagnosis:

Documented in-house procedures based on WHO Laboratory Manual 5th Edition (2010):

Semen Semen Volume

Sperm Count Sperm Motility Sperm Morphology

Manual method using documented in-house procedure SOP CHM-LP-412-H

H

Volume

Sperm presence/absence Manual Post-Vasectomy method using documented in-house procedure SOP CHM-LP-412-H

END

Schedule of Accreditation United Kingdom … Testing performed by the Organisation at the locations specified below Locations covered by the organisation and their relevant activities

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