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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
Local Contact Pauline Macmillan
Clinical Biochemistry
B
Address Gut Hormone Laboratory Commonwealth Building Imperial College Hammersmith Hospital London W12 0HS
Local Contact Pauline Macmillan
Clinical Biochemistry
C
Address Clinical Biochemistry Department (CX1/G) Charing Cross Hospital Fulham Palace Road London W6 8RF
Local Contact Pauline Macmillan
Clinical Biochemistry
D
Address Clinical Biochemistry Department (CX8/12) Charing Cross Hospital Fulham Palace Road London W6 8RF
Local Contact Pauline Macmillan
Clinical Biochemistry
E
8764
Accredited to
ISO 15189:2012
Schedule of Accreditation issued by
United Kingdom Accreditation Service 2 P ine Trees , Cher t sey Lane, S ta i nes -upon-Thames , TW 18 3HR, UK
Imperial College Healthcare NHS Trust operating as North West London Pathology
Issue No: 002 Issue date: 14 June 2018
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
Local Contact Pauline Macmillan
Clinical Biochemistry
F
Address Operating Theatre 1 Hammersmith Hospital London W12 0HS
Local Contact Pauline Macmillan
Clinical Biochemistry
G
Address Andrology Laboratory Area C, South Corridor Hammersmith Hospital W12 0HS
Local Contact Pauline Macmillan
Andrology
H
8764
Accredited to
ISO 15189:2012
Schedule of Accreditation issued by
United Kingdom Accreditation Service 2 P ine Trees , Cher t sey Lane, S ta i nes -upon-Thames , TW 18 3HR, UK
Imperial College Healthcare NHS Trust operating as North West London Pathology
Issue No: 002 Issue date: 14 June 2018
Testing performed by the Organisation at the locations specified
Assessment Manager: DE Page 3 of 12
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
Schedule of Accreditation issued by
United Kingdom Accreditation Service 2 P ine Trees , Cher t sey Lane, S ta i nes -upon-Thames , TW 18 3HR, UK
Imperial College Healthcare NHS Trust operating as North West London Pathology
Issue No: 002 Issue date: 14 June 2018
Testing performed by the Organisation at the locations specified
Assessment Manager: DE Page 4 of 12
Materials/Products tested
Type of test/Properties measured/Range of measurement
Standard specifications/ Equipment/Techniques used
Location
HUMAN BODY FLUIDS (CONT’D):
Biochemistry examination activities for the purposes of clinical diagnosis (cont’d):
In house documented procedures based on Abbott Architect manuals and as specified below:
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
Schedule of Accreditation issued by
United Kingdom Accreditation Service 2 P ine Trees , Cher t sey Lane, S ta i nes -upon-Thames , TW 18 3HR, UK
Imperial College Healthcare NHS Trust operating as North West London Pathology
Issue No: 002 Issue date: 14 June 2018
Testing performed by the Organisation at the locations specified
Assessment Manager: DE Page 5 of 12
Materials/Products tested
Type of test/Properties measured/Range of measurement
Standard specifications/ Equipment/Techniques used
Location
HUMAN BODY FLUIDS (CONT’D):
Biochemistry examination activities for the purposes of clinical diagnosis (cont’d):
In house documented procedures based on Abbott Architect manuals and as specified below:
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
Schedule of Accreditation issued by
United Kingdom Accreditation Service 2 P ine Trees , Cher t sey Lane, S ta i nes -upon-Thames , TW 18 3HR, UK
Imperial College Healthcare NHS Trust operating as North West London Pathology
Issue No: 002 Issue date: 14 June 2018
Testing performed by the Organisation at the locations specified
Assessment Manager: DE Page 6 of 12
Materials/Products tested
Type of test/Properties measured/Range of measurement
Standard specifications/ Equipment/Techniques used
Location
HUMAN BODY FLUIDS (CONT’D):
Biochemistry examination activities for the purposes of clinical diagnosis (cont’d):
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
Schedule of Accreditation issued by
United Kingdom Accreditation Service 2 P ine Trees , Cher t sey Lane, S ta i nes -upon-Thames , TW 18 3HR, UK
Imperial College Healthcare NHS Trust operating as North West London Pathology
Issue No: 002 Issue date: 14 June 2018
Testing performed by the Organisation at the locations specified
Assessment Manager: DE Page 7 of 12
Materials/Products tested
Type of test/Properties measured/Range of measurement
Standard specifications/ Equipment/Techniques used
Location
HUMAN BODY FLUIDS (CONT’D):
Biochemistry examination activities for the purposes of clinical diagnosis (cont’d):
In house documented procedures based on manufacturers manuals and as specified below:
In house documented procedures
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
Serum/plasma (trace element free tube)urine
Cobalt CHM-LP-477-X, CHM-LP-589-IMP, CHM-MP-042-X
D
Serum/plasma (trace element free tube)urine
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
Schedule of Accreditation issued by
United Kingdom Accreditation Service 2 P ine Trees , Cher t sey Lane, S ta i nes -upon-Thames , TW 18 3HR, UK
Imperial College Healthcare NHS Trust operating as North West London Pathology
Issue No: 002 Issue date: 14 June 2018
Testing performed by the Organisation at the locations specified
Assessment Manager: DE Page 8 of 12
Materials/Products tested
Type of test/Properties measured/Range of measurement
Standard specifications/ Equipment/Techniques used
Location
HUMAN BODY FLUIDS (CONT’D):
Biochemistry examination activities for the purposes of clinical diagnosis (cont’d):
In house documented procedures based on manufacturers manuals and as specified below:
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
In house documented procedures
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
Schedule of Accreditation issued by
United Kingdom Accreditation Service 2 P ine Trees , Cher t sey Lane, S ta i nes -upon-Thames , TW 18 3HR, UK
Imperial College Healthcare NHS Trust operating as North West London Pathology
Issue No: 002 Issue date: 14 June 2018
Testing performed by the Organisation at the locations specified
Assessment Manager: DE Page 9 of 12
Materials/Products tested
Type of test/Properties measured/Range of measurement
Standard specifications/ Equipment/Techniques used
Location
HUMAN BODY FLUIDS (CONT’D):
Biochemistry examination activities for the purposes of clinical diagnosis (cont’d):
In house documented procedures based on manufacturers manuals and as specified below:
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
Schedule of Accreditation issued by
United Kingdom Accreditation Service 2 P ine Trees , Cher t sey Lane, S ta i nes -upon-Thames , TW 18 3HR, UK
Imperial College Healthcare NHS Trust operating as North West London Pathology
Issue No: 002 Issue date: 14 June 2018
Testing performed by the Organisation at the locations specified
Assessment Manager: DE Page 10 of 12
Materials/Products tested
Type of test/Properties measured/Range of measurement
Standard specifications/ Equipment/Techniques used
Location
HUMAN BODY FLUIDS (CONT’D):
Biochemistry examination activities for the purposes of clinical diagnosis (cont’d):
In house documented procedures based on manufacturers manuals and as specified below:
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
Schedule of Accreditation issued by
United Kingdom Accreditation Service 2 P ine Trees , Cher t sey Lane, S ta i nes -upon-Thames , TW 18 3HR, UK
Imperial College Healthcare NHS Trust operating as North West London Pathology
Issue No: 002 Issue date: 14 June 2018
Testing performed by the Organisation at the locations specified
Assessment Manager: DE Page 11 of 12
Materials/Products tested
Type of test/Properties measured/Range of measurement
Standard specifications/ Equipment/Techniques used
Location
HUMAN BODY FLUIDS (CONT’D):
Biochemistry examination activities for the purposes of clinical diagnosis (cont’d):
In house documented procedures based on manufacturers manuals and as specified below:
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
Schedule of Accreditation issued by
United Kingdom Accreditation Service 2 P ine Trees , Cher t sey Lane, S ta i nes -upon-Thames , TW 18 3HR, UK
Imperial College Healthcare NHS Trust operating as North West London Pathology
Issue No: 002 Issue date: 14 June 2018
Testing performed by the Organisation at the locations specified
Assessment Manager: DE Page 12 of 12
Materials/Products tested
Type of test/Properties measured/Range of measurement
Standard specifications/ Equipment/Techniques used
Location
HUMAN BODY FLUIDS (CONT’D):
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