kettering general hospital nhs foundation trust

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Assessment Manager: RBB Page 1 of 5 Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK 8118 Accredited to ISO 15189:2012 Kettering General Hospital NHS Foundation Trust Issue No: 001 Issue date: 13 April 2016 Biochemistry Kettering General Hospital Rothwell Road Kettering NN16 8UZ Contact: James Maclean Tel: +44 (0) 1536 493368 Fax: +44 (0) 1536 492704 E-Mail: [email protected] Website: www.kgh.nhs.uk Testing performed at the above address only DETAIL OF ACCREDITATION Materials/Products tested Type of test/Properties measured/Range of measurement Standard specifications/ Equipment/Techniques used HUMAN BODY FLUIDS Biochemistry examination activities for the purposes of clinical diagnosis: Documented in house methods and manufacturers instructions for Quantitative determination of: Serum/Plasma/Fluid/Urine Sodium Potassium Chloride Roche Cobas ISE Module (ion selective electrodes) LP-BIO-ISES Serum/Plasma Albumin Alkaline Phosphatase ALT Amylase Bilirubin Cholesterol Creatine Kinase (CK) C Reactive Protein Gamma GT HDL Cholesterol Paracetamol Salicylate Total Protein Triglyceride Roche Cobas 702 Module (multi assay photometry) LB-BIO-ALB LP-BIO-ALP LP-BIO-ALT LP-BIO-AMY LP-BIO-BILI Total LP-BIO-CHOL LP-BIO-CK LP-BIO-CRP Gen3 LP-BIO-GGT LP-BIO-HDL3 LP-BIO-PARA LP-BIO-SAL LP-BIO-TP LP-BIO-TRIG Serum/Plasma/Urine Calcium Magnesium Phosphate LP-BIO-CA2 LP-BIO-MG LP-BIO-PHOS Serum/Plasma/Urine Creatinine Ethanol LP-BIO-CR LP-BIO-ETOH Serum/Plasma/CSF/Fluid Glucose LP-BIO-GLUC

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Assessment Manager: RBB Page 1 of 5

Schedule of Accreditation issued by

United Kingdom Accreditation Service

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

8118

Accredited to

ISO 15189:2012

Kettering General Hospital NHS Foundation Trust

Issue No: 001 Issue date: 13 April 2016

Biochemistry

Kettering General Hospital

Rothwell Road

Kettering

NN16 8UZ

Contact: James Maclean

Tel: +44 (0) 1536 493368

Fax: +44 (0) 1536 492704

E-Mail: [email protected]

Website: www.kgh.nhs.uk

Testing performed at the above address only

DETAIL OF ACCREDITATION

Materials/Products tested

Type of test/Properties

measured/Range of measurement

Standard specifications/

Equipment/Techniques used

HUMAN BODY FLUIDS Biochemistry examination activities

for the purposes of clinical diagnosis:

Documented in house methods and manufacturers instructions for

Quantitative determination of: Serum/Plasma/Fluid/Urine

Sodium Potassium Chloride

Roche Cobas ISE Module (ion selective electrodes) LP-BIO-ISES

Serum/Plasma

Albumin Alkaline Phosphatase ALT Amylase Bilirubin Cholesterol Creatine Kinase (CK) C Reactive Protein Gamma GT HDL Cholesterol Paracetamol Salicylate Total Protein Triglyceride

Roche Cobas 702 Module (multi assay photometry) LB-BIO-ALB LP-BIO-ALP LP-BIO-ALT LP-BIO-AMY LP-BIO-BILI Total LP-BIO-CHOL LP-BIO-CK LP-BIO-CRP Gen3 LP-BIO-GGT LP-BIO-HDL3 LP-BIO-PARA LP-BIO-SAL LP-BIO-TP LP-BIO-TRIG

Serum/Plasma/Urine

Calcium Magnesium Phosphate

LP-BIO-CA2 LP-BIO-MG LP-BIO-PHOS

Serum/Plasma/Urine

Creatinine Ethanol

LP-BIO-CR LP-BIO-ETOH

Serum/Plasma/CSF/Fluid Glucose LP-BIO-GLUC

8118

Accredited to ISO 15189:2012

Schedule of Accreditation issued by

United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK

Kettering General Hospital NHS Foundation Trust

Issue No: 001 Issue date: 13 April 2016

Testing performed at main address only

Assessment Manager:RBB Page 2 of 5

Materials/Products tested

Type of test/Properties

measured/Range of measurement

Standard specifications/

Equipment/Techniques used

HUMAN BODY FLUIDS (cont’d) Biochemistry examination activities

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

Documented in house methods and manufacturers instructions for

Roche Cobas 702 Module (multi assay photometry) (cont’d)

Serum/Plasma/Urine Urea LP-BIO-UREA Urine/Fluid/CSF

Urine Albumin Urine Protein

LP-BIO-UALB LP-BIO-UTP

Quantitative determination of: Serum/Plasma Serum/Plasma

AST Bicarbonate Direct Bilirubin Carbamazepine Iron LDH Phenytoin Theophylline UIBC

Roche Cobas 502 Module (multi assay photometry) LP-BIO-AST LP-BIO-BIC LP-BIO-DBIL LP-BIO-CARB LP-BIO-IRON LP-BIO-LDH LP-BIO-PHEN LP-BIO-THEO LP-BIO-UIBC

Serum/Plasma/Urine Plasma only

Uric Acid Lactate

LP-BIO-URIC ACID LP-BIO-LACT

8118

Accredited to ISO 15189:2012

Schedule of Accreditation issued by

United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK

Kettering General Hospital NHS Foundation Trust

Issue No: 001 Issue date: 13 April 2016

Testing performed at main address only

Assessment Manager:RBB Page 3 of 5

Materials/Products tested

Type of test/Properties

measured/Range of measurement

Standard specifications/

Equipment/Techniques used

HUMAN BODY FLUIDS (cont’d) Biochemistry examination activities

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

Documented in house methods and manufacturers instructions for

Serum/Plasma

AFP Pro-BNP CA125 CEA Cortisol Digoxin Oestradiol Ferritin Folate FSH FT4 hCG LH Progesterone Prolactin PSA Testosterone TSH Vitamin B12 Vitamin D

Roche Cobas 602 Module (sandwich and competitive chemiluminescent immunoassay) LP-BIO-AFP LP-BIO-BNP2 LP-BIO-CA125 LP-BIO-CEA LP-BIO-CORT LP-BIO-DIG LP-BIO-E2 LP-BIO-FERR LP-BIO-FOL LP-BIO-FSH LP-BIO-FT4 LP-BIO-hCG LP-BIO-LH LP-BIO-PROG LP-BIO-PROLACTIN II LP-BIO-PSA LP-BIO-TESTOST LP-BIO-TSH LP-BIO-VB12 LP-BIO VITD

Serum only

PTH Troponin T

Roche Cobas 602 Module (sandwich and competitive chemiluminescent immunoassay) LP-BIO-PTH LP-BIO-TnThs

Serum/Plasma

Lithium

Roche Integra 400 Analyser (ion selective electrode) LP-BIO-LI

8118

Accredited to ISO 15189:2012

Schedule of Accreditation issued by

United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK

Kettering General Hospital NHS Foundation Trust

Issue No: 001 Issue date: 13 April 2016

Testing performed at main address only

Assessment Manager:RBB Page 4 of 5

Materials/Products tested

Type of test/Properties

measured/Range of measurement

Standard specifications/

Equipment/Techniques used

HUMAN BODY FLUIDS (cont’d) Biochemistry examination activities

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

Documented in house methods and manufacturers instructions for

Plasma only Urine

Ammonia Drugs of Abuse Screen Cannabinoids Methadone Benzodiazepines Opiates Amphetamines

Roche Integra 400 Analyser (multi assay photometry) LP-BIO-AMM LP-BIO-DOA

Serum/Plasma

Gentamicin Vancomycin

Roche Integra 400 Analyser (fluorescence photometry) LP-BIO-GENT LP-BIO-VANC

Whole Blood

Blood Gas Analysis pH pCO2 pO2 tHb & derivatives

Roche Omni S Analyser (electrodes and co-oximetry) LP-OMNI S

Urine

Urine Catecholamines Urine 5-HIAA

Varian Prostar HPLC (reverse phase HPLC with electrochemical detection) LP-BIO-CATECHOL LP-BIO-5HIAA

Whole blood

HbA1c

TOSOH G8 (ion exchange chromatography) LP-BIO-HbA1c-G8

Serum/Plasma/Urine

Osmolality

Vitech 3320 Osmometer (freezing point depression) LP-BIO-OSMO3320

Whole blood/Urine/Faeces

Porphyrins

UNICAM UV 500 Spectrophotometer LP-BIO-Porphyrins

8118

Accredited to ISO 15189:2012

Schedule of Accreditation issued by

United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK

Kettering General Hospital NHS Foundation Trust

Issue No: 001 Issue date: 13 April 2016

Testing performed at main address only

Assessment Manager:RBB Page 5 of 5

Materials/Products tested

Type of test/Properties

measured/Range of measurement

Standard specifications/

Equipment/Techniques used

HUMAN BODY FLUIDS (cont’d) Biochemistry examination activities

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

Documented in house methods and manufacturers instructions for

Sweat

Sweat Test Chloride

Wescor Chlorochek Model 3400 LP-BIO-Sweat400

Urine

PBG

Trace kit for PBG (colorimetric utilising DMAB) LP-BIO-Porphyrins

Serum only

First Trimester Downs Screening PAPP-A Free bhCG

Perkin Elmer AutoDELFIA (fluorometric immunoassay) LP-BIO-PAPP-A Delfia LP-BIO-Free bhCG Delfia

Serum only

Second Trimester Downs Screening Total hCG UE3 AFP

Perkin Elmer AutoDELFIA (fluorometric immunoassay) LP-BIO-hCG Delfia LP-BIO-uE3 Delfia LP-BIO-AFP Delfia

Serum only

Inhibin-A

Beckman Coulter Access 2 (chemiluminescent immunoassay) LP-BIO-INHIBIN A

END