schedule of accreditation united kingdom accreditation … · blood sciences site manager blood...

Assessment Manager: DE of 13

Schedule of Accreditation issued by

United Kingdom Accreditation Service

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

8674

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

1st Floor Cambridge Wing

Praed Street

London

W2 1NY

Contact: Superna Kaur Sohal

E-Mail: [email protected]

Website: www.pathology.imperial.nhs.uk

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 Haematology & Blood Transfusion Department St Mary’s Hospital 1st Floor Cambridge Wing Praed Street London W2 1NY

Local contact Lorry Phelan (Blood Sciences Site Manager)

Haematology Coagulation Transfusion

A

Address Haematology & Blood Transfusion Department G Block Hammersmith Hospital Du Cane Road London W12 0HS

Local contact Andrew Osei-Bimpong (Blood Sciences Site Manager)


B

Address Foetal Medicine Centre Hammersmith Hospital Du Cane Road London W12 0HS


Haematology C

Address Haematology Day Care Centre Hammersmith Hospital Du Cane Road London W12 0HS


Haematology D

8674

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

Imperial College Healthcare NHS Trust operating as

North West London Pathology


Testing performed by the Organisation at the locations specified

Assessment Manager: DEP of 13

Location details Activity Location code Location details

Address Haematology & Blood Transfusion Department Charing Cross Hospital Fulham Palace Road London W6 8RF

Local contact Michael Lyall (Blood Sciences Site Manager)


E

Address Haematology & Blood Transfusion Department Chelsea and Westminster Hospital 2nd Floor Lab Block Fulham Road London SW10 9NH

Local contact Linda Wildrige (Blood Sciences Site Manager)


F

Site activities performed away from the locations listed above:

Location details Activity

Lindo Wing St Mary’s Hospital 1st Floor Cambridge Wing Praed Street London W2 1NY

Lorry Phelan Blood Sciences Site Manager

Blood Issue Fridge No testing occurs on this site, blood storage only

Labour Ward St Mary’s Hospital 1st Floor Cambridge Wing Praed Street London W2 1NY



Theatres St Mary’s Hospital 1st Floor Cambridge Wing Praed Street London W2 1NY



8674

Accredited to

ISO 15189:2012









Emergency Department St Mary’s Hospital 1st Floor Cambridge Wing Praed Street London W2 1NY



Main Theatres Hammersmith Hospital Du Cane Road London W12 0HS

Vashira Chiroma (Blood Transfusion Laboratory Manager)


Labour Ward, Queen Charlottes and Chelsea Hospital, Hammersmith Hospital Du Cane Road London W12 0HS

Vashira Chiroma (Blood Transfusion Laboratory Manager)


No satellite fridge at Charing Cross Hospital

Labour Ward Chelsea and Westminster Hospital 2nd Floor Lab Block Fulham Road London SW10 9NH

Saaba Ahmed-Khaderi (Blood Transfusion Laboratory Manager)


Paediatric Theatres Chelsea and Westminster Hospital 2nd Floor Lab Block Fulham Road London SW10 9NH



8674

Accredited to

ISO 15189:2012









Burns Unit Chelsea and Westminster Hospital 2nd Floor Lab Block Fulham Road London SW10 9NH



Main Theatres Chelsea and Westminster Hospital 2nd Floor Lab Block Fulham Road London SW10 9NH



8674

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

Code

HUMAN BODY FLUIDS: Transfusion examination

activities for the purposes of clinical diagnosis:

In house documented procedures in conjunction with Biorad IH1000 and Gel Station equipment manuals as specified below:

EDTA Whole Blood A,B,O, AB and RhD+/-

Baby /Cord blood Blood group BTS-LP-101-IMP (IH) BTS-LP-108-IMP (gel station)

A B E F E

Baby /Cord blood Blood group BTS-LP-101-IMP (IH) A B F Rh blood group antibodies:

• anti-Cw

• anti-C

• anti-c

• anti-D

• anti-E

• anti-e

BTS-LP-101- IMP (IH) BTS-LP-108-IMP (gel station)

A B E F E

Kell system blood group

antibodies:

• anti-K

• anti-k

• anti-Kpa

Kidd blood group antibodies:

• anti-Jka

• anti-Jkb

Duffy blood group antibodies:

• anti-Fya

• anti-Fyb

Lutheran blood group

antibodies:

• anti-Lua

MNS blood group antibodies:

• anti-M

• anti-N

• anti-S

• anti-s

8674

Accredited to

ISO 15189:2012













Location

Code

HUMAN BODY FLUIDS (cont’d):

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

In house manual Indirect Antiglobulin test procedure in conjunction with:

EDTA Whole Blood Lewis blood group antibodies:

• anti-Lea anti-Leb

BTS-LP-101- IMP (IH) BTS-LP-108-IMP (gel station)

A B E F E

P blood group antibodies:

• anti-P1

Direct Antiglobulin Test (DAT) BTS-LP-101-IMP A B E F Phenotype:

Rh/K BTS-LP-101-IMP and 108-IMP A B E F

Phenotype:

• Duffy

• Kidd

• Lewis

• Lua

• M/N

• Ss

Biorad Card system: BTS-LP-119-IMP

A B F

Phenotype:

Rh/K Biorad Card system: BTS – LP-119-IMP

A B E F

Rh blood group antibodies:

• anti-Cw

• anti-C

• anti-c

• anti-D

• anti-E

• anti-e

Biorad Card system: BTS-LP-122-IMP Glass tubes: BTS-LP-123-IMP

A B E F

Kell system blood group

antibodies:

• anti-K

• anti-k

• anti-Kpa

Kidd blood group antibodies:

• anti-Jka

• anti-Jkb

8674

Accredited to

ISO 15189:2012













Location

Code

HUMAN BODY FLUIDS (cont’d)

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

In house manual Indirect Antiglobulin test procedure in conjunction with:

EDTA Whole Blood Duffy blood group antibodies:

• anti-Fya

• anti-Fyb

Compatibility testing of

patients plasma with donor cells.

Biorad card system: BTS-LP-070-IMP

A B E F

Compatibility testing of

patients plasma with donor cells.

In house manual procedure in conjunction with, centrifuge and polypropylene tubes. Immediate-Spin (IS). BTS-LP-070-IMP

A B E F

Foetal Cell haemoglobin

(Kleihauer) In house manual procedure using inverclyde fixative and acid elution kit: BTS-LP-120-IMP

A B F

Rapid ABO Blood Group:

A,B,O,AB and Rh D+/- In house manual (tube method) procedure: BTS-LP-116-IMP

A B E F

Coagulation examination


In-house documented procedures in conjunction with Sysmex CS2100i equipment manuals as specified below:

Citrated Plasma 50:50 APTT mix

50:50 PT HAE-LP-279-M HAE-LP-235-H HAE-LP-882-X HAE-LP-1000-C

A B E F

80:20 APTT mix HAE-LP-279-M A Prothrombin time (PT) HAE-LP-279-M

HAE-LP-854-H HAE-LP-882-X HAE-LP-692-C

A B E F

8674

Accredited to

ISO 15189:2012













Location

Code


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


Citrated Plasma APTT (Activated Partial

Thromboplastin time)

HAE-LP-279-M HAE-LP-854-H HAE-LP-882-X HAE-LP-692-C

A B E F

Factor VIII Inhibitor screen HAE-LP-856-M


A B E F

Quantitation of Factor VIII

inhibitor (Bethesda Assay) HAE-LP-856-M HAE-LP-393-H

A B

Factor II,V,VII,VIII,IX,X,XI,XII

assay HAE-LP-1151-M & 1153-M HAE-LP-871-H HAE-LP-699-X HAE-LP-965-C

A B E F

Factor VIII assay HAE-LP-293-M (Chromogenic

Assay) HAE-LP-877-H (Refacto)

A B

Factor XIII assay HAE-LP-284-M

HAE-LP-879-H A B

Fibrinogen (clauss) HAE-LP-279-M


A B E F

Thrombin time HAE-LP-279-M


A B E F

Quantification of Protein C HAE-LP-1152-M,


A B E F

Protein S free Antigen HAE-LP-1149-IMP A,B,E,F

8674

Accredited to

ISO 15189:2012













Location

Code




Citrated Plasma Reptilase time HAE-LP-279-M A Quantification of Antithrombin HAE-LP-1152-M


A B E F

Antithrombin Antigen HAE-LP-370-H Latex assay B

Lupus Anticoagulant Screening


A B E F

Quantification of Dabigatran HAE-LP-1063-H B

Apixaban Anti Xa HAE-LP-1106-H B Rivaroxaban Anti Xa HAE-LP-1041-H B

Low Molecular Weight

Heparin Anti Xa HAE-LP-1139-IMP () (Hyphen)

A,B,E,F

In house documented procedures

in conjunction with Stago KC4 equipment manuals (Electromagnetic detection):

APTT HAE-LP-1130-M

HAE-LP-1054-X A E

Prothrombin Time and INR HAE-LP-1130-M

HAE-LP-1054-X A E

Anti PF4 / Heparin Antibodies

Screen Card chromatography for detection of Heparin Induced Thrombocytopenia using STic Expert HIT: HAE-LP- 1128 IMP

A,B,E,F

Citrated Plasma Anti PF4 / Heparin Antibodies

Quantitation ACL Acustar using chemiluminescent immunoassay: SOP HAE-LP-1126-IMP

B

8674

Accredited to

ISO 15189:2012













Location

Code



In house documented procedures in conjunction with Stago KC4 equipment manuals (Electromagnetic detection):

Von Willebrand Multimers

HAE-LP-232-H (Agar gel electrophoresis)

B

Von Willebrand Factor Latex

Antigen Assay HAE-LP-874-H B

VWF Ristocetin Cofactor

Assay HAE-LP-416-H (APACT 4 – Platelet agglutination)

B

Citrated Plasma Quantification of the binding of vWF to collagen (Collagen Binding Assay)

Manual Elisa using Technoclone vWF:CBA ELISA kit and DYNEX OPSYS MR microtitre plate reader: HAE-LP-380-H

B

Derived results: International Normalized Ratio

(INR)


A B E F

APTTR (Activated Partial

Thromboplastin time ratio)


A B E F

Haematology examination


Whole Blood: EDTA Haemoglobinopathy screen to

confirm or exclude presence of haemoglobin variant and / or thalassaemia

Haemoglobin separation using HPLC Biorad Variant II: HAE-LP-067-M HAE-LP-646-H

A B

Haemoglobinopathy screen to

confirm or exclude presence of haemoglobin variant and / or thalassaemia

Acid Agarose Gel electrophoresis: HAE-LP-055-M HAE-LP-546-H

A B

8674

Accredited to

ISO 15189:2012













Location

Code


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

Haemoglobin F Quantitation Cellulose Acetate Electrophoresis:

HAE-LP-598-H B

Deficiency or abnormality of

red cell Band 3 protein In house documented Dye binding Test using EMA (eosin-5-maleimide) dye and BD FACS Canto flow cytometry method: HAE-LP-743-H

B

G6PD In-house documented method in

conjunction with Trinity Biotech kit using spectrophotometry: HAE-LP-1147-M HAE-LP-622-H HAE-LP-816-C

A B F

Urine Identification of Haemosiderin In-house method for pearl iron

staining and microscopy: HAE-LP-019-M HAE-LP-590-H

HAE-LP-819-C

A B F

Whole Blood: EDTA Haptoglobins In house documented antibody/

antigen reaction method using immunodiffusion: HAE-LP-084-M

A

Whole Blood: EDTA Identification of normal and

abnormal morphologies including WBC differential count

In-house manual staining method, in conjunction with SP1000i stain maker instructions, examination by light microscopy (May-Grunwald and Geimsa stain): HAE-LP-013-M, -026-M,1107-M & 1055-M HAE-LP-494-H HAE-LP-868-X & -1094-X HAE-LP-708-C

A B E F

8674

Accredited to

ISO 15189:2012













Location

Code



Whole Blood: EDTA Malarial Parasite Antigen for

pLDH (plasmodium Lactate Dehydrogenase). Detects Plasmodium +/- Falciparum

In-house documented method in conjunction with Care start kit: HAE-LP-1111-IMP

A,B,E,F

Malaria screening for:

P. falciparum P. vivax P. ovale P. malariae P. knowlesi

In house documented manual microscopy method using: Giemsa Staining (Thick Film), and Leishmans staining (Thin Film): HAE-LP-1116-IMP HAE-LP-1117-IMP

A,B,E,F A,B,E,F

Full Blood Count:

WBC,Hb,Plt,RBC,MCV,MPV RDW,PCV,MCH,MCHC,Reticulocyte count, neutrophil count, lymphocyte count, monocyte count, basophil count, citrated platelet count

In-house documented method in conjunction with Sysmex XE2100: HAE-LP-1103-M HAE-LP-512-H HAE-LP-431-X & -1109-X HAE-LP-701-C & 702-C

A B E F

Full Blood Count:

WBC, Hb, Plt, RBC, MCV, MPV, RDW, PCV, MCH, MCHC, neutrophil count, lymphocyte count, monocytes

In-house documented method in conjunction with Sysmex PocH-100i: HAE-LP-500-H

C

Full Blood Count:

WBC, Hb, Plt, RBC, MCV, MPV, RDW, PCV, MCH, MCHC, reticulocyte count, neutrophil count, lymphocyte count, monocyte count, basophil count, citrated platelet count

In-house documented method in conjunction with SYSMEX XT2000i: HAE-LP-606-H

D

Detection of IgM antibodies

specific to Infectious Mononucleosis

In-house documented method Using Clearview IM II Mono kit: HAE-LP-1132-IMP

A B E F

8674

Accredited to

ISO 15189:2012













Location

Code



Whole Blood: EDTA Erythrocyte sedimentation rate

(ESR) In-house documented method in conjunction with Vesmatic 30: HAE-LP-039-M HAE-LP-1496-H

A B

In-house documented method in

conjunction with StaRRsed analyser: HAE-LP-428-X HAE-LP-703-C

E F

END

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