Schedule of Accreditation
issued by
United Kingdom Accreditation Service
2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK
The Doctors Laboratory Limited
Issue No:001
Issue date: 27 March 2018
The Halo Building
Contact: Sally Curtis
1 Mabledon Place
Tel: +44 (0) 20 7307 7342
8812
London
E-Mail: xxxxx.xxxxxx@xxxxxxxxxxxx.xxx
Accredited to
WC1H 9AX
Website: www.tdlpathology.com
ISO 15189:2012
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
Local contact
The Doctors Laboratory (Manchester)
Sally Curtis
Haematology
A
Michigan Avenue
Blood Transfusion
Salford Quays
Biochemistry
Greater Manchester
Microbiology
M50 2GY
Molecular Biology
Pathology Laboratory
Sally Curtis
Haematology
B
BMI Alexandra Hospital
Biochemistry
Mill Lane
Blood Fridge
Cheadle
Cheshire
SK8 2PX
Assessment Manager: MP
Page 1 of 9
S c h e d u l e o f Ac c r e d i t a t i o n
issued by
United Kingdom Ac c reditation Service
2 P i n e T r e e s , C h e r t s e y L a n e , S t a i n e s - u p o n - T h a m e s , T W 1 8 3 H R , U K
The Doctors Laboratory Limited
8812
Accredited to
Issue No: 001
Issue date: 27 March 2018
ISO 15189:2012
Testing performed by the Organisation at the locations specified
Site activities performed away from the locations listed above:
Location details
Activity
Location
code
BMI Highfield Hospital
Blood issue fridge for storage of blood
C
Manchester Road
products only; no testing occurs at this
Rochdale
site
Lancashire
OL11 4LZ
BMI Beardwood Hospital
Blood issue fridge for storage of blood
D
Preston New Road
products only; no testing occurs at this
Blackburn
site
Lancashire
BB2 7AE
BMI Beaumont Hospital
Blood issue fridge for storage of blood
E
Old Hall Clough
products only; no testing occurs at this
Chorley New Road
site
Bolton
Lancashire
BL6 4LA
BMI Huddersfield Hospital
Blood issue fridge for storage of blood
F
Birkby Hall Road
products only; no testing occurs at this
Huddersfield
site
HD2 2BL
Ramsay Renacres Hall Hospital
Blood issue fridge for storage of blood
G
Renacres Lane
products only; no testing occurs at this
Ormskirk
site
Lancashire
L39 8SE
Assessment Manager: MP
Page 2 of 9
S c h e d u l e o f Ac c r e d i t a t i o n
issued by
United Kingdom Ac c reditation Service
2 P i n e T r e e s , C h e r t s e y L a n e , S t a i n e s - u p o n - T h a m e s , T W 1 8 3 H R , U K
The Doctors Laboratory Limited
8812
Accredited to
Issue No: 001
Issue date: 27 March 2018
ISO 15189:2012
Testing performed by the Organisation at the locations specified
DETAIL OF ACCREDITATION
Materials/Products tested
Type of test/Properties
Standard specifications/
Location
measured/Range of
Equipment/Techniques used
Code
measurement
HUMAN BODY FLUIDS
Haematology examination
In-house documented procedures
activities for the purposes of
based on equipment manuals and
clinical diagnosis:
standard methods as specified
below:
EDTA Blood
Full Blood Count
SOP TDL-H-EQPT-007 using
A
(red blood cells, Neutrophils,
Sysmex XT1800i and SOP TDL-H-
Lymphocytes, Monocytes,
EQPT-001 using XS1000i
Eosinophils and Basophils),
Haemoglobin, HCT, MCV,
SOP TDL-H-EQPT-001 using
B
MCH, MCHC, RDW, Platelet
Sysmex XS1000i
Count, White Cell Count).
Citrated Sample
Coagulation
Prothrombin time
SOP TDL-H-EQPT-009 using
A
Sysmex CA540
Activated Partial
SOP TDL-H-EQPT-011 using
B
Thromboplastin time
Syxmex C660
Fibrinogen
EDTA Blood
Blood film assessment & cell
SOP TDL-H-004 by Speedy-diff
A & B
differential
staining and light microscopy
EDTA Blood
Sickle Cell Haemoglobin
SOP TDL-MAN-025 by qualitative
A
Screening Test
solubility using TCS Biosciences
Sickle-Check Hb-S Test Kit
EDTA Blood
Detection of Infectious
SOP TDL-H-008 using Accusay
A
Mononucleosis heterophile
Mono
antibodies
Blood
Erythrocyte sedimentation rate
SOP TDL-MAN-032 using Starrsed
A
(automated)
Auto-Compact
Blood
Erythrocyte sedimentation rate
SOP TDL-H-010 using Westergren
A & B
(manual)
Assessment Manager: MP
Page 3 of 9
S c h e d u l e o f Ac c r e d i t a t i o n
issued by
United Kingdom Ac c reditation Service
2 P i n e T r e e s , C h e r t s e y L a n e , S t a i n e s - u p o n - T h a m e s , T W 1 8 3 H R , U K
The Doctors Laboratory Limited
8812
Accredited to
Issue No: 001
Issue date: 27 March 2018
ISO 15189:2012
Testing performed by the Organisation at the locations specified
Materials/Products tested
Type of test/Properties
Standard specifications/
Location
measured/Range of
Equipment/Techniques used
Code
measurement
HUMAN BODY FLUIDS
Blood Transfusion
In house documented procedures
(cont’d)
in conjunction with equipment
General examination activities
manuals and standard methods as
for the purposes of clinical
specified below:
diagnosis:
EDTA Blood
Automated Blood Group:
SOP TDL-BT-021using Diamed
A
A Rh D negative/Positive
GelStation
O Rh D negative/Positive
B Rh D Negative/Positive
AB Rh D Negative/Positive
EDTA Blood
Automated Antibody detection:
SOP TDL-BT-021 using Diamed
A
GelStation and the following panels
Antibody screening:
(D,C,E,c,e,Cw,K,k,Kpb,Fya,Fyb,
Jka,Jkb,Lea,Leb,P1,M,N,S,s,Lub,
Xga )
Antibody detection:
using Bio-Rad Dia-Panel
(D, C, E, c, e & Kell)
Antibody detection:
using Bio-Rad Dia-Panel-P
(D, C, E, c, e & Kell)
(enzyme treated) and NHSBT IAT
panel
Direct Anti-Globulin test (DAT)
SOP TDL-BT-024 using Diamed
A
(IgG Antibody)
Gel cards
Manual Group & antibody
SOP-TDL-BT-025 using Diamed
A
screen
Gel cards
Manual Groups
SOP-TDL-BT-030 using manual
A
tube grouping method
Manual crossmatch
SOP-TDL-BT-087 using Diamen
A
Gelcards
Assessment Manager: MP
Page 4 of 9
S c h e d u l e o f Ac c r e d i t a t i o n
issued by
United Kingdom Ac c reditation Service
2 P i n e T r e e s , C h e r t s e y L a n e , S t a i n e s - u p o n - T h a m e s , T W 1 8 3 H R , U K
The Doctors Laboratory Limited
8812
Accredited to
Issue No: 001
Issue date: 27 March 2018
ISO 15189:2012
Testing performed by the Organisation at the locations specified
Materials/Products tested
Type of test/Properties
Standard specifications/
Location
measured/Range of
Equipment/Techniques used
Code
measurement
HUMAN
BODY
FLUIDS
General Biochemistry
In house documented procedures
(cont’d)
based on equipment manuals and
Biochemical examination
standard methods as specified
activities for the purposes of
below:
clinical diagnosis.
Serum / Plasma (unless
Quantification of:
SOP TDL-MAN-COB-006 using
otherwise stated)
Roche Cobas 6000 (Location A)
and TDL-B-EQPT-001 using
Cobas c111 (Location B) by ISE
Sodium
A & B
Potassium
A & B
Chloride
A & B
Serum / Plasma (unless
SOP TDL-MAN-COB-006 using
otherwise stated)
Roche Cobas 6000 (Location A)
and TDL-B-EQPT-001 using
Cobas c111 (Location B) by
photometry
Albumin
A & B
Alkaline Phosphatase (ALP)
A & B
Alanine Transaminase (ALT)
A & B
Amylase
A & B
Asparate Transaminase (AST)
A & B
Bilirubin (total)
A & B
Calcium
A & B
Cholesterol
A
Creatine Kinase
A & B
Bicarbonate
A
Assessment Manager: MP
Page 5 of 9
S c h e d u l e o f Ac c r e d i t a t i o n
issued by
United Kingdom Ac c reditation Service
2 P i n e T r e e s , C h e r t s e y L a n e , S t a i n e s - u p o n - T h a m e s , T W 1 8 3 H R , U K
The Doctors Laboratory Limited
8812
Accredited to
Issue No: 001
Issue date: 27 March 2018
ISO 15189:2012
Testing performed by the Organisation at the locations specified
Materials/Products tested
Type of test/Properties
Standard specifications/
Location
measured/Range of
Equipment/Techniques used
Code
measurement
HUMAN
BODY
FLUIDS
General Biochemistry
In house documented procedures
(cont’d)
based on equipment manuals and
Biochemical examination
standard methods as specified
activities for the purposes of
below:
clinical diagnosis. (cont’d)
Serum / Plasma (unless
Quantification of: (cont’d)
SOP TDL-MAN-COB-006 using
otherwise stated) (cont’d)
Roche Cobas 6000 (Location A)
and TDL-B-EQPT-001 using Cobas
c111 (Location B) by photometry
Creatinine
A & B
C-Reactive protein
A & B
Gamma-glutamyl
A & B
Transpeptidase (GGT)
Gentamicin
A
Glucose
A & B
HDL Cholesterol
A
Iron
Lactate Dehydrogenase
A & B
Magnesium
A & B
Phosphate
A
Phospholipase A2 (PLA2)
A
Total Protein
A & B
Transferrin
A
Triglyceride
A
Unsaturated Iron Binding
A
Capacity
Assessment Manager: MP
Page 6 of 9
S c h e d u l e o f Ac c r e d i t a t i o n
issued by
United Kingdom Ac c reditation Service
2 P i n e T r e e s , C h e r t s e y L a n e , S t a i n e s - u p o n - T h a m e s , T W 1 8 3 H R , U K
The Doctors Laboratory Limited
8812
Accredited to
Issue No: 001
Issue date: 27 March 2018
ISO 15189:2012
Testing performed by the Organisation at the locations specified
Materials/Products tested
Type of test/Properties
Standard specifications/
Location
measured/Range of
Equipment/Techniques used
Code
measurement
HUMAN
BODY
FLUIDS
General Biochemistry
In house documented procedures
(cont’d)
based on equipment manuals and
standard methods as specified
below:
Serum / Plasma (unless
Quantification of: (cont’d)
SOP TDL-MAN-COB-006 using
otherwise stated) (cont’d)
Roche Cobas 6000 (Location A)
and TDL-B-EQPT-001 using Cobas
c111 (Location B) by photometry
Urate
A
Urea
A & B
Vancomycin
A
Vitamin D
A
Testosterone (free)
SOP EXT-1034using Accubindon
A
BEST 2000 by ELISA
HbA1c
SOP WSL-AB-TOS-001 using
TOSOH G8 by HPLC
Immunoassay
In house documented procedures
based on equipment manuals and
Biochemical examination
standard methods as specified
activities for the purposes of
below:
clinical diagnosis.
Quantification of:
SOP TDL-MAN-COB-006 using A
Roche Cobas 6000
CA125
Carcinoembryonic antigen
(CEA)
Ferritin
Folate
Follicle Stimulating Hormone
Assessment Manager: MP
Page 7 of 9
S c h e d u l e o f Ac c r e d i t a t i o n
issued by
United Kingdom Ac c reditation Service
2 P i n e T r e e s , C h e r t s e y L a n e , S t a i n e s - u p o n - T h a m e s , T W 1 8 3 H R , U K
The Doctors Laboratory Limited
8812
Accredited to
Issue No: 001
Issue date: 27 March 2018
ISO 15189:2012
Testing performed by the Organisation at the locations specified
Materials/Products tested
Type of test/Properties
Standard specifications/
Location
measured/Range of
Equipment/Techniques used
Code
measurement
HUMAN
BODY
FLUIDS
Immunoassay
In house documented procedures
(cont’d)
based on equipment manuals and
Biochemical examination
standard methods as specified
activities for the purposes of
below:
clinical diagnosis. (cont’d)
Quantification of: (cont’d)
SOP TDL-MAN-COB-006 using A
Roche Cobas 6000
Human chorionic
gonadotrophin (HCG)
Lutenising Hormone
Oestradiol
Progesterone
Prolactin
Prostate specific antigen
(free & total)
T3 (free & toal)
T4 (total)
Testosterone
Thyroid Stimulating Hormone
Troponin T (high sensitivity)
Vitamin B12
Testosterone
Thyroid Stimulating Hormone
Troponin T (high sensitivity)
Vitamin B12
Assessment Manager: MP
Page 8 of 9
S c h e d u l e o f Ac c r e d i t a t i o n
issued by
United Kingdom Ac c reditation Service
2 P i n e T r e e s , C h e r t s e y L a n e , S t a i n e s - u p o n - T h a m e s , T W 1 8 3 H R , U K
The Doctors Laboratory Limited
8812
Accredited to
Issue No: 001
Issue date: 27 March 2018
ISO 15189:2012
Testing performed by the Organisation at the locations specified
Materials/Products tested
Type of test/Properties
Standard specifications/
Location
measured/Range of
Equipment/Techniques used
Code
measurement
HUMAN
BODY
FLUIDS
Viral Serology
In house documented procedures
(cont’d)
based on equipment manuals and
Serological examination
standard methods as specified
activities for the purposes of
below:
clinical diagnosis.
Quantification of:
SOP TDL-MAN-COB-006 using A
Roche
Cobas
6000
by
immunoassay
Hepatitis A total antibody
Hepatitis B surface antigen
Hepatitis B surface antibody
Hepatitis B core antibody
Hepatitis C IgG / IgM antibody
HIV p24 antigen & HIV1/2
antibody
Syphilis IgG and IgM
HIV-1 p24 Ag, HIV-1 Ab
SOP EXT-1672 using Bioplex HIV5
A
(Groups M & O), HIV-2 Ab
Molecular Biology
Molecular examination
In house documented procedures
activities for the purposes of
based on equipment manuals and
clinical diagnosis. Detection of:
standard methods by polymerase
chain reaction as specified below:
Swabs from nose, groin,
MRSA
SOP CH-M-4-2-17 using Cepheid
A
axilla
GeneXpert
Urine and Throat, Vaginal
Detection of Chlamydia
SOP TDL-I-1-92 using BD Viper
A
and Rectal swabs
trachomatis and Neisseria
XTR and Cepheid GeneXpert
gonorrhoea DNA
END
Assessment Manager: MP
Page 9 of 9