109
Department: Pathology Site Wythenshawe Hospital Revision No: 41 Document title: Laboratory Medicine Handbook Author: Andrew Sayce Document No: PG-D-HANDBOOK-1 Approved by: M Evans, K Morris, K Congdon Page 1 of 109 Last printed 05/02/2020 12:10:00 Division of Laboratory Medicine Wythenshawe Hospital Laboratory Medicine Handbook Table of Contents............................................................................................................... 1 1 Introduction .............................................................................................................. 5 1.1 Accreditation.................................................................................................................... 5 1.2 Quality assurance ............................................................................................................ 6 1.3 Key performance indicators ............................................................................................. 7 1.4 Protection of personal information ................................................................................... 7 1.5 Patient information........................................................................................................... 7 1.6 Sample acceptance ......................................................................................................... 7 1.6.1 Samples failing acceptance criteria ......................................................................................... 7 1.6.2 Exceptions ............................................................................................................................... 8 1.6.3 Two-Sample Rule .................................................................................................................... 8 1.6.4 Patient consent ........................................................................................................................ 9 1.7 Requesting and reporting of laboratory tests ................................................................... 9 1.8 What to do when there is an IT failure ............................................................................. 9 1.9 Sample containers ........................................................................................................... 9 1.10 Sample transportation ................................................................................................... 11 1.10.1 Hospital requirements ....................................................................................................... 12 1.10.2 GP requirements ............................................................................................................... 12 1.10.3 Postal samples .................................................................................................................. 12 1.11 Requesting further tests on samples already in the laboratory (‘add-on’ tests) .............. 12 1.11.1 Biochemistry ...................................................................................................................... 12 1.11.2 Haematology ..................................................................................................................... 12 1.11.3 Mycology Reference Centre .............................................................................................. 12 1.12 Turnaround times .......................................................................................................... 13 How to use this document: Do not print it. It may change, the most up-to-date version will always be available on the Trust internet/intranet Click on items in this table of contents to navigate to the required section Click to navigate between sections / open hyperlinks in a browser / email addresses to send a message Use bookmarks in the navigation pane in your PDF viewer to move around the document Ctrl +F to perform a word search Click for an A-Z list of tests

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Department: Pathology

Site Wythenshawe Hospital Revision No: 41

Document title: Laboratory Medicine Handbook

Author: Andrew Sayce Document No: PG-D-HANDBOOK-1

Approved by: M Evans, K Morris, K Congdon Page 1 of 109 Last printed 05/02/2020 12:10:00

Division of Laboratory Medicine

Wythenshawe Hospital

Laboratory Medicine Handbook

Table of Contents

Table of Contents............................................................................................................... 1

1 Introduction .............................................................................................................. 5

1.1 Accreditation .................................................................................................................... 5

1.2 Quality assurance ............................................................................................................ 6

1.3 Key performance indicators ............................................................................................. 7

1.4 Protection of personal information ................................................................................... 7

1.5 Patient information ........................................................................................................... 7

1.6 Sample acceptance ......................................................................................................... 7 1.6.1 Samples failing acceptance criteria ......................................................................................... 7 1.6.2 Exceptions ............................................................................................................................... 8 1.6.3 Two-Sample Rule .................................................................................................................... 8 1.6.4 Patient consent ........................................................................................................................ 9

1.7 Requesting and reporting of laboratory tests ................................................................... 9

1.8 What to do when there is an IT failure ............................................................................. 9

1.9 Sample containers ........................................................................................................... 9

1.10 Sample transportation ................................................................................................... 11 1.10.1 Hospital requirements ....................................................................................................... 12 1.10.2 GP requirements ............................................................................................................... 12 1.10.3 Postal samples .................................................................................................................. 12

1.11 Requesting further tests on samples already in the laboratory (‘add-on’ tests) .............. 12 1.11.1 Biochemistry ...................................................................................................................... 12 1.11.2 Haematology ..................................................................................................................... 12 1.11.3 Mycology Reference Centre .............................................................................................. 12

1.12 Turnaround times .......................................................................................................... 13

How to use this document:

Do not print it. It may change, the most up-to-date version will always be available on the Trust

internet/intranet

Click on items in this table of contents to navigate to the required section

Click to navigate between sections / open hyperlinks in a browser / email addresses to send a message

Use bookmarks in the navigation pane in your PDF viewer to move around the document

Ctrl +F to perform a word search

Click for an A-Z list of tests

Department: Pathology

Site Wythenshawe Hospital Revision No: 41

Document title: Laboratory Medicine Handbook

Author: Andrew Sayce Document No: PG-D-HANDBOOK-1

Approved by: M Evans, K Morris, K Congdon Page 2 of 109 Last printed 05/02/2020 12:10:00

1.13 Complaints or comments ............................................................................................... 13

2 DLM general contact details ................................................................................. 13

3 Phlebotomy ............................................................................................................ 14

3.1 Inpatient service ............................................................................................................ 14

3.2 Outpatient service .......................................................................................................... 14

3.3 General Practitioner service .......................................................................................... 14

4 Sample reception ................................................................................................... 16

5 Biochemistry .......................................................................................................... 17

5.1 Contact details ............................................................................................................... 18

5.2 Working hours ............................................................................................................... 18 5.2.1 Outside routine hours ............................................................................................................ 18

5.3 Urgent Requests............................................................................................................ 19

5.4 Examinations offered by Biochemistry ........................................................................... 19

5.5 Sample transportation ................................................................................................... 20

5.6 Add-on Tests ................................................................................................................. 20

5.7 Sample Information ....................................................................................................... 20

5.8 Test library ..................................................................................................................... 21

5.9 Factors known to significantly affect performance of tests/interpretation of results ........ 54

5.10 Effect of haemolysis, lipaemia and icterus: .................................................................... 55

5.11 Measurement uncertainty .............................................................................................. 55

5.12 Point of Care ................................................................................................................. 55

6 Haematology .......................................................................................................... 56

6.1 Contact details ............................................................................................................... 56

6.2 Routine Haematology .................................................................................................... 57 6.2.1 Test library ............................................................................................................................. 57

6.3 Coagulation ................................................................................................................... 61 6.3.1 Test library ............................................................................................................................. 61 6.3.2 Factors affecting the results or processing of coagulation tests ........................................... 62

6.4 Immunology ................................................................................................................... 62 6.4.1 Immunology test library ......................................................................................................... 63

6.5 Blood transfusion ........................................................................................................... 63 6.5.1 Two sample rule .................................................................................................................... 63 6.5.2 Test library ............................................................................................................................. 64

7 Cellular Pathology ................................................................................................. 67

7.1 Contact details ............................................................................................................... 67

7.2 General information ....................................................................................................... 69

7.3 Sample acceptance ....................................................................................................... 69

7.4 Clinical information ........................................................................................................ 69

7.5 Sample containers ......................................................................................................... 70

Department: Pathology

Site Wythenshawe Hospital Revision No: 41

Document title: Laboratory Medicine Handbook

Author: Andrew Sayce Document No: PG-D-HANDBOOK-1

Approved by: M Evans, K Morris, K Congdon Page 3 of 109 Last printed 05/02/2020 12:10:00

7.6 Histology sample collection ........................................................................................... 71

7.7 Supply of sample containers .......................................................................................... 71

7.8 Factors that prevent a detailed accurate diagnosis ........................................................ 71

7.9 Frozen sections ............................................................................................................. 71 7.9.1 Booking cardiothoracic frozen section requests .................................................................... 71 7.9.2 Booking other frozen section requests .................................................................................. 71 7.9.3 Once specimen has been taken ............................................................................................ 72

7.10 Bone Marrow Trephine specimens. ............................................................................... 72

7.11 Skin immunofluorescence specimens ............................................................................ 72

7.12 Oral immunofluorescence specimens ............................................................................ 72

7.13 Amputated limb specimens ............................................................................................ 73

7.14 Cytology samples .......................................................................................................... 73 7.14.1 Broncho-alveolar lavages (BAL) ....................................................................................... 76 7.14.2 Endobronchial ultrasound guided aspirate specimens (EBUS) ........................................ 76 7.14.3 Joint Fluids ........................................................................................................................ 76

7.15 Cervical Cytology ........................................................................................................... 76

7.16 Andrology ...................................................................................................................... 76 7.16.1 Infertility ............................................................................................................................. 76 7.16.2 Post vasectomy ................................................................................................................. 77

7.17 Sample transport ........................................................................................................... 79

7.18 Reports .......................................................................................................................... 80

7.19 RCPath cancer standards and data sets ....................................................................... 80

7.20 Multidisciplinary Team Meetings (MDT’s) ...................................................................... 81

7.21 Turnaround times .......................................................................................................... 81

7.22 Material sent away for further tests ................................................................................ 81

7.23 Return of tissues............................................................................................................ 81

7.24 Disposal of tissues ......................................................................................................... 82

7.25 Errors happen ................................................................................................................ 82

7.26 Manchester Cancer Research Centre Tissue Bank ....................................................... 82

7.27 Measurement uncertainty .............................................................................................. 82

8 Mortuary ................................................................................................................. 83

8.1 Contact details ............................................................................................................... 83

8.2 Opening hours: .............................................................................................................. 83

8.3 Adult post mortems ........................................................................................................ 83

8.4 Infectious bodies............................................................................................................ 85

8.5 Medical Devices ............................................................................................................ 85 8.5.1 Pacemakers and defibrillators ............................................................................................... 85 8.5.2 Fixion

TM intramedullary nails .................................................................................................. 85

8.6 Stillbirths and foetuses, post mortems and disposal ...................................................... 85 8.6.1 Wythenshawe Hospital patients ............................................................................................ 85 8.6.2 Tameside patients ................................................................................................................. 86

9 Microbiology .......................................................................................................... 87

Department: Pathology

Site Wythenshawe Hospital Revision No: 41

Document title: Laboratory Medicine Handbook

Author: Andrew Sayce Document No: PG-D-HANDBOOK-1

Approved by: M Evans, K Morris, K Congdon Page 4 of 109 Last printed 05/02/2020 12:10:00

9.1 Urgent requests out of hours ............................................ Error! Bookmark not defined.

9.2 Contact details .................................................................. Error! Bookmark not defined.

10 Mycology Reference Centre, Manchester ............................................................ 88

10.1 Contact Details .............................................................................................................. 88

10.2 Additional Tests ............................................................................................................. 89

10.3 Measurement Uncertainty .............................................................................................. 89

10.4 Antifungal Drug Levels................................................................................................... 89 10.4.1 Indications for monitoring .................................................................................................. 89

10.4.2 References ..................................................................................................................... 89

10.5 Identification and susceptibility testing of medically important fungi ............................... 89

11 Appendix A – A-Z List of tests ............................................................................ 103

Standards covered by this document:

ISO 15189:2012 5.4.2 Information for patients and users

MHRA QMS

specifications 5.4.1 There is an up to date user manual

HTA 2004

Department: Pathology

Site Wythenshawe Hospital Revision No: 41

Document title: Laboratory Medicine Handbook

Author: Andrew Sayce Document No: PG-D-HANDBOOK-1

Approved by: M Evans, K Morris, K Congdon Page 5 of 109 Last printed 05/02/2020 12:10:00

1 Introduction

The Division of Laboratory Medicine (DLM) at Manchester University NHS Foundation Trust (MFT)

Wythenshawe Hospital provides diagnostic services to Wythenshawe and Withington Hospitals as

well as General Practitioner surgeries in the South Manchester area and beyond. The Histopathology

Department also provide a service to Tameside and Glossop Integrated Care Organisation. There

are four departments within Division of Laboratory Medicine based at Wythenshawe Hospital;

Biochemistry, Haematology, Cellular Pathology (including provision of mortuary services), and the

Mycology Reference Centre Manchester (MRCM).

Laboratory Medicine (except MRCM) is housed in the Clinical Sciences Building on the

Wythenshawe Hospital site, shown in the bottom right corner of the map below. The Mycology

Reference Centre is based in the Education and Research Centre; also shown below, in orange.

This handbook relates to DLM services located at Wythenshawe Hospital. Information on laboratory

medicine services located at the Oxford Road Campus can be found here. The Microbiology

laboratory is based at the Oxford Road Campus.

1.1 Accreditation

Each department within Laboratory Medicine has undergone external accreditation by the United

Kingdom Accreditation Service, UKAS. Current accreditation status can be checked on the UKAS

website, using the UKAS numbers in the table. The accreditation process requires annual inspection

to ensure there is a system of quality management in place to give assurance that the results

released and advice given by the laboratory are of a high standard.

Department: Pathology

Site Wythenshawe Hospital Revision No: 41

Document title: Laboratory Medicine Handbook

Author: Andrew Sayce Document No: PG-D-HANDBOOK-1

Approved by: M Evans, K Morris, K Congdon Page 6 of 109 Last printed 05/02/2020 12:10:00

Laboratory UKAS Number

Biochemistry 9063

Haematology 9072

Histopathology 9083

Microbiology 8393

Mycology 10196

The Blood Transfusion laboratory, also known as blood bank, conforms to the UK Blood Safety and

Quality Regulations and is deemed compliant with these by the Medicines & Healthcare products

Regulatory Agency (MHRA). This compliance is assessed annually.

In England, Wales and Northern Ireland, mortuaries where post-mortem examinations take place are

licensed and inspected by the Human Tissue Authority (HTA). The HTA help mortuaries improve the

standard of care they provide, so the public can have confidence that deceased people are treated

with dignity and respect. The mortuary at MFT Wythenshawe is licenced by the HTA and is inspected

on a regular basis to ensure we are complying with all the relevant regulations.

1.2 Quality assurance

Test performed in the laboratories are enrolled either in a national/international External Quality

Assurance (EQA) scheme or a similar local scheme where no national scheme is available. This

ensures that our tests are performing well. We also use Internal Quality Assurance (IQA) and

Internal Quality Control (IQC) to monitor the performance of our tests.

Our clinical and some scientific staff are also enrolled on proficiency testing EQA schemes, where

they are tested on their interpretation of case studies involving pathology test results. This ensures

that the reports issued are correctly interpreted and the right advice is given.

Each laboratory is approved by the Institute of Biomedical Science for training of Biomedical

Scientists, which has its own quality assurance programme.

The Biochemistry and Histopathology Departments at Wythenshawe Hospital are recognised for

training Specialty Trainees (STs) in each discipline. The training programmes are recognised and

approved by the Royal College of Pathologists (and the General Medical Council) and are quality-

assured by Health Education England North West. The Biochemistry and Mycology departments are

approved training centres for the Scientific Trainee Programme (STP), which is accredited by the

National School of Healthcare Science.

As part of this training approval we have comprehensive training programmes for all grades of staff to

ensure that they have all the required knowledge and skills to perform their duties to the highest

level. This includes the provision of expert clinical advice to our users and interpretive comments on

reports.

We also have Quality Managers within the laboratories who are employed to oversee all aspects of

quality and ensure that we meet the requirements of our accrediting and regulatory bodies.

Department: Pathology

Site Wythenshawe Hospital Revision No: 41

Document title: Laboratory Medicine Handbook

Author: Andrew Sayce Document No: PG-D-HANDBOOK-1

Approved by: M Evans, K Morris, K Congdon Page 7 of 109 Last printed 05/02/2020 12:10:00

1.3 Key performance indicators

We use Key Performance Indicators (KPIs) to monitor the quality of the service we provide. There is

a Laboratory Medicine dashboard that contains all of these KPIs, which is reviewed monthly to

ensure we are performing to the required standard.

1.4 Protection of personal information

The laboratory adheres to the Trust-wide Policies on information governance for the protection of

patient information, including the Trust “Data Protection Policy”.

1.5 Patient information

The Pathology Handbook is available to patients online.

1.6 Sample acceptance

All samples must have a request form (paper or electronic). We require four patient identifiers on all

samples and request forms. All patient identifiers must match exactly between the sample and the

request form. These identifiers and further requirements are detailed in the table below.

ESSENTIAL DESIRABLE

Sam

ple

& F

orm

Essential patient identifiers 1. First name 2. Surname 3. NHS / District number, or equivalent 4. Date of birth

Other essential information

Date(s) of samples – all departments

Time(s) of samples – blood sciences, microbiology and mycology

If the patient is high risk, eg VHF.

Anatomical site and biopsy site (histology, cytology, microbiology and mycology) should exactly match that on the request form, particularly when there are multiple samples

Intact/complete barcode on samples requested via EPR or ICE

Gender of patient

For GP requests - home address and contact number for patients

Form

on

ly

Clinical information for histology/cytology samples

Location/address for report

Clinician in charge

Test/examination required

Any foreign travel must be recorded, where relevant

All relevant clinical information

Contact number/bleep for requestor/consultant in charge

Time(s) of samples – histology and cytology

1.6.1 Samples failing acceptance criteria

If samples fail to meet the acceptance criteria they will not be processed. A report will be issued

stating why the sample was rejected. Only unrepeatable samples will be processed, but not before

Department: Pathology

Site Wythenshawe Hospital Revision No: 41

Document title: Laboratory Medicine Handbook

Author: Andrew Sayce Document No: PG-D-HANDBOOK-1

Approved by: M Evans, K Morris, K Congdon Page 8 of 109 Last printed 05/02/2020 12:10:00

the requestor has attended the relevant laboratory to complete a “Specimen Labelling Amendment

Form”. This form becomes part of the patient’s record.

Examples of unrepeatable samples:

Sterile body fluids (ie peritoneal, CSF, pleural)

Bone marrow

Fine needle aspirates (FNA)

Tissue biopsies/surgical specimens/cytology samples (with the exception of sputum, urine and

andrology samples)

Blood cultures

Mycology isolates from any of the above specimens

Bronchoscopy/endoscopy specimens

Drug levels timed for treatment (peak and trough), as well as any from neonatal patients

Blood samples from patients with no venous access (ie femoral stabs)

Arterial samples

All other samples will be rejected if they fail to meet the acceptance criteria. It is in everyone’s

interest, particularly the patients’, that all samples and forms are correctly labelled before they are

sent to the laboratory.

Please do not use addressograph labels on blood tubes or other small containers. These stickers

are too large and the extra bulk they add means the samples will not pass through the automated

analysers in the laboratories. Small labels can be used, except for transfusion samples.

1.6.2 Exceptions

In certain circumstances, patient identification details are intentionally hidden or substituted with

particular ID numbers (e.g. Sexual Health, Clinical trials, donor samples) in such instances, a

properly coded identifier must be used.

During a major incident, patients presenting through A&E will be allocated a MAJAX identification.

This consists of a MAJAX number in the place of a district number, forename number in text format

(e.g. THIRTEEN) and a surname from the phonetic alphabet with a MAJAX pre-fix (MAJAX HOTEL).

1.6.3 Two-Sample Rule

In line with current BCSH guidelines, two samples will be required to determine the blood group of a

patient before cross-matched components are released. If a patient has a historical blood group on

record, just one sample for the current request is required.

Any patient that does not have a Transfusion history (a known Blood Group on the laboratory

computer system) will require a second Group and Antibody Screen. The Transfusion Laboratory will

inform the clinician if a second sample is required. Two samples (with two separate request forms)

are required. These samples should be taken by two different people, or if bled by the same person

must be taken at a different time e.g. two independent separate phlebotomies.

Department: Pathology

Site Wythenshawe Hospital Revision No: 41

Document title: Laboratory Medicine Handbook

Author: Andrew Sayce Document No: PG-D-HANDBOOK-1

Approved by: M Evans, K Morris, K Congdon Page 9 of 109 Last printed 05/02/2020 12:10:00

1.6.4 Patient consent

It is important that as well as the above, patient and family information is provided on the request

form, where relevant (e.g. for interpreting genetic examination results). We may have to refer

samples for testing to other laboratories if we are unable to perform the testing in-house. In these

cases we will have to send patient identifiers, such as name, date of birth and the clinical details we

have been given to enable these laboratories to perform appropriate testing and interpret results

correctly.

The patient presenting to the point of sample collection, or providing a sample themselves to their

healthcare provider implies consent. The individual requesting the tests has responsibility for

obtaining informed consent for these tests. Informed consent should cover all the tests requested,

the implications of any results and that personal details and clinical information will be shared with

the requesting organisation and any other organisations involved in providing the tests and results.

1.7 Requesting and reporting of laboratory tests

Electronic requesting must be used to request pathology investigations where it is available. Hand

written requests are more prone to sample labelling errors, transcription errors, sample collection

errors and reporting errors. Do not use hand written requests unless absolutely necessary.

Handwritten request forms are accepted in Histology because these have been designed to allow

annotation of anatomical diagrams.

Each request accepted by the laboratory for examination(s) shall be considered an agreement.

1.8 What to do when there is an IT failure

When there is a failure of the electronic requesting system and it is not possible to request pathology

tests electronically, handwritten request forms can be used. If required, blank request forms can be

sent from the laboratory via the pneumatic tube system. Wards should take the forms they need and

leave a stock of forms next to the pod station for other departments to use. If you require more

forms, please call the laboratory on ext. 4765.

Critical/urgent results will be telephoned by Laboratory staff to the requesting departments. Please

leave the Laboratory phone lines free for us to do this and do not contact us unnecessarily during

these times.

1.9 Sample containers

BD/Becton Dickinson sample collection tubes are used for adults and Sarstedt for paediatric patients.

The lid colours are shown in the table below.

Department: Pathology

Site Wythenshawe Hospital Revision No: 41

Document title: Laboratory Medicine Handbook

Author: Andrew Sayce Document No: PG-D-HANDBOOK-1

Approved by: M Evans, K Morris, K Congdon Page 10 of 109 Last printed 05/02/2020 12:10:00

Container type Colour Description Use

Fluoride

Grey Fluoride oxalate

Blood glucose

Ethanol

Lactate

Serum gel

Gold Serum gel

Routine biochemistry

Immunology

Please note these tubes MUST

NOT be used for mycology

tests

EDTA

(4ml tube)

Purple EDTA

Haematology

HbA1c

Immunology

Li Hep

Green Lithium heparin

gel

Serum

Red Clotted

Bacteriology

Viral serology

Immunology

Mycology

Some transfusion tests

EDTA

Pink EDTA

Blood group

Cross match

Please note these tubes MUST

NOT be used for routine

haematology tests

Citrate

Blue Citrate

Coagulation studies

D-Dimer

Fibrinogen

Trace metal

Royal

Blue

Trace metal

serum Zinc and Selenium

Rapid

Serum

Orange

Thrombin-

based clot

activator

Only for routine biochemistry

samples from A&E department

Paediatric tubes (1.3ml):

Glucose

fluoride Yellow Fluoride oxalate

Blood glucose

Ethanol

Lactate

Department: Pathology

Site Wythenshawe Hospital Revision No: 41

Document title: Laboratory Medicine Handbook

Author: Andrew Sayce Document No: PG-D-HANDBOOK-1

Approved by: M Evans, K Morris, K Congdon Page 11 of 109 Last printed 05/02/2020 12:10:00

Container type Colour Description Use

Serum gel

Brown Serum gel

Routine biochemistry

Immunology

Please note these tubes MUST

NOT be used for mycology

tests

EDTA

Red EDTA Haematology

Blood transfusion

Li Hep

Orange Lithium Heparin

Citrate

Green Citrate Coagulation

Serum (no

gel)

White Serum (no gel) Mycology only

Other sample containers:

Plain

universal

White Sterile container

Microbiology

CSF samples for biochemical

analysis

CSF samples for mycological

analysis

Cytology samples

Plain

universal with

scoop

Blue

Sterile container

with scoop for

collecting faeces

Microbiology culture

Biochemical analysis

24 hour urine

collection

24 hour urine

Return to Examinations offered by biochemistry

For containers relating to histology and cytology please see the histopathology sample container

section.

1.10 Sample transportation

Each sample or set of samples must be placed in the plastic bag that accompanies the request

form. This bag must be sealed to prevent any leakage or loss of samples in transit. Please do not

use staples to seal these bags. Please ensure that the request sticker is placed on the paper form

that is attached to the sample bag and NOT placed directly on to the plastic bag.

Department: Pathology

Site Wythenshawe Hospital Revision No: 41

Document title: Laboratory Medicine Handbook

Author: Andrew Sayce Document No: PG-D-HANDBOOK-1

Approved by: M Evans, K Morris, K Congdon Page 12 of 109 Last printed 05/02/2020 12:10:00

Samples must NOT be stored but should be sent to the laboratory immediately via porter or air tube

or, for off-site users, by the next available transport. Users must consider the time of the next

transport as delays may compromise certain results - if unsure, contact the relevant department.

1.10.1 Hospital requirements

Delivery in person to laboratory:

Samples must be sealed in plastic bags and must also be placed in an appropriate carrier, e.g. sturdy

carry box, sealed strong bag or other approved container whilst being carried to the laboratory.

Pneumatic tube:

Samples in sealed bags may be placed directly into the pods and sent through the system. See

below for more information on sample types that can and cannot be sent in a pod.

1.10.2 GP requirements

Samples collected from GP practices are gathered into strong polythene bags which are sealed. The

hospital transport drivers place these bags in the secure rigid sample transport boxes with sealable

lids that they carry in their vans.

These boxes must be labelled as “Diagnostic Specimens – UN3373” and have the department and

hospital name and contact telephone number.

1.10.3 Postal samples

Samples that are sent via the Royal Mail must be packed in special containers purchased from the

Royal Mail that conform to regulation UN No 3373 – Packing instructions for Diagnostic specimens

and Infectious substances (Packing instruction P650). This states that the ‘packaging must be of

good quality, strong enough to withstand the shocks and loadings normally encountered during

carriage’.

1.11 Requesting further tests on samples already in the laboratory (‘add-on’ tests)

1.11.1 Biochemistry

If you wish to request further tests on blood samples that you have already sent to us please call us

on ext. 4765 with the patient identifiers and the tests you require.

1.11.2 Haematology

If you wish to request further tests on blood samples that you have already sent to us please call us

on;

Haematology ext. 2141

Coagulation ext. 2127

Transfusion ext. 2160

1.11.3 Mycology Reference Centre

Please call us on ext. 2124 to request any additional tests, with patient identifiers. The addition of

extra tests is dependent on sufficient sample volume and date of original sample collection.

Department: Pathology

Site Wythenshawe Hospital Revision No: 41

Document title: Laboratory Medicine Handbook

Author: Andrew Sayce Document No: PG-D-HANDBOOK-1

Approved by: M Evans, K Morris, K Congdon Page 13 of 109 Last printed 05/02/2020 12:10:00

1.12 Turnaround times

Turnaround times that appear in this handbook are from time of receipt into the laboratory information

system (LIMS) to the time of reports being issued, except for histopathology turnaround times which

are from the date of sample collection to date of report issue.

Where possible the time of receipt in the laboratory is recorded on the request form and corrected in

the LIMS. This information is monitored monthly by each laboratory and is available on request.

1.13 Complaints or comments

We would hope that you do not have reason to complain about the service we provide. However, if

you do, please use the contact details below or the specific departmental contact details to raise this

with us in the first instance. Patient complaints can be made through the Trust website.

2 DLM general contact details

Name / Position Extension Email address

Kath Hayden

Clinical Head of Division [email protected]

David Brayshaw

Director of Laboratories [email protected]

Dr Leena Joseph

Clinical Director – Clinical Quality and Safety 4994/5606 [email protected]

Teresa Colilla

Pathology PA 5704 [email protected]

Nigel Martin

Pathology IT Manager 4802 [email protected]

Andrew Sayce

Pathology Quality & Service Lead 4930 [email protected]

Anne-Marie Burns

Phlebotomy Operational Manager 2115 [email protected]

All telephone extensions should be prefixed with 0161 291 when calling from outside the hospital unless otherwise stated

Please see departmental sections for departmental contact details.

Department: Pathology

Site Wythenshawe Hospital Revision No: 41

Document title: Laboratory Medicine Handbook

Author: Andrew Sayce Document No: PG-D-HANDBOOK-1

Approved by: M Evans, K Morris, K Congdon Page 14 of 109 Last printed 05/02/2020 12:10:00

3 Phlebotomy

The Phlebotomy Service is provided by the Division of Laboratory Medicine.

3.1 Inpatient service

A time limited service is provided to all medical and surgical wards Monday - Friday from between

8am and 12 noon for routine blood collection.

A restricted phlebotomy service is provided to the wards over the weekend and bank holidays to

assist in the collection of routine blood samples between 7.30am and 11.30am.

All requests must be made on EPR by 7am Monday - Friday and 7:15am Saturday/Sunday and Bank

holidays. EPR request forms should not be pre-printed. If EPR is unavailable, Biochemistry

Haematology request forms should be used. Please complete the forms in full.

Phlebotomists must have access to the blood collection cart upon arrival to the ward. All users are

responsible for the cleaning and maintenance of the blood collection carts. Blood collection carts

should be re-stocked and put back on charge when finished with and left on charge when not in use.

Faults or defects are to be reported to the IT helpdesk by the user as soon as possible.

All urgent blood requests must be taken by the doctor/nurse. Urgent requests should not be left for

the phlebotomist’s routine blood collection round.

3.2 Outpatient service

There is a drop-in phlebotomy service for out-patients. Please note this service is not for in-patient

use.

Site Location Days Hours

Wythenshawe

Hospital

Phlebotomy suite opposite first floor

Out-patient Department Monday - Friday

09:00 am - 16:45

pm

Withington

Community Hospital

Main Out-patients Department,

ground floor

Monday -

Thursday

08:30 am - 16:45

pm

Friday 08:30 am - 16:00

pm

Please note - all hospital patients must have a request on EPR or bring the appropriate request

forms with them. If it is known that a patient has restricted venous access and the volume of sample

taken may not be sufficient for full analysis the priority of the tests will need to be indicated on the

request.

3.3 General Practitioner service

General Practitioner patients must use the appointment system and call 0800 092 4020 or

0161 947 0770 to book an appointment. Please note - patients must attend phlebotomy with a blood

request form.

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Site Location Days Hours

Wythenshawe

Hospital

Phlebotomy suite opposite first floor

Out-patient Department Monday - Friday

08:15am –

09:25am

Withington

Community Hospital

Main Out-patients Department,

ground floor Monday - Friday

08:30 am – 12:25

pm

Burnage Health

Centre

347 Burnage Ln, Manchester

M19 1EW Friday

09:00 am – 10.55

am

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4 Sample reception

Pathology sample reception is open 24 hours a day, every day. Samples can be delivered directly to

the hatch at specimen reception at the front of the Clinical Sciences Building or sent via the

pneumatic tube. There are restrictions on samples that can be sent via the pneumatic tube, as

detailed below:

This sign should be on every pod station. If your pod station does not have this sign please contact

Sodexo on ext 5430.

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5 Biochemistry

Clinical Biochemistry is the study of the chemical and biochemical processes of the body in relation

to disease. This is a laboratory-based service which exists to help clinicians in the prevention,

diagnosis, treatment and management of disease. Diseases such as diabetes, thyroid problems,

kidney disease, heart attacks and cystic fibrosis can be diagnosed and monitored by the analysis of

body fluids such as blood, urine, saliva and CSF.

The department uses a fully automated analyser to analyse the majority of routine samples. This

analyser has a sophisticated sample tracking system which incorporates online decapping,

aliquotting, sealing and storage of samples within the analysing process. This system allows a high

throughput of samples with fast turnaround times. The department is also a specialist centre for

mass spectrometry, analysing samples from around the world for immunosuppressants, steroid

hormones, and markers of neuroendocrine tumours on six state-of-the-art mass spectrometers.

The Biochemistry department also actively promotes and supports Point-of-Care Testing (POCT),

managing blood gas analysers, blood glucose, ketone, urinalysis, haemoglobin, HbA1c and INR

testing meters throughout the Trust.

The majority of routine biochemistry results are returned within 24 hours, with a high percentage

being turned around within four hours. Exceptions include the more specialised tests which may

require batching, manual preparation or periods of incubation. Turnaround times are recorded for

each of the tests in the test library below. The test library is split into several sections:

Arterial blood gases Tumour markers Pleural fluid

Routine biochemistry CSF Other fluids

Therapeutic drug monitoring Faeces Specialist tests

Endocrinology Urinalysis Dynamic function tests

Specific proteins

Tests not available within the department are referred to specialist accredited laboratories. See

Referred Tests.

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5.1 Contact details

Extension Email address

Results/general enquiries 2126

To add on tests to samples already in the laboratory 4765

Clinical/Scientific advice - contact Duty Biochemist (DB) 2136

GTT and sweat test appointments Biochemistry Secretary

4787

Dr G Horsman Consultant Chemical Pathologist

4791 [email protected]

Lead Biomedical Scientist 4783

Professor A M Kelly Consultant Chemical Pathologist

2132 [email protected]

Secretary to Professor Kelly 2122

Professor B Keevil Consultant Clinical Scientist, Head of Biochemistry

2135 [email protected]

Mrs J Adaway Principal Biochemist

5084 [email protected]

Fax 2927

Out of hours Biomedical Scientist (BMS) Bleep 2023

For Point of Care Testing Enquiries:

Dee Patel POCT Coordinator

4781 [email protected]

[email protected]

See also the Point of Care page on the Intranet

All telephone extensions should be prefixed with 0161 291 when calling from outside the hospital unless otherwise stated

Return to General contact details Examinations offered by biochemistry Sample information CSF Sweat test

5.2 Working hours

The laboratory provides a 24-hour service. Routine throughput can vary throughout the day

depending on demand.

Routine hours: 09:00 - 17:30 Monday-Friday

Non Routine hours: 17:30 - 09:00 Monday – Friday

All day Saturday, Sunday and Bank Holidays

5.2.1 Outside routine hours

Only a limited number of staff are available to perform a restricted range of critical tests. Other tests

may be performed but require prior discussion with the laboratory by bleeping the on-call BMS on

2023, who may refer the request to the on-call Biochemist. For advice on result interpretation out of

hours, ask the switchboard to contact the on-call Biochemist on the air-call bleep.

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The following tests are available at all times without prior arrangement:

General Biochemistry

U & E (Sodium, potassium, urea, creatinine, eGFR) Lipase

LFT (Total protein, albumin, ALT, ALP, globulin & bilirubin), AST,

conjugated bilirubin, GGT

Uric Acid

Bone profile (Total protein, albumin, globulin, calcium, phosphate) Chloride

Arterial Blood gas (also available as point of care testing in the

hospital)

Venous Bicarbonate

CRP Lipids (Cholesterol, HDL, triglycerides,

LDL)

Troponin T & cardiac enzymes (CK, LDH, AST)

Glucose Ethanol

Lactate Vitamin B12 & folate

Ammonia Iron studies (Fe, ferritin, transferrin)

Magnesium

Bilirubin

Endocrinology & Tumour

markers

Drug monitoring CSF/Fluid

analysis

Thyroid function tests (TSH & fT4) Paracetamol & Salicylate Protein

Gonadotrophins (LH/FSH) Antiepileptic drugs – carbamazepine & phenytoin, valproate Glucose

Oestradiol Theophylline Lactate

hCG Antibiotics – gentamicin, vancomycin, tobramycin & amikacin

AFP Digoxin

PSA

Progesterone

Prolactin

5.3 Urgent Requests

Urgent requests need to be marked clearly on the request form.

For A&E and samples marked urgent, the above tests that are available at all times will be available

within 1 hour of receipt in sample reception 90% of the time. Please call the laboratory for results of

urgent endocrinology tests or tumour markers out of routine hours as these require extra

interpretation and may take longer to appear on EPR.

5.4 Examinations offered by Biochemistry

Please note: separate blood samples for each laboratory discipline are required – Mycology,

Microbiology, Immunology, Biochemistry and Haematology.

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All routine serum biochemistry tests can be analysed on one filled 5ml tube (gold top). For non-

routine tests please see the individual test information in the Test Library for sample type (or

Appendix A for a full A-Z list of tests from all departments).

Further details for non-routine tests: contact the Duty Biochemist.

5.5 Sample transportation

CSF, precious samples and samples that must reach the laboratory within a set time must not be

transported by pneumatic tube.

5.6 Add-on Tests

The majority of tests can be added onto an initial collection within 24 hours. Some tests are more

stable and can be added on up to 5 days. Urine samples are stored for 2 days, all other samples are

stored for a minimum of 5 days and then discarded. Please contact the add-on line on ext. 4765 to

request any additional tests.

5.7 Sample Information

Age and sex related reference ranges are available from the laboratory and will be provided with

reports, providing sufficient patient information is given when requesting.

Biochemistry samples should be filled to the line to allow enough sample for analysis.

Turnaround times are for routine samples. If tests are urgently required then please contact the Duty

Biochemist during routine working hours or, outside these times, bleep the on-call BMS.

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5.8 Test library

Arterial Blood Gases Return to: Biochemistry Information

Appendix A (list of tests)

Test TAT Sample type Biological Interval / Clinical Decision Values Special precautions/ Information

pH

1 hour

Heparinised

syringe

7.38 - 7.42

pCO2 4.7 - 6.0 kPa

pO2 12.0 - 14.6 kPa

Bicarbonate 21 - 25 mmol/L

Methaemoglobin <1.0% of total Hb

Base Excess -2 to +2 mmol/L

Carboxyhaemoglobin Non-smokers <5% Smokers 2 - 15%

Routine Biochemistry Return to: Biochemistry Information

Appendix A (list of tests)

Test TAT Sample type Biological Interval / Clinical Decision Values Special precautions/ Information

Sodium 4 hours

133 - 146 mmol/L Guidelines for management of hyponatraemia can be

found in the MFT Wythenshawe site formulary.

Potassium 4 hours

3.5 - 5.3 mmol/L

Neonate (1-3 weeks): 3.6 - 5.8 mmol/L

Guidelines for management of hypokalaemia /

hyperkalaemia can be found in the MFT Wythenshawe

site formulary.

Chloride 4 hours

95 - 108 mmol/L

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Routine Biochemistry Return to: Biochemistry Information

Appendix A (list of tests)

Test TAT Sample type Biological Interval / Clinical Decision Values Special precautions/ Information

Venous

Bicarbonate 4 hours

22 - 29 mmol/L

Urea 4 hours

2.5 - 7.8 mmol/L

Creatinine 4 hours

Female 45 - 84 µmol/L

Male 59 - 104 µmol/L

0 No evidence of AKI

1

An increase of serum creatinine >26 umol/L

from baseline in 48 hrs OR more than 1.5 to 2

fold from baseline

2 An increase of serum creatinine of more than

or equal to 2-3 fold from baseline

3

An increase of serum creatinine more than 3

fold from baseline OR serum creatinine >355

umol/L with an acute rise of at least 45 umol/L

More details are available http://uhsm-

intranet/imt/ICE/Pages/AKIAlerts.aspx

Also from the think Kidneys website -

https://www.thinkkidneys.nhs.uk/

eGFR 4 hours

≥60 mL/min/1.73m2

Results above 90 will be reported as > 90 ml/min/1.73m2

eGFR is only an estimate and is not validated for use in

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Routine Biochemistry Return to: Biochemistry Information

Appendix A (list of tests)

Test TAT Sample type Biological Interval / Clinical Decision Values Special precautions/ Information

the following: children, pregnancy, acute renal failure,

oedematous states, muscle wasting disease states,

amputees and malnourished patients. This measurement

is for Caucasian patients only. There is a correction factor

to be applied for Afro-Caribbean patients, and this will be

published on the report form.

Also refer to http://www.renal.org/information-

resources/the-uk-eckd-guide or the Think Kidneys

website

Glucose (fasting) * 4 hours

3.0 - 6.0 mmol/L

*Low/High glucose measurements using Point of Care

Testing equipment need to be verified by sending a

specimen to the laboratory.

Bilirubin 4 hours

<21 µmol/L

Calcium

(Amended) 4 hours

2.20 - 2.60 mmol/L

Amended calcium is calculated using a formula from local

population data, and which is monitored and updated

wherever required

Guidelines for management of hypercalcaemia and

hypocalcaemia can be found in the MFT Wythenshawe

site formulary.

Magnesium 4 hours

0.7 - 1.0 mmol/L Guidelines for management of hypomagnesaemia can be

found in the MFT Wythenshawe site formulary.

Phosphate 4 hours

0.80 - 1.50 mmol/L Guidelines for management of hypophosphataemia can

be found in the MFT Wythenshawe site formulary.

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Routine Biochemistry Return to: Biochemistry Information

Appendix A (list of tests)

Test TAT Sample type Biological Interval / Clinical Decision Values Special precautions/ Information

Total protein 4 hours

60 - 80 g/L

Albumin 4 hours

35 - 50 g/L

Globulin 4 hours

25 - 42 g/L

Iron 4 hours

5.8 - 34.5 µmol/L

Transferrin 4 hours

2.0 - 3.6 g/L

Urate 4 hours

Male: 200 - 430 µmol/L

Female: 140 - 360 µmol/L

CRP 4 hours

< 5 mg/L

ALP 4 hours

Adult: 30 - 130 IU/L

Lipase 4 hours

13 - 60 U/L

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Routine Biochemistry Return to: Biochemistry Information

Appendix A (list of tests)

Test TAT Sample type Biological Interval / Clinical Decision Values Special precautions/ Information

AST 4 hours

Male: <50 IU/L

Female: <35 IU/L

ALT 4 hours

Male: <50 IU/L

Female: <35 IU/L

GGT 4 hours

Male: 10 - 71 IU/L

Female: 6 - 42 IU/L

CK 4 hours

Male: <320 IU/L

Female: <200 IU/L

LDH 4 hours

≤250 U/L

Total cholesterol 4 hours

Dependent on coronary risk factors. See BNF for details

HDL cholesterol 4 hours

Male: >1.0 mmol/L

Female: >1.2 mmol/L

Fasting

triglycerides 4 hours

<1.7 mmol/L

Lactate 2 hours

Age related

Adult 0.6 - 2.5 mmol/L

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Routine Biochemistry Return to: Biochemistry Information

Appendix A (list of tests)

Test TAT Sample type Biological Interval / Clinical Decision Values Special precautions/ Information

ACE (Angiotensin

converting

enzyme)

72 hours

≤65 IU/L for patients above 14 years of age

Alcohol (Ethanol) 4 hours

Not detected

Ammonia 4 hours

Adult: 10-50 µmol/L

Ensure sample received in lab within 30 minutes

of collection. Air tube transport is not suitable,

deliver sample directly to lab

Osmolality 36 hours

275 - 295 mOsm/kg

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Routine Biochemistry Return to: Biochemistry Information

Appendix A (list of tests)

Test TAT Sample type Biological Interval / Clinical Decision Values Special precautions/ Information

HbA1c 96 hours

NON-DIABETIC 25 - 36 mmol/mol IFCC (equivalent to 4.5 - 5.5% DCCT)

GOOD Control: <49 mmol/mol IFCC (equivalent to

6.5% or less DCCT)

POOR Control >64 mmol/mol IFCC (equivalent to

8.1% or above DCCT)

BORDERLINE: 49 - 64 mmol/mol IFCC (equivalent to

6.6 - 8.0% DCCT)

An HbA1c of 48 mmol/mol is recognised as the cut point

for diagnosing diabetes mellitus (WHO 2011).

Diabetes mellitus is not excluded by an HbA1c < 48

mmol/mol.

An HbA1c of 42 - 47 mmol/mol indicates a high risk of

diabetes mellitus.

HbA1c is not appropriate for the diagnosis of diabetes

mellitus in some situations e.g increased red cell

turnover.

High Sensitivity

Troponin T 2 hours

Reference range: ≤14 ng/L

A change of 50% or more between the 0 and 3 hour

samples is significant (increase or decrease)

ICE will alert any change of 50% or more (whether

increasing or decreasing)

Click on the alert icon for details

The Chest Pain Pathway should be followed in all cases.

Send blood for troponin T measurement at 0 and 3 hrs

post admission if coming in to hospital or post chest pain

if already an inpatient.

B12 24 hours

197 - 771 ng/L

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Routine Biochemistry Return to: Biochemistry Information

Appendix A (list of tests)

Test TAT Sample type Biological Interval / Clinical Decision Values Special precautions/ Information

Ferritin 24 hours

Male: 30 - 400 µg/L

Female: 13 - 150 µg/L

Folate 24 hours

3.9 - 20 µg/L

Therapeutic Drug Monitoring Return to: Biochemistry Information

Appendix A (list of tests)

Test TAT Sample type Biological Interval / Clinical Decision Values Special precautions/ Information

Paracetamol 4 hours

Not detected

It is recommended to measure paracetamol 4 hour post

suspected overdose if an accurate history is possible.

Paracetamol levels may be falsely low when sample is

taken after starting treatment with N-acetyl cysteine.

Salicylate 4 hours

No reference range

If the patient has taken other drugs toxicity may be

enhanced. For advice contact the local poisons

information service: 0344 892 0111

Amikacin 4 hours

See comments. (Ranges from microbiology)

Antimicrobial interpretation should be directed to a

consultant microbiologist

Once daily dosing: Trough <5mg/L

Multiple daily dosing: Trough <10 mg/L Peak 25-30 mg/L

Carbamazepine 4 hours

4.0 - 12.0 mgl/L concern level: 25 mgl/L

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Therapeutic Drug Monitoring Return to: Biochemistry Information

Appendix A (list of tests)

Test TAT Sample type Biological Interval / Clinical Decision Values Special precautions/ Information

Cyclosporin 24 hours

Variable

Target ranges depend on specific use of the drug.

Suggest consult local specialist for advice.

Digoxin 4 hours

0.6 - 1.2 µg/L; concern level: 3.0 µgl/L

Results are only meaningful if taken > 6 hours after

previous dose.

Hypokalaemia and/or hypothyroidism can potentiate

toxicity.

Everolimus 24 hours

3 – 8 µg/L

Gentamicin 4 hours

See comments, reference ranges from microbiology

Once daily dosing:

Trough level: < 1 mg/L

Peak level: not required to assess therapy

Multiple daily dosing

Trough level: < 1 mg/L

Peak level: not usually required to assess therapy

Lithium 24 hours

0.4 - 1.0 mmol/L pre-dose or >12 hrs post dose

Mycophenolate 192

hours

2.5-4.5 mg/L trough level for heart and lung transplant

patients Pre-dose

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Therapeutic Drug Monitoring Return to: Biochemistry Information

Appendix A (list of tests)

Test TAT Sample type Biological Interval / Clinical Decision Values Special precautions/ Information

Phenytoin 4 hours

5.0 - 20.0 mg/L

Prednisolone 192

hours

Prednisolone should be detectable 1-8 hours post dose

Sirolimus 24 hours

See comment (Ranges from transplant team)

Trade name Rapamycin

Therapeutic range for heart and lung transplant only

4-12 µg/L initial therapy

12-20µg/L after cyclosporin elimination

FK506

(Tacrolimus) 24 hours

1.0 -12.0 µg/L

This range applies to heart and lung transplant

patients only. Consult local specialist for other

uses.2.0 µg/L

pre-dose

Teicoplanin 5 Days

Severe staph aureus infections pre-dose target range;

20-60 mg/l.

Other severe infections target levels;

10-60 mg/l

BNF states: Teicoplanin not measured routinely as a

relationship between plasma teicoplanin and toxicity has

not been established. Plasma teicoplanin concentration

may be used to optimise parental treatment in severe

sepsis or burns, deep seated staph infection,

endocarditis, renal impairment, elderly patients or iv drug

users.

Tobramycin 4 hours

See comments (Ranges from microbiology)

Antimicrobial interpretation should be directed to a

consultant microbiologist

Once daily dosing: Trough <1 mg/L. Peak levels not

needed to assess therapy

Multiple daily dosing: Trough <2 mg/L (< 1mg/L in CF)

Peak 6-10 mg/L (8-12 mg/L in CF)

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Therapeutic Drug Monitoring Return to: Biochemistry Information

Appendix A (list of tests)

Test TAT Sample type Biological Interval / Clinical Decision Values Special precautions/ Information

Finger prick samples are also accepted.

Theophylline 4 hours

Adult: 10 - 20 mg/L Pre-dose

TPMT

(Thiopurine S-

methyltransferase)

192

hours

Deficient: <10 mU/L

Low: 20-67 mU/L

Normal: 68-150 mU/L

High: >150 mU/L

Recent blood transfusions may mask a deficient TPMT

result

Vancomycin 4 hours

Trough level: 10 – 15 mg/L

Trough level: 15 – 20 mg/L for severe MRSA infections.

Antimicrobial interpretation should be directed to a

consultant microbiologist

Pre-dose

Endocrinology Return to: Biochemistry Information

Appendix A (list of tests)

Test TAT Sample type Biological Interval / Clinical Decision Values Special precautions/ Information

Free T4 4 hours

10 - 25 pmol/L

Free T3 72

hours

3.1 - 6.8 pmol/L

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Endocrinology Return to: Biochemistry Information

Appendix A (list of tests)

Test TAT Sample type Biological Interval / Clinical Decision Values Special precautions/ Information

TSH 4 hours

0.27 - 4.20 mU/L

TPO 96

hours

<34 IU/mL

LH 24

hours

Variable. See report

FSH 24

hours

Variable. See report

Progesterone 24

hours

Variable. See report

Oestradiol 24

hours

Variable. See report Mass spectrometry assay for oestradiol also available

with TAT of 10 days . Contact 2136 for details

Prolactin 24

hours Variable. See report

Testosterone

240

hours See report

Salivary

testosterone

744

hours

Saliva (passive

drool). Contact

See report Samples collected onto salivette swabs are NOT suitable.

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Endocrinology Return to: Biochemistry Information

Appendix A (list of tests)

Test TAT Sample type Biological Interval / Clinical Decision Values Special precautions/ Information

lab

SHBG 240

hours

See report

17-

hydroxyprogesterone

240

hours

Variable. See report Part of female testosterone profile

Androstenedione 240

hours

0.8-4.7 nmol/L Part of female testosterone profile

DHEAS 240

hours

Variable. See report Part of female testosterone profile

Metanephrines 240

hours

Metanephrine <510 pmol/L

Normetanephrine <1180 pmol/L

3-methoxytyramine (3-MT) <180 pmol/L

Sample must reach lab and be separated & frozen within

1 hour of collection.

Preferably take sample with patient recumbent after

overnight fast.

Macroprolactin 5 days

See report Usually added to requests by laboratory staff as required

PTH 24

hours

1.6 - 6.9 pmol/L for normocalcaemic patients

Renin 240

hours

0.3-2.2 nmol/L/hr

Aldosterone 240

hours

up to 630 pmol/L

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Endocrinology Return to: Biochemistry Information

Appendix A (list of tests)

Test TAT Sample type Biological Interval / Clinical Decision Values Special precautions/ Information

Cortisol 36

hours

Shows variation across day

0830-1130: 100-500 nmol/L

Salivary cortisol 240

hours (Contact lab)

See report

Vitamin A & E 360

hours

Vitamin A 1.05 – 2.97 µmol/L

Vitamin E 13.9 – 47.0 µmol/L

Vitamin D 168

hours

See report

Dexamethasone 360

hours

Dexamethasone concentrations <3.0 nmol/L suggest

impaired absorption or excess metabolism of

dexamethasone and an alternative biochemical screening

test to investigate hypercortisolism should then be

considered

Conversely, dexamethasone concentrations ≥3.0 nmol/L

suggest adequate absorption and metabolism of

dexamethasone

Several drugs/medications have been identified as

potential inducers or inhibitors of the CYP3A4 enzyme

resulting in accelerated or impaired metabolism of

dexamethasone. For further information contact the Duty

Biochemist.

Human chorionic

gonadotrophin

(hCG)

24

hours

Non-pregnant < 2.0 U/L

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Specific Proteins Return to: Biochemistry Information

Appendix A (list of tests)

Test TAT Sample type Biological Interval / Clinical Decision Values Special precautions/ Information

Alpha-1-

antitrypsin 96 hours

0.9 - 2.0 g/L

Assay performed Tuesday and Friday.

Low Alpha-1-antitrypsin results (< 1.1 g/L) and samples

from patients < 1 years will be sent away for phenotyping.

IgA 72 hours

See report

IgG 72 hours

See report

IgM 72 hours

See report

Protein

Electrophoresis

168

hours

Qualitative interpretation

The main use of this test is to exclude the presence of a

monoclonal protein, which may indicate myeloma, MGUS

or a lymphoproliferative disorder.

A urine sample for analysis of Bence Jones proteins is

also required to exclude the above disorders.

Polyclonal increases in immunoglobulins can be

associated with infection, inflammation or connective

tissue disease and do not indicate myeloma.

Rheumatoid

factor 4 hours

<14 IU/mL

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Tumour Markers Return to: Biochemistry Information

Appendix A (list of tests)

Test TAT Sample type Biological Interval / Clinical Decision Values Special precautions/ Information

5HIAA, serum 240

hours

<140 nmol/L Sample should be taken after overnight fast

Avoid serotonin containing foods

5HIAA, urine 240

hours Acidified

Normal <46 µmol/24hrs

May be dietary 46 – 90 µmol/24hrs

Unlikely to be dietary >90 µmol/24hrs

Avoid serotonin-containing foods (bananas, avocados,

aubergine, pineapples, kiwi fruit, walnuts tomatoes) and

cough medicines for 3-4 days prior to and during the

collection

AFP 24 hours

<6 IU/mL

PSA 24 hours

See report

CEA 96 hours

<5 µg/L

CA19-9 96 hours

<34 U/mL is considered normal

CA-125 96 hours

<35 U/mL is considered normal

Plasma

Metanephrines

240

hours

See report

Separate plasma within 1 hour of collection

Preferably take sample with patient recumbent after

overnight fast.

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CSF Return to: Biochemistry Information

Appendix A (list of tests)

Test TAT Sample type Biological Interval / Clinical Decision Values Special precautions/ Information

CSF protein 4 hours

Min 5 drops

(250 µl) of CSF

and blood in

either

Adults: 0.15 -0.45 g/L

This reference range is not applicable to neonates and

young children

Adults only - fluoride oxalate tube also acceptable for

CSF protein sample.

Paediatric Fluoride oxalate tube not acceptable as they

give falsely elevated results.

CSF glucose 4 hours

CSF

Blood

CSF glucose is usually ~ 60% of plasma value (2.5 - 5.5

mmol/L).

Adults only - fluoride oxalate tube also acceptable for

CSF glucose sample.

To interpret CSF glucose a plasma glucose sample is

required.

CSF lactate 4 hours CSF lactate normally parallels plasma concentration. Adults only - fluoride oxalate tube also acceptable for

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CSF Return to: Biochemistry Information

Appendix A (list of tests)

Test TAT Sample type Biological Interval / Clinical Decision Values Special precautions/ Information

CSF

Blood

CSF lactate sample.

To interpret CSF lactate a plasma lactate sample is

required.

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CSF Return to: Biochemistry Information

Appendix A (list of tests)

Test TAT Sample type Biological Interval / Clinical Decision Values Special precautions/ Information

Xanthochromia

Analysed

8am-

8pm*

4th sample of

LP (min 0.5ml)

CSF (total

protein)

Blood for

bilirubin

Xanthochromia Collection packs are available from

Biochemistry.

Xanthochromia test should only be requested in CT-scan

negative patients.

Sample must be 12 h post-onset of symptoms and within

14 days of symptoms.

CSF must be protected from light.

*Samples received outside of these times can be sent to an

external laboratory if result required urgently (minimum 700 µL

of sample required).

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Faeces Return to: Biochemistry Information

Appendix A (list of tests)

Test TAT Sample type Biological Interval / Clinical Decision Values Special precautions/ Information

Faecal elastase

(pancreatic)

336

hours

Random

faeces

(minimum pea

sized amount)

Severe insufficiency < 100 µg/g

Moderate insufficiency 100-200 µg/g

Normal > 200 µg/g normal

Watery/runny or mucousy stool samples may have falsely

low results due to dilution. Send a formed stool sample

where possible.

Urinalysis Return to: Biochemistry Information

Appendix A (list of tests)

Test TAT Sample type Biological Interval / Clinical Decision Values Special precautions/ Information

Bence-Jones

protein

192

hours

10ml urine

Screening test, Pos or Neg Early morning sample preferred

Calcium 4 hours

Acidified

2.5 - 7.5 mmol/24hrs

Citrate 240

hours Acidified

1680-6450 µmol/24hrs

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Urinalysis Return to: Biochemistry Information

Appendix A (list of tests)

Test TAT Sample type Biological Interval / Clinical Decision Values Special precautions/ Information

Cortisol 192

hours

No preservative

Up to 165nmol/24 hours

Cotinine 192

hours

See report Nicotine metabolite – may also be positive if patient is on

nicotine replacement therapy

Creatinine

Clearance 24 hours

No preservative

Blood for U&E

Age dependent. See report For most patients e-GFR is used to estimate glomerular

filtration

Cystine 240

hours

No preservative

<100 mg/24hrs

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Urinalysis Return to: Biochemistry Information

Appendix A (list of tests)

Test TAT Sample type Biological Interval / Clinical Decision Values Special precautions/ Information

Magnesium 24 hours

Acidified

2.4 - 6.6 mmol/24hr

Microalbumin

(ACR) 24 hours

10 ml EMU

ACR >2.9 mg/mmol should be regarded as clinically important proteinuria in all patients (NICE CG182)

Also known as albumin:creatinine ratio (ACR)

Osmolality 24 hours

10 ml random

Relative to hydration status

Oxalate 240

hours Acidified

See report Contact Duty Biochemist for paediatric reference ranges

Phosphate 24 hours

Acidified

15-50 mmol/24h Random urine phosphate also available

Potassium 24 hours

No preservative

25 - 125 mmol/L

Contact Duty Biochemist for further information

Random urine phosphate also available

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Urinalysis Return to: Biochemistry Information

Appendix A (list of tests)

Test TAT Sample type Biological Interval / Clinical Decision Values Special precautions/ Information

Protein 24 hours

No preservative

<140 mg/24hrs

Urine protein:creatinine ratio also available to detect

proteinuria in pregnancy. Albumin:creatinine ratio (ACR)

should be requested to detect proteinuria in all other

cases; protein:creatinine ratio will be added by the lab if

ACR is above measurement limits of assay.

Sodium 24 hours

No preservative

40 - 220 mmol/24 hr

Contact Duty Biochemist for further information

Random urine sodium also available

Urate 24 hours

No preservative

1.5 - 4.5 mmol/24hr

Pleural Fluid Return to: Biochemistry Information

Appendix A (list of tests)

Test TAT Sample type Biological Interval / Clinical Decision Values Special precautions/ Information

Total protein

24 hours

Fluid

Lights Criteria: Pleural fluid is suggestive of an exudate if

any of the following apply:

Fluid protein : Serum protein > 0.5

Fluid LDH : Serum LDH > 0.6

Fluid LDH > 2/3 of the upper reference limit

ASSAY NOT VALIDATED FOR FLUIDS

In order to differentiate a transudate from an exudate

please send fluid and serum samples for total protein and

LDH.

Analysis may not be possible on heavily blood stained

samples LDH

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Pleural Fluid Return to: Biochemistry Information

Appendix A (list of tests)

Test TAT Sample type Biological Interval / Clinical Decision Values Special precautions/ Information

Glucose 24 hours

Fluid

Glucose < 2.2 mmol/L is associated with empyema,

rheumatoid arthritis, tuberculosis or malignancy. This cut

off may not apply in patients with elevated plasma

glucose.

ASSAY NOT VALIDATED FOR FLUIDS

To interpret fluid glucose a plasma glucose sample is

required. Please contact the duty biochemist for further

advice.

pH 24 hours

Heparinised

syringe

pH < 7.3 is associated with empyema, TB, malignancy,

collagen vascular disease or haemothorax.

ASSAY NOT VALIDATED FOR FLUIDS

Please REMOVE needle and cap syringe prior to sending

sample to lab.

Analysis may not be possible on heavily blood stained

samples

Triglyceride 24 hours

Fluid

Fasting

> 1.26 mmol/L Suggestive of a Chylous effusion

< 0.57 mmol/L Not suggestive of a Chylous

effusion

0.57 – 1.26 mmol/L equivocal

ASSAY NOT VALIDATED FOR FLUIDS

To interpret fluid triglycerides a fasting serum sample is

required. Interpret fluid triglycerides with caution in

patients on TPN or those with hypertriglyceridemia. For

further information contact the Consultant Chemical

Pathologists.

Analysis may not be possible on heavily blood stained

samples

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Pleural Fluid Return to: Biochemistry Information

Appendix A (list of tests)

Test TAT Sample type Biological Interval / Clinical Decision Values Special precautions/ Information

Lipase 24 hours

Fluid

Blood

Fluid lipase higher than serum lipase may be suggestive

of pancreatic involvement.

ASSAY NOT VALIDATED FOR FLUIDS

This test should only be requested if a pancreatic cause

of pleural effusion is suspected.

To interpret fluid lipase a serum sample is required.

NOT TO BE USED FOR PANCREATIC CYST FLUID.

For further advice contact the duty biochemist

Albumin 24 hours

Fluid

An albumin gradient (serum albumin – fluid albumin) < 12

g/L is suggestive of a transudate and > 12 g/L is

suggestive of an exudate.

ASSAY NOT VALIDATED FOR FLUIDS

In order to differentiate a tansudate from an exudate

please request a fluid and serum samples for total

protein and LDH

Analysis may not be possible on heavily blood stained

samples

Other Fluids Return to: Biochemistry Information

Appendix A (list of tests)

Test TAT Sample type Biological Interval / Clinical Decision Values Special precautions/ Information

For fluids other than CSF, Pleural effusions and urine please contact duty biochemist for advice on appropriate test selection.

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Specialist Tests Return to: Biochemistry Information

Appendix A (list of tests)

Test TAT Sample type Biological Interval / Clinical Decision Values Special precautions/ Information

Cryoglobulins 192

hours

Normal result – cryoglobulins NOT detected.

Samples need to be sent to the laboratory at 37°C.

Sample must be collected into a pre-warmed tube and

transported to the laboratory in a vacuum flask

containing warm sand. Collect pre-warmed flask/tube

from Specimen Reception (Clinical Sciences Building) or

Out-patient phlebotomy.

Sweat test 34 hours Sweat

For child of 6 months of age or older:

Abnormal consistent with CF Chloride > 60 mmol/L

Equivocal Chloride 40 - 60 mmol/L

Normal Chloride < 40 mmol/L

For a child <6 months of age please contact the

laboratory or refer to the report.

These are performed in the Paediatric Outpatients

department on Thursday mornings.

A prior appointment is needed. Please contact the

Consultant Chemical Pathologists’ secretary.

A request form or referral letter with full patient details

must be sent to the department.

Renal stone

analysis 17 days Stone (calculi) See report

Please include information on the location the stone was

removed from.

Check www.UKAS.com for up to date accreditation status of referral laboratories.

Referred Tests Return to: Biochemistry Information

Appendix A (list of tests)

Test TAT Sample type Biological Interval /

Clinical Decision Values Special precautions/ Information

Referral Lab and Accreditation Number

ACTH 24 days

See report Must be received in lab within 15 minutes of

collection.

Clinical Biochemistry, The

Christie Hospital (8697)

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Referred Tests Return to: Biochemistry Information

Appendix A (list of tests)

Test TAT Sample type Biological Interval /

Clinical Decision Values Special precautions/ Information

Referral Lab and Accreditation Number

Acyl

carnitines/free

carnitine/MCADD

profile

2 weeks

Dried blood

spot or

See report Willink Laboratory (UKAS 9865)

Amino acids

(plasma) 35 days

See report CSF amino acids also available Willink Laboratory (UKAS 9865)

Amino acids

(urine) 35 days

5 mL random

urine sample

See report Willink Laboratory (UKAS 9865)

Β2 microglobulin 14 days

See report Department of Immunology,

MFT Oxford Road (UKAS 8195)

β-OH

butyrate/free fatty

acids

17 days

See report

Separate sample required. Take at time of

hypoglycaemia. Must be received in the lab

within 20 minutes of collection.

Paediatric Biochemistry, MFT

Oxford Road (UKAS 8651)

Caeruloplasmin 10 days

See report Requested with copper for investigation of

?Wilson’s disease

Biochemistry, MFT Oxford Road

( UKAS 8651)

Cholinesterase/ac

etylcholinesterase

4-6

weeks

See report

For investigation of suxamethonium/mivacurium

sensitivity (scoline apnoea). Apnoea

investigations should wait until patient is fully

recovered.

Biochemistry, MFT Oxford Road

(UKAS 8651)

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Referred Tests Return to: Biochemistry Information

Appendix A (list of tests)

Test TAT Sample type Biological Interval /

Clinical Decision Values Special precautions/ Information

Referral Lab and Accreditation Number

Chromium and

cobalt 5 weeks

See report

Take serum sample through needle first and

discard. Then take sample into trace element

tube through the same needle and send to lab.

Biochemistry, MFT Oxford Road

(UKAS 8651)

Copper (serum) 10 days

See report

Copper increases during the acute phase

response, and should not be measured in

patients with acute infection/inflammation. Fasting

samples preferred.

Biochemistry, MFT Oxford Road

(UKAS 8651)

Copper (urine) 4 weeks

24h urine

collection See report

No preservative or pre-treatment of the container

required

Biochemistry, MFT Oxford Road

(UKAS 8651)

Complement C3 7 days

See report Department of Immunology,

MFT Oxford Road (UKAS 8195)

Complement C4 7 days

See report Department of Immunology,

MFT Oxford Road (UKAS 8195)

Down’s syndrome

screening 5 days

Risk factor provided. Refer to

report. Reports sent directly to requestor.

Blood Sciences, Royal Bolton

Hospital (UKAS 9925)

Drugs of abuse

screen (urine) 14 days

Random urine

sample

See report Indicate on request form if cannabis and/or urine

ethanol are required.

Clinical Biochemistry, Salford

Royal Hospital (UKAS 8331)

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Referred Tests Return to: Biochemistry Information

Appendix A (list of tests)

Test TAT Sample type Biological Interval /

Clinical Decision Values Special precautions/ Information

Referral Lab and Accreditation Number

Faecal reducing

substances/faecal

sugar

chromatography

21 days Faeces See report Sample must be received in lab within 2 hours

of collection.

Paediatric Biochemistry, MFT

Oxford Road (UKAS 8651)

Fluid amylase 4 days Pancreatic cyst

fluid ONLY See report Pancreatic cyst fluid ONLY.

Christie Pathology Partnership

(UKAS 8697)

Galactosaemia

screening test 14 days

See report

Test not valid if patient has had recent blood

transfusion. Willink Laboratory (UKAS 9865)

Growth hormone 17 days

See report

Random growth hormone may be difficult to

interpret. IGF-1 more useful for patients with

?acromegaly. Consult Endocrinologist if further

advice required.

Biochemistry, MFT Oxford Road

(UKAS 8651)

Gut hormone

profile (fasting) 28 days

See report

Patient must be fasting. Sample must be

received in lab within 15 minutes of collection.

Includes glucagon, VIP, pancreatic polypeptide,

gastrin, somatostatin and chromogranin A and B.

Where safe to do so, patient must be off

omeprazole (& other proton pump inhibitors) for 2

weeks and H2 antagonists for 72 hours.

SAS Endocrine Laboratory,

Charing Cross Hospital (UKAS

8673)

Haptoglobin 10 days

See report Biochemistry Oldham (UKAS

8601)

IGF-1 17 days

Reference range varies with

age. See report

Biochemistry, MFT Oxford Road

(UKAS 8651)

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Referred Tests Return to: Biochemistry Information

Appendix A (list of tests)

Test TAT Sample type Biological Interval /

Clinical Decision Values Special precautions/ Information

Referral Lab and Accreditation Number

IgG subclasses

(IgG4 can also be

requested

separately)

10 days

See report

Investigation of suspected immunodeficiency, or

autoimmune pancreatitis which can be associated

with raised IgG4 levels.

Department of Immunology,

MFT Oxford Road (UKAS 8195)

Insulin and c-

peptide (adult

patients >16 years

of age, for

investigation of

hypoglycaemia)

17 days

See report

Sample must be received in the lab within 20

minutes of collection. Collect at time of

hypoglycaemia. Also send sample for glucose.

SAS Peptide Hormone

Laboratory, Royal Surrey

County Hospital (UKAS 9732)

Lamotrigine 1 working

day

See report Pre-dose Biochemistry, MFT Oxford Road

(UKAS 8651)

Mannose binding

lectin 17 days

See report Protein Reference Unit,

Sheffield (UKAS 8494)

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Referred Tests Return to: Biochemistry Information

Appendix A (list of tests)

Test TAT Sample type Biological Interval /

Clinical Decision Values Special precautions/ Information

Referral Lab and Accreditation Number

Oligoclonal bands

(CSF) 20 days

CSF with paired

serum sample

CSF

Blood

See report For diagnosis of multiple sclerosis Biochemistry, Salford Royal

Hospital (UKAS 8331)

Organic acids

(urine) 35 days

5 mL random

urine sample

See report Investigation of suspected inherited metabolic

disorders Willink Laboratory (UKAS 9865)

Orosomucoid

(Alpha-1 acid

glycoprotein)

17 days

See report Biochemistry, MFT Oxford Road

(UKAS 8651)

Phenobarbital 48 hours

See report Pre dose.

Biochemistry, MFT Oxford Road

(UKAS 8651)

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Referred Tests Return to: Biochemistry Information

Appendix A (list of tests)

Test TAT Sample type Biological Interval /

Clinical Decision Values Special precautions/ Information

Referral Lab and Accreditation Number

Porphyrin screen 17 days

Random urine

Blood

See report

Samples must be protected from light

immediately after collection. Provide full

clinical details. If acute porphyria is

suspected, sample should be collected at the

time of symptoms.

Porphyria Service, Medical

Biochemistry, University

Hospital of Wales, Cardiff

(UKAS 8989)

Procalcitonin 14 days

See report Biochemistry, MFT Oxford Road

(UKAS 8651)

PIIINP (Type III

procollagen

peptide)

35 days

See report Sample must be received within 4 hours of

collection. For patients on methotrexate therapy.

Biochemistry, MFT Oxford Road

(UKAS 8651)

Selenium 10 days

See report

Selenium is decreased in the acute phase

response, and should not be measured in

patients with acute infection/inflammation.

Results also affected by low albumin. Fasting

samples preferred.

Biochemistry, MFT Oxford Road

(UKAS 8651)

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Referred Tests Return to: Biochemistry Information

Appendix A (list of tests)

Test TAT Sample type Biological Interval /

Clinical Decision Values Special precautions/ Information

Referral Lab and Accreditation Number

Urine light chain

quantification 15 days

No preservative

See report Used in the monitoring of patients with myeloma Protein Reference Unit,

Sheffield (UKAS 8494)

Urine reducing

substances 21 days

Random urine

See report Sample must be received in the lab within 2 hours

of collection Willink Laboratory (UKAS 9865)

Valproate 48 hours

There are no evidence based

therapeutic ranges for serum

valproate concentrations.

There is not a clear

relationship between serum

valproate concentration and

efficacy and toxicity.

Pre-dose Biochemistry, MFT Oxford Road

(UKAS 8651)

Very long chain

fatty acids

(VLCFA)

35 days

See report Willink Laboratory (UKAS 9865)

Zinc 10 days

See report

Zinc is decreased in the acute phase response,

and should not be measured in patients with

acute infection/inflammation. Results also

affected by low albumin. Fasting samples

preferred.

Biochemistry, MFT Oxford Road

(UKAS 8651)

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Protocols are available from the Department directly for the following dynamic tests. If these need to be discussed, please contact the Duty Biochemist.

Dynamic Function Tests Return to: Biochemistry Information

Appendix A (list of tests)

Combined pituitary function test Insulin stimulation test

Dexamethasone suppression test Prolonged fasting test

Glucose tolerance test Short Synacthen test

Glucose tolerance test with GH suppression Water deprivation test

GnRH Stimulation test

5.9 Factors known to significantly affect performance of tests/interpretation of results

Problem Common Causes Affected Analyte

Delay in processing Overnight storage

>6 hour delay in separation Increased potassium, phosphate, LDH, AST.

Incorrect storage Storing unseparated sample in the fridge Increased phosphate and potassium

Decreased bicarbonate

Haemolysis

Expelling blood through needle

Vigorous shaking

Extreme temperature

Increased potassium, phosphate, LDH, AST.

Inappropriate Collection Site Sample taken from drip arm Increased drip analyte e.g. sodium, glucose

Decreased analytes - dilutional effect

Incorrect container or anticoagulant No fluoride oxalate Decreased glucose

K-EDTA contamination

Increased potassium

Decreased calcium, magnesium, alkaline

phosphatase

Lithium heparin tube Increased lithium

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5.10 Effect of haemolysis, lipaemia and icterus:

Haemolysis, lipaemia and icterus may cause false elevations or reductions in the measured

concentrations of several biochemistry analytes. The presence of haemolysis, lipaemia or icterus will

be detected in the laboratory and the affected analytes will be flagged. In cases where there is

significant interference, the affected analyte will not be reported. Further information can be obtained

from the Duty Biochemist.

5.11 Measurement uncertainty

All assays have a margin of error associated with the calculation of the numerical value. This is

referred to as the measurement uncertainty and is usually expressed as a percentage of the reported

figure. This calculation allows the user to understand the uncertainty of any numerical results and

can be assured with 95% confidence that the true result lies plus or minus the measurement

uncertainty around the reported value. Further information on the measurement of uncertainty for all

our laboratory assays is available by contacting the Duty Biochemist within routine working hours.

5.12 Point of Care

The relationship between values obtained in the laboratory and POCT are established and available

upon request.

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6 Haematology

6.1 Contact details

Extension Fax Email address

Dr Simon Watt Consultant Haematologist, Head of Haematology

2114

2125

[email protected]

Dr Sumaya El-Hanash Consultant Haematologist

2114 [email protected]

Dr Shiva Natarajan Consultant Haematologist

4797 [email protected]

Haematology secretaries 2114/4789

Medical emergencies Contact

switchboard

For non-urgent advice - haematology [email protected]

For non-urgent advice – immunology [email protected]

Results/general enquiries 2126

Laboratories:

Blood transfusion 2160/2161 2130

Haematology 2141

Coagulation 2127

Immunology 4762

Gareth Davies Lead Biomedical Scientist - Haematology

4777 [email protected]

Maggie Evans Lead Biomedical Scientist – Blood transfusion

4719 [email protected]

Out of hours Biomedical Scientist (BMS) Bleep 2033

All telephone extensions should be prefixed with 0161 291 when calling from outside the hospital unless otherwise stated

Return to: A-Z list of tests,

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6.2 Routine Haematology

6.2.1 Test library

Routine Haematology Return to: Haematology Information

Appendix A (list of tests)

Test TAT Sample type Biological Interval / Clinical Decision Values Special precautions/ Information

Full Blood Count

Urgent 1 hr

See table below

Minimum sample volume (Purple EDTA) 1.5ml

Minimum Paediatric sample volume 0.5ml

Specimens for FBC should be sent to the laboratory as

soon as possible after being taken. A FBC specimen

should be analysed no more than 24 hours after being

bled from the patient.

Extremes of temperature can affect FBC specimens –

where storage is required store between 2oC and 25oC –

Note that if a plasma viscosity is to be performed on the

same specimen, it must remain at ambient temperature.

Other factors that can affect FBC results include

lipaemia, haemolysis, hyperbilirubinemia,

Clotted specimens and sample volumes lower than the

specified minimum volume will not be processed

Routine 4 hrs

Plasma Viscosity 24 hours

See table below Minimum sample volume 1.5ml

DO NOT REFRIGERATE

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Routine Haematology Return to: Haematology Information

Appendix A (list of tests)

Test TAT Sample type Biological Interval / Clinical Decision Values Special precautions/ Information

Haemoglobinopathy

(Hb Variant

/thalassaemia)

5 days

See table below

FBC sample will be used

Please send sample for ferritin also. Recent transfusion

will interfere with test interpretation.

Note – abnormal variants will require further testing,

adding 2 weeks to the stated TAT.

Malaria screen 2 hours

See report FBC sample will be used. Give details of area visited.

Glandular Fever

screening test 24 hours

Screening test – reported as positive or negative FBC sample will be used

G6PD screening

test 5 days

See report FBC sample will be used

Sickle Cell Test Urgent 1 hour

Screening test – reported as positive or negative

FBC sample will be used

The lab must be contacted by phone for any urgent

requests.

Emergency pre-op only. Recent transfusion will interfere

with test interpretation

ESR 2 hours

See table below

PMR, GCA/Temporal arteritis/Takayasu’s arteritis only

Minimum sample volume 2ml

Reticulocytes Urgent 1 hr

See table below FBC sample will be used Routine 4 hrs

Blood film 72 hours

See table below FBC sample will be used

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Routine Haematology Return to: Haematology Information

Appendix A (list of tests)

Test TAT Sample type Biological Interval / Clinical Decision Values Special precautions/ Information

Bone Marrow

Examination 2 weeks

See report

Reported by Consultant Haematologists

Must be arranged with Consultant Haematologist

Pyruvate

Kinase (PK) 2 weeks

See report

Minimum sample volume 1ml

Referred to Kings, London for analysis

Must be arranged with Consultant Haematologist

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Haematology Adult Reference Ranges Return to: Haematology Test library

Male Female Units

Haemoglobin (Hb) 130 - 180 115 - 165 g/L

White Cell Count (WBC) 4.0 -15.0 4.0 - 15.0 109/L

Platelet Count (PLT) 150 - 400 150 - 400 109/L

Red Blood Count (RBC) 4.5 - 6.5 3.8 - 5.8 1012

/L

Mean Cell Volume (MCV) 80 - 97 80 - 97 fl

Packed Cell Volume (PCV)/Haematocrit (HCT) 0.40 - 0.54 0.37 - 0.47 L/L

Mean Cell Haemoglobin Concentration (MCHC) 300 - 360 300 - 360 g/L

Neutrophil Count 2.0 - 7.5 2.0 - 7.5 109/L

Lymphocyte Count 1.5 - 4.0 1.5 - 4.0 109/L

Monocyte Count 0.2 - 0.8 0.2 - 0.8 109/L

Eosinophil Count 0 - 0.4 0 - 0.4 109/L

Basophil Count 0 - 0.1 0 - 0.1 109/L

Reticulocytes 0.2 - 2.0

<100

0.2 - 2.0

<100

%

109/L

Plasma Viscosity 1.5 - 1.72 1.5 - 1.72 mPa

HbA2 2.3 - 3.4 2.3 - 3.4 %.

HbF 0 - 1.5 0 - 1.5 %

Erythrocyte Sedimentation Rate (ESR) 01 - 10.0 01 - 12.0 mm/hr

Adult reference ranges have been locally adapted from Haematology literature including Dacie and

Lewis Practical Haematology. The current age and sex specific ranges are included with each

report.

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6.3 Coagulation

6.3.1 Test library

Coagulation Return to: Haematology Information

Appendix A (list of tests)

Test TAT Sample type Biological Interval / Clinical Decision Values Special precautions/ Information

Coagulation screen Urgent 90 min

Clinical decision values are subject to change. Current

ranges available on report. Contact lab for any queries.

Routine 4 hrs

D-Dimer Urgent 90 min

Clinical decision values are subject to change. Current

ranges available on report. Contact lab for any queries.

Routine 4 hrs

Unfractionated (UF)

Heparin

Urgent 90 min

Clinical decision values are subject to change. Current

ranges available on report. Contact lab for any queries.

Send to lab urgently. Must be processed within

4 hours of collection. Routine 4 hrs

Oral anticoagulants Urgent 90 min

Clinical decision values are subject to change. Current

ranges available on report. Contact lab for any queries.

For dosing contact the Anticoagulant Clinic on

Ext 4747 Routine 4 hrs

Thrombophilia

screen 4 weeks 3x

Clinical decision values are subject to change. Current

ranges available on report. Contact lab for any queries.

Factor V Leiden and Prothrombin G20210A

mutation screen sent to referral laboratory. Testing

will be carried out in accordance with BCSH

guidelines.

Lupus

anticoagulant

2 weeks

2x

Clinical decision values are subject to change. Current

ranges available on report. Contact lab for any queries.

Anti 10a assay Urgent 4 hrs

Clinical decision values are subject to change. Current

ranges available on report. Contact lab for any queries.

Sample should be taken 3 to 4 hours post dose Routine ≤72 hrs

Factor Assays Urgent 4 hrs

2x

Clinical decision values are subject to change. Current

ranges available on report. Contact lab for any queries.

Must be arranged with Consultant

Haematologist Routine 4 wks

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Coagulation Return to: Haematology Information

Appendix A (list of tests)

Test TAT Sample type Biological Interval / Clinical Decision Values Special precautions/ Information

Von Willebrand

assays 4 weeks 2x

Clinical decision values are subject to change. Current

ranges available on report. Contact lab for any queries.

Must be arranged with Consultant

Haematologist

Direct Oral

Anticoagulants

(DOAC)

Clinical decision values are subject to change. Current

ranges available on report. Contact lab for any queries.

Contact laboratory first

Normal reference ranges For PT , APTT and Fibrinogen are re calculated with each new lot of reagent using known normal samples. All other

reference ranges have been adapted from Haematology literature including Dacie and Lewis Practical Haematology. The current age and sex related

ranges are included with each report.

6.3.2 Factors affecting the results or processing of coagulation tests

Problem with sample Laboratory comment

Under-filled Will not be processed

Haemolysed Will be processed, depending on degree of haemolysis

Clotted Will not be processed

Lipaemic Will be processed, depending on degree of lipaemia

6.4 Immunology

Immunology would recommend non urgent samples that require special treatment should not be sent on a Friday, especially if the Monday following is a

Bank Holiday.

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6.4.1 Immunology test library

All immunology tests should be requested electronically. This is because the request forms generated by this process state the number and type(s) of

sample tubes required to perform all the testing. Please contact the laboratory if the test you require is not available via electronic requesting.

Our immunology samples are referred to other laboratories for testing. The majority of our samples are sent to the Immunology Department at MFT

Oxford Road. It is not possible for us to maintain a list of tests performed at other laboratories, so they are not listed in this handbook.

6.5 Blood transfusion

6.5.1 Two sample rule

In line with current British Committee for Standards in Haematology (BCSH) guidelines, two samples will be required to determine the blood group of a

patient before cross matched components are released. If a patient has a historical blood group on record, just one sample for the current request is

required.

Any patient that does not have a transfusion history (a known blood group on the laboratory computer system) will require a second group and antibody

screen. The transfusion laboratory will inform the clinician if a second sample is required.

Two samples (with two separate request forms) are required. These samples should be taken by two different people, or if bled by the same person

must be taken at a different time e.g. two independent separate venepunctures.

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6.5.2 Test library

Transfusion Return to: Haematology Information

Appendix A (list of tests)

Test TAT Sample type Biological Interval / Clinical Decision Values Special precautions/ Information

Group and Save

Urgent 45 min

Valid for 3 days.

Patient ID stickers MUST NOT be used for transfusion

samples. Labels MUST be handwritten.

Two sample rule applies (see above)

Routine 24 hrs

Crossmatch

Urgent 45 min

Must have a valid Group and Save

Patient ID stickers MUST NOT be used for transfusion

samples. Labels MUST be handwritten. Routine 6 hrs

Direct Antiglobulin

Test (DAT) 24 hours

Not suitable for cord samples

Foetal cell count 48 hours

Kleihauer 48 hours Mate

rnal

Samples must be received in the lab within 24 hours of

delivery

Co

rd

Cold agglutinin titre 2 days

Telephone blood bank for advice

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Transfusion Return to: Haematology Information

Appendix A (list of tests)

Test TAT Sample type Biological Interval / Clinical Decision Values Special precautions/ Information

HLA specific

antibody screen 10 days

Request form 3A – Diagnostic Laboratory FRM745

http://hospital.blood.co.uk/media/27701/frm745-hi-

request-form-3a-diagnostic-lab.pdf

HLA B27 10 days

Request form 3A – Diagnostic Laboratory FRM745

http://hospital.blood.co.uk/media/27701/frm745-hi-

request-form-3a-diagnostic-lab.pdf

HLA type Class 1

10 days

Request form 3A – Diagnostic Laboratory FRM745

http://hospital.blood.co.uk/media/27701/frm745-hi-

request-form-3a-diagnostic-lab.pdf

Platelet antibodies 9 days

3x

Patient leaflet -

http://hospital.blood.co.uk/media/27109/inf283.pdf

Request form 3D – Platelet Immunology FRM999

http://hospital.blood.co.uk/media/27703/frm999-hi-

request-form-3d-platelet-immunology.pdf 1x

Neonatal

alloimmune

thrombocytopenia

9 days

Mu

m

Patient leaflet –

http://hospital.blood.co.uk/media/27109/inf283.pdf

Request form 3D – Platelet Immunology FRM999

http://hospital.blood.co.uk/media/27703/frm999-hi-

request-form-3d-platelet-immunology.pdf

Dad

Ch

ild

>0.5ml

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Transfusion Return to: Haematology Information

Appendix A (list of tests)

Test TAT Sample type Biological Interval / Clinical Decision Values Special precautions/ Information

Heparin induced

thrombocytopenia

(HIT)

9 days

Patient Leaflet -

http://hospital.blood.co.uk/media/1881/b45bc8e7-af47-

473d-87e8-8f3e96d811b9.pdf

Request form 3D – Platelet Immunology FRM999

http://hospital.blood.co.uk/media/27703/frm999-hi-

request-form-3d-platelet-immunology.pdf

Anti-neutrophil

antibodies 30 days

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7 Cellular Pathology

The Histology and Cytology laboratory (jointly referred to as Cellular Pathology) at the Wythenshawe

Site offers a diagnostic service for tissue and body fluid samples. The department provides a service

to the patients, clinicians and General Practitioners of the South Manchester and Tameside area

including Tameside and Glossop Integrated Care Organisation. The department specialises in

cardio-thoracic, breast, skin and gastrointestinal pathology.

Contact details for clinical or laboratory staff are available below for advice / interpretation of reports

or to enquire about further investigations, should the information you require not be in this handbook.

7.1 Contact details

Generic contact details Location Extension Information

Report enquiries Office 4813

At times, this number may have an

answering machine: please leave a

clear request and a number for us to

call you back

Report Fax Number Office 4809

Departmental nhs.net email address [email protected]

Return to Andrology, Histology sample collection, Frozen Sections, Booking frozen sections,

Consultant Name and Speciality Office Secretary Email address

Dr M Scott

Co-Head of Histopathology Gynaecology, Gastrointestinal, Urology

2144 2123 [email protected]

Dr N Ali Breast, Skin, Gynaecology, Gastrointestinal cytology

5663 4812 [email protected]

Dr P Bishop Cardiothoracic, Skin, Head & Neck, Haematolymphoid

Andrology 2159 2121 [email protected]

Dr A Davenport (part-time)

Co-Head of Histopathology Gastrointestinal

5311 2143 [email protected]

Dr H M Doran (part-time) Cardiothoracic

2138 2121 [email protected]

Dr V Howarth Skin, Gastrointestinal, Urology

2598 2123 [email protected]

Dr M Howe Breast, Urology

4806 4812 [email protected]

Dr R. Hunt Breast, Gastrointestinal, Gynaecology, Urology,

Gastrointestinal cytology 4807 4812 [email protected]

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Consultant Name and Speciality Office Secretary Email address

Dr L Joseph

Clinical Director of quality and safety for

Pathology

Skin, Breast, Cardiothoracic

4808 2123 [email protected]

Dr C Lelonek Skin, Gynaecology, Urology

5902 2143 [email protected]

Dr S Pritchard Breast, Gastrointestinal, Head & Neck, Gastrointestinal

cytology

4818 2143 [email protected]

Dr A Yates Skin, Gastro-intestinal, Gastrointestinal cytology

5642 2123 [email protected]

Dr A Paivi-Correia Cardiothoracic, max fax

4805 4810 [email protected]

Dr Kavita Singhal Breast, Skin

4793 2123 [email protected]

Dr Angeles Montero Breast, Skin, Cardiothoracic

4786 2123 [email protected]

Dr Nadine Elgeredly

Breast, Skin, Urology, Gastrointestinal 2819 2121 [email protected]

Speciality trainees 4814

4816

4815

4817

All telephone extensions should be prefixed

with 0161 291 when calling from outside the

hospital unless otherwise stated

Return to Infertility section Adult autopsies Histology sample collection, Frozen Sections,

Laboratory Fax Tel No. Email address

Sally Wood

Cell Path Laboratory Manager 0161 276 6138 [email protected]

Katherine Congdon

Cell Path Deputy Laboratory Manager 4804 [email protected]

Specimen reception 4800

Histology laboratory 4800

Histology laboratory fax 4801

Cytology laboratory 2156

All telephone extensions should be prefixed with 0161 291 when calling from outside the hospital unless otherwise stated

Return to: Histology sample collection, Frozen Sections, Trephines Specimens, Oral Immunofluorescence samples, Sample

transport, Return of tissues, Cytology sample table,

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7.2 General information

The histology / cytology laboratory is open from 8am until 5.30pm. Outside these hours relevant

personnel are on call for dealing with urgent cardio-thoracic transplant biopsies. Notice needs to be

given to the Consultant Histopathologist and the Biomedical Scientist of the intention to perform a

biopsy and to the Biomedical Scientist when the specimen is dispatched for transport to pathology.

All tissue taken for histological analysis will initially be stained with routine haematoxylin and eosin

(H&E) stain. Following this, additional staining tests may be performed to aid or confirm the initial

diagnosis. All cellular fluid samples are stained with H&E, papanicolaou, or giemsa stain, depending

on specimen type.

The Mortuary is open from 8.30am until 4pm and Anatomical Pathology Technicians operate a

limited on call service. They can be contacted via the duty manager in the first instance.

7.3 Sample acceptance

All specimens need to be accompanied by a correctly completed histology / cytology request form.

Please see sample acceptance criteria for more information.

It is recognised that histology samples are often not repeatable therefore the department has

protocols in place to deal with specimens and accompanied request forms that do not meet the

specimen acceptance criteria. A final report will not been issued until such details have been

corrected. The requesting clinician will be required to attend either the Laboratory at Wythenshawe

or Tameside. Samples from General Practitioners will be returned for amendment. All specimen

and/or request form amendments will need to have a specimen amendment form completed. If

amendments are not addressed within seven calendar days then an incident will be raised in

Ulysses.

7.4 Clinical information

In producing a final diagnostic histopathology or cytopathology report the Pathologists are essentially

looking to provide guidance and answers to clinical queries. Therefore it is essential that all relevant

clinical information is provided on the request form (paper based or electronic) so that the histological

and cytological features of the specimen can be interpreted within the clinical context. Rather than

simply repeating oneself under each heading give relevant clinical details, procedure details, medical

history and the clinically suspected (differential) diagnosis. This should include all previous

malignancies, whether in the same or any other organ system. Under Specimen Details, give the

precise anatomical site of the specimens sent. If there are multiple specimens, there should be a

one-to-one correspondence between the specimens listed on the card and the labelling of the

specimen pots. State any markers / sutures / clips, and their significance. Record any features of

the specimen that are likely to be difficult to interpret after fixation, particularly for complex resections.

If the relevant, appropriate clinical information is not provided this may lead to a delay in the final

report being issued.

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7.5 Sample containers

Container type Description Use

Fixed or air-

dried slides

Slide carrier

If alcohol spray fixative is required

(see cytology sample table), this

available from the cytology

laboratory.

Cytology samples

Plain

container

Sterile container

If MEM, cytology green collection

fluid, or cytorich red preservative

are required (see cytology sample

table), these are available from the

cytology laboratory.

Cytology samples

Plain

universal

Sterile container

If MEM,cytology green collection

fluid, or cytorich red preservative

are required (see cytology sample

table), these are available from the

cytology laboratory.

Cytology samples

CellPath

CellStor

Container prefilled with formalin

Available from the histology

laboratory

Small histopathology

samples

Bucket

Bucket prefilled with formalin

Available from the histology

laboratory .

Unfilled specimen containers for

specific, lung specimens to be

received fresh also available from

histology.

Larger

histopathology

samples

One-Piece

Microbiopsy

Cassette

Tissue Cassette For small tissue

biopsy samples.

Return to Cytology samples table

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7.6 Histology sample collection

The majority of specimens for histology need to be placed in an appropriately sized container with

adequate amount of formalin (ideally 10x the volume of the sample) as soon as removed from the

patient. Specimen containers of all sizes, pre-filled with formalin, are available from histology, please

contact the laboratory. For specimens to be sent to the department not in formalin, empty specimen

containers of all sizes are also available.

7.7 Supply of sample containers

We supply prefilled containers of all sizes to departments at Wythenshawe Hospital and empty

buckets and prefilled biopsy pots to Tameside Hospital.

The exceptions to this rule are specimens requiring an urgent frozen section report, lung wedges and

resection specimens and specimens being transferred to the department by the Biobank team for

which they will have explicit patient consent for sampling. These specimens should not be sent in

formalin.

Prefilled specimen pots are only to be transported by the Trust transport department using the

dedicated barrels.

Any formalin that is identified as out of date and therefore shouldn't be used should be returned to the

Histology department at Wythenshawe site so that the fluid can be safely disposed of.

7.8 Factors that prevent a detailed accurate diagnosis

There are several factors that prevent a detailed accurate diagnosis:

Insufficient tissue sent

Insufficient formalin or lack of formalin

Insufficient space within specimen container

Delay in placing specimen in formalin

Specimen being placed in a unsuitable solution, for example saline

Should any of these factors affect the issuing of a final report, then an incident may be raised in

Ulysses. If a final report is able to be issued, factors that may have affected this result will be

included in this report.

7.9 Frozen sections

7.9.1 Booking cardiothoracic frozen section requests

To book a cardiothoracic frozen please liaise with the cardiothoracic booking clerks who can access

the shared electronic diary for booking such requests. The laboratory access the electronic diary

regularly to see what frozen sections are booked. Any changes to these booking should be

communicated to the Cellular Pathology department as soon as these changes are known.

7.9.2 Booking other frozen section requests

Frozen section requests, from either Wythenshawe or Tameside, need to be booked 24 hours in

advance by calling the secretarial service.

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Should the notice for a frozen section be less than 24 hours, the service may be unavailable.

7.9.3 Once specimen has been taken

Once taken, the specimens should be delivered to the department fresh (not in formalin) as soon as

practically possible, together with the receipt book to audit the delivery of the specimen to the

department. Wythenshawe frozen sections requests are delivered directly to the Histopathology

department at Wythenshawe: specimens taken at Tameside are taken directly to the Tameside

Pathology laboratory. Delay in delivery of the specimen will delay the issuing of the frozen section

report.

If the frozen section service is no longer required please ring the laboratory as soon as possible to

notify us of the cancellation.

A preliminary report will be issued stating the diagnosis obtained from the frozen section. To ensure a

timely report is available, please provide contact details of where this report should be issued. A full

report will follow once the tissue has been formalin fixed and paraffin sections examined by a

Pathologist.

7.10 Bone Marrow Trephine specimens.

All bone marrow trephine specimens should be placed in formalin and referral request made on the

HODS database to be referred into the Manchester Haematological Cancers Diagnostic Partnership

(HCDP). These specimens are sent from the clinic to Central Specimen Reception at Oxford Road

Campus via the Haematology department at Wythenshawe Hospital.

7.11 Skin immunofluorescence specimens

Skin biopsies requiring immunofluorescence need two samples to be taken from the same area. One

is to be placed in formalin; the other for immunofluorescence should be placed in Mikel’s medium

which is obtainable from the Histopathology Department at Salford Royal Hospital. Specimens

should be sent to Wythenshawe hospital histopathology; these will be booked onto the Trust

laboratory system and then packaged by laboratory staff for hospital transport to Salford Royal

hospital. Reports are returned to Wythenshawe histopathology, where they are then uploaded onto

the laboratory information system.

7.12 Oral immunofluorescence specimens

The Oral Pathology Department at Oxford Road Campus has special gel tubes to preserve the

specimens. Please contact them for advice on how to source the relevant specimen containers and

any instructions that need to be adhered to for taking the specimen. Specimens should be sent to

Wythenshawe hospital histopathology in the gel tubes; these will be booked onto the Trust

laboratory system and then packaged by laboratory staff for hospital transport to Oxford Road

Campus. Reports are returned to Wythenshawe histopathology, where they are then uploaded onto

the laboratory information system.

If the specimen taken is larger than the containers in use then please contact the histopathology

department at Oxford Road Campus for further advice.

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7.13 Amputated limb specimens

If the patient would like their amputated limb returning to them following surgery, please contact the

histology department for further information. Amputated limbs for disposal should not be sent to

either the Mortuary or Histopathology for disposal. Should any limbs be received for disposal, the

requesting theatre will be contacted and arrangements made for the limb to be returned immediately.

7.14 Cytology samples

Cytology specimens are either fluid based or received as smears of fine needle aspirations (FNA) or

imprints of tissue biopsies on glass slides.

Cytology specimens should be sent in sample containers of an appropriate size to adequately hold

the specimen. Some specimens are received fresh, with no additives and therefore should be

delivered to the department as soon as collected to prevent deterioration of the sample (see table

below). Other specimens are received in cell collection fluid or a preservative such as cytorich red.

These preservatives assist with preservation of the cells within the sample. In the case of thyroid

aspirates some slides should be fixed using the alcohol based fixative spray and some air dried. The

air dried slides are for Giemsa staining.

Cytorich red and alcohol spray fixative are both available from cytology by contacting the cytology

laboratory.

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Cytology samples

Test TAT Sample type Biological Interval / Clinical

Decision Values Special precautions/ Information

Serous fluid 7 days

N/A N/A

Urine 7 days

Bronchial washings 7 days

Bronchial-alveolar

lavage 7 days

Sputum 7 days

Bladder washings 7 days

Urethral washings 7 days

Ureteric washings 7 days

Cyst fluid 7 days

Serous fluid 7 days

Urine 7 days

Bronchial washings 7 days

Bronchial-alveolar

lavage 7 days

FNA 7 days

N/A Cytorich red or cytology green collection fluid

required, available from the cytology laboratory.

EBUS 7 days

EUS 7 days

Bronchial brushings 7 days

Bile brushings 7 days

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Cytology samples

Test TAT Sample type Biological Interval / Clinical

Decision Values Special precautions/ Information

OR

FNA lymph node 7 days

OR

AND 2 air-dried slides

N/A Cytorich red or cytology green collection fluid

required, available from the cytology laboratory.

FNA thyroid 7 days

FNA parotid 7 days

FNA breast 7 days

N/A

4 fixed smear slides

Alcohol spray fixative is available from the

cytology laboratory

Buccal smears 7 days 1 fixed smear slide

Tongue smears 7 days

Department: Pathology

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7.14.1 Broncho-alveolar lavages (BAL)

These specimens requiring a differential cell count should be received on ice and by 5pm on working

days only. This is to ensure the appropriate slide preparations can be made. The cytology

department can examine for Pneumocystis carinii on Broncho-alveolar lavage specimens if required

however, the preferred method is for the sample to be sent to microbiology.

7.14.2 Endobronchial ultrasound guided aspirate specimens (EBUS)

These should be delivered to the department as soon as possible so that preparation of the samples

can be undertaken. It is appreciated that reports are wanted on these specimens in a timely fashion

for MDT discussion.

7.14.3 Joint Fluids

Joint fluids should be sent to Cytology. For any cases where microbiology testing is also required,

two separate samples should be collected and two requests made; one for cytology testing and the

other for microbiology testing. Failure to request separate testing will result in a delay in cytology

testing as the sample will first be sent to microbiology based at Oxford Road Campus, before being

returned to the Cytology department at Wythenshawe Hospital for testing. This may lead to an

erroneous result due to the delay in testing and potential degradation of the specimen.

7.15 Cervical Cytology

Cervical cytology is sent to Oxford Road Campus for reporting. The contact details are:

Jacquelyn Medlock [email protected] Cytology Manager Adanna Ehirim [email protected] Lead BMS Cytopathology Richard Lambert [email protected] Lead BMS Cytopathology

Manchester Cytology Centre Clinical Science Building 2 Manchester Royal Infirmary Oxford Road Manchester M13 9WL

Tel: 0161 276 5119 Fax: 0161 276 5113

7.16 Andrology

The Cytology department offers infertility and post vasectomy testing.

7.16.1 Infertility

Infertility services are performed at both the MFT Wythenshawe site and Tameside site on an

appointment based system. Appointments are available at Wythenshawe on Wednesday and Friday

and at Tameside on a Tuesday morning. Please contact the secretarial team at Wythenshawe for

information. Once a patient has made an appointment a kit will be posted, via Royal Mail, which

contains a specimen pot and instructions.

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Instructions for both Tameside and South Manchester patients are provided by the laboratory to GPs

and clinicians who wish to request these tests.

The bottom of this information leaflet needs to be completed by the patient when the sample has

been produced to inform the laboratory of information that may affect the quality of the result.

Infertility samples without a correctly completed request form from the requesting clinician / GP and

no or incomplete information sheet will be rejected. Infertility samples, which are not received in the

specimen pot provided, will also be rejected. The patient will then be expected to make another

appointment and produce another sample.

Reports are issued, in line with the fifth edition of the “WHO laboratory manual for the examination

and processing of human semen”.

In case of difficulty interpreting the new ranges below, please contact a consultant specialising in

andrology.

7.16.2 Post vasectomy

Vasectomy Analysis services are performed at Tameside on a Thursday morning. At Wythenshawe

they are undertaken every working day, during 8.30am until 3.30 pm. No appointment for this service

is required. Patients are required to be given the relevant information leaflet, which is provided by

the laboratory to GPs and clinicians who wish to request these tests.

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Infertility Reports Return to: Andrology expert

Infertility section

Test TAT Sample

type Biological Interval / Clinical Decision Values

Special precautions/ Information

Infertility

testing 3 weeks Semen

Volume: Although we may measure the weight of the sample but we report by

volume, the lower reference limit being 1.5 ml.

Sperm concentration The lower reference limit has been reduced to 15.106 per ml

Total sperm number The WHO editorial committee considered that total sperm number per

ejaculate provides a more accurate assessment of testicular function than

does sperm concentration. There is now a lower reference limit for the total

sperm number of 39.106 per ejaculate: we will calculate this.

pH: Lower reference range is 7.2. No upper limit is defined.

Motility: There are three categories: progressive motility (PR, spermatozoa moving

actively), non-progressive motility (NP, all other patterns of motility with an

absence of progression) and immotile (IM, no movement). The lower

reference limits are Total motility (PR + NP); 40%, Progressive motility

(PR); 32%.

Vitality 58% of spermatozoa are alive. Vitality will be assessed if the total motility is

less than 50%.

Sperm morphology The lower reference limit, which is 4% normal forms.

Infertility specimens to

be received in the

department 45 minutes

from production.

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7.17 Sample transport

Specimens for histology or cytology are not allowed to be transported via the pneumatic tube system.

The transport of the specimens to the department is undertaken by the respective hospital transport

from both the Wythenshawe and the Tameside site. Dedicated barrels are provided, by the histology

department, as the secondary packaging for use to transport the samples. The primary packaging

being the container the specimen is in. Urgent samples may be delivered to the department ad hoc;

these should be transported in an appropriate container, with a tightly fitting lid. Specimens should

not be transferred to the department without appropriate packaging. All specimens should be

received with a documented tracking sheet detailing the patient identifiers, specimen type and where

the specimen has been taken. These tracking sheets are checked on arrival in the histology

department and returned to the department or area the specimen was taken from for staff to record

that the specimen has been received safely in Histology.

For specimens received from hospitals where there is not a routine transport service arranged, a

courier service is used. This includes specimens transported from Stepping Hill Hospital. Transport

between Wythenshawe Histopathology and Oxford Road Campus is in place at regular intervals

throughout the day to ensure timely transport of specimens to be processed at each site.

If you have any queries or should extra transport be required for any reason please contact the Trust

transport department via switchboard.

Transport of the Tameside samples occurs twice daily. The transport collects specimens from

theatres, endoscopy and then pathology before leaving pathology at 9.30 am and 3.30 pm for

delivery to Wythenshawe Site histopathology. This transport also delivers samples from GP

surgeries within the Tameside borough. This transport also delivers supplies from Wythenshawe Site

back to Tameside for the relevant theatres and clinics.

Samples received from both Trusts are recorded using a paper based system and in some cases

electronically. Please ensure such records are completed before dispatch of samples. For paper

based requesting, only specimen request forms provided by histopathology should be used to

request specimen testing. These forms should not be photocopied, for a supply of forms, please

contact the laboratory.

Samples from the GP surgeries within the South Manchester District are delivered to the main

pathology reception area and then collected by histology staff on an ad hoc basis. Some of these

samples are requested electronically others are accompanied by hand written request forms. For

paper based requesting, only specimen request forms provided by histopathology should be used to

request specimen testing. These forms should not be photocopied, for a supply of forms, please

contact the laboratory.

If samples from Wythenshawe Site cannot be accepted due to failing the specimen acceptance

criteria, the requesting Clinician will be contacted and asked to attend the laboratory as soon as

possible to make the necessary amendments and complete a Specimen Labelling Amendment form.

This will form part of the record of this sample.

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If samples are from GP’s within the Wythenshawe borough, these are returned to the GP practice for

amendments and completion of a Specimen Labelling Amendment Form. The specimen can then be

returned to the Wythenshawe Histology department for processing.

If samples from Tameside Hospital cannot be accepted due to failing the specimen acceptance

criteria, the requesting Clinician will be contacted and informed the sample will be returned to

Tameside Pathology Specimen Reception. The Clinician should then attend the department to make

any necessary amendments and complete a Specimen Labelling Amendment form. This will form

part of the record of this sample. The sample is then returned to Histology at Wythenshawe Site for

processing.

If samples are from GP’s within the Tameside borough, these are returned to Tameside Specimen

Reception to then be sent to the GP practice for necessary amendments to be made and Specimen

Amendment Form. This is then returned to Wythenshawe Histology via Specimen Reception at

Tameside.

If specimens received from Stepping Hill Hospital cannot be accepted due to failing specimen

acceptance criteria, the requesting Clinician will be contacted and asked to attend the laboratory as

soon as possible to make the necessary amendments and complete a specimen amendment form.

This will form part of the record for this sample.

Please be aware that a final report will not be made available until the necessary amendments have

been made. Failure to amend the specimen request form of specimen pot in a timely fashion will lead

to a delay in the final report and if the specimen is not amended in 7 days, a Ulysses record will be

raised.

7.18 Reports

All reports issued by the department are available on the relevant Trusts’ electronic systems. This

will be EPR at Wythenshawe site and Lorenzo within Tameside. For primary care reports are

distributed to the GP practice systems.

Paper reports are still sent to the users at Tameside and some GP practices. Tameside reports,

including those for the Tameside GP practices, are transported back to the Pathology Department at

Tameside site using the twice daily transport. They are then distributed as required from Tameside

Pathology. Paper reports for GP practices within the Wythenshawe Site catchment area are sent via

second class post.

7.19 RCPath cancer standards and data sets

For cancer resections, the Department follows guidelines and reporting templates recommended in

the Royal College of Pathologists Cancer Data Sets.

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7.20 Multidisciplinary Team Meetings (MDT’s)

Histopathologists participate in MDT meetings as required, on both the Wythenshawe Tameside

sites. Participation in the Tameside MDTs and links into multi-centre MDTs is often via video

conferencing.

7.21 Turnaround times

The Cellular Pathology department monitors turnaround times in line with the RCPath key

performance indicators – proposals for implementation July 2013. This document states that 80% of

diagnostic cases should be reported within 7 calendar days and 90% within 10 calendar days.

For up to date information on the department’s current turnaround figures, please contact the Deputy

Manager.

7.22 Material sent away for further tests

The laboratory on occasion refers material (paraffin embedded blocks or stained slides) to the

Manchester Haematological Cancers Diagnostic Partnership. This is a joint partnership between

Manchester Foundation Trust and the Christie Hospital for confirmation and classification of

lymphomas and to the Christie Hospital for opinion and / or confirmation of pathology in a small

number of cases.

Material may also be referred to St. Marys Genetics department for Genetic / molecular testing which

quotes a 10 day turnaround time for results. This includes EGFR, BRAF and KRAS.

A very small number of cases are referred to other Specialist Histopathologists for expert second

opinion or review.

7.23 Return of tissues

On occasion, patients request the return of tissues following a surgical procedure. This may be for

various cultural or religious reasons. Patients have a right to have their tissues returned to them.

1. If there is no need for the tissue to be examined histologically and the patient wishes to take it

away immediately, then it does not need to be sent to the Pathology Department.

2. In some cases, the tissue needs to be examined histologically. The remaining tissue will then

be returned to the patient by the Pathology Department. Sometimes the patient is

hospitalised or is uncertain as to what he wants done with the tissue, in which case it will be

stored by the Pathology Department. In such cases, please speak to the Deputy Laboratory

Manager or a senior Biomedical Scientist to ensure that the patient’s wishes are met with

regard retention and return of their tissue sample. Please be aware that failure to inform the

department that the patient wishes to have their tissue sample retained and returned to them

may result in the specimen being disposed of as tissue samples are only kept in the

department for 4 weeks following the issue of a histology report. If the specimen is returned to

the patient, written advice as to the hazards of the formalin fixative used will be provided.

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7.24 Disposal of tissues

Specimens are not permitted to be sent to histology for disposal purpose. We provide a diagnostic

service, not a disposal service. Any specimens received where disposal is indicated will be

processed and a report issued. Only POC specimens may be disposed of without histological

examination if indicated by the patient on consent form 9.

7.25 Errors happen

There is evidence that the rate of clinically significant reporting errors for Histopathologists is 1 to 2%.

Since histology often provides the definitive diagnosis, error in histology may have a profound impact

on patient management. There are things that you can do to reduce the occurrence and impact of

errors:

Make sure that request cards and specimen pots meet the requirements of the sample

acceptance criteria with unambiguous and correct patient demographics.

Provide clinical information on the request card, including details of previous specimens,

whether here or in another hospital.

Question cases where there is an apparent discrepancy between the clinical, radiological and

pathological diagnosis.

Review cancers at an MDT

7.26 Manchester Cancer Research Centre Tissue Bank

The Manchester Cancer Research Centre (MCRC) Tissue Bank is an initiative to collect and bank

tissue samples from cancers to facilitate research. The project started collecting in April 2008. To

contact the team please ring 0161 446 3659 or click on the hyperlink above.

7.27 Measurement uncertainty

For information regarding measurement uncertainty for specimens in Cellular Pathology please

contact the laboratory.

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8 Mortuary

8.1 Contact details

Contact details for the Mortuary are available below should the information you require not be in this

handbook.

Mortuary

Victoria Edwards

Cellular Pathology Deputy Laboratory

Manager (ORC)

0161 701 0954

[email protected]

Neill White

Senior APT 2541 [email protected]

Mortuary office 2541

Mortuary Fax 5949

All telephone extensions should be prefixed with 0161 291 when calling from outside the hospital unless otherwise stated

8.2 Opening hours:

The Mortuary is staffed between the hours of 8:00am and 4:00pm, Monday to Friday. Outside of

these hours, and over the weekend, there is an on-call technician available via Switchboard between

the hours of 8:00am and 10:00pm.

For urgent advice between 10:00pm and 8:00am please contact switchboard and ask for the senior

mortuary technician

The Mortuary is open to Funeral Directors during the following times:

Monday to Friday : 9:00am - 15:30pm

The Mortuary has a dedicated viewing suite for relatives. This is available by appointment only for

immediate next of kin only.

The viewing suite is open via an appointment system Monday-Friday: 09:00am – 15:30pm. All

appointments are 30 minutes in duration and are booked through the mortuary via switchboard.

Out of these hours are booked through the Duty manager via switchboard (Monday-Friday: 16:00-

22:00 and Saturday/Sunday and Bank Holidays: 08:00-22:00).

8.3 Adult post mortems

Requests for post mortems should be made through the Bereavement Office:

Bereavement Office 2360

Margaret Butler

Adult Bereavement manager 2028

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[email protected]

Bereavement office fax 2665

Please be clear as to whether you wish to request a hospital (consent) post mortem, or you need to

refer a death to the coroner. The Coroner has indicated that he would like all deaths associated with

a hospital acquired infection reported to him: it would be appropriate for the reporting doctor to advise

whether the deceased died with the infection or of the infection, or that this is uncertain.

Please do not make promises to relatives that a post mortem will be done the next day. Post

mortems are performed in a timely fashion but there are multiple factors determining when they are

done. Refer the relatives to the bereavement office for this information.

The consent form for a hospital post mortem is extensive but logical. You need to familiarize yourself

with it before meeting with the next of kin.

In the event of the coroner ordering a post mortem examination, no consent from the next of kin is

required. However, the coroner's view of the information that is required from the post mortem is

likely to be narrower than that of a clinician. For example, the coroner will be satisfied with a

diagnosis of "carcinomatosis", where a clinician will want to know the tumour type and the site of the

primary. Once the pathologist is able to give a cause of death to the satisfaction of the coroner, there

is no authority for further investigation. In particular, the coroner has no authority to allow tissue to be

taken for histology, once a natural cause of death has been given. In order to satisfy the needs of

medical audit and education, it is necessary to obtain consent from the next of kin for investigations

over and above those authorised by the coroner. For this purpose, you need to ask the next of kin to

complete the consent form. Annotate it to indicate that this consent is being taken to supplement a

coroner's post mortem.

For hospital post mortem examinations, not under the authorisation of the coroner, consent must be

sought from the person in the highest ranking qualifying relationship as per the Human Tissue Act. A

member of the Consultant body who undertakes autopsies or the bereavement manager should be

present when consent is taken to ensure that this is taken in line with the Human Tissue Act.

The coroner has restricted the release of post mortem findings to clinicians. If you want to know

about a post mortem, permission needs to be obtained from the coroner. Phone: 0161 219 2222,

Fax: 0161 274 7329, [email protected].

Information relating to the Manchester coroner is available at www.manchester.gov.uk/coroners

The Wythenshawe Site holds a license from the Human Tissue Authority for the storage of bodies,

the making of a post-mortem examination and the removal of tissues at post mortem: we are listed at

the HTA web site under Wythenshawe Hospital. There is extensive advice from the Human Tissue

Authority at www.hta.gov.uk/guidance/codes_of_practice.cfm

Human Tissue Authority Designated 0161 291 5663 / 4812

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Individual

Dr Nisha Ali, Consultant Histopathologist

[email protected]

8.4 Infectious bodies

We inform undertakers of infectious risks by issuing an Infection control notification sheet. You will

be asked to complete this form at the same time as you complete a death certificate. The staff of the

Bereavement Office will advise, but if necessary, consult a histopathologist or microbiologist.

8.5 Medical Devices

8.5.1 Pacemakers and defibrillators

Implantable devices such as pacemakers and defibrillators contain batteries which explode on

incineration. It is therefore essential that they are removed from bodies prior to cremation. If you

know that a body contains such a device, please inform the Mortuary APT’s. If you are completing

the first part of the cremation form, you are required to state if a device is present

Defibrillators pose an additional hazard, in that they are liable to be triggered by the act of removing

them from the body if they have not first been inactivated. Increasingly, they are indistinguishable

from pacemakers on external inspection of the body. If you know that the device is a defibrillator, you

must inform the Mortuary APT’s specifically so that we can ask an ECG technician to inactivate the

device.

8.5.2 FixionTM intramedullary nails

FixionTM intramedullary nails have a saline-filled chamber. On incineration, the steam pressure is

sufficient to cause an explosion. You need to state on the first part of the cremation form if such an

implant is present. At the time of implantation, the next of kin should have been advised of this

hazard.

Removal of the above devices are completed by the Funeral Directors.

8.6 Stillbirths and foetuses, post mortems and disposal

Any live born baby that dies should be referred to a paediatric pathologist at St Mary’s Hospital for a

post mortem.

For post mortems on stillbirths and non-viable foetuses, please contact the bereavement midwife on

the maternity unit at Wythenshawe hospital on ext 2930 or 2963.

8.6.1 Wythenshawe Hospital patients

For first trimester miscarriages, any pregnancy remains should be sent to the histology department

accompanied by a Consent Form 9 “Consent for Histopathological Examination and Disposal of

Tissue Following Early Pregnancy Loss Up To 12 Weeks 6 Days” signed by the mother and

indicating her wishes for the remains from her miscarriage/ectopic pregnancy. Note Consent Form 9

solicits consent to histological examination of the non-fetal tissues only. The fetus will not be

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dissected or examined microscopically but may be commented as to the presence of it within the

specimen.

The specimen cannot be examined without appropriate consent; lack of an accompanying

appropriately completed or legible consent form will result in delay to reporting which may have

adverse effects on the patient's management. In such cases, staff in histopathology will contact the

clinicians, whom this patient is under, requesting a consent form to be sent as soon as possible

before the specimen can be examined. If no consent is received within seven calendar days, an

incident report will be raised in Ulysses.

If you have any questions, please speak to the laboratory or to the specialist midwife on maternity.

8.6.2 Tameside patients

For first trimester miscarriages, from patients’ at Tameside, any pregnancy remains should be sent to

the histology department accompanied by a Dukinfield cremation form. This is completed and signed

by the mother indicating her understanding of the specimen being sent for cremation following

histological examination.

Only non-fetal tissue is examined; any fetus will not be dissected or examined microscopically, but

may be commented as to the presence of it within the specimen. Should a cremation form be

received without parental signature, the form and specimen pot will be returned to the mortuary at

Tameside.

Staff at Tameside mortuary will then liaise with clinicians to ensure a cremation form is completed. If

no cremation form is received, a report may still be issued, however, staff from Wythenshawe Site

histology will contact clinicians at Tameside requesting a form to be sent. If this is received prior to

disposal, the form can be sent to Wythenshawe Site and matched with the specimen pot. If not

received prior to disposal, the specimen is returned to the Mortuary at Tameside, where staff will

continue to liaise with clinicians for completion of the cremation form.

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9 Microbiology

The Microbiology Laboratory service for Wythenshawe Hospital is provided by the Manchester

Medical Microbiology Partnership (MMMP), situated at the Oxford Road Campus. All information

regarding the microbiology service is available on the MFT Laboratory Medicine website. Click on the

MMMP User Manual link. The manual includes information on how to request samples out-of-hours

and a list of contact details.

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10 Mycology Reference Centre, Manchester

The UK NHS Mycology Reference Centre Manchester (MRCM) is situated on the second floor of the

Education & Research Centre at Wythenshawe Hospital. The MRCM provides specialist mycology

diagnostic services for Manchester University NHS Foundation Trust, and hospitals throughout

Greater Manchester and the UK.

Antifungal and mycological advice can be offered on the diagnosis of disease, clinical management

and care of patients.

The MRCM laboratory is open from 08:30 to 17:00 hours Monday to Friday. Urgent medical advice

can be obtained by contacting Wythenshawe Hospital switchboard and asking for the on-call

Infectious Diseases Consultant.

10.1 Contact Details

Member of staff Location Extension Email address

Professor MD Richardson Director of MRCM and Consultant Clinical

Scientist in Mycology

Office 5914

[email protected] Secretary 5839

Mobile 07545 994 936

Dr CB Moore Deputy Director of MRCM, and Principal

Clinical Scientist

Office 4223 [email protected]

[email protected] Secretary 5839

Dr R Richardson Consultant Medical Mycologist

Office 5941 [email protected]

General enquiries Office 5839 [email protected]

Test enquiries/results Laboratory 2124 [email protected]

Website www.mycologymanchester.org

All Wythenshawe Hospital samples should be sent to the Clinical Sciences Building, Wythenshawe

Hospital where appropriate transportation to the Mycology Reference Centre Laboratory will be

ensured.

External samples can be sent using the DX System. Our details are DX 332601 MANCHESTER

96M.

Alternatively samples may be posted, ensuring appropriate packaging (see 1.10.3), to:

Mycology Reference Centre Manchester 2nd Floor Laboratories Education and Research Centre Wythenshawe Hospital Southmoor Road Manchester M23 9LT

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10.2 Additional Tests

Additional tests can be requested by contacting the laboratory, although it must be recognised that

the archive sample available will have a limited volume. Furthermore, samples may be beyond the

validation period for particular tests.

10.3 Measurement Uncertainty

All assays have a margin of error associated with the calculation of the numerical value. This is

referred to as the measurement uncertainty. Further information on the measurement of uncertainty

for our laboratory assays is available by contacting the laboratory.

10.4 Antifungal Drug Levels

Please ensure that details of all antifungal drugs the patient is receiving are given - this information is

essential to ensure appropriate testing is performed.

Please record the date and time the specimen is taken, together with the time of last dose. These

details ensure correct interpretation of results.

10.4.1 Indications for monitoring

All patients receiving flucytosine

Patients receiving itraconazole - to check drug absorption and to monitor compliance

Patients receiving posaconazole - to check drug absorption and to monitor compliance

Patients receiving isavuconazole – to check drug absorption and to monitor compliance

All patients receiving voriconazole – a pre-dose sample is required

Fluconazole in patients on dialysis/haemofiltration

Patients failing azole therapy

If drug interactions are suspected

10.4.2 References

Richardson MD and Warnock DW. Fungal Infection: Diagnosis and Management. 4th Ed.

Oxford, Wiley-Blackwell, 2012.

Ashbee HR, Barnes RA, Johnson EM, Richardson MD, Gorton R, Hope WW.

Therapeutic drug monitoring (TDM) of antifungal agents: guidelines from the British

Society for Medical Mycology. J Antimicrob Chemother 2014; 69: 1162–1176.

10.5 Identification and susceptibility testing of medically important fungi

Respiratory, vaginal and oral swabs will be cultured within our laboratory. Identification and/or

susceptibility testing will be performed as appropriate.

Other original specimens will be processed by the Microbiology Department, MFT Manchester Royal

Infirmary. If fungus is isolated, the Microbiology Department will then send the culture on to the

Mycology Reference Centre for identification and/or susceptibility testing.

Please ensure that the request form states that mycological investigations (identification and

susceptibility testing) are required.

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10.5.1 Indications for testing

All life-threatening fungal infections, to ensure that the optimal therapy is administered

Isolates from patients at increased risk of fungal infection, such as those infected with HIV,

immunosuppressed or on ICU, so that appropriate antifungal therapy can be given

Mucosal candidosis not responding to therapy

Clinically significant non-Candida albicans species due to increasing incidences of both infection

and fluconazole resistance

Rare pathogens because of an increased incidence of resistance and unpredictability of

resistance patterns

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10.6 Test library

Antifungal Drug Levels Return to: Mycology Information

Appendix A (list of tests)

Test TAT Sample type Biological Interval / Clinical Decision

Values Special precautions/ Information

Antifungal drug

levels See below

Specimens should be transported to the laboratory as soon as possible. If

a delay is anticipated, samples should be refrigerated. Assays validated for

transportation of samples at room temperature for up to and including 5

days.

For all drugs, the time of previous dose and time of sampling should

be recorded accurately to allow correct interpretation.

Flucytosine

Generally

next

working

day

Adult 5ml Neonate

0.5ml

Adult Pre-dose 30-40 mg/L

Post-dose 70-80 mg/L

Neonate:

(<3 months)

Pre-dose 20-40 mg/L

Post-dose 50-80 mg/L

Levels >100mg/L are potentially toxic

Therapeutic Drug Monitoring is essential for clinical management

Pre-dose: Oral and IV: Just before dose*

Post dose: Oral: 2 hours post dose*

IV: 30 minutes post dose*

Commence: Around second/third dose

Frequency: Twice weekly, or more often if renal function is changing

Lab assay runs:

Day of receipt as required Samples must be notified or received before 1pm

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Antifungal Drug Levels Return to: Mycology Information

Appendix A (list of tests)

Test TAT Sample type Biological Interval / Clinical Decision

Values Special precautions/ Information

Itraconazole 1-2 days

Adult 5ml Neonate

0.5ml

Target level:

Prophylaxis: pre 0.5–1.0mg/L

Therapy: pre 1.0-2.0mg/L

Commence monitoring only after steady

state has been reached (1-2 weeks on

oral therapy, little variation through the

day)

Therapeutic Drug Monitoring is essential for clinical management

Pre-dose: Oral: not needed

Post dose: Oral: random*

Commence: Only after steady state has been reached.

Frequency: Dependent on patient - seek advice - usually monthly for the first three months and then every three months. Check levels two weeks after any dose change or if there might be a possible drug interaction. Repeat levels if concern about poor compliance / poor absorption.

Lab assay runs:

Each weekday

Posaconazole

1-2 days

Adult 5ml Neonate

0.5ml

Target level:

Prophylaxis: pre 0.7-1.5mg/L

Therapy: pre 1.0-3.75mg/L

Consider reduction if > 3.0mg/L

Commence monitoring only after steady

state has been reached (1-2 weeks on

oral therapy, little variation through the

day)

Therapeutic Drug Monitoring is essential for clinical management

Pre-dose: Oral: not needed

Post dose: Oral: random*

Commence: Only after steady state has been reached.

Frequency: Dependent on patient - seek advice - usually monthly for the first three months and then every three months. Check levels a few weeks after any dose change or if there may be a drug interaction. Repeat levels if concern about poor compliance / poor absorption.

Lab assay runs:

Each weekday

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Antifungal Drug Levels Return to: Mycology Information

Appendix A (list of tests)

Test TAT Sample type Biological Interval / Clinical Decision

Values Special precautions/ Information

Voriconazole 1-2 days

Adult 5ml Neonate

0.5ml

Pre-dose level target range 1.3 -

5.7mg/L

Dose escalation is advised for any level

less than 1.3mg/L

Due to the non-linear kinetics of the drug

in adults, informed clinical judgement

regarding target range is not possible on

any sample except pre-dose samples

Therapeutic Drug Monitoring is essential for clinical management

Pre-dose: Oral: 10-14h post-dose window* (ie pre-dose as BD dosing) IV: Just before dose*

Post dose: Not required

Commence: after 3 days of therapy

Frequency: Dependent on patient - seek advice. If patient has suspected invasive disease or very unwell, do a level at day 5 of treatment and repeat at least weekly until therapeutic levels obtained. If IV to oral switch done, repeat level about 5 days after switch. Once therapeutic levels achieved, repeat levels at 2, 4, 8 and 12 weeks, and every three months thereafter. For other diagnoses, do a level at week 2, 4, 8 and 12 of treatment and every three months thereafter. Repeat levels two weeks after any dose change or if a drug interaction is suspected. Repeat levels if concern about poor compliance / poor absorption.

Lab assay runs:

Each weekday

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Antifungal Drug Levels Return to: Mycology Information

Appendix A (list of tests)

Test TAT Sample type Biological Interval / Clinical Decision

Values Special precautions/ Information

Isavuconazole

1-2 days

Adult 5ml Neonate

0.5ml

Target levels not yet established and

informed clinical judgement is required

for dose adjustments. Consult Mycology

Reference Centre for advice.

Pre: 1-4mg/L.

The mean half-life of isavuconazole in

plasma is 130 hours and it has linear

kinetics.

Therapeutic Drug Monitoring is essential for clinical management

Pre-dose: Oral: 10-24 hours post-dose window* (ie pre-dose as BD dosing) IV: Just before dose*

Post dose: Not required

Commence: after 3 days of therapy

Frequency: Dependent on patient - seek advice. If patient has suspected invasive disease or very unwell, do a level at day 5 of treatment and repeat at least weekly until therapeutic levels obtained. Once therapeutic levels achieved, repeat levels at 2, 4, 8 and 12 weeks, and every three months thereafter. For other diagnoses, do a level at week 2, 4, 8 and 12 of treatment and every three months thereafter. Repeat levels two weeks after any dose change or if a drug interaction is suspected. Repeat levels if concern about poor compliance / poor absorption.

Lab assay runs:

Each weekday

* these samples are most useful for clinical management

Itraconazole, Posaconazole and Voriconazole TDM are performed by Biochemistry, Wythenshawe Hospital (UKAS 9063).

Isavuconazole TDM is performed by Antimicrobial Reference Laboratory, Bristol (UKAS 8099).

Check www.UKAS.com for up to date accreditation status of referral laboratories.

Fluconazole levels can be assayed to test compliance or absorption. Contact Mycology Reference Centre.

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Identification and Susceptibility Testing of Yeasts and Moulds Return to: Mycology Information

Appendix A (list of tests)

Test TAT Sample

type

Biological Interval / Clinical Decision

Values Special precautions/ Information

Full identification

and susceptibility

testing of all

medically

important yeasts

and moulds

Identification:

Yeast: 2-5 days

Mould: 2-7 days

Longer if molecular sequence-

based identification is required.

Susceptibility testing:

Yeast: 1-5 days

Longer for some yeasts and

drugs.

Mould: 3-7 days

Longer if culture requires

incubation.

As per Microbiology guidelines

N/A The following susceptibility tests are routinely performed :

Yeasts Moulds

Flucytosine Itraconazole

Fluconazole Amphotericin

Amphotericin Voriconazole

Itraconazole Posaconazole

Voriconazole Isavuconazole

Micafungin Micafungin

Anidulafungin Terbinafine

Posaconazole

Other drugs, including caspofungin, are available upon request

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Cryptococcal antigen latex agglutination test Return to: Mycology Information

Appendix A (list of tests)

Test TAT Sample type Biological Interval /

Clinical Decision Values

Special precautions/ Information

Latex

agglutination test

for cryptococcal

antigen.

Collection is not

time dependent.

Generally

same day

CSF by lumbar puncture, serum

and urine

Minimum 500 l

N/A

Indications for testing:

Testing for Cryptococcus neoformans capsular antigen is one of the

most reliable methods for the diagnosis of cryptococcosis.

Suspected cryptococcosis, including cryptococcal meningitis,

pulmonary and disseminated disease, in both immunocompromised,

e.g. HIV-positive, and immunocompetent patients.

With appropriate controls, a positive test is indicative of infection.

Perform repeat lumbar puncture after 2 weeks of treatment. Repeated

testing can be used to monitor response to treatment, monitor for

duration of treatment course, especially in HIV-positive patients.

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Culture and identification of dermatophytes and non-dermatophytes from skin, nail and hair

Test TAT Sample type Biological Interval /

Clinical Decision Values

Special precautions/ Information

Culture Direct microscopy: 1-2

days

Culture and

identification: 1-3 weeks

Skin: scrapings in Dermapak, or similar envelope. Hair: plucked hair roots and hair shaft Nail: nail clippings, scrapings of sub-ungual debris Subcutaneous lesions: scrapings, punch biopsies

Adequate scrapings and clippings for direct microscopy and culture

N/A No specific time of optimal collection, when patient presents with clinical

presentation of superficial fungal infection and onychomycosis

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Aspergillus galactomannan assay Return to: Mycology Information

Appendix A (list of tests)

Test TAT Sample type Biological Interval / Clinical Decision Values Special precautions/ Information

PLATELIA

assay for

Aspergillus

galactomannan

circulating

antigen in serum

and other body

fluids: this test is

indicated for

presumptive

diagnosis of

Aspergillus

infection

This assay

is

performed

every day,

Monday-

Friday.

TAT:

95% within

one

weekday.

Serum 700 µl

or 5 ml clotted

blood

The Platelia galactomannan (GM) test results are

expressed as an index value and are reported as negative,

weak positive, or positive – with the index value given.

Interpretation of values depend on the sample type:

Blood: GM index values of >0.5 are interpreted as positive

Bronchoalveolar lavage fluid: GM index values >1.0 are

interpreted as positive.

Index values 0.5-1.0 have a lower predictive value than

values >1.0 and are interpreted as weakly positive. Further

sampling is recommended.

Sputum: The test is not validated for sputum samples. GM

index values of >1.0 are interpreted as positive.

Specificity of the test is improved if two or more

consecutive specimens are positive.

No specific time of optimal collection. First clinical

indication of pulmonary or invasive aspergillosis.

Prospective screening twice weekly to monitor for evidence

of elevated and rising levels of galactomannan which

provides a convenient surrogate marker for invasive or

pulmonary Aspergillus disease (depending on sample type

tested).

This test should be used in conjunction with other

diagnostic procedures.

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Pan-fungal glucan assay Return to: Mycology Information

Appendix A (list of tests)

Test TAT Sample type Biological Interval / Clinical Decision Values Special precautions/ Information

FUNGITELL

assay for -1-3-D-

glucan: the

fungal glucan

test is indicated

for presumptive

diagnosis of

fungal infection

This assay

is

performed

most days,

Monday-

Friday.

TAT:

95% within

two

weekdays,

generally

available

within one

weekday.

5 ml clotted

blood

Samples are

easily

contaminated

- it is

recommended

that blood is

not separated

before

sending.

The Fungitell test results are expressed in pg/ml of serum

and range from undetectable (<31.250 pg/ml) to >500

pg/ml.

Glucan values of <60 pg/ml are interpreted as negative

results.

Values 80 pg/ml are interpreted as positive.

Values from 60 to 79 pg/ml are interpreted as

indeterminate results and suggest possible fungal infection.

Additional sampling is recommended.

The glucan test has a very high negative predictive

value.

This is the possibility that patients with a negative

screening test result do not have the disease (true

negative).

No specific time of optimal collection. First clinical

indication of invasive fungal infection.

Prospective screening twice weekly to monitor for evidence

of elevated and rising levels of glucan which provides a

convenient surrogate marker for invasive fungal disease.

This test should be used in conjunction with other

diagnostic procedures. The Fungitell –1-3-D Glucan assay

does not detect certain fungal species such as the genus

Cryptococcus, which produces very low levels of 1-3-D-

glucan. This assay also does not detect the Zygomycetes,

such as Lichtheimia, Mucor and Rhizopus, which are not

known to produce 1-3-D-glucan.

Aspergillus precipitin test Return to: Mycology Information

Appendix A (list of tests)

Test TAT Sample type Biological Interval / Clinical Decision Values Special precautions/ Information

Agar gel double

diffusion for

Aspergillus

precipitins

against

Aspergillus

fumigatus

7-10 days

Serum 700 µl

or 5 ml clotted

blood

No specific time of optimal collection. When patient

presents with aspergilloma (mycetoma, fungal ball),

allergic bronchopulmonary aspergillosis or other pulmonary

manifestations of aspergillosis.

Serial samples during treatment.

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Aspergillus PCR on respiratory samples Return to: Mycology Information

Appendix A (list of tests)

Test TAT Sample type Biological Interval / Clinical Decision Values Special precautions/ Information

Elitech

Aspergillus PCR

Seven

days

Respiratory

secretions

(BAL, sputum)

1-2 ml

minimum,

daily if

Aspergillus

infection is

suspected.

See report No specific time of optimal collection. First clinical

indication of pulmonary or invasive aspergillosis.

Assay for the quantitative detection of Aspergillus species

genomic DNA extracted from respiratory specimens from

the lower respiratory tract, as an aid to the diagnosis of

pulmonary and invasive Aspergillus infection. The results

need to be taken in context of the clinical condition of the

patient and other diagnostic test results.

Aspergillus fumigatus Cyp51A pyrosequencing Return to: Mycology Information

Appendix A (list of tests)

Test TAT Sample type Biological Interval /

Clinical Decision Values

Special precautions/ Information

Aspergillus

fumigatus

Cyp51A

pyrosequencing

assay

2 - 3

weeks.

Sometimes

DNA

amplificatio

n fails, and

no result is

possible.

Respiratory secretions (BAL,

sputum, 1-2 ml minimum), or

Aspergillus fumigatus isolates.

See report No specific time of optimal collection.

Assay for the pyrosequencing-based detection of triazole resistance-

associated polymorphisms of the Cyp51A gene in Aspergillus fumigatus. All

specimens are initially processed for Aspergillus PCR to determine

suitability. Please contact MRCM for further information.

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Pneumocystis PCR Return to: Mycology Information

Appendix A (list of tests)

Test TAT Sample type Biological Interval / Clinical Decision Values Special precautions/ Information

Pneumocystis

PCR assay 4 days

Respiratory

secretions

(BAL, sputum)

1-2 ml

minimum,

daily if

Pneumocystis

infection is

suspected.

See report No specific time of optimal collection. First clinical

indication of Pneumocystis infection.

This test is performed by Virology at MRI.

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Molecular identification of fungi from culture negative, microscopy positive specimens Return to: Mycology Information

Appendix A (list of tests)

Test TAT Sample type Biological Interval /

Clinical Decision Values

Special precautions/ Information

DNA extraction

and molecular

sequencing

Two

weeks.

Sometimes

DNA

extraction

fails, and

no result is

possible.

Original specimen, if a fluid

specimen, such as pus, BAL,

pleural fluid, peritoneal fluid,

transported at room

temperature and stored at 4°C,

-20°C or -80°C.

Fixed paraffin section (5-10

normal or thick sections placed

together in a sterile container

and transported at room

temperature)

Fungal identification

provided

Indications for testing: clinically significant fungal infection, with negative

culture and serology.

Using sophisticated DNA extraction technology, fungal DNA can be obtained

from most samples in which fungal hyphae are seen, including fixed paraffin

sections. In some cases, no sample was submitted for culture, in other

cases, culture is negative.

Cases should be discussed with the MRCM staff, who will advise.

Surveillance of hospital environments, homes, public buildings, for Aspergillus species and allergenic moulds

Test TAT Sample type Biological Interval / Clinical

Decision Values Special precautions/ Information

Culture of air

samples, culture

of dust and

material

samples.

5-7 days

Air samples,

settled dust,

surface

samples,

material

samples

N/A

No specific time. Surveillance during hospital construction, maintenance,

demolition and renovation, water damage, faulty air filtration and conditioning, and

outbreaks.

Minimum: one air sample and one dust sample from patients' rooms and general

hospital areas. More intensive sampling where reservoir of Aspergillus is most

likely to occur.

Sampling availability, processing of submitted samples, identification and

interpretation: please contact the laboratory for further information.

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11 Appendix A – A-Z List of tests

Test Department

5HIAA (urine) Biochemistry

5HIAA (serum) Biochemistry

17-hydroxyprogesterone Biochemistry

HbA1c Biochemistry

ACE (Angiotensin converting enzyme) Biochemistry

ACTH Biochemistry

Acyl carnitines/free carnitine/MCADD profile Biochemistry

AFP Biochemistry

Albumin (serum) Biochemistry

Albumin (pleural fluid) Biochemistry

Alcohol (Ethanol) Biochemistry

Aldosterone Biochemistry

ALP (adult) Biochemistry

Alpha-1-antitrypsin Biochemistry

ALT Biochemistry

Amino acids (plasma) Biochemistry

Amino acids (urine) Biochemistry

Ammonia Biochemistry

Lipase (serum) Biochemistry

Lipase (fluid) Biochemistry

Androstenedione Biochemistry

Anti 10a assay Haematology

Antifungal Drug Levels Mycology

Anti-neutrophil antibodies Haematology

Arterial Blood Gases Biochemistry

Aspergillus galactomannan Mycology

Aspergillus PCR Mycology

Aspergillus precipitin test Mycology

AST Biochemistry

B12 Biochemistry

B2 microglobulin Biochemistry

Base Excess Biochemistry

Bence-Jones protein Biochemistry

Bicarbonate (arterial blood gas) Biochemistry

Bicarbonate (serum) Biochemistry

Bilirubin Biochemistry

Blood film Haematology

Bone Marrow Examination Haematology

CA-125 Biochemistry

CA19-9 Biochemistry

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Test Department

Caeruloplasmin Biochemistry

Calcium Biochemistry

Calcium (Amended) Biochemistry

Carbamazepine Biochemistry

Carboxyhaemoglobin Biochemistry

Catecholamines Biochemistry

CEA Biochemistry

Chloride Biochemistry

Cholinesterase/acetylcholinesterase Biochemistry

Chromium and cobalt Biochemistry

Citrate Biochemistry

CK Biochemistry

Coagulation Haematology

Coagulation screen Haematology

Cold agglutinin titre Haematology

Combined pituitary function test Biochemistry

Complement C3 Biochemistry

Complement C4 Biochemistry

Copper (serum) Biochemistry

Copper (urine) Biochemistry

Cortisol (blood) Biochemistry

Cortisol (urine) Biochemistry

Cotinine Biochemistry

Creatinine Biochemistry

Creatinine Clearance Biochemistry

Crossmatch Haematology

CRP Biochemistry

Cryoglobulins Biochemistry

Cryptococcal antigen latex agglutination test Mycology

CSF Biochemistry

CSF glucose Biochemistry

CSF lactate Biochemistry

CSF protein Biochemistry

Culture and identification of dermatophytes and non-dermatophytes from skin, nail and hair

Mycology

Cyclosporin Biochemistry

Cystine Biochemistry

D-Dimer Haematology

Dexamethasone Biochemistry

Dexamethasone suppression test Biochemistry

DHEAS Biochemistry

Digoxin Biochemistry

Direct Antiglobulin Test (DAT) Haematology

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Test Department

Direct oral anticoagulants (A10a) Haematology

Down’s syndrome screening Biochemistry

Drugs of abuse screen (urine) Biochemistry

Dynamic Function Tests Biochemistry

eGFR Biochemistry

Endocrinology Biochemistry

ESR Haematology

Everolimus Biochemistry

Factor Assays Haematology

Faecal elastase (pancreatic) Biochemistry

Faecal reducing substances Biochemistry

Faeces Biochemistry

Fasting triglycerides Biochemistry

Ferritin Biochemistry

FK506 (Tacrolimus) Biochemistry

Fluconazole Mycology

Flucytosine Mycology

Foetal cell count Haematology

Folate Biochemistry

Free T3 Biochemistry

Free T4 Biochemistry

FSH Biochemistry

Full Blood Count Haematology

G6PD screening test Haematology

Galactosaemia screening test Biochemistry

Gentamicin Biochemistry

GGT Biochemistry

Glandular Fever screening test Haematology

Globulin Biochemistry

Glucose Biochemistry

Glucose (fasting) Biochemistry

Glucose tolerance test Biochemistry

Glucose tolerance test with GH suppression Biochemistry

GnRH Stimulation test Biochemistry

Group and Save Haematology

Growth hormone Biochemistry

Gut hormone profile (fasting) Biochemistry

Haemoglobinopathy (Hb Variant /thalassaemia) Haematology

Haptoglobin Biochemistry

hCG Biochemistry

HDL cholesterol Biochemistry

Heparin induced thrombocytopenia (HIT) Haematology

High Sensitivity Troponin T Biochemistry

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Test Department

HLA B27 Haematology

HLA specific antibody screen Haematology

HLA type Class 1 Haematology

Identification and Susceptibility Testing of Yeasts and Moulds Mycology

IgA Biochemistry

IGF-1 Biochemistry

IgG Biochemistry

IgG subclasses (IgG4 can also be requested separately) Biochemistry

IgM Biochemistry

Immunology - There are too many tests to list here and it is subject to change. Please contact the laboratory for further information.

Haematology

Infertility reports Histopathology

Insulin and c-peptide Biochemistry

Insulin stimulation test Biochemistry

Iron Biochemistry

Isavuconazole Mycology

Itraconazole Mycology

Kleihauer Haematology

Lactate Biochemistry

Lamotrigine Biochemistry

LDH (serum) Biochemistry

LDH (pleural fluid) Biochemistry

LH Biochemistry

Bio_Urine_Light_chains Biochemistry

Lithium Biochemistry

Lupus anticoagulant Haematology

Macroprolactin Biochemistry

Magnesium (serum) Biochemistry

Magnesium (urine) Biochemistry

Malaria screen Haematology

Mannose binding lectin Biochemistry

Metanephrines Biochemistry

Methaemoglobin Biochemistry

Microalbumin (ACR) Biochemistry

Molecular identification of fungi from culture negative, microscopy positive specimens

Mycology

Mycophenolate (MPA) Biochemistry

Neonatal alloimmune thrombocytopenia Haematology

Oestradiol Biochemistry

Oligoclonal bands (CSF) Biochemistry

Oral anticoagulants Haematology

Organic acids (urine) Biochemistry

Orosomucoid (Alpha-1 acid glycoprotein) Biochemistry

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Test Department

Osmolality (serum) Biochemistry

Osmolality (urine) Biochemistry

Other Fluids Biochemistry

Oxalate Biochemistry

Pan-fungal glucan assay Mycology

Paracetamol Biochemistry

pCO2 Biochemistry

pH (blood) Biochemistry

pH (pleural fluid) Biochemistry

Phenobarbital Biochemistry

Phenytoin Biochemistry

Phosphate (serum) Biochemistry

Phosphate (urine) Biochemistry

PIIINP (Type III procollagen peptide) Biochemistry

Plasma Metanephrines Biochemistry

Plasma Viscosity Haematology

Platelet antibodies Haematology

Pleural Fluid Biochemistry

Pneumocystis PCR Mycology

pO2 Biochemistry

Porphobilinogen/ urobilinogen / Porphyria screen Biochemistry

Porphyrin screen Biochemistry

Posaconazole Mycology

Potassium (serum) Biochemistry

Potassium (urine) Biochemistry

Prednisolone Biochemistry

Procalcitonin Biochemistry

Progesterone Biochemistry

Prolactin Biochemistry

Prolonged fasting test Biochemistry

Protein Biochemistry

Protein Electrophoresis Biochemistry

PSA Biochemistry

PTH Biochemistry

Pyruvate Kinase (PK) Haematology

Referred Tests Biochemistry

Renal stone analysis Biochemistry

Renin Biochemistry

Reticulocytes Haematology

Rheumatoid Factor Biochemistry

Routine Biochemistry Biochemistry

Routine Haematology Haematology

Salicylate Biochemistry

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Test Department

Salivary cortisol Biochemistry

Salivary Testosterone

Selenium Biochemistry

SHBG Biochemistry

Short Synacthen test Biochemistry

Sickle Cell Test Haematology

Sirolimus Biochemistry

Sodium (serum) Biochemistry

Sodium (urine) Biochemistry

Specialist Tests Biochemistry

Specific Proteins Biochemistry

Surveillance of hospital environments, homes, public buildings, for Aspergillus species and allergenic moulds

Mycology

Sweat test Biochemistry

Teicoplanin Biochemistry

Testosterone Biochemistry

Theophylline Biochemistry

Therapeutic Drug Monitoring Biochemistry

Thrombophilia screen Haematology

Tobramycin Biochemistry

Total cholesterol Biochemistry

Total protein (serum) Biochemistry

Total protein (pleural fluid) Biochemistry

TPMT (Thiopurine S-methyltransferase) Biochemistry

TPO Biochemistry

Transferrin Biochemistry

Transfusion Haematology

Triglyceride Biochemistry

TSH Biochemistry

Tumour Markers Biochemistry

Unfractionated Heparin Haematology

Urate (serum) Biochemistry

Urate (urine) Biochemistry

Urea Biochemistry

Urinalysis Biochemistry

Urine reducing substances Biochemistry

Valproate Biochemistry

Vancomycin Biochemistry

Very long chain fatty acids (VLCFA) Biochemistry

Vitamin A & E Biochemistry

Vitamin D Biochemistry

Von Willebrand assays Haematology

Voriconazole Mycology

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Test Department

Water deprivation test Biochemistry

Xanthochromia Biochemistry

Zinc Biochemistry

β-OH butyrate/free fatty acids Biochemistry