UHSM Pathology Handbook Pathology Revision No: 38 Document title: Pathology Handbook Author: P McHale Document No: PG-D-HANDBOOK-1 Approved by: Dawn

Department: Pathology Revision No: 38

Document title: Pathology Handbook

Author: P McHale Document No: PG-D-HANDBOOK-1

Approved by: Dawn Clarke Page 1 of 94 Last printed 14/08/2017 09:47:00

Table of Contents

1 Introduction .............................................................................................................. 4

1.1 Accreditation .................................................................................................................... 4

1.2 Quality assurance ............................................................................................................ 5

1.3 Key performance indicators ............................................................................................. 5

1.4 Protection of personal information ................................................................................... 5

1.5 Patient information ........................................................................................................... 6

1.6 Sample acceptance ......................................................................................................... 6 1.6.1 Samples failing acceptance criteria ......................................................................................... 7 1.6.2 Patient consent ........................................................................................................................ 7

1.7 Requesting and reporting of pathology tests .................................................................... 7

1.8 What to in an IT failure..................................................................................................... 8

1.9 Sample containers ........................................................................................................... 8

1.10 Sample transportation ..................................................................................................... 9 1.10.1 Hospital requirements ....................................................................................................... 10 1.10.2 GP requirements ............................................................................................................... 10 1.10.3 Postal samples .................................................................................................................. 10

1.11 Requesting further tests on samples already in pathology (‘add-on’ tests) ..................... 10 1.11.1 Biochemistry and haematology ......................................................................................... 10 1.11.2 Mycology Reference Centre .............................................................................................. 10

1.12 Turnaround times .......................................................................................................... 10

1.13 Complaints or comments ............................................................................................... 10

2 Pathology directorate general contact details .................................................... 11

3 Phlebotomy ............................................................................................................ 11

3.1 Inpatient service ............................................................................................................ 11

3.2 Outpatient service .......................................................................................................... 12

3.3 General Practitioner service .......................................................................................... 12

4 Sample reception ................................................................................................... 12

5 Biochemistry .......................................................................................................... 13

UHSM Pathology Handbook

How to use this document:

Do not print it! It may change, the most up-to-date version will always be hosted here:

https://www.uhsm.nhs.uk/services/pathology

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

https://www.uhsm.nhs.uk/services/pathology/





5.1 Contact details ............................................................................................................... 14

5.2 Working hours ............................................................................................................... 14 5.2.1 Outside routine hours ............................................................................................................ 14

5.3 Urgent Requests............................................................................................................ 15

5.4 Examinations offered by Biochemistry ........................................................................... 15

5.5 Sample transportation ................................................................................................... 16

5.6 Add-on Tests ................................................................................................................. 16

5.7 Sample Information ....................................................................................................... 16

5.8 Test library ..................................................................................................................... 17

5.9 Factors known to significantly affect performance of tests/interpretation of results ........ 47

5.10 Effect of haemolysis, lipaemia and icterus: .................................................................... 48

5.11 Measurement uncertainty .............................................................................................. 48

5.12 Point of Care ................................................................................................................. 48

6 Haematology .......................................................................................................... 49

6.1 Contact details ............................................................................................................... 49

6.2 Routine Haematology .................................................................................................... 50 6.2.1 Test library ............................................................................................................................. 50

6.3 Coagulation ................................................................................................................... 53 6.3.1 Test library ............................................................................................................................. 53 6.3.2 Factors affecting the results or processing of coagulation tests ........................................... 54

6.4 Immunology ................................................................................................................... 54 6.4.1 Immunology test library ......................................................................................................... 54

6.5 Blood transfusion ........................................................................................................... 56 6.5.1 Test library ............................................................................................................................. 56

7 Histopathology ....................................................................................................... 59

7.1 Contact details ............................................................................................................... 59

7.2 General information ....................................................................................................... 60

7.3 Sample acceptance ....................................................................................................... 61

7.4 Clinical information ........................................................................................................ 61

7.5 Sample containers ......................................................................................................... 62

7.6 Histology sample collection ........................................................................................... 62

7.7 Supply of sample containers .......................................................................................... 62

7.8 Factors that prevent a detailed accurate diagnosis ........................................................ 63

7.9 Frozen sections ............................................................................................................. 63 7.9.1 Booking cardiothoracic frozen section requests .................................................................... 63 7.9.2 Booking other frozen section requests .................................................................................. 63 7.9.3 Once specimen has been taken ............................................................................................ 63

7.10 Trephines samples ........................................................................................................ 64

7.11 Skin immunofluorescence specimens ............................................................................ 64

7.12 Oral immunofluorescence specimens ............................................................................ 64

7.13 Cytology samples .......................................................................................................... 64 7.13.1 Broncho-alveolar lavages (BAL) ....................................................................................... 67 7.13.2 Endobronchial ultrasound guided aspirate specimens (EBUS) ........................................ 67 7.13.3 Gastrointestinal endoscopy under ultrasound (GI EUS) ................................................... 67





7.13.4 Breast Cytology ................................................................................................................. 67 7.13.5 Joint Fluids ........................................................................................................................ 67

7.14 Cervical Cytology ........................................................................................................... 67

7.15 Andrology ...................................................................................................................... 68 7.15.1 Infertility ............................................................................................................................. 68 7.15.2 Post vasectomy ................................................................................................................. 68

7.16 Sample transport ........................................................................................................... 70

7.17 Reports .......................................................................................................................... 71

7.18 RCPath cancer standards and data sets ....................................................................... 71

7.19 Multidisciplinary Team Meetings (MDT’s) ...................................................................... 71

7.20 Turnaround times .......................................................................................................... 71

7.21 Material sent away for further tests ................................................................................ 71

7.22 Return of tissues............................................................................................................ 72

7.23 Disposal of tissues ......................................................................................................... 72

7.24 Errors happen ................................................................................................................ 72

7.25 Manchester Cancer Research Cancer Tissue Bank ...................................................... 72

7.26 Measurement uncertainty .............................................................................................. 72

8 Autopsies ............................................................................................................... 73

8.1 Adult autopsies .............................................................................................................. 73

8.2 Stillbirths and fetuses, autopsies and disposal ............................................................... 74 8.2.1 UHSM patients ....................................................................................................................... 74 8.2.2 Tameside patients ................................................................................................................. 74

8.3 Infectious bodies............................................................................................................ 74

8.4 Pacemakers and defibrillators........................................................................................ 75

8.5 FixionTM intramedullary nails .......................................................................................... 75

9 Microbiology .......................................................................................................... 75

9.1 Contact details ............................................................................................................... 75

10 Mycology Reference Centre.................................................................................. 76

10.1 Contact details ............................................................................................................... 76

10.2 Additional Tests ............................................................................................................. 76

10.3 Antifungal Drug Levels................................................................................................... 76 10.3.1 Indications for monitoring .................................................................................................. 77

10.4 References .................................................................................................................... 81

10.5 Identification and susceptibility testing of medically important fungi ............................... 81

11 Appendix A – A-Z List of tests .............................................................................. 89

Standards covered by this document:

CPA v2.02 E1 Information for users and patients

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





1 Introduction

The pathology department at University Hospital of South Manchester (UHSM) 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 pathology;

biochemistry, haematology, histopathology and microbiology. We are also fortunate to have the

Mycology Reference Centre Manchester (MRCM) located on the Wythenshawe site, in the Education

and Research Centre.

Between these laboratories we cover a population of 570,000 patients and receive around 4,500

samples every day. The pathology department is housed in the Clinical Sciences Building on the

Wythenshawe site, shown in the bottom right corner of the map below:

1.1 Accreditation

All pathology departments are accredited by Clinical Pathology Accreditation (CPA) which is a wholly

owned subsidiary of the United Kingdom Accreditation Service (UKAS). Our CPA accreditation will

be replaced by UKAS accreditation at each departments’ next inspection. The accreditation process

requires regular inspection to ensure there is a system of quality management in place to assure that

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

Laboratory CPA/UKAS Number

Biochemistry CP0223

Haematology CP0200

Histology CP0146

Microbiology 0635

Mycology 0635b

https://www.ukas.com/





The blood transfusion laboratory (sometimes 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 UHSM 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

Every test performed in pathology is enrolled 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, histopathology, microbiology, and departments at UHSM are all 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 a Quality Manager within pathology who is employed to oversee all aspects of quality

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

1.3 Key performance indicators

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

a pathology 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 UHSM “Data Protection Policy”.

https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency

https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency

https://www.hta.gov.uk/

https://www.ibms.org/home/

https://www.rcpath.org/

http://www.gmc-uk.org/

http://www.nshcs.hee.nhs.uk/





1.5 Patient information

We have created a Pathology Patient Guide for our patients, which can be found on the UHSM patient leaflets website at: https://www.uhsm.nhs.uk/content/uploads/2015/12/Pathology-guide.pdf 1.6 Sample acceptance

All samples must be accompanied by a request form. We require four identifiers on all samples and

request forms. These identifiers are:

1. First name

2. Surname

3. Date of birth

4. NHS or hospital number

ESSENTIAL DESIRABLE

Sam

ple

& F

orm

1. First name

Or unique coded identifier for GUM and other similar patient groups

2. Surname

Or unique coded identifier for GUM and other similar patient groups

3. NHS or RM2 number

Not for GUM patients

4. Date of birth

Date(s) of samples – all departments

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

If the patient is high risk/danger of infection the form should be labelled to indicate this (ICE forms have an icon for this)

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

Gender of patient

Patient’s address, including postcode

For GP requests: o 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

All relevant clinical information

Contact number/bleep for requestor/consultant in charge

Time(s) of samples – histology and cytology

Aliq

uo

ts

Full name

NHS or RM2 number

Date of birth

Sample number

Destination of the sample

https://www.uhsm.nhs.uk/content/uploads/2015/12/Pathology-guide.pdf





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.

1.6.1 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

the requestor has attended the pathology department to complete a “Specimen Labelling

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

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 everyone’s interest,

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

pathology department.

1.6.2 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 pathology tests

Electronic systems should be used to request pathology investigations where possible. Handwritten

request forms are accepted in histology because these have been designed to allow annotation of

anatomical diagrams.





1.8 What to in an IT failure

When there is a failure of the ICE system and it is not possible to request pathology tests

electronically handwritten request forms should be used. Blank request forms will be sent from the

pathology department 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 pathology staff to the requesting departments. Please

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

these times.

1.9 Sample containers

At UHSM BD/Becton Dickinson tubes are used for adults and Sarstedt for paediatric patients. These

lid colours are shown in the table below.

Container type Colour Description Use

Fluoride

Grey Fluoride oxalate

Blood glucose

Ethanol

Lactate

Serum gel

Gold Serum gel

Routine biochemistry

Immunology (see ICE instructions)

Mycology

EDTA

(4ml tube)

Purple EDTA

Haematology

HbA1c


Li Hep

Green Lithium heparin

gel

Serum

Red Clotted

Bacteriology

Viral serology


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





Container type Colour Description Use

Paediatric tubes (1.3ml):

Glucose

fluoride Yellow Fluoride oxalate

Blood glucose

Ethanol

Lactate

Serum gel

Brown Serum gel

Routine biochemistry


Mycology

EDTA

Red EDTA Haematology

Blood transfusion

Li Hep

Orange Lithium Heparin

Citrate

Green Citrate Coagulation

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.

All samples must NOT be stored but should be sent to the lab 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 Duty Biochemist.





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

UHSM 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 pathology (‘add-on’ tests)

1.11.1 Biochemistry and haematology

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 Mycology Reference Centre

Please call us on ext. 2124.

1.12 Turnaround times

All 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. Where possible the Time of receipt in

the lab 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 complaint about the service we use. 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.





2 Pathology directorate general contact details

Extension Email address

Dr Leena Joseph Clinical Director (Consultant Histopathologist)

4994/5606 [email protected]

Krys Kornecki Pathology Directorate Manager

4796 [email protected]

Teresa Colilla PA to Clinical Director


Nigel Martin Pathology IT Manager


Phaedra McHale Pathology Quality Manager & Training Coordinator


Anne-Marie Burns Phlebotomy Operational Manager


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

Please see departmental sections (biochemistry, haematology, histology, microbiology and

mycology) for departmental contact details.

3 Phlebotomy

The phlebotomy service is managed by the pathology department. All patients must bring the

appropriate request forms with them, as there are no facilities to print out forms at either phlebotomy

location.

If it is possible that a patient may have restricted venous access, or the volume of sample taken may

not be sufficient for full analysis (e.g. paediatric patients) please indicate this on the request form and

identify the priority of tests requested.

3.1 Inpatient service

A service is provided to all medical and surgical wards Monday - Friday from 08:00 am.

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

assist in the collection of blood samples.

All requests must be made through Sunquest ICE. Request forms for phlebotomy collection should

be printed by 8:00 am Monday - Friday and 7:30 am Saturday/Sunday and Bank holidays.

All urgent blood requests must be taken by the doctor/nurse not left for the phlebotomist

All request forms must be completed in full

Post-dated request forms should not be printed

If Sunquest ICE is not available, joint Biochemistry/Haematology request forms should be used.

Please ensure that the information is on both parts of the form and on all copies of the forms.

mailto:[email protected]










3.2 Outpatient service

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

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

3.3 General Practitioner service

General Practitioner patients must use the appointment system and call 0800 092 4020 to book an

appointment.

Site Location Days Hours

Wythenshawe Hospital Phlebotomy suite opposite first floor

Out-patient Department Monday - Friday 08:15 am – 09:30 pm

Withington Community

Hospital

Main Out-patients Department, ground

floor Monday - Friday 08:30 am – 12:30 pm

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.

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, meningitis 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.





5.1 Contact details


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


Mrs Michelle Miller Biochemistry Laboratory & POCT Manager


Dr A M Kelly Consultant Chemical Pathologist


Secretary to Dr Kelly 2122

Professor B Keevil Consultant Clinical Scientist, Head of Biochemistry


Mrs L Owen Principal Biochemist


Fax 2927

Out of hours Biomedical Scientist (BMS) Bleep 532

For Point of Care Testing Enquiries:

Dee Patel POCT Coordinator


[email protected]

See also the Point of Care page on the Intranet


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

532, 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.








http://uhsm-intranet/AZ/b/Biochemistry/PointOfCare/Pages/default.aspx





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

General Biochemistry

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

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 I & 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

Βeta-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 any may take longer to appear on Sunquest ICE.

5.4 Examinations offered by Biochemistry

Please note: separate blood samples for each pathology discipline – mycology, microbiology,

immunology, biochemistry and haematology is required.

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). Electronic requesting via Sunquest ICE

will advise on the number, volume and types of tubes required.





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 with 24 hours. Some tests are more

stable and can be added on up to 6 days. All samples are stored within the laboratory for 6 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.





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



Sodium 4 hours

132 - 144 mmol/L Guidelines for management of hyponatraemia can be

found in the UHSM formulary.

Potassium 4 hours

3.5 - 5.3 mmol/L Guidelines for management of hypokalaemia /

hyperkalaemia can be found in the UHSM formulary.

Chloride 4 hours

95 - 108 mmol/L

Bicarbonate 4 hours

22 - 29 mmol/L

http://uhsm-intranet/AZ/p/Pharmacy/09%20NUTRITION%20AND%20BLOOD/Hyponatraemia%20Treatment%20Guideline.pdf

http://uhsm-intranet/AZ/p/Pharmacy/09%20NUTRITION%20AND%20BLOOD/Hypokalaemia%20Treatment%20Guideline.pdf

http://uhsm-intranet/AZ/p/Pharmacy/09%20NUTRITION%20AND%20BLOOD/Hyperkalaemia%20Treatment%20Guideline.pdf








Urea 4 hours

2.5 - 7.8 mmol/L

Creatinine 4 hours

Female 40 - 90 µmol/L

Male 60 - 120 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

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

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.

http://uhsm-intranet/imt/ICE/Pages/AKIAlerts.aspx

http://uhsm-intranet/imt/ICE/Pages/AKIAlerts.aspx

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


http://www.renal.org/information-resources/the-uk-eckd-guide

http://www.renal.org/information-resources/the-uk-eckd-guide










Bilirubin 4 hours

<20 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 UHSM formulary.

Magnesium 4 hours

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

found in the UHSM formulary.

Phosphate 4 hours

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

be found in the UHSM formulary.

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

12 - 26 µmol/L

Transferrin 4 hours

1.7 – 3.8 g/L

Urate 4 hours

Female < 0.35 mmol/L

Male < 0.42 mmol/L

http://uhsm-intranet/AZ/p/Pharmacy/09%20NUTRITION%20AND%20BLOOD/Hypercalcaemia%20Treatment%20Guideline.pdf

http://uhsm-intranet/AZ/p/Pharmacy/09%20NUTRITION%20AND%20BLOOD/Hypocalcaemia%20Treatment%20Guideline.pdf

http://uhsm-intranet/AZ/p/Pharmacy/09%20NUTRITION%20AND%20BLOOD/Hypomagnesaemia%20Treatment%20Guidelines.pdf

http://uhsm-intranet/AZ/p/Pharmacy/09%20NUTRITION%20AND%20BLOOD/Hypophosphatemia%20Treatment%20Guidelines.pdf








CRP 4 hours

< 5 mg/L

ALP (adult) 4 hours

30 - 130 IU/L

Amylase 4 hours

25 - 125 IU/L

AST 4 hours

5 - 34 IU/L

ALT 4 hours

up to 55 IU/L

GGT 4 hours

Male < 65 IU/L

Female <37 IU/L

CK 4 hours

Male < 200 IU/L

Female <166 IU/L

LDH 4 hours

125 - 264 IU/L

Total cholesterol 4 hours

Depends on coronary risk factors. See BNF for details

HDL cholesterol 4 hours

<1.0 mmol/L: associated with increased risk of CHD








Fasting

triglycerides 4 hours

<1.7 mmol/L

Lactate 2 hours

Age related adult 0.6 - 2.5 mmol/L

ACE (Angiotensin

converting

enzyme)

72 hours

Age related. See report

Alcohol (Ethanol) 4 hours

NA (units = mg/L)

Ammonia 4 hours

10-50 µmol/L (adult ref. range)

Ensure sample received in lab within 10 minutes

of collection. Air tube transport is not suitable,

deliver sample directly to lab

Osmolality 36 hours

275 - 295 mOsm/kg

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)








High Sensitivity

Troponin I 2 hours

The reference ranges are gender specific

Male: <34 ng/L

Female: <16 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 I measurement at 0 and 3 hrs

post admission if coming in to hospital

or post chest pain if already an inpatient

B12 24 hours

187 - 883 ng/L

Ferritin 24 hours

Pre-menopausal females: 10 - 204 ug/L

Males & post-menopausal females: 22 - 275 ug/L

Folate 24 hours

3.1 - 20.5 ug/L





Therapeutic Drug Monitoring Return to: Biochemistry Information



Paracetamol 4 hours

< 3 mg/L

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

Concentrations > 300 mg/L are associated with toxicity

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

Once daily dosing:

Trough level: < 5 mg/L

Peak level: not required to assess therapy

Multiple daily dosing


Peak level: 25 - 30 mg/L

Carbamazepine 4 hours

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

Cyclosporin 24 hours

Variable

Target ranges depend on specific use of the drug.

Suggest consult local specialist for advice.

Digoxin 4 hours

0.8-2.0 µgl/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 96 hours

3 – 8 µg/L








Gentamicin 4 hours

Once daily dosing:





Peak level: not usually required to assess therapy

Lithium 4 hours

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

Phenytoin 4 hours

5.0 - 20.0 mg/L

Sirolimus 96 hours

4.0 – 12.0 µg/L

This range applies to heart and lung transplant patients

only. Consult local specialist for other uses.

FK506

(Tacrolimus) 24 hours

5.0 -12.0 µg/L pre-dose

Tobramycin 4 hours

Once daily dosing:




Trough level: < 2 mg/L (less than 1 mg/L in cystic

fibrosis)

Peak level: 6 – 10 mg/L (8 – 12 mg/L in cystic fibrosis)

Antimicrobial interpretation should be directed to a

consultant microbiologist

Finger prick samples are also accepted.








Theophylline 4 hours

10-20 mg/L adult 5 -10 mg/L neonatal apnoea (patients

vary) 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

Voriconazole 96 hours

Pre-dose reference range 1.3 – 5.7 mg/L

Antifungal interpretation should be directed to a

Consultant Infectious Diseases clinician or

Consultant Clinical Mycologist

Consider dose-escalation for any level (pre-dose, post-

dose or random) lower than 1.3 mg/L

As voriconazole has non-linear kinetics, seek expert

advice.

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

Valproate 192

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





Endocrinology Return to: Biochemistry Information



Free T4 4 hours

9-19 pmol/L

Free T3 72 hours

2.6-5.7 pmol/L

TSH 4 hours

0.35-5.0 mU/L

TPO 96 hours

<6 iU/mL

LH 24 hours

Variable. See report

FSH 24 hours


Progesterone 24 hours


Oestradiol 24 hours


Prolactin 24 hours


Testosterone 240

hours

See report








SHBG 240

hours

See report

Androstenedione 240

hours

0.8-4.7 nmol/L

DHEAS 240

hours


Metanephrines 240

hours

Metanephrine <510 pmol/L

Normetanephrine <1180 pmol/L

3-methoxytyramine (3-MT) <118 pmol/L

Must arrive in lab within 1 hr. On ice is preferable

Macroprolactin 96 hours

See report Usually added to requests by laboratory staff as required

PTH 24 hours

See report

Renin 240

hours

0.3-2.2 nmol/L/hr

Aldosterone 240

hours

up to 630 pmol/L

Cortisol 36 hours

Shows variation across day

0830-1130: 100-500 nmol/L

Salivary cortisol 240

hours (Contact lab)

See report








Serum 5HIAA 240

hours

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

Avoid serotonin containing foods

Vitamin A & E 360

hours

Vitamin A 1.05 – 2.97 umol/L

Vitamin E 13.9 – 47.0 umol/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

The following drugs/medications have been identified as

potential inducers or inhibitors of the CYP3A4 enzyme

resulting in accelerated or impaired metabolism of

dexamethasone respectively3:

Drugs that accelerate dexamethasone metabolism:

Ethanol, phenobarbital, phenytoin, carbamazepine,

primidone, rifampin, rifapentine, ethosuximide,

pioglitazone

Drugs that inhibit dexamethasone metabolism:

Aprepitant/fosaprepitant, itraconazole, ritonavir,

fluoxetine, diltiazem, cimetidine





Specific Proteins Return to: Biochemistry 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.

B2 microglobulin 192

hours

1.2 - 2.4 mg/L Assay performed Wednesday fortnightly

Complement C3 96 hours

0.75 - 1.65 g/L Assay performed Tuesday and Fridays

Complement C4 96 hours

0.14 - 0.54 g/L Assay performed Tuesday and Fridays

Haptoglobin 96 hours

Female: 0.4 - 2.5 g/L

Male: 0.1 - 2.6 g/L Assay performed Fridays

IgA 72 hours

0-2 weeks 0.01 - 0.08 g/L

2-5 weeks 0.02 - 0.15 g/L

5-12 weeks 0.05 - 0.4 g/L

12-26 weeks 0.10 - 0.5 g/L

26-38 weeks 0.15 - 0.7 g/L

38-51 weeks 0.20 - 0.7 g/L

1-2 years 0.3 - 1.3 g/L

2-5 years 0.4 - 0.2 g/L

5-8 years 0.5 - 2.4 g/L

8-11 years 0.7 - 2.5 g/L

11-14 years 0.8 - 2.8 g/L

14-44 years 0.8 - 2.8 g/L

>44 years 0.8 - 4.0 g/L








IgG 72 hours

0-2 weeks 5.0 - 17.0 g/L

2-5 weeks 3.9 - 13.0 g/L

5-12 weeks 2.1 - 7.7 g/L

12-26 weeks 2.4 - 8.8 g/L

26-38 weeks 3.0 - 9.0 g/L

38-51 weeks 3.0 - 10.9 g/L

1-2 years 3.7 - 15.8 g/L

2-5 years 4.9 - 16.1 g/L

5-14 years 5.4 - 16.1 g/L

>14 years 6 - 16 g/L

IgM 72 hours

0-2 weeks 0.05 - 0.2 g/L

2-5 weeks 0.08 - 0.4 g/L

5-12 weeks 0.15 - 0.7 g/L

12-26 weeks 0.2 - 1.0 g/L

26-38 weeks 0.4 - 1.6 g/L

38-51 weeks 0.6 - 2.1 g/L

1-2 years 0.5 - 2.2 g/L

2-5 years 0.5 - 2.0 g/L

5-11 years 0.5 - 1.8 g/L

11-44 years 0.5 - 1.9 g/L

>44 years 0.5 - 2.0 g/L








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.

Tumour Markers Return to: Biochemistry Information



AFP 24 hours

<5 IU/mL

Beta-hCG 24 hours

<5 U/L

PSA 24 hours

See report

CEA 96 hours

<6 µg/L

CA19-9 96 hours

<37 U/mL





Tumour Markers Return to: Biochemistry Information



CA-125 96 hours

<35 U/mL

Plasma

Metanephrines

240

hours

See report

Separate plasma within 1 hour of collection

Preferably take sample with patient recumbent after

overnight fast.

CSF Return to: Biochemistry 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

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).

To interpret CSF glucose a plasma glucose sample is

required.

CSF lactate 4 hours

CSF

Blood

CSF lactate normally parallels plasma concentration. To interpret CSF lactate a plasma lactate sample is

required.








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).





Faeces Return to: Biochemistry 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.

Faecal reducing

substances 2 hours

Random

faeces

(minimum

amount – 2x

pea size)

Normal result – negative for reducing substances.

Faecal pH ≥ 5.5

False negative results may occur if sample is not

received in the lab within 2 hours. Some medications

(e.g. penicillin, salicylate, ascorbic acid) can cause

positive interference. Test not indicated in adult patients.





Urinalysis Return to: Biochemistry 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

Catecholamines

Test no

longer

available

n/a Please request plasma metanephrines Contact Duty Biochemist for further information

Citrate 240

hours Acidified

1680-6450 µmol/24hrs

Cortisol 192

hours

No preservative

Up to 165 nmol/24 hours

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

5HIAA 192

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

Light chains

(quantitation)

384

hours

No preservative

NA Used in the monitoring of patients with myeloma

Magnesium 24 hours

Acidified

2.5 - 8.0 mmol/24hr

Microalbumin

(ACR) 24 hours

10 ml EMU

Male <2.5 mg/mmol

Female <3.5 mg/mmol

Also known as albumin:creatinine ratio (ACR)

Osmolality 24 hours

10 ml random

Relative to hydration status








Oxalate 192

hours Acidified

See report Contact Duty Biochemist for paediatric reference ranges

Phosphate 24 hours

Acidified

15-50 mmol/24h

Porphobilinogen/

urobilinogen /

Porphyria screen

14 days

10ml random

urine protect

from light

Pos/Neg

Potassium 24 hours

No preservative

Dietary dependent Contact Duty Biochemist for further information

Protein 24 hours

No preservative

<0.2 g/24hrs

Sodium 24 hours

No preservative

Dietary dependent Contact Duty Biochemist for further information

Urate 24 hours

No preservative

1.5 - 4.5 mmol/24hr





Pleural Fluid Return to: Biochemistry 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 tansudate 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

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.


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.


Please REMOVE needle and cap syringe prior to sending

sample to lab.


samples





Pleural Fluid Return to: Biochemistry Information



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


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.


samples

Amylase 24 hours

Fluid

Blood

Fluid amylase higher than serum amylase may be

suggestive of pancreatic involvement.


This test should only be requested if a pancreatic cause

of pleural effusion is suspected.

To interpret fluid amylase a serum sample is required.

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.


In order to differentiate a tansudate from an exudate

please request a fluid and serum samples for total

protein and LDH


samples





Other Fluids Return to: Biochemistry Information



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

Specialist Tests Return to: Biochemistry 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.

Urine reducing

substances 2 hours

Urine

Normal result – negative for reducing substances.

False negative results may occur if sample is not

received in the lab within 2 hours.

Some medications (e.g. penicillin, salicylate, ascorbic

acid) can cause positive interference. Test not indicated

in adult patients.





Referred Tests Return to: Biochemistry Information


Test TAT Sample type Biological Interval /

Clinical Decision Values Special precautions/ Information

Referral Lab and Accreditation Number

ACTH 2 weeks

See report Must be received in lab within 15 minutes of

collection.

Clinical Biochemistry, The

Christie Hospital (CPA 2315)

Acyl

carnitines/free

carnitine/MCADD

profile

2 weeks

Dried blood

spot or

See report Willink Laboratory (CPA 2766)

Amino acids

(plasma) 3 weeks

See report CSF amino acids also available Willink Laboratory (CPA 2766)

Amino acids

(urine) 3 weeks

5 mL random

urine sample


β-OH

butyrate/free fatty

acids

4 weeks

See report

Separate sample required. Take at time of

hypoglycaemia. Must be received in the lab

within 20 minutes of collection.

Paediatric Biochemistry, CMFT

(CPA 0865)

Caeruloplasmin 10 days

See report Requested with copper for investigation of

?Wilson’s disease

Biochemistry, CMFT (CPA

0865)

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.


0865)

Chromium and

cobalt 17 days

Trace element

tube (royal

blue)

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.

Southampton Trace Elements

(CPA 1004)










Copper 7 days

See report

Copper increases during the acute phase

response, and should not be measured in

patients with acute infection/inflammation. Fasting

samples preferred.


0865)

Down’s syndrome

screening 5 days

Risk factor provided. Refer to

report. Reports sent directly to requestor.

Blood Sciences, Royal Bolton

Hospital (CPA 2937)

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 (CPA 0253)

Galactosaemia

screening test 14 days

See report

Test not valid if patient has had recent blood

transfusion. Willink Laboratory (CPA 2766)

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.



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 (CPA

1050)










IGF-1 17 days

Reference range varies with

age. See report



IgG subclasses

(IgG4 can also be

requested

separately)

8 days

See report

Investigation of suspected immunodeficiency, or

autoimmune pancreatitis which can be associated

with raised IgG4 levels.

Department of Immunology,

CMFT (CPA 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 (CPA 1167)

Mannose binding

lectin 17 days

See report Protein Reference Unit,

Sheffield (CPA 0113)

Oligoclonal bands

(CSF) 20 days

CSF with paired

serum sample

CSF

Blood

See report For diagnosis of multiple sclerosis Immunology, Salford Royal

Hospital (CPA 0731)










Organic acids

(urine) 35 days

5 mL random

urine sample

See report Investigation of suspected inherited metabolic

disorders Willink Laboratory (CPA 2766)

Orosomucoid

(Alpha-1 acid

glycoprotein)

17 days Serum See report Protein Reference Unit,

Sheffield (CPA 0113)

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 (CPA

0841)

Procalcitonin 14 days

See report Biochemistry, CMFT (CPA

0865)

PIIINP (Type III

procollagen

peptide)

35 days

See report Sample must be received within 2 hours of

collection. For patients on methotrexate therapy.


0865)










Renal stone

analysis 17 days Stone (calculi) See report

Please include information on the location the

stone was removed from.

Clinical Biochemistry, City

Hospital, Birmingham (CPA

1267)

Selenium 7 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.


0865)

Total hCG (NOT

for pregnancy) 7 days

See report Clinical Biochemistry, Salford

Royal Hospital (CPA 0253)

Very long chain

fatty acids

(VLCFA)

4 weeks


Zinc 7 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.


0865)





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


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





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.





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


Dr Shiva Natarajan Consultant Haematologist


Haematology SHO Bleep 716

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


Maggie Evans Lead Biomedical Scientist – Blood transfusion


Out of hours Biomedical Scientist (BMS) Bleep 490


Return to: A-Z list of tests,












6.2 Routine Haematology

6.2.1 Test library

Routine Haematology Return to: Haematology Information



Full Blood Count Urgent 1 hr

See table below Minimum sample volume (Purple EDTA) 1.5ml

Minimum Paediatric sample volume 0.5ml Routine 4 hrs

Plasma Viscosity 24 hours

See table below Minimum sample volume 1.5ml

DO NOT REFRIGERATE

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.

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 1 hour

Screening test – reported as positive or negative

FBC sample will be used

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





Routine Haematology Return to: Haematology Information



Blood film 72 hours

See table below FBC sample will be used

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





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.





6.3 Coagulation

6.3.1 Test library

Coagulation Return to: Haematology 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



Routine 4 hrs

Unfractionated (UF)

Heparin

Urgent 90 min



Send to lab urgently. Must be processed within

4 hours of collection. Routine 4 hrs

Oral anticoagulants Urgent 90 min



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


Factor V Leiden and Prothrombin G20210A

mutation screen sent to referral laboratory. Testing

will be carried out in accordance with BCSH

guidelines. 1x

Lupus

anticoagulant

2 weeks

2x



Anti 10a assay Urgent 4 hrs



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

Factor Assays Urgent 4 hrs

2x



Must be arranged with Consultant

Haematologist Routine 4 wks

Von Willebrand

assays 4 weeks 2x



Must be arranged with Consultant

Haematologist

http://www.bcshguidelines.com/4_HAEMATOLOGY_GUIDELINES.html

http://www.bcshguidelines.com/4_HAEMATOLOGY_GUIDELINES.html





Coagulation Return to: Haematology Information



Direct Oral

Anticoagulants

(DOAC)



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.

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

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

http://www.cmft.nhs.uk/info-for-health-professionals/laboratory-medicine/immunology/a-z-of-immunology-tests









6.5 Blood transfusion

6.5.1 Test library

Transfusion Return to: Haematology Information



Group and Save

Urgent 45 min

Valid for 3 days.

Patient ID stickers MUST NOT be used for tranfsuion

samples. Labels MUST be handwritten. Routine 24 hrs

Crossmatch

Urgent 45 min

Must have a valid Group and Save

Patient ID stickers MUST NOT be used for tranfsuion

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

Haemolysin screen 24 hours

6ml

Cold agglutinin titre 2 days

Telephone blood bank for advice








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




HLA type Class 1

10 days




Platelet antibodies 9 days

3x

Patient leaflet -

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

Request form 3D – Platelet Immunology FRM999


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

Neonatal

alloimmune

thrombocytopenia

9 days

Mu

m

Patient leaflet –




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

Dad

Ch

ild

>0.5ml

http://hospital.blood.co.uk/media/27701/frm745-hi-request-form-3a-diagnostic-lab.pdf







http://hospital.blood.co.uk/media/27703/frm999-hi-request-form-3d-platelet-immunology.pdf












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.pdf

Anti-neutrophil

antibodies 30 days

http://hospital.blood.co.uk/media/1881/b45bc8e7-af47-473d-87e8-8f3e96d811b9.pdf

http://hospital.blood.co.uk/media/1881/b45bc8e7-af47-473d-87e8-8f3e96d811b9.pdf







7 Histopathology

The histology and cytology (sometimes jointly referred to as Cellular Pathology) laboratory at UHSM

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

Head of Histopathology Gynaecology, Gastrointestinal, Urology

2144 4812 [email protected]

Dr N Ali Breast, Skin, Gynaecology, Gastrointestinal cytology


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

Andrology 2159 2123 [email protected]

Dr A Chaturvedi Cardiothoracic, Skin, Head & Neck, Haematolymphoid


Dr A Davenport (part-time) Gastrointestinal


Dr H M Doran (part-time) Cardiothoracic


Dr V Howarth Skin, Gastrointestinal, Urology


Dr M Howe Breast, Urology


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

Gastrointestinal cytology 4807 4810 [email protected]















Consultant Name and Speciality Office Secretary Email address

Dr P Hyder Skin, Urology, Gynaecology, Head & Neck


Dr L Joseph Skin, Breast, Cardiothoracic


Dr C Lelonek Skin, Gynaecology, Urology


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

cytology


Dr A-M Quinn Cardiothoracic, Skin, Head & Neck, Haematolymphoid


Dr A Yates Skin, Gastro-intestinal, Gastrointestinal cytology


Speciality trainees 4814

4816

4815

4817


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

Laboratory Fax Tel No. Email address

Mrs Dawn Clarke

Head Biomedical Scientist 4804 [email protected]

Specimen reception 4800

Histology laboratory 4800

Histology laboratory fax 4801

Cytology laboratory 2156


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

transport, Return of tissues, Cytology sample table,

Mortuary

Richard Banks

UHSM Mortuary Manager 5949 richard [email protected]

UHSM Mortuary office 2541

UHSM Mortuary Fax 2542


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.








mailto:richard%[email protected]





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 UHSM or

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

form amendments will need to have a specimen amendment form completed. If amendments are not

addressed within seven calendar days then a HIRS will be raised.

7.4 Clinical information

In producing a final diagnostic histopathology or cytology 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, under Clinical / Radiological Details give relevant

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, 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.





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 or cytology green collection

fluid are required (see cytology

sample table), these are available

from the cytology laboratory.

Cytology samples

Plain

universal

Sterile container

If MEM or cytology green collection

fluid are required (see cytology

sample table), these are available

from the cytology laboratory.

Cytology samples

CellPath

CellStor

Container prefilled with formalin Small histopathology

samples

Bucket

Bucket prefilled with formalin

Larger

histopathology

samples

Return to Cytology samples table

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.

7.7 Supply of sample containers

We supply prefilled containers 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.

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

dedicated barrels.

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 a HIRS will be raised.

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.

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.

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. A full

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

Pathologist.





7.10 Trephines samples

All trephine specimens taken for histological examination should be placed in a special fixative /

decalcifying solution. These are available in pots from the histopathology department, and are

labelled accordingly. Failure to send a trephine in this fixative may delay the result being issued.

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 UHSM histopathology; these will be booked onto the UHSM laboratory system

and then packaged by laboratory staff for hospital transport to Salford Royal hospital. Reports are

returned to UHSM histopathology, where they are then uploaded onto the laboratory information

system.

7.12 Oral immunofluorescence specimens

The Oral Pathology Department at Central Manchester 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

UHSM histopathology in the gel tubes; these will be booked onto the UHSM laboratory system

and then packaged by laboratory staff for hospital transport to Central Manchester. Reports are

returned to UHSM 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 Central Manchester for further advice.

7.13 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 MEMS fluid, which assists 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.

MEM’s fluid and alcohol spray fixative are both available from cytology by contacting the cytology

laboratory.





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

OR

N/A MEM 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





Cytology samples



FNA lymph node 7 days

OR

AND 2 air-dried slides

N/A MEM 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





7.13.1 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.

7.13.2 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.

7.13.3 Gastrointestinal endoscopy under ultrasound (GI EUS)

Specimens are booked one week in advance by emailing the laboratory with a list of patients and the

location the procedure will take place in. On the day of the procedure the laboratory is to be phoned

when the clinician is about to take the sample so that a biomedical scientist can attend, set up the

required reagents and analyse the sample for adequacy.

7.13.4 Breast Cytology

The department offers a one stop reporting service for breast FNAs and imprint cytology. For UHSM

patients, this takes place in the Nightingale Centre where prepared slides are stained before being

presented to the breast Histopathologist for reporting. For Tameside patients, the sample is

transported by taxi to the UHSM laboratory, where it is processed before the stained slides are

presented to the breast Histopathologist for reporting urgently. The results for both patient settings

are communicated to the Clinician as soon as possible, by paper report or faxing a copy of the paper

report if the clinic is off site.

7.13.5 Joint Fluids

Joint fluids should be sent to microbiology. The microbiology laboratory will then aliquot a sample to

be forwarded to cytology to be examined for the presence of crystals.

7.14 Cervical Cytology

Cervical cytology is sent to Central Manchester NHS Trust for reporting. The contact details are:

Adanna Ehirim Lead BMS Cytopathology [email protected]

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

Tel: 0161 276 5119 Fax: 0161 276 5113






7.15 Andrology

This service offers both infertility and post vasectomy investigations.

7.15.1 Infertility

Infertility services are performed at both UHSM and Tameside site on an appointment based system.

Appointments are available at UHSM on Wednesday and Friday and at Tameside on a Tuesday

morning. Please contact the secretarial team at UHSM for information. Once a patient has made an

appointment a kit will be posted, via Royal Mail, which contains a specimen pot and instructions.

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.

7.15.2 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.





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.





7.16 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 UHSM 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.

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 UHSM histopathology. This transport also delivers samples from GP surgeries within the

Tameside Borough. This transport also delivers supplies from UHSM 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 a supply

of request cards 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.

Any questions relating to sample and transport requirements please telephone the laboratory.

If samples from UHSM 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. At this point, it will be highlighted that a final report will not be issued

until amendments are made. If samples are from GP’s within the UHSM 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 UHSM Histology department.

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 UHSM 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 UHSM Histology via Specimen Reception at Tameside.





7.17 Reports

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

will be ICE at South Manchester and Lorenzo within Tameside. For primary care patients (both

South Manchester and Tameside) 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 catchment area are sent via

second class post.

7.18 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.

7.19 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.

7.20 Turnaround times

Departmental targets:

Sample type Target

Urgent / HSC 205 / Two week wait (2ww) 95% within 7 calendar days

Diagnostic biopsies 80% within 7 calendar days

Resection specimens 70% within 10 calendar days

Overall diagnostic cases 80% within 7 calendar days

90% within 10 calendar days

7.21 Material sent away for further tests

The laboratory on occasion refers material (paraffin embedded blocks) to the Haematological

Malignancy Disease Service (HMDS) at Leeds 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 is also referred to Christie for some fluorescent in- situ hybridisation techniques that are

required on some cases to aid diagnosis. These include techniques for ALK and ROS-1 mutations.

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 opinion and / or

confirmation of pathology.





7.22 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 laboratory manager

or senior biomedical scientist. Written advice as to the hazards of the formalin fixative used

will be given to the patient.

7.23 Disposal of tissues

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

service, not a disposal service.

7.24 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 error and the 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

7.25 Manchester Cancer Research Cancer 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.

7.26 Measurement uncertainty

For information regarding measurement uncertainty for specimens in cellular pathology please

contact the laboratory.

http://www.mcrc.manchester.ac.uk/biobank/





8 Autopsies

8.1 Adult autopsies

Requests for autopsies should be made through the Bereavement Office:

Bereavement Office 2360

Bereavement manager 2028

Bereavement office fax 2665

Please be clear as to whether you wish to request a hospital (consent) autopsy, 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 an autopsy will be done the next day. Autopsies 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 autopsy 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 autopsy 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 authorize 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 autopsy.

The coroner has restricted the release of autopsy findings to clinicians. If you want to know about an

autopsy, 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

There is extensive advice from the Human Tissue Authority at

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

The Trust holds licenses 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

Dr P Bishop is the Designated Individual for the Trust's Pathology HTA licences.


http://www.manchester.gov.uk/coroners

http://www.hta.gov.uk/guidance/codes_of_practice.cfm





8.2 Stillbirths and fetuses, autopsies and disposal

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

autopsy.

For autopsies on stillbirths and non-viable fetuses, please contact the Maternity Department.

8.2.1 UHSM 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

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, a HIRS

will be raised.

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

8.2.2 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 UHSM 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 UHSM 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.

8.3 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.

http://uhsm-intranet/policies/Trustwide%20policies%20operational%20policies%20and%20guidel/Disposal%20of%20Pre-viable%20pregnancy%20remains%20V2,%20CONSENT%20FORM%209.pdf

http://uhsm-intranet/policies/Trustwide%20policies%20operational%20policies%20and%20guidel/Disposal%20of%20Pre-viable%20pregnancy%20remains%20V2,%20CONSENT%20FORM%209.pdf

http://portal.uhsm.nhs.uk:20002/Infection_control_notification_sheet_for_bodies_of_the_deceased.htm





8.4 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 morticians. If you are completing the first

part of the cremation form, you are required to state if a device is present and to arrange its removal.

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 mortician specifically so that we can ask an ECG technician to inactivate the device.

8.5 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.

9 Microbiology

The microbiology laboratory service at UHSM is provided by the Manchester Medical Microbiology

Partnership (MMMP). All information regarding the microbiology service is contained within the

Central Manchester University Hospitals pathology website.

9.1 Contact details


Dr Mairi Cullen

Clinical Lead

Consultant Microbiologist


Dr Firza Gronthoud

Consultant Microbiologist & Infection Control Doctor 2892 [email protected]

Dr Ibrahim Hassan,

Consultant Microbiologist 4756 [email protected]

Dr Stephanie Thomas

Consultant Microbiologist 4792 [email protected]

Dr Sajjad Mirza

Consultant Microbiologist & Deputy Infection Control Doctor 5812 [email protected]

Specialist Registrar 4784/4863

Mr David Weston

Laboratory Manager 4759 [email protected]

Angela Downes

Deputy Laboratory Manager 4758 [email protected]

Laboratory results & enquiries 4819

Clinical Advice Line 2885

Secretary/Office 4862/4754

Fax 4755


http://www.cmft.nhs.uk/info-for-health-professionals/laboratory-medicine/manchester-medical-microbiology-partnership












10 Mycology Reference Centre

The Mycology Reference Centre Manchester (MRCM) is situated on the second floor of the

Education & Research Centre at Wythenshawe Hospital. The MRCM provides a specialist mycology

diagnostic service for the Manchester Medical Microbiology Partnership, and hospitals throughout 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 the UHSM switchboard for the on-duty Infectious Diseases specialist.

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 5839 [email protected]

Dr R Richardson Consultant Medical Mycologist

Office 5941 [email protected]

General enquiries/results Laboratory 2124 [email protected]

Fax 5806

Website www.mycologymanchester.org

All samples should be sent to the Microbiology Department, Wythenshawe Hospital who will ensure

appropriate transportation to the Mycology Reference Centre Laboratory.

10.2 Additional Tests

Additional tests can be requested by telephoning or writing to 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 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.





http://www.mycologymanchester.org/





10.3.1 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

All patients receiving voriconazole

Fluconazole in patients on dialysis/haemofiltration

Patients failing azole therapy

If drug interactions are suspected





The following tests with the exception of voriconazole are carried out at the Mycology Reference Centre. For further advice contact extension 2124.

Voriconazole TDM is performed by Clinical Biochemistry. For all drugs, the time of previous dose and time of sampling should be recorded accurately.

Antifungal Drug Levels Return to: Mycology Information

Appendix A (list of tests) Indicative cost: £60.69 per sample

Test TAT Sample type Biological Interval / Clinical Decision

Values Special precautions/ Information

Antifungal drug

levels

Average

2.1 days See below

Specimens should be transported to the laboratory as soon as possible. If

a delay is anticipated, samples should be refrigerated. Assay validated for

transportation of samples at room temperature for up to and including 5

days.

Flucytosine

Levels

available

sooner

than for

other

anti-

fungals

or

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

Itraconazole Average

2.1 days As above

Target 5 – 17.0 mg/L

Commence monitoring only after steady

state has been reached (1-2 weeks on

oral therapy, little variation through the

day)


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 three monthly. Check levels two weeks after any dose change or if there might be a possible drug interaction. Repeat levels if concern about poor compliance / absorption.

Lab assay runs: Tuesdays and Thursdays Sample must be received before 2pm









Posaconazole Average

2.1 days

As above Target level for prophylaxis is >0.7 mg/L

and >1.3mg/L for therapy

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)


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 three monthly. 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: Tuesdays and Thursdays Sample must be received before 2pm

Voriconazole Average

2.1 days As above

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


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 then 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 then three monthly thereafter.

For other diagnoses, then do a level at week 2, 4, 8 and 12 of treatment and three monthly thereafter.

Repeat a level 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: Mondays, Wednesdays and Fridays at 12.30 by Biochemistry department, but consult Mycology Reference Centre for advice









Isavuconazole Average

2.1 days

As above Target levels not yet established and

informed clinical judgement is required

for dose adjustments.

Normal range on standard 200mg od

therapy at steady state is 2-4 mg/L

Dose escalation is advised for any level

less than 1 mg/L

The mean half-life of isavuconazole in

plasma is 130 hours and it has linear

kinetics.


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 then 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 then three monthly thereafter.

For other diagnoses, do a level at week 2, 4, 8 and 12 of treatment and three monthly thereafter.

Repeat a level 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: Laboratory assay once weekly, consult Mycology Reference Centre Laboratory for advice.

* these samples are most useful for clinical management

Fluconazole levels can be assayed to test compliance or absorption. Contact Mycology Reference Centre.





10.4 References

1. Richardson MD and Warnock DW. Fungal Infection: Diagnosis and Management. 4th Ed.

Oxford, Wiley-Blackwell, 2012.

2. 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

Original specimens will be processed by the Microbiology Department, Wythenshawe Hospital. If

fungus is isolated, the Microbiology department will then send the culture on to the Mycology

Reference Centre for identification and testing. Please ensure that the request form states that

mycological investigations (identification and susceptibility testing) are required.

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





Identification and Susceptibility Testing of Yeasts and Moulds Return to: Mycology Information

Appendix A (list of tests) Indicative cost: Varies – contact lab

Test TAT Sample

type

Biological Interval / Clinical Decision


Full identification

of all medically

important yeasts

and moulds

Identification: average

turnaround of 4 days, or longer

if molecular sequence-based

identification is required

Susceptibility of yeasts and

moulds: average turnaround of

3 – 4 days

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

Anidulafungin

Posaconazole

Other drugs are available upon request





Cryptococcal antigen latex agglutination test Return to: Mycology Information



Clinical Decision Values


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,

eg. 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.





Culture and identification of dermatophytes and non-dermatophytes from skin, nail and hair Indicative cost: £13.94per sample




Culture Direct microscopy: 1-2

days

Culture and

identification:

yeasts: 1-3 days

dermatophytes: 1-3

weeks

non-dermatophytes: 1

week

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





Pan-fungal glucan assay Return to: Mycology Information



FUNGITELL

assay for -1-3-D-

glucan: the

fungal glucan

test is indicated

for presumptive

diagnosis of

fungal infection

Currently,

this assay

is

performed

twice a

week. The

maximum

turnaround

time is 3

days.

Serum 700 µl

or 5 ml clotted

blood

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

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 -D Glucan assay

does not detect certain fungal species such as the genus

Cryptococcus, which produces very low levels of -D-

glucan. This assay also does not detect the Zygomycetes,

such as Lichtheimia, Mucor and Rhizopus, which are not

known to produce -D-glucan.

Note: the glucan test has a very high negative predictive

value.

Aspergillus precipitin test Return to: Mycology Information



Agar gel double

diffusion for

Aspergillus

precipitins

against

Aspergillus

fumigatus.

4-5 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





Aspergillus PCR Return to: Mycology Information



Elitech

Aspergillus PCR 2-3 days

Respiratory

secretions


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

Pneumocystis PCR Return to: Mycology Information



MycAssay

Pneumocystis

PCR assay

2-3 days

Respiratory

secretions

(BAL, sputum)

1-2 ml

minimum,

daily if

Pneumocystis

infection is

suspected


indication of Pneumocystis infection.

This product is currently out of production. We are

sending any PCP PCR requests to Virology at MRI





Surveillance of hospital environments, homes, public buildings, for Aspergillus species and allergenic moulds



Culture of air

samples, culture

of dust and

material

samples.

5 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 by MRCM staff: all inclusive fee of £100.69 (NHS cost), or £108.36

(private client cost) which includes processing, identification and interpretation,

plus £21 per hour sampling time, plus direct travel costs (public transport mileage

rate)

Processing of submitted samples, identification and interpretation: please contact

the laboratory





Molecular identification of fungi from culture negative, microscopy positive specimens Return to: Mycology Information

Appendix A (list of tests) Indicative cost:

£83.43 per sample




DNA extraction 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)

N/A 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.

See Manchester Medical Microbiology Partnership

For additional information see: https://www.uhsm.nhs.uk/services/mycology and www.mycologymanchester.org

http://www.cmft.nhs.uk/info-for-health-professionals/laboratory-medicine/manchester-medical-microbiology-partnership

https://www.uhsm.nhs.uk/services/mycology

http://www.mycologymanchester.org/





11 Appendix A – A-Z List of tests

Test Department

5HIAA 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

Amylase (serum) Biochemistry

Amylase (pleural fluid) Biochemistry

Androstenedione Biochemistry

Anti 10a assay Haematology

Antifungal Drug Levels Mycology

Anti-neutrophil antibodies Haematology

Arterial Blood Gases Biochemistry

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

Caeruloplasmin Biochemistry

Calcium Biochemistry

Calcium (Amended) Biochemistry

Carbamazepine Biochemistry

Carboxyhaemoglobin Biochemistry

Catecholamines Biochemistry





Test Department

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 Biochemistry

Cortisol (blood) Biochemistry

Cortisol (urine) 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

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





Test Department

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

Haemolysin screen Haematology

Haptoglobin Biochemistry

HCG Biochemistry

HDL cholesterol Biochemistry

Heparin induced thrombocytopenia (HIT) Haematology

High Sensitivity Troponin I Biochemistry

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





Test Department

Insulin and c-peptide Biochemistry

Insulin stimulation test Biochemistry

Iron Biochemistry

Isavuconazole Mycology

Itraconazole Mycology

Kleihauer Haematology

Lactate Biochemistry

LDH (serum) Biochemistry

LDH (pleural fluid) Biochemistry

LH Biochemistry

Light chains (quantitation) 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

Neonatal alloimmune thrombocytopenia Haematology

Oestradiol Biochemistry

Oligoclonal bands (CSF) Biochemistry

Oral anticoagulants Haematology

Organic acids (urine) Biochemistry

Orosomucoid (Alpha-1 acid glycoprotein) Biochemistry

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

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





Test Department

Pneumocystis PCR Mycology

pO2 Biochemistry

Porphobilinogen/ urobilinogen / Porphyria screen Biochemistry

Porphyrin screen Biochemistry

Posaconazole Mycology

Potassium (serum) Biochemistry

Potassium (urine) 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

Routine Biochemistry Biochemistry

Routine Haematology Haematology

Salicylate Biochemistry

Salivary cortisol Biochemistry

Selenium Biochemistry

Serum 5HIAA 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

Testosterone Biochemistry

Theophylline Biochemistry

Therapeutic Drug Monitoring Biochemistry

Thrombophilia screen Haematology

Tobramycin Biochemistry

Total cholesterol Biochemistry

Total hCG (NOT for pregnancy) Biochemistry

Total protein (serum) Biochemistry

Total protein (pleural fluid) Biochemistry





Test Department

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 Biochemistry

Voriconazole Mycology

Water deprivation test Biochemistry

Xanthochromia Biochemistry

Zinc Biochemistry

β-OH butyrate/free fatty acids Biochemistry

Documents

UHSM Pathology Handbook Pathology Revision No: 38 Document title: Pathology Handbook Author: P McHale Document No: PG-D-HANDBOOK-1 Approved by: Dawn