Pathology - Quality Management Pathology User Guide PATH ... · Tameside and Glossop Integrated...

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Pathology User Guide

Nicola Bullough

PATH.QM.002

Debbie Gulla, Nicola Bullough, and Tony Tetlow

3.5

22-May-2019

22-May-2019 10:14

Pathology - Quality Management

Authorised

Pathology User Guide - Version: 3.5. Index: PATH.QM.002. Printed: 22-May-2019 10:14

Authorised on: 22-May-2019. Authorised by: Nicola Bullough. Document Unique Reference: 1312-89467136. Due for review on: 22-May-2021

Author(s): Debbie Gulla, Nicola Bullough, Tony Tetlow

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INTRODUCTION

The information contained within this guide is intended for users of the services provided by the Pathology

Directorate at Tameside and Glossop Integrated Care NHS Foundation Trust. Please contact the Pathology

Quality Manager if you have any comments or suggestions concerning this guide.

AUTHORITY FOR ISSUE

This document has been authorised by the Pathology Management Team – See front page or iPassport for full

details.

DOCUMENT INFORMATION

See footer and front page for basic information; see iPassport QMS for full details.

REFERENCES

A list of references is not given in this document. Please contact the Pathology Quality Manager for more

information if required.

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Tameside and Glossop Integrated Care NHS Foundation Trust Pathology User Guide

Table of Contents

Introduction ............................................................................................................................................................ 1

Authority for Issue .............................................................................................................................................. 1

Document Information ....................................................................................................................................... 1

References .......................................................................................................................................................... 1

Contact Details ........................................................................................................................................................ 7

Pathology Management Team ............................................................................................................................ 7

Pathology IT Systems .......................................................................................................................................... 7

Pathology General ............................................................................................................................................... 7

Blood Sciences (Haematology, Biochemistry and Blood Transfusion) ................................................................ 7

Microbiology ....................................................................................................................................................... 7

Mortuary ............................................................................................................................................................. 7

General Information ............................................................................................................................................... 8

Service Provision ................................................................................................................................................. 9

Location ............................................................................................................................................................... 9

Address ............................................................................................................................................................. 10

Internet ............................................................................................................................................................. 10

Advice ................................................................................................................................................................ 10

Test Selection ................................................................................................................................................ 10

Individual cases ............................................................................................................................................. 10

Advice on the interpretation of results ......................................................................................................... 10

Complaints ........................................................................................................................................................ 10

Quality ............................................................................................................................................................... 11

Quality of results (The Uncertainty of Measurement) ...................................................................................... 11

Reference Ranges .............................................................................................................................................. 11

Consent ............................................................................................................................................................. 11

Confidentiality ................................................................................................................................................... 11

Tests not present in User Guide ........................................................................................................................ 11

Laboratory opening times ................................................................................................................................. 13

Blood Sciences & Transfusion ....................................................................................................................... 13

Microbiology ................................................................................................................................................. 13

Requesting and Reporting ..................................................................................................................................... 14

Requests for Blood Products: ........................................................................................................................ 15

Ward Order Communications ....................................................................................................................... 15

GP Electronic Reporting ................................................................................................................................ 15

Requests for further tests on samples already held by laboratory ............................................................... 15

Distribution of printed reports ...................................................................................................................... 15

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Telephoned results........................................................................................................................................ 16

Specimen Collection and Transport ...................................................................................................................... 18

Introduction ...................................................................................................................................................... 19

Basic Rules for Taking Specimens...................................................................................................................... 19

Problem Samples .......................................................................................................................................... 19

Caution – EDTA Contamination ..................................................................................................................... 20

Container Guide ................................................................................................................................................ 21

Biochemistry ................................................................................................................................................. 21

Haematology ................................................................................................................................................. 22

Transfusion .................................................................................................................................................... 22

Microbiology ................................................................................................................................................. 23

Labelling ............................................................................................................................................................ 28

Labelling for Transfusion ............................................................................................................................... 28

Mislabelled Samples.......................................................................................................................................... 28

Why it matters .............................................................................................................................................. 28

Good Labelling .............................................................................................................................................. 28

Bad Labelling ................................................................................................................................................. 29

Repeatable Samples ...................................................................................................................................... 29

Non-Repeatable Samples .............................................................................................................................. 29

Consent ............................................................................................................................................................. 29

Sending Samples ............................................................................................................................................... 30

Blood Sciences............................................................................................................................................... 30

Microbiology ................................................................................................................................................. 30

Urgent samples ............................................................................................................................................. 30

High Risk Specimens .......................................................................................................................................... 30

Phlebotomy ....................................................................................................................................................... 31

In-patients ..................................................................................................................................................... 31

Out-patients .................................................................................................................................................. 31

GP Patients .................................................................................................................................................... 31

Transport of samples to laboratory .................................................................................................................. 32

Pneumatic Tube Delivery System (pod) ........................................................................................................ 32

From Wards and Out-patient Departments .................................................................................................. 32

GP's ............................................................................................................................................................... 32

Specimen Spillage ......................................................................................................................................... 33

Referred investigations ................................................................................................................................. 33

Biochemistry Department ..................................................................................................................................... 34

Contact Details .................................................................................................................................................. 35

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Biochemical Profiles .......................................................................................................................................... 35

Common Tests Information – Sample requirements and reference ranges (adult) ......................................... 37

Paediatric Reference Ranges ............................................................................................................................. 49

Paracetamol Interpretation .............................................................................................................................. 51

Therapeutic Drug Monitoring ........................................................................................................................... 52

Acute Kidney Injury (AKI) Alerts ........................................................................................................................ 53

Interpretation of Vitamin D results ................................................................................................................... 53

Faecal Occult Blood ........................................................................................................................................... 54

Dynamic Function Tests and Special Tests ........................................................................................................ 55

Oral Glucose Tolerance test .......................................................................................................................... 55

Short Synacthen Test .................................................................................................................................... 58

Dexamethasone suppression test (low dose) ............................................................................................... 58

Renin and Aldosterone .................................................................................................................................. 59

Water Deprivation Test ................................................................................................................................. 60

Tumour Markers ............................................................................................................................................... 62

NICE guidance on tumour markers ............................................................................................................... 62

Drugs of abuse .................................................................................................................................................. 64

Virology ............................................................................................................................................................. 64

Porphyrin Screen ............................................................................................................................................... 65

Cryoglobulins..................................................................................................................................................... 65

Haematology Department .................................................................................................................................... 66

Contacts ............................................................................................................................................................ 67

Turnaround Times ............................................................................................................................................. 67

Note .............................................................................................................................................................. 67

Blood Count Requests ....................................................................................................................................... 68

ESR..................................................................................................................................................................... 69

Reticulocytes ..................................................................................................................................................... 69

Anticoagulants .................................................................................................................................................. 70

NOAC Patients on Rivaroxaban, Apixaban or Dabigatran (Non vitamin K Anticoagulants) .......................... 70

Therapeutic Range for patients on Warfarin ................................................................................................ 70

Coagulation Tests .............................................................................................................................................. 71

Indication ...................................................................................................................................................... 71

Coagulation test – sample requirements ...................................................................................................... 71

Haemoglobinopathies ....................................................................................................................................... 73

Haemoglobinopathy tests available: ............................................................................................................. 73

Antenatal screening .......................................................................................................................................... 73

Haemolytic disorders ........................................................................................................................................ 73

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Haematinic assays ............................................................................................................................................. 73

Bone marrow aspirate and trephine bone biopsy ............................................................................................ 73

Haematology adult reference ranges................................................................................................................ 73

Other Haematological Investigations ................................................................................................................ 74

Sample storage times ........................................................................................................................................ 74

Referred Investigations ..................................................................................................................................... 75

Blood Transfusion ................................................................................................................................................. 77

Contacts ............................................................................................................................................................ 78

Caution .............................................................................................................................................................. 78

Request Forms .................................................................................................................................................. 78

Specimen Requirements ................................................................................................................................... 79

Dextran .............................................................................................................................................................. 79

Routine Requests .............................................................................................................................................. 79

Reservation of cross-matched blood ............................................................................................................ 79

Group and Save Plasma................................................................................................................................. 80

Issue of Blood .................................................................................................................................................... 80

Emergency Group O Negative Blood ................................................................................................................. 80

POCT (Point of Care Testing) ................................................................................................................................. 81

POCT Policy ................................................................................................................................................... 82

POCT Committee ........................................................................................................................................... 82

Training ......................................................................................................................................................... 82

Sample integrity and results ......................................................................................................................... 82

Pathology support ......................................................................................................................................... 82

Instrument failure ......................................................................................................................................... 83

Immunology .......................................................................................................................................................... 84

Contacts ............................................................................................................................................................ 85

Microbiology and Virology .................................................................................................................................... 86

Contacts ............................................................................................................................................................ 87

Microbiology Department ................................................................................................................................. 87

Virology Department ......................................................................................................................................... 88

Cellular Pathology & Neuropathology .................................................................................................................. 89

Cellular Pathology ............................................................................................................................................. 90

Service and Contact Information ...................................................................................................................... 90

Contact Details .................................................................................................................................................. 90

Consultant Contact Details ............................................................................................................................ 90

Neuropathology Samples .................................................................................................................................. 91

Neuropathology – muscle and nerve biopsy samples ...................................................................................... 91

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Transport ....................................................................................................................................................... 91

Mortuary and Bereavement ................................................................................................................................. 92

Mortuary Opening Hours .................................................................................................................................. 93

Contacts ............................................................................................................................................................ 93

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CONTACT DETAILS

Directorate internal hospital numbers (prefix with 0161 922 if dialling from outside). If in doubt concerning who

part of the directorate to contact then please use General Enquiries on 6497 who will then be able to advise

and re-direct your call. Full list of phone numbers can be found on hospital intranet.

PATHOLOGY MANAGEMENT TEAM

Clinical Director Dr Vicki Howarth 4003

Diagnostics Manager Dawn Clarke 6110

PA to Ms Clarke 4412

Quality Management System Manager Nicola Bullough 6419

Administration and Clerical Manager Alison Reece 6609

PATHOLOGY IT SYSTEMS

Clinical IT Team 4619

PATHOLOGY GENERAL

General Enquiries (non-results) 6393

General Enquiries (results) 6497

Laboratory Fax 6496

Blood Transfusion Fax 6504

BLOOD SCIENCES (HAEMATOLOGY, BIOCHEMISTRY AND BLOOD TRANSFUSION)

Blood Sciences Manager Gillian Lewis 6318

POCT Manager Alison Shanahan 4620

General Enquiries – Haematology & Biochemistry 6497

General Enquiries – Blood Transfusion 6391

Consultant Clinical Scientist (Biochemistry) Tony Tetlow 6495

Consultant Haematologists secretary 6596 & 4196

Specialist Practitioner of Transfusion Caroline Holt 5484

MICROBIOLOGY

Consultant Microbiologist Dr P Unsworth 6500

Consultant Microbiologist / Infection control Dr H. Sacho 4086

Please note that laboratory services have now transferred to Manchester University NHS Foundation Trust

(central site). Please see relevant part of user guide.

MORTUARY

Mortuary Manager Sharon McMinn 6520

Mortuary Office 6059

On-call mortuary technician Via hospital switchboard

Histopathology

Please note that laboratory services have now transferred to Manchester University NHS Foundation Trust

(UHSM site). Please see relevant part of user guide.

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GENERAL INFORMATION

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SERVICE PROVISION

The Pathology Department at Tameside General Hospital is committed to providing a full comprehensive

Pathology Service for Haematology/Blood Transfusion, Biochemistry and Mortuary to all its users.

The mortuary provides post mortem and body storage facilities serving the Trust and the Coroner, acting as a

public mortuary.

The Cellular Pathology service is provided by Manchester University NHS Foundation Trust (Wythenshawe site)

with a Service Level Agreement under a Cooperation Agreement.

The Microbiology and Immunology services are provided by Manchester University NHS Foundation Trust

(Central site) under Service Level Agreements.

Information Technology (IT) Services are provided under Service Level Agreements by the Tameside and

Glossop Integrated Care NHS Trust IT department and the Systems Development department.

LOCATION

The Directorate of Laboratory Medicine (Pathology) is located on Fountain Street opposite the Hartshead

Building. The post code suitable for a Sat. Nav. is OL6 9RW

The entrance to the department is denoted by the ‘red arrow’. The entrance on Fountain Street is for goods

and laboratory staff only.

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ADDRESS

All Directorates in pathology can be contacted by post at the following address

Directorate of Laboratory Medicine

New Fountain House

Tameside and Glossop Integrated care NHS Foundation Trust

Fountain Street

Ashton-under-Lyne

OL6 9RW

INTERNET

http://www.tamesidehospital.nhs.uk/

ADVICE

TEST SELECTION

Please use this guide in the first instance; for more complex matters please contact the laboratory or the

relevant consultant.

INDIVIDUAL CASES

For advice on individual cases, please contact either the relevant consultant or the laboratory who will be able

to advise you further.

ADVICE ON THE INTERPRETATION OF RESULTS

Please be aware that not all staff can give advice on the interpretation of results. Clinical advice can only be

given by consultant staff, not by Medical Laboratory Assistants or Biomedical Scientists

COMPLAINTS

Complaints may be sent to departments by phone, email or mail. All complaints are dealt with using the Trust’s

complaints procedure which can be found on the intranet or internet site. Initial contact may be by phone,

email or in writing and attempts are made to deal with any complaint immediately and at the point of contact.

If the complainant is not satisfied with the response them they should ask to speak to a more senior member of

staff (see relevant section of User Guide). If the complainant is still not satisfied then they may be referred to

the Trust’s complaints procedure. The Complaints and Patients Advice and Liaison Service (Complaints and

PALS) should be contacted for advice. The contact details are:

Telephone: 0161 922 4466

Emails: [email protected]

Further details are available in the Patient Handbook which available on the Trust’s public site

(https://www.tamesidehospital.nhs.uk/).

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QUALITY AND ACCREDITATION

Tameside and Glossop Integrated Care NHS Foundation Trust Department of Blood Sciences a UKAS accredited

medical laboratory No. 8912. This accreditation is to ISO 15189:2012 Medical laboratories – Requirements for

quality and competence. It is strongly recommended that users check the UKAS website

(https://search.ukas.com/#/tabbed/search?q=8912&ati=1) for the current accreditation status of the service as

the scope of accreditation can change over time. Any questions about accreditation should be addressed to a

senior member of the management team.

The mortuary is licensed by the Human Tissue Authority for: Making of a Post Mortem Examination, Removal

of Relevant Material, Storage of a Body or Relevant Material (Licence number: 12067)

Where appropriate, departments also take part in External Quality Assurance schemes to ensure that we

provide a high quality service to our users.

The department has a formal Quality Management System that meets the requirements of ISO 15189:2012.

The Quality Policy and Quality Manual are available to service users on request. Please contact the Quality

Manager for further information

QUALITY OF RESULTS (THE UNCERTAINTY OF MEASUREMENT)

All analytical results are assessed via internal quality controls and external quality assurance. The interpretation

of all results is subject to an uncertainty due to inter and intra individual variability plus the analytical variability

which all assays are subject to. Data relating to this is available for all reported tests done in-house or can be

obtained for referred investigation. If you have any queries regarding the interpretation of results (biological,

analytical variation or reference ranges) then please contact a senior member of staff (contact details provided

in this guide).

REFERENCE RANGES

All quoted reference ranges have been either:

• Adapted from the Pathology Harmonisation program and checked against our current methodologies

using the distribution of results within the Tameside and Glossop area (a posteriori reference range

surveillance).

• Or a position of “best practice” is adopted in line with current guidelines.

• Reference ranges for referred investigation are taken from the referral laboratory.

CONSENT

When a sample is taken then consent is implied. The responsibility for consent lies with the requesting

clinician. Investigations will only be undertaken for the diagnosis and/or monitoring of a particular condition at

the request of and with the authority of the requesting clinician or their nominated individual.

CONFIDENTIALITY

The department (and the Trust) follows the NHS code of conduct and is bound by the General Data Protection

Regulations. The Trust’s policies regarding this can be obtained via the internet and intranet sites or contact

any senior member of the directorate for a copy.

TESTS NOT PRESENT IN USER GUIDE

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Please note that the User Guide does not mention all possible investigations for reasons of brevity, only the

most commonly requested tests are included. If an assay is required but is not in this document then please

contact the relevant department.

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LABORATORY OPENING TIMES

BLOOD SCIENCES & TRANSFUSION

The Haematology/Blood Transfusion and Biochemistry Departments (Blood Sciences) operate a 24 hours

service; one qualified staff member is on duty in each of the 2 disciplines outside routine working hours. These

departments also operate a senior staff “on-call” rota in collaboration with neighbouring hospitals (contactable

via the Biomedical Scientist on duty for Biochemistry and via switchboard for Haematology).

MICROBIOLOGY

The laboratory based service has now transferred to Manchester University NHS Foundation Trust (central

site). The consultant microbiologist service remains at Tameside with two consultants (contactable via the

switchboard). Please see Microbiology Department on page 87 for further details.

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REQUESTING AND REPORTING

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REQUESTS FOR BLOOD PRODUCTS (TRANSFUSION):

All request forms must be signed by the requesting clinician. Additionally the sample tube must be hand

written, signed and dated.

WARD ORDER COMMUNICATIONS

The hospital has an electronic link between the Patient Administration System (Lorenzo) and the Pathology

Computer System. The system is available for Haematology, Transfusion, Microbiology and

Biochemistry requests from all wards and clinics; all requests for these departments must be made

electronically.

A signed request is an absolute requirement for Group & Save and Crossmatch. Please note that the label

produced by Lorenzo for blood transfusion MUST NOT be attached to the sample, Samples must be hand

written as per previous section.

Medical staff training on this system is undertaken by the IT Department. All Haematology, Transfusion,

Biochemistry and Microbiology results are available on Lorenzo once they are released. Please look for the

results on Lorenzo before telephoning.

GP ELECTRONIC REQUESTING AND REPORTING

GP practices are provided with tQuest; an electronic order communications product that interfaces to the lab

system and the Practice Management System allowing electronic requesting of pathology tests.

The Pathology Directorate transfers results electronically to GP Practices. Results are sent continuously in order

that patients' results are available for viewing next morning on the GP's' own computer systems.

GPs can access results for investigations done within the hospital via Review which works with tQuest.

For any query about pathology IT issues please contact the Clinical IT Team

REQUESTS FOR FURTHER TESTS ON SAMPLES ALREADY HELD BY LABORATORY

It is occasionally possible for further testing to be done on samples held by the laboratory. Samples are held for

a minimum of 5 calendar days by Biochemistry and a minimum of 2 calendar days (minimum 2 day) by

Haematology (for Microbiology and Histology please contact relevant department). Requests for further tests

are possible after considerations of:

• If there is sufficient sample remaining.

• If the requested analyte is stable under the storage conditions.

• The sample is the correct type.

DISTRIBUTION OF PRINTED REPORTS

In-patients: There are 2 report distributions per day, 12:30 and 17:30

GP patients: Reports are sent by transport (daily).

Please note the directorate operates a no-faxing policy unless the fax machine has been

established as a “safe haven”. Please see Trust’s data protection policy for further details or

contact laboratory for advice.

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TELEPHONED RESULTS

It would be appreciated if telephone enquiries to the laboratory asking for results, could be kept to a minimum.

All results from pathology are electronically sent to the Lorenzo EPR, if the request is made electronically or the

RMP number is used on the request. So please check the Lorenzo system before telephoning for results.

If contacting the department by phone then please ensure you have full patient details, date of collection and

tests required.

Note: in line with the Royal College of Pathology’s guideline (2010):

“Out-of-hours reporting of markedly abnormal laboratory test results to primary care: Advice to pathologists”

and in consultation with service users the following limits for telephoning seriously abnormal results have been

agreed:

BIOCHEMISTRY

Analyte Units Action limits

Below Above

Pro

file

Co

mp

on

en

ts

Sodium mmol/L 120 160

Potassium mmol/L 2.5 6.0*

Urea mmol/L - 30

Creatinine µmol/L 250

Glucose mmol/L 2.5 20**

Calcium (corrected) mmol/L 1.80 3.00

Magnesium mmol/L 0.4 -

Phosphate mmol/L 0.3 -

NTproBNP Pg/ml - >400

AKI - AKI stage 2 and 3

En

zym

es AST U/L - 750

ALT U/L - 750

CK U/L - 5000

Amylase U/L - 500

Th

era

pe

uti

c D

rug

s Carbamazepine µmol/L - 60

Digoxin nmol/L - 3.5

Theophylline µmol/L - 150

Phenytoin µmol/L - 150

Lithium mmol/L - 1.5

Valproate mmol/L - 1500

Gentamicin mmol/L 12

Oth

er

Troponin I – male ng/L 42.9

Troponin I – female ng/L 18.3

Paracetamol mg/L 10

Salicylate mg/L 10

*Check sample is not haemolysed (sample quality check), EDTA contaminated (check magnesium, calcium and

alkaline phosphatase) or if there has been a delay in separation (check phosphate)

** >30 mmol/L if known diabetic

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HAEMATOLOGY

Analyte Units Action limits

below Above

Pro

file

co

mp

on

en

ts

Haemoglobin g/L 80

Total White Cell Count 109/L 2

Absolute Neutrophil Count 109/L 1

Platelet Count 109/L 30

INR 5.0

APTTR 3.0

Fibrinogen g/L 1.0

Newly presenting leukaemia

Newly presented malaria

Positive Sickle Cell Haemoglobin in patients about to undergo anaesthesia

ADDITIONALLY

CSF (total protein and glucose) If not requested by ward order coms (WOC).

Blood gases If not requested by WOC.

The directorate will make every endeavour to communicate any results requiring immediate attention to the

initiator of the request. If there are insufficient details on the request form this may be impossible outside of

core laboratory hours and may cause delays in these results being transmitted.

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SPECIMEN COLLECTION AND TRANSPORT

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INTRODUCTION

In order for the laboratory to provide the service that you require, the laboratory needs samples to be taken

and labelled correctly. Additional information can be found in PATH.PROC.013 – Specimen Packaging and

Transport.

BASIC RULES FOR TAKING SPECIMENS

1. Ensure you only deal with one patient at a time

2. Check the expiry date of the tube

3. Do not label bottles before you take the sample

4. Bottles MUST be labelled next to the patient

5. Ask patient to confirm their name where possible

6. Take patient details from the wrist band (when present)

7. Sample MUST have 3 positive patient identifiers on the container

8. All details on the sample and the request form must match

9. Take EDTA tubes last (to prevent sample contamination (leads to high K+))

PROBLEM SAMPLES

Please note the following pre-laboratory errors frequently occur but may be avoided by

• Correct sample for relevant test.

• Correct mixing of blood sample with contents of blood collection tube (minimum of 12 full inversions).

• Prompt delivery to the department.

The most common reasons for pre-analytical factors affecting results are:-

Problem Common causes Consequences

Delay in separation Overnight storage. Delay in transit Increased K+, PO4, ALT, LDH.

Decreased HCO3-, (Na+

occasionally)

Storage Storing at 4°C Increased K+ Decreased HCO3-

Haemolysis Expelling blood through needle into tube

Over vigorous mixing of specimen

Storing specimen in freezer (-20°C)

Excessive delay in transit

Leaving specimen in hot environment.

Difficulties encountered when accessing

suitable vein.

Increased K+, PO4, ALT, LDH

Inappropriate sampling

site

Specimen taken from drip arm Increased drip analyte e.g. glucose,

K+, Mg2+ (dilution effect)

Incorrect container or

anticoagulant

No enzyme inhibitor, EDTA tube or

transferring blood from one tube to another

Low glucose, Increased K+, Na+,

Decreased Ca2+, ALP, Mg2+

Lipaemia Specimen taken after a fatty meal. Decreased Na+

Clotting of sample Inadequate mixing of samples with

anticoagulant causing blood to clot

Affects FBC, ESR, Coagulation &

other samples

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CAUTION – EDTA CONTAMINATION

Plasma or serum samples (white, brown or orange tubes) must be taken before EDTA sample

(red, blue or pink tubes).

Contamination of blood specimens with potassium EDTA is a major problem for the Biochemistry department

and the following will explain why.

Q. What are the effects of EDTA contamination?

• Increased potassium - leading to an incorrect interpretation of potassium levels.

• Decreased calcium, magnesium and alkaline phosphatase.

Q. Why use EDTA if it is such a problem?

Potassium EDTA is the anticoagulant primarily used by the Haematology department because the cellular

components and morphology of the blood cells are preserved and it is the recommended anticoagulant for

haematology.

Q. How does it work?

EDTA inhibits clotting by chelating calcium and magnesium which inhibits several calcium and magnesium

dependent enzymes critical to the clotting cascade.

Q. Can it be spotted by the lab?

Gross contamination can be spotted by the lab due to unbelievable levels of calcium (and/or magnesium),

potassium and alkaline phosphatase. It only takes a trace of EDTA to alter the results and this may not be

obvious. THE LABORATORY CAN NOT RELIABLY IDENTIFY EDTA CONTAMINATION. The safe practice is to avoid

contamination in the first place and that is the responsibility of the person taking the blood sample.

Q. How can contamination be avoided?

When taking a series of blood specimens, it is essential that specimens for biochemistry (e.g. urea and

electrolytes) are taken first and EDTA samples are taken last.

If you have any doubts about the accuracy of a potassium e.g. if it does not agree with the

patient’s condition or with previous results then obtain a fresh sample (of which you are sure of

the integrity) and have it analysed as an emergency.

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CONTAINER GUIDE

BIOCHEMISTRY

Routine – Adult

Routine – Paediatric

Glucose/Alcohol – Adult

Glucose/Alcohol – Paediatric

Lithium Heparin – Adult

Lithium Heparin - Paediatric

EDTA Red Top – Ammonia

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HAEMATOLOGY

EDTA – Adult

EDTA – Paediatric

Coagulation – Adult

Coagulation – Paediatric

ESR

Do not place labels over the clear part

of the tube (this is where the ESR is

read). Please place it over the existing

label. When filled, blood should reach

the arrow.

TRANSFUSION

Transfusion – Adult

Transfusion – Paediatric

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MICROBIOLOGY

MICROBIOLOGY LABELLING AND PACKAGING

Because microbiology is booked in here and processed at MRI the

requirements for labelling are slightly different to those for Blood Sciences:

Label the sample as normal. Only one sample per bag is allowed; request forms must not go in the bag with the

sample; attach the form to the bag/tag; if the sample leaks we or MFT will only have to discard one sample but

we will have the demographics available to issue a report informing you that the sample leaked.

URGENT SAMPLES FOR MICROBIOLOGY

Please inform the laboratory at Tameside that an urgent sample is being sent so that they know to look out for

it so that it can be sent to MFT as soon as possible and is highlighted to them. Please also let the laboratory at

MFT know so that they are aware.

BACTERIOLOGY

SINGLE ESWAB (PINK TOP)

Wound swabs & Genital Swabs: Infection Screen

WOUND SWABS

For wound swabs or MRSA screening sites excluding nose and groin/perineum. Please provide a site and clinical

information

GENITAL SWABS: INFECTION SCREEN

This screen will cover all potential pathogens, depending upon clinical information provided, with the exception of

Trichomonas vaginalis*

*Vaginal swabs for trans patients can be requested as “Genital – Other” or as a Wound Swab

STERILE CONTAINER – URINE

Urine Samples: Clean Catch Urine, Mid-Stream Urine & Catheter Urines

Please provide clinical information

*For Mycobacteria culture collect 3 consecutive early morning urine samples in

200mL containers

*For Schistosoma collect terminal urine portions over a 24hrs in standard urine

containers

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DOUBLE HEAD SWAB (RED CAP)

CPE Screens – rectal swabs only

The double head red swab should only be

used for CPE screening

FAECES POTS

Enteric Samples: C. difficile and Routine Screen

Please provide clinical information including recent travel

history

CHARCOAL AMIES SWAB

Trichomonas vaginalis (TV) Screen

For patients with symptoms of TV, such as frothy discharge. A TV screen may be considered for:

• abnormal vaginal discharge that may be thick, thin or frothy and yellow-green in colour

• producing more discharge than normal, which may also have an unpleasant fishy smell

The use of this swab is an interim measure only; in the future TV requests will be processed by molecular methods

alongside Chlamydia and Gonorrhoea.

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BLOOD CULTURE PACK – NEONATAL

BLOOD CULTURE – PAEDIATRIC

BLOOD CULTURE – ADULT

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QUANTIFERON PLUS TB

Please read the package insert when using these as there are very specific requirements for how they are taken,

stored and transported.

VIROLOGY

COBAS PCR MEDIA – SWAB

Viral infection Screen; Chlamydia trachomatis & Neisseria gonorrhoea (NAAT)

Please ensure the correct swab is used

for the test requested or the sample

cannot be processed. Please note only

ONE swab should be returned in the

specimen tube.

COBAS PCR MEDIA – URINE

Viral infection Screen; Chlamydia

trachomatis & Neisseria gonorrhoea

(NAAT)

Urine specimens must be collected in a

sterile container and transferred to the

Cobas media tube within 24 hours. Fill

level must be between the black lines.

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VIRAL TRANSPORT MEDIA (RED CAP)

All other virology

CLOTTED BLOOD

For all serology

EDTA ANTICOAGULANT

PCR and Viral load

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LABELLING

The Specimen Acceptance Policy for both T&GICFT and MFT Trusts is:

On the Tube On the Form

Patients full name (surname & forename) Patients full name (surname & forename)

Date of Birth Date of Birth / Gender

RMP Number or NHS Number NHS or RMP Number

Date of Collection Location of report

Consultant or GP

Clinical information

The only time this does not apply is for GUM Clinic patients or when the identity of the patient is unknown.

Also refer to the ‘Specimen Acceptance Policy’ on the Trust intranet.

Where Lorenzo (Hospital) or tQuest (GP) is used to generate the form much of this information is automatically

transmitted form the requesting system to the laboratory system.

LABELLING FOR TRANSFUSION

Transfusion has particular requirements over and above other disciplines:

On the Tube On the Form

Patients full name (surname & forename) Patients full name (surname & forename)

Date of Birth Date of Birth / Gender

NHS or RMP Number NHS or RMP Number

Date & time sample was taken Location of report

Signature of member of staff Consultant or GP

Location Clinical information

Lorenzo Barcodes must NOT be placed on Transfusion samples

Also see the ‘Blood Transfusion Policy’ on the Trust intranet.

All transfusion samples are regarded as repeatable without exception (see Caution page 78).

MISLABELLED SAMPLES

WHY IT MATTERS

On an average day the laboratory deals with approximately:

• Samples 2550

• Requests 5400 (a sample can have multiple requests on it)

• Tests 16590 (e.g. a U&E is made up of 6 individual tests)

If even a small proportion of samples are poorly labelled it can have a significant impact on the department

taking staff time when they could be doing more useful things.

GOOD LABELLING

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The barcode runs along the length of the tube and the print is clear and dark allowing our analysers to read the

barcode, this speeds up our process and minimises the risk of error

BAD LABELLING

Labels that are not running along length of tube or are scratched or have pale print or are not properly adhered

to the tube are not acceptable as they will not scan on our analysers (or may even jam). These have to be

manually relabelled which takes significant time and introduces a risk of error when transferring demographics

etc.

Please only put one label on a tube, multiple labels can make it impossible to read them or fit them in the

analyser racks.

REPEATABLE SAMPLES

The Department of Laboratory Medicine reserves the right not to analyse any repeatable specimen that it

receives that has not been adequately labelled. All inadequately labelled repeatable specimens will be disposed

of in accordance with the Trusts Waste Disposal Policy. A clinical incident form will submitted

NON-REPEATABLE SAMPLES

When a non-repeatable specimen is received and has been found to be inadequately labelled the laboratory

will contact the ward/department to inform them of this. It is the responsibility of the Health Care Worker

responsible for the specimen to come to Department of Laboratory Medicine and complete an Amendment to

Specimen Labelling Form.

CONSENT

It is the responsibility of the requesting clinician to obtain consent for the collection of specimens from the

patient. For certain tests (e.g. HIV tests or genetic tests) fully informed consent may be needed; for some tests

a consent form may be required in addition to the request forms/informed consent

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SENDING SAMPLES

BLOOD SCIENCES

Label the sample(s) as required, put the sample(s) in the bag, one patient per bag, seal the bag and attach the

request form/sticker to the bag/tag (if there are multiple Lorenzo forms these can be placed in the bag).

MICROBIOLOGY

Because microbiology is booked in here and processed at MRI the requirements for labelling are slightly

different:

Label the sample as normal. Only one sample per bag is allowed; request forms must not go in the bag with the

sample; attach the form to the bag/tag; if the sample leaks only one sample will have to be discarded but we

will have the demographics available to issue a report informing you that the sample leaked.

URGENT SAMPLES

If the sample is urgent you must telephone the lab and inform them that the sample is urgent please give

Patient Name, Date of Birth and NHS number or District Number

HIGH RISK SPECIMENS

Specimens from a patient deemed to be high risk must be labelled and transported to the laboratory following

the Trust’s Policy for high risk specimens/patients. This is to comply with our responsibilities under the Control

of Substances Hazardous to Health regulations (COSHH) and ‘The Carriage of Dangerous Goods and

Transportable Pressure Equipment Regulations 2009’

Specimens that are very high risk and requiring special precautionary measures (e.g. MERS and Ebola): It is the

responsibility of the clinician to inform the laboratory of suspected highly contagious sample required extra

PPE for handling. All such cases should be discussed with a Consultant Microbiologist prior to submission of

sample to lab. The laboratory requires knowledge of such samples for analysis and transport to referral

laboratory and has policies and procedures for doing so.

Where departments have been found to not comply with these requirements, a clinical incident will be raised

and there are likely to be prosecutions under the above Regulations.

Fuller details of the safe packaging and transport of high risk specimens can be found in PATH.PROC.013 –

Specimen Collection and Transport.

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PHLEBOTOMY

Phlebotomy within the trust is managed by the nursing directorate.

The service can be accessed by the following:

IN-PATIENTS

Blood samples are normally taken by a phlebotomist, but if one is not available, the doctor or a trained support

worker may take the blood. Requests for phlebotomy may be made via Lorenzo and blood collected when the

phlebotomist visits the ward. A limited phlebotomy service is available on Saturdays, Sundays and Bank

Holidays.

The department has standardised on the "Monovette" blood collection system which acts as a combined

syringe/blood container, rather than the conventional syringe and needle.

OUT-PATIENTS

Blood can be collected from out-patients by referring them to the phlebotomists at the Blue Suite Clinic

(internal 6637) between 9:00am and 4:30pm Mon-Fri.

GP PATIENTS

Patients can be referred to the hospital for the collection of blood. The phlebotomists are present between

9.00 am and 4.30 pm at the Blue Clinic (as above).

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TRANSPORT OF SAMPLES TO LABORATORY

PNEUMATIC TUBE DELIVERY SYSTEM (POD)

Air tube stations are situated around the site. Full operating details are available at each station, and further

details can be obtained via Pathology or the Estates Department. Breakdowns and faults should be reported to

Estates Tel: 6999. Please note that the air tube system is NOT the responsibility of Laboratory Medicine.

Do not send the following sample types in the pod:

• Histology samples in formalin

• Semen samples

• Blood Gases

• Blood Products

• Specimens known to be High Risk

Specimens for tests that are unstable (please refer to relevant section in user guide), blood

gas/CSF specimens and for requests which are very urgent then the pod system should NOT

be used. These specimens should be transported directly to the laboratory without delay.

FROM WARDS AND OUT-PATIENT DEPARTMENTS

Apart from the air tube system samples are also picked up from the following collection points.

Time Location

10:30am Ante Natal Clinic

Yellow Suite

Blue Suite

11:45am Ante natal Clinic

Yellow Suite

Blue Suite

2:00pm Occupational health

Ante Natal Clinic

Yellow Suite

Blue Suite

For urgent samples both during and after the working day, it is the responsibility of the originator of the

request to make arrangements for the transport of the sample to the laboratory by e.g. air-tube or portering

services. During the working day, samples should be brought direct to the laboratory or sent via the air-tube.

Outside working hours specimens should be sent via the air-tube or taken to the directorate (access is gained

via a buzzer/intercom system).

GP'S

The laboratory provides a transport service which collects samples from GP surgeries in the Tameside and

Glossop district in the morning and afternoon, every day from Monday to Friday. Please contact laboratory for

collection times for each practice.

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SPECIMEN SPILLAGE

When spillages occur during transport of specimens then:

Ward and clinic areas – inform nursing staff and follow local policy.

Pneumatic tube system – inform maintenance (ext. 6999).

Laboratory areas – inform senior staff, policy for cleaning/decontamination to be found in Risk Management

Policy and Blood Sciences Health and Safety Policy. Consult iPassport for relevant policy (Health and Safety

Procedures).

All other areas – contact laboratory for advice.

REFERRED INVESTIGATIONS

Not all investigations requests are performed in the Pathology Directorate at Tameside General. Specialist

investigations and the less requested investigation may be referred to other more specialist laboratories in the

region or throughout the country. These investigations may take longer to be reported. The directorate does

audit these tests and in the event of an excessive delay, please contact the laboratory for help and/or advice.

An indication of turnaround time is made for many tests in this handbook but this can only act as a guide.

If you wish to contact the referral laboratory then the directorate maintains a list of contact numbers. We

would strongly recommend that you request the laboratory here to follow up non-returned results (which is

audited by each department) to enable us to establish why the delay has occur.

If you require a list of referral laboratories the laboratory can supply this. The accreditation status of referral

laboratories is monitored on an annual basis.

A list of laboratories used for referred tests is available later in the user guide. Should you need

to contact an external laboratory we strongly recommend you discuss this with the TGH

laboratory first. This will save time and confusion.

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BIOCHEMISTRY DEPARTMENT

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CONTACT DETAILS

General Enquiries – Haematology & Biochemistry Results 6497

Blood Sciences Manager Gillian Lewis 6318

Point of Care Manager Alison Shanahan 4620

Consultant Clinical Scientist (Biochemistry) Tony Tetlow 6495

When phoning from outside the hospital use 0161-922 then the extension number.

BIOCHEMICAL PROFILES

These are tests grouped together to simplify requesting. All profiles require 5ml sample (minimum); the only

exception is when the sample is from a paediatric patient when a full microtainer is required.

Most profiles will be analysed the same day and if indicated as urgent, within 1 hour.

The common profiles are:-

Profile Tests Reference Range

Routine profile

(GP only)

Sodium

Potassium

Chloride

Urea

Creatinine

Calcium (adjusted calcium)

Albumin

133 – 146 mmol/L

3.5 – 5.3 mmol/L

95 – 108 mmol/L

2.5 – 7.8 mmol/L

41 – 110 µmol/L

2.12 – 2.63 mmol/L

31 – 45 g/L

U&E

Sodium

Potassium

Urea

Creatinine

133 – 146 mmol/L

3.5 – 5.3 mmol/L

2.5 – 7.8 mmol/L

41 – 110 µmol/L

Liver profile Total Protein

Albumin

Globulin

Bilirubin

Alkaline Phosphatase (ALP)

Alanine Transaminase

γGlutamyl Transpeptidase (GGT)

62 – 80 g/L

31 – 45 g/L

24 – 43 g/L

3 – 21 µmol/L

20 – 125 IU/L

<60 IU/L

<50 IU/L

Bone Profile Calcium (adjusted calcium)

Albumin

Phosphate

Alkaline Phosphatase (ALP)

Total Protein

2.12 – 2.63 mmol/L

31 – 45 g/L

0.8 – 1.5 mmol/L

25 – 125 IU/L

62 – 80 g/L

Nutritional Marker Magnesium

Prealbumin

C-Reactive Protein (CRP)

0.7 – 1.0 mmol/L

150 – 350 mg/L

<8.0 mg/L

Thyroid profile Thyroid Stimulating Hormone

Free Thyroxine

0.4 – 4.5 mU/L

7 – 17 pmol/L

Drug Profile (urine) – 14

day TRT

Opiates

Benzodiazepines

Amphetamines

Cocaine metabolite

Methadone metabolite

Creatinine

Not detected

Not detected

Not detected

Not detected

Not detected

>1.8 mmol/L

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Profile Tests Reference Range

Lipid Profile Cholesterol (total)

HDL Cholesterol

LDL Cholesterol

Triglycerides (fasting)

<5.0 mmol/L

>1.2 mmol/L

<3.0 mmol/L

<1.8 mmol/L

Androgen Profile (Male)

– 6 day TRT

Testosterone 10 – 28 nmol/L

Androgen Profile

(female) – 14 day TRT

Testosterone

Sex Hormone Binding Globulin

Androstenedione

Free Androgen Index (calculated)

Androstenedione

<1.6 nmol/L

18 – 114 nmol/L

<6.0 nmol/L

< 4.5

<6 nmol/L

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COMMON TESTS INFORMATION – SAMPLE REQUIREMENTS AND REFERENCE RANGES (ADULT)

Due to the large number of possible requests not all assays are listed. If you require a non-listed test, please

contact the laboratory for an estimated turnaround time. We will contact the referral laboratory on your

behalf.

The turn-around times are when we expect at least 90% of assays to be completed. If result has not been

returned within the quoted time then please contact the laboratory who will then investigate.

Test Specimen

Type

Volume

Required

Turn

Around

Reference Range

Adrenocorticotrophin (ACTH).

Second line test for adrenal

dysfunction.

plasma (send

to lab on ice)

10ml Referred

test – 12

days

0 – 46 ng/L

Alanine Aminotransferase

(ALT).

Increased levels indicate liver cell

damage of any cause.

serum 5ml <24hr <60 IU/L

Albumin

Low levels due to renal/GI loss, low

synthesis, dietary, over hydration of

redistribution.

serum 5ml <24hr 31 – 45 g/L

Alcohol (blood) blood

(fluoride)

5ml <24hr Not Detected

Alcohol (urine) random

urine

5ml <24hr Not Detected

Aldosterone

Measured with renin for diagnosis

of Conn’s Syndrome. See page 59

Renin and Aldosterone

plasma 10ml Referred

test – 21

days

See report

Aldosterone: renin ratio

random sampling of these

hormones gives a ratio used as an

initial screen for primary

hyperaldosteronism.

The sample must be immediately

taken to the laboratory would must

be notified if impending arrival. See

renin. See page 59 Renin and

Aldosterone

plasma (send

to lab on ice)

10ml Referred

test – 21

days

<630 pmol/L

Alkaline Phosphatase

Elevated in bone and liver disease

(naturally elevated in children and

pregnancy).

serum 5ml <24hr 25 – 125 IU/L

Alpha-1-antitrypsin

Evaluation of COAD, emphysema

and liver disease. Acute phase

reactant.

serum 5ml referred

test – 14

days

1.1 – 2.1 g/L

Alpha-1-antitrypsin

(phenotyping)

Evaluation of low alpha-1-

antitrypsin levels

serum 5ml referred

test – 14

days

see report

Alpha-fetoprotein

Tumour marker for hepatocellular

carcinoma

serum 5ml <24hr <5 KU/L

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Test Specimen

Type

Volume

Required

Turn

Around

Reference Range

17-alpha-Hydroxyprogesterone

Diagnosis of CAH due to 21-

hydroxylase deficiency. 3rd line

investigation of hirsutism (late onset

CAH). Monitoring of CAH patients

serum 5ml referred

test - 14

days

<10 nmol/L

Amino acids (urine).

Disorders of amino acid metabolism

urine 10ml referred

test – 28

days

Normal pattern

Ammonia

Paediatric disorders e.g. urea cycle

disorders. Contact lab before

sending. Sample must be received in

ice immediately. Please contact

laboratory before sending.

Plasma –

EDTA - RED

microtainer

1ml <1hr Sick/prem = <150 µmol/L

neonate = <100 µmol/L

<16 yr. = <50 µmol/L

Amylase

Raises in acute pancreatitis


Amylase (urine)

Investigation of macroamylasaemia.

Comparison with serum, paired

sample should be taken at same

time

urine 10ml <24hr <35 IU/mmol creatinine.

Amylase:creatinine

clearance ratio: 0.02 – 0.05

Amino Acids

Investigation of inherited defects of

amino acid metabolism

urine 10ml referred

test – 28

days

see report

Androstenedione

Investigation of hirsutism

serum 5ml referred

test - 14

days

<6.0 nmol/L

Angiotensin converting enzyme

(ACE)

Monitoring sarcoidosis

serum 5ml referred

test – 12

days

15 – 55 IU/L

Antiepileptic drugs

Monitoring therapy and toxicity. See

page 52 Therapeutic Drug

Monitoring.

serum 5ml <24hr see individual drugs. See

also page 52 Therapeutic

Drug Monitoring.

Anti-Mullerian Hormone

Assessment of ovarian reserve.

Note: consultant request only.

serum 5ml referred

test - 14

days

<6.0 pmol/L low

6-24.pmol/L reduced

24 – 70 pmol/L optimum

>70 pmol/L PCOS

Aspartate aminotransferase

Raised in liver and muscle damage


Bence-Jones Protein

Monoclonal immunoglobulin free

light chains in urine

urine 20ml 14 days not detectable

Beta-2-microglobulin

prognostic indicator in

myelomatosis

serum 5ml 14 days 0.9 – 2.5 mg/L

Bicarbonate

acid-base status

serum 5ml <24hr 20 – 26 mmol/L

Bile acid

cholestasis of pregnancy

serum 5ml <24hr <14 µmol/L

Bilirubin

Raised in haemolysis, hepatocellular

damage or biliary obstruction

serum 5ml <24hr 3 – 21 µmol/L (adult)

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Reference Range

Bilirubin (neonate)

Spectrophotometric analysis only

suitable if <3 months old.

serum 0.5ml <24hr see paediatric ranges

Blood gases

Acid – base status – must be

received by lab within 30min of

sampling. Blood gas analysers

available in locations throughout the

hospital. Please note that the

sample must NOT contain any air

gaps and must have been

thoroughly mixed.

Heparinised

arterial blood or

capillary sample

2 ml <0.5hr see report

NOTE the blood gas analyser

recently changed from a

GEM 4000 to an ABL90 Flew

Plus. This test is out of the

scope of our ISO 15189:2012

accreditation. It is intended

to gain ISO 22870

accreditation in the future.

BNP (NTproBNP)

Use to identify patients with left

sided heart failure who may require

echo ECG and in diagnosis of acute

heart failure.

Whole blood

(EDTA)

5ml <4hr reported as NTproBNP,

normal <400 ng/L.

Ca125 – see special tests section Please see section on Tumour Markers page 62.

Ca19-9 – see special tests section

Ca15-3 – see special tests section

Caeruloplasmin

Copper binding serum protein,

decreased in Wilson’s Disease

serum 5ml referred

test – 18

days

0.20 – 0.45 g/L

Calcitonin

Useful in diagnosis and monitoring

of medullary carcinoma of the

thyroid. May require a pentagastrin

stimulation test for diagnosis.

serum 5ml referred

test – 14

days

<18.9ng/L

Calcium

Report value corrected for albumin

serum 5ml <24hr 2.12 – 2.63 mmol/L

Calcium (urine) urine collected

in acid

<24hr Female = <6.5 mmol/24hr

Male = <7.5 mmol/24hr

Calculi

Identify component of renal, biliary

or bronchial stones

- Complete

sample

sent

referred

test – 14

days

see report

Calprotectin

Differentiation of IBD and IBS

faeces 1g Referred

test – 14

days

<60µg/g

Carbamazepine

Anticonvulsant drug monitoring.

See page 52 Therapeutic Drug

Monitoring.

serum

(pre-dose)

5ml <24hr therapeutic range:

20-40 µmol/L

Carboxyhaemoglobin

Measure % of carbon monoxide

bound to haemoglobin

heparinised

sample

(orange top)

5ml <24hr up to 10% in smokers,

normally <2%

Carcinoembryonic antigen (CEA)

Monitoring of colonorectal cancer,

of no use for diagnosis.

serum 5ml <24hr <3 U/L (up to 10 in smokers)

C1-esterase inhibitor

hereditary angioneurotic oedema

(type 1). C4 should be requested at

the same time, C1-esterase will not

be measured if C4 normal.

serum 5ml referred

test – 14

days

0.21- 0.50 g/L

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Reference Range

Catecholamines

Investigation of hypertension,

suspected phaechromocytoma.

urine

(collected

into acid)

24hr

collection

referred

test – 22

days

see report

CCP (anti-)

raised in rheumatic disease, more

sensitive than rheumatoid factor

serum 5ml referred

tests –

21 days

<10 U/ml

Chloride serum 5ml <24hr 95 – 108 mmol/L

Cholesterol

Coronary artery disease

serum 5ml <24hr <5 mmol/L or <4 mmol/L if

in high risk group

Cholesterol - HDL

Inverse association between HDL

cholesterol levels and coronary

artery disease.

serum 5ml <24hr Female = >1.1 mmol/L

male = >0.9 mmol/L

Cholesterol - LDL

Calculated parameter from

cholesterol and HDL cholesterol.

Cannot be calculated if triglyceride

greater than 2.4mmol/L

- - <24hr <3.0 mmol/L or <2.0 mmol/L

if high risk

Cholinesterase

Anaesthetic sensitivity and

organophosphate poisoning. If

deficiency detected then whole

required for genotyping.

serum (plus

whole blood

(EDTA))

5ml referred

test – 27

days

see report

Chromium

Required to assess MoM joint wear

according to MHRA alert.

whole blood 5ml referred

test – 21

days

see report

Clozapine

Anti-psychotic drug requiring

monitoring. See page 52

Therapeutic Drug Monitoring.


test – 21

days

see report

Cobalt

Required to assess MoM joint wear

according to MHRA alert. Measured

with chromium (see above)


test – 21

days

see report

Complement

C3 and C4 assay for monitoring

inflammatory and autoimmune

conditions. Single point

determinations of limited value

serum 5ml referred

test – 17

days

see report

Copper

Reduced in Wilson’s Disease.

Increased in many inflammatory

disorders, pregnancy and OCP. Also

request Caeruloplasmin.

serum 5ml referred

test – 14

days

13 – 26 µmol/L

Copper (urine)

Increased in Wilson’s Disease.

24hr urine

collection

(acid washed

container)

- referred

test – 14

days

<1.0 µmol/24hr

Cortisol

Investigation of adrenal function.

Important to note time of specimen

as reference ranges relate to 09:00.

Hydrocortisone, prednisone and

prednisolone will interfere with this

test but not dexamethasone.

serum 5ml <48hr 09:00h ref. range: 140 - 500

nmol/L

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Reference Range

Cortisol (urinary free)

First line investigation for Cushing’s

Syndrome

24hr urine

collection

(plain

container)

- referred

test – 14

days

<180 nmol/L

Creatinine

Assessment of renal function.

Affected by muscle breakdown and

diet as well as renal function

serum 5ml <24hr 40 – 110 µmol/L (age and

muscle mass dependent)

Creatinine (urine)

See above. Used for calculation of

creatinine clearance.

24hr urine

collection

- <24hr see report

C-reactive protein

Acute phase reactant.

serum 5ml <24hr <8 mg/L

Creatine Kinase (CK)

Muscle enzyme, cardiac and skeletal

serum 5ml <24hr F = <145 IU/L

M = <170 IU/L

Cryoglobulin

Essential to keep sample at body

temperature on way to lab. Please

contact lab before taking sample,

see Cryoglobulins section of user

guide.

serum 5ml 10 days See report

CSF (Xanthochromia)

Estimation of haemoglobin and

bilirubin in (xanthochromia) CSF for

investigation of SAH. Sample must

be taken >12hr post event and may

remain abnormal for up to 10 days.

Do not send sample by “air tube” as

this may affect result.

CSF 1ml (min)

– sample

less than

1ml cannot

be

processed

<2 hr see report

Cyclosporine

Monitoring immunosuppressant

therapy. Trough level taken

although 2hr level often used as

better indication of therapy. See


Monitoring.

Whole blood

(EDTA)

5ml referred

test – 10

days

see report

Digoxin

To assess compliance and toxicity.

Levels cannot be interpreted if

sample taken less than 6 hr post

dose – pre-dose levels

recommended. See page 52


serum 5ml <24hr 1.0 – 2.6 nmol/L

Down’s Screening

Pre-natal detection of Down’s

Syndrome.

serum 5ml Reported directly from screening service

at Royal Bolton Hospital to ANC.

Drug Screen

Screening for detection and

monitoring of drug abuse – opiates,

benzodiazepines, cocaine,

amphetamines, methadone

metabolite. Cannabis,

buprenorphine and ethanol can be

added on request. Please see Drugs

of abuse page 64.

urine 15ml Referred

test – 14

days

not detected

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Reference Range

Dehydroepiandrosterone

(DHAS)

Investigation of hirsutism.

serum 5ml referred

test – 14

days

<12 µmol/L (female)

Electrophoresis

Detection of paraproteins, immune

deficiency and non-specific acute

and chronic phase deficiency.

serum 5ml <14 days see report

Erythropoietin

Investigations of rbc production

serum 5ml 28 days 3 – 18 mIU/ml

Ethanol

To identify intoxication

Plasma

(fluoride

oxalate,

yellow tube)

5ml <24hr not detected

Ethylene Glycol (and methanol)

For identification of ethylene

glycol poisoning. All requests

must be discussed with

Consultant Clinical Scientist first

as this requires urgent referral.

Plama

(lithium

heparin,

serum gell

samples are

not suitable)

5ml <4hr not detected

Faecal Elastase

Measure of exocrine pancreatic

function.

faecal

sample

1g referred

test – 14

days

see report

Faecal Occult Blood

Identification of blood in faeces.

Please see page Error! Bookmark

not defined.

Faecal Occult Blood

Faecal

sample

1g <24hr negative

Faecal Reducing Substances

Malabsorption/digestion of

carbohydrates (of paediatric

interest).

Please note that samples more than

1hr old will not be processed,

faecal

sample

(must be

delivered to

lab

immediately

1g referred

test – 14

days

not detected

Ferritin

Assessment of iron stores

serum 5ml <24hr M = 24 – 337 µg/L

F = 11 – 307 µg/L

Folate (serum)

Investigation of anaemia and

neuropathy.

serum 5ml <24hr 3.0 – 19.9 ng/L

Free Androgen Index

Ratio of testosterone to SHBG

expressed as a percentage.

Investigation of Hirsutism.

serum 5ml referred

test – 14

days

F = <4.5

FSH

Assessment of ovarian failure,

infertility, pituitary dysfunction.

serum 5ml <24hr F = cyclical (see report)

M = 1 -7 IU/L

Gamma Glutamyl

Transpeptidase (GGT)

Sensitive indicator of liver disease.

Increased after exposure to enzyme

inducing drugs (including ethanol)

serum 5ml <24hr M = <50 IU/L

F = <32 IU/L

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Required

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Reference Range

Gastrin

Diagnosis of gastrinomas. Patient

must be fasted and have not

received omeprazole for at least 2

weeks or H2 blockers for 3 days.

plasma

(must be

delivered to

lab on ice).

5ml referred

test – 28

days

<40 pmol/L

Gentamicin

Therapeutic drug monitoring is

essential to prevent complications

of therapy. See page 52 Therapeutic

Drug Monitoring.

Serum 5ml <24hr See Trust guidelines for

antibiotic prescribing and

sampling

Globulins

Elevated in myeloma, infections and

autoimmune disorders

calculated

result

5ml <24hr 24 – 43 g/L

Glucose

Primarily measured in DM.

Plasma

(fluoride

oxalate,

yellow tube)

1ml <24hr 3.0 – 6.0 mmol/L (fasting)

Glucose Tolerance Test

Diagnosis of DM. See page 55 Oral

Glucose Tolerance test

This test is no longer performed within the Pathology Directorate.

Phone Phlebotomists (6637) for appointment. For interpretation see

relevant section in user guide.

Growth Hormone

Measured in acromegaly, pituitary

gigantism and dwarfism. Random

levels are of little value and

secretion is best assessed by

stimulatory or suppressive testing

serum 5ml referred

test – 21

days

see report

Gut Hormone Profile

(gastrin, VIP, PP, glucagon,

neurotensin, somatostatin,

chromogranin A&B)

Diagnosis of neuroendocrine

tumours of the alimentary tract.

Contact lab before taking sample –

sample must be received within

10minutes of being taken

Plasma 10ml referred

test – 25

days

see report

Haptoglobin

Intravascular haemolysis,

haemolytic anaemia

Serum 5 ml <24hr 100 – 300 g/dl

HbA1c

Diagnosis and monitoring of

diabetes

EDTA. Whole

blood

1ml <24hr DCCT 4.5 – 5.9 %

IFCC 26 – 41 mmol/mol

Human Chorionic

Gonadotrophin (HCG)

Increased in pregnancy, ectopic

pregnancy, hydatidiform mole,

seminoma, testicular and ovarian

teratomas


HCG (urine)

Pregnancy test, only performed if

POCT devices are not available

urine

(random)

5ml <24hr see report

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Reference Range

5-Hydroxyindole-acetic acid

(HIAA)

Detection and monitoring of

carcinoid tumours. Some foods

(bananas, pineapples) can cause

increased levels.

24hr urine

collection

into acid

- referred

test – 27

days

<50 µmol/24hr

Immunoglobulins

Autoimmune disorders, liver

disease, infection and genetic

deficiencies.

serum 5ml <48hr IgG = 6.0 – 16.0 g/L

IgA = 0.8 – 4.0 g/L

IgM = 0.5 – 2.0 g/L

Immunoglobulin subclasses

Investigation of recurrent infection

in children

serum 5ml referred

test – 23

days

IgG1 = 2.4 – 12.6 g/L

IgG2 = 0.6 – 2.3 g/L

IgG3 = 0.2 – 1.4 g/L

IgG4 = 0.02 – 1.8 g/L

Immunoglobulin E

Allergic and atopic disease.

serum 5ml referred

test – 14

days

Age related – see report

Iron Studies

Investigation of deficiency and

overload.

serum 5ml <24hr

Iron 13 – 32 umol/L

Iron binding capacity 45 – 70 umol/L

% saturation 20 – 55 %

Transferrin 1.8 – 3.5 g/L (male)

2.0 – 3.6 g/L (female)

Insulin

Detection of insulinoma, Sample

must be taken during a

hypoglycaemic attack. Glucose must

be assayed at same time.

serum

(sample

must be sent

to lab on ice)

5ml referred

test – 13

days

see report

Insulin Growth Factor–1 (IGF-1)

Investigation of acromegaly and

growth disorders.

serum 5ml referred

test – 22

days

see report

Lactate

Send to lab immediately on ice

Serum

CSF

5ml 0.5 – 2.5 mmol/L

1.1 – 2.4 mmol/L

Lactate Dehydrogenase (LDH)

Measured in megablastic and

pernicious anaemias, leukaemias,

lymphomas and liver disease.


Lamotrigine

Anticonvulsant drug, TDM not

recommended. See page 52


serum 5ml referred

test – 21

days

3 – 15 mg/L

Lead

Monitoring environmental

exposure.

whole blood

EDTA

2ml referred

test – 14

days

see report

LH

Assessment of ovarian failure,

infertility, pituitary dysfunction.

serum 5ml <24hr F = cyclical (see report)

M = 3 – 12 IU/L

Lithium

Monitoring of lithium therapy.

Sample should be taken 12hr post

dose. See page 52 Therapeutic Drug

Monitoring.


(0.4 – 0.8 mmol/L if >65yr)

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Reference Range

Magnesium

Measured in case of hypocalcaemia

and hypoparathyroidism. Low levels

commonly seen due to intestinal

losses and diuretic therapy.


Mast Cell Tryptase

Suspected acute allergic reaction.

Sample should be taken at up to 3hr

post even and after 6 and 24hr.

serum 5ml referred

test – 14

days

<12.9 µg/L

Microalbumin (urine albumin)

Measured in diabetes as an

indicator of the development of

renal disease. Ratio to creatinine

urine

(random)

5ml <24hr <3.5 mg/mmol (male)

<2.5 mg/mmol (female)

Oestradiol

Investigation of female infertility

and monitoring of oestrogen

implants.

serum 5ml <48hr cyclical, see report

Organic Acids

Investigation of inherited defects in

organic acid metabolism.

urine 10ml referred

test – 47

days

see report

Osmolality

Estimation of “osmolar gap”.

Investigation of hyponatraemia.

serum 5ml <24hr 285 – 295 mOsm/kg

Osmolality (urine)

Investigation of SIADH (with serum

osmolality)

urine 5ml <24hr 250 – 750 mOsm/kg

Needs to be interpreted

with serum osmolality

Oxalate (oxalic acid)

Investigation of renal stones

serum 5ml referred

test – 24

days

see report

Oxalate (urine)

Investigation of renal stones

urine

(acidified)

5ml referred

test – 24

days

see report

P3NP (Procollagen Peptide)

Monitoring fibrogenic activity in the

liver of patients receiving long term

methotrexate

serum 5ml referred

test – 45

days

see report

Paracetamol

Paracetamol overdose, to assess

need for antidote. Sample must not

be taken less than 4hr since the

overdose. See Paracetamol

Interpretation page 51

serum 5ml <24hr Normal <10mg/L. For

overdose please see chart.

Parathyroid Hormone (PTH)

Investigation of hypo- and

hypercalcaemia. Sample must be

analysed within 4hr of being taken

serum 5ml <48hr 19 – 67 pg/ml

Phenobarbitone

Check for toxicity and compliance.


Monitoring.

serum 5ml referred

test – 21

days

15 – 50 mg/L

Phenytoin

Check for toxicity and compliance.


Monitoring.

serum 5ml <24hr 30 – 70 µmol/L

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Reference Range

Phosphate

Investigation of calcium

abnormalities.


Porphyrin Screen

Detection of porphyrias.

Investigation of such symptoms as

abdominal pain and skin

photosensitivity. All samples must

be kept in the dark. See Porphyrin

Screen page 65.

plasma

red cells

urine

faeces

5ml

2ml

20ml

10-15g

referred

test – 35

days

see report

Potassium

Seasonal and diurnal variation

observed. Old or haemolysed

samples are not suitable for

analysis. Please note that the

reference range applies to serum

samples only.


Potassium (urine)

Investigation of hypokalaemia

urine

(random)


Progesterone

Detection of ovulation and

evaluation of corpus luteum

function

serum 5ml <48hr Luteal Peak:

18 – 72 nmol/L

Prolactin

May cause infertility, amenorrhaoea

and galactorrhoea when increased.

serum 5ml <48hr F = 102-426 mU/L

M = 86 - 324 mU/L

Prostate Specific Antigen (PSA)

Detection and treatment of

prostatic cancer,

serum 5ml <48hr <2.5 ng/ml (18 -50 yr)

<3.5 ng/ml (50 – 60 yr)

<4.5 ng/ml (60 – 70 yr)

<6.5 ng/ml (over 70 yr)

Protein (Total)

Relates to liver function, state of

hydration and is part of myeloma

screening

serum 5ml <24hr 62 – 80 g/L

Protein (urine)

Renal protein loss.

urine

(24hr or

random)

5ml <24hr 50 – 80 mg/24hr

<20 mg/mmol (random)

Protein (CSF)

Increased in meningitis or tumours

of the CNS

CSF 1ml <24hr <0.45g/L

RAST

Allergen specific IgE. Must include

clinical details to ensure correct

allergen screened for.

serum 5ml referred

test – 17

days

see report

Urine reducing substances

Screening for presence of sugars in

urine

Urine

(random)


Renin

Diagnosis of primary

hyperaldosteronism (Conn’s).

Sample must be taken to laboratory

immediately on ice. Inform

laboratory before sample is taken.

See page 59 Renin and Aldosterone

plasma

(on ice)

5ml referred

test – 21

days

0.3 – 2.2 nmol/L/hr

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Reference Range

Rheumatoid Factor

Diagnosis of rheumatoid arthritis

and Sjogren’s Syndrome


Salicylate

Investigation of salicylate poisoning.

serum 5ml <24hr not detected

Selenium

Nutritional monitoring..

serum 5ml referred

test – 14

days

0.9 – 1.7 mol/L

Sex Hormone Binding Globulin

(SHBG)

Part of androgen profile. HRT and

OCP raise SHBG and obesity lower it.

Not indicated in males.

serum 5ml referred

test – 14

days

F: 18 – 114 nmol/L

Sodium

Main use is state of hydration.

serum 5ml <24hr 133-146 mmol/L

Sodium (urine)

Measure of sodium excretion in

investigation of hyponatraemia.

urine

(random or

24hr)

5ml <24hr 40 – 220 mmol/24hr

Tacrolimus

Immunosuppressant therapy.

Trough level or 2hr post dose. See


Monitoring.

whole blood

(EDTA)

5ml referred

test – <7

days

see report

T3 (free)

May be added to thyroid profile.

Used to monitor treatment of

thyrotoxicosis in first few months

post diagnosis. Occasionally for

detection of T3 toxicosis (free T4

and TSH suppressed)

serum 5ml <24hr 3.9 – 6.9 pmol/L

T4 (free)

Part of thyroid profile for the

investigation of thyroid disorders

serum 5ml <24hr 7 – 17 pmol/L

Testosterone

Investigation of androgen disorders

in male and female

serum 5ml referred

test – 21

days

F: <1.5 nmol/L

M: 10 – 28 nmol/L

Theophylline

Assayed to check compliance and

therapeutic levels. See page 52



Thiopurine Methyl Transferase

(TPMT)

Deficiency is a cause of intolerance

to azathioprine or 6-mercaptopurine

Whole blood

(EDTA)

5ml referred

test – 24

days

see report

Thyroid Peroxidase Antibodies

(TPO)

Diagnosis of pre-clinical

hypothyroidism


Thyroglobulin

This is used as a tumour marker,

post thyroidectomy only.

serum 5ml Referred

test – 21

days

See report

Thyroid Stimulation Hormone

(TSH)

Raised in hypothyroidism.

serum 5ml <48hr 0.4 – 4.5 IU/L

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Reference Range

Transthyretin (pre-albumin)

Nutritional assessment, always

measured with CRP to aid

interpretation.

serum 5ml <48hr 150 – 350 mg/L

Triglycerides

Measured as part of lipid

investigation

plasma 5ml <24hr <1.8 mmol/L

Troponin I

Currently best marker for cardiac

damage. Sample needs to be taken

>12 hours post suspected cardiac

event. Remains elevated for up to

10 days.

serum 5ml <24hr <40 ng/L

Urate

Raised in gout, renal failure,

malignancy and several other

conditions.

serum 5ml <48hr 200 – 430 µmol/L (male)

140 – 360 µmol/L (female)

Urea

Indication of renal function and

hydration. Low levels seen in

starvation and advanced liver

disease.


Valproate

Useful to check compliance or

overdose, little use for therapeutic

drug monitoring. See page 52



Vancomycin

Therapeutic drug monitoring is

essential to prevent complications

of therapy. See page 52 Therapeutic

Drug Monitoring.

serum 5ml <24hr See Trust guidelines for

antibiotic prescribing and

sampling or contact

Microbiology Department

VitaminB12

Investigation of anaemia

serum 5ml <24hr 145 – 910 ng/L

Vitamin D

Investigation of hypocalcaemia and

nutritional assessment. See page53

Interpretation of Vitamin D results

serum 5ml <24hr see report and section in

user guide

White cell enzymes

Investigation of suspected inborn

errors.

whole blood

(EDTA)

5ml referred

test – 36

days

see report

Xanthochromia (CSF) See CSF scan

Zinc

Nutritional assessment

serum 5ml referred

test – 15

days

12 – 22 mmol/L

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PAEDIATRIC REFERENCE RANGES

The following reference ranges are adapted from those in use at Royal Manchester Children’s’ Hospital (with

permission). They have been checked for consistency with the methods used within this trust but have not

been rigorously evaluated. This is not a complete list, please contact laboratory if further information required.

Please interpret results with this in mind. All reports for the following have age adjusted ranges.

Analyte Sample type Age Reference Range

Alanine Aminotransferase plasma up to 1 month

> 1month

<90 IU/L

<45 IU/L

Albumin plasma up to 1 month

1 to 6 months

Child

25 – 35 g/L

28 – 44 g/L

30 – 45 g/L

Alkaline Phosphatase (ALP) plasma 1 - 30 days

1 – 12 months

1 - 2 years

2 – 8 years

Pubertal

Adult

60 – 240 IU/L

52 – 444 IU/L

60 – 370 IU/L

60 – 320 IU/L

60 – 400 IU/L

20 – 125 IU/L

Ammonia

(Please ensure laboratory is

aware the sample is being

taken and transport to

laboratory immediately).

plasma Sick/prem = <150 µmol/L

neonate = <100 µmol/L

<16 yr. = <50 µmol/L

Bicarbonate plasma 20 – 26 mmol/L

Bilirubin, total plasma Full term infant

Child

Levels will rise from birth to

approximately 150 µmol/L at

5-6 days and then fall to

normal childhood levels by

day 10.

<17mmol/L

Bilirubin, conjugated plasma neonate up to 30µmol/L

Calcium plasma premature

up to 2 weeks

child

1.50 – 2.5 mmol/L

1.90 – 2.80 mmol/L

2.12 – 2.63 mmol/L

Chloride plasma 98 – 110 mmol/L

Cholesterol, total plasma up to 1 month

1m to 2 years

2 – 16 years

1.1 - 2.6 mmol/L

1.2 – 4.7 mmol/L

<5.0 mmol/L

Creatinine Kinase plasma up to 2 weeks

up to 1 month

up to 1 year

adult male

adult female

<600 IU/L

<400 IU/L

<300 IU/L

<170 IU/L

<145 IU/L

Creatinine plasma <1 week

1 – 2 weeks

2 – 4 weeks

1 month – 1 year

1 - 3 years

4 – 6 years

7 - 9 years

10 - 12 years

13 - 15 years

16 years - adult

<100 µmol/L

<80 µmol/L

<55 µmol/L

<40 µmol/L

<40 µmol/L

<46 µmol/L

10 - 56 µmol/L

30 - 60 µmol/L

40 - 96 µmol/L

Males 40 - 96 µmol/L

Females 26 - 86 mol/L

C-Reactive Protein plasma <8 mg/L

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Analyte Sample type Age Reference Range

Gamma Glutamyl

Transpeptidase

plasma 0 – 1 month

1 – 3 months

3 – 6 months

Adult

10 – 270 IU/L

10 – 155 IU/L

10 – 93 IU/L

10 – 50 IU/L

Glucose (fasting) plasma

(fluoride)

up to 1 month

child

2.5 – 6.5 mmol/L

3.0 – 6.5 mmol/L

Urea plasma 1 month

1 year

child

teens

2.0 – 5.0 mmol/L

2.5 – 6.0 mmol/L

2.5 - 6.5 mmol/L

3.0 – 7.5 mmol/L

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PARACETAMOL INTERPRETATION

Please note that levels can’t be interpreted without knowing the time since the paracetamol was taken. Levels

cannot be interpreted until 4hr post dose until the drug is in the elimination phase.

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THERAPEUTIC DRUG MONITORING

* The conversion factors are included since it is a national requirement to move to using mass units in the

immediate future.

** There is little evidence to support the therapeutic monitoring of valproate or lamotrigine.

*** Therapeutic range relates to peak levels. Samples should be take 2hr post dose for fast release and 4hr for

slow release preparation

Samples for non-standard anti-epileptic drugs (e.g. gabapentin) will NOT be processed as monitoring is not

necessary.

Drug Therapeutic

Range

Units Conversion

factor*

Half life Sampling

time

Time to

steady

state

Carbamazepine 20 – 40 µmol/L x 0.236

(µmol→mg/L)

10 – 20 hr pre-dose 2 - 6 days

Cyclosporine A variable – see

report

µg/L - 2 – 6 hr pre-dose 2 – 3 days

Digoxin 1.0 – 2.6 nmol/L x 0.781

(nmol→µg/L)

36 – 48 hr minimum of

6hr post dose

5 – 7 days

Lamotrigine** 3.0 – 15.0 mg/L - 20 – 35 hr pre-dose 4 – 15 days

Lithium 0.4 – 1.0 mmol/L - 10 – 35 hr 12hr post

dose

3 – 7 days

Phenobarbitone 10 - 30 mg/L - 80 – 120 hr pre-dose 10 – 25 days

Phenytoin 30 - 70 µmol/L x 0.253

(µmol→mg/L)

7 – 42hr pre-dose 7 – 35 days

Tacrolimus

(FK506)

4 - 12 µg/L - 4 – 33 hr pre-dose 2 days

Theophylline 55 - 110 µmol/L x 0.180

(µmol→mg/L)

3 – 13 hr *** 2 – 3 days

Valproic Acid** 400 - 700 µmol/L x 0.144

(µmol→mg/L)

8 – 20 hr pre-dose 2 – 4 days

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ACUTE KIDNEY INJURY (AKI) ALERTS

In line with national guidance the Biochemistry department reports all creatinine results with AKI staging. The

interpretation is as follows:

AKI Alert Stage Comment

NA Insufficient data to calculate AKI stage alert

0 AKI alert not activated by previous creatinine results

1 Increase of creatinine by >26.0 µmol/L or 1.6 to 1.9 times the baseline creatinine.

2 Increase of creatinine by 2.0 to 2.9 times the baseline creatinine.

3 Increase of creatinine by >3.0 times the baseline creatinine or a creatinine >354

mmol/L.

The above is part of the Trust’s response to NICE guidelines CG169. The algorithm used to calculate these alerts

can be found at http://www.england.nhs.uk/wp-content/uploads/2014/06/psa-aki-alg.pdf

Stage 2 and 3 alerts will be phoned to the wards and reported via Lorenzo/TQuest.

INTERPRETATION OF VITAMIN D RESULTS

Comments are appended to all vitamin D results. The Biochemistry Department reports total 25-OH vitamin D

(25-OH vitamin D2 and D3) and interprets according to the National Osteoporosis Society guidelines:

Total 25-OH vitamin D (nmol/L) Comment

<30 Consistent with vitamin D deficiency. Treatment with cholecalciferol

recommended.

30-50 May be inadequate in some patients. Treatment advised in high risk

groups

50-250 Adequate vitamin D status

>250 Associated with toxicity

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FAECAL OCCULT BLOOD

We use the hema-screen™ kit for faecal occult blood testing – the following text is taken from the package

insert.

SPECIMEN COLLECTION AND PREPARATION

The hema-screen™ test requires only a small faecal specimen. The specimen is applied to the guaiac paper of

the hema-screen™ slide as a thin smear using the applicator stick provided. The tests may be prepared and

developed immediately, or prepared and stored at room temperature, protected from heat and light for up to

twenty one (21) days before developing. Keep testing area, hands, etc. clean and free of blood to avoid false

positive results.

It is recommended for screening of asymptomatic persons that stool smears for testing be collected from at

least three consecutive bowel movements (i.e. hema-screen™ Patient Packs) since bleeding from

gastrointestinal lesions may be intermittent. Greegor recommends two samples per stool, with each test site (I,

II) prepared from a different part of each day's stool to increase the probability of detecting occult blood in each

stool.

INTERFERING SUBSTANCES

There are some oral medications such as aspirin, corticosteroids, reserpine phenylbutazone, indomethacin, etc.

that can cause gastrointestinal irritation and occult bleeding in some patients. Ascorbic acid (Vitamin C) taken

in units greater than 250 mg per day may cause false negative results. Iron or preparations containing Iron may

cause false positive results. Two days prior to and during the test period such medications should be avoided.

Patients with bleeding from other conditions such as haemorrhoids, dental work, constipation or menstrual

bleeding should not be tested while such conditions are present. Do not collect a specimen if patient is using

rectal preparations. The patient's physician should be consulted when discontinuing prescription medications.

PATIENT PREPARATION

For three days (3) before and during the stool collection period, avoid red meats (Beef, Lamb and Liver). Eat a

well-balanced diet including fibre such as bran cereals, fruits and vegetables. Raw fruits and vegetables which

contain peroxidase-like substances (turnips, broccoli, horseradish, cauliflower, cantaloupe, parsnips, red radish

etc.) should be avoided during the test period. A diet such as this helps reduce the number of false positive test

results and at the same time provides roughage to help uncover silent lesions which may bleed only

intermittently. If any of the above foods are known to cause patient discomfort, patient should be instructed not

to eat them or to make appropriate substitutions. In an initial three-test series, the patient may disregard the

recommended diet. If patient has one or more positive tests, then he or she should be placed on the above

suggested diet and retested for another three-test series. However it should be remembered that bleeding may

be intermittent and no positive test result should be disregarded.

For further advice or information, please contact the laboratory.

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DYNAMIC FUNCTION TESTS AND SPECIAL TESTS

ORAL GLUCOSE TOLERANCE TEST

PATIENT PREPARATION:

• This test is only necessary if fasting and/or random glucose measurements are equivocal i.e. 6.0 to 7.0

mmol/L.

• This test should NOT be performed in patients who fulfil the criteria for diabetes mellitus. These are:

o A fasting plasma glucose >7.0 mmol/L on two or more occasions and

o Clinical symptoms of diabetes e.g. polydipsia, polyuria, ketonuria and rapid weight loss with a

random plasma glucose of >11.1 mmol/L).

• This test should not be performed in patients who are under physical stress e.g. post-surgery, trauma,

infection or extreme psychological stress as these may give misleading results.

The patient should have a normal unrestricted diet with a minimum of 150g carbohydrate for at least 3 days

prior to test. Smoking prohibited on day of test. All drugs should be clearly indicated on the request form.

Patient should fast overnight (14 hrs) taking water only, and should sit quietly during the test.

INSTRUCTIONS:

• Collect fasting blood sample for glucose. Ensure tube is appropriately labelled fasting. The glucose is

analysed immediately (glucose meter). If the glucose is >8.0 mmol/L the sample should be sent

immediately to the laboratory for confirmatory analysis. If confirmed as >8.0 mmol/L; then the test

should be discontinued.

• Give patient 75g (anhydrous) oral glucose dissolved in 300 ml water.

o As an alternative the patient may be given 394ml of “Lucozade Energy” (73kcal/100 ml

formulation), which provides the equivalent of 75g anhydrous glucose. The glucose solution

should be drunk over a period no longer than 5 minutes. Please note that the some

formulations for “Lucozade Energy” are 70kcal/100 which will require 410ml to be given –

please check labelling on bottle.

• Two hours after giving the glucose load, take a further blood sample for glucose. Ensure tube is

appropriately labelled “2 hr sample”.

Both samples must be collected into fluoride oxalate tube and both should be sent immediately to the

laboratory on completion of the test

INTERPRETATION:

Normal OGTT Fasting glucose ≤6.0 mmol/L and 2hr blood glucose

<7.8 mmol/L.

Impaired fasting Glycaemia Fasting Glucose 6.1 – 6.9 and 2hr glucose <7.8

mmol/L.

Impaired Glucose Tolerance Fasting glucose ≤7.0 mmol/L and 2hr glucose

between 7.8 and 11.0 mmol/L

Diabetes Fasting glucose ≥7.0 mmol/L and 2hr fasting

glucose ≥11.1 mmol/L.

(from: Methods and Criteria for Diagnosing Diabetes Mellitus – WHO criteria, June 1st 2000).

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EXTENDED GTT

The GTT above can be extended for the investigation of reactive hypoglycaemia. Addition blood samples are

taken at 2.5hr, 3hr, 3.5hr and 4hr for glucose.

ADDITIONAL CRITERIA FOR DIABETES DIAGNOSIS

Recent guidelines from WHO for diabetes diagnoses (January 2011) have recommended the use of HbA1c for

diagnosis. The use of the following algorithm is now recommended.

HBA1C FOR MONITORING OF DM

The following has been recommended under advisement of the Diabetes Service and local practice the

following comments are added to reports:

“Patients with diabetes agree with their healthcare professional a documented personalised HbA1c target,

usually between 48 and 58 mmol/mol (6.5% and 7.5%), and receive ongoing review of treatment to minimise

hypoglycaemia. HbA1c levels <48 mmol/ml (6.5%) represent tight control but with increased risk of significant

hypoglycaemic attacks.”

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SHORT SYNACTHEN TEST

This test evaluates the ability of the adrenal gland to produce cortisol after stimulation by synthetic ACTH

(Synacthen) and forms part of the differential diagnosis of Addison’s Disease.


The patient need not be fasted for this test but the test must be performed in the morning. The difference

between morning and late afternoon cortisol may be as great as 100 nmol/L for the 30min post Synacthen

sample.

INSTRUCTIONS:

• Blood is taken for basal cortisol assay. Clearly marked sample as “baseline”.

• 250µg of Synacthen (from Pharmacy) is injected (IV or IM)

• 30 minutes post injection blood is taken for cortisol assay. Clearly mark sample as “30 min”.

INTERPRETATION

In normal individuals the serum cortisol should increase by minimum of 200 nmol/L to a level of at least 550

nmol/L at 30 minutes.

DEXAMETHASONE SUPPRESSION TEST (LOW DOSE)

This is a simple screening procedure for Cushing’s syndrome and may be performed on an outpatient basis.


The patient should not be on rifampicin, anticonvulsants or any other enzyme inducing drugs. This will cause

rapid metabolism of dexamethasone leading to an unreliable result. The patient should not be on any steroid

therapy (please note hydrocortisone is another name for cortisol) as this leads to adrenal suppression and an

unreliable result.

INSTRUCTIONS:

• Patient takes 1mg dexamethasone tablet at 23:00hr.

• At 09:00 (next day) a blood sample is taken for cortisol. The sample should labelled “post

dexamethasone”.

INTERPRETATION:

A normal response is shown by a suppression of 09:00hr cortisol to <50nmol/L.

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RENIN AND ALDOSTERONE

INDICATIONS

Investigation of hyperaldosteronism.


• Avoid salt losing diuretics, purgatives and correct gastrointestinal losses.

• Diet should contain 100-300 mmol/L Na+ per day and 50-100 mmol/L K+ per day for 10 days before

test.

• Correct hypokalaemia with oral potassium supplements before testing.

• A number of anti-hypertensive drugs may influence the interpretation of results.

EFFECT OF DRUGS ON RENIN AND ALDOSTERONE:

• Diuretics and vasodilators elevate renin and aldosterone.

• β-blockers in large doses lowers renin and aldosterone.

• Calcium channel blockers elevate renin and lower aldosterone.

• ACE inhibitors elevate renin and lower aldosterone.

• Indomethacin and other prostaglandin synthetase inhibitors lower renin and aldosterone.

• Aldosterone antagonists (spironolactone) produce variable effects on aldosterone.

RECOMMENDED LENGTH OF TIME FOR WHICH DRUGS SHOULD BE DISCONTINUED:

Spironolactone 6 weeks

Diuretics 2 weeks

Prostaglandin synthetase inhibitors 2 weeks

Cyproheptadine 2 weeks

ACE inhibitors 2 weeks

Vasodilators 1 week

Calcium channel blockers 1 week

Sympathomimetics 1 week

For patients in whom therapy cannot be withdrawn Prazosin, Doxazosin or Guanethidine would be the drug of

choice. NSAIDs should also be discontinued for two weeks prior to testing

PROCEDURE

• The patient should be seated for 10 min.

• Collect blood for renin and aldosterone (10 ml heparin tube, should be taken to laboratory urgently,

but not on ice and separated as soon as possible).

INTERPRETATION:

• Aldosterone secreting tumours or bilateral adrenal hyperplasia result in hyperaldosteronism and

suppression of renin levels.

• The upright posture normally stimulates renin and aldosterone release unless renin production is

suppressed by tumour induced hyperaldosteronism.

Adult Reference Range (Results are method dependent)

Aldosterone (pmol/L) Renin (pmol/ml/hr)

Random 100 – 800 0.5 – 3.1

Recumbent (overnight) 100 – 450 1.1 – 2.7

Ambulant (30 min) not applicable 2.8 – 4.5

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ALDOSTERONE / RENIN RATIO

The aldosterone / renin ratio provides additional useful information.

• Aldosterone/renin ratio less than 800, Conn’s syndrome unlikely.

• Aldosterone/renin ratio greater than 2000, Conn’s syndrome probable.

Diagnosis of the cause of primary hyperaldosteronism requires further investigation after the demonstration of

primary hyperaldosteronism and specialist endocrinological advice is recommended.

WATER DEPRIVATION TEST

Performed for the investigation of suspected cranial or nephrogenic diabetes insipidus and primary polydipsia.

SCREEN

24hr urine volume. Three 24hr urine collections are performed; if volumes are less than 3 litres then DI is

unlikely.

WATER DEPRIVATION TEST.

ADH secretion is stimulated by hypovolaemia and hypertonicity. Failure to maintain normal urine and plasma

osmolarity when dehydrated suggests DI. Failure to correct the osmolality with exogenous DDAVP suggests a

nephrogenic problem, whereas correction following exogenous DDAVP suggests ADH deficiency (cranial DI).

The Laboratory must be informed that this test is planned to ensure all analyses are performed promptly.

Samples must NOT be batched but sent to the laboratory immediately.

Patient preparation – do NOT restrict food or fluid until the start of the test. Exclude adrenocortical or thyroid

deficiency. No tobacco or alcohol for at least 24hr.

Note – this test is potentially dangerous and must be undertaken with care and under clinical supervision.

Patients unable to conserve water may become critically dehydrated within a few hours of water restriction.

STOP TEST IF:

• Weight loss >3% of baseline value (check plasma osmolality). Note test requires accurate weighing of

the patient.

• Urine osmolality ever greater than 800 (i.e. normal response to fluid restriction).

• Plasma osmolality >350 (give DDAVP 2mcg iv and fluids).

• Urine output exceeds 5 litres in absence of weight loss (suggests surreptitious drinking).

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PROTOCOL

0800hr – insert cannula, weight patient, patient empties bladder. Measure urine volume and send for

osmolality. Measure blood pressure, weight, urine osmolality, plasma osmolality and urine volume hourly for 8

hours according to the schedule:-

INTERPRETATION:

Post-dehydration osmolality

(mmol/kg)

Post-DDAVP osmolality

(mmol/kg)

Diagnosis

Plasma Urine Urine

283-293 >750 >750 Normal

>293 <300 >300 Nephrogenic diabetes insipidus

>293 <300 >750 Cranial diabetes insipidus

<293 300-750 <750 Chronic polydipsia

<293 300-750 >750 Partial nephrogenic DI or primary

polydipsia

Weight BP U&E Plasma

Osmolality

Urine

Osmolality

Urine

Volume

08:00

08:30

09:30

10:30

11:30

12:30

13:30

14:30

15:30

16:30

If urine osmolality remains <750, give DDAVP (desmopressin) 2mcg im.

Give free fluids from now on.

17:30

18:30

19:30

20:30

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TUMOUR MARKERS

Due to the over requesting of tumour markers, in particular “tumour marker screens” it was felt that some

guidance should be offered. No serum marker in current use is specific for malignancy.

• Many patients with early localized disease will have normal levels of serum tumour markers.

• No cancer marker has absolute organ specificity. PSA however, appears to be relatively specific for

prostate tissue.

• Requesting of multiple markers in an attempt to identify an unknown primary cancer is rarely of use

(see previous).

• Reference ranges for tumour marker are not well defined and are used for only guidance. A level

below the reference range does not exclude malignancy whilst levels above do not necessarily mean

the presence of cancer. Changes in levels over time are of more use that absolute levels at a single

point in time.

With the exception of PSA, tumour markers are only of use in monitoring response to treatment if the tumour

has been demonstrated to be excreting that marker. They are of little use in diagnosis.

Recently NICE has issued the following guidance (CG104) for the use of tumour markers in the investigation of

CUP (carcinoma of unknown primary):-

NICE GUIDANCE ON TUMOUR MARKERS

Identification of elevated serum tumour markers can sometimes facilitate diagnosis of certain treatable cancers

and their timely measurement in some circumstances can be associated with significant clinical gain.

In general however, tumour marker measurements are not recommended for diagnosis due to their low

sensitivity and specificity. Nevertheless, their use for this purpose had increased in recent years, due to their

routine availability on automated analysers in almost all clinical biochemistry laboratories. However,

inappropriately requested tumour marker results can lead to unnecessary and costly further investigations and

incorrect management as well as causing needless distress and worry to patients.

Clarifying which tumour markers should be measured and awareness of their significant limitations are critical

to their use in the diagnosis and management of patients with CUP.

Recommendation

• Do not measure tumour markers during diagnosis except for:

o AFP and hCG in patients with presentations compatible with germ-cell tumours (particularly

those with mediastinal and/or retroperitoneal masses and in young men).

o AFP in patients with presentations compatible with hepatocellular cancer.

o PSA in men with presentations compatible with prostate cancer.

o CA125 in women with presentations compatible with ovarian cancer (including those with

inguinal node, chest, pleural, peritoneal or retroperitoneal presentations). Carefully interpret

the results because of limited test specificity

Qualifying statement

Evidence to support recommendations on measurement of serum tumour markers for patients with MUO is

sparse and of low quality. These recommendations therefore rely on additional evidence of the diagnostic

utility of these markers in patients who do not have MUO. The GDG reached a strong consensus that tumour

markers should be limited.

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Further information can be found in following article:

C M Sturgeon, L C Lai and M J Duffy: “Serum tumour markers: how to order and interpret them”. BMJ 2009;

339: 852-858. https://www.bmj.com/content/339/bmj.b3527.full

And from the Association for Clinical Biochemistry and Laboratory Medicine - Recommendations as a Result of

the ACB National Audit on Tumour Marker Service Provision http://www.acb.org.uk/docs/default-

source/guidelines/tumour-marker-guidelines.pdf?sfvrsn=4

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DRUGS OF ABUSE

The approximate detection times for some of the commonly abused drugs are:

Drug Duration of detection in urine

Alcohol 4 - 12hrs

Amphetamines (including MDMA, MDA) 1 - 3 days

Benzodiazepines 1 – 3 days (can be significantly longer with chronic

use)

Cannabis 1 – 14 days (can be significantly longer with chronic

use)

Cocaine 1 – 3 days

Opiates 1 – 2 days

6-Monacetyl Morphine (6-MAM) up to 1 day (can be useful for confirming opiate

positive as heroin use)

Methadone 1 – 3 days (very dependent on dose)

Please note that detection times very approximate and are dependent on dose, its frequency, route of

administration, urine pH and urine dilution.

All samples have a creatinine measured. If level found to <1.8mmol/L then the sample is suspect. European

guidelines indicate that any sample with a creatinine less than 1.8 mmol/L should be considered too dilute and

not analysed.

Please contact laboratory for further information.

VIROLOGY

The biochemistry department does offer initial screening for the following:

• Hepatitis A, B and C

• Rubella

• HIV

Negative screen results are reported immediately (<24hr, Monday to Friday only) but positive results are

referred to a specialist laboratory for confirmation. The reports for positive results will be delayed for this

reason.

Please contact the laboratory for further information.

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PORPHYRIN SCREEN

The porphyrias are a group of eight inherited disorders classically presenting with either photosensitization or

neurological complaints such as abdominal pain. The sample requires are:

Sample type Volume/amount Test request

Urine 20ml Urinary porphyrins

Whole blood (EDTA), red top. 2.5ml RBC protoporphyrins and plasma

protoporphyrin screen.

Faeces A pea sized sample Faecal porphyrins

All samples must be protected from the light and delivered to the laboratory immediately after collection.

Porphyrins are photo-labile.

Please note that the pattern of porphyrin excretion is important in diagnosing the different types of porphyria.

In order to offer a full interpretation of the screen it is essential that full clinical details are written on the

request form.

Please note that some of the acute porphyria can show a normal excretion of porphyrins and their precursors.

It is important that any urine sample is obtained, if possible, during or as close as possible to any attack.

CRYOGLOBULINS

The laboratory must be contacted before the samples are taken. A Biomedical Scientist (BMS) will attend with a

Dewar flask containing sand at 37oC. The sample must not be taken until the BMS is in attendance, the sample

should then be taken and placed in the flask immediately. The BMS will return to the laboratory with the

sample. After separation at 37oC the sample is then referred to a specialist lab for analysis.

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HAEMATOLOGY DEPARTMENT

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CONTACTS

Haematology Department General Enquiries 6491

Consultant Haematologist 6501


Blood Science Manager Gillian Lewis

([email protected])

6318

Secretaries to Haematologists 6596 & 4196

TURNAROUND TIMES

Routine working hours are 09:00 to 17:30 Monday to Friday.

• All routine investigations which are required urgently - reports available within one hour.

• Routine investigations (inpatients) are reported within four hours (i.e.: FBC, INR, coagulation screen,

D-Dimers, malaria screen).

• GP samples processed within 24 hours

• Blood film reports within 48 routine working hours

• Haemoglobin Variant Screening for Antenatal Clinics within 72 routine working hours. Haemoglobin

Electrophoresis within 14 working days

Referred tests – please see Referred Investigations page 75.

NOTE

The haematinic and haemoglobinopathy tests are performed during normal working hours therefore out of

hours requests will be stored until the next batch is processed. Sickle screening however is available during all

working hours for urgent requests.

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BLOOD COUNT REQUESTS

This includes WBC, RBC, HB, HCT, MCV, MCH, MCHC, platelet count, and five part differential (neutrophil,

lymphocyte, monocyte, eosinophil and basophil populations).

Specimens that contain small clots and/or are leaking, will be assessed for suitability for testing and repeat

requested if necessary.

The sample requirement for a full blood count is 2.7ml blood in a red (EDTA) tube.

Blood films and WBC manual differential, will be performed when the clinical information indicates a particular

leucocyte problem, or the blood count indicates abnormal findings. If you, or your senior medical staff wish to

have it performed for any specific reason, or would like the opinion of the consultant haematologist, please

state that clearly on the request.

Reference ranges:

Test Range Units

White Blood Cell count (WBC) 4.0 – 11.0 10*9/L

Red Blood cell Count (RBC) Male: 4.6 – 6.0

Female: 3.9 – 5.7

10*12/L

Haemoglobin (Hb) Male: 130 - 180

Female: 115 – 165

g/L

Haemocrit (HCT) Male: 0.40 – 0.54

Female: 0.36 – 0.48

-

Mean Cell Volume (MCV) Male: 80.0 – 96.0

Female: 79.0 – 95.0

fL

Mean Cell Haemoglobin (MCH) 27.0 – 32.0 pg

Mean Cell Haemoglobin

Concentration (MCHC)

315 - 355 g/L

Platelets (PLT) 130 – 400 10*9/L

Mean Platelet Volume (MPV) 6.0 – 12.0 fL

Red Cell Distribution (RDW) 12.0 – 15.0 -

Neutrophil Count 1.8 – 7.5 10*9/L

Lymphocyte Count 1.5 – 4.0 10*9/L

Monocyte Count 0.2 – 1.0 10*9/L

Eosinophil Count <0.4 10*9/L

Basophil Count <0.1 10*9/L

Nucleated Red Cells Differential - 10*9/L

Please note the turnaround time for an emergency sample is <1hr and for all other samples this is <2hr (from

receipt at laboratory).

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ESR

The sample requirement for an ESR is 3.5 ml of blood in a citrate (purple) tube. Because of the amount of liquid

anticoagulant in an ESR tube, it is most important that the right amount of blood is used in the tube. A separate

specimen must be sent for an ESR request. Only proven or suspected cases of temporal arteritis indicate the

need for an urgent ESR request.

Reference range:

Sex Age (years) esr

Males 17- 50 0 - 10mm in first hour

51-60 0 - 12mm in first hour


>70 0 - 30mm in first hour

Female 17- 50 0 - 12mm in first hour



>70 0 - 35mm in first hour

RETICULOCYTES

Reticulocyte count is a useful but under-utilised test. It reflects the ability of marrow to respond to stress

(bleeding, haemolysis, etc.) or its response to haematinic therapy. It will be performed if blood film indicates

the need for it (reflex testing) or on request.

Reference range:

0.5 – 2.5% (20 – 100 x 109/L)

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ANTICOAGULANTS

It is beyond the scope of this publication to give a fully comprehensive account of anticoagulation. You are

advised to refer to B.N.F. or discuss problems and queries with your seniors or the Haematologist. It is worth

noting that recommendations and practices can change rapidly in this field.

Parenteral and oral anticoagulants are used with increasing frequency. Oral anticoagulants may be used alone

or in combination with Heparin.

NOAC PATIENTS ON RIVAROXABAN, APIXABAN OR DABIGATRAN (NON VITAMIN K ANTICOAGULANTS)

To assess the anticoagulant status of patients taking NOACs – samples are sent for referral to MFT. Please

contact the laboratory to make arrangements for these tests.

Sample required: 1 x Sodium Citrate (green, 5ml)

Expected TRT (days) Stated as 7 days. If required urgently then please contact

laboratory.

Stability: Must be received by laboratory, aliquoted and frozen within

2hr. Transported frozen.

THERAPEUTIC RANGE FOR PATIENTS ON WARFARIN

The following are the ranges recommended by the British Society of Haematology.

INR Clinical State

2.0 – 3.0 Treatment of deep vein thrombosis.

Pulmonary embolism.

Transient ischemic attacks.

3.0-4.0 Recurrent deep vein thrombosis and pulmonary embolism.

Arterial disease including myocardial infarction.

Arterial grafts.

Cardiac prosthetic valves and arterial grafts.

For details refer to the British Society of Haematology guidelines.

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COAGULATION TESTS

INDICATION

SUSPECTED BLEEDING DIATHESIS

It is important to take a full history of present and past bleeding incidents and to enquire about family history

and drug ingestion. For screening purposes, the following tests are normally sufficient:-

P.T. and INR, APTT, Fibrinogen, Platelet count.

Requests for bleeding time and platelet function studies should be discussed with the Consultant

Haematologist.

SUSPECTED DISSEMINATED INTRAVASCULAR COAGULATION (DIC)

PT, APTT, Fibrinogen and FDP (D-dimer), platelet count and blood film should be requested.

SCREENING FOR LIVER BIOPSY

PT, APTT and platelet count should be requested.

COAGULATION TEST – SAMPLE REQUIREMENTS

Analyte (Coagulation) Sample type Volume Turn

Around

Reference

Range

PT and INR Green Citrate

plasma (green)

2.7 ml <2hr INR: 0.8 – 1.2

PT: 8.5 - 12.5s

APTT Green Citrate

plasma (green)

2.7 ml <2hr 17 – 32 s

Fibrinogen Green Citrate

plasma (green)

2.7 ml <2hr 1.5 – 4.0 g/L

FDP (d-dimer).

Note, the sample must be analysed within

4hr of collection.

Green Citrate

plasma (green)

2.7 ml <2hr <500 ug/L

Factor assays Green Citrate

plasma (green)

2.7 ml x 2 Referred

investigation,

expected TRT

of 28 days.

See report

Thrombophilia screen Green Citrate

plasma

2.7ml x 5 Please note that some parts

of the screen have to be

referred to other

laboratories. The expected

turnaround time for this is

quoted as 4 weeks.

Serum (brown) 5 ml

EDTA 2.7ml x 2

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Analyte (Coagulation) –

Referred investigations

Sample type Volume(ml) Turn Around Reference

Range

Anti-Factor Xa Green citrate 1 x 2.7ml 11 days See report

Antithrombin III Green citrate 2 x 2.7ml 28 days See report

Protein C & Protein S Green citrate 2 x 2.7ml 28 days C: 77 – 148 IU/dl

S: 56 – 150 IU/dl

Anticardiolipin Antibodies Serum 5ml 13 days <16 units

Prothrombin Gene Variant EDTA 2.7ml 28 days See report

Factor V Leiden EDTA (2.7ml) 2.7 See report

Von Willebrands Factor Green citrate 2 x 2.7ml 28 days See report

Lupus anticoagulant Green citrate 4 x 2.7ml 28 days See report

Factors affecting coagulation tests

It is critical to fill the green citrate bottles to the line as they contain liquid anticoagulant – this must be in the

correct proportion to the blood to obtain the correct results, otherwise incorrect diagnosis and/or treatment

may occur. Under filled or overfilled samples will be rejected as will samples that are haemolysed or those

found to have a clot, as the results are unreliable. Samples should be sent directly to the laboratory without

delay. Results may also be unreliable in patients with very low or high haematocrits please contact the

laboratory if you wish to discuss.

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HAEMOGLOBINOPATHIES

For haemoglobinopathy screen please send an EDTA specimen in addition to one for FBC.

HAEMOGLOBINOPATHY TESTS AVAILABLE:

• Haemoglobin electrophoresis

• Haemoglobin A2 level

• Haemoglobin F level

• Sickle cell

Also a serum ferritin may be performed to assess iron status.

ANTENATAL SCREENING

Antenatal patients are tested following the NHS Sickle Cell and Thalassaemia Screening Programme.

HAEMOLYTIC DISORDERS

For screening purposes, a blood count, reticulocyte count, direct antiglobulin (Coombs) test and haptoglobins

should be requested together with bilirubin from the Biochemistry department. Having established the

presence of haemolysis, further tests should be carried out to detect the underlying cause. Please discuss this

with the Consultant Haematologist.

HAEMATINIC ASSAYS

Tests for investigations of B12, folate and/or ferritin deficiency – now performed by Biochemistry, see relevant

section.

Additional EDTA specimen required if RCF & FBC requested.

BONE MARROW ASPIRATE AND TREPHINE BONE BIOPSY

By arrangement after consultation with the Consultant Haematologist.

HAEMATOLOGY ADULT REFERENCE RANGES

Please see report form

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OTHER HAEMATOLOGICAL INVESTIGATIONS

Test Specimen Type Volume

required

Turn Around Ref Range

IM screen Serum (brown) 5ml <5 days See report

RA screen Serum (brown) 5ml <1 day <20 IU/ml

Haptoglobins Serum (brown) 5ml <1 day See report

IF antibodies Serum (brown) 5 ml <2 days See report

Malarial parasites Whole blood (red, EDTA) 2.7 ml <1 day See report

G-6-PD screen EDTA (2.7ml) 2.7ml <1 day See report

SAMPLE STORAGE TIMES

FBC, ESR, Retics, malaria samples - 24 hours

PT, APTT, Fibrinogen samples - 24 hours.

Haematinics, RA LE and IM screens - 7 days.

Any further tests required must be requested within these storage times.

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REFERRED INVESTIGATIONS

Analyte Specimen

Type

Volume

Required

Turn Around Ref range

Bone Marrow for MDT Stained Slides 14 days See report

Erythropoetin Serum 5 ml 15 days See report

HBE - Abnormal Hb. Variant

Confirmation

EDTA 4 x 2.7ml 25 days See report

Plasma Viscosity EDTA 1 x 2.7ml 14 days 1.45 – 1.80 cp

WT1 Marker Blood EDTA 4 x 2.7ml 14 days See report

WT1 Marker Marrow EDTA 1 x 2.7ml 14 days See report

BCR/ABL EDTA 2 x 2.7ml 28 days See report

HFE Hereditary Haemochromatosis

Gene Typing


CALR mutation EDTA 4 x 2.7ml 21 days See report

Janus Kinase 2 EDTA 3 x 2.7ml 28 days See report

Immunophenotyping - Blood Must

be received in laboratory before 12

noon on day of collection (Monday

to Thursday)

EDTA 2.7 ml x 2 14 days See report

Immunophenotyping – Marrow

Must be received in laboratory

before 12 noon on day of collection

(Monday to Thursday)

Special bottle 2ml 14 days See report

Spherocytosis must be fresh - by

arrangement with laboratory only

EDTA 1 x 2.7ml Contact

referral

laboratory

See report

Chromosome analysis - blood. Must

be received in laboratory before 12

noon on day of collection (Monday

to Thursday)


Chromosome analysis - marrow Special bottle 2ml 28 days See report

Pyruvate Kinase EDTA 2 x 2.7ml Contact

referral

laboratory

See report

HAMS / Paroxysmal Nocturnal

Haemoglobinuria

EDTA 2 bottles 14 days See report

Details of referral laboratories can be provided by the laboratory on request – see also page Error! Bookmark

not defined.. Please note that for brevity this is not a complete list of available tests, if in doubt please contact

laboratory.

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BLOOD TRANSFUSION

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CONTACTS

General Enquiries 6391



Secretaries to Haematologists 6596

Hospital Blood Transfusion Manager Gillian Lewis 6318

Advanced Biomedical Scientist Andrew Blackburn 6391

Specialist Practitioner of Transfusion Caroline Holt 5484

Trust Intranet page: http://tis/Pages/bloodtransfusion.asp

CAUTION

Fatal transfusion accidents still occur. Nationally reported errors show that a high

percentage is due to failure of the bedside check or specimen labelling errors. They are due

to carelessness and are avoidable. At every stage of the procedure from taking blood for the

cross-match specimen to the actual transfusion of the blood, meticulous attention to detail is

essential.

REQUEST FORMS

The Request form must be filled in completely and correctly – see Specimen Acceptance Policy available on

Trust Intranet

Phlebotomists have been instructed not to take blood if the name, district number and date of birth are not on

the request form and patient's wristband.

Please note that in line with national guidelines pre-printed labels (from any source) on samples

are not acceptable.

Please note (as previously stated):

All request forms must be signed by the requesting clinician.

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SPECIMEN REQUIREMENTS

Test Specimen requirement

Group and save plasma/Cross match EDTA (blue,4.5ml)

DAT EDTA (blue, 4.5ml)

ANC investigations

Kleihauer

Cord and Maternal bloods EDTA (blue, 4.5ml) from mother and baby

HLA typing (use NBA form) –

PLEASE CONTACT LABORATORY (ESSENTIAL)

EDTA (2 x 2.7ml)

HLA antibodies (use NBA form) 10ml clotted (white top)

Platelet antibodies (use NBA form) Contact laboratory

Requests for:

Platelets/Cryoprecipitate/fresh frozen plasma

Contact laboratory AND Consultant Haematologist

Requests for:

Human albumin

Send signed request form

Request for:

Novoseven/Prothrombin complex

Strictly by discussion with the Consultant

Haematologist

NB. When FFP or platelets are required a FBC and coagulation screen must be requested to assess the need

and/or dosage of the FFP, Cryoprecipitate or platelets. In case of major life threatening haemorrhage contact

the laboratory immediately. Full patient, clinical and requestor details must be provided.

DEXTRAN

Dextran and other plasma expanders may seriously interfere with cross-matching. Avoid giving them before

taking the cross-match specimen. If this is unavoidable the fact that they have been given should be indicated

on the request card.

ROUTINE REQUESTS

When non-urgent transfusions are planned, requests should be made at least 24 hours before the transfusion.

This allows time for extra investigations to be made if the cross-match is not straightforward.

RESERVATION OF CROSS-MATCHED BLOOD

Blood ordered for theatre and not used is taken back into stock for other patients at 9.00 am on the day

following operation. If blood is required after this, then please inform the laboratory before 9.00 am, or leave a

signed and dated note on the appropriate fridge.

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GROUP AND SAVE PLASMA

The use of group and save plasma is encouraged. For many operations it is not necessary to have cross-

matched blood available. Certain patients for elective surgery must have a group and save at pre-op

assessment – please refer to the Maximum Surgical Blood Order Schedule for in the Blood Transfusion Policy

for details.

For expected blood usage please refer to Maximum Surgical Blood Order Schedule:

http://tis/documents/BloodTransfusionPolicy.pdf

With group and save requests plasma is tested for irregular antibodies. If these are detected the M O. will be

informed. Patients for surgery with irregular antibodies should be discussed with the Blood Transfusion

Department a minimum of 24hr before surgery.

If blood is required, a signed request form should be sent to the laboratory stating the number of units

required. In the majority of cases (but not all cases) a sample is valid for issue of blood for 72hr – please contact

laboratory for information.

ISSUE OF BLOOD

N.B. blood left out of a specified blood fridge for more than 30 minutes must not be used -

please label any such unit indelibly on the front - not suitable for use, and inform the blood

transfusion department, tel. 6391

Blood must not be stored in any ward or drug fridge but only in designated controlled and

alarmed blood fridges.

EMERGENCY GROUP O NEGATIVE BLOOD

Contact Blood Transfusion (ext. 6391) before use. Note that the blood transfusion sample must be

taken before use.

2 units of uncross-matched blood Group O Negative, are kept in the A&E fridge for Accident and Emergency,

and 2 units in the Maternity fridge for use in life threatening emergency. These may not be suitable for patients

exhibiting adverse antibodies.

It is stressed that this blood is uncross-matched and its use should be governed by the patient's clinical

condition.

If any O Negative blood is used in an emergency, then the appropriate red form MUST be filled in and sent to

the laboratory immediately. The Blood Transfusion staff MUST also be informed by telephone in order that

replacement O Negative can be issued immediately on receipt of the completed red form.

Please see and read the hospital transfusion policy for comprehensive guidance

This guidance is also available on the Pathology website and also on the Trust Documents section on the

intranet.

Any problems or queries please contact the Blood Transfusion Laboratory, the Consultant Haematologist or the

Specialist Practitioner of Transfusion as appropriate.

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POCT (POINT OF CARE TESTING)

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Point of Care Testing (POCT) is defined as any analytical test performed by a Healthcare Professional outside

the conventional laboratory setting.

The POCT Service is required to comply with:

1. Guidelines from the MHRA; Management and use of IVD POCT devices

2. ISO 22870:2016 POCT Requirements for Quality and Competence

3. ISO 15189:2012 Medical Laboratories Quality and Competence

As the Pathology Directorate manages and leads on all POCT issues, direct liaison from the users of the POCT

service with the Pathology Directorate and primarily the POCT Co-ordinator is essential to ensure compliance is

achieved.

POCT POLICY

The POCT Policy is available on the Trust intranet and outlines the roles and responsibilities of all individuals

associated with POCT.

POCT COMMITTEE

The POCT Committee monitors and audits current POCT devices for compliance of policies and procedures and

report any issues and breaches of policy to Clinical Risk Management.

No POCT device is to be introduced and implemented within the Trust without approval from the POCT

Committee.

If considering the implementation of a POCT device, the POCT Co-ordinator must be contacted, not company

representatives regarding procurement. The POCT Co-ordinator will then assist with business case and

planning, including cost-benefit analysis, clinical need, and equipment evaluation and selection.

TRAINING

Only personnel who have completed training and demonstrated competence shall be issued passwords to carry

out POCT. Passwords MUST NOT be shared; sharing of passwords is a disciplinary offence.

To arrange training contact POCT Co-ordinator on Ext 4620

SAMPLE INTEGRITY AND RESULTS

Instructions for sample collection and preparation given during training are crucial to obtain accurate results.

PATHOLOGY SUPPORT

The Pathology Directorate provides advice on and facilitates the mechanism and methodology of the tests,

limitations of the method, troubleshooting, training, support, quality control and quality assurance, risk

management, health and safety and infection control issues.

Maintenance and daily monitoring of blood gas analysers is performed by Pathology staff.

Provision of the following consumables is also available via Pathology:

Blood Gas: Reagents, Printer Paper, Capillary Tubes

Glucose: Glucometer, Batteries, Quality Control, QC Record Book

Urinalysis: Urinalysis Results Stickers

All other consumables are ordered locally or via Pharmacy.

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INSTRUMENT FAILURE

In the event of equipment failures refer to local instructions; the laboratory needs to be informed immediately

and is available as backup and will assist where possible.

To report any issues ring Ext 4620 failing that 6498.

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IMMUNOLOGY

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The referral laboratory for immunological investigations is the Immunology Department at Manchester

University Hospital NHS Foundation Trust (previously CMFT)

Note: this service is not covered by the UKAS ISO 15189:2012 accreditation No. 8912; it operates under UKAS

accreditation number 8195.

CONTACTS

For test results call the results hotline on 0161 276 8766.

For other enquiries:

Information concerning laboratory services can be found at:

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

(If this link does not function then please copy/paste into your web browser)

Name Title Tel Email

Dr Tomaz Garcez Head of Service and Consultant

Immunologist

0161 276 6468 [email protected]

Dr Sara

Drinkwater

Consultant Immunologist 0161 276 6468 [email protected]

Dr Hana Alachkar Consultant Immunologist 0161 206 5572 [email protected]

Dr Archana

Herwadkar

Consultant Immunologist 0161 206 5572 [email protected]

Philippa Coles Laboratory Manager 0161 276 6442 [email protected]

John Hewitt Chief Biomedical Scientist

(Infomatics Lead)


Andrew Moran Chief Biomedical Scientist

(Training Lead)


Angela Bedford Administration Manager 0161 276 6468 [email protected]

Jill Edmonds Immunology Specialist Nurse 0161 276 6186 [email protected]

Colette McAlister Client Services Manager 0161 276 6042 [email protected]

- Clinic secretaries 0161 276

6686/5653

-

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MICROBIOLOGY AND VIROLOGY

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Please note that the service has now moved to Manchester University Hospital

NHS Foundation Trust (previously CMFT)


accreditation numbers 8393 and 10175.

CONTACTS

For test results call the results hotline on 0161 276 8766.

MICROBIOLOGY DEPARTMENT


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

partnership/opening-hours-clinical-advice-and-results-line/microbiology-department-cmft


Name External number

Dr Andrew Dodgson

Clinical Lead, Consultant Microbiologist, Infection Control Doctor (0161) 276 6010

Dr Ed Kaczmarski

Lead Consultant Microbiologist for Christie Hospital (0161) 276 5746

Dr Debasis Sanyal

Consultant Microbiologist (paediatrics) (0161) 276 5089

Dr Ahmed Qamruddin

Consultant Microbiologist (0161) 276 4282

Dr Kirsty Dodgson

Consultant Clinical Scientist & Deputy Infection Control Doctor (0161) 276 5746

Dr Barzo Faris

Consultant Microbiologist (0161) 746 2470

Mrs Geraldine Featherstone

Microbiology Secretary (0161) 276 5686

Specialist Registrars Office (0161) 276 6333

Mr Bernard Wood

PHE Regional Head of Laboratory Operations/Head BMS MMMP (0161) 276 4420

Mrs Rachel Jones

Laboratory Manager (0161) 276 5747

Mr Malcolm Armstrong

Deputy Laboratory Manager (0161) 276 8822

Mrs Katherine Mather


Fax (0161) 276 5744

Hospital Switchboard (0161) 276 1234

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VIROLOGY DEPARTMENT


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

partnership/opening-hours-clinical-advice-and-results-line/virology


Name External number

Dr Andrew Turner

Clinical Lead

Consultant Medical Virologist

(0161) 276 8853

Dr Nick Machin

Consultant Virologist (0161) 276 8838

Dr Louise Hesketh

Consultant Clinical Scientist (0161) 901 0188

Dr Malcolm Guiver

Consultant Clinical Scientist,

Head of Molecular Diagnostics

(0161) 276 8853

Miss Christel Matthews

Secretary (0161) 276 8787

Mr Peter Tilston

Clinical Scientist - Resistance testing (0161) 276 8849

Dr Alex Sargent

Clinical Scientist (HPV lead) (0161) 276 8680

Mr Benjamin Brown

Clinical Scientist (0161) 276 8680

Mr John Marsh

Laboratory Manager (0161) 276 8838

Mr Alan Lord


Fax (0161) 276 8787/5744

Hospital Switchboard (0161) 276 1234

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CELLULAR PATHOLOGY & NEUROPATHOLOGY

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CELLULAR PATHOLOGY

Please note that the service has now moved to Manchester University Hospital

NHS Foundation Trust (previously UHSM)


accreditation number 9083.

Please use the link below for all detail regarding the service provided by the Cellular Pathology service at

Wythenshawe Hospital

SERVICE AND CONTACT INFORMATION

https://mft.nhs.uk/wythenshawe/services/pathology/

The user handbook is a link available off this page (if this link does not function then please copy/paste into

your web browser)

CONTACT DETAILS

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

otherwise stated

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

Laboratory Tel No. (Fax No.)

Head Biomedical Scientist 4804

Specimen reception 4800

Histology laboratory 4800

Histology laboratory fax 4801

Cytology laboratory 2156

CONSULTANT CONTACT DETAILS

Please use the Wythenshawe website for this information to ensure the most up-to-date information is

accessed

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NEUROPATHOLOGY SAMPLES

Note: this service is not covered by the UKAS ISO 15189:2012 accreditation No. 8912; at the time of writing, the

service was not accredited to ISO15189:2012 by UKAS.

Neuropathology samples should not be sent to pathology as these need to go direct to the histology

department at Salford Royal Foundation Trust.

NEUROPATHOLOGY – MUSCLE AND NERVE BIOPSY SAMPLES

Diagnosis of neuromuscular disorders relies on ultrastructural and/or enzyme histochemical studies. Careful

and optimal handling is essential to preserve these features and avoid traumatic damage. Prompt submission

of freshly excised tissue is vital.

The department must be notified in advance that a sample for neuropathology is being sent –

0161 206 5015.

Biopsies sent from remote centres (where some time delay is inevitable) should be wrapped in gauze

dampened (not wetted) with isotonic saline to maintain humidity. DO NOT Place in formalin or other fixative

The biopsy must be taken and despatched in time so that it can arrive at the laboratory between the hours of

08:30 and 16:00, Monday to Friday (excluding bank holidays). Biopsies should preferably arrive by lunchtime as

they can then be dealt with the same day (optimal), but in any case before 16:00.

TRANSPORT

DO NOT send neuropathology samples to Pathology at Tameside General.

It is the responsibility of the referring department to arrange transport (by taxi) of neuropathology samples.

Please ensure that the request form is clearly marked that the sample is for Neuropathology and include full

clinical details to assist in making a diagnosis. The specimen acceptance criteria at SRFT are the same as at TGH;

please ensure that the request form and sample are correctly labelled

Ensure the sample is packed in a leakproof bag (e.g. a pathology sample bag).

Ensure the driver/courier is instructed to bring the specimen promptly to cellular pathology reception

Specimens should be handed directly to a member of the cellular pathology team and not left at specimen

reception.

ADDRESS

Cellular Pathology

Pathology at Wigan and Salford

Level 2, Turnberg Building

Salford Royal Hospital

Stott Lane

M6 8HD

Phone 0161 206 5015

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MORTUARY AND BEREAVEMENT

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The service is based at Tameside General Hospital.

The services that we provide to the Trust and the Community includes storing of the deceased, post mortem

examinations, tissue donations, identifications and viewings for the bereaved relatives.

Note: this service is not covered by the UKAS ISO 15189:2012 accreditation No. 8912

We follow strict guidelines under the HTA (Human Tissue Authority) license ensuring safety and security at all

times, also demonstrating respect and sensitivity for bereaved families.

Our dedicated and caring team deals with approximately >2,000 deaths a year from the hospital and the local

community, around >600 post mortem examinations are performed most of which from the direction of Her

Majesty’s Coroner for South Manchester.

The mortuary team consists of one Mortuary Manager and three Anatomical Pathology Technologists all who

show a caring dedicated approach in their roles.

The mortuary works very closely with the following services:

• HM Coroner’s office

• Greater Manchester police

• Doctors and Nursing staff

• Transplant teams

• Patient Advice and Liaison service (PALS)

• Chaplaincy

• Funeral Directors

MORTUARY OPENING HOURS

The mortuary is open Monday to Friday 8am-4.00pm.

Viewings and identifications can be made by appointment during these hours via the mortuary office.

An out of hours service is provided seven days a week until 8:00pm.

This is by appointment and arrangements can be made by contacting the on call technician via the hospital

switchboard.

CONTACTS

Telephone number (prefix 0161 922 from outside

hospital)

Sharon McMinn (Mortuary Manager ) 0161 922 6520

Mortuary Office 0161 922 6059

On call technician (via the hospital switchboard) 0161 922 6000

Bereavement service 0161 922 5192

The Mortuary department also includes Bereavement services and is located behind the Pathology Building

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Pathology - Quality Management Pathology User Guide PATH ... · Tameside and Glossop Integrated...

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Transcript of Pathology - Quality Management Pathology User Guide PATH ... · Tameside and Glossop Integrated...