Document Code: PUB_002 Version Number: 7.0 Date of Issue: 07Page: th January 2015 1 of 107
CLINICAL LABORATORY
SERVICES
LABORATORY HANDBOOK
A Guide for Clinical & Laboratory Staff
PUB_002, Version 7.0 January 2015 This is a Clinical Laboratory Services
Controlled Document subject to Version Control Editor: Maxine Croasdale Please ensure that you are using
the most up-to-date version. Group Quality Manager
Document Code: PUB_002 Version Number: 7.0 Date of Issue: 07Page: th January 2015 2 of 107
The correct
patient correct time At the Requesting the appropriate analysis
The analysis ordered
Step 1. The requesting clinician ensures:
Step 2. The phlebotomist, nurse or clinician collecting the specimen checks and ensures
(e.g. using patient wrist band double checked against the request form and specimen label): The correct patient and correct time The correct specimen taken
Step 3. The ward, theatre, department or surgery ensures:
Safe handling & Inf. Control
Step 5. The laboratory checks and ensures:
Step 6. The responsible clinician checks and ensures:
The correct patient Receipt of the result/advice The correct therapeutic action Secure and appropriate storage Timely onward transfer ** Safe handling & waste disposal
Step 4. The person undertaking logistics stage (e.g. porter, transport, courier) ensures:
** By the most appropriate means depending upon urgency
Safe
handling Secure and appropriate carriage Timely transfer to laboratory The validity of the patient record The correct
patient The correct specimen received The correct result/advice given Flow of responsibilities Correct & complete labelling Reasonable scheduling for transit
NB: The laboratory may reject an inappropriately collected, or labelled specimen, or inappropriate specimen type Notes the patient circumstances
appropriate to the analysis, e.g. fasting, prone or sitting etc.
Meeting H&S/ADR
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Document Scope: This Manual outlines guidance on laboratory services and the requirements and guidelines the safe and acceptable pre-analytical collection and handling of clinical specimens destined for analysis in the Clinical Laboratory Services. Clinical Immunology specimens are not within the scope of this manual.
References
(e.g. CPA standard): •• CPA (UK) Ltd standards C5, E2, E3, E4 & E5.2 ISO15189 Standards 5.4
• EC4 Essential Criteria 7.7 (Sample Transport & Handling)
• ADR 2009 - European Agreement Concerning the International Carriage of Dangerous Goods by Road. ISBN13 9789211391121
• Safe working and the prevention of infection in clinical laboratories and similar facilities(Health Services Advisory Committee HSE Books 2003) ISBN 0 7176 25133
• COSHH - Control of Substances Hazardous to Health Regulations 2002 Approved Code of Practice and Guidance L5(Health and Safety
Commission HSE Books 2002) ISBN 0 7176 2534 6
• British Standard BS EN 14820:2004 Single-use containers for human venous blood specimen collection
• British Standard BS 5213:1975 Specification for medical specimen containers for microbiology
• The Approved List of Biological Agents(Advisory Committee on Dangerous Pathogens). Downloadable from
http://www.hse.gov.uk/pubns/misc208.pdf
• The Classification, Packing and Labelling of Dangerous Substances Regulations 1984SI 1984 No 1244 HMSO ISBN 0 11 047244 6
Responsibilities: • Initial acceptance/rejection of samples and requests based on clear guidance noted in a Laboratory Procedure – all staff receiving specimens.
• Review for acceptance of equivocal or unrepeatable material referred up by Specimen Reception staff – designated staff.
Related
Documentation: •• All Trust Policies & Procedures UHB Trust Blood Transfusion Policy & Procedures
• UHB Infection Prevention & Control Policy
• UHB Information Security Policy
• PUB_003 Guide to Specimen Containers for Pathology Requests (except Cellular Pathology)
• PUB_005 Guidance on the Carriage of Laboratory Specimens for Porters, Drivers, Couriers.
• PUB 048 Guidance Notes on Transport of Clinical Specimens by Road
• PUB_006 Guidance for Laboratory Visitors
Document Code: PUB_002 Version Number: 7.0 Date of Issue: 07Page: th January 2015 4 of 107 1. Foreword ... 11 2. Introduction ... 12 2.1. Quality Management ... 12 2.2. User Satisfaction ... 12 3. Key Information ... 13
3.1. Current locations of Departments ... 13
3.2. Opening Hours ... 13 3.2.1. Weekdays ... 13 3.2.2. Saturdays ... 13 3.2.3. Sundays ... 13 3.2.4. Public Holidays ... 14 3.2.5. Out-of-hours ... 14
4. Senior Staff Contacts ... 16
5.
Clinical Biochemistry
... 175.1. Introduction ... 17
5.2. Laboratory Hours ... 17
5.2.1. Monday - Friday ... 17
5.2.2. Saturdays, Sundays and Statutory (Bank) Holidays ... 17
5.2.3. Overnight Service (every night of the year) ... 17
5.3. Urgent Samples ... 17
5.4. Useful Contact Numbers ... 18
5.5. Specimens ... 19
5.5.1. Blood ... 19
5.5.2. Urine Collections... 19
5.5.3. Add on tests ... 19
5.6. Specific Analyses ... 20
5.6.1. Glucose Tolerance Tests ... 20
5.6.2. Diabetes Mellitus ... 20
5.6.3. Coronary Heart Disease Risk Score... 21
5.6.4. Thyroid Function Tests ... 22
5.6.5. Management of the Menopause ... 22
5.6.6. Hormone Replacement Therapy ... 23
5.6.7. Prolactin and Macroprolactin ... 23
5.6.8. Troponin ... 23
5.7. Therapeutic Drug Monitoring ... 24
5.7.1. Overdoses/Drug Screens ... 24
5.8. Point-of-Care Testing (POCT or Near Patient Testing, NPT) ... 25
5.8.1. Blood Glucose Meters ... 25
5.8.2. Blood Gas Analysers (QEH) ... 25
5.9. Analyses Provided ... 25
5.10. Routine Analyses (Serum unless otherwise indicated) ... 26
5.10.1. CSF ... 28
5.10.2. Urine ... 28
5.10.3. Faeces ... 29
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5.11. Endocrine Analyses ... 29
5.11.1. Other Analyses not listed ... 33
5.11.2. Protocols ... 33
5.12. Therapeutic Drug Monitoring ... 33
5.12.1. How to get a valid and useful result... 33
5.12.2. Reporting of results. ... 35
5.12.3. Out-of-hours services ... 35
6.
Laboratory Haematology
... 376.1. Introduction ... 37
6.2. Useful Telephone Numbers... 37
6.3. Laboratory Hours ... 37
6.3.1. Queen Elizabeth Hospital Birmingham ... 37
6.4. Routine Investigations and Factors Affecting Analysis ... 38
6.4.1. Automated blood count ... 38
6.5. Blood Film Examination ... 38
6.5.1. ESR ... 38
6.5.2. Screening for Sickle Haemoglobin ... 38
6.5.3. Routine Coagulation ... 39
6.6. Bone Marrow Aspiration/Trephine ... 39
6.7. Repertoire of Routine Haematology Tests ... 39
6.7.1. General Screening ... 39
6.7.2. Routine Coagulation Screen ... 40
6.8. Urgent Samples ... 40
6.9. Specialist Investigations & Factors Affecting Analysis ... 41
6.9.1. Thrombophilia screen ... 41
6.9.2. von Willebrand complex screen ... 41
6.9.3. Factor Assays ... 42
6.9.4. Haemoglobinopathy Diagnosis ... 42
6.9.5. Haematinics ... 42
6.9.6. Various Specialist Tests ... 42
7.
Blood Bank ... 43
7.1. Introduction ... 43
7.2. Blood Bank Repertoire, Samples & Factors Affecting Analysis ... 43
7.3. Request Procedure ... 44
7.4. Timing of Requests ... 44
7.4.1. Planned Transfusion ... 44
7.4.2. Urgent Transfusion ... 45
7.4.3. Immediate Transfusion ... 45
7.5. Patients with Allo-antibodies ... 45
7.6. Repeat Transfusions (sample interval) ... 46
7.6.1. Patients transfused within the last 3 Months. ... 46
7.6.2. ROH, QEHB and Pre Assessment Clinics ... 46
7.6.3. Renal ... 46
7.6.4. Cardiac Clinic ... 46
7.6.5. Haematology Day Unit ... 46
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7.7. Massive Transfusion ... 46
7.8. Blood Component Red Cells ... 47
7.9. Non-Red Cell Components (General) ... 47
7.10. Blood Products ... 47
7.10.1. Prothrombin complex concentrate (Beriplex) ... 47
7.10.2. Albumin ... 47
7.10.3. Activated factor VII - rFVIIa (Novoseven) ... 47
7.10.4. Anti D ... 47
7.11. Blood Collection ... 47
7.11.1. Collection of blood or components ... 48
7.12. Return of Blood and Blood Components... 48
7.13. Reservation Period ... 48
7.13.1. Blood for surgery ... 48
7.13.2. Blood for anaemia... 48
7.14. Serious Adverse Reactions and Events - SHOT and SABRE ... 49
7.15. Traceability ... 49
8.
Clinical Microbiology
... 508.1. Introduction ... 50
8.2. Use of the Clinical Microbiology Department ... 51
8.2.1. Out-of-hours ... 51 8.2.2. Specimen Containers ... 51 8.2.3. Request Forms ... 52 8.3. Turnaround Times ... 52 8.4. Test Repertoire ... 52 8.4.1. Bacteriology ... 52 8.4.2. Antibiotic Assays... 52 8.4.3. Mycology ... 52 8.4.4. Virology ... 52
8.5. Serology (including antigen detection) ... 53
8.5.1. Viruses ... 53 8.5.2. Bacteria ... 54 8.5.3. Mycology ... 54 8.5.4. Parasitology ... 54 8.5.5. Molecular Biology ... 55 8.6. Add on Tests ... 55 8.7. Specimens ... 55 8.7.1. Swabs (general)... 55 8.7.2. Throat Swabs ... 55
8.7.3. MRSA Screen swabs ... 56
8.7.4. Conjunctival Swabs ... 56
8.7.5. Vaginal Swabs for culture and Intra-Uterine Contraceptive Devices ... 56
8.7.6. Chlamydia investigations ... 56
8.7.7. Gonorrhoea swab ... 56
8.7.8. Pus and Exudates... 56
8.7.9. Sputum Samples ... 57
8.7.10. Urine ... 57
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8.7.12. Cerebrospinal fluid (CSF) ... 58
8.7.13. Blood cultures ... 58
8.7.14. Fluids and Joint Aspirates received in Blood Culture Bottles ... 59
8.7.15. Intra-operative Tissue Samples. ... 59
8.7.16. Antibiotic assays ... 59
8.8. Pregnancy Testing ... 59
8.9. High Risk Specimens ... 60
8.9.1. Hazard Group 3 pathogens ... 60
8.9.2. Creutzfeldt Jacob Disease/TSE ... 61
8.9.3. Hazard Group 4 Pathogens ... 61
8.10. Procedure for the Notification of Infectious Diseases by Clinicians ... 61
8.11. Useful Telephone Numbers... 62
9.
Cellular Pathology
... 63 9.1. Location ... 63 9.2. Service Hours ... 63 9.3. Laboratory Management ... 63 9.4. Service Background ... 64 9.5. Consultant Pathologists... 649.6. Request Form Completion ... 66
9.7. Specimen Labelling and Multi-Part Cases ... 66
9.8. Hazardous Specimens ... 66
9.9. Specimen Containers ... 66
9.9.1. Yellow Topped 60 ml Containers ... 67
9.9.2. 350 ml White Topped “Honey Pots” ... 67
9.9.3. Specimen Buckets ... 67
9.9.4. “Mega” Specimen Buckets ... 67
9.9.5. Requesting Specimen Containers ... 67
9.10. Transportation of Specimens ... 67
9.11. Urgent Reporting ... 68
9.12. Histopathology ... 68
9.12.1. Intraoperative Frozen Sections ... 68
9.12.2. Neuropathological Smears ... 69
9.12.3. Small Biopsy Specimens ... 69
9.12.4. Urgent Biopsy Specimens (Rapid Paraffin Service) ... 70
9.12.5. Resection Specimens ... 70
9.13. Cytopathology ... 71
9.13.1. Senior Staff and Useful Telephone Numbers ... 71
9.13.2. Specimen Containers and Fixative ... 71
9.13.3. Receipt of specimens ... 71 9.13.4. Transport of Specimens ... 71 9.13.5. Sputum ... 71 9.13.6. Serous Fluids ... 72 9.13.7. Cerebrospinal Fluid (CSF) ... 72 9.13.8. Urine ... 72 9.13.9. Endoscopic brushings ... 72
9.13.10. Fine needle aspiration ... 72
Document Code: PUB_002 Version Number: 7.0 Date of Issue: 07Page: th January 2015 8 of 107 9.13.12. Cervical Smears ... 72 9.13.13. Reporting ... 72 9.14. Molecular Pathology ... 73 9.14.1. Transport of Specimens ... 73 9.14.2. Colorectal cancers ... 73 9.14.3. Lung cancers ... 73
9.14.4. Gastrointestinal Stromal Tumours (GIST) ... 74
9.14.5. Melanomas ... 74
9.14.6. Brain tumours ... 74
9.15. Electron Microscopy ... 75
9.16. Muscle Biopsy Service ... 75
9.17. Mortuary Services ... 76
9.17.1. Confirmation of Death ... 76
9.17.2. Deaths to be Reported to Her Majesty's Coroner ... 76
9.17.3. Requesting an Autopsy (Post Mortem Examination)... 76
9.17.4. An Autopsy ... 77
9.17.5. The Death Certificate ... 77
9.17.6. Cremation Form ... 77
9.18. Post Mortem Pathology ... 77
9.19. Turnaround Times ... 77
9.20. External Quality Assurance ... 78
10. Appendix 1 – Clinical Specimens, General ... 80
11. Appendix 2 – Clinical Specimens, Quick Reference ... 81
12. Appendix 3 - Health, Safety, Infection Control and Security ... 84
12.1. Security... 84
13. Appendix 4 - Requesting a Test or Examination ... 85
13.1. Responsibility & Accountability ... 85
13.2. Medico-legal examinations ... 85
13.3. Requesting Procedure ... 85
13.4. Request Form & Specimen Label ... 86
13.5. The Request Form – General Principles ... 86
13.6. Specimen Tracking ... 87
13.7. Minimum Data-set ... 87
14. Appendix 5 – Specimen Collection ... 89
14.1. Training... 89
14.2. Non-Laboratory Testing... 89
14.3. Collecting a Specimen ... 89
14.4. ‘Order of Draw’ ... 89
14.5. Specimen Container Colour Key ... 90
14.6. Request Forms and Other Supplies ... 90
14.7. Request Forms and Other Supplies for GPs... 90
15. Appendix 6 – Specimen Rejection ... 92
15.1. Specimen Rejection ... 92
15.1.1. Exception(s) to the Rejection Process ... 92
15.1.2. Exceptions - Reporting ... 93
15.1.3. Handling Rejected Specimens and Requests ... 93
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16.1. Handling & Storage ... 95
16.1.1. Specimen Degradation ... 95
16.1.2. Collection, Storage & Transit Times ... 95
16.1.3. Urgent Specimens ... 96
16.1.4. Routine Specimens ... 96
16.2. Porters ... 96
16.3. Specimen Delivery System ... 96
16.4. Transport Between Hospitals ... 97
16.5. Transport Regulations ... 97
16.5.1. Classification ... 98
16.5.2. Packaging ... 98
16.5.3. Labelling of Packaging ... 99
16.5.4. Bodies and Limbs ... 99
16.5.5. Transport beyond the Trust ... 99
16.5.6. Vehicle contamination/decontamination ... 99
16.5.7. Postal Regulations ... 99
16.6. Dispatch of Specimens to the Laboratory ... 99
16.6.1. Dispatch of Urgent Specimens ... 100
16.6.2. Dispatch of Routine Specimens ... 100
17. Appendix 8 - Laboratory Results... 101
17.1. Laboratory Reports ... 101
17.1.1. Electronic Reporting to wards. ... 101
17.1.2. Electronic Results for GPs ... 101
17.1.3. Printing Reports ... 101
17.2. GP Enquiries for Results ... 101
17.3. Referral of Specimens to Third Party Laboratories ... 102
18. Appendix 9 – Laboratory request form images ... 103
18.1. Hospital Request forms ... 103
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Definitions
Chain of Custody
Each sequential participant in the act of collecting and transporting a specimen from the patient to the laboratory. The effective documentation of this chain provides a valid audit trail for the specimen for accreditation or litigation purposes.
Clinical Laboratory
In the context of this manual - ‘Clinical Laboratory Services’, or Division 4 Group B.
Phlebotomy
The removal of blood from a vein using a needle, also known as venepuncture (although this may also indicate part of the process to inject into a vein) and sometimes venesection or venotomy (although these latter may also indicate surgical incision into a vein). Phlebotomy may be used to obtain blood for the purposes of diagnostic tests or as a treatment in itself for certain conditions.
PID
Patient Identification.
Urgent
Requiring immediate action or attention. It is important that if a specimen requires urgent analysis that this status is effectively conveyed to the participants in the ‘chain of custody’ from specimen collection to the laboratory. The abuse or overuse of this status overloads the process and devalues the term when there is a truly urgent situation; it should not be used lightly.
Specimen and sample are often used interchangeably. However:
• Specimen usually refers to an item to be characterized chemically or biologically.
• Sample can refer to a finite portion of that specimen which is taken for analysis.
For simplicity the term specimen is used here to indicate the discrete biological material of whatever size sent to the laboratory for analysis.
Specimen Collection
Producing a specimen from a patient for laboratory analysis.
Specimen Handling
The process of labelling, manipulating and storing of a collected patient’s specimen or packaging prior to transportation.
Specimen Transportation
The process of transporting the collected, labelled, and packaged patient’s specimen to the Clinical Laboratory Services for analysis.
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1. Foreword
Dear Colleague,This handbook has been prepared by Clinical Laboratory Services of the University Hospital Birmingham NHS Foundation Trust. It combines the information from the previous handbooks issued separately to GPs and to the Trust. You will find details within of the various clinical pathology services provided, including help with contacts, phlebotomy and specimen collection, logistical arrangements, tests available and reporting of results.
A link to The Guide to Specimen Containers for Pathology Requests is available in
Appendix 5, although some guidance is given here on suitable specimen containers there may be specific exceptions so please refer to this Guide for current requirements. Each
laboratory section has details about the service offered by that laboratory and some specific requirements depending on the assay/examination requested. There is also general advice about requesting and documentation, collecting and transporting of a clinical specimen for analysis to the laboratories and reporting of the result; this is contained in the series of Appendices at the end of this document. Please ensure that you understand the process and your specific responsibilities in this regard.
Clinical Laboratory Services work to all Trust Polices regarding the protection of personal information.
We welcome any comments on the service provided. This will enhance our programme of continuous review and upgrade of laboratory work to reflect changing clinical practice. Please direct any comments in writing to myself at the address below.
I hope you will find this information of value and trust that it will enable you to optimise your use of the services available.
Jacquie Roper
Lead Biomedical Scientist
Clinical Laboratory Services Level -1
University Hospitals Birmingham NHS Foundation Trust.
NB Where the ‘Trust’ is mentioned in this publication it refers to the University Hospitals Birmingham NHS Foundation Trust. Queen Elizabeth Hospital Birmingham may be abbreviated to QEHB, Queen Elizabeth Hospital to QEH and Selly Oak Hospital to SOH.
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2. Introduction
Clinical Laboratory Services provides a high quality, cost-effective service to the University Hospital Birmingham NHS Foundation Trust, GPs and community hospitals mainly within the South Birmingham PCT and is a referral centre for specialist services for other local and national Trusts. It is continually upgrading the test repertoire offered to reflect medical development. The laboratory services currently provided include:
Department of Clinical Biochemistry
Department of Clinical Microbiology (Including Virology)
Department of Laboratory Haematology ( Including Transfusion) Department of Cellular Pathology
All laboratories are staffed by qualified and experienced medical, scientific and technical personnel.
Please note that a Clinical Immunology service is provided by the Immunology Department of the University of Birmingham. This is based in the University Medical School and is not within the organisational structure of Clinical Laboratory Services.
2.1. Quality Management
All laboratories are subject to external accreditation by CPA (Clinical Pathology Accreditation [UK] Ltd.) to ISO15189. (UKAS)
Each of the laboratory departments runs a comprehensive quality management system, participating in all relevant National Quality Assessment Schemes, and operates a schedule of internal quality audit, corrective action and quality improvement.
The laboratories are recognised for training by the Health and Care Professions Council, the Royal College of Pathologists, the Association for Clinical Biochemistry and the Institute of Biomedical Sciences.
All work is performed with due care for the health and safety of staff and patients and with proper regard for the environment. The laboratories comply with comprehensive safety procedures and Control of Substances Hazardous to Health (COSHH) regulations.
2.2. User Satisfaction
As part of our quality management system and to ensure that we are meeting the needs of our users, we are always keen to receive any comments you may have regarding the quality of the service we provide and would welcome any suggestions on ways in which we might be able to improve the service.
Please feel free to email any of the Quality Team with any suggestions labsquality@uhb.nhs.uk or the individual department representatives.
Group Quality Manager Maxine.Croasdale@uhb.nhs.uk
Individual laboratory Quality Leads
Cellular Pathology Satveer.Kaur@uhb.nhs.uk
Clinical Chemistry Estelle.Williams@uhb.nhs.uk
Haematology David.Innes@uhb.nhs.uk
Transfusion vacant
Microbiology Verity.Pursglove@uhb.nhs.uk
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3. Key Information
3.1. Current locations of Departments
Department Location
Central Specimen Reception Clinical Biochemistry
Laboratory Haematology/Transfusion Clinical Microbiology
Infection Control Nurses Cellular Pathology
Mortuary & Chapel of Rest
Clinical Laboratory Services, Level-1 Queen Elizabeth Hospital Birmingham Mindelsohn Way Edgbaston, Birmingham B15 2GW Tel: 0121 627 2000 3.2. Opening Hours 3.2.1. Weekdays
A full laboratory service is available from each department between 8.00 and 20.00 weekdays but each individual laboratory may have extended core service times; please consult each section for details. Specimens for routine analysis should be submitted as soon as possible to the individual laboratories.
3.2.2. Saturdays
A more limited laboratory service is available in the following laboratories.
Clinical Microbiology
Laboratory Haematology
Clinical Biochemistry
'Routine' specimens for analysis will be accepted until 11.00 (last delivery time by porters). Some specialist biochemistry investigations can be performed by prior arrangement with the laboratory, and should reach the laboratory earlier in the day. A limited number of staff work in the laboratories on Saturday morning. Investigations should be restricted to those patients who require monitoring to alter or prescribe therapy for that day. Tests requiring urgent analysis should be brought to the attention of the laboratory staff by a prior telephone call.
3.2.3. Sundays
Limited services are provided to UHB Trust on a Sunday and vary dependent on the laboratory. Investigations should be restricted to those patients who require monitoring to alter or prescribe therapy for that day. Specimens for this type of analysis must be in the departments by 11.00 am. Some specialist biochemistry investigations can be performed by prior arrangement with the laboratory, but these are likely to have to reach the laboratory earlier in the day. The Specimen Delivery System is available for sending most
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specimens. There are limited collections by portering staff. Ad hoc porters can be called to take urgent specimens to the laboratory specimen reception. Transport should be contacted directly if the specimen cannot wait. Tests requiring urgent analysis should be brought to the attention of the laboratory staff by a prior telephone call.
3.2.4. Public Holidays
A limited service is available in the laboratories, details of which will be circulated prior to each public holiday.
3.2.5. Out-of-hours
An out-of-hours service is provided by the following departments:
Clinical Biochemistry
Laboratory Haematology
Clinical Microbiology
These services operate at all times when the laboratories are not open for 'routine' service. Out-of-hours you must make contact with the Duty Biomedical Scientist in each laboratory prior to dispatching any specimen. Investigations should only be requested out-of-hours when the results are required for immediate patient management. The out-of-hours Mortuary viewing service is provided by the Trust on-call manager.
All arrangements for specimen delivery to the departments must be made by the requesting doctor. Each department has a published repertoire of tests available out-of-hours and guidelines for requesting are available (see below). A senior member of the scientific or medical staff is available in each department for consultation at all times. If asked by the Duty Biomedical Scientist for your reasons for requesting a test, you should give the clinical indications; no reasonable request will be refused but the Biomedical Scientist will be at liberty to ask you to consult a senior member of the laboratory staff to discuss the necessity for the investigation.
Before any urgent specimens are sent to a Biochemistry and Microbiology out-of-hours, you must make prior contact with the department concerned and discuss your requirements. You must complete the request form and include your contact point (telephone or bleep number).
All results are electronically transferred to the PICS and Browser systems. The results of urgent requests may be notified to the requesting source if there are abnormal results that exceed critical limits. You must be prepared to accept results and must not delegate this responsibility to anyone else unless you have made arrangements that are made clear to the department concerned.
NB Without prior notification requests for priority written on request forms (e.g. "urgent" or "please telephone") may be ignored by the laboratory.
Department Contact Details
All results and general enquiries for Biochemistry, Haematology
& Microbiology 0121 371 5999
All general enquiries for Cellular Pathology 0121 371 3326
Biochemistry Urgent Requests 0121 371 5985 ( Bleep 2312 out of hours) Haematology Urgent Requests 0121 371 5986 (Bleep 1376 out of hours)
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Out-of-hours
On-call Medical Microbiologist, Virologist or Biomedical Scientist:
Radiopager/mobile phone via hospital switchboard (a rota operates for this service) (This service is provided by staff from home)
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4. Senior Staff Contacts
Title Name Contact Details
Director of Pathology Services Dr Robert Cramb 0121 371 5962
Lead Biomedical Scientist Jacquie Roper 0121 371 5959
Group & Business Manager Paula Hytch 0121 371 5958
Group Quality Manager Maxine Croasdale 0121 371 5965
Group IT Manager Colin Mason 0121 371 5956
Clinical Biochemistry,
Clinical Lead Consultant
Laboratory Manager Dr Robert Cramb Chris Gaskin 0121 371 59620121 371 5963
Microbiology,
Clinical Lead Consultant
Laboratory Manager Dr Pauline Jumaa Paul Arrowsmith 0121 371 61750121 371 5977
Haematology,
Clinical Lead Consultant
Laboratory Manager Dr Jonathan T. Wilde Chris Gaskin 0121 371 59610121 371 5963
Cellular Pathology,
Clinical Lead Consultant
Laboratory Manager Dr Shalini Chaudhri Susan Sharpe 0121 371 3347 0121 371 3343
Division A
Medical Director
Director of Operations Dr Ian Sharp Yma Choudhury 0121 371 2789 0121 371 2787
There is a more comprehensive list of senior staff and their telephone numbers in the departmental sections (below). Please note the instructions given by each of the departments with respect to clinical advice as opposed to technical queries.
The following is now a corporate responsibility and no longer part of the Laboratory management structure (from 2008):
Infection Control,
Consultants responsible for Infection Control:-
Infection Lead Nurse:-
Dr Pauline Jumaa
Dr Ira Das 0121 371 61750121 371 6172 Bleep: 1847 0121 371 3785
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5. Clinical Biochemistry
5.1. IntroductionClinical Biochemistry is a CPA (UK) Ltd. accredited clinical laboratory service that uses biochemical analysis to provide results used for the diagnosis and monitoring of disease. The laboratory is automated for the majority of tests but some testing requires more complex apparatus and manual techniques.
The Department actively promotes and supports Point-of-Care Testing (POCT) managing blood gas analysers across multiple hospital sites, blood glucose, ketone and INR testing meters and provides an on-site laboratory service in the Diabetes Centre.
The Department provides a comprehensive clinical biochemistry service to the Trust. In addition, a full service is provided to the South Birmingham community Trust, the Royal Orthopaedic Hospital and GP practices. The Department also provides specialist services including endocrinology to other Hospitals in the city, the West Midlands Region, the rest of the UK and the Republic of Ireland.
The Department provides a clinical advisory service, which includes the clinical interpretation of results, advice on the appropriate selection of laboratory tests and investigation and monitoring strategies for individual patients and for specific diseases. There is close liaison with clinicians and other healthcare personnel within the Trust, the Community and in other hospitals to ensure best practice in the use of the Clinical Biochemistry Service, for clinical governance and clinical audit purposes and ensure that the clinical biochemistry service is an integrated component of patient care pathways. This section outlines the use of the laboratory and many of the tests available. It is not completely comprehensive and advice should be sought if there are queries, from the Duty Biochemist within hours or the consultant on-call rota out-of-hours (contact the on-call Biomedical Scientist first).
5.2. Laboratory Hours
5.2.1. Monday - Friday
The department provides a full service from 08.00 am to 20.00hrs.
5.2.2. Saturdays, Sundays and Statutory (Bank) Holidays
A Limited service is provided from 08.00 to 12.30 hrs. An emergency service is provided from 12.30 to 20.00 hrs
5.2.3. Overnight Service (every night of the year)
An emergency service is provided from 20.00 to 08.00 hrs
5.3. Urgent Samples
Specimens requiring immediate attention on receipt should be identified by obtaining an urgent number from the extension 15985. Only specimens requiring urgent analysis where there is a need for clinical management decisions that can only be taken by biochemical investigation should use this service. Many of the urgent management
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decisions can be taken using results supplied by the Point-of-Care instruments available in the emergency department and intensive care units.
Prior to sending any urgent specimens, you must telephone the laboratory before dispatch of the specimen so that you can be given an urgent specimen identification number. This urgent specimen number must be noted on the request form to provide easy identification for the laboratory staff on arrival within the department, as must the correct location of the patient. This will facilitate its processing and ensure that the results are returned directly to the requesting source. It is important to do this in order that we identify urgent specimens amongst the 4,000 requests we receive daily. You must do this at any time of day or night in order to facilitate fast processing.
Samples collected in ED and CDU will be processed as urgent 24 hours a day and the results will be available with 60 min.
Arrangements for urgent endocrine tests, e.g. neonatal 17-hydroxyprogesterone, should be made via the Endocrine Duty Biochemist on extension 16544 during normal working hours.
For pregnancy testing, a urine test is the first line investigation and will normally be done as a Point-of-Care Test (POCT) in accordance with Trust policy. The Microbiology Department is able to offer this test during normal laboratory hours, if POCT is not available. For a patient with suspected ectopic pregnancy who is being/has been referred, Birmingham Women’s Hospital have a restricted service for serum hCG on weekend early mornings but do not have an out-of-hours service. Any arrangements for a serum hCG in this situation will be made by Birmingham Women’s Hospital clinical staff.
5.4. Useful Contact Numbers
Title Contact Details
Duty Biochemist (Chemistry) Extension 16543 Duty Biochemist (Endocrine) Extension 16544
Specimen Enquires Extension 15999
Point of care Bleep 1189
Urgent Requests
GPs 0121 371 5985
Hospital inpatients or out patients Extension 15985 (Bleep 2312 between 8pm and 8am)
For a more extensive list of telephone numbers please consult the guide at the end of the Clinical Biochemistry section.
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5.5. Specimens
5.5.1. Blood
In general the following blood collection bottles are required (colour reference is Greiner Vacuette® system only, other systems may vary):
For routine and urgent analyses Yellow Top tube containing gel (4 mL)
Glucose Grey Top tube (fluoride oxalate, 2 mL)
Most Drug assays (for details see the Guide to Specimen Containers...)
Red Top tube (6 mL) Thyroid Function Tests, LH, FSH,
Testosterone, Cortisol Yellow Top tube containing gel but Red Top can be used Prolactin and Progesterone Red Top tube
hCG Red Top tube as an additional tube
AFP, CEA, Ca125, Ca153, Ca199 Yellow Top tube containing gel
Digoxin Red Top tube - Yellow top cannot be used
Ferritin, Folate, Vitamin B12 Yellow top tube containing gel (4mL) Ciclosporin & Tacrolimus Purple Top tube (EDTA, 4 mL)
PTH Purple Top tube (EDTA, 4mL) – send straight to lab
Other Endocrine tests See section 5.12
For all tubes please mix thoroughly. A few analyses require special anticoagulants and if there is any doubt you should contact the duty biochemist.
5.5.2. Urine Collections
Bottles for 24 hour urine collections can be obtained from the Clinical Biochemistry Department. Different preservatives are required for different analyses. Please ensure that ward staff/portering staff/patients who are sent to collect containers know which analyses will be required. Please ensure that patient information on the specimen bottles is complete before they are returned to the laboratory.
5.5.3. Add on tests
1. QEHB In patients and out patients
Please send a request form with the patient’s details and tests required, clearly stating it is an add-on request
2. Moseley Hall Hospice, Royal Orthopaedic Hospital and GP surgeries
Please phone extension 16543 to request additional tests.
Please note that add-on tests will not be dealt with urgently. Due to sample storage
procedures within the department, it may not be possible to access a sample quickly, if an add-on result is required urgently, it may be appropriate to re-bleed the patient. Please call extension 16543 to discuss.
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5.6. Specific Analyses
The Department of Clinical Biochemistry performs most assays in-house. A small number of specialist assays are forwarded on to centres elsewhere in the UK although advice and interpretation will always be available locally.
The Department of Clinical Biochemistry has particular expertise in; the investigation of diabetes mellitus, lipid disorders, gastroenterology, rheumatology, tumour markers and endocrinology. A therapeutic drug monitoring service is available with advice and interpretation provided by the Trust's Pharmacy Service. An extensive analytical service is provided within the Diabetes Centre.
5.6.1. Glucose Tolerance Tests
Contact the duty biochemist on 0121 371 16543 to discuss whether an OGTT is required for a particular patient and/or to book an OGTT. OGTT are performed at the Diabetes Centre Laboratory in Nuffield House on the QEHB site. In addition, a protocol can be provided for performing an OGTT on wards or in the community.
5.6.2. Diabetes Mellitus
Haemoglobin A1c and the diagnosis of diabetes mellitus
Conventionally diabetes mellitus has been diagnosed by high fasting or random blood glucose concentrations, or abnormal oral glucose tolerance tests (OGTT). Haemoglobin A1c (HbA1c) has been used to monitor longer term glycaemic control in patients with known diabetes mellitus.
In 2011, the World Health Organisation (WHO 2011) recommended that HbA1c measurements should also be used to diagnose diabetes in the majority of asymptomatic individuals, and this recommendation has been agreed in the UK (NHS Diabetes 2011).
HbA1c of 48 mmol/mol or more (≥ 6.5%) is consistent with diabetes: if the patient has
no symptoms then a second HbA1c result must be obtained within 2 weeks, and if ≥
48 mmol/mol (≥ 6.5%) confirms diabetes mellitus.
HbA1c values of 42 to 47 mmol/mol (6.0 to 6.4%) suggest a high risk of future diabetes. Such individuals should be offered structured lifestyle education and support to delay/prevent development of diabetes, and have an annual HbA1c test.
HbA1c must be measured in an accredited laboratory undertaking recommended quality assurance procedures. Near patient testing is not appropriate when HbA1c is used for the diagnosis of diabetes.
HbA1c is now the preferred method to diagnose diabetes, except in the following
situations where this test would be unreliable, and in whom the traditional methods of diagnosis with blood glucose concentrations remain the method of choice:
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• Haemoglobinopathies
• Increased red cell turnover
• Anaemia (haemoglobin < 8 g/dL)
• ?Type 1 diabetes or acute onset of symptoms of diabetes
• ?Gestational diabetes
• Children and adolescents
• Patients taking steroids and antipsychotic or other medications that cause rapid rise in blood glucose
Despite this new approach, if an individual has abnormally high random or fasting blood glucose levels or abnormal OGTTs, which would be consistent with diabetes on the traditional criteria, then that patient should be considered to have diabetes irrespective of their HbA1c value. Without symptoms of diabetes two abnormal tests of the same type (two high fasting or random blood glucoses or a diabetic OGTT) are required to confirm diabetes mellitus.
References
NHS Diabetes (2011) Use of Haemoglobin A1c (HbA1c) in the diagnosis of diabetes. WHO (2011) Use of Glycated Haemoglobin (HbA1c) in the diagnosis of Diabetes Mellitus
www.who.int/diabetes/publications/report-hba1c_2011.pdf
This bulletin was issued by Dr Robert Cramb on 31.01.2012.
An annual update on the diagnosis and classification of diabetes mellitus is published in Diabetes Care by the American Diabetes Association. It can be accessed on line from
http://care.diabetesjournals.org/ .
Monitoring glycaemic control in patients with diabetes
HbA1c is routinely measured for this purpose. The assay is run daily on weekdays and requires an EDTA vacuette (purple top - KFK 303 Greiner bio-one). Fructosamine can be used as an alternative when HbA1c is not appropriate. Fructosamine reflects blood glucose over two weeks rather than 2 to 3 months as it reflects glycation of albumin rather than haemoglobin. It is performed on serum (gold top vacuette - KFK 303 Greiner bio-one) and run daily.
5.6.3. Coronary Heart Disease Risk Score
Standard 4 of the National Service Framework for Coronary Heart Disease states that:
“General Practitioners and Primary Health Care teams should identify all people at significant risk of cardiovascular disease (CVD) but whom have not yet developed symptoms and offer them appropriate advice and treatment to reduce their risk”.
Numerous risk calculators are available to calculate risk for coronary disease and these are all based on the Framingham model. The JBS II or the QRISK calculators are used for
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the calculation of cardiovascular disease risk. The South Birmingham PCT requires general practice to screen for CVD and any request for ‘CVD risk’ will generate a total cholesterol, HDL-cholesterol, creatinine and random glucose (a yellow top and grey top bottle must be supplied). We previously supplied a ‘CHD risk’ (Coronary heart disease risk) that calculated a risk at least 50% lower than total cardiovascular risk and did not up-regulate risk for younger age ranges. We no longer provide a CHD risk with calculations as these are freely available to download from a number of sites:
http://cvrisk.mvm.ed.ac.uk/calculator/framingham.htm
Any request for a coronary heart disease risk or a cardiovascular disease risk will be assumed to be that which is requested on behalf of the PCT to assess risk of individuals for cardiovascular disease and will therefore include a cholesterol, HDL cholesterol, non-fasting glucose and creatinine. To request this profile you must clearly ask for a CHD risk
or a CVD risk. Individual requests for these constituents without asking for either a CHD risk or a CVD risk will not generate the correct request. Please note that any other additional tests requested will be concurrently analysed along with a CHD or CVD risk. Please note HDL cholesterol is only measured when the CHD risk score is requested. We do not provide HDL cholesterol otherwise on any request for a lipid profile. Often we are asked to provide LDL cholesterol calculations. For your convenience the calculation of LDL cholesterol is provided below but you should recognise that this can only be valid where patients attend fasting for at least 12 hours in order to suppress triglyceride concentrations. Triglyceride concentrations >4.5 mmol/L negate the use of the calculation.
LDL cholesterol = Total cholesterol – HDL cholesterol – (Triglyceride/2.19)
5.6.4. Thyroid Function Tests
TSH and free thyroxine (fT4) are provided as first-line tests. Since many drugs and treatments affect thyroid function tests details of all drugs or other treatment must be provided in order that further tests can be initiated by the laboratory as appropriate. Please indicate on request form if patient is on thyroid hormone replacement.
Please Note. Thyroid hormone measurements can be misleading in patients with acute and non-thyroid
illness. Thyroid status should only be assessed after recovery from acute non-thyroidal illness. 'Screening' of patients in hospital for thyroid illness is not recommended. Free T3 is analysed only according to an agreed protocol and full clinical details must be given on the request form.
Please see the UK Guidelines for the Use of Thyroid Function Tests at:
http://www.british-thyroid-association.org/Guidelines/ 5.6.5. Management of the Menopause
The menopausal transition is best diagnosed on clinical grounds. Endocrine investigation may be helpful where the pattern of age, menstrual history and features of oestrogen deficiency are unusual.
Please indicate the woman’s date of birth, recent menstrual pattern and date of last menstrual period/day of cycle on which the blood sample was collected. A rise in follicle stimulating hormone (FSH) is the earliest sign of the approaching menopause. Measurement of serum FSH is the recommended first investigation if biochemical confirmation is necessary. The measurement of luteinising hormone (LH), oestradiol or progesterone is not appropriate. A serum FSH in the reference range for the follicular phase does not exclude the perimenopause.
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5.6.6. Hormone Replacement Therapy
HRT when prescribed (orally or transdermally) for the relief of menopausal symptoms does not require endocrine monitoring. Where there is unexpected failure of treatment, for example due to non-compliance or malabsorption, investigation may be useful. Different formulations of HRT may or may not be detected by oestradiol assays. Therefore please indicate on the request form the HRT preparation prescribed.
The main indication for measuring oestradiol in women on HRT is in those receiving implants containing oestradiol. Early replacement of the implant may result in accumulation of oestradiol. Monitoring of serum oestradiol before the implant is replaced has been recommended to avoid supraphysiological concentrations.
Sometimes testosterone implants are used in HRT. Measurement of testosterone in an analogous fashion to oestradiol may help to assess whether a further implant may be necessary.
5.6.7. Prolactin and Macroprolactin
The laboratory will perform a screening test for immunoglobulin bound prolactin (macroprolactin) on samples with a prolactin greater than 600 mIU/L. Please contact the laboratory for further information.
5.6.8. Troponin
This policy applies to the use of Troponin in the diagnosis of acute myocardial infarction (AMI) and acute coronary syndrome (ACS) in patients with a short history of chest pain. Cardiac Troponins are proteins that are involved in the contraction of the myocardium. Minimal myocardial damage can be reflected by large rises in the cardiac Troponins which are specific to cardiac muscle. The 2 common Troponin types measured are Troponin T and Troponin I. In this Trust cardiac Troponin T (cTnT) is the Troponin of choice.
Principle
cTnT is a cardio-specific, highly sensitive marker for myocardial damage. Cardiac TnT increases within 3-4 hours after myocardial infarction (AMI) and may be detectably raised for up to 2 weeks. In contrast to ST-elevation myocardial infarction (STEMI) the diagnosis of non-ST elevation myocardial infarction (NSTEMI) relies on the cTnT result. The new universal definition of myocardial infarction (MI) defines this as blood levels of cTnT above the 99th percentile of the reference limit of a healthy population together with evidence of myocardial ischemia that include typical symptoms, ECG changes and/or imaging results. The definition requires a troponin assay with an imprecision (coefficient of variation; CV) at the 99th percentile is less than or equal to 10%. cTnT is an independent prognostic marker which can predict the outcome of patients with acute coronary syndrome.
Two measurements of cTnT are considered essential to meet the universal guidelines. Highly sensitive assays of Troponin are now introduced and these are better at detecting the early release of cTnT from damaged myocardium and there is overwhelming evidence to support highly sensitive Troponin T (cTnT hs) measurements. Measurements of cTnT are recommended in the NICE guidelines. At present these guidelines suggest that a second measurement is made 10-12 hours post chest pain but this guidance was based on the data from the conventional cTnT assay. Studies with cTnT hs assays suggest that patients may be identified in as little as 3 hours with 100% sensitivity and 100% negative predictive value.
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Procedure and Interpretation
Recommendations for the use of cTnT hs are as follows:
• Samples for cTnT hs need not wait for 12 hours post ‘event’.
• Blood should be collected into a gel tube on arrival into hospital and a second sample approximately 6 hours post arrival.
• From these data myocardial infarction (MI) and Acute Coronary syndrome can be ruled out within 6 hours provided both cTnT hs levels are <14 ng/L.
• A rise in cTnT hs of 100% in 6 hours is indicative of myocardial damage consistent with AMI and NSTEMI.
5.7. Therapeutic Drug Monitoring
For details of tubes required and details of the scope of therapeutic drug monitoring (TDM) see 'other analyses' below.
A TDM service is at present provided in the department of Clinical Biochemistry. Any request for urgent therapeutic drug analysis must be discussed with the duty biochemist, or when out-of-hours with the duty Biomedical Scientist who may ask you to discuss this with the duty consultant. In some circumstances additional discussion with a pharmacist is required. Some specimens requiring analysis out-of-hours may need to be sent to the Toxicology unit at the City Hospital and if you organise this without consulting the Pharmacy department you will incur charges to the thrust that will not be the responsibility of Clinical Biochemistry.
If a drug level is not available on PICS or the Browser after you request it may not have reached the laboratory or still be in analysis. Where samples are above the therapeutic range (and are above critical limits) we contact the requesting doctor (or a nominated deputy or telephone the ward or out-patient area). For some drugs, you may wish to discuss the results in depth and we shall let you know if a pharmacist should be contacted. For general practice patients, we may contact the deputising service outside routine hours where there are concerns about drug levels that may be life threatening.
5.7.1. Overdoses/Drug Screens
Samples for a 'Drug Screen' are analysed at the Regional Toxicology Laboratory (RTL) at City Hospital. A request for a "drug screen" requires:-
At least 10mL of urine
Detailed patient information
Clinical condition e.g. coma grade, fitting
Current known prescribed drugs
Overdose drug(s) if known
Urine specimen type e.g. voided or catheter
Blood samples taken for a ‘Drug Screen’ are of little use unless there is prior knowledge of the agent ingested. Discuss whether a blood sample is of use with the duty biochemist or duty consultant (via the out-of-hours Biomedical scientist). Paracetamol, Salicylate and Lithium measurements are available on a 24 hr basis. All requests for other ingested drugs must be discussed with the Poisons Unit and Regional Toxicology Laboratory and samples sent only by prior arrangement. Any samples requiring urgent analysis at the Regional Toxicology Laboratory will require direct dispatch to that laboratory and must not be sent to the Clinical Biochemistry department. Charges realised by these analysis will be forwarded to the relevant division.
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5.8. Point-of-Care Testing (POCT or Near Patient Testing, NPT)
Please Note: The use of all point of care devices from simple dip-stick tests to blood gas analysis machines is governed by a comprehensive Trust policy. Please ensure that you are aware of the requirements of this policy before you embark on point of care testing.
5.8.1. Blood Glucose Meters
Ward based glucose meters that measure blood glucose using a 'dry-chemistry' stick are used throughout the Trust. These meters must only be used by authorised staff that have received training via the scheme organised in conjunction with the meter manufacturer. The working range of all glucose meters is limited and for accurate determination at the extremes of the range (2.5 - 20.0 mmol/L for the UHB meters) blood should be taken into a grey-top Vacuette tube and sent to the laboratory if the result is unexpected.
N.B. Values below the working range must be confirmed by a laboratory glucose measurement. Consult the biochemist/consultant on duty prior to taking the blood so that appropriate samples can be collected for the investigation of insulinoma, should this be warranted.
5.8.2. Blood Gas Analysers (QEH)
The department has rationalised blood gas instrumentation in the Trust and identical instruments are sited throughout the Trust. All analysers measure pH, pCO2, pO2, sodium, potassium and ionised calcium. They provide full co-oximetry and derive values for base excess and bicarbonate. Glucose and lactate measurement is available on both sites, but not on all analysers.
The blood gas analysers are located throughout QEHB and QEH.
Relevant staff are trained by staff of the POCT team. The laboratories do not have any blood gas analysers.
5.9. Analyses Provided
A guide to reference ranges are shown, but please refer to reference range (which may be age or gender related) quoted on the report form. Turnaround times quoted relate to the maximum time from receipt of the specimen in the laboratory to the reporting of the result.
User Information for Key Performance of Analytes
It is not practical to list all of the analytes key performances in this manual but below is a guide to some of the more common factors seen.
- Haemolysis, icteric and lipaemia interfere with certain analytes and as a consequence some analytes may not be reported. However, a comment will be included on the report to indicate why.
Common analytes affected include: sodium, potassium, bilirubin, magnesium, phosphate, AST, ALT and cTnT hs.
- Serum samples should be processed (centrifuged and serum separated from the cells) within 12 hours of collection. Any delay can influence the potassium and enzyme results. - Extreme temperatures (cold and hot) can cause abnormal levels of some analytes
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especially potassium.
- Sodium is affected by abnormal levels of protein and lipids. A direct ISE measurement will be performed and this report (plus appropriate comment) will be issued.
- A high platelet and white blood count can cause a falsely elevated potassium (a condition known as pseudohyperkalaemia). It is suggested that in these suspected cases blood is collected into both a lithium heparin tube and a yellow top tube and sent to the Biochemistry department as soon as possible for potassium analysis to confirm.
- It is important that blood is collected in the correct tubes and in the correct order to reduce the risk of anti coagulant interference. e.g. EDTA interference with calcium assays.
- CSF samples for Xanthochromia should be protected from light.
- HbA1c will not be reported on patients with known haemoglobinopathies. It is recommended that fructosamine is measured on these patients.
5.10. Routine Analyses (Serum unless otherwise indicated)
All specimens should be sent in yellow topped tubes unless otherwise marked.
Test Adult Reference Range Turnaround
Amylase < 100 U/L
24 hours
Albumin 34-51 g/L
Alkaline Phosphatase (ALP) Adult male: 40-130 U/L Adult female: 35-105 U/L Paediatric:
Males and females:
Less than 1 year <281 U/L
1 to 3 years <281 U/L
4 to 6 years <269 U/L
7 to 12 years <300 U/L Males, 13 to 17 years <390U/L Females, 13 to 17 yrs <187 U/L Aspartate Aminotransferase (AST) 5-43 U/L
Bilirubin 1-22 µmol/L
Calcium (Total) 2.10-2.60 mmol/L
Cholesterol (Total, JBS guidelines) Optimal concentration <4.0 mmol/L Creatine Kinase (CK) 24-170 U/L female
24-195 U/L male
Creatinine Males 60 - 126 μmol/L
Females:
<60 yrs 50 - 101 μmol/L ≥60 yrs 50 - 111 μmol/L Gamma Glutamyltransferase 7-40 U/L female
9-50 U/L male Glucose (Grey Top Vacuette, plasma) Not stated
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Magnesium 0.70-0.95 mmol/L
Phosphate (Fasting) 0.80-1.40 mmol/L
Potassium (serum) 3.4-5.2 mmol/L
Sodium 134-146 mmol/L
Triglyceride (JBS guidelines) Optimal level (Joint British Societies guidelines) is <1.7 mmol/L Urea Males: < 40 years 3.2-7.6 mmol/L 40 – 49 years 3.4-7.6 mmol/L 50 – 59 years 3.4-7.8 mmol/L > 60 years 3.4-8.0 mmol/L Females: <30 years 2.6-7.1 mmol/L 30 – 39 years 2.8-7.1 mmol/L 40 – 49 years 3.0-7.1 mmol/L 50 – 59 years 3.2-7.6 mmol/L > 60 years 3.4-8.0 mmol/L
Uric Acid (Urate) 160-400 µmol/L
Alanine Aminotransferase (ALT) 5-41 U/L 24 Hours
Alkaline phosphatase isoenzymes Monthly
Alpha (α) 1-antitrypsin 1.0-1.9 g/L 24 Hours
Alpha (α) fetoprotein; Tumour marker < 6 KU/L 24 Hours
Angiotensin Converting Enzyme
(ACE) 12-68 U/L Weekly
hCG Human chorionic gonadotrophin:
tumour marker < 2 IU/L female (non pregnant) < 7 IU/L female (postmenopausal) < 2 IU/L male
24 Hours
Bilirubin <22 µmol/L
24 Hours
Caeruloplasmin 0.2-0.45 g/L
Ca125 <36 kU/L (females)
Ca153 <26 kU/L
Ca199 <28 kU/L
CEA <5 µg/L
C-reactive protein (CRP) < 10 mg/L Cryoglobulins *
obtain warm transport flask from the laboratory prior to taking specimens
3 days Ciclosporin (Purple Top tube)
NB. sample usually prior to next dose
24 Hours Alcohol (non-legal)
(Grey Top tube, as full as possible)
>100 mg/dL = intoxication, 350-450 mg/dL = severe intoxication, >550 mg/dL = usually fatal
Fructosamine 200-285 µmol/L
Haptoglobin 0.46-2.60 g/L female
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HDL-Cholesterol > 1.2 mmol/L female > 1.0 mmol/L male
Iron 5-30 µmol/L female
10-32 µmol/L male
IgG 8.0-14.5 g/L
IgA 0.65-3.75 g/L
IgM 0.2-3.0 g/L
Lactate dehydrogenase (LDH) Adult males 135 – 225 U/L Adult females 135 – 214 U/L
Males and females < 16 years 120 – 300 U/L
Lactate The measurement is only available on the Blood Gas Analysers. No facility is available within the Biochemistry Department.
Osmolality 274-294 mOsmol/Kg 24 Hours
Paracetamol (overdose)
Protein electrophoresis 72 Hours
PSA (Prostate Specific Antigen) Referral Thresholds:
24 Hours ≤49y 2.5 µg/L
50-59y 3.5 µg/L 60-69y 4.5 µg/L ≥70y 6.5 µg/L
Rheumatoid Factor <14IU/mL
Salicylate (overdose) Tacrolimus (Purple top tube)
Total CO2 22-29 mmol/L
Transferrin 2.0-3.6 g/L
NB. You may find the reported ranges are different depending on the details that you complete on the
request card. Many of these reference ranges are age and gender linked. 5.10.1. CSF
Test Adult Reference
Range Turnaround Routine
Protein (Plain bottle) 0.15-0.45 g/L
24 Hours Glucose (Grey Top tube)
concurrent plasma specimen must be sent 2.0-5.0 mmol/L
CSF Scan for Xanthochromia* Interpretation
Report As Required
5.10.2. Urine
Test Routine
Turnaround
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Send urine (20 mL plain bottle) and concurrent blood (serum) Urine sample ideally an EMU collection
Creatinine Clearance:
Usually on 24 hr specimens (Urine and Serum sent concurrently with accurate timing.)
24 Hours Protein excretion (24 hr collection)
Calcium excretion (24 hr collection) Osmolality
Spot random urine sent immediately to the Lab
Urinary Free Catecholamine excretion
Acid collection bottle, 24 hr collection
24 Hours 5 Hydroxy-indole Acetic Acid (5HIAA)
Acid collection bottle, 24 hr collection Weekly
‘Microalbumin’ (albumin:creatinine ratio) 24 Hours
Porphyrin Screen including Porphobilinogen (PBG) #
Protect from light As Required
Electrolytes
24 hr collection for balance studies. Random specimen for investigation of electrolyte problems
24 Hours Urea
Inorganic Phosphate excretion
Other analyses may be available, please contact the duty biochemist for details. 5.10.3. Faeces
Test Adult Reference Range Routine
Turnaround Faecal Elastase (Send to lab ASAP) >200 µg/g stool 15 working days
Faecal Porphyrin Screen # Referred 24 Hours
# Specimens which give positive screening tests will be followed up with the requesting doctor. Blood, urine and faecal specimens will be referred to a specialist laboratory for confirmation.
5.11. Endocrine Analyses
Test Reference Range
Routine Turnaround (Please bleep 1417 for non-routine request) Specimen Tube Adrenocorticotrophic Hormone (ACTH)
Plasma - contact laboratory for collection
details as ACTH is not stable. 72 Hours
Purple top (EDTA) On ice straight to lab 0700h - 1000h Adults 7.2-63.3 ng/L Aldosterone
Fortnightly Red top standing 111-860 pmol/L
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Test Reference Range
Routine Turnaround (Please bleep 1417 for non-routine request) Specimen Tube Recumbent 28-444 pmol/L
Alpha-1-antitrypsin phenotyping Weekly Yellow top
Alpha sub-unit
3 weeks Red top adult (male & female) <1 IU/L
post-menopausal & mid cycle <3 IU/L Cortisol
24 Hours Yellow top (or Red top) 0900h 170-540 nmol/L
2400h <130 nmol/L Urinary free cortisol <130 nmol/L /24h
Weekly 24hr collection plain bottle ∆4-Androstenedione
Weekly Yellow top Neonates <8
Females (1-9 y; Tanner stage 1) <1.8 Males (1-9 y; Tanner stage 1) <1.1
Females and males (9-18 y) D4 changes significantly during puberty. Interpret in relation to Tanner stage
Females Males Tanner stage 2 0.5-4.8 <0.3-1.7 Tanner stage 3 1.3-7.8 0.5-3.0 Tanner stage 4+5 1.2-7.1 0.9-3.7 Adult females > 18 years (pre-menopausal) 0.9-7.5
Adult females (post-menopausal) 0.4-2.9 Adult Males 18-40 y 1.1-4.7 Adult Males 40-67 y 0.8-3.1
C-peptide* Special collection conditions, contact the laboratory. Referred test
Dehydroepiandrosterone Sulphate (DHAS)
Age and gender related reference range, contact laboratory 24 Hours Yellow top
Follicle Stimulating Hormone (FSH)
24 Hours Yellow top adult female, follicular 3.5-12.5U/L
adult female, mid-cycle peak 4.7-21.5 IU/L adult female, luteal 1.7-7.7 IU/L
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Test Reference Range
Routine Turnaround (Please bleep 1417 for non-routine request) Specimen Tube adult female, post-menopausal 25.8-134.8 IU/L
adult male (< 60y) 1.5-12.4 IU/L
Free Thyroxine (FT4) 10-22 pmol/L 24 Hours
Yellow top
Free Triiodothyronine (FT3) 3.1-6.8 pmol/L 24 Hours
Growth Hormone (GH): GH secretion is pulsatile and random samples are of
little diagnostic value 24 Hours
Human chorionic gonadotrophin (hCG)[fertility]
24 Hours Red top as a separate additional tube
female, menopausal <7 IU/L female, non-pregnant <2 IU/L male <2 IU/L 17 hydroxyprogesterone (OHP)
72 Hours Yellow top Full-term newborn (>48 hours old) <8.0
In premature, sick or stressed neonates 17-OHP may be inappropriately elevated
Adult males 1.2 – 5.0 Adult females (follicular) 0.6 – 4.0
Adult females (luteal) Tanner stage 1 males Tanner stage 1 females
1.0 – 6.0 <5.0 <5.0 Insulin*
Special collection conditions, please contact the laboratory.
Proinsulin*
Special collection conditions, please contact the laboratory. Referred test
Insulin - like Growth Factor 1 (IGF 1)
Weekly Red top <2y 2.6-17 nmol/L 2 - 3y 4.1-26 nmol/L 4 - 6y 5.0-30 nmol/L male 8.2-30 nmol/L female 7 - 9y 6.2-38 nmol/L male 13-38 nmol/L female 10 - 12y 7.8-74 nmol/L male
15-74 nmol/L female 13 -15y 19-89 nmol/L male
29-89 nmol/L female 16 - 20y 25-64 nmol/L
